Skip to Content

We invite you to try out our new beta eCFR site at https://ecfr.federalregister.gov. We’ve made big changes to make the eCFR easier to use. Be sure to leave feedback using the 'Feedback' button on the bottom right of each page!

Proposed Rule

Medicare Program; CY 2022 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment Policies; Medicare Shared Savings Program Requirements; Provider Enrollment Regulation Updates; Provider and Supplier Prepayment and Post-Payment Medical Review Requirements.

This document has a comment period that ends in 49 days. (09/13/2021) Submit a formal comment

Thank you for taking the time to create a comment. Your input is important.

Once you have filled in the required fields below you can preview and/or submit your comment to the Health and Human Services Department for review. All comments are considered public and will be posted online once the Health and Human Services Department has reviewed them.

You can view alternative ways to comment or you may also comment via Regulations.gov at, https://www.regulations.gov/commenton/CMS-2021-0119-0053.

  1. Note: You can attach your comment as a file and/or attach supporting documents to your comment. Attachment Requirements.


  2. this will NOT be posted on regulations.gov


  3. An Individual

    An Organization

    Anonymous




  1. Preview Comment
Please review the Regulations.gov privacy notice and user notice .
Document Details

Information about this document as published in the Federal Register.

Document Statistics
Document page views are updated periodically throughout the day and are cumulative counts for this document. Counts are subject to sampling, reprocessing and revision (up or down) throughout the day.
Enhanced Content

Relevant information about this document from Regulations.gov provides additional context. This information is not part of the official Federal Register document.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Start Preamble Start Printed Page 39104

AGENCY:

Centers for Medicare & Medicaid Services (CMS), Health and Human Services (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; updates to the Quality Payment Program; Medicare coverage of opioid use disorder services furnished by opioid treatment programs; updates to certain Medicare provider enrollment policies; requirements for prepayment and post-payment medical review activities; requirement for electronic prescribing for controlled substances for a covered Part D drug under a prescription drug plan, or a Medicare Advantage Prescription Drug (MA-PD) plan; updates to the Medicare Ground Ambulance Data Collection System; changes to the Medicare Diabetes Prevention Program (MDPP) expanded model; and amendments to the physician self-referral law regulations.

DATES:

To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on September 13, 2021.

ADDRESSES:

In commenting, please refer to file code CMS-1751-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-1751-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-1751-P, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.

Start Further Info

FOR FURTHER INFORMATION CONTACT:

DivisionofPractitionerServices@cms.hhs.gov, for any issues not identified below.

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

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

Donta Henson, (410) 786-1947, Patrick Sartini, (410) 786-9252, and Larry Chan, (410) 786-6864, for issues related to telehealth services and other services involving communications technology.

Julie Adams, (410) 786-8932, for issues related to payment for anesthesia services.

Sarah Leipnik, (410) 786-3933, for issues related to split (or shared) services.

Christiane LaBonte, (410) 786-7237, for issues related to indirect practice expense, PFS payment for critical care services, and PFS payment for teaching physician services.

DivisionofPractitionerServices@cms.hhs.gov, for issues related to payment for vaccine administration services.

Regina Walker-Wren, (410) 786-9160, for issues related to billing for services of physician assistants.

Pamela West, (410) 786-2302, for issues related to PFS payment for therapy services, medical nutrition therapy services, and services of registered dieticians and nutrition professionals.

Liane Grayson, (410) 786-6583, and Donta Henson, (410) 786-1947, for issues related to coinsurance for certain colorectal cancer screening services.

Lisa Parker, (410) 786-4949, for issues related to RHCs and FQHCs.

Laura Kennedy, (410) 786-3377, for issues related to drugs payable under Part B.

Heather Hostetler, (410) 786-4515, and Elizabeth Truong, 410-786-6005, for issues related to removal of select national coverage determinations.

Sarah Fulton, (410) 786-2749, for issues related to Appropriate Use Criteria for Advanced Diagnostic Imaging (AUC); and Pulmonary Rehabilitation, Cardiac Rehabilitation and Intensive Cardiac Rehabilitation.

Rachel Katonak, (410) 786-8564, for issues related to Medical Nutrition Therapy.

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, repayment mechanism requirements, and benchmarking methodology.

Naseem Tarmohamed, (410) 786-0814, or SharedSavingsProgram@cms.hhs.gov, for inquiries related to Shared Savings Program application, compliance and beneficiary notification requirements.

Amy Gruber, AmbulanceDataCollection@cms.hhs.gov, for issues related to the Medicare Ground Ambulance Data Collection System.

Juliana Tiongson, (410) 786-0342, for issues related to the Medicare Diabetes Prevention Program (MDPP).

Laura Ashbaugh, (410) 786-1113, for issues related to Clinical Laboratory Fee Schedule: Laboratory Specimen Collection and Travel Allowance and Use of Electronic Travel Logs.

Frank Whelan, (410) 786-1302, for issues related to Medicare provider enrollment regulation updates.

Thomas J. Kessler, (410) 786-1991, for issues related to provider and supplier prepayment and post-payment medical review requirements.

Lindsey Baldwin, (410) 786-1694, and Michele Franklin, (410) 786-9226, for issues related to Medicare coverage of opioid use disorder treatment services furnished by opioid treatment programs.

Lisa O. Wilson, (410) 786-8852, or Meredith Larson, (410) 786-7923, for inquiries related to the physician self-referral law.

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.

Kathleen Ott, (410) 786-4246, for issues related to open payments.Start Printed Page 39105

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://www.regulations.gov. Follow the search instructions on that website to view public comments. CMS will not post on Regulations.gov public comments that make threats to individuals or institutions or suggest that the individual will take actions to harm the individual. CMS continues to encourage individuals not to submit duplicative comments. We will post acceptable comments from multiple unique commenters even if the content is identical or nearly identical to other 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 2022 PFS proposed rule, refer to item CMS-1751-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 DivisionofPractitionerServices@cms.hhs.gov.

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 2020 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

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 Consolidated Appropriations Act, 2021 (CAA, 2021) (Pub. L. 116-260, December 27, 2020), 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 major proposed rule includes proposals regarding other Medicare payment policies described in sections III. and IV.

A. 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 each year by regulation the payment amounts for physicians' services paid under the PFS, including 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 2022 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.)
  • Valuation of Specific Codes (section II.E.)
  • Evaluation and Management Visits (section II.F.)
  • Billing for Physician Assistant Services (section II.G.)
  • Therapy Services (section II.H.)
  • Changes to Beneficiary Coinsurance for Additional Procedures Furnished During the Same Clinical Encounter as Certain Colorectal Cancer Screening Tests (section II.I.)
  • Vaccine Administration Services (section II.J.)
  • Payment for Medical Nutrition Therapy Services and Related Services (section II.K.)
  • Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs) (sections III.A., III.B., and III.C.)
  • Requiring Certain Manufacturers to Report Drug Pricing Information for Part B and Determination of ASP for Certain Self-administered Drug Products (sections III.D.1. and 2.)
  • Medicare Part B Drug Payment for Drugs Approved under Section 505(b)(2) of the Federal Food, Drug, & Cosmetic Act (section III.E.)
  • Appropriate Use Criteria for Advanced Diagnostic Imaging (section III.F.)
  • Removal of Select National Coverage Determinations (section III.G.)
  • Pulmonary Rehabilitation, Cardiac Rehabilitation and Intensive Cardiac Rehabilitation (section III.H.)
  • Medical Nutrition Therapy (section III.I.)
  • Medicare Shared Savings Program (section III.J.)
  • Medicare Ground Ambulance Data Collection System (section III.K.)
  • Medicare Diabetes Prevention Program (MDPP) (section III.L.)
  • Clinical Laboratory Fee Schedule: Laboratory Specimen Collection and Travel Allowance for Clinical Diagnostic Laboratory Tests and Use of Electronic Travel Logs (section III.M.)
  • Medicare Provider and Supplier Enrollment Changes (section III.N.1.)
  • Provider/Supplier Medical Review Requirements: Addition of Provider/Supplier Requirements related to Prepayment and Post-payment Reviews (section III.N.2.)
  • Modifications Related to Medicare Coverage for Opioid Use Disorder (OUD) Treatment Services Furnished by Opioid Treatment Programs (OTPs) (section III.O.)
  • Updates to the Physician Self-Referral Regulations (section III.P.)
  • Requirement for Electronic Prescribing for Controlled Substances for a Covered Part D Drug under a Prescription Drug Plan or an MA-PD Plan (section 2003 of the SUPPORT Act) (section III.Q.)
  • Open Payments (section III.R.)
  • Updates to the Quality Payment Program (section IV.)
  • Collection of Information Requirements (section V.)
  • Response to Comments (section VI.)
  • Regulatory Impact Analysis (section VII.)Start Printed Page 39106

3. 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 VII., Regulatory Impact Analysis, of this proposed rule.

II. Provisions of the Proposed Rule for the PFS

A. Background

Since January 1, 1992, Medicare has paid for physicians' services under section 1848 of the Social Security Act (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 (OBRA '89) (Pub. L. 101-239, December 19, 1989), and the Omnibus Budget Reconciliation Act of 1990 (OBRA '90) (Pub. L. 101-508, November 5, 1990). 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, 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 (BBA `97) (Pub. L. 105-33, August 5, 1997) 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 (BBRA) (Pub. L. 106-113, November 29, 1999) directed the Secretary of Health and Human Services (the Secretary) to establish a process under which we accept and use, to the maximum extent practicable and consistent with sound data practices, data collected or developed by entities and organizations to supplement the data we normally collect in determining the PE component. On May 3, 2000, we published the interim final rule (65 FR 25664) that set forth the criteria for the submission of these supplemental PE survey data. The criteria were modified in response to comments received, and published in the Federal Register (65 FR 65376) as part of a November 1, 2000 final rule. The PFS final rules published in 2001 and 2003, respectively, (66 FR 55246 and 68 FR 63196) extended the period during which we would accept these supplemental data through March 1, 2005.

In the CY 2007 PFS final rule with comment period (71 FR 69624), we revised the methodology for calculating direct PE RVUs from the top-down to the bottom-up methodology beginning in CY 2007. We adopted a 4-year transition to the new PE RVUs. This transition was completed for CY 2010. In the CY 2010 PFS final rule with Start Printed Page 39107comment 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 from one another. 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 will 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 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).

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, Start Printed Page 39108nationally 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 2022 PFS proposed rule PE/HR” on the CMS website under downloads for the CY 2022 PFS proposed rule at http://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​PhysicianFeeSched/​PFS-Federal-Regulation-Notices.html.

For CY 2022, we have incorporated the available utilization data for two new specialties, each of which became a recognized Medicare specialty during 2020. These specialties are Micrographic Dermatologic Surgery (MDS) and Adult Congenital Heart Disease (ACHD). We are proposing to use proxy PE/HR values for these new specialties, as there are no PPIS data for these specialties, by crosswalking the PE/HR as follows from specialties that furnish similar services in the Medicare claims data:

  • Micrographic Dermatologic Surgery (MDS) from Dermatology; and
  • Adult Congenital Heart Disease (ACHD from Cardiology.

These updates are reflected in the “CY 2022 PFS proposed rule PE/HR” file available on the CMS website under the supporting data files for the CY 2022 PFS proposed rule at http://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​PhysicianFeeSched/​PFS-Federal-Regulation-Notices.html.

c. Allocation of PE to Services

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

(1) Direct Costs

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

(2) Indirect Costs

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

  • For a given service, we use the direct portion of the PE RVUs calculated as previously described and the average percentage that direct costs represent of total costs (based on survey data) across the specialties that furnish the service to determine an initial indirect allocator. That is, the initial indirect allocator is calculated so that the direct costs equal the average percentage of direct costs of those specialties furnishing the service. For example, if the direct portion of the PE RVUs for a given service is 2.00 and direct costs, on average, represent 25 percent of total costs for the specialties that furnish the service, the initial indirect allocator would be calculated so that it equals 75 percent of the total PE RVUs. Thus, in this example, the initial indirect allocator would equal 6.00, resulting in a total PE RVU of 8.00 (2.00 is 25 percent of 8.00 and 6.00 is 75 percent of 8.00).
  • Next, we add the greater of the work RVUs or clinical labor portion of the direct portion of the PE RVUs to this initial indirect allocator. In our example, if this service had a work RVU of 4.00 and the clinical labor portion of the direct PE RVU was 1.50, we would add 4.00 (since the 4.00 work RVUs are greater than the 1.50 clinical labor portion) to the initial indirect allocator of 6.00 to get an indirect allocator of 10.00. In the absence of any further use of the survey data, the relative relationship between the indirect cost portions of the PE RVUs for any two services would be determined by the relative relationship between these indirect cost allocators. For example, if one service had an indirect cost allocator of 10.00 and another service had an indirect cost allocator of 5.00, Start Printed Page 39109the 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 2022 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 use the expected specialty that we identify on a list developed based on medical review and input from expert stakeholders. We display this list of expected specialty assignments as part of the annual set of data files we make available as part of notice and comment rulemaking and consider recommendations from the RUC and other stakeholders on changes to this list on an annual basis. Services for which the specialty is automatically assigned based on previously finalized policies under our established methodology (for example, “always therapy” services) are unaffected by the list of expected specialty assignments. We also finalized in the CY 2018 PFS final rule (82 FR 52982 through 59283) a policy to apply these service-level overrides for both PE and MP, rather than one or the other category.

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 Start Printed Page 39110allocator 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 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 final 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.
Start Printed Page 39111

  • 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.
Start Printed Page 39112

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.

Beginning in CY 2022, section 1834(v)(1) of the Act requires that we apply a 15 percent payment reduction for outpatient occupational therapy services and outpatient physical therapy services that are provided, in whole or in part, by a physical therapist assistant (PTA) or occupational therapy assistant (OTA). Section 1834(v)(2)(A) of the Act required CMS to establish modifiers to identify these services, which we did in the CY 2019 PFS final rule (83 FR 59654 through 59661), creating the CQ and CO payment modifiers for services provided in whole or in part by PTAs and OTAs, respectively. These payment modifiers are required to be used on claims for services with dates of service beginning January 1, 2020, as specified in the CY 2020 PFS final rule (84 FR 62702 through 62708). We will apply the 15 percent payment reduction to therapy services provided by PTAs (using the CQ modifier) or OTAs (using the CO modifier), as required by statute. Under sections 1834(k) and 1848 of the Act, payment is made for outpatient therapy services at 80 percent of the lesser of the actual charge or applicable fee schedule amount (the allowed charge). The remaining 20 percent is the beneficiary copayment. For therapy services to which the new discount applies, payment will be made at 85 percent of the 80 percent of allowed charges. Therefore, the volume discount factor for therapy services to which the CQ and CO modifiers apply is: (0.20 + (0.80* 0.85), which equals 88 percent.

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 final 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.Start Printed Page 39113

In the CY 2021 PFS final rule, we finalized a proposal 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. In the rare cases where items are replaced every few months, we noted that we believe 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 a more detailed discussion of the methodology associated with very short equipment life durations, we refer readers to the CY 2021 PFS final rule (85 FR 84482 through 84483).

  • Maintenance: We finalized the 5 percent factor for annual maintenance 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 noted that we 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 noted that we did not believe 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 did not propose a variable maintenance factor for equipment cost per minute pricing as we did not believe that we have sufficient information at present. We noted that we would 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 3.

We are not proposing any changes to the equipment interest rates for CY 2022.

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 2022 direct PE input public use files, which are available on the CMS website under downloads for the CY 2022 PFS proposed rule at http://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​PhysicianFeeSched/​PFS-Federal-Regulation-Notices.html.

a. Standardization of Clinical Labor Tasks

As we noted in the CY 2015 PFS final rule with comment period (79 FR 67640 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 Start Printed Page 39114codes 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 not contain any clinical labor for the CA007 activity. In these situations, we continue to believe that in these cases, the 3 total minutes of clinical staff time would be more accurately described by the CA013 “Prepare room, equipment and supplies” activity code, and we finalized these clinical labor refinements. For additional details, we direct readers to the discussion in the CY 2019 PFS final rule (83 FR 59463 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 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 2022, 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 2022 PFS proposed rule at http://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​PhysicianFeeSched/​PFS-Federal-Regulation-Notices.html.

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

For CY 2022, we are proposing to address the following:

  • Following the publication of the CY 2021 PFS proposed rule, several commenters questioned the proposed RVUs associated with several occupational therapy evaluation procedures (CPT codes 97165 through 97167). Commenters stated that the PE valuation for these codes appeared to be illogical as it was counterintuitive for the PE RVU to go down as the level of complexity increased. Commenters stated that the distribution of code usage has not changed in any manner to justify a reduction in the code values and that all three evaluation codes should reimburse at the same rate. In response to the commenters, we noted that although the three codes in question shared the same work RVU and the same direct PE inputs, they did not share the same specialty distribution in the claims data and therefore would not necessarily receive the same allocation of indirect PE. In the CY 2021 PFS final rule (85 FR 84490), we finalized the implementation of a technical change intended to ensure that these three services received the same allocation of indirect PE. We agreed with commenters that it was important to avoid a potential rank order anomaly in which the simple case for a service was valued higher than the complex case.

After the publication of the CY 2021 PFS final rule, stakeholders stated their appreciation for the technical change made in the final rule to ensure that the indirect PE allocation was the same for all three levels of occupational therapy evaluation codes. However, stakeholders expressed concern that the PE RVUs we finalized for CPT codes Start Printed Page 3911597165-97167 decreased as compared to the PE RVUs we proposed for CY 2021. Stakeholders stated that nothing had occurred in the past year that would account for a reduction to the proposed PE for these codes, especially in a year where the proposed PE increased for the corresponding physical therapy evaluation procedures (CPT codes 97161-97163), and stakeholders questioned whether there had been an error in applying the indirect PE methodology.

We reviewed the indirect PE allocation for CPT codes 97165-97167 in response to the stakeholder inquiry and we do not agree that there was an error in applying the indirect PE methodology. We finalized a technical change in the CY 2021 PFS final rule intended to ensure that these three services received the same allocation of indirect PE, which achieved its desired goal of assigning equivalent indirect PE to these three services. However, by forcing CPT codes 97165-97167 to have the same indirect PE allocation, the indirect PE values for these codes no longer relied on the claims data, which ended up affecting the indirect practice cost index for the wider occupational therapy specialty. Because CPT codes 97165-97167 are high volume services, this resulted in a lower indirect practice cost index for the occupational therapy specialty and a smaller allocation of indirect PE for CY 2021 than initially proposed.

We are addressing this issue for CY 2022 by proposing to assign all claims data associated with CPT codes 97165-97167 to the occupational therapy specialty. This should ensure that CPT codes 97165-97167 would always receive the same indirect PE allocation as well as preventing any fluctuations to the indirect practice cost index for the wider occupational therapy specialty. This proposal is intended to avoid a potential rank order anomaly in which the simple case for a service is valued higher than the complex case. As the utilization for CPT codes 97165-97167 is overwhelmingly identified as performed by occupational therapists, we do not anticipate that assigning all of the claims data for these codes to the occupational therapy specialty will have a noticeable effect on their valuation. We are soliciting public comments regarding this proposal, and specifically on what commenters suggest as the most appropriate method of assigning indirect PE allocation for these services.

