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Proposed Rule

Medicare Program; CY 2020 Revisions to Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment Policies; Medicare Shared Savings Program Requirements; Medicaid Promoting Interoperability Program Requirements for Eligible Professionals; Establishment of an Ambulance Data Collection System; Updates to the Quality Payment Program; Medicare Enrollment of Opioid Treatment Programs and Enhancements to Provider Enrollment Regulations Concerning Improper Prescribing and Patient Harm; and Amendments to Physician Self-Referral Law Advisory Opinion Regulations

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Start Preamble Start Printed Page 40482

AGENCY:

Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION:

Proposed rule.

SUMMARY:

This major proposed rule addresses: Changes to the physician fee schedule (PFS); other changes to Medicare Part B payment policies to ensure that payment systems are updated to reflect changes in medical practice, relative value of services, and changes in the statute; Medicare Shared Savings Program quality reporting requirements; Medicaid Promoting Interoperability Program requirements for eligible professionals; the establishment of an ambulance data collection system; updates to the Quality Payment Program; Medicare enrollment of Opioid Treatment Programs and enhancements to provider enrollment regulations concerning improper prescribing and patient harm; and amendments to Physician Self-Referral Law advisory opinion regulations.

DATES:

Comment date: To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on September 27, 2019.

ADDRESSES:

In commenting, please refer to file code CMS-1715-P. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission.

Comments, including mass comment submissions, must be submitted in one of the following three ways (please choose only one of the ways listed):

1. Electronically. You may submit electronic comments on this regulation to http://www.regulations.gov. Follow the “Submit a comment” instructions.

2. By regular mail. You may mail written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-1715-P, P.O. Box 8016, Baltimore, MD 21244-8016.

Please allow sufficient time for mailed comments to be received before the close of the comment period.

3. By express or overnight mail. You may send written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-1715-P, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.

Start Further Info

FURTHER INFORMATION CONTACT:

Jamie Hermansen, (410) 786-2064, for any issues not identified below.

Michael Soracoe, (410) 786-6312, for issues related to practice expense, work RVUs, conversion factor, and impacts.

Geri Mondowney, (410) 786-1172, or Tourette Jackson, (410) 786-4735, for issues related to malpractice RVUs and geographic practice cost indicies (GPCIs).

Larry Chan, (410) 786-6864, for issues related to potentially misvalued services under the PFS.

Lindsey Baldwin, (410) 786-1694, or Emily Yoder, (410) 786-1804, for issues related to telehealth services.

Pierre Yong, (410) 786-8896, or Lindsey Baldwin, (410) 786-1694, for issues related to Medicare coverage of opioid use disorder treatment services furnished by opioid treatment programs (OTPs).

Lindsey Baldwin, (410) 786-1694, for issues related to bundled payments under the PFS for substance use disorders.

Emily Yoder, (410) 786-1804, or Christiane LaBonte, (410) 786-7237, for issues related to the comment solicitation on opportunities for bundled payments under the PFS.

Regina Walker-Wren, (410) 786-9160, for issues related to physician supervision for physician assistant (PA) services and review and verification of medical record documentation.

Ann Marshall, (410) 786-3059, Emily Yoder, (410) 786-1804, Liane Grayson, (410) 786-6583, or Christiane LaBonte, (410) 786-7237, for issues related to care management services.

Kathy Bryant, (410) 786-3448, for issues related to coinsurance for colorectal cancer screening tests.

Pamela West, (410) 786-2302, for issues related to therapy services.

Ann Marshall, (410) 786-3059, Emily Yoder, (410) 786-1804, or Christiane LaBonte, (410) 786-7237, for issues related to payment for evaluation and management services.

Kathy Bryant, (410) 786-3448, for issues related to global surgery data collection.

Thomas Kessler, (410) 786-1991, for issues related to ambulance physician certification statement.

Felicia Eggleston, (410) 786-9287, or Amy Gruber, (410) 786-1542, for issues related to the ambulance fee schedule-BBA of 2018 requirements for Medicare ground ambulance services data collection system.

Linda Gousis, (410) 786-8616, for issues related to intensive cardiac rehabilitation.

David Koppel, (303) 844-2883, or Elizabeth LeBreton, (202) 615-3816, for issues related to the Medicaid Promoting Interoperability Program.

Fiona Larbi, (410) 786-7224, for issues related to the Medicare Shared Savings Program (Shared Savings Program) Quality Measures.

Katie Mucklow, (410) 786-0537, or Diana Behrendt, (410) 786-6192, for issues related to open payments.

Cheryl Gilbreath, (410) 786-5919, for issues related to home infusion therapy benefit.

Joseph Schultz, (410) 786-2656, for issues related to Medicare enrollment of opioid treatment programs, and enhancements to provider enrollment regulations concerning improper prescribing and patient harm.

Jacqueline Leach, (410) 786-4282, for issues related to Deferring to State Scope of Practice Requirements: Ambulatory Surgical Centers (ASC).

Mary Rossi-Coajou, (410) 786-6051, for issues related to Deferring to State Scope of Practice Requirements: Hospice.

1877AdvisoryOpinion@cms.hhs.gov, for issues related to Advisory Opinions on Application of the Physician Self-referral law.

Molly MacHarris, (410) 786-4461, for inquiries related to Merit-based Incentive Payment System (MIPS).

Megan Hyde, (410) 786-3247, for inquiries related to Alternative Payment Models (APMs).

End Further Info End Preamble Start Supplemental Information

SUPPLEMENTARY INFORMATION:

Addenda Available Only Through the Internet on the CMS Website

The PFS Addenda along with other supporting documents and tables referenced in this proposed rule are available on the CMS website at http://www.cms.gov/​Medicare/​Medicare-Fee-Start Printed Page 40483for-Service-Payment/​PhysicianFeeSched/​PFS-Federal-Regulation-Notices.html. Click on the link on the left side of the screen titled, “PFS Federal Regulations Notices” for a chronological list of PFS Federal Register and other related documents. For the CY 2020 PFS proposed rule, refer to item CMS-1715-P. Readers with questions related to accessing any of the Addenda or other supporting documents referenced in this proposed rule and posted on the CMS website identified above should contact Jamie Hermansen at (410) 786-2064.

CPT (Current Procedural Terminology) Copyright Notice

Throughout this proposed rule, we use CPT codes and descriptions to refer to a variety of services. We note that CPT codes and descriptions are copyright 2019 American Medical Association. All Rights Reserved. CPT is a registered trademark of the American Medical Association (AMA). Applicable Federal Acquisition Regulations (FAR) and Defense Federal Acquisition Regulations (DFAR) apply.

I. Executive Summary

A. Purpose

This major proposed rule proposes to revise payment polices under the Medicare PFS and make other policy changes, including proposals to implement certain provisions of the Bipartisan Budget Act of 2018 (BBA of 2018) (Pub. L. 115-123, February 9, 2018) and the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act (the SUPPORT Act) (Pub. L. 115-271, October 24, 2018), related to Medicare Part B payment, applicable to services furnished in CY 2020 and thereafter. In addition, this proposed rule includes proposals related to payment policy changes that are addressed in section III. of this proposed rule. We are requesting public comments on all of the proposals being made in this proposed rule.

1. Summary of the Major Provisions

The statute requires us to establish payments under the PFS based on national uniform relative value units (RVUs) that account for the relative resources used in furnishing a service. The statute requires that RVUs be established for three categories of resources: Work; practice expense (PE); and malpractice (MP) expense. In addition, the statute requires that we establish by regulation each year's payment amounts for all physicians' services paid under the PFS, incorporating geographic adjustments to reflect the variations in the costs of furnishing services in different geographic areas.

In this major proposed rule, we are proposing to establish RVUs for CY 2020 for the PFS to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services, as well as changes in the statute. This proposed rule also includes discussions and proposals regarding several other Medicare Part B payment policies, Medicare Shared Savings Program quality reporting requirements, Medicaid Promoting Interoperability Program requirements for eligible professionals, the establishment of an ambulance data collection system, updates to the Quality Payment Program, Medicare enrollment of Opioid Treatment Programs and enhancements to provider enrollment regulations concerning improper prescribing and patient harm; and amendments to Physician Self-Referral Law advisory opinion regulations. This proposed rule addresses:

  • Practice Expense RVUs (section II.B.)
  • Malpractice RVUs (section II.C.)
  • Geographic Practice Cost Indices (GPCIs) (section II.D.)
  • Potentially Misvalued Services Under the PFS (section II.E.)
  • Telehealth Services (section II.F.)
  • Medicare Coverage for Opioid Use Disorder Treatment Services Furnished by Opioid Treatment Programs (section II.G.)
  • Bundled Payments Under the PFS for Substance Use Disorders (section II.H.)
  • Physician Supervision for Physician Assistant (PA) Services (section II.I.)
  • Review and Verification of Medical Record Documentation (section II.J.)
  • Care Management Services (section II.K.)
  • Coinsurance for Colorectal Cancer Screening Tests (section II.L.)
  • Therapy Services (section II.M.)
  • Valuation of Specific Codes (section II.N.)
  • Comment Solicitation on Opportunities for Bundled Payments Under the PFS (section II.O.)
  • Payment for Evaluation and Management (E/M) Services (section II.P.)
  • Ambulance Coverage Services—Physician Certification Statement (section III.A.)
  • Ambulance Fee Schedule—Medicare Ground Ambulance Services Data Collection System (section III.B.)
  • Intensive Cardiac Rehabilitation (section III.C.)
  • Medicaid Promoting Interoperability Program Requirements for Eligible Professionals (EPs) (section III.D.)
  • Medicare Shared Savings Program Quality Measures (section III.E.)
  • Open Payments (section III.F.)
  • Home Infusion Therapy Benefit (section III.G.)
  • Medicare Enrollment of Opioid Treatment Programs and Enhancements to Existing General Enrollment Policies Related to Improper Prescribing and Patient Harm (section III.H.)
  • Deferring to State Scope of Practice Requirements (section III.I.)
  • Advisory Opinions on the Application of the Physician Self-Referral Law (section III.J.)
  • Updates to the Quality Payment Program (section III.K.)

2. Summary of Costs and Benefits

We have determined that this major proposed rule is economically significant. For a detailed discussion of the economic impacts, see section VI. of this proposed rule.

II. Provisions of the Proposed Rule for the PFS

A. Background

Since January 1, 1992, Medicare has paid for physicians' services under section 1848 of the Act, “Payment for Physicians' Services.” The PFS relies on national relative values that are established for work, practice expense (PE), and malpractice (MP), which are adjusted for geographic cost variations. These values are multiplied by a conversion factor (CF) to convert the relative value units (RVUs) into payment rates. The concepts and methodology underlying the PFS were enacted as part of the Omnibus Budget Reconciliation Act of 1989 (Pub. L. 101-239, enacted on December 19, 1989) (OBRA '89), and the Omnibus Budget Reconciliation Act of 1990 (Pub. L. 101-508, enacted on November 5, 1990) (OBRA '90). The final rule published in the November 25, 1991 Federal Register (56 FR 59502) set forth the first fee schedule used for payment for physicians' services.

We note that throughout this major proposed rule, unless otherwise noted, the term “practitioner” is used to describe both physicians and nonphysician practitioners (NPPs) who are permitted to bill Medicare under the PFS for the services they furnish to Medicare beneficiaries.

1. Development of the RVUs

a. Work RVUs

The work RVUs established for the initial fee schedule, which was Start Printed Page 40484implemented on January 1, 1992, were developed with extensive input from the physician community. A research team at the Harvard School of Public Health developed the original work RVUs for most codes under a cooperative agreement with the Department of Health and Human Services (HHS). In constructing the code-specific vignettes used in determining the original physician work RVUs, Harvard worked with panels of experts, both inside and outside the federal government, and obtained input from numerous physician specialty groups.

As specified in section 1848(c)(1)(A) of the Act, the work component of physicians' services means the portion of the resources used in furnishing the service that reflects physician time and intensity. We establish work RVUs for new, revised and potentially misvalued codes based on our review of information that generally includes, but is not limited to, recommendations received from the American Medical Association/Specialty Society Relative Value Scale Update Committee (RUC), the Health Care Professionals Advisory Committee (HCPAC), the Medicare Payment Advisory Commission (MedPAC), and other public commenters; medical literature and comparative databases; as well as a comparison of the work for other codes within the Medicare PFS, and consultation with other physicians and health care professionals within CMS and the federal government. We also assess the methodology and data used to develop the recommendations submitted to us by the RUC and other public commenters, and the rationale for their recommendations. In the CY 2011 PFS final rule with comment period (75 FR 73328 through 73329), we discussed a variety of methodologies and approaches used to develop work RVUs, including survey data, building blocks, crosswalk to key reference or similar codes, and magnitude estimation. More information on these issues is available in that rule.

b. Practice Expense RVUs

Initially, only the work RVUs were resource-based, and the PE and MP RVUs were based on average allowable charges. Section 121 of the Social Security Act Amendments of 1994 (Pub. L. 103-432, enacted on October 31, 1994), amended section 1848(c)(2)(C)(ii) of the Act and required us to develop resource-based PE RVUs for each physicians' service beginning in 1998. We were required to consider general categories of expenses (such as office rent and wages of personnel, but excluding MP expenses) comprising PEs. The PE RVUs continue to represent the portion of these resources involved in furnishing PFS services.

Originally, the resource-based method was to be used beginning in 1998, but section 4505(a) of the Balanced Budget Act of 1997 (Pub. L. 105-33, enacted on August 5, 1997) (BBA of 1997) delayed implementation of the resource-based PE RVU system until January 1, 1999. In addition, section 4505(b) of the BBA of 1997 provided for a 4-year transition period from the charge-based PE RVUs to the resource-based PE RVUs.

We established the resource-based PE RVUs for each physicians' service in the November 2, 1998 final rule (63 FR 58814), effective for services furnished in CY 1999. Based on the requirement to transition to a resource-based system for PE over a 4-year period, payment rates were not fully based upon resource-based PE RVUs until CY 2002. This resource-based system was based on two significant sources of actual PE data: The Clinical Practice Expert Panel (CPEP) data; and the AMA's Socioeconomic Monitoring System (SMS) data. These data sources are described in greater detail in the CY 2012 PFS final rule with comment period (76 FR 73033).

Separate PE RVUs are established for services furnished in facility settings, such as a hospital outpatient department (HOPD) or an ambulatory surgical center (ASC), and in nonfacility settings, such as a physician's office. The nonfacility RVUs reflect all of the direct and indirect PEs involved in furnishing a service described by a particular HCPCS code. The difference, if any, in these PE RVUs generally results in a higher payment in the nonfacility setting because in the facility settings some resource costs are borne by the facility. Medicare's payment to the facility (such as the outpatient prospective payment system (OPPS) payment to the HOPD) would reflect costs typically incurred by the facility. Thus, payment associated with those specific facility resource costs is not made under the PFS.

Section 212 of the Balanced Budget Refinement Act of 1999 (Pub. L. 106-113, enacted on November 29, 1999) (BBRA) directed the Secretary of Health and Human Services (the Secretary) to establish a process under which we accept and use, to the maximum extent practicable and consistent with sound data practices, data collected or developed by entities and organizations to supplement the data we normally collect in determining the PE component. On May 3, 2000, we published the interim final rule (65 FR 25664) that set forth the criteria for the submission of these supplemental PE survey data. The criteria were modified in response to comments received, and published in the Federal Register (65 FR 65376) as part of a November 1, 2000 final rule. The PFS final rules published in 2001 and 2003, respectively, (66 FR 55246 and 68 FR 63196) extended the period during which we would accept these supplemental data through March 1, 2005.

In the CY 2007 PFS final rule with comment period (71 FR 69624), we revised the methodology for calculating direct PE RVUs from the top-down to the bottom-up methodology beginning in CY 2007. We adopted a 4-year transition to the new PE RVUs. This transition was completed for CY 2010. In the CY 2010 PFS final rule with comment period, we updated the practice expense per hour (PE/HR) data that are used in the calculation of PE RVUs for most specialties (74 FR 61749). In CY 2010, we began a 4-year transition to the new PE RVUs using the updated PE/HR data, which was completed for CY 2013.

c. Malpractice RVUs

Section 4505(f) of the BBA of 1997 amended section 1848(c) of the Act to require that we implement resource-based MP RVUs for services furnished on or after CY 2000. The resource-based MP RVUs were implemented in the PFS final rule with comment period published November 2, 1999 (64 FR 59380). The MP RVUs are based on commercial and physician-owned insurers' MP insurance premium data from all the states, the District of Columbia, and Puerto Rico. For more information on MP RVUs, see section II.C. of this proposed rule, Determination of Malpractice Relative Value Units.

d. Refinements to the RVUs

Section 1848(c)(2)(B)(i) of the Act requires that we review RVUs no less often than every 5 years. Prior to CY 2013, we conducted periodic reviews of work RVUs and PE RVUs independently. We completed 5-year reviews of work RVUs that were effective for calendar years 1997, 2002, 2007, and 2012.

Although refinements to the direct PE inputs initially relied heavily on input from the RUC Practice Expense Advisory Committee (PEAC), the shifts to the bottom-up PE methodology in CY 2007 and to the use of the updated PE/HR data in CY 2010 have resulted in significant refinements to the PE RVUs in recent years.Start Printed Page 40485

In the CY 2012 PFS final rule with comment period (76 FR 73057), we finalized a proposal to consolidate reviews of work and PE RVUs under section 1848(c)(2)(B) of the Act and reviews of potentially misvalued codes under section 1848(c)(2)(K) of the Act into one annual process.

In addition to the 5-year reviews, beginning for CY 2009, CMS and the RUC identified and reviewed a number of potentially misvalued codes on an annual basis based on various identification screens. This annual review of work and PE RVUs for potentially misvalued codes was supplemented by the amendments to section 1848 of the Act, as enacted by section 3134 of the Affordable Care Act, that require the agency to periodically identify, review and adjust values for potentially misvalued codes.

e. Application of Budget Neutrality to Adjustments of RVUs

As described in section VI. of this proposed rule, the Regulatory Impact Analysis, in accordance with section 1848(c)(2)(B)(ii)(II) of the Act, if revisions to the RVUs cause expenditures for the year to change by more than $20 million, we make adjustments to ensure that expenditures do not increase or decrease by more than $20 million.

2. Calculation of Payments Based on RVUs

To calculate the payment for each service, the components of the fee schedule (work, PE, and MP RVUs) are adjusted by geographic practice cost indices (GPCIs) to reflect the variations in the costs of furnishing the services. The GPCIs reflect the relative costs of work, PE, and MP in an area compared to the national average costs for each component. Please refer to the CY 2017 PFS final rule with comment period for a discussion of the last GPCI update (81 FR 80261 through 80270).

RVUs are converted to dollar amounts through the application of a CF, which is calculated based on a statutory formula by CMS's Office of the Actuary (OACT). The formula for calculating the Medicare PFS payment amount for a given service and fee schedule area can be expressed as:

Payment = [(RVU work × GPCI work) + (RVU PE × GPCI PE) + (RVU MP × GPCI MP)] × CF

3. Separate Fee Schedule Methodology for Anesthesia Services

Section 1848(b)(2)(B) of the Act specifies that the fee schedule amounts for anesthesia services are to be based on a uniform relative value guide, with appropriate adjustment of an anesthesia CF, in a manner to ensure that fee schedule amounts for anesthesia services are consistent with those for other services of comparable value. Therefore, there is a separate fee schedule methodology for anesthesia services. Specifically, we establish a separate CF for anesthesia services and we utilize the uniform relative value guide, or base units, as well as time units, to calculate the fee schedule amounts for anesthesia services. Since anesthesia services are not valued using RVUs, a separate methodology for locality adjustments is also necessary. This involves an adjustment to the national anesthesia CF for each payment locality.

B. Determination of PE RVUs

1. Overview

Practice expense (PE) is the portion of the resources used in furnishing a service that reflects the general categories of physician and practitioner expenses, such as office rent and personnel wages, but excluding MP expenses, as specified in section 1848(c)(1)(B) of the Act. As required by section 1848(c)(2)(C)(ii) of the Act, we use a resource-based system for determining PE RVUs for each physicians' service. We develop PE RVUs by considering the direct and indirect practice resources involved in furnishing each service. Direct expense categories include clinical labor, medical supplies, and medical equipment. Indirect expenses include administrative labor, office expense, and all other expenses. The sections that follow provide more detailed information about the methodology for translating the resources involved in furnishing each service into service-specific PE RVUs. We refer readers to the CY 2010 PFS final rule with comment period (74 FR 61743 through 61748) for a more detailed explanation of the PE methodology.

2. Practice Expense Methodology

a. Direct Practice Expense

We determine the direct PE for a specific service by adding the costs of the direct resources (that is, the clinical staff, medical supplies, and medical equipment) typically involved with furnishing that service. The costs of the resources are calculated using the refined direct PE inputs assigned to each CPT code in our PE database, which are generally based on our review of recommendations received from the RUC and those provided in response to public comment periods. For a detailed explanation of the direct PE methodology, including examples, we refer readers to the 5-year review of work relative value units under the PFS and proposed changes to the practice expense methodology CY 2007 PFS proposed notice (71 FR 37242) and the CY 2007 PFS final rule with comment period (71 FR 69629).

b. Indirect Practice Expense per Hour Data

We use survey data on indirect PEs incurred per hour worked, in developing the indirect portion of the PE RVUs. Prior to CY 2010, we primarily used the PE/HR by specialty that was obtained from the AMA's SMS. The AMA administered a new survey in CY 2007 and CY 2008, the Physician Practice Expense Information Survey (PPIS). The PPIS is a multispecialty, nationally representative, PE survey of both physicians and NPPs paid under the PFS using a survey instrument and methods highly consistent with those used for the SMS and the supplemental surveys. The PPIS gathered information from 3,656 respondents across 51 physician specialty and health care professional groups. We believe the PPIS is the most comprehensive source of PE survey information available. We used the PPIS data to update the PE/HR data for the CY 2010 PFS for almost all of the Medicare-recognized specialties that participated in the survey.

When we began using the PPIS data in CY 2010, we did not change the PE RVU methodology itself or the manner in which the PE/HR data are used in that methodology. We only updated the PE/HR data based on the new survey. Furthermore, as we explained in the CY 2010 PFS final rule with comment period (74 FR 61751), because of the magnitude of payment reductions for some specialties resulting from the use of the PPIS data, we transitioned its use over a 4-year period from the previous PE RVUs to the PE RVUs developed using the new PPIS data. As provided in the CY 2010 PFS final rule with comment period (74 FR 61751), the transition to the PPIS data was complete for CY 2013. Therefore, PE RVUs from CY 2013 forward are developed based entirely on the PPIS data, except as noted in this section.

Section 1848(c)(2)(H)(i) of the Act requires us to use the medical oncology supplemental survey data submitted in 2003 for oncology drug administration services. Therefore, the PE/HR for medical oncology, hematology, and hematology/oncology reflects the continued use of these supplemental survey data.

Supplemental survey data on independent labs from the College of Start Printed Page 40486American Pathologists were implemented for payments beginning in CY 2005. Supplemental survey data from the National Coalition of Quality Diagnostic Imaging Services (NCQDIS), representing independent diagnostic testing facilities (IDTFs), were blended with supplementary survey data from the American College of Radiology (ACR) and implemented for payments beginning in CY 2007. Neither IDTFs, nor independent labs, participated in the PPIS. Therefore, we continue to use the PE/HR that was developed from their supplemental survey data.

Consistent with our past practice, the previous indirect PE/HR values from the supplemental surveys for these specialties were updated to CY 2006 using the Medicare Economic Index (MEI) to put them on a comparable basis with the PPIS data.

We also do not use the PPIS data for reproductive endocrinology and spine surgery since these specialties currently are not separately recognized by Medicare, nor do we have a method to blend the PPIS data with Medicare-recognized specialty data.

Previously, we established PE/HR values for various specialties without SMS or supplemental survey data by crosswalking them to other similar specialties to estimate a proxy PE/HR. For specialties that were part of the PPIS for which we previously used a crosswalked PE/HR, we instead used the PPIS-based PE/HR. We use crosswalks for specialties that did not participate in the PPIS. These crosswalks have been generally established through notice and comment rulemaking and are available in the file called “CY 2020 PFS Proposed Rule PE/HR” on the CMS website under downloads for the CY 2020 PFS proposed rule at http://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​PhysicianFeeSched/​PFS-Federal-Regulation-Notices.html.

For CY 2020, we have incorporated the available utilization data for two new specialties, each of which became a recognized Medicare specialty during 2018. These specialties are Medical Toxicology and Hematopoietic Cell Transplantation and Cellular Therapy. We are proposing to use proxy PE/HR values for these new specialties, as there are no PPIS data for these specialties, by crosswalking the PE/HR as follows from specialties that furnish similar services in the Medicare claims data:

  • Medical Toxicology from Emergency Medicine; and
  • Hematopoietic Cell Transplantation and Cellular Therapy from Hematology/Oncology.

These updates are reflected in the “CY 2020 PFS Proposed Rule PE/HR” file available on the CMS website under the supporting data files for the CY 2020 PFS proposed rule at http://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​PhysicianFeeSched/​PFS-Federal-Regulation-Notices.html.

c. Allocation of PE to Services

To establish PE RVUs for specific services, it is necessary to establish the direct and indirect PE associated with each service.

(1) Direct Costs

The relative relationship between the direct cost portions of the PE RVUs for any two services is determined by the relative relationship between the sum of the direct cost resources (that is, the clinical staff, medical supplies, and medical equipment) typically involved with furnishing each of the services. The costs of these resources are calculated from the refined direct PE inputs in our PE database. For example, if one service has a direct cost sum of $400 from our PE database and another service has a direct cost sum of $200, the direct portion of the PE RVUs of the first service would be twice as much as the direct portion of the PE RVUs for the second service.

(2) Indirect Costs

We allocate the indirect costs at the code level on the basis of the direct costs specifically associated with a code and the greater of either the clinical labor costs or the work RVUs. We also incorporate the survey data described earlier in the PE/HR discussion. The general approach to developing the indirect portion of the PE RVUs is as follows:

  • For a given service, we use the direct portion of the PE RVUs calculated as previously described and the average percentage that direct costs represent of total costs (based on survey data) across the specialties that furnish the service to determine an initial indirect allocator. That is, the initial indirect allocator is calculated so that the direct costs equal the average percentage of direct costs of those specialties furnishing the service. For example, if the direct portion of the PE RVUs for a given service is 2.00 and direct costs, on average, represent 25 percent of total costs for the specialties that furnish the service, the initial indirect allocator would be calculated so that it equals 75 percent of the total PE RVUs. Thus, in this example, the initial indirect allocator would equal 6.00, resulting in a total PE RVU of 8.00 (2.00 is 25 percent of 8.00 and 6.00 is 75 percent of 8.00).
  • Next, we add the greater of the work RVUs or clinical labor portion of the direct portion of the PE RVUs to this initial indirect allocator. In our example, if this service had a work RVU of 4.00 and the clinical labor portion of the direct PE RVU was 1.50, we would add 4.00 (since the 4.00 work RVUs are greater than the 1.50 clinical labor portion) to the initial indirect allocator of 6.00 to get an indirect allocator of 10.00. In the absence of any further use of the survey data, the relative relationship between the indirect cost portions of the PE RVUs for any two services would be determined by the relative relationship between these indirect cost allocators. For example, if one service had an indirect cost allocator of 10.00 and another service had an indirect cost allocator of 5.00, the indirect portion of the PE RVUs of the first service would be twice as great as the indirect portion of the PE RVUs for the second service.
  • Next, we incorporate the specialty-specific indirect PE/HR data into the calculation. In our example, if, based on the survey data, the average indirect cost of the specialties furnishing the first service with an allocator of 10.00 was half of the average indirect cost of the specialties furnishing the second service with an indirect allocator of 5.00, the indirect portion of the PE RVUs of the first service would be equal to that of the second service.

(3) Facility and Nonfacility Costs

For procedures that can be furnished in a physician's office, as well as in a facility setting, where Medicare makes a separate payment to the facility for its costs in furnishing a service, we establish two PE RVUs: Facility and nonfacility. The methodology for calculating PE RVUs is the same for both the facility and nonfacility RVUs, but is applied independently to yield two separate PE RVUs. In calculating the PE RVUs for services furnished in a facility, we do not include resources that would generally not be provided by physicians when furnishing the service. For this reason, the facility PE RVUs are generally lower than the nonfacility PE RVUs.

(4) Services With Technical Components and Professional Components

Diagnostic services are generally comprised of two components: A professional component (PC); and a technical component (TC). The PC and TC may be furnished independently or by different providers, or they may be Start Printed Page 40487furnished together as a global service. When services have separately billable PC and TC components, the payment for the global service equals the sum of the payment for the TC and PC. To achieve this, we use a weighted average of the ratio of indirect to direct costs across all the specialties that furnish the global service, TCs, and PCs; that is, we apply the same weighted average indirect percentage factor to allocate indirect expenses to the global service, PCs, and TCs for a service. (The direct PE RVUs for the TC and PC sum to the global.)

(5) PE RVU Methodology

For a more detailed description of the PE RVU methodology, we refer readers to the CY 2010 PFS final rule with comment period (74 FR 61745 through 61746). We also direct readers to the file called “Calculation of PE RVUs under Methodology for Selected Codes” which is available on our website under downloads for the CY 2020 PFS proposed rule at http://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​PhysicianFeeSched/​PFS-Federal-Regulation-Notices.html. This file contains a table that illustrates the calculation of PE RVUs as described in this proposed rule for individual codes.

(a) Setup File

First, we create a setup file for the PE methodology. The setup file contains the direct cost inputs, the utilization for each procedure code at the specialty and facility/nonfacility place of service level, and the specialty-specific PE/HR data calculated from the surveys.

(b) Calculate the Direct Cost PE RVUs

Sum the costs of each direct input.

Step 1: Sum the direct costs of the inputs for each service.

Step 2: Calculate the aggregate pool of direct PE costs for the current year. We set the aggregate pool of PE costs equal to the product of the ratio of the current aggregate PE RVUs to current aggregate work RVUs and the projected aggregate work RVUs.

Step 3: Calculate the aggregate pool of direct PE costs for use in ratesetting. This is the product of the aggregate direct costs for all services from Step 1 and the utilization data for that service.

Step 4: Using the results of Step 2 and Step 3, use the CF to calculate a direct PE scaling adjustment to ensure that the aggregate pool of direct PE costs calculated in Step 3 does not vary from the aggregate pool of direct PE costs for the current year. Apply the scaling adjustment to the direct costs for each service (as calculated in Step 1).

Step 5: Convert the results of Step 4 to a RVU scale for each service. To do this, divide the results of Step 4 by the CF. Note that the actual value of the CF used in this calculation does not influence the final direct cost PE RVUs as long as the same CF is used in Step 4 and Step 5. Different CFs would result in different direct PE scaling adjustments, but this has no effect on the final direct cost PE RVUs since changes in the CFs and changes in the associated direct scaling adjustments offset one another.

(c) Create the Indirect Cost PE RVUs

Create indirect allocators.

Step 6: Based on the survey data, calculate direct and indirect PE percentages for each physician specialty.

Step 7: Calculate direct and indirect PE percentages at the service level by taking a weighted average of the results of Step 6 for the specialties that furnish the service. Note that for services with TCs and PCs, the direct and indirect percentages for a given service do not vary by the PC, TC, and global service.

We generally use an average of the 3 most recent years of available Medicare claims data to determine the specialty mix assigned to each code. Codes with low Medicare service volume require special attention since billing or enrollment irregularities for a given year can result in significant changes in specialty mix assignment. We finalized a policy in the CY 2018 PFS final rule (82 FR 52982 through 59283) to use the most recent year of claims data to determine which codes are low volume for the coming year (those that have fewer than 100 allowed services in the Medicare claims data). For codes that fall into this category, instead of assigning specialty mix based on the specialties of the practitioners reporting the services in the claims data, we instead use the expected specialty that we identify on a list developed based on medical review and input from expert stakeholders. We display this list of expected specialty assignments as part of the annual set of data files we make available as part of notice and comment rulemaking and consider recommendations from the RUC and other stakeholders on changes to this list on an annual basis. Services for which the specialty is automatically assigned based on previously finalized policies under our established methodology (for example, “always therapy” services) are unaffected by the list of expected specialty assignments. We also finalized in the CY 2018 PFS final rule (82 FR 52982 through 59283) a policy to apply these service-level overrides for both PE and MP, rather than one or the other category.

For CY 2020, we are proposing to clarify the expected specialty assignment for a series of cardiothoracic services. Prior to the creation of the expected specialty list for low volume services in CY 2018, we previously finalized through rulemaking a crosswalk to the thoracic surgery specialty for a series of cardiothoracic services that typically had fewer than 100 services reported each year (see, for example, the CY 2012 PFS final rule (76 FR 73188-73189)). However, we noted that for many of the affected codes, the expected specialty list for low volume services incorrectly listed a crosswalk to the cardiac surgery specialty instead of the thoracic surgery specialty. We are proposing to update the expected specialty list to accurately reflect the previously finalized crosswalk to thoracic surgery for these services. The affected codes are shown in Table 1.

Table 1—Proposed Updates to Expected Specialty

CPT codeCY 2019 expected specialtyUpdated CY 2020 expected specialty
33414Cardiac SurgeryThoracic Surgery.
33468Cardiac SurgeryThoracic Surgery.
33470Cardiac SurgeryThoracic Surgery.
33471Cardiac SurgeryThoracic Surgery.
33476Cardiac SurgeryThoracic Surgery.
33478Cardiac SurgeryThoracic Surgery.
33502Cardiac SurgeryThoracic Surgery.
33503Cardiac SurgeryThoracic Surgery.
33504Cardiac SurgeryThoracic Surgery.
33505Cardiac SurgeryThoracic Surgery.
33506Cardiac SurgeryThoracic Surgery.
33507Cardiac SurgeryThoracic Surgery.
33600Cardiac SurgeryThoracic Surgery.
33602Cardiac SurgeryThoracic Surgery.
33606Cardiac SurgeryThoracic Surgery.
33608Cardiac SurgeryThoracic Surgery.
33610Cardiac SurgeryThoracic Surgery.
33611Cardiac SurgeryThoracic Surgery.
33612Cardiac SurgeryThoracic Surgery.
33615Cardiac SurgeryThoracic Surgery.
33617Cardiac SurgeryThoracic Surgery.
33619Cardiac SurgeryThoracic Surgery.
33620Cardiac SurgeryThoracic Surgery.
33621Cardiac SurgeryThoracic Surgery.
33622Cardiac SurgeryThoracic Surgery.
33645Cardiac SurgeryThoracic Surgery.
33647Cardiac SurgeryThoracic Surgery.
33660Cardiac SurgeryThoracic Surgery.
33665Cardiac SurgeryThoracic Surgery.
33670Cardiac SurgeryThoracic Surgery.
33675Cardiac SurgeryThoracic Surgery.
33676Cardiac SurgeryThoracic Surgery.
33677Cardiac SurgeryThoracic Surgery.
33684Cardiac SurgeryThoracic Surgery.
33688Cardiac SurgeryThoracic Surgery.
33690Cardiac SurgeryThoracic Surgery.
33692Cardiac SurgeryThoracic Surgery.
33694Cardiac SurgeryThoracic Surgery.
33697Cardiac SurgeryThoracic Surgery.
33702Cardiac SurgeryThoracic Surgery.
33710Cardiac SurgeryThoracic Surgery.
33720Cardiac SurgeryThoracic Surgery.
33722Cardiac SurgeryThoracic Surgery.
33724Cardiac SurgeryThoracic Surgery.
33726Cardiac SurgeryThoracic Surgery.
33730Cardiac SurgeryThoracic Surgery.
33732Cardiac SurgeryThoracic Surgery.
33735Cardiac SurgeryThoracic Surgery.
33736Cardiac SurgeryThoracic Surgery.
Start Printed Page 40488
33737Cardiac SurgeryThoracic Surgery.
33750Cardiac SurgeryThoracic Surgery.
33755Cardiac SurgeryThoracic Surgery.
33762Cardiac SurgeryThoracic Surgery.
33764Cardiac SurgeryThoracic Surgery.
33766Cardiac SurgeryThoracic Surgery.
33767Cardiac SurgeryThoracic Surgery.
33768Cardiac SurgeryThoracic Surgery.
33770Cardiac SurgeryThoracic Surgery.
33771Cardiac SurgeryThoracic Surgery.
33774Cardiac SurgeryThoracic Surgery.
33775Cardiac SurgeryThoracic Surgery.
33776Cardiac SurgeryThoracic Surgery.
33777Cardiac SurgeryThoracic Surgery.
33778Cardiac SurgeryThoracic Surgery.
33779Cardiac SurgeryThoracic Surgery.
33780Cardiac SurgeryThoracic Surgery.
33781Cardiac SurgeryThoracic Surgery.
33782Cardiac SurgeryThoracic Surgery.
33783Cardiac SurgeryThoracic Surgery.
33786Cardiac SurgeryThoracic Surgery.
33788Cardiac SurgeryThoracic Surgery.
33800Cardiac SurgeryThoracic Surgery.
33802Cardiac SurgeryThoracic Surgery.
33803Cardiac SurgeryThoracic Surgery.
33813Cardiac SurgeryThoracic Surgery.
33814Cardiac SurgeryThoracic Surgery.
33820Cardiac SurgeryThoracic Surgery.
33822Cardiac SurgeryThoracic Surgery.
33824Cardiac SurgeryThoracic Surgery.
33840Cardiac SurgeryThoracic Surgery.
33845Cardiac SurgeryThoracic Surgery.
33851Cardiac SurgeryThoracic Surgery.
33852Cardiac SurgeryThoracic Surgery.
33853Cardiac SurgeryThoracic Surgery.
33917Cardiac SurgeryThoracic Surgery.
33920Cardiac SurgeryThoracic Surgery.
33922Cardiac SurgeryThoracic Surgery.
33924Cardiac SurgeryThoracic Surgery.
33925Cardiac SurgeryThoracic Surgery.
33926Cardiac SurgeryThoracic Surgery.
35182Cardiac SurgeryThoracic Surgery.

We note that the cardiac surgery and thoracic surgery specialties are similar to one another, sharing the same PE/HR data for PE valuation and nearly identical MP risk factors for MP valuation. As a result, we do not anticipate this proposal having a discernible effect on the valuation of the codes listed above. For additional discussion on this issue, we refer readers to section II.C of this proposed rule, Malpractice. The complete list of expected specialty assignments for individual low volume services, including the assignments for the codes identified in Table 1, is available on our website under downloads for the CY 2020 PFS proposed rule at http://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​PhysicianFeeSched/​PFS-Federal-Regulation-Notices.html.

Step 8: Calculate the service level allocators for the indirect PEs based on the percentages calculated in Step 7. The indirect PEs are allocated based on the three components: The direct PE RVUs; the clinical labor PE RVUs; and the work RVUs.

For most services the indirect allocator is: indirect PE percentage * (direct PE RVUs/direct percentage) + work RVUs.

There are two situations where this formula is modified:

  • If the service is a global service (that is, a service with global, professional, and technical components), then the indirect PE allocator is: indirect percentage (direct PE RVUs/direct percentage) + clinical labor PE RVUs + work RVUs.
  • If the clinical labor PE RVUs exceed the work RVUs (and the service is not a global service), then the indirect allocator is: indirect PE percentage (direct PE RVUs/direct percentage) + clinical labor PE RVUs.

(Note: For global services, the indirect PE allocator is based on both the work RVUs and the clinical labor PE RVUs. We do this to recognize that, for the PC service, indirect PEs would be allocated using the work RVUs, and for the TC service, indirect PEs would be allocated using the direct PE RVUs and the clinical labor PE RVUs. This also allows the global component RVUs to equal the sum of the PC and TC RVUs.)

For presentation purposes, in the examples in the download file called “Calculation of PE RVUs under Methodology for Selected Codes”, the formulas were divided into two parts for each service.

  • The first part does not vary by service and is the indirect percentage (direct PE RVUs/direct percentage).
  • The second part is either the work RVU, clinical labor PE RVU, or both depending on whether the service is a global service and whether the clinical PE RVUs exceed the work RVUs (as described earlier in this step).

Apply a scaling adjustment to the indirect allocators.

Step 9: Calculate the current aggregate pool of indirect PE RVUs by multiplying the result of step 8 by the average indirect PE percentage from the survey data.

Step 10: Calculate an aggregate pool of indirect PE RVUs for all PFS services by adding the product of the indirect PE allocators for a service from Step 8 and the utilization data for that service.

Step 11: Using the results of Step 9 and Step 10, calculate an indirect PE adjustment so that the aggregate indirect allocation does not exceed the available aggregate indirect PE RVUs and apply it to indirect allocators calculated in Step 8.

Calculate the indirect practice cost index.

Step 12: Using the results of Step 11, calculate aggregate pools of specialty-specific adjusted indirect PE allocators for all PFS services for a specialty by adding the product of the adjusted indirect PE allocator for each service and the utilization data for that service.

Step 13: Using the specialty-specific indirect PE/HR data, calculate specialty-specific aggregate pools of indirect PE for all PFS services for that specialty by adding the product of the indirect PE/HR for the specialty, the work time for the service, and the specialty's utilization for the service across all services furnished by the specialty.

Step 14: Using the results of Step 12 and Step 13, calculate the specialty-specific indirect PE scaling factors.

Step 15: Using the results of Step 14, calculate an indirect practice cost index at the specialty level by dividing each specialty-specific indirect scaling factor by the average indirect scaling factor for the entire PFS.

Step 16: Calculate the indirect practice cost index at the service level to ensure the capture of all indirect costs. Calculate a weighted average of the practice cost index values for the specialties that furnish the service. (Note: For services with TCs and PCs, we calculate the indirect practice cost index across the global service, PCs, and TCs. Under this method, the indirect practice cost index for a given service (for example, echocardiogram) does not vary by the PC, TC, and global service.)

Step 17: Apply the service level indirect practice cost index calculated in Step 16 to the service level adjusted indirect allocators calculated in Step 11 to get the indirect PE RVUs.

(d) Calculate the Final PE RVUs

Step 18: Add the direct PE RVUs from Step 5 to the indirect PE RVUs from Step 17 and apply the final PE budget neutrality (BN) adjustment. The final PE BN adjustment is calculated by comparing the sum of steps 5 and 17 to the proposed aggregate work RVUs scaled by the ratio of current aggregate PE and work RVUs. This adjustment ensures that all PE RVUs in the PFS account for the fact that certain specialties are excluded from the calculation of PE RVUs but included in maintaining overall PFS budget neutrality. (See “Specialties excluded from ratesetting calculation” later in this proposed rule.)

Step 19: Apply the phase-in of significant RVU reductions and its associated adjustment. Section 1848(c)(7) of the Act specifies that for services that are not new or revised codes, if the total RVUs for a service for a year would otherwise be decreased by an estimated 20 percent or more as compared to the total RVUs for the previous year, the applicable Start Printed Page 40489adjustments in work, PE, and MP RVUs shall be phased in over a 2-year period. In implementing the phase-in, we consider a 19 percent reduction as the maximum 1-year reduction for any service not described by a new or revised code. This approach limits the year one reduction for the service to the maximum allowed amount (that is, 19 percent), and then phases in the remainder of the reduction. To comply with section 1848(c)(7) of the Act, we adjust the PE RVUs to ensure that the total RVUs for all services that are not new or revised codes decrease by no more than 19 percent, and then apply a relativity adjustment to ensure that the total pool of aggregate PE RVUs remains relative to the pool of work and MP RVUs. For a more detailed description of the methodology for the phase-in of significant RVU changes, we refer readers to the CY 2016 PFS final rule with comment period (80 FR 70927 through 70931).

(e) Setup File Information

  • Specialties excluded from ratesetting calculation: For the purposes of calculating the PE and MP RVUs, we exclude certain specialties, such as certain NPPs paid at a percentage of the PFS and low-volume specialties, from the calculation. These specialties are included for the purposes of calculating the BN adjustment. They are displayed in Table 2.

Table 2—Specialties Excluded From Ratesetting Calculation

Specialty codeSpecialty description
49Ambulatory surgical center.
50Nurse practitioner.
51Medical supply company with certified orthotist.
52Medical supply company with certified prosthetist.
53Medical supply company with certified prosthetist-orthotist.
54Medical supply company not included in 51, 52, or 53.
55Individual certified orthotist.
56Individual certified prosthetist.
57Individual certified prosthetist-orthotist.
58Medical supply company with registered pharmacist.
59Ambulance service supplier, e.g., private ambulance companies, funeral homes, etc.
60Public health or welfare agencies.
61Voluntary health or charitable agencies.
73Mass immunization roster biller.
74Radiation therapy centers.
87All other suppliers (e.g., drug and department stores).
88Unknown supplier/provider specialty.
89Certified clinical nurse specialist.
96Optician.
97Physician assistant.
A0Hospital.
A1SNF.
A2Intermediate care nursing facility.
A3Nursing facility, other.
A4HHA.
A5Pharmacy.
A6Medical supply company with respiratory therapist.
A7Department store.
A8Grocery store.
B1Supplier of oxygen and/or oxygen related equipment (eff. 10/2/2007).
B2Pedorthic personnel.
B3Medical supply company with pedorthic personnel.
B4Rehabilitation Agency.
B5Ocularist.
C1Centralized Flu.
C2Indirect Payment Procedure.
C5Dentistry.
  • Crosswalk certain low volume physician specialties: Crosswalk the utilization of certain specialties with relatively low PFS utilization to the associated specialties.
  • Physical therapy utilization: Crosswalk the utilization associated with all physical therapy services to the specialty of physical therapy.
  • Identify professional and technical services not identified under the usual TC and 26 modifiers: Flag the services that are PC and TC services but do not use TC and 26 modifiers (for example, electrocardiograms). This flag associates the PC and TC with the associated global code for use in creating the indirect PE RVUs. For example, the professional service, CPT code 93010 (Electrocardiogram, routine ECG with at least 12 leads; interpretation and report only), is associated with the global service, CPT code 93000 (Electrocardiogram, routine ECG with at least 12 leads; with interpretation and report).
  • Start Printed Page 40490
  • Payment modifiers: Payment modifiers are accounted for in the creation of the file consistent with current payment policy as implemented in claims processing. For example, services billed with the assistant at surgery modifier are paid 16 percent of the PFS amount for that service; therefore, the utilization file is modified to only account for 16 percent of any service that contains the assistant at surgery modifier. Similarly, for those services to which volume adjustments are made to account for the payment modifiers, time adjustments are applied as well. For time adjustments to surgical services, the intraoperative portion in the work time file is used; where it is not present, the intraoperative percentage from the payment files used by contractors to process Medicare claims is used instead. Where neither is available, we use the payment adjustment ratio to adjust the time accordingly. Table 3 details the manner in which the modifiers are applied.

Table 3—Application of Payment Modifiers to Utilization Files

ModifierDescriptionVolume adjustmentTime adjustment
80,81,82Assistant at Surgery16%Intraoperative portion.
ASAssistant at Surgery—Physician Assistant14% (85% * 16%)Intraoperative portion.
50 or LT and RTBilateral Surgery150%150% of work time.
51Multiple Procedure50%Intraoperative portion.
52Reduced Services50%50%.
53Discontinued Procedure50%50%.
54Intraoperative Care onlyPreoperative + Intraoperative Percentages on the payment files used by Medicare contractors to process Medicare claimsPreoperative + Intraoperative portion.
55Postoperative Care onlyPostoperative Percentage on the payment files used by Medicare contractors to process Medicare claimsPostoperative portion.
62Co-surgeons62.5%50%.
66Team Surgeons33%33%.

We also make adjustments to volume and time that correspond to other payment rules, including special multiple procedure endoscopy rules and multiple procedure payment reductions (MPPRs). We note that section 1848(c)(2)(B)(v) of the Act exempts certain reduced payments for multiple imaging procedures and multiple therapy services from the BN calculation under section 1848(c)(2)(B)(ii)(II) of the Act. These MPPRs are not included in the development of the RVUs.

For anesthesia services, we do not apply adjustments to volume since we use the average allowed charge when simulating RVUs; therefore, the RVUs as calculated already reflect the payments as adjusted by modifiers, and no volume adjustments are necessary. However, a time adjustment of 33 percent is made only for medical direction of two to four cases since that is the only situation where a single practitioner is involved with multiple beneficiaries concurrently, so that counting each service without regard to the overlap with other services would overstate the amount of time spent by the practitioner furnishing these services.

  • Work RVUs: The setup file contains the work RVUs from this proposed rule.

(6) Equipment Cost per Minute

The equipment cost per minute is calculated as:

(1/(minutes per year * usage)) * price * ((interest rate/(1−(1/((1 + interest rate)−life of equipment)))) + maintenance)

Where:

minutes per year = maximum minutes per year if usage were continuous (that is, usage=1); generally 150,000 minutes.

usage = variable, see discussion below in this proposed rule.

price = price of the particular piece of equipment.

life of equipment = useful life of the particular piece of equipment.

maintenance = factor for maintenance; 0.05.

interest rate = variable, see discussion below in this proposed rule.

Usage: We currently use an equipment utilization rate assumption of 50 percent for most equipment, with the exception of expensive diagnostic imaging equipment, for which we use a 90 percent assumption as required by section 1848(b)(4)(C) of the Act.

Stakeholders have often suggested that particular equipment items are used less frequently than 50 percent of the time in the typical setting and that CMS should reduce the equipment utilization rate based on these recommendations. We appreciate and share stakeholders' interest in using the most accurate assumption regarding the equipment utilization rate for particular equipment items. However, we believe that absent robust, objective, auditable data regarding the use of particular items, the 50 percent assumption is the most appropriate within the relative value system. We welcome the submission of data that would support an alternative rate.

Start Printed Page 40491

Maintenance: This factor for maintenance was finalized in the CY 1998 PFS final rule with comment period (62 FR 33164). As we previously stated in the CY 2016 PFS final rule with comment period (80 FR 70897), we do not believe the annual maintenance factor for all equipment is precisely 5 percent, and we concur that the current rate likely understates the true cost of maintaining some equipment. We also believe it likely overstates the maintenance costs for other equipment. When we solicited comments regarding sources of data containing equipment maintenance rates, commenters were unable to identify an auditable, robust data source that could be used by CMS on a wide scale. We do not believe that voluntary submissions regarding the maintenance costs of individual equipment items would be an appropriate methodology for determining costs. As a result, in the absence of publicly available datasets regarding equipment maintenance costs or another systematic data collection methodology for determining a different maintenance factor, we do not believe that we have sufficient information at present to propose a variable maintenance factor for equipment cost per minute pricing. We continue to investigate potential avenues for determining equipment maintenance costs across a broad range of equipment items.

Interest Rate: In the CY 2013 PFS final rule with comment period (77 FR 68902), we updated the interest rates used in developing an equipment cost per minute calculation (see 77 FR 68902 for a thorough discussion of this issue). The interest rate was based on the Small Business Administration (SBA) maximum interest rates for different categories of loan size (equipment cost) and maturity (useful life). We are not proposing any changes to these interest rates for CY 2020. The Interest rates are listed in Table 4.

Table 4—SBA Maximum Interest Rates

PriceUseful life yearsInterest rate (%)
<$25K<77.50
$25K to $50K<76.50
>$50K<75.50
<$25K7+8.00
$25K to $50K7+7.00
>$50K7+6.00

3. Changes to Direct PE Inputs for Specific Services

This section focuses on specific PE inputs. The direct PE inputs are included in the CY 2020 direct PE input public use files, which are available on the CMS website under downloads for the CY 2020 PFS proposed rule at http://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​PhysicianFeeSched/​PFS-Federal-Regulation-Notices.html.

a. Standardization of Clinical Labor Tasks

As we noted in the CY 2015 PFS final rule with comment period (79 FR 67640-67641), we continue to make improvements to the direct PE input database to provide the number of clinical labor minutes assigned for each task for every code in the database instead of only including the number of clinical labor minutes for the preservice, service, and postservice periods for each code. In addition to increasing the transparency of the information used to set PE RVUs, this level of detail would allow us to compare clinical labor times for activities associated with services across the PFS, which we believe is important to maintaining the relativity of the direct PE inputs. This information would facilitate the identification of the usual numbers of minutes for clinical labor tasks and the identification of exceptions to the usual values. It would also allow for greater transparency and consistency in the assignment of equipment minutes based on clinical labor times. Finally, we believe that the detailed information can be useful in maintaining standard times for particular clinical labor tasks that can be applied consistently to many codes as they are valued over several years, similar in principle to the use of physician preservice time packages. We believe that setting and maintaining such standards would provide greater consistency among codes that share the same clinical labor tasks and could improve relativity of values among codes. For example, as medical practice and technologies change over time, changes in the standards could be updated simultaneously for all codes with the applicable clinical labor tasks, instead of waiting for individual codes to be reviewed.

In the CY 2016 PFS final rule with comment period (80 FR 70901), we solicited comments on the appropriate standard minutes for the clinical labor tasks associated with services that use digital technology. After consideration of comments received, we finalized standard times for clinical labor tasks associated with digital imaging at 2 minutes for “Availability of prior images confirmed”, 2 minutes for “Patient clinical information and questionnaire reviewed by technologist, order from physician confirmed and exam protocoled by radiologist”, 2 minutes for “Review examination with interpreting MD”, and 1 minute for “Exam documents scanned into PACS.” Exam completed in RIS system to generate billing process and to populate images into Radiologist work queue.” In the CY 2017 PFS final rule (81 FR 80184 through 80186), we finalized a policy to establish a range of appropriate standard minutes for the clinical labor activity, “Technologist QCs images in PACS, checking for all images, reformats, and dose page.” These standard minutes will be applied to new and revised codes that make use of this clinical labor activity when they are reviewed by us for valuation. We finalized a policy to establish 2 minutes as the standard for the simple case, 3 minutes as the standard for the intermediate case, 4 minutes as the standard for the complex case, and 5 minutes as the standard for the highly complex case. These values were based upon a review of the existing minutes assigned for this clinical labor activity; we determined that 2 minutes is the duration for most services and a small number of codes with more complex forms of digital imaging have higher values.Start Printed Page 40492

We also finalized standard times for clinical labor tasks associated with pathology services in the CY 2016 PFS final rule with comment period (80 FR 70902) at 4 minutes for “Accession specimen/prepare for examination”, 0.5 minutes for “Assemble and deliver slides with paperwork to pathologists”, 0.5 minutes for “Assemble other light microscopy slides, open nerve biopsy slides, and clinical history, and present to pathologist to prepare clinical pathologic interpretation”, 1 minute for “Clean room/equipment following procedure”, 1 minute for “Dispose of remaining specimens, spent chemicals/other consumables, and hazardous waste”, and 1 minute for “Prepare, pack and transport specimens and records for in-house storage and external storage (where applicable).” We do not believe these activities would be dependent on number of blocks or batch size, and we believe that these values accurately reflect the typical time it takes to perform these clinical labor tasks.

In reviewing the RUC-recommended direct PE inputs for CY 2019, we noticed that the 3 minutes of clinical labor time traditionally assigned to the “Prepare room, equipment and supplies” (CA013) clinical labor activity were split into 2 minutes for the “Prepare room, equipment and supplies” activity and 1 minute for the “Confirm order, protocol exam” (CA014) activity. We proposed to maintain the 3 minutes of clinical labor time for the “Prepare room, equipment and supplies” activity and remove the clinical labor time for the “Confirm order, protocol exam” activity wherever we observed this pattern in the RUC-recommended direct PE inputs. Commenters explained in response that when the new version of the PE worksheet introduced the activity codes for clinical labor, there was a need to translate old clinical labor tasks into the new activity codes, and that a prior clinical labor task was split into two of the new clinical labor activity codes: CA007 (“Review patient clinical extant information and questionnaire”) in the preservice period, and CA014 (“Confirm order, protocol exam”) in the service period. Commenters stated that the same clinical labor from the old PE worksheet was now divided into the CA007 and CA014 activity codes, with a standard of 1 minute for each activity. We agreed with commenters that we would finalize the RUC-recommended 2 minutes of clinical labor time for the CA007 activity code and 1 minute for the CA014 activity code in situations where this was the case. However, when reviewing the clinical labor for the reviewed codes affected by this issue, we found that several of the codes did not include this old clinical labor task, and we also noted that several of the reviewed codes that contained the CA014 clinical labor activity code did not contain any clinical labor for the CA007 activity. In these situations, we continue to believe that in these cases the 3 total minutes of clinical staff time would be more accurately described by the CA013 “Prepare room, equipment and supplies” activity code, and we finalized these clinical labor refinements. For additional details, we direct readers to the discussion in the CY 2019 PFS final rule (83 FR 59463-59464).

Historically, the RUC has submitted a “PE worksheet” that details the recommended direct PE inputs for our use in developing PE RVUs. The format of the PE worksheet has varied over time and among the medical specialties developing the recommendations. These variations have made it difficult for both the RUC's development and our review of code values for individual codes. Beginning with its recommendations for CY 2019, the RUC has mandated the use of a new PE worksheet for purposes of their recommendation development process that standardizes the clinical labor tasks and assigns them a clinical labor activity code. We believe the RUC's use of the new PE worksheet in developing and submitting recommendations will help us to simplify and standardize the hundreds of different clinical labor tasks currently listed in our direct PE database. As we did in previous calendar years, to facilitate rulemaking for CY 2020, we are continuing to display two versions of the Labor Task Detail public use file: One version with the old listing of clinical labor tasks, and one with the same tasks crosswalked to the new listing of clinical labor activity codes. These lists are available on the CMS website under downloads for the CY 2020 PFS proposed rule at http://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​PhysicianFeeSched/​PFS-Federal-Regulation-Notices.html.

b. Equipment Recommendations for Scope Systems

During our routine reviews of direct PE input recommendations, we have regularly found unexplained inconsistencies involving the use of scopes and the video systems associated with them. Some of the scopes include video systems bundled into the equipment item, some of them include scope accessories as part of their price, and some of them are standalone scopes with no other equipment included. It is not always clear which equipment items related to scopes fall into which of these categories. We have also frequently found anomalies in the equipment recommendations, with equipment items that consist of a scope and video system bundle recommended, along with a separate scope video system. Based on our review, the variations do not appear to be consistent with the different code descriptions.

To promote appropriate relativity among the services and facilitate the transparency of our review process, during the review of the recommended direct PE inputs for the CY 2017 PFS proposed rule, we developed a structure that separates the scope, the associated video system, and any scope accessories that might be typical as distinct equipment items for each code. Under this approach, we proposed standalone prices for each scope, and separate prices for the video systems and accessories that are used with scopes.

(1) Scope Equipment

Beginning in the CY 2017 PFS proposed rule (81 FR 46176 through 46177), we proposed standardizing refinements to the way scopes have Start Printed Page 40493been defined in the direct PE input database. We believe that there are four general types of scopes: Non-video scopes; flexible scopes; semi-rigid scopes, and rigid scopes. Flexible scopes, semi-rigid scopes, and rigid scopes would typically be paired with one of the scope video systems, while the non-video scopes would not. The flexible scopes can be further divided into diagnostic (or non-channeled) and therapeutic (or channeled) scopes. We proposed to identify for each anatomical application: (1) A rigid scope; (2) a semi-rigid scope; (3) a non-video flexible scope; (4) a non-channeled flexible video scope; and (5) a channeled flexible video scope. We proposed to classify the existing scopes in our direct PE database under this classification system, to improve the transparency of our review process and improve appropriate relativity among the services. We planned to propose input prices for these equipment items through future rulemaking.

We proposed these changes only for the reviewed codes for CY 2017 that made use of scopes, along with updated prices for the equipment items related to scopes utilized by these services. We did not propose to apply these policies to codes with inputs reviewed prior to CY 2017. We also solicited comment on this separate pricing structure for scopes, scope video systems, and scope accessories, which we could consider proposing to apply to other codes in future rulemaking. We did not finalize price increases for a series of other scopes and scope accessories, as the invoices submitted for these components indicated that they are different forms of equipment with different product IDs and different prices. We did not receive any data to indicate that the equipment on the newly submitted invoices was more typical in its use than the equipment that we were currently using for pricing.

We did not make further changes to existing scope equipment in CY 2017 to allow the RUC's PE Subcommittee the opportunity to provide feedback. However, we believed there was some miscommunication on this point, as the RUC's PE Subcommittee workgroup that was created to address scope systems stated that no further action was required following the finalization of our proposal. Therefore, we made further proposals in the CY 2018 PFS proposed rule (82 FR 33961 through 33962) to continue clarifying scope equipment inputs, and sought comments regarding the new set of scope proposals. We considered creating a single scope equipment code for each of the five categories detailed in this rule: (1) A rigid scope; (2) a semi-rigid scope; (3) a non-video flexible scope; (4) a non-channeled flexible video scope; and (5) a channeled flexible video scope. Under the current classification system, there are many different scopes in each category depending on the medical specialty furnishing the service and the part of the body affected. We stated our belief that the variation between these scopes was not significant enough to warrant maintaining these distinctions, and we believed that creating and pricing a single scope equipment code for each category would help provide additional clarity. We sought public comment on the merits of this potential scope organization, as well as any pricing information regarding these five new scope categories.

After considering the comments on the CY 2018 PFS proposed rule, we did not finalize our proposal to create and price a single scope equipment code for each of the five categories previously identified. Instead, we supported the recommendation from the commenters to create scope equipment codes on a per-specialty basis for six categories of scopes as applicable, including the addition of a new sixth category of multi-channeled flexible video scopes. Our goal was to create an administratively simple scheme that would be easier to maintain and help to reduce administrative burden. In 2018, the RUC convened a Scope Equipment Reorganization Workgroup to incorporate feedback from expert stakeholders with the intention of making recommendations to us on scope organization and scope pricing. Since the workgroup was not convened in time to submit recommendations for the CY 2019 PFS rulemaking cycle, we delayed proposals for any further changes to scope equipment until CY 2020 in order to incorporate the feedback from the aforementioned workgroup.

(2) Scope Video System

We proposed in the CY 2017 PFS proposed rule (81 FR 46176 through 46177) to define the scope video system as including: (1) A monitor; (2) a processor; (3) a form of digital capture; (4) a cart; and (5) a printer. We believe that these equipment components represent the typical case for a scope video system. Our model for this system was the “video system, endoscopy (processor, digital capture, monitor, printer, cart)” equipment item (ES031), which we proposed to re-price as part of this separate pricing approach. We obtained current pricing invoices for the endoscopy video system as part of our investigation of these issues involving scopes, which we proposed to use for this re-pricing. In response to comments, we finalized the addition of a digital capture device to the endoscopy video system (ES031) in the CY 2017 PFS final rule (81 FR 80188). We finalized our proposal to price the system at $33,391, based on component prices of $9,000 for the processor, $18,346 for the digital capture device, $2,000 for the monitor, $2,295 for the printer, and $1,750 for the cart. In the CY 2018 PFS final rule (82 FR 52991 through 52993), we outlined, but did not finalize, a proposal to add an LED light source into the cost of the scope video system (ES031), which would remove the need for a separate light source in these procedures. We also described a proposal to increase the price of the scope video system by $1,000 to cover the expense of miscellaneous small equipment associated with the system that falls below the threshold of individual equipment pricing as scope accessories (such as cables, microphones, foot pedals, etc.). With the addition of the LED light (equipment code EQ382 at a price of $1,915), the updated total price of the scope video system would be set at $36,306.

