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Proposed Rule

Medicare Program; CY 2021 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; Quality Payment Program; Coverage of Opioid Use Disorder Services Furnished by Opioid Treatment Programs; Medicare Enrollment of Opioid Treatment Programs; Electronic Prescribing for Controlled Substances for a Covered Part D Drug Under a Prescription Drug Plan or an MA-PD Plan; Payment for Office/Outpatient Evaluation and Management Services; Hospital IQR Program; Establish New Code Categories; and Medicare Diabetes Prevention Program (MDPP) Expanded Model Emergency Policy

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Start Preamble Start Printed Page 50074

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 requirements; Medicaid Promoting Interoperability Program requirements for Eligible Professionals; updates to the Quality Payment Program; Medicare coverage of opioid use disorder services furnished by opioid treatment programs; Medicare enrollment of Opioid Treatment Programs; payment for office/outpatient evaluation and management services; Requirement for Electronic Prescribing for Controlled Substances for a Covered Part D drug under a prescription drug plan or an MA-PD plan and Medicare Diabetes Prevention Program (MDPP) expanded model Emergency Policy.

DATES:

To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on October 5, 2020. (See the SUPPLEMENTARY INFORMATION section of this proposed rule for a list of provisions open for comment.)

ADDRESSES:

In commenting, please refer to file code CMS-1734-P.

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-1734-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-1734-P, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.

Start Further Info

FOR 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 specialty-specific impacts of PFS proposals.

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

Emily Yoder, (410) 786-1804, Donta Henson, (410) 786-1947, and Patrick Sartini, (410) 786-9252, for issues related to telehealth and other services involving communications technology.

Liane Grayson, (410) 786-6583, for issues related to care management services and remote physiologic monitoring services.

Emily Yoder, (410) 786-1804, Christiane LaBonte, (410) 786-7237, Ann Marshall, (410) 786-3059, and Patrick Sartini, (410) 786-9252, for issues related to payment for office/outpatient evaluation and management visits.

Christiane LaBonte, (410) 786-7237, for issues related to teaching physician services.

Roberta Epps, (410) 786-4503, and Regina Walker-Wren, (410) 786-9160, for issues related to supervision of diagnostic tests.

Ann Marshall, (410) 786-3059, for issues related to incident to pharmacist services.

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

Sarah Leipnik, (410) 786-3933, for issues related to medical record documentation.

Lindsey Baldwin, (410) 786-1694 and Terry Simananda, (410) 786-8144, for issues related to Medicare coverage of opioid use disorder treatment services furnished by opioid treatment programs.

Laura Ashbaugh, (410) 786-1113, for issues related to Clinical Laboratory Fee Schedule: Revised Data Reporting Period and Phase-in of Payment Reductions.

Joseph Schultz, (410) 786-2656, for issues related to opioid treatment program provider enrollment regulation updates for institutional claim submissions.

Lisa Parker, (410) 786-4949, for issues related to RHCs and FQHCs, primary care management services, and the FQHC market basket.

Rachel Katonak, (410) 786-8564, for issues related to comprehensive screenings for seniors: Section 2002 of the Substance Use-Disorder Prevention that Promote Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act).

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 performance standard and quality reporting requirements.

Janae James, (410) 786-0801, or Elizabeth November, (410) 786-4518, or SharedSavingsProgram@cms.hhs.gov, for issues related to Shared Savings Program beneficiary assignment and repayment mechanism requirements.

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

Heather Hostetler, (410) 786-4515, for issues related to removal of selected national coverage determinations.

Joella Roland, (410) 786-7638, for issues related to requirement for electronic prescribing for controlled substances for a covered Part D drug under a prescription drug plan or an MA-PD plan.

Edmund Kasaitis, (410) 786-0477, for issues related to Part B drug payment and Food Drug & Cosmetic Act section 505(b)(2) drug products.

Elizabeth Holland, (410) 786-1309, for issues related to updates to certified electronic health record technology due to the 21st Century Cures Act.

Julia Venanzi, (410) 786-1471, for issues related to the Hospital Inpatient Quality Reporting (IQR) Program

Irina Akelaitis, (410) 786-4602, for issues related to HCPCS Level II codes.Start Printed Page 50075

Amanda Rhee, (410) 786-3888, for the Medicare Diabetes Prevention Program (MDPP) expanded model emergency policy.

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

Brittany LaCouture, (410) 786-0481, for inquiries related to Alternative Payment Models (APMs).

End Further Info End Preamble Start Supplemental Information

SUPPLEMENTARY INFORMATION:

Inspection of Public Comments: All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following website as soon as possible after they have been received: http://regulations.gov. Follow the search instructions on that website to view public comments.

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 https://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​PhysicianFeeSched/​index.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 2021 PFS proposed rule, refer to item CMS-1734-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 makes 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. In addition, this proposed rule includes provisions related to other payment policy changes that are addressed in section III. of 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 2021 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 provisions regarding several other Medicare Part B payment policies.

Specifically, this proposed rule addresses:

  • Practice Expense RVUs (section II.B.)
  • Potentially Misvalued Services Under the PFS (section II.C.)
  • Telehealth and Other Services Involving Communications Technology (section II.D.)
  • Care Management Services and Remote Physiologic Monitoring Services (section II.E.)
  • Refinements to Values for Certain Services to Reflect Revisions to Payment for Office/Outpatient Evaluation and Management (E/M) Visits and Promote Payment Stability during the COVID-19 Pandemic (section II.F.)
  • Scopes of Practice and Related Issues (section II.G.)
  • Valuation of Specific Codes (section II.H.)
  • Modifications related to Medicare Coverage for Opioid Use Disorder (OUD) Services Furnished by Opioid Treatment Programs (OTPs) (section II.I.)
  • Clinical Laboratory Fee Schedule: Revised Data Reporting Period and Phase-in of Payment Reductions, and a Comment Solicitation on Payment for Specimen Collection for Covid-19 Tests (section III.A.)
  • Opioid Treatment Program Provider Enrollment Regulation Updates for Institutional Claim Submissions (section III.B.)
  • Payment for Primary Care Management Services in RHCs and FQHCs (section III.C.)
  • Changes to the Federally Qualified Health Center Prospective Payment System (FQHC PPS) for CY 2021: Proposed Rebasing and Revising of the FQHC Market Basket (section III.D.)
  • Comprehensive Screenings for Seniors: Section 2002 of the Substance Use-Disorder Prevention that Promote Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act) (section III.E.)
  • Medicaid Promoting Interoperability Program Requirements for Eligible Professionals (EPs) (section III.F.)
  • Medicare Shared Savings Program (section III.G.)
  • Notification of Infusion Therapy Options Available Prior to Furnishing Home Infusion Therapy Services (section III.H.)
  • Modifications to Quality Reporting Requirements and Comment Solicitation on Modifications to the Extreme and Uncontrollable Circumstances Policy for Performance Year 2020 (section III.I.)
  • Proposal to Remove Selected National Coverage Determinations (section III.J.)
  • Requirement for Electronic Prescribing for Controlled Substances for a Covered Part D drug under a prescription drug plan or an MA-PD plan (section III.K.)
  • Medicare Part B Drug Payment for Drugs Approved Through the Pathway Established Under Section 505(b)(2) of the Food, Drug, and Cosmetic Act (section III.L.)
  • Updates to Certified Electronic Health Record Technology due to the 21st Century Cures Act Final Rule (section III.M.)
  • Proposal to Establish New Code Categories (section III.N.)
  • Medicare Diabetes Prevention Program (MDPP) expanded model Emergency Policy (section III.O.)
  • CY 2021 Updates to the Quality Payment Program (section IV.)
  • Planned 30-day Delayed Effective Date for the Final Rule (section V.)
  • Collection of Information Requirements (section VI.)
  • Response to Comments (section VII.)
  • Regulatory Impact Analysis (section VIII.)Start Printed Page 50076

2. Summary of Costs and Benefits

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

3. Waiver of the 60-Day Delayed Effective Date for the Final Rule

The United States is responding to an outbreak of respiratory disease caused by a novel (new) coronavirus that has now been detected in more than 190 locations internationally, including in all 50 States and the District of Columbia. The virus has been named “SARS CoV 2” and the disease it causes has been named “Coronavirus disease 2019” (abbreviated “COVID-19”).

Due to the significant devotion of resources to the COVID-19 response, as discussed in section V. of the preamble of this proposed rule, we are hereby waiving the 60-day delay in the effective date of the final rule, and replacing it with a 30-day delay in the effective date of the final 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 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 implemented 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 by 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 ’97) delayed implementation of the resource-based PE RVU system until January 1, 1999. In addition, section 4505(b) of the BBA ’97 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 Start Printed Page 5007725664) 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 ’97 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.

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.

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 VII. 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 2020 PFS final rule for a discussion of the last GPCI update (84 FR 62615 through 62623).

RVUs are converted to dollar amounts through the application of a CF, which is calculated based on a statutory formula by CMS' 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 PE methodology CY 2007 PFS proposed Start Printed Page 50078notice (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 American 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 titled “CY 2021 PFS Proposed Rule PE/HR” on the CMS website under downloads for the CY 2021 PFS proposed rule at http://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​PhysicianFeeSched/​PFS-Federal-Regulation-Notices.html.

As noted above, we have established PE/HR values for various specialties without SMS or PPIS survey data by crosswalking them to other similar specialties to estimate a proxy PE/HR. On this note, stakeholders have raised concerns regarding the appropriate specialty crosswalk used for home PT/INR monitoring services. These services are currently classified under the independent diagnostic testing facilities specialty for PE/HR purposes, due to a lack of survey data for these services, and stakeholders have suggested to CMS that this specialty does not reflect the indirect costs associated with furnishing these services. Stakeholders have raised concerns that the practice pattern of PT/INR monitoring services are markedly different from that of the dominant parent specialty as most of the services are furnished remotely and require long-term relationship with beneficiaries similar to chronic therapy. Stakeholders also stated that this is a unique request due to the lack of home PT/INR monitoring supplier involvement in the last PPIS, and that payments for these services are derived from previously used supplemental survey data from the Association for Quality Imaging (AQI), blended with supplementary survey data from the American College of Radiology (ACR)—neither of which reflect indirect cost inputs for home PT/INR monitoring.

Therefore, we are soliciting comment from the public regarding the most accurate specialty crosswalk to use for indirect PE when it comes to home PT/INR monitoring services. We are seeking information on any additional costs associated with these services that are not reflected in our currently assigned PE/HR for independent diagnostic testing facilities, as well as which specialties would best capture these costs through the use of a crosswalk.

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 Start Printed Page 50079calculated 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.
  • Then, 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 furnished 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 titled “Calculation of PE RVUs under Methodology for Selected Codes” which is available on our website under downloads for the CY 2021 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 Start Printed Page 50080other 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.

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 titled “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 adjustments 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 1.
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  • 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).
  • 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 2 details the manner in which the modifiers are applied.
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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.

Useful Life: In the CY 2005 PFS final rule we stated that we updated the useful life for equipment items primarily based on the AHA's “Estimated Useful Lives of Depreciable Hospital Assets” guidelines (69 FR 66246). The most recent edition of these guidelines was published in 2018. This reference material provides an estimated useful life for hundreds of different types of equipment, the vast majority of which fall in the range of 5 to 10 years, and none of which are lower than 2 years in duration. We believe that the updated editions of this reference material remain the most accurate source for estimating the useful life of depreciable medical equipment.

We note that stakeholders including the RUC, specialty societies, and other commenters suggested a useful life of less than 1 year for several of the new equipment items for CY 2021, and as low as three months in one case. We have rarely, if ever, received requests for equipment useful life of less than one year in duration and note that these very short useful life durations are significantly lower than anything in our current equipment database, and if finalized would represent major outliers when compared to the rest of the equipment. Table 3 details the distribution of useful life durations of the equipment currently in our database:

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As Table 3 demonstrates, the vast majority of equipment items have a useful life duration of 5 to 10 years, and only 4 out of the 777 equipment codes have a useful life duration of less than 3 years. We also note that due to the formula used to calculate the equipment cost per minute, decreasing the useful life of any equipment item from 5 years to 3 months has the same effect as increasing the price of the equipment 20 times over. In other words, decreasing the useful life from 5 years to 0.25 years has the same multiplicative effect as increasing the price of the equipment from $5,000 to 100,000 due to the formula listed above. Since we currently do not have any equipment items in our database with a useful life of less than one year, we are proposing a clarification on how to address these cases.

We disagree that assigning a useful life at these very short durations would be typical for new equipment, especially in light of the data provided by the AHA's “Estimated Useful Lives of Depreciable Hospital Assets” reference. The equipment life durations listed in Table 3 were finalized over the last 15 years through the use of this reference material. We have concerns that assigning very low useful life durations to equipment items would fail to maintain relativity with other equipment on the PFS, effectively assigning a much higher price than other equipment items with more typical useful life durations. We believe that equipment items with very low useful life durations represent outlier cases that are not handled appropriately by the current equipment methodology and which we seek to clarify through this rulemaking. We also note that the equipment cost per minute formula was designed under the assumption that each equipment item would remain in use for a period of several years and depreciate over that span of time. Our current equipment formula is not designed to address cases in which equipment is replaced multiple times per year, and we believe that applying a multi-year depreciation in these situations would not be reflective of market pricing. We do not believe that items which are replaced on a monthly basis can be accurately priced using a formula which assumes they will be in use for years at a time, and that the use of such a formula would distort relativity with the overwhelming majority of equipment items which are in use for 5-10 years.

Therefore, we proposing to treat equipment life durations of less than 1 year as having a duration of 1 year for the purpose of our equipment price per minute formula. We believe that this is the most accurate way to incorporate these short equipment life durations within the framework of our current methodology. In the rare cases where items are replaced every few months, we believe that it is more accurate to treat these items as disposable supplies with a fractional supply quantity as opposed to equipment items with very short equipment life durations. For example, we are proposing to establish the EECP compression equipment package (SD341) and the EECP electrical equipment package (SD342) as disposable supplies instead of equipment items as described in the Valuation of Specific Codes (section II.H. of this proposed rule) portion of the preamble. We expect these situations to occur only rarely, and we will evaluate them on an individual case-by-case basis. Our criteria will be based on whether or not the item in question could be more accurately classified as a disposable supply while maintaining overall relativity within our PE methodology. We welcome additional comments from stakeholders regarding the subject of useful life durations for new equipment items with unique useful life durations as described above and any additional suggestions on alternative ways to incorporate these items into our methodology or potential wider changes to the equipment cost per minute formula more broadly.

  • 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 are not proposing a variable maintenance factor for equipment cost per minute pricing as we do not believe that we have sufficient information at present. 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). The Interest rates are listed in Table 4.
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We are not proposing any changes to the equipment interest rates for CY 2021.

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 final 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 through 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 post service 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” and “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. We also finalized standard times for a series of clinical labor tasks associated with pathology services in the CY 2016 PFS final rule with comment period (80 FR 70902). We do not believe these activities would be dependent on number of blocks or batch size, and we believe that the finalized standard 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 Start Printed Page 50085not 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 and 59464).

Following the publication of the CY 2020 PFS proposed rule, a commenter expressed concern with the published list of common refinements to equipment time. The commenter stated that these refinements were the formulaic result of the applying refinements to the clinical labor time and did not constitute separate refinements; the commenter requested that CMS no longer include these refinements in the table published each year. In the CY 2020 PFS final rule, we agreed with the commenter that that these equipment time refinements did not reflect errors in the equipment recommendations or policy discrepancies with the RUC's equipment time recommendations. However, we believed that it was important to publish the specific equipment times that we were proposing (or finalizing in the case of the final rule) when they differed from the recommended values due to the effect that these changes can have on the direct costs associated with equipment time. Therefore, we finalized the separation of the equipment time refinements associated with changes in clinical labor into a separate table of refinements. For additional details, we direct readers to the discussion in the CY 2020 PFS final rule (84 FR 62584).

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 2021, 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 2021 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 been 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 noted 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 Start Printed Page 50086stated 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. Based on the recommendations from the workgroup, we proposed to establish 23 new scope equipment codes. For the eight new scope equipment items where we received submitted invoices for pricing, we proposed to replace the existing scopes with the new scope equipment at the same amount of equipment time. This scope replacement involved approximately 100 HCPCS codes in total and was detailed in a table published in the CY 2020 proposed rule (84 FR 40495 through 40498). We noted that we did not receive pricing information along with the workgroup recommendations for the other 15 new scope equipment items. Therefore, although we proposed to establish new equipment codes for these scopes, we did not propose to replace existing scope equipment with the new equipment items as we did for the other eight new scope equipment items for CY 2020.

Following the publication of the CY 2020 PFS proposed rule, commenters provided additional information regarding pricing for the new scope equipment and their associated HCPCS codes. Based on this information provided by the commenters, we finalized a price for eight additional new scope equipment items and finalized the replacement of the existing scopes with the new scope equipment at the same amount of equipment time for approximately two dozen additional HCPCS codes (84 FR 62593 through 62595). Table 5 lists the CY 2020 finalized price for the new scope equipment codes:

Start Printed Page 50087

We noted that although we updated the scope equipment pricing for CY 2020 such that the ES087 and ES089 scopes shared the same price with the ES088 scope, and the ES090 scope shared the same price with the ES085 scope, we did not mean to suggest that these scopes that shared pricing were identical with one another. We assigned the same price to these scopes because they replaced the same current scope equipment codes, and because we did not have individual pricing information for them. We remain open to the submission of additional invoices to establish individual pricing for these scopes, and we continue to welcome more data to help identify pricing for the remaining seven scope equipment codes that still lack invoices.

(5) Scope Proposals for CY 2021

We did not receive further recommendations from the Scope Equipment Reorganization Workgroup organized by the RUC following the publication of the CY 2020 final rule. However, we did receive invoices associated with the pricing of the scope video system (monitor, processor, digital capture, cart, printer, LED light) (ES031) equipment item as part of the review of the Esophagogastroduodenoscopy (EGD) with Biopsy and the Colonoscopy code families. We previously finalized a price of $36,306 for the ES031 equipment based on the sum of 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, $1,750 for the cart, $1,915 for the LED light, and $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.) We received 37 invoices associated with the components of the ES031 scope video system, which averaged out to prices of $21,988.89 for the processor, $16,175.87 for the digital capture device, $6,987.56 for the monitor, $7,922.80 for the printer, $4,945.45 for the cart, and $12,652.82 for the LED light. Based on the sum of these component prices, we are proposing to update the price the ES031 scope video system equipment to $70,673.38. We are not proposing to include an additional $1,000 to cover the expense of miscellaneous small equipment as the products listed on the component invoices indicated that cost of cables were already included in this significantly higher equipment pricing. We are soliciting additional comments from stakeholders regarding the pricing of the full ES031 scope equipment system as well as its components.

As part of our market-based supply and equipment pricing transition, we finalized a policy in CY 2019 to phase in any updated pricing established during the 4-year transition period for very commonly used supplies and equipment that are included in 100 or more codes, even if invoices are provided as part of the formal review of a code family (83 FR 59473 through 59475). Because the ES031 scope equipment system is utilized by more than 250 HCPCS codes, we are proposing to transition this pricing increase over the remaining two years of the pricing update, such that the CY 2021 equipment price will be $53,489.69 before moving to its destination price of $70,673.38 in CY 2022. We note that this transition policy also applies to the price of the suction machine (Gomco) (EQ235) equipment, which, although it is not a scope, is utilized by approximately 360 HCPCS codes, and therefore, is another example of this pricing transition policy. We are proposing to transition the EQ235 pricing increase over the remaining 2 years of the pricing update, such that the CY 2021 equipment price will be $1,981.66 before moving to its destination price of $ $3,195.85 in CY 2022. As we stated previously, this Start Printed Page 50088policy is intended to minimize any potential disruptive effects during the pricing transition period due to the high number of services that make use of these very common supply and equipment items included in 100 or more HCPCS codes.

We also received invoices for the colonoscopy videoscope (ES033) and gastroscopy videoscopy (ES034) as part of the review of the Esophagogastroduodenoscopy (EGD) with Biopsy and the Colonoscopy code families. We finalized the replacement of both of these scope equipment items in the CY 2020 final rule (84 FR 62588 through 62590), replacing the colonoscopy videoscope (ES033) with the multi-channeled flexible digital scope, colonoscopy (ES086) equipment item and the gastroscopy videoscopy (ES034) with the multi-channeled flexible digital scope, esophagoscopy gastroscopy duodenoscopy (EGD) (ES087) equipment item. In both cases, the submitted invoices were nearly identical to the finalized prices for the ES086 ($38,058.81) and ES087 ($34,585.35) equipment. We believe that these invoices reinforce the prices finalized through rulemaking last year, and therefore, we are not proposing to further update the prices of these scopes.

We remain open to further comments regarding the pricing of the remaining seven scope equipment codes that still lack invoices, as well as additional data regarding the pricing of the scope equipment codes that currently share the same price.

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

For CY 2021, we are proposing to address the following inconsistencies:

  • Following the publication of the CY 2020 PFS final rule, stakeholders contacted CMS and clarified that CPT code 0466T (Insertion of chest wall respiratory sensor electrode or electrode array, including connection to pulse generator) is always performed on an add-on basis and would never be used as a standalone code. Therefore, we are proposing to update the global period for CPT code 0466T to add-on status (ZZZ) to more accurately reflect the way in which this service is performed.

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 requests to update equipment and supply price and equipment useful life inputs through annual rulemaking, beginning with the CY 2012 PFS proposed rule. For CY 2021, we are proposing to update the price of one supply and four equipment items 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 2021 for these items instead of being phased in over 4 years. These supply and equipment items with updated prices associated with the formal review of a code family are listed in the valuation of specific codes section of the preamble under Table 27: CY 2021 Invoices Received for Existing Direct PE Inputs.

(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, enacted April 1, 2014) 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).
  • The 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 Start Printed Page 50089CMS 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 we 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-up” 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 6.

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 timeframe will allow more opportunities for public Start Printed Page 50090comment 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 through 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 through 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 accuracy, 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 2021, we received invoice submissions for approximately a dozen supply and equipment codes from stakeholders as part of the third year of the market-based supply and equipment pricing update. The submitted invoices were used in many cases to supplement the pricing originally proposed for the CY 2019 PFS rule cycle. We 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 supply and equipment items listed in Table 7 of the CY 2021 PFS proposed rule.

We finalized a policy in CY 2019 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 6. For CY 2021, one half of the difference between the CY 2020 price and the final price will be implemented as per the previously finalized policy. Table 7 contains the list of proposed CY 2021 market-based supply and equipment pricing updates:

The proposed prices for the supply and equipment items listed in Table 7 were calculated based on averaging together the prices on the submitted invoices. In the case of the vascular sheath (SD136) and RF endovenous occlusion catheter (SD155) supplies, the proposed price was determined by removing the sheath or catheter from the eight submitted kit invoices and then averaging the resulting price together with the single standalone sheath/catheter invoice.

In addition to submitting invoices with information updating the price of Start Printed Page 50091the “Vmax 22d and 62j (PFT equip, autobox, computer system)” (EQ041) equipment, stakeholders also clarified that the “Vmax 229 (spirometry testing equip, computer system)” (EQ040) and “Vmax 29s (spirometry testing equip, computer system)” (EQ043) equipment items have become obsolete and are no longer typically used in any HCPCS codes. Based on the information supplied by the stakeholders, we are proposing to remove the EQ040 and EQ043 equipment items, replacing them with the EQ041 equipment at the same number of minutes in the six HCPCS codes where they are utilized.

We are not proposing to update the price of additional supply and equipment items for which invoices were submitted following the publication of the CY 2020 PFS final rule. We are not proposing to update the price for the “pipette, transfer 23ml” (SL109), “slide specimen mailer (1-5 microscope slides)” (SL121), “stain, hematoxylin” (SL135), “stain, eosin” (SL201), and “stain, PAP OG-6” (SL491) supplies. In each case we received a single invoice for these five supplies detailing price increases ranging from 82 percent to 160 percent above the current pricing. These supplies are commonly used in cytopathology procedures and we disagree that the typical price for these supplies has more than doubled since being reviewed by the StrategyGen contractor two years ago for CY 2019.

We are also not proposing to update the price for the “embedding mold” (SL060) supply or the “microscope, compound” (EP060) equipment based on the same rationale. The submitted invoices represent pricing increases of 339 percent for the compound microscope and 7800 percent for the embedding mold and, based on the recent review of the pricing of these items by our contractor, we do not believe that the submitted invoices reflect typical market-based pricing. The same stakeholder also submitted an invoice to update the price of the surgical mask (SB033) supply by 617 percent over the current price. However, the invoice in question contains the price for a surgical mask with face shield, which is described by the SB034 supply code, not the SB033 supply code. Therefore, we are not proposing to update the price of the surgical mask (SB033) supply based on this invoice. Finally, we received an invoice for a ClosureFast Procedure Pack (CFP) but it was unclear what supply or equipment item this invoice was intended to update. As a result, we were unable to use this invoice to make a pricing proposal.

(2) Invoice Submission

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 2021 PFS proposed rule at http://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​PhysicianFeeSched/​PFS-Federal-Regulation-Notices.html.

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. 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 will 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. Stakeholders are encouraged to submit invoices as part of their public comments or, if outside the public comment process, via email at PE_Price_Input_Update@cms.hhs.gov.

(3) Updated Supply Pricing for Venous and Arterial Stenting Services

Following the publication of the CY 2020 PFS final rule, stakeholders contacted CMS and presented additional information regarding supply pricing for certain venous and arterial stenting services. These stakeholders stated that the use of the “stent, vascular, deployment system, Cordis SMART” (SA103) supply was no longer typical in CPT codes 37238 (Transcatheter placement of an intravascular stent(s), open or percutaneous, including radiological supervision and interpretation and including angioplasty within the same vessel, when performed; initial vein) and 37239 (Transcatheter placement of an intravascular stent(s), open or percutaneous, including radiological supervision and interpretation and including angioplasty within the same vessel, when performed; each additional vein). The stakeholders stated that a new venous stent system had become the typical standard of care for these services, and they supplied ten invoices for use in pricing this supply.

The stakeholders also requested additional information regarding the nature of the “stent, balloon, implantable” (SD299) supply included in CPT codes 37236 (Transcatheter placement of an intravascular stent(s) (except lower extremity artery(s) for occlusive disease, cervical carotid, extracranial vertebral or intrathoracic carotid, intracranial, or coronary), open or percutaneous, including radiological supervision and interpretation and including all angioplasty within the same vessel, when performed; initial artery) and 37237 (Transcatheter placement of an intravascular stent(s) (except lower extremity artery(s) for occlusive disease, cervical carotid, extracranial vertebral or intrathoracic carotid, intracranial, or coronary), open or percutaneous, including radiological supervision and interpretation and including all angioplasty within the same vessel, when performed; each additional artery). The stakeholders specifically were unclear what the implantable stent balloon represented and sought guidance on whether pricing involved a stent, a balloon, or a combination of both.

In response to the additional information provided by the stakeholders, we are proposing to remove the SA103 supply item from CPT codes 37238 and 37239. We are proposing to replace it with a newly created “venous stent system” (SD340) supply at the same supply quantity. We are proposing a price of $1,750.00 for the venous stent system based on the median price of the ten invoices supplied by the stakeholders. We are proposing the use of the median price due to the presence of several invoices that appear to be outliers which are not reflective of market pricing for the venous stent system. With regards to the request for additional information regarding the nature of the “stent, balloon, implantable” (SD299) supply, the original invoice used to price this supply during the CY 2015 rule cycle listed an item named “Renal and Biliary Stent System 7.0 mm x 15 mm x 135 cm”. We welcome additional information from stakeholders regarding the nature and pricing of this supply item.

(4) Myocardial PET Equipment Inputs

Following the publication of the CY 2020 PFS final rule, stakeholders contacted CMS and presented additional information regarding the direct PE inputs for several codes associated with Myocardial PET services. The stakeholders stated that the nuclide rod source set (ER044) equipment was inadvertently excluded Start Printed Page 50092from the direct PE recommendations for CPT codes 78432 (Myocardial imaging, positron emission tomography (PET), combined perfusion with metabolic evaluation study (including ventricular wall motion[s] and/or ejection fraction[s], when performed), dual radiotracer (e.g., myocardial viability);), 78459 (Myocardial imaging, positron emission tomography (PET), metabolic evaluation study (including ventricular wall motion[s] and/or ejection fraction[s], when performed), single study;), 78491 (Myocardial imaging, positron emission tomography (PET), perfusion study (including ventricular wall motion[s] and/or ejection fraction[s], when performed); single study, at rest or stress (exercise or pharmacologic)), and 78492 (Myocardial imaging, positron emission tomography (PET), perfusion study (including ventricular wall motion[s] and/or ejection fraction[s], when performed); multiple studies at rest and stress (exercise or pharmacologic)), and requested that CMS add this equipment to the direct inputs for this group of CPT codes. The stakeholders also stated that the current useful life of 5 years for the ER044 equipment was incorrect as these sources are replaced every 9 months to 1 year. The stakeholders requested that CMS update the useful life of ER044 to 0.75 years. Finally, the stakeholders stated that the costs for the purchase of the Rubidium PET Generator (ER114) equipment are captured elsewhere through the billing of HCPCS supply code A9555, and the stakeholders recommended that we remove equipment item ER114 to avoid incorrect billing duplication.

We appreciate the additional information submitted by the stakeholders regarding the direct PE inputs for these Myocardial PET services. In response to this new information, we are proposing to update the price for the nuclide rod source set (ER044) equipment to $2,081.17 based on averaging together the price of the three submitted invoices after removing the shipping and delivery costs according to our standard pricing methodology. We are also proposing to add the ER044 equipment to CPT codes 78432, 78459, 78491, and 78492 as requested, assigning the same equipment time utilized by the “PET Refurbished Imaging Cardiac Configuration” (ER110) equipment in each service. We are proposing to update the useful life of the ER044 equipment to one year in accordance with our proposed policy to treat equipment useful life durations of less than 1 year as having a duration of one year. As we stated previously in section II.B we have concerns that assigning very low useful life durations of less than 1 year would fail to maintain relativity with other equipment on the PFS, and the equipment cost per minute formula was designed under the assumption that each equipment item would remain in use for a period of several years and depreciate over that span of time. We direct readers to the previous discussion regarding equipment cost per minute methodology earlier in section II.B. of this proposed rule. Finally, we are removing the “PET Generator (Rubidium)” (ER114) equipment from our database as requested by the stakeholders. We note that since the technical components for CPT codes 78432, 78459, 78491, and 78492 are all contractor-priced, there will be no change to the national pricing of these codes.

(5) 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 2021, we are proposing to continue with the fourth and final year of the transition of this adjustment to the standard process for allocating indirect PE.

e. Update on Technical Expert Panel Related to Practice Expense

The RAND Corporation is currently studying potential improvements to CMS' PE allocation methodology and the data that underlie it. As we noted earlier in this section, our current system for setting PE RVUs relies in part on data collected in the Physician Practice Information Survey (PPIS), which was administered by the AMA in CY 2007 and 2008.

RAND, in its first phase of research, available at https://www.rand.org/​pubs/​research_​reports/​RR2166.html, found that the PPIS data are outdated and may no longer reflect the resource allocation, staffing arrangements, and cost structures that describe practitioners' resource requirements in furnishing services to Medicare beneficiaries, and consequently may not accurately capture the indirect PE resources required to furnish services to Medicare FFS beneficiaries. For example, the PPIS preceded the widespread adoption of electronic health records, quality reporting programs, billing codes that promote team-based care, and hospital acquisition of physician practices. Notably, RAND found that practice ownership was strongly associated with indirect PE, with physician-owned practices requiring 190% higher indirect PE compared to facility-owned practices, suggesting a need to potentially update demographic information. Additionally, RAND found that aggregating Medicare provider specialties into broader categories resulted in small specialty-level impacts relative to the current system, suggesting that specialty-specific inputs may not be required to accurately reflect resource costs.

To follow up on these and other issues raised in the first phase of RAND's research, in the CY 2020 PFS, we announced that RAND was convening a technical expert panel (TEP) to obtain input from stakeholders including physicians, practice and health system managers, health care accountants, and health policy experts. The TEP occurred on January 10, 2020 and its report is available at https://www.rand.org/​pubs/​working_​papers/​WR1334.html. Topics discussed included identifying issues with the current system; changes in medicine that have affected PE; how PE inputs could be updated, including through a potential new survey instrument; how best to aggregate PE categories if there were to be new survey instrument; ways to maximize response rates in a potential new survey; and using existing data to inform PFS PE rates. In addition, RAND has issued the results of its subsequent phase of research, available at www.rand.org/​t/​RR3248. This report is also available as a public use file displayed on the CMS website under downloads for the CY 2021 PFS proposed rule at http://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​PhysicianFeeSched/​PFS-Federal-Regulation-Notices.html. Start Printed Page 50093

Based on the results of the TEP and RAND's other ongoing research, we are interested in potentially refining the PE methodology and updating the data used to make payments under the PFS. We believe that potential refinements could improve payment accuracy and strengthen Medicare. Our goals are to balance obtaining the data as soon as practicable and in a way that would allow stakeholders and CMS to collectively examine many of the issues the TEP and RAND's research identified. We are thinking through several questions, including how to best incorporate market-based information, which could be similar to the market research that we recently conducted to update supply and equipment pricing used to determine direct PE inputs under the PFS payment methodology. For example, stakeholders have expressed an interest in updating the clinical labor data that we use for direct PE inputs based on current salaries and compensation for the health care workforce. We are soliciting comment regarding how we might update the clinical labor data. Historically, we have used data from the Bureau of Labor Statistics and are seeking comment to determine if this is the best data source or if there is an alternative. We are also interested in hosting a Town Hall meeting at a date to be determined to provide an open forum for discussion with stakeholders on our ongoing research to potentially update the PE methodology and the underlying inputs. Finally, we welcome feedback from all interested parties regarding RAND's report and we are not making any proposals based on this report at this time. Stakeholders are encouraged to submit feedback as part of their public comments or, if outside the public comment process, via email at PE_Price_Input_Update@cms.hhs.gov.

C. 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.H. of this proposed rule, Valuation of Specific Codes, each year we develop appropriate adjustments to the RVUs taking into account recommendations provided by the American Medical Association Resource-Based Relative Value Scale (RVS) Update Committee (RUC), Medicare Payment Advisory Commission (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 costs decline. 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 costs 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 same 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 Start Printed Page 50094furnished 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” and the referencing CPT code number(s) and/or the CPT descriptor(s) in the subject line. Physical letters for nominations should be sent via the U.S. Postal Service to the Centers for Medicare & Medicaid Services, 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 over 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 as 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). We have continued each year to consider and finalize a list of potentially misvalued codes that have or will be reviewed and revised as appropriate in future rulemaking.

3. CY 2021 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.Start Printed Page 50095
  • 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 submissions nominating codes for review under the potentially misvalued code initiative, and several requests for review of practice expense related inputs prior to our February 10, 2020 deadline. We refer readers to section II.B. of this proposed rule, Determination of Practice Expense RVUs, for further discussion on the PE-related submissions. Our summary of the submissions reviewed under the potentially misvalued code initiative is discussed below.

We received multiple submissions requesting that CMS consider CPT code 22867 (Insertion of interlaminar/interspinous process stabilization/distraction device, without fusion, including image guidance when performed, with open decompression, lumbar; single level) for nomination as potentially misvalued. In their request, the submitters suggested that the physician work assigned to this code significantly undervalues the procedure relative to the value of CPT code 63047 (Laminectomy, facetectomy and foraminotomy (unilateral or bilateral with decompression of spinal cord, cauda equina and/or nerve root[s], [eg, spinal or lateral recess stenosis]), single vertebral segment; lumbar). The submitters stated that the work performed during the surgical steps to perform a laminectomy for both procedures is generally similar except for the additional intensity and complexity involved in CPT code 22867 to implant the interspinous stabilization device. The submitters also requested that the malpractice RVUs assigned to this code be increased to better align with similar spine procedures, in terms of specialty level and service level risk factors, in addition to the intensity and complexity of the procedure. After considering the information provided by the submitter, which suggests that the current valuation for the service may not reflect the level of intensity inherent in furnishing the service relative to other similar services with inputs that exceed those for the nominated service we are proposing to nominate CPT code 22867 as potentially misvalued and welcome public comment on this code.

D. Telehealth and Other Services Involving Communications Technology

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

As discussed in this proposed 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.

a. Adding Services to the Medicare Telehealth Services List

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 Medicare telehealth services list 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 Medicare telehealth services list 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 Medicare telehealth services list. 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 Medicare telehealth services list. 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 Medicare telehealth services list, including the additions described later in this section, is available on the CMS website at https://www.cms.gov/​Medicare/​Medicare-General-Information/​Telehealth/​index.html.

For CY 2021, requests to add services to the Medicare telehealth services list must have been submitted and received by February 10, 2020. Each request to add a service to the Medicare telehealth services list 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 Start Printed Page 50096make changes to the Medicare telehealth services list, 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 Medicare telehealth services list, including where to mail these requests, see our website at https://www.cms.gov/​Medicare/​Medicare-General-Information/​Telehealth/​index.html.

b. Requests To Add Services to the Medicare Telehealth Services List for CY 2021

Under our current policy, we add services to the Medicare telehealth services list on a Category 1 basis when we determine that they are similar to services on the existing Medicare telehealth services list for the roles of, and 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 Medicare telehealth services list that resemble those services already on the Medicare telehealth services list. We received several requests to add various services as Medicare telehealth services effective for CY 2021. We also conducted an internal review of potential services to add to the Medicare telehealth services list.

In response to the PHE for the COVID-19 pandemic, CMS undertook emergency rulemaking to add a number of services to the Medicare telehealth services list on an interim final basis. In the “Medicare and Medicaid Programs; Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency” interim final rule with comment period (IFC), (85 FR 19230, 19234 through 19241, March 31, 2020) (hereinafter referred to as the “March 31st COVID-19 IFC”), on an interim final basis for the duration of the PHE for the COVID-19 pandemic, we also finalized the addition of a number of services to the Medicare telehealth services list on a Category 2 basis. The following is a list of those services:

  • Emergency Department (ED) Visits, Levels 1-5 (CPT codes 99281-99285).
  • Initial and Subsequent Observation and Observation Discharge Day Management (CPT codes 99217-99220; CPT codes 99224-99226; CPT codes 99234-99236).
  • Initial hospital care and hospital discharge day management (CPT codes 99221-99223; CPT codes 99238-99239).
  • Initial nursing facility visits, All levels (Low, Moderate, and High Complexity) and nursing facility discharge day management (CPT codes 99304-99306; CPT codes 99315-99316).
  • Critical Care Services (CPT codes 99291-99292).
  • Domiciliary, Rest Home, or Custodial Care services, New and Established patients (CPT codes 99327-99328; CPT codes 99334-99337).
  • Home Visits, New and Established Patient, All levels (CPT codes 99341-99345; CPT codes 99347-99350).
  • Inpatient Neonatal and Pediatric Critical Care, Initial and Subsequent (CPT codes 99468-99473; CPT codes 99475-99476).
  • Initial and Continuing Intensive Care Services (CPT code 99477-994780).
  • Assessment and Care Planning for Patients with Cognitive Impairment (CPT code 99483).
  • Group Psychotherapy (CPT code 90853).
  • End-Stage Renal Disease (ESRD) Services (CPT codes 90952, 90953, 90959, and 90962).
  • Psychological and Neuropsychological Testing (CPT codes 96130-96133; CPT codes 96136-96139).
  • Therapy Services, Physical and Occupational Therapy, All levels (CPT codes 97161-97168; CPT codes 97110, 97112, 97116, 97535, 97750, 97755, 97760, 97761, 92521-92524, 92507).
  • Radiation Treatment Management Services (CPT codes 77427).

When we previously considered adding these services to the Medicare telehealth services list, either through a public request or through our own internal review, we considered whether these services met the Category 1 or Category 2 criteria. In many cases, we reviewed requests to add these services on a Category 1 basis, but did not receive or identify information that allowed us to review the services on a Category 2 basis. While we stated in the March 31st COVID-19 IFC that we did not believe the context of the PHE for the COVID-19 pandemic changes the assessment of these services as Category 1, we did reassess all of these services on a Category 2 basis in the context of the widespread presence of COVID-19 in the community. Given the exposure risks for beneficiaries, the health care work force, and the community at large, we stated that in-person interaction between professionals and patients poses an immediate potential risk that would not have been present when we previously reviewed these services. We were concerned that this new risk created a unique circumstance where health care professionals might have to choose between the best means to mitigate exposure risk for themselves and for their patients or seeking Medicare payment for the service. For example, certain persons, especially older adults who are particularly vulnerable to complications from this specific viral infection; those considered at risk because of underlying health conditions; and those known to be recently exposed or diagnosed, and therefore, likely to spread the virus to others, were often being directed by local public health officials to self-isolate as much as possible. At the same time, we noted that the risk to medical professionals treating patients is high and we considered it likely that medical professionals would try to treat patients as effectively as possible without exposing themselves or their patients unnecessarily. We explained that, in some cases, the use of telecommunication technology could mitigate the exposure risk; and in such cases, there is a clear clinical benefit of using such technology in furnishing the service. In other words, patients who should not be seen by a professional in-person due to the exposure risk were highly likely to be without access to clinically appropriate treatment or diagnostic options unless they have access to services furnished through interactive communication technology. Therefore, in the context of the PHE for the COVID-19 pandemic, we believed that all of the services we added met the Category 2 criteria to be added to the Medicare telehealth services list on the basis that there was a patient population that would otherwise not have access to clinically appropriate treatment. We noted that, as with other services on the Medicare telehealth services list, it may not be clinically appropriate or possible to use telecommunications technology to furnish these particular services to every person or in every circumstance. However, in the context of the PHE for the COVID-19 pandemic with specific regard to the exposure risks noted above, we recognized the clinical benefit of access to medically reasonable and necessary services furnished using telecommunications technology as opposed to the potential lack of access that could occur to mitigate the risk of disease exposure.

In addition to considering public requests and services identified through internal review for additions to the Medicare telehealth services list, we have also considered which of the services added to the Medicare Start Printed Page 50097telehealth services list on an interim basis should remain on the Medicare telehealth services list permanently or on an interim basis after the end of the PHE. The following presents a discussion of these services and related proposals.

After reviewing the requests we received, the services we identified, and the services we added to the Medicare telehealth services list on an interim basis for the duration of the PHE, we identified the services we have listed in Table 8 as being sufficiently similar to services currently on the Medicare telehealth services list to be added on a Category 1 basis. Therefore, we are proposing to add the services in Table 8 to the Medicare telehealth services list on a Category 1 basis for CY 2021.

Start Printed Page 50098

We believe the services described by the HCPCS codes in Table 8 are similar to services currently on the Medicare telehealth services list. The add-on codes to the office/outpatient E/M services are, by definition, part of the office/outpatient E/M services since they cannot be billed with any other codes. The Assessment of and Care Planning for Patients with Cognitive Impairment was defined as a service meant to be billed in specific clinical scenarios in lieu of a level 5 office/outpatient E/M visit. As such, these services fall within the Category 1 criteria because they are similar to the office visits that are already on the Medicare telehealth services list. As it describes group therapy, CPT code 90853 is similar to the other group therapy services currently on the Medicare telehealth services list.

While the patient's home cannot serve as an originating site (where the patient is located) for purposes of most Medicare telehealth services, the SUPPORT for Patients and Communities Act amended section 1834(m)(4)(C) of the Act and added a new paragraph at section 1834(m)(7) of the Act to remove geographic limitations and authorize the patient's home to serve as a telehealth originating site for purposes of treatment of a substance use disorder or a co-occurring mental health disorder, furnished on or after July 1, 2019, to an individual with a substance use disorder diagnosis. These domiciliary/home visits contain the same elements and similar descriptors to the office/outpatient E/M visits, and therefore, we believe there is sufficient justification to add them to the Medicare telehealth services list on a Category 1 basis. Additionally, we believe that, due to the vulnerability of this particular patient population, who are receiving treatment for a diagnosed substance use disorder or co-occurring mental health disorder, we should maximize the availability of telehealth services for the treatment of substance use disorders and co-occurring mental health disorders. We note that, because the home is not generally a permissible telehealth originating site, these services could be billed when furnished as telehealth services only for treatment of a substance use disorder or co-occurring mental health disorder.

Finally, we received a request to add CPT code 96121 (Neurobehavioral status exam (clinical assessment of thinking, reasoning and judgment, [e.g., acquired knowledge, attention, language, memory, planning and problem solving, and visual spatial abilities]), by physician or other qualified health care professional, both face-to-face time with the patient and time interpreting test results and preparing the report; each additional hour (List separately in addition to code for primary procedure)) on the basis that this is an add-on code to CPT code 96116 (Neurobehavioral status exam (clinical assessment of thinking, reasoning and judgment, [e.g., acquired knowledge, attention, language, memory, planning and problem solving, and visual spatial abilities]), by physician or other qualified health care professional, both face-to-face time with the patient and time interpreting test results and preparing the report; first hour) which is currently on the Medicare telehealth services list. In the past we have added services to the Medicare telehealth services list that are add-on codes that describe a continuation or additional elements of services currently on the Medicare telehealth services list since the services would only be considered telehealth services when billed as an add-on to codes already on the Medicare telehealth services list (82 FR 53008). Therefore, we are proposing to add CPT code 96121 to the Medicare telehealth services list.

We also received a request to add services to the Medicare telehealth services list that do not meet our criteria for addition to the Medicare telehealth services list, as explained below. We are not proposing to add the services listed in Table 9 to the Medicare telehealth services list.

We received a request to add Medical Genetics services to the Medicare telehealth services list. We note that CPT code 96040 is considered bundled into office/outpatient E/M visits, which are already on the Medicare telehealth services list. Therefore, we do not believe it is necessary to add CPT code 96040. As we stated in the CY 2012 PFS final rule with comment period (76 FR 73096 through 73097), physicians and nonphysician practitioners who may independently bill Medicare for their services and who are counseling individuals would generally report office or other outpatient evaluation and management (E/M) CPT codes for office visits that involve significant counseling, including genetic counseling, and these office visit CPT codes are already on the Medicare telehealth services list. CPT code 96040 would only be reported by genetic counselors for genetic counseling services. Genetic counselors are not among the practitioners who can bill Medicare directly for their professional services, and they are also not practitioners who can furnish telehealth services as specified in section 1834(m)(4)(E) of the Act. As such, we do not believe that it would be necessary or appropriate to add CPT code 96040 to the Medicare telehealth services list.