  • In the CY 2020 PFS final rule (84 FR 63102 through 63104), we created two new HCPCS G codes, G2082 and G2083, effective January 1, 2020 on an interim final basis for the provision of self-administered esketamine. In the CY 2021 PFS final rule, we finalized a proposal to refine the values for HCPCS codes G2082 and G2083 using a building block methodology that summed the values associated with several codes (85 FR 84641 through 84642). Following the publication of the CY 2021 PFS final rule, stakeholders expressed their concern that the finalized PE RVU had decreased for HCPCS codes G2082 and G2083 as compared to the proposed valuation and as compared to the previous CY 2020 interim final valuation. Stakeholders questioned whether there had been an error in the PE allocation since CMS had finalized increases in the direct PE inputs for the services.

We reviewed the indirect PE allocation for HCPCS codes G2082 and G2083 in response to the stakeholder inquiry and discovered a technical change that was applied in error. Specifically, we inadvertently assigned a different physician specialty than we intended (“All Physicians”) to HCPCS codes G2082 and G2083 for indirect PE allocation in our ratesetting process during valuation of these codes in the CY 2020 PFS final rule, and continued that assignment into the CY 2021 PFS proposed rule. This specialty assignment caused the PE value for these services to be higher than anticipated for CY 2020. We intended to revise the assigned physician specialty for these codes to “General Practice” in the CY 2021 PFS final rule; however, we neglected to discuss this change in the course of PFS rulemaking for CY 2021. Since we initially applied this technical change in the CY 2021 PFS final rule without providing an explanation, we issued a correction notice (86 FR 14690) to remove this change from the CY 2021 PFS final rule, and to instead maintain the All Physicians specialty assignment through CY 2021. We apologize for any confusion this may have caused.

For CY 2022, we are proposing to maintain the currently assigned physician specialty for indirect PE allocation for HCPCS codes G2082 and G2083. We are proposing to assign these two services to the All Physicians specialty for indirect PE allocation which will maintain payment consistency with the rates published in the CY 2020 PFS final rule and the CY 2021 PFS proposed rule. Although we had previously intended to assign the General Practice specialty to these codes, stakeholders have provided additional information about these services suggesting that maintaining the All Physicians specialty assignment for these codes will help maintain payment stability and preserve access to this care for beneficiaries. We are soliciting public comments to help us discern which specialty would be the most appropriate to use for indirect PE allocation for HCPCS codes G2082 and G2083. We note that the PE methodology, which relies on the allocation of indirect costs based on the magnitude of direct costs, should appropriately reflect the typical costs for the specialty the commenters suggest. For example, we do not believe it would be appropriate to assign the Psychiatry specialty for these services given that HCPCS codes G2082 and G2083 include the high direct costs associated with esketamine supplies. The Psychiatry specialty is an outlier compared to most other specialties, allocating indirect costs at a 15:1 ratio based on direct costs because psychiatry services typically have very low direct costs. Assignment of most other specialties would result in allocation of direct costs at roughly a 3:1 ratio. We request that commenters explain in their comments how the indirect PE allocation would affect the payment for these services. Specifically, to ensure appropriate payment for HCPCS codes G2082 and G2083, we would like to get a better understanding of the indirect costs associated with these services, relative to other services furnished by the suggested specialty.

  • A stakeholder contacted us regarding a potential error involving the intraservice work time for CPT code 35860 (Exploration for postoperative hemorrhage, thrombosis or infection; extremity). The stakeholder stated that the RUC recommended an intraservice work time of 90 minutes for this code when it was last reviewed in the CY 2012 PFS final rule and we finalized the work time without refinement at 60 minutes (76 FR 73131). The stakeholder requested that the intraservice work time for CPT code 35860 should be updated to 90 minutes.

We reviewed the intraservice work time for CPT code 35860 and found that the RUC inadvertently recommended a time of 60 minutes for the code, which we proposed and finalized without comment in rulemaking for the CY 2012 PFS. As a result, we do not believe that this is a technical error on our part. However, since the stakeholder has clarified that the RUC intended to recommend 90 minutes of intraservice work time for CPT code 35860 based on the surveyed median time, we are proposing to update the intraservice work time to 90 minutes to match the survey results.Start Printed Page 39116

c. 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 2022, we are proposing to update the price of six supplies and two equipment items in response to the public submission of invoices. Since this is the final year of the supply and equipment pricing update, the new pricing for each of these supply and equipment items will take effect for CY 2022 as there are no remaining years of the transition. The six supply and equipment items with proposed updated prices are listed in the valuation of specific codes section of the preamble under Table 16: CY 2022 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, 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 CMS price. Specifically, preliminary data indicated that there was no statistically significant difference between the estimated commercial prices and the current CMS prices for both equipment and supplies. This cumulative stable pricing for medical equipment and supplies appears similar to the pricing impacts of non-medical technology advancements where some historically high-priced equipment (that is, desktop PCs) has been increasingly substituted with current technology (that is, laptops and tablets) at similar or lower price points. However, while there were no statistically significant differences in pricing at the aggregate level, medical specialties would experience increases or decreases in their Medicare payments if 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-Start Printed Page 39117up” 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 4.

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 comment and submission of additional, applicable data. We welcomed feedback from stakeholders on the proposed updated supply and equipment pricing, including the submission of additional invoices for consideration.

We received many comments regarding the market-based supply and equipment pricing proposal following the publication of the CY 2019 PFS proposed rule. For a full discussion of these comments, we direct readers to the CY 2019 PFS final rule (83 FR 59475 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 Start Printed Page 39118associated with the market research study to update the PFS direct PE inputs for supply and equipment pricing. We continue to believe that implementing the 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 updated supply and equipment pricing, including the submission of additional invoices for consideration.

For CY 2022, we received invoice submissions from stakeholders for approximately half a dozen supply and equipment codes as part of the fourth year of the market-based supply and equipment pricing update. We used these submitted invoices in many cases to supplement the pricing originally proposed for the CY 2019 PFS rule cycle. We reviewed the invoices, as well as our own 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 review, we are proposing to update the prices of six supply items listed in the valuation of specific codes section of the preamble under Table 16: CY 2022 Invoices Received for Existing Direct PE Inputs. Since this is the final year of the supply and equipment pricing update, the new pricing for each of these supply and equipment items would take effect immediately for CY 2022.

The proposed prices for the supply and equipment items listed in Table 16 of CY 2022 were generally calculated following our standard methodology of averaging together the prices on the submitted invoices. In the case of the Liquid coverslip (Ventana 650-010) (SL479) supply, we are proposing a price of $0.051 based on the median invoice due to the presence of an outlier invoice that substantially increased the pricing when using an average. We believe that the proposed price of $0.051 would be more typical for the SL479 supply based on the pricing information contained on the other submitted invoices. We also received several invoices for the 3C patch system (SD343) supply; however, since we established a price of $625.00 for this supply in last year's CY 2021 PFS final rule and the submitted invoices had an average price of $612.50, we are not proposing to update the price. We believe that the submitted invoices confirm that the current pricing of $625.00 is typical for the SD343 supply.

(2) Invoice Submission

The full list of updated supply and equipment pricing as 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 2022 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 with their public comments or, if outside the notice and comment rulemaking process, via email at PE_Price_Input_Update@cms.hhs.gov.

(3) Autologous Platelet-Rich Plasma (HCPCS Code G0460) Supply Inputs

We did not make any proposals associated with HCPCS code G0460 (Autologous platelet rich plasma for chronic wounds/ulcers, including phlebotomy, centrifugation, and all other preparatory procedures, administration and dressings, per treatment) in the CY 2021 PFS proposed rule. Following publication of the rule, stakeholders contacted CMS regarding the creation of a new 3C patch system supply, which is topically applied for the management of exuding cutaneous wounds, such as leg ulcers, pressure ulcers, and diabetic ulcers and mechanically or surgically-debrided wounds. Stakeholders first sought clarification on how CMS calculated the underlying nonfacility PE RVUs for HCPCS code G0460. Stakeholders also stated that autologous platelet rich plasma administration procedures furnished in clinical trials (including the new 3C patch system) are reported using HCPCS code G0460 and requested that CMS revalue the service to reflect the PEs associated with the new patch system supply. The stakeholders stated that the use of the new 3C patch system will represent the typical case for HCPCS code G0460, and suggested that, therefore, the cost inputs for this supply should be used to establish the RVUs for this code, as the current PFS payment rate is substantially less than the amount it costs to furnish the 3C patch.

We want to clarify that the direct PE inputs for HCPCS code G0460 increased for CY 2021 as a result of the ongoing market-based supply and equipment pricing update. However, there was also a minor decrease in the indirect PE allocation associated with this service for CY 2021, with the net result that the proposed PE RVU coincidentally ended up remaining the same as in the previous year. We also clarify that HCPCS code G0460 is not included in the Anticipated Specialty Assignment for Low Volume Services list, and therefore, was unaffected by low utilization in the claims data. In addition, as a contractor priced service, HCPCS code G0460 is unaffected by inclusion or exclusion from this list.

We share the concerns of the stakeholders that patient access to the 3C patch could be materially impacted if CMS maintains the current PE RVUs for HCPCS G0460. In the CY 2021 PFS final rule, we established contractor pricing for HCPCS code G0460 for CY 2021. We believe that the use of contractor pricing again for CY 2022 will allow us additional time to consider the most appropriate resource inputs and PE RVUs for HCPCS code G0460. We also added the 3C patch system to our supply database under supply code SD343 at a price of $625.00 based on an average of the submitted invoices. We are proposing to maintain contractor pricing for CY 2022 for HCPCS code G0460 as we do not currently have sufficient information to establish national pricing. It remains unclear to us what the typical supply inputs would be for HCPCS code G0460 and whether they would include the use of the new 3C patch system. We believe that it would be more appropriate to maintain contractor pricing for the service, which will allow for more flexibility in pricing. We are soliciting any additional information that commenters can supply that CMS should consider to establish national payment for HCPCS code G0460.

d. Clinical Labor Pricing Update

Section 220(a) of the PAMA 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 Start Printed Page 39119that 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.

Since 2019, we have been updating the supply and equipment prices used for PE as part of a market-based pricing transition; CY 2022 will be the final year of this 4-year transition. We initiated a market research contract with StrategyGen to conduct an in-depth and robust market research study to update the supply and equipment pricing for CY 2019, and we finalized a policy in CY 2019 to phase in the new pricing over a period of 4 years. However, we did not propose to update the clinical labor pricing, and the pricing for clinical labor has remained unchanged during this pricing transition. Clinical labor rates were last updated for CY 2002 using Bureau of Labor Statistics (BLS) data and other supplementary sources where BLS data were not available; we refer readers to the full discussion in the CY 2002 PFS final rule for additional details (66 FR 55257 through 55262).

Stakeholders have raised concerns that the long delay since clinical labor pricing was last updated has created a significant disparity between CMS' clinical wage data and the market average for clinical labor. In recent years, a number of stakeholders have suggested that certain wage rates are inadequate because they do not reflect current labor rate information. Some stakeholders have also stated that updating the supply and equipment pricing without updating the clinical labor pricing could create distortions in the allocation of direct PE. Since the pool of aggregated direct PE inputs is budget neutral, if these rates are not routinely updated, clinical labor may become undervalued over time relative to equipment and supplies, especially since the supply and equipment prices are in the process of being updated. There has been considerable stakeholder interest in updating the clinical labor rates, and when we solicited comment on this topic in past rules, such as in the CY 2019 PFS final rule (83 FR 59480), stakeholders supported the idea.

Therefore, we are proposing to update the clinical labor pricing for CY 2022, in conjunction with the final year of the supply and equipment pricing update. We believe it is important to update the clinical labor pricing to maintain relativity with the recent supply and equipment pricing updates. We are proposing to use the methodology outlined in the CY 2002 PFS final rule (66 FR 55257), which draws primarily from BLS wage data, to calculate updated clinical labor pricing. As we stated in the CY 2002 PFS final rule, the BLS' reputation for publishing valid estimates that are nationally representative led to the choice to use the BLS data as the main source. We believe that the BLS wage data continues to be the most accurate source to use as a basis for clinical labor pricing and this data will appropriately reflect changes in clinical labor resource inputs for purposes of setting PE RVUs under the PFS. We used the most current BLS survey data (2019) as the main source of wage data for this proposal.

We recognize that the BLS survey of wage data does not cover all the staff types contained in our direct PE database. Therefore, we crosswalked or extrapolated the wages for several staff types using supplementary data sources for verification whenever possible. In situations where the price wages of clinical labor types were not referenced in the BLS data, we have used the national salary data from the Salary Expert, an online project of the Economic Research Institute that surveys national and local salary ranges and averages for thousands of job titles using mainly government sources. (A detailed explanation of the methodology used by Salary Expert to estimate specific job salaries can be found at www.salaryexpert.com). We previously used Salary Expert information as the primary backup source of wage data during the last update of clinical labor pricing in CY 2002. If we did not have direct BLS wage data available for a clinical labor type, we used the wage data from Salary Expert as a reference for pricing, then crosswalked these clinical labor types to a proxy BLS labor category rate that most closely matched the reference wage data, similar to the crosswalks used in our PE/HR allocation. For example, there is no direct BLS wage data for the Mammography Technologist (L043) clinical labor type; we used the wage data from Salary Expert as a reference and identified the BLS wage data for Respiratory Therapists as the best proxy category. We calculated rates for the “blend” clinical labor categories by combining the rates for each labor type in the blend and then dividing by the total number of labor types in the blend.

As in the CY 2002 clinical labor pricing update, the proposed cost per minute for each clinical staff type was derived by dividing the average hourly wage rate by 60 to arrive at the per minute cost. In cases where an hourly wage rate was not available for a clinical staff type, the proposed cost per minute for the clinical staff type was derived by dividing the annual salary (converted to 2021 dollars using the Medicare Economic Index) by 2080 (the number of hours in a typical work year) to arrive at the hourly wage rate and then again by 60 to arrive at the per minute cost. To account for the employers' cost of providing fringe benefits, such as sick leave, we used the same benefits multiplier of 1.366 as employed in CY 2002. As an example of this process, for the Physical Therapy Aide (L023A) clinical labor type, the BLS data reflected an average hourly wage rate of $14.03, which we multiplied by the 1.366 benefits modifier and then divided by 60 minutes to arrive at the proposed per-minute rate of $0.32.

Table 5 lists our proposed updates to the clinical labor prices. The BLS occupational code used as a source of wage data is listed for each clinical labor type; for the “blend” clinical labor types, this may include multiple BLS occupational codes and other clinical labor types which were calculated separately and then averaged together. Clinical labor types without a direct BLS labor category where we are employing a proxy BLS wage rate are indicated with an asterisk in Table 5.

Start Printed Page 39120

We are proposing to use the 75th percentile of the average wage data for the Medical Physicist (L152A) clinical labor type because we believe this level Start Printed Page 39121would most closely fit with the historic wage data for this clinical labor type. A Medical Physicist is a specific type of physicist, and the available BLS wage data describes the more general category of physicist which is paid at a lower rate. In this specific case, the 75th percentile more accurately describes the clinical labor type in question based on how it has historically been paid. We are also proposing to maintain the current clinical labor pricing for the Behavioral Health Care Manager (L057B) clinical labor type rather than update it. Although the BLS data reflected a decreased clinical labor rate for the Behavioral Health Care Manager labor type, we do not believe that the typical wages have decreased for this clinical labor type given that every other clinical labor type has increased over the past 5 years since the Behavioral Health Care Manager clinical labor type was created. The Behavioral Health Care Manager labor type was initially established in the CY 2017 PFS final rule (81 FR 80350). It seems more likely that we misidentified the proper BLS category for this clinical labor type than that wages have decreased since 2017. We believe that the clinical labor rate for the Behavioral Health Care Manager should be held constant for CY 2022 pending additional public feedback.

We are soliciting comments on the proposed updated clinical labor pricing. We are particularly interested in additional wage data for the clinical labor types for which we lacked direct BLS wage data and made use of proxy labor categories for pricing. We understand that the clinical labor undertaken by, for example, a Histotechnologist (L037B) is not the same as the clinical labor provided by the Health Information Technologist category of BLS wage data that we employed as a proxy for pricing. Although these occupations are not directly analogous to each other in terms of the work they do, we nonetheless believe that the proposed crosswalks are appropriate in terms of the resulting hourly wage data. We appreciate any additional information that commenters can supply both in terms of direct wage data, as well as identifying the most accurate types of BLS categories that could be used as proxies to update pricing for clinical labor types that lack direct BLS wage data. We isolated the anticipated effects of the clinical labor pricing update on specialty payment impacts by comparing the proposed CY 2022 PFS rates with and without the clinical labor pricing updates in place:

Start Printed Page 39122

Start Printed Page 39123

The potential effects of the clinical labor pricing update on specialty payment impacts are largely driven by the share that labor costs represent of the direct PE inputs for each specialty. Specialties with a substantially lower or higher than average share of direct costs attributable to labor would experience significant declines or increases, respectively, if this proposal is finalized. For example, the Family Practice specialty has a higher share of direct costs associated with clinical labor, and payments to services comprising the specialty would be expected to increase as a result of this clinical labor pricing update. In contrast, Diagnostic Testing Facilities have a lower share of direct costs that are associated with clinical labor, and payments to services comprising the specialty would be expected to decrease. Other specialty-level payment impacts for the proposed clinical labor pricing changes are driven by changes in wage rates for a clinical labor category that affects a given specialty more than average. One such example would be the proposed increase of 11 percent for Oncology nurses as opposed to the average increase for nurses of 63 percent. We emphasize that these are not the projected impacts by specialty of all the policies we are proposing in this proposed rule for CY 2022, only the anticipated effect of the isolated clinical labor pricing update, should this clinical labor pricing update be finalized as proposed.