We did not finalize this updated pricing to the scope video system in CY 2018, but we did propose and finalize the updated pricing for CY 2019 to $36,306 along with changing the name of the ES031 equipment item to “scope video system (monitor, processor, digital capture, cart, printer, LED light)” to reflect the fact that the use of the ES031 scope video system is not limited to endoscopy procedures.

(3) Scope Accessories

We understand that there may be other accessories associated with the use of scopes. We finalized a proposal in the CY 2017 PFS final rule (81 FR 80188) to separately price any scope accessories outside the use of the scope video system, and individually evaluate their inclusion or exclusion as direct PE inputs for particular codes as usual under our current policy based on whether they are typically used in furnishing the services described by the particular codes.

(4) Scope Proposals for CY 2020

The Scope Equipment Reorganization Workgroup organized by the RUC submitted detailed recommendations to CMS for consideration in the CY 2020 rule cycle, describing 23 different types of scope equipment, the HCPCS codes associated with each scope type, and a series of invoices for scope pricing. We Start Printed Page 40494appreciate the information provided by the workgroup and continue to welcome additional comments and feedback from stakeholders. Based on the recommendations from the workgroup, we are proposing to establish 23 new scope equipment codes (see Table 5).

Table 5—CY 2020 Proposed New Scope Equipment Codes

CMS codeProposed scope equipment descriptionProposed priceNumber of invoices
ES070rigid scope, cystoscopy0
ES071rigid scope, hysteroscopy0
ES072rigid scope, otoscopy0
ES073rigid scope, nasal/sinus endoscopy0
ES074rigid scope, proctosigmoidoscopy0
ES075rigid scope, laryngoscopy$3,966.085
ES076rigid scope, colposcopy14,500.001
ES077non-channeled flexible digital scope, hysteroscopy0
ES078non-channeled flexible digital scope, nasopharyngoscopy0
ES079non-channeled flexible digital scope, bronchoscopy0
ES080non-channeled flexible digital scope, laryngoscopy21,485.517
ES081channeled flexible digital scope, cystoscopy0
ES082channeled flexible digital scope, hysteroscopy0
ES083channeled flexible digital scope, bronchoscopy0
ES084channeled flexible digital scope, laryngoscopy18,694.395
ES085multi-channeled flexible digital scope, flexible sigmoidoscopy17,360.001
ES086multi-channeled flexible digital scope, colonoscopy38,058.816
ES087multi-channeled flexible digital scope, esophagoscopy gastroscopy duodenoscopy (EGD)0
ES088multi-channeled flexible digital scope, esophagoscopy34,585.355
ES089multi-channeled flexible digital scope, ileoscopy0
ES090multi-channeled flexible digital scope, pouchoscopy0
ES091ultrasound digital scope, endoscopic ultrasound0
ES092non-video flexible scope, laryngoscopy5,078.044

We note that we did not receive invoices for many of the new scope equipment items. There also was some inconsistency in the workgroup recommendations regarding the non-channeled flexible digital scope, laryngoscopy (ES080) equipment item and the non-video flexible scope, laryngoscopy (ES092) equipment item. These scopes were listed as a single equipment item in some of the workgroup materials and listed as separate equipment items in other materials. We are proposing to establish them as separate equipment items based on the submitted invoices, which demonstrated that these were two different types of scopes with distinct price points of approximately $17,000 and $5,000 respectively.

We noted a similar issue with the submitted invoices for the rigid scope, laryngoscopy (ES075) equipment item. Among the eight total invoices, five of them were clustered around a price point of approximately $4,000 while the other three invoices had prices of roughly $15,000 apiece. The invoices indicated that these prices came from two distinct types of equipment, and as a result we are proposing to consider these items separately. We are proposing to use the initial five invoices to establish a proposed price of $3,966.08 for the rigid scope, laryngoscopy (ES075) equipment item. We note that this is a close match for the current price of $3,178.08 used by the endoscope, rigid, laryngoscopy (ES010) equipment, which is the closest equivalent scope equipment. The other three invoices appear to describe a type of stroboscopy system rather than a scope, and they have an average price of $14,737. This is a reasonably close match for the price of our current stroboscoby system (ES065) equipment, which has a CY 2020 price of $17,950.28 as it transitions to a final CY 2022 destination price of $16,843.87 (see the 4-year pricing transition of the market-based supply and equipment pricing update discussed later in this section for more information). We believe that these invoices reinforce the value established by the market-based pricing update for the stroboscoby system carried out last year, and we are not proposing to update the price of the ES065 equipment at this time. However, we are open to feedback from stakeholders if they believe it would be more accurate to assign a price of $14,737 to the stroboscoby system based on these invoice submissions, as opposed to maintaining the current pricing transition to a CY 2022 price of $16,843.87.

For the eight new scope equipment items where we have submitted invoices for pricing, we are proposing to replace the existing scopes with the new scope equipment. We received recommendations from the RUC's scope workgroup regarding which HCPCS codes make use of the new scope equipment items, and we are proposing to make this scope replacement for approximately 100 HCPCS codes in total (see Table 6).

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In all but three cases, we are proposing for the new scope equipment item to replace the existing scope with the identical amount of equipment time. For CPT codes 92612 (Flexible endoscopic evaluation of swallowing by cine or video recording), 92614 (Flexible endoscopic evaluation, laryngeal sensory testing by cine or video recording), and 92616 (Flexible endoscopic evaluation of swallowing and laryngeal sensory testing by cine or video recording), the current scopes in use are the FEES video system (ES027) and the FEESST video system (ES028). Since we are proposing the use of a non-channeled flexible digital scope that requires a corresponding scope video system, we are adding the ES080 equipment at the same equipment time Start Printed Page 40499to these three procedures rather than replacing the ES027 and ES028 equipment. In all other cases, we are proposing to replace the current scope equipment listed in Table 6 with the new scope equipment, while maintaining the same amount of equipment time.

We identified inconsistencies with the workgroup recommendations for a small number of HCPCS codes. CPT code 45350 (Sigmoidoscopy, flexible; with band ligation(s) (e.g., hemorrhoids)) was recommended to include a multi-channeled flexible digital scope, flexible sigmoidoscopy (ES085), however, we noted that this CPT code does not include any scopes among its current direct PE inputs. CPT code 31595 was recommended to include a non-channeled flexible digital scope, laryngoscopy (ES080) but it no longer exists as a CPT code after having been deleted for CY 2019. CPT code 43232 (Esophagoscopy, flexible, transoral; with transendoscopic ultrasound-guided intramural or transmural fine needle aspiration/biopsy(s)) was recommended to include a multi-channeled flexible digital scope, esophagoscopy (ES088), but it does not include a scope amongst its direct PE inputs any longer following clarification from the same workgroup recommendations that CPT code 43232 is never performed in the nonfacility setting. In all three of these cases, we are not proposing to add one of the new scope equipment items to these procedures.

We did not receive pricing information along with the workgroup recommendations for the other 15 new scope equipment items. For CY 2020, we are proposing to establish new equipment codes for these scopes as detailed in Table 5. However, due to a lack of pricing information, we are not proposing to replace existing scope equipment with the new equipment items as we did for the other eight new scope equipment items for CY 2020. We welcome additional feedback from stakeholders regarding the pricing of these scope equipment items, especially the submission of detailed invoices with pricing data. We are proposing to transition the scopes for which we do have pricing information over to the new equipment items for CY 2020, and we look forward to engaging with stakeholders to assist in pricing and then transitioning the remaining scopes in future rulemaking.

c. Technical Corrections to Direct PE Input Database and Supporting Files

Subsequent to the publication of the CY 2019 PFS final rule, stakeholders alerted us to several clerical inconsistencies in the direct PE database. We are proposing to correct these inconsistencies as described below and reflected in the CY 2020 proposed direct PE input database displayed on the CMS website under downloads for the CY 2020 PFS proposed rule at http://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​PhysicianFeeSched/​PFS-Federal-Regulation-Notices.html.

For CY 2020, we are proposing to address the following inconsistencies:

  • The RUC's Scope Equipment Reorganization Workgroup recommended deletion of the non-facility inputs for CPT codes 43231 (Esophagoscopy, flexible, transoral; with endoscopic ultrasound examination) and 43232 (Esophagoscopy, flexible, transoral; with transendoscopic ultrasound-guided intramural or transmural fine needle aspiration/biopsy(s)). The gastroenterology specialty societies stated that these services are never performed in the non-facility setting. After our own review of these services, we agree with the workgroup's recommendation, and we are proposing to remove the non-facility direct PE inputs for these two CPT codes.
  • In rulemaking for CY 2018, we reviewed a series of CPT codes describing nasal sinus endoscopy surgeries. At that time, we sought comments on whether the broader family of nasal sinus endoscopy surgery services should be subject to the special rules for multiple endoscopic procedures instead of the standard multiple procedure payment reduction. We received very few comments in response to our solicitation. In the CY 2018 PFS final rule (82 FR 53043), we indicated that we would continue to explore this option for future rulemaking. We are proposing to apply the special rule for multiple endoscopic procedures to this family of codes beginning in CY 2020. This proposal would treat this group of CPT codes consistently with other similar endoscopic procedures when codes within the CPT code family are billed together with another endoscopy service in the same family. Similar to other similar endoscopic procedure code families, we are proposing that CPT code 31231 (Nasal endoscopy, diagnostic, unilateral or bilateral (separate procedure)) would be the base procedure for the remainder of nasal sinus endoscopies. The codes affected by this proposal are as follows (see Table 7).

Table 7—Proposed Nasal Sinus Endoscopy Codes Subject to Special Rules for Multiple Endoscopic Procedures

CPT codeShort descriptor
31231Nasal endoscopy dx.
31233Nasal/sinus endoscopy dx.
31235Nasal/sinus endoscopy dx.
31237Nasal/sinus endoscopy surg.
31238Nasal/sinus endoscopy surg.
31239Nasal/sinus endoscopy surg.
31240Nasal/sinus endoscopy surg.
31241Nsl/sins ndsc w/artery lig.
31253Nsl/sins ndsc total.
31254Nsl/sins ndsc w/prtl ethmdct.
31255Nsl/sins ndsc w/tot ethmdct.
31256Exploration maxillary sinus.
31257Nsl/sins ndsc tot w/sphendt.
31259Nsl/sins ndsc sphn tiss rmvl.
31267Endoscopy maxillary sinus.
31276Nsl/sins ndsc frnt tiss rmvl.
31287Nasal/sinus endoscopy surg.
31288Nasal/sinus endoscopy surg.
31290Nasal/sinus endoscopy surg.
31291Nasal/sinus endoscopy surg.
31292Nasal/sinus endoscopy surg.
31293Nasal/sinus endoscopy surg.
31294Nasal/sinus endoscopy surg.
31295Sinus endo w/balloon dil.
31296Sinus endo w/balloon dil.
31297Sinus endo w/balloon dil.
31298Nsl/sins ndsc w/sins dilat.

Special rules for multiple endoscopic procedures would apply if any of the procedures listed in Table 7 are billed together for the same patient on the same day. We apply the multiple endoscopy payment rules to a code family before ranking the family with other procedures performed on the same day (for example, if multiple endoscopies in the same family are reported on the same day as endoscopies in another family, or on the same day as a non-endoscopic procedure). If an endoscopic procedure is reported together with its base procedure, we do not pay separately for the base procedure. Payment for the base procedure is included in the payment for the other endoscopy. For additional information about the payment adjustment under the special rule for multiple endoscopic services, we refer readers to the CY 1992 PFS final rule where this policy was established (56 FR 59515) and to Pub. 100-04, Medicare Claims Processing Manual, Chapter 23 (available on the CMS website at https://www.cms.gov/​Regulations-and-Guidance/​Guidance/​Manuals/​Downloads/​clm104c23.pdf).

d. Updates to Prices for Existing Direct PE Inputs

In the CY 2011 PFS final rule with comment period (75 FR 73205), we finalized a process to act on public Start Printed Page 40500requests to update equipment and supply price and equipment useful life inputs through annual rulemaking, beginning with the CY 2012 PFS proposed rule. For CY 2020, we are proposing the following price updates for existing direct PE inputs.

We are proposing to update the price of one supply and one equipment item in response to the public submission of invoices. As these pricing updates were each part of the formal review for a code family, we are proposing that the new pricing take effect for CY 2020 for these items instead of being phased in over 4 years. For the details of these proposed price updates, please refer to Table 22, Proposed CY 2020 Invoices Received for Existing Direct PE Inputs in section II.N., Proposed Valuation of Specific Codes, of this proposed rule.

We are also proposing to update the name of the EP001 equipment item from “DNA/digital image analyzer (ACIS)” to “DNA/Digital Image Analyzer” due to clarification from stakeholders regarding the typical use of this equipment.

(1) Market-Based Supply and Equipment Pricing Update

Section 220(a) of the Protecting Access to Medicare Act of 2014 (PAMA) (Pub. L. 113-93) provides that the Secretary may collect or obtain information from any eligible professional or any other source on the resources directly or indirectly related to furnishing services for which payment is made under the PFS, and that such information may be used in the determination of relative values for services under the PFS. Such information may include the time involved in furnishing services; the amounts, types and prices of PE inputs; overhead and accounting information for practices of physicians and other suppliers, and any other elements that would improve the valuation of services under the PFS.

As part of our authority under section 1848(c)(2)(M) of the Act, we initiated a market research contract with StrategyGen to conduct an in-depth and robust market research study to update the PFS direct PE inputs (DPEI) for supply and equipment pricing for CY 2019. These supply and equipment prices were last systematically developed in 2004-2005. StrategyGen submitted a report with updated pricing recommendations for approximately 1300 supplies and 750 equipment items currently used as direct PE inputs. This report is available as a public use file displayed on the CMS website under downloads for the CY 2019 PFS final rule at http://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​PhysicianFeeSched/​PFS-Federal-Regulation-Notices.html.

The StrategyGen team of researchers, attorneys, physicians, and health policy experts conducted a market research study of the supply and equipment items currently used in the PFS direct PE input database. Resources and methodologies included field surveys, aggregate databases, vendor resources, market scans, market analysis, physician substantiation, and statistical analysis to estimate and validate current prices for medical equipment and medical supplies. StrategyGen conducted secondary market research on each of the 2,072 DPEI medical equipment and supply items that CMS identified from the current DPEI. The primary and secondary resources StrategyGen used to gather price data and other information were:

  • Telephone surveys with vendors for top priority items (Vendor Survey).
  • Physician panel validation of market research results, prioritized by total spending (Physician Panel).
  • The General Services Administration system (GSA).
  • An aggregate health system buyers database with discounted prices (Buyers).
  • Publicly available vendor resources, that is, Amazon Business, Cardinal Health (Vendors).
  • Federal Register, current DPEI data, historical proposed and final rules prior to CY 2018, and other resources; that is, AMA RUC reports (References).

StrategyGen prioritized the equipment and supply research based on current share of PE RVUs attributable by item provided by CMS. StrategyGen developed the preliminary Recommended Price (RP) methodology based on the following rules in hierarchical order considering both data representativeness and reliability.

(1) If the market share, as well as the sample size, for the top three commercial products were available, the weighted average price (weighted by percent market share) was the reported RP. Commercial price, as a weighted average of market share, represents a more robust estimate for each piece of equipment and a more precise reference for the RP.

(2) If no data were available for commercial products, the current CMS prices were used as the RP.

GSA prices were not used to calculate the StrategyGen recommended prices, due to our concern that the GSA system curtails the number and type of suppliers whose products may be accessed on the GSA Advantage website, and that the GSA prices may often be lower than prices that are available to non-governmental purchasers. After reviewing the StrategyGen report, we proposed to adopt the updated direct PE input prices for supplies and equipment as recommended by StrategyGen.

StrategyGen found that despite technological advancements, the average commercial price for medical equipment and supplies has remained relatively consistent with the current CMS price. Specifically, preliminary data indicated that there was no statistically significant difference between the estimated commercial prices and the current CMS prices for both equipment and supplies. This cumulative stable pricing for medical equipment and supplies appears similar to the pricing impacts of non-medical technology advancements where some historically high-priced equipment (that is, desktop PCs) has been increasingly substituted with current technology (that is, laptops and tablets) at similar or lower price points. However, while there were no statistically significant differences in pricing at the aggregate level, medical specialties would experience increases or decreases in their Medicare payments if CMS were to adopt the pricing updates recommended by StrategyGen. At the service level, there may be large shifts in PE RVUs for individual codes that happened to contain supplies and/or equipment with major changes in pricing, although we note that codes with a sizable PE RVU decrease would be limited by the requirement to phase in significant reductions in RVUs, as required by section 1848(c)(7) of the Act. The phase-in requirement limits the maximum RVU reduction for codes that are not new or revised to 19 percent in any individual calendar year.

We believe that it is important to make use of the most current information available for supply and equipment pricing instead of continuing to rely on pricing information that is more than a decade old. Given the potentially significant changes in payment that would occur, both for specific services and more broadly at the specialty level, in the CY 2019 PFS proposed rule we proposed to phase in our use of the new direct PE input pricing over a 4-year period using a 25/75 percent (CY 2019), 50/50 percent (CY 2020), 75/25 percent (CY 2021), and 100/0 percent (CY 2022) split between new and old pricing. This approach is consistent with how we have previously incorporated significant new data into the calculation of PE RVUs, such as the 4-year transition period finalized in CY 2007 PFS final rule with comment period when changing to the “bottom-Start Printed Page 40501up” PE methodology (71 FR 69641). This transition period will not only ease the shift to the updated supply and equipment pricing, but will also allow interested parties an opportunity to review and respond to the new pricing information associated with their services.

We proposed to implement this phase-in over 4 years so that supply and equipment values transition smoothly from the prices we currently include to the final updated prices in CY 2022. We proposed to implement this pricing transition such that one quarter of the difference between the current price and the fully phased-in price is implemented for CY 2019, one third of the difference between the CY 2019 price and the final price is implemented for CY 2020, and one half of the difference between the CY 2020 price and the final price is implemented for CY 2021, with the new direct PE prices fully implemented for CY 2022. An example of the transition from the current to the fully-implemented new pricing is provided in Table 8.

Table 8—Example of Direct PE Pricing Transition

Current Price$100
Final Price200
Year 1 (CY 2019) Price1251/4 difference between $100 and $200.
Year 2 (CY 2020) Price1501/3 difference between $125 and $200.
Year 3 (CY 2021) Price1751/2 difference between $150 and $200.
Final (CY 2022) Price200

For new supply and equipment codes for which we establish prices during the transition years (CYs 2019, 2020 and 2021) based on the public submission of invoices, we proposed to fully implement those prices with no transition since there are no current prices for these supply and equipment items. These new supply and equipment codes would immediately be priced at their newly established values. We also proposed that, for existing supply and equipment codes, when we establish prices based on invoices that are submitted as part of a revaluation or comprehensive review of a code or code family, they will be fully implemented for the year they are adopted without being phased in over the 4-year pricing transition. The formal review process for a HCPCS code includes a review of pricing of the supplies and equipment included in the code. When we find that the price on the submitted invoice is typical for the item in question, we believe it would be appropriate to finalize the new pricing immediately along with any other revisions we adopt for the code valuation.

For existing supply and equipment codes that are not part of a comprehensive review and valuation of a code family and for which we establish prices based on invoices submitted by the public, we proposed to implement the established invoice price as the updated price and to phase in the new price over the remaining years of the proposed 4-year pricing transition. During the proposed transition period, where price changes for supplies and equipment are adopted without a formal review of the HCPCS codes that include them (as is the case for the many updated prices we proposed to phase in over the 4-year transition period), we believe it is important to include them in the remaining transition toward the updated price. We also proposed to phase in any updated pricing we establish during the 4-year transition period for very commonly used supplies and equipment that are included in 100 or more codes, such as sterile gloves (SB024) or exam tables (EF023), even if invoices are provided as part of the formal review of a code family. We would implement the new prices for any such supplies and equipment over the remaining years of the proposed 4-year transition period. Our proposal was intended to minimize any potential disruptive effects during the proposed transition period that could be caused by other sudden shifts in RVUs due to the high number of services that make use of these very common supply and equipment items (meaning that these items are included in 100 or more codes).

We believed that implementing the proposed updated prices with a 4-year phase-in would improve payment accuracy, while maintaining stability and allowing stakeholders the opportunity to address potential concerns about changes in payment for particular items. Updating the pricing of direct PE inputs for supplies and equipment over a longer time frame will allow more opportunities for public comment and submission of additional, applicable data. We welcomed feedback from stakeholders on the proposed updated supply and equipment pricing, including the submission of additional invoices for consideration.

We received many comments regarding the market-based supply and equipment pricing proposal following the publication of the CY 2019 PFS proposed rule. For a full discussion of these comments, we direct readers to the CY 2019 PFS final rule (83 FR 59475-59480). In each instance in which a commenter raised questions about the accuracy of a supply or equipment code's recommended price, the StrategyGen contractor conducted further research on the item and its price with special attention to ensuring that the recommended price was based on the correct item in question and the clarified unit of measure. Based on the commenters' requests, the StrategyGen contractor conducted an extensive examination of the pricing of any supply or equipment items that any commenter identified as requiring additional review. Invoices submitted by multiple commenters were greatly appreciated and ensured that medical equipment and supplies were re-examined and clarified. Multiple researchers reviewed these specified supply and equipment codes for accuracy and proper pricing. In most cases, the contractor also reached out to a team of nurses and their physician panel to further validate the accuracy of the data and pricing information. In some cases, the pricing for individual items needed further clarification due to a lack of information or due to significant variation in packaged items. After consideration of the comments and this additional price research, we updated the recommended prices for approximately 70 supply and equipment codes identified by the commenters. Table 9 in the CY 2019 PFS final rule lists the supply and equipment codes with price changes based on feedback from the commenters and the resulting additional research into pricing (83 FR 59479-59480).

After consideration of the public comments, we finalized our proposals associated with the market research study to update the PFS direct PE inputs for supply and equipment pricing. We continue to believe that implementing the proposed updated prices with a 4-year phase-in will improve payment Start Printed Page 40502accuracy, while maintaining stability and allowing stakeholders the opportunity to address potential concerns about changes in payment for particular items. We continue to welcome feedback from stakeholders on the proposed updated supply and equipment pricing, including the submission of additional invoices for consideration.

For CY 2020, we received invoice submissions for approximately 30 supply and equipment codes from stakeholders as part of the second year of the market-based supply and equipment pricing update. These invoices were reviewed by the StrategyGen contractor and the submitted invoices were used in many cases to supplement the pricing originally proposed for the CY 2019 PFS rule cycle. The contractor reviewed the invoices, as well as prior data for the relevant supply/equipment codes to make sure the item in the invoice was representative of the supply/equipment item in question and aligned with past research. Based on this research, we are proposing to update the prices of the following supply and equipment items:

Start Printed Page 40503

For most supply and equipment items, there was an alignment between the research carried out by the StrategyGen contractor and the submitted invoice. The updated CY 2020 pricing was calculated using an average between the previous market research and the newly submitted invoices in these cases. In some cases the submitted invoices were not representative of market prices, such as for the centrifuge with rotor (EP007) equipment item where the invoice price of $8,563 appeared to be an outlier. We did not use the invoices to calculate our pricing recommendation in these situations and instead continued to rely on our prior pricing data. In other instances, such as for the kit, probe, cryoablation, prostate (Galil-Endocare) Start Printed Page 40504(SA099) supply item, our research indicated that the submitted invoice price was more representative of the commercial price than our CY 2019 research and pricing. We are proposing the new invoice prices for these supply and equipment items due to our belief in their greater accuracy.

For some of the remaining supply and equipment items, such as the five-gallon paraffin (EP031) equipment and the Olympus DP21 camera (EP089) equipment, we maintained the extant pricing for CY 2019 due to a lack of sufficient data to update the pricing. In these situations where we did not have an updated price for CY 2019, we believe that the newly submitted invoices are more representative of the current commercial prices that are being paid on the market. We are again proposing the new invoice prices for these supply and equipment items due to our belief in their greater accuracy.

In addition, we were alerted by stakeholders that the price of the EM visit pack (SA047) supply did not match the sum of the component prices of the supplies included in the pack. After reviewing the prices of the individual component supplies, we agree with the stakeholders that there was a discrepancy in the previous pricing of this supply pack. We are proposing to update the price of the EM visit pack to $5.47 to match the sum of the prices of the component supplies, and proposing to continue to transition towards this price over the remaining years of the phase-in period.

We finalized a policy last year to phase in the new supply and equipment pricing over 4 years so that supply and equipment values transition smoothly from their current prices to the final updated prices in CY 2022. We finalized our proposal to implement this pricing transition such that one quarter of the difference between the current price and the fully phased in price was implemented for CY 2019, one third of the difference between the CY 2019 price and the final price is implemented for CY 2020, and one half of the difference between the CY 2020 price and the final price is implemented for CY 2021, with the new direct PE prices fully implemented for CY 2022. An example of the transition from the current to the fully-implemented new pricing is provided in Table 8. For CY 2020, one third of the difference between the CY 2019 price and the final price will be implemented as per the previously finalized policy.

The full list of updated supply and equipment pricing as it will be implemented over the 4-year transition period will be made available as a public use file displayed on the CMS website under downloads for the CY 2020 PFS proposed rule at http://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​PhysicianFeeSched/​PFS-Federal-Regulation-Notices.html.

(2) Invoice Submission

We routinely accept public submission of invoices as part of our process for developing payment rates for new, revised, and potentially misvalued codes. Often these invoices are submitted in conjunction with the RUC-recommended values for the codes. For CY 2020, we noted that some stakeholders have submitted invoices for new, revised, or potentially misvalued codes after the February 10th deadline established for code valuation recommendations. To be included in a given year's proposed rule, we generally need to receive invoices by the same February 10th deadline we noted for consideration of RUC recommendations. However, we would consider invoices submitted as public comments during the comment period following the publication of the PFS proposed rule, and would consider any invoices received after February 10th or outside of the public comment process as part of our established annual process for requests to update supply and equipment prices.

(3) Adjustment to Allocation of Indirect PE for Some Office-Based Services

In the CY 2018 PFS final rule (82 FR 52999 through 53000), we established criteria for identifying the services most affected by the indirect PE allocation anomaly that does not allow for a site of service differential that accurately reflects the relative indirect costs involved in furnishing services in nonfacility settings. We also finalized a modification in the PE methodology for allocating indirect PE RVUs to better reflect the relative indirect PE resources involved in furnishing these services. The methodology, as described, is based on the difference between the ratio of indirect PE to work RVUs for each of the codes meeting eligibility criteria and the ratio of indirect PE to work RVU for the most commonly reported visit code. We refer readers to the CY 2018 PFS final rule (82 FR 52999 through 53000) for a discussion of our process for selecting services subject to the revised methodology, as well as a description of the methodology, which we began implementing for CY 2018 as the first year of a 4-year transition. For CY 2020, we are proposing to continue with the third year of the transition of this adjustment to the standard process for allocating indirect PE.

C. Determination of Malpractice Relative Value Units (RVUs)

1. Overview

Section 1848(c) of the Act requires that each service paid under the PFS be composed of three components: Work, PE, and malpractice (MP) expense. As required by section 1848(c)(2)(C)(iii) of the Act, beginning in CY 2000, MP RVUs are resource based. Section 1848(c)(2)(B)(i) of the Act also requires that we review, and if necessary adjust, RVUs no less often than every 5 years. In the CY 2015 PFS final rule with comment period, we implemented the third review and update of MP RVUs. For a comprehensive discussion of the third review and update of MP RVUs, see the CY 2015 proposed rule (79 FR 40349 through 40355) and final rule with comment period (79 FR 67591 through 67596). In the CY 2018 proposed rule (82 FR 33965 through 33970), we proposed to update the specialty-level risk factors used in the calculation of MP RVUs, prior to the next required 5 year update (CY 2020), using the updated MP premium data that were used in the eighth Geographic Practice Cost Index (GPCI) update for CY 2017; however the proposal was ultimately not finalized for CY 2018.

We consider the following factors when we determine MP RVUs for individual PFS services: (1) Specialty-level risk factors derived from data on specialty-specific MP premiums incurred by practitioners; (2) service-level risk factors derived from Medicare claims data of the weighted average risk factors of the specialties that furnish each service; and (3) an intensity/complexity of service adjustment to the service-level risk factor based on either the higher of the work RVU or clinical labor portion of the direct PE RVU. Prior to CY 2016, MP RVUs were only updated once every 5 years, except in the case of new and revised codes.

As explained in the CY 2011 PFS final rule with comment period (75 FR 73208), MP RVUs for new and revised codes effective before the next 5-year review of MP RVUs were determined either by a direct crosswalk from a similar source code or by a modified crosswalk to account for differences in work RVUs between the new/revised code and the source code. For the modified crosswalk approach, we adjusted (or scaled) the MP RVU for the new/revised code to reflect the difference in work RVU between the source code and the new/revised work RVU (or, if greater, the difference in the Start Printed Page 40505clinical labor portion of the fully implemented PE RVU) for the new code. For example, if the proposed work RVU for a revised code was 10 percent higher than the work RVU for its source code, the MP RVU for the revised code would be increased by 10 percent over the source code MP RVU. Under this approach, the same risk factor was applied for the new/revised code and source code, but the work RVU for the new/revised code was used to adjust the MP RVUs for risk.

In the CY 2016 PFS final rule with comment period (80 FR 70906 through 70910), we finalized a policy to begin conducting annual MP RVU updates to reflect changes in the mix of practitioners providing services (using Medicare claims data), and to adjust MP RVUs for risk for intensity and complexity (using the work RVU or clinical labor RVU). We also finalized a policy to modify the specialty mix assignment methodology (for both MP and PE RVU calculations) to use an average of the three most recent years of data instead of a single year of data. Under this approach, for new and revised codes, we generally assign a specialty-level risk factor to individual codes based on the same utilization assumptions we make regarding specialty mix we use for calculating PE RVUs and for PFS budget neutrality. We continue to use the work RVU or clinical labor RVU to adjust the MP RVU for each code for intensity and complexity. In finalizing this policy, we stated that the specialty-level risk factors would continue to be updated through notice and comment rulemaking every 5 years using updated premium data, but would remain unchanged between the 5-year reviews.

Section 1848(e)(1)(C) of the Act requires us to review, and if necessary, adjust the GPCIs at least every 3 years. For CY 2020, we are conducting the statutorily required 3-year review of the GPCIs, which coincides with the statutorily required 5-year review of the MP RVUs. We note that the MP premium data used to update the MP GPCIs are the same data used to determine the specialty-level risk factors, which are used in the calculation of MP RVUs. Going forward, we believe it would be logical and efficient to align the update of MP premium data used to determine the MP RVUs with the update of the MP GPCI. Therefore, we are proposing to align the update of MP premium data with the update to the MP GPCIs, that is, we are proposing to review, and if necessary update the MP RVUs at least every 3 years, similar to our review and update of the GPCIs. If we align the two updates, we would conduct the next statutorily-mandated review and update of both the GPCI and MP RVU for implementation in CY 2023. We are proposing to implement the fourth comprehensive review and update of MP RVUs for CY 2020 and are seeking comment on these proposals.

2. Methodology for the Proposed Revision of Resource-Based Malpractice RVUs

a. General Discussion

We calculated the proposed MP RVUs using updated malpractice premium data obtained from state insurance rate filings. The methodology used in calculating the proposed CY 2020 review and update of resource-based MP RVUs largely parallels the process used in the CY 2015 update; however, we are proposing to incorporate several methodological refinements, which are described below in this proposed rule. The MP RVU calculation requires us to obtain information on specialty-specific MP premiums that are linked to specific services, and using this information, we derive relative risk factors for the various specialties that furnish a particular service. Because MP premiums vary by state and specialty, the MP premium information must be weighted geographically and by specialty. We calculated the proposed MP RVUs using four data sources: Malpractice premium data presumed to be in effect as of December 31, 2017; CY 2018 Medicare payment and utilization data; higher of the CY 2020 proposed work RVUs or the clinical labor portion of the direct PE RVUs; and CY 2019 GPCIs. We will use the higher of the CY 2020 final work RVUs or clinical labor portion of the direct PE RVUs in our calculation to develop the CY 2020 final MP RVUs while maintaining overall PFS budget neutrality.

Similar to the CY 2015 update, the proposed MP RVUs were calculated using specialty-specific malpractice premium data because they represent the expense incurred by practitioners to obtain malpractice insurance as reported by insurers. For CY 2020, the most current malpractice premium data available, with a presumed effective date of no later than December 31, 2017, were obtained from insurers with the largest market share in each state. We identified insurers with the largest market share using the National Association of Insurance Commissioners (NAIC) market share report. This annual report provides state-level market share for entities that provide premium liability insurance (PLI) in a state. Premium data were downloaded from the System for Electronic Rates & Forms Filing Access Interface (SERFF) (accessed from the NAIC website) for participating states. For non-SERFF states, data were downloaded from the state-specific website (if available online) or obtained directly from the state's alternate access to filings. For SERFF states and non-SERFF states with online access to filings, the 2017 market share report was used to select companies. For non-SERFF states without online access to filings, the 2016 market share report was used to identify companies. These were the most current data available during the data collection and acquisition process.

Malpractice insurance premium data were collected from all 50 States, and the District of Columbia. Efforts were made to collect filings from Puerto Rico; however, no recent filings were submitted at the time of data collection and therefore filings from the previous update were used. Consistent with the CY 2015 update, no filings were collected for the other U.S. territories: American Samoa, Guam, Virgin Islands, or Northern Mariana Islands. Malpractice premiums were collected for coverage limits of $1 million/$3 million, mature, claims-made policies (policies covering claims made, rather than those covering losses occurring, during the policy term). A $1 million/$3 million liability limit policy means that the most that would be paid on any claim is $1 million and the most that the policy would pay for claims over the timeframe of the policy is $3 million. Adjustments were made to the premium data to reflect mandatory surcharges for patient compensation funds (PCF, funds used to pay for any claim beyond the state's statutory amount, thereby limiting an individual physician's liability in cases of a large suit) in states where participation in such funds is mandatory.

Premium data were included for all physician and NPP specialties, and all risk classifications available in the collected rate filings. Although premium data were collected from all states, the District of Columbia, and previous filings for Puerto Rico were utilized, not all specialties had distinct premium data in the rate filings from all states. In previous updates, specialties for which premium data were not available for at least 35 states, and specialties for which there were not distinct risk groups (surgical, non-surgical, and surgical with obstetrics) among premium data in the rate filings, were crosswalked to a similar specialty, either conceptually or based on available premium data. This resulted in not using those premium data because Start Printed Page 40506the 35 state threshold was not met. In this proposed CY 2020 update, we note that the proposed methodological improvement discussed below in this proposed rule expands the specialties and amount of filings data used to develop the proposed risk factors, which are used to develop the proposed MP RVUs.

b. Proposed Methodological Refinements

For the CY 2020 update, we are proposing the following methodological improvements to the development of MP premium data:

(1) Downloading and using a broader set of filings from the largest market share insurers in each state, beyond those listed as “physician” and “surgeon” to obtain a more comprehensive data set.

(2) Combining minor surgery and major surgery premiums to create the surgery service risk group, which yields a more representative surgical risk factor. In the previous update, only premiums for major surgery were used in developing the surgical risk factor.

(3) Utilizing partial and total imputation to develop a more comprehensive data set when CMS specialty names are not distinctly identified in the insurer filings, which sometimes use unique specialty names.

In instances where insurers report data for some (but not all) specialties that explicitly corresponded to a CMS specialty, where those data were missing, we propose to use partial imputation based on available data to establish what the premiums would likely have been had that specialty been delineated in the filing. In instances where there are no data corresponding to a CMS specialty in the filing, we propose to use total imputation to establish premiums.

For example, if a specialty of Sleep Medicine is listed on the insurer's rate filing, this rate will be matched to the CMS specialty Sleep Medicine (C0). However, if the Sleep Medicine specialty is not listed on the insurer's rate filing, under our proposed methodology, the insurer's rate filing for General Practice would be matched to the CMS specialty of Sleep Medicine (C0). In this example, we believe General Practice is likely to be consistent with the rate that a Sleep Medicine provider would be charged by that insurer. This proposed methodological improvement means that instead of discarding specialty-specific information from some insurers' filings because other insurers lacked that same level of detail, we would instead impute the missing rates at the insurer/specialty level in an effort to utilize as much of the information from the filings as possible.

We are seeking comment on these proposed methodological improvements. Additional technical details are available in our interim report, “Interim Report for the CY 2020 Update of GPCIs and MP RVUs for the Medicare Physician Fee Schedule,” on our website. It is located under the supporting documents section for the CY 2020 PFS proposed rule located at https://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​PhysicianFeeSched/​index.html.

c. Steps for Calculating Malpractice RVUs

Calculation of the proposed MP RVUs conceptually follows the specialty-weighted approach used in the CY 2015 final rule with comment period (79 FR 67591), along with the above proposed methodological improvements. The specialty-weighted approach bases the MP RVUs for a given service on a weighted average of the risk factors of all specialties furnishing the service. This approach ensures that all specialties furnishing a given service are reflected in the calculation of the MP RVUs. The steps for calculating the proposed MP RVUs are described below.

Step (1): Compute a preliminary national average premium for each specialty.

Insurance rating area malpractice premiums for each specialty are mapped to the county level. The specialty premium for each county is then multiplied by its share of the total U.S. population (from the U.S. Census Bureau's 2013-2017 American Community Survey (ACS) 5-year estimates). This is in contrast to the method used for creating national average premiums for each specialty in the 2015 update; in that update, specialty premiums were weighted by the total RVU per county, rather than by the county share of the total U.S. population. We refer readers to the CY 2016 PFS final rule with comment period (80 FR 70909) for a discussion of why we have adopted a weighting method based on share of total U.S. population. This calculation is then divided by the average MP GPCI across all counties for each specialty to yield a normalized national average premium for each specialty. The specialty premiums are normalized for geographic variation so that the locality cost differences (as reflected by the 2019 GPCIs) would not be counted twice. Without the geographic variation adjustment, the cost differences among fee schedule areas would be reflected once under the methodology used to calculate the MP RVUs and again when computing the service specific payment amount for a given fee schedule area.

Step (2): Determine which premium service risk groups to use within each specialty.

Some specialties had premium rates that differed for surgery, surgery with obstetrics, and non-surgery. These premium classes are designed to reflect differences in risk of professional liability and the cost of malpractice claims if they occur. To account for the presence of different classes in the malpractice premium data and the task of mapping these premiums to procedures, we calculated distinct risk factors for surgical, surgical with obstetrics, and nonsurgical procedures where applicable. However, the availability of data by surgery and non-surgery varied across specialties. Historically, no single approach accurately addressed the variability in premium class among specialties, and we previously employed several methods for calculating average premiums by specialty. These methods are discussed below.

Developing Distinct Service Risk Groups: We determined that there were sufficient data for surgery and non-surgery premiums, as well as sufficient differences in rates between classes for 15 specialties (there were 10 such specialties in the CY 2015 update). These specialties are listed in Table 10. Additionally, as described in the proposed methodological refinements, in some instances, we combined minor surgery and major surgery premiums to create a premium to develop the surgery service risk group, rather than discard minor surgery premium data as was done in the previous update. Therefore, we calculated a national average surgical premium and non-surgical premium for those specialties. For all other specialties (those that are not listed in Table 10) that typically do not distinguish premiums as described above, a single risk factor was calculated, and that specialty risk factor was applied to all services performed by those specialties.

This is consistent with prior practice; however, we have refined the nomenclature to more precisely describe that some specialties are delineated into service risk groups, as is the case for surgical, non-surgical, and surgical with obstetrics, and some specialties are not further delineated into service risk subgroups and are instead referred to as “All”—meaning that all services performed by that specialty receive the same risk factor.Start Printed Page 40507

Table 10—Proposed Specialties Subdivided Into Service Risk Groups

Service risk groupsSpecialties
Surgery/No SurgeryOtolaryngology (04), Cardiology (06), Dermatology (07), Gastroenterology (10), Neurology (13), Ophthalmology (18), Urology (34), Geriatric Medicine (38), Nephrology (39), Endocrinology (46), Podiatry (48), Emergency Medicine (93).
Surgery/No Surgery/OBGeneral Practice (01), Family Practice (08), OB/GYN (16).

Step (3): Calculate a risk factor for each specialty.

The relative differences in national average premiums between specialties are expressed in our methodology as a specialty-level risk factor. These risk factors are calculated by dividing the national average premium for each specialty by the national average premium for the specialty with the lowest premiums for which we had sufficient and reliable data, which remains allergy and immunology (03). For specialties with rate filings that are indicative of sufficient surgical and non-surgical premium data, we recognized those service-risk groups (that is, surgical, and non-surgical) as risk groups of the specialty and we calculated both a surgical and non-surgical risk factor. Similarly, for specialties with rate filings that distinguished surgical premiums with obstetrics, we recognized that service-risk subgroup of the specialty and calculated a separate surgical with obstetrics risk factor.

(a) Technical Component (TC) Only Services

We note that for determining the risk factor for suppliers of TC-only services in the CY 2015 update, we updated the premium data for independent diagnostic testing facilities (IDTFs) that we used in the CY 2010 update. Those data were obtained from a survey conducted by the Radiology Business Management Association (RBMA) in 2009; we ultimately used those data to calculate an updated TC specialty risk factor. We applied the updated TC specialty risk factor to suppliers of TC-only services. In the CY 2015 final rule with comment period (79 FR 67595), RBMA voluntarily submitted updated MP premium information collected from IDTFs in 2014, and requested that we use the data for calculating the CY 2015 MP RVUs for TC-only services. We declined to utilize the data and stated that we believe further study is necessary and we would consider this matter and propose any changes through future rulemaking. We continue to believe that data for a broader set of TC-only services are needed, and are working to acquire a broader set of data.

For CY 2020, we propose to assign a risk factor of 1.00 for TC-only services, which corresponds to the lowest physician specialty-level risk factor. We assigned the risk factor of 1.00 to the TC-only services because we do not have sufficient comparable professional liability premium data for the full range of clinicians that furnish TC-only services. In lieu of comprehensive, comparable data, we propose to assign 1.00, the lowest physician specialty-level risk factor calculated using the updated premium data, as the default minimum risk factor. However, we seek information on the most comparable and appropriate proxy for the broader set of TC-only services for future use, as well as any empirical information that would support assignment of an alternative risk factor for these services.

Table 11 shows the proposed risk factors by specialty type and service risk group.

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Step (4): Calculate malpractice RVUs for each CPT/HCPCS code.

Resource-based MP RVUs were calculated for each CPT/HCPCS code that has work or PE RVUs. The first step was to identify the percentage of services furnished by each specialty for each respective CPT/HCPCS code. This Start Printed Page 40510percentage was then multiplied by each respective specialty's risk factor as calculated in Step 3. The products for all specialties for the CPT/HCPCS code were then added together, yielding a specialty-weighted service specific risk factor reflecting the weighted malpractice costs across all specialties furnishing that procedure. The service specific risk factor was multiplied by the greater of the work RVU or clinical labor portion of the direct PE RVU for that service, to reflect differences in the complexity and risk-of-service between services.

Low volume service codes: As we discussed above in this proposed rule, for low volume services code, we finalized the proposal in the CY 2018 PFS final rule (82 FR 53000 through 53006) to apply the list of expected specialties instead of the claims-based specialty mix for low volume services to address stakeholder concerns about the year to year variability in PE and MP RVUs for low volume services (which also includes no volume services); these are defined as codes that have 100 allowed services or fewer. These service-level overrides are used to determine the specialty for low volume procedures for both PE and MP.

In the CY 2018 PFS final rule (82 FR 53000 through 53006), we also finalized our proposal to eliminate general use of an MP-specific specialty-mix crosswalk for new and revised codes. However, we indicated that we would continue to consider, in conjunction with annual recommendations, specific recommendations regarding specialty mix assignments for new and revised codes, particularly in cases where coding changes are expected to result in differential reporting of services by specialty, or where the new or revised code is expected to be low-volume. Absent such information, the specialty mix assumption for a new or revised code would derive from the analytic crosswalk in the first year, followed by the introduction of actual claims data, which is consistent with our approach for developing PE RVUs.

For CY 2020, we are soliciting public comment on the list of expected specialties. We also note that the list has been updated to include a column indicating if a service is identified as a low volume service for CY 2020, and therefore, whether or not the service-level override is being applied for CY 2020. The proposed list of codes and expected specialties is available on our website under downloads for the CY 2020 PFS proposed rule at http://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​PhysicianFeeSched/​PFS-Federal-Regulation-Notices.html.

Step (5): Rescale for budget neutrality.

The statute requires that changes to fee schedule RVUs must be budget neutral. Thus, the last step is to adjust for relativity by rescaling the proposed MP RVUs so that the total proposed resource based MP RVUs are equal to the total current resource based MP RVUs scaled by the ratio of the pools of the proposed and current MP and work RVUs. This scaling is necessary to maintain the work RVUs for individual services from year to year while also maintaining the overall relationship among work, PE, and MP RVUs.

Specialties Excluded from Ratesetting Calculation: In section II.B. of this proposed rule, Determination of Practice Expense Relative Value Units, we discuss specialties that are excluded from ratesetting for the purposes of calculating PE RVUs. We are proposing to treat those excluded specialties in a consistent manner for the purposes of calculating MP RVUs. We note that all specialties are included for purposes of calculating the final BN adjustment. The list of specialties excluded from the ratesetting calculation for the purpose of calculating the PE RVUs that we are proposing to also exclude for the purpose of calculating MP RVUs is available in section II.B. of this proposed rule, Determination of Practice Expense Relative Value Units. The proposed resource based MP RVUs are shown in Addendum B, which is available on the CMS website under the downloads section of the CY 2020 PFS rule at https://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​PhysicianFeeSched/​index.html.

Because a different share of the resources involved in furnishing PFS services is reflected in each of the three fee schedule components, implementation of the resource-based MP RVU update will have much smaller payment effects than implementing updates of resource-based work RVUs and resource-based PE RVUs. On average, work represents about 50.9 percent of payment for a service under the fee schedule, PE about 44.8 percent, and MP about 4.3 percent. Therefore, a 25 percent change in PE RVUs or work RVUs for a service would result in a change in payment of about 11 to 13 percent. In contrast, a corresponding 25 percent change in MP values for a service would yield a change in payment of only about 1 percent. Estimates of the effects on payment by specialty type can be found in section VI. of this proposed rule, Regulatory Impact Analysis.

Additional information on our proposed methodology for updating the MP RVUs is available in the “Interim Report for the CY 2020 Update of GPCIs and MP RVUs for the Medicare Physician Fee Schedule,” which is available on the CMS website under the downloads section of the CY 2020 PFS proposed rule at https://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​PhysicianFeeSched/​index.html.

D. Geographic Practice Cost Indices (GPCIs)

1. Background

Section 1848(e)(1)(A) of the Act requires us to develop separate Geographic Practice Cost Indices (GPCIs) to measure relative cost differences among localities compared to the national average for each of the three fee schedule components (that is, work, practice expense (PE), and malpractice (MP)). We discuss the localities established under the PFS below in this section. Although the statute requires that the PE and MP GPCIs reflect full relative cost differences, section 1848(e)(1)(A)(iii) of the Act requires that the work GPCIs reflect only one-quarter of the relative cost differences compared to the national average. In addition, section 1848(e)(1)(G) of the Act sets a permanent 1.5 work GPCI floor for services furnished in Alaska beginning January 1, 2009, and section 1848(e)(1)(I) of the Act sets a permanent 1.0 PE GPCI floor for services furnished in frontier states (as defined in section 1848(e)(1)(I) of the Act) beginning January 1, 2011. Additionally, section 1848(e)(1)(E) of the Act provided for a 1.0 floor for the work GPCIs, which was set to expire at the end of 2017. Section 50201 of the Bipartisan Budget Act of 2018 (BBA of 2018) (Pub. L. 115-123, enacted February 9, 2018) amended the statute to extend the 1.0 floor for the work GPCIs through CY 2019 (that is, for services furnished no later than December 31, 2019).

Section 1848(e)(1)(C) of the Act requires us to review and, if necessary, adjust the GPCIs at least every 3 years. Section 1848(e)(1)(C) of the Act requires that, if more than 1 year has elapsed since the date of the last previous GPCI adjustment, the adjustment to be applied in the first year of the next adjustment shall be 1/2 of the adjustment that otherwise would be made. Therefore, since the previous GPCI update was implemented in CYs 2017 and 2018, we are proposing to phase in 1/2 of the latest GPCI adjustment in CY 2020.Start Printed Page 40511

We have completed a review of the GPCIs and are proposing new GPCIs in this proposed rule. We also calculate a geographic adjustment factor (GAF) for each PFS locality. The GAFs are a weighted composite of each PFS localities work, PE and MP expense GPCIs using the national GPCI cost share weights. While we do not actually use GAFs in computing the fee schedule payment for a specific service, they are useful in comparing overall areas costs and payments. The actual effect on payment for any actual service would deviate from the GAF to the extent that the proportions of work, PE and MP RVUs for the service differ from those of the GAF.

As noted above, section 50201 of the BBA of 2018 extended the 1.0 work GPCI floor for services furnished only through December 31, 2019. Therefore, the proposed CY 2020 work GPCIs and summarized GAFs do not reflect the 1.0 work floor. However, as required by sections 1848(e)(1)(G) and (I) of the Act, the 1.5 work GPCI floor for Alaska and the 1.0 PE GPCI floor for frontier states are permanent, and therefore, applicable in CY 2020. See Addenda D and E to this proposed rule for the CY 2020 proposed GPCIs and summarized proposed GAFs available on the CMS website under the supporting documents section of the CY 2020 PFS proposed rule at https://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​PhysicianFeeSched/​index.html.

2. Payment Locality Background

Prior to 1992, Medicare payments for physicians' services were made under the reasonable charge system. Payments under this system largely reflected the charging patterns of physicians, which resulted in large differences in payment for physicians' services among types of services, physician specialties and geographic payment areas.

Local Medicare carriers initially established 210 payment localities, to reflect local physician charging patterns and economic conditions. These localities changed little between the inception of Medicare in 1967 and the beginning of the PFS in 1992. In 1994, we undertook a study that culminated in a comprehensive locality revision (based on locality resource cost differences as reflected by the GPCIs) that we implemented in 1997. The development of the current locality structure is described in detail in the CY 1997 PFS final rule (61 FR 34615) and the subsequent final rule with comment period (61 FR 59494). The revised locality structure reduced the number of localities from 210 to 89, and increased the number of statewide localities from 22 to 34.

Section 220(h) of the Protecting Access to Medicare Act (PAMA) (Pub. L. 113-93, enacted April 1, 2014) required modifications to the payment localities in California for payment purposes beginning with 2017. As a result, in the CY 2017 PFS final rule (81 FR 80265 through 80268) we established 23 additional localities, increasing the total number of PFS localities from 89 to 112. The 112 payment localities include 34 statewide areas (that is, only one locality for the entire state) and 75 localities in the other 16 states, with 10 states having two localities, two states having three localities, one state having four localities, and three states having five or more localities. The remainder of the 112 PFS payment localities are comprised as follows: The combined District of Columbia, Maryland, and Virginia suburbs; Puerto Rico; and the Virgin Islands. We note that the localities generally represent a grouping of one or more constituent counties.

The current 112 fee schedule areas are defined alternatively by state boundaries (for example, Wisconsin), metropolitan areas (for example, Metropolitan St. Louis, MO), portions of a metropolitan area (for example, Manhattan), or rest-of-state areas that exclude metropolitan areas (for example, Rest of Missouri). This locality configuration is used to calculate the GPCIs that are in turn used to calculate locality adjusted payments for physicians' services under the PFS.

As stated in the CY 2011 PFS final rule with comment period (75 FR 73261), changes to the PFS locality structure would generally result in changes that are budget neutral within a state. For many years, before making any locality changes, we have sought consensus from among the professionals whose payments would be affected. We refer readers to the CY 2014 PFS final rule with comment period (78 FR 74384 through 74386) for further discussion regarding additional information about locality configuration considerations.

3. GPCI Update

As required by the statute, we developed GPCIs to measure relative cost differences among payment localities compared to the national average for each of the three fee schedule components (that is, work, PE, and MP). We describe the data sources and methodologies we use to calculate each of the three GPCIs below in this section. Additional information on the CY 2020 GPCI update is available in an interim report, “Interim Report for the CY 2020 Update of GPCIs and MP RVUs for the Medicare Physician Fee Schedule,” on our website located under the supporting documents section for the CY 2020 PFS proposed rule at https://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​PhysicianFeeSched/​index.html.

a. Work GPCIs

The work GPCIs are designed to reflect the relative cost of physician labor by Medicare PFS locality. As required by statute, the work GPCI reflects one quarter of the relative wage differences for each locality compared to the national average.

To calculate the work GPCIs, we use wage data for seven professional specialty occupation categories, adjusted to reflect one-quarter of the relative cost differences for each locality compared to the national average, as a proxy for physicians' wages. Physicians' wages are not included in the occupation categories used in calculating the work GPCI because Medicare payments are a key determinant of physicians' earnings. Including physician wage data in calculating the work GPCIs would potentially introduce some circularity to the adjustment since Medicare payments typically contribute to or influence physician wages. That is, including physicians' wages in the physician work GPCIs would, in effect, make the indices, to some extent, dependent upon Medicare payments.

The work GPCI updates in CYs 2001, 2003, 2005, and 2008 were based on professional earnings data from the 2000 Census. However, for the CY 2011 GPCI update (75 FR 73252), the 2000 data were outdated and wage and earnings data were not available from the more recent Census because the “long form” was discontinued. Therefore, we used the median hourly earnings from the 2006 through 2008 Bureau of Labor Statistics (BLS) Occupational Employment Statistics (OES) wage data as a replacement for the 2000 Census data. The BLS OES data meet several criteria that we consider to be important for selecting a data source for purposes of calculating the GPCIs. For example, the BLS OES wage and employment data are derived from a large sample size of approximately 200,000 establishments of varying sizes nationwide from every metropolitan area and can be easily accessible to the public at no cost. Additionally, the BLS OES is updated regularly, and includes a comprehensive set of occupations and industries (for example, 800 occupations in 450 industries). For the CY 2014 GPCI update, we used updated BLS OES data (2009 through 2011) as a Start Printed Page 40512replacement for the 2006 through 2008 data to compute the work GPCIs; and for the CY 2017 GPCI update, we used updated BLS OES data (2011 through 2014) as a replacement for the 2009 through 2011 data to compute the work GPCIs.

Because of its reliability, public availability, level of detail, and national scope, we believe the BLS OES data continue to be the most appropriate source of wage and employment data for use in calculating the work GPCIs (and as discussed below, the employee wage component and purchased services component of the PE GPCI). Therefore, for the proposed CY 2020 GPCI update, we used updated BLS OES data (2014 through 2017) as a replacement for the 2011 through 2014 data to compute the work GPCIs.

b. Practice Expense (PE) GPCIs

The PE GPCIs are designed to measure the relative cost difference in the mix of goods and services comprising PEs (not including MP expenses) among the PFS localities as compared to the national average of these costs. Whereas the physician work GPCIs (and as discussed later in this section, the MP GPCIs) are comprised of a single index, the PE GPCIs are comprised of four component indices (employee wages; purchased services; office rent; and equipment, supplies and other miscellaneous expenses). The employee wage index component measures geographic variation in the cost of the kinds of skilled and unskilled labor that would be directly employed by a physician practice. Although the employee wage index adjusts for geographic variation in the cost of labor employed directly by physician practices, it does not account for geographic variation in the cost of services that typically would be purchased from other entities, such as law firms, accounting firms, information technology consultants, building service managers, or any other third-party vendor. The purchased services index component of the PE GPCI (which is a separate index from employee wages) measures geographic variation in the cost of contracted services that physician practices would typically buy. For more information on the development of the purchased service index, we refer readers to the CY 2012 PFS final rule with comment period (76 FR 73084 through 73085). The office rent index component of the PE GPCI measures relative geographic variation in the cost of typical physician office rents. For the medical equipment, supplies, and miscellaneous expenses component, we believe there is a national market for these items such that there is not significant geographic variation in costs. Therefore, the equipment, supplies and other miscellaneous expense cost index component of the PE GPCI is given a value of 1.000 for each PFS locality.

For the previous update to the GPCIs (implemented in CY 2017), we used 2011 through 2014 BLS OES data to calculate the employee wage and purchased services indices for the PE GPCI. As discussed previously in this section, because of its reliability, public availability, level of detail, and national scope, we continue to believe the BLS OES is the most appropriate data source for collecting wage and employment data. Therefore, in calculating the proposed CY 2020 GPCI update, we used updated BLS OES data (2014 through 2017) as a replacement for the 2011 through 2014 data for purposes of calculating the employee wage component and purchased service index component of the PE GPCI. In calculating the proposed CY 2020 GPCI update, for the office rent index component of the PE GPCI we used the most recently available, 2013 through 2017, American Community Survey (ACS) 5-year estimates as a replacement for the 2009 through 2013 ACS data.

c. Malpractice Expense (MP) GPCIs

The MP GPCIs measure the relative cost differences among PFS localities for the purchase of professional liability insurance (PLI). The MP GPCIs are calculated based on insurer rate filings of premium data for $1 million to $3 million mature claims-made policies (policies for claims made rather than losses occurring during the policy term). For the CY 2017 GPCI update, we used 2014 and 2015 malpractice premium data. The proposed CY 2020 MP GPCI update reflects premium data presumed in effect as of December 30, 2017. We note that we finalized a few technical refinements to the MP GPCI methodology in CY 2017, and refer readers to the CY 2017 PFS final rule (81 FR 80270) for additional discussion.

d. GPCI Cost Share Weights

For CY 2020 GPCIs, we are proposing to continue to use the current cost share weights for determining the PE GPCI values and locality GAFs. We refer readers to the CY 2014 PFS final rule with comment period (78 FR 74382 through 74383), for further discussion regarding the 2006-based MEI cost share weights revised in CY 2014 that we also finalized for use in the CY 2017 GPCI update.

The proposed GPCI cost share weights for CY 2020 are displayed in Table 12.

Table 12—Proposed Cost Share Weights for CY 2020 GPCI Update

Expense categoryCurrent cost share weight (%)Proposed CY 2020 cost share weight (%)
Work50.86650.866
Practice Expense44.83944.839
—Employee Compensation16.55316.553
—Office Rent10.22310.223
—Purchased Services8.0958.095
—Equipment, Supplies, Other9.9689.968
Malpractice Insurance4.2954.295
Total100.000100.000

e. PE GPCI Floor for Frontier States

Section 10324(c) of the Affordable Care Act added a new subparagraph (I) under section 1848(e)(1) of the Act to establish a 1.0 PE GPCI floor for physicians' services furnished in frontier states effective January 1, 2011. In accordance with section 1848(e)(1)(I) of the Act, beginning in CY 2011, we applied a 1.0 PE GPCI floor for physicians' services furnished in states determined to be frontier states. In general, a frontier state is one in which at least 50 percent of the counties are “frontier counties,” which are those that Start Printed Page 40513have a population per square mile of less than 6. For more information on the criteria used to define a frontier state, we refer readers to the FY 2011 Inpatient Prospective Payment System (IPPS) final rule (75 FR 50160 through 50161). There are no changes in the states identified as Frontier States for the CY 2020 PFS proposed rule. The qualifying states are: Montana; Wyoming; North Dakota; South Dakota; and Nevada. In accordance with statute, we would apply a 1.0 PE GPCI floor for these states in CY 2020.

f. Methodology for Calculating GPCIs in the U.S. Territories

Prior to CY 2017, for all the island territories other than Puerto Rico, the lack of comprehensive data about unique costs for island territories had minimal impact on GPCIs because we used either the Hawaii GPCIs (for the Pacific territories: Guam; American Samoa; and Northern Mariana Islands) or used the unadjusted national averages (for the Virgin Islands). In an effort to provide greater consistency in the calculation of GPCIs given the lack of comprehensive data regarding the validity of applying the proxy data used in the States in accurately accounting for variability of costs for these island territories, in the CY 2017 PFS final rule (81 FR 80268 through 80270), we finalized a policy to treat the Caribbean Island territories (the Virgin Islands and Puerto Rico) in a consistent manner. We do so by assigning the national average of 1.0 to each GPCI index for both Puerto Rico and the Virgin Islands. We refer readers to the CY 2017 PFS final rule for a comprehensive discussion of this policy.

g. California Locality Update to the Fee Schedule Areas Used for Payment Under Section 220(h) of the Protecting Access to Medicare Act

Section 220(h) of the PAMA added a new section 1848(e)(6) to the Act that modified the fee schedule areas used for payment purposes in California beginning in CY 2017. Prior to CY 2017, the fee schedule areas used for payment in California were based on the revised locality structure that was implemented in 1997 as previously discussed. Beginning in CY 2017, section 1848(e)(6)(A)(i) of the Act required that the fee schedule areas used for payment in California must be Metropolitan Statistical Areas (MSAs) as defined by the Office of Management and Budget (OMB) as of December 31 of the previous year; and section 1848(e)(6)(A)(ii) of the Act required that all areas not located in an MSA must be treated as a single rest-of-state fee schedule area. The resulting modifications to California's locality structure increased its number of localities from 9 under the current locality structure to 27 under the MSA-based locality structure; although for the purposes of payment the actual number of localities under the MSA-based locality structure is 32. We refer readers to the CY 2017 PFS final rule (81 FR 80267) for a detailed discussion of this operational consideration.

Section 1848(e)(6)(D) of the Act defined transition areas as the fee schedule areas for 2013 that were the rest-of-state locality, and locality 3, which was comprised of Marin County, Napa County, and Solano County. Section 1848(e)(6)(B) of the Act specified that the GPCI values used for payment in a transition area are to be phased in over 6 years, from 2017 through 2022, using a weighted sum of the GPCIs calculated under the new MSA-based locality structure and the GPCIs calculated under the current PFS locality structure. That is, the GPCI values applicable for these areas during this transition period are a blend of what the GPCI values would have been for California under the current locality structure, and what the GPCI values would be for California under the MSA-based locality structure. For example, in CY 2020, which represents the fourth year, the applicable GPCI values for counties that were previously in rest-of-state or locality 3 and are now in MSAs are a blend of 2/3 of the GPCI value calculated for the year under the MSA-based locality structure, and 1/3 of the GPCI value calculated for the year under the current locality structure. The proportions continue to shift by 1/6 in each subsequent year so that, by CY 2021, the applicable GPCI values for counties within transition areas are a blend of 5/6 of the GPCI value for the year under the MSA-based locality structure, and 1/6 of the GPCI value for the year under the current locality structure. Beginning in CY 2022, the applicable GPCI values for counties in transition areas are the values calculated solely under the new MSA-based locality structure. For clarity, we reiterate that this incremental phase-in is only applicable to those counties that are in transition areas that are now in MSAs, which are only some of the counties in the 2013 California rest-of state locality and locality 3.