HCPCS code S0265 is a Medication, Supplies, and Services code; and there is no separate payment under the PFS for this category of codes. Therefore, we are not proposing to add this service to the Medicare telehealth services list.

c. Proposed Temporary Addition of a Category 3 Basis for Adding to or Deleting Services From the Medicare Telehealth Services List

Recently enacted legislation to address the COVID-19 pandemic provided the Secretary with new authorities under section 1135(b)(8) of the Act, as added by section 102 of the Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 (Pub. L. 116-123, March 6, 2020) and subsequently amended by section 6010 of the Families First Coronavirus Response Act (Pub. L. 116-127, March 18, 2020) and section 3703 of the Start Printed Page 50099Coronavirus Aid, Relief, and Economic Security Act (CARES Act) (Pub. L. 116-136, March 27, 2020)), to waive or modify Medicare telehealth payment requirements during the PHE for the COVID-19 pandemic. Due to the circumstances of the COVID-19 pandemic, particularly the need to maintain physical distance to avoid exposure to the virus, we anticipate that health care practitioners are developing new approaches to providing care using various forms of technology when they are not physically present with the patient. We have established several flexibilities to accommodate these changes in the delivery of care. Through waiver authority under section 1135(b)(8) of the Act, in response to the PHE for the COVID-19 pandemic, we have removed the geographic and site of service originating site restrictions in section 1834(m)(4)(C) of the Act, as well as the restrictions in section 1834(m)(4)(E) of the Act on the types of practitioners who may furnish telehealth services, for the duration of the PHE for the COVID-19 pandemic. We also used waiver authority to allow certain telehealth services to be furnished via audio-only communication technology. In the March 31st COVID-19 IFC, we added to the Medicare telehealth services list on an interim basis the services identified at the beginning of this section. Through the May 1st COVID-19 IFC, on an interim basis, we removed the requirement that we undertake rulemaking to add or delete services on the Medicare telehealth services list so that we could consider the addition of services on a subregulatory basis as they were recommended by the public or identified internally. On a subregulatory basis, we simultaneously added several more additional services to the Medicare telehealth services list when we issued the May 1st COVID-19 IFC. At the conclusion of the PHE, these waivers and interim policies will expire, payment for Medicare telehealth services will once again be limited by the requirements of section 1834(m) of the Act, and we will return to the policies established through the regular notice and comment rulemaking process, including the previously established Medicare telehealth services list. We believe that the experiences of clinicians who are furnishing telehealth services during the PHE will be useful to inform decisions about which of the services we added temporarily to the Medicare telehealth services list might be appropriate to add on a permanent basis. However, we also recognize that the annual PFS rulemaking schedule may not align perfectly with the expiration of the PHE, and that the clinicians providing services via telehealth during the PHE may not have the opportunity to conduct the kinds of review or develop the kind of evidence we usually consider when adding services to the Medicare telehealth services list on a permanent basis. In the event that the PHE ends prior to the end of calendar year 2021, stakeholders might not have the opportunity to use our current consideration process for telehealth services to request permanent additions to the Medicare telehealth services list prior to those services being removed from the Medicare telehealth services list. This is especially true for those services that might need to be considered on a Category 2 basis, which involves providing supporting documentation to illustrate the clinical benefit of such services. Recognizing the extent to which practice patterns are shifting as a result of the PHE from a model of care based on in-person services to one that relies on a combination of in-person services and virtual care, we believe that it would be disruptive to both clinical practice and beneficiary access to abruptly eliminate Medicare payment for these services when furnished via telehealth as soon as the PHE ends without first providing an opportunity to use information developed during the PHE to support requests for permanent changes to the Medicare telehealth services list.

As previously noted, in response to the PHE for the COVID-19 pandemic, we have added a broad range of services to the Medicare telehealth services list. Before eliminating the full range of these services from the Medicare telehealth services list and potentially jeopardizing beneficiary access to those services that have been clinically beneficial, based primarily on the timing of annual rulemaking, we believe it would be prudent to collect information from the public regarding which, where and how various telehealth services have been in use in various communities during the COVID-19 response. Feedback from patients and clinicians is essential to help CMS understand how the use of telehealth services may have contributed positively to, or negatively affected, the quality of care provided to beneficiaries during the PHE for the COVID-19 pandemic so that we can understand which services should be retained on the Medicare telehealth services list until we can give them full consideration under our established rulemaking process.

Therefore, we are proposing to create a third category of criteria for adding services to the Medicare telehealth services list on a temporary basis. This new category would describe services that would be included on the Medicare telehealth services list on a temporary basis. We would include in this category the services that were added during the PHE for which there is likely to be clinical benefit when furnished via telehealth, but for which there is not yet sufficient evidence available to consider the services as permanent additions under Category 1 or Category 2 criteria. Recognizing that the services we would add on a temporary basis under Category 3 would ultimately need to meet the criteria under categories 1 or 2 in order to be permanently added to the Medicare telehealth services list, and the potential for evidence development that could continue through the Category 3 temporary addition period, we considered each of the services we added on an interim final basis during the PHE. In developing the proposal to add specific services on a Category 3 basis, we conducted a clinical assessment to identify those services for which we could foresee a reasonable potential likelihood of clinical benefit when furnished via telehealth outside the circumstances of the PHE and that we anticipate would be able to demonstrate that clinical benefit in such a way as to meet our Category 2 criteria in full. Any service added under the proposed Category 3 would remain on the Medicare telehealth services list through the calendar year in which the PHE ends. When assessing whether there was a potential likelihood of clinical benefit for a service such that it should be added to the Medicare telehealth services list on a Category 3 basis, we considered the following factors:

  • Whether, outside of the circumstances of the PHE, there are increased concerns for patient safety if the service is furnished as a telehealth service.
  • Whether, outside of the circumstances of the PHE, there are concerns about whether the provision of the service via telehealth is likely to jeopardize quality of care.
  • Whether all elements of the service could fully and effectively be performed by a remotely located clinician using two-way, audio/video telecommunications technology.

We recognize that the circumstances of the PHE have provided clinicians with the opportunity to use telecommunications technology in health care delivery in a scope and manner far surpassing the telehealth services described under section 1834(m) of the Act, particularly as a Start Printed Page 50100result of the removal of geographic and site of service restrictions, and the addition of many services to the Medicare telehealth services list. When adding services to the Medicare telehealth services list on an interim basis during the PHE, we reassessed services on a Category 2 basis in the context of the widespread presence of COVID-19 in the community. We recognized that healthcare access issues could arise due to the immediate potential exposure risks to patients and healthcare workers, and that the use of telecommunication technology could mitigate risk and facilitate clinically appropriate treatment. In the context of the PHE for the COVID-19 pandemic, we found that the added services met the Category 2 criteria on the basis that there is a patient population that would otherwise not have access to clinically appropriate care (85 FR 19234). While the interim addition of a broad swath of services to the Medicare telehealth services list is responsive to critical needs during the COVID-19 PHE, the impact of adding these services to the Medicare telehealth services list on a permanent basis is currently unknown. Specifically, although it is possible to assess the uptake among health care practitioners of the added telehealth services, the extent to which service delivery via telehealth demonstrates clinical benefit outside the conditions of the PHE is not known at this time. Adding services to the Medicare telehealth services list on a Category 3 basis will give the public the opportunity to gather data and generate requests to add certain services to the Medicare telehealth services list permanently, which would be adjudicated on a Category 1 or Category 2 basis during future PFS annual rulemaking, while maintaining access to telehealth services with potential likelihood of clinical benefit. We are also proposing that the Category 3 criteria and basis for considering additions to the Medicare telehealth services list would be temporary, to expire at the end of the calendar year in which the PHE expires.

We have identified a number of services that we believe, based on our clinical assessment, fit the Category 3 criteria enumerated above in that we did not identify significant concerns over patient safety, quality of care, or the ability of clinicians to provide all elements of the service remotely if these services were to remain on the Medicare telehealth services list for an additional period beyond the PHE. Therefore we are proposing to continue including these services on the Medicare telehealth services list through the calendar year in which the PHE ends. These services are listed in Table 10. We invite public comment on the services we identified for temporary addition to the Medicare telehealth services list through the Category 3 criteria—including whether some should not be considered as Category 3 temporary additions to the Medicare telehealth services list, or whether services currently not proposed as Category 3 additions to the Medicare telehealth services list should be considered as such. While our clinical assessment indicated that the services in Table 10 demonstrate potential likelihood of clinical benefit when furnished as telehealth services and, as such, the potential to meet the Category 1 or Category 2 criteria for permanent addition to the Medicare telehealth services list with the development of additional evidence, we are seeking information from the public that would supplement our clinical assessment and assist us in consideration of our proposals regarding the Category 3 addition of services, even though we recognize that formal analyses may not yet be available. The following are examples of the kinds of information we are seeking from the public to help inform our decisions about proposed additions under Category 3:

  • By whom and for whom are the services being delivered via telehealth during the PHE;
  • What practical safeguards are being employed to maintain safety and clinical effectiveness of services delivered via telehealth; and how are practices quickly and efficiently transitioning patients from telehealth to in-person care as needed;
  • What specific health outcomes data are being or are capable of being gathered to demonstrate clinical benefit;
  • How is technology being used to facilitate the acquisition of clinical information that would otherwise be obtained by a hands-on physical examination if the service was furnished in person. Certain services on the Medicare telehealth services list prior to the PHE, specifically the office/outpatient E/M code set, involve a physical exam. With the telehealth expansions during the PHE, clinicians may have had valuable experience providing other telehealth services to patients in higher acuity settings of care, such as an emergency department, that involve a hands-on physical examination when furnished in person.
  • Whether patient outcomes are improved by the addition of one or more services to the Medicare telehealth services list, including whether inclusion on the Medicare telehealth services list increases access, safety, patient satisfaction, and overall quality of care;
  • Whether furnishing this service or services via telecommunication technology promotes prudent use of resources;
  • Whether the permanent addition of specific, individual services or categories of services to the Medicare telehealth services list supports quick responses to the spread of infectious disease or other emergent circumstances that may require widespread use of telehealth; and
  • What is the impact on the health care workforce of the inclusion of one or more services or categories of services on the Medicare telehealth services list (for example, whether the health care workforce and its capabilities to provide care are expanded).

In addition, we note that CMS is committed to the following broad goals, and these weigh heavily in our decision-making around the addition, whether temporary or permanent, of a service or services to the Medicare telehealth services list. We request that commenters consider these goals in conjunction with their comments on our proposals for the treatment of the telehealth services we added on an interim basis during the PHE for the COVID-19 pandemic:

  • Maintaining the capacity to enable rapid assessment of patterns of care, safety, and outcomes in the Medicare, Medicaid, CHIP and Marketplace populations;
  • Establishing system safeguards to detect and avert unintended patient harms that result from policy adjustments;
  • Ensuring high quality care is maintained;
  • Demonstrating ongoing quality improvement efforts by Medicare participating providers, while maintaining access to necessary care;
  • Establishing protections for vulnerable beneficiary populations (those with multiple chronic conditions, functional limitations, heart failure, COPD, diabetes, dementia), and sites of heightened vulnerability (such as nursing homes, rural communities) with high risk of adverse outcomes;
  • Ensuring appropriate resource utilization and supporting cost efficiency;
  • Supporting emergency preparedness and maintaining capacity to surge for potential coronavirus resurgence or other healthcare issues; and
  • Considering timing and pace of policy corrections in light of local and Start Printed Page 50101regional variations in systems of care and the impact of the COVID-19 pandemic.

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d. Comment Solicitation on Medicare Telehealth Services Added on an Interim Basis During the PHE for the COVID-19 Pandemic That CMS Is Not Proposing To Retain After the PHE Ends

In the March 31st COVID-19 IFC and the May 1st COVID-19 IFC, we finalized on an interim basis during the PHE for the COVID-19 pandemic the addition of a number of services to the Medicare telehealth services list. While a number of these services were previously requested and reviewed for addition by external stakeholders as part of our standard process for updating the Medicare telehealth services list, a few were identified through internal review. As discussed above, we conducted a clinical assessment of each of the services added to the Medicare telehealth services list to identify those for which we could foresee a reasonable potential likelihood of clinical benefit when furnished via telehealth outside the circumstances of the PHE. In our clinical review of these services, we did not identify sufficient information to suggest there is a potential likelihood of clinical benefit for these services such that they could meet the Category 1 or Category 2 criteria outside the circumstances of the PHE. We specifically considered the potential for these services to be furnished, outside the circumstances of the PHE, without increased concerns for patient safety or jeopardizing quality of care; and furnished fully and effectively, including all elements of the service, by a remotely located clinician via two-way, audio/video telecommunications technology. Due to these concerns, we did not find a potential likelihood that the services could meet Category 2 criteria even with development of additional evidence. However, we are inviting public comment on whether any service added to the Medicare telehealth services list for the duration of the PHE for the COVID-19 pandemic should be added to the Medicare telehealth services list on a temporary, Category 3 basis, based on the criteria outlined above. We welcome additional information from commenters about these services, as outlined in our request for comment for services we are proposing to add to the Medicare telehealth services list on a Category 3 basis.

We are also seeking specific comment on the following considerations associated with particular services. Comments on these specific concerns will also inform our final decisions on whether these services should be added to the Medicare telehealth services list on a temporary, Category 3 basis:

  • Initial and final/discharge interactions (CPT codes 99234-99236 and 99238-99239): We believe that the potential acuity of the patient described by these codes would require an in-person physical exam in order to fulfill the requirements of the service. We have concerns that without an in-person physical examination the need for the physician or health care provider to fully understand the health status of the person with whom they are establishing a clinical and therapeutic relationship would be compromised. We believe that the need for an in-person interaction would rise beyond any specific diagnosis, and serves as the foundation upon which any and all clinical decisions are based for these services. We are concerned that, without an in-person interaction, care planning that includes risk-benefit considerations and clinical decision-making will be less well-informed and create risk of patient harm.
  • Higher level emergency department visits (CPT codes 99284-99285): We are concerned that the full scope of service elements of these codes cannot be met via two-way, audio/video telecommunications technology as higher levels are indicated by patient characteristics, clinical complexity, urgency for care, and require complex decision-making. We also believe, due to the acuity of the patient described by these codes, that an in-person physical examination is necessary to fulfill the service requirements.
  • Hospital, Intensive Care Unit, Emergency care, Observation stays (CPT Start Printed Page 50103codes CPT 99217-99220; 99221-99226; 99484-99485, 99468-99472, 99475-99476, and 99477-99480): These codes describe visits that are furnished to patients who are ill enough to require hospital evaluation and care. We believe that the codes describe an evaluation for these potentially high acuity patients that is comprehensive and includes an in-person physical examination. Our view that in-person care is necessary to fulfill the requirements of the code is driven by the need for the physician or health provider to fully understand the health status of the person with whom they are establishing a clinical and therapeutic relationship. We believe that the need for an in-person interaction would rise above any specific diagnosis, and serves as the foundation upon which any and all clinical decisions are based for these services. We are concerned that, without an in-person interaction, care planning that includes risk-benefit considerations and clinical decision-making will be less well-informed and create risk of patient harm.
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With regard to the physical therapy, occupational therapy, and speech-language pathology services in Table C received a number of requests that we add therapy services to the Medicare telehealth services list. In the CY 2018 PFS final rule, we noted that section 1834(m)(4)(E) of the Act specifies the types of practitioners who may furnish and bill for Medicare telehealth services as those practitioners under section 1842(b)(18)(C) of the Act. Physical therapists (PTs), occupational therapists (OTs) and speech-language pathologists (SLPs) are not among the practitioners identified in section 1842(b)(18)(C) of the Act. We stated in the CY 2017 PFS final rule (81 FR 80198) that because these services are predominantly furnished by PTs, OTs, and SLPs, we did not believe it would be appropriate to add them to the Medicare telehealth services list at this time. In a subsequent request to consider adding these services for 2018, the original requester suggested that we might propose these services to be added to the Medicare telehealth services list so that payment can be made for them when furnished via telehealth by physicians or practitioners who can serve as distant site practitioners. We stated that since the majority of the codes are furnished over 90 percent of the time by therapy professionals who are not included on the statutory list of eligible distant site practitioners, we believed that adding therapy services to the Medicare telehealth services list could result in confusion about who is authorized to furnish and bill for these services when furnished via telehealth. While we continue to believe this is generally the case, and we are not proposing to add these services permanently to the Medicare telehealth services list, we are seeking comment on whether these services should be added to the Medicare telehealth services list so that, in instances when a practitioner who is eligible to bill for telehealth services furnishes these services via telehealth, they could bill and receive payment for them. We are also seeking comment on whether all aspects of these services can be fully and effectively furnished via two-way, audio/video telecommunications technology. We also note that given our clarification regarding telehealth services furnished incident to the professional services of a physician or practitioner (85 FR 27562), if these services were added to the Medicare telehealth services list, they could be furnished by a therapist and billed by a physician or practitioner who can furnish and bill for telehealth services provided that all of the “incident to” requirements are met.

With regard to the critical care services listed in Table 11, we have received a number of requests in prior years to add these services to the Medicare telehealth services list. In response to one such request, we finalized creation of two HCPCS G codes, G0508 (Telehealth consultation, critical care, initial, physicians typically spend 60 minutes communicating with the patient and providers via telehealth) and G0509 (Telehealth consultation, critical care, subsequent, physicians typically spend 50 minutes communicating with the patient and providers via telehealth), to describe the work associated with furnishing consultation services via Medicare telehealth to critically ill patients in the CY 2017 PFS final rule. We stated that CPT guidance makes clear that a variety of other services are bundled into the payment rates for critical care, including gastric intubations and vascular access procedures, among others. While we continue to believe that the full range of care for critically ill patients cannot be performed via two-way, audio/video telecommunications technology for the reasons articulated above, we are seeking comment on whether current coding (either through the CPT codes describing in-person critical care or the HCPCS G codes describing critical care consults furnished via telehealth) does not reflect additional models of critical care delivery, specifically, models of care delivery that utilize a combination of remote monitoring and clinical staff at the location of the beneficiary to allow, when an onsite practitioner is not available, for a practitioner at a distant site to monitor vital signs and direct in-person care as needed.

We are seeking comment on the definition, potential coding and valuation for this kind of remote service. We are also seeking comment on the following concerns:

  • How to distinguish the technical component of the remote monitoring portion of the service from the diagnosis-related group (DRG) payment already being provided to the hospital.
  • How to provide payment only for monitoring and interventions furnished to Medicare beneficiaries when the remote intensivist is monitoring multiple patients, some of which may not be Medicare beneficiaries.
  • How this service intersects with both the critical care consult G codes and the in-person critical care services.
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2. Technical Refinement to the Medicare Telehealth Services List To Reflect Current Coding

For CY 2020, the CPT Editorial Panel deleted the six existing Health and Behavior Assessment and Intervention procedure CPT codes and replaced them with nine new CPT codes. The six deleted CPT codes include CPT code 96150 (Health and behavior assessment (e.g., health-focused clinical interview, behavioral observations, psychophysiological monitoring, health oriented questionnaires), each 15 minutes face-to-face with the patient; initial assessment), CPT code 96151 (Health and behavior assessment (e.g., health-focused clinical interview, behavioral observations, psychophysiological monitoring, health oriented questionnaires), each 15 minutes face-to-face with the patient; reassessment), CPT code 96152 (Health and behavior intervention, each 15 minutes, face-to-face; individual), CPT code 96153 (Health and behavior intervention, each 15 minutes, face-to-face; group (2 or more patients)), CPT code 96154 (Health and behavior intervention, each 15 minutes, face-to-face; family (with the patient present)), and CPT code 96155 (Health and behavior intervention, each 15 minutes, face-to-face; family (without the patient present)). However, we inadvertently neglected to make the corresponding update to reflect these coding changes on the Medicare telehealth services list in CY 2020 PFS rulemaking. Therefore, we are proposing to delete CPT codes 96150-96155 from the Medicare telehealth services list and replace them with the following successor codes: CPT code 96156 (Health behavior assessment, including reassessment (i.e., health-focused clinical interview, Start Printed Page 50111behavioral observations, clinical decision making)); CPT code 96158 (Health behavior intervention, individual, face-to-face; initial 30 minutes); CPT code 96159 (Health behavior intervention, individual, face-to-face; each additional 15 minutes (list separately in addition to code for primary service)); CPT code 96164 (Health behavior intervention, group (2 or more patients), face-to-face; initial 30 minutes); CPT code 96165 (Health behavior intervention, group (2 or more patients), face-to-face; each additional 15 minutes (list separately in addition to code for primary service)); CPT code 96167 (Health behavior intervention, family (with the patient present), face-to-face; initial 30 minutes); CPT code 96168 (Health behavior intervention, family (with the patient present), face-to-face each additional 15 minutes (list separately in addition to code for primary service)); CPT code 96170 (Health behavior intervention, family (without the patient present), face-to-face; initial 30 minutes); and CPT code 96171 (Health behavior intervention, family (without the patient present), face-to-face; each additional 15 minutes (list separately in addition to code for primary service).

We are also proposing to amend our regulations to stipulate that when new codes are issued to replace codes that describe the same clinical services that are currently on the Medicare telehealth services list, we will consider those new codes to be successor codes to those that are on the Medicare telehealth services list, and will update the Medicare telehealth services list accordingly. At § 410.78(f), we are proposing to revise the final sentence of the paragraph to read: CMS maintains on the CMS website the Medicare telehealth services list under this section, including the current HCPCS codes that describe the services.

3. Furnishing Telehealth Visits in Inpatient and Nursing Facility Settings, and Critical Care Consultations

The long term care facility regulations at § 483.30(c) require that residents of SNFs receive an initial visit from a physician, and periodic personal visits subsequently by either a physician or other nonphysician practitioner (NPP). In the CY 2010 PFS final rule with comment period (74 FR 61762) we stated that these regulations ensure that at least a minimal degree of personal contact between a physician or a qualified NPP and a resident is maintained, both at the point of admission to the facility and periodically during the course of the resident's stay. In that rule we stated that we believe that these federally-mandated visits should be conducted in-person, and not as Medicare telehealth services. We therefore revised § 410.78 to restrict physicians and practitioners from using telehealth to furnish the physician visits required under § 483.30(c).

During the PHE for the COVID-19 pandemic, we waived the requirement in 42 CFR 483.30 for physicians and nonphysician practitioners to personally perform required visits for nursing home residents, and allowed visits to be conducted via telehealth (https://www.cms.gov/​files/​document/​summary-covid-19-emergency-declaration-waivers.pdf).

We are seeking public comment on whether it would be appropriate to maintain this flexibility on a permanent basis outside of the PHE for the COVID-19 pandemic. We invite public comment on whether the in-person visit requirement is necessary, or whether two-way, audio/video telecommunications technology would be sufficient in instances when, due to continued exposure risk, workforce capacity, or other factors, the clinician determines an in-person visit is not necessary.

We have also received requests to revise our frequency limitations for telehealth subsequent inpatient and nursing facility visits. Currently, we limit the provision of subsequent inpatient visits via Medicare telehealth to once every 3 days and subsequent nursing facility visits to once every 30 days. We received a request to remove the frequency limitation on the subsequent inpatient services and a separate request to revise the subsequent nursing facility visits to once every 3 days, rather than 30 days.

As we stated in the CY 2019 PFS final rule, we believed the potential acuity of illness of hospital inpatients is greater than that of patients who are likely to receive services that were on the Medicare telehealth services list at that time. We also stated that it would be appropriate to permit some subsequent hospital care services to be furnished through telehealth to ensure that hospitalized patients have frequent encounters with their admitting practitioner. In addition, we expressed our belief that the majority of these visits should be furnished in person to facilitate the comprehensive, coordinated, and personal care that medically volatile, acutely ill patients require on an ongoing basis. Because of our concerns regarding the potential acuity of illness of hospital inpatients, we finalized the addition of CPT codes 99231-99233 to the Medicare telehealth services list, but limited the provision of these subsequent hospital care services through telehealth to once every 3 days. We continue to believe that admitting practitioners should continue to make appropriate in-person visits to all patients who need such care during their hospitalization. Our concerns with, and position on, the provision of subsequent hospital care services via telehealth have not changed (83 FR 59493). Therefore, we are not proposing to modify our current policy.

In the CY 2018 PFS final rule, we reiterated that we believed it would be appropriate to permit some subsequent nursing facility (NF) care services to be furnished through telehealth to ensure that complex nursing facility patients have frequent encounters with their admitting practitioner, but because of our concerns regarding the potential acuity and complexity of NF inpatients, we limited the provision of subsequent NF care services furnished through telehealth to once every 30 days. We also stated that we continued to have concerns regarding more routine use of telehealth given the potential acuity and complexity of NF inpatients, and therefore, we were not proposing to remove the frequency limitation for subsequent NF care services (83 FR 59494). We have received comments from stakeholders who stated that the once every 30-day frequency limitation for subsequent NF visits furnished via Medicare telehealth limits access to care for Medicare beneficiaries in the NF setting. Stakeholders stated that the use of Medicare telehealth is crucial to maintaining a continuum of care in this setting and that CMS should leave it up to clinicians to decide how frequently a visit may be furnished as a Medicare telehealth service rather than in person depending on the needs of specific patients. We are persuaded by the comments from these stakeholders, and therefore, are proposing to revise the frequency limitation from one visit every 30 days to one visit every 3 days. We believe this interval strikes the right balance between requiring in-person visits and allowing flexibility to furnish services via telehealth when clinically appropriate to do so. We are also seeking comment on whether frequency limitations broadly are burdensome and limit access to necessary care when services are available only through telehealth, and how best to ensure that patients are receiving necessary in-person care.Start Printed Page 50112

4. Proposed Technical Amendment To Remove References to Specific Technology

The final sentence of our regulation at § 410.78(a)(3) prohibits the use of telephones, facsimile machines, and electronic mail systems for purposes of furnishing Medicare telehealth services. In the March 31st COVID-19 IFC, we added a new § 410.78(a)(3)(i) (and reserved § 410.78(a)(3)(ii) for later use) to provide for an exception that removes application of that sentence during the PHE for the COVID-19 pandemic. We added the new section on an interim final basis because we believe that the first sentence of § 410.78(a)(3) adequately describes the technology requirements for an interactive telecommunication system that may be used to furnish a Medicare telehealth service. That sentence defines interactive telecommunication system as “multimedia communications equipment that includes, at a minimum, audio and video equipment permitting two-way, real-time interactive communication.” We were also concerned that the reference to “telephones” in the second sentence of the regulation as impermissible technology could cause confusion in instances where an otherwise eligible device, such as a smart phone, may also be used as a telephone. Because these concerns are not situation- or time-limited to the PHE for COVID-19, we are proposing to remove the second sentence of the regulation at § 410.78(a)(3) which specifies that “[t]elephones, facsimile machines, and electronic mail systems do not meet the definition of an interactive telecommunications system.” As we are proposing to adopt this change on a permanent basis, we are also proposing to delete the subparagraphs at § 410.78(a)(3)(i) and 410.78(a)(3)(ii). We believe these amendments to our regulations would remove outdated references to specific types of technology and provide a clearer statement of our policy.

5. Communication Technology-Based Services (CTBS)

In the CY 2019 PFS final rule, we finalized separate payment for a number of services that could be furnished via telecommunications technology, but that are not considered Medicare telehealth services. Specifically, we 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), and 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). We finalized maintenance of these codes as part of the set of codes that is only reportable by those practitioners that can furnish E/M services. We stated that we believed this was appropriate since the service describes a check-in directly with the billing practitioner to assess whether an office visit is needed. However, we did note that similar check-ins provided by nurses and other clinical staff can be important aspects of coordinated patient care (83 FR 59486).

In the CY 2020 PFS final rule, we finalized separate payment for HCPCS codes G2061 (Qualified nonphysician healthcare professional online assessment and management, for an established patient, for up to seven days, cumulative time during the 7 days; 5-10 minutes), G2062 (Qualified nonphysician healthcare professional online assessment and management service, for an established patient, for up to seven days, cumulative time during the 7 days; 11-20 minutes), and G2063 (Qualified nonphysician qualified healthcare professional assessment and management service, for an established patient, for up to seven days, cumulative time during the 7 days; 21 or more minutes). In that rule, we stated that these codes may be billed by nonphysician practitioners (NPPs) consistent with the definition of their respective benefit category, although we did not provide specific examples (84 FR 62796).

We have received a number of questions regarding which benefit categories HCPCS codes G2061 through G2063 fall under. In the March 31st COVID-19 IFC (85 FR 19244-19245) we established on an interim basis for the duration of the PHE for the COVID-19 pandemic that these services could be billed for example, by licensed clinical social workers and clinical psychologists, as well as PTs, OTs, and SLPs who bill Medicare directly for their services when the service furnished falls within the scope of these practitioner's benefit categories. We are proposing to adopt that policy on a permanent basis. We note that this is not an exhaustive list and we are seeking comment on other benefit categories into which these services fall.

We are also proposing to allow billing of other CTBS by certain nonphysician practitioners, consistent with the scope of these practitioners' benefit categories through the creation of two additional HCPCS G codes that can be billed by practitioners who cannot independently bill for E/M services:

  • G20X0 (Remote assessment 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 service provided within the previous 7 days nor leading to a service or procedure within the next 24 hours or soonest available appointment.)
  • G20X2 (Brief communication technology-based service, e.g. virtual check-in, by a qualified health care professional who cannot 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 a service or procedure within the next 24 hours or soonest available appointment; 5-10 minutes of medical discussion).

We are proposing to value these services identically to HCPCS codes G2010 and G2012, respectively. We acknowledge that it has been agency policy, in general, to differentially value similar services that are performed by practitioners who can and cannot, respectively, bill independently for E/M services, with higher values for the service performed by practitioners who can independently bill E/M services. However, given the relatively low values for HCPCS codes G2010 and G2012, we do not think that there is a significant differential in resource costs to warrant different values, but are seeking comment on whether we should value these services differentially, including potentially increasing the valuation of HCPCS codes G2010 and G2012.

Further, to facilitate billing of the CTBS by therapists, we are proposing to designate HCPCS codes G20X0, G20X2, G2061, G2062, and G2063 as “sometimes therapy” services. When billed by a private practice PT, OT, or SLP, the codes would need to include the corresponding GO, GP, or GN therapy modifier to signify that the CTB are furnished as therapy services furnished under an OT, PT, or SLP plan of care.Start Printed Page 50113

We also note that in section II.K. of this proposed rule we are proposing for CY 2021 to replace the eVisit G codes with corresponding CPT codes, and that this policy would also apply to those codes.

For all of these CTBS, we are also making clear that the consent from the patient to receive these services can be documented by auxiliary staff under general supervision, as well as by the billing practitioner. While we continue to believe that beneficiary consent is necessary so that the beneficiary is notified of cost sharing when receiving these services, we do not believe that the timing or manner in which beneficiary consent is acquired should interfere with the provision of one of these services. We are retaining the requirement that, in instances when the brief communication technology-based service originates from a related E/M service (including one furnished as a telehealth service) provided within the previous 7 days by the same physician or other qualified health care professional, this service would be considered bundled into that previous E/M service and would not be separately billable.

6. Comment Solicitation on Continuation of Payment for Audio-Only Visits

In the March 31st COVID-19 IFC, we established separate payment for audio-only telephone evaluation and management (E/M) services (85 FR 19264 through 19266). The telephone E/M services are CPT codes 99441 (Telephone evaluation and management service by a physician or other qualified health care professional who may report evaluation and management services provided to an established patient, parent, or guardian 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); 99442 (Telephone evaluation and management service by a physician or other qualified health care professional who may report evaluation and management services provided to an established patient, parent, or guardian 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; 11-20 minutes of medical discussion); and 99443 (Telephone evaluation and management service by a physician or other qualified health care professional who may report evaluation and management services provided to an established patient, parent, or guardian 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; 21-30 minutes of medical discussion). We noted that, although these services were previously considered non-covered under the PFS, in the context of the PHE and with the goal of reducing exposure risks associated with the COVID-19 pandemic, especially in the case that two-way, audio and video technology is not available to furnish a Medicare telehealth service, we believed there are circumstances where prolonged, audio-only communication between the practitioner and the patient could be clinically appropriate, yet not fully replace a face-to-face visit. For example, an established patient who was experiencing an exacerbation of their condition could have a 25-minute phone conversation with their physician during which the physician determines that an adjustment to the patient's medication would alleviate their symptoms. The use of CPT code 99443 in this situation prevents a similar in-person service as the evaluation of the patient's symptoms and determination to adjust medication could be conducted without patient and the practitioner being in the same location. We stated our belief that these telephone E/M codes, with their established description and valuation, were the best way to recognize the relative resource costs of these kinds of services and make payment for them under the PFS. For these codes, we initially finalized on an interim basis during the PHE for the COVID-19 pandemic, work relative value units (RVUs) as recommended by the American Medical Association (AMA) Relative Value Scale Update Committee (RUC), as discussed in the CY 2008 PFS final rule with comment period (72 FR 66371), of 0.25 for CPT code 99441, 0.50 for CPT code 99442, and 0.75 for CPT code 99443. We also finalized the RUC-recommended direct practice expense (PE) inputs which consist of 3 minutes of post-service Registered Nurse/Licensed Practical Nurse/Medical Technical Assistant clinical labor time for each code.

In the May 1st COVID-19 IFC, we noted that in the time since we established these payment amounts, stakeholders had informed us that use of audio-only services was more prevalent than we had previously considered, especially because many beneficiaries were not utilizing video-enabled communication technology from their homes. In other words, there were many cases where practitioners would under ordinary circumstances utilize telehealth or in-person visits to evaluate and manage patients' medical concerns, but were instead using audio-only interactions to manage more complex care (85 FR 27589 through 27590). While we had previously acknowledged the likelihood that, under the circumstances of the PHE, more time would be spent interacting with the patient via audio-only technology, we stated that the intensity of furnishing an audio-only visit to a beneficiary during the unique circumstances of the COVID-19 pandemic was not accurately captured by the valuation of these services we established in the March 31st COVID-19 IFC. This would be particularly true to the extent that these audio-only services are actually serving as a substitute for office/outpatient Medicare telehealth visits for beneficiaries not using video-enabled telecommunications technology contrary to the situation we anticipated when establishing payment for them in the March 31st COVID-19 IFC. We stated that, given our understanding that these audio-only services were being furnished primarily as a replacement for care that would otherwise be reported as an in-person or telehealth visit using the office/outpatient E/M codes, we established new RVUs for the telephone E/M services based on crosswalks to the most analogous office/outpatient E/M codes, based on the time requirements for the telephone codes and the times assumed for valuation for purposes of the office/outpatient E/M codes. Specifically, we crosswalked CPT codes 99212, 99213, and 99214 to CPT codes 99441, 99442, and 99443, respectively. We therefore finalized, on an interim basis and for the duration of the COVID-19 PHE, the following work RVUs: 0.48 for CPT code 99441; 0.97 for CPT code 99442; and 1.50 for CPT code 99443. We also finalized the direct PE inputs associated with CPT code 99212 for CPT code 99441, the direct PE inputs associated with CPT code 99213 for CPT code 99442, and the direct PE inputs associated with CPT code 99214 for CPT code 99443. We did not finalize increased payment rates for CPT codes 98966-98968 as these codes describe services furnished by practitioners who cannot independently bill for E/M services and so these telephone assessment and management services, by definition, are not being furnished in lieu of an office/outpatient E/M service. We noted that to the extent that these extended phone services are taking Start Printed Page 50114place instead of office/outpatient E/M visits (either in-person or via telehealth), the direct crosswalk of RVUs also better maintains overall budget neutrality and relativity under the PFS. We stated that we believed that the resources required to furnish these services during the PHE for the COVID-19 pandemic are better captured by the RVUs associated with the level 2-4 established patient office/outpatient E/M visits. Additionally, we stated that, given our understanding that these audio-only services were being furnished as substitutes for office/outpatient E/M services, we recognized that they should be considered as telehealth services, and added them to the Medicare telehealth services list for the duration of the PHE. For these audio-only E/M services, we separately issued a waiver under section 1135(b)(8) of the Act, as amended by section 3703 of the CARES Act, of the requirements under section 1834(m) of the Act and our regulation at § 410.78 that Medicare telehealth services must be furnished using video technology.

We are not proposing to continue to recognize these codes for payment under the PFS after conclusion of the PHE for the COVID-19 pandemic because, outside of the circumstances of the PHE, we are not able to waive the requirement that telehealth services be furnished using an interactive telecommunications system that includes two-way, audio/video communication technology. However, we recognize that the need for audio-only interaction could remain as beneficiaries continue to try to avoid sources of potential infection, such as a doctor's office; and in that circumstance, a longer phone conversation may be needed to determine if an in-person visit is necessary than what is described by the virtual check-in. We are seeking comment on whether CMS should develop coding and payment for a service similar to the virtual check-in but for a longer unit of time and with an accordingly higher value. We are seeking input from the public on the appropriate duration interval for such services and the resources in both work and PE that would be associated with furnishing them. We are also seeking comment on whether separate payment for such telephone-only services should be a provisional policy to remain in effect until a year or some other period after the end of the PHE or if it should be PFS payment policy permanently.

7. Comment Solicitation on Coding and Payment for Virtual Services

The health care community uses the term “telehealth” broadly to refer to medical services furnished via communications technology. Under current PFS payment rules, Medicare routinely pays for many of these kinds of services. This includes some kinds of remote patient monitoring (either as separate services or as parts of bundled services), interpretations of diagnostic tests when furnished remotely and, under conditions specified in section 1834(m) of the Act, services that would otherwise be furnished in person but are instead furnished via real-time, interactive communication technology. Over the past several years, we have also established several PFS policies to make separate payment for non-face-to-face services included as part of ongoing care management. Although all of the kinds of services stated above might be called “telehealth” by patients, other payers and health care providers, we have generally used the term “Medicare telehealth services” to refer to the subset of services defined in section 1834(m) of the Act. Section 1834(m) of the Act defines Medicare telehealth services and specifies the payment amounts and circumstances under which Medicare makes payment for a discrete set of services, all of which must ordinarily be furnished in-person, when they are instead furnished using interactive, real time telecommunication technology.

We believe that the provisions in section 1834(m) of the Act apply particularly to the kinds of professional services explicitly enumerated in the statutory provisions, like professional consultations, office visits, and office psychiatry services. Generally, the services we have added to the Medicare telehealth services list are similar to these kinds of services. As has long been the case, certain other kinds of services that are furnished remotely using communications technology are not considered “Medicare telehealth services” and are not subject to the restrictions articulated in section 1834(m) of the Act. This is true for services that were routinely paid separately prior to the enactment of the provisions in section 1834(m) of the Act and do not usually include patient interaction (such as remote interpretation of diagnostic imaging tests), and for services that were not discretely defined or separately paid for at the time of enactment and that do include patient interaction (such as chronic care management services).

In recent years, we have begun making separate payment for a number of services that use telecommunications technology but are not considered Medicare telehealth services. These CTB services include, for example, certain kinds of remote patient monitoring (either as separate services or as parts of bundled services), a virtual check-in, and a remote asynchronous service. These services are different than the kinds of services specified in section 1834(m) of the Act, in that they are not the kind of services that are ordinarily furnished in person but are routinely furnished using a telecommunications system.

In the past, we have received requests to add certain services, such as chronic care management or remote physiologic monitoring to the Medicare telehealth services list. However, as these services fall outside the scope of services addressed, and the enumerated list of services included in section 1834(m) of the Act, they are not considered telehealth services and, therefore, are not subject to the same restrictions. We are seeking comment on whether there are additional services that fall outside the scope of telehealth services under section 1834(m) of the Act where it would be helpful for us to clarify that the services are inherently non-face-to-face, so do not need to be on the Medicare telehealth services list in order to be billed and paid when furnished using telecommunications technology rather than in person with the patient present. We are also seeking comment on physicians' services that use evolving technologies to improve patient care that may not be fully recognized by current PFS coding and payment, including, for example, additional or more specific coding for care management services. Finally, we are broadly seeking comment on any impediments that contribute to healthcare provider burden and that may result in practitioners being reluctant to bill for CTBS. We appreciate the ongoing engagement and additional information from stakeholders as we work to improve coding and payment for these services that utilize telecommunications technology.

8. Proposed Clarification of Existing PFS Policies for Telehealth Services

In response to the waiver of statutory requirements and the relaxation of regulatory requirements for telehealth during the PHE for the COVID-19 pandemic, we received a number of requests to clarify existing PFS policy for telehealth. For example, we received questions as to whether Medicare allows incident-to billing for telehealth services, particularly for practitioners such as counselors who are supervised Start Printed Page 50115by a physician in private practice. We note that there are no Medicare regulations that explicitly prohibit eligible distant site practitioners from billing for telehealth services provided incident to their services. However, we also note that our existing definition of direct supervision requires on-site presence of the billing clinician when the service is provided. That requirement could make it difficult for a billing clinician to provide the direct supervision of services provided via telehealth incident to their professional services by auxiliary personnel. Under our proposed amendment to the definition of direct supervision to permit virtual presence, we acknowledge that billing practitioners could more easily meet the direct supervision requirements for telehealth services provided incident to their services. Consequently, we believe that services provided incident to the professional services of an eligible distant site physician or practitioner could be reported when they meet direct supervision requirements at both the originating and distant site through the virtual presence of the billing physician or practitioner. Therefore, we are proposing to clarify that services that may be billed incident-to may be provided via telehealth incident to a physicians' service and under the direct supervision of the billing professional. This is consistent with a policy clarification that we made through the May 1st COVID-19 IFC (85 FR 27562).

We have also received questions as to whether services should be reported as telehealth services when the individual physician or practitioner furnishing the service is in the same location as the beneficiary; for example, if the physician or practitioner furnishing the service is in the same institutional setting but is utilizing telecommunications technology to furnish the service due to exposure risks. We are clarifying, as we did in the May 1st COVID-19 IFC (85 FR 27562) that if audio/video technology is used in furnishing a service when the beneficiary and the practitioner are in the same institutional or office setting, then the practitioner should bill for the service furnished as if it was furnished in person, and the service would not be subject to any of the telehealth requirements under section 1834(m) of the Act or § 410.78 of our regulations.

9. Direct Supervision by Interactive Telecommunications Technology

Many services for which payment is made under the PFS can be furnished under a level of physician or NPP supervision rather than being performed directly by the billing practitioner. In many cases, the supervision requirements necessitate the presence of the physician or NPP in a particular location, usually in the same location as the beneficiary when the service is provided. For example, as described at § 410.26, services furnished by auxiliary personnel incident to a physician's or NPP's professional service usually require the direct supervision of the physician or NPP. In addition to these “incident to” services, there are a number of diagnostic services under the PFS that also must be furnished under direct supervision. As currently defined in §§ 410.26 and 410.32(b)(3)(ii), direct supervision means that the physician or NPP must be present in the office suite and immediately available to furnish assistance and direction throughout the performance of the procedure. Direct supervision does not require the physician or NPP to be present in the room when the service or procedure is performed.

For the duration of the PHE for the COVID-19 pandemic, for purposes of limiting exposure to COVID-19, we adopted an interim final policy revising the definition of direct supervision to include virtual presence of the supervising physician or practitioner using interactive audio/video real-time communications technology (85 FR 19245). We recognized that in some cases, the physical proximity of the physician or practitioner might present additional infection exposure risk to the patient and/or practitioner. In the context of the PHE for the COVID-19 pandemic, given the risks of exposure, the immediate risk of foregone medical care, the increased demand for healthcare professionals, and the widespread use of telecommunications technology, we believed that individual practitioners were in the best position to make decisions about how to meet the requirement to provide appropriate direct supervision based on their clinical judgment in particular circumstances.

We are proposing to extend this policy until the later of the end of the calendar year in which the PHE ends or December 31, 2021, to recognize the different and unique circumstances faced by individual communities that may continue after the PHE ends, and provide time to solicit public input on circumstances where the flexibility to use interactive audio/video real-time communications technology to provide virtual direct supervision could still be needed and appropriate. The extension of this flexibility would allow time for clinicians to make adjustments and for us to obtain public input on services and circumstances for which this policy might be appropriate on a permanent basis. We note that if we finalize this proposal and the PHE ends before the CY 2021 PFS final rule takes effect, the interim policy adopted during the PHE to allow direct supervision using real-time, interactive audio and video technology would no longer be in effect during the period between expiration of the PHE and the date the final policy takes effect.

Given our continued interaction with practitioners during the PHE and our growing understanding of how services may be furnished remotely and safely, we now have a better understanding of how, in some cases, depending upon the unique circumstances of individual patients and billing practitioners or physicians, telecommunications technology could safely allow the practitioner or physician's immediate availability to furnish assistance and direction without necessarily requiring the supervising practitioner's or physician's physical presence in the location where the service is being furnished. In such cases, the use of real-time, audio and video telecommunications technology may allow the supervising practitioner or physician to observe the beneficiary and the auxiliary staff performing the service or be engaged (Direct supervision does not require the physician or NPP to be present in the room when the service or procedure is performed) to provide assistance and direction of the service through virtual means, and without the supervising practitioner or physician being physically present.

Consequently, we are proposing to revise § 410.32(b)(3)(ii) to allow direct supervision to be provided using real-time, interactive audio and video technology through the later of the end of the calendar year in which the PHE ends or December 31, 2021. Specifically, we propose to continue our current rule that “Direct supervision” in the office setting means the physician (or other supervising practitioner) must be present in the office suite and immediately available to furnish assistance and direction throughout the performance of the procedure. It does not mean that the physician (or other supervising practitioner) must be present in the room when the procedure is performed. We propose to add that, until the later of the end of the calendar year in which the PHE ends or December 31, 2021, the presence of the physician (or other practitioner) may include virtual presence through audio/video real-time communications technology (excluding audio-only) subject to the clinical judgement of the Start Printed Page 50116supervising physician or (other supervising practitioner). In response to questions received since we issued our interim policy for the PHE, we are clarifying that, to the extent our policy allows direct supervision through virtual presence using audio/video real-time communications technology, the requirement could be met by the supervising physician (or other practitioner) being immediately available to engage via audio/video technology (excluding audio-only), and would not require real-time presence or observation of the service via interactive audio and video technology throughout the performance of the procedure.

While flexibility to provide direct supervision through audio/video real-time communications technology was adopted to be responsive to critical needs during the PHE to ensure beneficiary access to care, reduce exposure risk and to increase the capacity of practitioners and physicians to respond to COVID-19, we are concerned that direct supervision through virtual presence may not be sufficient to support PFS payment on a permanent basis, beyond the PHE, due to issues of patient safety. For instance, in complex, high-risk, surgical, interventional, or endoscopic procedures, or anesthesia procedures, a patient's clinical status can quickly change and we believe it is necessary for such services to be furnished or supervised in person to allow for rapid on-site decision-making in the event of an adverse clinical situation. For example, there could be a case in which a practitioner or physician uses audio/video interactive communications to virtually supervise a nurse performing a post-op evaluation following surgery for hip fracture, and the nurse might note that the patient is uncooperative. In this scenario, had a full exam been performed directly by the practitioner or physician, or under the in-person supervision of a practitioner or physician who was physically or immediately available in the clinic to provide the necessary direction, the physician or practitioner would have recognized that the patient exhibited signs of crystal-mediated acute arthritis, and that the patient's lack of cooperation was likely due to hypoactive delirium. Instead, the supervising practitioner or physician may not have been able to identify this clinical issue as a result of being available only via audio/video interactive communications technology. In this case, the presence of the supervising practitioner or physician through audio/video interactive communications technology would have been insufficient. There also may be certain patient populations that require greater clinical attentiveness and skill than the supervising practitioner or physician could provide via audio/video interactive communications technology. For example, patients with cognitive impairment or dementia, or patients with communication disabilities, may require the experience and skill of a physically present supervising practitioner or physician to recognize needs such as the need for specialized testing. It may not be possible for a supervising practitioner or physician to recognize or meet these clinical needs while being present for the service only through audio/video interactive communications technology. Moreover, the virtual connection between the individual performing the service and the supervising practitioner or physician could be disrupted, making it challenging for the supervising practitioner or physician to remain immediately available to provide assistance and direction to the physically present clinical staff or auxiliary personnel to furnish appropriate care to the patient.

We are seeking information from commenters as to whether there should be any additional “guardrails” or limitations to ensure patient safety/clinical appropriateness, beyond typical clinical standards, as well as restrictions to prevent fraud or inappropriate use if we were to finalize a policy to permit direct supervision through audio/video interactive communications technology, with consideration of relevant patient safety, clinical appropriateness criteria or other restrictions, on a temporary basis through the later of the end of the calendar year in which the PHE ends or December 31, 2021, or consider it beyond the time specified. We are also seeking information on what risks this policy might introduce to beneficiaries as they receive care from practitioners that would supervise care virtually in this way. Further we are seeking comment on potential concerns around induced utilization and fraud, waste, and abuse and how those concerns might be addressed. We also invite commenters to provide data and information about their implementation experience with direct supervision using virtual presence during the PHE, and are interested in comments on the degree of aging and disability competency training that is required for effective use of audio/video real-time communications technology.

10. Comment Solicitation on PFS Payment for Specimen Collection for COVID-19 Tests

When physicians and other practitioners collect specimens for clinical diagnostic laboratory tests as part of their professional services, Medicare generally makes payment for the services under the PFS, though often that payment is bundled into the payment rate for other services, including office and outpatient visits. Typically, collection of a specimen via nasal swab or other method during the provision of a service might be reported as part of (bundled with) an office/outpatient E/M visit (CPT codes 99201 through 99205, 99211 through 99215). In visits where a patient has a face-to-face interaction with a billing professional with whom they have an established relationship, these services are generally reported with a level 2 through a level 5 visit (CPT codes 99212 through 99215). In cases where the specimen is collected during a visit where the face-to-face interaction only involves clinical staff of the billing professional with whom the patient has an established relationship, these services are generally reported using CPT code 99211.