When updates to our payment methodology based on new data produce significant shifts in payment, we often consider whether it would be appropriate to implement the updates through a phased transition across several calendar years. For example, we utilized a 4-year transition for the market-based supply and equipment pricing update concluding in CY 2022. We are considering the use of a similar 4-year transition to implement the clinical labor pricing update. A multi-year transition could smooth out the increases and decreases in payment caused by the pricing update for affected stakeholders, promoting payment stability. However, a phased transition would delay the full implementation of updated pricing and continue to rely in part on outdated data for clinical labor pricing. We discuss a potential 4-year transition for the clinical labor pricing update as an alternative considered in the Regulatory Impact Analysis (section VII.I) of this rule.

e. Proposal To Establish Values for Remote Retinal Imaging (CPT Code 92229), Comment Solicitation for Fractional Flow Reserve Derived From Computed Tomography (CPT Code 0503T), and Comment Solicitation for Codes Involving Innovative Technology

Rapid advances in innovative technology are having a profound effect on every facet of the economy, including in the delivery of health care. Emerging and evolving technologies are introducing advances in treatment options that have the potential to increase access to care for Medicare beneficiaries, improve outcomes, and reduce overall costs to the program. While new services have emerged over the last several years, it is possible that the COVID-19 public health emergency (PHE) could be accelerating the supply and demand for these innovations. Emerging and evolving technologies could be useful tools for improving disparities in care that have been exacerbated by the PHE. Some of these new applications have codes for which innovative technology is substituting for and/or augmenting physician work. For example, the CPT Editorial Panel created CPT code 92229 (Imaging of retina for detection or monitoring of disease; point-of-care automated analysis and report, unilateral or bilateral), a diagnostic test for diabetic retinopathy that uses a software algorithm, and the RUC provided valuation recommendations which included a retinal camera and an analysis fee for remote imaging. In the CY 2021 PFS final rule (85 FR 84629 through 84630), we considered CPT code 92229 to be a diagnostic service under the PFS, contractor-priced it, and stated that we would have ongoing conversations with stakeholders. The following section will discuss proposed policies to establish RVUs for CPT code 92229, solicit feedback to establish RVUs for CPT code 0503T (Noninvasive estimated coronary fractional flow reserve (FFR) derived from coronary computed tomography angiography data using computation fluid dynamics physiologic simulation software analysis of functional data to assess the severity of coronary artery disease; analysis of fluid dynamics and simulated maximal coronary hyperemia, and generation of estimated FFR model), and solicit feedback to help us better understand the resource costs for services involving the use of innovative technologies such as software algorithms and artificial intelligence (AI).

In our discussion of CPT code 92229 in the CY 2021 PFS final rule (85 FR 84629 through 84630), we wrote that as the data used in our PE methodology have aged, and more services have begun to include innovative technology such as software algorithms and AI, these innovative applications are not well accounted for in our PE methodology. As described earlier in this section, PE resources involved in furnishing services are characterized as either direct or indirect costs. Direct costs of the PE resources involved in furnish a service are estimated for each code and include clinical labor, medical supplies, and medical equipment. Indirect costs include administrative labor, office expenses, and all other expenses. Indirect PE is allocated to each service based on physician work, direct costs, and a specialty-specific indirect percentage. The source of the specialty specific indirect percentage was the Physician Practice Information Survey (PPIS), last administered in 2007 and 2008, when emerging technologies that rely primarily on software, licensing, and analysis fees, with minimal costs in equipment and hardware may not have been typical. Thus, these costs are not well accounted for in the PE methodology.

Consistent with our PE methodology and as we have stated in past PFS rulemaking (83 FR 59557), we have considered most computer software and associated analysis and licensing fees to be indirect costs tied to costs for associated hardware that is considered to be medical equipment. In the case of CPT code 92229, the hardware is a retinal camera used for remote imaging. Given that indirect costs are based on physician work, direct costs, and Start Printed Page 39124specialty-specific indirect percentages that can include high-cost equipment, our concern is that if we were to consider an analysis fee to be a supply cost, as was recommended by the RUC, it is possible that we would inadvertently allocate too many indirect costs for a supply item that may not require additional indirect expenses. Unlike a piece of equipment, such as the retinal camera, an analysis fee for software does not require physical space in an office or administrative staff hours to maintain it.

However, increasingly, stakeholders have routinely expressed concerns with our policy to consider analysis fees as indirect costs, especially for evolving technologies that rely primarily on these fees with minimal costs in equipment or hardware. In comments in the CY 2021 PFS final rule (85 FR 84629 through 84630) responding to our proposal to price the analysis fee for remote imaging as an indirect cost, stakeholders stated that there would be no service if the software was not used. There are two aspects that distinguish CPT code 92229 from other services. First, most of the RUC's recommended resource costs for CPT code 92229 were for the analysis fee, rather than high-cost equipment or other supplies that require commensurate indirect costs to accommodate for space or administrative labor. Second, the innovative technology incorporated into the service is a software algorithm, which interprets data collected during the test, either augmenting the work of the physician or NPP performing the test, or in some cases replacing at least some work that a physician would typically furnish. In general, it is possible that physician work time and intensity of furnishing care to patients could be affected as more services that involve innovative technologies such as software algorithms or AI become available.

We finalized a policy to establish contractor pricing for CPT code 92229 (85 FR 84629 through 84630) because analysis fees for software algorithms and AI applications are not well accounted for our PE methodology, and to recognize that practitioners do incur resource costs for purchase and ongoing use of the software. We stated that we would continue to seek out new data sources and have ongoing conversations with stakeholders while also considering other approaches to reflect overall resource costs for these technologies in our PE methodology.

As we described in the CY 2021 PFS final rule (85 FR 84498 through 84499), the RAND Corporation is currently studying potential improvements to CMS' PE allocation methodology and the data that underlie it. RAND has found that the PPIS data last collected in 2007-2008 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. Our experience with the challenge of accurately accounting for resource costs for innovative and emerging technologies such as ongoing service-specific software costs that are included in CPT code 92229 is another reason we continue to be interested in potentially refining the PE methodology and updating the data used to establish RVUs and payment rates under the PFS. We commonly employ a crosswalk to recognize resource costs when we lack the inputs that we would need to calculate work, PE, and/or malpractice RVUs for a service otherwise. When we use a crosswalk to value a service, we substitute the established RVUs for other services with similar resource costs in the physician office setting to set RVUs and the national payment rates for that particular service.

For CY 2022, we are proposing to establish values for CPT code 92229 using our crosswalk approach, and thus this service would no longer be contractor-priced. We continue to believe that the software algorithm present in the analysis fee for CPT code 92229 is not well accounted for in our PE methodology; however, we recognize that practitioners are incurring resource costs for purchase of the software and its ongoing use. We are proposing to use a crosswalk that reflects the overall relative resource costs for this service while we continue to consider potentially refining the PE methodology and updating the data we use to establish PE RVUs under the PFS. Specifically, we are proposing a crosswalk to CPT code 92325 (Modification of contact lens (separate procedure), with medical supervision of adaptation), a PE-only code used for the eye, as we believe it reflects overall resource costs for CPT code 92229 in the physician office setting. We recognize that the services described by CPT code 92325 are not the same as the services in CPT code 92229; however, we believe that the total resource costs would be similar across these two codes. We believe that crosswalking the RVUs for CPT code 92229 to a code with similar resource costs allows CMS to recognize that practitioners are incurring resource costs for the purchase and ongoing use of the software employed in CPT code 92229, which would not typically be considered direct PE under our current methodology. We are also soliciting comments on our proposal to crosswalk CPT code 92229 to CPT code 92325, and whether other codes would provide a more appropriate crosswalk in terms of resource costs. In addition, as discussed in section II.E of this proposed rule, we are proposing to use our crosswalk approach for CPT code 77X01 (Trabecular bone score (TBS), structural condition of the bone microarchitecture; using dual X-ray absorptiometry (DXA) or other imaging data on gray-scale variogram, calculation, with interpretation and report on fracture risk) and CPT code 77X03 (Trabecular bone score (TBS), structural condition of the bone microarchitecture; using dual X-ray absorptiometry (DXA) or other imaging data on gray-scale variogram, calculation, with interpretation and report on fracture risk, technical calculation only).

We are aware of other services that use similar innovative technologies to those used for the diagnostic test for diabetic retinopathy and trabecular bone score, and that those technologies also are not well-accounted for in our PE methodology. For CY 2018, the AMA CPT Editorial Panel established four new Category III CPT codes for fractional flow reserve derived from computed tomography (FFRCT): CPT code 0501T (Noninvasive estimated coronary fractional flow reserve (FFR) derived from coronary computed tomography angiography data using computation fluid dynamics physiologic simulation software analysis of functional data to assess the severity of coronary artery disease; data preparation and transmission, analysis of fluid dynamics and simulated maximal coronary hyperemia, generation of estimated FFR model, with anatomical data review in comparison with estimated FFR model to reconcile discordant data, interpretation and report) CPT code 0502T (Noninvasive estimated coronary fractional flow reserve (FFR) derived from coronary computed tomography angiography data using computation fluid dynamics physiologic simulation software analysis of functional data to assess the severity of coronary artery disease; data preparation and transmission); CPT code 0503T (Noninvasive estimated coronary fractional flow reserve (FFR) derived from coronary computed tomography angiography data using computation fluid dynamics physiologic Start Printed Page 39125simulation software analysis of functional data to assess the severity of coronary artery disease; analysis of fluid dynamics and simulated maximal coronary hyperemia, and generation of estimated FFR model); and CPT code 0504T (Noninvasive estimated coronary fractional flow reserve (FFR) derived from coronary computed tomography angiography data using computation fluid dynamics physiologic simulation software analysis of functional data to assess the severity of coronary artery disease; anatomical data review in comparison with estimated FFR model to reconcile discordant data, interpretation and report). FFRCT is a noninvasive diagnostic service that allows physicians to measure coronary artery disease in a patient through coronary CT scans. It uses a proprietary data analysis process performed at a central facility to develop a three-dimensional image of a patient's coronary arteries, which allows physicians to identify the fractional flow reserve to assess whether or not patients should undergo further invasive testing or treatment (typically, a coronary angiogram). We understand that FFRCT can show through non-invasive imaging whether a beneficiary has coronary artery disease thereby potentially avoiding an invasive coronary procedure. Medicare began payment for CPT code 0503T in the hospital outpatient department setting under the Outpatient Prospective Payment System (OPPS) in CY 2018 (82 FR 59284). For the PFS, we typically assign contractor pricing for Category III codes since they are temporary codes assigned to emerging technology and services. We followed this established process for Category III codes by assigning and listing them as contractor pricing in Appendix B in the CY 2018 PFS final rule (available at https://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​PhysicianFeeSched/​PFS-Federal-Regulation-Notices-Items/​CMS-1676-F). We have since been trying to understand the costs of the PE resource inputs for CPT code 0503T in the physician office setting. In the CY 2021 PFS final rule, we stated that we found FFRCT to be similar to other technologies that use algorithms, artificial intelligence, or other innovative forms of analysis to determine a course of treatment, where the analysis portion of the service cannot adequately be reflected under the PE methodology; and that our recent reviews for the overall cost of CPT code 0503T have shown the costs in the physician office setting to be similar to costs reflected in payment under the OPPS (85 FR 84630). For the CY 2021 OPPS/ASC final rule, we found that the geometric mean cost reported by hospital outpatient departments for the service was $804.35 (85 FR 85943). We believe the costs reported under the OPPS are instructive as they reflect actual costs that hospitals incurred in furnishing the service described by CPT code 0503T to Medicare beneficiaries, and, as we stated in the CY 2021 PFS final rule, we believe that these costs would be similar in the physician office setting. Using the geometric mean costs under the OPPS as a proxy, we then searched for services paid under the PFS that could potentially serve as a crosswalk. Specifically, we looked for services paid under the PFS that include only a technical component because CPT code 0503T is a technical component-only service, and that have similar total costs to CPT code 0503T. We identified the following potential crosswalks, and seek public comment on which, if any of them, would be appropriate: CPT code 93455 (Catheter placement in coronary artery(s) for coronary angiography, including intraprocedural injection(s) for coronary angiography, imaging supervision and interpretation; with catheter placement(s) in bypass graft(s) (internal mammary, free arterial, venous grafts) including intraprocedural injection(s) for bypass graft angiography) and CPT code 93458 (Catheter placement in coronary artery(s) for coronary angiography, including intraprocedural injection(s) for coronary angiography, imaging supervision and interpretation; with left heart catheterization including intraprocedural injection(s) for left ventriculography, when performed). We are also seeking comment on whether other codes would provide a more appropriate crosswalk in terms of resource costs.

We are also more broadly soliciting public comment to help us better understand the resource costs for services involving the use of innovative technologies, including but not limited to software algorithms and AI. Specifically, we are requesting commenters consider the following questions:

  • To what extent are services involving innovative technologies such as software algorithms and/or AI substitutes and/or supplements for physician work? To what extent do these services involving innovative technology inform, augment, or replace physician work? For example, CPT code 92229 is a PE-only code in which the software algorithm may be substituting for some work of an ophthalmologist to diagnose/detect diabetic retinopathy. CPT code 77X01 is a service in which the trabecular bone score software may be supplementing physician work to predict and detect fracture risk. CPT code 0503T may be both substituting for, and supplementing physician work to detect coronary artery disease.
  • How has innovative technology such as software algorithms and/or AI affected physician work time and intensity of furnishing services involving the use of such technology to Medicare beneficiaries? For example, if a new software algorithm or AI technology for a diagnostic test results in a reduction in the amount of time that a practitioner spends reviewing and interpreting the results of a diagnostic test that previously did not involve such software algorithm or AI technology, and if the software algorithm or AI could be considered in part a substitute for at least some physician work, it may follow that the intensity of the service decreases. It is also possible that a software algorithm for a diagnostic test that is supplementing other tests to establish a diagnosis or treatment pathway for a particular condition could result in an increase in the amount of time that a practitioner spends explaining the test to a patient and then reviewing the results.
  • How is innovative technology such as software algorithms and/or AI changing cost structures in the physician office setting? As discussed previously, the PPIS data that underlie the PE methodology were last collected in 2007 and 2008, which was prior to the widespread adoption of electronic health records and services that involve care management, non-face-to-face and/or asynchronous remote care; the need to use electronic clinical quality measure data to support quality improvement, disparity identification and resolution, and value based payment; and the emergence of software algorithms and/or AI and other technologies that use data to inform, augment, or replace physician work in the delivery of health care. Do costs for innovative technology such as software algorithms and/or AI to furnish services to patients involve a one-time investment and/or recurring costs? How should CMS consider costs for software algorithms and/or AI that use patient data that were previously collected as part of another service? As technology adoption grows, do these costs decrease over time?
  • How is innovative technology affecting beneficiary access to Medicare-covered services? How are services involving software algorithms and/or AI being furnished to Medicare beneficiaries and what is important for Start Printed Page 39126CMS to understand as it considers how to accurately pay for services involving software algorithms and/or AI? For example, it is possible that services that involve software algorithms and/or AI may allow a practitioner to more efficiently furnish care to more Medicare beneficiaries, potentially increasing access to care. Additionally, to what extent have services that involve innovative technology such as software algorithms and/or AI affected access to Medicare-covered services in rural and/or underserved areas, or for beneficiaries that may face barriers (homelessness, lack of access to transportation, lower levels of health literacy, lower rates of internet access, mental illness, having a high number of chronic conditions/frailty, etc.) in obtaining health care?
  • Compared to other services paid under the PFS, are services that are driven by or supported by innovative technology such as software algorithms and/or AI at greater risk of overutilization or more subject to fraud, waste, and abuse? As we are considering appropriate payment for services enabled by new technologies, there are considerations for program integrity. For example, section 218(b) of the PAMA required that we establish an Appropriate Use Criteria Program to promote appropriate use of advanced diagnostic imaging services provided to Medicare beneficiaries.[1] To what extent do services involving innovative technology require mechanisms such as appropriate use criteria to guard against overutilization, fraud, waste, or abuse?
  • Compared to other services paid under the PFS, are services driven by or supported by innovative technology such as software algorithms and/or AI associated with improvements in the quality of care or improvements in health equity? For example, increased access to services to detect diabetic retinopathy such as the service described by CPT code 92229 could eventually lead to fewer beneficiaries losing their vision. Because CPT code 92229 can be furnished in a primary care practice's office and may not require the specialized services of an ophthalmologist, more beneficiaries could have access to a test, including those who live in areas with fewer ophthalmologists. Additionally, taking into consideration that a software algorithm and/or AI may introduce bias into clinical decision making that could influence outcomes for racial and ethnic minorities and people who are socioeconomically disadvantaged, are there guardrails, such as removing the source of bias in a software algorithm and/or AI, that Medicare should require as part of considering payment amounts for services enabled by software algorithm and/or AI?
  • Our proposals to use crosswalks to set values for codes describing diabetic retinopathy and trabecular bone score would allow us to account for overall resource costs involved in furnishing the services. The possible crosswalks for FFRCT may also account for overall resource costs involved in furnishing the service. We also believe it is important to accurately account for resource costs for innovative and emerging technologies such as ongoing service-specific software costs and, as explained above, such costs are not well accounted for in the PE methodology. We continue to be interested in potentially refining the PE methodology and updating the underlying data, including the PPIS data that are the data source that underpins the indirect PE allocation. How might CMS consider updating such data to reflect ongoing advances in technology so that we could establish appropriate relative values without resorting to crosswalks? The RAND Corporation laid out a number of issues for CMS to consider in two reports. We refer readers to RAND's first phase of research, available at https://www.rand.org/​pubs/​research_​reports/​RR2166.html, and RAND's second phase of research, available at https://www.rand.org/​pubs/​research_​reports/​RR3248.html.

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 relative value units (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.E. 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 (AMA) Resource-Based Relative Value Scale (RVS) Update Committee (RUC), the 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 statute. 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 Start Printed Page 39127required 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 furnished at the same time as other services.
  • Codes with high intraservice work per unit of time.
  • Codes with high PE RVUs.
  • Codes with high cost supplies.
  • Codes as determined appropriate by the Secretary.

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

2. Progress in Identifying and Reviewing Potentially Misvalued Codes

To fulfill our statutory mandate, we have identified and reviewed numerous potentially misvalued codes as specified in section 1848(c)(2)(K)(ii) of the Act, and we intend to continue our work examining potentially misvalued codes in these areas over the upcoming years. As part of our current process, we identify potentially misvalued codes for review, and request recommendations from the RUC and other public commenters on revised work RVUs and direct PE inputs for those codes. The RUC, through its own processes, also identifies potentially misvalued codes for review. Through our public nomination process for potentially misvalued codes established in the CY 2012 PFS final rule with comment period, other individuals and stakeholder groups submit nominations for review of potentially misvalued codes as well. Individuals and stakeholder groups may submit codes for review under the potentially misvalued codes initiative to CMS in one of two ways. Nominations may be submitted to CMS via email or through postal mail. Email submissions should be sent to the CMS emailbox MedicarePhysicianFeeSchedule@cms.hhs.gov, with the phrase “Potentially Misvalued Codes” 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 Start Printed Page 39128the “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 continue 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 2022 Identification and Review of Potentially Misvalued Services

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

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

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

a. Public Nominations

In this proposed rule, we are soliciting comments regarding the potentially misvalued codes nominated by the public to inform our decision on whether to establish the codes as potentially misvalued in the CY 2022 PFS final rule. We received public nominations for potentially misvalued codes by February 10th. We display these public nominations on our public website, including the submitter's name and their associated organization to provide full transparency. Among the public nominations that we received this year, one was a request for CMS to review a PE-related input for a code. We refer readers to section II.B. of this proposed rule, Determination of PE RVUs, for further discussion on the PE-related submission. The summary of this year's submissions under the potentially misvalued code initiative are discussed below.