Additionally, section 1848(e)(6)(C) of the Act establishes a hold harmless for transition areas beginning with CY 2017 whereby the applicable GPCI values for a year under the new MSA-based locality structure may not be less than what they would have been for the year under the current locality structure. There are a total of 58 counties in California, 50 of which are in transition areas as defined in section 1848(e)(6)(D) of the Act. The eight counties that are not within transition areas are: Orange; Los Angeles; Alameda; Contra Costa; San Francisco; San Mateo; Santa Clara; and Ventura counties.

For the purposes of calculating budget neutrality and consistent with the PFS budget neutrality requirements as specified under section 1848(c)(2)(B)(ii)(II) of the Act, we finalized the policy to start by calculating the national GPCIs as if the current localities are still applicable nationwide; then, for the purposes of payment in California, we override the GPCI values with the values that are applicable for California consistent with the requirements of section 1848(e)(6) of the Act. This approach is consistent with the implementation of the GPCI floor provisions that have previously been implemented—that is, as an after-the-fact adjustment that is implemented for purposes of payment after both the GPCIs and PFS budget neutrality have already been calculated.

Additionally, section 1848(e)(1)(C) of the Act requires that, if more than 1 year has elapsed since the date of the last previous GPCI adjustment, the adjustment to be applied in the first year of the next adjustment shall be 1/2 of the adjustment that otherwise would be made. However, since section 1848(e)(6)(B) of the Act provides for a gradual phase in of the GPCI values under the new MSA-based locality structure for California, specifically in one-sixth increments over 6 years, if we were to also apply the requirement to phase in 1/2 of the adjustment in year 1 of the GPCI update then the first year increment would effectively be 1/12. Therefore, in CY 2017, we finalized a policy that the requirement at section 1848(e)(1)(C) of the Act to phase in 1/2 of the adjustment in year 1 of the GPCI update would not apply to counties that were previously in the rest-of-state or locality 3 and are now in MSAs that are subject to the blended phase-in as described above in this section. We reiterate that this is only applicable through CY 2021 since, beginning in CY 2022, the GPCI values for such areas in an MSA would be fully based on the values calculated under the new MSA-based locality structure for California. For a comprehensive discussion of this provision, transition areas, and operational considerations, we refer readers to the CY 2017 PFS final rule (81 FR 80265 through 80268).Start Printed Page 40514

h. Refinements to the GPCI Methodology

In the process of calculating GPCIs for the purposes of this proposed rule, we identified two technical refinements to the methodology that yield improvements over the current method; these refinements are applicable to the work GPCI and the employee wage index and purchased services index components of the PE GPCI. We are proposing to weight by total employment when computing county median wages for each occupation code which addresses the fact that the occupation wage can vary by industry within a county. Additionally, we are also proposing to use a weighted average when calculating the final county-level wage index; this removes the possibility that a county index would imply a wage of 0 for any occupation group not present in the county's data. These proposed methodological refinements yield improved mathematical precision. Additional information on the GPCI methodology and the proposed refinements are available in the interim report, “Interim Report for the CY 2020 Update of GPCIs and MP RVUs for the Medicare Physician Fee Schedule” on our website located under the supporting documents section of the CY 2020 PFS proposed rule at https://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​PhysicianFeeSched/​index.html.

i. Proposed GPCI Update Summary

As explained above in the Background section above, the periodic review and adjustment of GPCIs is mandated by section 1848(e)(1)(C) of the Act. At each update, the proposed GPCIs are published in the PFS proposed rule to provide an opportunity for public comment and further revisions in response to comments prior to implementation. The proposed CY 2020 updated GPCIs for the first and second year of the 2-year transition, along with the GAFs, are displayed in Addenda D and E to this proposed rule available on our website under the supporting documents section of the CY 2020 PFS proposed rule web page at https://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​PhysicianFeeSched/​index.html.

E. Potentially Misvalued Services Under the PFS

1. Background

Section 1848(c)(2)(B) of the Act directs the Secretary to conduct a periodic review, not less often than every 5 years, of the RVUs established under the PFS. Section 1848(c)(2)(K) of the Act requires the Secretary to periodically identify potentially misvalued services using certain criteria and to review and make appropriate adjustments to the relative values for those services. Section 1848(c)(2)(L) of the Act also requires the Secretary to develop a process to validate the RVUs of certain potentially misvalued codes under the PFS, using the same criteria used to identify potentially misvalued codes, and to make appropriate adjustments.

As discussed in section II.N. of this proposed rule, Valuation of Specific Codes, each year we develop appropriate adjustments to the RVUs taking into account recommendations provided by the RUC, MedPAC, and other stakeholders. For many years, the RUC has provided us with recommendations on the appropriate relative values for new, revised, and potentially misvalued PFS services. We review these recommendations on a code-by-code basis and consider these recommendations in conjunction with analyses of other data, such as claims data, to inform the decision-making process as authorized by law. We may also consider analyses of work time, work RVUs, or direct PE inputs using other data sources, such as Department of Veteran Affairs (VA), National Surgical Quality Improvement Program (NSQIP), the Society for Thoracic Surgeons (STS), and the Merit-based Incentive Payment System (MIPS) data. In addition to considering the most recently available data, we assess the results of physician surveys and specialty recommendations submitted to us by the RUC for our review. We also consider information provided by other stakeholders. We conduct a review to assess the appropriate RVUs in the context of contemporary medical practice. We note that section 1848(c)(2)(A)(ii) of the Act authorizes the use of extrapolation and other techniques to determine the RVUs for physicians' services for which specific data are not available and requires us to take into account the results of consultations with organizations representing physicians who provide the services. In accordance with section 1848(c) of the Act, we determine and make appropriate adjustments to the RVUs.

In its March 2006 Report to the Congress (http://www.medpac.gov/​docs/​default-source/​reports/​Mar06_​Ch03.pdf?​sfvrsn=​0), MedPAC discussed the importance of appropriately valuing physicians' services, noting that misvalued services can distort the market for physicians' services, as well as for other health care services that physicians order, such as hospital services. In that same report, MedPAC postulated that physicians' services under the PFS can become misvalued over time. MedPAC stated, “When a new service is added to the physician fee schedule, it may be assigned a relatively high value because of the time, technical skill, and psychological stress that are often required to furnish that service. Over time, the work required for certain services would be expected to decline as physicians become more familiar with the service and more efficient in furnishing it.” We believe services can also become overvalued when PE declines. This can happen when the costs of equipment and supplies fall, or when equipment is used more frequently than is estimated in the PE methodology, reducing its cost per use. Likewise, services can become undervalued when physician work increases or PE rises.

As MedPAC noted in its March 2009 Report to Congress (http://www.medpac.gov/​docs/​default-source/​reports/​march-2009-report-to-congress-medicare-payment-policy.pdf), in the intervening years since MedPAC made the initial recommendations, CMS and the RUC have taken several steps to improve the review process. Also, section 1848(c)(2)(K)(ii) of the Act augments our efforts by directing the Secretary to specifically examine, as determined appropriate, potentially misvalued services in the following categories:

  • Codes that have experienced the fastest growth.
  • Codes that have experienced substantial changes in PE.
  • Codes that describe new technologies or services within an appropriate time period (such as 3 years) after the relative values are initially established for such codes.
  • Codes which are multiple codes that are frequently billed in conjunction with furnishing a single service.
  • Codes with low relative values, particularly those that are often billed multiple times for a single treatment.
  • Codes that have not been subject to review since implementation of the fee schedule.
  • Codes that account for the majority of spending under the PFS.
  • Codes for services that have experienced a substantial change in the hospital length of stay or procedure time.
  • Codes for which there may be a change in the typical site of service since the code was last valued.
  • Codes for which there is a significant difference in payment for the Start Printed Page 40515same service between different sites of service.
  • Codes for which there may be anomalies in relative values within a family of codes.
  • Codes for services where there may be efficiencies when a service is furnished at the same time as other services.
  • Codes with high intraservice work per unit of time.
  • Codes with high PE RVUs.
  • Codes with high cost supplies.
  • Codes as determined appropriate by the Secretary.

Section 1848(c)(2)(K)(iii) of the Act also specifies that the Secretary may use existing processes to receive recommendations on the review and appropriate adjustment of potentially misvalued services. In addition, the Secretary may conduct surveys, other data collection activities, studies, or other analyses, as the Secretary determines to be appropriate, to facilitate the review and appropriate adjustment of potentially misvalued services. This section also authorizes the use of analytic contractors to identify and analyze potentially misvalued codes, conduct surveys or collect data, and make recommendations on the review and appropriate adjustment of potentially misvalued services. Additionally, this section provides that the Secretary may coordinate the review and adjustment of any RVU with the periodic review described in section 1848(c)(2)(B) of the Act. Section 1848(c)(2)(K)(iii)(V) of the Act specifies that the Secretary may make appropriate coding revisions (including using existing processes for consideration of coding changes) that may include consolidation of individual services into bundled codes for payment under the PFS.

2. Progress in Identifying and Reviewing Potentially Misvalued Codes

To fulfill our statutory mandate, we have identified and reviewed numerous potentially misvalued codes as specified in section 1848(c)(2)(K)(ii) of the Act, and we intend to continue our work examining potentially misvalued codes in these areas over the upcoming years. As part of our current process, we identify potentially misvalued codes for review, and request recommendations from the RUC and other public commenters on revised work RVUs and direct PE inputs for those codes. The RUC, through its own processes, also identifies potentially misvalued codes for review. Through our public nomination process for potentially misvalued codes established in the CY 2012 PFS final rule with comment period, other individuals and stakeholder groups submit nominations for review of potentially misvalued codes as well. Individuals and stakeholder groups may submit codes for review under the potentially misvalued codes initiative to CMS in one of two ways. Nominations may be submitted to CMS via email or through postal mail. Email submissions should be sent to the CMS emailbox MedicarePhysicianFeeSchedule@cms.hhs.gov, with the phrase “Potentially Misvalued Codes” in the subject line. Physical letters for nominations should be sent via the U.S. Postal Service to the Centers for Medicare and Medicaid Service, Mail Stop: C4-01-26, 7500 Security Blvd., Baltimore, Maryland 21244. Envelopes containing the nomination letters must be labeled “Attention: Division of Practitioner Services, Potentially Misvalued Codes”. Nominations for consideration in our next annual rule cycle should be received by our February 10th deadline. Since CY 2009, as a part of the annual potentially misvalued code review and Five-Year Review process, we have reviewed approximately 1,700 potentially misvalued codes to refine work RVUs and direct PE inputs. We have assigned appropriate work RVUs and direct PE inputs for these services as a result of these reviews. A more detailed discussion of the extensive prior reviews of potentially misvalued codes is included in the Medicare Program; Payment Policies Under the Physician Fee Schedule, Five-Year Review of Work Relative Value Units, Clinical Laboratory Fee Schedule: Signature on Requisition, and Other Revisions to Part B for CY 2012; Final Rule (76 FR 73052 through 73055) (hereinafter referred to as the CY 2012 PFS final rule with comment period). In the CY 2012 PFS final rule with comment period (76 FR 73055 through 73958), we finalized our policy to consolidate the review of physician work and PE at the same time, and established a process for the annual public nomination of potentially misvalued services.

In the Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule, DME Face-to-Face Encounters, Elimination of the Requirement for Termination of Non-Random Prepayment Complex Medical Review and Other Revisions to Part B for CY 2013 (77 FR 68892) (hereinafter referred to as the CY 2013 PFS final rule with comment period), we built upon the work we began in CY 2009 to review potentially misvalued codes that have not been reviewed since the implementation of the PFS (so-called “Harvard-valued codes”). In the Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2009; and Revisions to the Amendment of the E-Prescribing Exemption for Computer Generated Facsimile Transmissions; Proposed Rule (73 FR 38589) (hereinafter referred to the CY 2009 PFS proposed rule), we requested recommendations from the RUC to aid in our review of Harvard-valued codes that had not yet been reviewed, focusing first on high-volume, low intensity codes. In the fourth Five-Year Review (76 FR 32410), we requested recommendations from the RUC to aid in our review of Harvard-valued codes with annual utilization of greater than 30,000 services. In the CY 2013 PFS final rule with comment period, we identified specific Harvard-valued services with annual allowed charges that total at least $10,000,000 as potentially misvalued. In addition to the Harvard-valued codes, in the CY 2013 PFS final rule with comment period we finalized for review a list of potentially misvalued codes that have stand-alone PE (codes with physician work and no listed work time and codes with no physician work that have listed work time).

In the Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY 2016 final rule with comment period (80 FR 70886) (hereinafter referred to as the CY 2016 PFS final rule with comment period), we finalized for review a list of potentially misvalued services, which included eight codes in the neurostimulators analysis-programming family (CPT codes 95970-95982). We also finalized as potentially misvalued 103 codes identified through our screen of high expenditure services across specialties.

In the Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY 2017; Medicare Advantage Bid Pricing Data Release; Medicare Advantage and Part D Medical Loss Ratio Data Release; Medicare Advantage Provider Network Requirements; Expansion of Medicare Diabetes Prevention Program Model; Medicare Shared Savings Program Requirements final rule (81 FR 80170) (hereinafter referred to as the CY 2017 PFS final rule), we finalized for review a list of potentially misvalued services, which included eight codes in the end-stage renal disease home dialysis family (CPT codes 90963-90970). We also finalized as potentially misvalued 19 codes Start Printed Page 40516identified through our screen for 0-day global services that are typically billed with an evaluation and management (E/M) service with modifier 25.

In the CY 2018 PFS final rule, we finalized arthrodesis of sacroiliac joint (CPT code 27279) as potentially misvalued. Through the use of comment solicitations with regard to specific codes, we also examined the valuations of other services, in addition to, new potentially misvalued code screens (82 FR 53017 through 53018).

3. CY 2020 Identification and Review of Potentially Misvalued Services

In the CY 2012 PFS final rule with comment period (76 FR 73058), we finalized a process for the public to nominate potentially misvalued codes. In the CY 2015 PFS final rule with comment period (79 FR 67606 through 67608), we modified this process whereby the public and stakeholders may nominate potentially misvalued codes for review by submitting the code with supporting documentation by February 10th of each year. Supporting documentation for codes nominated for the annual review of potentially misvalued codes may include the following:

  • Documentation in peer reviewed medical literature or other reliable data that demonstrate changes in physician work due to one or more of the following: Technique, knowledge and technology, patient population, site-of-service, length of hospital stay, and work time.
  • An anomalous relationship between the code being proposed for review and other codes.
  • Evidence that technology has changed physician work.
  • Analysis of other data on time and effort measures, such as operating room logs or national and other representative databases.
  • Evidence that incorrect assumptions were made in the previous valuation of the service, such as a misleading vignette, survey, or flawed crosswalk assumptions in a previous evaluation.
  • Prices for certain high cost supplies or other direct PE inputs that are used to determine PE RVUs are inaccurate and do not reflect current information.
  • Analyses of work time, work RVU, or direct PE inputs using other data sources (for example, VA, NSQIP, the STS National Database, and the MIPS data).
  • National surveys of work time and intensity from professional and management societies and organizations, such as hospital associations.

We evaluate the supporting documentation submitted with the nominated codes and assess whether the nominated codes appear to be potentially misvalued codes appropriate for review under the annual process. In the following year's PFS proposed rule, we publish the list of nominated codes and indicate for each nominated code whether we agree with its inclusion as a potentially misvalued code. The public has the opportunity to comment on these and all other proposed potentially misvalued codes. In that year's final rule, we finalize our list of potentially misvalued codes.

a. Public Nominations

We received three submissions that nominated codes for review under the potentially misvalued code initiative, prior to our February 10, 2019 deadline. In addition to three public nominations, CMS also nominated one additional code for review.

One commenter requested that CMS consider CPT code 10005 (Fine needle aspiration biopsy, including ultrasound guidance; first lesion) and CPT code 10021 (Fine needle aspiration biopsy, without imaging guidance; first lesion) for nomination as potentially misvalued. We note that these two CPT codes were recently reviewed within a family of 13 similar codes. Our review of these codes and our rationale for finalizing the current values are discussed extensively in the CY 2019 PFS final rule (83 FR 59517). For CPT code 10021, the RUC recommended a 32 percent reduction from its previous physician time and a 5 percent reduction in the work RVU. The commenter disagreed with this change and stated that there was a change in intensity of the procedure now as compared to what it was in 1995 when this code was last evaluated. The commenter also stated that there was a change in intensity of the work performed due to use of more complicated equipment, more stringent specimen sampling that allow for extensive examination of smaller and deeper lesions within the body. The commenter disagreed with the CMS' crosswalked CPT code 36440 (Push blood transfusion, patient 2 years or younger) and presented CPT codes 40490 (Biopsy of lip) and 95865 (Needle measurement and recording of electrical activity of muscles of voice box) as more appropriate crosswalks.

Another commenter requested that CMS consider HCPCS code G0166 (External counterpulsation, per treatment session) as potentially misvalued. This code was reviewed for the CY 2019 PFS final rule (83 FR 59578), and the work RVU and direct PE inputs as recommended by the AMA RUC were finalized by CMS. We finalized the valuation of this code with no refinements. However, the commenter noted that the PE inputs that were considered for this code did not fully reflect the total resources required to deliver the service. We will review the commenter's submission of additional new data and public comments received in combination with what was previously presented in the CY 2019 PFS final rule.

CMS nominated CPT code 76377 (3D rendering with interpretation and reporting of computed tomography, magnetic resonance imaging, ultrasound, or other tomographic modality with image postprocessing under concurrent supervision; requiring image postprocessing on an independent workstation) as potentially misvalued. CPT code 76376 (3D rendering with interpretation and reporting of computed tomography, magnetic resonance imaging, ultrasound, or other tomographic modality with image postprocessing under concurrent supervision; not requiring image postprocessing on an independent workstation) was reviewed by the AMA RUC at the April 2018 RUC meeting. However, CPT code 76377, which is very similar to CPT code 76376, was not reviewed, and is likely now misvalued, in light of the similarities between the two codes. The specialty societies noted that the two codes are different because they are utilized by different patient populations (as evidenced by the ICD-10 diagnoses); however, we view both codes to be similar enough that CPT code 76377 should be reviewed to maintain relativity in the code family.

We are proposing the aforementioned public and CMS nominated codes as potentially misvalued and welcome public comment on these codes.

Another commenter provided information to CMS in which they stated that the work involved in furnishing services represented by the office/outpatient evaluation and management (E/M) code set (CPT codes 99201-99215) has changed sufficiently to warrant revaluation. Specifically, the commenter stated that these codes have not been reviewed in over 12 years and in that time have suffered passive devaluation as more and more procedures and other services have been added to the CPT code set, which are subsequently valued in a budget neutral manner, through notice and comment rulemaking, on the Medicare PFS. The commenter also stated that re-evaluation of these codes is critical to the success Start Printed Page 40517of CMS' objective of advancing value-based care through the introduction of advanced alternative payment models (APMs) as these APMs rely on the underlying E/M codes as the basis for payment or reference price for bundled payments.

We acknowledge the points made by the commenter, and continue to consider the best ways to recognize the significant changes in healthcare practice as discussed by the commenter. We agree, in principle, that the existing set of office/outpatient E/M CPT codes may not be correctly valued. In recent years, we have specifically considered how best to update and revalue the E/M codes, which represent a significant proportion of PFS expenditures, and have also engaged in ongoing dialogue with the practitioner community. In the CY 2019 PFS proposed and final rules, in part due to these ongoing stakeholder discussions, we proposed and finalized changes to E/M payment and documentation requirements to implement policy objectives focused on reducing provider documentation burden (83 FR 59625). Concurrently, the CPT Editorial Panel, under similar burden reduction guiding principles, convened a workgroup and proposed to refine and revalue the existing E/M office/outpatient code set. We thank the commenter for the views represented in their comment. As stated earlier in this section, we agree in principle that the existing set of office/outpatient E/M CPT codes may not be correctly valued, and therefore, we will continue to consider opportunities to revalue these codes, in light of their significance to payment for services billed under Medicare.

Table 13 lists the HCPCS and CPT codes that we are proposing as potentially misvalued.

Table 13—HCPCS and CPT Codes Proposed as Potentially Misvalued

CPT/HCPCS codeShort description
10005Fna bx w/us gdn 1st les.
10021Fna bx w/o img gdn 1st les.
763773d render w/intrp postproces.
G0166Extrnl counterpulse, per tx.

F. Payment for Medicare Telehealth Services Under Section 1834(m) of the Act

As discussed in this rule and in prior rulemaking, several conditions must be met for Medicare to make payment for telehealth services under the PFS. For further details, see the full discussion of the scope of Medicare telehealth services in the CY 2018 PFS final rule (82 FR 53006) and in 42 CFR 410.78 and 414.65.

1. Adding Services to the List of Medicare Telehealth Services

In the CY 2003 PFS final rule with comment period (67 FR 79988), we established a process for adding services to or deleting services from the list of Medicare telehealth services in accordance with section 1834(m)(4)(F)(ii) of the Act. This process provides the public with an ongoing opportunity to submit requests for adding services, which are then reviewed by us. Under this process, we assign any submitted request to add to the list of telehealth services to one of the following two categories:

  • Category 1: Services that are similar to professional consultations, office visits, and office psychiatry services that are currently on the list of telehealth services. In reviewing these requests, we look for similarities between the requested and existing telehealth services for the roles of, and interactions among, the beneficiary, the physician (or other practitioner) at the distant site and, if necessary, the telepresenter, a practitioner who is present with the beneficiary in the originating site. We also look for similarities in the telecommunications system used to deliver the service; for example, the use of interactive audio and video equipment.
  • Category 2: Services that are not similar to those on the current list of telehealth services. Our review of these requests includes an assessment of whether the service is accurately described by the corresponding code when furnished via telehealth and whether the use of a telecommunications system to furnish the service produces demonstrated clinical benefit to the patient. Submitted evidence should include both a description of relevant clinical studies that demonstrate the service furnished by telehealth to a Medicare beneficiary improves the diagnosis or treatment of an illness or injury or improves the functioning of a malformed body part, including dates and findings, and a list and copies of published peer reviewed articles relevant to the service when furnished via telehealth. Our evidentiary standard of clinical benefit does not include minor or incidental benefits.

Some examples of clinical benefit include the following:

  • Ability to diagnose a medical condition in a patient population without access to clinically appropriate in-person diagnostic services.
  • Treatment option for a patient population without access to clinically appropriate in-person treatment options.
  • Reduced rate of complications.
  • Decreased rate of subsequent diagnostic or therapeutic interventions (for example, due to reduced rate of recurrence of the disease process).
  • Decreased number of future hospitalizations or physician visits.
  • More rapid beneficial resolution of the disease process treatment.
  • Decreased pain, bleeding, or other quantifiable symptom.
  • Reduced recovery time.

The list of telehealth services, including the proposed additions described later in this section, can be located on the CMS website at https://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​PhysicianFeeSched/​PFS-Federal-Regulation-Notices.html.

Historically, requests to add services to the list of Medicare telehealth services had to be submitted and received no later than December 31 of each calendar year to be considered for the next rulemaking cycle. However, beginning in CY 2019 we stated that for CY 2019 and onward, we intend to accept requests through February 10, consistent with the deadline for our receipt of code valuation recommendations from the RUC. For example, to be considered during PFS rulemaking for CY 2021, requests to add services to the list of Medicare telehealth services must be submitted and received by February 10, 2020. Each request to add a service to the list of Medicare telehealth services must include any supporting documentation the requester wishes us to consider as we review the request. Because we use the annual PFS rulemaking process as the vehicle to make changes to the list of Medicare telehealth services, requesters should be advised that any information submitted as part of a request is subject to public disclosure for this purpose. For more information on submitting a request to add services to the list of Medicare telehealth services, including where to mail these requests, see our website at https://www.cms.gov/​Medicare/​Medicare-General-Information/​Telehealth/​index.html.

2. Requests To Add Services to the List of Telehealth Services for CY 2020

Under our current policy, we add services to the telehealth list on a Category 1 basis when we determine that they are similar to services on the existing telehealth list for the roles of, Start Printed Page 40518and interactions among, the beneficiary, physician (or other practitioner) at the distant site and, if necessary, the telepresenter. As we stated in the CY 2012 PFS final rule with comment period (76 FR 73098), we believe that the Category 1 criteria not only streamline our review process for publicly requested services that fall into this category, but also expedite our ability to identify codes for the telehealth list that resemble those services already on this list.

We did not receive any requests from the public for additions to the Medicare Telehealth list for CY 2020. We believe that the vast majority of services under the PFS that can be appropriately furnished as Medicare telehealth services have already been added to the list.

However, there are three HCPCS G-codes describing new services being proposed in section II.H. of this rule for CY 2020 which we believe are sufficiently similar to services currently on the telehealth list to be added on a Category 1 basis. Therefore, we are proposing to add the face-to-face portions of the following services to the telehealth list on a Category 1 basis for CY 2020:

  • HCPCS code GYYY1: Office-based treatment for opioid use disorder, including development of the treatment plan, care coordination, individual therapy and group therapy and counseling; at least 70 minutes in the first calendar month.
  • HCPCS code GYYY2: Office-based treatment for opioid use disorder, including care coordination, individual therapy and group therapy and counseling; at least 60 minutes in a subsequent calendar month.
  • HCPCS code GYYY3: Office-based treatment for opioid use disorder, including care coordination, individual therapy and group therapy and counseling; each additional 30 minutes beyond the first 120 minutes (List separately in addition to code for primary procedure).

Similar to our addition of the required face-to-face visit component of TCM services to the Medicare Telehealth list in the CY 2014 PFS final rule with comment period (78 FR 74403), since HCPCS codes GYYY1, GYYY2, and GYYY3 include face-to-face psychotherapy services, we believe that the face-to-face portions of these services are sufficiently similar to services currently on the list of Medicare telehealth services for these services to be added under Category 1. Specifically, we believe that the psychotherapy portions of the bundled codes are similar to the psychotherapy codes described by CPT codes 90832 and 90853, which are currently on the Medicare telehealth services list. We note that like certain other non-face-to-face PFS services, the other components of HCPCS codes GYYY1-3 describing care coordination are commonly furnished remotely using telecommunications technology, and do not require the patient to be present in-person with the practitioner when they are furnished. As such, we do not need to consider whether the non-face-to-face aspects of HCPCS codes GYYY1-3 are similar to other telehealth services. Were these components of HCPCS codes GYYY1-3 separately billable, they would not need to be on the Medicare telehealth list to be covered and paid in the same way as services delivered without the use of telecommunications technology.

As discussed in the CY 2019 PFS final rule (83 FR 59496), we note that section 2001(a) of the SUPPORT Act (Pub. L. 115-271, October 24, 2018) amended section 1834(m) of the Act, adding a new paragraph (7) that removes the geographic limitations for telehealth services furnished on or after July 1, 2019, for individuals diagnosed with a substance use disorder (SUD) for the purpose of treating the SUD or a co-occurring mental health disorder. Section 1834(m)(7) of the Act also allows telehealth services for treatment of a diagnosed SUD or co-occurring mental health disorder to be furnished to individuals at any telehealth originating site (other than a renal dialysis facility), including in a patient's home. Section 2001(a) of the SUPPORT Act additionally amended section 1834(m) of the Act to require that no originating site facility fee will be paid in instances when the individual's home is the originating site. We believe that adding HCPCS codes GYYY1, GYYY2, and GYYY3 will complement the existing policies related to flexibilities in treating SUDs under Medicare Telehealth.

We note that we welcome public nominations for additions to the Medicare telehealth list. More information on the nomination process is posted under the Telehealth section of the CMS website, which can be accessed at the following web address https://www.cms.gov/​Medicare/​Medicare-General-Information/​Telehealth/​index.html.

G. Medicare Coverage for Opioid Use Disorder Treatment Services Furnished by Opioid Treatment Programs (OTPs)

1. Overview

Opioid use disorder (OUD) and deaths from prescription and illegal opioid overdoses have reached alarming levels. The Centers for Disease Control and Prevention (CDC) estimated 47,000 overdose deaths were from opioids in 2017 and 36 percent of those deaths were from prescription opioids.[1] OUD has become a public health crisis. On October 26, 2017, Acting Health and Human Services Secretary, Eric D. Hargan declared a nationwide public health emergency on the opioid crisis as requested by President Donald Trump.[2] This public health emergency was renewed by Secretary Alex M. Azar II on January 24, 2018, April 24, 2018, July 23, 2018, and October 21, 2018, January 17, 2019 and most recently, on April 19, 2019.[3]

The Medicare population, including individuals who are eligible for both Medicare and Medicaid, has the fastest growing prevalence of OUD compared to the general adult population, with more than 300,000 beneficiaries diagnosed with OUD in 2014.[4] An effective treatment for OUD is known as medication-assisted treatment (MAT). The Substance Abuse and Mental Health Services Administration (SAMHSA) defines MAT as the use of medication in combination with behavioral health services to provide an individualized approach to the treatment of substance use disorder, including opioid use disorder (42 CFR 8.2). Currently, Medicare covers medications for MAT, including buprenorphine, buprenorphine-naloxone combination products, and extended-release injectable naltrexone under Part B or Part D, but does not cover methadone. Medicare also covers counseling and behavioral therapy services that are reasonable and necessary and furnished by practitioners that can bill and receive payment under Medicare.

Historically, Medicare has not covered methadone for MAT because of the unique manner in which this drug is dispensed and administered. Medicare Part B covers physician-administered drugs, drugs used in Start Printed Page 40519conjunction with durable medical equipment, and certain other statutorily specified drugs. Medicare Part D covers drugs that are dispensed upon a prescription by a pharmacy. Methadone for MAT is not a drug administered by a physician under the incident to benefit like other MAT drugs (that is, implanted buprenorphine or injectable extended-release naltrexone) and therefore has not previously been covered by Medicare Part B. Methadone for MAT is also not a drug dispensed by a pharmacy like certain other MAT drugs (that is buprenorphine or buprenorphine-naloxone combination products) and therefore is not covered under Medicare Part D. Methadone for MAT is a schedule II controlled substance that is highly regulated because it has a high potential for abuse which may lead to severe psychological or physical dependence. As a result, methadone for MAT can only be dispensed and administered by an opioid treatment program (OTP) as provided under section 303(g)(1) of the Controlled Substances Act (21 U.S.C. 823(g)(1)) and 42 CFR part 8. Additionally, OTPs, which are healthcare entities that focus on providing MAT for people diagnosed with OUD, were not previously entities that could bill and receive payment from Medicare for the services they furnish. Therefore, there has historically been a gap in Medicare coverage of MAT for OUD since methadone (one of the three FDA-approved drugs for MAT) has not been covered.

Section 2005 of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (the SUPPORT Act) (Pub. L. 115-271, enacted October 24, 2018) added a new section 1861(jjj) to the Act, establishing a new Part B benefit category for OUD treatment services furnished by an OTP beginning on or after January 1, 2020. Section 1861(jjj)(1) of the Act defines OUD treatment services as items and services furnished by an OTP (as defined in section 1861(jjj)(2)) for treatment of OUD. Section 2005 of the SUPPORT Act also amended the definition of “medical and other health services” in section 1861(s) of the Act to provide for coverage of OUD treatment services and added a new section 1834(w) to the Act and amended section 1833(a)(1) of the Act to establish a bundled payment to OTPs for OUD treatment services furnished during an episode of care beginning on or after January 1, 2020.

OTPs must have a current, valid certification from SAMHSA to satisfy the Controlled Substances Act registration requirement under 21 U.S.C. 823(g)(1). To obtain SAMHSA certification, OTPs must have a valid accreditation by an accrediting body approved by SAMHSA, and must be certified by SAMHSA as meeting federal opioid treatment standards in 42 CFR 8.12. There are currently about 1,700 OTPs nationwide.[5] All states except Wyoming have OTPs. Approximately 74 percent of patients receiving services from OTPs receive methadone for MAT, with the vast majority of the remaining patients receiving buprenorphine.[6]

Many payers currently cover MAT services for treatment of OUD. Medicaid [7] is one of the largest payers of medications for substance use disorder (SUD), including methadone for MAT provided in OTPs.[8] OUD treatment services and MAT are also covered by other payers such as TRICARE and private insurers. TRICARE established coverage and payment for MAT and OUD treatment services furnished by OTPs in late 2016 (81 FR 61068). In addition, as discussed in the “Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2020” proposed rule, many qualified health plans covered MAT medications for plan year 2018 (84 FR 285).

In the CY 2019 PFS final rule (83 FR 59497), we included a Request for Information (RFI) to solicit public comments on the implementation of the new Medicare benefit category for OUD treatment services furnished by OTPs established by section 2005 of the SUPPORT Act. We received 9 public comments. Commenters were generally supportive of the new benefit and expanding access to OUD treatment for Medicare beneficiaries. We received feedback that the bundled payments to OTPs should recognize the intensity of services furnished in the initiation stages, durations of care, the needs of patients with more complex needs, costs of emerging technologies, and use of peer support groups. We also received feedback that costs associated with care coordination among the beneficiary's practitioners should be included in the bundled payment given the myriad of health issues beneficiaries with OUD face. We considered this feedback as we developed our proposals for implementing the new benefit category for OUD treatment services furnished by OTPs and the proposed bundled payments for these services.

To implement section 2005 of the SUPPORT Act, we are proposing to establish rules to govern Medicare coverage of and payment for OUD treatment services furnished in OTPs. In the following discussion, we propose to establish definitions of OUD treatment services and OTP for purposes of the Medicare Program. We also propose a methodology for determining Medicare payment for such services provided by OTPs. We are proposing to codify these policies in a new section of the regulations at § 410.67. For a discussion about Medicare enrollment requirements and the proposed program integrity approach for OTPs, we refer readers to section III.H. Medicare Enrollment of Opioid Treatment Programs, in this proposed rule.

2. Proposed Definitions

a. Opioid Use Disorder Treatment Services

The SUPPORT Act amended section 1861 of the Act by adding a new subsection (jjj)(1) that defines “opioid use disorder treatment services” as the items and services that are furnished by an OTP for the treatment of OUD, as set forth in subparagraphs (A) through (F) of section 1861(jjj)(1) of the Act which include:

  • Opioid agonist and antagonist treatment medications (including oral, injected, or implanted versions) that are approved by the Food and Drug Administration (FDA) under section 505 of the Federal Food, Drug, and Cosmetic Act (FFDCA) (21 U.S.C. 355) for use in the treatment of OUD;
  • Dispensing and administration of such medications, if applicable;
  • Substance use counseling by a professional to the extent authorized under state law to furnish such services;
  • Individual and group therapy with a physician or psychologist (or other mental health professional to the extent authorized under state law);
  • Toxicology testing; and
  • Other items and services that the Secretary determines are appropriate (but in no event to include meals or transportation).

As described previously, section 1861(jjj)(1)(A) of the Act defines covered OUD treatment services to include oral, Start Printed Page 40520injected, and implanted opioid agonist and antagonist medications approved by FDA under section 505 of the FFDCA for use in the treatment of OUD. There are three drugs currently approved by the FDA for the treatment of opioid dependence: Buprenorphine, methadone, and naltrexone.[9] FDA notes that all three of these medications have been demonstrated to be safe and effective in combination with counseling and psychosocial support and that those seeking treatment for an OUD should be offered access to all three options as this allows providers to work with patients to select the medication best suited to an individual's needs.[10] Each of these medications is discussed below in more detail.

Buprenorphine is FDA-approved for acute and chronic pain in addition to opioid dependence. It is listed by the Drug Enforcement Administration (DEA) as a Schedule III controlled substance because of its moderate to low potential for physical and psychological dependence.[11] [12] The medication's partial agonist properties allow for its use in opioid replacement therapy, which is a process of treating OUD by using a substance, for example, buprenorphine or methadone, to substitute for a stronger full agonist opioid.[13] Buprenorphine drug products that are currently FDA-approved and marketed for the treatment of opioid dependence include oral buprenorphine and naloxone [14] films and tablets, an extended-release buprenorphine injection for subcutaneous use, and a buprenorphine implant for subdermal administration.[15] In most patients with opioid dependence, the initial oral dose is 2 to 4 mg per day with a maintenance dose of 8-12 mg per day.[16] Dosing for the extended-release injection is 300 mg monthly for the first 2 months followed by a maintenance dose of 100 mg monthly.[17] The extended-release injection is indicated for patients who have initiated treatment with an oral buprenorphine product for a minimum of 7 days.[18] The buprenorphine implant consists of four rods containing 74.2 mg of buprenorphine each, and provides up to 6 months of treatment for patients who are clinically stable on low-to-moderate doses of an oral buprenorphine-containing product.[19] Currently, federal regulations permit buprenorphine to be prescribed or dispensed by qualifying physicians and qualifying other practitioners at office-based practices and dispensed in OTPs.[20] [21]

Methadone is FDA-approved for management of severe pain in addition to opioid dependence. It is listed by the DEA as a Schedule II controlled substance because of its high potential for abuse, with use potentially leading to severe psychological or physical dependence.[22] [23] Methadone drug products that are FDA-approved for the treatment of opioid dependence include oral methadone concentrate and tablets.[24] In patients with opioid dependence, the total daily dose of methadone on the first day of treatment should not ordinarily exceed 40 mg, unless the program physician documents in the patient's record that 40 milligrams did not suppress opioid abstinence, with clinical stability generally achieved at doses between 80 to 120 mg/day.[25] By law, methadone can only be dispensed through an OTP certified by SAMHSA.[26]

Naltrexone is FDA-approved to treat alcohol dependence in addition to opioid use disorder.[27] Unlike buprenorphine and methadone, which activate opioid receptors, naltrexone binds and blocks opioid receptors and reduces opioid cravings.[28] Therefore, naltrexone is not a scheduled substance; there is no abuse and diversion potential with naltrexone.[29 30] The naltrexone drug product that is FDA-approved for the treatment of opioid dependence is an extended-release, intramuscular injection.[31] The recommended dose is 380 mg delivered intramuscularly every 4 weeks or once a month after the patient has achieved an opioid-free duration of a minimum of 7-10 days.[32] Naltrexone can be prescribed by any health care provider who is licensed to prescribe medications.[33]

We propose that the OUD treatment services that may be furnished by OTPs include the first five items and services listed in the statutory definition described above, specifically the medications approved by the FDA under section 505 of the FFDCA for use in the treatment of OUD; the dispensing and administration of such medication, if applicable; substance use counseling; individual and group therapy; and toxicology testing. We also propose to use our discretion under section 1861(jjj)(1)(F) of the Act to include other items and services that the Secretary determines are appropriate to include the use of telecommunications for certain services, as discussed later in this section. We propose to codify this definition of OUD treatment services furnished by OTPs at § 410.67(b). As part of this definition, we also propose to specify that an OUD treatment service is an item or service that is furnished by an OTP that meets the applicable requirements to participate in the Medicare Program and receive payment.

We seek comment on any other items and services (not including meals or transportation as they are statutorily prohibited) currently covered and paid for under Medicare Part B when furnished by Medicare-enrolled providers/suppliers that the Secretary should consider adding to this definition, including any evidence supporting the impact of the use of such items and services in the treatment of OUD and enumeration of their costs. We are particularly interested in public feedback on whether intake activities, which may include services such as an initial physical examination, initial assessments and preparation of a treatment plan, as well as periodic assessments, should be included in the definition of OUD treatment services. Additionally, we understand that while the current FDA-approved medications under section 505 of the FFDCA for the treatment of OUD are opioid agonists and antagonist medications, other Start Printed Page 40521medications that are not opioid agonist and antagonist medications, including drugs and biologicals, could be developed for the treatment of OUD in the future. We would like public feedback on whether there are any drug development efforts in the pipeline that could result in medications intended for use in the treatment of OUD with a novel mechanism of action that does not involve opioid agonist and antagonist mechanisms (that is, outside of activating and/or blocking opioid receptors). We also welcome comment on how medications that may be approved by the FDA in the future for use in the treatment of OUD with a novel mechanism of action, such as medications approved under section 505 of the FFDCA to treat OUD and biological products licensed under section 351 of the Public Health Service Act to treat OUD, should be considered in the context of OUD treatment services provided by OTPs, and whether CMS should use the discretion afforded under section 1861(jjj)(1)(F) of the Act to include such medications in the definition of OUD treatment services given the possibility that such medications could be approved in the future.

b. Opioid Treatment Program

Section 2005 of the SUPPORT Act also amended section 1861 of the Act by adding a new subsection (jjj)(2) to define an OTP as an entity meeting the definition of OTP in 42 CFR 8.2 or any successor regulation (that is, a program or practitioner engaged in opioid treatment of individuals with an opioid agonist treatment medication registered under 21 U.S.C. 823(g)(1)), that meets the additional requirements set forth in subparagraphs (A) through (D) of section 1861(jjj)(2) of the Act. Specifically that the OTP:

  • Is enrolled under section 1866(j) of the Act;
  • Has in effect a certification by SAMHSA for such a program;
  • Is accredited by an accrediting body approved by SAMHSA; and
  • Meets such additional conditions as the Secretary may find necessary to ensure the health and safety of individuals being furnished services under such program and the effective and efficient furnishing of such services.

These requirements are discussed in more detail in this section.

(1) Enrollment

As discussed previously, under section 1861(jjj)(2)(A) of the Act, an OTP must be enrolled in Medicare to receive Medicare payment for covered OUD treatment services under section 1861(jjj)(1) of the Act. We refer the reader to section III.H. of this proposed rule, Medicare Enrollment of Opioid Treatment Programs, for further details on our proposed policies related to enrollment of OTPs.

(2) Certification by SAMHSA

As provided in section 1861(jjj)(2)(B) of the Act, OTPs must be certified by SAMHSA to furnish Medicare-covered OUD treatment services. SAMHSA has created a system to certify and accredit OTPs, which is governed by 42 CFR part 8, subparts B and C. This regulatory framework allows SAMHSA to focus its oversight efforts on improving treatment rather than solely ensuring that OTPs are meeting regulatory criteria, and preserves states' authority to regulate OTPs. To be certified by SAMHSA, OTPs must comply with the federal opioid treatment standards as outlined in § 8.12, be accredited by a SAMHSA-approved accreditation body, and comply with any other conditions for certification established by SAMHSA. Specifically, SAMHSA requires OTPs to provide the following services:

  • General—OTPs shall provide adequate medical, counseling, vocational, educational, and other assessment and treatment services.
  • Initial medical examination services—OTPs shall require each patient to undergo a complete, fully documented physical evaluation by a program physician or a primary care physician, or an authorized healthcare professional under the supervision of a program physician, before admission to the OTP.
  • Special services for pregnant patients—OTPs must maintain current policies and procedures that reflect the special needs of patients who are pregnant. Prenatal care and other gender specific services for pregnant patients must be provided either by the OTP or by referral to appropriate healthcare providers.
  • Initial and periodic assessment services—Each patient accepted for treatment at an OTP shall be assessed initially and periodically by qualified personnel to determine the most appropriate combination of services and treatment.
  • Counseling services—OTPs must provide adequate substance abuse counseling to each patient as clinically necessary by a program counselor, qualified by education, training, or experience to assess the patient's psychological and sociological background.
  • Drug abuse testing services—OTPs must provide adequate testing or analysis for drugs of abuse, including at least eight random drug abuse tests per year, per patient in maintenance treatment, in accordance with generally accepted clinical practice. For patients in short-term detoxification treatment, defined in 42 CFR 8.2 as detoxification treatment not in excess of 30 days, the OTP shall perform at least one initial drug abuse test. For patients receiving long-term detoxification treatment, the program shall perform initial and monthly random tests on each patient.

The provisions governing recordkeeping and patient confidentiality at § 8.12(g)(1) require that OTPs shall establish and maintain a recordkeeping system that is adequate to document and monitor patient care. All records are required to be kept confidential in accordance with all applicable federal and state requirements. The requirements at § 8.12(g)(2) state that OTPs shall document in each patient's record that the OTP made a good faith effort to review whether or not the patient is enrolled in any other OTP. A patient enrolled in an OTP shall not be permitted to obtain treatment in any other OTP except in exceptional circumstances, which is determined by the medical director or program physician of the OTP in which the patient is enrolled (42 CFR 8.12(g)(2)). Additionally, the requirements at § 8.12(h) address medication administration, dispensing, and use.

SAMHSA requires that OTPs shall ensure that opioid agonist treatment medications are administered or dispensed only by a practitioner licensed under the appropriate state law and registered under the appropriate state and federal laws to administer or dispense opioid drugs, or by an agent of such a practitioner, supervised by and under the order of the licensed practitioner. OTPs shall use only those opioid agonist treatment medications that are approved by the FDA for use in the treatment of OUD. They must maintain current procedures that are adequate to ensure that the dosing requirements are met, and each opioid agonist treatment medication used by the program is administered and dispensed in accordance with its approved product labeling.

At § 8.12(i), regarding unsupervised or “take-home” use of opioid agonist treatment medications, SAMHSA has specified that OTPs must follow requirements specified by SAMHSA to limit the potential for diversion of opioid agonist treatment medications to the illicit market when dispensed to patients as take-homes, including maintaining current procedures to identify the theft or diversion of take-Start Printed Page 40522home medications. The requirements at § 8.12(j) for interim maintenance treatment, state that the program sponsor of a public or nonprofit private OTP subject to the approval of SAMHSA and the state, may place an individual, who is eligible for admission to comprehensive maintenance treatment, in interim maintenance treatment if the individual cannot be placed in a public or nonprofit private comprehensive program within a reasonable geographic area and within 14 days of the individual's application for admission to comprehensive maintenance treatment. Patients in interim maintenance treatment are permitted to receive daily dosing, but take-homes are not permitted. During interim maintenance treatment, initial treatment plans and periodic treatment plan evaluations are not required and a primary counselor is not required to be assigned to the patient. The OTP must be able to transfer these patients from interim maintenance into comprehensive maintenance treatment within 120 days. Interim maintenance treatment must be provided in a manner consistent with all applicable federal and state laws.

The SAMHSA requirements at § 8.12(b) address administrative and organizational structure, requiring that an OTP's organizational structure and facilities shall be adequate to ensure quality patient care and meet the requirements of all pertinent federal, state, and local laws and regulations. At a minimum, each OTP shall formally designate a program sponsor and medical director who is a physician who is licensed to practice medicine in the jurisdiction in which the OTP is located. The program sponsor shall agree on behalf of the OTP to adhere to all requirements set forth in 42 CFR part 8, subpart C and any regulations regarding the use of opioid agonist treatment medications in the treatment of OUD, which may be promulgated in the future. The medical director shall assume responsibility for administering all medical services performed by the OTP. In addition, the medical director shall be responsible for ensuring that the OTP is in compliance with all applicable federal, state, and local laws and regulations.

The provision governing patient admission criteria at § 8.12(e) requires that an OTP shall maintain current procedures designed to ensure that patients are admitted to maintenance treatment by qualified personnel who have determined, using accepted medical criteria such as those listed in the Diagnostic and Statistical Manual of Mental Disorders, including that the person has an OUD, and that the person has had an OUD at least 1 year before admission for treatment. If under 18 years of age, the patient is required to have had two documented unsuccessful attempts at short-term detoxification or drug-free treatment within a 12-month period and have the written consent of a parent, legal guardian or responsible adult designated by the relevant state authority to be eligible for maintenance treatment.

To ensure continuous quality improvement, the requirements at § 8.12(c) state that an OTP must maintain current quality assurance and quality control plans that include, among other things, annual reviews of program policies and procedures and ongoing assessment of patient outcomes and a current Diversion Control Plan as part of its quality assurance program.

The requirements at § 8.12(d) with respect to staff credentials, state that each person engaged in the treatment of OUD must have sufficient education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions.

In addition to meeting the criteria described above, OTPs must apply to SAMHSA for certification. As part of the conditions for certification, SAMHSA specifies that OTPs shall:

  • Comply with all pertinent state laws and regulations.
  • Allow inspections and surveys by duly authorized employees of SAMHSA, by accreditation bodies, by the DEA, and by authorized employees of any relevant State or federal governmental authority.
  • Comply with the provisions of 42 CFR part 2 (regarding confidentiality of substance use disorder patient records).
  • Notify SAMHSA within 3 weeks of any replacement or other change in the status of the program sponsor or medical director.
  • Comply with all regulations enforced by the DEA under 21 CFR chapter II, and be registered by the DEA before administering or dispensing opioid agonist treatment medications.
  • Operate in accordance with federal opioid treatment standards and approved accreditation elements.

Furthermore, SAMHSA has issued additional guidance for OTPs that describes how programs can achieve and maintain compliance with federal regulations.[34]

(3) Accreditation of OTPs by a SAMHSA-Approved Accrediting Body

As provided in section 1861(jjj)(2)(C) of the Act, OTPs must be accredited by a SAMHSA-approved accrediting body in order to furnish Medicare-covered OUD treatment services. In 2001, the Department of Health and Human Services (HHS) and SAMHSA issued final regulations to establish a new oversight system for the treatment of substance use disorders with MAT (42 CFR part 8). SAMHSA-approved accrediting bodies evaluate OTPs and perform site visits to ensure SAMHSA's opioid dependency treatment standards are met. SAMHSA also requires OTPs to be accredited by a SAMHSA-approved accrediting body (42 CFR 8.11).

The SAMHSA regulations establish procedures for an entity to apply to become a SAMHSA-approved accrediting body (42 CFR 8.3). When determining whether to approve an applicant as an accreditation body, SAMHSA examines the following:

  • Evidence of the nonprofit status of the applicant (that is, of fulfilling Internal Revenue Service requirements as a nonprofit organization) if the applicant is not a state governmental entity or political subdivision;
  • The applicant's accreditation elements or standards and a detailed discussion showing how the proposed accreditation elements or standards will ensure that each OTP surveyed by the applicant is qualified to meet or is meeting each of the federal opioid treatment standards set forth in § 8.12;
  • A detailed description of the applicant's decision-making process, including:

++ Procedures for initiating and performing onsite accreditation surveys of OTPs;

++ Procedures for assessing OTP personnel qualifications;

++ Copies of an application for accreditation, guidelines, instructions, and other materials the applicant will send to OTPs during the accreditation process;

++ Policies and procedures for notifying OTPs and SAMHSA of deficiencies and for monitoring corrections of deficiencies by OTPs; for suspending or revoking an OTP's accreditation; and to ensure processing of applications for accreditation and for renewal of accreditation within a timeframe approved by SAMHSA; and;

++ A description of the applicant's appeals process to allow OTPs to contest adverse accreditation decisions.

  • Policies and procedures established by the accreditation body to avoid conflicts of interest, or the appearance of conflicts of interest;Start Printed Page 40523
  • A description of the education, experience, and training requirements for the applicant's professional staff, accreditation survey team membership, and the identification of at least one licensed physician on the applicant's staff;
  • A description of the applicant's training policies;
  • Fee schedules, with supporting cost data;
  • Satisfactory assurances that the applicant will comply with the requirements of § 8.4, including a contingency plan for investigating complaints under § 8.4(e);
  • Policies and procedures established to protect confidential information the applicant will collect or receive in its role as an accreditation body; and
  • Any other information SAMHSA may require.

SAMHSA periodically evaluates the performance of accreditation bodies primarily by inspecting a selected sample of the OTPs accredited by the accrediting body and by evaluating the accreditation body's reports of surveys conducted, to determine whether the OTPs surveyed and accredited by the accreditation body are in compliance with the federal opioid treatment standards. There are currently six SAMHSA-approved accreditation bodies.[35]

(4) Provider Agreement

Section 2005(d) of the SUPPORT Act amends section 1866(e) of the Act by adding a new paragraph (3) which includes opioid treatment programs (but only with respect to the furnishing of opioid use disorder treatment services) as a “provider of services” for purposes of section 1866 of the Act. All providers of services under section 1866 of the Act must enter into a provider agreement with the Secretary and comply with other requirements specified in that section. These requirements are implemented at 42 CFR part 489. Therefore, we are proposing to amend part 489 to include OTPs (but only with respect to the furnishing of opioid use disorder treatment services) as a provider. Specifically, we are proposing to add OTPs (but only with respect to the furnishing of opioid use disorder treatment services) to the list of providers in § 489.2. This addition makes clear that the other requirements specified in Section 1866, and implemented in part 489, which include the limits on charges to beneficiaries, would apply to OTPs (with respect to the furnishing of opioid use disorder treatment services). We are also proposing additional changes to make clear that certain parts of part 489, which implement statutory requirements other than section 1866 of the Act, do not apply to OTPs. For example, since we are not proposing any conditions of participation for OTPs, we are proposing to amend § 489.10(a), which states that providers specified in § 489.2 must meet conditions of participation, to add that OTPs must meet the requirements set forth in part 489 and elsewhere in that chapter. In addition, we are proposing to specify that the effective date of the provider agreement is the date on which CMS accepts a signed agreement (proposed amendment to § 489.13(a)(2)), and is not dependent on surveys or an accrediting organization's determination related to conditions of participation. Finally, as noted earlier in the preamble, OTPs are required to be certified by SAMHSA and accredited by an accrediting body approved by SAMHSA. In § 489.53, we are proposing to create a basis for termination of the provider agreement if the OTP no longer meets the requirements set forth in part 489 or elsewhere in that chapter (including if it no longer has a SAMHSA certification or accreditation by a SAMHSA-approved accrediting body). Finally, we are also proposing to revise 42 CFR part 498 to ensure that OTPs have access to the appeal process in case of an adverse determination concerning continued participation in the Medicare program. Specifically, we are amending the definition of provider in § 498.2 to include OTPs. We are continuing to review the application of the provider agreement requirements to OTPs and may make further amendments to parts 489 and 498 as necessary to ensure that the existing provider agreement regulations are applied to OTPs consistent with our proposals and Section 2005 of the SUPPORT Act.

(5) Additional Conditions

As provided in section 1861(jjj)(2)(D) of the Act, to furnish Medicare-covered OUD treatment services, OTPs must meet any additional conditions as the Secretary may find necessary to ensure the health and safety of individuals being furnished services under such program and the effective and efficient furnishing of such services. The comprehensive OTP standards for certification of OTPs address the same topics as would be addressed by CMS supplier standards, such as client assessment and the services required to be provided. Furthermore, the detailed process established by SAMHSA for selecting and overseeing its accreditation organizations is similar to the accrediting organization oversight process that would typically be established by CMS. Thus, we believe the existing SAMHSA certification and accreditation requirements are both appropriate and sufficient to ensure the health and safety of individuals being furnished services by OTPs, as well as the effective and efficient furnishing of such services. We also believe that creating additional conditions at this time for participation in Medicare by OTPs could create unnecessary regulatory duplication and could be potentially burdensome for OTPs. Therefore, CMS is not proposing any additional conditions for participation in Medicare by OTPs at this time. We welcome public comments on this proposed approach, including input on whether there are any additional conditions that should be required for OTPs furnishing Medicare-covered OUD treatment services.

(6) Proposed Definition of Opioid Treatment Program

We propose to define “opioid treatment program” at § 410.67(b) as an entity that is an opioid treatment program as defined in 42 CFR 8.2 (or any successor regulation) and meets the applicable requirements for an OTP. We propose to codify this definition at § 410.67(b). In addition, we propose that for an OTP to participate and receive payment under the Medicare program, the OTP must be enrolled under section 1866(j) of the Act, have in effect a certification by SAMHSA for such a program, and be accredited by an accrediting body approved by SAMHSA. We are also proposing that an OTP must have a provider agreement as required by section 1866(a) of the Act. We propose to codify these requirements at § 410.67(c). We welcome public comments on the proposed definition of OTP and the proposed Medicare requirements for OTPs.

3. Proposed Bundled Payments for OUD Treatment Services

Section 1834(w) of the Act, added by section 2005 of the SUPPORT Act, directs the Secretary to pay to the OTP an amount that is equal to 100 percent of a bundled payment for OUD treatment services that are furnished by the OTP to an individual during an episode of care. We are proposing to establish bundled payments for OUD treatment services which, as discussed above, would include the medications approved by the FDA under section 505 Start Printed Page 40524of the FFDCA for use in the treatment of OUD; the dispensing and administration of such medication, if applicable; substance use counseling; individual and group therapy; and toxicology testing. In calculating the proposed bundled payments, we propose to apply separate payment methodologies for the drug component (which includes the medications approved by the FDA under section 505 of the FFDCA for use in the treatment of OUD) and the non-drug component (which includes the dispensing and administration of such medications, if applicable; substance use counseling; individual and group therapy; and toxicology testing) of the bundled payments. We propose to calculate the full bundled payment rate by combining the drug component and the non-drug components. Below, we discuss our proposals for determining the bundled payments for OUD treatment services. As part of this discussion, we address payment rates for these services under the Medicaid and TRICARE programs, duration of the episode of care for which the bundled payment is made (including partial episodes), methodology for determining bundled payment rates for the drug and non-drug components, site of service, coding and beneficiary cost sharing. We propose to codify the methodology for determining the bundled payment rates for OUD treatment services at § 410.67(d).

a. Review of Medicaid and TRICARE Programs

Section 1834(w)(2) of the Act, added by section 2005(c) of the SUPPORT Act, provides that in developing the bundled payment rates for OUD treatment services furnished by OTPs, the Secretary may consider payment rates paid to the OTPs for comparable services under the state plans under title XIX of the Act (Medicaid) or under the TRICARE program under chapter 55 of title 10 of the United States Code (U.S.C.). The payments for comparable services under TRICARE and Medicaid programs are discussed below. We understand that many private payers cover services furnished by OTPs, and welcome comment on the scope of private payer OTP coverage and the payment rates private payers have established for OTPs furnishing comparable OUD treatment services. We may consider this information as part of the development of the final bundled payment rates for OUD treatment services furnished by OTPs in the final rule.

(1) TRICARE

In the “TRICARE: Mental Health and Substance Use Disorder Treatment” final rule, which appeared in the September 2, 2016 Federal Register (81 FR 61068) (hereinafter referred to as the 2016 TRICARE final rule), the Department of Defense (DOD) finalized its methodology for determining payments for services furnished to TRICARE beneficiaries by an OTP in the regulations at 32 CFR 199.14(a)(2)(ix). The payments are also described in Chapter 7, Section 5 and Chapter 1, Section 15 of the TRICARE Reimbursement Manual 6010.61-M, April 1, 2015. As discussed in the 2016 TRICARE final rule, a number of commenters indicated that they believed the rates established by DOD are near market rates and acceptable (81 FR 61079).

In the 2016 TRICARE final rule, DOD established separate payment methodologies for treatment in OTPs based on the particular medication being administered. DOD finalized a weekly all-inclusive per diem rate for OTPs when furnishing methadone for MAT. Under 32 CFR 199.14(a)(2)(ix)(A)(3)(i), this weekly rate includes the cost of the drug and the cost of related non-drug services (that is, the costs related to the intake/assessment, drug dispensing and screening and integrated psychosocial and medical treatment and supportive services), hereafter referred as the non-drug services. We note that the services included in the TRICARE weekly bundle are generally comparable to the definition of OUD treatment services in Section 2005 of the SUPPORT Act. The weekly all-inclusive per diem rate for these services was determined based on preliminary review of industry billing practices (which included Medicaid and other third-party payers) for the dispensing of methadone, including an estimated daily drug cost of $3 and a daily estimated cost of $15 for the non-drug services. These daily costs were converted to an estimated weekly per diem rate of $126 ($18 per day × 7 days) in the 2016 TRICARE final rule. Under 32 CFR 199.14(a)(2)(iv)(C)(S), this rate is updated annually by the Medicare hospital inpatient prospective payment system (IPPS) update factor. The 2019 TRICARE weekly per diem rate for methadone treatment in an OTP is $133.15.[36] Beneficiary cost-sharing consists of a flat copayment that may be applied to this weekly rate.

DOD also established payment rates for other medications used for MAT (buprenorphine and extended-release injectable naltrexone) to allow OTPs to bill for the full range of medications available. Under 32 CFR 199.14(a)(2)(ix)(A)(3)(ii), DOD established a fee-for-service payment methodology for buprenorphine and extended-release injectable naltrexone because they are more likely to be prescribed and administered in an office-based treatment setting but are still available for treatment furnished in an OTP. DOD stated in the 2016 TRICARE final rule (81 FR 61080) that treatment with buprenorphine and naltrexone is more variable in dosage and frequency than with methadone. Therefore, TRICARE pays for these medications and the accompanying non-drug services separately on a fee-for-service basis. Buprenorphine is paid based on 95 percent of average wholesale price (AWP) and the non-drug component is paid on a per visit basis at an estimated cost of $22.50 per visit. Extended-release injectable naltrexone is paid at the average sales price (ASP) plus a drug administration fee while the non-drug services are also paid at an estimated per visit cost of $22.50. DOD also reserved discretion to establish the payment methodology for new drugs and biologicals that may become available for the treatment of SUDs in OTPs.

DOD instructed that OTPs use the “Alcohol and/or other drug use services, not otherwise specified” H-code for billing the non-drug services when buprenorphine or naltrexone is used, and required OTPs to also include both the J-code and the National Drug Code (NDC) for the drug used, as well as the dosage and acquisition cost on the claim form.[37] Drugs listed on Medicare's Part B ASP files are paid using the ASP.[38] Drugs not appearing on the Medicare ASP file are paid at the lesser of billed charges or 95 percent of the AWP.[39] Using this methodology, TRICARE estimated a daily drug cost of $10 for buprenorphine and a monthly drug cost of $1,129 for extended-release injectable naltrexone.[40]

Start Printed Page 40525

(2) Medicaid (Title XIX)

States have the flexibility to administer the Medicaid program to meet their own needs within the Medicaid program parameters set forth in federal statute and regulations. All states cover and pay for some form of medications for medication-assisted treatment of OUD under their Medicaid programs. However, as of 2018, only 42 states covered methadone for MAT for OUD under their Medicaid programs.[41] We note that section 1006(b) of the SUPPORT Act amends sections 1902 and 1905 of the Social Security Act to require that Medicaid State plans cover all drugs approved under section 505 of the FFDCA to treat OUD, including methadone, and all biological products licensed under section 351 of the Public Health Service Act to treat OUD, beginning October 1, 2020. This requirement sunsets on September 30, 2025.

In reviewing Medicaid payments for OUD treatment services furnished by OTPs in a few states, we found significant variation in the MAT coverage, OUD treatment services, and payment structure among the states. Thus, it is difficult to identify a standardized Medicaid payment amount for OTP services. A number of factors such as the unit of payment, types of services bundled within a payment code, and how MAT services are paid varied among the states. For example, for treatment of OUD using methadone for MAT, most OTPs bill under HCPCS code H0020 (Alcohol and/or drug services; methadone administration and/or service (provision of the drug by a licensed program)) under the Medicaid program; however, the unit of payment varies by state from daily, weekly, or monthly. For example, the unit of payment in California is daily for methadone treatment,[42] while the unit of payment in Maryland for methadone maintenance is weekly,[43] and Vermont uses a monthly unit [44] of payment of these OUD treatment items and services.

For the other MAT drugs, all states cover buprenorphine and the buprenorphine-naloxone medications; [45] however, fewer than 70 percent cover the implanted or extended-release injectable versions of buprenorphine.[46] In addition, all states cover the extended-release injectable naltrexone.[47] We also found that many states pay different rates based on the specific type of drug used for MAT.