In the May 1st COVID-19 IFC (85 FR 27604-27605), we finalized on an interim basis that physicians and NPPs may use CPT code 99211 to bill for services furnished incident to their professional services, for both new and established patients, when clinical staff assess symptoms and collect specimens for purposes of COVID-19 testing, if the billing practitioner does not also furnish a higher level E/M service to the patient on the same day. We are considering whether to extend or make permanent the policy to allow physicians and NPPs to use CPT code 99211 to bill for services furnished incident to their professional services, for both new and established patients, when clinical staff assess symptoms and collect specimens for purposes of COVID-19 testing, and are soliciting public comments on whether we should continue this policy for a period of time, or permanently, after the COVID-19 PHE ends.

E. Care Management Services and Remote Physiologic Monitoring Services

1. Background

In recent years, we have updated PFS policies to improve payment for care management and 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 describe services that involve direct patient Start Printed Page 50117contact (for some services, in-person) or do not involve direct patient contact; represent a single encounter, monthly service, or both; are timed services; address specific conditions; and represent the work of the billing practitioner, auxiliary personnel (specifically, clinical staff), or both (see Table 13). In this proposed rule for CY 2021, we continue our work to improve payment for care management services through proposed code refinements related to remote physiologic monitoring (RPM), transitional care management (TCM), and psychiatric collaborative care model (CoCM) services.

2. Digitally Stored Data Services/Remote Physiologic Monitoring/Treatment Management Services (RPM)

RPM involves the collection and analysis of patient physiologic data that are used to develop and manage a treatment plan related to a chronic and/or acute health illness or condition. In recent years, we have finalized payment for seven CPT codes in the RPM code family. Five of the seven codes have been the focus of frequent questions from stakeholders.

In response to proposals in the CY 2019 PFS proposed rule (83 FR 35771) and the CY 2020 PFS proposed rule (84 FR 40555 through 40556), stakeholders requested that we clarify how we interpret aspects of the RPM code descriptors for CPT codes 99453, 99454, 99091, and 99457. Commenters asked us, for example, to identify who can furnish RPM services, what kinds of medical devices can be used to collect data, how data should be collected, and how “interactive communication” is defined. We stated in the CY 2020 PFS final rule (84 FR 62697) that we would provide guidance in the future about the codes. For CY 2021, we are clarifying how we read CPT code descriptors and instructions associated with CPT codes 99453, 99454, 99091, and 99457 (and the add-on code, CPT code 99458) and their use to describe remote monitoring of physiologic parameters of a patient's health.

The RPM process begins with two practice expense (PE) only codes, CPT codes 99453 and 99454, finalized in the CY 2019 PFS final rule (83 FR 39574 through 39576). As PE only codes they are valued to include clinical staff time, supplies, and equipment, including the medical device for the typical case of remote monitoring. 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) is Start Printed Page 50118valued to reflect clinical staff time that includes instructing a patient and/or caregiver about using one or more medical devices. CPT code 99454 (Remote monitoring of physiologic parameter(s) (e.g., weight, blood pressure, pulse oximetry, respiratory flow rate), initial; device(s) supply with daily recording(s) or programmed alert(s) transmission, each 30 days) is valued to include the medical device or devices supplied to the patient and the programming of the medical device for repeated monitoring. We reviewed the PE inputs for CPT code 99454 for purposes of this proposal, and are clarifying that the medical device or devices that are supplied to the patient and used to collect physiologic data are considered equipment and as such are direct PE inputs for the code.

Review of CPT prefatory language (CPT® 2020 Professional Codebook (hereafter, CPT Codebook), p. 42) provides additional information about the two PE only codes. For example, the CPT prefatory language indicates that monitoring must occur over at least 16 days of a 30-day period in order for CPT codes 99453 and 99454 to be billed. Additionally, these two codes are not to be reported for a patient more than once during a 30-day period. This language suggests that even when multiple medical devices are provided to a patient, the services associated with all the medical devices can be billed only once per patient per 30-day period and only when at least 16 days of data have been collected. We also note that CPT 99453 can be billed only once per episode of care where an episode of care is defined as “beginning when the remote physiologic monitoring service is initiated and ends with attainment of targeted treatment goals” (CPT Codebook, p. 42).

Other stakeholder inquiries about CPT codes 99453 and 99454 focus upon the kinds of medical devices that can be used to collect the patient's physiologic data. Prefatory language in the CPT Codebook states that “the device must be a medical device as defined by the FDA.” CPT simply specifies that the device must meet the FDA's definition of a medical device as described in section 201(h) of the Federal, Food, Drug and Cosmetic Act (FFDCA). We have found no language in the CPT Codebook indicating that a medical device must be FDA cleared as some stakeholders have suggested although such clearance may be appropriate. Nor have we found information that suggests a medical device must be prescribed by a physician, although this could be possible depending upon the medical device. Beyond acknowledging the CPT specification that the medical device supplied for CPT code 99454 must meet the FDA definition of a medical device, we are clarifying that the medical device should digitally (that is, automatically) upload patient physiologic data (that is, data are not patient self-recorded and/or self-reported). We note also that use of the medical device or devices that digitally collect and transmit a patient's physiologic data must, as usual for most Medicare covered services, be reasonable and necessary for the diagnosis or treatment of the patient's illness or injury or to improve the functioning of a malformed body member. Further, the device must be used to collect and transmit reliable and valid physiologic data that allow understanding of a patient's health status to develop and manage a plan of treatment.

The CPT Codebook lists the RPM codes under the main heading Evaluation and Management (E/M). We are clarifying that as E/M codes, CPT codes 99453, 99454, 99091, 99457, and 99458, can be ordered and billed only by physicians or nonphysician practitioners (NPPs) who are eligible to bill Medicare for E/M services.

Although we initially described RPM services in the CY 2019 PFS final rule (83 FR 35771) as services furnished to patients with chronic conditions, we are also clarifying that practitioners may furnish these services to remotely collect and analyze physiologic data from patients with acute conditions, as well as from patients with chronic conditions.

After the 30-day data collection period for CPT codes 99453 and 99454, the physiologic data that are collected and transmitted are analyzed and interpreted by the physician or practitioner as described by CPT code 99091, a code that includes only professional work, that is, there are no direct PE inputs. We finalized payment for CPT code 99091 (Collection and interpretation of physiologic data 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 requiring a minimum of 30 minutes of time, each 30 days) in the CY 2018 PFS final rule (82 FR 59473). The valuation for CPT code 99091 includes a total time of 40 minutes of physician or nonphysician practitioner work broken down as follows: 5 minutes of preservice work (for example, chart review); 30 minutes of intra-service work (for example, data analysis and interpretation, report based upon the physiologic data, as well as a possible phone call to the patient); and 5 minutes of post-service work (that is, chart documentation). We note that stakeholders have expressed confusion about the specification in the code descriptor for CPT code 99091 that the service is furnished by a “physician or other qualified health care professional, qualified by education, training, licensure/regulation.” The phrase “physician or other qualified healthcare professional” is defined by CPT as, “an individual who is qualified by education, training, licensure/regulation (when applicable) and facility privileging (when applicable) who performs a professional service within his/her scope of practice and independently reports that professional service. These professionals are distinct from “clinical staff . . . [which refers to] a person who works under the supervision of a physician or other qualified healthcare professional and who is allowed by law, regulation, and facility policy to perform or assist in the performance of a specified professional service but does not individually report that professional service.” [1] Accordingly, when referring to a particular service described by a CPT code for Medicare purposes, a physician or other qualified healthcare professional is an individual whose scope of practice and Medicare benefit category includes the service and who is authorized to independently bill Medicare for the service. See our previous discussion of this in the CY 2016 PFS final rule at 80 FR 70957. Medicare also covers and makes payment for certain services performed by auxiliary personnel (which includes clinical staff) “incident to” the professional services of the billing practitioner. Our regulation at § 410.26(a) defines auxiliary personnel (a term that includes clinical staff) and delineates the conditions for payment for “incident to” services.

After analyzing and interpreting a patient's remotely collected physiologic data, the next step in the process of RPM is the development of a treatment plan that is informed by the analysis and interpretation of the patient's data. It is at this point that the physician or nonphysician practitioner develops a treatment plan with the patient and/or caregiver (that is, patient-centered care) and then manages the plan until the targeted goals of the treatment plan are attained, which signals the end of the episode of care. CPT code 99457 (Remote physiologic monitoring treatment management services, clinical staff/physician/other qualified health care professional time in a calendar Start Printed Page 50119month requiring interactive communication with the patient/caregiver during the month; first 20 minutes) and its add-on code, CPT code 99458 (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; each additional 20 minutes) describe the treatment and management services associated with RPM. Medicare stakeholders have requested that we clarify aspects of these two codes. The two most frequently asked questions include, “Who can furnish the services described by CPT codes 99457 and 99458? ” and “What does it mean to have an `interactive communication' with a patient? ”

We addressed who can furnish CPT codes 99457 and 99458 in the CY 2020 PFS final rule (84 FR 62697 through 62698) when we designated both codes as care management services. We explained that, like other care management services, CPT codes 99457 and 99458 can be furnished by clinical staff under the general supervision of the physician or NPP. We note that RPM services are not considered to be diagnostic tests; that is, they cannot be furnished and billed by an Independent Diagnostic Testing Facility on the order of a physician or NPP.

The services described by CPT codes 99457 and 99458 are services that are typically furnished remotely using communications technologies that allow “interactive communication,” which we read as real-time interaction, between a patient and the physician, nonphysician practitioner, or clinical staff who provide the services. Stakeholders have requested that we define “interactive communication” as used in the code descriptors for CPT codes 99457 and 99458. We see this remote, non-face-to-face exchange as being similar to the exchange that occurs in providing services described by HCPCS code G2012, Brief Communication Technology Based Service, which we finalized in the CY 2019 final rule (83 FR 59483 through 59486). Thus, we are clarifying that “interactive communication” for purposes of CPT codes 99457 and 99458 involves, at a minimum, a real-time synchronous, two-way audio interaction that is capable of being enhanced with video or other kinds of data transmission. As indicated in the code descriptor for CPT code 99457, the interactive communication must total at least 20 minutes of interactive time with the patient over the course of a calendar month for CPT code 99457 to be reported. Each additional 20 minutes of interactive communication between the patient and the physician/nonphysician practitioner/clinical staff is reported using CPT code 99458. The CPT Codebook states that unless there are code- or code-range specific instructions, parenthetical instructions, or code descriptors to the contrary, time is considered to be the “face-to-face” time with the patient or patient's caregiver/medical decision-maker. See the CPT Codebook, page xvii, as well as pages 10, 13, and 16 for more information about measuring time. Where, as here, the services are not typically furnished in person with the patient, we interpret time in the code descriptor to mean the time spent in direct, real-time interactive communication with the patient.

Lastly, we are proposing to establish as permanent policy two of the changes we made on an interim basis to the requirements for furnishing RPM services in response to the PHE for the COVID-19 pandemic. (See 85 FR 19264 and 85 FR 27605 through 27606 for the interim modifications and clarifications to RPM services in response to the PHE for the COVID-19 pandemic).

Our goals during the PHE for the COVID-19 pandemic have been to reduce exposure risks to the Novel Coronavirus for practitioners and patients while also increasing access to health care services. We eliminated as many obstacles as possible to allow timely delivery of reasonable and necessary health care. We wanted patients to be able to access services quickly and without barriers. With the goals of reducing exposure and increasing access to services, we finalized that RPM services could be furnished to new patients, as well as established patients. We also finalized on an interim basis for the duration of the PHE for the COVID-19 pandemic policies to allow consent to be obtained at the time services are furnished, and by individuals providing RPM services under contract with the billing physician or practitioner; and to allow RPM codes to be billed for a minimum of 2 days of data collection over a 30-day period, rather than the required 16 days of data collection over a 30-day period as provided in the CPT code descriptors.

For CY 2021, we are proposing on a permanent basis to allow consent to be obtained at the time that RPM services are furnished. Because the CPT code descriptors do not specify that clinical staff must perform RPM services, we are also proposing to allow auxiliary personnel (which includes other individuals who are not clinical staff but are employees, or leased or contracted employees) to furnish services described by CPT codes 99453 and 99454 under the general supervision of the billing physician or practitioner.

When the PHE for the COVID-19 pandemic ends, we again will require that RPM services must be furnished only to an established patient. We believe that a physician or practitioner who has an established relationship with a patient would likely have had an opportunity to provide a new patient E/M service. During the new patient E/M service, the physician or practitioner would have collected relevant patient history and conducted a physical exam, as appropriate. As a result, the physician or practitioner would possess information needed to understand the current medical status and needs of the patient prior to ordering RPM services to collect and analyze the patient's physiologic data and to develop a treatment plan. Additionally, and in keeping with the CPT prefatory language for CPT codes 99453 and 99454, when the PHE for the COVID-19 pandemic ends, we will once again require that 16 days of data be collected within 30 days to meet the requirements to bill CPT codes 99453 and 99454.

Finally, in response to the May 19, 2020 Executive Order 13924, “Regulatory Relief To Support Economic Recovery,” (85 FR 31353 through 31356), we are seeking comment from the medical community and other members of the public on whether the current RPM coding accurately and adequately describes the full range of clinical scenarios where RPM services may be of benefit to patients. For example, CPT codes 99453 and 99454 currently require use of a medical device (as defined by the FDA) that digitally collects and transmits 16 or more days of data every 30 days in order for the codes to be billed. However, some patients may not require remote monitoring for 16 or more days in a 30-day period. For some patients, continuous short-term monitoring might be more appropriate. For example, a post-surgical patient who is recovering at home might benefit from remote monitoring of his or her body temperature as a means of assessing infection and managing medications or dosage. In some situations, monitoring several times throughout a day, over a period of 10 days, may be reasonable and necessary. Sixteen or more days might be unnecessary. We are asking for information that would help us to understand whether it would be beneficial to consider establishing Start Printed Page 50120coding and payment rules that would allow practitioners to bill and be paid for RPM services with shorter monitoring periods. Specifically, we are interested in understanding whether one or more codes that describe a shorter duration, for example, 8 or more days of remote monitoring within 30 days, might be useful. We welcome comments including any additional information that the medical community and other members of the public believe may provide further clarification on how RPM services are used in clinical practice, and how they might be coded, billed and valued under the Medicare PFS.

3. Transitional Care Management (TCM)

Payment for TCM CPT codes 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 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) was finalized in the CY 2013 PFS final rule (77 FR 68979 through 68993). At that time, we identified a list of 57 HCPCS codes (see 77 FR 68990 for the original guidance) that we stated could not be billed concurrently with TCM services because of potential duplication of services.

For CY 2020, recognizing that use of TCM services was low when compared to the number of Medicare beneficiaries with eligible discharges and that increased utilization of medically necessary TCM services could improve patient outcomes, one of our proposals included modifying our prior rule that prohibited the billing of TCM services with many other services that we had viewed as duplicative (77 FR 68990). In the CY 2020 PFS final rule (84 FR 40549 through 40550), we finalized a policy to allow concurrent billing of TCM services, when reasonable and necessary, with 16 actively priced (that is, not bundled or non-covered) codes during the 30-day period covered by TCM services. We stated at the time that we would continue to refine our billing policies for TCM through future notice and comment rulemaking.

We are proposing now for CY 2021 to remove 14 additional actively priced (not bundled or non-covered) HCPCS codes from the list of remaining HCPCS codes that cannot be billed concurrently with TCM. We believe that no overlap exists that would warrant preventing concurrent reporting between TCM and the services of these 14 codes. We are also proposing to allow the new Chronic Care Management code HCPCS code G2058 to be billed concurrently with TCM when reasonable and necessary. We note that the minutes counted for TCM services cannot also be counted towards other services. See Table 14 for the list of 15 codes that we are proposing could be billed concurrently with TCM services when reasonable and necessary. We welcome comment on our proposal to allow these additional services to billed concurrently with the TCM service.

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4. Psychiatric Collaborative Care Model (CoCM) Services (HCPCS Code GCOL1)

In the CY 2017 PFS final rule (81 FR 80230), we established G-codes used to bill for monthly services furnished using the Psychiatric Collaborative Care Model (CoCM), an evidence-based approach to behavioral health integration that enhances “usual” primary care by adding care management support and regular psychiatric inter-specialty consultation. These G-codes were replaced by CPT codes 99492-99494, which we established for payment under the PFS in the CY 2018 PFS final rule (82 FR 53077).

Stakeholders have requested additional coding to capture shorter increments of time spent, for example, when a patient is seen for services, but is then hospitalized or referred for specialized care, and the number of minutes required to bill for services using the current coding is not met. To accurately account for these resources costs, we are proposing to establish a G-code to describe 30 minutes of behavioral health care manager time. Since this code would describe one half of the time described by the existing code that describes subsequent months of CoCM services, we are proposing to price this code based on one half the work and direct PE inputs for 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 practitioners;
  • 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.

Therefore, the proposed work RVU for the new proposed code is 0.77. We are proposing that this code could be used for either the initial month or subsequent months. We note that the existing CPT time rules for the CoCM services would apply. The proposed code is:

  • GCOL1: Initial or subsequent psychiatric collaborative care management, first 30 minutes in a 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.

We are proposing that the required elements listed for CPT code 99493 would also be required elements for billing HCPCS cod GCOL1. Additionally, we propose that CPT time rules would apply, consistent with the guidance in the CPT codebook for CPT codes 99492-99494.

In the CY 2017 PFS final rule (81 FR 80235), we finalized that CCM and BHI services could be billed during the same month for the same beneficiary if all the requirements to bill each service are separately met. We are also proposing that HCPCS code GCOL1 could be billed during the same month as CCM and TCM services, provided that all requirements to report each service are met and time and effort are not counted more than once. We note that the patient consent requirement would apply to each service independently.

In the CY 2017 PFS final rule (81 FR 80235), we finalized that the psychiatric CoCM services may be furnished under general supervision because we do not believe it is clinically necessary that the professionals on the team who provide services other than the treating practitioner (namely, the behavioral health care manager and the psychiatric consultant) must have the billing practitioner immediately available to them at all times, as would be required under a higher level of supervision. Therefore, consistent with the other codes in this code family (CPT codes 99492-99494), we propose to add HCPCS code GCOL1 to the list of designated care management services for which we allow general supervision.

We welcome comments on the proposal to create this new code, as well as the proposed valuation.

F. Refinements to Values for Certain Services To Reflect Revisions to Payment for Office/Outpatient Evaluation and Management (E/M) Visits and Promote Payment Stability During the COVID-19 Pandemic

1. Background

a. Evaluation and Management (E/M) Visits Overview

Physicians and other practitioners who are paid under the PFS bill for common office visits for evaluation and management (E/M) visits using a relatively generic set of CPT codes (Level I HCPCS codes) that distinguish visits based on the level of complexity, site of service, and whether the patient is new or established. These CPT codes are broadly referred to as E/M visit codes and historically have included three key components within their code descriptors: History of present illness (history), physical examination (exam), and medical decision-making (MDM).[2]

Currently, there are five levels of office/outpatient E/M visits. There are five codes representing each level for new patients (CPT codes 99201 through 99205), and five codes representing each level for established patients (CPT codes 99211 through 99215). CPT code 99211 (Level 1 established patient) is the only code in the office/outpatient E/M visit code set that describes a visit that may be performed by the billing practitioner or by clinical staff under supervision, and that has no specified history, exam or MDM (see Table 15).

In total, E/M visits billed using these CPT codes comprise approximately 40 percent of allowed charges for PFS services; and office/outpatient E/M visits, in particular, comprise approximately 20 percent of allowed charges for PFS services. Within the E/M visits represented in these percentages, there is wide variation in the volume and level of E/M visits billed by different specialties. According to Medicare claims data, E/M visits are furnished by nearly all specialties, but represent a greater share of total allowed charges for physicians and other practitioners who do not routinely furnish procedural interventions or diagnostic tests. Generally, these practitioners include primary care practitioners and certain other specialists such as neurologists, endocrinologists and rheumatologists. Certain specialties, such as podiatry, tend to furnish lower level E/M visits more often than higher level E/M visits. Some specialties, such as dermatology, Start Printed Page 50122tend to bill more E/M visits on the same day as they bill minor procedures.

b. Overview of Policies Finalized in CY 2020 for CY 2021

In the CY 2020 PFS final rule (84 FR 62844 through 62860), for the office/outpatient E/M visit code set (CPT codes 99201 through 99215), we finalized a policy to generally adopt the new coding, prefatory language, and interpretive guidance framework that has been issued by the AMA's CPT Editorial Panel (see https://www.ama-assn.org/​practice-management/​cpt/​cpt-evaluation-and-management) and will be effective January 1, 2021. Under this new CPT coding framework, history and exam will no longer be used to select the level of code for office/outpatient E/M visits. Instead, an office/outpatient E/M visit will include a medically appropriate history and exam, when performed. The clinically outdated system for number of body systems/areas reviewed and examined under history and exam will no longer apply, and the history and exam components will only be performed when, and to the extent, reasonable and necessary, and clinically appropriate.

As indicated in Table 15, the changes will include deletion of CPT code 99201 (Level 1 office/outpatient visit, new patient), which the CPT Editorial Panel decided to eliminate because CPT codes 99201 and 99202 are both straightforward MDM and currently largely differentiated by history and exam elements. Table 15 provides an overview of how the level 1 and level 2 office/outpatient E/M visits are currently structured, demonstrating this current overlap.

For levels 2 through 5 office/outpatient E/M visits, selection of the code level to report will be based on either the level of MDM (as redefined in the new AMA/CPT guidance framework, also available on the AMA website at https://www.ama-assn.org/​practice-management/​cpt/​cpt-evaluation-and-management or the total time personally spent by the reporting practitioner on the day of the visit (including face-to-face and non-face-to-face time). We continue to believe these policies will further our ongoing effort to reduce administrative burden, improve payment accuracy, and update the office/outpatient E/M visit code set to better reflect the current practice of medicine.

Regarding prolonged visits, we finalized separate payment for a new prolonged visit add-on CPT code (CPT code 99XXX), and discontinued the use of CPT codes 99358 and 99359 (prolonged E/M visit without direct patient contact) to report prolonged time associated with office/outpatient E/M visits. We refer readers to the CY 2020 PFS final rule for a detailed discussion of this policy (84 FR 62849 through 62850).

Also we finalized separate payment for HCPCS code GPC1X, to provide payment for visit complexity inherent to evaluation and management associated with medical care services that serve as the continuing focal point for all needed health care services and/or with medical care services that are part of ongoing care related to a patient's single, serious, or complex chronic condition.

The AMA RUC resurveyed and revalued the revised office/outpatient E/M visit code set, concurrent with the CPT Editorial Panel redefining the services and associated interpretive guidance, and provided us with its recommendations. In the CY 2020 PFS final rule, we also addressed and responded to the AMA RUC recommendations. We finalized new values for CPT codes 99202 through 99215, and assigned RVUs to the new office/outpatient E/M prolonged visit CPT code 99XXX, as well as the new HCPCS code GPC1X. These valuations were finalized with an effective date of January 1, 2021. In Table 16, we provide a summary of the codes and work RVUs finalized in the CY 2020 PFS final rule for CY 2021.

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c. Continuing Stakeholder Feedback

Since issuing the CY 2020 PFS final rule, we have continued to engage with the stakeholder community on the issues addressed in this section of our proposed rule. In the CY 2020 PFS final rule (84 FR 62859 through 62860), we discussed public comments we received in response to our request for comment about whether it would be appropriate to revalue certain services, other than the global surgical codes which we addressed separately, for which the values are closely tied to the values of the office/outpatient E/M visit codes in order to improve payment accuracy and maintain relativity within the PFS. We responded that we would consider the commenters' recommendations for future rulemaking. Since publication of the CY 2020 PFS final rule, we have received additional feedback from stakeholders, in the form of written requests and in-person meetings, indicating that certain other services on which we did not seek comment in the CY 2020 PFS proposed rule, but which are similar to the office/outpatient E/M visits, have values that were established relative to values for the office/outpatient E/M visits or contain office/outpatient E/M visits as constituent parts of the bundled services included in the code for the service. We address many of these requests in the following section, and are seeking comment on whether there are additional, similarly situated services for which we should consider similar adjustment or revaluation through future rulemaking. We have also received questions about the definition and utilization assumptions for the HCPCS add on code GPC1X.

2. Proposals for CY 2021

a. Time Values for Levels 2-5 Office/Outpatient E/M Visit Codes

In the CY 2020 PFS proposed rule (84 FR 62568), we sought comment on the times associated with the office/outpatient E/M visits as recommended by the AMA RUC. When surveying these services for purposes of valuation, the AMA RUC requested that survey respondents consider the total time spent on the day of the visit, as well as any pre- and post-service time occurring within a timeframe of 3 days prior to the visit and 7 days after, respectively. In developing its recommendations to us, the AMA RUC then separately averaged the survey results for pre-service, day of service, and post-service times, and the survey results for total time, with the result that, for some of the codes, the sum of the times associated with the three service periods does not match the RUC-recommended total time. The approach used by the AMA RUC to develop recommendations sometimes resulted in two conflicting sets of times: The component times as surveyed and the total time as surveyed. In the CY 2020 PFS final rule, we finalized adoption of the RUC-recommended times as explained below, but stated that we would continue to consider whether this issue has implications for the PFS broadly. When we establish pre-, intra-, and post-service times for a service under the PFS, these times always sum to the total time. We believe it would be illogical for component times not to sum to the total, and this idea is reflected in our ratesetting system which requires component times to sum to the total time. Commenters on the CY 2020 PFS proposed rule (84 FR 62849) stated that we should adopt the times as recommended by the RUC, and did not provide any additional details on the times they believed we should use when the total time is not the sum of the component times. Table 17 illustrates the AMA RUC surveyed times for each service period and the surveyed total time. It also shows the actual total time calculated as the sum of the component times.

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Given the lack of clarity provided by commenters on the CY 2020 PFS proposed rule about why the sum of minutes in the components would differ from the total minutes, and our view and systems requirement that total time must equal the mathematical total of component times, we are proposing beginning for CY 2021 to adopt the actual total times (defined as the sum of the component times) rather than the total times recommended by the RUC for CPT codes 99202 through 99215.

b. Revaluing Services That Are Analogous to Office/Outpatient E/M Visits

In the CY 2020 PFS proposed rule, we recognized that there are services other than the global surgical codes for which the values are closely tied to the values of the office/outpatient E/M visit codes. We specifically identified transitional care management (TCM) services (CPT codes 99495, 99496); cognitive impairment assessment and care planning (CPT code 99483); certain end-stage renal disease (ESRD) services (CPT codes 90951 through 90970); and the annual wellness visit (AWV) and initial preventive physical exam (IPPE) (HCPCS codes G0402, G0438, G0439). Many of these services were valued via a building block methodology and have office/outpatient E/M visits explicitly built into their definition or valuation. We stated that we may consider adjusting the RVUs for these services in future rulemaking, and we sought public input on such a policy. We noted that, unlike the global surgical codes, some of these services always include an office/outpatient E/M visit(s) furnished by the reporting practitioner as part of the service, and therefore, it may be appropriate to adjust their valuations commensurate with any changes made to the values for office/outpatient E/M visits. Some of these services do not actually include an E/M visit, but we valued them using a direct crosswalk to the RVUs assigned to an office/outpatient E/M visit(s), and for this reason they are closely tied to values for office/outpatient E/M visits. Overall, we believe that the magnitude of the changes to the values of the office/outpatient E/M visit codes and the associated redefinitions of the codes themselves are significant enough to warrant an assessment of the accuracy of the values of services containing, or closely analogous to, office/outpatient E/M visits. These proposals take into account input from the public and our own internal review.

We received public comments in support of revaluing certain services relative to the new office/outpatient E/M visit values. There was particular support for revaluing the ESRD monthly capitation payment (MCP) services, TCM services, cognitive impairment assessment and care planning services, and the emergency department (ED) visits. Based on input provided since publication of the CY 2020 PFS final rule by the American College of Obstetricians and Gynecologists (ACOG), we have also considered the maternity surgical packages which, unlike other global surgery services, were valued using a methodology, described in more detail below, that allowed the valuation of the composite parts of the package to sum to the total value. Additionally, unlike the 10- and 90-day global surgical services codes (referred to in this section as 10- and 90-day globals), we have never expressed concerns as to the accuracy of the values of the maternity packages, and these services were not part of the policy we adopted to transition all 10- and 90-day globals to 0-day globals (79 FR 67591), though that policy was overridden by statutory amendments before it took effect.

(1) End-Stage Renal Disease Monthly Capitation Payment Services

In the CY 2004 PFS final rule with comment period (68 FR 63216), we established new Level II HCPCS G codes for ESRD services and established MCP rates for them as specified under section 1881(b)(3)(A)(ii) of the Act. For ESRD center-based patients, payment for the G codes varied based on the age of the beneficiary and the number of face-to-face visits furnished each month (for example, 1 visit, 2-3 visits and 4 or more visits). We believed that many physicians would provide 4 or more visits to center-based ESRD patients, and a small proportion would provide 2-3 visits or only one visit per month. Under the MCP methodology, to receive the highest payment, a physician would have to furnish at least 4 ESRD-related visits per month. In contrast, payment for home dialysis MCP services only varied by the age of beneficiary. Although we did not initially specify a frequency of required visits for home dialysis MCP services, we stated that we expect physicians to provide clinically appropriate care to manage the home dialysis patient.

The CPT Editorial Panel created new CPT codes to replace the G codes for monthly ESRD-related services, and we finalized the new codes for use under the PFS in CY 2009 (73 FR 69898). The codes created were CPT codes 90951 through 90962 for monthly ESRD-related services with a specified number of visits; CPT codes 90963 through 90966 for monthly ESRD-related services for home dialysis patients; and CPT codes 90967 through 90970 for home dialysis patients with less than a full month of services. The latter set of codes are billed per encounter and valued to be 1/30 of the value of CPT codes 90965 and 90966.

In response to our comment solicitation in the CY 2020 PFS final rule and interim final rule regarding Start Printed Page 50125whether to adjust the values of the ESRD MCP codes to reflect the increased values of the office/outpatient E/M visit codes, we received a number of supportive comments, particularly from specialty societies representing nephrologists. These commenters pointed out that the MCP bundled payments for all ESRD-related care for a month were constructed using a building block methodology and a number of office/outpatient E/M visits were component parts of those bundles; and that the specified number of visits in the code descriptor must be furnished in order to bill for the service. Commenters also noted that although the values of office/outpatient E/M visit codes have been increased once since the creation of the MCP G codes and once after adoption of the MCP CPT codes, the valuation of the ESRD MCP codes was never adjusted to account for increases to the office/outpatient E/M visit codes. In Table 18, we provide a summary of the visits bundled into each ESRD MCP service.

In the past, we have not updated the valuation of this code set to reflect updates to the valuation of the office/outpatient E/M visit code set and so over time, the values of the ESRD MCP codes have become out of step with valuation of their constituent visits. We believe there is sufficient reason to revalue these services to take into account the changes in valuation for the office/outpatient E/M visits. These services were initially valued using a building block methodology which summed the value of the individual service from its components, and for some of the codes in this code set, a specified number of visits must be furnished in order to bill for the respective ESRD MCP code because they are included in the code descriptor.

Therefore, we believe that the ESRD MCP codes should be updated to more accurately account for the associated office/outpatient E/M visits. We are proposing to increase the work, physician time, and PE inputs in the form of clinical staff time of the ESRD MCP codes based on the marginal difference between the 2020 and 2021 office/outpatient E/M visit work, physician time, and PE inputs built into each code, as summarized in Tables 19 and 20. By improving payment accuracy for the ESRD MCP codes, we would also be supporting broader efforts at advancing kidney health.[3] We believe the majority of the visits included in the ESRD MCP bundles are being furnished, but are seeking comment on whether there are instances where the number and level of visits being furnished are not consistent with the number and level of visits built into the valuation of the code.

3. TCM Services (CPT Codes 99495 and 99496)

The goal of TCM services is to improve the health outcomes of patients recently discharged from inpatient and certain outpatient facility stays. We began making separate payment for TCM services in CY 2013. At that time, CPT code 99495 (Transitional Care Management Services with the following required elements: Communication (direct contact, telephone, electronic) Start Printed Page 50126with the patient and/or caregiver with 2 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) was valued to include one, level 4 established patient office/outpatient visit, while CPT code 99496 (Transitional Care Management Services with the following required elements: Communication (direct contact, telephone, electronic) with the patient and/or caregiver with 2 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) was valued to include one, level 5 established patient office/outpatient visit (77 FR 68991). In the CY 2020 PFS final rule (84 FR 62687), we finalized the RUC-recommended work and direct PE inputs for the TCM codes which resulted in small RVU increases for both codes.

Because both TCM codes include a required face-to-face E/M visit (either a level 4 or 5 office/outpatient E/M visit), we are proposing to increase the work RVUs associated with the TCM codes commensurate with the new valuations for the level 4 (CPT code 99214) and level 5 (CPT code 99215) office/outpatient E/M visits for established patients. Please see Tables 19 and 20 for long descriptors, as well as current and proposed work RVUs, physician time, and clinical staff time, for the TCM codes.

4. Maternity Services

In the CY 2002 PFS final rule with comment period (66 FR 55393), we finalized separate payment for maternity care services. The maternity packages are unlike other services for which payment is made under the PFS in that they are the only global codes that provide a single payment for almost 12 months of services, including visits, surgical services, and imaging (among other services); and were valued using a building-block methodology as opposed to the magnitude estimation method that is commonly used to value the 10- and 90-day global services. There are 17 CPT codes that are used for billing delivery, antepartum, and postpartum maternity care services, and these codes are all designated with a unique global period indicator “MMM.”

For CY 2021, the AMA RUC made a recommendation to revalue these services, along with their recommendations to revalue the 10- and 90-day global surgical packages, to account for increases in the values of office/outpatient E/M visits. In the CY 2020 PFS final rule, we decided not to make changes to the valuation of 10- and 90-day global surgical packages to reflect changes made to values for the office/outpatient E/M visit codes while we continue to collect and analyze the data on the number and level of office/outpatient E/M visits that are actually being performed as part of these services.

The 10- and 90-day global surgical packages are commonly valued using a methodology known as magnitude estimation. Magnitude estimation refers to a methodology for valuing work that identifies 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. Since its inception, the AMA RUC has worked under the prevailing assumption that magnitude estimation is the standard for valuation of all physicians' services, including those with global surgical packages. Consequently, the work values associated with expected typical E/M visits within a code's global period are not necessarily added to the physician work value for the code to determine the final work RVU. The postoperative visits in the 10- or 90-day global surgical code periods are often valued with reference to RVUs for separately-billed E/M visits, but the bundled post-operative visit RVUs do not directly contribute a certain number of RVUs to the valuation of the procedures. However, the MMM codes are unique in both the length of the global period and the methodology under which they were valued. When CMS established values for the maternity packages, we based them on RUC recommendations developed by the relevant specialty societies using the building block methodology. When it is used for a CPT code representing a bundle of services, the building block methodology components are the CPT codes that make up the bundled code and the inputs associated with those codes. Therefore, when the maternity packages were valued, the work (and other inputs) associated with the office/outpatient E/M visits in each package were explicitly accounted for.

In addition, unlike the global surgical codes, we have reason to believe the visits included in the maternity codes are actually furnished given the evidence-based standards and professional guidelines for obstetrical care. For example, The Guidelines for Perinatal Care state that “a woman with an uncomplicated first pregnancy is examined every 4 weeks for the first 28 weeks of gestation, every 2 weeks until 36 weeks of gestation, and weekly thereafter.” [4] For this reason, we excluded the maternity codes from our recent global surgery data collection.

Given the valuation methodology and expectations for office/outpatient E/M visits in the maternity package codes, and the revaluation recommendation developed by the AMA RUC, we believe that the maternity packages should be updated to more accurately reflect the values of the office/outpatient E/M visits included in the packages. We believe that, due to the use of the building block valuation methodology rather than magnitude estimation, and the likelihood that the bundled visits are actually being furnished, the valuations recommended to us by the AMA RUC more accurately reflect the resource costs associated with furnishing these services. In the past, the work, physician time, and PE for these services have not been revalued to reflect changes to the office/outpatient E/M visits that are included as part of the package and therefore, the valuation of the MMM surgical packages have become misaligned with the valuation of their constituent office visits.

When revaluing the maternity packages, the AMA RUC used a methodology similar to what we used when revaluing the ESRD MCP codes and TCM by adding in the marginal differences in work, physician time, and practice expense (PE) in the form of clinical staff time between the current and 2021 E/M values. We believe that this method accurately accounts for the increase in valuation relative to the office/outpatient E/M visits, and therefore, we are proposing to increase the work RVUs, physician time, and PE inputs in the form of clinical staff time associated with the maternity packages by accepting the revaluation recommendation from the AMA RUC as detailed in Tables 19 and 20.

We would also note that, in addition to appropriately reflecting changes to values of the office and outpatient E/M visits, increases made to the valuation of the maternity package codes would be consistent with our broader focus on improving maternal health and birth outcomes. The proposed changes would account for additional resources involved with additional work that is needed on the part of practitioners to improve care for this patient population, such as risk identification and ensuring appropriate interventions and referrals.[5]

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5. Assessment and Care Planning for Patients With Cognitive Impairment (CPT Code 99483)

In CY 2017, we established payment for HCPCS code G0505 (Assessment and care planning for patients with cognitive impairment) to provide payment for cognitive impairment assessment and care planning, believing that the CPT Editorial Panel was developing new coding for that service. In response to the CY 2017 PFS proposed rule, the AMA RUC submitted recommended values for this code, which we adopted in the CY 2017 PFS final rule. In CY 2018, the CPT Editorial Panel created CPT code 99483 for reporting of this service and in CY 2018, CMS adopted CPT code 99483 (deleting HCPCS code G0505) without changing the service valuation. Based on input from commenters and the AMA RUC, the valuation of this service reflected the complexity involved in assessment and care planning for patients with cognitive impairment by including resource costs that are greater than the highest valued office/outpatient E/M visit (CPT code 99205, new patient level 5 visit) (81 FR 80352). Specifically, the service includes a cognition-focused evaluation including a pertinent history and examination, and medical decision making of moderate or high complexity, in addition to many functional and other assessments specific to cognitive status. With the revaluation we finalized in the CY 2020 PFS final rule for CPT code 99205 effective beginning in CY 2021, the current work RVU for CPT code 99483 would have a lower work RVU than a new patient level 5 office/outpatient E/M visit, which would create a rank order anomaly between the two codes that, given the way the code was valued, we do not believe would be appropriate. Rather, because CPT code 99483 was valued in relation to a level 5 office/outpatient E/M visit, we believe that an adjustment to the work, physician time, and PE for this service to reflect the marginal difference between the value of the level 5 new patient office/outpatient E/M visit in CY 2020 and CY 2021 would be appropriate to maintain payment accuracy. Therefore, we are proposing to adjust the work, time, and PE in the form of clinical staff time for CPT code 99483 as shown in Tables 19 and 20.

6. Initial Preventive Physical Examination (IPPE) and Initial and Subsequent Annual Wellness (AWV) Visits

In the CY 2011 PFS final rule with comment period, we finalized separate payment for HCPCS codes G0438 (Annual wellness visit; includes a personalized prevention plan of service (pps), initial visit) and G0439 (Annual wellness visit, includes a personalized prevention plan of service (pps), subsequent visit). These services were valued via a direct crosswalk to the work, time, and direct PE inputs associated with CPT codes 99204 and 99214, respectively. In that same rule, we stated that the HCPCS code G0402 (Initial preventive physical examination; face-to-face visit, services limited to new beneficiary during the first 12 months of Medicare enrollment) was also valued based on a direct crosswalk to the work, time, and direct PE inputs for CPT code 99204 (75 FR 73408-73411).

Because these codes are valued using direct crosswalks to office/outpatient E/M visits, and based on the principles articulated above, we believe that to maintain payment accuracy for the IPPE and the AWV, their values should be adjusted to reflect the changes in value for CPT codes 99204 and 99214. Therefore, we are proposing to revise the work, physician time, and direct PE inputs for these codes as shown in Tables 19 and 20.

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7. Emergency Department Visits

The ED visit codes have been revalued under the PFS three times- in 1997, 2007, and most recently in 2018 as part of the misvalued code initiative for CY 2020 rulemaking. Each subsequent revaluation was done in part to maintain relativity with the office/outpatient E/M visit codes. Specifically, when these services were revalued in prior rulemaking, the principle was that levels 1 through 3 of the ED visits should have the same value as the level 1 through 3 new patient office/outpatient E/M visits and that the levels 4 and 5 ED visits should be valued higher than the levels 4 and 5 new patient office/outpatient E/M visits to reflect higher typical intensity in the ED setting. In the CY 2018 PFS final rule, we finalized a proposal to nominate the level 1 through level 5 ED visit codes (CPT codes 99281-99285, see Table 21 for long descriptors) as potentially misvalued based on information suggesting that the work RVUs for ED visits may not appropriately reflect the full resources involved in furnishing these services. Specifically, stakeholders expressed concerns that the work RVUs for these services have been undervalued given the increased acuity of the patient population and the heterogeneity of the sites, such as freestanding and off-campus EDs, where ED visits are furnished (82 FR 53018). The AMA RUC surveyed and reviewed five of these codes for the April 2018 RUC meeting and provided a recommendation to CMS for consideration in CY 2020 rulemaking. In the CY 2020 PFS final rule, we finalized the RUC-recommended work RVUs of 0.48 for CPT code 99281, a work RVU of 0.93 for CPT code 99282, a work RVU of 1.42 for 99283, a work RVU of 2.60 for 99284, and a work RVU of 3.80 for CPT code 99285. The RUC did not recommend, and we did not finalize, any direct PE inputs for the codes in this family. The AMA RUC submitted these recommended values to CMS prior to the submission of the RUC-recommended revaluation of the office/outpatient E/M visit code family.

In response to our comment solicitation in CY 2020 PFS rulemaking regarding whether certain services should be revalued to maintain relativity with office/outpatient E/M visits, the American College of Emergency Physicians submitted a public comment stating that relativity between the ED visits and office/outpatient E/M visits should be maintained, and provided CMS with a specific recommendation for CPT codes 99283-99285. The association believed we should continue to preserve the same relationship between the ED and office/outpatient E/M visit code sets that was established in prior years and would have likely been maintained had the office/outpatient E/M visits been revalued prior to the ED visits. They have also submitted a subsequent letter to this effect. We agree with the society, particularly since the justification provided by the AMA RUC recommendations we accepted for the CY 2020 revaluation was, in part, to maintain relativity with the office/outpatient E/M visits, and that relativity would be disrupted if they were to remain unadjusted. The proposed values are consistent with the principle that the levels 1-3 ED visits should remain the same as the levels 1-3 new patient office visits but the levels 4-5 ED visits should have a higher value than the corresponding office visits, due to the complexity of the patients requiring that level of emergency care. Therefore, we are proposing the values recommended by ACEP as shown in Table 21.

8. Therapy Evaluations

There are a number of services paid under the PFS that are similar in many respects to the office/outpatient E/M visit code set, but do not specifically include, were not valued to include, and were not necessarily valued relative to, Start Printed Page 50134office/outpatient E/M visits. These codes inherently include work associated with assessment and work associated with management, similar to the work included in the office/outpatient E/M visits, which involve time spent face-to-face assessing and treating the patient. These services include therapy evaluation services and psychiatric diagnostic evaluation services. The practitioners who furnish these services are prohibited by CMS from billing E/M services due to the limitations of their Medicare benefit categories. As such, the CPT Editorial Panel has created specific coding to describe the services furnished by these practitioners. Although these services are billed using specific, distinct codes relating to therapy evaluations and psychiatric diagnostic evaluations, we believe that a significant portion of the overall work in the codes is for assessment and management of patients, as it is for the office/outpatient E/M visit codes.

Therefore, we are proposing to adjust the work RVUs for these services based on a broad-based estimate of the overall change in the work associated with assessment and management to mirror the overall increase in the work of the office/outpatient E/M visits. We calculated this adjustment based on a volume-weighted average of the increases to the office/outpatient E/M visit work RVUs from CY 2020 to CY 2021. Details on this calculation are available as a public use file on the CMS website at https://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​PhysicianFeeSched/​PFS-Federal-Regulation-Notices. We are proposing to apply that percentage increase, which we estimate to be approximately 28 percent, to the work RVUs for the therapy evaluation and psychiatric diagnostic evaluation services codes. We believe that it is important to the relativity of the PFS to revalue these services to reflect the overall increase in value associated with spending time assessing and managing patients, as reflected in the changes to work values for the office/outpatient E/M visits, particularly in recognition of the value of the clinicians' time which is spent treating a growing number of patients with greater needs and multiple medical conditions. We recognize that this is not the methodology typically used to value services under the PFS and are seeking comment on potential alternative methodologies or specific values for these services, particularly about whether commenters believe it would be better to develop values using comparator codes from the office/outpatient E/M visit code set, and if so, why.

9. Behavioral Healthcare Services

The psychotherapy code set is divided into psychotherapy that can be furnished as a standalone service and psychotherapy furnished in conjunction with an office/outpatient E/M visit. The standalone psychotherapy services are CPT codes 90832, 90834, and 90837 (See Table 21 for long descriptors). The CPT codes describing psychotherapy furnished in conjunction with an office/outpatient E/M visit are CPT codes 90833 (Psychotherapy, 30 minutes with patient when performed with an evaluation and management service (List separately in addition to the code for primary procedure)), 90836 (Psychotherapy, 45 minutes with patient when performed with an evaluation and management service (List separately in addition to the code for primary procedure)) and 90838 (Psychotherapy, 60 minutes with patient when performed with an evaluation and management service (List separately in addition to the code for primary procedure)). As the values for the office/outpatient E/M visits are increasing, there will necessarily be an increase in the overall value for psychotherapy furnished in conjunction with office/outpatient E/M visits. We believe that it is important, both in terms of supporting access to behavioral health services through appropriate payment and maintaining relativity within this code family, to increase the values for the standalone psychotherapy services to reflect changes to the value of the office/outpatient E/M visits which are most commonly furnished with the add-on psychotherapy services with equivalent times. For example, under the finalized revaluation of the office/outpatient E/M visits, the proportional work value of the standalone psychotherapy CPT code 90834 (Psytx w pt 45 minutes) would decrease relative to the combined work RVUs for CPT code 99214 (Level 4 Office/outpatient visit est) when billed with CPT code 90836 (Psytx w pt w e/m 45 min). The current combined work RVU for CPT code 99214 when reported with CPT code 90836 is 3.40 (1.90 + 1.50) and the current work RVU for CPT code 90834 is 2.0. With the revaluation of the office/outpatient E/M visits beginning for CY 2021, the combined work RVU for CPT codes 99214 and 90836 would be 3.82 (1.90 + 1.92), while the current work RVU for 90834 would remain at 2.0, resulting in a change to relativity between these services.

To maintain the current relativity, which we believe to be appropriate based on the proportionate difference between these services, we are proposing to increase the work RVU for CPT code 90834 from 2.00 to 2.25 based on the marginal increase in work value for CPT code 99214 from CY 2020 to CY 2021. Similarly, for CPT code 90832, which describes 30 minutes of psychotherapy, we are proposing to increase its work RVU based on the increase to CPT code 99213, which is most commonly billed with the 30 minutes of psychotherapy add-on, CPT code 90833. For CPT code 90837, which describes 60 minutes of psychotherapy, we propose to increase the work RVU based on the proportional increase to CPT codes 99214 and 90838, which is the office/outpatient E/M visit code most frequently billed with the 60 minutes of psychotherapy add-on. Table 21 provides a summary of the current and proposed RVUs for these services.

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10. Ophthalmological Services

We received a request to revalue the following ophthalmological services which we are not proposing to revalue:

  • CPT code 92002: Ophthalmological services: medical examination and evaluation with initiation of diagnostic and treatment program; intermediate, new patient.