A stakeholder nominated CPT code 22551 (Fusion of spine bones with removal of disc at upper spinal column, anterior approach, complex) “and common related services” as potentially misvalued. Citing the CY 2021 PFS final rule (84 FR 84501) where CMS agreed with the public nomination of CPT code 22867 (Insertion of interlaminar/interspinous process stabilization/distraction device, without fusion, including image guidance when performed, with open decompression, lumbar; single level) as potentially misvalued, and discussed the relationship between CPT code 22867 and CPT code 63047 (Laminectomy, facetectomy and foraminotomy (unilateral or bilateral with decompression of spinal cord, cauda equina and/or nerve root[s], [e.g., spinal or lateral recess stenosis]), single vertebral segment; lumbar), this stakeholder suggests that there are additional CPT code values related to spine procedures that are in need of contemporaneous review with CPT code 22867. The stakeholder believes that CMS has an interest in reviewing associated anterior cervical discectomy and fusion (ACDF) procedures as well, and suggests that CPT code 22551 “and common related services” can result in cumulative RVUs that do not sufficiently reflect physician work, time, or outcomes.

In their submission, the stakeholder expressed concern that there is a discrepancy between the typical total RVUs for codes billed for vertebral fusion procedures performed using three synthetic cage devices with plate and vertebral fusion procedures performed using three allografts with plate. Both methods of vertebral fusion are described by CPT code 22551 (includes a 90-day global period), which has a work RVU of 25.00. Both methods of vertebral fusion involve two units of CPT code 22552 (Arthrodesis, anterior interbody, including disc space preparation, discectomy, osteophytectomy and decompression of spinal cord and/or nerve roots; cervical below C2, each additional interspace (List separately in addition to code for primary procedure) (ZZZ global period)) with a total work RVU of 13.00 (6.50 × 2); and both methods of vertebral fusion involve 1 unit of CPT code 22846 (Anterior instrumentation; 4 to 7 vertebral segments (List separately in addition to code for primary procedure) (ZZZ global period)) with a work RVU of 12.40. The vertebral fusion method employing three synthetic cage devices with a plate would involve CPT code 22853 (Insertion of interbody biomechanical device (s) (e.g., synthetic cage, mesh) with integral anterior instrumentation for device anchoring (e.g., screws, flanges), when performed, to intervertebral disc space in conjunction with interbody arthrodesis, each interspace (List separately in addition to code for primary procedure) (ZZZ global period)) for the insertion of synthetic cage devices for a total work RVU of 12.75 (4.25 × 3), and CPT code 20930 (Allograft, morselized, or Start Printed Page 39129placement of osteopromotive material, for spine surgery only (List separately in addition to code for primary procedure)) with a work RVU of 0.00 (because Medicare considers this code to be bundled into codes for other services). The stakeholder stated that the total work RVUs for the typical vertebral fusion employing three synthetic cage devices with plate would be 63.15 work RVUs.

In contrast, the stakeholder asserted that the vertebral fusion method employing three allografts with plate involves the same set of services and codes (CPT code 22551 (090 global period) and CPT code 22846 (ZZZ global period)), but instead of CPT codes 22853 or 20930, involve CPT code 20931 (Allograft, structural, for spine surgery only (List separately in addition to code for primary procedure) (ZZZ global period) with a work RVU of 1.81. Altogether, the total work RVUs for CPT codes involved in this vertebral fusion method is 52.21. The stakeholder suggested that this difference in total work RVUs, 63.15 versus 52.21, is evidence that these services are misvalued, and that the total work RVUs do not reflect the differences in the amount of work, resources, and intensity between the two vertebral fusion methods.

This stakeholder's description of the potential misvaluation of CPT code 22551 “and common related services” differs from the CMS approach to identifying potentially misvalued services by using certain criteria, as described in the beginning of this section. Our determination that one or more codes are potentially misvalued generally revolves around the specific RVUs assigned to an individual code, or several codes within a family of codes. CMS generally does not examine the summed differences in total RVUs based on billing patterns using different codes in different scenarios, representing different physician work, and then comparing the two methods of a procedure, in this case, the use or non-use, of the synthetic cage devices in the vertebral fusion with removal of the disc in the upper spinal column. We do not believe that the stakeholder has provided support for the premise that CPT code 22551 alone is misvalued, or that any of the codes identified as common related services are misvalued. Therefore, we are not inclined to propose this code as potentially misvalued. However, we welcome additional comment, including any analysis or studies demonstrating that one or more of these codes meet the criteria listed above under “Identification and Review of Potentially Misvalued Services,” particularly in regard to any changes in the resources to providing a service, or are otherwise potentially misvalued.

A stakeholder nominated CPT code 49436 (Delayed creation of exit site from embedded subcutaneous segment of intraperitoneal cannula or catheter) as potentially misvalued, as it has not been valued for payment in the non-facility/office setting. This stakeholder did not include in their submission detailed recommendations for the items, quantities, and unit costs for the supplies, equipment types, and clinical labor (if any), that might be incurred in the non-facility/office setting, all of which are key factors when determining potential valuation or mis-valuation of a service. Medicare claims data for 2018, 2019, and 2020 show that CPT code 49436 is solely performed in the facility ambulatory surgical center (ASC) setting. We are not inclined to propose this code as potentially misvalued; however, we welcome additional comment, including any analysis or studies demonstrating that this code meets the criteria listed above under “Identification and Review of Potentially Misvalued Services,” particularly in regard to any changes in the resources to providing a service, or is otherwise potentially misvalued.

A stakeholder nominated CPT code 55880 (Ablation of malignant prostate tissue, transrectal, with high intensity-focused ultrasound (HIFU), including ultrasound guidance) as potentially misvalued, as it has not been valued in the non-facility/office setting. This stakeholder also did not include in their submission detailed recommendations for items, quantities, and unit costs for the supplies, equipment types, and clinical labor (if any), that might be incurred in the non-facility/office setting, all of which are key factors when determining valuation or mis-valuation. This stakeholder stated that the advances in High Intensity Focused Ultrasound (HIFU) technology toward the destruction of cancerous tissues in the prostate gland have matured to the point where this procedure is now equally as effective and as safe as the cryoablation procedure described by CPT code 55873 (Cryosurgical ablation of the prostate (includes ultrasonic guidance and monitoring)), which is currently valued in the non-facility/office setting (186.69 total RVUs, approximately $6,514) and has been for approximately 10 years. We note that CPT code 55880 was reviewed and valued in the CY 2021 PFS final rule (85 FR 84614 through 84615) in the facility setting only. Accordingly, we do not have enough claims data for this code to make accurate comparisons to similar codes that may be furnished in non-facility settings. There is no case presented here that constitutes a misvaluation of CPT code 55880, and therefore, we are not inclined to put this code forward as potentially misvalued for CY 2022; however, we welcome additional comment, including any analysis or studies demonstrating that this code meets the criteria listed above under “Identification and Review of Potentially Misvalued Services,” particularly in regard to any changes in the resources to providing a service, or is otherwise potentially misvalued.

A stakeholder nominated CPT code 59200 (Insertion cervical dilator (e.g., laminaria, prostaglandin) as potentially misvalued because the direct PE inputs do not include the supply item, Dilapan-S. This stakeholder had sought to establish a Level II HCPCS code for Dilapan-S, but CMS did not find sufficient evidence to support that request. The stakeholder now submits Dilapan-S to be considered as PE supply input to a Level I CPT code(s). This stakeholder seeks to add Dilapan-S to the nonfacility/office PE inputs for CPT code 59200. Specifically, the stakeholder recommends adding 4 rods of Dilapan-S at $80.00 per unit, for a total of $320.00, as a replacement for the current PE supply item, laminaria tent (a small rod of dehydrated seaweed that when inserted in the cervix, rehydrates, absorbing the water from the surrounding tissue in the woman's body), which is currently listed at $4.0683 per unit, with a total of 3 units, for a total of $12.20. We welcome additional comment, including any analysis or studies demonstrating that this code meets the criteria listed above under “Identification and Review of Potentially Misvalued Services,” particularly in regard to any changes in the resources to providing a service, or is otherwise potentially misvalued.

A stakeholder nominated CPT codes 66982 through 66986 as potentially misvalued, as they have not been valued in the non-facility/office setting. This stakeholder did not submit other details or reasoning to support their nomination. We note that some of these cataract-related procedures were initially reviewed and valued in CY 2020 PFS final rule (84 FR 62751), and that presently, additional codes in this family are scheduled to be reviewed and valued in this CY 2022 PFS proposed rule (we refer readers to section II.E. of this proposed rule, Valuation of Specific Codes). The highest utilization of these cataract codes are CPT code 66982 (Extracapsular cataract removal with insertion of intraocular lens prosthesis Start Printed Page 39130(1-stage procedure), manual or mechanical technique (e.g., irrigation and aspiration or phacoemulsification), complex, requiring devices or techniques not generally used in routine cataract surgery (e.g., iris expansion device, suture support for intraocular lens, or primary posterior capsulorrhexis) or performed on patients in the amblyogenic developmental stage; without endoscopic cyclophotocoagulation) and CPT code 66984 (Extracapsular cataract removal with insertion of intraocular lens prosthesis (1-stage procedure), manual or mechanical technique (e.g., irrigation and aspiration or phacoemulsification); without endoscopic cyclophotocoagulation). In 2018 and 2019, these services were almost all performed in the ASC facility setting, but based on 2020 claims, the most common setting appears to have shifted to the hospital inpatient or hospital outpatient facility setting. There is no case presented here that constitutes a misvaluation of CPT codes 66982 to 66986, and therefore, we are not inclined to put this code family forward as potentially misvalued for CY 2022; however, we welcome additional comment, including any analysis or studies demonstrating that one or more of these codes meet the criteria listed above under “Identification and Review of Potentially Misvalued Services,” particularly in regard to any changes in the resources to providing a service, or are otherwise potentially misvalued.

D. Telehealth and Other Services Involving Communications Technology, and Interim Final Rule With Comment Period for Coding and Payment of Virtual Check-In Services—Payment for Medicare Telehealth Services Under Section 1834(m) of the Act

As discussed in prior rulemaking, several conditions must be met for Medicare to make payment for telehealth services under the PFS. See further details and full discussion of the scope of Medicare telehealth services in the CY 2018 PFS final rule (82 FR 53006) and CY 2021 PFS final rule (85 FR 84502) and in 42 CFR 410.78 and 414.65.

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

a. Proposed Changes to the Medicare Telehealth Services List

In the CY 2003 PFS final rule with comment period (67 FR 79988), we established a regulatory 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 (42 CFR 410.78(f)). This process provides the public with an ongoing opportunity to submit requests for adding services, which are then reviewed by us and assigned to categories established through notice and comment rulemaking. Specifically, 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 the 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 other clinical benefits that we would consider 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.
  • Category 3: In the CY 2021 PFS final rule (85 FR 84507), we created a third category of criteria for adding services to the Medicare telehealth services list on a temporary basis following the end of the PHE for the COVID-19 pandemic. This new category describes services that were added to the Medicare telehealth services list during the PHE for which there is likely to be clinical benefit when furnished via telehealth, but there is not yet sufficient evidence available to consider the services for permanent addition under the Category 1 or Category 2 criteria. Services added on a temporary, Category 3 basis would ultimately need to meet the criteria under Category 1 or 2 in order to be permanently added to the Medicare telehealth services list. 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 Start Printed Page 39131when furnished via telehealth. We considered the following factors:

++ Whether, outside of the circumstances of the PHE for COVID-19, there are concerns for patient safety if the service is furnished as a telehealth service.

++ Whether, outside of the circumstances of the PHE for COVID-19, 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.

In the CY 2021 PFS final rule (85 FR 84507), we also temporarily added several services to the Medicare telehealth services list using the Category 3 criteria described above. In this proposed rule, we are considering additional requests to add services to the Medicare telehealth services list on a Category 3 basis using the previously described Category 3 criteria.

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.

Beginning in CY 2019, we stated that for CY 2019 and onward, we intend to accept requests through February 10, consistent with the deadline for our receipt of code valuation recommendations from the RUC (83 FR 59491). For CY 2022, requests to add services to the Medicare telehealth services list must have been submitted and received by February 10, 2021. Each request to add a service to the Medicare telehealth services list must have included any supporting documentation the requester wishes us to consider as we review the request. Because we use the annual PFS rulemaking process as the vehicle to make changes to the Medicare telehealth services list, requesters are 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 in the future 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 2022

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 permanently add various services to the Medicare telehealth services list effective for CY 2022. We found that none of the requests we received by the February 10th submission deadline met our Category 1 or Category 2 criteria for permanent addition to the Medicare telehealth services list. The requested services are listed in Table 8.

Start Printed Page 39132

Start Printed Page 39133

We remind stakeholders that the criterion for adding services to the Medicare telehealth list under Category 1 is that the requested services are similar to professional consultations, office visits, and office psychiatry services that are currently on the Medicare telehealth services list, and that the criterion for adding services under Category 2 is that there is evidence of clinical benefit if provided as telehealth. As explained below, we find that none of the requested services met the Category 1 criterion.

We received a request to permanently add CPT code 51741 (Complex uroflowmetry (e.g., calibrated electronic equipment)) to the Medicare telehealth services list. This CPT code describes the acquisition of uroflowmetric information and analysis of that information. The code includes a technical component and a professional component. The technical component describes the acquisition of the uroflowmetric information when billed as a standalone service. The professional component describes the analysis for the uroflowmetric information when it is billed as a standalone service. As we have explained in previous rulemaking (see 83 FR 59483), the remote interpretation of diagnostic tests is not considered to be a telehealth service under section 1834(m) of the Act or our regulation at § 410.78. We do not believe that the technical component, which would include acquisition of the uroflowmetric Start Printed Page 39134information, would meet the criterion to be added on a Category 1 basis because it is not similar to other services on the Medicare telehealth list. Moreover, we do not believe the uroflowmetric information can be accurately and effectively collected using two-way, audio/video communication technology to the degree that would make the results clinically useful. We believe the patient would need to be in the same location as the equipment; thus, making it impracticable to achieve via telehealth. Due to these concerns, we do not believe that the submitted information demonstrates sufficient clinical benefit to support the addition of CPT code 51741 to the Medicare telehealth services list.

We received a request to permanently add several biofeedback, services, CPT codes 90901, 90912, and 90913, to the Medicare telehealth services list. We do not believe these services are similar to Category 1 services on the Medicare telehealth list in that these services describe the application of electrodes directly to the patient's skin and using them to monitor the patient's response. Therefore, we do not believe they meet the criterion for addition to the Medicare telehealth services list on a Category 1 basis. We also believe that proper application of electrodes and monitoring of the patient's response would require the furnishing practitioner to be in the same physical location as the beneficiary. As such, we do not believe these services would meet the criteria for addition to the Medicare telehealth list on a Category 2 basis. When we reviewed these biofeedback services on a Category 2 basis, we found that the information supplied with the requests was not detailed enough to determine if the objective functional outcomes (that is, Activities of Daily Living (ADLs) and Instrumental Activities of Daily Living (IADLs) of the telehealth patients) were similar to that of patients treated in person. Moreover, we believe that the ADLs/IADLs alone are not sufficient to determine if these services, when performed via telehealth, demonstrate a clinical benefit to a patient. We would request that stakeholders supply a more comprehensive set of objective data in order to fully illustrate any benefits, to better enable us to evaluate all outcomes.

We received requests to permanently add Neuropsychological/Psychological Testing services, CPT codes 96130-96133 and 96136-96139, to the Medicare telehealth services list. We separately reviewed each of the services in these two code families. In prior years' rulemaking, we have declined to add these services on a Category 1 basis because, in contrast to other services on the telehealth list these services require close observation by the furnishing practitioner to monitor how a patient responds and progresses through the testing (see 81 FR 80197). We continue to believe that this is the case. All of these codes describe services that involve a very thorough observation and testing process, and require the tester to observe the following: Speed of responses; the ability to adjust focus; written, sometimes manual tasks; following tasks that display the patients' visuospatial mapping abilities, pattern recognition, abstraction, calculation—all while appreciating that the patient may be distracted or aided by environmental cues. The tester must also maintain some subjective amount of flexibility to allow the patient to be in their environment. Additionally, the tester has to maintain professional scrutiny through dynamic tasks. Given all of the above, remote observation by the furnishing practitioner to accomplish the testing in question seems impractical and potentially creates the risk of inaccuracies in diagnosis and subsequent treatment. We note that the information supplied by stakeholders did not address these concerns, and as such, we have concerns over patient safety and the ability of these services to be accurately and thoroughly performed via telehealth to demonstrate a clinical benefit to Medicare beneficiaries. Therefore, we do not believe these services meet the Category 2 criteria for permanent addition to the Medicare telehealth list of services. Consequently, we are not proposing to add these services to the Medicare telehealth services list. We encourage stakeholders to submit information addressing the concerns we have stated in any future requests to have these services added to the Medicare telehealth list of services.

We received requests to add Therapy Procedures, CPT codes 97110, 97112, 97116, 97150, and 97530; Physical Therapy Evaluations, CPT codes 97161-97164; Therapy Personal Care services, CPT codes 97535, 97537, and 97542; and Therapy Tests and Measurements services, CPT codes 97750, 97755, and 97763, to the Medicare telehealth services list. In the CY 2017 PFS final rule (81 FR 80198), 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 also stated in the CY 2017 PFS final rule 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 that time. In a subsequent request to consider adding these services for 2018, the original requester suggested that we might propose these services 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. We continue to believe this to be true; however, we reviewed each therapy service separately, and have categorized them together here for convenience as the same set of information accompanied the request for each of these services.

We determined that these services did not meet the Category 1 criteria for addition to the Medicare telehealth services because they are therapeutic in nature and in many instances involve direct physical contact between the practitioner and the patient. In assessing the evidence that was supplied by stakeholders in support of adding these services to the Medicare telehealth services list on a Category 2 basis, we concluded that it did not provide sufficient detail to determine whether all of the necessary elements of the service could be furnished remotely, and whether the objective functional outcomes of ADL and IADL for the telehealth patients were similar to those of patients receiving the services in person. As we stated above when discussing the request to add certain biofeedback services to the telehealth list, we do not believe ADLs and IADLS alone are sufficient to demonstrate clinical benefit to a Medicare beneficiary. We have enumerated above some examples of the types of clinical benefits we would consider when evaluating services using the Category 2 criterion.

Therefore, we do not believe the supplied information demonstrates that the services meet either the Category 1 or the Category 2 criteria. We are not Start Printed Page 39135proposing to add these services to the Medicare telehealth services list. We continue to encourage commenters to supply sufficient data for us to be able to see all measurements/parameters performed, so that we may evaluate all outcomes.

We received requests to add the services in Table 9, and we note that these services are generally not separately payable under the Medicare PFS. Given that these services are not separately payable when furnished in-person, they would not be separately payable when furnished as telehealth. Section 1834(m)(2)(A) of the Act provides that payment for a service when furnished as a telehealth services is equal to the payment when the service is furnished in person. CPT code 90849 has a restricted payment status, indicating that claims must be adjudicated on a case-by-case basis when furnished in-person. Accordingly, any separate payment for that service would require special consideration and not be routine. Therefore, we do not believe this service should be added to the Medicare telehealth list. CPT codes 98960-98962 are bundled services, and therefore, payment for these services is always bundled into payment of other services. For that reason, we are not proposing to add them to the Medicare list of telehealth services.