Non-drug items and services may be included in a bundled payment with the drug or paid separately, depending on the state, and can include dosing, dispensing and administration of the drug, individual and group counseling, and toxicology testing. In some states, certain services such as assessments, individual and group counseling, and toxicology testing can be billed separately. For example, some states (such as Maryland,[48] Texas,[49] and California) [50] separately reimburse for individual and group counseling services, while other states (such as Vermont [51] and New Mexico) [52] included these services in the OUD bundled payment.

b. Aspects of the Bundle

(1) Duration of Bundle

Section 1834(w)(1) of the Act requires the Secretary to pay an OTP an amount that is equal to 100 percent of the bundled payment for OUD treatment services that are furnished by the OTP to an individual during an episode of care (as defined by the Secretary) beginning on or after January 1, 2020. We are proposing that the duration of an episode of care for OUD treatment services would be a week (that is, a contiguous 7-day period that may start on any day of the week). This is similar to the structure of the TRICARE bundled payment to OTPs for methadone, which is based on a weekly bundled rate (81 FR 61079), as well as the payments by some state Medicaid programs. Given this similarity to existing coding structures, we believe a weekly duration for an episode of care would be most familiar to OTPs and therefore the least disruptive to adopt. We welcome comments on whether we should consider a daily or monthly bundled payment. We are proposing to define an episode of care at § 410.67(b) as a 1 week (contiguous 7-day) period.

We recognize that patients receiving MAT are often on this treatment regimen for an indefinite amount of time and therefore, we are not proposing any maximum number of weeks during an overall course of treatment for OUD.

(a) Requirements for an Episode

We note that SAMHSA requires OTPs to have a treatment plan for each patient that identifies the frequency with which items and services are to be provided (§ 8.12(f)(4)). We recognize that there is a range of service intensity depending on the severity of a patient's OUD and stage of treatment and therefore, a “full weekly bundle” may consist of a very different frequency of services for a patient in the initial phase of treatment compared to a patient in the maintenance phase of treatment, but that we would still consider the requirements to bill for the full weekly bundle to be met if the patient is receiving the majority of the services identified in their treatment plan at that time. However, for the purposes of valuation, we assumed one substance use counseling session, one individual therapy session, and one group therapy session per week and one toxicology test per month. Given the anticipated changes in service intensity over time based on the individual patient's needs, we expect that treatment plans would be updated to reflect these changes or noted in the patient's medical record, for example, in a progress note. In cases where the OTP has furnished the majority (51 percent or more) of the services identified in the patient's current treatment plan (including any changes noted in the patient's medical record) over the course of a week, we propose that it could bill for a full weekly bundle. We are proposing to codify the payment methodology for full episodes of care (as well as partial episodes of care and non-drug episodes of care, as discussed below) in § 410.67(d)(2).

(b) Partial Episode of Care

We understand that there may be instances in which a beneficiary does not receive all of the services expected in a given week due to any number of issues, including, for example, an inpatient hospitalization during which a Start Printed Page 40526beneficiary would not be able to go to the OTP or inclement weather that impedes access to transportation. To provide more accurate payment to OTPs in cases where a beneficiary is not able to or chooses not to receive all items and services described in their treatment plan or the OTP is unable to furnish services, for example, in the case of a natural disaster, we are proposing to establish separate payment rates for partial episodes that correspond with each of the full weekly bundles. In cases where the OTP has furnished at least one of the items or services (for example, dispensing one day of an oral MAT medication or one counseling session or one toxicology test) but less than 51 percent of the items and services included in OUD treatment services identified in the patient's current treatment plan (including any changes noted in the patient's medical record) over the course of a week, we propose that it could bill for a partial weekly bundle. In cases in which the beneficiary does not receive a drug during the partial episode, we propose that the code describing a non-drug partial weekly bundle must be used. For example, the OTP could bill for a partial episode in instances where the OTP is transitioning the beneficiary from one OUD medication to another and therefore the beneficiary is receiving less than a week of one type of medication. In those cases, two partial episodes could be billed, one for each of the medications, or one partial episode and one full episode, if all requirements for billing are met. We intend to monitor this issue and will consider whether we would need to make changes to this policy in future rulemaking to ensure that the billing for partial episodes is not being abused. We are proposing to define a partial episode of care in § 410.67(b) and to codify the payment methodology for partial episodes in § 410.67(d). We seek comments on our proposed approach to full and partial episodes, including the threshold that should be applied to determine when an OTP may bill for the full weekly bundle versus a partial episode. We also seek comment on the minimum threshold that should be applied to determine when a partial episode could be billed (for example, at least one item or service, or an alternative threshold such as 10 or 25 percent of the items and services included in OUD treatment services identified in the patient's current treatment plan (including any changes noted in the patient's medical record) over the course of a week). We also welcome feedback regarding whether any other payers of OTP services allow for billing partial bundles and what thresholds they use.

(c) Non-Drug Episode of Care

In addition to the bundled payments for full and partial episodes of care that are based on the medication administered for treatment (and include both a drug and non-drug component described in detail below), we are proposing to establish a non-drug episode of care to provide a mechanism for OTPs to bill for non-drug services, including substance use counseling, individual and group therapy, and toxicology testing that are rendered during weeks when a medication is not administered, for example, in cases where a patient is being treated with injectable buprenorphine or naltrexone on a monthly basis or has a buprenorphine implant. We are proposing to codify this non-drug episode of care at § 410.67(d).

(2) Drug and Non-Drug Components

As discussed above, in establishing the bundled payment rates, we propose to develop separate payment methodologies for the drug component and the non-drug (which includes the dispensing and administration of such medication, if applicable; substance use counseling; individual and group therapy; and toxicology testing) components of the bundled payment. Each of these components is discussed in this section.

(a) Drug Component

As discussed previously, the cost of medications used by OTPs to treat OUD varies widely. Creating a single bundled payment rate that does not reflect the type of drug used could result in access issues for beneficiaries who might be best served by treatment using a more expensive medication. As a result, we believe that the significant variation in the cost of these drugs needs to be reflected adequately in the bundled payment rates for OTP services to avoid impairing access to appropriate care.

Section 1834(w)(2) of the Act states that the Secretary may implement the bundled payment to OTPs though one or more bundles based on a number of factors, including the type of medication provided (such as buprenorphine, methadone, extended-release injectable naltrexone, or a new innovative drug). Accordingly, consistent with the discretion afforded under section 1834(w)(2) of the Act, and after consideration of payment rates paid to OTPs for comparable services by other payers as discussed above, we propose to base the OTP bundled payment rates, in part, on the type of medication used for treatment. Specifically, we propose the following categories of bundled payments to reflect those drugs currently approved by the FDA under section 505 of the FFDCA for use in treatment of OUD:

  • Methadone (oral).
  • Buprenorphine (oral).
  • Buprenorphine (injection).
  • Buprenorphine (implant).
  • Naltrexone (injection).

In addition, we propose to create a category of bundled payment describing a drug not otherwise specified to be used for new drugs (as discussed further below). We are also proposing a non-drug bundled payment to be used when medication is not administered (as discussed further below). We believe creating these categories of bundled payments based on the drug used for treatment would strike a reasonable balance between recognizing the variable costs of these medications and the statutory requirement to make a bundled payment for OTP services. We propose to codify this policy of establishing the categories of bundled payments based on the type of opioid agonist and antagonist treatment medication in § 410.67(d)(1).

i. New Drugs

We anticipate that there may be new FDA-approved opioid agonist and antagonist treatment medications to treat OUD in the future. In the scenario where an OTP furnishes MAT using a new FDA-approved opioid agonist or antagonist medication for OUD treatment that is not specified in one of our existing codes, we propose that OTPs would bill for the episode of care using the medication not otherwise specified (NOS) code, HCPCS code GXXX9 (or GXXX19 for a partial episode). In such cases, we propose to use the typical or average maintenance dose to determine the drug cost for the new bundle. Then, we propose that pricing would be determined based on the relevant pricing methodology as described later in this section (section II.G.) of the proposed rule or invoice pricing in the event the information necessary to apply the relevant pricing methodology is not available. For example, in the case of injectable and implantable drugs, which are generally covered and paid for under Medicare Part B, we propose to use the methodology in section 1847A of the Act (which bases most payments on ASP). For oral medications, which are generally covered and paid for under Medicare Part D, we propose to use ASP-based payment when we receive manufacturer-submitted ASP data for Start Printed Page 40527these drugs. In the event that we do not receive manufacturer-submitted ASP pricing data, we are considering several potential pricing mechanisms (as discussed further below) to estimate the payment amounts for oral drugs typically paid for under Medicare Part D but that would become OTP drugs paid under Part B when used as part of MAT furnished in an OTP. We are not proposing a specific pricing mechanism at this time for the situation in which we do not receive manufacturer-submitted ASP pricing data, but are requesting public comment on several potential approaches for estimating the acquisition cost and payment amounts for these drugs. We will consider the comments received in developing our final policy for determining these drug prices. If the information necessary to apply the alternative pricing methodology chosen for the oral drugs is also not available to price the new medication, we propose to use invoice pricing until either ASP pricing data or the information necessary to apply the chosen pricing methodology becomes available to price the medication. We are proposing to codify this approach for determining the amount of the bundled payment for new medications in § 410.67(d)(2).The medication NOS code would be used until CMS has the opportunity to consider through rulemaking establishing a unique bundled payment for episodes of care during which the new drug is furnished. We welcome comments on this proposed approach to the treatment of new drugs used for MAT in OTPs.

As discussed above, we also welcome comments on how new medications that may be approved by the FDA in the future for use in the treatment of OUD with a novel mechanism of action (for example, not an opioid agonist and/or antagonist), such as medications approved under section 505 of the FFDCA to treat OUD and biological products licensed under section 351 of the Public Health Service Act to treat OUD, should be considered in the context of OUD treatment services provided by OTPs. We additionally welcome comments on how such new drugs with a novel mechanism of action should be priced, and specifically whether pricing for these new non-opioid agonist and/or antagonist medications should be determined using the same pricing methodology proposed for new opioid agonist and antagonist treatment medications, described above or whether an alternative pricing methodology should be used.

(b) Non-Drug Component

i. Counseling, Therapy, Toxicology Testing, and Drug Administration

As discussed above, the bundled payment is for OUD treatment services furnished during the episode of care, which we are proposing to define as the FDA-approved opioid agonist and antagonist treatment medications, the dispensing and administration of such medications (if applicable), substance use disorder counseling by a professional to the extent authorized under state law to furnish such services, individual and group therapy with a physician or psychologist (or other mental health professional to the extent authorized under state law), and toxicology testing. The non-drug component of the OUD treatment services includes all items and services furnished during an episode of care except for the medication.

Under the SAMSHA certification standards at § 8.12(f)(5), OTPs must provide adequate substance abuse counseling to each patient as clinically necessary. We note that section 1861(jjj)(1)(C) of the Act, as added by section 2005(b) of the SUPPORT Act defines OUD treatment services as including “substance use counseling by a professional to the extent authorized under state law to furnish such services.” Therefore, professionals furnishing therapy or counseling services for OUD treatment must be operating within state law and scope of practice. These professionals could include licensed professional counselors, licensed clinical alcohol and drug counselors, and certified peer specialists that are permitted to furnish this type of therapy or counseling by state law and scope of practice. To the extent that the individuals furnishing therapy or counseling services are not authorized under state law to furnish such services, the therapy or counseling services would not be covered as OUD treatment services.

Additionally, under SAMSHA certification standards at § 8.12(f)(6), OTPs are required to provide adequate testing or analysis for drugs of abuse, including at least eight random drug abuse tests per year, per patient in maintenance treatment, in accordance with generally accepted clinical practice. These drug abuse tests (which are identified as toxicology tests in the definition of OUD treatment services in section 1861(jjj)(1)(E) of the Act) are used for diagnosing, monitoring and evaluating progress in treatment. The testing typically includes tests for opioids and other controlled substances. Urinalysis is primarily used for this testing; however, there are other types of testing such as hair or fluid analysis that could be used. We note that any of these types of toxicology tests would be considered to be OUD treatment services and would be included in the bundled payment for services furnished by an OTP.

The non-drug component of the bundle also includes the cost of drug dispensing and/or administration, as applicable. Additional details regarding our proposed approach for pricing this aspect of the non-drug component of the bundle are included in our discussion of payment rates later in this section.

ii. Other Services

As discussed earlier, we are proposing to define OUD treatment services as those items and services that are specifically enumerated in section 1861(jjj)(1) of the Act, including services that are furnished via telecommunications technology, and are seeking comment on any other items and services we might consider including as OUD treatment services under the discretion given to the Secretary in subparagraph (F) of that section to determine other appropriate items and services. If we were to finalize a definition of OUD treatment services that includes any other items or services, such as intake activities or periodic assessments as discussed above, we would consider whether any changes to the payment rates for the bundled payments are necessary. See below for additional discussion related to how we could price these services.

(3) Adjustment to Bundled Payment Rate for Additional Counseling or Therapy Services

In addition to the items and services already included in the proposed bundles, we recognize that counseling and therapy are important components of MAT and that patients may need to receive counseling and/or therapy more frequently at certain points in their treatment. We seek to ensure that patients have access to these needed services. Accordingly, we are proposing to adjust the bundled payment rates through the use of an add-on code in order to account for instances in which effective treatment requires additional counseling or group or individual therapy to be furnished for a particular patient that substantially exceeds the amount specified in the patient's individualized treatment plan. As noted previously, we understand that there is variability in the frequency of services a patient might receive in a given week depending on the patient's severity and stage of treatment; however, we assume Start Printed Page 40528that a typical case might include one substance use counseling session, one individual therapy session, and one group therapy session per week. We further understand that the frequency of services will vary among patients and will change over time based on the individual patient's needs. We expect that the patient's treatment plan or the medical record will be updated to reflect when there are changes in the expected frequency of medically necessary services based on the patient's condition and following such an update, the add-on code should no longer be billed if the frequency of the patient's counseling and/or therapy services is consistent with the treatment plan or medical record. In the case of unexpected or unforeseen circumstances that are time-limited, resolve quickly, and do not lead to updates to the treatment plan, we expect that the medical necessity for billing the add-on code would be documented in the medical record. This add-on code (HCPCS code GXX19) would describe each additional 30 minutes of counseling or group or individual therapy furnished in a week of MAT, which could be billed in conjunction with the codes describing the full episode of care or the partial episodes. For example, there may be some weeks when a patient has a relapse or unexpected psychosocial stressors arise that warrant additional reasonable and necessary counseling services that were not foreseen at the time that the treatment plan was developed. Additionally, we note that there may be situations in which the add-on code could be billed in conjunction with the code for a partial episode; for example, if a patient requires prolonged counseling services on the initial day of treatment, but does not return for any of the other services specified in their treatment plan, such as daily medication dispensing, for the remainder of that week. We acknowledge that an unintended consequence of using the treatment plan is a potential incentive for OTPs to document minimal counseling and/or therapy needs for a beneficiary, thereby resulting in increased opportunity for billing the add-on code. We expect that OTPs will ensure that treatment plans reflect the full scope of services expected to be furnished during an episode of care and that they will update treatment plans regularly to reflect changes. We intend to monitor this issue and will consider whether we need to make changes to this policy through future rulemaking to ensure that this adjustment is not being abused. We welcome comments on the proposed add-on code and the threshold for billing. We propose to codify this adjustment to the bundled payment rate for additional counseling or therapy services in § 410.67(d)(3)(i).

(4) Site of Service (Telecommunications)

In recent years, we have sought to decrease barriers to access to care by furthering policies that expand the use of communication technologies. In the CY 2019 PFS final rule (83 FR 59482), we finalized new separate payments for communication technology-based services, including a virtual check-in and a remote evaluation of pre-recorded patient information. SAMHSA's federal guidelines (https://store.samhsa.gov/​system/​files/​pep15-fedguideotp.pdf) for OTPs refer to the CMS guidance on telemedicine and also state that OTPs are advised to proceed with full understanding of requirements established by state or health professional licensing boards. SAMHSA's federal guidelines for OTPs state that exceptional attention needs to be paid to data security and privacy in this evolving field. Telemedicine services should, under no circumstances, expand the scope of practice of a healthcare professional or permit practice in a jurisdiction (the location of the patient) where the provider is not licensed.

We are proposing to allow OTPs to furnish the substance use counseling, individual therapy, and group therapy included in the bundle via two-way interactive audio-video communication technology, as clinically appropriate, in order to increase access to care for beneficiaries. We believe this is an appropriate approach because, as discussed previously, we expect the telehealth services that will be furnished by OTPs will be similar to the Medicare telehealth services furnished under section 1834(m) of the Act, and the use of two-way interactive audio-video communication technology is required for these Medicare telehealth services under § 410.78(a)(3). By allowing use of communication technology in furnishing these services, OTPs in rural communities or other health professional shortage areas could facilitate treatment through virtual care coming from an urban or other external site; however, we note that the physicians and other practitioners furnishing these services would be required to comply with all applicable requirements related to professional licensing and scope of practice.

We note that section 1834(m) of the Act applies only to Medicare telehealth services furnished by a physician or other practitioner. Because OUD treatment services furnished by an OTP are not considered to be services furnished by a physician or other practitioner, the restrictions of section 1834(m) of the Act would not apply. Additionally, we note that counseling or therapy furnished via communication technology as part of OUD treatment services furnished by an OTP must not be separately billed by the practitioner furnishing the counseling or therapy because these services would already be paid through the bundled payment made to the OTP.

We are proposing to include language in § 410.67(b) in the definition of opioid use disorder treatment services to allow OTPs to use two-way interactive audio-video communication technology, as clinically appropriate, in furnishing substance use counseling and individual and group therapy services, respectively. We invite comment as to whether this proposal, including whether furnishing these services through communication technology is clinically appropriate. We also invite public comment on other components of the bundle that may be clinically appropriate to be furnished via communication technology, while also considering SAMHSA's guidance that OTPs should pay exceptional attention to data security and privacy.

(5) Coding

We are proposing to adopt a coding structure for OUD treatment services that varies by the medication administered. To operationalize this approach, we are proposing to establish G codes for weekly bundles describing treatment with methadone, buprenorphine oral, buprenorphine injectable, buprenorphine implants (insertion, removal, and insertion/removal), extended-release injectable naltrexone, a non-drug bundle, and one for a medication not otherwise specified. We also propose to establish partial episode G codes to correspond with each of those bundles, respectively. Additionally, we propose to create an add-on code to describe additional counseling that is furnished beyond the amount specified in the patient's treatment plan. As discussed above, we are seeking comment on whether to include intake activities and periodic assessments in the definition of OUD treatment services. Were we to finalize including these activities in the definition of OUD treatment services, we welcome feedback on whether we should consider modifying the payment associated with the bundle or creating add-on codes for services such as the Start Printed Page 40529initial physical examination, initial assessments and preparation of a treatment plan, periodic assessments or additional toxicology testing, and if so, what inputs we might consider in pricing such services, such as payment amounts for similar services under the PFS or Clinical Lab Fee Schedule (CLFS). For example, to price the initial assessment, medical examination, and development of a treatment plan, we could crosswalk to the Medicare payment rate for a level 3 Evaluation and Management (E/M) visit for a new patient and to price the periodic assessments, we could crosswalk to the Medicare payment rate for a level 3 E/M visit for an established patient. To price additional toxicology testing, we could crosswalk to the Medicare payment for presumptive drug testing, such as that described by CPT code 80305. Additionally, we welcome feedback on whether we should consider creating codes to describe bundled payments that include only the cost of the drug and drug administration as applicable in order to account for beneficiaries who are receiving interim maintenance treatment (as described previously in this section) or other situations in which the beneficiary is not receiving all of the services described in the full bundles.

Regarding the non-drug bundle, we note that this code would be billed for services furnished during an episode of care or partial episode of care when a medication is not administered. For example, when a patient receives a buprenorphine injection on a monthly basis, the OTP will only require payment for the medication during the first week of the month when the injection is given, and therefore, would bill the code describing the bundle that includes injectable buprenorphine during the first week of the month and would bill the code describing the non-drug bundle for the remaining weeks in that month for services such as substance use counseling, individual and group therapy, and toxicology testing.

As discussed previously, we propose that the codes describing the bundled payment for an episode of care with a medication not otherwise specified, HCPCS codes GXXX9 and GXX18, should be used when the OTP furnishes MAT with a new opioid agonist or antagonist treatment medication approved by the FDA under section 505 of the FFDCA for the treatment of OUD. OTPs would use these codes until we have the opportunity to propose and finalize a new G code to describe the bundled payment for treatment using that drug and price it accordingly in the next rulemaking cycle. We note that the code describing the weekly bundle for a medication not otherwise specified should not be used when the drug being administered is not a new opioid agonist or antagonist treatment medication approved by the FDA under section 505 of the FFDCA for the treatment of OUD, and therefore, for which Medicare would not have the authority to make payment since section 1861(jjj)(1)(A) of the Act requires that the medication must be an opioid agonist or antagonist treatment medication approved by the FDA under section 505 of the FFDCA for the treatment of OUD. Given the program integrity concerns regarding the potential for misuse of such a code, we also welcome comments as to whether this code is needed.

The codes and long descriptors for the proposed OTP bundled services are:

  • HCPCS code GXXX1: Medication assisted treatment, methadone; weekly bundle including dispensing and/or administration, substance use counseling, individual and group therapy, and toxicology testing, if performed (provision of the services by a Medicare-enrolled Opioid Treatment Program).
  • HCPCS code GXXX2: Medication assisted treatment, buprenorphine (oral); weekly bundle including dispensing and/or administration, substance use counseling, individual and group therapy, and toxicology testing if performed (provision of the services by a Medicare-enrolled Opioid Treatment Program).
  • HCPCS code GXXX3: Medication assisted treatment, buprenorphine (injectable); weekly bundle including dispensing and/or administration, substance use counseling, individual and group therapy, and toxicology testing if performed (provision of the services by a Medicare-enrolled Opioid Treatment Program).
  • HCPCS code GXXX4: Medication assisted treatment, buprenorphine (implant insertion); weekly bundle including dispensing and/or administration, substance use counseling, individual and group therapy, and toxicology testing if performed (provision of the services by a Medicare-enrolled Opioid Treatment Program).
  • HCPCS code GXXX5: Medication assisted treatment, buprenorphine (implant removal); weekly bundle including dispensing and/or administration, substance use counseling, individual and group therapy, and toxicology testing if performed (provision of the services by a Medicare-enrolled Opioid Treatment Program).
  • HCPCS code GXXX6: Medication assisted treatment, buprenorphine (implant insertion and removal); weekly bundle including dispensing and/or administration, substance use counseling, individual and group therapy, and toxicology testing if performed (provision of the services by a Medicare-enrolled Opioid Treatment Program).
  • HCPCS code GXXX7: Medication assisted treatment, naltrexone; weekly bundle including dispensing and/or administration, substance use counseling, individual and group therapy, and toxicology testing if performed (provision of the services by a Medicare-enrolled Opioid Treatment Program).
  • HCPCS code GXXX8: Medication assisted treatment, weekly bundle not including the drug, including substance use counseling, individual and group therapy, and toxicology testing if performed (provision of the services by a Medicare-enrolled Opioid Treatment Program).
  • HCPCS code GXXX9: Medication assisted treatment, medication not otherwise specified; weekly bundle including dispensing and/or administration, substance use counseling, individual and group therapy, and toxicology testing, if performed (provision of the services by a Medicare-enrolled Opioid Treatment Program).
  • HCPCS code GXX10: Medication assisted treatment, methadone; weekly bundle including dispensing and/or administration, substance use counseling, individual and group therapy, and toxicology testing if performed (provision of the services by a Medicare-enrolled Opioid Treatment Program); partial episode. Do not report with GXXX1.
  • HCPCS code GXX11: Medication assisted treatment, buprenorphine (oral); weekly bundle including dispensing and/or administration, substance use counseling, individual and group therapy, and toxicology testing if performed (provision of the services by a Medicare-enrolled Opioid Treatment Program); partial episode. Do not report with GXXX2.
  • HCPCS code GXX12: Medication assisted treatment, buprenorphine (injectable); weekly bundle including dispensing and/or administration, substance use counseling, individual and group therapy, and toxicology testing if performed (provision of the services by a Medicare-enrolled Opioid Treatment Program); partial episode. Do not report with GXXX3. Start Printed Page 40530
  • HCPCS code GXX13: Medication assisted treatment, buprenorphine (implant insertion); weekly bundle including dispensing and/or administration, substance use counseling, individual and group therapy, and toxicology testing if performed (provision of the services by a Medicare-enrolled Opioid Treatment Program); partial episode (only to be billed once every 6 months). Do not report with GXXX4.
  • HCPCS code GXX14: Medication assisted treatment, buprenorphine (implant removal); weekly bundle including dispensing and/or administration, substance use counseling, individual and group therapy, and toxicology testing if performed (provision of the services by a Medicare-enrolled Opioid Treatment Program); partial episode. Do not report with GXXX5.
  • HCPCS code GXX15: Medication assisted treatment, buprenorphine (implant insertion and removal); weekly bundle including dispensing and/or administration, substance use counseling, individual and group therapy, and toxicology testing if performed (provision of the services by a Medicare-enrolled Opioid Treatment Program); partial episode. Do not report with GXXX6.
  • HCPCS code GXX16: Medication assisted treatment, naltrexone; weekly bundle including dispensing and/or administration, substance use counseling, individual and group therapy, and toxicology testing if performed (provision of the services by a Medicare-enrolled Opioid Treatment Program); partial episode. Do not report with GXXX7.
  • HCPCS code GXX17: Medication assisted treatment, weekly bundle not including the drug, including substance use counseling, individual and group therapy, and toxicology testing if performed (provision of the services by a Medicare-enrolled Opioid Treatment Program); partial episode. Do not report with GXXX8.
  • HCPCS code GXX18: Medication assisted treatment, medication not otherwise specified; weekly bundle including dispensing and/or administration, substance use counseling, individual and group therapy, and toxicology testing, if performed (provision of the services by a Medicare-enrolled Opioid Treatment Program); partial episode. Do not report with GXXX9.
  • HCPCS code GXX19: Each additional 30 minutes of counseling or group or individual therapy in a week of medication assisted treatment, (provision of the services by a Medicare-enrolled Opioid Treatment Program); List separately in addition to code for primary procedure.

See Table 15 for proposed valuations for HCPCS codes GXXX1-GXX19. We propose that only an entity enrolled with Medicare as an OTP could bill these codes. Additionally, we propose that OTPs would be limited to billing only these codes describing bundled payments, and may not bill for other codes, such as those paid under the PFS.

(6) Payment Rates

The codes describing the proposed OTP bundled services (HCPCS codes GXXX1-GXX19) would be assigned flat dollar payment amounts, which are listed in Table 15. As discussed previously, section 2005 of the SUPPORT Act amended the definition of “medical and other health services” in section 1861(s) of the Act to provide for coverage of OUD treatment services furnished by an OTP and also added a new section 1834(w) to the Act and amended section 1833(a)(1) of the Act to establish a bundled payment to OTPs for OUD treatment services furnished during an episode of care beginning on or after January 1, 2020. Therefore, OUD treatment services and the payments for such services are wholly separate from physicians' services, as defined under section 1848(j)(3) of the Act, and for which payment is made under the section 1848 of the Act. Because OUD treatment services are not considered physicians' services and are paid outside the PFS, they would not be priced using relative value units (RVUs).

Consistent with section 1834(w) of the Act, which requires the Secretary to make a bundled payment for OUD treatment services furnished by OTPs, we are proposing to build the payment rates for OUD treatment services by combining the cost of the drug and the non-drug components (as applicable) into a single bundled payment as described in more detail below.

(a) Drug Component

As part of determining a payment rate for these proposed bundles for OUD treatment services, a dosage of the applicable medication must be selected in order to calculate the costs of the drug component of the bundle. We propose to use the typical or average maintenance dose, as discussed earlier in this section, to determine the drug costs for each of the proposed bundles. As dosing for some, but not all, of these drugs varies considerably, this approach attempts to strike an appropriate balance between high- and low-dose drug regimens in the context of a bundled payment. Specifically, we propose to calculate payment rates using a 100 mg daily dose for methadone, a 10 mg daily dose for oral buprenorphine, a 100 mg monthly dose for the extended-release buprenorphine injection, four rods each containing 74.2 mg of buprenorphine for the 6-month buprenorphine implant, and a 380 mg monthly dose for extended-release injectable naltrexone. We invite public comments on our proposal to use the typical maintenance dose in order to calculate the drug component of the bundled payment rate for each of the proposed codes. We also seek comment on the specific typical maintenance dosage level that we have identified for each drug, and a process for identifying the typical maintenance dose for new opioid agonist or antagonist treatment medication approved by the FDA under section 505 of the FFDCA when such medications are billed using the medication NOS code, such as using the FDA-approved prescribing information or a review of the published, preferably peer-reviewed, literature. We note that the bundled payment rates are intended to be comprehensive with respect to the drugs provided; therefore, we do not intend to include any other amounts related to drugs, other than for administration, as discussed below. This means, for example, that we would not pay for drug wastage, which we do not anticipate to be significant in the OTP setting.

i. Potential Drug Pricing Data Sources

Payment structures that are closely tailored to the provider's actual acquisition cost reduce the likelihood that a drug will be chosen primarily for a reason that is unrelated to the clinical care of the patient, such as the drug's profit margin for a provider. We are proposing to estimate an OTP's costs for the drug component of the bundles based on available data regarding drug costs rather than a provider-specific cost-to-charge ratio or another more direct assessment of facility or industry-specific drug costs. OTPs do not currently report costs associated with their services to the Medicare program, and we do not believe that a cost-to-charge ratio based on such reported information could be available for a significant period of time. Furthermore, we are unaware of any industry-specific data that may be used to more accurately assess the prices at which OTPs acquire the medications used for OUD treatment. Therefore, at this time, we are proposing to estimate an OTP's costs for the drugs used in MAT based on other available data sources, rather than applying a cost-to-charge ratio or Start Printed Page 40531another more direct assessment of drug acquisition cost, though we intend to continue to explore alternate ways to gather this information. As described in greater detail below, we propose that the payment amounts for the drug component of the bundles be based on CMS pricing mechanisms currently in place. We request comment on other potential data sources for pricing OUD treatment medications either generally or specifically with respect to acquisition by OTPs. In the case of oral drugs that we are proposing to include in the OTP bundled payments and for which we do not receive manufacturer-submitted ASP data, we are considering several potential approaches for determining the payment amounts for the drug component of the bundles. Although we are not proposing a specific pricing mechanism at this time, we are soliciting comments on several different approaches, and we intend to develop a final policy for determining the payment amount for the drug component of the relevant bundles after considering the comments received.

In considering the payment amount for the drug component of each of the bundled payments that include a drug, we will begin by breaking the drugs into two categories based on their current coverage and payment by Medicare. First, we discuss the injectable and implantable drugs, which are generally covered and paid for under Medicare Part B, and then discuss the oral medications, which are generally covered and paid for under Medicare Part D.[53] Buprenorphine (injection), buprenorphine (implant), and naltrexone (injection) would fall into the former category and methadone and buprenorphine (oral) would fall into the latter category.

ii. Part B Drugs

Part B includes a limited drug benefit that encompasses drugs and biologicals described in section 1861(t) of the Act. Currently, covered Part B drugs fall into three general categories: Drugs furnished incident to a physician's services, drugs administered via a covered item of durable medical equipment, and other drugs specified by statute (generally in section 1861(s)(2) of the Act). Types of providers and suppliers that are paid for all or some of the Medicare-covered Part B drugs that they furnish include physicians, pharmacies, durable medical equipment suppliers, hospital outpatient departments, and end-stage renal disease (ESRD) facilities.

The majority of Part B drug expenditures are for drugs furnished incident to a physician's service. Drugs furnished incident to a physician's service are typically injectable drugs that are administered in a non-facility setting (covered under section 1861(s)(2)(A) of the Act) or in a hospital outpatient setting (covered under section 1861(s)(2)(B) of the Act). The statute (sections 1861(s)(2)(A) and 1861(s)(2)(B) of the Act) limits “incident to” services to drugs that are not usually self-administered; self-administered drugs, such as orally administered tablets and capsules are not paid for under the “incident to” provision. Payment for drugs furnished incident to a physician's service falls under section 1842(o) of the Act. In accordance with section 1842(o)(1)(C) of the Act, “incident to” drugs furnished in a non-facility setting are paid under the methodology in section 1847A of the Act. “Incident to” drugs furnished in a facility setting also are paid using the methodology in section 1847A of the Act when it has been incorporated under the relevant payment system (for example, the Hospital Outpatient Prospective Payment System (OPPS) [54] ).

In most cases, determining payment using the methodology in section 1847A of the Act means payment is based on the ASP plus a statutorily mandated 6 percent add-on. The payment for these drugs does not include costs for administering the drug to the patient (for example, by injection or infusion); payments for these physician and hospital services are made separately, and the payment amounts are determined under the PFS [55] and the OPPS, respectively. The ASP payment amount determined under section 1847A of the Act reflects a volume-weighted ASP for all NDCs that are assigned to a HCPCS code. The ASP is calculated quarterly using manufacturer-submitted data on sales to all purchasers (with limited exceptions as articulated in section 1847A(c)(2) of the Act such as sales at nominal charge and sales exempt from best price) with manufacturers' rebates, discounts, and price concessions reflected in the manufacturer's determination of ASP.

Although the Part B drug benefit is generally considered to be limited in scope, it includes many categories of drugs and encompasses a variety of care settings and payment methodologies. In addition to the “incident to” drugs described above, Part B also covers and pays for certain oral drugs with specific benefit categories defined under section 1861(s) of the Act including certain oral anti-cancer drugs and certain oral antiemetic drugs. In accordance with section 1842(o)(1) of the Act or through incorporation under the relevant payment system as discussed above, most of these oral Part B drugs are also paid based on the ASP methodology described in section 1847A of the Act.

However, at times Part B drugs are paid based on wholesale acquisition cost (WAC) as authorized under section 1847A(c)(4) of the Act [56] or average manufacturer price (AMP)-based price substitutions as authorized under section 1847A(d) of the Act.[57] Also, in accordance with section 1842(o) of the Act, other payment methodologies may be applied to determine the payment amount for certain Part B drugs, for example, AWP-based payments (using current AWP) are made for influenza, pneumococcal pneumonia, and hepatitis B vaccines.[58] We also use current AWP to make payment under the OPPS for very new drugs without an ASP.[59] Contractors may also make independent payment amount determinations in situations where a national price is not available for physician and other supplier claims and for drugs that are specifically excluded from payment based on section 1847A of the Act (for example, radiopharmaceuticals as noted in section 303(h) of the Medicare Prescription Drug, Improvement and Modernization Act of 2003 (MMA) (Pub. L. 108-173, enacted December 8, 2003). In such cases, pricing may be determined based on compendia or invoices.[60]

While most Part B drugs are paid based on the ASP methodology, MedPAC has noted that the ASP methodology may encourage the use of more expensive drugs because the 6 percent add-on generates more revenue Start Printed Page 40532for more expensive drugs.[61] The ASP payment amount also does not vary based on the price an individual provider or supplier pays to acquire the drug. The statute does not identify a reason for the additional 6 percent add-on above ASP; however, as noted in the MedPAC report (and by sources cited in the report), the add-on is needed to account for handling and overhead costs and/or for additional mark-up in the distribution channels that are not captured in the manufacturer-reported ASP.[62]

We propose to use the methodology in section 1847A of the Act (which bases most payments on ASP) to set the payment rates for the “incident to” drugs. However, we propose to limit the payment amounts for “incident to” drugs to 100 percent of the volume-weighted ASP for a HCPCS code instead of 106 percent of the volume-weighted ASP for a HCPCS code. We believe limiting the add-on will incentivize the use of the most clinically appropriate drug for a given patient. In addition, we understand that many OTPs purchase directly from drug manufacturers, thereby limiting the markup from distribution channels. We also propose to use the same version of the quarterly manufacturer-submitted data used for calculating the most recently posted ASP data files in preparing the CY 2020 payment rates for OTPs. Please note that the quarterly ASP Drug Pricing Files include ASP plus 6 percent payment amounts.[63] Accordingly, we would adjust these amounts consistent with our proposal to limit the payment amounts for these drugs to 100 percent of the volume-weighted ASP for a HCPCS code. Proposed payment rates are provided below in this section of this proposed rule. A discussion of the proposed annual payment update methodology is also provided below. We propose to codify the ASP payment methodology for the drug component at § 410.67(d)(2). We solicit public comment on these proposals, as well as on using alternative ASP-based payments to price these drugs, such as a rolling average of the past year's ASP payment rates.

iii. Oral Drugs

We propose to use ASP-based payment, which would be determined based on ASP data that have been calculated consistent with the provisions in 42 CFR part 414, subpart 800, to set the payment rates for the oral product categories when we receive manufacturer-submitted ASP data for these drugs. We believe that using the ASP pricing data for oral OTP drugs currently covered under Part D [64] would facilitate the computation of the estimated costs of these drugs. However, we do not collect ASP pricing information under section 1927(b) of the Act for these drugs. We request public comment on whether manufacturers would be willing to submit ASP pricing data for OTP drugs currently covered under Part D on a voluntary basis.

We also propose to limit the payment amounts for oral drugs to 100 percent of the volume-weighted ASP for a HCPCS code instead of 106 percent of the volume-weighted ASP for a HCPCS code. We believe limiting the add-on will incentivize the use of the most clinically appropriate drug for a given patient. In addition, we understand that many OTPs purchase directly from drug manufacturers, thereby limiting the markup from distribution channels. We propose to use the same version of the quarterly manufacturer-submitted data used for calculating the most recently posted ASP data files in preparing the CY 2020 payment rates for OTPs. Please note that the quarterly ASP Drug Pricing Files include ASP plus 6 percent payment amounts.[65] Accordingly, we would adjust these amounts consistent with our proposal to limit the payment amounts for these drugs to 100 percent of the volume-weighted ASP for a HCPCS code. Proposed payment rates are provided below in this section of this proposed rule. A discussion of the proposed annual payment update methodology is also provided below. We propose to codify the ASP payment methodology for the drug component at § 410.67(d)(2). We solicit public comment on these proposals, as well as on using alternative ASP-based payments to price these drugs, such as a rolling average of the past year's ASP payment rates.

In the event that we do not receive manufacturer-submitted ASP pricing data, we are considering several potential pricing mechanisms to estimate the payment amounts for oral drugs typically paid for under Medicare Part D but that would become OTP drugs paid under Part B when used as part of MAT in an OTP. We are not proposing a specific pricing mechanism for these drugs at this time, but are requesting public comment on the following potential approaches for estimating the acquisition cost and payment amounts for these drugs and on alternative approaches. We will consider the comments received in developing our final policy for determining these drug prices.

Approach 1: The Methodology in Section 1847A of the Act

One approach for estimating the cost of the drugs that are currently covered under Part D and for which ASP data are not available would be to use the methodology in section 1847A of the Act. Please see above for a discussion of the methodology in section 1847A of the Act. Under the methodology in section 1847A of the Act, when ASP data are not available, this option would price drugs using, for example, WAC or invoice pricing.

Approach 2: Medicare's Part D Prescription Drug Plan Finder Data

On January 28, 2005, we issued the “Medicare Program; Medicare Prescription Drug Benefit” final rule (70 FR 4194) which implemented the Medicare voluntary prescription drug benefit, as enacted by section 101 of the MMA. Beginning on January 1, 2006, a prescription drug benefit program was available to beneficiaries with much broader drug coverage than was previously provided under Part B to include: Brand-name prescription drugs and biologicals, generic drugs, biosimilars, vaccines, and medical supplies associated with the injection of insulin.[66] This prescription drug benefit is offered to Medicare beneficiaries through Medicare Advantage Drug Plans (MA-PDs) and stand-alone Prescription Drug Plans (PDPs). The prescription drug benefit under Medicare Part D is administered based on the “negotiated prices” of covered Part D drugs. Under § 423.100 of the Part D regulations, the negotiated price of a Part D drug equals the amount paid by the Part D sponsor (or its pharmacy benefit manager) to the pharmacy at the point-of-sale for that drug. Typically, these Part D “negotiated prices” are based on AWP minus a percentage for brand drugs or either the maximum allowable cost, which is based on proprietary methodologies used to establish the same payment for therapeutically equivalent products marketed by multiple labelers with different AWPs, Start Printed Page 40533or the Generic Effective Rate, which guarantees aggregate minimum reimbursement (for example, AWP-85 percent). The negotiated price under Part D also includes a dispensing fee (for example, $1-$2), which is added to the cost of the drug.

Many of the beneficiaries who choose to enroll in Part D drug plans must pay premiums, deductibles, and copayments/co-insurance. The Medicare Prescription Drug Plan Finder is an online tool available at http://www.medicare.gov. This web tool allows beneficiaries to make informed choices about enrolling in Part D plans by comparing the plans' benefit packages, premiums, formularies, pharmacies, and pricing data. PDPs and MA-PDs are required to submit this information to CMS for posting on the Medicare Drug Plan Finder. The database structure provides the drug pricing and pharmacy network information necessary to accurately communicate plan information in a comparative format. The Medicare Prescription Drug Plan Finder displays information on pharmacies that are contracted to participate in the sponsors' network as either retail or mail order pharmacies.

Another approach for estimating the cost of the drugs that are currently covered under Part D and for which ASP data are not available would be to use data retrieved from the online Medicare Prescription Drug Plan Finder. For example, the Part D drug prices for each drug used by an OTP as part of MAT could be estimated based on a national average price charged by all Part D plans and their network pharmacies. However, the prices listed in the Medicare Prescription Drug Plan Finder generally reflect the prices that are negotiated by larger buying groups, as larger pharmacies often have significant buying power and smaller pharmacies generally contract with a pharmacy services administrative organization (PSAO). As a result, our primary concern with this pricing approach is that such prices may fail to reflect the drug prices that smaller OTP facilities may pay in acquiring these drugs and could therefore disadvantage these facilities. If we were to select this pricing approach for oral drugs for which ASP data are not available, we would anticipate setting the pricing for these drugs using the most recent Medicare Drug Plan Finder data available at the drafting of the CY 2020 PFS final rule. We note that, for the Part B ESRD prospective payment system (PPS) outlier calculation, which provides ESRD facilities with additional payment in situations where the costs for treating patients exceed an established threshold under the ESRD PPS, we chose to adopt the ASP methodology in section 1847A of the Act, and the other pricing methodologies under section 1847A of the Act, as appropriate, when ASP data are not available, to price the renal dialysis drugs and biological products that were or would have been separately billable under Part B prior to implementation of the ESRD PPS,[67] and the national average drug prices based on the Medicare Prescription Drug Plan Finder as the data source for pricing the renal dialysis drugs or biological products that were or would have been separately covered under Part D prior to implementation of the ESRD PPS.[68]

We believe that all of the MAT drugs proposed for inclusion in the OTP benefit that are currently covered under Part D have clinical treatment indications beyond MAT such as for the treatment of pain.[69] These drugs will continue to be covered under Part D for these other indications. Buprenorphine will continue to be covered under Part D for MAT as well. Consequently, Part D pricing information should continue to be available for these drugs and could be used in the computation of payment under the approach discussed above.

Because, by law, methadone used in MAT cannot be dispensed by a pharmacy, it is not currently considered a Part D drug when used for MAT. Methadone used for this purpose can be dispensed only through an OTP certified by SAMHSA. However, methadone dispensed for pain may be considered a Part D drug and can be dispensed by a pharmacy. Accordingly, we also seek comment on the applicability of Part D payment rates for methadone dispensed by a pharmacy to methadone dispensed by an OTP for MAT.

Approach 3: Wholesale Acquisition Cost (WAC)

Another approach for estimating the cost of the oral drugs that we propose to include as part of the bundled payments but for which ASP data are not available would be to use WAC. Section 1847A(c)(6)(B) of the Act defines WAC as the manufacturer's list price for the drug to wholesalers or direct purchasers in the U.S., not including prompt pay or other discounts, rebates, or reductions in price, for the most recent month for which the information is available, as reported in wholesale price guides or other publications of drug pricing data. As noted above in the discussion of Part B drugs, WAC is used as the basis for pricing some Part B drugs; for example, it is used when it is less than ASP in the case of single source drugs (section 1847A(b)(4) of the Act) and in cases where ASP is unavailable during the first quarter of sales (section 1847A(c)(4) of the Act).

Because WAC is the manufacturer's list price to wholesalers, we believe that it is more reflective of the price paid by the end user than the AWP. As a result, we believe that this pricing mechanism would be consistent with pricing that currently occurs for drugs that are separately billable under Part B. However, we have concerns about the fact that WAC does not include prompt pay or other discounts, rebates, or reductions in price. If we select this option to estimate the cost of certain drugs, we would develop pricing using the most recent data files available at the drafting of the CY 2020 PFS final rule.

Approach 4: National Average Drug Acquisition Cost (NADAC)

Another approach for estimating the cost of the oral drugs that we propose to include as part of the bundled payments but for which ASP data are not available would be to use Medicaid's NADAC survey. This survey provides another national drug pricing benchmark. CMS conducts surveys of retail community pharmacy prices, including drug ingredient costs, to develop the NADAC pricing benchmark. The NADAC was designed to create a national benchmark that is reflective of the prices paid by retail community pharmacies to acquire prescription and over-the-counter covered outpatient drugs and is available for consideration by states to assist with their individual pharmacy payment policies.

State Medicaid agencies reimburse pharmacy providers for prescribed covered outpatient drugs dispensed to Medicaid beneficiaries. The reimbursement formula consists of two parts: (1) Drug ingredient costs; and (2) a professional dispensing fee. In a final rule with comment period titled “Medicaid Program; Covered Outpatient Drugs,” which appeared in the February 1, 2016 Federal Register (81 FR 5169), we revised the methodology that state Medicaid programs use to determine drug ingredient costs, establishing an Actual Acquisition Cost (AAC) based determination, as opposed to a determination based on estimated acquisition costs (EAC). AAC is defined Start Printed Page 40534at 42 CFR 447.502 as the agency's determination of the pharmacy providers' actual prices paid to acquire drugs marketed or sold by specific manufacturers. As explained in the Covered Outpatient Drugs final rule with comment period (81 FR 5175), CMS believes shifting from an EAC to an AAC based determination of ingredient costs is more consistent with the dictates of section 1902(a)(30)(A) of the Act. In 2010, a working group within the National Association of State Medicaid Directors (NASMD) recommended the establishment of a single national pricing benchmark based on average drug acquisition costs. Pricing metrics based on actual drug purchase prices provide greater accuracy and transparency in how drug prices are established and are more resistant to manipulation. The NASMD requested that CMS coordinate, develop, and support this benchmark.

Section 1927(f) of the Act provides, in part, that CMS may contract with a vendor to conduct monthly surveys with respect to prices for covered outpatient drugs dispensed by retail community pharmacies. We entered into a contract with Myers & Stauffer, LLC to perform a monthly nationwide retail price survey of retail community pharmacy covered outpatient drug prices (CMS-10241, OMB 0938-1041) and to provide states with weekly updates on pricing files, that is, the NADAC files. The NADAC survey process focuses on drug ingredient costs for retail community pharmacies. The survey collects acquisition costs for covered outpatient drugs purchased by retail pharmacies, which include invoice prices from independent and chain retail community pharmacies. The survey data provide information that CMS uses to assure compliance with federal requirements. We believe NADAC data could be used to set the prices for the oral drugs furnished by OTPs for which ASP data are not available. Survey data on invoice prices provide the closest pricing metric to ASP that we are aware of. However, similar to the other available pricing metrics, we have concerns about the applicability of retail pharmacy prices to the acquisition costs available to OTPs since we have no evidence to suggest that these entities would be able to acquire drugs at a similar price point. If we select this option, we would develop pricing using the most recent data files available at the drafting of the CY 2020 PFS final rule.

Alternative Methadone Pricing: TRICARE

We are also considering an approach for estimating the cost of methadone using the amount calculated by TRICARE. As discussed above in this section of this proposed rule, the TRICARE rates for medications used in OTPs to treat opioid use disorder are spelled out in the 2016 TRICARE final rule (81 FR 61068); in the regulations at § 199.14(a)(2)(ix); and in Chapter 7, Section 5 and Chapter 1, Section 15 of the TRICARE Reimbursement Manual 6010.61-M, April 1, 2015.

In the 2016 TRICARE final rule, DOD established separate payment methodologies for OTPs based on the particular medication being administered for treatment.[70] Based on TRICARE's review of industry billing practices, the initial weekly bundled rate for administration of methadone included a daily drug cost of $3, which is subject to an update factor.[71]

This option would only be applicable for methadone because TRICARE has developed a fee-for-service payment methodology for buprenorphine and naltrexone.[72] In the 2016 TRICARE final rule, the DOD stated that the payments for buprenorphine and naltrexone are more variable in dosage and frequency for both the drug and non-drug services.[73] Accordingly, TRICARE pays for drugs listed on Medicare's Part B ASP files, such as the injectable and implantable versions of buprenorphine using the ASP; drugs not appearing on the Medicare ASP file, such as oral buprenorphine, are priced at the lesser of billed charges or 95 percent of the AWP.[74]

We believe that pricing methadone consistent with the TRICARE payment rate may provide a reasonable payment amount for methadone when ASP data are not available. As DOD noted in the 2016 TRICARE final rule, “a number of commenters indicated that they believed the rates DOD proposed for OTPs' services are near market rates and are acceptable.” [75]

We are proposing to codify this proposal to apply an alternative approach for determining the payment rate for oral drugs only if ASP data are not available in § 410.67(d)(2). We request public comment on the potential alternative approaches set forth above for estimating the cost of oral drugs that we propose to include as part of the bundled payments but for which ASP data are not available, including any other alternate sources of data to estimate the cost of these oral MAT drugs. Payment rates based on these different options are set forth in Table 14. We will consider the comments received on these different potential approaches when deciding on the approach that we will use to determine the payment rates for these drugs in the CY 2020 PFS final rule. We also invite public comment on any other potential data sources for estimating the provider acquisition costs of OTP drugs currently paid under either Part B or Part D. As noted previously, we welcome comments on how new drugs with a novel mechanism of action should be priced, and specifically whether pricing for non-opioid agonist and/or antagonist medications should be determined using the same pricing methodology, including the alternatives discussed above, as would be used for medications included in the proposed definition of OUD treatment services.

TABLE 14—Estimated * Initial Drug Payment Rates for Each Pricing Approach

Pricing approach (or alternative)Estimated initial weekly drug payment for methadoneEstimated initial weekly drug payment for oral buprenorphine
Proposal: ASP-Based PaymentASPs currently not reportedASPs currently not reported.
Approach 1: The Methodology in Section 1847A of the Act$29.61$117.68.
Approach 2: Medicare's Part D Prescription Drug Plan Finder Data22.4797.65.
Approach 3: WAC27.93111.02.
Approach 4: NADAC11.7697.02.
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Alternative Methadone Pricing: TRICARE22.19N/A.
* The estimated payment amounts in this table are based on data files posted at the time of the drafting of this proposed rule. We would develop the final pricing for CY 2020 using the most recent data files available at the drafting of the CY 2020 PFS final rule.

(b) Non-Drug Component

To price the non-drug component of the bundled payments, we are proposing to use a crosswalk to the non-drug component of the TRICARE weekly bundled rate for services furnished when a patient is prescribed methadone. As described above, in 2016, TRICARE finalized a weekly bundled rate for administration of methadone that included a daily drug cost of $3, along with a $15 per day cost for non-drug services (that is, the costs related to the intake/assessment, drug dispensing and screening and integrated psychosocial and medical treatment and supportive services). The daily projected per diem cost ($18/day) was converted to a weekly rate of $126 ($18/day × 7 days) (81 FR 61079). TRICARE updates the weekly bundled methadone rate for OTPs annually using the Medicare update factor used for other mental health care services rendered (that is, the Inpatient Prospective Payment System update factor) under TRICARE (81 FR 61079). The updated amount for CY 2019 to $133.15 (of which $22.19 is the methadone cost and the remainder, $110.96, is for the non-drug services).[76] We believe using the TRICARE weekly bundled rate is a reasonable approach to setting the payment rate for the non-drug component of the bundled payments to OTPs, particularly given the time constraints in developing a payment methodology prior to the January 1, 2020 effective date of this new Medicare benefit category. The TRICARE rate is an established national payment rate that was established through notice and comment rulemaking. As a result, OTPs and other interested parties had an opportunity to present information regarding the costs of these services. Furthermore the TRICARE rate describes a generally similar bundle of services to those services that are included in the definition of OUD treatment services in section 1861(jjj)(1) of the Act. We recognize that there are differences in the patient population for TRICARE compared with the Medicare beneficiary population. However, as OTP services have not previously been covered by Medicare, it is not clear what impact, if any, these differences would have on the cost of the services included in the non-drug component of the proposed bundled payments. We are proposing to codify the methodology for determining the payment rate for the non-drug component of the bundled payments using the TRICARE weekly rate for non-drug services at § 410.67(d)(2). As part of this proposal, we would plan to monitor utilization of non-drug services by Medicare beneficiaries and, if needed, would consider in future rulemaking ways we could tailor the TRICARE payment rate for these non-drug services to the Medicare population, including dually eligible beneficiaries.

Because the TRICARE payment rate for the non-drug services included in its weekly bundled rate for methadone includes daily administration of methadone, as part of our proposed approach we would adjust the TRICARE payment rate for non-drug services for most of the other bundled payments to more accurately reflect the cost of administering the other drugs used in MAT. For the oral buprenorphine bundled payment, we propose to retain the same amount as the rate for the methadone bundled payment based on an assumption that this drug is also being dispensed daily. We understand that patients who have stabilized may be given 7-14 day supplies of oral buprenorphine at a time, but for the purposes of developing the proposed rates, we valued this service to include daily drug dispensing to account for cases where daily drug dispensing is occurring. For the injectable drugs (buprenorphine and naltrexone), we propose to subtract from the non-drug component, an amount that is comparable to the dispensing fees paid by several state Medicaid programs ($10.50) for a week of daily dispensing of methadone. This adjustment accounts for the fact that these injectable drugs are not oral drugs that are dispensed daily; we would then instead add the fee that Medicare pays for the administration of an injection (which is currently $16.94 under the CY 2019 non-facility Medicare payment rate for CPT code 96372). We propose to update the amount of this adjustment annually using the same methodology that we are proposing to use to update the non-drug component of the bundled payments.

Similarly, the payment rates for the non-drug component of the codes for the weekly bundled payments for buprenorphine implants would be adjusted to add an amount for insertion and/or removal based on a direct crosswalk to the non-facility payment rates under the Medicare PFS for the insertion, removal, or insertion and removal of these implants, which describe the physician work, practice expense (PE), and malpractice costs associated with these procedures, and to remove the costs of daily drug dispensing (determined based on the dispensing fees paid by several state Medicaid programs for a week of daily dispensing of methadone, currently $10.50). For HCPCS code GXXX5, we would use a crosswalk to the rate for HCPCS code G0516 (Insertion of non-biodegradable drug delivery implants, 4 or more (services for subdermal rod implant)); for HCPCS code GXXX6, we would use a crosswalk to the rate for HCPCS code G0517 (Removal of non-biodegradable drug delivery implants, 4 or more (services for subdermal implants)); and for HCPCS code GXXX7, we would use a crosswalk to the rate for HCPCS code G0518 (Removal with reinsertion, non-biodegradable drug delivery implants, 4 or more (services for subdermal implants)). The amounts for HCPCS codes G0516, G0517 and G0518 under the CY 2019 non-facility Medicare payment rate are $111.00, $126.86, and $204.70, respectively.

In order to determine the payment rates for the code describing a non-drug bundled payment, HCPCS code GXXX8, we propose to use a crosswalk to the reimbursement rate for the non-drug services included in the TRICARE weekly bundled rate for administration of methadone, adjusted to subtract the cost of methadone dispensing (using an amount that is comparable to the dispensing fees paid by several state Medicaid programs for a week of daily dispensing of methadone, which is currently $10.50).

We propose that the payment rate for the add-on code, HCPCS code GXX19, would be based on 30 minutes of Start Printed Page 40536substance use counseling and valued based on a crosswalk to the rates set by state Medicaid programs for similar services.

i. Medication Not Otherwise Specified

We would expect the non-drug component for medication not otherwise specified bundled payments (HCPCS code GXXX9) to be consistent with the pricing methodology for the other bundled payments and therefore, be based on a crosswalk to the TRICARE rate, adjusted for any applicable administration and dispensing fees. For example, for oral medications, we would use the rate for the non-drug services included in the TRICARE methadone bundle, based on an assumption that the drug is also being dispensed daily. For the injectable medications, we would adjust the TRICARE payment rate for non-drug services using the same methodology we are proposing for injectable medications above (to subtract an amount for daily dispensing and add the non-facility Medicare payment rate for administration of the injection). For implantable medications, we would also use the same methodology we propose above, with the same crosswalked non-facility Medicare payment rates (for insertion, removal, and insertion and removal). We welcome comments on all of the proposed pricing methodologies described in this section. As noted above, we also welcome comments on how new drugs with a novel mechanism of action (that is, drugs that are not opioid agonists and/or antagonists) should be priced. We additionally welcome comments on how the price of the non-drug component of such bundled payments should be determined, in particular the dispensing and/or administration fees, including whether the methodology we propose above for determining the payment rate for the non-drug component of an episodes of are that includes a new opioid agonist and antagonist medication (which is based on whether the drug is oral, injectable, or implantable) would be appropriate to use for these new drugs.

(c) Partial Episode of Care

For HCPCS codes GXX10 and GXX11 (codes describing partial episodes for methadone and oral buprenorphine), we propose that the payment rates for the non-drug component would be calculated by taking one half of the payment rate for the non-drug component for the corresponding weekly bundles. We chose one half as the best approximation of the median cost of the services furnished during a partial episode consistent with our proposal above to make a partial episode bundled payment when the majority of services described in a beneficiary's treatment plan are not furnished during a specific episode of care. However, we welcome comment on other methods that could be used to calculate these payment rates. We propose that the payment rates for the drug component of these partial episode bundles would be calculated by taking one half of the payment rate for the drug component of the corresponding weekly bundles.

For HCPCS codes GXX12 and GXX16 (codes describing partial episodes for injectable buprenorphine and naltrexone), we propose that the payment rates for the drug component would be the same as the payment rate for the drug component of the full weekly bundle so that the OTP would be reimbursed for the cost of the drug that is given at the start of the episode. For the non-drug component, we propose that the payment rate would be calculated as follows: The TRICARE non-drug component payment rate ($110.96), adjusted to remove the cost of daily administration of an oral drug ($10.50), then divided by two; that amount would be added to the fee that Medicare pays for the administration of an injection (which is currently $16.94 under the CY 2019 non-facility Medicare payment rate for CPT code 96372).

For HCPCS codes GXX13, GXX14, GXX15 (codes describing partial episodes for the buprenorphine implant insertion, removal, and insertion and removal, respectively) we propose that the payment rates for drug component would be the same as the payment rate for the corresponding weekly bundle. For the non-drug component, we propose that the payment rate would be calculated as follows: The TRICARE non-drug component payment rate ($110.96), adjusted to remove the cost of daily administration of an oral drug ($10.50), then divided by two; that amount would be added to the Medicare non-facility payment rate for the insertion, removal, or insertion and removal of the implants, respectively (based on the non-facility rates for HCPCS codes G0516, G0517, and G0518, which are currently $111.00, $126.86, and $204.70, respectively).

For HCPCS code GXX17 (code describing a non-drug partial episode of care), we propose that the payment rate would be calculated by taking one half of the payment rate for the corresponding weekly bundle.

We propose that the payment rate for the code describing partial episodes for a medication not otherwise specified (HCPCS code GXX18) would be calculated based on whether the medication is oral, injectable or implantable, following the methodology described above. For oral drugs, we would follow the methodology described for HCPCS codes GXX10 and GXX11. For injectable drugs, we would follow the methodology described for HCPCS codes GXX12 and GXX16. For implantable drugs, we would follow the methodology described for HCPCS codes GXX13, GXX14, and GXX15. We welcome comments on how partial episodes of care using new drugs with a novel mechanism of action (that is, non-opioid agonist and/or antagonist treatment medications) should be priced. For example, we could use the same approach described previously for pricing new opioid agonist and antagonist medications not otherwise specified, which is to follow the methodology based on whether the drug is oral, injectable or implantable.

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(8) Place of Service (POS) Code for Services Furnished at OTPs

We are creating a new POS code specific to OTPs since there are no existing POS codes that specifically describe OTPs. Claims for OTP services would include this place of service code. We note that POS codes are available for use by all payers. We are not proposing to make any differential payment based on the use of this new POS code. Further guidance will be issued regarding the POS code that should be used by OTPs.

c. Duplicative Payments Under Parts B or D

Section 1834(w)(1) of the Act, added by section 2005(c) of the SUPPORT Act, requires the Secretary to ensure, as determined appropriate by the Secretary, that no duplicative payments are made under Part B or Part D for items and services furnished by an OTP. We note that many of the individual items or services provided by OTPs that would be included in the bundled payment rates under our proposal may also be appropriately available to beneficiaries through other Medicare benefits. Although we recognize the potential for significant program integrity concerns when similar items or services are payable under separate Medicare benefits, we also believe that it is important that any efforts to prevent duplicative payments not inadvertently restrict Medicare beneficiaries' access to other Medicare benefits even for the time period they are being treated by an OTP. For example, we believe that a beneficiary receiving counseling or therapy as part of an OTP bundle of services may also be receiving medically reasonable and necessary counseling or therapy as part of a physician's service during the same time period. Similarly, we believe there could be circumstances where Medicare beneficiaries with OUD could receive treatment and/or medication from non-OTP entities that would not result in duplicative payments, presuming that both the OTP and the other entity appropriately furnished separate medically necessary services or items. Consequently, we do not believe that provision of the same kinds of services by both an OTP and a separate provider or supplier would itself constitute a duplicative payment.