CPT code 92004: Ophthalmological services: medical examination and evaluation with initiation of diagnostic and treatment program; comprehensive, new patient, 1 or more visits.

CPT code 92012: Ophthalmological services: medical examination and evaluation, with initiation or continuation of diagnostic and treatment program; intermediate, established patient.

CPT code 92014: Ophthalmological services: medical examination and evaluation, with initiation or continuation of diagnostic and treatment program; comprehensive, established patient, 1 or more visits.

We are not proposing to revalue these services because they are not sufficiently analogous or connected to the office/outpatient E/M visit codes. While these ophthalmological services have historically been valued relative to office/outpatient E/M visits, they have not been reviewed by the RUC since 2007. Two of these ophthalmological services can include more than one visit, and the number of visits included in the package is uncertain and therefore are not so closely tied to office and outpatient E/M services which describe a single visit. In addition, starting in 2021, the office/outpatient E/M visit codes will be substantially redefined to allow time or medical decision-making for code level selection, concepts that do not apply in these ophthalmological visits which rely on criteria specific to evaluation, examination, specified technical procedures, and treatment of ocular conditions for purposes of level selection.[6] The number of levels within the two code sets differs, and the number of levels has changed for office/outpatient E/M visits. Given the revised code set and framework for level selection for office/outpatient E/M visits, the level of office/outpatient E/M visits to which the ophthalmological visits might be analogous is no longer clear. We are also aware that ophthalmologists report office/outpatient E/M visits as well these ophthalmologic-specific evaluation codes. The relationship between the two separate code sets and the reason for relying on both of them is unclear.

In addition, the four ophthalmological evaluation codes are reported with modifier -25 (significant, separately identifiable E/M service by the same physician on the same day of the procedure or other service) approximately 4 to 14 percent of the time (depending on the code in question). Similarly, ED visits are reported with modifier -25 approximately 4 to 12 percent of the time (depending on the code in question). In contrast, the office/outpatient E/M visit codes are reported with modifier -25 approximately 18 to 35 percent of the time (depending on the code in question). We are in the process of analyzing these data further to assess how often the accompanying service is a minor procedure rather than a visit. We believe that visit/evaluation codes furnished the same day as a minor procedure are not closely analogous to stand-alone office/outpatient E/M visits, and therefore should not be revalued commensurate with the increase to stand-alone office/outpatient E/M visits for 2021. As we discussed in prior PFS rules, we continue to believe that separately identifiable visits occurring on the same day as minor procedures (such as zero-day global procedures) have resources that are sufficiently distinct from the costs associated with furnishing office/outpatient E/M visits to warrant different payment (see, for example, the CY 2019 PFS final rule, 83 FR 59639)). As we continue our analysis, we are seeking public comment on whether visits/evaluations that are furnished frequently with same-day procedures should be revalued commensurate with increases to the office/outpatient E/M visits, or whether they are substantially different enough to warrant independent valuation. We note that the stand-alone psychotherapy services would be revalued to maintain relativity with the psychotherapy services that can be performed in conjunction with an E/M visit. Standalone psychotherapy services cannot be billed with office/outpatient E/M visits while ophthalmological visits can, as well as with a separate procedure.Start Printed Page 50138

c. Comment Solicitation on the Definition of HCPCS Code GPC1X

Although we believe that the RUC-recommended values for the revised office/outpatient E/M visit codes will more accurately reflect the resources involved in furnishing a typical office/outpatient E/M visit, we continue to believe that the typical visit described by the revised and revalued office/outpatient E/M visit code set still does not adequately describe or reflect the resources associated with primary care and certain types of specialty visits. Therefore, in the CY 2020 PFS final rule (84 FR 62856), we finalized the HCPCS add-on code GPC1X which describes the “visit complexity inherent to evaluation and management associated with medical care services that serve as the continuing focal point for all needed health care services and/or with medical care services that are part of ongoing care related to a patient's single, serious, or complex condition.” We stated that we were not restricting billing based on specialty, but that we did assume that certain specialties furnished these types of visits more than others.

Since the publication of the CY 2020 PFS final rule, some specialty societies have stated that our definition of this service, as articulated in the code descriptor and the associated preamble discussion, is unclear. For example, some stakeholders have suggested that HCPCS add-on code GPC1X, as currently described, could be applicable for every office/outpatient E/M visit. They have also expressed concerns regarding our utilization assumptions, since we assumed that specialties that predominantly furnish the kind of care described by the code would bill it with every visit. Therefore, we are soliciting from the public comments providing additional, more specific information regarding what aspects of the definition of HCPCS add-on code GPC1X are unclear, how we might address those concerns, and how we might refine our utilization assumptions for the code.

We continue to believe that the time, intensity, and PE involved in furnishing services to patients on an ongoing basis that result in a comprehensive, longitudinal, and continuous relationship with the patient and involves delivery of team-based care that is accessible, coordinated with other practitioners and providers, and integrated with the broader health care landscape, are not adequately described by the revised office/outpatient E/M visit code set. We believe the inclusion of HCPCS add-on code GPC1X appropriately recognizes the resources involved when practitioners furnish services that are best-suited to patients' ongoing care needs and potentially evolving illness. We also believe the work reflected in HCPCS add-on code GPC1X is inherently distinct from existing coding that describes preventive and care management services. For example, the AWV describes and pays for a static annual health assessment rather than the time, intensity, and PE involved in furnishing services to patients on an ongoing basis. Similarly, TCM service codes are focused on care management for 30 days following a discharge rather than the time, intensity, and PE involved in furnishing services to patients on an ongoing basis. Chronic care management and principal care management service codes are limited to patients with chronic condition(s). Under chronic care management codes, patients have two or more chronic conditions that place the patient at significant risk of death, acute exacerbation/decompensation, or functional decline, whereas principal care management services are for patients who have a single high-risk disease of sufficient severity to place the patient at risk of hospitalization or have been the cause of recent hospitalization. In contrast, we believe HCPCS add-on code GPC1X reflects the time, intensity, and PE when practitioners furnish services that enable them to build longitudinal relationships with all patients (that is, not only those patients who have a chronic condition or single-high risk disease) and to address the majority of patients' health care needs with consistency and continuity over longer periods of time. For example, in the context of primary care, HCPCS add-on code GPC1X could recognize the resources inherent in holistic, patient-centered care that integrates the treatment of illness or injury, management of acute and chronic health conditions, and coordination of specialty care in a collaborative relationship with the clinical care team. In the context of specialty care, HCPCS add-on code GPC1X could recognize the resources inherent in engaging the patient in a continuous and active collaborative plan of care related to an identified health condition the management of which requires the direction of a clinician with specialized clinical knowledge, skill and experience. Such collaborative care includes patient education, expectations and responsibilities, shared decision-making around therapeutic goals, and shared commitments to achieve those goals. In both examples, HCPCS add-on code GPC1X reflects the time, intensity, and PE associated with providing services that result in care that is personalized to the patient. Finally, we believe that the HCPCS add-on code GPC1X could bolster the efforts of practitioners in rural communities, including NPPs, to deliver the comprehensive and longitudinal care that HCPCS add-on code GPC1X describes.

d. Prolonged Office/Outpatient E/M Visits (CPT Code 99XXX)

We reviewed our final policy for 2021 regarding the reporting of prolonged office/outpatient E/M visits finalized in the CY 2020 PFS final rule (84 FR 62848 through 62850). To report these visits beginning in 2021, we finalized CPT code 99XXX (Prolonged office or other outpatient evaluation and management service(s) (beyond the total time of the primary procedure which has been selected using total time), requiring total time with or without direct patient contact beyond the usual service, on the date of the primary service; each additional 15 minutes (List separately in addition to CPT codes 99205, 99215 for office or other outpatient evaluation and management services)). CPT code 99XXX is only reported when time is used to select the visit level, and only time of the physician or qualified healthcare professional is counted. In the CY 2020 PFS final rule, we stated that our interpretation of revised CPT prefatory language and reporting instructions would mean that CPT code 99XXX could be reported when the physician's (or NPP's) time is used for code level selection and the time for a level 5 office/outpatient E/M visit (the floor of the level 5 time range) is exceeded by 15 minutes or more on the date of service (84 FR 62848 through 62849). The intent of the CPT Editorial Panel was unclear because of the use of the terms “total time” and “usual service” in the CPT code descriptor (“requiring total time with or without direct patient contact beyond the usual service.”) The term “total time” is unclear because office/outpatient E/M visits now represent a range of time, and “total” time could be interpreted as including prolonged time. Further, the term, “usual service” is undefined. There is no longer a typical time in the code descriptor that could be used as point of reference for when the “usual time” is exceeded for all practitioners, and there would be variation (as well as potential double counting of time) if applied at the individual practitioner level.

Having reviewed the policy we finalized last year, we believe that allowing reporting of CPT code 99XXX Start Printed Page 50139after the minimum time for the level 5 visit is exceeded by at least 15 minutes would result in double counting time. As a specific example, the time range for CPT code 99215 is 40-54 minutes. If the reporting practitioner spent 55 minutes of time, 14 of those minutes are included in the services described by CPT code 99215. Therefore, only 1 minute should be counted towards the additional 15 minutes needed to report CPT code 99XXX and prolonged services should not be reportable as we finalized last year (see Table 33 of the CY 2020 PFS final rule (84 FR 62849)). Therefore, we are proposing that when the time of the reporting physician or NPP is used to select office/outpatient E/M visit level, CPT code 99XXX could be reported when the maximum time for the level 5 office/outpatient E/M visit is exceeded by at least 15 minutes on the date of service. In Tables 22 and 23, we provide examples.

G. Scope of Practice and Related Issues

We are proposing several policies consistent with the President's Executive Order 13890 on “Protecting and Improving Medicare for Our Nation's Seniors” to modify supervision and other requirements of the Medicare program that limit healthcare professionals from practicing at the top of their license (84 FR 53573, October 8, 2019, Executive Order #13890). In December 2019, we requested feedback in response to part of this Executive Order seeking the public's help in identifying additional Medicare regulations which contain more restrictive supervision requirements than existing state scope of practice laws, or which limit health professionals from practicing at the top of their license (the request for feedback is available at https://www.cms.gov/​files/​document/​request-information-reducing-scope-practice-burden.pdf). Through review of the feedback we received, we identified the policies in this section to address in the PFS proposed rule. We believe that physicians, NPPs, and other professionals should be able to furnish services to Medicare beneficiaries in accordance with their scope of practice and state licensure, including education and training, to the extent permitted under the Medicare statute, as long as it is not likely to result in fraud, waste or abuse. These proposed policies may also help ensure an adequate number of clinicians, in addition to physicians are able to furnish critical services including primary care services in areas where there is a shortage of physicians.[7] Some of the proposals may also help alleviate the opioid crisis.

We note that the responses to our request for feedback on the topics in this section did not indicate the number of states that have more flexible scope of practice rules than our federal regulations, or whether facilities (such as hospitals or nursing facilities) have relevant policies that limit the ability of the impacted professionals to perform certain services. For example, if Medicare payment policy provided for payment of diagnostic tests supervised by NPPs, there may still be facility- or state-specific policies in place that limit NPPs' ability to supervise some or all diagnostic tests, and those limitations would inform the potential impact of changing our policy. While our proposed flexibility may increase the capacity and availability of practitioners who can supervise diagnostic tests, which would alleviate some of the demand on physicians as the only source to perform this particular function, we have not located information indicating the degree to which NPP scope of practice includes supervision of auxiliary staff, especially for the subset of services that are diagnostic tests. There is a wide range of diagnostic tests, from a simple strep throat swab to more sophisticated and/or invasive tests such as x-rays and cardiology procedures. We would need to understand the scope of practice for many types of auxiliary staff (some of whom are not licensed) who could potentially provide these tests under the supervision of an NPP, including RNs, LPNs, medical assistants, radiologic technicians, and many others. To the extent practice patterns change, there Start Printed Page 50140could be induced utilization that would increase costs, but this might be offset by reduced payment rates because direct payment to NPPs is at a lower rate than payment to physicians. Therefore, in this proposed rule, we are also seeking information about the number and names of states that have licensure or scope of practice laws in place, as well as any facility-specific policies, that would impact the ability of clinicians to exercise the flexibilities we are proposing, to help us assess the potential impact of, or challenges for, our proposed changes. Information about specific services (service-level information) would be especially helpful. We are seeking public comment on whether applicable state laws, scope of practice, and facility policies would permit practitioners to exercise the proposed flexibilities if CMS were to adopt the policies proposed in this section, and to what extent practitioners would be permitted to exercise these proposed flexibilities, such as for all diagnostic tests or only a subset.

1. Teaching Physician and Resident Moonlighting Policies

a. Background

In the March 31st COVID-19 IFC (85 FR 19258 through 19261) and the May 1st COVID-19 IFC (85 FR 27550 through 27629), we implemented several policies on an interim final basis related to PFS payment for the services of teaching physicians involving residents and resident moonlighting regulations. The comment periods for both the March 31st COVID-19 IFC (85 FR 19230) and the May 1st COVID-19 IFC (85 FR 27550) have closed. Therefore, we plan to address the IFC comments for issues in which we have proposals in this proposed rule when we publish the PFS final rule. We are considering whether these policies should be extended on a temporary basis (that is, if the PHE ends in 2021, these policies could be extended to December 31, 2021 to allow for a transition period before reverting to status quo policy) or be made permanent, and are soliciting public comments on whether these policies should continue once the PHE ends. We believe public comment will assist us in identifying appropriate policy continuation decisions that we would consider finalizing in the CY 2021 PFS final rule.

For teaching physicians, section 1842(b)(7)(A)(i)(I) of the Act specifies that in the case of physicians' services furnished to a patient in a hospital with a teaching program, the Secretary shall not provide payment for such services unless the physician renders sufficient personal and identifiable physicians' services to the patient to exercise full, personal control over the management of the portion of the case for which payment is sought.

Regulations regarding PFS payment for teaching physician services and services of moonlighting residents are codified in 42 CFR part 415. In general, under § 415.170, payment is made under the PFS for services furnished in a teaching hospital setting if the services are personally furnished by a physician who is not a resident, or the services are furnished by a resident in the presence of a teaching physician, with exceptions as specified in subsequent regulatory provisions in part 415. Under § 415.172, if a resident participates in a service furnished in a teaching setting, PFS payment is made only if the teaching physician is present during the key portion of any service or procedure for which payment is sought. The regulation at § 415.180 states that, for the interpretation of diagnostic radiology and other diagnostic tests, PFS payment is made if the interpretation is performed or reviewed by a physician other than a resident. Under § 415.184, PFS payment is made for psychiatric services furnished under an approved graduate medical education (GME) program if the requirements of §§ 415.170 and 415.172 are met, except that the requirement for the presence of the teaching physician during psychiatric services in which a resident is involved may be met by observation of the service by use of a one-way mirror, video equipment, or similar device.

b. Supervision of Residents in Teaching Settings Through Audio/Video Real-Time Communications Technology

In both the March 31st COVID-19 IFC (85 FR 19258 through 19261) and the May 1st COVID-19 IFC (85 FR 27550 through 27629), we adopted a policy on an interim basis during the COVID-19 PHE that, under § 415.172, the requirement for the presence of a teaching physician during the key portion of the service furnished with the involvement of a resident can be met using audio/video real-time communications technology. In other words, the teaching physician must be present, either in person or virtually through audio/video real-time communications technology, during the key portion of the service. This policy generally requires real-time observation (not mere availability) by the teaching physician through audio and video technology, and does not include audio-only technology (for example, telephone without video). For the primary care exception under § 415.174(c), we adopted a policy on an interim final basis for the duration of the COVID-19 PHE to allow the teaching physician to direct the care furnished by the resident, and to review the services furnished by the resident during or immediately after the visit, remotely using audio/video real-time communications technology.

Under § 415.180, we adopted a policy on an interim basis for the duration of the COVID-19 PHE to allow PFS payment to be made for the interpretation of diagnostic radiology and other diagnostic tests if the interpretation is performed by a resident when the teaching physician is present through audio/video real-time communications technology. A physician other than the resident must still review the resident's interpretation. Under § 415.184, we adopted a policy on an interim basis during the COVID-19 PHE that the requirement for the presence of the teaching physician during the psychiatric service in which a resident is involved may be met by the teaching physician's direct supervision using audio/video real-time communications technology.

We are considering whether the flexibilities described above that we implemented on an interim basis during PHE under §§ 415.172, 415.174, 415.180, and 415.184 should be extended on a temporary basis (that is, if the PHE ends in 2021, these policies could be extended to December 31, 2021 to allow for a transition period before reverting to status quo policy) or be made permanent, and are soliciting public comments on whether these policies should continue once the PHE ends. We believe public comment will assist us in identifying appropriate policy continuation decisions that we would consider finalizing in the CY 2021 PFS final rule. In addition, we are proposing to make a technical edit to the regulation text at § 415.184 to eliminate the term “direct supervision” to conform with the language in sections §§ 415.172, 415.174, and 415.180 regarding the presence of the teaching physician via audio/video real-time communications technology.

While we believe it was appropriate to permit teaching physicians to be involved in services furnished with residents through audio/video real-time communications technology to respond to critical needs during the PHE to reduce exposure risk and to increase the capacity of teaching settings to respond to COVID-19, we are concerned that continuing to permit teaching physicians to be involved through their virtual presence may not be sufficient to warrant PFS payment to the teaching Start Printed Page 50141physician on a temporary or permanent basis. Absent the circumstances of the PHE, the physical, in-person presence of the teaching physician may be necessary to provide oversight to ensure that care furnished to Medicare beneficiaries is medically reasonable and necessary, and to ensure that the teaching physician renders sufficient personal services to exercise full, personal control of the key portion of the case.

We also have some concerns about patient safety when the teaching physician is only virtually present. For example, in the March 31st COVID-19 IFC, we excluded the surgical, high risk, interventional, endoscopic, or other complex procedures identified under § 415.172(a)(1), and anesthesia services under § 415.178 from the policy to allow the teaching physician to be present using audio-video real-time communications technology because we believe the requirement for the physical, in-person presence of the teaching physician for either the entire procedure or the key portion of the service with immediate availability throughout the procedure, as applicable, is necessary for patient safety given the risks associated with these services. In complex, high-risk, surgical, interventional, or endoscopic procedures, or anesthesia procedures, a patient's clinical status can quickly change. To permit payment under the PFS for these teaching physician services, we believe the services must be furnished with a certain level of personal oversight and involvement of the teaching physician who has the experience and judgment that is necessary for rapid on-site decision-making during these procedures.

There may be circumstances in which virtual presence of the teaching physician, considered in light of the potential risks to patient safety and absent exposure risk concerns due to COVID-19, does not demonstrate sufficient personal involvement in the service to the patient to warrant payment to the teaching physician under the PFS. For example, a resident could evaluate a patient for change in mental status following surgery for hip fracture, perform a physical exam and report it as unrevealing, and note that the patient is uncooperative with a full exam. If a full exam had been performed by the teaching physician or with the physical presence of the teaching physician (or with the teaching physician immediately available in the clinic to provide the necessary direction, under the primary care exception) to render personal and identifiable physicians' services to the patient, the exam would likely have revealed crystal-mediated acute arthritis, and that the patient's lack of cooperation was due to hypoactive delirium. However, the teaching physician may not have been able to identify this concern through the use of audio/video interactive communications technology. In this case, the presence of the teaching physician through audio/video interactive communications technology might have been insufficient to allow the teaching physician to render personal and identifiable physicians' services to exercise full, personal control over the key portion of the encounter.

There also may be certain patient populations that require greater clinical attentiveness and skill than the teaching physician could provide via audio/video interactive communications technology. For example, patients with cognitive impairment or dementia may require the experience and skill to recognize a need for specialized testing, and patients with communication disabilities may require more experience and skill to recognize specialized needs. It may not be possible for the teaching physician to meet these clinical needs and exercise full, personal control while being present for the key portion of the service through audio/video interactive communications technology. Moreover, the virtual connection between the teaching physician and the resident who is with the patient could be disrupted (as with any virtual supervision scenario), rendering it impossible for the teaching physician to provide necessary direction for the resident to furnish appropriate care to the patient, thus foreclosing the ability of the teaching physician to exercise full, personal control over the key portion of the services, and potentially putting the patient's safety at risk.

While we have significant concerns about extending our interim policy to permit virtual presence of the teaching physician, whether on a temporary or permanent basis, we believe public comment would be helpful as we further consider the status of this policy. For example, because COVID-19 may continue to persist in some communities after the expiration of the PHE, we are considering extending our policy to permit the teaching physician to be present through audio/video interactive communications technology on a temporary basis until the end of the calendar year in which the PHE ends. The presence of COVID-19 may result in a need for some teaching settings to continue to limit exposure risks, especially for high risk patients isolated for their own protection or in cases where the teaching physician has been exposed to the virus and must be under quarantine. If the teaching physician is under quarantine, termination of the policy to permit virtual presence of the teaching physician could unintentionally limit the number of licensed practitioners available to furnish services to Medicare patients in some communities, and could have the unintended consequence of limiting access to services for Medicare patients. Some communities may experience a resurgence of COVID-19, and extending our policy until the end of the calendar year in which the PHE ends to permit PFS payment when the teaching physician is present through audio/video real-time communications technology could temporarily help teaching settings remain prepared with surge capacity.

Based on the clinical experience gained during the PHE, we might identify circumstances or procedures for which the teaching physician can routinely render sufficient personal and identifiable services to the patient to exercise full, personal control over the management of the key portion of the case when the services are furnished by a resident with the teaching physician present through audio/video real-time communications technology. For example, under ordinary circumstances for the primary care exception at § 415.174, we permit PFS payment to the teaching physician when a resident furnishes office/outpatient evaluation and management (E/M) visit codes of lower and mid-level complexity and annual wellness visits without the presence of a teaching physician (these codes are discussed in section II.F. of this proposed rule). Additionally, the teaching physician may be able to provide sufficient involvement for simple procedures such as CPT code 36410 (Venipuncture, age 3 years or older, necessitating the skill of a physician or other qualified health care professional (separate procedure), for diagnostic or therapeutic purposes (not to be used for routine venipuncture) or CPT code 51701 (Insertion of non-indwelling bladder catheter (e.g., straight catheterization for residual urine). For such circumstances and procedures, it may be appropriate to continue the virtual presence policy on a temporary or permanent basis.

We note that having the virtual presence policy in place temporarily or permanently would not preclude teaching physicians from providing a greater degree of involvement in services furnished with residents, and teaching physicians would still have discretion to determine whether, and if Start Printed Page 50142so, when it is appropriate to be present virtually rather than in person depending on the services being furnished and the experience of the particular residents involved. We seek comment to help us understand how the option to provide for teaching physician presence using audio/video real-time communications technology would support patient safety for all patients and particularly for at-risk patients (for example, patients who are aged and/or who have a disability); ensure burden reduction without creating risks to patient care or increasing fraud; avoid duplicative payment between the PFS and the IPPS for GME programs; and support emergency preparedness. We also invite commenters to provide data and other information on their experiences implementing this policy during the PHE.

c. Virtual Teaching Physician Presence During Medicare Telehealth Services

In the March 31st COVID-19 IFC (85 FR 19260), we adopted a policy on an interim basis to allow Medicare to make payment under the PFS for teaching physician services when a resident furnishes Medicare telehealth services to beneficiaries while a teaching physician is present using audio/video real-time communications technology. We are considering whether this policy should be extended on a temporary basis (that is, if the PHE ends in 2021, this policy could be extended to December 31, 2021 to allow for a transition period before reverting to status quo policy) or be made permanent, and are soliciting public comments on whether this policy should continue once the PHE ends. We believe public comment will assist us in identifying appropriate policy continuation decisions that we would consider finalizing in the CY 2021 PFS final rule. Outside the circumstances of the PHE, under the requirements at section 1834(m) of the Act that discuss payment for telehealth services, the patient would be located at a telehealth originating site, and the teaching physician would be furnishing the service as the distant site practitioner with the involvement of the resident.

While teaching physician presence through audio/video real-time communications technology when a resident furnishes Medicare telehealth services was responsive to critical needs during the PHE to reduce exposure risk and to increase the capacity of teaching settings to respond to COVID-19, we are concerned that the policy to permit virtual presence of the teaching physician may not allow for sufficient personal and identifiable physicians' services to exercise full, personal control over the services such that PFS payment to the teaching physician would be appropriate outside the circumstances of the PHE on a temporary or permanent basis. We are concerned that if the resident was furnishing the service at the distant site and the teaching physician was at a third site and present with the resident through audio/video real-time communications technology, the teaching physician may not be able to render sufficient personal and identifiable physicians' services to the patient to exercise full, personal control over the service to warrant separate payment on the PFS.

Absent the need to reduce exposure risk to COVID-19 during the PHE, we also have some concerns about patient safety when the teaching physician is present only virtually during a telehealth service furnished by a resident. For example, the virtual connection between the teaching physician and the resident who is with the patient could be disrupted (as with any virtual supervision scenario), rendering it impossible for the teaching physician to provide necessary direction for the resident to furnish appropriate care to the patient, thus foreclosing the ability of the teaching physician to exercise full, personal control over the key portion of the service, and potentially putting the patient's safety at risk.

However, because COVID-19 may continue to persist in some communities and some communities may experience a resurgence of COVID-19 after the expiration of the PHE, we are seeking comment about whether it would be appropriate to extend this policy on a temporary basis until the end of the calendar year in which the PHE ends. The presence of COVID-19 may result in a need to continue to limit exposure risks. In cases where the teaching physician has been exposed to the virus and is under quarantine, termination of the policy to permit virtual presence of the teaching physician could unintentionally limit the number of licensed practitioners available to furnish services to Medicare patients in some communities, and could have the unintended consequence of limiting access for Medicare patients. Finally, based on experience gained during the PHE, we might identify circumstances for which the teaching physician can routinely render sufficient personal and identifiable services to the patient to exercise full, personal control over the management of the key portion of the case while providing virtual presence during Medicare telehealth services furnished by a resident on a permanent basis. For example, under ordinary circumstances for the primary care exception at § 415.174, we permit PFS payment to the teaching physician when a resident furnishes office/outpatient E/M visit codes of lower and mid-level complexity and annual wellness visits without the presence of a teaching physician (these codes are discussed in section II.F. of this proposed rule). For such services, it may be appropriate to continue the virtual presence policy on a temporary or permanent basis. We seek comment to help us understand how the option to allow teaching physician presence using audio/video real-time communications technology could support patient safety for all patients and particularly for at-risk patients (for example, patients who are aged and/or who have a disability), ensure burden reduction without creating risks to patient care or increasing fraud, avoid duplicative payment between the PFS and the IPPS for GME programs, and support emergency preparedness. We also invite commenters to provide data and other information on their experiences implementing this policy during the PHE.

d. Resident Moonlighting in the Inpatient Setting

Under certain conditions, the services of a licensed resident physician who is “moonlighting” are considered to be furnished by the individual in their capacity as a physician, rather than as a resident in an approved GME program. As specified in the regulation at § 415.208, except during the PHE, as defined in the regulation at § 400.200, the services of residents to inpatients of hospitals in which the residents have their approved GME program are not considered separately billable as physicians' services and instead are payable under §§ 413.75 through 413.83 regarding direct GME payments, whether or not the services are related to the approved GME training program. When a resident furnishes services that are not related to their approved GME programs in an outpatient department or emergency department of a hospital in which they have their training program, those services can be billed separately as physicians' services and payable under the PFS if they meet the criteria described in our regulation at § 415.208(b)(2) (i) through (iii). In addition, under § 415.208(c), services of a licensed resident furnished outside the scope of an approved GME program when moonlighting in a hospital or other setting that does not participate in Start Printed Page 50143the approved GME program are payable under the PFS when the resident is fully licensed to practice in the state where the services are furnished, and the resident's time spent in patient care activities in that setting is not counted for the purpose of Medicare direct GME payments.

In the March 31st COVID-19 IFC, we amended our regulation at § 415.208 to state that, during the PHE for COVID-19, the services of residents that are not related to their approved GME programs and are furnished to inpatients of a hospital in which they have their training program are separately billable physicians' services for which payment can be made under the PFS provided that the services are identifiable physicians' services and meet the conditions for payment of physicians' services to beneficiaries in providers in § 415.102(a), the resident is fully licensed to practice medicine, osteopathy, dentistry, or podiatry by the state in which the services are performed, and the services can be separately identified from those services that are required as part of the approved GME program.

We are considering whether this flexibility that we implemented on an interim basis should be extended on a temporary basis (that is, if the PHE ends in 2021, these policies could be extended to December 31, 2021 to allow for a transition period before reverting to status quo policy) or be made permanent, and are soliciting public comments on whether this policy should continue once the PHE ends. We are concerned that there may be risks to program integrity in allowing residents to furnish separately billable physicians' services to inpatients in the teaching hospitals where they are training when the services are outside the scope of their approved GME program. For example, there could be a risk of duplicate Medicare payment for the resident's services under the IPPS for GME and the PFS if the physicians' services furnished by residents were not adequately separately identified from those services that are required as part of the GME program. However, because COVID-19 may continue to persist in some communities or some communities may experience a resurgence of COVID-19 after the expiration of the PHE, it may be appropriate for us to extend this policy on a temporary basis to meet the needs of teaching hospitals to ensure that there are as many qualified practitioners available as possible. We believe public comment will assist us in identifying appropriate policy continuation decisions that we would consider finalizing in the CY 2021 PFS final rule. We also invite commenters to provide data and other information on their experiences implementing this policy during the PHE.

e. Primary Care Exception Policies

The regulation at § 415.174 sets forth an exception to the conditions for PFS payment for services furnished in teaching settings in the case of certain E/M services furnished in certain centers. Under the so-called “primary care exception,” Medicare makes PFS payment in certain teaching hospital primary care centers for certain services of lower and mid-level complexity furnished by a resident without the physical presence of a teaching physician. Section 415.174(a)(3) requires that the teaching physician must not direct the care of more than four residents at a time, and must direct the care from such proximity as to constitute immediate availability (that is, provide direct supervision) and must review with each resident during or immediately after each visit, the beneficiary's medical history, physical examination, diagnosis, and record of tests and therapies. Section 415.174(a)(3) also requires that the teaching physician must have no other responsibilities at the time, assume management responsibility for the beneficiaries seen by the residents, and ensure that the services furnished are appropriate.

As provided in the regulation at § 415.174(a), the codes of lower and mid-level complexity that can be furnished under the primary care exception are specified in section 100 of chapter 12 of the Medicare Claims Processing Manual (https://www.cms.gov/​Regulations-and-Guidance/​Guidance/​Manuals/​Downloads/​clm104c12.pdf). They are the following:

  • CPT code 99201 (Office or other outpatient visit for the evaluation and management of a new patient, which requires these 3 key components: A problem focused history; A problem focused examination; Straightforward medical decision making. Counseling and/or coordination of care with other physicians, other qualified health care professionals, or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. Usually, the presenting problem(s) are self-limited or minor. Typically, 10 minutes are spent face-to-face with the patient and/or family);
  • CPT code 99202 (Office or other outpatient visit for the evaluation and management of a new patient, which requires these 3 key components: An expanded problem focused history; An expanded problem focused examination; Straightforward medical decision making. Counseling and/or coordination of care with other physicians, other qualified health care professionals, or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. Usually, the presenting problem(s) are of low to moderate severity. Typically, 20 minutes are spent face-to-face with the patient and/or family);
  • CPT code 99203 (Office or other outpatient visit for the evaluation and management of a new patient, which requires these 3 key components: A detailed history; A detailed examination; Medical decision making of low complexity. Counseling and/or coordination of care with other physicians, other qualified health care professionals, or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. Usually, the presenting problem(s) are of moderate severity. Typically, 30 minutes are spent face-to-face with the patient and/or family);
  • CPT code 99211 (Office or other outpatient visit for the evaluation and management of an established patient, that may not require the presence of a physician or other qualified health care professional. Usually, the presenting problem(s) are minimal. Typically, 5 minutes are spent performing or supervising these services);
  • CPT code 99212 (Office or other outpatient visit for the evaluation and management of an established patient, which requires at least 2 of these 3 key components: A problem focused history; A problem focused examination; Straightforward medical decision making. Counseling and/or coordination of care with other physicians, other qualified health care professionals, or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. Usually, the presenting problem(s) are self-limited or minor. Typically, 10 minutes are spent face-to-face with the patient and/or family);
  • CPT code 99213 (Office or other outpatient visit for the evaluation and management of an established patient, which requires at least 2 of these 3 key components: An expanded problem focused history; An expanded problem focused examination; Medical decision making of low complexity. Counseling and coordination of care with other physicians, other qualified health care professionals, or agencies are provided consistent with the nature of the problem(s) and the patient's and/or Start Printed Page 50144family's needs. Usually, the presenting problem(s) are of low to moderate severity. Typically, 15 minutes are spent face-to-face with the patient and/or family);
  • HCPCS code G0402 (Initial preventive physical examination; face-to-face visit, services limited to new beneficiary during the first 12 months of Medicare enrollment);
  • HCPCS code G0438 (Annual wellness visit; includes a personalized prevention plan of service (PPS), initial visit); and
  • HCPCS code G0439 (Annual wellness visit, includes a personalized prevention plan of service (PPS), subsequent visit).

In the March 31st COVID-19 IFC, we amended § 415.174 of our regulations to allow, during the PHE for COVID-19, all levels of office/outpatient E/M visits to be furnished by the resident and billed by the teaching physician under the primary care exception. In the May 1st COVID-19 IFC (85 FR 27550 through 27629), we further expanded the list of services included in the primary care exception during the PHE for COVID-19. We also allowed PFS payment to the teaching physician for services furnished by residents via telehealth under the primary care exception if the services were also on the list of Medicare telehealth services.

We are considering whether these policies should be extended on a temporary basis (that is, if the PHE ends in 2021, these policies could be extended to December 31, 2021 to allow for a transition period before reverting to status quo policy) or be made permanent, and are soliciting public comments on whether these policies should continue once the PHE ends. We believe public comment will assist us in identifying appropriate policy continuation decisions that we would consider finalizing in the CY 2021 PFS final rule. We are also considering whether specific services added under the primary care exception should be extended temporarily or made permanent and are soliciting public comment on whether these services should continue as part of the primary care exception once the PHE ends. These services are the following:

  • CPT code 99204 (Office or other outpatient visit for the evaluation and management of a new patient, which requires these 3 key components: A comprehensive history; A comprehensive examination; Medical decision making of moderate complexity. Counseling and/or coordination of care with other physicians, other qualified health care professionals, or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. Usually, the presenting problem(s) are of moderate to high severity. Typically, 45 minutes are spent face-to-face with the patient and/or family);
  • CPT code 99205 (Office or other outpatient visit for the evaluation and management of a new patient, which requires these 3 key components: A comprehensive history; A comprehensive examination; Medical decision making of high complexity. Counseling and/or coordination of care with other physicians, other qualified health care professionals, or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. Usually, the presenting problem(s) are of moderate to high severity. Typically, 60 minutes are spent face-to-face with the patient and/or family);
  • CPT code 99214 (Office or other outpatient visit for the evaluation and management of an established patient, which requires at least 2 of these 3 key components: A detailed history; A detailed examination; Medical decision making of moderate complexity. Counseling and/or coordination of care with other physicians, other qualified health care professionals, or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. Usually, the presenting problem(s) are of moderate to high severity. Typically, 25 minutes are spent face-to-face with the patient and/or family);
  • CPT code 99215 (Office or other outpatient visit for the evaluation and management of an established patient, which requires at least 2 of these 3 key components: A comprehensive history; A comprehensive examination; Medical decision making of high complexity. Counseling and/or coordination of care with other physicians, other qualified health care professionals, or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. Usually, the presenting problem(s) are of moderate to high severity. Typically, 40 minutes are spent face-to-face with the patient and/or family);
  • 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);
  • 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);
  • CPT code 99421 (Online digital evaluation and management service, for an established patient, for up to 7 days, cumulative time during the 7 days; 5-10 minutes);
  • CPT code 99422 (Online digital evaluation and management service, for an established patient, for up to 7 days, cumulative time during the 7 days; 11-20 minutes);
  • CPT code 99423 (Online digital evaluation and management service, for an established patient, for up to 7 days, cumulative time during the 7 days; 21 or more minutes);
  • CPT code 99452 (Interprofessional telephone/internet/electronic health record referral service(s) provided by a treating/requesting physician or qualified health care professional, 30 minutes);
  • CPT 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); and
  • 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).

Expanding the array of services for which Medicare may make PFS payment to the teaching physician when furnished by a resident under the primary care exception was responsive to critical needs during the PHE for patients who may be quarantined at home or who may need to be isolated for purposes of minimizing exposure risk based on presumed or confirmed COVID-19 infection. Because COVID-19 may continue to persist in some communities or some communities may experience a resurgence of COVID-19 Start Printed Page 50145after the expiration of the PHE, it may be appropriate for us to extend all of these services on a temporary basis (that is, until the end of the calendar year in which the PHE ends).

However, we are concerned that it may be inappropriate to extend all of these services on a temporary basis or add them to the primary care exception permanently. The intent of the primary care exception as described in § 415.174 is that E/M visits of lower and mid-level complexity furnished by residents are simple enough for a teaching physician to be able to direct and manage the care of up to four residents at any given time and direct the care from such proximity as to constitute immediate availability. While CPT code 99421 and HCPCS code G2012 may be simple services, others such as levels 4 and 5 office/outpatient E/M visits (CPT codes 99204 through 99205 and CPT codes 99214 through 99215) and transitional care management codes (CPT codes 99495 through 99496) require medical decision making that is of at least moderate complexity. We are concerned that the teaching physician may not be able to maintain sufficient personal involvement in all of the care to warrant PFS payment for the services being furnished by up to four residents when some or all of the residents might be furnishing services that are more than lower and mid-level complexity. We are also concerned that when the teaching physician is directing the care of a patient that requires moderate or higher medical decision making, the ability to be immediately available to other residents could be compromised, potentially putting patients at risk. Thus, we are considering whether, upon expiration of the PHE, we should extend on a temporary basis some or all of the services we added to the primary care exception list during the PHE and are soliciting public comments on whether these services should continue as part of the primary care exception after the PHE ends. We also invite commenters to provide data and other information on their experiences implementing this policy during the PHE.

We are also considering whether our interim final policy that PFS payment could be made to the teaching physician when residents furnish telehealth services under the primary care exception should be extended on a temporary basis or be made permanent, and are soliciting public comments on whether this policy should continue once the PHE ends. In these cases, outside the circumstances of the PHE, the patient would be at the originating site and the resident furnishing the care, along with the teaching physician billing for it, would be located at the primary care center as the distant site practitioner. If we were to temporarily extend or add permanently to the primary care exception services such as e-visits or communication technology-based services, it may also make sense to permit PFS payment to the teaching physician when the resident furnishes an office/outpatient E/M visit via telehealth, on the basis that the patient is not physically in the clinic and that these services all involve the use of virtual technology (for example, patient portals for e-visits, telecommunications technology for the office/outpatient E/M visit) to facilitate care delivery. If we were to remove the services that we added to the primary care exception on an interim basis, we could separately consider continuing to permit PFS payment to the teaching physician when the resident furnishes an office/outpatient E/M visit via telehealth because the teaching physician would be immediately available in the distant site clinic with the resident to direct and manage the care.

f. Conclusion

In summary, we remind stakeholders that during the PHE we implemented these policies on an interim basis to support our goals of ensuring beneficiary access to necessary services and maintenance of sufficient workforce capacity through flexibilities afforded to providers to safely furnish services to patients. While we anticipate reverting to our previous teaching physician policy that was in place prior to the PHE for the reasons discussed above, we are considering whether the teaching physician and resident moonlighting policies that we implemented on an interim basis should be extended on a temporary basis (that is, if the PHE ends in 2021, these policies could be extended to December 31, 2021 to allow for a transition period before reverting to status quo policy) or be made permanent policy for CY 2021. We are soliciting public comments on whether these policies should be continued, and if so, whether they should be made permanent, or temporarily extended and the appropriate scope of the extension. As discussed above, we are concerned that the teaching physician may not be able to maintain sufficient personal involvement in all of the care to warrant PFS payment for the services being furnished by up to four residents when some or all of the residents might be furnishing services that are more than lower and mid-level complexity. We are also concerned that when the teaching physician is directing the care of a patient that requires moderate or higher medical decision making, the ability to be immediately available to other residents could be compromised, potentially putting patients at risk. We will also consider under which scenarios our policies for moonlighting or virtual presence as discussed above, should apply, if any. As discussed for our moonlighting policy, we are concerned that there may be risks to program integrity in allowing residents to furnish separately billable physicians' services to inpatients in the teaching hospitals where they are training when the services are outside the scope of their approved GME program. For example, there could be a risk of duplicate Medicare payment for the resident's services under the IPPS for GME and the PFS if the physicians' services furnished by residents were not adequately separately identified from those services that are required as part of the GME program. Under our discussion of virtual presence, we highlighted concerns about how continuing to permit teaching physicians to be involved through their virtual presence may not be sufficient to warrant PFS payment to the teaching physician on a temporary or permanent basis. Absent the circumstances of the PHE, the physical, in-person presence of the teaching physician may be necessary to provide oversight to ensure that care furnished to Medicare beneficiaries is medically reasonable and necessary, and to ensure that the teaching physician renders sufficient personal services to exercise full, personal control of the key portion of the case. We also discussed concerns about patient safety when the teaching physician is only virtually present.

We believe public comment, especially those that focus on the variables we identify above regarding the specific services included on the primary exception list, clinical scenarios under which residents could moonlight or furnish certain types of services under the supervision of a teaching physician via virtual presence, will assist us in identifying the appropriate policy continuation decisions after the end of the PHE, which we will consider finalizing in the CY 2021 PFS final rule. As part of our review of public comments, we will weigh and make decisions based on the potential benefits and risks associated with the potential temporary or permanent continuation, in whole or in part, of these policies. The benefits of continuation may include limiting COVID-19 exposure risk for practitioners and patients, increasing workforce capacity of teaching settings Start Printed Page 50146to respond to continuing effects following the PHE as practitioners may be asked to assist with the response, and increasing access so that we do not unintentionally limit the number of licensed practitioners available to furnish services to Medicare beneficiaries, which could have the unintended consequence of limiting access to services paid under the PFS. The risks may include the potential for duplicative payment with Medicare Part A reimbursement for graduate medical education training programs, the potential for increases to cost-sharing for Medicare beneficiaries that could result from additional Part B claims for services furnished by the teaching physician with the involvement of residents, and potential risks to patient safety.

2. Supervision of Diagnostic Tests by Certain NPPs

In response to Executive Order #13890 discussed above, we sought assistance from stakeholders in identifying Medicare regulations that contain more restrictive supervision requirements than existing state scope of practice laws, or that limit health professionals from practicing at the top of their license. In response to our request for feedback discussed above, physician assistants (PAs) and nurse practitioners (NPs) recommended regulatory changes that would allow them to supervise the performance of diagnostic tests because they are currently authorized to do so under their state scope of practice rules in many states. In the May 1st COVID-19 IFC (85 FR 27550 through 27629), we established on an interim basis during the COVID-19 PHE, a policy to permit these and certain other NPPs to supervise diagnostic tests. We now propose to make those changes permanent by making modifications to the regulations at § 410.32. We are planning to address comments we receive on our proposals included in this proposed rule and comments received on the May 1st COVID-19 IFC (85 FR 27550 through 27629) simultaneously in the final rule since the comment period for the May 1, 2020 COVID-19 IFC (85 FR 27550 through 27629) recently closed on July 7, 2020.

Prior to the COVID-19 PHE, under § 410.32(a)(2), physicians, NPs, CNSs, PAs, certified nurse-midwives (CNMs), clinical psychologists (CPs), and clinical social workers (CSWs) who are treating a beneficiary for a specific medical problem may order diagnostic tests when they use the results of the tests in the management of the beneficiary's specific medical problem. However, generally only physicians were permitted to supervise diagnostic tests. The regulation at § 410.32(b)(1) provided as a basic general rule that all diagnostic tests paid under the PFS must be furnished under an appropriate level of supervision by a physician as defined in section 1861(r) of the Act. Section 410.32(b)(2) then provided for certain exceptions to which this basic rule did not apply. For instance, under § 410.32(b)(2)(v), the requirement that diagnostic tests must be furnished under the appropriate level of supervision by a physician did not apply for tests performed by an NP or CNS authorized under applicable state law to furnish the test. (We note that, as for all services furnished by a NP or CNS, they would have to be furnished working in collaboration with a physician as provided in regulations at §§ 410.75 and 410.76, respectively). Similarly, under the regulation at § 410.32(b)(2)(vii), the requirement that diagnostic tests must be furnished under the appropriate level of supervision by a physician did not apply for tests performed by a CNM authorized under applicable state law to furnish the test. This exception is in place because the Medicare statute does not include any physician supervision requirement for CNM services. Thus, while NPs, CNSs, PAs, and CNMs were permitted to furnish diagnostic tests to the extent they were authorized under state law and their scope of practice to do so, the regulations at § 410.32 did not address whether these practitioners could supervise others who furnished diagnostic tests.

In light of stakeholder feedback to CMS on identifying additional Medicare regulations that contain more restrictive supervision requirements than existing state scope of practice laws, or that limit health professionals from practicing at the top of their license, effective January 1, 2021, we are proposing to amend the basic rule under the regulation at § 410.32(b)(1) to allow NPs, CNSs, PAs or CNMs to supervise diagnostic tests on a permanent basis as allowed by state law and scope of practice. These NPPs have separately enumerated benefit categories under Medicare law that permit them to furnish services that would be physician's services if furnished by a physician, and are authorized to receive payment under Medicare Part B for the professional services they furnish either directly or “incident to” their own professional services, to the extent authorized under state law and scope of practice.

We are proposing to amend the regulation at § 410.32(b)(2)(iii)(B) on a permanent basis to specify that supervision of diagnostic psychological and neuropsychological testing services can be done by NPs, CNS's, PAs or CNMs to the extent that they are authorized to perform the tests under applicable State law and scope of practice, in addition to physicians and CPs who are currently authorized to supervise these tests. We are also proposing to amend on a permanent basis, the regulation at § 410.32 to add paragraph (b)(2)(ix) to specify that diagnostic tests performed by a PA in accordance with their scope of practice and State law do not require the specified level of supervision assigned to individual tests, because the relationship of PAs with physicians under § 410.74 would continue to apply. We are also proposing to make permanent the removal of the parenthetical, previously made as part of the May 1, 2020 COVID-19 IFC (85 FR 27550 through 27629), at § 410.32(b)(3) that required a general level of physician supervision for diagnostic tests performed by a PA.

3. Pharmacists Providing Services Incident to Physicians' Services

Stakeholders have asked us to clarify that pharmacists can provide services incident to the professional services of a physician or other NPP just as other clinical staff may do. These stakeholders have asked us, in particular, about pharmacists who provide medication management services. Medication management is covered under both Medicare Part B and Part D. We are reiterating the clarification we provided in the May 1st COVID-19 IFC (85 FR 27550 through 27629), that pharmacists fall within the regulatory definition of auxiliary personnel under our regulations at § 410.26. As such, pharmacists may provide services incident to the services, and under the appropriate level of supervision, of the billing physician or NPP, if payment for the services is not made under the Medicare Part D benefit. This includes providing the services incident to the services of the billing physician or NPP and in accordance with the pharmacist's state scope of practice and applicable state law.