We received requests to temporarily add Neurostimulators, CPT codes 95970-95972, and Neurostimulators, Analysis-Programming services, CPT codes 95983 and 95984, to the Medicare telehealth services list using the Category 3 criteria (see Table 10). In their submission, the requestor noted they would conduct a future study and would submit the study data to CMS at a later date. These services are on the expanded telehealth services list for the PHE, but were not added by CMS on a category 3 basis in the CY 2021 PFS final rule. We do not yet have sufficient information to adjudicate whether these services are likely to meet the category 1 or category 2 criteria given additional time on the Medicare telehealth services list, without having evaluated the full data, and we encourage commenters to submit all available information, when available, for future consideration. As a result, we are not proposing to add these services to the Medicare telehealth list of services on a Category 3 basis at this time.

Start Printed Page 39136

c. Revised Timeframe for Consideration of Services Added to the Telehealth List on a Temporary Basis

In the CY 2021 PFS final rule (85 FR 84506), in response to the PHE for COVID-19, we created a third category of criteria for adding services to the Medicare telehealth services list on a temporary basis. We included in this category the services that were added during the PHE for COVID-19 for which we believed 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. We recognized that the services we added 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 that there was a potential for evidence development that could continue through the Category 3 temporary addition period. We also stated that any service added on a temporary basis under Category 3 would remain on the Medicare telehealth services list through the end of the calendar year in which the PHE for COVID-19 ends.

We added 135 services to the Medicare telehealth list in CY 2020 on an interim basis in response to the PHE for COVID-19 through the interim final rule with comment period (IFC) (March 31st COVID-19 IFC (85 FR 19234-19243) and the subregulatory process established in the May 8th COVID-19 IFC (85 FR 27550-27649). Since the publication of the May 8th COVID-19 IFC, we have added several services to the Medicare telehealth list of services using this subregulatory process (please see https://www.cms.gov/​Medicare/​Medicare-General-Information/​Telehealth/​Telehealth-Codes for the list of codes available for telehealth under the PFS). As discussed in the CY 2021 PFS final rule (FR 85 84507), at the conclusion of the PHE for COVID-19, associated 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, as modified by subsequent changes in policies and additions to the telehealth services list adopted through rulemaking. Services that were temporarily added on an interim basis during the PHE for COVID-19 would not be continued on the list after the end of the PHE for COVID-19.

Numerous stakeholders have continued to note that there is uncertainty about when the PHE for COVID-19 may end, and express concerns that the services added to the telehealth list on a temporary basis could be removed from the list before practitioners have had time to compile Start Printed Page 39137and submit evidence to support the permanent addition of these services on a Category 1 or Category 2 basis. To respond to these continuing concerns, we are proposing to revise the timeframe for inclusion of the services we added to the Medicare telehealth services list on a temporary, Category 3 basis. Extending the temporary inclusion of these services on the telehealth list will allow additional time for stakeholders to collect, analyze and submit data on those services to support their consideration for permanent addition to the list on a Category 1 or Category 2 basis.

We propose to retain all services added to the Medicare telehealth services list on a Category 3 basis until the end of CY 2023. This will allow us time to collect more information regarding utilization of these services during the pandemic, and provide stakeholders the opportunity to continue to develop support for the permanent addition of appropriate services to the telehealth list through our regular consideration process, which includes notice-and-comment rulemaking. By keeping these services on the Medicare telehealth services list through CY 2023, we will facilitate the submission of requests to add services permanently to the Medicare telehealth services list for consideration in the CY 2023 PFS rulemaking process and for consideration in the CY 2024 PFS rule.

See Table 11 for a list of services that were added to the Medicare telehealth services list on an interim basis to respond to the PHE for COVID-19, but were not extended on a temporary Category 3 basis in the CY 2021 PFS final rule. Under our current policy, these services will be removed from the Medicare telehealth services list as of the date that the PHE for COVID-19 ends. We recognize that, during the time between the publication of the CY 2021 PFS final rule and this proposed rule, practitioners may have used that time to compile new evidence of clinical benefit to support addition to the Medicare telehealth services list on a category 3 basis, including information that suggests that a certain service would likely meet the category 1 or category 2 criteria if provided with more time. We are soliciting comment on whether any of the services that were added to the Medicare telehealth list for the duration of the PHE for COVID-19 should now be added to the Medicare telehealth list on a Category 3 basis to allow for additional data collection for submission for CMS to consider as part of the rulemaking process described in prior paragraphs.

Start Printed Page 39138

Start Printed Page 39139

Start Printed Page 39140

Start Printed Page 39141

Start Printed Page 39142

Start Printed Page 39143

Start Printed Page 39144

Start Printed Page 39145

d. Implementation of Provisions of the Consolidated Appropriations Act, 2021 (CAA)

The Consolidated Appropriations Act, 2021 (CAA) (Pub. L. 116-260, December 27, 2020) included a number of provisions pertaining to Medicare telehealth services. The Medicare telehealth statute at section 1834(m)(4)(C) of the Act generally limits the scope of telehealth services to those furnished in rural areas and in certain enumerated types of “originating sites” including physician offices, hospitals, and other medical care settings. Section 1834(m)(7) of the Act, (as added by section 2001(a) of the SUPPORT for Patients and Communities Act (Pub. L. 115-271, October 24, 2018), specifies that the geographic restrictions under section 1834(m)(4)(C)(i) of the Act do not apply, and includes the patient's home as a permissible originating site, for telehealth services furnished to a patient with a diagnosed substance use disorder (SUD) for treatment of that disorder or a co-occurring mental health disorder. Section 123(a) of Division CC of the CAA amended section 1834(m)(7)(A) of the Act to broaden the scope of services for which the geographic restrictions under section 1834(m)(4)(C)(i) of the Act do not apply and for which the patient's home is a permissible originating site to include telehealth services furnished for the purpose of diagnosis, evaluation, or treatment of a mental health disorder, effective for services furnished on or after the end of the PHE for COVID-19.[2]

Section 123(a) of the CAA also added subparagraph (B) to section 1834(m)(7) of the Act to prohibit payment for a telehealth service furnished in the patient's home under paragraph (7) unless the physician or practitioner furnishes an item or service in-person, without the use of telehealth, within 6 months prior to the first time the physician or practitioner furnishes a telehealth service to the beneficiary, and thereafter, at such times as the Secretary determines appropriate. However, section 123(a) of the CAA added a clarification at section 1834(m)(7)(B)(ii) of the Act that the periodic requirement for an in-person item or service does not apply if payment for the telehealth service furnished would have been allowed without the new amendments. As such, the requirement for a periodic in-person item or service applies only for telehealth services furnished for purposes of diagnosis, evaluation, or treatment of a mental health disorder other than for treatment of a diagnosed SUD or co-occurring mental health disorder, and only in locations that do not meet the geographic requirements in section 1834(m)(4)(C)(i) of the Act or when the originating site is the home of the patient, regardless of geography. We are seeking comment on whether we Start Printed Page 39146should adopt a claims-based mechanism to distinguish between the mental health telehealth services that are within the scope of the CAA amendments and those that are not (in other words, the services for which payment was newly authorized by the CAA amendments, and those for which payment was authorized before the CAA amendments), and if so, what that mechanism should be. In the event that we need to distinguish between the mental health telehealth services that are within the scope of the CAA amendments and those that are not we are also seeking comment on whether a clarification should be added to the regulation at § 410.78 as follows (which would take into account the other amendments we are proposing to § 410.78):

The requirement that the physician or practitioner must furnish an item or service in person, without the use of telehealth, within a specified time frame shall not apply to telehealth services furnished for treatment of a diagnosed substance use disorder or co-occurring mental health disorder, or to services furnished in an originating site described in paragraphs (b)(3)(i) through (viii) or (xiii) that meets the geographic requirements specified in paragraph (b)(4) other than (b)(4)(iv)(D).

As we noted above, section 123(a) of the CAA amends section 1834(m)(7)(B)(i)(I) of the Act to prohibit payment for telehealth services under that paragraph unless the physician or practitioner furnished an item or service to the patient in person, without the use of telehealth, within 6 months before the first telehealth service. Thereafter, section 1834(m)(7)(B)(i)(II) of the Act leaves the Secretary discretion to specify the times or intervals at which an in-person, non-telehealth service is required as a condition of payment for these telehealth services. Therefore, in order to implement the new statutory requirement to specify when an in-person service is required, we propose that, as a condition of payment for a mental health telehealth service described in section 1834(m)(7)(A) of the Act other than services described in section 1834(m)(7)(B)(ii) of the Act (that is, services for which payment was authorized before the CAA amendments), the billing physician or practitioner must have furnished an in-person, non-telehealth service to the beneficiary within the 6-month period before the date of the telehealth service.

We are also seeking comment on whether the required in-person, non-telehealth service could also be furnished by another physician or practitioner of the same specialty and same subspecialty within the same group as the physician or practitioner who furnishes the telehealth service. We note that the language in the CAA states that the physician or practitioner furnishing the in-person, non-telehealth service must be the same person as the practitioner furnishing the telehealth service. There are several circumstances, however, under which we have historically treated the billing practitioner and other practitioners of the same specialty or subspecialty in the same group as if they were the same individual. For instance, for purposes of deciding whether a patient is a new or established patient, or whether to bill for initial or subsequent visit, practitioners of the same specialty/subspecialty in the same group are treated as the same person. For example, when Physician A and Physician B are of the same specialty and subspecialty and in the same group, if Physician A furnishes an initial critical care service to a patient, and Physician B subsequently furnishes additional critical care services to the same beneficiary for the same condition on the same day, Physician B would bill for a subsequent critical care service rather than an initial critical care visit. As we explain in in section II.F.2 of this proposed rule, because practitioners in the same specialty and same group often cover for one another to provide concurrent services, we believe the total time for critical care services furnished to a patient on the same day by the practitioners in the same group with the same specialty should be reflected as if it were a single set of critical care services furnished to the patient. See section II.F.2 of this proposed rule for further discussion of our current and proposed policies for billing critical care services. Similarly, if Physician A furnished a service to a patient, and then Physician B furnished a service to the patient a few months later, that patient would be considered an established patient with respect to both Physician A and Physician B. For example, Physician B could initiate care management services for the patient as an established patient. An example of guidance to this effect can be found in the Medicare Claims Processing Manual (IOM Pub. 100-04, Chapter 12, § 30.6.7), which defines “new patient” as a patient who has not received any professional services, that is, E/M service or other face-to-face service (for example, surgical procedure) from the physician or physician group (same physician specialty) within the previous 3 years, for E/M services.

We note that this manual provision is also consistent with CPT guidance on whether a patient is a new or established patient.[3]

We are interested in comments regarding the extent to which a patient routinely receiving mental health services from one practitioner in a group might have occasion to see a different practitioner of the same specialty in that group for treatment of the same condition. This might occur when practitioners in a group cover for each other when a particular practitioner is unavailable or when a practitioner has left the group, but the beneficiary continues to receive services furnished by the group. In addition, fee-for-time compensation arrangements (formerly referred to as locum tenens arrangements), as described in section 1842(b)(6)(D) of the Act, allow for payment to be made to a physician for physicians' services (and services furnished incident to such services) furnished by a second physician to patients of the first physician if the first physician is unavailable to provide the services, and the services are furnished pursuant to an arrangement that is either informal and reciprocal, or involves per diem or other fee-for-time compensation for such services.

Recognizing the importance of ensuring access to mental health telehealth services to beneficiaries who are unable to see the same practitioner who furnished the prerequisite in-person services due to the practitioner's unavailability, we are seeking comments on an alternative policy to also allow the prerequisite in-person, non-telehealth service for certain mental health telehealth services to be furnished by a practitioner in the same specialty/subspecialty in the same group when the physician or practitioner who furnishes the telehealth service is unavailable or the two professionals are practicing as a team.

As amended by the CAA, section 1834(m)(7)(B)(i)(II) of the Act specifies that for subsequent mental health telehealth service, an in-person, non-telehealth service is required at such times as the Secretary determines appropriate. We are proposing to require that an in-person, non-telehealth service must be furnished by the physician or practitioner at least once within 6 months before each telehealth service furnished for the diagnosis, evaluation, or treatment of mental health disorders by the same practitioner, other than for Start Printed Page 39147treatment of a diagnosed SUD or co-occurring mental health disorder, and that the distinction between the telehealth and non-telehealth services must be documented in the patient's medical record. We distinguish between mental health services furnished for a diagnosed SUD or co-occurring mental health disorder and those furnished to beneficiaries without a SUD diagnosis on the basis of ICD-10 diagnosis codes included on claims when the services are billed. We chose this interval because we are concerned that an interval less than 6 months may impose potentially burdensome travel requirements on the beneficiary, but that an interval greater than 6 months could result in the beneficiary not receiving clinically necessary in-person care/observation. The proposed 6-month interval also matches the specified statutory interval for the initial telehealth service. We believe that a 6-month interval strikes an appropriate balance between these competing considerations, but are seeking comment on whether a different interval, whether shorter, such as 3-4 months or longer, such as 12 months, may be appropriate to balance program integrity and patient safety concerns with increased access to care. However, we note that regardless of the time interval we establish, the practitioner is not precluded from scheduling in-person visits at a more frequent interval should such visit be determined to be clinically appropriate or preferred by the patient.

As discussed below in this section of this proposed rule, “e. Payment for Medicare Telehealth Services Furnished Using Audio-Only Communication Technology,” we are proposing to revise our regulatory definition of “interactive telecommunications system” to permit use of audio-only communications technology for mental health telehealth services under certain conditions when provided to beneficiaries located in their home. Therefore, we are also seeking comment on whether it would be appropriate to establish a different interval for these telehealth services, for the diagnosis, evaluation, or treatment of mental health disorders, other than for treatment of diagnosed SUD or co-occurring mental health disorder, when furnished as permitted through audio-only communications technology.

In any event, we propose that there would need to be an in-person visit within 6 months of any telehealth service furnished for the diagnosis, evaluation, or treatment of mental health disorders (other than for treatment of a diagnosed SUD or co-occurring mental health disorder), and the in-person visit would need to be documented in the patient's medical record. Payment would not be made for these telehealth services unless the required in-person service was furnished within 6 months of the telehealth service.

Given the addition of the home of the individual as a permissible originating site for telehealth services for purposes of diagnosis, evaluation, or treatment of a mental health disorder, we are proposing to revise our regulation at § 410.78(b)(3) to add a new paragraph (xiv) to identify the home of a beneficiary as an originating site for telehealth services for the diagnosis, evaluation, or treatment of a mental health disorder, effective for services furnished on or after the first day after the end of the PHE as defined § 400.200 of our regulations; and to provide that payment will not be made for a telehealth service furnished under this paragraph unless the physician or practitioner has furnished an item or service in person, without the use of telehealth, for which Medicare payment was made (or would have been made if the patient were entitled to, or enrolled for, Medicare benefits at the time the item or service is furnished) within 6 months of the telehealth service. We are also proposing to revise our regulation at § 410.78(b)(4)(iv)(D) to specify that the geographic restrictions in § 410.78(b)(4) do not apply to telehealth services furnished for the diagnosis, evaluation, or treatment of a mental health disorder, effective for services furnished on or after the first day after the end of the PHE as defined in our regulation at § 400.200.

In addition, section 125(c) of the CAA amended section 1834(m)(4)(C)(ii) of the Act to add to the list of permissible telehealth originating sites a rural emergency hospital, which is a new Medicare provider type added by section 125 of the CAA effective beginning in CY 2023.

We are also proposing to amend our regulation at § 410.78, Telehealth services, to conform with the statutory change to include rural emergency hospitals as telehealth originating sites beginning in CY 2023. In accordance with section 1834(m)(4)(C)(ii)(XI) of the Act, as added by section 125(c) of the CAA, we propose to revise § 410.78(b)(3) of our regulations to add a rural emergency hospital, as defined in section 1861(kkk)(2) of the Act, as a permissible originating site for telehealth services furnished on or after January 1, 2023.

e. Payment for Medicare Telehealth Services Furnished Using Audio-Only Communication Technology

Section 1834(m) of the Act outlines the requirements for Medicare payment for telehealth services that are furnished via a “telecommunications system,” and specifies that, only for purposes of Medicare telehealth services through a federal telemedicine demonstration program conducted in Alaska or Hawaii, the term “telecommunications system” includes asynchronous, store-and-forward technologies. We further defined the term, “telecommunications system,” in the regulation at § 410.78(a)(3) to mean an interactive telecommunications system, which is defined as multimedia communications equipment that includes, at a minimum, audio and video equipment permitting two-way, real-time interactive communication between the patient and distant site physician or practitioner.

During the PHE for COVID-19, we used waiver authority under section 1135(b)(8) of the Act to temporarily waive the requirement, for certain behavioral health and/or counseling services and for audio-only evaluation and management (E/M) visits, that telehealth services must be furnished using an interactive telecommunications system that includes video communications technology. Therefore, for certain services furnished during the PHE for COVID-19, we make payment for these telehealth services when they are furnished using audio-only communications technology. Emergency waiver authority is no longer available after the PHE for COVID-19 ends, and telehealth services will again be subject to all statutory and regulatory requirements.

In the CY 2021 PFS final rule (85 FR 84535), we noted that we continued to believe that our longstanding regulatory definition of “telecommunications system” reflected the intent of statute and that the term should continue to be defined as including two way, real-time, audio/video communication technology.

Historically, we have not proposed any permanent modifications to the definition of “interactive telecommunications system” to allow for use of audio-only communications technology due to our interpretation of the statutory requirements, as well as concerns over program integrity and quality of care. Specifically, we were concerned that the use of audio-only communications technology for Medicare telehealth services could lead to inappropriate overutilization, and believed that video visualization of the patient generally was necessary to fulfill Start Printed Page 39148the full scope of service elements of the codes included on the Medicare telehealth list. We believe it is reasonable to reassess these concerns, given the now widespread utilization during the PHE for COVID-19 of Medicare telehealth services furnished using audio-only communication technology. Based upon an initial review of claims data collected during the PHE for COVID-19, which describe audio-only telephone E/M services, we observed that the audio-only E/M visits have been some of the most commonly performed telehealth services during the PHE, and that most of the beneficiaries receiving these services were receiving them for treatment of a mental health condition. Given the generalized shortage of mental health care professionals (https://bhw.hrsa.gov/​sites/​default/​files/​bureau-health-workforce/​data-research/​technical-documentation-health-workforce-simulation-model.pdf), and the existence of areas and populations where there is limited access to broadband due to geographic or socioeconomic challenges, we believe beneficiaries may have come to rely upon the use of audio-only communication technology in order to receive mental health services, and that a sudden discontinuation of this flexibility at the end of the PHE could have a negative impact on access to care.