We believe that duplicative payments would result from the submission of claims to Medicare leading to payment for drugs furnished to a Medicare beneficiary and the associated dispensing fees on a certain date of service to both an OTP and another provider or supplier under a different benefit. In these circumstances, we would consider only one of the claims to be paid for appropriately. Accordingly, for purposes of implementing section 1834(w)(1) of the Act, we propose to consider payment for medications delivered, administered or dispensed to the beneficiary as part of the OTP bundled payment to be a duplicative payment if delivery, administration or dispensing of the same medications was also separately paid under Medicare Parts B or D. We propose to codify this policy at § 410.67(d)(4). We understand that some OTPs negotiate arrangements whereby community pharmacies supply MAT-related medications to OTPs. If the OTP provides medically necessary MAT-related medications as part of an episode of care, we would expect the OTP to take measures to ensure that there is no claim for payment for these drugs other than as part of the OTP bundled payment. (For example, the MAT drugs billed by an OTP as part of a bundled payment should not be reported to or paid under a Part D plan.) We expect that OTPs will take reasonable steps to ensure that the items and services furnished under their care are not reported or billed under a different Medicare benefit. CMS intends to monitor for duplicative payments, and would take appropriate action as needed when such duplicative payments are identified. Therefore, we are proposing that in cases where a payment for drugs used as part of an OTP's treatment plan is identified as being a duplicative payment because the same costs were paid under a different Medicare benefit, CMS will generally recoup the duplicative payment made to the OTP as the OTP would be in the best position to know whether or not the drug that is included as part of the beneficiary's treatment plan is furnished by the OTP or by another provider or supplier given that the OTP is responsible for managing the beneficiary's overall OUD treatment. We propose to codify this policy at § 410.67(d)(4). CMS notes that this general approach would not preclude CMS or other auditors from conducting appropriate oversight of duplicative payments made to the other provider or suppliers, particularly in cases of fraud and/or abuse.Start Printed Page 40540

d. Cost Sharing

Section 2005(c) of the SUPPORT Act amends section 1833(a)(1) of the Act, relating to payment of Part B services, by adding a new subparagraph (CC), which specifies with respect to OUD treatment services furnished by an OTP during an episode of care that the amount paid shall be equal to the amount payable under section 1834(w) of the Act less any copayment required as specified by the Secretary. Section 1834(w) of the Act, which was also added by section 2005(c) of the SUPPORT Act, requires that the Secretary pay an amount that is equal to 100 percent of a bundled payment under this part for OUD treatment services. Given these two provisions, we believe that there is flexibility for CMS to set the copayment amount for OTP services either at zero or at an amount above zero. Therefore, we are proposing to set the copayment at zero for a time-limited duration (for example, for the duration of the national opioid crisis), as we believe this would minimize barriers to patient access to OUD treatment services. Setting the copayment at zero also ensures OTP providers receive the full Medicare payment amount for Medicare beneficiaries if secondary payers are not available or do not pay the copayment, especially for those dually eligible for Medicare and Medicaid.[77] We intend to continue to monitor the opioid crisis in order to determine at what point in the future a copayment may be imposed. At such a time we deem appropriate, we would institute cost sharing through future notice and comment rulemaking. We welcome feedback from the public on our proposal to set the copayment at zero for a time-limited duration, such as for the duration of the national opioid crisis, and any other metrics CMS might consider using to determine when to start requiring a copayment. In developing our proposed approach, we also considered other alternatives, such as setting the copayment at a fixed fee calculated based on 20 percent of the payment rate for the bundle, consistent with the standard copayment requirement for other Part B services, or applying a flat dollar copayment amount similar to TRICARE's copayment; however, we recognize that setting the copayment for OUD services at a non-zero amount could create a barrier to access to treatment for many beneficiaries. We propose to codify the proposed copayment amount of zero at § 410.67(e). We welcome feedback on our proposal to set the copayment amount for OTP services at zero, and on the alternatives considered, including whether we should consider any of these alternatives for CY 2020 or future years.

Separately, we note that the Part B deductible would apply for OUD treatment services, as mandated for all Part B services by section 1833(b) of the Act.

4. Adjustments to Bundled Payment Rates for OUD Treatment Services

The costs of providing OUD treatment services will likely vary over time and depending on the geographic location where the services are furnished. Below we discuss our proposed adjustments to the bundled payment rates to account for these factors.

a. Locality Adjustment

Section 1834(w)(2) of the Act, as added by section 2005(c) of the SUPPORT Act provides that the Secretary may implement the bundled payment for OUD treatment services furnished by OTPs through one or more bundles based on the type of medications, the frequency of services, the scope of services furnished, characteristics of the individuals furnished such services, or other factors as the Secretary determines appropriate. The cost for the provision of OTP treatment services, like many other healthcare services covered by Medicare, will likely vary across the country based upon the differing cost in a given geographic locality. To account for such geographic cost differences in the provision of services, in a number of payment systems, Medicare routinely applies geographic locality adjustments to the payment rates for particular services. As we believe OTP treatment services will also be subject to varying cost based upon the geographic locality where the services are furnished, we propose to apply a geographic locality adjustment to the bundled payment rate for OTP treatment services. Below, we discuss our proposed approach with respect to the drug component (which reflects payment for the drug) and the non-drug component (which reflects payment for all other services furnished to the beneficiary by the OTP, such as drug administration, counseling, toxicology testing, etc.) of the bundled payment.

(1) Drug Component

Because our proposed approaches for pricing the MAT drugs included in the bundles all reflect national pricing, and because there is no geographic adjustment factor applied to the payment of Part B drugs under the ASP methodology, we do not believe that it is necessary to adjust the drug component of the bundled payment rates for OTP services based upon geographic locality. Therefore, we are proposing not to apply a geographic locality adjustment to the drug component of the bundled payment rate for OTP services.

(2) Non-Drug Component

Unlike the national pricing of drugs, the costs for the services included in the non-drug component of the OTP bundled payment for OUD treatments are not constant across all geographic localities. For example, OTPs' costs for rent or employee wages could vary significantly across different localities and could potentially result in disparate costs for the services included in the non-drug component of OUD treatment services. Because the costs of furnishing the services included in the non-drug component of the OTP bundled payment for OUD treatment services will vary based upon the geographic locality in which the services are provided, we believe it would be appropriate to apply a geographic locality adjustment to the non-drug component of the bundled payments. We believe that the geographic variation in cost of the non-drug services provided by OTPs will be similar to the geographic variation in the cost of services furnished in physician offices. Therefore, to account for the differential costs of OUD treatment services across the country, we are proposing to adjust the non-drug component of the bundled payment rates for OUD treatment services using an approach similar to the established methodology used to geographically adjust payments under the PFS based upon the location where the service is furnished. The PFS currently provides for an adjustment to the payment for PFS services based upon the fee schedule area in which the service is provided through the use of Geographic Practice Cost Indices (GPCIs), which measure the relative cost differences among localities compared to the national average for each of the Start Printed Page 40541three fee schedule components (work, PE, and malpractice).

Although we are proposing to adjust the non-drug component of the OUD treatment services using an approach similar to the established methodology used to adjust PFS payment for geographic locality, because GPCIs provide for the application of geographic locality adjustments to the three distinct components of PFS services, and the OTP bundled payment is a flat rate payment for all OUD treatment services furnished during an episode of care, a single factor would be required to apply the geographic locality adjustment to the non-drug component of the OTP bundled payment rate. Therefore, to apply a geographic locality adjustment to the non-drug component of the OTP bundled payment for OUD treatment services through a single factor, we are proposing to use the Geographic Adjustment Factor (GAF) at § 414.26. Specifically, we are proposing to use the GAF to adjust the payment for the non-drug component of the OTP bundled payment to reflect the costs of furnishing the non-drug component of OUD treatment services in each of the PFS fee schedule areas. The GAF is calculated using the GPCIs under the PFS, and is used to account for cost differences in furnishing physicians' services in differing geographic localities. The GAF is calculated for each fee schedule area as the weighted composite of all three GPCIs (work, PE, and malpractice) for that given locality using the national GPCI cost share weights. In developing this proposal, we also considered geographically adjusting the payment for the non-drug component of the OTP bundled payment using only the PE GPCI value for each fee schedule area. However, because the the non-drug component of OUD treatment services is comprised of work, PE, and malpractice expenses, we ultimately decided to propose using the GAF as we believe the weighted composite of all three GPCIs reflected in the GAF would be the more appropriate geographic adjustment factor to reflect geographic variations in the cost of furnishing these services.

The GAF, which is determined under § 414.26, is further discussed earlier in section II.D.1. of this proposed rule and the specific GAF values for each payment locality are posted in Addendum D to this proposed rule. In developing the proposed geographic locality adjustment for the non-drug component of the OUD treatment services payment rate, we also considered other potential locality adjustments, such as the Inpatient Prospective Payment System (IPPS) hospital wage index. However, we have opted to propose using the GAF as we believe the services provided in an OTP more closely resemble the services provided at a physician office than the services provided in other settings, such as inpatient hospitals. We propose to codify using the GAF to adjust the non-drug component of the OTP bundled payments to reflect the cost differences in furnishing these services in differing geographic localities at § 410.67(d)(3)(ii). We invite public comment on our proposal to adjust the non-drug component of the OTP bundled payments for geographic variations in the costs of furnishing OUD treatment services using the GAF. We also welcome comments on any factors, other than the GAF, that could be used to make this payment adjustment.

Additionally, we note that the majority of OTPs operate in urban localities. In light of this fact, we are interested in receiving information on whether rural areas have appropriate access to treatment for OUD. We are particularly interested in any potential limitations on access to care for OUD in rural areas and whether there are additional adjustments to the proposed bundled payments that should be made to account for the costs incurred by OTPs in furnishing OUD treatment services in rural areas. We invite public comment on this issue and potential solutions we could consider adopting to address this potential issue through future rulemaking.

b. Annual Update

Section 1834(w)(3) of the Act, as added by section 2005(c) of the SUPPORT Act, requires that the Secretary provide an update each year to the OTP bundled payment rates. To fulfill this statutory requirement, we are proposing to apply a blended annual update, comprised of distinct updates for the drug and non-drug components of the bundled payment rates, to account for the differing rate of growth in the prices of drugs relative to other services. We propose that this blended annual update for the OTP bundled payment rates would first apply for determining the CY 2021 OTP bundled payment rates. The specific details of the proposed updates for the drug and non-drug components respectively are discussed in this section.

(1) Drug Component

As stated above, we are proposing to establish the pricing of the drug component of the OTP bundled payment rates for OUD treatment services based on CMS pricing mechanisms currently in place. To recognize the potential change in costs of the drugs used in MAT from year to year and to fulfill the requirement to provide an annual update to the OTP bundled payment rates, we are proposing to update the payment for the drug component based upon the changes in drug costs reported under the pricing mechanism used to establish the pricing of the drug component of the applicable bundled payment rate, as discussed earlier. As an example, if we were to finalize our proposal to price the drug component of the bundled payment rate for episodes of care that include injectable and implantable drugs generally covered and paid under Medicare Part B using ASP data, the pricing of the drug component for these OTP bundled payments, would be updated using the most recently available ASP data at the time of ratesetting for the applicable calendar year. Similarly, if we finalize our proposal to price the drug component of the bundled payment rate for episodes of care that include oral drugs using ASP data, if such data are available, we would also update the pricing of the drug component using the most recently available ASP data at the time of ratesetting for the applicable calendar year. Previously, we also discussed a number of alternative data sources that could be used to price oral drugs in the drug component of OTP bundled payments in cases when we do not receive manufacturer-submitted ASP pricing data. As an example, if we were to use NADAC data as discussed as one of the alternatives, to determine the payment for the drug component of the bundled payment for oral drugs in cases when we do not have manufacturer-submitted ASP pricing data, this payment rate would also be updated using the most recently available NADAC data at the time of ratesetting for the applicable calendar year. We propose to codify this methodology for determining the annual update to the payment rate for the drug component at § 410.67(d)(3)(i).

In developing the proposal to annually update the pricing of the drug component of the OUD treatment services payment rate, we also considered other methodologies, including applying a single uniform update factor to the drug and non-drug components of the proposed payment rates. We ultimately determined not to propose the use of a single uniform update factor, because we believe that it is important to apply an annual update to the payment rates that recognizes the differing rate of growth of drug costs Start Printed Page 40542compared to the rate of growth in the cost of the other services. In addition, we also considered annually updating the pricing of the drug component of the OUD treatment services payment rate via an established update factor such as the Producer Price Index (PPI) for chemicals and allied products, analgesics (WPU06380202). The PPI for chemicals and allied products, analgesics is a subset of the PPI produced by the Bureau of Labor Statistics, which measures the average change over time in the selling prices received by domestic producers for their output. Ultimately we decided against updating the pricing of the drug component of the OUD treatment services payment rate via an established update factor such as the PPI in favor of our proposed approach because we believe the proposed approach updated the pricing of the drug component of the OUD treatment services payment rate in the manner most familiar to stakeholders. We invite public comment on our proposed approach to updating the drug component of the bundled payment rates. We also seek comment on possible alternate methodologies for updating the drug component of the payment rate for OUD treatment services, such as use of the PPI for chemicals and allied products, analgesics.

(2) Non-Drug Component

To account for the potential changing costs of the services included in the non-drug component of the bundled payment rates for OUD treatment services, we are proposing to update the non-drug component of the bundled payment for OUD treatment services based upon the Medicare Economic Index (MEI). The MEI is defined in section 1842(i)(3) of the Act and the methodology for computing the MEI is described in § 405.504(d). The MEI is used to update the payment rates for physician services under section 1842(b)(3) of the Act, which states that prevailing charge levels beginning after June 30, 1973, may not exceed the level from the previous year except to the extent that the Secretary finds, on the basis of appropriate economic index data, that such a higher level is justified by year-to-year economic changes. The MEI is a fixed-weight input price index that reflects the physicians' own time and the physicians' practice expenses, with an adjustment for the change in economy-wide, private nonfarm business multifactor productivity. The MEI was last revised in the CY 2014 PFS final rule with comment period (78 FR 74264). In developing the proposed update factor for the non-drug component of the OUD treatment services payment rate, we considered other potential update factors, such as the Bureau of Labor Statistics Consumer Price Index for All Items for Urban Consumers (Bureau of Labor Statistics #CUUR0000SA0 (https://www.bls.gov/​cpi/​data.htm) and the IPPS hospital market basket reduced by the multifactor productivity adjustment. The Consumer Price Index for All Items (CPI-U) is a measure of the average change over time in the prices paid by urban consumers for a market basket of consumer goods and services. However, we concluded that a healthcare-specific update factor, such as the MEI, would be more appropriate for OTPs than the CPI-U, which measures general inflation, as the MEI would more accurately reflect the change in the prices of goods and services included in the non-drug component of the OTP bundled payments.

Similarly, we believe the MEI would be more appropriate than the IPPS market basket to update the non-drug component of the bundled payment rates as the services provided by an OTP more closely resemble the services provided at a physician office than the services provided by an inpatient hospital. Accordingly, we propose to update the payment amount for the non-drug component of each of the bundled payment rates for OUD treatment services furnished by OTPs based upon the most recently available historical annual growth in the MEI available at the time of rulemaking. We propose to codify this proposal at § 410.67(d)(3)(iii). We invite public comment on this proposal.

H. Bundled Payments Under the PFS for Substance Use Disorders

1. Background and Proposal

In the CY 2019 PFS proposed rule (83 FR 35730), we solicited comment on creating a bundled episode of care payment for management and counseling treatment for substance use disorders. We received approximately 50 comments on this topic, most of which were supportive of creating a separate bundled payment for these services. Some commenters recommended focusing the bundle on services related to medication assisted treatment (MAT) used in treatment for opioid use disorder (OUD). Several commenters also recommended that we establish higher payment amounts for patients with more complex needs who require more intensive services and management, and also expressed concern that an episode of care that limited the duration of treatment would not be conducive to treating OUD, given the chronic nature of this disorder. Other commenters recommended that we establish separate bundled payments for treatment of substance use disorders that does, and does not, involve MAT.

In response to the public comments, we are proposing to establish bundled payments for the overall treatment of OUD, including management, care coordination, psychotherapy, and counseling activities. We note that, if a patient's treatment involves MAT, this proposed bundled payment would not include payment for the medication itself. Billing and payment for medications under Medicare Part B or Part D would remain unchanged. Additionally, payment for medically necessary toxicology testing would not be included in the proposed OUD bundle, and would continue to be billed separately under the Clinical Lab Fee Schedule. We are also proposing in this proposed rule to implement the new Medicare Part B benefit added by section 2005 of the SUPPORT Act for coverage of certain services furnished by Opioid Treatment Programs (OTPs) beginning in CY 2020. We believe the proposed bundled payment under the PFS for OUD treatment described below will create an avenue for physicians and other health professionals to bill for a bundle of services that is similar to the new bundled OUD treatment services benefit, but not furnished by an OTP. By creating a separate bundled payment for these services under the PFS, we hope to incentivize increased provision of counseling and care coordination for patients with OUD in the office setting, thereby expanding access to OUD care.

To implement this new bundled payment, we are proposing to create two HCPCS G-codes to describe monthly bundles of services that include overall management, care coordination, individual and group psychotherapy and counseling for office-based OUD treatment. Although we considered proposing weekly-reported codes to describe a bundle of services that would align with the proposed OTP bundle, we believe that monthly-reported codes will better align with the practice and billing of other types of care management services furnished in office settings and billed under the PFS (for example, behavioral health integration (BHI) services). We believe monthly-reported codes would be less administratively burdensome for practitioners, and more likely to be consistent with care management and prescribing patterns in the office setting (as compared with an OTP) given the increased use of long-acting MAT drugs (such as injectable naltrexone or Start Printed Page 40543implanted buprenorphine) in the office setting compared to the OTP setting. Based on feedback we received through the comment solicitation, we are proposing to create a code to describe the initial month of treatment, which would include intake activities and development of a treatment plan, as well as assessments to aid in development of the treatment plan in addition to care coordination, individual therapy, group therapy, and counseling; a code to describe subsequent months of treatment including care coordination, individual therapy, group therapy, and counseling; and an add-on code that could be billed in circumstances when effective treatment requires additional resources for a particular patient that substantially exceed the resources included in the base codes. In other words, the add-on code would address extraordinary circumstances that are not contemplated by the bundled code. We acknowledge that the course of treatment for OUD is variable, and in some instances, the first several months of treatment may be more resource intensive. We welcome comments on whether we should consider creating a separately billable code or codes to describe additional resources involved in furnishing OUD treatment-related services after the first month, for example, when substantial revisions to the treatment plan are needed, and what resource inputs we might consider in setting values for such codes.

We believe that, in general, bundled payments create incentives to provide efficient care by mitigating incentives tied to volume of services furnished, and that these incentives can be undermined by creating separate billing mechanisms to account for higher resource costs for particular patients. However, we share some of the concerns raised by commenters that an OUD bundle should not inadvertently limit the appropriate amount of OUD care furnished to patients with varying medical needs. In consideration of this concern, we are proposing to create an add-on code to make appropriate payment for additional resource costs in order to mitigate the risks that the bundled OUD payment might limit clinically-indicated patient care for patients that require significantly more care than is in the range of what is typical for the kinds of care described by the base codes. However, we are also interested in comments regarding ways we might better stratify the coding for OUD treatment to reflect the varying needs of patients (based on complexity or frequency of services, for example) while maintaining the full advantage of the bundled payment, including increased efficiency and flexibility in furnishing care.

We anticipate that these services would often be billed by addiction specialty practitioners, but note that these codes are not limited to any particular physician or non-physician practitioner specialty. Additionally, unlike the codes that describe care furnished using the psychiatric collaborative care model (CPT codes 99492, 99493, and 99494), which require consultation with a psychiatric consultant, we are not proposing to require consultation with a specialist as a condition of payment for these codes.

The codes and descriptors for the proposed services are:

  • HCPCS code GYYY1: Office-based treatment for opioid use disorder, including development of the treatment plan, care coordination, individual therapy and group therapy and counseling; at least 70 minutes in the first calendar month.
  • HCPCS code GYYY2: Office-based treatment for opioid use disorder, including care coordination, individual therapy and group therapy and counseling; at least 60 minutes in a subsequent calendar month.
  • HCPCS code GYYY3: Office-based treatment for opioid use disorder, including care coordination, individual therapy and group therapy and counseling; each additional 30 minutes beyond the first 120 minutes (List separately in addition to code for primary procedure).

For the purposes of valuation for HCPCS codes GYYY1 and GYYY2, we are assuming two individual psychotherapy sessions per month and four group psychotherapy sessions per month; however, we understand that the number of therapy and counseling sessions furnished per month will vary among patients and also fluctuate over time based on the individual patient's needs. Consistent with the methodology for pricing other services under the PFS, HCPCS codes GYYY1, GYYY2, and GYYY3 are valued based on what we believe to be a typical case, and we understand that based on variability in patient needs, some patients will require more resources, and some fewer. In order to maintain the advantages inherent in developing a payment bundle, we are proposing that the add-on code (HCPCS code GYYY3) can only be billed when the total time spent by the billing professional and the clinical staff furnishing the OUD treatment services described by the base code exceeds double the minimum amount of service time required to bill the base code for the month. We believe it is appropriate to limit billing of the add-on code to situations where medically necessary OUD treatment services for a particular patient exceed twice the minimum service time for the base code because, as noted above, the add-on code is intended to address extraordinary situations where effective treatment requires additional resources that substantially exceed the resources included in the base codes. For example, the needs of a particular patient in a month may be unusually acute, well beyond the needs of the typical patient; or there may be some months when psychosocial stressors arise that were unforeseen at the time the treatment plan was developed, but warrant additional or more intensive therapy services for the patient. We are proposing that when the time requirement is met, HCPCS code GYYY3 could be billed as an add-on code during the initial month or subsequent months of OUD treatment. Practitioners should document the medical necessity for the use of the add-on code in the patient's medical record. We welcome comments on this proposal.

We are proposing to value HCPCS codes GYYY1, GYYY2, and GYYY3 using a building block methodology that sums the work RVUs and direct PE inputs from codes that describe the component services we believe would be typical, consistent with the approach we have previously used in valuing monthly care management services that include face-to-face services within the payment. For HCPCS code GYYY1, we developed proposed inputs using a crosswalk to CPT code 99492 (Initial psychiatric collaborative care management, first 70 minutes in the first calendar month of behavioral health care manager activities, in consultation with a psychiatric consultant, and directed by the treating physician or other qualified health care professional, with the following required elements: Outreach to and engagement in treatment of a patient directed by the treating physician or other qualified health care professional; initial assessment of the patient, including administration of validated rating scales, with the development of an individualized treatment plan; review by the psychiatric consultant with modifications of the plan if recommended; entering patient in a registry and tracking patient follow-up and progress using the registry, with appropriate documentation, and participation in weekly caseload consultation with the psychiatric Start Printed Page 40544consultant; and provision of brief interventions using evidence-based techniques such as behavioral activation, motivational interviewing, and other focused treatment strategies.), which is assigned a work RVU of 1.70, plus CPT code 90832 (Psychotherapy, 30 minutes with patient), which is assigned a work RVU of 1.50 (assuming two over the course of the month), and CPT code 90853 (Group psychotherapy (other than of a multiple-family group)), which is assigned a work RVU of 0.59 (assuming four over the course of a month), for a work RVU of 7.06. The required minimum number of minutes described in HCPCS code GYYY1 is also based on a crosswalk to CPT codes 99492. Additionally, for HCPCS code GYYY1, we are proposing to use a crosswalk to the direct PE inputs associated with CPT code 99492, CPT code 90832 (times two), and CPT code 90853 (times four). We believe that the work and practice expense described by these crosswalk codes is analogous to the services described in HCPCS code GYYY1 because HCPCS code GYYY1 includes similar care coordination activities as described in CPT code 99492 and bundles in the psychotherapy services described in CPT codes 90832 and 90853.

We are proposing to value HCPCS code GYYY2 using a crosswalk to CPT code 99493 (Subsequent psychiatric collaborative care management, first 60 minutes in a subsequent month of behavioral health care manager activities, in consultation with a psychiatric consultant, and directed by the treating physician or other qualified health care professional, with the following required elements: Tracking patient follow-up and progress using the registry, with appropriate documentation; participation in weekly caseload consultation with the psychiatric consultant; ongoing collaboration with and coordination of the patient's mental health care with the treating physician or other qualified health care professional and any other treating mental health providers; additional review of progress and recommendations for changes in treatment, as indicated, including medications, based on recommendations provided by the psychiatric consultant; provision of brief interventions using evidence-based techniques such as behavioral activation, motivational interviewing, and other focused treatment strategies; monitoring of patient outcomes using validated rating scales; and relapse prevention planning with patients as they achieve remission of symptoms and/or other treatment goals and are prepared for discharge from active treatment), which is assigned a work RVU of 1.53, plus CPT code 90832, which is assigned a work RVU of 1.50 (assuming two over the course of the month), and CPT code 90853, which is assigned a work RVU of 0.59 (assuming four over the course of a month), for a work RVU of 6.89. The required minimum number of minutes described in HCPCS code GYYY2 is also based on a crosswalk to CPT codes 99493. For HCPCS code GYYY2, we are proposing to use a crosswalk to the direct PE inputs associated with CPT code 99493, CPT code 90832 (times two), and CPT code 90853 (times four). We believe that the work and practice expense described by these crosswalk codes is analogous to the services described in HCPCS code GYYY2 because HCPCS code GYYY2 includes similar care coordination activities as described in CPT code 99493 and bundles in the psychotherapy services described in CPT codes 90832 and 90853.

We are proposing to value HCPCS code GYYY3 using a crosswalk to CPT code 99494 (Initial or subsequent psychiatric collaborative care management, each additional 30 minutes in a calendar month of behavioral health care manager activities, in consultation with a psychiatric consultant, and directed by the treating physician or other qualified health care professional (List separately in addition to code for primary procedure)), which is assigned a work RVU of 0.82. The required minimum number of minutes described in HCPCS code GYYY2 is also based on a crosswalk to CPT codes 99493. For HCPCS code GYYY3, we are proposing to use a crosswalk to the direct PE inputs associated with CPT code 99494. We believe that the work and practice expense described by this crosswalk code is analogous to the services described in HCPCS code GYYY3 because HCPCS code GYYY3 includes similar care coordination activities as described in CPT code 99494.

For additional details on the proposed direct PE inputs for HCPCS codes GYYY1-GYYY3, see Table 22.

We understand that many beneficiaries with OUD have comorbidities and may require medically-necessary psychotherapy services for other behavioral health conditions. In order to avoid duplicative billing, we are proposing that, when furnished to treat OUD, CPT codes 90832, 90834, 90837, and 90853 may not be reported by the same practitioner for the same beneficiary in the same month as HCPCS codes GYYY1, GYYY2, and GYYY3. We welcome comments on this proposal.

We are proposing that practitioners reporting the OUD bundle must furnish a separately reportable initiating visit in association with the onset of OUD treatment, since the bundle requires a level of care coordination that cannot be effective without appropriate evaluation of the patient's needs. This is similar to the requirements for chronic care management (CCM) services (CPT codes 99487, 99489, 99490, and 99491) and BHI services (CPT codes 99484, 99492, 99493, and 99494) finalized in the CY 2017 PFS final rule (81 FR 80239) The initiating visit would establish the beneficiary's relationship with the billing practitioner, ensure the billing practitioner assesses the beneficiary to determine clinical appropriateness of MAT in cases where MAT is being furnished, and provide an opportunity to obtain beneficiary consent to receive care management services (as discussed further below). We propose that the same services that can serve as the initiating visit for CCM services and BHI services can serve as the initiating visit for the proposed services described by HCPCS codes GYYY1-GYYY3. For new patients or patients not seen by the practitioner within a year prior to the commencement of CCM services and BHI services, the billing practitioner must initiate the service during a “comprehensive” E/M visit (levels 2 through 5 E/M visits), annual wellness visit (AWV) or initial preventive physical exam (IPPE). The face-to-face visit included in transitional care management (TCM) services (CPT codes 99495 and 99496) also qualifies as a “comprehensive” visit for CCM and BHI initiation. We propose that these visits could similarly serve as the initiating visit for OUD services.

We are proposing that the counseling, therapy, and care coordination described in the proposed OUD treatment codes could be provided by professionals who are qualified to provide the services under state law and within their scope of practice “incident to” the services of the billing physician or other practitioner. We are also proposing that the billing clinician would manage the patient's overall care, as well as supervise any other individuals participating in the treatment, similar to the structure of the BHI codes describing the psychiatric collaborative care model finalized in the CY 2017 PFS final rule (81 FR 80229), in which services are reported by a treating physician or other qualified health care professional and include the services of the treating physician or other qualified health care professional, Start Printed Page 40545as well as the services of other professionals who furnish services incident to the services of the treating physician or other qualified health care professional. Additionally, we are proposing to add these codes to the list of designated care management services for which we allow general supervision of the non-face-to-face portion of the required services. Consistent with policies for other separately billable care management services under the PFS, because these proposed OUD treatment bundles include non-face-to-face care management components, we are proposing that the billing practitioner or clinical staff must document in the beneficiary's medical record that they obtained the beneficiary's consent to receive the services, and that, as part of the consent, they informed the beneficiary that there is cost sharing associated with these services, including potential deductible and coinsurance amounts, for both in-person and non-face-to-face services that are provided.

We are also proposing to allow any of the individual therapy, group therapy and counseling services included in HCPCS codes GYYY1, GYYY2, and GYYY3 to be furnished via telehealth, as clinically appropriate, in order to increase access to care for beneficiaries. As discussed in section II.F. of this proposed rule regarding Telehealth Services, like certain other non-face-to-face PFS services, the components of HCPCS codes GYYY1 through GYYY3 describing care coordination are commonly furnished remotely using telecommunications technology, and do not require the patient to be present in-person with the practitioner when they are furnished. As such, these services are not considered telehealth services for purposes of Medicare, and we do not need to consider whether the non-face-to-face aspects of HCPCS codes GYYY1 through GYYY3 are similar to other telehealth services. If the non-face-to-face components of HCPCS codes GYYY1 through GYYY3 were separately billable, they would not need to be on the Medicare telehealth list to be covered and paid in the same way as services delivered without the use of telecommunications technology.

Section 2001(a) of the SUPPORT Act amended section 1834(m) of the Act, adding a new paragraph (7) that removes the geographic limitations for telehealth services furnished on or after July 1, 2019, to an individual with a substance use disorder (SUD) diagnosis for purposes of treatment of such disorder or co-occurring mental health disorder. The new paragraph at section 1834(m)(7) of the Act also allows telehealth services for treatment of a diagnosed SUD or co-occurring mental health disorder to be furnished to individuals at any telehealth originating site (other than a renal dialysis facility), including in a patient's home. As discussed in section II.F. of this proposed rule, Telehealth Services, we are proposing to add HCPCS codes GYYY1, GYYY2, and GYYY3 to the list of Medicare Telehealth services. Because certain required services (such as individual psychotherapy or group psychotherapy services) that are included in the proposed OUD bundled payment codes would be furnished to treat a diagnosed SUD, and would ordinarily require a face-to-face encounter, they could be furnished more broadly as telehealth services as permitted under section 1834(m)(7) of the Act.

For these proposed services described above (HCPCS codes GYYY1, GYYY2, and GYYY3), we seek comment on how these potential codes, descriptors, and payment rates align with state Medicaid coding and payment rates for the purposes of state payment of cost sharing for Medicare-Medicaid dually eligible individuals. Additionally, we understand that treatment for OUD can vary, and that MAT alone has demonstrated efficacy. In cases where a medication such as buprenorphine or naltrexone is used to treat OUD alone, without therapy or counseling, we note that existing applicable codes can be used to furnishing and bill for that care (for example, using E/M visits, in lieu of billing the bundled OUD codes proposed here).

As discussed in section II.G. of this proposed rule, Medicare Coverage for Certain Services Furnished by Opioid Treatment Programs, we are proposing to set the copayment at zero for OUD services furnished by an OTP, given the flexibility in section 1834(w)(1) of the Act for us to set the copayment amount for OTP services either at zero or at an amount above zero. We note that we do not have the statutory authority to eliminate the deductible and coinsurance requirements for the bundled OUD treatment services under the PFS. We acknowledge the potential impact of coinsurance on patient health care decisions and intend to monitor its impact if these proposals were to be finalized.

Finally, we recognize that historically, the CPT Editorial Panel has frequently created CPT codes describing services that we originally established using G-codes and adopted them through the CPT Editorial Panel process. We note that we would consider new using any available CPT coding to describe services similar to those described here in future rulemaking, as early as CY 2021. We would consider and adopt any such CPT codes through subsequent rulemaking.

Additionally, we understand that in some cases, OUD can first become apparent to practitioners in the emergency department setting. We recognize that there is not specific coding that describes diagnosis of OUD or the initiation of, or referral for, MAT in the emergency department setting. We are seeking comment on the use of MAT in the emergency department setting, including initiation of MAT and the potential for either referral or follow-up care, as well as the potential for administration of long-acting MAT agents in this setting, in order to better understand typical practice patterns to help inform whether we should consider making separate payment for such services in future rulemaking. We welcome feedback from stakeholders and the public on other potential bundles describing services for other substance use disorders for our consideration in future rulemaking.

2. Rural Health Clinics (RHCs) and Federally-Qualified Health Centers (FQHCs)

In the CY 2018 PFS final rule (82 FR 53169 through 53180), we established payment for General Care Management (CCM) services using HCPCS G0511 which is an RHC and FQHC-specific G code for at least 20 minutes of CCM, complex CCM, or general behavioral health services. Payment for this code is currently set at the average of the non-facility, non-geographically adjusted payment rates for CPT codes 99490, 99487, 99491, and 99484. The types of chronic conditions that are eligible for care management services include mental health or behavioral health conditions, including substance use disorders.

In the CY 2018 PFS final rule with comment period (82 FR 53169 through 53180), we also established payment for psychiatric Collaborative Care Services (CoCM) using HCPCS code G0512, which is an RHC and FQHC specific G-code for at least 70 minutes in the first calendar month, and at least 60 minutes in subsequent calendar months of psychiatric CoCM services. Payment for this code is set at the average of the non-facility, non-geographically adjusted rates for CPT codes 99492 and 99493. The psychiatric CoCM model of care may be used to treat patients with any behavioral health condition that is being treated by the billing practitioner, including substance use disorders.Start Printed Page 40546

RHCs and FQHCs can also bill for individual psychotherapy services using CPT codes 90791, 90792, 90832, 90834, 90837, 90839, or 90845, which are billable visits under the RHC all-inclusive rate (AIR) and FQHC Prospective Payment System (PPS) when furnished by an RHC or FQHC practitioner. If a qualified mental health service is furnished on the same day as a qualified primary care service, the RHC or FQHC can bill for 2 visits.

RHCs and FQHCs are engaged primarily in providing services that are furnished typically in a physician's office or an outpatient clinic. As a result of the proposed bundled payment under the PFS for OUD treatment furnished by physicians, we reviewed the applicability of RHCs and FQHCs furnishing and billing for similar services. Specifically, we considered establishing a new RHC and FQHC specific G code for OUD treatment with the payment rate set at the average of the non-facility, non-geographically adjusted payment rates for GYYY1 and GYYY2, beginning on January 1, 2020. The requirements to bill the services would be similar to the requirements under the PFS for GYYY1 and GYYY2, including that an initiating visit with a primary care practitioner must occur within one year before OUD services begin, and that consent be obtained before services are furnished.

However, because RHCs and FQHCs that choose to furnish OUD services can continue to report these individual codes when treating OUD, and can also offer their patients comprehensive care coordination services using HCPCS codes G0511 and G0512, we do not believe that adding a new and separate code to report a bundle of OUD services is necessary. Therefore, we are not proposing to add a new G code for a bundle of OUD service.

I. Physician Supervision for Physician Assistant (PA) Services

1. Background

Section 4072(e) of the Omnibus Budget Reconciliation Act of 1986 (Pub. L. 99-509, October 21, 1986), added section 1861(s)(2)(K)(i) of the Act to establish a benefit for services furnished by a physician assistant (PA) under the supervision of a physician. We have interpreted this physician supervision requirement in the regulation at § 410.74(a)(2)(iv) to require PA services to be furnished under the general supervision of a physician. This general supervision requirement was based upon another longstanding regulation at § 410.32(b)(3)(i) that defines three levels of supervision for diagnostic tests, which are general, direct and personal supervision. Of these three supervision levels, general supervision is the most lenient. Specifically, the general supervision requirement means that PA services must be furnished under a physician's overall direction and control, but the physician's presence is not required during the performance of PA services.

In the CY 2018 PFS proposed rule (82 FR 34172 through 34173), we published a request for information (RFI) on CMS flexibilities and efficiencies. In response to this RFI, commenters including PA stakeholders informed us about recent changes in the practice of medicine for PAs, particularly regarding physician supervision. These commenters also reached out separately to CMS with their concerns. They stated that PAs are now practicing more autonomously, like nurse practitioners (NPs) and clinical nurse specialists (CNSs), as members of medical teams that often consist of physicians, nonphysician practitioners and other allied health professionals. This changed approach to the delivery of health care services involving PAs has resulted in changes to scope of practice laws for PAs regarding physician supervision across some states. According to these commenters, some states have already relaxed their requirements for PAs related to physician supervision, some states have made changes and are now silent about their physician supervision requirements, while other states have not yet changed their PA scope of practice in terms of their physician supervision requirements. Overall, these commenters believe that as states continue to make changes to their physician supervision requirements for PAs, the Medicare requirement for general supervision of PA services may become increasingly out of step with current medical practice, imposing a more stringent standard than state laws governing physician supervision of PA services. Furthermore, as currently defined, stakeholders have suggested that the supervision requirement is often misinterpreted or misunderstood in a manner that restricts PAs' ability to practice to the full extent of their education and expertise. The stakeholders have suggested that the current regulatory definition of physician supervision as it applies to PAs could inappropriately restrict the practice of PAs in delivering their professional services to the Medicare population.

We note that we have understood our current policy to require general physician supervision for PA services to fulfill the statutory physician supervision requirement; and we believe that general physician supervision gives PAs flexibility to furnish their professional services without the need for a physician's physical presence or availability. Nonetheless, we appreciate the concerns articulated by stakeholders. To more fully understand the current landscape for medical practice involving PA services and how the current regulatory definition may be problematic, we invite public comments on specific examples of changes in state law and state scope of practice rules that enable PAs to practice more broadly such that those rules are in tension with the Medicare requirement for general physician supervision of PA services that has been in place since the inception of the PA benefit category under Medicare law.

Given the commenters' understanding of ongoing changes underway to the state scope of practice laws regarding physician supervision of PA services, commenters on our CY 2018 RFI have requested that CMS reconsider its interpretation of the statutory requirement that PA services must be furnished under the supervision of a physician to allow PAs to operate similarly to NPs and CNSs, who are required by section 1861(s)(2)(K)(ii) of the Act to furnish their services “in collaboration” with a physician. In general, we have interpreted collaboration for this purpose at §§ 410.75(c)(3) and 410.76(c)(3) of our regulations to mean a process in which an NP or CNS (respectively) works with one or more physicians to deliver health care services within the scope of the practitioner's expertise, with medical direction and appropriate supervision as provided by state law in which the services are performed. The commenters stated that allowing PA services to be furnished using such a collaborative process would offer PAs the flexibility necessary to deliver services more effectively under today's health care system in accordance with the scope of practice in the state(s) where they practice, rather than being limited by the system that was in place when PA services were first covered under Medicare Part B over 30 years ago.

2. Proposal

After considering the comments we received on the RFI, as well as information we received regarding the scope of practice laws in some states regarding supervision requirements for PAs, we are proposing to revise the regulation at § 410.74 that establishes physician supervision requirements for PAs. Specifically, we are proposing to Start Printed Page 40547revise § 410.74(a)(2) to provide that the statutory physician supervision requirement for PA services at section 1861(s)(2)(K)(i) of the Act would be met when a PA furnishes their services in accordance with state law and state scope of practice rules for PAs in the state in which the services are furnished, with medical direction and appropriate supervision as provided by state law in which the services are performed. In the absence of state law governing physician supervision of PA services, the physician supervision required by Medicare for PA services would be evidenced by documentation in the medical record of the PA's approach to working with physicians in furnishing their services. Consistent with current rules, such documentation would need to be available to CMS, upon request. This proposed change would substantially align the regulation on physician supervision for PA services at § 410.74(a)(2) with our current regulations on physician collaboration for NP and CNS services at §§ 410.75(c)(3) and 410.76(c)(3). We continue to engage with key stakeholders on this issue and receive information on the expanded role of nonphysician practitioners as members of the medical team. As we are informed about transitions in state law and state scope of practice governing physician supervision, as well as changes in the way that PAs practice, we acknowledge the state's role and autonomy to establish, uphold, and enforce their state laws and PA scope of practice requirements to ensure that an appropriate level of physician oversight occurs when PAs furnish their professional services to Medicare Part B patients. Our policy proposal on this issue largely defers to state law and state scope of practice and enables states the flexibility to develop requirements for PA services that are unique and appropriate for their respective state, allowing the states to be accountable for the safety and quality of health care services that PAs furnish.

J. Review and Verification of Medical Record Documentation

1. Background

In an effort to reduce mandatory and duplicative medical record evaluation and management (E/M) documentation requirements, we finalized an amended regulatory provision at 42 CFR part 415, subpart D, in the CY 2019 PFS final rule (83 FR 59653 through 59654). Specifically, § 415.172(a) requires as a condition of payment under the PFS that the teaching physician (as defined in § 415.152) must be present during certain portions of services that are furnished with the involvement of residents (individuals who are training in a graduate medical education program). Section 415.174(a) provides for an exception to the teaching physician presence requirements in the case of certain E/M services under certain conditions, but requires that the teaching physician must direct and review the care provided by no more than four residents at a time. Sections 415.172(b) and 415.174(a)(6), respectively require that the teaching physician's presence and participation in services involving residents must be documented in the medical record. We amended these regulations to provide that a physician, resident, or nurse may document in the patient's medical record that the teaching physician presence and participation requirements were met. As a result, for E/M visits furnished beginning January 1, 2019, the extent of the teaching physician's participation in services involving residents may be demonstrated by notes in the medical records made by a physician, resident, or nurse.

For the same burden reduction purposes, we issued CR 10412, Transmittal 3971 https://www.cms.gov/​Regulations-and-Guidance/​Guidance/​Transmittals/​2018Downloads/​R3971CP.pdf on February 2, 2018, which revised a paragraph in our manual instructions on “Teaching Physician Services” at Pub. 100-04, Medicare Claims Processing Manual, Chapter 12, Section 100.1.1B., to reduce duplicative documentation requirements by allowing a teaching physician to review and verify (sign/date) notes made by a student in a patient's medical record for E/M services, rather than having to re-document the information, largely duplicating the student's notes. We issued corrections to CR 10412 through Transmittal 4068 https://www.cms.gov/​Regulations-and-Guidance/​Guidance/​Transmittals/​2018Downloads/​R4068CP.pdf and re-issued the CR on May 31, 2018. Pub. 100-04, Medicare Claims Processing Manual, Chapter 12, Section 100 contains a list of definitions pertinent to teaching physician services. Following these amendments to our regulations and manual, certain stakeholders raised concerns about the definitions in this section, particularly those for teaching physician, student, and documentation; and when considered in conjunction with the interpretation of the manual provision at Pub. 100-04, Medicare Claims Processing Manual, Chapter 12, Section 100.1.1B., which addresses documentation of E/M services involving students. While there is no regulatory definition of student, the manual instruction defines a student as an individual who participates in an accredited educational program (for example, a medical school) that is not an approved graduate medical education (GME) program. The manual instructions also specify that a student is never considered to be an intern or a resident, and that Medicare does not pay for services furnished by a student (see Section 100.1.1B. for a discussion concerning E/M service documentation performed by students).

We are aware that nonphysician practitioners who are authorized under Medicare Part B to furnish and be paid for all levels of E/M services are seeking similar relief from burdensome E/M documentation requirements that would allow them to review and verify medical record notes made by their students, rather than having to re-document the information. These nonphysician practitioners include nurse practitioners (NPs), clinical nurse specialists (CNSs), and certified nurse-midwives (CNMs), collectively referred to hereafter for purposes of this discussion as advanced practice registered nurses (APRNs), as well as physician assistants (PAs). Subsequent to the publication of the CY 2019 PFS final rule (83 FR 59653 through 59654), through feedback from listening sessions hosted by CMS' Documentation Requirements Simplification workgroup, we began to hear concerns from a variety of stakeholders about the requirements for teaching physician review and verification of documentation added to the medical record by other individuals. Physician and nonphysician practitioner stakeholders expressed concern about the scope of the changes to §§ 415.172(b) and 415.174(a)(6) which authorize only a physician, resident, or nurse to include notes in the medical record to document E/M services furnished by teaching physicians, because they believed that students and other members of the medical team should be similarly permitted to provide E/M medical record documentation. In addition to students, these stakeholders indicated that “other members of the medical team” could include individuals who the teaching physician, other physicians, PA and APRN preceptors designate as being appropriate to document services in the medical record, which the billing practitioner would then review and verify, and rely upon for billing purposes.

Subsequent to the publication of the student documentation manual Start Printed Page 40548instruction change at section 100.1.1B of the Medicare Claims Processing Manual, representatives of PAs and APRNs requested clarification about whether PA and APRN preceptors and their students were subject to the same E/M documentation requirements as teaching physicians and their medical students. These stakeholders suggested that the reference to “student” in the manual instruction on E/M documentation provided by students is ambiguous because it does not specify “medical student”. These stakeholders also suggested that the definition of “student” in section 100 of this manual instruction is ambiguous because PA and APRN preceptors also educate students who are individuals who participate in an accredited educational program that is not an approved GME program. Accordingly, these stakeholders expressed concern that the uncertainty throughout the health care industry, including among our contractors, concerning the student E/M documentation review and verification policy under these manual guidelines results in unequal treatment as compared to teaching physicians. The stakeholders stated that depending on how the manual instruction is interpreted, PA and APRN preceptors may be required to re-document E/M services in full when their students include notes in the medical records, without having the same option that teaching physicians do to simply review and verify medical student documentation.

2. Proposal

After considering the concerns expressed by these stakeholders, we believe it would be appropriate to provide broad flexibility to the physicians, PAs and APRNs (regardless of whether they are acting in a teaching capacity) who document and who are paid under the PFS for their professional services. Therefore, we propose to establish a general principle to allow the physician, the PA, or the APRN who furnishes and bills for their professional services to review and verify, rather than re-document, information included in the medical record by physicians, residents, nurses, students or other members of the medical team. This principle would apply across the spectrum of all Medicare-covered services paid under the PFS. Because this proposal is intended to apply broadly, we propose to amend regulations for teaching physicians, physicians, PAs, and APRNs to add this new flexibility for medical record documentation requirements for professional services furnished by physicians, PAs and APRNs in all settings. We invite comments on this proposal.

Specifically, to reflect our simplified and standardized approach to medical record documentation for all professional services furnished by physicians, PAs and APRNs paid under the PFS, we are proposing to amend §§ 410.20 (Physicians' services), 410.74 (PA services), 410.75 (NP services), 410.76 (CNS services) and 410.77 (CNM services) to add a new paragraph entitled, “Medical record documentation.” This paragraph would specify that, when furnishing their professional services, the clinician may review and verify (sign/date) notes in a patient's medical record made by other physicians, residents, nurses, students, or other members of the medical team, including notes documenting the practitioner's presence and participation in the services, rather than fully re-documenting the information. We note that, while the proposed change addresses who may document services in the medical record, subject to review and verification by the furnishing and billing clinician, it does not modify the scope of, or standards for, the documentation that is needed in the medical record to demonstrate medical necessity of services, or otherwise for purposes of appropriate medical recordkeeping.

We are also proposing to make conforming amendments to §§ 415.172(b) and 415.174(a)(6) to also allow physicians, residents, nurses, students, or other members of the medical team to enter information in the medical record that can then be reviewed and verified by a teaching physician without the need for re-documentation. We invite comments on these proposed amendments to our regulations.

K. Care Management Services

1. Background

In recent years, we have updated PFS payment policies to improve payment for care management and care coordination. Working with the CPT Editorial Panel and other clinicians, we have expanded the suite of codes describing these services. New CPT codes were created that distinguish between services that are face-to-face; represent a single encounter, monthly service or both; are timed services; represent primary care versus specialty care; address specific conditions; and represent the work of the billing practitioner, their clinical staff, or both (see Table 16). Additional information regarding recent new codes and associated PFS payment rules is available on our website at https://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​PhysicianFeeSched/​Care-Management.html.

Table 16—Summary of Special Care Management Codes

ServiceSummary
Care Plan Oversight (CPO) (also referred to as Home Health Supervision, Hospice Supervision) (HCPCS Codes G0181, G0182)Supervision of home health, hospice, per month.
ESRD Monthly Services (CPT Codes 90951-70)ESRD management, with and without face-to-face visits, by age, per month.
Transitional Care Management (TCM) (adopted in 2013) (CPT Codes 99495, 99496)Management of transition from acute care or certain outpatient stays to a community setting, with face-to-face visit, once per patient within 30 days post-discharge.
Chronic Care Management (CCM) (adopted in 2015, 2017, 2019) (CPT Codes 99487, 99489, 99490, 99491)Management of all care for patients with two or more serious chronic conditions, timed, per month.
Advance Care Planning (ACP) (adopted in 2016) (CPT Codes 99497, 99498)Counseling/discussing advance directives, face-to-face, timed.
Behavioral Health Integration (BHI) (adopted in 2017) (CPT Codes 99484, 99492, 99493, 99494)Management of behavioral health conditions(s), timed, per month.
Assessment/Care Planning for Cognitive Impairment (adopted in 2017) (CPT Code 99483)Assessment and care planning of cognitive impairment, face-to-face visit.
Prolonged Evaluation & Management (E/M) Without Direct Patient Contact (adopted in 2017) (CPT Codes 99358, 99359)Non-face-to-face E&M work related to a face-to-face visit, timed.
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Remote Patient Monitoring (adopted in 2019) (CPT Code 99091)Review and analysis of patient-generated health data, timed, per 30 days.
Interprofessional Consultation (adopted in 2019) (CPT Codes 99446, 99447, 99448, 99449, 99451, 99452)Inter-practitioner consultation.

Based on our review of the Medicare claims data we estimate that approximately 3 million unique beneficiaries (9 percent of the Medicare fee-for-service (FFS) population) receive these services annually, with higher use of chronic care management (CCM), transitional care management (TCM), and advance care planning (ACP) services. We believe gaps remain in coding and payment, such as for care management of patients having a single, serious, or complex chronic condition. In this proposed rule, we continue our ongoing work in this area through code set refinement related to TCM services and CCM services, in addition to proposing new coding for principal care management (PCM) services, and addressing chronic care remote physiologic monitoring (RPM) services.

2. Transitional Care Management (TCM) Services

Utilization of TCM services has increased each year since CMS established coding and began paying separately for TCM services. Specifically, there were almost 300,000 TCM professional claims during 2013, the first year of TCM services, and almost 1.3 million professional claims during 2018, the most recent year of complete claims data. However, based upon an analysis of claims data by Bindman and Cox,[78] utilization of TCM services is low when compared to the number of Medicare beneficiaries with eligible discharges. Additionally, Bindman and Cox noted that the beneficiaries who received TCM services demonstrated reduced readmission rates, lower mortality, and decreased health care costs. Based upon these findings, we believe that increasing utilization of TCM services could positively affect patient outcomes.

In developing a proposal designed to increase utilization of TCM services, we considered possible factors contributing to low utilization. Bindman and Cox identified two likely contributing factors: The administrative burdens associated with billing TCM services and the payment amount to physicians for services.

We focused initially on the requirements for billing TCM services. In reviewing the TCM billing requirements, we noted that we had established in the CY 2013 PFS final rule with comment period a list of 57 HCPCS codes that cannot be billed during the 30-day period covered by TCM services by the same practitioner reporting TCM (77 FR 68990). This list mirrored reporting restrictions put in place by the CPT Editorial Panel for the TCM codes upon their creation. At the time we established separate payment for the TCM CPT codes, we agreed with the CPT Editorial Panel that the services described by the 57 codes could be overlapping and duplicative with TCM in their definition and scope; although, many of these codes were not separately payable or covered under the PFS so even if they were reported for PFS payment, they would not be have been separately paid (see, for example, 77 FR 68985). In response to those concerns, we adopted billing restrictions to avoid duplicative billing and payment for covered services. In our recent analysis of the services associated with the 57 codes, we found that the majority of codes on the list remain either bundled, noncovered by Medicare, or invalid for Medicare payment purposes. Table 17 provides detailed information regarding the subset of these codes that would be separately payable under the PFS (Status Indicator “A”) and, as such, are the focus of this year's CY 2020 proposed policy for TCM. Fourteen (14) codes on the list represent active codes that are paid separately under the PFS and that upon reconsideration, we believe may not substantially overlap with TCM services and should be separately payable alongside TCM. For example, CPT code 99358 (Prolonged E/M service before and/or after direct patient care; first hour; non-face-to-face time spent by a physician or other qualified health care professional on a given date providing prolonged service) would allow the physician or other qualified healthcare professional extra time to review records and manage patient support services after the face-to-face visit required as part of TCM services. CPT code 99091 (Collection & interpretation of physiologic data, requiring a minimum of 30 minutes each 30 days) would permit the physician or other qualified healthcare professional to collect and analyze physiologic parameters associated with the patient's chronic disease.

Thus, after review of the services described by these 14 HCPCS codes, we believe these codes, when medically necessary, may complement TCM services rather than substantially overlap or duplicate services. We also believe removing the billing restrictions associated with these codes may increase utilization of TCM services.

Table 17—14 HCPCS Codes That Currently Cannot Be Billed Concurrently With TCM by the Same Practitioner and Are Active Codes Payable by Medicare PFS

Code familyHCPCS codeDescriptor
Prolonged Services without Direct Patient Contact99358Prolonged E/M service before and/or after direct patient care; first hour; non-face-to-face time spent by a physician or other qualified health care professional on a given date providing prolonged service.
99359Prolonged E/M service before and/or after direct patient care; each additional 30 minutes beyond the first hour of prolonged services.
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Home and Outpatient International Normalized Ratio (INR) Monitoring Services93792 93793Patient/caregiver training for initiation of home INR monitoring. Anticoagulant management for a patient taking warfarin; includes review and interpretation of a new home, office, or lab INR test result, patient instructions, dosage adjustment and scheduling of additional test(s).
End Stage Renal Disease Services (patients who are 20+ years)90960ESRD related services monthly with 4 or more face-to-face visits per month; for patients 20 years and older.
90961ESRD related services monthly with 2-3 face-to-face visits per month; for patients 20 years and older.
90962ESRD related services with 1 face-to-face visit per month; for patients 20 years and older.
90966ESRD related services for home dialysis per full month; for patients 20 years and older.
90970ESRD related services for dialysis less than a full month of service; per day; for patient 20 years and older.
Interpretation of Physiological Data99091Collection & interpretation of physiologic data, requiring a minimum of 30 minutes each 30 days.
Complex Chronic Care Management Services99487 99489Complex Chronic Care with 60 minutes of clinical staff time per calendar month. Complex Chronic Care; additional 30 minutes of clinical staff time per month.
Care Plan Oversight ServicesG0181Physician supervision of a patient receiving Medicare-covered services provided by a participating home health agency (patient not present) requiring complex and multidisciplinary care modalities within a calendar month; 30+ minutes.
G0182Physician supervision of a patient receiving Medicare-covered hospice services (Pt not present) requiring complex and multidisciplinary care modalities; within a calendar month; 30+ minutes.

Thus, with the goal of increasing medically appropriate use of TCM services, we are proposing to revise our billing requirements for TCM by allowing TCM codes to be billed concurrently with any of these codes. Before we finalize such a rule, however, we seek comment on whether overlap of services exists, and if so, which services should be restricted from being billed concurrently with TCM. We also seek comment on whether any overlap would depend upon whether the same or a different practitioner reports the services. We note that CPT reporting rules generally apply at the practitioner level, and we are seeking input from stakeholders as to whether our policy should differ based on whether it is the same or a different practitioner reporting the services. We are seeking comment on whether the newest CPT code in the chronic care management services family (CPT code 99491 for CCM by a physician or other qualified health professional, established in 2019) overlaps with TCM or should be reportable and separately payable in the same service period.

As part of our analysis of the utilization data for TCM services, we also examined how current payment rates for TCM might negatively affect the appropriate utilization of TCM services, an idea proposed by Bindman and Cox. CPT code 99495 (Transitional Care Management services with the following required elements: Communication (direct contact, telephone, electronic) with the patient and/or caregiver within two business days of discharge; medical decision making of at least moderate complexity during the service period; face-to-face visit within 14 calendar days of discharge) and CPT code 99496 (Transitional Care Management services with the following required elements: Communication (direct contact, telephone, electronic) with the patient and/or caregiver within two business days of discharge; medical decision making of at least high complexity during the service period; face-to-face visit within 7 calendar days of discharge) were resurveyed during 2018 as part of a regular RUC review of new technologies or services. For this RUC resurvey, several years of claims data were available and clinicians had more experience to inform their views about the work required to furnish TCM services. Based upon the results of the 2018 RUC survey of the two TCM codes, the RUC recommended a slight increase in work RVUs for both codes. We believe the results from the new survey will better reflect the work involved in furnishing TCM services as care management services. Thus, also for CY 2020, we are proposing the RUC-recommended work RVU of 2.36 for CPT code 99495 and the RUC-recommended work RVU of 3.10 for CPT code 99496. We are not proposing any direct PE refinements to the RUC's recommendations for this code family.

3. Chronic Care Management (CCM) Services

CCM services are comprehensive care coordination services per calendar month, furnished by a physician or non-physician practitioner (NPP) managing overall care and their clinical staff, for patients with two or more serious chronic conditions. There are currently two subsets of codes: One for non-complex chronic care management (starting in 2015, with a new code for 2019) and a set of codes for complex chronic care management (starting in 2017). Table 17 provides a high-level summary of the CCM service elements.

Early data show that, in general, CCM services are increasing patient and practitioner satisfaction, saving costs and enabling solo practitioners to remain in independent practice.[79] Utilization has reached approximately 75 percent of the level we initially assumed under the PFS when we began paying for CCM services separately under the PFS. While these are positive results, we believe that CCM services (especially complex CCM services) continue to be underutilized. In addition, we note that, at the February 2019 CPT Editorial Panel meeting, certain specialty associations requested refinements to the existing CCM codes, and consideration of their proposal was postponed. Also, we have heard from some stakeholders suggesting that the Start Printed Page 40551time increments for non-complex CCM performed by clinical staff should be changed to recognize finer increments of time, and that certain requirements related to care planning are unclear. Based on our consideration of this ongoing feedback, we believe some of the refinements requested by specialty associations and other stakeholders may be necessary to improve payment accuracy, reduce unnecessary burden and help ensure that beneficiaries who need CCM services have access to them. Accordingly, we are proposing the following changes to the CCM code set for CY 2020.

a. Non-Complex CCM Services by Clinical Staff (CPT Code 99490, HCPCS Codes GCCC1 and GCCC2)

Currently, the clinical staff CPT code for non-complex CCM, CPT code 99490 (Chronic care management services, at least 20 minutes of clinical staff time directed by a physician or other qualified health care professional, per calendar month, with the following required elements: Multiple (two or more) chronic conditions expected to last at least 12 months, or until the death of the patient; chronic conditions place the patient at significant risk of death, acute exacerbation/decompensation, or functional decline; comprehensive care plan established, implemented, revised, or monitored.) describes 20 or more minutes of clinical staff time spent performing chronic care management activities under the direction of a physician/qualified health care professional. When we initially adopted this code for payment and, in feedback we have since received, a number of stakeholders suggested that CMS undervalued the PE RVU because we assumed that the minimum time for the code (20 minutes of clinical staff time) would be typical (see, for example, 79 FR 67717 through 67718). In the CY 2017 PFS final rule with comment period, we continued to consider whether the payment amount for CPT code 99490 is appropriate, given the amount of time typically spent furnishing CCM services (81 FR 80243 through 80244). We adopted the complex CCM codes for payment beginning in CY 2017, in part, to pay more appropriately for services furnished to beneficiaries requiring longer service times.

There are two CPT codes for complex CCM:

  • CPT code 99487 (Complex chronic care management services, with the following required elements: Multiple (two or more) chronic conditions expected to last at least 12 months, or until the death of the patient; chronic conditions place the patient at significant risk of death, acute exacerbation/decompensation, or functional decline; establishment or substantial revision of a comprehensive care plan; moderate or high complexity medical decision making; 60 minutes of clinical staff time directed by physician or other qualified health care professional, per calendar month. (Complex chronic care management services of less than 60 minutes duration, in a calendar month, are not reported separately); and
  • CPT code 99489 (each additional 30 minutes of clinical staff time directed by a physician or other qualified health care professional, per calendar month (List separately in addition to code for primary procedure).

Complex CCM describes care management for patients who require not only more clinical staff time, but also complex medical decision-making. Some stakeholders continue to recommend that, in addition to separate payment for the complex CCM codes, we should create an add-on code for non-complex CCM, such that non-complex CCM would be defined and valued in 20-minute increments of time with additional payment for each additional 20 minutes, or extra payment for 20 to 40 minutes of clinical staff time spent performing care management activities.

We agree that coding changes that identify additional time increments would improve payment accuracy for non-complex CCM. Accordingly, we propose to adopt two new G codes with new increments of clinical staff time instead of the existing single CPT code (CPT code 99490). The first G code would describe the initial 20 minutes of clinical staff time, and the second G code would describe each additional 20 minutes thereafter. We intend these would be temporary G codes, to be used for PFS payment instead of CPT code 99490 until the CPT Editorial Panel can consider revisions to the current CPT code set. We would consider adopting any CPT code(s) once the CPT Editorial Panel completes its work. We acknowledge that imposing a transitional period during which G codes would be used under the PFS in lieu of the CPT codes is potentially disruptive, and are seeking comment on whether the benefit of proceeding with the proposed G codes outweighs the burden of transitioning to their use in the intervening year(s) before a decision by the CPT Editorial Panel.

We are proposing that the base code would be HCPCS code GCCC1 (Chronic care management services, initial 20 minutes of clinical staff time directed by a physician or other qualified health care professional, per calendar month, with the following required elements: Multiple (two or more) chronic conditions expected to last at least 12 months, or until the death of the patient; chronic conditions place the patient at significant risk of death, acute exacerbation/decompensation, or functional decline; and comprehensive care plan established, implemented, revised, or monitored. (Chronic care management services of less than 20 minutes duration, in a calendar month, are not reported separately)). We propose a work RVU of 0.61 for HCPCS code GCCC1, which we crosswalked from CPT code 99490. We believe these codes have a similar amount of work since they would have the same intra-service time of 15 minutes.

We propose an add-on HCPCS code GCCC2 (Chronic care management services, each additional 20 minutes of clinical staff time directed by a physician or other qualified health care professional, per calendar month (List separately in addition to code for primary procedure). (Use GCCC2 in conjunction with GCCC1). (Do not report GCCC1, GCCC2 in the same calendar month as GCCC3, GCCC4, 99491)). We are proposing a work RVU of 0.54 for HCPCS code GCCC2 based on a crosswalk to CPT code 11107 (Incisional biopsy of skin (eg, wedge) (including simple closure, when performed); each separate/additional lesion (List separately in addition to code for primary procedure)), which has a work RVU of 0.54, which we believe accurately reflects the work associated with each additional 20 minutes of CCM services. Both codes have the same intraservice time of 15 minutes. We note that the nature of the PFS relative value system is such that all services are appropriately subject to comparisons to one another. Although codes that describe clinically similar services are sometimes stronger comparator codes, codes need not share the same site of service, patient population, or utilization level to serve as an appropriate crosswalk. In this case, CPT code 11107 shares a similar work intensity to proposed HCPCS code GCCC2. Furthermore, although HCPCS codes GCCC1 and GCCC2 share the same intraservice time, add-on codes often have lower intensity than the base codes because they describe the continuation of an already initiated service.