We note that when a pharmacist provides services that are paid under the Part D benefit, the services are not also reportable or paid for under Part B. In addition to circumstances where medication management is offered as part of the Part D benefit, Part B payment is also not available for services included in the Medicare Part D dispensing fees, such as a pharmacist's time in checking the computer for information about an individual's coverage, measurement or Start Printed Page 50147mixing of the covered Part D drug, filling the container, physically providing or delivering the completed prescription to the Part D enrollee. Similarly, performing required quality assurance activities consistent with § 423.153(c)(2), such as screening for potential drug therapy problems due to therapeutic duplication, age/gender-related contraindications, potential over-utilization and under-utilization, drug-drug interactions, incorrect drug dosage or duration of drug therapy, drug-allergy contraindications, and clinical abuse/misuse are considered part of dispensing fees under Part D and are not separately reportable services under Part B. Additionally, services and supplies paid under the incident to benefit must be an integral, though incidental, part of the service of a physician (or other practitioner) in the course of diagnosis or treatment of an injury or illness (§ 410.26). We also note that our manual provisions specify that “incident to” services must be of a type that are medically appropriate to provide in the office setting; and that where a physician supervises auxiliary personnel to assist him or her in rendering services to patients and includes the charges for their services in his or her own bills, the services of such personnel are considered incident to the physicians' service if there is a physicians' service rendered to which the services of such personnel are an incidental part and there is direct supervision by the physician (section 60.1 of chapter 15 of the Medicare Benefit Policy Manual (Pub. 100-02) available on the CMS website at https://www.cms.gov/​Regulations-and-Guidance/​Guidance/​Manuals/​Downloads/​bp102c15.pdf).

Although it is fully consistent with current CMS policy for pharmacists to provide services incident to the services of the billing physician or NPP, we believe this clarification may encourage pharmacists to work with physicians and NPPs in new ways where pharmacists are working at the top of their training, licensure and scope of practice. It may free up the time of physicians and NPPs for other work and increase access to medication management services, for individuals with chronic conditions and other conditions. As an example, we found that this clarification was helpful in recently addressing in the May 1st COVID-19 IFC (85 FR 27550 through 27629), the ability of pharmacies to enroll as laboratories and work with physicians in the assessment of clinical information, specimen collection and reporting results of COVID-19 clinical diagnostic laboratory tests.

4. Provision of Maintenance Therapy by Therapy Assistants

In response to our request for feedback on scope of practice (noted above), consistent with Executive Order #13890, respondents requested that we allow physical therapist assistants (PTAs) and occupational therapy assistants (OTAs) to furnish maintenance therapy services associated with a maintenance program. The respondents said that our Part B therapy policy is not consistent with policies for these services when provided to patients in the skilled nursing facility (SNF) and home health (HH) settings paid under Part A. Other respondents told us that because the therapist is responsible for a patient's care over an episode, that this should include assigning responsibilities for maintenance therapy to an assistant when it is clinically appropriate. Some respondents stated that permitting PTAs and OTAs to furnish maintenance therapy services would give Medicare patients greater access to care and permit therapists and therapy providers more flexibility for resource utilization.

After considering respondents' concerns about the incongruity between our Part B and Part A maintenance therapy policy, and to provide flexibility to increase the availability of needed health care services during the COVID-19 PHE, we amended our policy on an interim final basis in the May 1st COVID-19 IFC (85 FR 27550 through 27629) to allow the physical therapist (PT) or occupational therapist (OT) who established the maintenance program to assign the duties to a PTA or OTA, as clinically appropriate, to perform maintenance therapy services.

We explained that making this change could free-up the PT or OT to furnish other services, particularly those related to the COVID-19 PHE that require a therapist's assessment and evaluation skills, and including the CTBS, that is, e-visits, virtual visits, remote evaluations, and phone evaluations—that were added as “sometimes therapy” services in the March 31st COVID-19 IFC for PTs, OTs and speech-language pathologists (SLPs). We stated explicitly that the maintenance therapy services furnished by therapist-supervised OTAs and PTAs will be paid in the same manner as those we already pay for as rehabilitative therapy services, and referred the reader to regulatory payment conditions for Part B outpatient occupational and physical therapy services (§§ 410.59 and 410.60, respectively) that require, as a basic rule, that the services be provided by an individual meeting qualifications in 42 CFR part 484 for an OT or PT, or an appropriately supervised OTA or PTA.

In this proposed rule, we are proposing to make permanent our Part B policy for maintenance therapy services effective January 1, 2021 in order to create greater conformity in payment policy for maintenance therapy services that are furnished and paid under Part B with those in SNF and HH settings under Part A. If adopted, our policy would dovetail with our amended policy set forth in the May 1st COVID-19 IFC (85 FR 27550 through 27629) that grants PTs and OTs the discretion to delegate maintenance therapy services to the PTAs and OTAs, as clinically appropriate, for the duration of the PHE. If the PHE is ended prior to January 1, 2021, the therapist would need to personally furnish the maintenance therapy services until the proposed policy change takes effect. We plan to address comments from the May 1st COVID-19 IFC in conjunction with the comments from this proposed rule in the final rule, given the comment period has only just closed on that IFC.

Our policy for maintenance therapy services is explained in section 220.2 of chapter 15 of the Medicare Benefit Policy Manual (see https://www.cms.gov/​Regulations-and-Guidance/​Guidance/​Manuals/​Downloads/​bp102c15.pdf) in cases where rehabilitative services, requiring the improvement in the patient's functional status, are no longer or were not previously covered. This manual section explains that skilled therapy services related to a reasonable and necessary maintenance program are available for the establishment or design of the maintenance program and the delivery of the maintenance program, that is, maintenance therapy, when it needs to be carried out as maintenance therapy services. Maintenance programs that can be carried out by the patient alone or with the assistance of caregivers, are not covered. Sections 230.1 and 230.2 of chapter 15 of the Medicare Benefit Policy Manual specify that a PTA or OTA may not provide skilled maintenance program services.

In considering our proposal, we reviewed regulatory requirements for conditions of payment for outpatient occupational therapy, physical therapy, and speech-language pathology services at §§ 410.59, 410.60 and 410.62; the regulation for therapy treatment plans at § 410.61, and the regulations specifying treatment plan certification and recertification requirements at § 424.24 for Part B occupational therapy, physical therapy, and speech-language Start Printed Page 50148pathology services, in addition to the above mentioned manual provisions.

Given that we already make payment for rehabilitative services requiring improvement in the patient's functional status when they are furnished by PTAs and OTAs at the discretion of the supervising therapist treating the patient in accordance with the therapist-established plan of care, we believe that it would be appropriate for the therapist to use that same judgement in deciding whether to delegate to the PTA or OTA the performance of maintenance therapy services under the associated plan of care. We believe that there is little difference between the rehabilitative therapy services furnished to improve a patient's functional status and those for maintenance therapy services other than the goals set by the therapist in the therapy plan that are aimed to maintain, slow or prevent further decline of a patient's condition. We do not believe that the therapist-only maintenance therapy requirement is needed in the case of outpatient physical or occupational therapy services, and instead believe that it would be appropriate for an OT or PT to be permitted to use their professional judgement to assign the performance of maintenance therapy services to an OTA or PTA when it is clinically appropriate to do so.

As such, we propose to allow, on a permanent basis, therapists to delegate performance of maintenance therapy services to an OTA or PTA for outpatient occupational and physical therapy services in Part B settings beginning January 1, 2021. This proposal would better align our Part B policy with that in SNFs and HH paid under Part A where maintenance therapy services may be performed by a therapist or a therapy assistant. Since our regulations at §§ 410.59, 410.60, 410.61, 410.62 and 424.24, do not now distinguish between rehabilitative and maintenance therapy services, we are not proposing to amend them. Instead, we propose to revise sections 220.2, 230.1 and 230.2 of chapter 15 of the Medicare Benefit Policy Manual to clarify that PTs and OTs no longer need to personally perform maintenance therapy services and to specifically remove the prohibitions on PTAs and OTAs from furnishing such services. Therefore, we believe our proposal to allow PTs and OTs to delegate maintenance therapy services to their supervised assistants is in keeping with Executive Order #13890 and appeals by respondents to our request for feedback on scope of practice that followed, rather than the alternative option of maintaining the pre-COVID-19 policy of requiring PTs and OTs to personally furnish them, after the COVID-19 PHE is ended.

We note that therapists and therapy providers should consult the CQ and CO modifier policies to consider whether these modifiers should be applied to claims for services furnished in whole or in part by PTAs and OTAs which will, beginning January 1, 2022, be paid at 85 percent of the amount that would otherwise apply for the service, as required by section 1834(v) of the Act which was added by section 53107 of the Bipartisan Budget Act of 2018. See the CY 2020 PFS rulemaking for policies related to the application of CQ and CO modifiers and the associated regulatory requirements (84 FR 40558 through 40564 (proposed rule) and 84 FR 62702 through 60708 (final rule)).

5. Medical Record Documentation

As we established in the CY 2020 PFS final rule (84 FR 62681 through 62684), and similarly expressed in the May 1st COVID-19 IFC (85 FR 27556 through 27557), any individual who is authorized under Medicare law to furnish and bill for their professional services, whether or not they are acting in a teaching role, may review and verify (sign and date) the medical record for the services they bill, rather than re-document, notes in the medical record made by physicians, residents, nurses, and students (including students in therapy or other clinical disciplines), or other members of the medical team. We note that although there are currently no documentation requirements that would impact payment for PTs, OTs, or SLPs when documentation is added to the medical record by persons other than the therapist, we are responding in this proposed rule to stakeholder requests for clarification. Specifically, we are clarifying that the broad policy principle that allows billing clinicians to review and verify documentation added to the medical record for their services by other members of the medical team also applies to therapists. This will help ensure that therapists are able to spend more time furnishing therapy services, including pain management therapies to patients that may minimize the use of opioids and other medications, rather than spending time documenting in the medical record. We emphasize that, while any member of the medical team may enter information into the medical record, only the reporting clinician may review and verify notes made in the record by others for the services the reporting clinician furnishes and bills. We also emphasize that information entered into the medical record should document that the furnished services are reasonable and necessary.

H. 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.C. 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 Start Printed Page 50149new 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 re-proposed 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 within 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 proposed 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 includes 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.Start Printed Page 50150

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 a 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.

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 valuation considered for specific codes. Table 24 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, 2020. The proposed work RVUs, work time and other payment information for all CY 2021 payable codes are available on the CMS website under downloads for the CY 2021 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 Start Printed Page 50151PE 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 25 details our 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 refinements that would be common across codes. Refinements to particular codes are addressed in the portions of this section that are dedicated to particular codes. We note that 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 25 result in changes under the $0.35 threshold and are unlikely to result in a change to the RVUs.

We also note that the direct PE inputs for CY 2021 are displayed in the CY 2021 direct PE input files, available on the CMS website under the downloads for the CY 2021 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 CY 2021 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 Start Printed Page 50152specialty societies to provide us copies of sales invoices. For CY 2021 we received invoices for several new supply and equipment items. Tables 27 and 28 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.

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 27 and 28 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 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 2021 are available on the CMS website under downloads for the CY 2021 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 2021

(1) Fine Needle Aspiration (CPT Codes 10021, 10004, 10005, 10006, 10007, 10008, 10009, 10010, 10011, and 10012)

In June 2017, the CPT Editorial Panel deleted CPT code 10022, revised CPT code 10021, and created nine new codes to describe fine needle aspiration procedures with and without imaging guidance. These ten codes were surveyed and reviewed for the October 2017 and January 2018 RUC meetings. In the CY 2019 final rule, we finalized the RUC-recommended work RVU for seven of the ten codes in the family, while finalizing a lower work RVU for CPT codes 10005 (Fine needle aspiration biopsy, including ultrasound guidance; first lesion), 10009 (Fine needle aspiration biopsy, including CT guidance; first lesion), and 10021 (Fine needle aspiration biopsy, without imaging guidance; first lesion). For a full discussion of this review, we refer readers to the CY 2019 PFS final rule (83 FR 59517 through 59521).

Following the publication of the CY 2019 final rule, RUC staff stated that CMS erroneously double-counted the utilization for new codes that had image guidance bundled. We disagreed that this constituted a technical error and communicated to the RUC in conversations following the publication of the rule that the surveying specialties could instead nominate the affected codes from these families as being potentially misvalued. At the January 2020 RUC meeting, the RUC reaffirmed its CY 2019 recommendations for physician work and direct practice expense (PE) for the ten codes in the Fine Needle Aspiration code family.

In discussing this group of codes, we would like to clarify again that we disagree with the RUC and do not believe that utilization was erroneously double-counted for this code family. We publish our proposed utilization crosswalk each year as a public use file available on the CMS website; the current such file is available under downloads for the CY 2021 PFS proposed rule at http://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​PhysicianFeeSched/​PFS-Federal-Regulation-Notices.html. During the CY 2019 rule cycle, we proposed the utilization crosswalk for the Fine Needle Aspiration family as it was recommended to CMS by the RUC, and we did not receive any comments on this subject until after the valuation of these codes had been finalized. We proposed and finalized the utilization crosswalk for this code family as recommended by the RUC without receiving any comments from the RUC or other stakeholders. If the RUC or other stakeholders believed that what CMS had proposed was incorrect or misunderstood what the RUC had recommended, there was an opportunity to comment during the 60 days following the publication of the proposed rule. We disagree that the utilization crosswalk was erroneous, and we did not make a technical correction following the publication of the CY 2019 final rule for this reason.

We also disagree with the RUC that the utilization crosswalk was “the Start Printed Page 50153principle reason CMS rejected the RUC recommendations” for the codes in the Fine Needle Aspiration family, as stated in the RUC's CY 2021 recommendations for this code family. As we stated in the CY 2019 proposed rule and restated in the CY 2019 final rule, our refinements to the work RVUs of CPT codes 10021, 10005, and 10009 were primarily based on changes in surveyed work time and the relationship between the codes in the family. For example, this was our rationale for refining the work RVU of CPT code 10021 from the RUC-recommended value of 1.20 to the finalized value of 1.03: In reviewing CPT code 10021, we noted that the recommended intraservice time is decreasing from 17 minutes to 15 minutes (12 percent reduction), and the recommended total time is decreasing from 48 minutes to 33 minutes (32 percent reduction); however, the RUC-recommended work RVU is only decreasing from 1.27 to 1.20, which is a reduction of just over 5 percent. In the case of CPT code 10021, we believed that it was more accurate to propose a work RVU of 1.03 based on a crosswalk to CPT code 36440 to account for these decreases in the surveyed work time (83 FR 59518). We note that this primary rationale for refining the work RVU did not mention the utilization crosswalk at all.

When we communicated to the RUC following the publication of the CY 2019 final rule that the codes in the Fine Needle Aspiration family could be nominated as potentially misvalued, we indicated that we were open to receiving new information about the valuation of these codes. In reaffirming its recommendations from CY 2019, however, the RUC has not provided any new information that was not already presented for the previous CMS review of these codes. Therefore, we are not proposing any changes to the codes in the Fine Needle Aspiration family, as the reaffirmed CY 2021 RUC recommendations are identical to the CY 2019 RUC recommendations that already went through notice and comment rulemaking. We welcome the submission of new information regarding these services that was not part of the previous CY 2019 review of the code family.

(2) Tissue Expander Other Than Breast (CPT Code 11960)

This service was included in a larger group of similarly related codes that were recommended for review for the October 2019 RUC meeting. The RUC recommended to re-review this code at a more granular level for the January 2020 RUC meeting.

We disagree with the RUC-recommended work RVU of 12.40 for CPT code 11960 (tissue expander other than breast). We are proposing to maintain the current work RVU of 11.49 supported by a reference code, CPT code 45560 (repair of rectocele (separate procedure)), which has a work RVU of 11.50. CPT code 45560 shares the same intraservice time of 90 minutes with CPT code 11960 and has a slightly higher total time of 367 minutes. The recommended total time for CPT code 11960 decreased from 444 minutes to 357 minutes, with a slight increase in intraservice time of 78 minutes to 90 minutes. We believe the similar work RVU of the reference CPT code 45560, as well as the reduction in total time, supports maintaining the current work RVU of 11.49 for CPT code 11960. We are proposing the RUC-recommended direct PE inputs for CPT code 11960 without refinements.

(3) Breast Implant-Expander Placement (CPT Codes 11970, 19325, 19340, 19342, and 19357)

These services were included in a larger group of 22 breast reconstruction and similarly related codes that were recommend for survey for the October 2019 RUC meeting. At the October 2019 RUC meeting, these codes were recommended for a more granular review for the January 2020 RUC meeting.

We disagree with the RUC-recommended work RVU of 8.01 for CPT code 11970 (replacement of tissue expander with permanent implant). We are proposing a work RVU of 7.49 supported by a reference code CPT code 35701 (exploration not followed by surgical repair, artery; neck (e.g., carotid, subclavian)), which has a work RVU of 7.50. CPT code 35701 shares the same intraservice time of 60 minutes with CPT code 11970 and has a slightly higher total time of 229 minutes as compared to 216 minutes. In addition, during our review of CPT code 11970, we noted that the recommended intraservice time is decreasing from 78 minutes to 60 minutes and the recommended total time of 231 minutes is decreasing to 216 minutes. We also note that our proposed work RVU of 7.49 for CPT code 11970 is equal to the total time ratio amount, which is the current total time compared to the RUC-recommended total time. We are proposing the RUC-recommended direct PE inputs for CPT code 11970.

We disagree with the RUC-recommended work RVU of 8.64 for CPT code 19325 (breast augmentation with implant). Although we disagree with the RUC-recommended work RVU, we concur that the relative difference in work between CPT codes 11970 and 19325 is equivalent to the RUC-recommended interval of 0.63 RVUs. Therefore, we are proposing a work RVU of 8.12 for CPT code 19325, based on the recommended interval of 0.63 additional RVUs above our proposed work RVU of 7.49 for CPT code 11970. We believe the use of an incremental difference between these CPT codes is a valid methodology for setting values, especially in valuing services within a family of revised codes where it is important to maintain appropriate intra-family relativity. We are also supporting our proposed work RVU of 8.12 based on a reference code, CPT code 25652 (open treatment of ulnar styloid fracture). CPT code 25652 shares the same intraservice time of 60 minutes and the same total time of 225 minutes with a lower work RVU of 8.06. In addition, during our review of CPT code 19325, we noted that the total time has decreased from 244 minutes to 225 minutes and the intraservice time has decreased from 90 minutes to 60 minutes. We are proposing the RUC-recommended direct PE inputs for CPT code 19325.

We disagree with the RUC-recommended work RVU of 11.00 for CPT code 19340 (insertion of breast implant on same day of mastectomy (i.e. immediate)). Although we disagree with the RUC-recommended work RVU, we concur that the relative difference in work between CPT codes 19325 and 19340 is equivalent to the RUC-recommended interval of 2.36 RVUs. Therefore, we are proposing a work RVU of 10.48 for CPT code 19340, based on the recommended interval of 2.36 additional RVUs above our proposed work RVU of 8.12 for CPT code 19325. We are also supporting our proposed work RVU of 10.48 based on a reference code, CPT code 47562 (laparoscopy, surgical; cholecystectomy). CPT code 47562 shares the same intraservice time of 80 minutes and only a slightly lower total time of 251 minutes with a similar work RVU of 10.47. In addition, during our review of CPT code 19340, we noted that the total time has decreased from 366 minutes to 261 minutes and the intraservice time has decreased from 120 minutes to 80 minutes. We are proposing the RUC-recommended direct PE inputs for CPT code 19340.

We disagree with the RUC-recommended work RVU of 11.00 for CPT code 19342 (insertion or replacement of breast implant on different day from mastectomy). Although we disagree with the RUC-recommended work RVU, we concur that the relative difference in work Start Printed Page 50154between CPT codes 19325 and 19342 is equivalent to the RUC-recommended interval of 2.36 RVUs. Therefore, we are proposing a work RVU of 10.48 for CPT code 19342, based on the recommended interval of 2.36 additional RVUs above our proposed work RVU of 8.12 for CPT code 19325. We also note that the RUC-recommended work RVU of 11.00 is equal to the RUC-recommended work RVU for CPT code 19340 because they have stated that both services involve an identical amount of physician work and similar times. We are also supporting our proposed work RVU of 10.48 based on a reference code, CPT code 47562 (laparoscopy, surgical; cholecystectomy). CPT code 47562 shares the same intraservice time of 80 minutes and only a slightly lower total time of 251 minutes with a similar work RVU of 10.47. The total time for CPT code 19342 has decreased from 320 minutes to 252 minutes and the intraservice time has decreased from 115 minutes to 80 minutes. We are proposing the RUC-recommended direct PE inputs for CPT code 19342.

We disagree with the RUC-recommended work RVU of 15.36 for CPT code 19357 (tissue expander placement in breast reconstruction, including subsequent expansion). Although we disagree with the RUC-recommended work RVU, we concur that the relative difference in work between CPT codes 11970 and 19357 is equivalent to the RUC-recommended interval of 7.35 RVUs. Therefore, we are proposing a work RVU of 14.84 for CPT code 19357, based on the recommended interval of 7.35 additional RVUs above our proposed work RVU of 7.49 for CPT code 11970. We are also supporting our proposed work RVU of 14.84 based on a reference code, CPT code 37605 (ligation; internal or common carotid artery). CPT code 37605 shares the same intraservice time of 90 minutes and only a slightly lower total time of 342 minutes with a lower work RVU of 14.28. In addition, during our review of CPT code 19357, we noted that the total time has decreased from 468 minutes to 344 minutes and the intraservice time has decreased from 110 minutes to 90 minutes. We are proposing the RUC-recommended direct PE inputs for CPT code 19357.

(4) Breast Implant-Expander Removal (CPT Codes 11971, 19328, and 19330)

These services were included in a group of codes that were recommended for survey for the October 2019 RUC meeting as part of a large group of 22 breast reconstruction and similarly related services. At the October 2019 RUC meeting, they agreed that a 22 code family was too expansive. They recommended these codes be re-reviewed as part of a smaller and more granular code family for the January 2020 RUC meeting.

We disagree with the RUC-recommended work RVU of 7.02 for CPT code 11971 (removal of tissue expander w/out insertion of implant). Although we disagree with the RUC-recommended work RVU, we concur that the relative difference in work between CPT codes 11970 and 11971 is equivalent to the RUC recommended interval of 0.99 RVUs. Therefore, we are proposing a work RVU of 6.50 for CPT code 11971, based on the recommended interval of 0.99 RVUs below our proposed work RVU of 7.49 for CPT code 11970. We note that as stated previously, we believe the use of an incremental difference between these CPT codes is a valid methodology for setting values, especially in valuing services within families of similarly revised codes. We are also supporting our proposed work RVU of 6.50 based on a reference code, CPT code 25671 (percutaneous skeletal fixation of distal radioulnar dislocation). CPT code 25671 shares the same intraservice time of 45 minutes and a slightly less total time of 210 minutes with a very similar work RVU of 6.46. In addition, during our review of CPT code 11971, we noted that the total time has decreased from 303 minutes to 215 minutes and the intraservice time has decreased from 90 to 45 minutes. We are proposing the RUC-recommended direct PE inputs for CPT code 11971.

We disagree with the RUC-recommended work RVU of 7.44 for CPT code 19328 (removal of intact breast implant). Although we disagree with the RUC-recommended work RVU, we propose increasing the current work RVU from 6.48 to 6.92 to account for the increases in total and intraservice time. We also concur that the relative difference in work between CPT codes 11971 and 19328 is equivalent to the RUC recommended interval of 0.42 RVUs. Therefore, we are proposing a work RVU of 6.92 for CPT code 19328, based on the recommended interval of 0.42 additional RVUs above our proposed work RVU of 6.50 for CPT code 11970. We are also supporting our proposed work RVU of 6.92 based on a reference code, CPT code 28289 (Hallux rigidus correction with cheilectomy, debridement and capsular release of the first metatarsophalangeal joint; without implant). CPT code 28289 shares the same intraservice time of 45 minutes and a slightly higher total time of 210 minutes with a very similar work RVU of 6.90. The total time for CPT code 19328 has increased from 173 minutes to 199 minutes and the intraservice time has increased from 38 to 45 minutes. We are proposing the RUC-recommended direct PE inputs for CPT code 19328.

We are proposing the RUC-recommended work RVU of 9.00 for CPT code 19330 (removal of ruptured breast implant, including implant contents). The survey total time for CPT code 19330 has increased from 218 minutes to 229 minutes and the intraservice time has increased from 62 minutes to 75 minutes. We are also proposing the RUC-recommended direct PE inputs for this code without refinements.

(5) Modified Radical Mastectomy (CPT Code 19307)

The RUC recommended that CPT code 19307 (Mastectomy, modified radical, including axillary lymph nodes, with or without pectoralis minor muscle, but excluding pectoralis major muscle) be surveyed for the January 2020 RUC meeting for site of service anomaly. The Relativity Assessment Workgroup identified services performed less than 50 percent of the time in the inpatient setting yet included inpatient hospital E/M services within the global period and with 2018 Medicare utilization over 5,000. The RUC recommended lowering the work RVU to 17.99 which is the survey 25th percentile.

We are proposing the RUC-recommended work RVUs of 17.99 for CPT code 19307. We are also proposing the RUC-recommended direct PE inputs for this code.

(6) Breast Lift-Reduction (CPT Codes 19316 and 19318)

These services were included in a larger code group of similarly related services that were recommended for review for the October 2019 RUC meeting. CPT code 19316 (mastopexy) and CPT code 19318 (Breast reduction) were then recommended for a more granular review for the January 2020 RUC meeting.

We are proposing the RUC-recommended work RVU of 11.09 for CPT code 19316 (mastopexy) and 16.03 for CPT code 19318 (Breast reduction). We are proposing the RUC-recommended direct PE inputs for this code family without refinements.

(7) Secondary Breast Mound Procedure (CPT Codes 19370, 19371, and 19380)

These services were included in a large group of breast reconstruction codes that were recommended to be surveyed for the October 2019 RUC meeting. At the October 2019 RUC meeting, the RUC concurred with the Start Printed Page 50155more granular code families but recommended these codes be re-surveyed for the January 2020 RUC meeting.

We disagree with the RUC-recommended work RVU of 10.0 for CPT code 19370 (Revision of peri-implant capsule, breast, including capsulorrhaphy, and/or partial capsulectomy). We are proposing to maintain the current work RVU of 9.17 based on a supporting reference code, CPT code 28299 (Correction, hallux valgus (bunionectomy), with sesamoidectomy, when performed; with double osteotomy, any method), which has a work RVU of 9.29. CPT code 28299 shares a similar intraservice time of 75 minutes with CPT code 19370 and has a slightly higher total time of 256 minutes. In addition, we noted during our review of CPT code 19370 that the recommended total time has increased minimally from 253 minutes to 255 minutes, with a slight decrease in intraservice time of 82 minutes to 78 minutes. We believe the similar work RVU of the supporting CPT code 28299, as well as the minimal changes in physician work time for CPT code 19370, supports maintaining the current work RVU of 9.17. We are proposing the RUC-recommended direct PE inputs for CPT code 19370 without refinements.

We disagree with the RUC-recommended work RVU of 10.81 for CPT code 19371 (Peri-implant capsulectomy, breast, complete, including removal of all intra-capsular contents). Although we disagree with the RUC-recommended work RVU, we concur that the relative difference in work between CPT codes 19370 and 19371 is equivalent to the RUC recommended interval of 0.81 RVUs. Therefore, we are proposing a work RVU of 9.98 for CPT code 19371, based on the recommended interval of 0.81 additional RVUs above our proposed work RVU of 9.17 for CPT code 19370. We note that as stated previously, we believe the use of an incremental difference between these CPT codes is a valid methodology for setting values, especially in valuing services within a family of revised codes where it is important to maintain appropriate intra-family relativity. We are also supporting our proposed work RVU of 9.98 based on a reference code, CPT code 25628 (Open treatment of carpal scaphoid (navicular) fracture, includes internal fixation, when performed). CPT code 25628 shares the same intraservice time of 90 minutes and a slightly higher total time of 277 minutes with a work RVU of 9.67. In addition, during our review of CPT code 19371, we noted that the total time for CPT code 19371 has decreased from 306 minutes to 261 minutes and the intraservice time has decreased from 117 to 90 minutes. We are proposing the RUC-recommended direct PE inputs for CPT code 19371.

We disagree with the RUC-recommended work RVU of 12.00 for CPT code 19380 (Revision of reconstructed breast (eg, significant removal of tissue, re-advancement and/or re-inset of flaps in autologous reconstruction or significant capsular revision combined with soft tissue excision in implant-based reconstruction)). Although we disagree with the RUC-recommended work RVU, we concur that the relative difference in work between CPT codes 19371 and 19380 is equivalent to the RUC recommended interval of 1.19 RVUs. Therefore, we are proposing a work RVU of 11.17 for CPT code 19380, based on the recommended interval of 1.19 additional RVUs above our proposed work RVU of 9.98 for CPT code 19371. We are also supporting our proposed work RVU of 11.17 based on a reference code, CPT code 64569 (Revision or replacement of cranial nerve (eg, vagus nerve) neurostimulator electrode array, including connection to existing pulse generato). CPT code 64569 shares the same intraservice time of 120 minutes and only a slightly higher total time of 312 minutes with a work RVU of 11.0. The total time increased from 277 minutes to 307 minutes and the intraservice time has increased from 89 minutes to 120 minutes. We are proposing the RUC-recommended direct PE inputs for CPT code 19380.

(8) Hip-Knee Arthroplasty (CPT Codes 27130 and 27447)

CPT codes 27130 (Arthroplasty, acetabular and proximal femoral prosthetic replacement (total hip arthroplasty), with or without autograft or allograft) and 27447 (Arthroplasty, knee, condyle and plateau; medial AND lateral compartments with or without patella resurfacing (total knee arthroplasty)) were identified as potentially misvalued codes under the CMS high expenditure procedural code screen in the CY 2014 final rule with comment period (78 FR 74334). These codes were reviewed by the AMA RUC who provided recommendations for work RVUs and physician time for these services for CY 2014. We agreed with the RUC recommendation to value CPT code 27130 and CPT code 27447 equally and thus established the same CY 2014 interim final work RVUs for these two procedures (78 FR 74334). This change resulted in a 1.12 work RVU increase for the visits in the global period. We added the additional work to the AMA RUC-recommended work RVU of 19.60 for CPT codes 27130 and 27447, resulting in an interim final work RVU of 20.72 for both services.

In the CY 2015 final rule with comment period (79 FR 67632), we discussed how in the CY 2014 final rule with comment period, we sought public comment regarding the appropriate work RVUs for these services and the most appropriate reconciliation for the conflicting information regarding time values for these services as presented to us by the physician community. We did not find the rationales provided for modifying the interim final work values established in CY 2014 compelling, and thus we finalized the CY 2014 interim final values for these procedures based upon the best data we had available and to preserve appropriate relativity with other codes.

In the CY 2019 final rule (83 FR 59500 through 595303), CPT code 27130 and CPT code 27447 were added to the list of potentially misvalued codes. A stakeholder submitted information requesting that CMS nominate these codes as potentially misvalued. The stakeholder stated that there were substantial overestimates in pre-service and post-service time including follow-up inpatient and outpatient visits that do not take place included in the valuation of the service. As a result the codes were resurveyed for the October 2019 RUC meeting.

We are proposing the RUC-recommended work RVU of 19.60 for CPT code 27130 and the RUC-recommended work RVU of 19.60 for CPT code 27447. We are also proposing the RUC-recommended direct PE inputs for both codes. Additionally, we are seeking comment from the medical community on how to consider and/or include pre-optimization time (pre-service work and/or activities to improve surgical outcomes) going forward. We are also interested in stakeholders' thoughts on what codes could be used to capture these pre-optimization activities that could be billed in conjunction with the services discussed previously. Overall, we are interested in continuing our ongoing dialog with stakeholders about how CMS might pay more accurately for improved clinical outcomes that may result from increased efficiency in furnishing care through activities, such as pre-optimization and are appreciative of information provided by the medical community. We invite the medical community to continue to engage with CMS on this and other topics.Start Printed Page 50156

(9) Toe Amputation (CPT Codes 28820 and 28825)

These services were identified by the RUC Relativity Assessment Workgroup through a site of service anomaly screen based on the review of 3 years of data (2015, 2016 and 2017) for services with utilization over 10,000 in which a service is typically performed in the inpatient hospital setting, yet only a half discharge day management identified by CPT code 99238 is included. Prior to conducting the RUC survey, the specialty societies recommended that it would be appropriate for these services to have their global period changed from 090-day to 000-day so the site of service is less of a contributing factor to the codes' valuation. These codes were surveyed as a 000-day global service, and we are proposing them as 000-day global services.

We disagree with the RUC-recommended work RVU of 4.10 for CPT code 28820 (Amputation, toe; metatarsophalangeal joint). We believe that it would be more accurate to propose a work RVU of 3.51, and we are supporting this value with a crosswalk to CPT code 33958 (Extracorporeal membrane oxygenation (ECMO)/extracorporeal life support (ECLS) provided by physician; reposition peripheral (arterial and/or venous) cannula(e), percutaneous, 6 years and older (includes fluoroscopic guidance, when performed)), which has a work RVU of 3.51, to account for the decrease in the surveyed work time. We do not believe the RUC-recommended reduction in work RVU from the current value of 5.82 is commensurate with the RUC-recommended 102-minute reduction in total time. We believe that a further reduction in work RVUs is warranted given the significant reduction in RUC-recommended physician time.

We disagree with the RUC-recommended work RVU of 4.00 for CPT code 28825 (Amputation, toe; interphalangeal joint). We are proposing a work RVU of 3.41 based on the RUC-recommended increment relationship between this code and CPT 28820 (a difference of -0.10), which we apply to our proposed value for the latter code. We do not believe the RUC-recommended reduction in work RVU from the current value of 5.37 is commensurate with the RUC-recommended 97-minute reduction in total time. We believe that a further reduction in work RVUs is warranted given the significance of RUC-recommended reduction in physician time.

For the direct PE inputs, we are proposing to refine the pre-service clinical labor times to conform to the 000-day global period standards for both codes in the family for CPT codes 28820 and 28825. We are also proposing to refine the clinical labor times for the “Provide education/obtain consent” (CA011) and the “Prepare room, equipment and supplies” (CA013) activities to conform to our established standard time of 2 minutes each in the non-facility setting for CPT codes 28820 and 28825. We are also proposing to refine the equipment time to conform to these changes in the clinical labor time for both codes.

(10) Shoulder Debridement (CPT Codes 29822 and 29823)

In September 2019, the CPT Editorial Panel approved revision of CPT code 29822 (Arthroscopy, shoulder, surgical; debridement, limited, 1 or 2 discrete structures (eg, humeral bone, humeral articular cartilage, glenoid bone, glenoid articular cartilage, biceps tendon, biceps anchor complex, labrum, articular capsule, articular side of the rotator cuff, bursal side of the rotator cuff, subacromial bursa, foreign body[ies])) and CPT code 29823 (Arthroscopy, shoulder, surgical; debridement, extensive, 3 or more discrete structures (eg, humeral bone, humeral articular cartilage, glenoid bone, glenoid articular cartilage, biceps tendon, biceps anchor complex, labrum, articular capsule, articular side of the rotator cuff, bursal side of the rotator cuff, subacromial bursa, foreign body[ies])) to clarify limited and extensive debridement by specifying the number of discrete structures debrided and providing examples of the structures.

We are proposing the RUC-recommended work RVU of 7.03 for CPT code 29822 and 7.98 for CPT code 29823 without refinement.

For the direct PE inputs, we are proposing the RUC recommendations CPT codes 29822 and 29823 without refinement.

(11) Absorbable Nasal Implant Repair (CPT Codes 30XX0)

In September 2019, the CPT Editorial Panel approved the addition of CPT code 30XX0 (Repair of nasal valve collapse with subcutaneous/submucosal lateral wall implant(s)) to report repair of nasal valve collapse with subcutaneous/submucosal lateral wall implant(s)).

We are proposing the RUC-recommended value of 2.80 work RVUs without refinement for CPT code 30XX0.

For the direct PE inputs, were also proposing the RUC-recommended values without refinement.

(12) Lung Biopsy-CT Guidance Bundle (CPT Code 324X0)

CPT codes 32405 (Biopsy, lung or mediastinum, percutaneous needle) and 77012 (Computed tomography guidance for needle placement (eg, biopsy, aspiration, injection, localization device), radiological supervision and interpretation) were identified by the AMA through a screen of code pairs that are reported on the same day, same patient and same NPI number at or more than 75 percent of the time. The CPT Editorial Panel deleted CPT code 32405 and replaced it with 324X0 (Core needle biopsy, lung or mediastinum, percutaneous, including imaging guidance, when performed).

We are not proposing the RUC-recommended work RVU of 4.00, which is the survey median, because we believe this value somewhat overstates the increase in intensity. Although we do not imply that the decrease in time, when considering the aggregate time values for CPT codes 32405 and 77012, 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 the work RVU. Intraservice and total time ratios using the aggregate time values of current CPT codes 32405 and 77012 suggest a significantly lower work RVU; however, we do not believe a decrease from the current aggregate value of 32405 and 77012 is warranted. We believe there is some overlap in physician work and time for the two current services, and that the recommended increase to 4.00 does not appropriately recognize this overlap. Therefore, we are proposing a work RVU of 3.18, which is the sum of the work RVUs of the two base codes.

We are proposing the RUC-recommended direct PE inputs without refinement.

(13) Atrial Septostomy (CPT Codes 33XX0, 33XX1, 33XX2)

Septostomy procedures are performed on extremely small newborns and neonates with severe forms of congenital heart disease and are lifesaving/temporizing procedures that do not provide definitive therapy to these critically ill patients. These procedures are not typical of the Medicare population and are of low volume. CPT code 92992 (Atrial septectomy or septostomy; transvenous Start Printed Page 50157method, balloon (eg, Rashkind type) (includes cardiac catheterization)) and CPT code 92993 (Atrial septectomy or septostomy; blade method (Park septostomy) (includes cardiac catheterization)), are carrier-priced codes. These services were not formally designated as potentially misvalued in the CY 2019 PFS final rule (83 FR 59500), but we did make mention that the RUC had signaled their intention to review these two codes. Both services were referred to the CPT Editorial Panel by the specialty societies who indicated that CPT code 92992 may not have included related imaging guidance, and also commented that CPT code 92993 was antiquated and rarely performed, so both CPT codes were deleted and are now being replaced with the following proposed CPT codes.

CPT code 33XX0 (Transcatheter atrial septostomy (TAS) for congenital cardiac anomalies to create effective atrial flow, including all imaging guidance by the proceduralist, when performed, any method (eg, Rashkind, Sang-Park, balloon, cutting balloon, blade)), is one of three codes intending to replace the two deleted Septostomy codes. For CPT code 33XX0, the RUC recommends an RVU only crosswalk to CPT code 33340 (Percutaneous transcatheter closure of the left atrial appendage with endocardial implant, including fluoroscopy, transseptal puncture, catheter placement(s), left atrial angiography, left atrial appendage angiography, when performed, and radiological supervision and interpretation), which has a work RVU of 14.00. The RUC recommends 20 minutes of preservice evaluation time, 15 minutes of preservice positioning time, 15 minutes preservice scrub/dress/wait time, 55 minutes intraservice time and 45 minutes immediate postservice time, for 150 minutes total time. We are proposing the RUC recommended work RVU of 14.00 and physician times without refinement.

CPT code 33XX1 (Transcatheter intracardiac shunt (TIS) creation by stent placement for congenital cardiac anomalies to establish effective intracardiac flow, all imaging guidance by the proceduralist when performed, left and right heart diagnostic cardiac catherization for congenital cardiac anomalies, and target zone angioplasty, when performed (eg, atrial septum, Fontan fenestration, right ventricular outflow tract, Mustard/Senning/Warden baffles); initial intracardiac shunt) is another proposed new procedure currently performed on neonate infants to children with severe forms of congenital heart disease, by having a stent implanted inside of an infant's beating heart (and not within a blood vessel). This stent replaces the methods in the old atrial septostomy codes utilizing the balloon and blade method. The RUC recommends 25 minutes preservice evaluation time, 15 minutes preservice positioning time, 15 minutes preservice scrub/dress/wait time, 92 minutes intraservice time and 60 minutes immediate postservice time, for 207 minutes total time. The RUC recommends 20.00 work RVUs for CPT code 33XX1. We are proposing the RUC recommended work RVUs and their recommended physician times.

CPT code 33XX2, (Transcatheter intracardiac shunt (TIS) creation by stent placement for congenital cardiac anomalies to establish effective intracardiac flow, all imaging guidance by the proceduralist when performed, left and right heart diagnostic cardiac catherization for congenital cardiac anomalies, and target zone angioplasty, when performed (eg, atrial septum, Fontan fenestration, right ventricular outflow tract, Mustard/Senning/Warden baffles); each additional intracardiac shunt location (List separately in addition to code for primary procedure)), is the add-on code to the proposed new procedure CPT code 33XX1, for 60 minutes of physician intraservice time. The RUC recommends a work RVU of 10.50 for CPT code 33XX2. This value for the add-on code, in comparison to the recommended work value of 20.00 RVUs with 92 minutes/intraservice time and 207 minutes of total time for CPT code 33XX1 appears to be unsupportable given the 60 minutes of additional physician intraservice time. We are instead proposing a work RVU of 8.00 for add-on CPT code 33XX2, which is the 25th percentile value from the survey and of similar valuation from reference CPT code 93592 (Percutaneous transcatheter closure of paravalvular leak; each additional occlusion device (List separately in addition to code for primary procedure)).

This family of CPT codes are facility-only services and have no direct PE inputs.

(14) Percutaneous Ventricular Assist Device Insertion (CPT Codes 339X1, 33990, 33991, 33992, 339X2, and 33993)

In May 2019, the CPT Editorial Panel approved the revision of four codes to clarify the insertion and removal of right and left heart percutaneous ventricular assist devices (PVAD), and the addition of two codes to report insertion of PVAD venous access and removal of right heart PVAD. These codes were surveyed with 000-day global periods and reviewed at the October 2019 RUC meeting.

We are proposing the RUC-recommended work RVUs for all six codes in the family. We are proposing a work RVU of 6.75 for CPT code 33990 (Insertion of ventricular assist device, percutaneous, including radiological supervision and interpretation; left heart, arterial access only), a work RVU of 6.75 for CPT code 339X1 (Insertion of ventricular assist device, percutaneous, including radiological supervision and interpretation; right heart, venous access only), a work RVU of 8.84 for CPT code 33991 (Insertion of ventricular assist device, percutaneous, including radiological supervision and interpretation; left heart, both arterial and venous access, with transseptal puncture), a work RVU of 3.55 for CPT code 33992 (Removal of percutaneous left heart ventricular assist device, arterial or arterial and venous cannula(s), separate and distinct session from insertion), a work RVU of 3.00 for CPT code 339X2 (Removal of percutaneous right heart ventricular assist device, venous cannula, separate and distinct session from insertion), and a work RVU of 3.10 for CPT code 33993 (Repositioning of percutaneous right or left heart ventricular assist device, with imaging guidance, at separate and distinct session from insertion).

Stakeholders contacted CMS regarding the valuation of the codes in this family following the arrival of the RUC recommendations. They stated that the RUC recommendations did not accurately reflect the work time of these procedures, which they stated to be increasing due to the adoption of new technology. The stakeholders requested that CMS propose to maintain the current work RVUs for the codes in this family and to crosswalk the work RVU of the new codes to existing codes.

We disagree with the stakeholders and are proposing the RUC-recommended work RVUs for each code in this family as noted previously. We note that in this case where the surveyed work times for the existing codes are decreasing and the utilization of CPT code 33990 is increasing significantly (quadrupling in the last 5 years), we have reason to believe that practitioners are becoming more efficient at performing the procedure, which, under the resource-based nature of the RVU system, lends support for proposing the RUC's recommended work RVUs. Although the incorporation of new technology can sometimes make services more complex and difficult to perform, it can also have the opposite effect by making services less reliant on manual skill and technique. We disagree Start Printed Page 50158with the stakeholders that the incorporation of this new technology would necessarily be grounds for maintaining the current work RVU, as improvements in technology are commonplace across many different services and are not specific to this procedure. As detailed earlier, we also have reason to believe that the improved technology has led to greater efficiencies in the procedure which, under the resource-based nature of the RVU system, lends further support for proposing a lower work RVU for the existing CPT codes.

The RUC did not recommend and we are not proposing any direct PE inputs for this facility only code family. We are proposing a 000-day global period for all six codes as surveyed by the RUC.

(15) Esophagogastroduodenoscopy (EGD) With Biopsy (CPT Code 43239)

In the CY 2019 PFS final rule (83 FR 59500), CPT code 43239 (Esophagogastroduodenoscopy, flexible, transoral; with biopsy, single or multiple) was publicly nominated for review under the potentially misvalued code initiative. As requested, the specialty societies conducted a survey for the April 2019 RUC meeting. The RUC survey results showed that the current work RVU of 2.39, which is below the survey 25th percentile work RVU of 2.50, accurately reflects the physician work for CPT code 43239.

We are proposing to maintain the current work RVU of 2.39 as recommended by the RUC. We are proposing the RUC-recommended direct PE inputs for CPT code 43239 without refinement.

(16) Colonoscopy (CPT Code 45385)

In the CY 2019 final rule (83 FR 59500), CPT code 45385 (Colonoscopy, flexible; with removal of tumor(s), polyp(s), or other lesion(s) by snare technique) was publicly nominated for review under the potentially misvalued code initiative. As requested, the specialty societies conducted a survey for the April 2019 RUC meeting. The RUC survey results showed that the current work RVU of 4.57, which is slightly above the survey 25th percentile work RVU of 4.50, accurately reflects the physician work for CPT code 45385.

We are proposing to maintain the current work RVU of 4.57 as recommended by the RUC. We are proposing the RUC-recommended direct PE inputs for CPT code 45385 without refinement.

(17) Transrectal High Intensity Focused US Prostate Ablation (CPT Codes 558XX)

In May 2019, the CPT Editorial Panel established a new code to report ablation of malignant prostate tissue with high intensity focused ultrasound (HIFU), including ultrasound guidance. For CPT code 558XX, we are not proposing the RUC recommendation to use the survey median work RVU of 20.00 to value this service because we believe total time ratios to the two key reference codes, CPT codes 55840 (Prostatectomy, retropubic radical, with or without nerve sparing) and 55873 (Cryosurgical ablation of the prostate (includes ultrasonic guidance and monitoring)) indicate that this value is somewhat overstated and does not accurately reflect the physician time, and because an analysis of all 090-global period codes with similar time values indicates that this service is overvalued. We are proposing a work RVU of 17.73 based on a crosswalk to CPT code 69930 (Cochlear device implantation, with or without mastoidectomy) which has similar total time and identical intraservice time values and is more consistent with other codes of similar time. We are proposing the RUC-recommended PE inputs without refinement.

(18) Computer-Aided Mapping of Cervix Uteri (CPT Code 57XX0)

In September 2019, the addition of CPT code 57XX0 (Computer-aided mapping of cervix uteri during colposcopy, including optical dynamic spectral imaging and algorithmic quantification of the acetowhitening effect (List separately in addition to code for primary procedure)) was approved by the CPT Editorial Panel to report computer-aided mapping of cervix uteri during colposcopy. The RUC recommended the survey median work RVU of 0.81 for this service. We are proposing the RUC-recommended value of 0.81 for CPT code 57XX0. We are also proposing the RUC-recommended direct PE inputs for this code.

We are seeking comment on a new medical supply indicated on the PE spreadsheet submitted by the RUC. A “computer aided spectral imaging system (colposcopy) disposal speculum” was noted in the RUC PE meeting materials. This name suggests it is digital. However, on the actual invoice submitted, the supply item in question was listed as a “disposable medium speculum” with no mention of a spectral imaging system or a digital component. We researched this speculum and could not find any evidence that it has a digital component. Therefore, we are proposing to change the name of this new supply item to “disposable speculum, medium” (SD337) to reflect the actual product on the invoice submitted. We are seeking clarification as to what aspect of the speculum is digital or if a cheaper, non-digital speculum would suffice. We note for example that the vaginal specula (SD118) supply has a CY 2021 price of $1.12 and we were able to find disposable medium specula readily available online for a price of roughly $1.00. We are proposing the new SD337 supply at the $5.80 price as listed on the invoice submitted in the RUC materials and are seeking comment as to why other disposable speculums at a lower price would not be typical for this procedure.