As explained above, section 123 of the CAA removes the geographic restrictions for Medicare telehealth services for the diagnosis, evaluation, or treatment of a mental health disorder, and adds the patient's home as a permissible originating site for these telehealth services. We also believe that mental health services are different from most other services on the Medicare telehealth services list in that many of the services primarily involve verbal conversation where visualization between the patient and furnishing physician or practitioner may be less critical to provision of the service. While we continue to believe that two-way, audio/video communications technology is the appropriate, general standard for telehealth services, and that there may be particular instances where visual cues may help a practitioner's ability to assess and treat patients with mental health disorders, especially where opioids or other mental health medications are involved (for example, visual cues as to patient hygiene, or indicators of self-destructive behavior), we note that stakeholders have suggested to us that the availability of telehealth services for mental health care via audio-only communications technology would increase access to care. This is especially true in areas with poor broadband infrastructure and among patient populations that do not wish to use, do not have access to, and/or are unable to utilize devices that permit a two-way, audio/video interaction. Our preliminary analysis of Medicare claims data, as well as information provided to us by stakeholders on the popularity of these services, indicates that use of interactive communication technology for mental health care would likely continue to be high even beyond the circumstances of the COVID-19 pandemic. According to our analysis of Medicare Part B claims data for services furnished via Medicare telehealth during the PHE for COVID-19, utilization of telehealth for many professional services spiked around April 2020 and has diminished over the ensuing months. In contrast, preliminary analysis of Medicare claims data suggest that, for many mental health services that were permanently and temporarily added to the Medicare Telehealth list, there is a steady utilization trend from April 2020 and thereafter. Furthermore, as described above, according to preliminary analysis of claims data which examined utilization by diagnosis, the codes for audio-only E/M services have been highly utilized during the PHE, particularly for beneficiaries with mental health conditions.

Given these considerations, we now believe that it would be appropriate to revisit our regulatory definition of “interactive telecommunications system” beyond the circumstances of the PHE to allow for the inclusion of audio-only services under certain circumstances. Therefore, we are proposing to amend our regulation at § 410.78(a)(3) to define interactive telecommunications system to include audio-only communications technology when used for telehealth services for the diagnosis, evaluation, or treatment of mental health disorders furnished to established patients when the originating site is the patient's home. We believe this proposal is consistent with the expansion of at-home access to mental health telehealth services in section 1834(m)(7) of the Act, as amended by section 123 of the CAA, which required that the beneficiary must have received a Medicare-paid (or payable), in-person item or service from the physician or practitioner furnishing the mental health services through telehealth within 6 months of the first mental health telehealth service. We are proposing to adopt a similar ongoing requirement that an in-person item or service must be furnished within 6 months of such a mental health telehealth service. We reiterate that our proposed policy to permit audio-only telehealth services is limited to services where the home is the originating site. This is because the other enumerated telehealth originating sites are medical settings that are far more likely to have access to reliable broadband internet service. When a patient is located at one of these originating sites, access to care is far less likely to be limited by access to broadband that facilitates a video connection. In contrast, access to broadband, devices, and user expertise to enable a video connection is less likely to be available in the patient's home. As described in prior paragraphs, we also believe that mental health services are distinct from other kinds of services on the Medicare telehealth list in that many of the services do not necessarily require visualization of the patient to fulfill the full scope of service elements.

We are also proposing to limit payment for audio-only services to services furnished by physicians or practitioners who have the capacity to furnish two-way, audio/video telehealth services but are providing the mental health services via audio-only communication technology in an instance where the beneficiary is unable to use, does not wish to use, or does not have access to two-way, audio/video technology. We believe that this requirement will ensure that mental health services furnished via telehealth are only conducted using audio-only communication technology in instances where the use of audio-only technology is facilitating access to care that would be unlikely to occur otherwise, given the patient's technological limitations or preferences. In the interests of monitoring utilization and program integrity concerns for audio-only telehealth services furnished under the terms of this proposed exception, we are proposing to create a service-level modifier that would identify these mental health telehealth services furnished to a beneficiary in their home using audio-only communications technology. The use of this modifier would also serve to certify that the audio-only telehealth service meets the requirements for the exception specified in proposed on § 410.78(a)(3), including that the furnishing physician or practitioner has the capacity to furnish the service using interactive two-way, real-time audio/video communication technology, but instead used audio-only Start Printed Page 39149technology under the conditions specified in the regulation.

We are proposing to amend our regulation at § 410.78(a)(3) to specify that an interactive telecommunications system can include interactive, real-time, two-way audio-only technology for telehealth services furnished for the diagnosis, evaluation, or treatment of a mental health disorder as described under paragraph (b)(4)(D), under the following conditions: The patient is located in their home at the time of service as described at § 410.78 (b)(3)(xiv); the distant site physician or practitioner has the technical capability at the time of the service to use an interactive telecommunications system that includes video; and the patient is not capable of, or does not consent to, the use video technology for the service.

We are seeking comment on these proposals, as well as what, if any, additional documentation should be required in the patient's medical record to support the clinical appropriateness of providing audio-only telehealth services for mental health in the event of an audit or claims denial. Additional required documentation could include information about the patient's level of risk and any other guardrails that are appropriate to demonstrate clinical appropriateness, and minimize program integrity and patient safety concerns.

We are also seeking comment on whether, for purposes of the proposed audio-only mental health telehealth services exception, we should exclude certain higher-level services, such as level 4 or 5 E/M visit codes, when furnished alongside add-on codes for psychotherapy, or codes that describe psychotherapy with crisis. We are seeking comment on whether the full scope of service elements for these codes could be performed via audio-only communication technology. However, we also note that maintaining the availability of these services through audio-only communication technology might give patients access to care needed to address their higher level or acute mental health needs in instances where they are unable to access two-way, audio/video communication technology.

2. Other Non-Face-to-Face Services Involving Communications Technology Under the PFS

a. Expiration of PHE Flexibilities for Direct Supervision Requirements

Under section 1861 of the Act and at § 410.32(b)(3) of the regulations, Medicare requires certain types of services to be furnished under specific levels of supervision of a physician or practitioner, including diagnostic tests, services incident to physician services, and other services. For professional services furnished incident to the services of a billing physician or practitioner (see § 410.26) and many diagnostic tests (see § 410.32), direct supervision is required. Additionally, for pulmonary rehabilitation services (see § 410.47) and for cardiac rehabilitation and intensive cardiac rehabilitation services (see § 410.49), requirements for immediate availability and accessibility of a physician are considered to be satisfied if the physician meets the requirements for direct supervision for physician office services at § 410.26 and for hospital outpatient services at § 410.27. Outside the circumstances of the PHE, direct supervision requires the immediate availability of the supervising physician or other practitioner, but the professional need not be present in the same room during the service, and we have interpreted this “immediate availability” requirement to mean in-person, physical, not virtual, availability.

Through the March 31st COVID-19 IFC, we changed the definition of “direct supervision” during the PHE for COVID-19 (85 FR 19245 through 19246) as it pertains to supervision of diagnostic tests, physicians' services, and some hospital outpatient services, to allow the supervising professional to be immediately available through virtual presence using real-time audio/video technology, instead of requiring their physical presence. In the CY 2021 PFS final rule (85 FR 84538 through 84540), we finalized continuation of this policy through the later of the end of the calendar year in which the PHE for COVID-19 ends or December 31, 2021. In that rule, we also solicited comment on issues related to the policy allowing virtual provision of direct supervision, specifically whether there should be any additional guardrails or limitations put in place to ensure patient safety/clinical appropriateness, beyond typical clinical standards, and whether we should consider potential restrictions to prevent fraud or inappropriate use. We also stated that we will consider this and other information as we contemplate future policy regarding use of communication technology to satisfy supervision requirements, as well as the best approach for safeguarding patient safety while promoting use of technology to enhance access.

We also note that the temporary exception to allow immediate availability for direct supervision through virtual presence facilitates the provision of telehealth services by clinical staff of physicians and other practitioners incident to their own professional services. This is discussed in the March 31st COVID-19 IFC (85 FR 19246). This is especially relevant for services such as physical therapy, occupational therapy, and speech language pathology services, since those practitioners can only bill Medicare directly for telehealth services under telehealth waivers that are effective only during the PHE for COVID-19. We note that sections 1834(m)(4)(D) and (E) of the Act specifies the types of clinicians who may furnish and bill for Medicare telehealth services, and include only physicians as defined in section 1861(r) of the Act and practitioners described in section 1842(b)(18)(C) of the Act.

We continue to seek information on whether this flexibility should be continued beyond the later of the end of the PHE for COVID-19 or CY 2021. Specifically, we are seeking comment on the extent to which the flexibility to meet the immediate availability requirement for direct supervision through the use of real-time, audio/video technology is being used during the PHE, and whether physicians and practitioners anticipate relying on this flexibility after the end of the PHE. We are seeking comment on whether this flexibility should potentially be made permanent, meaning that we would revise the definition of “direct supervision” at § 410.32(b)(3)(ii) to include immediate availability through the virtual presence of the supervising physician or practitioner using real-time, interactive audio/video communications technology without limitation after the PHE for COVID-19, or if we should continue the policy in place for a short additional time to facilitate a gradual sunset of the policy. We are soliciting comment on whether the current timeframe for continuing this flexibility at § 410.32(b)(3)(ii), which is currently the later of the end of the year in which the PHE for COVID-19 ends or December 31, 2021, remains appropriate, or if this timeframe should be extended through some later date to facilitate the gathering of additional information in recognition that, due to the on-going nature of the PHE for COVID-19, practitioners may not yet have had time to assess the implications of a permanent change in this policy. We also seek comment regarding the possibility of permanently allowing immediate availability for direct supervision through virtual presence using real-time audio/video technology for only a subset of services, as we recognize that it may be inappropriate to allow direct Start Printed Page 39150supervision without physical presence for some services, due to potential concerns over patient safety if the practitioner is not immediately available in-person. We are also seeking comment on, were this policy to be made permanent, if a service level modifier should be required to identify when the requirements for direct supervision were met using two-way, audio/video communications technology.

b. Interim Final Provisions in the CY 2021 PFS Final Rule

In the CY 2021 PFS final rule (85 FR 84536), we finalized the establishment of HCPCS code G2252 (Brief communication technology-based service, e.g., virtual check-in service, 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; 11-20 minutes of medical discussion) on an interim basis. We stated that, given the widespread concerns expressed by commenters about the continuing need for audio-only conversations with patients and our determination that we would not continue to pay for audio-only E/M visits after the conclusion of the PHE (see 85 FR 84533 through 84535 for further discussion of that policy), we believed it would be expedient to establish additional coding and payment for an extended virtual check-in, which could be furnished using any form of synchronous communication technology, including audio-only, on an interim basis for CY 2021. We stated that we believed establishing payment for this service on an interim basis will support access to care for beneficiaries who may be reluctant to return to in-person visits unless absolutely necessary, and allow us to consider whether this policy should be adopted on a permanent basis. In that rule, we finalized a direct crosswalk to CPT code 99442, the value of which we believe most accurately reflects the resources associated with a longer service delivered via synchronous communication technology, which can include audio-only communication. Commenters supported the creation and interim final adoption of this service. Commenters stated that, as beneficiaries and practitioners may be reluctant to return to primarily in-person services post-PHE, payment for a longer virtual check-in would be necessary to account for circumstances where more time is spent determining whether an in-person visit is needed beyond the 5-10 minutes accounted for by 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). Commenters also supported valuing HCPCS code G2252 through a direct crosswalk to CPT code 99442. We agree with commenters that additional time may be needed to assess the necessity of an in-person service given concerns over exposure to illnesses beyond the duration of the PHE for COVID-19 and that current coding may not accurately reflect that time. Based on support from commenters, we are proposing to permanently adopt coding and payment for CY 2022, HCPCS code G2252 as described in the CY 2021 PFS final rule.

E. 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 new services. For CY 2017, we proposed new values in the CY 2017 PFS proposed rule for the vast majority of new, revised, and potentially misvalued codes for which we received complete RUC recommendations by February 10, 2016. To complete the transition to this new process, for codes for which we established interim final values in the CY 2016 PFS final rule with comment period (81 FR 80170), we reviewed the comments received during the 60-day public comment period following release of the CY 2016 PFS final rule with comment period (80 FR 70886), and 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 Start Printed Page 39151federal 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. Section 1848(c)(1)(A) of the Act specifically defines the work component as the resources that reflect time and intensity 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 E/M service, we believe that there is overlap between the two services in some of the activities furnished during the preservice evaluation and postservice time. Our longstanding adjustments have reflected a broad assumption that at least one-third of the work time in both the preservice evaluation and postservice period is duplicative of work furnished during the E/M visit.

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

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

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

We have observed that for many codes reviewed by the RUC, recommended work RVUs have appeared to be incongruous with recommended assumptions regarding the resource costs in time. This has been the case for 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 Start Printed Page 39152RVUs to account for significant changes in time, we have started by looking at the change in the time in the context of the RUC-recommended work RVU. When the recommended work RVUs do not appear to account for significant changes in time, we have employed the different approaches to identify potential values that reconcile the recommended work RVUs with the recommended time values. Many of these methodologies, such as survey data, building block, crosswalks to key reference or similar codes, and magnitude estimation have long been used in developing work RVUs under the PFS. In addition to these, we sometimes use the relationship between the old time values and the new time values for particular services to identify alternative work RVUs based on changes in time components.

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

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

Several stakeholders, including the RUC, have expressed general objections to our use of these methodologies and deemed our actions in adjusting the recommended work RVUs as inappropriate; other stakeholders have also expressed general concerns with CMS refinements to RUC-recommended values in general. In the CY 2017 PFS final rule (81 FR 80272 through 80277), we responded in detail to several comments that we received regarding this issue. In the CY 2017 PFS proposed rule (81 FR 46162), we requested comments regarding potential alternatives to making adjustments that would recognize overall estimates of work in the context of changes in the resource of time for particular services; however, we did not receive any specific potential alternatives. As described earlier in this section, crosswalks to key reference or similar codes are one of the many methodological approaches we have employed to identify potential values that reconcile the RUC-recommend work RVUs with the recommended time values when the RUC-recommended work RVUs did not appear to account for significant changes in time.

In response to comments, in the CY 2019 PFS final rule (83 FR 59515), we clarified that terms “reference services”, “key reference services”, and “crosswalks” as described by the commenters are part of the RUC's process for code valuation. These are not terms that we created, and we do not agree that we necessarily must employ them in the identical fashion for the purposes of discussing our valuation of individual services that come up for review. However, in the interest of minimizing confusion and providing clear language to facilitate stakeholder feedback, we will seek to limit the use of the term, “crosswalk,” to those cases where we are making a comparison to a CPT code with the identical work RVU. We also occasionally make use of a “bracket” for code valuation. A “bracket” refers to when a work RVU falls between the values of two CPT codes, one at a higher work RVU and one at a lower work RVU.

We look forward to continuing to engage with stakeholders and commenters, including the RUC, as we prioritize our obligation to value new, revised, and potentially misvalued codes; and will continue to welcome feedback from all interested parties regarding valuation of services for consideration through our rulemaking process. We refer readers to the detailed discussion in this section of the valuation considered for specific codes. Table 13 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, 2021. The proposed work RVUs, work time and other payment information for all CY 2022 payable codes are available on the CMS website under downloads for the CY 2022 PFS proposed rule at https://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​PhysicianFeeSched/​index.html).

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

a. Background

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

Our review and refinement of the RUC-recommended direct PE inputs includes many refinements that are common across codes, as well as refinements that are specific to particular services. Table 14 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 addressed certain refinements that would be common across codes. Refinements to particular codes are addressed in the portions of that section that are dedicated to particular codes. We noted that for each refinement, we Start Printed Page 39153indicated the impact on direct costs for that service. We noted 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 noted that many of the refinements listed in Table 14 result in changes under the $0.35 threshold and are unlikely to result in a change to the RVUs.

We also noted that the direct PE inputs for CY 2022 are displayed in the CY 2022 direct PE input files, available on the CMS website under the downloads for the CY 2022 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 2022 PE RVUs as displayed in Addendum B.

b. Common Refinements

(1) Changes in Work Time

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

(2) Equipment Time

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

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

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

(3) Standard Tasks and Minutes for Clinical Labor Tasks

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

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

(4) Recommended Items That Are Not Direct PE Inputs

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

(5) New Supply and Equipment Items

The RUC generally recommends the use of supply and equipment items that already exist in the direct PE input database for new, revised, and potentially misvalued codes. However, some recommendations include supply or equipment items that are not currently in the direct PE input database. In these cases, the RUC has historically recommended that a new item be created and has facilitated our pricing of that item by working with the specialty societies to provide us copies of sales invoices. For CY 2022 we received invoices for several new supply and equipment items. Tables 16 and 17 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 encourage 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 encourage stakeholders to submit invoices or other information to improve the accuracy of pricing for these items in the direct PE database by February 10th of the following year for consideration in future rulemaking, similar to our process for consideration of RUC recommendations.Start Printed Page 39154

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 16 and 17 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 include 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 list of services for the upcoming calendar year that are subject to the MPPR on diagnostic cardiovascular services, diagnostic imaging services, diagnostic ophthalmology services, and therapy services; and the 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; are displayed in the public use files for the PFS proposed and final rules for each year. The public use files for CY 2022 are available on the CMS website under downloads for the CY 2022 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).

Effective January 1, 2007, section 5102(b)(1) of the Deficit Reduction Act of 2005 (Pub. L. 109-171) (DRA) amended section 1848(b)(4) of the Act to require that, for imaging services, if—(i) The technical component (including the technical component portion of a global fee) of the service established for a year under the fee schedule without application of the geographic adjustment factor, exceeds (ii) The Medicare OPD fee schedule amount established under the prospective payment system (PPS) for hospital outpatient department services under section 1833(t)(3)(D) of the Act for such service for such year, determined without regard to geographic adjustment under paragraph (t)(2)(D) of such section, the Secretary shall substitute the amount described in clause (ii), adjusted by the geographic adjustment factor [under the PFS], for the fee schedule amount for such technical component for such year. As required by the section 1848(b)(4)(A) of the statute, for imaging services furnished on or after January 1, 2007, we cap the TC of the PFS payment amount for the year (prior to geographic adjustment) by the Outpatient Prospective Payment System (OPPS) payment amount for the service (prior to geographic adjustment). We then apply the PFS geographic adjustment to the capped payment amount. Section 1848(b)(4)(B) of the Act defines imaging services as “imaging and computer-assisted imaging services, including X-ray, ultrasound (including echocardiography), nuclear medicine (including PET), magnetic resonance imaging (MRI), computed tomography (CT), and fluoroscopy, but excluding diagnostic and screening mammography.” For more information regarding the history of the cap on the TC of the PFS payment amount under the DRA (the “OPPS cap”), we refer readers to the CY 2007 PFS final rule with comment period (71 FR 69659 through 69662).