We are soliciting public comment on whether we should limit the number of times this add-on code (HCPCS code GCCC2) can be reported in a given service period for a given beneficiary. It Start Printed Page 40552is not clear how often more than 40 minutes of clinical staff time is currently spent or is medically necessary. In addition, once 60 minutes of clinical staff time is spent, many or most patients might also require complex medical decision-making, and such patients would be already described under existing coding for complex CCM. A limit (such as allowing the add-on code to be reported only once per service period per beneficiary) may be appropriate in order to maintain distinctions between complex and non-complex CCM, as well as appropriately limit beneficiary cost sharing and program spending to medically necessary services. We note that complex CCM already describes (in part) 60 or more minutes of clinical staff time in a service period. We are seeking comment on whether and how often beneficiaries who do not require complex CCM (for example, do not require the complex medical decision making that is part of complex CCM) would need 60 or more minutes of non-complex CCM clinical staff time and thereby warrant more than one use of HCPCS code GCCC2 within a service period.

b. Complex CCM Services (CPT Codes 99487 and 99489, and HCPCS Codes GCCC3 and GCCC4)

Currently, the CPT codes for complex CCM include in the code descriptors a requirement for establishment or substantial revision of the comprehensive care plan (see above). The code descriptors for complex CCM also include moderate to high complexity medical decision-making (moderate to high complexity medical decision-making is an explicit part of the services). We propose to adopt two new G codes that would be used for billing under the PFS instead of CPT codes 99487 and 99489, and that would not include the service component of substantial care plan revision. We believe it is not necessary to explicitly include substantial care plan revision because patients requiring moderate to high complexity medical decision making implicitly need and receive substantial care plan revision. The service component of substantial care plan revision is potentially duplicative with the medical decision making service component and, therefore, we believe it is unnecessary as a means of distinguishing eligible patients. Instead of CPT code 99487, we propose to adopt HCPCS code GCCC3 (Complex chronic care management services, with the following required elements: Multiple (two or more) chronic conditions expected to last at least 12 months, or until the death of the patient; chronic conditions place the patient at significant risk of death, acute exacerbation/decompensation, or functional decline; comprehensive care plan established, implemented, revised, or monitored; moderate or high complexity medical decision making; 60 minutes of clinical staff time directed by physician or other qualified health care professional, per calendar month. (Complex chronic care management services of less than 60 minutes duration, in a calendar month, are not reported separately)). We are proposing a work RVU of 1.00 for HCPCS code GCCC3, which is a crosswalk to CPT code 99487.

Instead of CPT code 99489, we propose to adopt HCPCS code GCCC4 (each additional 30 minutes of clinical staff time directed by a physician or other qualified health care professional, per calendar month (List separately in addition to code for primary procedure). (Report GCCC4 in conjunction with GCCC3). (Do not report GCCC4 for care management services of less than 30 minutes additional to the first 60 minutes of complex chronic care management services during a calendar month)). We are proposing a work RVU of 0.50 for HCPCS code GCCC4, which is a crosswalk to CPT code 99489.

We intend these would be temporary G codes to remain in place until the CPT Editorial Panel can consider revising the current code descriptors for complex CCM services. We would consider adopting any new or revised complex CCM CPT code(s) once the CPT Editorial Panel completes its work. We acknowledge that imposing a transitional period during which G codes would be used under the PFS in lieu of the CPT codes is potentially disruptive. We are seeking comment on whether the benefit of proceeding with the proposed G codes outweighs the burden of transitioning to their use in the intervening year(s) before a decision by the CPT Editorial Panel.

c. Typical Care Plan

In 2013, in working with the physician community to develop and propose the CCM codes for PFS payment, the medical community recommended and CMS agreed that adequate care planning is integral to managing patients with multiple chronic conditions. We stated our belief that furnishing care management to beneficiaries with multiple chronic conditions requires complex and multidisciplinary care modalities that involve, among other things, regular physician development and/or revision of care plans and integration of new information into the care plan (78 FR 43337). In the CY 2014 PFS final rule with comment period (78 FR 74416 through 74418), consistent with recommendations CMS received in 2013 from the AMA's Complex Chronic Care Coordination Workgroup, we finalized a CCM scope of service element for a patient-centered plan of care with the following characteristics: It is a comprehensive plan of care for all health problems and typically includes, but is not limited to, the following elements: Problem list; expected outcome and prognosis; measurable treatment goals; cognitive and functional assessment; symptom management; planned interventions; medical management; environmental evaluation; caregiver assessment; community/social services ordered; how the services of agencies and specialists unconnected to the practice will be directed/coordinated; identify the individuals responsible for each intervention, requirements for periodic review; and when applicable, revisions of the care plan.

The CPT Editorial Panel also incorporated and adopted this language in the prefatory language for Care Management Services codes (page 49 of the 2019 CPT Codebook) including CCM services.

As we continue to consider the need for potential refinements to the CCM code set, we have heard that there is still some confusion in the medical community regarding what a care plan typically includes. We have re-reviewed this language for CCM, and we believe there may be aspects of the typical care plan language we adopted for CCM that are redundant or potentially unduly burdensome. We note that because these are “typical” care plan elements, these elements do not comprise a set of strict requirements that must be included in a care plan for purposes of billing for CCM services; the elements are intended to reflect those that are typically, but perhaps not always, included in a care plan as medically appropriate for a particular beneficiary. Nevertheless, we are proposing to eliminate the phrase “community/social services ordered, how the services of agencies and specialists unconnected to the practice will be directed/coordinated, identify the individuals responsible for each intervention” and insert the phrase “interaction and coordination with outside resources and practitioners and providers.” We believe simpler language would describe the important work of interacting and coordinating with resources external to the practice. While it is preferable, when feasible, to identify who is responsible for Start Printed Page 40553interventions, it may be difficult to maintain an up-to-date listing of responsible individuals especially when they are outside of the practice, for example, when there is staff turnover or assignment changes.

Our proposed new language would read: The comprehensive care plan for all health issues typically includes, but is not limited to, the following elements:

  • Problem list.
  • Expected outcome and prognosis.
  • Measurable treatment goals.
  • Cognitive and functional assessment.
  • Symptom management.
  • Planned interventions.
  • Medical management.
  • Environmental evaluation.
  • Caregiver assessment.
  • Interaction and coordination with outside resources and practitioners and providers.
  • Requirements for periodic review.
  • When applicable, revision of the care plan.

We welcome feedback on our proposal, including language that would best guide practitioners as they decide what to include in their comprehensive care plan for CCM recipients.

Additional information regarding the existing requirements for billing CCM, including links to prior rules, is available on our website at https://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​PhysicianFeeSched/​Care-Management.html.

4. Principal Care Management (PCM) Services

A gap we identified in coding and payment for care management services is care management for patients with only one chronic condition. The current CCM codes require patients to have two or more chronic conditions. These codes are primarily billed by practitioners who are managing a patient's total care over a month, including primary care practitioners and some specialists such as cardiologists or nephrologists. We have heard from a number of stakeholders, especially those in specialties that use the office/outpatient E/M code set to report the majority of their services, that there can be significant resources involved in care management for a single high risk disease or complex chronic condition that is not well accounted for in existing coding (FR 78 74415). This issue has also been raised by the stakeholder community in proposal submissions to the Physician-Focused Payment Model Technical Advisory Committee (PTAC), which are available at https://aspe.hhs.gov/​ptac-physician-focused-payment-model-technical-advisory-committee. Therefore, we are proposing separate coding and payment for Principal Care Management (PCM) services, which describe care management services for one serious chronic condition. A qualifying condition would typically be expected to last between three months and a year, or until the death of the patient, may have led to a recent hospitalization, and/or place the patient at significant risk of death, acute exacerbation/decompensation, or functional decline.

While we are not proposing any restrictions on the specialties that could bill for PCM, we expect that most of these services would be billed by specialists who are focused on managing patients with a single complex chronic condition requiring substantial care management. We expect that, in most instances, initiation of PCM would be triggered by an exacerbation of the patient's complex chronic condition or recent hospitalization such that disease-specific care management is warranted. We anticipate that in the majority of instances, PCM services would be billed when a single condition is of such complexity that it could not be managed as effectively in the primary care setting, and instead requires management by another, more specialized, practitioner. For example, a typical patient may present to their primary care practitioner with an exacerbation of an existing chronic condition. While the primary care practitioner may be able to provide care management services for this one complex chronic condition, it is also possible that the primary care practitioner and/or the patient could instead decide that another clinician should provide relevant care management services. In this case, the primary care practitioner would still oversee the overall care for the patient while the practitioner billing for PCM services would provide care management services for the specific complex chronic condition. The treating clinician may need to provide a disease-specific care plan or may need to make frequent adjustments to the patient's medication regimen. The expected outcome of PCM is for the patient's condition to be stabilized by the treating clinician so that overall care management for the patient's condition can be returned to the patient's primary care practitioner. If the beneficiary only has one complex chronic condition that is overseen by the primary care practitioner, then the primary care practitioner would also be able to bill for PCM services. We are proposing that PCM services include coordination of medical and/or psychosocial care related to the single complex chronic condition, provided by a physician or clinical staff under the direction of a physician or other qualified health care professional.

We anticipate that many patients will have more than one complex chronic condition. If a clinician is providing PCM services for one complex chronic condition, management of the patient's other conditions would continue to be managed by the primary care practitioner while the patient is receiving PCM services for a single complex condition. It is also possible that the patient could receive PCM services from more than one clinician if the patient experiences an exacerbation of more than one complex chronic condition simultaneously.

For CY 2020, we are proposing to make separate payment for PCM services via two new G codes: HCPCS code GPPP1 (Comprehensive care management services for a single high-risk disease, e.g., Principal Care Management, at least 30 minutes of physician or other qualified health care professional time per calendar month with the following elements: One complex chronic condition lasting at least 3 months, which is the focus of the care plan, the condition is of sufficient severity to place patient at risk of hospitalization or have been the cause of a recent hospitalization, the condition requires development or revision of disease-specific care plan, the condition requires frequent adjustments in the medication regimen, and/or the management of the condition is unusually complex due to comorbidities) and HCPCS code GPPP2 (Comprehensive care management for a single high-risk disease services, e.g., Principal Care Management, at least 30 minutes of clinical staff time directed by a physician or other qualified health care professional, per calendar month with the following elements: One complex chronic condition lasting at least 3 months, which is the focus of the care plan, the condition is of sufficient severity to place patient at risk of hospitalization or have been cause of a recent hospitalization, the condition requires development or revision of disease-specific care plan, the condition requires frequent adjustments in the medication regimen, and/or the management of the condition is unusually complex due to comorbidities). HCPCS code GPPP1 would be reported when, during the calendar month, at least 30 minutes of physician or other qualified health care provider time is spent on comprehensive care management for a Start Printed Page 40554single high risk disease or complex chronic condition. HCPCS code GPPP2 would be reported when, during the calendar month, at least 30 minutes of clinical staff time is spent on comprehensive management for a single high risk disease or complex chronic condition.

For HCPCS code GPPP1, we are proposing a crosswalk to the work value associated with CPT code 99217 (Observation care discharge day management (This code is to be utilized to report all services provided to a patient on discharge from outpatient hospital “observation status” if the discharge is on other than the initial date of “observation status.” To report services to a patient designated as “observation status” or “inpatient status” and discharged on the same date, use the codes for Observation or Inpatient Care Services [including Admission and Discharge Services, 99234-99236 as appropriate])) as we believe these values most accurately reflect the resource costs associated when the billing practitioner performs PCM services. CPT code 99217 has the same intraservice time as HCPCS code GPPP1 and the physician work is of similar intensity. Therefore, we are proposing a work RVU of 1.28 for HCPCS code GPPP1.

For HCPCS code GPPP2 we are proposing a crosswalk to the work and PE inputs associated with CPT code 99490 (clinical staff non-complex CCM) as we believe these values reflect the resource costs associated with the clinician's direction of clinical staff who are performing the PCM services, and the intraservice times and intensity of the work for the two codes would be the same. Therefore, we are proposing a work RVU of 0.61 for HCPCS code GPPP2.

While we are proposing separate coding and payment for PCM services performed by clinical staff with the oversight of the billing professional and services furnished directly by the billing professional, we are seeking comment on whether both codes are necessary to appropriately describe and bill for PCM services. We note that we are basing this coding structure on the codes for CCM services with CPT code 99491 reflecting care management by the billing professional and CPT code 99490 reflecting care management by clinical staff directed by a physician or other qualified health care professional.

We acknowledge that we are concurrently proposing revisions for both complex and non-complex CCM services. Were we not to finalize the proposed changes for both complex and non-complex CCM services, we believe that the overall structure and description of the CCM services remain close enough to serve as a model for the coding structure and description of services for the proposed PCM services. We are seeking public comment on whether it would be appropriate to create an add-on code for additional time spent each month (similar to HCPCS code GCCC2 discussed above) when PCM services are furnished by clinical staff under the direction of the billing practitioner.

While we believe that PCM services describe a situation where a patient's condition is severe enough to require care management for a single complex chronic condition beyond what is described by CCM or performed in the primary care setting, we are concerned that a possible unintended consequence of making separate payment for care management for a single chronic condition is that a patient with multiple chronic conditions could have their care managed by multiple practitioners, each only billing for PCM, which could potentially result in fragmented patient care, overlaps in services, and duplicative services. While we are not proposing additional requirements for the proposed PCM services, we did consider alternatives such as requiring that the practitioner billing PCM must document ongoing communication with the patient's primary care practitioner to demonstrate that there is continuity of care between the specialist and primary care settings, or requiring that the patient have had a face-to-face visit with the practitioner billing PCM within the prior 30 days to demonstrate that they have an ongoing relationship. We are seeking comment on whether requirements such as these are necessary or appropriate, and whether there should be additional requirements to prevent potential care fragmentation or service duplication.

Due to the similarity between the description of the PCM and CCM services, both of which involve non-face-to-face care management services, we are proposing that the full CCM scope of service requirements apply to PCM, including documenting the patient's verbal consent in the medical record. We are seeking comment on whether there are required elements of CCM services that the public and stakeholders believe should not be applicable to PCM, and should be removed or altered. A high level summary of these requirements is available in Table 18 and available at https://www.cms.gov/​Outreach-and-Education/​Medicare-Learning-Network-MLN/​MLNProducts/​Downloads/​ChronicCareManagement.pdf. Both the initiating visit and the patient's verbal consent are necessary as not all patients who meet the criteria to receive separately billable PCM services may want to receive these services. The beneficiary should be educated as to what PCM services are and any cost sharing that may apply. Additionally, as practitioners have informed us that beneficiary cost sharing is a significant barrier to provision of other care management services, we are seeking comment on how best to educate practitioners and beneficiaries on the benefits of PCM services.

Additionally, we are proposing to add GPPP2 to the list of designated care management services for which we allow general supervision as described in our regulation at § 410.26(b)(5). Due to the potential for duplicative payment, we are proposing that PCM could not be billed by the same practitioner for the same patient concurrent with certain other care management services, such as CCM, behavioral health integration services, and monthly capitated ESRD payments. We are also proposing that PCM would not be billable by the same practitioner for the same patient during a surgical global period, as we believe those resource costs would already be included in the valuation of the global surgical code.

Table 18—Chronic Care Management Services Summary

CCM Service Summary *
Verbal Consent:
• Inform regarding availability of the service; that only one practitioner can bill per month; the right to stop services effective at the end of any service period; and that cost sharing applies (if no supplemental insurance).
• Document that consent was obtained.
Initiating Visit for New Patients (separately paid).
Certified Electronic Health Record (EHR) Use:
• Structured Recording of Core Patient Information Using Certified EHR (demographics, problem list, medications, allergies).
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24/7 Access (“On Call” Service).
Designated Care Team Member.
Comprehensive Care Management:
• Systematic needs assessment (medical and psychosocial).
• Ensure receipt of preventive services.
• Medication reconciliation, management and oversight of self-management.
Comprehensive Electronic Care Plan:
• Plan is available timely within and outside the practice (can include fax).
• Copy of care plan to patient/caregiver (format not prescribed).
• Establish, implement, revise or monitor the plan.
Management of Care Transitions/Referrals (e.g., discharges, ED visit follow up, referrals):
• Create/exchange continuity of care document(s) timely (format not prescribed).
Home- and Community-Based Care Coordination:
• Coordinate with any home- and community-based clinical service providers, and document communication with them regarding psychosocial needs and functional deficits.
Enhanced Communication Opportunities:
• Offer asynchronous non-face-to-face methods other than telephone, such as secure email.
* All elements that are medically reasonable and necessary must be furnished during the month, but all elements do not necessarily apply every month. Consent need only be obtained once, and initiating visits are only for new patients or patients not seen within a year prior to initiation of CCM.

We are also seeking comment on any potential for duplicative payment between the proposed PCM services and other services, such as interprofessional consultation services (CPT codes 99446-99449 (Interprofessional telephone/internet/electronic health record assessment and management service provided by a consultative physician, including a verbal and written report to the patient's treating/requesting physician or other qualified health care professional), CPT code 99451 (Interprofessional telephone/internet/electronic health record assessment and management service provided by a consultative physician, including a written report to the patient's treating/requesting physician or other qualified health care professional, 5 minutes or more of medical consultative time), and CPT code 99452 (Interprofessional telephone/internet/electronic health record referral service(s) provided by a treating/requesting physician or other qualified health care professional, 30 minutes)) or remote patient monitoring (CPT code 99091 (Collection and interpretation of physiologic data (e.g., ECG, blood pressure, glucose monitoring) digitally stored and/or transmitted by the patient and/or caregiver to the physician or other qualified health care professional, qualified by education, training, licensure/regulation (when applicable) requiring a minimum of 30 minutes of time, each 30 days), CPT code 99453 (Remote monitoring of physiologic parameter(s) (e.g., weight, blood pressure, pulse oximetry, respiratory flow rate), initial; set-up and patient education on use of equipment), and CPT code 99457 (Remote physiologic monitoring treatment management services, 20 minutes or more of clinical staff/physician/other qualified health care professional time in a calendar month requiring interactive communication with the patient/caregiver during the month)).

5. Chronic Care Remote Physiologic Monitoring Services

Chronic Care remote physiologic monitoring (RPM) services involve the collection, analysis, and interpretation of digitally collected physiologic data, followed by the development of a treatment plan, and the managing of a patient under the treatment plan. The current CPT code 99457 is a treatment management code, billable after 20 minutes or more of clinical staff/physician/other qualified professional time with a patient in a calendar month.

In September 2018, the CPT Editorial Panel revised the CPT code structure for CPT code 99457 effective beginning in CY 2020. The new code structure retains CPT code 99457 as a base code that describes the first 20 minutes of the treatment management services, and uses a new add-on code to describe subsequent 20 minute intervals of the service. The new code descriptors for CY 2020 are: CPT code 99457 (Remote physiologic monitoring treatment management services, clinical staff/physician/other qualified health care professional time in a calendar month requiring interactive communication with the patient/caregiver during the month; initial 20 minutes) and CPT code 994X0 (Remote physiologic monitoring treatment management services, clinical staff/physician/other qualified health care professional time in a calendar month requiring interactive communication with the patient/caregiver during the month; additional 20 minutes).

In considering the work RVUs for the new add-on CPT code 994X0, we first considered the value of its base code. We previously valued the base code at 0.61 work RVUs. Given the value of the base code, we do not agree with the RUC-recommended work RVU of 0.61 for the add-on code. Instead, we are proposing a work RVU of 0.50 for the add-on code. This value is supported by CPT code 88381 (Microdissection (i.e., sample preparation of microscopically identified target); manual), which has the same intraservice and total times of 20 minutes with an XXX global period and work RVU of 0.53, as well as the survey value at the 25th percentile. We are proposing the RUC-recommended direct PE inputs for CPT code 994X0.

Finally, we are proposing that RPM services reported with CPT codes 99457 and 994X0 may be furnished under general supervision rather than the currently required direct supervision. Because care management services include establishing, implementing, revising, or monitoring treatment plans, as well as providing support services, and because RPM services (that is, CPT codes 99457 and 994X0) include establishing, implementing, revising, and monitoring a specific treatment plan for a patient related to one or more chronic conditions that are monitored remotely, we believe that CPT codes 99457 and 994X0 should be included as designated care management services. Designated care management services can be furnished under general Start Printed Page 40556supervision. Section 410.26(b)(5) of our regulations states that designated care management services can be furnished under the general supervision of the “physician or other qualified health care professional (who is qualified by education, training, licensure/regulation and facility privileging)” (see also 2019 CPT Codebook, page xii) when these services or supplies are provided incident to the services of a physician or other qualified healthcare professional. The physician or other qualified healthcare professional supervising the auxiliary personnel need not be the same individual treating the patient more broadly. However, only the supervising physician or other qualified healthcare professional may bill Medicare for incident to services.

6. Comment Solicitation on Consent for Communication Technology-Based Services

In the CY 2019 PFS Final Rule, CMS finalized separate payment for a number of services that could be furnished via telecommunications technology. Specifically, CMS finalized HCPCS code G2010 (Remote evaluation of recorded video and/or images submitted by an established patient (e.g., store and forward), including interpretation with follow-up with the patient within 24 business hours, not originating from a related E/M service provided within the previous 7 days nor leading to an E/M service or procedure within the next 24 hours or soonest available appointment)), HCPCS code G2012 (Brief communication technology-based service, e.g. virtual check-in, by a physician or other qualified health care professional who can report evaluation and management services, provided to an established patient, not originating from a related E/M service provided within the previous 7 days nor leading to an E/M service or procedure within the next 24 hours or soonest available appointment; 5-10 minutes of medical discussion)), CPT codes 99446-99449 (Interprofessional telephone/internet/electronic health record assessment and management service provided by a consultative physician, including a verbal and written report to the patient's treating/requesting physician or other qualified health care professional), CPT code 99451 (Interprofessional telephone/internet/electronic health record assessment and management service provided by a consultative physician, including a written report to the patient's treating/requesting physician or other qualified health care professional, 5 minutes or more of medical consultative time), and CPT code 99452 (Interprofessional telephone/internet/electronic health record referral service(s) provided by a treating/requesting physician or other qualified health care professional, 30 minutes).

As discussed in that rule, (83 FR 59490-59491), while a few commenters suggested that it would be less burdensome to obtain a general consent for multiple services at once, we stipulated that verbal consent must be documented in the medical record for each service furnished so that the beneficiary is aware of any applicable cost sharing. This is similar to the requirements for other non-face-to-face care management services under the PFS.

We have continued to hear from stakeholders that requiring advance beneficiary consent for each of these services is burdensome. For HCPCS codes G2010 and G2012, stakeholders have stated that it is difficult and burdensome to obtain consent at the outset of each of what are meant to be brief check-in services. For CPT codes 99446-99449, 99451 and 99452, practitioners have informed us that it is particularly difficult for the consulting practitioner to obtain consent from a patient they have never seen. Given our longstanding goals to reduce burden and promote the use of communication technology-based services, we are seeking comment on whether a single advance beneficiary consent could be obtained for a number of communication technology-based services. During the consent process, the practitioner would make sure the beneficiary is aware that utilization of these services will result in a cost sharing obligation. We are seeking comment on the appropriate interval of time or number of services for which consent could be obtained, for example, for all these services furnished within a 6 month or one year period, or for a set number of services, after which a new consent would need to be obtained. We are also seeking comment on the potential program integrity concerns associated with allowing advance consent and how best to minimize those concerns.

7. Rural Health Clinics (RHCs) and Federally-Qualified Health Centers (FQHCs)

RHCs and FQHCs are paid for general care management services using HCPCS code G0511, which is an RHC and FQHC-specific G-code for 20 minutes or more of CCM services, complex CCM services, or general behavioral health services. Payment for this service is set at the average of the national, non-facility payment rates for CPT codes 99490, 99487, and 99484. We are proposing to use the non-facility payment rates for HCPCS codes GCCC1 and GCCC3 instead of the non-facility payment rates for CPT codes 99490 and 99487, respectively, if these changes are finalized for practitioners billing under the PFS. We note that we are not proposing any changes in the valuation of these codes. Upon finalization, the payment for HCPCS code G0511 would be set at the average of the national, non-facility payment rates for HCPCS codes GCCC1 and GCCC3 and CPT code 99484.

L. Coinsurance for Colorectal Cancer Screening Tests

Section 1861(pp) of the Act defines “colorectal cancer screening tests” and, under sections 1861(pp)(1)(B) and (C) of the Act, “screening flexible sigmoidoscopy” and “screening colonoscopy” are two of the recognized procedures. Among other things, section 1861(pp)(1)(D) of the Act authorizes the Secretary to include other tests or procedures in the definition, and modifications to the tests and procedures described under this subsection, “with such frequency and payment limits, as the Secretary determines appropriate, in consultation with appropriate organizations.” Section 1861(s)(2)(R) of the Act includes these colorectal cancer screening tests in the definition of the medical and other health services that fall within the scope of Medicare Part B benefits described in section 1832(a)(1) of the Act. Section 1861(ddd)(3) of the Act includes these colorectal cancer screening services within the definition of “preventive services.” In addition, section 1833(a)(1)(Y) of the Act provides for payment for preventive services recommended by the United States Preventive Services Task Force (USPSTF) with a grade of A or B under the PFS at 100 percent of the lesser of the actual charge or the fee schedule amount for these colorectal cancer screening tests, and under the OPPS at 100 percent of the OPPS payment amount. As such, there is no beneficiary responsibility for coinsurance for recommended colorectal cancer screening tests as defined in section 1861(pp)(1) of the Act.

Under these statutory provisions, we have issued regulations governing payment for colorectal cancer screening tests at 42 CFR 410.152(l)(5). We pay 100 percent of the Medicare payment amount established under the applicable payment methodology for the setting for providers and suppliers, and beneficiaries are not required to pay Part B coinsurance.Start Printed Page 40557

In addition to screening tests, which typically are furnished to patients in the absence of signs or symptoms of illness or injury, Medicare also covers various diagnostic tests (§ 410.32). In general, diagnostic tests must be ordered by the physician or practitioner who is treating the beneficiary, and who uses the results of the diagnostic test in the management of the patient's specific medical problem. Under Part B, Medicare may cover flexible sigmoidoscopies and colonoscopies as diagnostic tests when those tests are reasonable and necessary as specified in section 1862(a)(1)(A) of the Act. When these services are furnished as diagnostic tests rather than as screening tests, patients are responsible for the Part B coinsurance (normally 20 percent) associated with these services.

We define “colorectal cancer screening tests” in our regulation at § 410.37(a)(1) to include “flexible screening sigmoidoscopies” and “screening colonoscopies, including anesthesia furnished in conjunction with the service.” Under our current policies, we exclude from the definition of colorectal screening services colonoscopies and sigmoidoscopies that begin as a screening service, but where a polyp or other growth is found and removed as part of the procedure. The exclusion of these services from the definition of colorectal cancer screening services is based upon separate provisions of the statute dealing with the detection of lesions or growths during procedures (62 FR 59048, 59082, October 31, 1997). Section 1834(d)(2)(D) of the Act provides that if, during the course of a screening flexible sigmoidoscopy, a lesion or growth is detected which results in a biopsy or removal of the lesion or growth, payment under Medicare Part B shall not be made for the screening flexible sigmoidoscopy but shall be made for the procedure classified as a flexible sigmoidoscopy with such biopsy or removal. Similarly, section 1834(d)(3)(D) of the Act that provides if, during the course of a screening colonoscopy, a lesion or growth is detected which results in a biopsy or removal of the lesion or growth, payment under Medicare Part B shall not be made for the screening colonoscopy but shall be made for the procedure classified as a colonoscopy with such biopsy or removal.

Because we interpret sections 1834(d)(2)(C)(ii) and 1834(d)(3)(C)(ii) of the Act to require us to pay for these tests as diagnostic tests, rather than as screening tests, the 100 percent payment rate for recommended preventive services under section 1833(a)(1)(Y) of the Act, as codified in our regulation at § 410.152(l)(5), would not apply to those diagnostic procedures. As such, beneficiaries are responsible for the usual coinsurance that applies to the services (20 or 25 percent of the cost of the services depending on the setting).

Under section 1833(b) of the Act, before making payment under Medicare Part B for expenses incurred by a beneficiary for covered Part B services, beneficiaries must first meet the applicable deductible for the year. Section 4104 of the Affordable Care Act (that is, the Patient Protection and Affordable Care Act (Pub. L. 111-148, enacted March 23, 2010), and the Health Care and Education Reconciliation Act of 2010 (Pub. L. 111-152, enacted March 30, 2010), collectively referred to as the “Affordable Care Act”) amended section 1833(b)(1) of the Act to make the deductible inapplicable to expenses incurred for certain preventive services that are recommended with a grade of A or B by the USPSTF, including colorectal cancer screening tests as defined in section 1861(pp) of the Act. Section 4104 of the Affordable Care Act also added a sentence at the end of section 1833(b)(1) of the Act specifying that the exception to the deductible shall apply with respect to a colorectal cancer screening test regardless of the code that is billed for the establishment of a diagnosis as a result of the test, or for the removal of tissue or other matter or other procedure that is furnished in connection with, as a result of, and in the same clinical encounter as the screening test. Although the Affordable Care Act addressed the applicability of the deductible in the case of a colorectal cancer screening test that involves biopsy or tissue removal, it did not alter the coinsurance provision in section 1833(a) of the Act for such procedures. Although public commenters encouraged the agency to also eliminate the coinsurance in these circumstances, the agency found that the statute did not provide for elimination of the coinsurance (75 FR 73170, 73431, November 29, 2010).

Beneficiaries have continued to contact us noting their “surprise” that a coinsurance (20 or 25 percent depending on the setting) applies when they expected to receive a colorectal screening procedure to which coinsurance does not apply, but instead received what Medicare considers to be a diagnostic procedure because polyps were discovered and removed. Similarly, physicians have also expressed concerns about the reactions of beneficiaries when they are informed that they will be responsible for coinsurance if polyps are discovered and removed during what they expected to be a screening procedure to which coinsurance does not apply. Other stakeholders and some members of Congress have regularly expressed to us that they consider the agency's policy on coinsurance for colorectal screening procedures during which tissue is removed to be a misinterpretation of the law.

Over the years, we have released a wide variety of publicly available educational materials that explain the Medicare preventive services benefits as part of our overall outreach activities to Medicare beneficiaries. These materials contain a complete description of the Medicare preventive services benefits, including information on colorectal cancer screening, and also provide relevant details on the applicability of cost sharing. These materials can be found at https://www.cms.gov/​Outreach-and-Education/​Medicare-Learning-Network-MLN/​MLNProducts/​MLN-Publications-Items/​CMS1243319.html. We believe that the information in these materials can be instrumental in continuing to educate physicians and beneficiaries about cost sharing obligations in order to mitigate instances of “surprise” billing. We invite comment on whether we should consider establishing a requirement that the physician who plans to furnish a colorectal cancer screening notify the patient in advance that a screening procedure could result in a diagnostic procedure if polyps are discovered and removed, and that coinsurance may apply. We specifically invite comment on whether we should require the physician, or their staff, to provide a verbal notice with a notation in the medical record, or whether we should consider a different approach to informing patients of the copay implications, such as a written notice with standard language that we would require the physician, or their staff, to provide to patients prior to a colorectal cancer screening. We note that we would consider adopting such a requirement in the final rule in accordance with public comments. We also invite comment on what mechanism, if any, we should consider using to monitor compliance with a notification requirement if we decide to finalize one for CY 2020 or through future rulemaking.Start Printed Page 40558

M. Therapy Services

1. Repeal of the Therapy Caps and Limitation To Ensure Appropriate Therapy

a. Background

In the CY 2019 PFS proposed and final rules (83 FR 34850; 83 FR 59654 and 59661), we discussed the statutory requirements of section 50202 of the Bipartisan Budget Act of 2018 (BBA of 2018) (Pub. L. 115-123, February 9, 2018). Beginning January 1, 2018, section 50202 of the BBA of 2018 repealed the Medicare outpatient therapy caps and the therapy cap exceptions process, while retaining the cap amounts as limitations and requiring medical review to ensure that therapy services are furnished when appropriate. Section 50202 of the BBA of 2018 amended section 1833(g) of the Act by adding a new paragraph (7)(A) requiring that after expenses incurred for the beneficiary's outpatient therapy services for the year have exceeded one or both of the previous therapy cap amounts, all therapy suppliers and providers must continue to use an appropriate modifier on claims. We implemented this provision by continuing to require use of the existing KX modifier. By using the KX modifier on the claim, the therapy supplier or provider is attesting that the services are medically necessary and that supportive justification is documented in the medical record. As with the incurred expenses for the prior therapy cap amounts, there is one amount for physical therapy (PT) and speech language pathology (SLP) services combined, and a separate amount for occupational therapy (OT) services. These KX modifier threshold amounts are indexed annually by the Medicare Economic Index (MEI). After the beneficiary's incurred expenditures for outpatient therapy services exceed the KX modifier threshold amount for the year, claims for outpatient therapy services without the KX modifier are denied.

Section 50202 of the BBA of 2018 also added a new paragraph 7(B) to section 1833(g) of the Act which retained the targeted medical review (MR) process for 2018 and subsequent years, but established a lower threshold amount of $3,000 rather than the $3,700 threshold amount that had applied for the original manual MR process established by section 3005(g) of the Middle Class Tax Relief and Jobs Creation Act of 2012 (MCTRJCA) (Pub. L. 112-96, February 22, 2012). The manual MR process with a threshold amount of $3,700 was replaced by the targeted MR process with the same threshold amount through amendments made by section 202 of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) (Pub. L. 114-10, April 16, 2015).

With the latest amendments made by the BBA of 2018, for CY 2018 (and each successive calendar year until 2028, at which time it is indexed annually by the MEI), the MR threshold is $3,000 for PT and SLP services and $3,000 for OT services. For purposes of applying the targeted MR process, we use a criteria-based process for selecting providers and suppliers that includes factors such as a high percentage of patients receiving therapy beyond the medical review threshold as compared to peers. For information on the targeted medical review process, please visit https://www.cms.gov/​Research-Statistics-Data-and-Systems/​Monitoring-Programs/​Medicare-FFS-Compliance-Programs/​Medical-Review/​TherapyCap.html.

In the CY 2019 PFS final rule (83 FR 59661), when discussing our tracking and accrual process for outpatient therapy services in the section on the KX Threshold Amounts, we noted that we track each beneficiary's incurred expenses for therapy services annually by applying the PFS-based payment amount for each service less any applicable multiple procedure reduction for CMS-designated “always therapy” services. We also stated that we use the PFS rates to accrue expenses for therapy services provided in critical access hospitals (CAHs) as required by section 1833(g)(6)(B) of the Act, added by section 603(b) of the American Taxpayer Relief Act of 2012 (ATRA) (Pub. L. 112-240, January 2, 2013). As discussed below, we mistakenly indicated that this statutory requirement was extended by subsequent legislation, including section 50202 of the BBA of 2018.

b. Proposed Regulatory Revisions

While we explained and implemented the changes required by section 50202 of the BBA of 2018 in CY 2019 PFS rulemaking (83 FR 34850; 83 FR 59654 and 59661), we did not codify those changes in regulation text. We are now proposing to revise the regulations at §§ 410.59 (outpatient occupational therapy) and 410.60 (physical therapy and speech-language pathology) to incorporate the changes made by section 50202 of the BBA of 2018. We propose to add a new paragraph (e)(1)(v) to §§ 410.59 and 410.60 to clarify that the specified amounts of annual per-beneficiary incurred expenses are no longer applied as limitations but as threshold amounts above which services require, as a condition of payment, inclusion of the KX modifier; and that use of the KX modifier confirms that the services are medically necessary as justified by appropriate documentation in the patient's medical record. We propose to amend paragraph (e)(2) in §§ 410.59 and 410.60 to specify the therapy services and amounts that are accrued for purposes of applying the KX modifier threshold, including the continued accrual of therapy services furnished by CAHs directly or under arrangements at the PFS-based payment rates. We are also proposing to amend paragraph (e)(3) in §§ 410.59 and 410.60 for the purpose of applying the medical review threshold to clarify the threshold amounts and the applicable years for both the manual MR process originally established through section 3005(g) of MCTRJCA and the targeted MR process established by the MACRA, and including the changes made through section 50202 of the BBA of 2018 as discussed previously.

In the CY 2019 PFS final rule (83 FR 59661), we incorrectly stated that section 1833(g)(6)(B) of the Act continues to require that we accrue expenses for therapy services furnished by CAHs at the PFS rate because the provision, originally added by section 603(b) of the ATRA, was extended by subsequent legislation, including section 50202 of the BBA of 2018. The requirement in section 1833(g)(6)(B) of the Act was actually time-limited to services furnished in CY 2013. To apply the therapy caps (and now the KX modifier thresholds) after the expiration of the requirement in 1833(g)(6)(B) of the Act, we needed a process to accrue the annual expenses for therapy services furnished by CAHs and, in the CY 2014 PFS final rule with comment period, we elected to continue the process prescribed in section 1833(g)(6)(B) of the Act (78 FR 74405 through 74410).

2. Proposed Payment for Outpatient PT and OT Services Furnished by Therapy Assistants

a. Background

Section 53107 of the BBA of 2018 added a new subsection 1834(v) to the Act to require in paragraph (1) that, for services furnished on or after January 1, 2022, payment for outpatient physical and occupational therapy services for which payment is made under sections 1848 or 1834(k) of the Act which are furnished in whole or in part by a therapy assistant must be paid at 85 percent of the amount that is otherwise applicable. Section 1834(v)(2) of the Act further required that we establish a modifier to identify these services by January 1, 2019, and that claims for outpatient therapy services furnished in Start Printed Page 40559whole or in part by a therapy assistant must include the modifier effective for dates of service beginning on January 1, 2020. Section 1834(v)(3) of the Act required that we implement the subsection through notice and comment rulemaking.

In the CY 2019 PFS proposed and final rules (83 FR 35850 through 35852 and 83 FR 59654 through 50660, respectively), we established two modifiers—one to identify services furnished in whole or in part by a physical therapist assistant (PTA) and the other to identify services furnished in whole or in part by an occupational therapy assistant (OTA). The modifiers are defined as follows:

  • CQ Modifier: Outpatient physical therapy services furnished in whole or in part by a physical therapist assistant.
  • CO Modifier: Outpatient occupational therapy services furnished in whole or in part by an occupational therapy assistant.

In the CY 2019 PFS final rule, we clarified that the CQ and CO modifiers are required to be used when applicable for services furnished on or after January 1, 2020, on the claim line of the service alongside the respective GP or GO therapy modifier to identify services furnished under a PT or OT plan of care. The GP and GO therapy modifiers, along with the GN modifier for speech-language pathology (SLP) services, have been used since 1998 to track and accrue the per-beneficiary incurred expenses amounts to different therapy caps, now KX modifier thresholds, one amount for PT and SLP services combined and a separate amount for OT services. We also clarified in the CY 2019 PFS final rule that the CQ and CO modifiers will trigger application of the reduced payment rate for outpatient therapy services furnished in whole or in part by a PTA or OTA, beginning for services furnished in CY 2022.

In response to public comments on the CY 2019 PFS proposed rule, we did not finalize our proposed definition of “furnished in whole or in part by a PTA or OTA” as a service for which any minute of a therapeutic service is furnished by a PTA or OTA. Instead, we finalized a de minimis standard under which a service is considered to be furnished in whole or in part by a PTA or OTA when more than 10 percent of the service is furnished by the PTA or OTA.

We also explained in the CY 2019 PFS proposed and final rules (83 FR 35850 through 35852 and 83 FR 59654 through 59660, respectively) that the CQ and CO modifiers would not apply to claims for outpatient therapy services that are furnished by, or incident to the services of, physicians or nonphysician practitioners (NPPs) including nurse practitioners, physician assistants, and clinical nurse specialists. This is because our regulations for outpatient physical and occupational therapy services require that an individual furnishing outpatient therapy services incident to the services of a physician or NPP must meet the qualifications and standards for a therapist. As such, only therapists and not therapy assistants can furnish outpatient therapy services incident to the services of a physician or NPP (83 FR 59655 through 59656); and, the new PTA and OTA modifiers cannot be used on the line of service of the professional claim when the rendering NPI identified on the claim is a physician or an NPP. We also intend to revise our manual provisions at Pub. 100-02, Medicare Benefit Policy Manual (MBPM), Chapter 15, section 230, as appropriate, to reflect requirements for the new CQ and CO modifiers that will be used to identify services furnished in whole or in part by a PTA or OTA starting in CY 2020. We anticipate amending these manual provisions for CY 2020 to reflect the policies we adopt through the CY 2020 PFS notice and comment rulemaking process.

In PFS rulemaking for CY 2019, we identified certain situations when the therapy assistant modifiers do apply. The modifiers are applicable to:

  • Therapeutic portions of outpatient therapy services furnished by PTAs/OTAs, as opposed to administrative or other non-therapeutic services that can be performed by others without the education and training of OTAs and PTAs.
  • Services wholly furnished by PTAs or OTAs without physical or occupational therapists.
  • Evaluative services that are furnished in part by PTAs/OTAs (keeping in mind that PTAs/OTAs are not recognized to wholly furnish PT and OT evaluation or re-evaluations).

We also identified some situations when the therapy assistant modifiers do not apply. They do not apply when:

  • PTAs/OTAs furnish services that can be done by a technician or aide who does not have the training and education of a PTA/OTA.
  • Therapists exclusively furnish services without the involvement of PTAs/OTAs.

Finally, we noted that we would be further addressing application of the modifiers for therapy assistant services and the 10 percent de minimis standard more specifically in PFS rulemaking for CY 2020, including how the modifiers are applied in different scenarios for different types of services.

b. Applying the CQ and CO Modifiers

CMS interprets the references in section 1834(v)(1) and (2) of the Act to outpatient physical therapy “service” and outpatient occupational therapy “service” to mean a specific procedure code that describes a PT or OT service. This interpretation makes sense because section 1834(v)(2) of the Act requires the use of a modifier to identify on each request for payment, or bill submitted for an outpatient therapy service furnished in whole or in part by a PTA/OTA. For purposes of billing, each outpatient therapy service is identified by a procedure code.

To apply the de minimis standard under which a service is considered to be furnished in whole or in part by a PTA or OTA when more than 10 percent of the service is furnished by the PTA or OTA, we propose to make the 10 percent calculation based on the respective therapeutic minutes of time spent by the therapist and the PTA/OTA, rounded to the nearest whole minute. The minutes of time spent by a PTA/OTA furnishing a therapeutic service can overlap partially or completely with the time spent by a physical or occupational therapist furnishing the service. We propose that the total time for a service would be the total time spent by the therapist (whether independent of, or concurrent with, a PTA/OTA) plus any additional time spent by the PTA/OTA independently furnishing the therapeutic service. When deciding whether the therapy assistant modifiers apply, we propose that if the PTA/OTA participates in the service concurrently with the therapist for only a portion of the total time that the therapist delivers a service, the CQ/CO modifiers apply when the minutes furnished by the therapy assistant are greater than 10 percent of the total minutes spent by the therapist furnishing the service. If the PTA/OTA and the therapist each separately furnish portions of the same service, we propose that the CQ/CO modifiers would apply when the minutes furnished by the therapy assistant are greater than 10 percent of the total minutes—the sum of the minutes spent by the therapist and therapy assistant—for that service. We propose to apply the CQ/CO modifier policies to all services that would be billed with the respective GP or GO therapy modifier. We believe this is appropriate because it is the same way that CMS currently identifies physical therapy or occupational therapy services for purposes of accruing incurred expenses for the thresholds and targeted review process.Start Printed Page 40560

For purposes of deciding whether the 10 percent de minimis standard is exceeded, we offer two different ways to compute this. The first is to divide the PTA/OTA minutes by the total minutes for the service—which is (a) the therapist's total time when PTA/OTA minutes are furnished concurrently with the therapist, or (b) the sum of the PTA/OTA and therapist minutes when the PTA/OTA's services are furnished separately from the therapist; and then to multiply this number by 100 to calculate the percentage of the service that involves the PTA/OTA. We propose to round to the nearest whole number so that when this percentage is 11 percent or greater, the 10 percent de minimis standard is exceeded and the CQ/CO modifier is applied. The other method is simply to divide the total time for the service (as described above) by 10 to identify the 10 percent de minimis standard, and then to add one minute to identify the number of minutes of service by the PTA/OTA that would be needed to exceed the 10 percent standard. For example, where the total time of a service is 60 minutes, the 10 percent standard is six (6) minutes, and adding one minute yields seven (7) minutes. Once the PTA/OTA furnishes at least 7 minutes of the service, the CQ/CO modifier is required to be added to the claim for that service. As noted above, we propose to round the minutes and percentages of the service to the nearest whole integer. For example, when the total time for the service is 45 minutes, the 10 percent calculation would be 4.5 which would be rounded up to 5, and the PTA/OTA's contribution would need to meet or exceed 6 minutes before the CQ/CO modifier is required to be reported on the claim. See Table 19 for minutes needed to meet or exceed using the “simple” method with typical times for the total time of a therapy service.

Table 19—Simple Method for Determining When CQ/CO Modifiers Apply

Method Two: simple method to apply 10 percent de minimis standard
Total Time * examples using typical service total timesDetermine the 10 percent standard by dividing service Total Time by 10Round 10 percent standard to next whole integerPTA/OTA Minutes needed to exceed—apply CQ/CO
101.01.02.0
151.52.03.0
202.02.03.0
303.03.04.0
454.55.06.0
606.06.07.0
757.58.09.0
Total Time equals total therapist minutes plus any PTA/OTA independent minutes. Concurrent minutes: When PTA/OTA's minutes are furnished concurrently with the therapist, total time equals the total minutes of the therapist's service. Separate minutes: When PTA/OTA's minutes are furnished separately from the minutes furnished by the therapist, total time equals the sum of the minutes of the service furnished by the PT/OT plus the minutes of the service furnished separately by the PTA/OTA.

We want to clarify that the 10 percent de minimis standard, and therefore the CQ/CO modifiers, are not applicable to services in which the PTA/OTA did not participate. To the extent that the PTA/OTA and the physical therapist/occupational therapist (PT/OT) separately furnish different services that are described by procedure codes defined in 15-minute increments, billing examples and proposed policies are included below in Scenario Two.

As we indicated in the CY 2019 PFS final rule, we are addressing more specifically in this proposed rule the application of the 10 percent de minimis standard in various clinical scenarios to decide when the CQ/CO modifiers apply. We acknowledge that application of the 10 percent de minimis standard can work differently depending on the types of services and scenarios involving both the PTA/OTA and the PT/OT. Therapy services are typically furnished in multiple units of the same or different services on a given treatment day, which can include untimed services (not billable in multiple units) and timed services that are defined by codes described in 15-minute intervals. The majority of the untimed services that therapists bill for fall into three categories: (1) Evaluative procedures, (2) group therapy, and (3) supervised modalities. We discuss each of these in greater detail below. Only one (1) unit can be reported in the claim field labeled “units” for each procedure code representing an untimed service. The preponderance of therapy services, though, are billed using codes that are described in 15-minute increments. These services are typically furnished to a patient on a single day in multiple units of the same and/or different services. Under our current policy, the total number of units of one or more timed services that can be added to a claim depends on the total time for all the 15-minute timed codes that were delivered to a patient on a single date of service. We address our proposals for applying the CQ/CO modifiers using the 10 percent de minimis standard, along with applicable billing scenarios, by category below. In each of these scenarios, we assume that the PTA/OTA minutes are for therapeutic services.

  • Evaluations and re-evaluations: CPT codes 97161 through 97163 for physical therapy evaluations for low, moderate, and high complexity level, and CPT code 97164 for physical therapy re-evaluation; and CPT codes 97165 through 97167 for occupational therapy evaluations for low, moderate, and high complexity level, and CPT 97168 for occupational therapy re-evaluation. These PT and OT evaluative procedures are untimed codes and cannot be billed in multiple units—one unit is billed on the claim. As discussed in CY 2019 PFS rulemaking (83 FR 35852 and 83 FR 59656) and noted above, PTAs/OTAs are not recognized to furnish evaluative or assessment services, but to the extent that they furnish a portion of an evaluation or re-evaluation (such as completing clinical labor tasks for each code) that exceeds the 10 percent de minimis standard, the appropriate therapy assistant modifier (CQ or CO) must be used on the claim. We note that it is possible for the PTA/OTA to furnish these minutes either concurrently or separately from the therapist. For example, when the PTA/OTA assists the PT/OT concurrently for a 5-minute portion of the 30 minutes that a PT or OT spent furnishing an evaluation (for example, CPT code 97162 for moderate complexity PT evaluation or CPT code 97165 for a low complexity OT evaluation—each have a typical therapist face-to-face time of 30 Start Printed Page 40561minutes), the respective CQ or CO modifier is applied to the service because the 5 minutes surpasses the 10 percent de minimis standard. In other words, 10 percent of 30 minutes is 3 minutes, and the CQ or CO modifier applies if the PTA/OTA furnishes more than 3 minutes, meaning at least 4 minutes, of the service. If the PTA/OTA separately furnishes a portion of the service that takes 5 minutes (for example, performing clinical labor tasks such as obtaining vital signs, providing self-assessment tool to the patient and verifying its completion), and then the PT/OT separately (without the PTA/OTA) furnishes a 30 minute face-to-face evaluative procedure—bringing the total time of the service to 35 minutes (the sum of the separate PTA/OTA minutes, that is, 5 minutes, plus the 30-minute therapist service), the CQ or CO modifier would be applied to the service because the 5 minutes of OTA/PTA time exceeds 10 percent of the 35 total minutes for the service. In other words, 10 percent of 35 minutes is 3.5 minutes which is rounded up to 4 minutes. The CQ or CO modifier would apply when the PTA/OTA furnishes 5 or more minutes of the service, as discussed above and referenced in Table 19.
  • Group Therapy: CPT code 97150 (requires constant attendance of therapist or assistant, or both). CPT code 97150 describes a service furnished to a group of 2 or more patients. Like evaluative services, this code is an untimed service and cannot be billed in multiple units on the claim, so one unit of the service is billed for each patient in the group. For the group service, the CQ/CO modifier would apply when the PTA/OTA wholly furnishes the service without the therapist. The CQ/CO modifier would also apply when the total minutes of the service furnished by the PTA/OTA (whether concurrently with, or separately from, the therapist), exceed 10 percent of the total time, in minutes, of the group therapy service (that is, the total minutes of service spent by the therapist (with or without the PTA/OTA) plus any minutes spent by the PTA/OTA separately from the therapist). For example, the modifiers would apply when the PTA/OTA participates concurrently with the therapist for 5 minutes of a total group therapy service time of 40-minutes (based on the time of the therapist); or when the PTA/OTA separately furnishes 5 minutes of a total group time of 40 minutes (based on the sum of minutes of the PTA/OTA (5) and therapist (35)).
  • Supervised Modalities: CPT codes 97010 through 97028, and HCPCS codes G0281, G0183, and G0329. Modalities, in general, are physical agents that are applied to body tissue in order to produce a therapeutic change through various forms of energy, including but not limited to thermal, acoustic, light, mechanical or electric. Supervised modalities, for example vasopneumatic devices, paraffin bath, and electrical stimulation (unattended), do not require the constant attendance of the therapist or supervised therapy assistant, unlike the modalities defined in 15-minute increments that are discussed in the below category. When a supervised modality, such as whirlpool (CPT code 97022), is provided without the direct contact of a PT/OT and/or PTA/OTA, that is, it is furnished entirely by a technician or aide, the service is not covered and cannot be billed to Medicare. Supervised modality services are untimed, so only one unit of the service can be billed regardless of the number of body areas that are treated. For example, when paraffin bath treatment is provided to both of the patient's hands, one unit of CPT code 97018 can be billed, not two. For supervised modalities, the CQ or CO modifier would apply to the service when the PTA/OTA fully furnishes all the minutes of the service, or when the minutes provided by the PTA or OTA exceed 10 percent of total minutes of the service. For example, the CQ/CO modifiers would apply when either (1) the PTA/OTA concurrently furnishes 2 minutes of a total 8-minute service by the therapist furnishing paraffin bath treatment (HCPCS code 97018) because 2 minutes is greater than 10 percent of 8 minutes (0.8 minute, or 1 minute after rounding); or (2) the PTA/OTA furnishes 3 minutes of the service separately from the therapist who furnishes 5 minutes of treatment for a total time of 8 minutes (total time equals the sum of the PT/OT minutes plus the separate PTA/OTA minutes) because 3 minutes is greater than 10 percent of 8 total minutes (0.8 minute rounded to 1 minute).
  • Services defined by 15-minute increments/units: These timed codes are included in the following current CPT code ranges: CPT codes 97032 through 97542—including the subset of codes for modalities in the series CPT codes 97032 through 97036; and, codes for procedures in the series CPT codes 97110-97542; CPT codes 97750-97755 for tests and measurements; and CPT codes: 97760-97763 for orthotic management and training and prosthetic training. Based on CPT instructions for these codes, the therapist (or their supervised therapy assistant, as appropriate) is required to furnish the service directly in a one-on-one encounter with the patient, meaning they are treating only one patient during that time. Examples of modalities requiring one-on-one patient contact include electrical stimulation (attended), CPT code 97032, and ultrasound, CPT code 97035. Examples of procedures include therapeutic exercise, CPT code 97110, neuromuscular reeducation, CPT 97112, and gait training, CPT code 97116.

Our policy for reporting of service units with HCPCS codes for both untimed services and timed services (that is, only those therapy services defined in 15-minute increments) is explained in section 20.2 of Chapter 5 of the Medicare Claims Processing Manual (MCPM). To bill for services described by the timed codes (hereafter, those codes described per each 15-minutes) furnished to a patient on a date of service, the therapist or therapy assistant needs to first identify all timed services furnished to a patient on that day, and then total all the minutes of all those timed codes. Next, the therapist or therapy assistant needs to identify the total number of units of timed codes that can be reported on the claim for the physical or occupational therapy services for a patient in one treatment day. Once the number of billable units is identified, the therapist or therapy assistant assigns the appropriate number of unit(s) to each timed service code according to the total time spent furnishing each service. For example, to bill for one 15-minute unit of a timed code, the qualified professional (the therapist or therapy assistant) must furnish at least 8 minutes and up to 22 minutes of the service; to bill for 2 units, at least 23 minutes and up to 37 minutes, and to bill for 3 units, at least 38 minutes and up to 52 minutes. We note that these minute ranges are applicable when one service, or multiple services, defined by timed codes are furnished by the qualified professional on a treatment day. We understand that the therapy industry often refers to these billing conventions as the “eight-minute rule.” The idea is that when a therapist or therapy provider bills for one or more units of services that are described by timed codes, the therapist's direct, one-on-one patient contact time would average 15 minutes per unit. This idea is also the basis for the work values we have established for these timed codes. Our current policies for billing of timed codes and related documentation do not take into consideration whether a service is furnished “in whole or in Start Printed Page 40562part” by a PTA/OTA, or otherwise address the application of the CQ/CO modifier when the 10 percent de minimis standard is exceeded, for those services in which both the PTA/OTA and the PT/OT work together to furnish a service or services.

To support the number of 15-minute timed units billed on a claim for each treatment day, we require that the total timed-code treatment time be documented in the medical record, and that the treatment note must document each timed service, whether or not it is billed, because the unbilled timed service(s) can impact billing. The minutes that each service is furnished can be, but are not required to be, documented. We also require that each untimed service be documented in the treatment note in order to support these services billed on the claim; and, that the total treatment time for each treatment day be documented—including minutes spent providing services represented by the timed codes (the total timed-code treatment time) and the untimed codes. To minimize burden, we are not proposing changes to these documentation requirements in this proposed rule.

Beginning January 1, 2020, in order to provide support for application of the CQ/CO modifier(s) to the claim as required by section 1834(v)(2)(B) of the Act and our proposed regulations at §§ 410.59(a)(4) and 410.60(a)(4), we propose to add a requirement that the treatment notes explain, via a short phrase or statement, the application or non-application of the CQ/CO modifier for each service furnished that day. We would include this documentation requirement in subsection in Chapter 15, MBPM, section 220.3.E on treatment notes. Because the CQ/CO modifiers also apply to untimed services, our proposal to revise our documentation requirement for the daily treatment note extends to those codes and services as well. For example, when PTAs/OTAs assist PTs/OTs to furnish services, the treatment note could state one of the following, as applicable: (a) “Code 97110: CQ/CO modifier applied—PTA/OTA wholly furnished”; or, (b) “Code 97150: CQ/CO modifier applied—PTA/OTA minutes = 15%”; or “Code 97530: CQ/CP modifier not applied—PTA/OTA minutes less than 10% standard.” For those therapy services furnished exclusively by therapists without the use of PTAs/OTA, the PT/OT could note one of the following: “CQ/CO modifier NA”, or “CQ/CO modifier NA—PT/OT fully furnished all services.” Given that the minutes of service furnished by or with the PTA/OTA and the total time in minutes for each service (timed and untimed) are used to decide whether the CQ/CO modifier is applied to a service, we seek comment on whether it would be appropriate to require documentation of the minutes as part of the CQ/CO modifier explanation as a means to avoid possible additional burden associated with a contractor's medical review process conducted for these services. We are also interested in hearing from therapists and therapy providers about current burden associated with the medical review process based on our current policy that does not require the times for individual services to be documented. Based on comments received, if we were to adopt a policy to include documentation of the PTA/OTA minutes and total time (TT) minutes, the CQ/CO modifier explanation could read similar to the following: “Code 97162 (TT = 30 minutes): CQ/CO modifier not applied—PTA/OTA minutes (3) did not exceed the 10 percent standard.”

To recap, under our proposed policy, therapists or therapy assistants would apply the therapy assistant modifiers to the timed codes by first following the usual process to identify all procedure codes for the 15-minute timed services furnished to a beneficiary on the date of service, add up all the minutes of the timed codes furnished to the beneficiary on the date of service, decide how many total units of timed services are billable for the beneficiary on the date of service (based on time ranges in the chart in the manual), and assign billable units to each billable procedure code. The therapist or therapy assistant would then need to decide for each billed procedure code whether or not the therapy assistant modifiers apply.

As previously explained, the CQ/CO modifier does not apply if all units of a procedure code were furnished entirely by the therapist; and, where all units of the procedure code were furnished entirely by the PTA/OTA, the appropriate CQ/CO modifier would apply. When some portion of the billed procedure code is furnished by the PTA/OTA, the therapist or therapy assistant would need to look at the total minutes for all the billed units of the service, and compare it to the minutes of the service furnished by the PTA/OTA as described above in order to decide whether the 10 percent de minimis standard is exceeded. If the minutes of the service furnished by the PTA/OTA are more than 10 percent of the total minutes of the service, the therapist or therapy assistant would assign the appropriate CQ or CO modifier. We would make clarifying technical changes to chapter 5, section 20.2 of the MCPM to reflect the policies adopted through in this rulemaking related to the application or non-application of the therapy assistant modifiers. We anticipate that we will add examples to illustrate when the applicable therapy assistant modifiers must be applied, similar to the examples provided below.

We are providing the following examples of clinical scenarios to illustrate how the 10 percent de minimis standard would be applied under our proposals when therapists and their assistants work together concurrently or separately to treat the same patient on the same day. These examples reflect how the therapist or therapy provider would decide whether the CQ or CO therapy assistant modifier should be included when billing for one or more service units of the 15-minute timed codes. In the following scenarios, “PT” is used to represent physical therapist and “OT” is used to refer to an occupational therapist for ease of reference; and, the services of the PTA/OTA are assumed to be therapeutic in nature, and not services that a technician or aide without the education and training of a PTA/OTA could provide.

  • Scenario One: Where only one service, described by a single HCPCS code defined in 15-minute increments, is furnished in a treatment day:

(1) The PT/OT and PTA/OTA each separately, that is individually and exclusively, furnish minutes of the same therapeutic exercise service (HCPCS code 97110) in different time frames: The PT/OT furnishes 7 minutes and the PTA furnishes 7 minutes for a total of 14 minutes, one unit can be billed using the total time minute range of at least 8 minutes and up to 22 minutes.

Billing Example: One 15-minute unit of HCPCS code 97110 is reported on the claim with the CQ/CO modifier to signal that the time of the service furnished by the PTA/OTA (7 minutes) exceeded 10 percent of the 14-minute total service time (1.4 minutes rounded to 1 minute, so the modifier would apply if the PTA/OTA had furnished 2 or more minutes of the service).

(2) The PT/OT and PTA/OTA each separately, exclusive of the other, furnish minutes of the same therapeutic exercise service (HCPCS code 97110) in different time frames: The PT/OT furnishes 20 minutes and the PTA/OTA furnishes 25 minutes for a total of 45 minutes, three units can be billed using the total time minute range of at least 38 minutes and up to 52 minutes.

Billing Example: All three units of CPT code 97110 are reported on the claim with the corresponding CQ/CO modifier because the 25 minutes Start Printed Page 40563furnished by the PTA/OTA exceeds 10 percent of the 45-minute total service time (4.5 minutes rounded to 5 minutes, so the modifier would apply if the PTA/OTA had furnished 6 or more minutes of the service).

(3) The PTA/OTA works concurrently with the respective PT/OT as a team to furnish the same neuromuscular reeducation service (HCPCS code 97112) for a 30-minute session, resulting in 2 billable units of the service (at least 23 minutes and up to 37 minutes).

Billing Example: Both units of HCPCS code 97112 are reported with the appropriate CQ or CO modifier because the service time furnished by the PTA/OTA (30 minutes) exceeded 10 percent of the 30-minute total service time (3 minutes, so the modifier would apply if the PTA/OTA had furnished 4 or more minutes of the service).

  • Scenario Two: When services that are represented by different procedure codes are furnished. Follow our current policy to identify the procedure codes to bill and the units to bill for the service(s) provided for the most time. We propose that when the PT/OT and the PTA/OTA each independently furnish a service defined by a different procedure code for the same number of minutes, for example 10 minutes, for a total time of 20 minutes, qualifying for 1 unit to be billed (at least 8 minutes up to 23 minutes), the code for the service furnished by the PT/OT is selected to break the tie—one unit of that service would be billed without the CQ/CO modifier.

(1) When only one unit of a service can be billed (requires a minimum of 8 minutes but less than 23 minutes):

(a) The PT/OT independently furnishes 15 minutes of manual therapy (HCPCS code 97140) and the PTA/OTA independently furnishes 7 minutes of therapeutic exercise (HCPCS code 97110). One unit of HCPCS code 97140 can be billed (at least 8 minutes and up to 22 minutes).

Billing Example: One unit of HCPCS code 97140 is billed without the CQ/CO modifier because the PT/OT exclusively (without the PTA/OTA) furnished a full unit of a service defined by 15-minute time interval (current instructions require “1” unit to be reported). The 7 minutes of a different service delivered solely by the PTA/OTA do not result in a billable service. Both services, though, are documented in the medical record, noting which services were furnished by the PT/OT or PTA/OTA; and, the 7 minutes of HCPCS code 97110 would be included in the total minutes of timed codes that are considered when identifying the procedure codes and units of each that can be billed on the claim.