(19) Colpopexy (CPT Codes 57282 and 57283)

The CPT codes 57282 (Colpopexy, vaginal; extra-peritoneal approach (sacrospinous, iliococcygeus)) and 57283 (Colpopexy, vaginal; intra-peritoneal approach (uterosacral, levator myorrhaphy)) were identified by the RUC Relativity Assessment Workgroup as services performed less than 50 percent of the time in the inpatient setting yet include inpatient hospital E/M services within the global period and the 2018 Medicare utilization is over 5,000. This code family was surveyed and reviewed for the January 2020 RUC meeting. For CY 2021, the RUC recommended a work RVU of 13.48 for CPT code 57282, and a work RVU of 13.51 for CPT code 57283.

We disagree with the RUC-recommended work RVUs for the CPT code family of 57282 and 57283. We are proposing a work RVU of 11.63 for CPT code 57282, and are also proposing to maintain the current work RVU of 11.66 for CPT code 57283. For CPT code 57283, we based our disagreement on the total time ratio between the current time of 349 minutes and the recommended time established by the survey of 231 minutes. This ratio equals 66 percent, and 66 percent of the current work RVU of 11.66 for CPT code 57283 equals a work RVU of 7.70. When we reviewed CPT code 57283, we found that the recommended work RVU was higher than other codes with similar time values. This is supported by the reference CPT codes we compared to CPT code 57283 with 90 minutes of intraservice time; reference CPT code 19350 (Nipple/areola reconstruction) has a work RVU of 9.11 with 229 minutes of total time, and reference CPT Start Printed Page 50159code 47563 (Laparoscopy, surgical; cholecystectomy with cholangiography) which has a work RVU of 11.47 with 238 minutes of total time. 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 reflected in decreases to work RVUs. The recommendation from the RUC acknowledged that the time had decreased for CPT code 57283, and also noted that there has been an increase in intensity due to a change in technique and knowledge necessary to perform the service. In the case of CPT code 57283, we believe it would be more accurate to propose maintaining the current work RVU of 11.66 instead of the RUC-recommended work RVU of 13.51 to account for these decreases in the surveyed work time while still accounting for the increase in intensity. We also note that the intensity of CPT code 57283 would nearly double by maintaining the proposed work RVU of 11.66, due to the significant decreases in surveyed work time, which we believe supports the RUC's contention that the intensity of this code has increased over time.

For CPT code 57282, we disagree with the RUC-recommended RVU of 13.48. We note that the significant decrease in total time for code 57282 suggests an RVU lower than 13.48. Although we disagree with the RUC-recommended work RVU, we concur that the relative difference in work between CPT codes 57282 and 57283 is equivalent to the RUC-recommended interval of 0.03 RVUs. We believe the use of an incremental difference between these CPT codes is a valid methodology for setting values, especially in valuing services within a family of revised codes where it is important to maintain appropriate intra-family relativity. Therefore, we are proposing a work RVU of 11.63 for CPT code 57282, based on the RUC recommended interval of 0.03 RVUs below our proposed work RVU of 11.66 for CPT code 57283.

We are proposing the RUC-recommended direct PE inputs for the CPT code family of 57282 and 57283 without refinement.

(20) Laparoscopic Colpopexy (CPT Code 57425)

The CPT code 57425 (Laparoscopy, surgical, colpopexy (suspension of vaginal apex)) was identified by the RUC Relativity Assessment Workgroup as a service performed less than 50 percent of the time in the inpatient setting yet includes inpatient hospital E/M services within the global period and the 2018 Medicare utilization is over 5,000. This service was surveyed and reviewed for the January 2020 RUC meeting.

We disagree with the RUC-recommended work RVU of 18.02 for CPT code 57425 and propose to maintain the current RVU of 17.03 based on the total time ratio between the current time of 404 minutes and the recommended time established by the survey of 351 minutes. This is supported by the reference CPT codes we compared to CPT code 57425 with the same intraservice time; reference CPT code 26587 (Reconstruction of polydactylous digit, soft tissue and bone) which has a work RVU of 14.50, and reference CPT code 20696 (Application of multiplane (pins or wires in more than 1 plane), unilateral, external fixation with stereotactic computer-assisted adjustment (e.g., spatial frame), including imaging; initial and subsequent alignment(s), assessment(s), and computation(s) of adjustment schedule(s)) which has a work RVU of 17.56. Both CPT codes 26587 and 20696 have 180 minutes of intraservice time, which is equal to the 180 minutes of intraservice time in the RUC recommendation for CPT code 57425, and over 400 minutes of total time. The total time for CPT code 57425 decreased from 404 to 351 minutes and the RUC did not appear to take this into account. Therefore, we are proposing to maintain the current work RVU of 17.03.

We are proposing the RUC-recommended direct PE inputs for CPT code 57425 without refinement.

(21) Intravitreal Injection (CPT Code 67028)

CPT code 67028 (Intravitreal injection of a pharmacologic agent) was identified via the RUC's Relativity Assessment Workgroup as a code where the original valuation was based on a crosswalk code that had since been revalued. The RUC recommended that CPT code 67028 should be surveyed for the April 2019 RUC meeting. We are proposing the RUC-recommended work RVU of 1.44 for CPT code 67028.

For the direct PE inputs, we are proposing to refine the clinical labor time for the “Clean room/equipment by clinical staff” (CA024) activity from the RUC-recommended 5 minutes to 3 minutes for CPT code 67028, because 3 minutes is the standard time for this clinical labor activity code, and we disagree that there would typically be a need for 2 additional minutes for cleaning, sterilizing, and re-packaging a reusable eyelid speculum in a sterile package to prepare for its next case. Additionally, 3 minutes is the standard time for cleaning the room and cleaning the equipment; although we agree that these cleaning tasks would take place, we do not believe that the removal of the same day E/M visit would result in the need for 2 additional minutes of cleaning time. We note that we are proposing to maintain the current time for this clinical labor activity, which was previously finalized in the CY 2011 PFS final rule at the standard value of 3 minutes (75 FR 73353). We are also proposing to refine the equipment times to match the change in clinical labor time.

(22) Dilation of Eustachian Tube (CPT Codes 697XX and 697X1)

In September 2019, the CPT Editorial Panel created two new codes CPT code 697XX (Nasopharyngoscopy, surgical, with dilation of eustachian tube (ie, balloon dilation); unilateral) and CPT code 697X1(Nasopharyngoscopy, surgical, with dilation of eustachian tube (ie, balloon dilation); bilateral)) to describe the dilation of the eustachian tube via surgical nasopharyngoscopy, unilateral and bilateral. We are proposing the RUC-recommended work RVUs of 3.00 and 4.27 for CPT codes 697XX and 697X1, respectively. For the direct PE inputs, we are proposing the RUC-recommended values without refinement.

(23) X-Ray of Eye (CPT Code 70030)

CPT code 70030 (Radiologic examination, eye, for detection of foreign body) was identified through an updated screen of CMS/Other source codes with Medicare utilization over 20,000. We are proposing the RUC-recommended work RVU of 0.18 for this service. We are proposing the RUC-recommended direct PE inputs without refinement.

(24) CT Head-Brain (CPT Codes 70450, 70460, and 70470)

In the CY 2019 PFS final rule (83 FR 59500 through 59503), a stakeholder nominated CPT code 70450 (Computed tomography, head or brain; without contrast material) as potentially misvalued, citing GAO and MedPAC reports that suggest that work RVUs are overstated for procedures such as these, and the specialty society surveyed family codes 70460 (Computed tomography, head or brain; with contrast material(s)) and 70470 (Computed tomography, head or brain; without contrast material, followed by contrast material(s) and further sections). We are proposing the RUC Start Printed Page 50160recommendation to maintain the current work RVUs of 0.85, 1.13, and 1.27 for CPT codes 70450, 70460, and 70470, respectively. For CPT code 70450, we note that the surveyed times are nearly identical to the current times for these services, and we believe that the RUC's reference to CPT code 70486 (Computed tomography, maxillofacial area; without contrast material), which has similar physician time and the same work RVU, is appropriate. For CPT code 70460, we note that the surveyed times are nearly identical to the current times for these services, and we believe that the RUC's reference to CPT code 70487 (Computed tomography, maxillofacial area; with contrast material(s)), which has similar physician time and the same work RVU is appropriate. Similarly, for CPT code 70470, we note that the surveyed times are nearly identical to the current times for these services, and we believe that the RUC's reference to CPT code 70488 (Computed tomography, maxillofacial area; without contrast material, followed by contrast material(s) and further sections)), which has similar physician time and the same work RVU, is appropriate. We also note that these codes are relatively consistently valued compared to other codes with similar time values and a global period of XXX. We are proposing the RUC-recommended direct PE inputs without refinement.

(25) Screening CT of Thorax (CPT Codes 71250, 71260, 71270, and 712X0)

In October 2018, AMA staff identified the CMS/Other Source codes with 2017 Medicare utilization over 30,000. HCPCS code G0297 (Low dose ct scan (ldct) for lung cancer screening) was identified. In January 2019, the RUC recommended to refer to CPT Editorial Panel to establish a permanent code for this procedure. In May 2019, the CPT Editorial Panel revised three codes and added one code to distinguish diagnostic computed tomography, thorax from computed tomography, thorax, low dose for lung cancer screening.

For CPT code 71250 (Computed tomography, thorax; without contrast material), we are not proposing the RUC recommendation to maintain the current work RVU of 1.16 as we believe this does not accurately reflect the reduction in physician work time, and because an analysis of all XXX-global period codes with similar time values indicates that this service is overvalued. We are instead recommending to propose a work RVU of 1.08 based on the ratio of current to RUC-recommended intraservice time. As support for this value, we note that it falls slightly below CPT code 76391 (Magnetic resonance (eg, vibration) elastography), which has a work RVU of 1.10 and also has higher physician time values.

Similarly, for CPT code 71260 (Computed tomography, thorax; with contrast material(s)), we are not proposing the RUC recommendation to maintain the current work RVU of 1.24 as we believe this does not accurately reflect the reduction in physician time, and we are instead proposing a work RVU of 1.16 based the ratio of current to RUC-recommended intraservice time. Although we disagree with the RUC-recommended work RVU, we concur that the relative difference between CPT codes 71250 and 71260 is equivalent to the RUC-recommended interval of 0.08 RVUs. As stated previously, we believe the use of an incremental difference between these CPT codes is a valid methodology for setting values, especially in valuing services within a family of revised codes where it is important to maintain appropriate intra-family relativity. We note that that the proposed work RVU of 1.16 maintains the RUC-recommended interval of 0.08 additional RVUs above our proposed work RVU of 1.08 for CPT code 71250.

For CPT code 71270 (Computed tomography, thorax; without contrast material, followed by contrast material(s) and further sections)), we are not proposing the RUC recommendation to maintain the current work RVU of 1.38 as we believe this does not accurately reflect the reduction in physician time, and we are instead proposing a work RVU of 1.25 with a crosswalk to CPT code 93284 (Programming device evaluation (in person) with iterative adjustment of the implantable device to test the function of the device and select optimal permanent programmed values with analysis, review and report by a physician or other qualified health care professional; multiple lead transvenous implantable defibrillator system) and we support this value by noting that it is slightly higher than values suggested by the ratio of current to RUC-recommended intraservice time For CPT code 712X0 (Computed tomography, thorax, low dose for lung cancer screening, without contrast material(s)), we are not proposing the RUC-recommended work RVU of 1.16, and we are instead proposing a work RVU of 1.08 so that the value of this code is consistent with that of CPT code 71250 as current code G0297 is valued based on the value of CPT code 71250, and to maintain the relative relationship among these codes. In the CY 2016 PFS final rule (80 FR 70974) we finalized that CPT code G0297 should be identically valued to CPT code 71250.

We are proposing the RUC-recommended direct PE inputs without refinement for CPT codes 71250, 71260, and 71270. For the direct PE inputs for CPT code 712X0, we are proposing 2 minutes for the clinical labor activity CA011: “Provide education/obtain consent” rather than the RUC-recommended 3 minutes to be consistent with other non-contrast screening codes, and we are proposing 4 minutes for the clinical labor activity CA038 “Coordinate post-procedure services” rather than the RUC-recommended 6 minutes to be consistent with other screening services, and because we do not see any compelling evidence that this service has changed significantly since G0297 was implemented for CY 2015 to warrant the recommended 2 additional minutes.

(26) X-Ray Bile Ducts (CPT Codes 74300, 74328, 74329, and 74330)

CPT codes 74300 (Cholangiography and/or pancreatography; intraoperative, radiological supervision and interpretation) and 74328 (Endoscopic catheterization of the biliary ductal system, radiological supervision and interpretation) were identified through a screen of CMS/Other Source codes with 2017 Medicare utilization over 30,000. CPT codes 74329 (Endoscopic catheterization of the pancreatic ductal system, radiological supervision and interpretation) and 74330 (Combined endoscopic catheterization of the biliary and pancreatic ductal systems, radiological supervision and interpretation) were included as part of the same code family and the family was surveyed. The codes describe x-rays of the liver, pancreas, and bile ducts. They are performed in facilities and have no direct PE inputs.

We disagree with the RUC-recommended work RVU of 0.32 for CPT code 74300. We are proposing a work RVU of 0.27 based on a crosswalk to CPT code 74021 (Radiologic examination, abdomen; 3 or more views), one of the reference services from the RUC survey and that has an intraservice time of 4 minutes, nearly identical to the RUC's recommendation of 5 minutes of intraservice time for CPT code 74300. Our proposal is supported by CPT code 93922 (Limited bilateral noninvasive physiologic studies of upper or lower extremity arteries) with a work RVU of 0.25 and an intraservice time of 5 minutes and a total time of 10 minutes. These times are nearly identical to the RUC's recommended Start Printed Page 50161intraservice of 5 minutes and total time of 10 minutes for CPT code 74300.

We are proposing the RUC-recommended work RVU of 0.47 for CPT code 74328 (Endoscopic catheterization of the biliary ductal system, radiological supervision and interpretation), with an intraservice time of 10 minutes and a total time of 20 minutes.

We disagree with the RUC's recommended work RVU of 0.50 for CPT code 74329 (Endoscopic catheterization of the pancreatic ductal system, radiological supervision and interpretation). We are proposing a crosswalk to CPT code 74328 at a work RVU of 0.47 because the intraservice and total times for both codes are identical and we believe the work involved in the biliary ductal and pancreatic ductal systems is similar.

We disagree with the RUC's recommended work RVU of 0.70 for CPT code 74330 (Combined endoscopic catheterization of the biliary and pancreatic ductal systems, radiological supervision and interpretation) and we are proposing a work RVU of 0.56 based on our proposal of the RUC's recommendation for CPT code 74328 to create internal consistency within the code family, based on our time ratio methodology and further supported by a reference to CPT code 93228 (External mobile cardiovascular telemetry with electrocardiographic recording, concurrent computerized real time data analysis and greater than 24 hours of accessible ECG data storage (retrievable with query) with ECG triggered and patient selected events transmitted to a remote attended surveillance center for up to 30 days; review and interpretation with report by a physician or other qualified health care professional) with nearly identical and total time values to CPT code 74330.

The RUC did not recommend and we are not proposing any direct PE inputs for these codes.

(27) Venography (CPT Codes 75820 and 75822)

The review of CPT code 75820 (Venography, extremity, unilateral, radiological supervision and interpretation) was prompted by the Relativity Assessment Workgroup Medicare utilization screen of over 20,000 claims in a year. CPT code 75820 currently has a work RVU of 0.70 with 14 minutes of total time. This service involves the supervision and interpretation of a contrast injection and imaging of either the upper or lower extremity. For CPT code 75820, the RUC recommends 12 minutes preservice time, 20 minutes intraservice time, 10 minutes postservice time and 42 minutes of total time. The specialty societies' survey at the 25th percentile yielded a 1.05 work RVU, and it is the RUC's recommended work value. We are proposing the RUC recommended value for CPT code 75820.

CPT code 75822 (Venography, extremity, bilateral, radiological supervision and interpretation) is reviewed as part of the family of codes included with CPT code 75820. CPT code 75822 has a current 1.06 work RVU and 21 minutes of total time. The RUC recommends 15 minutes preservice time, 30 minutes intraservice time, 12 minutes postservice time and 57 minutes of total time, and the survey's 25th percentile work RVU of 1.48. The service is similar to CPT 75820, except that this CPT code is bilateral, involving the supervision and interpretation of a contrast injection and imaging of both of either the upper or lower extremities. The RUC recommends 1.48 work RVU and 57 minutes of total time for CPT code 75822. We are proposing these RUC recommended values for CPT code 75822.

(28) Introduction of Catheter or Stent (CPT Code 75984)

The RUC recommended reviewing CPT code 75984 (Change of percutaneous tube or drainage catheter with contrast monitoring (e.g., genitourinary system, abscess) radiological supervision and interpretation) after more utilization data was available, which resulted in this service being surveyed and reviewed for the April 2019 RUC meeting. We are proposing the work RVU of 0.83 as recommended by the RUC. We are proposing the RUC-recommended direct PE inputs for CPT code 75984 without refinement.

(29) Medical Physics Dose Evaluation (CPT Code 7615X)

The CPT Editorial Panel created CPT code 7615X (Medical physics dose evaluation for radiation exposure that exceeds institutional review threshold, including report), which is a new PE-only code. Because of the high amount of clinical staff time and the fact that there are not analogous services, the PE Subcommittee requested that the specialty societies conduct a PE survey. In addition, they stated that the service is stand-alone, meaning that the medical physicist works independently from a physician and there are no elements of the PE that are informed by time from a physician work survey. Following the meeting, the specialty societies developed a PE survey which was reviewed and approved by the Research Subcommittee. We are proposing the RUC-recommended direct PE inputs for CPT code 7615X without refinement.

(30) Ophthalmic Ultrasound Anterior Segment (CPT Code 76513)

CPT code 76513 (Ophthalmic ultrasound, diagnostic; anterior segment ultrasound, immersion (water bath) B-scan or high resolution biomicroscopy) was identified by the RUC due to volume growth, attributed to improved equipment. The CPT Editorial Panel has since revised this code to clarify that it is either unilateral or bilateral (it was previously unilateral). It was then surveyed. The code describes a test for glaucoma and is performed on the same day as an office/outpatient evaluation and management (O/O E/M) visit. The CPT and RUC removed CPT code 76513 from its former code family, creating a family of 1 service.

In reviewing this code, we noted that the recommended total time is decreasing from 19 minutes to 15 minutes (21 percent) while the RUC-recommended work RVU is decreasing from 0.66 to 0.60 (9 percent). 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 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 76513, we believe that it would be more accurate to propose a work RVU of 0.53 based on a crosswalk to CPT code 74230 (Radiologic examination, swallowing function, with cineradiography/videoradiography, including scout neck radiograph(s) and delayed image(s), when performed, contrast (eg, barium) study) with identical intraservice and total times.

For the direct PE inputs, we are proposing to make two refinements to the clinical labor times of CPT code 76513. We are proposing a reduction of 1 minute for the clinical labor task CA009: “Greet patient, provide gowning, ensure appropriate medical records are available” because the EHR information should already be linked from the preceding O/O E/M visit and the entry of information would be redundant and paid under indirect PE. We are also proposing a reduction of 1 minute for the clinical labor task CA011: “Provide education/obtain consent” to be consistent with the time for this Start Printed Page 50162clinical labor task for the services in CPT code 76513's former code family.

(31) Radiation Treatment Delivery (CPT Code 77401)

CPT code 77401 (Radiation treatment delivery, superficial and/or ortho voltage, per day) was identified by the RUC Relativity Assessment Workgroup through a screen of high-volume growth, for services with 2017 Medicare utilization of 10,000 or more that has increased by at least 100 percent from 2012 through 2017. In January 2019, the RUC recommended to refer to this service to the CPT Editorial Panel to better define the set of services associated with delivery of superficial radiation therapy (SRT).

We are proposing the following direct PE refinements: A reduction of 2 minutes for the clinical labor task CA024: “Clean room/equipment by clinical staff,” to the standard 3 minutes, and we are not proposing to include the new equipment item ER119 “Lead Room,” as we do not have enough information on what this equipment item contains, and we are requesting more information to allow us to determine if it is more accurately priced as direct or indirect PE. CPT code 77401 is a PE only code and we are proposing to maintain the current work RVU of 0.00.

(32) Proton Beam Treatment Delivery (CPT Codes 77520, 77522, 77523, and 77525)

In April 2018, the RUC's Relativity Assessment Workgroup (RAW) identified CPT code 77522 (Proton treatment delivery; simple, with compensation) and CPT code 77523 (Proton treatment delivery; intermediate) as contractor-priced Category I CPT codes with 2017 estimated Medicare utilization over 10,000 services. Although the RAW agreed with the specialty society that this family of codes should remain contractor priced, the RUC determined that these services should be surveyed for PE. CPT codes 77520 (Proton treatment delivery; simple, without compensation) and 77525 (Proton treatment delivery; complex) were added to the family and the group was surveyed for PE for the April 2019 RUC meeting.

We encountered significant difficulties in reviewing the recommended direct PE inputs for the codes in the Proton Beam Treatment Delivery family. These difficulties were largely associated with determining a price for the two new equipment items in the code family, the Proton Treatment Vault (ER115) and the Proton Treatment Delivery System (ER116). These equipment items had extraordinarily high prices of $19,001,914 and $30,400,000 respectively on the invoices submitted with the code family. By way of comparison, the highest equipment price currently existing in our database for CY 2021 is the “SRS system, Linac” (ER082) equipment item at $4,233,825. We have concerns that establishing equipment pricing for the proton treatment vault and delivery system at a rate that is so much higher than anything else in our equipment database could distort relativity.

We also have concerns about the information provided on the submitted invoices used for the pricing of these two new equipment items. The invoices for both the Proton Treatment Vault and the Proton Treatment Delivery System contained building construction costs such as asphalt paving, masonry and carpentry expenses, drywall packaging, and the installation of electrical systems. We understand that these proton treatment equipment items are extremely capital-intensive and require the construction of custom-built offices to house the equipment. However, the expenses associated with constructing new office facilities fall outside of our direct PE methodology, and would be more accurately classified as a form of building maintenance or office rent under indirect PE. We do not agree that construction costs should be included as a form of direct PE because they are not individually allocable to a particular patient for a particular service. Although we agree that the provider does need to bear the costs associated with the storage of this equipment, this is a form of indirect PE under our methodology. We do not believe that it would serve the interests of relativity to include these building construction costs for the proton treatment equipment as a type of direct PE expense.

As a result, we are proposing to maintain contractor pricing for CPT codes 77520, 77522, 77523, and 77525 instead of proposing active pricing for these services. We believe that maintaining contractor pricing will allow the limited providers of these very expensive services to adapt more quickly to shifts in the market-based costs associated with the proton treatment equipment. The RUC similarly expressed concern in its recommendations about the extremely high cost of this equipment, agreed that these services were extremely hard to value, and noted the difficulties that had taken place in surveying the family of codes. The recommendations from the RUC also noted that proton treatment is a rapidly changing technology and the change in the treatment equipment often requires extensive modification to the vault. We believe that these frequent changes can be more accurately captured through contractor pricing as opposed to the need to update the pricing of the proton treatment equipment on an annual basis.

If we were to propose active pricing for the codes in this family, we believe that we would need to remove the building construction costs from the Proton Treatment Vault and the Proton Treatment Delivery System as forms of indirect PE, which would substantially lower their overall equipment prices. We would also refine the equipment times to the standard formula for highly technical equipment, which would result in 3 minutes less time for each equipment item (such as 14 minutes for all three equipment items in CPT code 77522).

(33) Immunization Administration (CPT Codes 90460, 90461, 90471, 90472, 90473, and 90474 and HCPCS codes G0008, G0009, and G0010)

Especially in the context of the current Public Health Emergency (PHE) related to the COVID-19 pandemic, it is evident that consistent beneficiary access to vaccinations is vital to public health. Many stakeholders have raised concerns regarding the reductions in payment rates for vaccine administration services over the past several years. The codes that describe these services have generally been valued based on a direct crosswalk to CPT code 96372 (Therapeutic, prophylactic, or diagnostic injection (specify substance or drug); subcutaneous or intramuscular). Because we proposed and finalized reductions in valuation for that code for CY 2018 and because the reductions in overall valuation have been subject to the multi-year phase-in of significant reductions in RVUs, the payment rate for the vaccine administration codes has been concurrently reduced.

In the CY 2020 PFS final rule, we acknowledged that it is in the public interest to ensure appropriate resource cost are reflected in the valuation of the immunization administration services that are used to deliver vaccines and noted that we planned to review the valuations for these services in future rulemaking. For CY 2020, we maintained the CY 2019 national payment amount for immunization administration services described by HCPCS codes G0008 (Administration of influenza virus vaccine), G0009 (Administration of pneumococcal Start Printed Page 50163vaccine), and G0010 (Administration of hepatitis b vaccine) in the interim.

The RUC has recently re-submitted recommendations from 2009 regarding the appropriate valuation for the broader range of vaccine administration services, including CPT codes 90460 (Immunization administration through 18 years of age via any route of administration, with counseling by physician or other qualified health care professional; first or only component of each vaccine or toxoid administered), 90471 (Immunization administration (includes percutaneous, intradermal, subcutaneous, or intramuscular injections); 1 vaccine (single or combination vaccine/toxoid)), and 90473 (Immunization administration by intranasal or oral route; 1 vaccine (single or combination vaccine/toxoid)). In its recommendation, the RUC noted that the current RVUs assigned are directly crosswalked from CPT code 96372 (like the vaccine administration G-codes had been) and the resulting payment rates are substantially lower than current Centers for Disease Control and Prevention (CDC) regional maximum charges. The RUC also pointed out that that appropriate payment for immunization administration that reflects resource cost is critical in maintaining high immunization rates in the United States, as well as having the capacity to respond quickly to vaccinate against preventable disease outbreaks.

We agree with the RUC's assertions regarding the importance of appropriate resource based valuations for vaccine administration services. We also recognize that the importance of these services is increased in the context of the current PHE related to the COVID-19 pandemic, especially should there be a vaccine for this particular disease.

We reviewed and considered the 2009 RUC-recommended direct PE inputs for CPT codes 90460-90474 (as well as the related G-codes) in place of the existing policy based on a crosswalk to CPT code 96372. However, the RUC-recommended direct PE inputs from 2009 would result in significant decreases in valuation for these 6 CPT codes even compared to the current crosswalk. At this time, we do not believe that either the existing crosswalk or the RUC recommendations from over a decade ago reflect the relative resource costs associated with these services. Without updated information to use in developing rates specific to these codes based on direct PE inputs, and in consideration of the import of these services for Medicare beneficiaries, as well as the public health concerns raised by commenters, we believe that it would be most appropriate to value these services using a crosswalk methodology that better reflects the relative resources involved in furnishing all of these services.

Therefore, we are proposing to crosswalk the valuation of CPT codes 90460, 90471, and 90473 and HCPCS codes G0008, G0009, and G0010 to CPT code 36000 (Introduction of needle or intracatheter, vein). CPT code 36000 is a service with a nearly identical work RVU (0.18 as compared to 0.17 for CPT codes 90460, 90471, and 90473) and a similar clinical vignette. We believe that the additional clinical labor, supply, and equipment resources associated with the furnishing of CPT code 36000 more accurately capture the costs associated with these immunization codes. We also note that this crosswalk will result in payment rates for vaccine administration services at approximately the same CY 2017 rates that were paid prior to the revaluation of CPT code 96372, which had previously served as the basis of the crosswalk. We believe that the proposed crosswalk is the most accurate valuation of these services and will also serve to ensure the appropriate relative resources involved in furnishing all of these services is reflected in the payment for these critical immunization and vaccination services in the context of the health needs of Medicare beneficiaries.

Regarding the add-on codes associated with these services, CPT codes 90461 (Immunization administration through 18 years of age via any route of administration, with counseling by physician or other qualified health care professional; each additional vaccine or toxoid component administered), 90472 (Immunization administration (includes percutaneous, intradermal, subcutaneous, or intramuscular injections); each additional vaccine (single or combination vaccine/toxoid)), and 90474 (Immunization administration by intranasal or oral route; each additional vaccine (single or combination vaccine/toxoid)), we note that the previous valuation methodology set their RVUs at approximately half of the valuation for the associated base codes, described above. Absent additional information, we are proposing to maintain that approach by valuing the three add-on codes at half of the RVUs of the aforementioned crosswalk to CPT code 36000.

Finally, we are proposing this valuation to apply to all of these existing vaccine administration codes, using the valuation of CPT code 90471 for base codes and CPT code 90472 for add-on codes. Should a vaccine for COVID-19 or other infectious disease become available during CY 2021, we would anticipate applying the same approach to valuing the administration of such vaccines, regardless of whether separate coding for such services would need to be introduced.

(34) Liver Elastography (CPT Code 91200)

CPT code 91200 (Liver elastography, mechanically induced shear wave (eg, vibration), without imaging, with interpretation and report) was targeted for review through the RUC's new technology/new services screen. The RUC reviewed 3 years of available Medicare claims data (2016, 2017 and 2018) and surveyed the code for the January 2020 meeting.

We are proposing the RUC-recommended work RVU of 0.21. We are also proposing the RUC-recommended direct PE inputs for CPT code 91200 without refinement.

(35) Remote Retinal Imaging (CPT Codes 92227, 92228, and 9225X)

The AMA CPT Editorial Panel revised CPT code 92227 (Imaging of retina for detection or monitoring of disease; with remote clinical staff review and report, unilateral or bilateral) and CPT code 92228 (Imaging of retina for detection or monitoring of disease; with remote physician or qualified health professional review and report, unilateral or bilateral) that are reported for the treatment of diabetic retinopathy. Two practice sites are involved in these services: The acquiring site (for example, a primary care practice) and the reading site (for example, the ophthalmology practice). Both codes can be used to report diagnostic and monitoring services and the distinction is in whom provides the service: Physician (CPT code 92228) or clinical staff only (CPT code 92227). Thus, only CPT code 92228 includes work, accounting for the physician at the reading site. For both CPT codes 92227 and 92228, direct PE pays for the clinical staff at both sites.

The AMA CPT Editorial Panel also created CPT code 9225X (Imaging of retina for detection or monitoring of disease; with point-of-care automated analysis with diagnostic report; unilateral or bilateral) for point-of-care automated analysis that uses innovative artificial intelligence technology to perform the interpretation of the eye exam, without requiring that an ophthalmologist interpret the results. CPT code 9225X can be used at a primary care practice site and the artificial intelligence technology Start Printed Page 50164interprets the test instead of a remotely located ophthalmologist. Because no physician is involved, this service is PE only. We are considering CPT code 9225X to be a diagnostic service under the PFS and are creating separate payment for it.

For CPT code 92228, we are proposing the RUC's recommended work RVU of 0.32. CPT codes 92227 and 9225X are PE only codes, and we are proposing a work RVU of 0.00 for both codes.

For both CPT codes 92227 and 92228, we are proposing the AMA RUC's recommended direct PE inputs. We are proposing two refinements to the direct PE inputs for CPT code 9225X. We are proposing a reduction of 1 minute for the clinical labor task CA009, “Greet patient, provide gowning, ensure appropriate medical records are available,” to be consistent with the amount of clinical labor for this task in CPT codes 92228 and 92227. We are also not proposing the RUC's recommendation of a $25 analysis fee for remote imaging because we consider this a service fee that constitutes a form of indirect PE and that this cost is appropriately captured via the indirect PE methodology as opposed to being included as a separate direct PE input. We do not believe that the analysis fee would be allocated to the use of an individual patient for an individual service, and can be better understood as an indirect cost similar to other administrative expenses.

(36) Auditory Evoked Potentials (CPT Codes 92584, 92X51, 92X52, 92X53, and 92X54)

CPT codes 92585 (Auditory evoked potentials for evoked response audiometry and/or testing of the central nervous system; comprehensive) and 92586 (Auditory evoked potentials for evoked response audiometry and/or testing of the central nervous system; limited) were identified through a RAW requested screen of CMS/Other Source codes with 2017 Medicare utilization over 30,000. Since these codes were last valued, audiologists, the primary reporter of these services, can now report Medicare services independently. As a result, the audiologist work for these services is moving from PE to work.

To better describe tests of auditory function, the CPT created CPT code 92584 (Electrocochleography) and replaced CPT codes 92585 and 92586 with four new services. We are proposing the RUC-recommended work RVUs of 1.00 for CPT code 92584, 1.00 for CPT code 92X52 (Auditory evoked potentials; for hearing status determination, broadband stimuli, with interpretation and report), 1.50 for CPT code 92X53 (Auditory evoked potentials; for threshold estimation at multiple frequencies, with interpretation and report), and 1.05 for CPT code 92X54 (Auditory evoked potentials; neurodiagnostic, with interpretation and report). CPT code 92X51 (Auditory evoked potentials; screening of auditory potential with broadband stimuli, automated analysis) is a screening service and is not payable by Medicare. Therefore, we are not proposing a valuation for this code; however, we will display the RUC-recommended work RVU of 0.25.

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

(37) Vestibular Evoked Myogenic Potential Testing (CPT Codes 925X1, 925X2, and 925X3)

In response to a 2017 RAW request, AMA staff compiled a list of CMS/Other codes with Medicare Utilization of 30,000 or more. CPT code 92585 (Auditory evoked potentials for evoked response audiometry and/or testing of the central nervous system; comprehensive) was identified as one of the codes. In 2018, the AMA/RUC referred CPT code 92585 and its family member CPT code 92586 (Auditory evoked potentials for evoked response audiometry and/or testing of the central nervous system; limited) to the February 2019 CPT Editorial Panel meeting to clarify code descriptors and define the terms “limited” and “comprehensive” auditory evoked potentials.

During the discussion of CPT codes 92585 and 92586 at the February 2019 CPT Editorial Panel meeting, specialty societies introduced a new procedure, Vestibular Evoked Myogenic Potential (VEMP), and suggested new coding. As a result, the CPT Editorial Panel created 3 new codes: CPT code 925X1 (Vestibular evoked myogenic potential testing, with interpretation and report; cervical (cVEMP)); CPT code 925X2 (Vestibular evoked myogenic potential testing, with interpretation and report; ocular (oVEMP)); and CPT code 925X3 (Vestibular evoked myogenic potential testing, with interpretation and report; cervical and ocular). The RUC reviewed the three codes at its April 2019 meeting.

We are proposing the RUC-recommended work RVU of 0.80 for CPT codes 925X1 and 925X2. For CPT code 925X3, we are proposing the RUC-recommended work RVU of 1.20. We also are proposing the RUC-recommended direct PE inputs without refinement for these three VEMP codes.

(38) Complete Electrocardiogram (CPT Codes 93000, 93005, and 93010)

In the CY 2019 PFS final rule (83 FR 59452), CPT code 93000 was nominated for review under the potentially misvalued code initiative. The RUC reviewed these services at the April 2019 meeting where the specialty societies explained that the family of electrocardiogram (ECG) codes were relatively unique in that CPT code 93000 (Electrocardiogram, routine ECG with at least 12 leads; with interpretation and report) is the global service which is billed in the hospital setting, CPT 93005 (Electrocardiogram, routine ECG with at least 12 leads; tracing only, without interpretation and report) is the technical component and CPT 93010 is the professional component.

We are proposing the RUC-recommended work RVU of 0.17, which is the current value for both codes, for CPT codes 93000 and 93010. CPT code 93005 is a PE only technical component code, and we are proposing to maintain the current work RVU of 0.00.

For the direct PE inputs, we are also proposing the RUC-recommended values without refinement.

(39) External Extended ECG Monitoring (CPT Codes 93224, 93225, 93226, 93227, 93XX0, 93XX1, 93XX2, 93XX3, 93XX4, 93XX5, 93XX6, and 93XX7)

In September 2019, the CPT Editorial Panel replaced four Category III codes with 8 new Category I codes to report external electrocardiographic (ECG) recording by continuous rhythm recording and storage for periods longer than 48 hours. The existing Holter monitor codes (CPT codes 93224 through 93227) that include up to 48 hours of continuous recording were also reviewed as part of this family of services at the January 2020 RUC meeting.

We are proposing the RUC-recommended work RVU for all 12 codes in the family. We are proposing a work RVU of 0.39 for CPT codes 93224 (External electrocardiographic recording up to 48 hours by continuous rhythm recording and storage; includes recording, scanning analysis with report, review and interpretation by a physician or other qualified health care professional) and 93227 (External electrocardiographic recording up to 48 hours by continuous rhythm recording and storage; review and interpretation by a physician or other qualified health care professional); a work RVU of 0.50 for CPT codes 93XX0 (External electrocardiographic recording for more than 48 hours up to 7 days by Start Printed Page 50165continuous rhythm recording and storage; includes recording, scanning analysis with report, review and interpretation) and 93XX3 (External electrocardiographic recording for more than 48 hours up to 7 days by continuous rhythm recording and storage; review and interpretation); and a work RVU of 0.55 for CPT codes 93XX4 (External electrocardiographic recording for more than 7 days up to 15 days by continuous rhythm recording and storage; includes recording, scanning analysis with report, review and interpretation) and 93XX7 (External electrocardiographic recording for more than 7 days up to 15 days by continuous rhythm recording and storage; review and interpretation).

The other six codes in the family are technical component codes that do not have a work RVU; we are proposing a work RVU of 0.00 for CPT codes 93225 (External electrocardiographic recording up to 48 hours by continuous rhythm recording and storage; recording (includes connection, recording, and disconnection)), 93226 (External electrocardiographic recording up to 48 hours by continuous rhythm recording and storage; scanning analysis with report), 93XX1 (External electrocardiographic recording for more than 48 hours up to 7 days by continuous rhythm recording and storage; recording (includes connection and initial recording)), 93XX2 (External electrocardiographic recording for more than 48 hours up to 7 days by continuous rhythm recording and storage; scanning analysis with report), 93XX5 (External electrocardiographic recording for more than 7 days up to 15 days by continuous rhythm recording and storage; recording (includes connection and initial recording)), and 93XX6 (External electrocardiographic recording for more than 7 days up to 15 days by continuous rhythm recording and storage; scanning analysis with report).

For the direct PE inputs, we are proposing to refine the clinical labor time for the “Perform procedure/service—NOT directly related to physician work time” (CA021) activity for CPT codes 93XX0, 93XX2, 93XX4, and 93XX6. We are proposing to reduce the clinical labor time by 5 minutes for each code as the description of the tasks taking place in the recommended materials includes activities that are considered to be indirect PE under our methodology. The recommended materials stated that “incoming patch deliveries are sorted and distributed to work queues. The return box is opened, diary book removed, top housing is removed using a custom tool to expose USB connection, and device is plugged in to extract serial number and diagnostic logs.” These unboxing and filing activities are classified as administrative expenses under our PE methodology, and therefore, do not constitute clinical labor as a direct expense. We are proposing to remove 5 minutes from the clinical labor to reflect these activities which are indirect as opposed to direct costs. We are also proposing to refine the equipment time for the desktop computer (ED021) to reflect these changes in the clinical labor time.

We noted an inconsistency in the RUC-recommended direct PE inputs for CPT codes 93XX0 and 93XX4. Both of these codes are the “global component” for their respective group of codes, such that the direct costs for CPT codes 93XX1-93XX3 must sum up to the direct cost of CPT code 93XX0 and the direct costs for CPT codes 93XX5 through 93XX7 must sum up to the direct cost of CPT code 93XX4. However, CPT codes 93XX0 and 93XX4 each contained 2 pairs of non-sterile gloves (SB022) whereas their constituent technical component codes (93XX1 and 93XX5 respectively) only contained a single pair of non-sterile gloves. Therefore, we are proposing to refine the quantity of the non-sterile gloves down to 1 pair for CPT codes 93XX0 and 93XX4 to correct this inconsistency. We also considered increasing the quantity of the gloves to 2 as in CPT codes 93224 through 93227. However, we believe that only 1 pair of gloves would typically be needed to attach the ECGs, as the patient does not return to have the ECGs removed in CPT codes 93XX0 through 93XX7 as opposed to CPT codes 93224 through 93227 where the patient does return for ECG removal.

We are proposing the RUC-recommended equipment time of 1474 minutes for the Holter monitor (EQ127) equipment included in CPT codes 93224 and 93226, based on an equipment time of 34 minutes during the procedure along with 1440 minutes (24 hours) of equipment time thereafter. We note that an external stakeholder wrote to request that the number of minutes of equipment time for the Holter monitor be increased from 1440 minutes (24 hours) to 2160 minutes (36 hours) to reflect the average length of equipment time. The stakeholder wrote that the 24-hour and 48-hour test were each performed approximately 50 percent of the time and stated that the most accurate number of equipment minutes would be the average time. The RUC disagreed with the stakeholder's request in its review because it concluded that there was insufficient evidence to warrant a change from the current 24 hours of equipment time; the RUC-recommended equipment time for the Holter monitor was based on the typical rather than the average service. We are proposing the RUC-recommended equipment time of 1474 minutes because our PE methodology is indeed based on the typical case, specifically what would be typical and reasonable and necessary for the procedure in question. Although we appreciate the feedback from the stakeholder, our previously finalized PE methodology establishes pricing based on the typical case. For a detailed explanation of the direct PE methodology, including examples, we refer readers to the 5-year review of work RVUs under the PFS and proposed changes to the PE methodology CY 2007 PFS proposed notice (71 FR 37242) and the CY 2007 PFS final rule with comment period (71 FR 69629).

The recommendations for this family of codes contain one new supply item, the “extended external ECG patch, medical magnetic tape recorder” (SD339). We did not receive a traditional invoice to establish a price for this supply item, instead receiving pricing information from two sources: A weighted median of claims data with the cost of the other direct PE inputs removed, and a top-down approach calculating the cost of the supply per service based on summing the total costs of the provider and dividing by the total number of tests furnished. The former methodology yielded a supply price of approximately $440 while the latter methodology produced an estimated supply price of $416.85. Stakeholders also submitted a series of invoices from the clinical study marketplace with a price of $595. Although we are appreciative of the data provided by the stakeholder, we require an invoice representative of commercial market pricing to establish a national price for a new supply or equipment item. Although we are aware of the unusual circumstances surrounding the “extended external ECG patch, medical magnetic tape recorder” in terms of how it uploads data to the provider, we cannot establish supply pricing based on an analysis of claims data and in absence of a representative invoice.

Therefore, we are proposing to employ a crosswalk to an existing supply for use as a proxy price until we have an invoice to use for the “extended external ECG patch, medical magnetic tape recorder” item. We are proposing to use the “kit, percutaneous neuro test stimulation” (SA022) supply as our proxy item at a price of $413.24. Start Printed Page 50166Although this kit is not clinically similar to the extended external ECG patch, we believe that it is the closest match from a pricing perspective to employ as a proxy until we are able to arrive at an invoice that is representative of commercial market pricing. We welcome the submission of invoices or other additional information for use in pricing the “extended external ECG patch, medical magnetic tape recorder” supply.

(40) Complete Transthoracic Echocardiography (TTE) With Doppler (CPT Code 93306)

In the CY 2019 PFS final rule (83 FR 59500), a submitter nominated CPT code 93306 (Echocardiography, transthoracic, real-time with image documentation (2D), includes M-mode recording, when performed, complete, with spectral Doppler echocardiography, and with color flow Doppler echocardiography) as potentially misvalued, citing GAO, MedPAC, and Urban Institute reports that suggest the work RVUs are overstated. Although the code was most recently surveyed in 2016, the specialty societies and the RUC stated that there has been a change in the technique and technology used to perform the procedure, so they resurveyed the code. The RUC recommended decreasing the work RVU from 1.50 to 1.46 and we are proposing this value.

Although we are proposing the RUC's recommended direct PE inputs without refinement we note that the RUC's recommendation included both 25 mL and 50 mL of ultrasound transmission gel. We are proposing a supply quantity of 25 mL and seeking clarification on the correct amount.

(41) Pacing Heart Stimulation (CPT Code 93623)

Review of CPT code 93623 (Programmed stimulation and pacing after intravenous drug infusion (List separately in addition to code for primary procedure)), was prompted by the Relativity Assessment Workgroup Medicare utilization screen of over 30,000 claims in a year. This service is to create an arrhythmia by an intravenous drug infusion and it is an add-on code with 60 minutes of total time and a current work RVU of 2.85.

The RUC recommends the 25th percentile survey value of 2.04 work RVUs and 20 minutes of intraservice time.

The revision of CPT code 93623 physician's time adjusting from the current 60 minutes to 20 minutes is a significant change. 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 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 93623, we believe that it would be more accurate to propose a work RVU of 0.98 based on CPT code 76810 (Ultrasound, pregnant uterus, real time with image documentation, fetal and maternal evaluation, after first trimester (> or = 14 weeks 0 days), transabdominal approach; each additional gestation (list separately in addition to code for primary procedure)) with 20 minutes of intraservice time. We are proposing a work RVU of 0.98 with 20 minutes of intraservice time for CPT code 93623.

This CPT code is a facility-only service and has no direct PE inputs.

(42) Intracardiac Echocardiography (ECG) (CPT Code 93662)

The review of CPT code 93662 (Intracardiac echocardiography during therapeutic/diagnostic intervention, including imaging supervision and interpretation (List separately in addition to code for primary procedure), was prompted by the Relativity Assessment Workgroup Medicare utilization screen of over 10,000 claims in a year that had an increase in volume by 100 percent between the 2012 to 2017. This procedure has since changed from its last review, in its reduced use of fluoroscopy, now replaced with ultrasound that create arrhythmia mapping systems with intracardiac echo images processed to produce 3-dimensional electroanatomical maps. The physician can now visualize better and have more accurate details for more effective catheter ablation for a wide range of arrhythmias. CPT code 93662 currently has a work RVU of 2.80 with 5 minutes of preservice evaluation time, 55 minutes of intraservice time, 10 minutes of immediate postservice time, and 70 minutes of total time.

The survey resulted in a median intraservice time of 25 minutes, a significant shift from the current intraservice time of 55 minutes. The RUC recommends a work RVU of 2.53 and 25 minutes of intraservice time for add-on CPT code 93662. 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 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. CPT code 92979 (Endoluminal imaging of coronary vessel or graft using intravascular ultrasound (ivus) or optical coherence tomography (oct) during diagnostic evaluation and/or therapeutic intervention including imaging supervision, interpretation and report; each additional vessel (list separately in addition to code for primary procedure)), with 1.44 work RVUs and 25 minutes of intraservice time, is a good equivalent comparator code in light of the significant physician time reduction from 55 minutes. A similarly proportioned reduction of physician intraservice time from the current 55 minutes to the surveyed 25 minutes, if applied to the current work RVU would result in a value much lower than our reference CPT code 92979's work RVU, so we are proposing a work RVU of 1.44 and 25 minutes of intraservice time for add-on CPT code 93662.

This CPT code is a facility only service and has no direct PE inputs.

(43) Ventricular Assist Device (VAD) Interrogation (CPT Code 93750)

The review of CPT code 93750, (Interrogation of ventricular assist device (VAD), in person, with physician or other qualified health care professional analysis of device parameters (eg, drivelines, alarms, power surges), review of device function (eg, flow and volume status, septum status, recovery), with programming, if performed, and report) was prompted by the Relativity Assessment Workgroup Medicare utilization screen of over 10,000 claims in a year and had had an increased in volume by 100 percent between the 2012 to 2017. CPT code 93750 currently has a work RVU of 0.92 with 30 minutes of intraservice time.

For physician times, the societies' survey for CPT code 93750 yielded 6 minutes preservice time, 10 minutes intraservice time, 7 minutes immediate post-service time, and 23 minutes of total time. The 25th percentile surveyed work RVU was 0.96. The RUC compared the survey code to CPT code 78598 (Quantitative differential pulmonary perfusion and ventilation (eg, aerosol or gas), including imaging when performed) (0.85 work RVU and 5 minutes of preservice time, 10 minutes of intraservice time, 9 minutes of immediate postservice time, and total time of 24 minutes). The RUC Start Printed Page 50167recommends crosswalking the work RVU of 0.85 from CPT code 78598 to 93750.

CPT code 93289 (Interrogation device evaluation (in person) with analysis, review and report by a physician or other qualified health care professional, includes connection, recording and disconnection per patient encounter; single, dual, or multiple lead transvenous implantable defibrillator system, including analysis of heart rhythm derived data elements), with 0.75 work RVUs and 5 minutes of preservice time, 10 minutes of intraservice time, 8.5 minutes of immediate postservice time, and total time of 23.5 minutes, we believe is a more precise comparator code. CPT code 93289's intraservice times, pre and post times, and total times are almost identical to CPT code 93750's survey times, so we are proposing a work RVU of 0.75 and 23 minutes of total time for CPT code 93750.