For CY 2022, we identified new and revised codes to determine which services meet the definition of “imaging services” as defined above for purposes of this cap. Beginning for CY 2022, we are proposing to include the following services on the list of codes to which the OPPS cap applies: CPT codes 0633T (Computed tomography, breast, including 3D rendering, when performed, unilateral; without contrast material), 0634T (Computed tomography, breast, including 3D rendering, when performed, unilateral; with contrast material(s)), 0635T (Computed tomography, breast, including 3D rendering, when performed, unilateral; without contrast, followed by contrast material(s)), 0636T (Computed tomography, breast, including 3D rendering, when performed, bilateral; without contrast material(s)), 0637T (Computed tomography, breast, including 3D rendering, when performed, bilateral; with contrast material(s)), 0638T (Computed tomography, breast, including 3D rendering, when performed, bilateral; without contrast, followed by contrast material(s)), 0648T (Quantitative magnetic resonance for analysis of tissue composition (e.g., fat, iron, water content), including multiparametric data acquisition, data preparation and transmission, interpretation and report, obtained without diagnostic MRI examination of the same anatomy (e.g., organ, gland, tissue, target structure) during the same session), 0649T (Quantitative magnetic resonance for analysis of tissue composition (e.g., fat, iron, water content), including multiparametric data acquisition, data preparation and transmission, interpretation and report, obtained with diagnostic MRI examination of the same anatomy (e.g., organ, gland, tissue, target structure) (List separately in addition to code for primary procedure)), 77X01 (Trabecular bone score (TBS), structural condition of the bone microarchitecture; using dual X-ray absorptiometry (DXA) or other imaging data on gray-scale variogram, calculation, with interpretation and report on fracture risk), 77X02 Start Printed Page 39155(Trabecular bone score (TBS), structural condition of the bone microarchitecture; using dual X-ray absorptiometry (DXA) or other imaging data on gray-scale variogram, calculation, with interpretation and report on fracture risk, technical preparation and transmission of data for analysis to be performed elsewhere), 77X03 (Trabecular bone score (TBS), structural condition of the bone microarchitecture; using dual X-ray absorptiometry (DXA) or other imaging data on gray-scale variogram, calculation, with interpretation and report on fracture risk, technical calculation only), 77X04 (Trabecular bone score (TBS), structural condition of the bone microarchitecture; using dual X-ray absorptiometry (DXA) or other imaging data on gray-scale variogram, calculation, with interpretation and report on fracture risk interpretation and report on fracture risk only, by other qualified health care professional), 9111X (Gastrointestinal tract imaging, intraluminal (e.g., capsule endoscopy), colon, with interpretation and report), and 933X0 (3D echocardiographic imaging and postprocessing during transesophageal echocardiography or transthoracic echocardiography for congenital cardiac anomalies for the assessment of cardiac structure(s) (e.g., cardiac chambers and valves, left atrial appendage, intraterial septum, interventricular septum) and function, when performed). We believe these codes meet the definition of imaging services under section 1848(b)(4)(B) of the Act, and thus, should be subject to the OPPS cap.

4. Proposed Valuation of Specific Codes for CY 2022

(1) Anesthesia for Cardiac Electrophysiologic Procedures (CPT Code 00537)

In October 2019, the RUC reviewed CPT code 00537 (Anesthesia for cardiac electrophysiologic procedures including radiofrequency ablation) and recommended that the code be surveyed for the October 2020 meeting. This service was identified by the RUC via the high volume growth screen for services with total Medicare utilization of 10,000 or more that have increased by at least 100 percent from 2009 through 2014. Additionally, at the October 2019 RUC meeting, the RUC approved an anesthesia reference service list (RSL) and a method to assess the relativity among services on the anesthesia fee schedule that uses a revised building block methodology and a regression line analysis. The RUC has stated that the revised building block methodology generates “proxy RVUs” that are then compared against the RSL regression line to assess relativity among anesthesia services. The RUC has indicated that their primary and approved method for anesthesia base unit valuation continues to be the anesthesia survey results, and that the building block and regression line analysis are used as a supplemental validation measure.

The RUC recommended a valuation of 12 base units for CPT code 00537.We disagree with the RUC-recommended valuation of 12 base units for CPT code 00537. After performing a RUC database search of codes with similar total times and post-induction period procedure anesthesia (PIPPA) times, 12 base units appears to be on the very high range. We are proposing a valuation of 10 base units supported by reference codes CPT code 00620 (anesthesia for procedures on the thoracic spine and cord, not otherwise specified) and CPT code 00600 (Anesthesia for procedures on cervical spine and cord; not otherwise specified), which both have a valuation of 10 base units. CPT code 00620 has a very similar total time of 235 minutes and CPT code 00600 has a higher total time of 257 minutes and the same base unit value of 10, which indicates that this is an appropriate valuation. Additionally, we note that the survey total time for CPT code 00537 increased from 150 to 238 minutes, resulting in a survey result 25th percentile valuation of 10 base units.

We are proposing the RUC-recommended direct PE inputs for CPT code 00537.

(2) Anesthesia Services for Image-Guided Spinal Procedures (CPT Codes 01XX2, 01XX3, 01XX4, 01XX5, 01XX6, and 01XX7)

In 2017, the RUC identified CPT code 01936 (Anesthesia for percutaneous image guided procedures on the spine and spinal cord; therapeutic) as possibly needing refinement due to inaccurate reporting via the high volume growth screen. The Relativity Assessment Workgroup reviewed data on what procedures were reported with this anesthesia code. In October 2019, the Workgroup reviewed this service and recommended that it be referred to the CPT Editorial Panel to create more granular codes. In October 2020, the CPT Editorial Panel replaced CPT codes 01935 and 01936 with six new codes to report percutaneous image-guided spine and spinal cord anesthesia procedures. These CPT codes are 01XX2 (Anesthesia for percutaneous image-guided injection, drainage or aspiration procedures on the spine or spinal cord; cervical or thoracic), 01XX3 (Anesthesia for percutaneous image guided injection, drainage or aspiration procedures on the spine or spinal cord; lumbar or sacral), 01XX4 (Anesthesia for percutaneous image guided destruction procedures by neurolytic agent on the spine or spinal cord; cervical or thoracic), 01XX5 (Anesthesia for percutaneous image guided destruction procedures by neurolytic agent on the spine or spinal cord; lumbar or sacral), 01XX6 (Anesthesia for percutaneous image guided neuromodulation or intravertebral procedures (e.g., Kyphoplasty, vertebroplasty) on the spine or spinal cord; cervical or thoracic) and 01XX7 (Anesthesia for percutaneous image guided neuromodulation or intravertebral procedures (e.g., Kyphoplasty, vertebroplasty) on the spine or spinal cord; lumbar or sacral).

We are proposing the RUC-recommended valuation of 4 base units for CPT codes 01XX2, 01XX3, 01XX4, and 01XX5.

We disagree with the RUC-recommend valuation of 6 base units for CPT codes 01XX6 and 01XX7. After performing a RUC database search of codes with similar total times and post-induction period procedure anesthesia (PIPPA) times, 6 base units for CPT codes 01XX6 and 01XX7 appears to be a high valuation. We are proposing a valuation of 5 base units for both codes supported by a reference code, CPT code 00813 (Anesthesia for combined upper and lower gastrointestinal endoscopic procedures, endoscope introduced both proximal to and distal to the duodenum). CPT code 00813 has a valuation of 5 base units with a higher PIPPA time of 40 minutes as well as a higher total time of 70 minutes. The RUC notes that CPT codes 01XX6 and 01XX7 should have a higher base unit valuation than the other similar codes within this family due to the complex nature of these procedures that have a more intensive anesthesia process. The RUC supports their recommendation with a crosswalk code, CPT code 00732 (Anesthesia for upper gastrointestinal endoscopic procedures, endoscope introduced proximal to duodenum; endoscopic retrograde cholangiopancreatography (ECRP)). CPT code 00732 has a valuation of 6 base units, a total time of 100 minutes, and a PIPPA time of 65 minutes. CPT codes 01XX6 and 01XX7 have a total time of 58 minutes and a PIPPA time of 20 minutes. We agree that a more complex procedure may require a higher base unit valuation within a code family; however, given the disparity in total and PIPPA time, we disagree with the use of Start Printed Page 39156this crosswalk code to support a valuation of 6 base units and instead propose a valuation of 5 base units supported by reference CPT code 00813, which has higher times and the same base unit valuation.

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

(3) Closed Treatment of Nasal Bone Fracture (CPT Codes 21315 and 21320)

We agree with the RUC's recommendation to change CPT codes 21315 (Closed treatment of nasal bone fracture; without stabilization) and 21320 (Closed treatment of nasal bone fracture; with stabilization) to 000-day global period codes from 010-day global period codes to account for the degree of swelling within 10 days post-procedure, and because the patient can remove their own splint at home for CPT code 21320. For CPT codes 21315 and 21320, we disagree with the RUC-recommended work RVUs of 2.00 and 2.33, respectively, as we believe these values do not adequately reflect the surveyed reductions in physician time and the change to a 000-day global period from a 010-day global period for these CPT codes. We are proposing a work RVU of 0.96 for CPT code 21315 and 1.59 for CPT code 21320 based on the reverse building block methodology to remove the RVUs associated with the 010-day global period and the surveyed reductions in physician time. We believe that the proposed work RVU of 0.96 for CPT code 21315 adequately accounts for the 50 percent decrease in intraservice and postservice time, a 31-minute decrease in total time, and a change to a 000-day global period which will allow for separately billable E/M visits as medically necessary. We believe that the proposed work RVU of 1.59 for CPT code 21320 adequately accounts for the 5-minute decrease in intraservice time, 3-minute decrease in total time, and 48 percent decrease in postservice time. Absent an explicitly stated rationale for an intensity increase for CPT codes 21315 and 21320, we are proposing to adjust the work RVU to reflect significant decreases in surveyed physician time.

The global period changes from 010-day to 000-day allow for separately billable E/M visits relating to CPT codes 21315 and 21320, therefore we removed RVUs that we believed were attributable to the currently bundled E/M visits totaling 1.30 RVUs for CPT code 21315 and 0.35 RVUs for CPT code 21320. CPT code 21315 is currently bundled with one post-operative follow up office visit, CPT code 99213 (Office or other outpatient visit for the evaluation and management of an established patient, which requires a medically appropriate history and/or examination and low level of medical decision making. When using time for code selection, 20-29 minutes of total time is spent on the date of the encounter). CPT code 21320 is currently bundled with half of a post-operative follow up office visit, CPT code 99212 (Office or other outpatient visit for the evaluation and management of an established patient, which requires a medically appropriate history and/or examination and straightforward medical decision making. When using time for code selection, 10-19 minutes of total time is spent on the date of the encounter). We do not believe the RUC adequately accounted for the loss of these E/M visits in their recommended work RVUs for CPT codes 21315 and 21320. The RUC's recommendations also seem to dismiss the significant changes in surveyed physician time, without a persuasive explanation of a significant increase in IWPUT that results from the RUC's recommended work RVUs for CPT codes 21315 and 21320. We believe the surveyed decreases in physician time in conjunction with the loss of the post-operative visits for CPT codes 21315 and 21320 merit decreases in the work RVUs from the current work RVUs.

We considered using a modified total time ratio methodology given the age and potentially flawed methodology used to arrive at the current valuation. The modified total time ratio calculation does not include the loss of 8 minutes of post-operative time attributable to the change from a 010-day global period to a 000-day global period for CPT code 21320 and loss of 23 minutes of post-operative time for CPT code 23215. This modified time ratio methodology reflects how the physician time is changing in the pre-, intra-, and postservice periods when a code's global period is changing, given that E/M services can be billed as medically necessary and appropriate for a 000-day global code. The total time ratio between the current and proposed total times for CPT code 21315, excluding the 23 minutes of post-operative time in the current total time, equals 1.64. We arrived at 1.64 by modifying the original total time ratio equation to equal the proposed new total time divided by the current time, less any time attributable to the post-operative global period, then multiplied by the current work RVU. The current total time for CPT code 21315 without the 23 minutes of post-operative time that will be lost by going from a 010-day to a 000-day global period code is 76 minutes, therefore, the modified total time ratio = (68 minutes/(99 minutes−23 minutes)) * 1.83 = 1.64. When using the original total time ratio methodology for CPT code 21315, it shows a 31 percent decrease in total time [(68 minutes−99 minutes)/99 minutes = −0.31], whereas the modified methodology shows that there is only an 11 percent decrease in newly proposed pre-, intra-, and postservice time from the current times [(68 minutes−76 minutes)/76 minutes = −0.11]. The same modified total time ratio methodology could be applicable to CPT code 21320. The current total time for CPT code 21320 without the 8 minutes of post-operative time that will be lost by going from a 010-day to a 000-day global period code is 70 minutes, therefore, the modified total time ratio = (75 minutes/(78 minutes−8 minutes) * 1.88 = 2.01. The modified methodology shows that the pre-, intra-, and postservice time is increasing by 7 percent for CPT code 21320, whereas the original methodology, which accounts for the loss of the 8 post-operative minutes in the total time ratio, shows a 4 percent decrease in total time that would indicate the need for a work RVU decrease. We recognize that we have not previously used a modified total time approach to consider work RVU values when there is a change in the global period for a service in conjunction with significant surveyed changes to the pre-, intra-, and postservice times; therefore, we are seeking comment on application of the modified total time ratio approach to value services that have a global period change and significant surveyed physician time changes. We believe this methodology may account for the loss of post-operative visits and the surveyed changes in the pre-, intra-, and postservice times in this unique situation, given the potentially flawed methodology used to arrive at the current valuations for CPT codes 21315 and 21320 that are used in the total time ratios.

We are also proposing the RUC-recommended direct PE inputs without refinements and the surveyed physician times for CPT codes 21315 and 21320.

(4) Insertion of Interlaminar/Interspinous Device (CPT Code 22867)

We are proposing the RUC-recommended work RVU of 15.00 for CPT code 22867 (Insertion of interlaminar/interspinous process stabilization/distraction device, without fusion, including image guidance when performed, with open decompression, lumbar; single level). The RUC is not recommending changes to the current Start Printed Page 39157PE inputs, and CMS is not proposing any changes to the current PE inputs.

(5) Treatment of Foot Infection (CPT Codes 28001, 28002, and 28003)

Through a screen of codes with 010-day global period service with more than one post-operative follow-up office visit, the RUC identified this family of major surgical codes that did not have consistent global periods. The RUC conducted a survey of these codes as 000-day globals for their April 2020 meeting, and the review was postponed until October 2020. CPT code 28001 (Incision and drainage, bursa, foot) (work RVU of 2.78 with 31 minutes of intraservice time) currently has a 010-day global period with one post-operative follow-up office visit, 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). Survey results from podiatrists and orthopedic surgeons yielded a median work RVU of 2.00 with 17 minutes of preservice evaluation time, 3 minutes of preservice positioning time, 5 minutes of preservice scrub/dress/wait time, 20 minutes intraservice time, and 15 minutes immediate postservice time for a total of 60 minutes total time. We are proposing the RUC-recommended work RVU of 2.00 and the surveyed physician times for this 000-day global code.

CPT code 28002 (Incision and drainage below fascia, with or without tendon sheath involvement, foot; single bursal space) (work RVU of 5.34 with 30 minutes of intraservice time) currently has a 010-day global period with two post-operative follow-up office visits, 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 family'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); and a half day hospital discharge CPT code 99238 (Hospital discharge day management; 30 minutes or less). For CPT code 28002, the RUC recommended 30 minutes of preservice evaluation time, 5 minutes of preservice positioning time, 15 minutes of preservice scrub/dress/wait time, 30 minutes of intraservice time, and 20 minutes of immediate postservice time, for a total of 100 minutes total time. The RUC recommended a work RVU of 3.50 and the surveyed physician times for this 000-day global code.

We note that the result from the survey's 50th percentile work RVU was 3.73 and that the survey's 25th percentile work RVU was 2.80. As this CPT code is converting from a 010-day global to a 000-day global we find the reference CPT code 43193 (Esophagoscopy, rigid, transoral; with biopsy, single or multiple) as a more suitable value of 2.79 work RVUs with a similar 30 minutes of intraservice physician time and 106 minutes of total time. We are proposing a work RVU of 2.79 for CPT code 28002 and we are proposing the RUC surveyed physician times for this 000-day global code.

CPT code 28003 (Incision and drainage below fascia, with or without tendon sheath involvement, foot; multiple areas) currently has a 090-day global period with two post-operative follow-up office visits, 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); three post-operative follow-up office visits, 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 family'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.); one post-operative CPT code 99231 (Subsequent hospital care, per day, for the evaluation and management of a patient, which requires at least 2 of these 3 key components: A problem focused interval history; A problem focused examination; Medical decision making that is straightforward or 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 patient is stable, recovering or improving. Typically, 15 minutes are spent at the bedside and on the patient's hospital floor or unit); one post-operative CPT code 99232 (Subsequent hospital care, per day, for the evaluation and management of a patient, which requires at least 2 of these 3 key components: An expanded problem focused interval history; An expanded problem focused 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 patient is responding inadequately to therapy or has developed a minor complication. Typically, 25 minutes are spent at the bedside and on the patient's hospital floor or unit), and one hospital discharge CPT code 99238 (Hospital discharge day management; 30 minutes or less), for a total of eight post op follow-up visits, across five types of E/M and hospital care codes. For CPT code 28003, the RUC recommends 40 minutes of preservice evaluation time, 10 minutes of preservice positioning time, 15 minutes of preservice scrub/dress/wait time, 45 minutes of intraservice time, and 20 minutes of immediate postservice time, for a total time of 130 minutes. We are proposing the RUC-recommended work RVU of 5.28 and surveyed physician times for this 000-day global code.

In order to complete the adjustments for making these Treatment of Foot Infection codes consistent as 000-day global codes, the RUC adjusted the PE inputs for these codes to reflect their proposed global periods from 010 and 090-day globals to 000-day global, and to reflect the use of more typical supplies, equipment, and clinical labor Start Printed Page 39158employed now, than what was necessary a decade ago. Some relatively small valued supply items were removed, while other items were added, and clinical labor times were largely adjusted to remove minutes from the post-operative follow-up office visit times in the 010 and 090-day global codes. We are proposing all of the PE refinements as recommended by the RUC for these codes, which can be found in section II.B. of this proposed rule, under the Determination of Practice Expense RVUs.

(6) Percutaneous Cerebral Embolic Protection (CPT Codes 33XXX)

CPT code 33XXX (Transcatheter placement and subsequent removal of cerebral embolic protection device(s), including arterial access, catheterization, imaging, and radiological supervision and interpretation, percutaneous (List separately in addition to code for primary procedure)) was created in October 2020, by the CPT Editorial Panel as a new add-on code to report transcatheter placement and subsequent removal of cerebral embolic protection device(s). The CPT Editorial Panel also added instructions to report the new code in the Aortic Valve guidelines. The RUC reviewed the survey results for the new add-on code and noted that the survey respondents likely overvalued the physician work involved in performing this service, with a 25th percentile work value of 3.43. The RUC recommends a work RVU of 2.50 for CPT code 33XXX.

We are proposing the RUC-recommended work RVU of 2.50 for CPT code 33XXX. This is a facility-based add-on code with no direct PE inputs.