(b) If instead, the PT/OT independently furnished 7 minutes of CPT code 97140 and the PTA/OTA independently furnished a full 15-minutes of CPT code 97110, one unit of CPT code 97110 is billed and the CQ/CO modifier is applied; the 7 minutes of the PT/OT service (CPT code 97140) do not result in billable service, but all the minutes are documented and included in the total minutes of the timed codes that are considered when identifying the procedure codes and units of each that can be billed on the claim.

(c) If the PT/OT and PTA/OTA each independently furnish an equal number of minutes of CPT codes 97140 and 97110, respectively, that is less than the full 15-minute mark, and the total minutes of the timed codes qualify for billing one unit of a service, the code furnished by the PT/OT would be selected to break the tie and billed without a CQ/CO modifier because the PT/OT furnished that service independently of the PTA/OTA.

If instead the PT/OT furnishes an 8-minute service (CPT code 97140) and the PTA/OTA delivers a 13-minute service (CPT code 97110), one unit of the 13-minute PTA/OTA-delivered service (CPT code 97110) would be billed consistent with our current policy to bill the service with the greater time; and the service would be billed with a CQ/CO modifier because the PTA/OTA furnished the service independently.

(2) When two or more units can be billed (requires a minimum of 23 minutes), follow current instructions for billing procedure codes and units for each timed code.

(a) The PT/OT furnishes 20 minutes of neuromuscular reeducation (CPT code 97112) and the PTA/OTA furnishes 8 minutes of therapeutic exercise (CPT code 97110) for a total of 28 minutes, which permits two units of the timed codes to be billed (at least 23 minutes and up to 37 minutes).

Billing Example: Following our usual process for billing for the procedure codes and units based on services furnished with the most minutes, one unit of each procedure code would be billed—one unit of CPT code 97112 is billed without a CQ/CO modifier and one unit of CPT code 97110 is billed with a CQ/CO modifier. This is because, under our current policy, the two billable units of timed codes are allocated among procedure codes by assigning the first 15 minutes of service to code 97112 (the code with the highest number of minutes), which leaves another 13 minutes of timed services: 5 minutes of code 97112 (20 minus 15) and 8 minutes of code 97110. Since the 8 minutes of code 97110 is greater than the remaining 5 minutes of code 97112, the second billable unit of service would be assigned to 97110. The CQ/CO modifier would not apply to CPT code 97112 because the therapist furnished all minutes of that service independently. The CQ/CO modifier would apply to CPT code 97110 because the PTA/OTA furnished all minutes of that service independently.

(b) The PT/OT furnishes 32 minutes of neuromuscular reeducation (CPT code 97112), the PT/OT and the PTA/OTA each separately furnish 12 minutes and 14 minutes, respectively, of therapeutic exercise (CPT code 97110) for a total of 26 minutes, and the PTA/OTA independently furnishes 12 minutes of self-care (CPT code 97535) for a total of 70 minutes of timed code services, permitting five units to be billed (68-82 minutes). Under our current policy, the five billable units would be assigned as follows: Two units to CPT code 97112, two units to CPT code 97110, and one unit to CPT code 97535.

Billing Example: The two units of CPT code 97112 would be billed without a CQ/CO modifier because all 32 minutes of that service were furnished independently by the PT/OT. The two units of CPT code 97110 would be billed with the CQ/CO modifier because the PTA/OTA's 14 minutes of the service are greater than 10 percent of the 26 total minutes of the service (2.6 minutes which is rounded to 3 minutes, so the modifiers would apply if the PTA/OTA furnished 4 or more minutes of the service), and the one unit of CPT code 97535 would be billed with a CQ/CO modifier because the PTA/OTA independently furnished all minutes of that service.

(c) The PT/OT independently furnishes 12 minutes of neuromuscular reeducation activities (CPT code 97112) and the PTA/OTA independently furnishes 8 minutes of self-care activities (CPT code 97535) and 7 minutes of therapeutic exercise (CPT code 97110)—the total treatment time of 27 minutes allows for two units of service to be billed (at least 23 minutes and up to 37 minutes). Under our current policy, the two billable units would be assigned as follows: One unit of CPT code 97112 and one unit of CPT code 97535.

Billing Example: The one unit of HCPCS code 97112 would be billed without the CQ/CO modifier because it was furnished independently by the PT/OT; and, the one unit of CPT code 97535 is billed with the CQ/CO modifier because it was independently furnished Start Printed Page 40564by the PTA/OTA. In this example, CPT code 97110 is not billable; however, the minutes for all three codes are documented and counted toward the total time of the timed code services furnished to the patient on the date of service.

(d) The PT/OT furnishes 15 minutes of each of two services described by CPT codes 97112 and 97535, and is assisted by the PTA/OTA who furnishes 3 minutes of each service concurrently with the PT/OT. The total time of 30 minutes allows two 15-minute units to be billed—one unit each of CPT code 97112 and CPT code 97535.

Billing Example: Both CPT codes 97112 and 97535 are billed with the applicable CQ/CO modifier because the time the PTA/OTA spent assisting the PT/OT for each service exceeds 10 percent of the 15-minute total time for each service (1.5 minutes which is rounded to 2 minutes, so that the modifiers apply if the PTA/OTA furnishes 3 or more minutes of the service).

c. Proposed Regulatory Provisions

In accordance with section 1834(v)(2)(B) of the Act, we are proposing to amend §§ 410.59(a)(4) and 410.60(a)(4) for outpatient physical and occupational therapy services, respectively, and § 410.105(d) for physical and occupational therapy services furnished by comprehensive outpatient rehabilitation facilities (CORFs) as authorized under section 1861(cc) of the Act, to establish as a condition of payment that claims for services furnished in whole or in part by an OTA or PTA must include a prescribed modifier; and that services will not be considered furnished in part by an OTA or PTA unless they exceed 10 percent of the total minutes for that service, beginning for services furnished on and after January 1, 2020. To implement section 1834(v)(1) of the Act, we are proposing to amend §§ 410.59(a)(4) and 410.60(a)(4) for outpatient physical and occupational therapy services, respectively, and at § 410.105(d) for physical and occupational therapy services furnished by CORFs to specify that claims from physical and occupational therapists in private practice paid under section 1848 of the Act and from providers paid under section 1834(k) of the Act for physical therapy and occupational therapy services that contain a therapy assistant modifier, are paid at 85 percent of the otherwise applicable payment amount for the service for dates of service on and after January 1, 2022. As specified in the CY 2019 PFS final rule, we also note that the CQ or CO modifier is to be applied alongside the corresponding GP or GO therapy modifier that is required on each claim line of service for physical therapy or occupational therapy services. Beginning for dates of service and after January 1, 2020, claims missing the corresponding GP or GO therapy modifier will be rejected/returned to the therapist or therapy provider so they can be corrected and resubmitted for processing.

As discussed in the CY 2019 PFS proposed and final rules (see 83 FR 35850 and 83 FR 59654), we established that the reduced payment rate under section 1834(v)(1) of the Act for the outpatient therapy services furnished in whole or in part by therapy assistants is not applicable to outpatient therapy services furnished by CAHs, for which payment is made under section 1834(g) of the Act. We would like to take this opportunity to clarify that we do not interpret section 1834(v) of the Act to apply to outpatient physical therapy or occupational therapy services furnished by CAHs, or by other providers for which payment for outpatient therapy services is not made under section 1834(k) of the Act based on the PFS rates.

N. Valuation of Specific Codes

1. Background: Process for Valuing New, Revised, and Potentially Misvalued Codes

Establishing valuations for newly created and revised CPT codes is a routine part of maintaining the PFS. Since the inception of the PFS, it has also been a priority to revalue services regularly to make sure that the payment rates reflect the changing trends in the practice of medicine and current prices for inputs used in the PE calculations. Initially, this was accomplished primarily through the 5-year review process, which resulted in revised work RVUs for CY 1997, CY 2002, CY 2007, and CY 2012, and revised PE RVUs in CY 2001, CY 2006, and CY 2011, and revised MP RVUs in CY 2010 and CY 2015. Under the 5-year review process, revisions in RVUs were proposed and finalized via rulemaking. In addition to the 5-year reviews, beginning with CY 2009, CMS and the RUC identified a number of potentially misvalued codes each year using various identification screens, as discussed in section II.E. of this proposed rule, Potentially Misvalued Services under the PFS. Historically, when we received RUC recommendations, our process had been to establish interim final RVUs for the potentially misvalued codes, new codes, and any other codes for which there were coding changes in the final rule with comment period for a year. Then, during the 60-day period following the publication of the final rule with comment period, we accepted public comment about those valuations. For services furnished during the calendar year following the publication of interim final rates, we paid for services based upon the interim final values established in the final rule. In the final rule with comment period for the subsequent year, we considered and responded to public comments received on the interim final values, and typically made any appropriate adjustments and finalized those values.

In the CY 2015 PFS final rule with comment period (79 FR 67547), we finalized a new process for establishing values for new, revised and potentially misvalued codes. Under the new process, we include proposed values for these services in the proposed rule, rather than establishing them as interim final in the final rule with comment period. Beginning with the CY 2017 PFS proposed rule (81 FR 46162), the new process was applicable to all codes, except for new codes that describe truly new services. For CY 2017, we proposed new values in the CY 2017 PFS proposed rule for the vast majority of new, revised, and potentially misvalued codes for which we received complete RUC recommendations by February 10, 2016. To complete the transition to this new process, for codes for which we established interim final values in the CY 2016 PFS final rule with comment period (81 FR 80170), we reviewed the comments received during the 60-day public comment period following release of the CY 2016 PFS final rule with comment period (80 FR 70886), and reproposed values for those codes in the CY 2017 PFS proposed rule.

We considered public comments received during the 60-day public comment period for the proposed rule before establishing final values in the CY 2017 PFS final rule. As part of our established process, we will adopt interim final values only in the case of wholly new services for which there are no predecessor codes or values and for which we do not receive recommendations in time to propose values.

As part of our obligation to establish RVUs for the PFS, we thoroughly review and consider available information including recommendations and supporting information from the RUC, the Health Care Professionals Advisory Committee (HCPAC), public commenters, medical literature, Medicare claims data, comparative databases, comparison with other codes Start Printed Page 40565within the PFS, as well as consultation with other physicians and healthcare professionals within CMS and the federal government as part of our process for establishing valuations. Where we concur that the RUC's recommendations, or recommendations from other commenters, are reasonable and appropriate and are consistent with the time and intensity paradigm of physician work, we propose those values as recommended. Additionally, we continually engage with stakeholders, including the RUC, with regard to our approach for accurately valuing codes, and as we prioritize our obligation to value new, revised, and potentially misvalued codes. We continue to welcome feedback from all interested parties regarding valuation of services for consideration through our rulemaking process.

2. Methodology for Establishing Work RVUs

For each code identified in this section, we conduct a review that included the current work RVU (if any), RUC-recommended work RVU, intensity, time to furnish the preservice, intraservice, and postservice activities, as well as other components of the service that contribute to the value. Our reviews of recommended work RVUs and time inputs generally include, but have not been limited to, a review of information provided by the RUC, the HCPAC, and other public commenters, medical literature, and comparative databases, as well as a comparison with other codes within the PFS, consultation with other physicians and health care professionals within CMS and the federal government, as well as Medicare claims data. We also assess the methodology and data used to develop the recommendations submitted to us by the RUC and other public commenters and the rationale for the recommendations. In the CY 2011 PFS final rule with comment period (75 FR 73328 through 73329), we discussed a variety of methodologies and approaches used to develop work RVUs, including survey data, building blocks, crosswalks to key reference or similar codes, and magnitude estimation (see the CY 2011 PFS final rule with comment period (75 FR 73328 through 73329) for more information). When referring to a survey, unless otherwise noted, we mean the surveys conducted by specialty societies as part of the formal RUC process.

Components that we use in the building block approach may include preservice, intraservice, or postservice time and post-procedure visits. When referring to a bundled CPT code, the building block components could include the CPT codes that make up the bundled code and the inputs associated with those codes. We use the building block methodology to construct, or deconstruct, the work RVU for a CPT code based on component pieces of the code. Magnitude estimation refers to a methodology for valuing work that determines the appropriate work RVU for a service by gauging the total amount of work for that service relative to the work for a similar service across the PFS without explicitly valuing the components of that work. In addition to these methodologies, we frequently utilize an incremental methodology in which we value a code based upon its incremental difference between another code and another family of codes. The statute specifically defines the work component as the resources in time and intensity required in furnishing the service. Also, the published literature on valuing work has recognized the key role of time in overall work. For particular codes, we refine the work RVUs in direct proportion to the changes in the best information regarding the time resources involved in furnishing particular services, either considering the total time or the intraservice time.

Several years ago, to aid in the development of preservice time recommendations for new and revised CPT codes, the RUC created standardized preservice time packages. The packages include preservice evaluation time, preservice positioning time, and preservice scrub, dress and wait time. Currently, there are preservice time packages for services typically furnished in the facility setting (for example, preservice time packages reflecting the different combinations of straightforward or difficult procedure, and straightforward or difficult patient). Currently, there are three preservice time packages for services typically furnished in the nonfacility setting.

We developed several standard building block methodologies to value services appropriately when they have common billing patterns. In cases where a service is typically furnished to a beneficiary on the same day as an evaluation and management (E/M) service, we believe that there is overlap between the two services in some of the activities furnished during the preservice evaluation and postservice time. Our longstanding adjustments have reflected a broad assumption that at least one-third of the work time in both the preservice evaluation and postservice period is duplicative of work furnished during the E/M visit.

Accordingly, in cases where we believe that the RUC has not adequately accounted for the overlapping activities in the recommended work RVU and/or times, we adjust the work RVU and/or times to account for the overlap. The work RVU for a service is the product of the time involved in furnishing the service multiplied by the intensity of the work. Preservice evaluation time and postservice time both have a long-established intensity of work per unit of time (IWPUT) of 0.0224, which means that 1 minute of preservice evaluation or postservice time equates to 0.0224 of a work RVU.

Therefore, in many cases when we remove 2 minutes of preservice time and 2 minutes of postservice time from a procedure to account for the overlap with the same day E/M service, we also remove a work RVU of 0.09 (4 minutes × 0.0224 IWPUT) if we do not believe the overlap in time had already been accounted for in the work RVU. The RUC has recognized this valuation policy and, in many cases, now addresses the overlap in time and work when a service is typically furnished on the same day as an E/M service.

The following paragraphs contain a general discussion of our approach to reviewing RUC recommendations and developing proposed values for specific codes. When they exist we also include a summary of stakeholder reactions to our approach. We note that many commenters and stakeholders have expressed concerns over the years with our ongoing adjustment of work RVUs based on changes in the best information we had regarding the time resources involved in furnishing individual services. We have been particularly concerned with the RUC's and various specialty societies' objections to our approach given the significance of their recommendations to our process for valuing services and since much of the information we used to make the adjustments is derived from their survey process. We are obligated under the statute to consider both time and intensity in establishing work RVUs for PFS services. As explained in the CY 2016 PFS final rule with comment period (80 FR 70933), we recognize that adjusting work RVUs for changes in time is not always a straightforward process, so we have applied various methodologies to identify several potential work values for individual codes.

We have observed that for many codes reviewed by the RUC, recommended work RVUs have appeared to be incongruous with recommended assumptions regarding the resource costs in time. This has been the case for Start Printed Page 40566a significant portion of codes for which we recently established or proposed work RVUs that are based on refinements to the RUC-recommended values. When we have adjusted work RVUs to account for significant changes in time, we have started by looking at the change in the time in the context of the RUC-recommended work RVU. When the recommended work RVUs do not appear to account for significant changes in time, we have employed the different approaches to identify potential values that reconcile the recommended work RVUs with the recommended time values. Many of these methodologies, such as survey data, building block, crosswalks to key reference or similar codes, and magnitude estimation have long been used in developing work RVUs under the PFS. In addition to these, we sometimes use the relationship between the old time values and the new time values for particular services to identify alternative work RVUs based on changes in time components.

In so doing, rather than ignoring the RUC-recommended value, we have used the recommended values as a starting reference and then applied one of these several methodologies to account for the reductions in time that we believe were not otherwise reflected in the RUC-recommended value. If we believe that such changes in time are already accounted for in the RUC's recommendation, then we do not make such adjustments. Likewise, we do not arbitrarily apply time ratios to current work RVUs to calculate proposed work RVUs. We use the ratios to identify potential work RVUs and consider these work RVUs as potential options relative to the values developed through other options.

We do not imply that the decrease in time as reflected in survey values should always equate to a one-to-one or linear decrease in newly valued work RVUs. Instead, we believe that, since the two components of work are time and intensity, absent an obvious or explicitly stated rationale for why the relative intensity of a given procedure has increased, significant decreases in time should be reflected in decreases to work RVUs. If the RUC's recommendation has appeared to disregard or dismiss the changes in time, without a persuasive explanation of why such a change should not be accounted for in the overall work of the service, then we have generally used one of the aforementioned methodologies to identify potential work RVUs, including the methodologies intended to account for the changes in the resources involved in furnishing the procedure.

Several stakeholders, including the RUC, have expressed general objections to our use of these methodologies and deemed our actions in adjusting the recommended work RVUs as inappropriate; other stakeholders have also expressed general concerns with CMS refinements to RUC-recommended values in general. In the CY 2017 PFS final rule (81 FR 80272 through 80277), we responded in detail to several comments that we received regarding this issue. In the CY 2017 PFS proposed rule (81 FR 46162), we requested comments regarding potential alternatives to making adjustments that would recognize overall estimates of work in the context of changes in the resource of time for particular services; however, we did not receive any specific potential alternatives. As described earlier in this section, crosswalks to key reference or similar codes are one of the many methodological approaches we have employed to identify potential values that reconcile the RUC-recommend work RVUs with the recommended time values when the RUC-recommended work RVUs did not appear to account for significant changes in time. In response to comments in the CY 2019 PFS final rule (83 FR 59515), we clarify that terms “reference services”, “key reference services”, and “crosswalks” as described by the commenters are part of the RUC's process for code valuation. These are not terms that we created, and we do not agree that we necessarily must employ them in the identical fashion for the purposes of discussing our valuation of individual services that come up for review. However, in the interest of minimizing confusion and providing clear language to facilitate stakeholder feedback, we will seek to limit the use of the term, “crosswalk,” to those cases where we are making a comparison to a CPT code with the identical work RVU.

We look forward to continuing to engage with stakeholders and commenters, including the RUC, as we prioritize our obligation to value new, revised, and potentially misvalued codes; and will continue to welcome feedback from all interested parties regarding valuation of services for consideration through our rulemaking process. We refer readers to the detailed discussion in this section of the proposed valuation considered for specific codes. Table 20 contains a list of codes and descriptors for which we are proposing work RVUs; this includes all codes for which we received RUC recommendations by February 10, 2019. The proposed work RVUs, work time and other payment information for all CY 2020 payable codes are available on the CMS website under downloads for the CY 2020 PFS proposed rule at https://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​PhysicianFeeSched/​index.html).

3. Methodology for the Direct PE Inputs To Develop PE RVUs

a. Background

On an annual basis, the RUC provides us with recommendations regarding PE inputs for new, revised, and potentially misvalued codes. We review the RUC-recommended direct PE inputs on a code by code basis. Like our review of recommended work RVUs, our review of recommended direct PE inputs generally includes, but is not limited to, a review of information provided by the RUC, HCPAC, and other public commenters, medical literature, and comparative databases, as well as a comparison with other codes within the PFS, and consultation with physicians and health care professionals within CMS and the federal government, as well as Medicare claims data. We also assess the methodology and data used to develop the recommendations submitted to us by the RUC and other public commenters and the rationale for the recommendations. When we determine that the RUC's recommendations appropriately estimate the direct PE inputs (clinical labor, disposable supplies, and medical equipment) required for the typical service, are consistent with the principles of relativity, and reflect our payment policies, we use those direct PE inputs to value a service. If not, we refine the recommended PE inputs to better reflect our estimate of the PE resources required for the service. We also confirm whether CPT codes should have facility and/or nonfacility direct PE inputs and refine the inputs accordingly.

Our review and refinement of the RUC-recommended direct PE inputs includes many refinements that are common across codes, as well as refinements that are specific to particular services. Table 21 details our proposed refinements of the RUC's direct PE recommendations at the code-specific level. In section II.B. of this proposed rule, Determination of Practice Expense Relative Value Units (PE RVUs), we address certain proposed refinements that would be common across codes. Proposed refinements to particular codes are addressed in the portions of this section that are dedicated to particular codes. We note Start Printed Page 40567that for each refinement, we indicate the impact on direct costs for that service. We note that, on average, in any case where the impact on the direct cost for a particular refinement is $0.35 or less, the refinement has no impact on the PE RVUs. This calculation considers both the impact on the direct portion of the PE RVU, as well as the impact on the indirect allocator for the average service. We also note that approximately half of the refinements listed in Table 21 result in changes under the $0.35 threshold and are unlikely to result in a change to the RVUs.

We also note that the proposed direct PE inputs for CY 2020 are displayed in the CY 2020 direct PE input files, available on the CMS website under the downloads for the CY 2020 PFS proposed rule at http://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​PhysicianFeeSched/​PFS-Federal-Regulation-Notices.html. The inputs displayed there have been used in developing the proposed CY 2020 PE RVUs as displayed in Addendum B.

b. Common Refinements

(1) Changes in Work Time

Some direct PE inputs are directly affected by revisions in work time. Specifically, changes in the intraservice portions of the work time and changes in the number or level of postoperative visits associated with the global periods result in corresponding changes to direct PE inputs. The direct PE input recommendations generally correspond to the work time values associated with services. We believe that inadvertent discrepancies between work time values and direct PE inputs should be refined or adjusted in the establishment of proposed direct PE inputs to resolve the discrepancies.

(2) Equipment Time

Prior to CY 2010, the RUC did not generally provide CMS with recommendations regarding equipment time inputs. In CY 2010, in the interest of ensuring the greatest possible degree of accuracy in allocating equipment minutes, we requested that the RUC provide equipment times along with the other direct PE recommendations, and we provided the RUC with general guidelines regarding appropriate equipment time inputs. We appreciate the RUC's willingness to provide us with these additional inputs as part of its PE recommendations.

In general, the equipment time inputs correspond to the service period portion of the clinical labor times. We clarified this principle over several years of rulemaking, indicating that we consider equipment time as the time within the intraservice period when a clinician is using the piece of equipment plus any additional time that the piece of equipment is not available for use for another patient due to its use during the designated procedure. For those services for which we allocate cleaning time to portable equipment items, because the portable equipment does not need to be cleaned in the room where the service is furnished, we do not include that cleaning time for the remaining equipment items, as those items and the room are both available for use for other patients during that time. In addition, when a piece of equipment is typically used during follow-up postoperative visits included in the global period for a service, the equipment time would also reflect that use.

We believe that certain highly technical pieces of equipment and equipment rooms are less likely to be used during all of the preservice or postservice tasks performed by clinical labor staff on the day of the procedure (the clinical labor service period) and are typically available for other patients even when one member of the clinical staff may be occupied with a preservice or postservice task related to the procedure. We also note that we believe these same assumptions would apply to inexpensive equipment items that are used in conjunction with and located in a room with non-portable highly technical equipment items since any items in the room in question would be available if the room is not being occupied by a particular patient. For additional information, we refer readers to our discussion of these issues in the CY 2012 PFS final rule with comment period (76 FR 73182) and the CY 2015 PFS final rule with comment period (79 FR 67639).

(3) Standard Tasks and Minutes for Clinical Labor Tasks

In general, the preservice, intraservice, and postservice clinical labor minutes associated with clinical labor inputs in the direct PE input database reflect the sum of particular tasks described in the information that accompanies the RUC-recommended direct PE inputs, commonly called the “PE worksheets.” For most of these described tasks, there is a standardized number of minutes, depending on the type of procedure, its typical setting, its global period, and the other procedures with which it is typically reported. The RUC sometimes recommends a number of minutes either greater than or less than the time typically allotted for certain tasks. In those cases, we review the deviations from the standards and any rationale provided for the deviations. When we do not accept the RUC-recommended exceptions, we refine the proposed direct PE inputs to conform to the standard times for those tasks. In addition, in cases when a service is typically billed with an E/M service, we remove the preservice clinical labor tasks to avoid duplicative inputs and to reflect the resource costs of furnishing the typical service.

We refer readers to section II.B. of this proposed rule, Determination of Practice Expense Relative Value Units (PE RVUs), for more information regarding the collaborative work of CMS and the RUC in improvements in standardizing clinical labor tasks.

(4) Recommended Items That Are Not Direct PE Inputs

In some cases, the PE worksheets included with the RUC's recommendations include items that are not clinical labor, disposable supplies, or medical equipment or that cannot be allocated to individual services or patients. We addressed these kinds of recommendations in previous rulemaking (78 FR 74242), and we do not use items included in these recommendations as direct PE inputs in the calculation of PE RVUs.

(5) New Supply and Equipment Items

The RUC generally recommends the use of supply and equipment items that already exist in the direct PE input database for new, revised, and potentially misvalued codes. However, some recommendations include supply or equipment items that are not currently in the direct PE input database. In these cases, the RUC has historically recommended that a new item be created and has facilitated our pricing of that item by working with the specialty societies to provide us copies of sales invoices. For CY 2020, we received invoices for several new supply and equipment items. Tables 22 and 23 detail the invoices received for new and existing items in the direct PE database. As discussed in section II.B. of this proposed rule, Determination of Practice Expense Relative Value Units, we encouraged stakeholders to review the prices associated with these new and existing items to determine whether these prices appear to be accurate. Where prices appear inaccurate, we encouraged stakeholders to submit invoices or other information to improve the accuracy of pricing for these items in the direct PE database by February 10th of the following year for consideration in future rulemaking, similar to our process for consideration of RUC recommendations.Start Printed Page 40568

We remind stakeholders that due to the relativity inherent in the development of RVUs, reductions in existing prices for any items in the direct PE database increase the pool of direct PE RVUs available to all other PFS services. Tables 22 and 23 also include the number of invoices received and the number of nonfacility allowed services for procedures that use these equipment items. We provide the nonfacility allowed services so that stakeholders will note the impact the particular price might have on PE relativity, as well as to identify items that are used frequently, since we believe that stakeholders are more likely to have better pricing information for items used more frequently. A single invoice may not be reflective of typical costs and we encourage stakeholders to provide additional invoices so that we might identify and use accurate prices in the development of PE RVUs.

In some cases, we do not use the price listed on the invoice that accompanies the recommendation because we identify publicly available alternative prices or information that suggests a different price is more accurate. In these cases, we include this in the discussion of these codes. In other cases, we cannot adequately price a newly recommended item due to inadequate information. Sometimes, no supporting information regarding the price of the item has been included in the recommendation. In other cases, the supporting information does not demonstrate that the item has been purchased at the listed price (for example, vendor price quotes instead of paid invoices). In cases where the information provided on the item allows us to identify clinically appropriate proxy items, we might use existing items as proxies for the newly recommended items. In other cases, we included the item in the direct PE input database without any associated price. Although including the item without an associated price means that the item does not contribute to the calculation of the final PE RVU for particular services, it facilitates our ability to incorporate a price once we obtain information and are able to do so.

(6) Service Period Clinical Labor Time in the Facility Setting

Generally speaking, our direct PE inputs do not include clinical labor minutes assigned to the service period because the cost of clinical labor during the service period for a procedure in the facility setting is not considered a resource cost to the practitioner since Medicare makes separate payment to the facility for these costs. We address proposed code-specific refinements to clinical labor in the individual code sections.

(7) Procedures Subject to the Multiple Procedure Payment Reduction (MPPR) and the OPPS Cap

We note that the public use files for the PFS proposed and final rules for each year display the services subject to the MPPR for diagnostic cardiovascular services, diagnostic imaging services, diagnostic ophthalmology services, and therapy services. We also include a list of procedures that meet the definition of imaging under section 1848(b)(4)(B) of the Act, and therefore, are subject to the OPPS cap for the upcoming calendar year. The public use files for CY 2020 are available on the CMS website under downloads for the CY 2020 PFS proposed rule at http://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​PhysicianFeeSched/​PFS-Federal-Regulation-Notices.html. For more information regarding the history of the MPPR policy, we refer readers to the CY 2014 PFS final rule with comment period (78 FR 74261 through 74263). For more information regarding the history of the OPPS cap, we refer readers to the CY 2007 PFS final rule with comment period (71 FR 69659 through 69662).

4. Proposed Valuation of Specific Codes for CY 2020

(1) Tissue Grafting Procedures (CPT Codes 15X00, 15X01, 15X02, 15X03, and 15X04)

CPT code 20926 (Tissue grafts, other (e.g., paratenon, fat, dermis)), was identified through a review of services with anomalous sites of service when compared to Medicare utilization data. The CPT Editorial Panel subsequently replaced CPT code 20926 with five codes in the Integumentary section to better describe tissue grafting procedures.

We are proposing the RUC-recommended work RVUs of 6.68 for CPT code 15X00 (Grafting of autologous soft tissue, other, harvested by direct excision (e.g., fat, dermis, fascia)), 6.73 for CPT code 15X01 (grafting of autologous fat harvested by liposuction technique to trunk, breasts, scalp, arms, and/or legs; 50cc or less injectate), 2.50 for CPT code 15X02 (grafting of autologous fat harvested by liposuction technique to trunk, breasts, scalp, arms, and/or legs; each additional 50cc injectate, or part thereof (list separately in addition to code for primary procedure)), 6.83 for CPT code 15X03 (grafting of autologous fat harvested by liposuction technique to face, eyelids, mouth, neck, ears, orbits, genitalia, hands, and/or feet; 25cc or less injectate), and 2.41 for CPT code 15X04 (grafting of autologous fat harvested by liposuction technique to face, eyelids, mouth, neck, ears, orbits, genitalia, hands, and/or feet; each additional 25cc injectate, or part thereof (list separately in addition to code for primary procedure)).

We are proposing the RUC-recommended direct PE inputs for this code family without refinement.

(2) Drug Delivery Implant Procedures (CPT Codes 11981, 11982, 11983, 206X0, 206X1, 206X2, 206X3, 206X4, and 206X5)

CPT codes 11980-11983 were identified as potentially misvalued since the majority specialty found in recent claims data differs from the two specialties that originally surveyed the codes. The current valuation of CPT code 11980 (Subcutaneous hormone pellet implantation (implantation of estradiol and/or testosterone pellets beneath the skin)) was reaffirmed by the RUC as the physician work had not changed since the last review. The CPT Editorial Panel revised the other three existing codes in the family and created six additional add-on codes to describe orthopaedic drug delivery. These codes were surveyed and reviewed for the October 2018 RUC meeting.

CPT code 11980 (Subcutaneous hormone pellet implantation (implantation of estradiol and/or testosterone pellets beneath the skin)) with the current work value of 1.10 RVUs and 12 minutes of intraservice time, and 27 minutes of total time, was determined to be unchanged since last reviewed and was recommended by the RUC to be maintained. We concur. We also are not proposing any direct PE refinements to CPT code 11980. CPT code 11981 (Insertion, non-biodegradable drug delivery implant) has a current work RVU of 1.48, with 39 minutes of total physician time. The specialty society survey recommended a work RVU of 1.30, with 31 minutes of total physician time and 5 minutes of intraservice time. The RUC recommended a work RVU of 1.30 (25th percentile), with 30 minutes of total physician time and 5 minutes of intraservice time. For comparable reference CPT codes to CPT code 11981, the RUC and the survey respondents had selected CPT code 55876 (Placement of interstitial device(s) for radiation therapy guidance (e.g., fiducial markers, dosimeter), prostate (via needle, any approach), single or multiple (work RVU = 1.73, 20 minutes intraservice time and 59 total minutes)) and CPT code 57500 (Biopsy of cervix, Start Printed Page 40569single or multiple, or local excision of lesion, with or without fulguration (separate procedure) (work RVU = 1.20, 15 minutes intraservice time and 29 total minutes)). The RUC further offers for comparison, CPT code 67515 (Injection of medication or other substance into Tenon's capsule (work RVU = 1.40 (from CY 2018), 5 minutes intraservice time and 21 minutes total time)), CPT code 12013 (Simple repair of superficial wounds of face, ears, eyelids, nose, lips and/or mucous membranes; 2.6 cm to 5.0 cm (work RVU = 1.22 and 27 total minutes)) and CPT code 12004 (Simple repair of superficial wounds of scalp, neck, axillae, external genitalia, trunk and/or extremities (including hands and feet); 7.6 cm to 12.5 cm) (work RVU = 1.44 and 29 total minutes)). In addition, we offer CPT code 67500 (Injection of medication into cavity behind eye) (work RVU = 1.18 and 5 minutes intraservice time and 33 total minutes) for reference. Given that the CPT code 11981 incurs a 23 percent reduction in the new total physician time and with reference to CPT code 67500, we are proposing a work RVU of 1.14, and accept the survey recommended 5 minutes for intraservice time and 30 minutes of total time. We are not proposing any direct PE refinements to CPT code 11981.

CPT code 11982 (Removal, non-biodegradable drug delivery implant) has a current work RVU of 1.78, with 44 minutes of total physician time. The specialty society survey recommended a work RVU of 1.70 RVU, with 10 minutes of intraservice time and 34 minutes of total physician time. The RUC also recommended a work RVU of 1.70, with 10 minutes of intraservice time and 33 minutes of total physician time. The RUC confirmed that removal (CPT code 11982), requires more intraservice time to perform than the insertion (CPT code 11981). For comparable reference codes to CPT code 11982, the RUC and the survey respondents had selected CPT code 54150 (Circumcision, using clamp or other device with regional dorsal penile or ring block) (work RVU = 1.90, 15 minutes intraservice time and 45 total minutes)) and CPT code 12004 (Simple repair of superficial wounds of scalp, neck, axillae, external genitalia, trunk and/or extremities (including hands and feet); 7.6 cm to 12.5 cm) (work RVU = 1.44, with 17 minutes intraservice time and 29 minutes total time)). We offer CPT code 64486 (Injections of local anesthetic for pain control and abdominal wall analgesia on one side) (work RVU = 1.27, 10 minutes intraservice time and 35 total minutes)) for reference. Given that the CPT code 11982 incurs a 25 percent reduction in the new total physician time and with reference to CPT code 64486, we are proposing a work RVU of 1.34, and accept the RUC-recommended 10 minutes for intraservice time and 33 minutes of total time. We are not proposing any direct PE refinements to CPT code 11982.

CPT code 11983 (Removal with reinsertion, non-biodegradable drug delivery implant) has a current work RVU of 3.30, with 69 minutes of total physician time. The specialty society survey recommended a work RVU of 2.50 RVU, with 15 minutes of intraservice time and 41 minutes of total physician time. The RUC also recommended a work RVU of 2.10, with 15 minutes of intraservice time and 40 minutes of total physician time. The RUC confirmed that CPT code 11983 requires more intraservice time to perform than the insertion CPT code 11981. For comparable reference codes to CPT code 11983, the RUC and the survey respondents had selected CPT code 55700 (Biopsy, prostate; needle or punch, single or multiple, any approach) (work RVU = 2.50, 15 minutes intraservice time and 35 total minutes)), CPT code 54150 (Circumcision, using clamp or other device with regional dorsal penile or ring block) (work RVU = 1.90, 15 minutes intraservice time and 45 total minutes)) and CPT code 52281 (Cystourethroscopy, with calibration and/or dilation of urethral stricture or stenosis, with or without meatotomy, with or without injection procedure for cystography, male or female) (work RVU = 2.75 and 20 minutes intraservice time and 46 minutes total time)). We offer CPT code 62324 (Insertion of indwelling catheter and administration of substance into spinal canal of upper or middle back) (work RVU = 1.89, 15 minutes intraservice time and 43 total minutes)) for reference. Given that the CPT code 11983 incurs a 42 percent reduction in new total physician time and with reference to CPT code 62324, we are proposing a work RVU of 1.91, and accept the RUC-recommended 15 minutes for intraservice time and 40 minutes of total time. We are not proposing any direct PE refinements to CPT code 11983.

The new proposed add-on CPT codes 206X0-206X5 are intended to be typically reported with CPT codes 11981-11983, with debridement or arthrotomy procedures done primarily by orthopedic surgeons. The specialty society's survey for CPT code 206X0 (Manual preparation and insertion of drug delivery device(s), deep (e.g., subfascial)) found a 2.00 work RVU value at the median and a 1.50 work RVU value at the 25th percentile, with 20 minutes of intraservice time and 30 minutes of total physician time, for the preparation of the antibiotic powder and cement, rolled into beads and threaded onto suture for insertion into the infected bone. The RUC recommended a work RVU of 1.50, with 20 minutes of intraservice time and 27 minutes of total physician time. The RUC's reference CPT codes included CPT code 11047 (Debridement, bone (includes epidermis, dermis, subcutaneous tissue, muscle and/or fascia, if performed); each additional 20 sq cm, or part thereof) (work RVU = 1.80, and 30 minutes intraservice time)), CPT codes 64484 (Injection(s), anesthetic agent and/or steroid, transforaminal epidural, with imaging guidance (fluoroscopy or CT); lumbar or sacral, each additional level) (work RVU = 1.00 and 10 minutes intraservice time)), and CPT code 36227 (Selective catheter placement, external carotid artery, unilateral, with angiography of the ipsilateral external carotid circulation and all associated radiological supervision and interpretation) (work RVU = 2.09 and 20 minutes intraservice time)). Our review of similar add-on CPT codes yielded CPT code 64634 (Destruction of upper or middle spinal facet joint nerves with imaging guidance) (work RVU = 1.32 and 20 minutes intraservice time)). We are proposing for CPT code 206X0, a work RVU of 1.32, and accept the RUC-recommended 20 minutes of intraservice time and 20 minutes of total time.

The specialty society's survey for CPT code 206X1 (Manual preparation and insertion of drug delivery device(s), intramedullary) found a 3.25 work RVU value at the median and a 2.50 work RVU value at the 25th percentile, with 25 minutes of intraservice time and 38 minutes of total physician time, for the preparation of the “antibiotic nail” ready for insertion into the intramedullary canal with fluoroscopic guidance. The RUC recommended a work RVU of 2.50, with 25 minutes of intraservice time and 32 minutes of total physician time. The RUC's reference CPT codes included CPT code 11047 (Debridement, bone (includes epidermis, dermis, subcutaneous tissue, muscle and/or fascia, if performed); each additional 20 sq cm, or part thereof) (work RVU = 1.80, and 30 minutes intraservice time)), CPT code 57267 (Insertion of mesh or other prosthesis for repair of pelvic floor defect, each site (anterior, posterior compartment), vaginal approach (work Start Printed Page 40570RVU = 4.88 and 45 minutes intraservice time)), and CPT code 36227 (Selective catheter placement, external carotid artery, unilateral, with angiography of the ipsilateral external carotid circulation and all associated radiological supervision and interpretation (work RVU = 2.09 and 15 minutes intraservice time)). We find that the reference CPT code 11047, with 30 minutes of intraservice time, is suitable, but we adjust our proposed work RVU of 1.70 to account for the 25 minutes, instead of our reference code's 30 minutes of intraservice time (and the 32 minutes of total time), for CPT code 206X1.

The specialty society's survey for CPT code 206X2 (Manual preparation and insertion of drug delivery device(s), intra-articular) found a 4.00 work RVU value at the median and a 2.60 work RVU value at the 25th percentile, with 30 minutes of intraservice time and 45 minutes of total physician time, for the preparation of the antibiotic cement inserted into a pre-fabricated silicone mold, when after setting up, will be cemented to the end of the bone (with the joint). The RUC recommended a work RVU of 2.60, with 30 minutes of intraservice time and 37 minutes of total physician time. The RUC's reference CPT codes included CPT code 11047 (Debridement, bone (includes epidermis, dermis, subcutaneous tissue, muscle and/or fascia, if performed); each additional 20 sq cm, or part thereof (work RVU = 1.80, and 30 minutes intraservice time)), CPT code 57267 (Insertion of mesh or other prosthesis for repair of pelvic floor defect, each site (anterior, posterior compartment), vaginal approach (work RVU = 4.88 and 45 minutes intraservice time)), and CPT code 36227 (Selective catheter placement, external carotid artery, unilateral, with angiography of the ipsilateral external carotid circulation and all associated radiological supervision and interpretation (work RVU = 2.09 and 20 minutes intraservice time)). We find that the reference CPT code 11047, with 30 minutes of intraservice time, is a suitable guide and we are proposing the work RVU of 1.80 with the RUC-recommended 30 minutes of intraservice time and 37 minutes of total time, for CPT code 206X2.

The specialty society's survey for CPT code 206X3 (Removal of drug delivery device(s), deep (e.g., subfascial)) found a 1.75 work RVU value at the median and a 1.13 work RVU value at the 25th percentile, with 15 minutes of intraservice time and 18 minutes of total physician time. The work includes a marginal dissection to expose the drug delivery device and to remove it. The RUC recommended a work RVU of 1.13, with 18 minutes of total physician time and 15 minutes of intraservice time. The RUC's reference CPT codes included CPT code 11047 (Debridement, bone (includes epidermis, dermis, subcutaneous tissue, muscle and/or fascia, if performed); each additional 20 sq cm, or part thereof (work RVU = 1.80, and 30 minutes intraservice time)), CPT code 64484 (Injection(s), anesthetic agent and/or steroid, transforaminal epidural, with imaging guidance (fluoroscopy or CT); lumbar or sacral, each additional level (work RVU = 1.00 and 10 minutes intraservice time)), and CPT code 64480 (Injection(s), anesthetic agent and/or steroid, transforaminal epidural, with imaging guidance (fluoroscopy or CT); cervical or thoracic, each additional level (work RVU = 1.20 and 15 minutes intraservice time)). We are proposing the RUC-recommended work RVU of 1.13 with 15 minutes of intraservice time and 18 minutes of total time for 206X3.

The specialty society's survey for CPT code 206X4 (Removal of drug delivery device(s), intramedullary) found a 2.50 work RVU value at the median and a 1.80 work RVU value at the 25th percentile, with 20 minutes of intraservice time and 28 minutes of total physician time. The work includes a marginal dissection, in addition to what was in the base procedure, to loosen and expose the drug delivery device and to remove it, any remaining drug delivery device shards that may have broken off. The RUC recommended a work RVU of 1.80, with 20 minutes of intraservice time and 23 minutes of total physician time. The RUC's reference CPT codes included CPT code 11047 (Debridement, bone (includes epidermis, dermis, subcutaneous tissue, muscle and/or fascia, if performed); each additional 20 sq cm, or part thereof (work RVU = 1.80, and 30 minutes intraservice time)), CPT codes 37253 (Intravascular ultrasound (noncoronary vessel) during diagnostic evaluation and/or therapeutic intervention, including radiological supervision and interpretation; each additional noncoronary vessel (work RVU = 1.44 and 20 minutes intraservice time)), and CPT code 36227 (Selective catheter placement, external carotid artery, unilateral, with angiography of the ipsilateral external carotid circulation and all associated radiological supervision and interpretation (work RVU = 2.09 and 15 minutes intraservice time)). We are proposing the RUC-recommended work RVU of 1.80 with 20 minutes of intraservice time and 23 minutes of total time for 206X4.

The specialty society's survey for CPT code 206X5 (Removal of drug delivery device(s), intra-articular) found a 3.30 work RVU value at the median and a 2.15 work RVU value at the 25th percentile, with 25 minutes of intraservice time and 28 minutes of total physician time. The work includes the removal of the intra-articular drug delivery device that is cemented to both sides of the joint without removing too much bone in the process. The RUC recommended a work RVU of 2.15, with 25 minutes of intraservice time and 28 minutes of total physician time. The RUC's reference CPT codes included CPT code 11047 (Debridement, bone (includes epidermis, dermis, subcutaneous tissue, muscle and/or fascia, if performed); each additional 20 sq cm, or part thereof (work RVU = 1.80, and 30 minutes intraservice time)), CPT code 36476 (Endovenous ablation therapy of incompetent vein, extremity, inclusive of all imaging guidance and monitoring, percutaneous, radiofrequency; subsequent vein(s) treated in a single extremity, each through separate access sites (work RVU = 2.65 and 30 minutes intraservice time)), and CPT code 36227 (Selective catheter placement, external carotid artery, unilateral, with angiography of the ipsilateral external carotid circulation and all associated radiological supervision and interpretation (work RVU = 2.09 and 15 minutes intraservice time)). We are proposing the RUC-recommended work RVU of 2.15 with 25 minutes of intraservice time and 28 minutes of total time for 206X5.

(3) Bone Biopsy Trocar-Needle (CPT Codes 20220 and 20225)

In October 2017, CPT code 20225 (Biopsy, bone, trocar, or needle; deep (e.g., vertebral body, femur)) was identified as being performed by a different specialty than the one that originally surveyed this service. CPT code 20220 (Biopsy, bone, trocar, or needle; superficial (e.g., ilium, sternum, spinous process, ribs)) was added as part of the family, and both codes were surveyed and reviewed for the January 2019 RUC meeting.

We disagree with the RUC-recommended work RVU of 1.93 for CPT code 20220 and we are proposing a work RVU of 1.65 based on a crosswalk to CPT code 47000 (Biopsy of liver, needle; percutaneous). CPT code 47000 shares the same intraservice time of 20 minutes with CPT code 20220 and has slightly higher total time at 55 minutes as compared to 50 minutes. It Start Printed Page 40571is also one of the top reference codes selected by the survey respondents. In our review of CPT code 20220, we noted that the recommended intraservice time is decreasing from 22 minutes to 20 minutes (9 percent reduction), and that the recommended total time is increasing from 49 minutes to 50 minutes (2 percent increase). However, the RUC-recommended work RVU is increasing from 1.27 to 1.93, which is an increase of 52 percent. Although we do not imply that the decrease in time as reflected in survey values must equate to a one-to-one or linear decrease in the valuation of work RVUs, we believe that since the two components of work are time and intensity, changes in surveyed work time should be appropriately reflected in the proposed work RVUs.

In the case of CPT code 20220, we believe that it would be more accurate to propose a work RVU of 1.65, based on a crosswalk to CPT code 47000, to account for the decrease in the surveyed intraservice work time. We believe that the work carried out by the practitioner in CPT code 47000 is potentially more intense than the work performed in CPT code 20220, as the reviewed code is a superficial bone biopsy as opposed to the non-superficial biopsy taking place on an internal organ (the liver) described by CPT code 47000. We also note that the survey respondents considered CPT code 47000 to have similar intensity to CPT code 20220: 50 percent or more of the survey respondents rated the two codes as “identical” under the categories of Mental Effort and Judgment, Physical Effort Required, and Psychological Stress, along with a plurality of survey respondents rating the two codes as identical in the category of Technical Skill Required. We believe that this provides further support for our belief that CPT code 20220 should be crosswalked to CPT code 47000 at the same work RVU of 1.65.

We disagree with the RUC-recommended work RVU of 3.00 for CPT code 20225 and we are proposing a work RVU of 2.45 based on a crosswalk to CPT code 30906 (Control nasal hemorrhage, posterior, with posterior nasal packs and/or cautery, any method; subsequent). CPT code 30906 shares the same intraservice time of 30 minutes and has 1 fewer minute of total time as compared to CPT code 20225. When reviewing this code, we observed a pattern similar to what we had seen with CPT code 20220. We note that the recommended intraservice time for CPT code 20225 is decreasing from 60 minutes to 30 minutes (50 percent reduction), and the recommended total time is decreasing from 135 minutes to 64 minutes (53 percent reduction); however, the RUC-recommended work RVU is increasing from 1.87 to 3.00, which is an increase of about 60 percent. As we noted earlier, we do not believe that the decrease in time as reflected in survey values must equate to a one-to-one or linear decrease in the valuation of work RVUs, and we are not proposing a linear decrease in the work valuation based on these time ratios. Indeed, we agree with the RUC recommendation that the work RVU of CPT code 20225 should increase over the current valuation. However, we believe that since the two components of work are time and intensity, significant decreases in time should be appropriately reflected in changes to the work RVUs, and we do not believe that it would be accurate to propose the recommended work RVU of 3.00 given the significant decreases in surveyed work time.

Instead, we believe that it would be more accurate to propose a work RVU of 2.45 for CPT code 20225 based on a crosswalk to CPT code 30906. We note that this proposed work RVU is a very close match to the intraservice time ratio between the two codes in the family; we are proposing a work RVU of 1.65 for CPT code 20220 with 20 minutes of intraservice work time, and a work RVU of 2.45 for CPT code 20225 with 30 minutes of intraservice work time. (The exact intraservice time ratio calculates to a work RVU of 2.47.) We believe that the proposed work RVUs maintain the relative intensity of the two codes in the family, and better preserve relativity with the rest of the codes on the PFS.

For the direct PE inputs, we are proposing to replace the bone biopsy device (SF055) supply with the bone biopsy needle (SC077) in CPT code 20225. We note that this code currently makes use of the bone biopsy needle, and there was no rationale provided in the recommended materials to explain why it would now be typical for the bone biopsy needle to be replaced by the bone biopsy device. We are proposing to maintain the use of the current supply item. We are also proposing to adopt a 90 percent utilization rate for the use of the CT room (EL007) equipment in CPT code 20225. We previously finalized a policy in the CY 2010 PFS final rule (74 FR 61754 through 61755) to increase the equipment utilization rate to 90 percent for expensive diagnostic equipment priced at more than $1 million, and specifically cited the use of CT and MRI equipment which would be subject to this utilization rate.

(4) Trigger Point Dry Needling (CPT Codes 205X1 and 205X2)

For CY 2020, the CPT Editorial Panel approved two new codes to report dry needling of musculature trigger points. These codes were surveyed and reviewed by the HCPAC for the January 2019 RUC meeting.

We disagree with the HCPAC-recommended work RVU of 0.45 for CPT code 205X1 (Needle insertion(s) without injection(s), 1 or 2 muscle(s)) and we are proposing a work RVU of 0.32 based on a crosswalk to CPT code 36600 (Arterial puncture, withdrawal of blood for diagnosis). CPT code 36600 shares the identical intraservice time, total time, and intensity with CPT code 205X1, which makes it an appropriate choice for a crosswalk. In our review of CPT code 205X1, we compared the procedure to the top reference code chosen by the survey participants, CPT code 97140 (Manual therapy techniques (e.g., mobilization/manipulation, manual lymphatic drainage, manual traction), 1 or more regions, each 15 minutes). This therapy procedure has 50 percent more intraservice time than CPT code 205X1, as well as higher total time; however, the recommended work RVU of 0.45 was higher than the work RVU of 0.43 for the top reference code from the survey. We did not agree that CPT code 205X1 should be valued at a higher rate, and therefore, we are proposing a work RVU of 0.32 based on the aforementioned crosswalk to CPT code 36600.

We disagree with the HCPAC-recommended work RVU of 0.60 for CPT code 205X2 (Needle insertion(s) without injection(s), 3 or more muscle(s)) and we are proposing a work RVU of 0.48 based on a crosswalk to CPT codes 97113 (Therapeutic procedure, 1 or more areas, each 15 minutes; aquatic therapy with therapeutic exercises) and 97542 (Wheelchair management (e.g., assessment, fitting, training), each 15 minutes). Both of these codes share the same work RVU of 0.48 and the same intraservice time of 15 minutes as CPT code 205X2, with CPT code 97113 having two fewer minutes of total time and CPT code 97542 having two additional minutes of total time. We note that this proposed work RVU is an exact match of the intraservice time ratio between the two codes in the family; we are proposing a work RVU of 0.32 for CPT code 205X1 with 10 minutes of intraservice work time, and a work RVU of 0.48 for CPT code 205X2 with 15 minutes of intraservice work time. We also considered crosswalking the work RVU of CPT code 205X2 to the Start Printed Page 40572top reference code from the survey, CPT code 97140, at a work RVU of 0.43. However, we chose to employ the crosswalk to CPT codes 97113 and 97542 at a work RVU of 0.48 instead, due to the fact that the survey respondents indicated that CPT code 205X2 was more intense than CPT code 97140.

We are also proposing to designate CPT codes 205X1 and 205X2 as “always therapy” procedures, and we are soliciting comments on this designation. We are proposing the RUC-recommended direct PE inputs for all codes in the family.

(5) Closed Treatment Vertebral Fracture (CPT Code 22310)

This service was identified through a screen of services with a negative IWPUT and Medicare utilization over 10,000 for all services or over 1,000 for Harvard valued and CMS/Other source codes.

For CPT code 22310 (Closed treatment of vertebral body fracture(s), without manipulation, requiring and including casting or bracing), we disagree with the recommended work RVU of 3.75 because we do not believe that this reduction in work RVU from the current value of 3.89 is commensurate with the RUC-recommended a 33-minute reduction in intraservice time and a 105-minute reduction in total time. While we understand that the RUC considers the current Harvard study time values for this service to be invalid estimations, we believe that a further reduction in work RVUs is warranted given the significance of the RUC-recommended reduction in physician time. We believe that it would be more accurate to propose a work RVU of 3.45 with a crosswalk to CPT code 21073 (Manipulation of temporomandibular joint(s) (TMJ), therapeutic, requiring an anesthesia service (i.e., general or monitored anesthesia care)), which has an identical intraservice time and similar total time as those proposed by the RUC for CPT code 22310, as we believe that this better accounts for the decrease in the surveyed work time.

For the direct PE inputs, we are proposing to refine the equipment time for the power table (EF031) to conform to our established standard for non-highly technical equipment.

(6) Tendon Sheath Procedures (CPT Codes 26020, 26055, and 26160)

The RUC identified these services through a screen of services with a negative IWPUT and Medicare utilization over 10,000 for all services or over 1,000 for Harvard valued and CMS/Other source codes. For CPT code 26020 (Drainage of tendon sheath, digit and/or palm, each), we do not agree with the RUC-recommended work RVU of 7.79 based on the survey median. While we agree that the survey data validate an increase in work RVU, we see no compelling reason that this service would be significantly more intense to furnish than services of similar time values. Therefore, we are proposing a work RVU of 6.84 which is the survey 25th percentile. As further support for this value, we note that it falls between the work RVUs of CPT code 28122 (Partial excision (craterization, saucerization, sequestrectomy, or diaphysectomy) bone (e.g., osteomyelitis or bossing); tarsal or metatarsal bone, except talus or calcaneus), with a work RVU of 6.76, and CPT code 28289 (Hallux rigidus correction with cheilectomy, debridement and capsular release of the first metatarsophalangeal joint; without implant), with a work RVU of 6.90; both codes have intraservice time values that are identical to, and total time values that are similar to, the RUC-recommended time values for CPT code 26020.

For CPT code 26055 (Tendon sheath incision (e.g., for trigger finger)), we do not agree with the RUC recommendation to increase the work RVU to 3.75 despite a reduction in physician time. Instead, we are proposing to maintain the current work RVU of 3.11; we are supporting this based on a total time increment methodology between the CPT code 26020 and CPT code 26055. The total time ratio between the recommended time of 119 minutes and the recommended 262 minutes for code 26020 equals 45 percent, and 45 percent of our proposed RVU of 6.84 for CPT code 26020 equals a work RVU of 3.10, which we believe validates the current work RVU of 3.11. We are proposing the RUC-recommended work RVU of 3.57 for CPT code 26160 (Excision of lesion of tendon sheath or joint capsule (e.g., cyst, mucous cyst, or ganglion), hand or finger). We note that our proposed work RVUs validate the RUC's contention that CPT code 26160 is slightly more intense to perform than CPT code 26055.

For the direct PE inputs, we are proposing to refine the quantity of the impervious staff gown (SB027) supply from 2 to 1 for CPT codes 26055 and 26160. We believe that the second impervious staff gown supply is duplicative due to the inclusion of this same supply in the surgical cleaning pack (SA043). The recommended materials state that a gown is worn by the practitioner and one assistant, which are provided by one standalone gown and a second gown in the surgical cleaning pack.

(7) Closed Treatment Fracture—Hip (CPT Code 27220)

This service was identified through a screen of services with a negative IWPUT and Medicare utilization over 10,000 for all services or over 1,000 for Harvard valued and CMS/Other source codes. For CPT code 27220 (Closed treatment of acetabulum (hip socket) fracture(s); without manipulation), we disagree with the RUC-recommended work RVU of 6.00 based on the survey median value, because we do not believe that this reduction in work RVU from the current value of 6.83 is commensurate with the RUC-recommended a 19-minute reduction in intraservice time and an 80-minute reduction in total time. While we understand that the RUC considers the current Harvard study time values for this service to be invalid estimations, we believe that a further reduction in work RVUs is warranted given the significance of the RUC-recommended reduction in physician time. We believe that it would be more accurate to propose the survey 25th percentile work RVU of 5.50, and we are supporting this value with a crosswalk to CPT code 27267 (Closed treatment of femoral fracture, proximal end, head; without manipulation) to account for the decrease in the surveyed work time.

For the direct PE inputs, we are proposing to refine the equipment time for the power table (EF031) to conform to our established standard for non-highly technical equipment.

(8) Arthrodesis—Sacroliliac Joint (CPT Code 27279)

In the CY 2018 PFS final rule (82 FR 53017), CPT code 27279 (Arthrodesis, sacroiliac joint, percutaneous or minimally invasive (indirect visualization), with image guidance, includes obtaining bone graft when performed, and placement of transfixing device) was nominated for review by stakeholders as a potentially misvalued service. We stated that CPT code 27279 is potentially misvalued, and that a comprehensive review of the code values was warranted. This code was subsequently reviewed by the RUC. According to the specialty societies, the previous 2014 survey of CPT code 27279, was based on flawed methodology that resulted in an underestimation of intraoperative intensity. When CPT code 27279 was surveyed in 2014, there was a low rate of response. Due to the dearth of survey data and the RUC's agreement with the specialty society at the time that the Start Printed Page 40573survey respondents had somewhat overvalued the work involved in performing this service, the RUC used a crosswalk to CPT code 62287 (Decompression procedure, percutaneous, of nucleus pulposus of intervertebral disc, any method utilizing needle based technique to remove disc material under fluoroscopic imaging or other form of indirect visualization, with discography and/or epidural injection(s) at the treated level(s), when performed, single or multiple levels, lumbar) to recommend a work RVU of 9.03. The specialty societies indicated that with increased and broader utilization of this technique, the 2018 survey is a more robust assessment of physician work and intensity and provides more data with which to make a crosswalk recommendation. According to the RUC, there is no compelling evidence that the physician work, intensity or complexity has changed for this service.

We are proposing to maintain the current work RVU of 9.03 as recommended by the RUC. A stakeholder stated that maintaining this RVU would constitute the continued undervaluation of this service, and that this would incentivize use of a more intensive and invasive procedure, CPT code 27280 (Arthrodesis, open, sacroiliac joint, including obtaining bone graft, including instrumentation, when performed), as well as incentivize this service to be inappropriately furnished on an inpatient basis. This stakeholder has requested that, in the interest of protecting patient access, we implement payment parity between the two services by proposing to crosswalk the work RVU of CPT code 27279 to that of CPT code 27280, which has a work RVU of 20.00. While we are proposing the RUC-recommended work RVU, we are soliciting public comment on whether an alternative valuation of 20.00 would be more appropriate. This alternative valuation would recognize relative parity between these two services in terms of the work inherent in furnishing them.

We are proposing the RUC-recommended direct PE inputs for CPT code 27279.

(9) Pericardiocentesis and Pericardial Drainage (CPT Code 3X000, 3X001, 3X002, and 3X003)

CPT code 33015 (Tube pericardiostomy) was identified as potentially misvalued on a Relativity Assessment Workgroup (RAW) screen of codes with a negative IWPUT and Medicare utilization over 10,000 for all services or over 1,000 for Harvard valued and CMS or other source codes. In September 2018, the CPT Editorial Panel deleted four existing codes and created four new codes to describe periodcardiocentesis drainage procedures to differentiate by age and to include imaging guidance.

We are proposing to refine the work RVU for all four codes in the family. We disagree with the RUC-recommended work RVU of 5.00 for CPT code 3X000 (Pericardiocentesis, including imaging guidance, when performed) and are proposing a work RVU of 4.40 based on a crosswalk to CPT code 43244 (Esophagogastroduodenoscopy, flexible, transoral; with band ligation of esophageal/gastric varices). CPT code 43244 shares the same intraservice time of 30 minutes with CPT code 3X000 and has a slightly longer total time of 81 minutes as compared to 75 minutes for the reviewed code. In our review of CPT code 3X000, we noted that the recommended intraservice time as compared to the current initial pericardiocentesis procedure (CPT code 33010) is increasing from 24 minutes to 30 minutes (25 percent), and the recommended total time is remaining the same at 75 minutes; however, the RUC-recommended work RVU is increasing from 1.99 to 5.00, which is an increase of 151 percent. Although we did not imply that the decrease in time as reflected in survey values must equate to a one-to-one or linear increase in the valuation of work RVUs, we believe that since the two components of work are time and intensity, modest increases in time should be appropriately reflected with a commensurate increase the work RVUs. We also conducted a search in the RUC database among 0-day global codes with 30 minutes of intraservice time and comparable total time of 65-85 minutes. Our search identified 49 codes and all 49 of these codes had a work RVU lower than 5.00. We do not believe that it would serve the interests of relativity to establish a new maximum work RVU for this range of time values.

As a result, we believe that it is more accurate to propose a work RVU of 4.40 for CPT code 3X000 based on a crosswalk to CPT code 43244 to account for these modest increases in the surveyed work time as compared to the predecessor pericardiocentesis codes. We are aware that CPT code 3X000 is bundling imaging guidance into the new procedure, which was not included in the previous pericardiocentesis codes. However, we do not believe that the recoding of the services in this family has resulted in an increase in their intensity, only a change in the way in which they will be reported, and therefore, we do not believe that it would serve the interests of relativity to propose the RUC-recommended work values for all of the codes in this family. We also note that, through the bundling of some of these frequently reported services, it is reasonable to expect that the new coding system will achieve savings via elimination of duplicative assumptions of the resources involved in furnishing particular servicers. For example, a practitioner would not be carrying out the full preservice work twice for CPT codes 33010 and 76930, but preservice times were assigned to both codes under the old coding. We believe the new coding assigns more accurate work times, and thus, reflects efficiencies in resource costs that existed but were not reflected in the services as they were previously reported. If the addition of imaging guidance had made the new CPT codes significantly more intense to perform, we believe that this would have been reflected in the surveyed work times, which were largely unchanged from the predecessor codes.

We disagree with the RUC-recommended work RVU of 5.50 for CPT code 3X001 (Pericardial drainage with insertion of indwelling catheter, percutaneous, including fluoroscopy and/or ultrasound guidance, when performed; 6 years and older without congenital cardiac anomaly) and are proposing a work RVU of 4.62 based on a crosswalk to CPT code 52234 (Cystourethroscopy, with fulguration (including cryosurgery or laser surgery) and/or resection of; SMALL bladder tumor(s) (0.5 up to 2.0 cm)). CPT code 52234 shares the same intraservice time of 30 minutes with CPT code 3X001 and has 2 additional minutes of total time at 79 minutes as compared to 77 minutes for the reviewed code. In our review of CPT code 3X001, we noted many of the same issues that we had raised with CPT code 3X000, in particular with the increase in the work RVU greatly exceeding the increase in the surveyed work times as compared to the predecessor pericardiocentesis codes. We searched the RUC database again for 0-day global codes with 30 minutes of intraservice time and comparable total time of 67-87 minutes. Our search identified 43 codes and again all 43 of these codes had a work RVU lower than 5.50. As we stated with regard to CPT code 3X000, we do not believe that it would serve the interests of relativity to establish a new maximum work RVU for this range of time values. We believe that it is more accurate to propose a work RVU of 4.62 for CPT code 3X001 based on a crosswalk to CPT code 52234 based on the same rationale that we Start Printed Page 40574detailed with regards to CPT code 3X000.