The PE Subcommittee corrected the equipment times based on the formulas as provided by CMS. In addition, the PE Subcommittee changed the clinical staff type for direct labor item ID CA013 Prepare Room, Equipment and Supplies, from an RN to the RN/LPN/MTA blend and the direct equipment item ID EQ168 light, exam was removed from CPT code 93750. We are proposing to accept the RUC-recommended direct PE inputs.

(44) Spirometry (CPT Codes 94010 and 94060)

CPT code 94010 (spirometry, including graphic record, total and timed vital capacity, expiratory flow rate measurement(s), with or without maximal voluntary ventilation) and CPT code 94060 (Bronchodilation responsiveness, spirometry as in 94010, pre- and post-bronchodilator administration) were identified as part of a Relativity Assessment Workgroup (RAW) review of action plans on the status of services that were RUC referrals to develop CPT Assistant articles. These codes were recommended to be surveyed.

We are proposing the RUC-recommended work RVU of 0.17 for CPT code 94010 (spirometry, including graphic record, total and timed vital capacity, expiratory flow rate measurement(s), with or without maximal voluntary ventilation) and the RUC-recommended work RVU of 0.22 for CPT code 94060 (Bronchodilation responsiveness, spirometry as in 94010, pre- and post-bronchodilator administration). We are proposing the RUC-recommended direct PE inputs for this code family without refinements.

(45) Exercise Test for Bronchospasm (CPT Codes 946X0, 94617, 94618, and 94621)

In 2018, the CPT Editorial Panel created CPT code 94617 (Exercise test for bronchospasm, including pre- and post-spirometry, electrocardiographic recording(s), and pulse oximetry), and CPT code 94618 (Pulmonary stress testing (eg, 6-minute walk test), including measurement of heart rate, oximetry, and oxygen titration, when performed) from the now deleted CPT code 94620 (Pulmonary stress testing; simple (eg, 6-minute walk test, prolonged exercise test for bronchospasm with pre- and post-spirometry and oximetry)), and revised CPT code 94621 (Cardiopulmonary exercise testing, including measurements of minute ventilation, co2 production, o2 uptake, and electrocardiographic recordings) to better describe the specialty's pulmonary exercise test. Shortly after the creation and revision of these codes, the specialty society became aware of some providers performing CPT code 94617 without ECG monitoring, so to more accurately account for this work without the ECG monitoring, The CPT Editorial Panel proposed to establish CPT code 946X0 with the descriptor, (Exercise test for bronchospasm, including pre- and post-spirometry and pulse oximetry; without electrocardiographic recording(s)). For the October 2019 RUC meeting, the specialty societies surveyed CPT code 946X0, and included a request to reaffirm the values of the rest of the codes in the code family.

For CPT code 946X0, the surveyed physician time yielded 5 minutes of preservice time, 9 minutes of intraservice time, followed by 10 minutes of immediate post-service time, for a total time of 24 minutes. This distribution of physician times is of course very similar to the times for CPT code 94617, total time of 26 minutes, except without the task of including an electrocardiographic recording. The RUC recommends the survey's median work RVU of 0.49 for CPT code 946X0.

We are proposing the RUC's recommendation of a work RVU of 0.49 and a total physician time of 24 minutes for CPT code 946X0.

This CPT family of codes that includes CPT code 946X0, are CPT codes 94617, 94618, and 94621 and there are no changes to their physician service times, no change to their descriptors, nor their work RVUs, and remain as they currently are. The specialty societies reaffirmed these current valuations and we propose to accept them without change.

We are proposing the RUC-recommended PE changes without refinement.

(46) Evaluation of Wheezing (CPT Codes 94640, 94667, 94668, and 94669)

At the April 2019 RUC meeting, four PE only CPT codes from the Evaluation of Wheezing code family were reviewed. The codes included CPT codes 94640 (Pressurized or nonpressurized inhalation treatment for acute airway obstruction for therapeutic purposes and/or for diagnostic purposes such as sputum induction with an aerosol generator, nebulizer, metered dose inhaler or intermittent positive pressure breathing (IPPB) device), 94667 (Manipulation chest wall, such as cupping, percussing, and vibration to facilitate lung function; initial demonstration and/or evaluation), 94668 (Manipulation chest wall, such as cupping, percussing, and vibration to facilitate lunch function; subsequent), and 94669 (Mechanical chest wall oscillation to facilitate lung function, per session).

We are proposing the RUC-recommended direct PE inputs for the four PE only codes. The RUC did not recommend work RVUs and we are proposing to maintain the current work RVU of 0.00 for all four codes.

(47) Exhaled Nitric Oxide Measurement (CPT Code 95012)

In January 2019, the RAW reviewed services with 2017 Medicare utilization of 10,000 or more that had increased by at least 100 percent from 2012 through 2017. The RUC recommended that CPT code 95012 (Nitric oxide expired gas determination) be surveyed for the April 2019 meeting. We are proposing the direct PE inputs for CPT code 95012 without refinement. CPT code 95012 is a PE-only code with no work RVU, and we are proposing to maintain the current work RVU of 0.00.

(48) Acupuncture Services (CPT Codes 97810, 97811, 97813, and 97814)

The CPT Editorial Panel created two new codes and two new add-on codes in 2004 to describe the appropriate time or additional time and levels of service that can be performed using acupuncture and electroacupuncture, acupuncture therapy with electrical stimulation. These codes were designated as noncovered services since Medicare did not reimburse for acupuncture services at the time. In January 2020, we issued a decision memo stating that Medicare will cover acupuncture for chronic low back pain Start Printed Page 50168under section 1862(a)(1)(A) of the Act (CAG-00452N). This was reflected in the April 2020 PFS Quarterly Update which changed CPT codes 97810 through 97814 to active payment status (CMS Change Request 11661). Because we had never conducted a review of these four acupuncture codes, the CY 2020 payment rate consisted of the work RVUs recommended by the RUC in 2004.

For CY 2021, we are proposing to establish work RVUs for these four acupuncture codes based on a pair of crosswalks to two recently reviewed codes in the Dry Needling family. We are proposing a work RVU of 0.48 for CPT codes 97810 (Acupuncture, 1 or more needles; without electrical stimulation, initial 15 minutes of personal one-on-one contact with the patient) and 97813 (Acupuncture, 1 or more needles; with electrical stimulation, initial 15 minutes of personal one-on-one contact with the patient) based on a crosswalk to CPT code 20561 (Needle insertion(s) without injection(s); 3 or more muscles). We are proposing a work RVU of 0.32 for CPT codes 97811 (Acupuncture, 1 or more needles; without electrical stimulation, each additional 15 minutes of personal one-on-one contact with the patient, with re-insertion of needle(s)) and 97814 (Acupuncture, 1 or more needles; with electrical stimulation, each additional 15 minutes of personal one-on-one contact with the patient, with re-insertion of needle(s)) based on a crosswalk to CPT code 20560 (Needle insertion(s) without injection(s); 1 or 2 muscle(s)).

CPT codes 20560 and 20561 are clinically similar services associated with dry needling that were reviewed last year for CY 2020. We finalized work RVUs of 0.32 and 0.48 respectively for these two codes following our review of their associated RUC recommendations, while noting that dry needling services were non-covered by Medicare unless otherwise specified through a national coverage determination (NCD) (84 FR 62722 through 62724). Like the acupuncture codes, CPT codes 20560 and 20561 were updated to active payment status in the April 2020 PFS Quarterly Update to reflect the Medicare coverage of acupuncture for chronic low back pain. We note that CPT codes 97810 and 97813 share the identical work time values with CPT code 20561, and that CPT codes 97811 and 97814 differ from CPT code 20560 by only 1 minute of work time, 15 minutes as compared to 16 minutes. Although we do not imply that codes with similar work times must equate to a one-to-one or linear relationship in the valuation of work RVUs, we believe that, since the two components of work are time and intensity, clinically related services with similar intensities and work times should, generally speaking, be valued similarly. Due to the similar clinical nature of these services and their nearly identical work times, we believe that it is more accurate to propose crosswalking CPT codes 97810 through 97814 to the work RVUs of the Dry Needling codes, which were finalized last year, as opposed to proposing work RVUs from 2004, which were never reviewed by CMS.

The RUC did not make any recommendations and we are not proposing any changes to the direct PE inputs for CPT codes 97810 through 97814.

(49) Chronic Care Management Services (CPT Code 994XX and HCPCS Code G2058)

We established payment for HCPCS code G2058 (Chronic care management services, each additional 20 minutes of clinical staff time directed by a physician or other qualified healthcare professional, per calendar month) in the CY 2020 PFS final rule (84 FR 62690). At the January 2020 RUC meeting, specialty societies requested a temporary crosswalk through CY 2021 between the value established by CMS for HCPCS code G2058 and the value of new CPT code 994XX (with a descriptor identical to G2058). The Chronic Care Management code family will be resurveyed during CY 2020 and is expected to be presented for review as part of the 2022 RUC review process.

For CY 2021, we are proposing the RUC-recommended work RVU of 0.54 and the RUC-recommended direct PE inputs for CPT code 994XX.

(50) External Counterpulsation (HCPCS Code G0166)

In the CY 2020 PFS proposed rule (84 FR 40516), an external stakeholder nominated HCPCS code G0166 as potentially misvalued due to concerns that the PE RVUs for this code did not fully reflect the total resources required to deliver the service and CMS proposed G0166 as potentially misvalued. The RUC reviewed the direct PE inputs for HCPCS code G0166 at the October 2019 RUC meeting.

We are proposing the RUC-recommended preservice period, service period and postservice period with refinements. We propose to replace CA010 (obtain vital signs) during the postservice of service period with CA023 (monitor patient following procedure/service, no multitasking).

For the equipment items, we are proposing to update the price of the “EECP, external counterpulsation system” (EQ012) equipment to $101,247.50 based on an average of the five invoices submitted along with the recommendations. We note that the EQ012 equipment is the only current equipment item in our direct PE database with an equipment utilization rate of 25 percent and the only equipment item with a utilization rate under 50 percent. Although we are not proposing to change the equipment utilization rate, we are soliciting feedback from commenters regarding the utilization rate for the EQ012 equipment to help us understand why it should differ from all other medical equipment.

We also received invoices for a series of additional equipment items: An EECP service contract, an EECP compression equipment package, and an EECP electrical equipment package. We are not proposing to establish a price for the EECP service contract, as service contracts are considered to be an administrative expense and a form of indirect PE under our methodology. As for the two equipment packages, there were a number of unusual factors involving these items that created difficulties for our equipment methodology. Both equipment packages had a suggested utilization rate of 25 percent, half of our typical utilization rate of 50 percent, and both had a suggested useful life duration of only 3 months. As we stated in section II.B. of this proposed rule, Determination of Practice Expense RVUs, we have concerns that assigning very low useful life durations to this type of equipment would fail to maintain relativity with other equipment on the PFS. We also noted that the equipment cost per minute formula was designed under the assumption that each equipment item would remain in use for a period of several years and depreciate over that span of time. Our current equipment formula is not designed to address cases in which equipment is replaced multiple times per year, and we believe that applying a multi-year depreciation in these situations would not be reflective of market pricing. Although we agree that these costs should be reflected in the pricing of HCPCS code G0166, we believe that the very frequent replacement of the items in the two equipment packages makes them a poor fit under our equipment methodology.

Therefore, we are proposing to treat the two EECP equipment packages as supplies instead of treating them as equipment. We are proposing to establish the EECP compression Start Printed Page 50169equipment package (SD341) as a supply with a cost of $645 based on an average of the submitted invoices, and proposing to establish the EECP electrical equipment package (SD342) as a supply with a cost of $500 again based on an average of the submitted invoices. Based on information provided by stakeholders, we are proposing a supply quantity of 1/325 for these two items (0.00308) based on the supply being used on average five times per day and replaced every 3 months (5 uses * 5 days * 13 weeks = 325). We believe that assigning these two items as supplies rather than equipment more accurately captures the unusual circumstances associated with providing this service.

(51) Molecular Pathology Interpretation (HCPCS Code G0452)

At the October 2018 RUC meeting, the Relativity Assessment Workgroup (RAW) identified HCPCS code G0452 (Molecular pathology procedure; physician interpretation and report) as potentially misvalued on a CMS/Other screen. The RUC had never reviewed HCPCS code G0452 and assumptions regarding work and time were based upon a 1995 vignette. In addition, the specialty society noted that the technology available for furnishing the service, as well as the patient population receiving the service, had changed since the code was valued by CMS.

The RUC requested a physician work survey be completed for the October 2019 RUC meeting. It was during the October meeting that the work and PE values for HCPCS code G0452 were reviewed and recommended.

For CY 2021, we are proposing the RUC-recommended work RVU of 0.93 and the RUC-recommended direct PE inputs for HCPCS code G0452.

(52) Evaluation and Management, Observation and Provision of Self-Administered Esketamine (HCPCS Codes G2082 and G2083)

In the CY 2020 PFS final rule (84 FR 63102 through 63104), we issued an interim final rule with comment period (IFC) to establish coding and payment for E/M, observation, and the provision of self-administered Esketamine to facilitate beneficiary access to care for treatment-resistant depression as efficiently as possible. We created two new HCPCS G codes, G2082 and G2083, effective January 1, 2020 on an interim final basis. For CY 2020, we established RVUs for these services that reflect the relative resource costs associated with the E/M, observation and provision of the self-administered esketamine product. The HCPCS G-codes are described as follows: HCPCS code G2082 (Office or other outpatient visit for the evaluation and management of an established patient that requires the supervision of a physician or other qualified health care professional and provision of up to 56 mg of esketamine nasal self-administration, includes 2 hours post-administration observation) and HCPCS code G2083 (Office or other outpatient visit for the evaluation and management of an established patient that requires the supervision of a physician or other qualified health care professional and provision of greater than 56 mg esketamine nasal self-administration, includes 2 hours post-administration observation).

In developing the interim final values for these codes, we used a building block methodology that sums the values associated with several codes. For the overall E/M and observation elements of the services, we incorporated the work RVUs, work time and direct PE inputs associated with a level two office/outpatient visit for an established patient, CPT code 99212 (Office or other outpatient visit for the evaluation and management of an established patient, which requires at least 2 of these 3 key components: A problem focused history; A problem focused examination; Straightforward medical decision making. Counseling and/or coordination of care with other physicians, other qualified health care professionals, or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. Usually, the presenting problem(s) are self limited or minor. Typically, 10 minutes are spent face-to-face with the patient and/or family), which has a work RVU of 0.48 and a total work time of 16 minutes, which is based on a pre-service evaluation time of 2 minutes, an intraservice time of 10 minutes, and a postservice time of 4 minutes.

We also incorporated CPT codes 99415 (Prolonged clinical staff service (the service beyond the typical service time) during an evaluation and management service in the office or outpatient setting, direct patient contact with physician supervision; first hour (List separately in addition to code for outpatient Evaluation and Management service)) and 99416 (Prolonged clinical staff service (the service beyond the typical service time) during an evaluation and management service in the office or outpatient setting, direct patient contact with physician supervision; each additional 30 minutes (List separately in addition to code for prolonged service)) in which neither code has a work RVU, but includes direct PE inputs reflecting the prolonged time for clinical staff under the direct supervision of the billing practitioner.

Additionally, to account for the cost of the provision of the self-administered esketamine as a direct PE input, we incorporated the wholesale acquisition cost (WAC) data from the most recent available quarter. For HCPCS code G2082, we are using a price of $590.02 for the supply input that describes 56 mg (supply code SH109) and for HCPCS code G2083, we are using a price of $885.02 for the supply input describing 84 mg of esketamine (supply code SH110).

We sought comment on the interim final values we established for HCPCS codes G2082 and G2083, including the assigned work RVUs, work times, and direct PE inputs. We received public comments on this policy. The following is a summary of the comments we received and our responses.

Comment: Overall, commenters were supportive of CMS establishing coding and payment for E/M, observation and the provision of self-administered esketamine. However, a few commenters were not in support of the proposal, noting that IV ketamine is cheaper and has been proven to be more effective than esketamine.

Response: We appreciate the support for our interim final rule with comment period. We continue to believe that it is in the public interest to ensure beneficiaries have access to new, potentially life-saving treatment for treatment-resistant depression (TRD) using esketamine. Therefore, we are proposing to maintain HCPCS codes G2082 and G2083 that describe E/M, observation and the provision of self-administered esketamine.

Comment: Several commenters suggested including psychotherapy, CPT codes 90833 and 90836, in the valuation of HCPCS codes G2083 and G2083.

Response: We disagree that psychotherapy should be included in the valuation of HCPCS codes G2082 and G2083. HCPCS codes G2082 and G2083 were created to establish coding and payment for E/M, observation and the provision of self-administered esketamine to facilitate beneficiary access to care for treatment-resistant depression as efficiently as possible. However, practitioners who furnish other allowable, billable services, including psychotherapy, on the same day as an E/M, observation and provision of self-administered esketamine service can bill separately for those services using other codes.

Comment: Some commenters recommended that esketamine should Start Printed Page 50170have its own J code in addition to the G codes.

Response: HCPCS codes G2082 and G2083 are bundled services that include, as discussed previously, the E/M, observation and the provision of self-administered esketamine. The self-administered esketamine is considered a supply item for this bundled service. Therefore, esketamine cannot be billed separately along with HCPCS codes G2082 and G2033 under the PFS.

Comment: Several commenters disagreed with the use of 99212 to establish codes G2082 and G2083. Commenters suggested using 99213, 99214, and/or 99215 instead of 99212. Some commenters indicated that the intraservice work time of 10 minutes is insufficient, and one commenter stated a minimum of 20 minutes would be more appropriate. Another commenter suggested unbundling the code and, in part, indicated that face-to-face visits with the psychiatrist are not required at each visit.

Response: We appreciate the feedback received from the commenters regarding the E/M elements of the service. We have considered the wide range of recommendations that were received from commenters regarding the E/M elements of the service. One commenter indicated that there is variability in performance and level of E/M services associated with the service (in which self-administered esketamine is provided and observed). Another commenter noted that a face-to face visit with the psychiatrist is not required at each visit, while other commenters recommended using E/M CPT codes up to 99215. We continue to believe that the building block methodology we used incorporating CPT code 99212 is appropriate for valuing this service. Therefore, we are not proposing to change the E/M element of the service by incorporating the work RVUs, work time and direct PE input associated with a level two office/outpatient visit for an established patient, CPT code 99212.

Comment: Many commenters urged CMS to ensure PFS payment rates are sufficient to capture the complexity and time for the provision of esketamine.

A commenter recommended unbundling all the services. The commenter stated that the way the bundled payments are currently constructed fails to recognize the possible variability of E/M services that may be required, the time and effort required of clinical staff to monitor the patient during the lengthy observation period, and the amount of pre- and post-service work required. The commenter also stated that bundling the physician E/M services and the observation services performed by clinical staff is problematic and including the medication in the bundle is problematic because in many instances the psychiatrist may not be incurring the cost of the medication. The commenter stated that clinical staff time and effort comprise a significant and separate service, including not only the time spent observing and actively monitoring the patient's condition for possible adverse side-effects (that is, nausea, vomiting, escalation in blood pressure), but also extensive pre- and post-service preparation that does not appear to have been included as part of the bundled payment and is not described by existing CPT codes.

The commenter recommended increasing the proposed valuation of clinical staff time to more appropriately account for the clinical staff time and the effort required for pre-, intra-, and post- service work. This includes acquisition of the drug, delivery of the medication to the patient, and the observation of the self-administration, followed by active monitoring of the patient's condition (vitals, etc.) for a minimum of 2 hours, the commenter suggested that the more appropriate comparison for the clinical staff time related to the 2-hour observation period is 95076, Ingestion challenge test (sequential and incremental ingestion of test items, e.g., food, drug or other substance); initial 120 minutes of testing (110 minutes intra service time; PE RVU 1.81). Both services, the G2082 and G2083 codes and the 95076, require a lengthy observation time (minimum of 2 hours) with clinical staff monitoring for adverse side-effects. The total PE RVU of the 95076 is 1.81 RVUs versus 0.51 RVUs (99415 × 1, 99416 × 2 or 0.27 + (0.12 × 2) = 0.51 RVUs) of the combined 99415 and 99416. The associated add-on code for 95076 is 95079, Ingestion challenge test (sequential and incremental ingestion of test items, e.g., food, drug or other substance); each additional 60 minutes of testing (List separately in addition to code for primary procedure) (40 minutes intra-service time; PE RVU 0.99), which would account for additional time for this service when required. Procedurally these services are similar in staff time, staff type and effort, and both are reported separately from the E/M service. The commenter requested that we use the PE RVUs for the 95076 and the 95079 in lieu of the 99415 and 99416 in calculating the values for the clinical staff component, to more accurately reflect the time and effort of the clinical staff in the observation of the patient.

Response: After consideration of comments requesting that we reconsider aspects of our current valuation for these services, including at least 2 hours of post-administration observation, we believe some of the refinements discussed by stakeholders may be appropriate to improve payment accuracy and help ensure that beneficiaries who need esketamine for treatment have access to it. Based on our review of the Spravato Prescribing Information, Medication Guide and REMS requirements, the FDA-approved conditions/requirements indicate that the drug is only available as an integral component of a physician's service.[8] [9] [10] Spravato is only dispensed and administered to patients in a medically supervised healthcare setting that monitors these patients.[11] Therefore, we continue to believe this treatment should be paid for as a bundled service. In consideration of the comment urging us to account for clinical staff time spent observing and actively monitoring the patient for possible side-effects, along with pre- and post-service preparation, we are proposing to refine the direct PE inputs of HCPCS codes G2082 and G2083, in part, by using the clinical labor time for CPT codes 95076 and the 95079 in lieu of the clinical labor time of CPT codes 99415 and 99416. We are specifically proposing 150 minutes of observation time for HCPCS codes G2082 and G2083 based on the sum of the clinical labor for CPT code 95076 (110 minutes) and CPT code 95079 (40 minutes). This would replace our previous interim final valuation of 30 minutes of observation time based on the sum of the clinical labor for CPT code 99415 (15 minutes) and two billings of CPT code 99416 (8 minutes). We are seeking comment on this proposal. Additionally, under circumstances where the health care professional supervising the self-administration and observation does not also provide the esketamine product, the physician or practitioner cannot report HCPCS codes G2082 or G2083. Rather, the visit and the extended observation (by either the billing professional or clinical staff) could be reported using the existing E/M codes that describe the visit and the prolonged Start Printed Page 50171service of the professional or the clinical staff.

Comment: One commenter urged CMS to align the HCPCS codes G2082 and G2083 for a visit for the provision of esketamine with prescribing recommendations from the drug manufacturer that include at least 2 hours of post-administration observation until a patient is safe to leave the facility. Another commenter questioned whether the codes should be valued using CPT codes 99213, 99214 and even 99215, with 99354 (Prolonged evaluation and management or psychotherapy service(s) (beyond the typical service time of the primary procedure) in the office or other outpatient setting requiring direct patient contact beyond the usual service; first hour (List separately in addition to code for office or other outpatient Evaluation and Management or psychotherapy service)) and 99355 (Prolonged evaluation and management or psychotherapy service(s) (beyond the typical service time of the primary procedure) in the office or other outpatient setting requiring direct patient contact beyond the usual service; each additional 30 minutes (List separately in addition to code for prolonged service)).

Response: As previously stated, we are proposing to continue valuing HCPCS codes G2082 and G2083, in part, on the basis of a level 2 established patient office/outpatient E/M visit. However, as previously stated, after considering comments regarding the esketamine post-administration observation time, we are proposing to refine the direct PE inputs of HCPCS codes G2082 and G2083, in part, by using the clinical labor time for CPT codes 95076 and the 95079, specifically proposing 150 minutes of observation time. We are seeking comment on this proposal.

Comment: Some commenters indicated that the proposed PE inputs do not reflect the costs of, and overall drug cycle management needed to safely administer, esketamine. One commenter indicated that, after conducting an analysis associated with each patient encounter to include: Physician time and technician time, reception time, rent, furniture, monitoring, electronic health record (EHR), supplies, waste management, etc., their direct overhead cost is $1000 per patient per encounter, not including direct cost and management of the drug. Therefore, the commenter recommends we revise payment by adding 20 percent to the direct expense and mandatory overhead costs of $1000 per patient encounter. Some commenters indicated that the proposed PE inputs do not reflect the costs of initial capital requirements for ongoing resources, maintaining the Risk Evaluation and Mitigation Strategy (REMS) standards with the FDA and overall drug cycle management needed to safely administer esketamine. Specifically, one commenter indicated that Spravato will need to be delivered in the community setting. A typical community psychiatry practice does not have a large enough physical plant to accommodate a 2 hour monitoring period, requiring a lease or purchase of additional space. In addition, Spravato requires administrative support for medication procurement, appropriate storage equipment (for example, Pyxis machine or similar) to mitigate abuse and diversion potential, medically appropriate staffing (for the required observation of self-administration, multiple vital signs checks, completion of REMS monitoring forms and other administrative requirements of the REMS, and discharge assessment), and equipment and services including a chair that can recline and controlled substance waste removal compliance. One commenter indicated that the pricing methodology used for esketamine, whether WAC, ASP or compendia pricing, does not take into account the costs associated with full-management of the drug cycle including ordering, storage, inventory tracking, billing, etc. Therefore, the commenter recommends valuing the bundled esketamine by adding 20 percent to ASP.

Response: Under our PE methodology, the costs identified by the commenter for reception time, rent, furniture, electronic health records (EHRs), and waste management are all types of indirect costs. This means that they are not individually allocable to a particular patient for a particular service, and therefore they are not summed up as separate itemized direct costs for codes such as HCPCS codes G2082 and G2083. CMS is still paying practitioners for these costs through our indirect PE methodology; we note that for a typical HCPCS code, indirect costs make up roughly 75 percent of the total PE. If we were to itemize administrative costs such as rent and furniture as direct costs, we would be double counting them in violation of our standard PE methodology. As previously discussed, we are proposing to refine the direct PE inputs of HCPCS codes G2082 and G2083, in part, by using the clinical labor time for CPT codes 95076 and 95079, in lieu of the clinical labor time of CPT codes 99415 and 99416 to account for the clinical staff time, such that the proposed refinements would increase the clinical labor time from 30 minutes to 150 minutes. We believe this refinement would account for the clinical staff time and efforts including the acquisition and delivery of the medication to the patient as required by the REMS.

Comment: One commenter requested clarification on whether payment is fixed for 2020 or whether the payment will be adjusted to reflect 2020 changes in WAC, for example updated data made available from the most recent quarter. The commenter also questioned whether regulatory changes made under the PFS to values of the component services would also be applied to the G codes, for example, whether changes to values of the E/M codes would also be incorporated into the RVU inputs for G codes. For instance the outpatient E/M values are set to increase in 2021, and the commenter asked whether that increase would automatically be included in the valuation of the bundle, and whether the payment currently ascribed to the bundle for the cost of the medication be updated if the input prices for the services change over time.

Response: Historically, supply input prices are updated on a code-by-code basis and periodically through annual notice and comment rulemaking. The prices, including for a variety of pharmaceutical products, are not routinely updated like Part B drugs paid under the ASP methodologies. For the supply inputs for the esketamine product used in developing rates for HCPCS codes G2082 and G2083, we used the most recent available quarter of WAC data for 2020 pricing, but we anticipate using either data reported for purposes of determining payments under section 1847A of the Act (such as ASP) or compendia pricing information (such as WAC) in future years. Since we reviewed and are proposing refinements to HCPCS codes G2082 and G2083 for the CY 2021 rulemaking cycle, we propose to update the payment to reflect the most recent available quarter of WAC data for CY 2021 pricing, and propose to update the payment to reflect the E/M values (CPT code 99212) for CY 2021. Therefore, to account for the cost of the provision of the self-administered esketamine as a direct PE input, we incorporated the wholesale acquisition cost (WAC) data from the most recent available quarter. For HCPCS code G2082, we propose to update the supply input that describes 56 mg (supply code SH109) from a price of $590.02 to $616.93 and for HCPCS code G2083, we propose to update the price from $885.02 to $928.38 for the supply input Start Printed Page 50172describing 84 mg of esketamine (supply code SH110).

Comment: One commenter indicated that the CMS approach to the E/M component of the interim G codes includes inputs associated with an established patient for the first visit or any subsequent treatment, and requested clarification that, if reasonable and necessary, the health care provider could complete an E/M service that is distinct from the E/M services necessary for esketamine administration, and in such an event, separate E/M service would be eligible to be paid separately with E/M codes.

Response: Given that HCPCS codes G2082 and G2083 already take into account E/M services in their valuations, it would be duplicative to bill for a separate E/M code along with HCPCS codes G2082 and G2083. However, other reasonable and necessary E/M services may be furnished and billed for a patient on dates before and after HCPCS code G2082 or G2083, for example, when the services are furnished in the course of treating and diagnosing treatment-resistant depression.

After considering the comments we received, we are proposing to refine the values for HCPCS codes G2082 and G2083 using a building block methodology that sums the values associated with several codes. For the overall E/M and observation elements of the services, we are incorporating the work RVUs, work time and direct PE inputs associated with a level two office/outpatient visit for an established patient, CPT code 99212. We are also proposing to include the clinical labor for CPT 95076 and 95079 (in lieu of CPT codes 99415 and 99416 as detailed earlier); and to account for the cost of the provision of the self-administered esketamine as a direct PE input, we are proposing to incorporate the wholesale acquisition cost (WAC) data from the most recent available quarter. We are seeking comment on this updated payment proposal and valuation of HCPCS code G2082 and G2083.

(53) Bundled Payments Under the PFS for Substance Use Disorders (HCPCS Codes G2086, G2087, and G2088)

In the CY 2020 PFS final rule (84 FR 62673), we finalized the creation of new coding and payment describing a bundled episode of care for the treatment of Opioid Use Disorder (OUD). The codes and descriptors we finalized for CY 2020 were:

  • HCPCS code G2086: 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 G2087: 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 G2088: 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).

As noted in the CY 2020 PFS final rule (84 FR 62673), if a patient's treatment involves MAT, this 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.

We have received requests to expand these bundled payments to be inclusive of other SUDs, not just OUD. We agree that doing so could expand access to needed care. We are proposing to expand these bundled payments to be inclusive of all SUDs. To accomplish this, we are proposing to revise the code descriptors for HCPCS codes G2086, G2087, and G2088 by replacing “opioid use disorder” with “a substance use disorder.” The payment and billing rules would otherwise remain unchanged. We note that HCPCS codes G2086, G2087, and G2088 were added to the Medicare Telehealth list in the CY 2020 PFS final rule (84 FR 62628). The proposed revised code descriptors are:

  • HCPCS code G2086: Office-based treatment for a substance 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 G2087: Office-based treatment for a substance use disorder, including care coordination, individual therapy and group therapy and counseling; at least 60 minutes in a subsequent calendar month.
  • HCPCS code G2088: Office-based treatment for a substance 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).

Additionally, in the CY 2020 PFS final rule we stated that we anticipate that the services described by HCPCS codes G2086, G2087, and G2088 would often be billed by addiction specialty practitioners, but note that these codes are not limited to any particular physician or nonphysician practitioner (NPP) specialty. We also noted that consultation was not a required condition of payment for these codes, but that consultation with a specialist could be counted toward the minutes required for billing HCPCS codes G2086, G2087, and G2088 (84 FR 62674). Although it is not a requirement for billing the code, we encourage that practitioners consult with specialists in cases where it is warranted and refer the patient to specialty care as needed.

We note that while these codes describe treatment for any SUD, information about which specific SUDs are being treated would provide valuable information that can help assess local, state, and national trends and needs. We believe it is important that the diagnosis codes listed on the claim form reflect all SUDs being treated, however, we also do not wish to add any additional burden on practitioners related to claims submission, therefore, we are seeking information on whether there are sources of data we could explore in order to provide this information. We are also seeking information on whether there are differences in the resource costs associated with furnishing services for the various SUDs, and accordingly whether there is a need for more stratified coding to describe these services. We note that in some instances, the CPT Editorial Panel has created CPT codes to replace G codes created by CMS, and that we would welcome such input on these services. We look forward to receiving public comments on this proposal in order to help evaluate whether more granular coding is needed.

(54) Initiation of Medication Assisted Treatment (MAT) in the Emergency Department (HCPCS Code GMAT1)

In the CY 2020 PFS proposed rule (84 FR 40545), we sought comment on the use of medication assisted treatment (MAT) in the emergency department (ED) setting, including initiation of MAT and the potential for either referral or follow-up care, to better understand typical practice patterns to help inform whether we should consider making separate payment for such services in future rulemaking. We note that the term MAT generally refers to treatment of OUD that includes both an FDA-approved medication for the treatment of OUD and behavioral/psychosocial treatment, but that care provided in the ED typically would include medication for the treatment of OUD and referral or linkage to primary care or a hospital-Start Printed Page 50173based bridge clinic for continuation of medication and potentially other services, including counseling and other psychosocial services.

The public comments received in response to the comment solicitation were supportive of us making a proposal, several citing research that indicates improved outcomes for patients who initiate medications for the treatment of OUD in the ED. One commenter noted that by implementing this treatment regimen, practitioners can address a patient's immediate withdrawal symptoms, which allows time to coordinate care and provide a referral to substance use disorder specialists and other community resources who can appropriately carry out long-term treatment. Another commenter cited that the national rate of overdose-related visits seen in EDs nearly doubled between 2005 and 2014 and noted that hospital-based care represents a critical opportunity to initiate treatment and connect patients with OUD to care, noting that patients who receive information about drug treatment in the hospital post-overdose are more likely to seek treatment.[12] The commenter also cited a randomized clinical trial that showed that more patients were engaged in treatment 30 days after buprenorphine was initiated in the ED and coupled with a referral, compared to interventions that did not include buprenorphine.[13] Another study found that ED induction of buprenorphine was more cost-effective than either brief intervention or referral upon discharge.[14] One commenter suggested that CMS institute a G-code to address this coding gap in the short term, while a more permanent solution is pursued to address this site-of-service specification.

We are persuaded by the comments received in response to our comment solicitation that this work is not currently accounted for in the existing code set. To account for the resource costs involved with initiation of medication for the treatment of opioid use disorder in the ED and referral for follow-up care, we are proposing to create one add-on G-code to be billed with E/M visit codes used in the ED setting. This code would include payment for assessment, referral to ongoing care, follow-up after treatment begins, and arranging access to supportive services, but we note that the drug itself would be paid separately. The proposed code is:

  • HCPCS code GMAT1: Initiation of medication for the treatment of opioid use disorder in the emergency department setting, including assessment, referral to ongoing care, and arranging access to supportive services (List separately in addition to code for primary procedure).

To price this service, we are proposing to use a direct crosswalk to the work and direct PE inputs for HCPCS code G0397 (Alcohol/subs interv >30 min), which is assigned a work RVU of 1.30. We believe that the work and PE described by this crosswalk code is similar in nature and magnitude to the services described in HCPCS code GMAT1. We note that unlike the requirements for reference code, we are not proposing a required number of minutes to bill HCPCS code GMAT1. We welcome comment on this proposal and whether we should consider a different valuation to account for the resource costs involved with these services.

(55) Percutaneous Creation of an Arteriovenous Fistula (AVF) (HCPCS Code G2170 and G2171)

We received a comment in response to the CY 2020 PFS proposed rule (84 FR 40481), as well as inquiries from stakeholders, requesting that we establish new coding for the percutaneous creation of an arteriovenous fistula (AVF) used for dialysis access.

For CY 2019, based on two new technology applications for arteriovenous fistula creation, we established two new HCPCS codes to describe the two modalities of this service. Specifically, we established HCPCS code C9754 (Creation of arteriovenous fistula, percutaneous; direct, any site, including all imaging and radiologic supervision and interpretation, when performed and secondary procedures to redirect blood flow (e.g., transluminal balloon angioplasty, coil embolization, when performed)) and HCPCS code C9755 (Creation of arteriovenous fistula, percutaneous using magnetic-guided arterial and venous catheters and radiofrequency energy, including flow-directing procedures (e.g., vascular coil embolization with radiologic supervision and interpretation, when performed) and fistulogram(s), angiography, venography, and/or ultrasound, with radiologic supervision and interpretation, when performed). The HCPCS codes were created for institutional payment systems, and thus do not allow for payment for the physician's work portion of the service. Stakeholders have stated that the lack of proper coding to report the physician work associated with these procedures is problematic, as physicians are either billing an unlisted procedure code, or are billing other CPT codes that do not appropriately reflect the resource cost associated with the physician work portion of the service. Stakeholders stated that separate coding for physician payment will allow billing when the procedures are furnished in either a physician office or an institutional setting, and be paid under the respective payment systems, as appropriate. We have recognized that the lack of appropriate coding for this critical physician's service has become an even greater burden given the PHE that was declared effective January 27, 2020 for the COVID-19 epidemic. In order to mitigate potential health risks to beneficiaries, physicians and practitioners as a result of having this procedure performed in an institutional setting, we have created two HCPCS G codes for percutaneous creation of an arteriovenous fistula (AVF). The codes are contractor priced and effective July 1, 2020. This will allow for more accurate billing and coding of a crucial physician service that could then be performed in both institutional and office settings, thus mitigating unnecessary risk to beneficiaries, physicians and practitioners caused by disease transmission. The HCPCS G codes are described as follows:

  • HCPCS G code G2170 (Percutaneous arteriovenous fistula creation (AVF), direct, any site, by tissue approximation using thermal resistance energy, and secondary procedures to redirect blood flow (e.g., transluminal balloon angioplasty, coil embolization) when performed, and includes all imaging and radiologic guidance, supervision and interpretation, when performed.)
  • HCPCS G code G2171 (Percutaneous arteriovenous fistula creation (AVF), direct, any site, using magnetic-guided arterial and venous catheters and radiofrequency energy, including flow-directing procedures (e.g., vascular coil embolization with radiologic supervision and interpretation, wen performed) and fistulogram(s), angiography, venography, and/or ultrasound, with Start Printed Page 50174radiologic supervision and interpretation, when performed.)

We are proposing to maintain contractor pricing for these HCPCS codes for CY 2021, however, we are also seeking information from stakeholders on the resource costs involved in furnishing the services described by HCPCS codes G2170 and G2171 to ensure proper payment for these physician's services, for consideration in future rulemaking. We note that under the Outpatient Prospective Payment System (OPPS) these services are assigned to APC 5193, which for CY 2020 has an assigned payment rate of $15,938.20.

(56) Insertion, Removal, and Removal and Insertion of Implantable Interstitial Glucose Sensor System (Category III CPT Codes 0446T, 0447T, and 0448T)

Category III CPT codes 0446T, 0447T, and 0448T describe the services related to the insertion, removal, and removal and insertion of an implantable interstitial glucose sensor from subcutaneous pocket, in a subcutaneous pocket via incision. The implantable interstitial glucose sensors are part of systems that can allow real-time glucose monitoring, provides glucose trend information, and signal alerts for detection and prediction of episodes of low blood glucose (hypoglycemia) and high blood glucose (hyperglycemia). The codes that describe the implantation, removal, and removal and implantation of implantable interstitial glucose sensors are currently contractor-priced.

  • Category III CPT code 0446T (Creation of subcutaneous pocket with insertion of implantable interstitial glucose sensor, including system activation and patient training);
  • Category III CPT code 0447T (Removal of implantable interstitial glucose sensor from subcutaneous pocket via incision); and
  • Category III CPT code 0448T (Removal of implantable interstitial glucose sensor with creation of subcutaneous pocket at different anatomic site and insertion of new implantable sensor, including system activation).

In the CY 2020 PFS final rule (84 FR 62627), we requested information from stakeholders to ensure proper payment for this important physician's service and welcomed recommendations on appropriate valuation for these services to be considered in future rulemaking.

We are proposing to establish national payment amounts for the codes describing the insertion, removal, and removal and insertion of an implantable interstitial glucose sensor, effective January 1, 2021. We are proposing a work RVU of 1.14 for Category III CPT code 0446T, a work RVU of 1.34 for Category III CPT code 0447T, and work RVU of 1.91 for Category III CPT code 0448T based on a crosswalk to the work RVUs, work time, and direct PE inputs of CPT codes 11981 (Insertion, non-biodegradable drug delivery implant), 11982 (Removal, non-biodegradable drug delivery implant), and 11983 (Removal with reinsertion, non-biodegradable drug delivery implant), respectively, due to the similar clinical nature of these procedures.

We are also proposing to include one supply and one equipment item to the direct PE inputs crosswalked from CPT codes 11981-11983. We are adding a new “implantable interstitial glucose sensor” (supply code SD334) for Category III CPT codes 0446T and 0448T to include the supply costs of the “implantable interstitial glucose sensor” (supply code SD334) included in these procedures, which we propose to price at $1,500.00, based on information we received from stakeholders. We are also proposing to include the smart transmitter associated with the use of this implantable interstitial glucose sensor. We propose to price the smart transmitter involved in furnishing this service by using a similar equipment item finalized in the CY 2019 PFS final rule (83 FR 59624) as a proxy, the “heart failure patient physiologic monitoring equipment package” (EQ392); the EQ392 has a price of $1,000.00, and is similarly used for long term remote monitoring of patients. We are proposing to use the EQ392 equipment as a proxy for the valuation of the smart transmitter associated with the implantable interstitial glucose sensor, to which we are assigning a time of 25,920 minutes for EQ392 in Category III CPT codes 0446T and 0448T. This time is derived from 60 minutes per hour times 24 hours per day times 90 days per billing quarter, divided by 1 minute of equipment use out of every 5 minutes of time. We are not including either the implantable interstitial glucose sensor or the EQ392 equipment proxy for Category III CPT code 0447T, as it describes only a removal procedure.

We are seeking comment on the proposed values for these Category III CPT codes (0446T, 0447T, and 0448T), and we are seeking comment on the appropriateness and accuracy of the proposed work RVUs, work times, and direct PE inputs.

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I. Modifications Related to Medicare Coverage for Opioid Use Disorder (OUD) Treatment Services Furnished by Opioid Treatment Programs (OTPs)

1. Background

Section 2005 of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities (SUPPORT) Act established a new Medicare Part B benefit category for OUD treatment services furnished by OTPs during an episode of care beginning on or after January 1, 2020. In the CY 2020 PFS final rule (84 FR 62630 through 62677), we implemented coverage requirements and established new codes describing the bundled payments for episodes of care for the treatment of OUD furnished by OTPs. We established new codes for and finalized bundled payments for weekly episodes of care that include methadone, oral buprenorphine, implantable buprenorphine, injectable buprenorphine or naltrexone, and non-drug episodes of care, as well as add-on codes for intake and periodic assessments, take-home dosages for methadone and oral buprenorphine, and additional counseling. We are monitoring Medicare enrollment by OTPs and utilization of the new benefit to ensure that Medicare beneficiaries have appropriate access to care. For CY 2021, we are proposing several refinements and seek to provide clarification on certain issues that stakeholders have brought to our attention.

2. Definition of OUD Treatment Services

In the CY 2020 PFS final rule (84 FR 62631 through 62635), we finalized a definition of “OUD treatment services” that reflects the statutory definition in section 1861(jjj)(1)(A) of the Act, which defines covered OUD treatment services to include oral, injected, and implanted opioid agonist and antagonist treatment Start Printed Page 50203medications approved by the Food and Drug Administration (FDA) under section 505 of the FFDCA for use in the treatment of OUD. There are three drugs currently approved by FDA for the treatment of opioid dependence: Buprenorphine; methadone; and naltrexone. In the CY 2020 PFS final rule, we noted that we had received comments supporting the proposed definition of OUD treatment services but also requesting that CMS include naloxone to treat opioid overdose in that definition as a medication used in treatment of OUD. Although we did not finalize including naloxone in the definition of OUD treatment services in that final rule, we indicated that as we continue to work on refining this new Medicare benefit, we would consider including additional drugs in the definition of OUD treatment services under our discretionary authority in section 1861(jjj)(1)(F) of the Act to include other items and services the Secretary determines are appropriate. After further consideration, we have determined that it is appropriate to propose to extend the definition of OUD treatment services to include opioid antagonist medications, such as naloxone, that are approved by FDA under section 505 of the FFDCA for emergency treatment of opioid overdose.

Naloxone is an opioid antagonist indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression.[15] [16] Naloxone should be given to a person who shows signs of an opioid overdose or when an overdose is suspected. FDA-approved naloxone products for overdose reversal are effective in reversing opioid overdose, including fentanyl-involved opioid overdoses, although overdoses involving potent (for example, fentanyl) or large quantities of opioids may require higher-than-normal doses of naloxone or repeated administration to reverse overdose.[17]

Naloxone attaches to opioid receptors and reverses and blocks the effects of other opioids.[18] FDA has approved injectable naloxone, intranasal naloxone, and naloxone auto-injector as emergency treatments for opioid overdose. The nasal spray is a prefilled, needle-free device that requires no assembly and can deliver a single dose into each nostril with two sprays. The auto-injector is injected into the outer thigh to deliver naloxone to the muscle (intramuscular). These forms of naloxone can easily be administered by persons who do not have medical training and they may be prescribed to a patient who is receiving medication-assisted treatment (MAT) for OUD, especially if the patient is considered to be at risk for opioid overdose.[19] Both the nasal spray and naloxone auto-injector are packaged in a carton containing two doses to allow for repeat dosing if needed.20 21

The U.S. Surgeon General Jerome M. Adams, M.D., M.P.H. has released a public health advisory stating that, “Research shows that when naloxone and overdose education are available to community members, overdose deaths decrease in those communities. Therefore, increasing the availability and targeted distribution of naloxone is a critical component of our efforts to reduce opioid-related overdose deaths and, when combined with the availability of effective treatment, to ending the opioid epidemic.” 22

We are proposing to add naloxone to the definition of OUD treatment services in order to increase access to this important emergency treatment and to allow OTPs to be paid under Medicare for dispensing naloxone to Medicare beneficiaries who are receiving other OUD treatment services from the OTP. Under this proposal, beneficiaries receiving OUD treatment services from the OTP would be able to receive naloxone from the OTP under the OUD treatment services benefit, to the extent it is medically reasonable and necessary as part of their OUD treatment. We note that naloxone is already covered under Medicare Part D. In 2017, 72.5 percent of all Medicare beneficiaries were enrolled in Medicare Part D plans.23 However, we believe allowing beneficiaries to access this important emergency treatment at the OTP may help decrease barriers to access because there currently are no copayments for services furnished by OTPs and beneficiaries would not need to visit a separate provider to access naloxone.

Accordingly, to align with efforts to end the opioid epidemic, under the discretionary authority in section 1861(jjj)(1)(F) of the Act, we propose to amend the definition of OUD treatment services at § 410.67(b) by adding § 410.67(b)(8) to include opioid antagonist medications that are approved by FDA under section 505 of the FFDCA for the emergency treatment of known or suspected opioid overdose. We are proposing to amend the definition of OUD treatment services under the discretionary authority in section 1861(jjj)(1)(F) of the Act rather than the authority under section 1861(jjj)(1)(A) of the Act because section 1861(jjj)(1)(A) of the Act pertains to opioid agonist and antagonist treatment medications (including oral, injected, or implanted versions) that are approved by FDA under section 505 of the FFDCA for use in the treatment of opioid use disorder. Naloxone is not one of the three drugs currently approved by FDA for the treatment of opioid dependence (buprenorphine, methadone, and naltrexone); and, as a result, we do not believe naloxone fits the criteria of section 1861(jjj)(1)(A) of the Act. We seek comment on our proposal to expand the definition of OUD treatment services.

Additionally, we agree with the public health advisory quoted previously that community education related to overdose prevention is needed to address the opioid crisis. We believe that prevention and community education efforts would increase awareness of treatment options and could play a role in decreasing opioid overdose deaths. We welcome comments on whether the definition of OUD treatment services should be further revised to include overdose education. Additionally, we welcome comments on whether payment for providing overdose education to the beneficiary and/or the beneficiary's family or partner should be considered to be included in the current weekly bundled payments for episodes of care or whether we should consider establishing an add-on payment for education related to overdose prevention when such services are furnished by OTPs. We are specifically seeking information related to what inputs we might consider in developing the payment rate for such a service, such as payment amounts for similar services under the PFS, if we were to include this type of education as part of the proposed new add-on codes for naloxone discussed later in this section (HCPCS codes GOTP1 and GOTP2). For example, in order to establish a payment rate for education related to overdose prevention for the beneficiary and/or Start Printed Page 50204beneficiary's family or partner, we could consider a crosswalk to the Medicare payment rate for CPT code 96161 (Administration of caregiver-focused health risk assessment instrument (e.g, depression inventory) for the benefit of the patient, with scoring and documentation, per standardized instrument). The current non-facility payment rate under the PFS for CPT code 96161 is $2.53.

a. Proposed Adjustment Made to the Bundled Payments for OUD Treatment Services

Consistent with our proposal to expand the definition of OUD treatment services to include opioid antagonist medications indicated for the emergency treatment of known or suspected opioid overdose, we believe it is appropriate to propose changes to the payment rates for the bundled payments to reflect the costs of these medications. Therefore, we propose to adjust the bundled payment rates through the use of add-on codes to account for instances in which OTPs provide Medicare beneficiaries with naloxone. We believe that beneficiaries receiving naloxone will need a supply at the start of treatment and would only require refills later if the supply is used in an emergency. As a result, we would not expect naloxone to be provided weekly to all patients, but only on an as-needed basis. Accordingly, we believe that making payment for naloxone through the use of an add-on code is the most accurate approach to pricing rather than including the costs of these medications as part of the bundled payment rates for all episodes of care.

We propose to adopt the following add-on G codes:

  • HCPCS code GOTP1: Take-home supply of nasal naloxone (provision of the services by a Medicare-enrolled Opioid Treatment Program); List separately in addition to code for primary procedure.
  • HCPCS code GOTP2: Take-home supply of auto-injector naloxone (provision of the services by a Medicare-enrolled Opioid Treatment Program); List separately in addition to code for primary procedure.

We are proposing to adopt an approach similar to the pricing methodology that was used to price the drug component of the bundled payments in the CY 2020 PFS final rule to determine the payment rate for these proposed new add-on codes for naloxone. In the CY 2020 PFS proposed rule (84 FR 40530), we explained that 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. Therefore, we believe it is appropriate to use a similar methodology to determine the payment rates for the add-on codes for naloxone as we adopted in the CY 2020 PFS final rule for purposes of determining the payment rate for the drug component of the bundled payments because it provides our best estimate of an OTP's cost in dispensing naloxone.

In the CY 2020 PFS final rule, we adopted a policy under which we apply the methodology set forth in section 1847A of the Act to determine the payment amount for the drug component of the bundled payment for an episode of care that includes implantable or injectable medications, except that the payment amount shall be 100 percent of the average sales price (ASP), if ASP is used. For oral medications, the payment for the drug component is based on 100 percent of ASP, if ASP data are available. However, if ASP is not available, the payment amount for methadone will be based on the TRICARE rate and the payment amount for oral buprenorphine is calculated using the national average drug acquisition cost (NADAC).

Drug Pricing for Nasal Naloxone

Consistent with the approach that we adopted for pricing the drug component of the weekly bundled payments, we are proposing to price the add-on code describing the take home supply of nasal naloxone, HCPCS code GOTP1, using the same methodology we previously adopted for pricing the drug component of an episode of care that include implantable or injectable medications. Accordingly, the payment methodology would be based upon the methodology set forth in section 1847A of the Act, except that payment amounts determined based on ASP and wholesale acquisition cost (WAC) would not include any add-on percentages. We recognize that nasal naloxone is not an oral, implantable or injectable medication; however, ASP data are available. As noted in the CY 2020 PFS final rule (84 FR 62653), we believe using ASP provides a transparent and public benchmark for manufacturers' pricing as it reflects the manufacturers' actual sales prices to all purchasers (with limited exceptions as noted in section 1847A(c)(2) of the Act) and is the only pricing methodology that includes off-invoice rebates and discounts as described in section 1847A(c)(3) of the Act. Therefore, we believe ASP to be the most market-based approach to set drug prices. We seek public comment on our proposal to use ASP+0 to price the add-on payment for nasal naloxone and other potential sources of pricing data for nasal naloxone either generally or specifically with respect to acquisition by OTPs.

Drug Pricing for Auto-Injector Naloxone

We are proposing to price the add-on code describing the take-home supply of auto-injector naloxone, HCPCS code GOTP2, using the lowest pricing available (the lower of ASP + 0, WAC + 0, or NADAC). Currently, there is no ASP or NADAC reported or calculated for auto-injector naloxone. Accordingly, we propose to use WAC + 0 to determine the pricing for the add-on payment for auto-injector naloxone. We believe 100 percent of WAC is a closer estimate of the actual acquisition cost for OTPs compared to WAC with an add-on percentage because, as defined in section 1847A(c)(6)(B) of the Act, WAC does not include prompt pay discounts, rebates or reductions in price. Thus, there should be no need to pay an add-on percentage to ensure OTPs are reimbursed for their acquisition costs for auto-injector naloxone. However, in the future, we believe using the lowest pricing available for auto-injector naloxone may be most appropriate, because if ASP and/or NADAC pricing were to become available for auto-injector naloxone, they would be more reflective of actual costs than a list price.

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We note that auto-injector naloxone is available in both a generic and brand name version. We considered comparing the Medicare Part D utilization for each formulation to determine the frequency with which the generic and brand name versions might dispensed by OTPs. However, because the generic auto-injector naloxone is rather new to the marketplace,24 there are limited utilization data available for the generic product. Based on historical information reflecting a trend of increased generic utilization uptake,25 we believe that in most cases where the auto-injector naloxone is prescribed and dispensed by OTPs to beneficiaries, it will be the generic formulation of the product. Therefore, we believe using the price for the generic formulation is a reasonable approach to pricing the proposed add-on code for auto-injector naloxone and will ensure that beneficiaries who need this drug as part of their treatment for OUD have access to it and that OTPs receive a reasonable payment for dispensing the drug. Accordingly, we are proposing to use the price of the generic formulation, determined as WAC + 0, to pay for auto-injector naloxone when the drug is provided by an OTP as part of an episode of care. We seek comment on our proposed pricing methodology to pay for auto-injector naloxone and other potential sources of pricing data for auto-injector naloxone either generally or specifically with respect to acquisition by OTPs.

Frequency Limit

We note that Medicare Part D allows prescription drug plans to place quantity limits (QL) on most drugs, including on naloxone. While most Part D plans do not limit the amount of naloxone a beneficiary is able to receive in a given month, when they do, they most frequently allow a plan enrollee a maximum of 4 units per 30 days (2 boxes of 2 units). In the current contract year (2020) only 22 percent of Medicare Part D formularies apply a QL to naloxone (115/535 formularies), while for the 2021 contract year only 19 percent of Part D formularies plan to apply a QL to this product (106/564 formularies). However, a review of Part D claims data shows that beneficiaries who use naloxone most frequently use only one box (2 units) within a 30-day period even though nearly all plans would have permitted additional doses. Under TRICARE, auto-injector naloxone is covered for a maximum quantity of one carton at retail network pharmacies for up to a 30-day supply.[26] We believe it would be appropriate to apply a similar limit on the frequency of the add-on payment for naloxone dispensed by OTPs. We believe that applying a frequency limit would assist in enhancing patient safety and discourage misuse, waste and abuse. Furthermore, we believe such a limitation is reasonable because there are other services that OTPs should already be performing, and which are already included in the weekly bundled payments for episodes of care, such as counseling and individual and group therapy, that should limit the need for this emergency treatment. However, we do not want to limit access to naloxone when it is a medically reasonable and necessary part of the treatment for OUD. Therefore, we propose to limit Medicare payment to OTPs for naloxone to one add-on code (HCPCS code GOTP1 or GOTP2) every 30 days to the extent that it is medically reasonable and necessary. We seek comment on whether this proposed limit is reasonable and whether special circumstances may arise under which more frequent payment is medically reasonable and necessary and the types of circumstances that should qualify for more frequent payment. However, we note that we also expect OTPs and their treating practitioners will use their clinical judgment as to whether there may be cases in which a referral to a higher level of care may be needed for some beneficiaries in order to reduce the risk of overdose and the need for more frequent emergency treatment. We propose to add § 410.67(d)(4)(i)(E) to describe payment for a take-home supply of opioid antagonist medications that are approved by FDA under section 505 of the FFDCA for the emergency treatment of known or suspected opioid overdose.

We invite public comments on the proposed pricing for nasal naloxone and auto-injector naloxone. We also seek comment on our proposal to limit payment for the proposed add-on codes for take-home supplies of these medications to once every 30 days to the extent that it is medically reasonable and necessary.

Additionally, we seek comment on whether we should consider creating a code and establishing an add-on payment for injectable naloxone. We note that all three forms of naloxone (injectable, auto-injector, and nasal spray) are FDA-approved and may be considered as options for community distribution and use by individuals with or without medical training to stop or reverse the effects of an opioid overdose.[27] If we were to establish an add-on payment for injectable naloxone, we would consider using the same methodology we adopted for pricing the drug component of an episode of care that includes implantable or injectable medications, as described in § 410.67(d)(2)(i)(A).

Table 30 details the proposed coding and summarizes the proposed payment amounts for nasal naloxone and auto-injector naloxone.

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Duplicative Payment

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 under our proposal, OTPs would be able to provide naloxone to Medicare beneficiaries and bill for it as an add-on to the bundled payment. Consistent with § 410.67(e), the beneficiary's copayment amount would remain zero. We also realize that naloxone may also be appropriately available to beneficiaries through other Medicare benefits, including, for example, Medicare Part D, under which the beneficiary would be responsible for the applicable cost sharing. As discussed in the CY 2020 PFS final rule (84 FR 62664) and codified at § 410.67(d)(5), we define duplicative payment to involve only those circumstances where medications that are delivered, administered or dispensed to a beneficiary are paid as part of the OTP bundled payment, and where the delivery, administration or dispensing of the same medication (that is, same drug, dosage and formulation) is also separately paid under Medicare Part B or Part D for the same beneficiary on the same date of service. Because we are proposing to pay for naloxone as an add-on to the weekly bundled payment, any payment to an OTP for naloxone would be duplicative if the same medication is separately paid under Medicare Part B or Part D for the same beneficiary on the same date of service. Consistent with § 410.67(d)(5), CMS would recoup any duplicative payment made to an OTP for naloxone.

Additionally, we understand that some OTPs negotiate arrangements whereby community pharmacies supply MAT-related medications to OTPs. However, as we stated in the CY 2020 PFS final rule, if the OTP provides reasonable and 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. Thus, naloxone billed by an OTP as an add-on to the bundled payment should not be reported to or paid under a Part D plan. We expect that OTPs will take reasonable steps to prevent duplicative payment for naloxone furnished under their care by ensuring it is not reported or billed under a different Medicare benefit. We intend to monitor for duplicative payments, and would take appropriate action as needed when and if such duplicative payments are identified.

3. WAC Pricing

Section 1834(w) of the Act gives the Secretary significant discretion to establish bundled payment rates for OUD treatment services. In the CY 2020 PFS final rule, we finalized a payment methodology for the drug component of the bundled payment rates for OUD treatment services, under which we use the payment methodology set forth in section 1847A of the Act (which bases most payment on ASP) to set the payment rates for implantable and injectable drugs and limited the payment amount for these drugs to 100 percent of the volume-weighted ASP for a drug category or code, if ASP is used. We codified this payment methodology at § 410.67(d)(2)(i)(A).

Section 1847A of the Act provides for the use of other payment methodologies when ASP is not available, including WAC and average manufacturer price (AMP). In the CY 2020 PFS final rule, we limited payments to OTPs for injectable and implantable drugs to 100 percent of ASP, but did not otherwise diverge from the payment methodology that would apply under section 1847A of the Act. In this proposed rule, we believe that it is necessary to amend the OTP drug pricing methodology in order to limit WAC-based payments to 100 percent of WAC. As discussed previously, we are proposing to use WAC pricing to determine the payment rate for the add-on code for the auto-injector naloxone. Although none of the drugs that are currently included in the drug component of an episode of care is currently paid based on WAC, we believe it is possible that we may use WAC to determine the payment for the drug component of an episode of care in the future, and want to establish, in advance, the methodology that would apply for purposes of determining the payment rate.

As authorized under section 1847A of the Act, some Part B drugs are paid based on WAC. For example, for single source drugs, payment is 106 percent of the lesser of WAC or ASP (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), 103 percent of WAC is used. Additionally, there are some instances where drugs lack ASP data for reasons other than being new, for example, in cases where the manufacturer had no sales in a reporting quarter. In those situations, the Medicare payment method varies, but in some cases, the payment may be 106 percent of the WAC.[28] As we stated in the CY 2020 PFS final rule (84 FR 62651), 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 Start Printed Page 50207to the clinical care of the patient, such as the drug's profit margin for a provider. The WAC is defined in section 1847A(c)(6)(B) as the manufacturer's list price for a drug to wholesalers or direct purchasers in the United States, not including prompt pay or other discounts, rebates, or reductions in price. A drug's WAC is ultimately controlled by the manufacturer. Unlike ASP, a drug's WAC does not incorporate prompt-pay or other discounts. If discounts are available on drugs reimbursed by Medicare at 106 percent of WAC, then Medicare is paying more for drugs than it otherwise would under the ASP-based formula.[29] Therefore, consistent with our existing policy to set the payment amount at 100 percent of the ASP, if ASP is used to determine the payment for the drug component of an episode of care, we are proposing that when WAC-based pricing is used, the payment amount shall be WAC + 0. We are proposing to amend the provision at § 410.67(d)(2)(i)(A) to reflect this limitation.

We welcome comments on this proposed alternative pricing methodology when the payment for an implantable or injectable medication included in the drug component of an episode of care is determined using the methodology set forth in section 1847A of the Act, and ASP pricing data are not available.

4. Billing and Payment Policies

a. Institutional Claim Forms

We have received several requests to allow OTPs to bill on an institutional claim form. We were informed by representatives from the state of New York that all OTPs in New York state bill on institutional claim forms, not just those that are part of a hospital system. Given the public health need related to the opioid epidemic, we are exploring claims processing flexibilities requested by some OTPs that would allow them to bill services on institutional claims. See also section III.B. of this proposed rule, OTP Provider Enrollment Regulation Updates for Institutional Claim Submissions, for a discussion related to OTP enrollment as it relates to institutional claims. There would be no differences in coverage or payment between services billed on the institutional claim form versus the professional claim form. We note that the National Uniform Billing Committee (NUBC) approved a new Type Of Bill (087x) for Freestanding Non-residential Opioid Treatment Program provider billing, as well as a new condition code (89) for Opioid Treatment Program/Indicates claim for opioid treatment program services, to be used on hospital based OTP claims (TOB 013x and 085x). We are seeking information on the reasons this flexibility is necessary for OTPs, and will address any changes to provider billing policies in subsequent claims processing instructions.

b. Periodic Assessments

In the CY 2020 PFS final rule (84 FR 62634), we stated that we understood that intake activities and periodic assessments are integral services for the establishment and maintenance of OUD treatment for a beneficiary at an OTP, and therefore, we believed it was reasonable to include these services in the definition of OUD treatment services. Accordingly, we finalized a definition of OUD treatment services in § 410.67(b) that reflected the required intake activities and periodic assessments. We stated it was our understanding that these services are furnished much less frequently than the other services included in the weekly bundled payments; therefore, we created add-on G codes to describe these services, which would allow us to make more targeted payments for these services. We noted that the add-on code describing intake activities should only be billed for new patients (that is, patients starting treatment at the OTP). We agreed with the commenters that the level 4 office/outpatient E/M visits for new and established patients are a good approximation of the services provided at intake and during periodic assessments at OTPs based on the expected acuity of patients with OUD receiving services at OTPs, who are likely to have multiple co-morbidities and present with problems that are of moderate to high severity and require medical decision making of moderate complexity. The finalized add-on codes are HCPCS code G2076 (Intake activities; including initial medical examination that is a complete, fully documented physical evaluation and initial assessment conducted by a program physician or a primary care physician, or an authorized health care professional under the supervision of a program physician or qualified personnel that includes preparation of a treatment plan that includes the patient's short-term goals and the tasks the patient must perform to complete the short-term goals; the patient's requirements for education, vocational rehabilitation, and employment; and the medical, psycho-social, economic, legal, or other supportive services that a patient needs, conducted by qualified personnel) and HCPCS code G2077 (Periodic assessment; assessing periodically by qualified personnel to determine the most appropriate combination of services and treatment). The medical services described by these add-on codes can be furnished by a program physician, a primary care physician or an authorized healthcare professional under the supervision of a program physician or qualified personnel such as nurse practitioners (NPs) and physician assistants (PAs). The other assessments, including psychosocial assessments can be furnished by practitioners who are eligible to do so under state law and their scope of licensure. We noted that to bill for the add-on code, the services need to be medically reasonable and necessary and that OTPs should document the rationale for billing the add-on code in the patient's medical record (84 FR 62647).

We have received inquiries from stakeholders related to what activities would qualify to bill the add-on code for periodic assessments, HCPCS code G2077. In the CY 2020 PFS final rule (84 FR 62647), we noted that the add-on code describing periodic assessments can be billed for each periodic assessment performed for patients that require multiple assessments during an episode of care, such as patients who are pregnant or postpartum. We noted that in order to bill for the add-on code, the services would need to be medically reasonable and necessary and that OTPs should document the rationale for billing the add-on code in the patient's medical record. Based on our understanding of the typical resources costs involved in furnishing periodic assessments, we priced HCPCS code G2077 based on a crosswalk to a level 4 office/outpatient E/M visit. Consistent with our understanding of the expected acuity of patients with OUD receiving services at OTPs, including the likelihood of the patient having multiple co-morbidities and presenting with problems that are of moderate to high severity and requiring medical decision making of moderate complexity, as well as the associated payment rate assigned to this code, we believe it is important for the clinician to be able to visually assess the patient as part of any periodic assessment. Therefore, for CY 2021, we are proposing that in order to bill for HCPCS code G2077, a face-to-face medical exam or biopsychosocial assessment would need to have been performed. Accordingly, we are proposing to amend the definition of periodic assessment in § 410.67(b)(7) to Start Printed Page 50208provide that the definition is limited to a face-to-face encounter.

Additionally, we note that in the May 8th COVID-19 IFC, CMS revised § 410.67(b)(7) on an interim final basis to allow periodic assessments to be furnished during the PHE for the COVID-19 pandemic via two-way interactive audio-video communication technology and, in cases where beneficiaries do not have access to two-way audio-video communication technology, to permit the periodic assessments to be furnished using audio-only telephone calls rather than via two-way interactive audio-video communication technology, provided all other applicable requirements are met. We believe that allowing periodic assessments to be furnished via two-way interactive audio-video communication technology beyond the conclusion of the PHE for the COVID-19 pandemic would help to expand access to care for patients who may have a difficult time getting to the OTP in person. Therefore, in this proposed rule, we are proposing to revise § 410.67(b)(7) to allow periodic assessments to be furnished via two-way interactive audio-video communication technology, provided all other applicable requirements are met. We note that we are currently permitting the use of audio-only telephone calls to furnish these services during the PHE for the COVID-19 pandemic, because we believe it is important to maintain access to these services while the public is following infection control guidelines to stay at home and practice social distancing, and not all beneficiaries receiving OUD treatment services from OTPs may have access to interactive audio-video communication technology. However, we do not believe this flexibility will be needed in order to ensure access after the PHE ends. Therefore, under this proposal, the flexibility to use audio-only telephone services to furnish periodic assessments would not be permitted once the PHE for the COVID-19 pandemic has ended. We note that we would consider payment for any periodic assessment-related services furnished via audio-only telephone calls to be included in the bundled payment, but that audio-only telephone services would not qualify for billing HCPCS code G2077 after the end of the PHE for the COVID-19 pandemic. We are seeking input from the public on whether we should consider continuing to make add-on payments for audio-only periodic assessments furnished by OTPs after the conclusion of the PHE for the COVID-19 pandemic, and if so, whether the payment rate for audio-only services should reflect any differences in resource costs.

c. Date of Service

In the CY 2020 PFS final rule (84 FR 62641), we defined an episode of care as a 1-week (contiguous 7-day) period at § 410.67(b). We have received inquiries related to the date of service used on claims for the weekly bundles and add-on codes, particularly related to an approach that many providers informed us they use, which is to establish a “standard billing cycle” in which episodes of care for all patients at that OTP begin on the same day of the week. We do not believe that the definition of an episode of care that was finalized for CY 2020 precludes the use of a “standard billing cycle.” Therefore, OTPs may choose to apply a standard billing cycle by setting a particular day of the week to begin all episodes of care. In this case, the date of service would be the first day of the OTP's billing cycle. If a beneficiary starts treatment at the OTP on a day that is in the middle of the OTP's standard weekly billing cycle, the OTP may still bill the applicable code for that episode of care provided that the threshold to bill for the code has been met. Alternatively, OTPs may choose to adopt weekly billing cycles that vary across patients. Under this approach, the initial date of service will depend upon the day of the week when the patient was first admitted to the program or when Medicare billing began. Therefore, under this approach of adopting weekly billing cycles that vary across patients, when a patient is beginning treatment or re-starting treatment after a break in treatment, the date of service would reflect the first day the patient was seen and the date of service for subsequent consecutive episodes of care would be the first day after the previous 7-day period ends. For the codes describing add-on services (HCPCS codes G2076-G2080), the date of service should reflect the date that service was furnished; however, if the OTP has chosen to apply a standard weekly billing cycle, the date of service for codes describing add-on services may be the same as the first day in the weekly billing cycle.

We note that this approach is consistent with earlier guidance that was issued in the OTP Billing and Payment Fact sheet that is posted on the CMS OTP web page (https://www.cms.gov/​files/​document/​otp-billing-and-payment-fact-sheet.pdf).

d. Coding

We recognize the importance of allowing OTPs to become accustomed to billing Medicare using the coding that was established in the CY 2020 PFS final rule; however, we remain interested in refining the code set through future rulemaking, including stratifying the coding and associated payment amounts to account for significant differences in resource costs among patients, especially in relation to amounts of expected counseling. In the CY 2020 PFS final rule (84 FR 62645), we finalized an add-on code to describe an adjustment to the bundled payment when additional counseling or therapy services are furnished, HCPCS code G2080. This add-on code may be billed when counseling or therapy services are furnished that substantially exceed the amount specified in the patient's individualized treatment plan. We have received feedback from stakeholders noting a range of OTP attendance patterns that represent a continuum of care and service intensity, noting significant differences in services received during the induction phase versus the maintenance phase. We also understand that patients' needs for service may fluctuate over time, depending on a variety of factors and circumstances. We welcome comments on how we might better account for differences in resource costs among patients over the course of treatment. We will consider the comments received in developing any proposed refinements to our coding policies in future rulemaking.

5. Annual Updates

In the CY 2020 PFS final rule (84 FR 62667 through 62669), we finalized a policy under which the payment for the drug component of episodes of care will be determined using the most recent data available at the time of ratesetting for the applicable calendar year. The payment for the non-drug component of the bundled payment for OUD treatment services will be updated annually based upon the Medicare Economic Index. The list of the payment rates for OUD treatment services furnished by OTPs, with the annual update applied for CY 2021, is available in the file called CY 2021 OTP Proposed Payment Rates on the CMS website under downloads for the CY 2021 PFS proposed rule at http://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​PhysicianFeeSched/​PFSFederal-Regulation-Notices.html. Additionally, we note that the current rates, as finalized in the CY 2020 PFS final rule, both with and without locality adjustments, can be found on the CMS OTP web page under Billing and Payment at https://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Start Printed Page 50209Payment/​Opioid-Treatment-Program/​billing-payment.

III. Other Provisions of the Proposed Rule

A. Clinical Laboratory Fee Schedule: Revised Data Reporting Period and Phase-in of Payment Reductions, and a Comment Solicitation on Payment for Specimen Collection for Covid-19 Tests

1. Background on the Clinical Laboratory Fee Schedule

Prior to January 1, 2018, Medicare paid for clinical diagnostic laboratory tests (CDLTs) on the Clinical Laboratory Fee Schedule (CLFS), with certain exceptions, under section 1833(a), (b), and (h) of the Act. Under the previous payment system, CDLTs were paid based on the lesser of: (1) The amount billed; (2) the local fee schedule amount established by the Medicare Administrative Contractor (MAC); or (3) a national limitation amount (NLA), which is a percentage of the median of all the local fee schedule amounts (or 100 percent of the median for new tests furnished on or after January 1, 2001). In practice, most tests were paid at the NLA. Under the previous payment system, the CLFS amounts were updated for inflation based on the percentage change in the Consumer Price Index for All Urban Consumers (CPI-U), and reduced by a multi-factor productivity adjustment and other statutory adjustments, but were not otherwise updated or changed. Coinsurance and deductibles generally do not apply to CDLTs paid under the CLFS.

Section 1834A of the Act, as established by section 216(a) of the Protecting Access to Medicare Act of 2014 (PAMA), required significant changes to how Medicare pays for CDLTs under the CLFS. In the June 23, 2016 Federal Register (81 FR 41036), we published a final rule entitled Medicare Clinical Diagnostic Laboratory Tests Payment System (CLFS final rule), that implemented section 1834A of the Act at 42 CFR part 414, subpart G.

Under the CLFS final rule, “reporting entities” must report to CMS during a “data reporting period” “applicable information” collected during a “data collection period” for their component “applicable laboratories.” The first data collection period occurred from January 1, 2016 through June 30, 2016. The first data reporting period occurred from January 1, 2017 through March 31, 2017. On March 30, 2017, we announced a 60-day period of enforcement discretion for the application of the Secretary's potential assessment of Civil Monetary Penalties (CMPs) for failure to report applicable information with respect to the initial data reporting period. This announcement is available on the CMS website at https://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​ClinicalLabFeeSched/​Downloads/​2017-March-Announcement.pdf.

In the CY 2018 PFS proposed rule (82 FR 34089 through 34090), we solicited public comments from applicable laboratories and reporting entities to better understand the applicable laboratories' experiences with data reporting, data collection, and other compliance requirements for the first data collection and reporting periods. We discussed these comments in the CY 2018 PFS final rule (82 FR 53181 through 53182) and stated that we would consider the comments for potential future rulemaking or guidance.

As part of the CY 2019 Medicare PFS rulemaking, we finalized two changes to the definition of “applicable laboratory” at § 414.502 (see 83 FR 59667 through 59681, 60074; 83 FR 35849 through 35850; 83 FR 35855 through 35862). First, we excluded Medicare Advantage (MA) plan payments under Part C from the denominator of the Medicare revenues threshold calculation, in an effort to broaden the types of laboratories qualifying as an applicable laboratory. Specifically, excluding MA plan payments could allow additional laboratories of all types serving a significant population of beneficiaries enrolled in Medicare Part C to meet the majority of Medicare revenues threshold and potentially qualify as an applicable laboratory (if they also meet the low expenditure threshold) and report data to CMS during the data reporting period. Because MA plan payments are now excluded from the total Medicare revenues calculation, the denominator amount (total Medicare revenues) would decrease. If the denominator amount decreases, the likelihood increases that a laboratory would qualify as an applicable laboratory. This is because the laboratory's PFS and CLFS revenues are being compared to a lower total Medicare payment amount (than what they would have been compared to if MA plan payments remained in the denominator). Second, consistent with our goal of obtaining a broader representation of laboratories that could potentially qualify as an applicable laboratory and report data we also amended the definition of applicable laboratory to include hospital outreach laboratories that bill Medicare Part B using the CMS-1450 14x Type of Bill.

2. Payment Requirements for Clinical Diagnostic Laboratory Tests

In general, under section 1834A of the Act, the payment amount for each CDLT on the CLFS furnished beginning January 1, 2018, is based on the applicable information collected during the data collection period and reported to CMS during the data reporting period, and is equal to the weighted median of the private payor rates for the test. The weighted median is calculated by arraying the distribution of all private payor rates, weighted by the volume for each payor and each laboratory. The payment amounts established under the CLFS are not subject to any other adjustment, such as geographic, budget neutrality, or annual update, as required by section 1834A(b)(4)(B) of the Act. Additionally, section 1834A(b)(3) of the Act, implemented at § 414.507(d), provides for a phase-in of payment reductions, limiting the amounts the CLFS rates for each CDLT (that is not a new advanced diagnostic laboratory test (ADLT) or new CDLT) can be reduced as compared to the payment rates for the preceding year. Under the provisions enacted by section 216(a) of PAMA, for the first 3 years after implementation (CY 2018 through CY 2020), the reduction cannot be more than 10 percent per year, and for the next 3 years (CY 2021 through CY 2023), the reduction cannot be more than 15 percent per year. Under section 1834A(a)(1) and (b) of the Act, as enacted by PAMA, for CDLTs that are not ADLTs, the data collection period, data reporting period, and payment rate update occur every 3 years. As such, the second data collection period for CDLTs that are not ADLTs occurred from January 1, 2019 through June 30, 2019, and the next data reporting period was scheduled to take place from January 1, 2020 through March 31, 2020, with the next update to the Medicare payment rates for these tests based on that reported applicable information scheduled to take effect as of January 1, 2021.

Section 216(a) of PAMA established a new subcategory of CDLTs known as ADLTs, with separate reporting and payment requirements under section 1834A of the Act. As defined in § 414.502, an ADLT is a CDLT covered under Medicare Part B that is offered and furnished only by a single laboratory, and cannot be sold for use by a laboratory other than the single laboratory that designed the test or a successor owner. Also, an ADLT must meet either Criterion (A), which implements section 1834A(d)(5)(A) of the Act, or Criterion (B), which Start Printed Page 50210implements section 1834A(d)(5)(B) of the Act, as follows:

  • Criterion (A): The test is an analysis of multiple biomarkers of deoxyribonucleic acid (DNA), ribonucleic acid (RNA), or proteins; when combined with an empirically derived algorithm, yields a result that predicts the probability a specific individual patient will develop a certain condition(s) or respond to a particular therapy(ies); provides new clinical diagnostic information that cannot be obtained from any other test or combination of tests; and may include other assays; or:
  • Criterion (B): The test is cleared or approved by FDA.

Generally, under section 1834A(d) of the Act, the Medicare payment rate for a new ADLT is equal to its actual list charge during an initial period of 3 calendar quarters. After the new ADLT initial period, ADLTs are paid using the same methodology based on the weighted median of private payor rates as other CDLTs. However, under section 1834A(d)(3) of the Act, updates to the Medicare payment rates for ADLTs occur annually instead of every 3 years.

Additional information on the private payor rate-based CLFS is detailed in the CLFS final rule (81 FR 41036 through 41101) and is available on the CMS website at https://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​ClinicalLabFeeSched/​PAMA-regulations.html.

3. Statutory Revisions to the Data Reporting Period and Phase-In of Payment Reductions

Section 105(a) of the Further Consolidated Appropriations Act, 2020 (FCAA) (Pub. L. 116-94, enacted on December 20, 2019), and section 3718 of the Coronavirus Aid, Relief, and Economic Security Act, 2020 (CARES Act) (Pub. L. 116-136, enacted on March 27, 2020), made revisions to the CLFS requirements for the next data reporting period for CDLTs that are not ADLTs under section 1834A of the Act. Additionally, the CARES Act made revisions to the phase-in of payment reductions under section 1834A of the Act. Specifically, section 105(a)(1) of the FCAA amended the data reporting requirements in section 1834A(a) of the Act to delay the next data reporting period for CDLTs that are not ADLTs by 1 year, so that data reporting would be required during the period of January 1, 2021 through March 31, 2021; the 3-year data reporting cycle for CDLTs that are not ADLTs would resume after that data reporting period. Section 105(a)(1) of the FCAA also specified that the data collection period that applies to the data reporting period of January 1, 2021 through March 30, 2021 would be the period of January 1, 2019 through June 30, 2019, which is the same data collection period that would have applied absent the amendments. In addition, section 105(a)(2) of the FCAA amended section 1834A(b)(3) of the Act regarding the phase-in of payment reductions to provide that payments may not be reduced by more than 10 percent as compared to the amount established for the preceding year through CY 2020, and for CYs 2021 through 2023, payment may not be reduced by more than 15 percent as compared to the amount established for the preceding year. These statutory changes were consistent with our regulations implementing the private payor rate-based CLFS (81 FR 41036; § 414.507(d)).

Subsequently, section 3718 of the CARES Act further amended the data reporting requirements for CDLTs that are not ADLTs and the phase-in of payment reductions under the CLFS. Specifically, section 3718(a) of the CARES Act amended section 1834A(a)(1)(B) of the Act to delay the next data reporting period for CDLTs that are not ADLTs by one additional year, to require data reporting during the period of January 1, 2022 through March 31, 2022. As amended by the CARES Act, section 1834A(a)(1)(B) of the Act now provides that in the case of reporting with respect to CDLTs that are not ADLTs, the Secretary shall revise the reporting period under subparagraph (A) such that—(i) no reporting is required during the period beginning January 1, 2020, and ending December 31, 2021; (ii) reporting is required during the period beginning January 1, 2022, and ending March 31, 2022; and (iii) reporting is required every 3 years after the period described in clause (ii).

The CARES Act does not modify the data collection period that applies to the next data reporting period for these tests. Thus, under section 1834A(a)(4)(B) of the Act, as amended by section 105(a)(1) of the FCAA, the next data reporting period for CDLTs that are not ADLTs (January 1, 2022 through March 31, 2022) will be based on the data collection period of January 1, 2019 through June 30, 2019. In § 414.502, the current definition of data collection period is defined as the 6 months from January 1 through June 30 during which applicable information is collected and that precedes the data reporting period. Additionally, in § 414.502 the data reporting period is defined as the 3-month period, January 1 through March 31, during which a reporting entity reports applicable information to CMS and that follows the preceding data collection period. Unless we revise our current definitions of data collection period and data reporting period, the definitions will be incorrect with regard to the data collection period that applies to the next data reporting period. Therefore, in section III.A.4. of this proposed rule, “Proposed Conforming Regulatory Changes,” we are proposing to revise the definitions of data collection period and data reporting period in § 414.502 to reflect that the data collection period will be January 1, 2019 through June 30, 2019 for the data reporting period of January 1, 2022 through March 31, 2022.

Section 3718(b) of the CARES Act further amends the provisions in section 1834A(b)(3) of the Act regarding the phase-in of payment reductions under the CLFS. First, it extends the statutory phase-in of payment reductions resulting from private payor rate implementation by an additional year, that is, through CY 2024. It further amends section 1834A(b)(3)(B)(ii) of the Act to specify that the applicable percent for CY 2021 is 0 percent, meaning that the payment amount determined for a CDLT for CY 2021 shall not result in any reduction in payment as compared to the payment amount for that test for CY 2020. Section 3718(b) of the CARES Act further amends section 1834A(b)(3)(B)(iii) of the Act to state that the applicable percent of 15 percent will apply for CYs 2022 through 2024, instead of CYs 2021 through 2023.

4. Proposed Conforming Regulatory Changes

In accordance with section 105(a) of the FCAA and section 3718 of the CARES Act, we are proposing to make certain conforming changes to the data reporting and payment requirements at 42 CFR part 414, subpart G. Specifically, we are proposing to revise § 414.502 to update the definitions of both the data collection period and data reporting period, specifying that for the data reporting period of January 1, 2022 through March 31, 2022, the data collection period is January 1, 2019 through June 30, 2019. We are also proposing to revise § 414.504(a)(1) to indicate that initially, data reporting begins January 1, 2017 and is required every 3 years beginning January 2022. In addition, we are proposing to make conforming changes to our requirements for the phase-in of payment reductions to reflect the CARES Act amendments. Specifically, we are proposing to revise § 414.507(d) to indicate that for CY 2021, payment may not be reduced by Start Printed Page 50211more than 0.0 percent as compared to the amount established for CY 2020, and for CYs 2022 through 2024, payment may not be reduced by more than 15 percent as compared to the amount established for the preceding year.

5. Comment Solicitation on Payment for Specimen Collection for COVID-19 Clinical Diagnostic Tests

In the “Medicare and Medicaid Programs; Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency” interim final with comment period (IFC) (85 FR 19256 through 19258), which published in the April 6, 2020 Federal Register, we established that Medicare will pay a nominal specimen collection fee and associated travel allowance to independent laboratories for the collection of specimens for COVID-19 clinical diagnostic laboratory testing for homebound and non-hospital inpatients. This policy provides independent laboratories with additional resources to provide COVID-19 testing and helps with efforts to limit patients' exposure to the general population and alleviate patients' unease with leaving the home. To identify specimen collection for COVID-19 testing specifically, we established two new level II HCPCS codes, Code G2023 (specimen collection for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]), any specimen source); and G2024 (specimen collection for severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2) (Coronavirus disease [COVID-19]), from an individual in a SNF or by a laboratory on behalf of a HHA, any specimen source), for independent laboratories to use when billing Medicare for the nominal specimen collection fee for COVID-19 testing for the duration of the COVID-19 PHE.

We indicated in the April 6, 2020 IFC that this specimen collection fee policy was established for the duration of the Public Health Emergency (PHE) for the COVID-19 pandemic (85 FR 19256). We are requesting comments on whether we should delete HCPCS Codes G2023 and G2024 once the COVID-19 PHE ends. Comments received may inform a future proposal. Specifically, we are seeking public input on why these codes, and their corresponding payment amounts, which are higher than the nominal fees for specimen collection for other conditions, would be necessary or useful outside of the context of the PHE. We are particularly interested in why separate, increased payment for specimen collection specifically for COVID-19 tests, in contrast to other tests, might be needed following the end of the PHE.

B. OTP Provider Enrollment Regulation Updates for Institutional Claim Submissions

1. Modifications to OTP Enrollment Process

a. Background

Under 42 CFR 424.510, a provider or supplier must complete, sign, and submit to its assigned Medicare Administrative Contractor (MAC) the Form CMS-855 (OMB Control No. 0938-0685) application to enroll in the Medicare program and obtain Medicare billing privileges. The Form CMS-855, which can be submitted via paper or electronically through the internet-based Provider Enrollment, Chain, and Ownership System (PECOS) process (SORN: 09-70-0532, Provider Enrollment, Chain, and Ownership System), captures information about the provider or supplier that CMS or its MACs reviews and verifies to determine whether the provider or supplier meets all Medicare requirements. (The specific Form CMS-855 application (of which there are several variations) to be completed will depend upon the type of provider or supplier submitting said application.) This process of enrollment helps ensure that: (1) All prospective providers and suppliers are carefully screened and vetted; and (2) unqualified providers and suppliers are kept out of the Medicare program, which helps protect the Trust Funds and Medicare beneficiaries. Indeed, without this process, billions of taxpayer dollars might be paid to fraudulent or otherwise non-compliant parties.

b. Completion of Form CMS-855

Existing § 424.67 outlines a number of enrollment requirements for OTPs. One requirement, addressed in § 424.67(b)(1), is that OTPs must complete the Form CMS-855B application (Medicare Enrollment Application: Clinics/Group Practices and Certain Other Suppliers; OMB #0938-0685) to enroll in Medicare. The reference to the Form CMS-855B in § 424.67(b)(1) was predicated in part on the assumption that OTPs would generally submit the CMS-1500 claim form (Health Insurance Claim Form; OMB Control No.: 0938-1197) to receive payment for their services. However, as mentioned previously in section II.I.4. of this proposed rule, we have received requests to allow OTPs to bill for services on an institutional claim form (specifically, the 837I). To do so, these OTPs would have to enroll in Medicare via the Form CMS-855A (Medicare Enrollment Application for Institutional Providers (OMB #0938-0685)). To account for circumstances where an OTP wishes to pursue Form CMS-855A enrollment for the reason stated above, we propose the following revisions to § 424.67:

  • Current § 424.67(b)(1) states that a newly enrolling OTP must fully complete and submit the Form CMS-855B application (or its successor application). We propose to revise this paragraph to state that the newly enrolling OTP must fully complete and submit, as applicable, the Form CMS-855A or Form CMS-855B application (or their successor applications).
  • Existing § 424.67(b)(1)(ii) requires the OTP to certify compliance with the requirements and standards described in paragraphs § 424.67(b) and (d) via the Form CMS-855B and/or the applicable supplement or attachment thereto. We propose to revise this paragraph such that the OTP must certify compliance with the above-referenced requirements and standards via the Form CMS-855A or Form CMS-855B (as applicable) and/or the applicable supplement or attachment thereto.
  • Existing § 424.67(b)(5) requires the OTP to report on the Form CMS-855B and/or any applicable supplement all OTP staff who meet the definition of “managing employee” in § 424.502. We propose to change this to state that the OTP must report on the Form CMS-855A or Form CMS-855B (as applicable) and/or any applicable supplement all OTP staff who meet the said definition.

We believe these revisions would accomplish two objectives. First, they would permit OTPs to submit a Form CMS-855A in lieu of a Form CMS-855B based on their preferred method of billing. Second, they would confirm that the requirements of § 424.67 apply to all OTPs regardless of whether they complete the Form CMS-855A or the Form CMS-855B.

c. Screening Activities Associated With Risk Designation

Section 424.518 outlines provider enrollment screening categories and requirements based on our assessment of the degree of risk of fraud, waste, and abuse posed by a particular category of provider or supplier. In general, the higher the level of risk that a certain provider or supplier type presents, the greater the degree of scrutiny with which we will screen and review enrollment applications submitted by providers or suppliers within that category. There are three levels of screening addressed in § 424.518: Limited; moderate; and high. Start Printed Page 50212Irrespective of which level a provider or supplier type falls within, the MAC performs certain minimum screening functions upon receipt of an initial enrollment application, a revalidation application, or an application to add a new practice location. These include:

  • Verification that the provider or supplier meets all applicable federal regulations and state requirements for their provider or supplier type.
  • State license verifications.
  • Database reviews on a pre- and post-enrollment basis to ensure that providers and suppliers continue to meet the enrollment criteria for their provider or supplier type.

Providers and suppliers at the moderate and high categorical risk levels must also undergo a site visit. Moreover, for those in the high categorical risk level, the MAC performs two additional functions under § 424.518(c)(2). First, the MAC requires the submission of a set of fingerprints for a national background check from all individuals who maintain a 5 percent or greater direct or indirect ownership interest in the provider or supplier. Second, it conducts a fingerprint-based criminal history record check of the Federal Bureau of Investigation's (FBI) Integrated Automated Fingerprint Identification System on all individuals who maintain a 5 percent or greater direct or indirect ownership interest in the provider or supplier. These additional verification activities are intended to correspond to the heightened risk involved with such provider or supplier types.

For newly enrolling OTPs, those that have been fully and continuously certified by the Substance Abuse and Mental Health Services Administration (SAMHSA) since October 23, 2018 fall within the moderate level of categorical screening. OTPs that have not been so certified since the aforementioned date are subject to the high screening level. We recognize that certain providers and suppliers have already enrolled as OTPs via the Form CMS-855B—and, accordingly, undergone a site visit and, if applicable, fingerprinting—but would seek to newly enroll via the Form CMS-855A should our proposals be finalized. (Said enrollment would be considered “new” for purposes of enrollment because the OTP would be enrolling via a different variation of the Form CMS-855.) While not seeking to minimize the importance of the enhanced screening activities associated with the moderate and high categorical levels, we do not wish to unduly burden currently enrolled OTPs that would pursue Form CMS-855A enrollment as an OTP. More specifically, we do not believe such OTPs should have to undergo another site visit and, if applicable, fingerprinting when they previously did so as an OTP via their original Form CMS-855B enrollment. This, in our view, would constitute an unnecessary expenditure of CMS, MAC, and OTP resources. We add that the same would hold true if, in the future, an OTP that is enrolled via the Form CMS-855A under revised § 424.67(b) decides to change to a Form CMS-855B enrollment. In both cases, we believe a duplication of effort should be avoided to the extent consistent with safeguarding the integrity of the Medicare program.

Existing § 424.67(b)(3) states that an enrolling OTP must successfully complete the assigned categorical risk level screening required under, as applicable, § 424.518(b) and (c) (which outline the screening requirements for newly enrolling parties in, respectively, the moderate and high categorical levels). Given the foregoing discussion, we propose several changes to § 424.67(b)(3). First, we would re-designate existing § 424.67(b)(3) as new § 424.67(b)(3)(i), though with an exception to its requirements. Second, new paragraph (b)(3)(ii) (which would address this exception) would state that currently enrolled OTPs that are changing their OTP enrollment from a Form CMS-855B to a Form CMS-855A, or vice versa, must successfully complete the limited level of categorical screening under § 424.518(a) if the OTP has already completed, as applicable, the moderate or high level of categorical screening under § 424.518(b) or (c), respectively. Third, we propose to redesignate existing § 424.518(a)(1)(xii) through (xvii) as § 424.518(a)(1)(xiii) through (xviii). Fourth, new § 424.518(a)(1)(xii) would add OTPs that fall within the purview of new paragraph (b)(3)(ii) to the provider and supplier types subject to limited risk categorical screening.

d. Additional OTP Enrollment Clarifications Regarding the Form CMS-855A

We propose three additional clarifications related to our previously mentioned OTP enrollment provisions. To incorporate these into § 424.67, we would redesignate existing paragraphs (c), (d), (e), and (f) as paragraphs (d), (e), (f), and (g), respectively. The three clarifications would be included in new paragraph (c).

With the redesignation of existing paragraph (d) as paragraph (e), we also propose to change the reference to:

  • Paragraph (d) in existing paragraph (b)(1)(ii) to paragraph (e).
  • Paragraph (d)(1) in existing paragraph (d)(2)(i) to paragraph (e)(1) in redesignated paragraph (e)(2)(i).)

(1) Single Enrollment

We propose in new § 424.67(c)(1) that an OTP may only be enrolled as such via the Form CMS-855A or the Form CMS-855B but not both. The OTP, in other words, must opt for either Form CMS-855A enrollment or Form CMS-855B enrollment. This is to help ensure that the OTP does not bill twice for the same service via separate claim vehicles (specifically, the CMS-1500 and the 837I).

(2) Effective Date of Billing

Section 424.520(d) outlines the effective date of billing privileges for newly enrolling OTPs (and certain other provider and supplier types). This date is the later of: (1) The date of the OTP's filing of a Medicare enrollment application that was subsequently approved by a Medicare contractor; or (2) the date that the OTP first began furnishing services at a new practice location. In a similar vein, § 424.521(a) states that OTPs (and certain other provider and supplier types) may retrospectively bill for services when the OTP has met all program requirements (including state licensure requirements), and services were provided at the enrolled practice location for up to—

  • 30 days prior to their effective date if circumstances precluded enrollment in advance of providing services to Medicare beneficiaries; or
  • 90 days prior to their effective date if a Presidentially-declared disaster under the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121 through 5206 (Stafford Act) precluded enrollment in advance of providing services to Medicare beneficiaries.

In light of proposed § 424.67(c)(1) (and as further explained in the collection of information section of this proposed rule), we anticipate that a number of OTPs would end their existing enrollment and apply as a new OTP via, as applicable, the Form CMS-855A or Form CMS-855B. Given this, we believe it is important to clarify for stakeholders the new enrollment's effective date of billing. Accordingly, at § 424.67, we propose in new paragraph (c)(2) that if a Form CMS-855B-enrolled OTP changes to a Form CMS-855A enrollment, or vice versa, the effective date of billing that was established for the OTP's prior enrollment under §§ 424.520(d) and 424.521(a) would be applied to the OTP's new enrollment. This would allow OTPs that have been Start Printed Page 50213unable to bill for furnished services via their preferred claim form (and have consequently chosen to delay the submission of these claims for services) to do so retroactive to the effective billing date of its prior enrollment. To illustrate, suppose an OTP initially enrolled via the Form CMS-855B in 2020. The effective date of billing was Apr