We disagree with the RUC-recommended work RVU of 6.00 for CPT code 3X002 (Pericardial drainage with insertion of indwelling catheter, percutaneous, including fluoroscopy and/or ultrasound guidance, when performed; birth through 5 years of age, or any age with congenital cardiac anomaly) and are proposing a work RVU of 5.00 based on the survey 25th percentile value. In our review of CPT code 3X002, we noted many of the same issues that we had raised with CPT codes 3X000 and 3X001, in particular with the increase in the work RVU greatly exceeding the increase in the surveyed work times as compared to the predecessor pericardiocentesis codes. The recommended work RVU of 6.00 was based on a crosswalk to CPT code 31603 (Tracheostomy, emergency procedure; transtracheal), which shares the same intraservice time of 30 minutes with CPT code 3X002 and very similar total time. While we agree that CPT code 31603 is a close match to the surveyed work times for CPT code 3X002, we do not believe that it is the most accurate choice for a crosswalk due to the fact that CPT code 31603 is a clear outlier in work valuation. We searched for 0-day global codes in the RUC database with 30 minutes of intraservice time and a comparable 90-120 minutes of total time. There were 21 codes that met this criteria, and the recommended crosswalk to CPT code 31603 had the highest work RVU of any of these codes at the recommended 6.00. Furthermore, there was only one other code with a work RVU above 5.00, another tracheostomy procedure described by CPT code 31600 (Tracheostomy, planned (separate procedure)) at a work RVU of 5.56. None of the other codes had a work RVU higher than 4.69, and the median work RVU of the group comes out to only 4.00. The two tracheostomy procedures have work RVUs more than a full standard deviation above any of the other codes in this group of 0-day global procedures.

We do not mean to suggest that the work RVU for a given service must always fall in the middle of a range of codes with similar time values. We recognize that it would not be appropriate to develop work RVUs solely based on time given that intensity is also an element of work. Were we to disregard intensity altogether, the work RVUs for all services would be developed based solely on time values and that is definitively not the case, as indicated by the many services that share the same time values but have different work RVUs. However, we also do not believe that it would serve the interests of relativity by crosswalking the work RVU of CPT code 3X002 to tracheostomy procedures that are higher than anything else in this group of codes, procedures that we believe to be outliers due to the serious risk of patient mortality associated with their performance. We believe that it is this patient risk which is responsible for the otherwise anomalously high intensity in CPT codes 31600 and 31603. Therefore, we are proposing a work RVU of 5.00 for CPT code 3X002 based on the survey 25th percentile, which we believe more accurately captures both the time and intensity associated with the procedure.

We disagree with the RUC-recommended work RVU of 5.00 for CPT code 3X003 (Pericardial drainage with insertion of indwelling catheter, percutaneous, including CT guidance) and are proposing a work RVU of 4.29 based on the survey 25th percentile value. In our review of CPT code 3X003, we noted many of the same issues that we had raised with CPT codes 3X000-3X002, in particular with the increase in the work RVU greatly exceeding the increase in the surveyed work times as compared to the predecessor pericardiocentesis codes. We searched for 0-day global codes in the RUC database with 30 minutes of intraservice time (slightly higher than the 28 minutes of intraservice time in CPT code 3X003) and a comparable 70-100 minutes of total time. Our search identified 45 codes and again all 45 of these codes had a work RVU lower than 5.00, which led us to believe that the recommended work RVU for CPT code 3X003 was overvalued. We also compared CPT code 3X003 to the most similar code in the family, CPT code 3X001, and noted that the survey respondents indicated that CPT code 3X003 should have a lower work RVU at both the survey 25th percentile and survey median values. Therefore, we are proposing a work RVU of 4.29 for CPT code 3X003 based on the survey 25th percentile value. We are supporting this proposal with a reference to CPT code 31254 (Nasal/sinus endoscopy, surgical with ethmoidectomy; partial (anterior)), a recently-reviewed code with an intraservice work time of 30 minutes, a total time of 84 minutes, and a work RVU of 4.27.

The RUC did not recommend and we are not proposing any direct PE inputs for the codes in this family.

(10) Pericardiotomy (CPT Codes 33020 and 33025)

CPT code 33020 (Pericardiotomy for removal of clot or foreign body (primary procedure)) was identified as potentially misvalued on a Relativity Assessment Workgroup (RAW) screen of codes with a negative IWPUT and Medicare utilization over 10,000 for all services or over 1,000 for Harvard valued and CMS or other source codes. The RAW determined that CPT code 33020 should be surveyed for April 2018; CPT code 33025 (Creation of pericardial window or partial resection for drainage) was included for review as part of this code family.

We disagree with the RUC-recommended work RVU of 14.31 (25th percentile survey value) for CPT code 33020 and are proposing a work RVU of 12.95. Our proposed work RVU is based on a crosswalk to CPT code 58700 (Salpingectomy, complete or partial, unilateral or bilateral (separate procedure)), which has an identical work RVU of 12.95, identical 60 minutes intraservice time, and near identical total time values as CPT code 33020.

In our review of CPT code 33020, we note that the RUC-recommended intraservice time is decreasing from 85 minutes to 60 minutes (29 percent reduction), and that the RUC- recommended total time is decreasing from 565 minutes to 321 minutes (43 percent reduction). However, the RUC-recommended work RVU is only decreasing from 14.95 to 14.31, which is a reduction of less than 5 percent. Although we do not imply that the decrease in time as reflected in survey values must equate to a one-to-one or linear decrease in the valuation of work RVUs, we believe that since the two components of work are time and intensity, significant decreases in time should be appropriately reflected in decreases to work RVUs. In the case of CPT code 33020, we believe that it would be more accurate to propose a work RVU of 12.95, based on a crosswalk to CPT code 58700 to account for these decreases in surveyed work times.

For CPT code 33025, the RUC recommended a work RVU of 13.20 (survey 25th percentile value). Although we disagree with the RUC-recommended work RVU of 13.20, based on RUC survey results and the time resources involved in furnishing these two procedures we agree that the relative difference in work RVUs between CPT codes 33020 and 33025 is equivalent to the RUC-recommended incremental difference of 1.11 less work RVUs. Therefore, we are proposing a work RVU of 11.84 based on a reference to CPT code 34712 (Transcatheter delivery of enhanced fixation devices(s) to the endograft (e.g., anchor, screw, Start Printed Page 40575tack) and all associated radiological supervision and interpretation), which has a work RVU of 12.00, identical intraservice time of 60 minutes, and similar total time as CPT code 33025.

In reviewing CPT code 33025, we note that the RUC-recommended intraservice time is decreasing from 66 minutes to 60 minutes (9 percent reduction), and that the RUC-recommended total time is decreasing from 410 minutes to 301 minutes (27 percent reduction). However, the RUC-recommended work RVU is only decreasing from 13.70 to 13.20, which is a reduction of less than 5 percent. Although we do not imply that the decrease in time as reflected in survey values must equate to a one-to-one or linear decrease in the valuation of work RVUs, we believe that since the two components of work are time and intensity, significant decreases in time should be appropriately reflected in decreases to work RVUs. In the case of CPT code 33025, we believe that it would be more accurate to propose a work RVU of 11.84, based on less the incremental difference of 1.11 work RVUs between CPT codes 33020 and 33025 and a crosswalk to CPT code 34712 to account for these decreases in surveyed work times.

We are proposing the RUC-recommended direct PE inputs for all the codes in this family.

(11) Transcatheter Aortic Valve Replacement (TAVR) (CPT Codes 33361, 33362, 33363, 33364, 33365, and 33366)

In October 2016, the RUC's RAW reviewed codes that had been flagged in the period from October 2011 to April 2012, using 3 years of available Medicare claims data (2013, 2014 and preliminary 2015 data). The RUC workgroup determined that the technology for these transcatheter aortic valve replacement (TAVR) services was evolving, as the typical site of service had shifted from being provided in academic centers to private centers, and the RUC recommended that CPT codes 33361-33366 be resurveyed for physician work and practice expense. These six codes were surveyed and reviewed at the April 2018 RUC meeting using a survey methodology that reflected the unique nature of these codes. CPT codes 33361-33366 are currently the only codes on the PFS where the -62 co-surgeon modifier is required 100 percent of the time.

We are proposing the RUC-recommended work RVU for all six of the codes in this family. We are proposing a work RVU of 22.47 for CPT code 33361 (Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; percutaneous femoral artery approach), a work RVU of 24.54 for CPT code 33362 (Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; open femoral artery approach), a work RVU of 25.47 for CPT code 33363 (Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; open axillary artery approach), a work RVU of 25.97 for CPT code 33364 (Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; open iliac artery approach), a work RVU of 26.59 for CPT code 33365 (Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; transaortic approach (e.g., median sternotomy, mediastinotomy)), and a work RVU of 29.35 for CPT code 33366 (Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; transapical exposure (e.g., left thoracotomy)).

Although we have some concerns that the RUC-recommended work RVUs for these six codes do not match the decreases in surveyed work time, we recognize that the technology described by the TAVR procedures is in the process of being adopted by a much wider audience, and that there will be greater intensity on the part of the practitioner when this particular new technology is first being adopted. However, we intend to continue examining whether these services are appropriately valued, in light of the proposed national coverage determination proposing to use TAVR for the treatment of symptomatic aortic valve stenosis that we posted on March 26, 2019. We will also consider any further improvements to the valuation of these services, as their use becomes more commonplace, through future notice and comment rulemaking. The text of the proposed national coverage determination is available on the CMS website at https://www.cms.gov/​medicare-coverage-database/​details/​nca-proposed-decision-memo.aspx?​NCAId=​293.

We are proposing the RUC-recommended direct PE inputs for all codes in the family.

(12) Aortic Graft Procedures (CPT Codes 338XX, 338X1, 33863, 33864, 338X2, and 33866)

In 2017, CPT created a new add-on code, CPT code 33866 (Aortic hemiarch graft including isolation and control of the arch vessels, beveled open distal aortic anastomosis extending under one or more of the arch vessels, and total circulatory arrest or isolated cerebral perfusion (List separately in addition to code for primary procedure)). For CY 2019, we finalized the RUC's recommended work RVU for this code on an interim basis (83 FR 59528). CPT revised the code set to develop distinct codes for ascending aortic repair for dissection and ascending aortic repair for other ascending aortic disease such as aneurysms and congenital anomalies, creating two new codes, as well as revaluating the two other codes in the family.

For CPT code 338XX (Ascending aorta graft, with cardiopulmonary bypass, includes valve suspension, when performed; for aortic dissection), we disagree with the RUC-recommended work RVU of 65.00, because the RUC is recommending an increase in work RVU that is not commensurate with a reduction in physician time, and because we do not believe that the RUC's recommendation that this service be increased to a value that would place it among the highest valued of all services of similar physician time is appropriate; we think a comparison to other services of similar time indicates that the RUC's recommended increase overstates the work. Instead, we are proposing to increase the work RVU to 63.40 based on a crosswalk to CPT code 61697 (Surgery of complex intracranial aneurysm, intracranial approach; carotid circulation). For CPT code 338X1 (Ascending aorta graft, with cardiopulmonary bypass, includes valve suspension, when performed; for aortic disease other than dissection (e.g., aneurysm)), we disagree with the RUC-recommended work RVU of 50.00, because we do not believe it adequately reflects the recommended decrease in physician time, and because we do not believe this service should be assigned a value that is among the highest of all 90-day global services with similar physician time values. Instead, we are proposing a work RVU of 45.13 based on a crosswalk to CPT code 33468 (Tricuspid valve repositioning and plication for Ebstein anomaly), which is a code with an identical intraservice time and similar total time value.

For CPT code 33863 (Ascending aorta graft, with cardiopulmonary bypass, with aortic root replacement using valved conduit and coronary reconstruction (e.g., Bentall)), according to the RUC, the survey respondents underestimated the intraservice time of the procedure and the RUC recommended a work RVU of 59.00 based on the 75th percentile of survey responses for intraservice time. We believe the use of the survey 75th percentile value to be problematic, as the intraservice time values should generally reflect the survey median. We are requesting that this code be Start Printed Page 40576resurveyed to determine more accurate physician time values, and we are proposing to maintain the current RVU of 58.79 for CY 2020. For CPT code 33864 (Ascending aorta graft, with cardiopulmonary bypass with valve suspension, with coronary reconstruction and valve-sparing aortic root remodeling (e.g., David Procedure, Yacoub procedure)), we do not agree with the RUC-recommended work RVU of 63.00, because we believe this increase is not justified given that the intraservice time is not changing from its current value, and the physician total time value is decreasing. Therefore, we are proposing to maintain the current work RVU of 60.08 for this service.

For CPT code 338X2 (Transverse aortic arch graft, with cardiopulmonary bypass, with profound hypothermia, total circulatory arrest and isolated cerebral perfusion with reimplantation of arch vessel(s) (e.g., island pedicle or individual arch vessel reimplantation)), we disagree with the RUC's recommended work RVU of 65.75. While we agree that an increase in work RVU is justified, as discussed above, we believe that the use of the 75th percentile of physician intraservice work time is problematic, and believe such a significant increase in work RVU is not validated. Therefore, we are proposing a less significant increase to 60.88 using the RUC-recommended difference in work value between CPT code 338X1 and the code in question, CPT code 338X2 (a difference of 15.75). As further support for this value, we note that it falls between CPT codes 33782 (Aortic root translocation with ventricular septal defect and pulmonary stenosis repair (i.e., Nikaidoh procedure); without coronary ostium reimplantation), which has a work RVU of 60.08, and CPT code 43112 (Total or near total esophagectomy, with thoracotomy; with pharyngogastrostomy or cervical esophagogastrostomy, with or without pyloroplasty (i.e., McKeown esophagectomy or tri-incisional esophagectomy)), which has a work RVU of 62.00. Both of these bracketing reference codes have similar intraservice and total time values. For CPT code 33X01 (Aortic hemiarch graft including isolation and control of the arch vessels, beveled open distal aortic anastomosis extending under one or more of the arch vessels, and total circulatory arrest or isolated cerebral perfusion (List separately in addition to code for primary procedure)), we are proposing the RUC-recommended work RVU of 17.75.

For the direct PE inputs, we are proposing to refine the clinical labor to align with the number of post-operative visits. Thus, we are proposing to add 12 minutes of clinical labor time for “Discharge day management” for CPT codes 338X1, 33863, 33864, and 338X2, as each of these codes include a 99238 discharge visit within their global periods that should be reflected in the clinical labor inputs.

(13) Iliac Branched Endograft Placement (CPT Codes 34X00 and 34X01)

For CY 2018, the CPT Editorial Panel created a family of 20 new and revised codes that redefined coding for endovascular repair of the aorta and iliac arteries. The iliac branched endograft technology has become more mainstream over time, and two new CPT codes were created to capture the work of iliac artery endovascular repair with an iliac branched endograft. These two new codes were surveyed and reviewed for the January 2019 RUC meeting.

We are proposing the RUC-recommended work RVU of 9.00 for CPT code 34X00 (Endovascular repair of iliac artery at the time of aorto-iliac artery endograft placement by deployment of an iliac branched endograft including pre-procedure sizing and device selection, all ipsilateral selective iliac artery catheterization(s), all associated radiological supervision and interpretation, and all endograft extension(s) proximally to the aortic bifurcation and distally in the internal iliac, external iliac, and common femoral artery(ies), and treatment zone angioplasty/stenting, when performed, for rupture or other than rupture (e.g., for aneurysm, pseudoaneurysm, dissection, arteriovenous malformation, penetrating ulcer, traumatic disruption), unilateral) and the RUC-recommended work RVU of 24.00 for CPT code 34X01 (Endovascular repair of iliac artery, not associated with placement of an aorto-iliac artery endograft at the same session, by deployment of an iliac branched endograft, including pre-procedure sizing and device selection, all ipsilateral selective iliac artery catheterization(s), all associated radiological supervision and interpretation, and all endograft extension(s) proximally to the aortic bifurcation and distally in the internal iliac, external iliac, and common femoral artery(ies), and treatment zone angioplasty/stenting, when performed, for other than rupture (e.g., for aneurysm, pseudoaneurysm, dissection, arteriovenous malformation, penetrating ulcer), unilateral).

We are proposing the RUC-recommended direct PE inputs for all codes in the family.

(14) Exploration of Artery (CPT Codes 35701, 35X01, and 35X01)

CPT code 35701 (Exploration not followed by surgical repair, artery; neck (e.g., carotid, subclavian)) was identified via a screen for services with a ne.g.ative IWPUT and Medicare utilization over 10,000 for all services or over 1,000 for Harvard valued and CMS/Other source codes. In September 2018, the CPT Editorial Panel revised one code, added two new codes, and deleted three existing codes in the family to report major artery exploration procedures and to condense the code set due to low frequency.

We are proposing the RUC-recommended work RVU for all three codes in the family. We are proposing a work RVU of 7.50 for CPT code 35701, a work RVU of 7.12 for CPT code 35X00 (Exploration not followed by surgical repair, artery; upper extremity (e.g., axillary, brachial, radial, ulnar)), and a work RVU of 7.50 for CPT code 35X01 (Exploration not followed by surgical repair, artery; lower extremity (e.g., common femoral, deep femoral, superficial femoral, popliteal, tibial, peroneal)).

For the direct PE inputs, we are proposing to refine the clinical labor, supplies, and equipment to match the number of office visits contained in the global periods of the codes under review. We are proposing to refine the clinical labor time for the “Post-operative visits (total time)” (CA039) activity from 36 minutes to 27 minutes for CPT codes 35701 and 35X00, and from 63 minutes to 27 minutes for CPT code 35X01. Each of these CPT codes contains a single postoperative level 2 office visit (CPT code 99212) in its global period, and 27 minutes of clinical labor is the time associated with this office visit. We are proposing to refine the equipment time for the exam table (EF023) to the same time of 27 minutes for each code to match the clinical labor time. Finally, we are also proposing to refine the quantity of the minimum multi-specialty visit pack (SA048) from 2 to 1 for CPT code 35X01 to match the single postoperative visit in the code's global period. We believe that the additional direct PE inputs in the recommended materials were an accidental oversight due to revisions that took place at the RUC meeting following the approval of the PE inputs for these codes.

(15) Intravascular Ultrasound (CPT Codes 37252 and 37253)

In CY 2014, the CPT Editorial Panel deleted CPT codes 37250 (Ultrasound evaluation of blood vessel during Start Printed Page 40577diagnosis or treatment )and 37251 (Ultrasound evaluation of blood vessel during diagnosis or treatment) and created new bundled codes 37252 (Intravascular ultrasound (noncoronary vessel) during diagnostic evaluation and/or therapeutic intervention, including radiological supervision and interpretation; initial noncoronary vessel) and 37253 (Intravascular ultrasound (noncoronary vessel) during diagnostic evaluation and/or therapeutic intervention, including radiological supervision and interpretation; each additional noncoronary vessel) to describe intravascular ultrasound (IVUS). CPT codes 37252 and 37253 were reviewed at the January 2015 RUC meeting. The RUC's recommendation for these codes were to result in an overall work savings that should have been redistributed back to the Medicare conversion factor. The codes have had a 44 percent increase in work RVUs over the old codes, CPT codes 37250 and 37251, from 2015 to 2016 and the utilization has doubled from that of the previous coding structure, not considering the radiological activities. In April 2018, the RUC reviewed this code family and determined the utilization of the bundling of these services was underestimated. Consequently, the RUC recommended that these services be surveyed for October 2018. The RUC indicated that the specialty societies should research why there was such an increase in the utilization. Accordingly, the specialty society surveyed these ZZZ-day global codes, and the survey results indicated the intraservice and total work times, along with the work RVU should remain the same despite the underestimation in utilization.

We disagreed with the RUC-recommended work RVU of 1.80 for CPT code 37252 and are proposing a work RVU of 1.55 based on a crosswalk to CPT code 19084. CPT code 19084 is a recently reviewed code with 20 minutes of intraservice time and 25 minutes of total time. In reviewing CPT code 37252, we note, as mentioned above, that in CY 2015 the specialty society stated that bundling this service would achieve savings. However, since 2015 observed utilization for CPT code 37252 has greatly exceeded proposed estimates, thus we are proposing to restore work neutrality to the intravascular ultrasound code family to achieve the initial estimated savings.

For CPT code 37253, we disagreed with the RUC-recommended work RVU of 1.44 and we are proposing a work RVU of 1.19. Although we disagreed with the RUC-recommended work RVU, we note the relative difference in work between CPT codes 37252 and 37253 is an interval of 0.36 RVUs. Therefore, we are proposing a work RVU of 1.19 for CPT code 37253, based on the recommended interval of 0.36 fewer RVUs than our proposed work RVU of 1.55 for CPT code 37252.

We are proposing the RUC-recommended direct PE inputs for all codes in the family.

(16) Stab Phlebectomy of Varicose Veins (CPT Codes 37765 and 37766)

These services were identified in February 2008 via the High Volume Growth screen, for services with a total Medicare utilization of 1,000 or more that have increased by at least 100 percent from 2004 through 2006. The RUC subsequently recommended monitoring and reviewing changes in utilization over multiple years. In October 2017, the RUC recommended that this service be surveyed for April 2018. We are proposing the RUC-recommended work RVUs of 4.80 for CPT code 37765 (Stab phlebectomy of varicose veins, 1 extremity; 10-20 stab incisions) and 6.00 for CPT code 37766 (Stab phlebectomy of varicose veins, 1 extremity; more than 20 incisions). We are proposing the RUC-recommended direct PE inputs for all codes in the family.

(17) Biopsy of Mouth Lesion (CPT Code 40808)

CPT code 40808 (Biopsy, vestibule of mouth) was identified via a screen for services with a negative IWPUT and Medicare utilization over 10,000 for all services or over 1,000 for Harvard valued and CMS/Other source codes.

We disagree with the RUC's recommended work RVU of 1.05 with a crosswalk to CPT code 11440 (Excision, other benign lesion including margins, except skin tag (unless listed elsewhere), face, ears, eyelids, nose, lips, mucous membrane; excised diameter 0.5 cm or less), as we believe this increase in work RVU is not commensurate with the RUC-recommended 5-minute reduction in intraservice time and a 10-minute reduction in total time. While we understand that the RUC considers the current time values for this service to be invalid estimations, we do not see compelling evidence that would indicate that an increase in work RVU that would be concurrent with a reduction in physician time is appropriate. Therefore, we are proposing to maintain the current work RVU of 1.01, and note that implementing the current work RVU with the RUC-recommended revised physician time values would correct the negative IWPUT anomaly.

For the direct PE inputs, we are proposing to refine the clinical labor time for the “Prepare room, equipment and supplies” (CA013) activity to 3 minutes and to refine the clinical labor time for the “Confirm order, protocol exam” (CA014) activity to 0 minutes. As we detailed when discussing this issue in the CY 2019 PFS final rule (83 FR 59463 through 59464), CPT code 40808 does not include the old clinical labor task “Patient clinical information and questionnaire reviewed by technologist, order from physician confirmed and exam protocoled by radiologist” on a prior version of the PE worksheet, nor does the code contain any clinical labor for the CA007 activity (“Review patient clinical extant information and questionnaire”). CPT code 40808 does not appear to be an instance where an old clinical labor task was split into two new clinical labor activities, and we continue to believe that in these cases the 3 total minutes of clinical staff time would be more accurately described by the CA013 “Prepare room, equipment and supplies” activity code. We also note that there is no effect on the total clinical labor direct costs in these situations, since the same 3 minutes of clinical labor time is still being furnished.

We are also proposing to refine the equipment time for the electrocautery-hyfrecator (EQ110) to conform to our established standard for non-highly technical equipment.

(18) Transanal Hemorrhoidal Dearterialization (CPT Codes 46945, 46946, and 46X48)

We are proposing the RUC-recommended work RVU for all three codes in the family. We are proposing a work RVU of 3.69 for CPT code 46945 (Hemorrhoidectomy, internal, by ligation other than rubber band; single hemorrhoid column/group, without imaging guidance), a work RVU of 4.50 for CPT code 46946 (2 or more hemorrhoid columns/groups, without imaging guidance), and a work RVU of 5.57 for CPT code 46X48 (Hemorrhoidectomy, internal, by transanal hemorrhoidal dearterialization, 2 or more hemorrhoid columns/groups, including ultrasound guidance, with mucopexy when performed).

We are proposing the RUC-recommended direct PE inputs for all codes in the family.

(19) Preperitoneal Pelvic Packing (CPT Codes 490X1 and 490X2)

In May 2018, the CPT Editorial Panel approved the addition of two codes for preperitoneal pelvic packing, removal Start Printed Page 40578and/or repacking for hemorrhage associated with pelvic trauma. These new codes were surveyed and reviewed for the October 2018 RUC meeting.

We disagree with the RUC-recommended work RVU of 8.35 for CPT code 490X1 (Preperitoneal pelvic packing for hemorrhage associated with pelvic trauma, including local exploration) and are proposing a work RVU of 7.55 based on a crosswalk to CPT code 52345 (Cystourethroscopy with ureteroscopy; with treatment of ureteropelvic junction stricture (e.g., balloon dilation, laser, electrocautery, and incision)). We are also proposing to reduce the immediate postservice work time from 60 minutes to 45 minutes, which results in a total work time of 140 minutes for this procedure. We believe that the survey respondents overstated the immediate postservice work time that would typically be required to perform CPT code 490X1, which we investigated by comparing this new service against the existing 0-day global codes on the PFS. We found that among the roughly 1,100 codes with 0-day global periods, only 21 codes had an immediate postservice work time of 60 minutes or longer. The 21 codes that fell into this category had significantly higher intraservice work times than CPT code 490X1, with an average intraservice work time of 111 minutes as compared to the 45 minutes of intraservice work time in CPT code 490X1. Generally speaking, it is extremely rare for a service to have more immediate postservice work time than intraservice work time, and in fact only 28 out of the roughly 1,100 codes with 0-day global periods had more immediate postservice work time than intraservice work time. While we agree that each service on the PFS is its own unique entity, these comparisons to other 0-day global codes suggest that the survey respondents overestimated the amount of immediate postservice work time that would typically be associated with CPT code 490X1.

As a result, we believe that it would be more accurate to reduce the immediate postservice work time to 45 minutes and to propose a work RVU of 7.55 based on a crosswalk to CPT code 52345. This crosswalk code shares an intraservice work time of 45 minutes and a similar total time of 135 minutes after taking into account the reduced immediate postservice work time that we are proposing for CPT code 490X1. We searched the RUC database for 0-day global procedures with 45 minutes of intraservice work time, and at the recommended work RVU of 8.35, CPT code 490X1 would establish a new maximum value, higher than all of the 79 other codes that fall into this category. We recognize that CPT code 490X1 describes a preperitoneal pelvic packing service associated with pelvic trauma, and that this is a difficult and intensive procedure that rightly has a higher work RVU than many of these other 0-day global codes. However, we believe that it better maintains relativity to propose a crosswalk to CPT code 52345 at a work RVU of 7.55, which would still assign this code the second-highest work RVU among all 0 day global codes with 45 minutes of intraservice work time, as opposed to proposing the survey median work RVU of 8.35 at a rate higher than anything in the current RUC database.

We disagree with the RUC-recommended work RVU of 6.73 for CPT code 490X2 (Re-exploration of pelvic wound with removal of preperitoneal pelvic packing including repacking, when performed) and are proposing a work RVU of 5.70 based on the 25th percentile survey value. We believe that the survey 25th percentile work RVU more accurately describes the work of re-exploring this type of pelvic wound, and by proposing the survey 25th percentile we are maintaining the general increment in RVUs between the two codes in the family (a difference of 1.62 RVUs as recommended by the RUC as compared to 1.85 RVUs as proposed here). We are supporting this valuation with a reference to CPT code 39401 (Mediastinoscopy; includes biopsy(ies) of mediastinal mass (e.g., lymphoma), when performed), a recently reviewed code from CY 2015 which shares the same intraservice time of 45 minutes, a slightly higher total time of 142 minutes and a lower work RVU of 5.44.

We are proposing the RUC-recommended direct PE inputs for all codes in the family.

(20) Cystourethroscopy Insertion Transprostatic Implant (CPT Codes 52441 and 52442)

In 2005, the AMA RUC began the process of flagging services that represent new technology or new services as they were presented to the AMA/Specialty Society RVS Update Committee. This service was reviewed at the October 2018 RAW meeting, and the RAW indicated that the utilization is increasing and questioned the time required to perform these services. These two codes were surveyed and reviewed for the January 2019 RUC meeting.

We disagree with the RUC-recommended work RVU of 4.50 (current value) for CPT code 52441 (Cystourethroscopy, with insertion of permanent adjustable transprostatic implant; single implant) and are proposing a work RVU of 4.00. This proposed work RVU is based on a crosswalk from recently reviewed CPT code 58562 (Hysterscopy, surgical; with removal of impacted foreign body), which has a work RVU of 4.00, and an identical 25 minutes of intraservice time as CPT code 52441.

We disagree with the RUC-recommended work RVU of 1.20 (current value) for CPT code 52442 (Cystourethroscopy, with insertion of permanent adjustable transprostatic implant; each additional permanent adjustable transprostatic implant (List separately in addition to code for primary procedure)) and are proposing a work RVU of 1.01. This proposed work RVU is based on a crosswalk from CPT code 36218 (Selective catheter placement, arterial system; additional second order, third order, and beyond, thoracic or brachiocephalic branch, within a vascular family (List in addition to code for initial second or third order vessel as appropriate)), which has a work RVU of 1.01, and an identical 15 minutes of intraservice time as CPT code 52442. The RUC survey showed a reduction in time, and the work should reflect these changes.

We are proposing the RUC-recommended direct PE inputs for all codes in the family without refinement.

(21) Orchiopexy (CPT Code 54640)

The CPT Editorial Panel revised existing CPT code 54640 to describe an additional approach for orchiopexy (scrotal) and to clearly indicate that hernia repair is separately reportable. This code was surveyed and reviewed for the January 2019 RUC meeting.

We are proposing to maintain the current work RVU of 7.73 as recommended by the RUC. We are proposing the RUC-recommended direct PE inputs for CPT code 54640 without refinement.

(22) Radiofrequency Neurootomy Sacroiliac Joint (CPT Codes 6XX00, 6XX01)

In September 2018, the CPT Editorial Panel created two new codes to describe injection and radiofrequency ablation of the sacroiliac joint with image guidance for somatic nerve procedures. We are proposing the RUC-recommended work RVU of 1.52 for CPT code 6XX00 (Injection(s), anesthetic agent(s) and/or steroid; nerves innervating the sacroiliac joint, with image guidance (i.e., fluoroscopy or computed tomography)) and the RUC-recommended work RVU of 3.39 for CPT code 6XX01 (Radiofrequency ablation, nerves innervating the sacroiliac joint, with Start Printed Page 40579image guidance (i.e., fluoroscopy or computed tomography)).

For the direct PE inputs, we are proposing to refine the quantity of the “needle, 18-26g 1.5-3.5in, spinal” (SC028) supply from 3 to 1 for CPT code 6XX00. There are no spinal needles in use in the reference code associated with CPT code 6XX00, and there was no explanation in the recommended materials explaining why three such needles would be typical for this procedure. We agree that the service being performed in CPT code 6XX00 would require a spinal needle, but we do not believe that the use of three such needles would be typical.

We are proposing to refine the quantity of the “cannula (radiofrequency denervation) (SMK-C10)” (SD011) supply from 4 to 2 for CPT code 6XX01. We do not believe that the use of 4 of these cannula would be typical for the procedure, as the reference code currently used for destruction by neurolytic agent contains only a single cannula. We believe that the nerves would typically be ablated one at a time using this cannula, as opposed to ablating four of them simultaneously as suggested in the recommended direct PE inputs. We also searched in the RUC database for other CPT codes that made use of the SD011 supply, and out of the seven codes that currently use this item, none of them include more than 2 cannula. As a result, we are proposing to refine the supply quantity to 2 cannula to match the highest amount contained in an existing code on the PFS. We are also refining the equipment time for the “radiofrequency kit for destruction by neurolytic agent” (EQ354) equipment from 164 minutes to 82 minutes. The RUC's equipment time recommendation was predicated on the use of 4 of the SD011 supplies for 41 minutes apiece, and we are refining the equipment time to reflect our supply refinement to 2 cannula. It was unclear in the recommended materials as to whether the radiofrequency kit equipment was in use simultaneously or sequentially along with the cannula supplies, and therefore, we are soliciting comments on the typical use of this equipment.

Finally, we are proposing to refine the equipment time for the technologist PACS workstation (ED050) equipment to match our standard equipment time formulas, which results in an increase of 5 minutes of equipment time for both codes.

(23) Lumbar Puncture (CPT Codes 62270, 622X0, 62272, and 622X1)

In October 2017, these services were identified as being performed by a different specialty than the specialty that originally surveyed this service. In January 2018, the RUC recommended that these services be referred to CPT to bundle image guidance. At the September 2018 CPT Editorial Panel meeting, the Panel created two new codes to bundle diagnostic and therapeutic lumbar puncture with fluoroscopic or CT image guidance and revised the existing diagnostic and therapeutic lumbar puncture codes so they would only be reported without fluoroscopic or CT guidance.

For CPT code 62270 (Spinal puncture, lumbar, diagnostic), we disagree with the RUC-recommended work RVU of 1.44 and we are proposing a work RVU of 1.22 based on a crosswalk to CPT code 40490 (Biopsy of lip). CPT code 40490 has the same intraservice time of 15 minutes and 2 additional minutes of total time. In reviewing CPT code 62270, we noted that the recommended intraservice time is decreasing from 20 minutes to 15 minutes (25 percent reduction), and the recommended total time is decreasing from 40 minutes to 32 minutes (20 percent reduction); however, the RUC-recommended work RVU is increasing from 1.37 to 1.44, which is an increase of just over 5 percent. Although we do not imply that the decrease in time as reflected in survey values must equate to a one-to-one or linear decrease in the valuation of work RVUs, we believe that since the two components of work are time and intensity, significant decreases in time should be appropriately reflected in decreases to work RVUs. In the case of CPT code 62270, we believed that it was more accurate to propose a work RVU of 1.22 based on a crosswalk to CPT code 40490 to account for these decreases in the surveyed work time.

For CPT code 622X0 (Spinal puncture, lumbar, diagnostic; with fluoroscopic or CT guidance), we disagree with the RUC-recommended work RVU of 1.95 and we are proposing a work RVU of 1.73. Although we disagree with the RUC-recommended work RVU, we note that the relative difference in work between CPT codes 62270 and 622X0 is equivalent to an interval of 0.51 RVUs. Therefore, we are proposing a work RVU of 1.73 for CPT code 622X0, based on the recommended interval of 0.51 additional RVUs above our proposed work RVU of 1.22 for CPT code 62270.

For CPT code 62272 (Spinal puncture, therapeutic, for drainage of cerebrospinal fluid (by needle or catheter), we disagree with the RUC-recommended work RVU of 1.80 and we are proposing a work RVU of 1.58. Although we disagree with the RUC-recommended work RVU, we note that the relative difference in work between CPT codes 62270 and 622X0 is equivalent to the RUC-recommended interval of 0.36 RVUs. Therefore, we are proposing a work RVU of 1.58 for CPT code 62272, based on the recommended interval of 0.36 additional RVUs above our proposed work RVU of 1.22 for CPT code 62270.

For CPT code 622X1 (Spinal puncture, therapeutic, for drainage of cerebrospinal fluid (by needle or catheter); with fluoroscopic or CT guidance), we disagree with the RUC-recommended work RVU of 2.25 and we are proposing a work RVU of 2.03. Although we disagree with the RUC-recommended work RVU, we note that the relative difference in work between CPT codes 62270 and 622X1 is equivalent to the recommended interval of 0.81 RVUs. Therefore, we are proposing a work RVU of 2.03 for CPT code 622X1, based on the recommended interval of 0.81 additional RVUs above our proposed work RVU of 1.22 for CPT code 62270.

(24) Electronic Analysis of Implanted Pump (CPT Codes 62367, 62368, 62369, and 62370)

CPT code 62368 (Electronic analysis of programmable, implanted pump for intrathecal or epidural drug infusion (includes evaluation of reservoir status, alarm status, drug prescription status); with reprogramming) was identified by the RUC on a list of services which were originally surveyed by one specialty but are now typically performed by a different specialty. It was reviewed along with three other codes in the family for PE only at the April 2018 RUC meeting. The RUC did not recommend work RVUs for these codes and we are not proposing to change the current work RVUs.

For the direct PE inputs, we are proposing to remove the minimum multi-specialty visit pack (SA048) from CPT code 62370 as a duplicative supply due to the fact that this code is typically billed with an E/M or other evaluation service.

(25) Somatic Nerve Injection (CPT Codes 64400, 64408, 64415, 64416, 64417, 64420, 64421, 64425, 64430, 64435, 64445, 64446, 64447, 64448, 64449, and 64450)

In May 2018, the CPT Editorial Panel approved the revision of descriptors and guidelines for the codes in this family and the deletion of three CPT codes to clarify reporting (i.e., separate reporting of imaging guidance, number of units and a change from a 0-day global to ZZZ for one of the CPT codes in this Start Printed Page 40580family). This family of services describe the injection of an anesthetic agent(s) and/or steroid into a nerve plexus, nerve, or branch; reported once per nerve plexus, nerve, or branch as described in the descriptor regardless of the number of injections performed along the nerve plexus, nerve, or branch described by the code.

CPT codes 64400 (Injection(s), anesthetic agent(s); trigeminal nerve, each branch (ie ophthalmic, maxillary, mandibular)), 64408 (Injection(s), anesthetic agent(s), and/or steroid; vagus nerve), 64415 (Injection(s), anesthetic agent(s) and/or steroid; brachial plexus), 64416 (Injection(s), anesthetic agent(s) and/or steroid; brachial plexus, continuous infusion by catheter (including catheter placement)), 64417 (Injection(s), anesthetic agent(s) and/or steroid; axillary nerve), 64420 (Injection(s), anesthetic agent(s) and/or steroid; intercostal nerve, single level), 64421 (Injection(s), anesthetic agent(s) and/or steroid; intercostal nerves, each additional level (List separately in addition to code for primary procedure)), 64425 (Injection(s), anesthetic agent(s) and/or steroid; ilioinguinal, iliohypogastric nerves), 64430 (Injection(s), anesthetic agent(s) and/or steroid; pudendal nerve), 64435 (Injection(s), anesthetic agent(s) and/or steroid; paracervical (uterine) nerve), 64445 (Injection(s), anesthetic agent(s) and/or steroid; sciatic nerve), 64446 (Injection(s), anesthetic agent(s) and/or steroid; sciatic nerve, continuous infusion by catheter (including catheter placement)), 64447 (Injection(s), anesthetic agent(s); femoral nerve), 64448 (Injection(s), anesthetic agent(s) and/or steroid; femoral nerve, continuous infusion by catheter (including catheter placement)), 64449 (Injection(s), anesthetic agent(s) and/or steroid; lumbar plexus, posterior approach, continuous infusion by catheter (including catheter placement)), and 64450 (Injection(s), anesthetic agent(s); other peripheral nerve or branch) were reviewed for work and PE at the October 2018 RUC meeting. The PE for CPT code 64450 was re-reviewed during the RUC January 2019 meeting.

During the October 2018 RUC presentation for this family of services, the specialty societies stated that CPT codes 64415, 64416, 64417, 64446, 66447, and 64448 were reported with CPT code 76942 (Ultrasonic guidance for needle placement (e.g., biopsy, aspiration, injection, localization device), imaging supervision and interpretation) more than 50 percent of the time. Specifically, 76 percent with CPT code 64415, 85 percent with CPT code 64416, 68 percent with CPT code 64417, 77 percent with CPT code 64446, 77 percent with CPT code 66447, and 79 percent with CPT code 64448. It was also noted in the RUC recommendations that this overlap was accounted for in the RUC recommendations submitted for these services. Furthermore, the RUC recommendations sated that the RUC referred CPT codes 64415, 64416, 64417, 64446, 64447 and 64448 to be bundled with ultrasound guidance, CPT code 76942 to the CPT Editorial Panel for CPT 2021.

In reviewing this family of services, our proposed work and PE values for CPT codes 64415, 64416, 64417, 64446, 64447 and 64448 do not consider the overlap of imaging as noted in the RUC recommendations. We note that the RUC recommendations did not include values to support the valuation for the bundling of imaging in their work or PE recommendations and that the CPT code descriptors do not state that imaging is included.

For CY 2020, we are proposing the RUC-recommended work RVUs for CPT codes 64417 (work RVU of 1.27), 64435 (work RVU of 0.75), 64447 (work RVU of 1.10), and 64450 (work RVU of 0.75), the RUC reaffirmed work RVU of 0.94 for CPT code 64405 (Injection, anesthetic agent; greater occipital nerve), which is the current work RVU finalized in the CY 2019 final rule (83 FR 59542), and the RUC reaffirmed work RVU of 1.10 for CPT code 64418 (Injection, anesthetic agent; suprascapular nerve), which is the current work RVU value finalized in the CY 2018 final rule (82 FR 53054). Although we are proposing the RUC reaffirmed work RVUs for these two codes, as submitted in the RUC recommendations, we note that comparable codes in this family of services have lower work RVUs. Thus, these two codes may have become misvalued since their last valuation, as they were not resurveyed under this code family during the October 2018 RUC meeting.

In continuing our review of this code family, we disagree with the RUC-recommended work RVU of 1.00 for CPT code 64400 and are proposing a work RVU of 0.75, to maintain rank order in this code family. Our proposed work RVU is based on a crosswalk to another code in this family, CPT code 64450, which has an identical work RVU of 0.75 and near identical intraservice and total time values to CPT code 64400.

We note that the RUC-recommended intraservice time decreased from 37 to 6 minutes (84 percent reduction) and the RUC-recommended total time decreased from 69 to 20 minutes (71 percent reduction) for CPT code 64400. However, the RUC-recommended work RVU only decreased by 0.11, a 10 percent reduction. We do not believe the RUC-recommended work RVU appropriately accounts for the substantial reductions in the surveyed work times for the procedure. Although we do not imply that the decrease in time as reflected in survey values must always equate to a one-to-one or linear decrease in the valuation of work RVUs, we believe that since the two components of work and time are intensity, absent an obvious or explicitly stated rationale for why the relative intensity of a given procedure has increased, significant decreases in time should be reflected in decreases to work RVUs. In the case of CPT code 64400, we believe that it would be more accurate to propose a work RVU of .075 based on a crosswalk to CPT code 64450, which has an identical work RVU of 0.75 and near identical intraservice and total times to CPT code 64400. We further note that our proposed work RVU maintains rank order in this code family among comparable codes.

For CPT code 64408, we disagree with the RUC-recommended work RVU of 0.90 and are proposing a work RVU of 0.75, to maintain rank order in this code family. Our proposed work RVU is based on a crosswalk to another code in this family, CPT code 64450, which has an identical work RVU of 0.75, and near identical intraservice and total time values to CPT code 64408.

We note that the RUC-recommended intraservice time decreased from 16 to 5 minutes (69 percent reduction) and RUC-recommended total time decreased from 36 to 20 minutes (44 percent reduction) for CPT code 64408. Although the RUC-recommended work RVU decreased by 0.51, a 36 percent reduction, we do not believe the RUC-recommended work RVU appropriately accounts for the substantial reductions in the surveyed work times for the procedure. Although we do not imply that the decrease in time as reflected in survey values must always equate to a one-to-one or linear decrease in the valuation of work RVUs, we believe that since the two components of work and time are intensity, absent an obvious or explicitly stated rationale for why the relative intensity of a given procedure has increased, significant decreases in time should be reflected in decreases to work RVUs. In the case of CPT code 64408, we believe that it would be more accurate to propose a work RVU of .075, based on a crosswalk CPT code 64450, Start Printed Page 40581to account for these decrease in the surveyed work times. We further note that our proposed work RVU maintains rank order in this code family among comparable codes.

For CPT code 64415, we disagree with the RUC-recommended work RVU of 1.42 and are proposing a work RVU of 1.35, based on our time ratio methodology and further supported by a reference to CPT code 49450 (Replacement of gastrostomy or cecostomy (or other colonic) tube, percutaneous, under fluoroscopic guidance including contrast injections(s), image documentation and report), which has a work RVU of 1.36 and similar intraservice and total time values to CPT code 64415.

We note that the RUC-recommended intraservice time decreased from 15 to 12 minutes (20 percent reduction) and RUC-recommended total time decreased from 44 to 40 minutes (9 percent reduction). However, the RUC-recommended work RVU only decreased by 0.06, which is a 4 percent reduction. We do not believe the RUC-recommended work RVU appropriately accounts for the substantial reductions in the surveyed work times for the procedure. Although we do not imply that the decrease in time as reflected in survey values must always equate to a one-to-one or linear decrease in the valuation of work RVUs, we believe that since the two components of work and time are intensity, absent an obvious or explicitly stated rationale for why the relative intensity of a given procedure has increased, significant decreases in time should be reflected in decreases to work RVUs. In the case of CPT code 64415, we believe that it would be more accurate to propose a work RVU of 1.35, based on our time ratio methodology and a reference to CPT code 49450, to account for these decrease in the surveyed work times.

For CPT code 64416, we disagree with the RUC-recommended work RVU of 1.81 and are proposing a work RVU of 1.48, based on our time ratio methodology and further supported by a bracket of CPT code 62270 (Spinal puncture, lumbar, diagnostic), which has a work RVU of 1.37, identical intraservice, and similar total time to CPT code 64416 and CPT code 91035 (Esophagus, gastroesophageal reflux test; with mucosal attached telemetry pH electrode placement, recording, analysis and interpretation), which has a work RVU of 1.59, identical intraservice, and near identical total time values to CPT code 64416.

We note that while the RUC-recommended intraservice time remained unchanged, the RUC-recommended total time decreased from 60 to 49 minutes (18 percent reduction). However, the RUC recommended maintaining the current work RVU of 1.81. We do not believe the RUC-recommended work RVU appropriately accounts for the substantial reductions in the surveyed total time for the procedure. Although we do not imply that the decrease in time as reflected in survey values must always equate to a one-to-one or linear decrease in the valuation of work RVUs, we believe that since the two components of work and time are intensity, absent an obvious or explicitly stated rationale for why the relative intensity of a given procedure has increased, significant decreases in time should be reflected in decreases to work RVUs. In the case of CPT code 64416, we believe that it would be more accurate to propose a work RVU of 1.48, based on our time ratios methodology and a bracket of CPT code 62270 and CPT code 91035, to account for these decreases in the surveyed work times.

For CPT code 64420, we disagree with the RUC-recommended work RVU of 1.18 and are proposing a work RVU of 1.08, based on our time ratio methodology and further supported by a reference to CPT code 12011 (Simple repair of superficial wounds of face, ears, eyelids, nose, lips and/or mucous membranes; 2.5 cm or less), which has a work RVU of 1.07 and similar intraservice and total time values to CPT code 64420.

We note that the RUC-recommended intraservice time decreased from 17 to 10 minutes (41 percent reduction) and the RUC-recommended total time decreased from 37 to 34 minutes (8 percent reduction). However, the RUC recommended to maintaining the current work RVU of 1.18. We do not believe the RUC-recommended work RVU appropriately accounts for the substantial reductions in the surveyed work times for the procedure. Although we do not imply that the decrease in time as reflected in survey values must always equate to a one-to-one or linear decrease in the valuation of work RVUs, we believe that since the two components of work and time are intensity, absent an obvious or explicitly stated rationale for why the relative intensity of a given procedure has increased, significant decreases in time should be reflected in decreases to work RVUs. In the case of CPT code 64420, we believe that it would be more accurate to propose a work RVU of 1.08 based on our times ratio methodology and a crosswalk to CPT code 12011, to account for these decreases in the surveyed work times.

For CPT code 64421, we disagree with the RUC-recommended work RVU of 0.60 and are proposing a work RVU of 0.50, based on our time ratio methodology and to maintain rank order among comparable codes in the family. Our proposed work RVU is further supported by a crosswalk to CPT code 15276 (Application of skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits, total wound surface area up to 100 sq cm; each additional 25 sq cm wound surface area, or part thereof (List separately in addition to code for primary procedure)), which has a work RVU of 0.50 and identical intraservice and total times to CPT code 64421.

We note that our time ratio methodology suggests the code is better valued at 0.50. Furthermore, the RUC-recommended work RVU of 0.60 creates a rank order anomaly in the code family. In the case of CPT code 64421, we believe that it would be more accurate to propose a work RVU of 0.50, based on our time ratio methodology and a crosswalk to CPT code 15276, to maintain rank order among comparable codes in the family.

For CPT code 64425, we disagree with the RUC-recommended work RVU of 1.19 and are proposing a work RVU of 1.00, to maintain rank order among comparable codes in the family, based on a bracket of CPT code 12001 (Simple repair of superficial wounds of scalp, neck, axillae, external genitalia, trunk and/or extremities (including hands and feet); 2.5 cm or less) which has a work RVU of 0.84 and near identical intraservice and total time values to CPT code 64425 and CPT code 30901 (Control nasal hemorrhage, anterior, simple (limited cautery and/or packing) any method), which has a work RVU of 1.10 and near identical intraservice and total times to CPT code 64425.

We note that the RUC-recommended work RVU of 1.19 creates a rank order anomaly in the code family. In the case of CPT code 64425, we believe that it would be more accurate to propose a work RVU of 1.00, based on a bracket of CPT codes 12001 and 30901 to maintain rank order among comparable codes in the family.

For CPT code 64430, we disagree with the RUC-recommended work RVU of 1.15 and are proposing a work RVU of 1.00, to maintain rank order among comparable codes in the family, based on a bracket of CPT code 45330 (Sigmoidoscopy, flexible; diagnostic, including collection of specimen(s) by brushing or washing, when performed (separate procedure)), which has a work RVU of 0.84 and near identical Start Printed Page 40582intraservice and total time values to CPT code 64430 and CPT code 31576 (Laryngoscopy, flexible; with biopsy(ies)), which has a work RVU of 1.89 and near identical intraservice and total time values to CPT code 64430.

We note that the RUC-recommended intraservice time decreased from 17 to 10 minutes (41 percent reduction) and the RUC-recommended total time increased from 39 to 43 minutes (10 percent increase). While the RUC-recommended work RVU is decreasing by 0.31, a 21 percent reduction, we do not believe the RUC-recommended work RVU appropriately accounts for the substantial reductions in the surveyed intraservice work time for the procedure. Although we do not imply that the decrease in time as reflected in survey values must always equate to a one-to-one or linear decrease in the valuation of work RVUs, we believe that since the two components of work and time are intensity, absent an obvious or explicitly stated rationale for why the relative intensity of a given procedure has increased, significant decreases in time should be reflected in decreases to work RVUs. In the case of CPT code 64430, we believe that it would be more accurate to propose a work RVU of 1.00, based on a bracket of CPT codes 45300 and 31576 to account for these decreases in surveyed work times and to maintain rank order among comparable codes in this family.

For CPT code 64445, we disagree with the RUC-recommended work RVU of 1.18 and are proposing a work RVU of 1.00, based on our time ratio methodology and to maintain rank order among comparable codes in the family. Our proposed work RVU is based on a bracket of CPT code 12001 (Simple repair of superficial wounds of scalp, neck, axillae, external genitalia, trunk and/or extremities (including hands and feet); 2.5 cm or less), which has a work RVU of 0.84 and near identical intraservice and total times to CPT code 64445 and CPT code 30901 (Control nasal hemorrhage, anterior, simple (limited cautery and/or packing) any method), which has a work RVU of 1.10 and near identical intraservice and total time values to CPT code 64445.

We note that the RUC-recommended intraservice time decreased from 15 to 10 minutes (33 percent reduction) and the RUC-recommended total time decreased from 48 to 24 minutes (50 percent reduction). While the RUC-recommended work RVU is decreasing by 0.30, a 21 percent reduction, we do not believe the RUC-recommended work RVU appropriately accounts for the substantial reductions in the surveyed intraservice work time for the procedure. Although we do not imply that the decrease in time as reflected in survey values must always equate to a one-to-one or linear decrease in the valuation of work RVUs, we believe that since the two components of work and time are intensity, absent an obvious or explicitly stated rationale for why the relative intensity of a given procedure has increased, significant decreases in time should be reflected in decreases to work RVUs. In the case of CPT code 64445, we believe that it would be more accurate to propose a work RVU of 1.00, based on a bracket of CPT codes 12001 and 30901 to account for these decreases in surveyed work times and to maintain rank order among comparable codes in the family.

For CPT code 64446, we disagree with the RUC-recommended work RVU of 1.54 and are proposing a work RVU of 1.36 based on our time ratios methodology and further supported by a reference to CPT code 51710 (Change of cystostomy tube; complicated), which has a near identical work RVU of 1.35 and near identical intraservice and total time values to CPT code 64446.

We note that RUC-recommended intraservice time decreased from 20 to 15 minutes (25 percent reduction) and the RUC-recommended total time decreased from 64 to 40 minutes (38 percent reduction). While the RUC-recommended work RVU is decreasing by 0.27, a 15 percent reduction, we do not believe the RUC-recommended work RVU appropriately accounts for the substantial reductions in the surveyed intraservice work time for the procedure. Although we do not imply that the decrease in time as reflected in survey values must always equate to a one-to-one or linear decrease in the valuation of work RVUs, we believe that since the two components of work and time are intensity, absent an obvious or explicitly stated rationale for why the relative intensity of a given procedure has increased, significant decreases in time should be reflected in decreases to work RVUs. In the case of CPT code 64446, we believe that it would be more accurate to propose a work RVU of 1.36, based on our time ratios methodology and a reference to CPT code 51710 to account for these decreases in surveyed times and to maintain rank order among comparable codes in the family.

For CPT code 64448, we disagree with the RUC-recommended work RVU of 1.55 and are proposing a work RVU of 1.41, based our time ratio methodology and a reference to CPT code 27096 (Injection procedure for sacroiliac joint, anesthetic/steroid, with image guidance (fluoroscopy or CT) including arthrography when performed), which has a work RVU of 1.48 and near identical intraservice time and identical total time values to CPT code 64448.

We note that RUC-recommended intraservice time decreased from 15 to 13 minutes (13 percent reduction) and the RUC-recommended total time decreased from 55 to 38 minutes (62 percent reduction). While the RUC-recommended work RVU is only decreasing by 0.08, which is only a 5 percent reduction. We do not believe the RUC-recommended work RVU appropriately accounts for the substantial reductions in the surveyed intraservice work time for the procedure. Although we do not imply that the decrease in time as reflected in survey values must always equate to a one-to-one or linear decrease in the valuation of work RVUs, we believe that since the two components of work and time are intensity, absent an obvious or explicitly stated rationale for why the relative intensity of a given procedure has increased, significant decreases in time should be reflected in decreases to work RVUs. In the case of CPT code 64448, we believe that it would be more accurate to propose a work RVU of 1.41, based on our time ratios methodology and a crosswalk to CPT code 27096 to account for these decreases in surveyed times and to maintain rank order among comparable codes in the family.

For CPT code 64449, we disagree with the RUC-recommended work RVU of 1.55 and are proposing a work RVU of 1.27, based our time ratio methodology and a reference to CPT code 11755 (Biopsy of nail unit (eg, plate, bed, matrix, hyponychium, proximal and lateral nail folds) (separate procedure)), which has a work RVU of 1.25 and near identical intraservice and total times to CPT code 64449.

We note that RUC-recommended intraservice time decreased from 20 to 14 minutes (30 percent reduction) and the RUC-recommended total time decreased from 60 to 38 minutes (37 percent reduction). While the RUC-recommended work RVU is decreasing by 0.26, a 14 percent reduction, we do not believe the RUC-recommended work RVU appropriately accounts for the substantial reductions in the surveyed intraservice work time for the procedure. Although we do not imply that the decrease in time as reflected in survey values must always equate to a one-to-one or linear decrease in the valuation of work RVUs, we believe that since the two components of work and time are intensity, absent an obvious or explicitly stated rationale for why the relative intensity of a given procedure has increased, significant decreases in time should be reflected in decreases to Start Printed Page 40583work RVUs. In the case of CPT code 64449, we believe that it would be more accurate to propose a work RVU of 1.27, based on our time ratios methodology and a reference to CPT code 11755 to account for these decreases in surveyed times and to maintain rank order among comparable codes in the family.

For the direct PE inputs, we are proposing to remove the clinical labor time for the “Confirm availability of prior images/studies” (CA006) activity for CPT code 64450. This code does not currently include this clinical labor time, and unlike the new code, CPT code 64XX1, in the Genicular Injection and RFA code family, in which the PE for CPT code 64450 was resurveyed at the January 2019 RUC for PE, CPT code 64450 does not include imaging guidance in its code descriptor. When CPT code 64450 is performed with imaging guidance, it would be billed together with a separate imaging code that already includes clinical labor time for confirming the availability of prior images. As a result, it would be duplicative to include this clinical labor time in CPT code 64450. We are also proposing to refine the clinical labor time for the “Assist physician or other qualified healthcare professional—directly related to physician work time (100 percent)” (CA018) activity from 10 to 5 minutes for CPT code 64450, to match the intraservice work time and proposing to refine the equipment times in accordance with our standard equipment time formulas for CPT code 64450.

Additionally, we are proposing to refine the clinical labor time for the “provide education/obtain consent” (CA011) from 3 minutes to 2 minutes, for CPT codes 64400, 64408, 64415, 64417, 64420, 64425, 64430, 64435, 64445, 64447 and 64450, to conform to the standard for this clinical labor task. We are also proposing to refine the equipment time in accordance with our standard equipment time formula for these codes. We note that there were no RUC-recommended direct PE inputs provided for CPT codes 64416, 64446, and 64448.

(26) Genicular Injection and RFA (CPT Codes 64640, 64XX0, and 64XX1)

In May 2018, the CPT Editorial Panel approved the addition of two codes to report injection of anesthetic and destruction of genicular nerves by neurolytic agent. In October 2018, the RUC discussed the issues surrounding the survey of this family of services and supported the specialty societies' request for CPT codes 64640 (Destruction by neurolytic agent; other peripheral nerve or branch), 64XX0 (Injection(s), anesthetic agent(s) and/or steroid; genicular nerve branches including imaging guidance, when performed), and 64XX1 (Destruction by neurolytic agent genicular nerve branches including imaging guidance, when performed) to be resurveyed and presented at the January 2019 RUC meeting, based on their concern that many survey respondents appeared to be confused about the number of nerve branch injections involved with these three codes. The RUC resurveyed these services at the January 2019 RUC meeting.

For CY 2020, we are proposing the RUC-recommended work RVUs for two of the three codes in this family. We are proposing the RUC-recommended work RVU of 1.98 (25th percentile survey value) for CPT code 64640 and the RUC-recommended work RVU of 1.52 (25th percentile survey value) for CPT code of 64XX0.

For CPT code 64XX1, we disagree with the RUC-recommended work RVU of 2.62, which is higher than the 25th percentile survey value, a work RVU 2.50, and are proposing a work RVU of 2.50 (25th percentile survey value) based on a reference to CPT code 11622 (Excision, malignant lesion including margins, trunk, arms, or legs; excised diameter 1.1 to 2.0 cm), which has a work RVU of 2.41 and near identical intraservice and total times to CPT code 64XX1.

In our review of CPT code 64XX1, we examined the intraservice time ratio for the new code, CPT code 64XX1, in relation to an existing code in this family of services, CPT code 64640. CPT code 64XX1 has a RUC-recommended work RVU of 2.62, 25 minutes of intraservice time, and 74 minutes of total time. CPT code 64640 has a RUC-recommended work RVU of 1.98, 20 minutes of intraservice time, and 64 minutes of total time. To derive our proposed work RVU of 2.50, we calculated the intraservice time ratio between these two codes, which is a calculated value of 1.25, and applied this ratio times the RUC-recommended work RVU of 1.98 for CPT code 64650, which resulted in a calculated value of 2.48. This value is nearly identical to the January 2018 RUC 25th percentile survey value for CPT code 64XX1, a work RVU of 2.50. Our proposed work RVU of 2.50 is further supported by a reference to CPT code 11622.

For the direct PE inputs, we are proposing to remove the clinical labor time for the “Confirm availability of prior images/studies” (CA006) activity for CPT code 64640. This code does not currently include this clinical labor time, and unlike the new code in the family (CPT code 64XX1), CPT code 64640 does not include imaging guidance in its code descriptor. When CPT code 64640 is performed with imaging guidance, it would be billed together with a separate imaging code that already includes clinical labor time for confirming the availability of prior images. As a result, it would be duplicative to include this clinical labor time in CPT code 64640. We are proposing to refine the clinical labor time for the “Assist physician or other qualified healthcare professional—directly related to physician work time (100 percent)” (CA018) activity from 25 to 20 minutes for CPT code 64640, to match the intraservice work time. We are also proposing to refine the equipment times in accordance with our standard equipment time formulas for CPT code 64640.

We are proposing the RUC-recommended direct PE inputs for CPT code 64XX0 without refinement.

For CPT code 64XX1, we are proposing to refine the quantity of the “cannula (radiofrequency denervation) (SMK-C10)” (SD011) supply from 3 to 1. We do not believe that the use of 3 of this supply item would be typical for the procedure. We note that the RUC recommendations for another code in this family, CPT code 64640 only contains 1 of this supply item. We believe that the nerves would typically be ablated one at a time using this cannula, as opposed to ablating three of them simultaneously as suggested in the recommended direct PE inputs. We also searched in the RUC database for other CPT codes that made use of the SD011 supply, and out of the seven codes that currently use this item, none of them include more than 2 cannula. As a result, we are proposing to refine the supply quantity to 2 cannula to match the highest amount contained in an existing code on the PFS. We are also refining the equipment time for the “radiofrequency kit for destruction by neurolytic agent” (EQ354) equipment from 141 minutes to 47 minutes. The equipment time recommendation was predicated on the use of 3 of the SD011 supplies for 47 minutes apiece, and we are refining the equipment time to reflect our supply refinement to 1 cannula. It was unclear in the RUC recommendation materials as to whether the radiofrequency kit equipment was in use simultaneously or sequentially along with the cannula supplies, and therefore, we are soliciting comments on the typical use of this equipment.Start Printed Page 40584

(27) Cyclophotocoagulation (CPT Codes 66711, 66982, 66983, 66984, 66X01, and 66X02)

In October 2017, CPT codes 66711 (Ciliary body destruction; cyclophotocoagulation, endoscopic) and 66984 (Extracapsular catarac