(7) Exclusion of Left Atrial Appendage (CPT Codes 33XX3, 33XX4, and 33XX5)

In May 2020, the CPT Editorial Panel approved the creation of three new codes to describe open and thoracoscopic left atrial appendage management procedures when performed as stand-alone procedures or in conjunction with other procedures. The codes represent new technology and surgical techniques that may be used to treat atrial fibrillation at the time of another surgical procedure and include CPT code 33XX3 (Exclusion of left atrial appendage, open, any method (e.g., excision, isolation via stapling, oversewing, ligation, plication, clip), CPT code 33XX4 (Exclusion of left atrial appendage, open, performed at the time of other sternotomy or thoracotomy procedure(s), any method (e.g., excision, isolation via stapling, oversewing, ligation, plication, clip) (List separately in addition to code for primary procedure)), and CPT code 33XX5 (Exclusion of left atrial appendage, thoracoscopic, any method (e.g., excision, isolation via stapling, oversewing, ligation, plication, clip). CPT codes 33XX3 and 33XX5 are 090-day global codes while CPT code 33XX4 is a ZZZ global code.

In October 2020, the RUC reviewed and recommended work and PE values for the three new codes. Recommended work values include 18.50 RVUs for CPT code 33XX3, 2.50 work RVUs for CPT code 33XX4, and 14.31 work RVUs for CPT code 33XX5.

We are proposing the RUC-recommended work RVUs for the three new codes. We are also proposing the RUC-recommended direct PE inputs for CPT codes 33XX3 and 33XX5. We note that CPT code 33XX4 has no direct PE inputs.

(8) Endovascular Repair of Aortic Coarctation (CPT Codes 338X1, 338X2, and 338X0)

In October 2020, the CPT Editorial Panel created CPT codes 338X1 (Endovascular stent repair of coarctation of the ascending, transverse, or descending thoracic or abdominal aorta, involving stent placement; across major side branches) and 338X2 (Endovascular stent repair of coarctation of the ascending, transverse, or descending thoracic or abdominal aorta, involving stent placement; not crossing major side branches) to report endovascular stent repair of coarctation of the thoracic or abdominal aorta; and CPT code 338X0 (Percutaneous transluminal angioplasty of native or recurrent coarctation of the aorta) to report trans-liminal angioplasty for repair of native or recurrent percutaneous coarctation of the aorta. For CY 2022, the RUC recommended a work RVU of 21.70 for CPT code 338X1, a work RVU 17.97 for CPT code 338X2, and a work RVU 14.00 for CPT code 338X0.

We disagree with the RUC-recommended work RVUs for the CPT code family of 338X1, 338X2, and 338X0. We found that the recommended work RVUs for these CPT codes were high when compared to other codes with similar time values. Therefore, we are proposing the RUC survey 25th percentile of 18.27 as the work RVU for 338X1, we are proposing a work RVU of 14.54 for 338X2, and we are proposing a work RVU of 10.81 for 338X0.

When we reviewed CPT code 338X1, we found that the recommended work RVU was high compared to other codes with similar time values. The RUC survey 25th percentile of 18.27 falls within the range of RVUs with similar intra service time. This is supported by the reference CPT codes we compared to CPT code 338X1 with intra service time similar to the 134 minutes of intra service time for CPT code 338X1; reference CPT code 37231 (Revascularization, endovascular, open or percutaneous, tibial, peroneal artery, unilateral, initial vessel; with transluminal stent placement(s) and atherectomy, includes angioplasty within the same vessel, when performed) has a work RVU of 14.75 with 135 minutes of intra service time, and CPT code 93590 (Percutaneous transcatheter closure of paravalvular leak; initial occlusion device, mitral valve) has a work RVU of 21.70 with 135 minutes of intra service time. We note that the RUC-recommended RVU of 21.70 is a crosswalk from CPT code 93590 and is the highest value code within the range of reference codes we reviewed with similar intra service time. Again, we believe the RUC survey 25th percentile of 18.27 is a more appropriate value overall than 21.70 when compared to the range of codes with similar intra service time.

The RUC-recommended RVU of 17.97 for CPT code 338X2 was higher than other codes with the same 120 minutes of intra service time and similar total time. Although we disagree with the RUC-recommended work RVU for 338X2, we concur that the relative difference in work between CPT codes 338X1 and 338X2 is equivalent to the RUC-recommended interval of 3.73 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 codes where it is important to maintain an appropriate intra-family relativity. Therefore, we are proposing a work RVU of 14.54 for CPT code 338X2, based on the RUC-recommended interval of 3.73 RVUs below our proposed work RVU of 18.27 for CPT code 338X1.

The RUC-recommended work RVU of 14.00 for CPT code 338X0 was higher than other codes with the same 90 minutes of intra service time and similar total time and we believe it would be more accurate to propose a work RVU that maintains the 3.73 incremental difference between the codes in this family. Therefore, for CPT code 338X0, we propose a work RVU of 10.81 which also continues the 3.73 incremental difference used between CPT codes 338X1 and 338X2, instead of the RUC incremental difference of 3.97 between CPT codes 338X2 and 338X0. Although Start Printed Page 39159the work RVU of 10.81 we are proposing for CPT code 338X0 is lower than the RUC recommendation, the 3.73 incremental difference between CPT codes 338X2 and 338X0 we are proposing is more generous than the RUC incremental difference of 3.97 between CPT codes 338X2 and 338X0.

We are proposing no direct PE inputs for the CPT code family of 338X1, 338X2, and 338X0, as recommended by the RUC. These services are provided exclusively in the facility setting.

(9) Harvest of Upper Extremity Artery (CPT Codes 35XX0 and 35600)

In May 2020, the CPT Editorial Panel created CPT code 35XX0 (Harvest of upper extremity artery, 1 segment, for coronary artery bypass procedure, endoscopic) to describe endoscopic radial artery harvest via an endoscopic approach, and CPT code 35600 (Harvest of upper extremity artery, 1 segment, for coronary artery bypass procedure, open) was modified to only include an open approach for the upper extremity harvesting procedure. The RUC also stated that CPT codes 35XX0 and 35600 are almost always exclusively performed in conjunction with coronary artery bypass grafting (CABG) procedures. For CY 2022, the RUC-recommended a work RVU of 3.75 for CPT code 35XX0 and a work RVU of 4.00 for CPT code 35600.

We disagree with the RUC-recommended RVUs for the CPT code family of 35XX0 and 35600. We found that the recommended work RVUs for these CPT codes were high when compared to other codes with similar time values. Therefore, we are proposing 3.34 as the work RVU for 35XX0 and we are proposing a work RVU of 3.59 for 35600.

We disagree with the RUC-recommended work RVU for CPT code 35XX0 and are proposing an RVU of 3.34 which is a direct work RVU crosswalk from CPT code 35686 (Creation of distal arteriovenous fistula during lower extremity bypass surgery (non-hemodialysis) (List separately in addition to code for primary procedure)). The RUC-recommended value of 3.75 is higher than other codes with similar intra service time and total time. This is supported by the reference CPT codes we compared to CPT code 35XX0 with the same 35 minutes of intra service time and 35 minutes of total time as CPT code 35XX0; reference CPT code 74713 (Magnetic resonance (e.g., proton) imaging, fetal, including placental and maternal pelvic imaging when performed; each additional gestation (List separately in addition to code for primary procedure)) has a work RVU of 1.85, and CPT code 35686 has a work RVU of 3.34.

Although we disagree with the RUC-recommended work RVU for CPT code 35600, we concur that the relative difference in work between CPT codes 35XX0 and 35600 is equivalent to the RUC-recommended interval of 0.25 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 codes where it is important to maintain an appropriate intra-family relativity. Therefore, we are proposing a work RVU of 3.59 for CPT code 35600, based on the RUC-recommended interval of 0.25 RVUs above our proposed work RVU of 3.34 for CPT code 35XX0.

We are proposing no direct PE inputs for the CPT code family of 35XX0 and 35600 as recommended by the RUC. These services are provided exclusively in the facility setting.

The RUC acknowledged that CPT codes 35XX0 and 35600 are almost always exclusively performed in conjunction with coronary artery bypass grafting (CABG) procedures. Such codes are designated as add-on procedures and are assigned a ZZZ-day global period (that is, code related to another service and is always included in the global period of the other service). The RUC also requested that the global period for both CPT codes 35XX0 and 35600 be an XXX-day global period (that is, global concept does not apply) and not a ZZZ-day global period as is customary for add-on codes. The RUC stated that an XXX-day global period would allow the individual that performs the harvest of upper extremity artery procedure (often separate from the surgeon performing the base CABG procedure) to report it under their own provider number. The RUC noted that it is often a nurse practitioner (NP) or physician's assistant (PA) who performs the harvest procedure. However, the RUC surveyed CPT codes 35XX0 and 35600 using reference codes with the ZZZ-day global period. Therefore, we believe it is appropriate to use that same ZZZ-day global period for CPT codes 35XX0 and 35600, and we are proposing to assign the ZZZ-day global period to CPT codes 35XX0 and 35600 for CY 2022. Through our scrutiny of comparing the code descriptions of codes with matching intra service times, we find much more clinically coherent similarities with codes with a ZZZ-day global period (procedures complementary, and sometimes necessary, to complete a larger procedure) than codes with an XXX-day global period.

However, we are compelled to understand more about the billing circumstances presented by the RUC and stakeholders that have presented this approach for CPT codes 35XX0 and 35600 to CMS for consideration. We are seeking comments and requesting information that may inform why CPT codes 35XX0 and 35600 should have an XXX-day global period instead of the ZZZ-day global period that is customary for add-on codes.

(10) Needle Biopsy of Lymph Nodes (CPT Code 38505)

CPT code 38505 (Biopsy or excision of lymph node(s); by needle, superficial (e.g., cervical, inguinal, axillary)) was identified in October 2019 as Harvard Valued with a utilization of over 30,000 claims. In January 2020, the RUC recommended that the code be surveyed for October 2020 RUC meeting. The RUC recommended increasing the work RVU to 1.59 which is the survey 25th percentile, acknowledging a change in the service, which now involves larger tissue samples as well as a change in technology, and a change in the dominant specialty now reporting the service.

We are proposing the RUC-recommended work RVU of 1.59 for CPT code 38505. We are also proposing the RUC-recommended direct PE inputs for this code.

(11) Drug Induced Sleep Endoscopy (CPT Codes 42XXX)

CPT code 42XXX (Drug induced sleep endoscopy; with dynamic evaluation of velum, pharynx, tongue base, and larynx for evaluation of sleep disordered breathing; flexible, diagnostic) is a new code created to report drug induced sleep endoscopy (DISE) flexible, diagnostic. The RUC recommended, and we agree, that the survey 25th percentile for the work RVU of 1.90 accurately reflects the typical physician work necessary to perform this service.

Since this is a drug induced sleep endoscopy, we are proposing CPT code 31575 (Diagnostic laryngoscopy) as the endoscopic base code for CPT code 42XXX because the description of the proposed CPT code is the same as what is described for CPT code 31575 with the additional component of the patient being sedated. The procedure is performed with a flexible endoscope or laryngoscope. CPT code 42XXX is not an add-on code, it has a 0-day global period. The endoscopic base code that it is using is a specific type of multiple procedure discount that applies to some endoscopy codes.

We are proposing the RUC-recommended work RVU of 1.90 for Start Printed Page 39160CPT code 42XXX. We are also proposing the RUC-recommended direct PE inputs for this code.

(12) Per-Oral Endoscopic Myotomy (POEM) (CPT Codes 434XX)

In May 2020, the CPT Editorial Panel created a new CPT code 434XX (Lower esophageal myotomy, transoral (i.e., peroral endoscopic myotomy [POEM])) to describe a Per-Oral Endoscopic Myotomy (POEM), which involves the visualization and dissection of the esophageal muscle layers via an endoscope to treat esophageal motility disorders such as achalasia. This procedure accomplishes a comparable myotomy to what traditional open and laparoscopic myotomy (Heller) accomplishes. POEM utilizes an endoscope and specially designed dissecting, cutting, and cauterizing instruments to create a long submucosal tunnel beginning in the mid-esophagus and extending several centimeters into the cardia. For CY 2022, the RUC recommended a work RVU of 15.50 for CPT code 434XX.

We disagree with the RUC-recommended work RVU for CPT code 434XX and are proposing a work RVU of 13.29 based on a direct work RVU crosswalk from CPT code 36819 (Arteriovenous anastomosis, open; by upper arm basilic vein transposition). CPT code 36819 has the same 120 minutes of intra service time as CPT code 434XX, and has 283 minutes of total time, which is 2 minutes more than the 281 minutes of total time than for 434XX. The RUC used CPT codes 43279 (Laparoscopy, surgical, esophagomyotomy (Heller type), with fundoplasty, when performed) and 43180 (Esophagoscopy, rigid, transoral with diverticulectomy of hypopharynx or cervical esophagus (e.g., Zenker's diverticulum), with cricopharyngeal myotomy, includes use of telescope or operating microscope and repair, when performed) as reference codes for CPT code 434XX. However, the intra service time of 150 minutes and total time of 404 minutes for the RUC reference CPT code 43279, and intra service time of 60 minutes and total time of 201 minutes for the RUC reference CPT code 43180, are not adequate comparisons since they do not have similar time values to those of CPT code 434XX. Therefore, we believe the proposed work RVU of 13.29 for CPT code 434XX based on a direct work RVU crosswalk from CPT code 36819 is a better representation of the work being performed and is more appropriate based on the same intra service time and similar total time.

We are proposing the RUC-recommended direct PE inputs for CPT code 434XX without refinement.

(13) Placement-Removal of Seton (CPT Codes 46020 and 46030)

For CPT codes 46020 (Placement of seton) and 46030 (Removal of anal seton, other marker), we disagree with the RUC-recommended work RVUs of 3.50 and 2.00, respectively, as we believe these values do not adequately reflect the surveyed reductions in physician time for CPT code 46020 and the change to a 000-day global period from a 010-day global period for these CPT codes. Instead, we are proposing a work RVU of 1.86 for CPT code 46020 and 1.48 for CPT code 46030 based on a reverse building block methodology.

The survey showed that total time and intraservice time are decreasing for CPT code 46020 by 26 minutes and 5 minutes, respectively. We believe the surveyed decreases in physician time in conjunction with the loss of the post-operative visits for CPT code 46020 merit a decrease in work RVU from the current work RVU.

We note that the proposed work RVU of 1.48 for CPT code 46030 falls between CPT code 57410 (Pelvic examination under anesthesia (other than local)), which has a work RVU of 1.75, and CPT code 64487 (Transversus abdominis plane (TAP) block (abdominal plane block, rectus sheath block) unilateral; by continuous infusion(s) (includes imaging guidance, when performed)), which has a work RVU of 1.48. Both of these bracketing reference codes have identical intraservice times and similar total time values. While we understand that total time is going up for CPT code 46030, this increase is a result of significant increases to evaluation, positioning, and scrub, dress, wait preservice times, which is mostly low-intensity physician work.

We agree with the RUC's recommendation to change CPT codes 46020 and 46030 to 000-day global period codes from 010-day global period codes to account for the highly variable follow-up care for these services, but we note that the differences in RUC-recommended work RVUs and our proposed work RVUs largely reflect the change in global period and loss of physician time to provide the E/M services. The global period changes from 010-day to 000-day allow for separately billable E/M visits relating to CPT codes 46020 and 46030, therefore we removed RVUs that we believed were attributable to the currently bundled E/M visits totaling 2.04 RVUs for CPT code 46020 and 0.35 RVUs for CPT code 46030. CPT code 46020 is currently bundled with two post-operative follow up office visits, CPT code 99212 (Office or other outpatient visit for the evaluation and management of an established patient, which requires a medically appropriate history and/or examination and straightforward medical decision making. When using time for code selection, 10-19 minutes of total time is spent on the date of the encounter), and a half hospital discharge CPT code 99238 (Hospital discharge day management; 30 minutes or less). CPT code 46030 is currently bundled with half of a post-operative follow up office visit, CPT code 99212 (Office or other outpatient visit for the evaluation and management of an established patient, which requires a medically appropriate history and/or examination and straightforward medical decision making. When using time for code selection, 10-19 minutes of total time is spent on the date of the encounter). We do not believe the RUC adequately accounted for the loss of these E/M visits in their recommended work RVUs for CPT codes 46020 and 46030.

The RUC proposed the standard 090-day preservice times for the clinical labor activities CA001, CA002, CA003, CA004, and CA005 for CPT code 46020 in the facility. We note that the RUC recommended 090-day preservice clinical labor times despite surveying the service as a 000-day service. We disagree with the RUC-recommended 090-day preservice clinical labor times as we believe 000-day services should have times consistent with 000-day services, not 090-day services. However, we recognize there is time needed to coordinate this service. Therefore, we are proposing the following standard clinical labor times for extensive use of clinical staff for a 000-day global code:

  • Complete preservice diagnostic and referral forms (CA001) 5 minutes.
  • Coordinate pre-surgery services (including test results) (CA002) 10 minutes.
  • Schedule space and equipment in facility (CA003) 5 minutes.
  • Provide preservice education/obtain consent (CA004) 7 minutes.
  • Complete pre-procedure phone calls and prescription (CA005) 3 minutes.

We are also proposing to refine the direct PE input for Coordinate post-procedure services (CA038) to 0 minutes from the RUC-recommended 3 minutes to align with 000-day standards instead of 090-day standards for CPT code 46020.

For CPT code 46030, the RUC recommended the standard 000-day Start Printed Page 39161extensive use of clinical staff preservice times for clinical activities CA001, CA002, CA003, CA004, and CA005 in the facility and non-facility settings. Preservice times for 000-day codes are presumed to be zero unless there is sufficient justification that preservice time is warranted. We do not agree that sufficient justification was presented to warrant preservice time in the non-facility setting, therefore, we are proposing the following standard clinical labor times for use of clinical staff in the non-facility setting. We are also proposing the standards for minimal use of clinical staff in the facility setting, as we recognize there is time needed to coordinate this service for CPT code 46030:

  • Complete preservice diagnostic and referral forms (CA001) 0 minutes for non-facility and 3 minutes for facility.
  • Coordinate pre-surgery services (including test results) (CA002) 0 minutes for non-facility and 3 minutes for facility.
  • Schedule space and equipment in facility (CA003) 0 minutes for non-facility and 3 minutes for facility.
  • Provide preservice education/obtain consent (CA004) 0 minutes for non-facility and 3 minutes for facility.
  • Complete pre-procedure phone calls and prescription (CA005) 0 minutes for non-facility and 3 minutes for facility.

We are also proposing to refine the direct PE input for Coordinate post-procedure services (CA038) to 0 minutes from the RUC-recommended 3 minutes to align with 000-day standards instead of 090-day standards for CPT code 46030.

(14) Periurethral Balloon Continence Device Procedures (CPT Codes 53XX1, 53XX2, 53XX3, and 53XX4)

In October 2020, the CPT Editorial Panel replaced four CPT Category III codes with four new CPT Category I codes to report periurethral adjustable balloon continence devices. Given the low utilization and the low survey response rate for the four new codes, the RUC recommended that CMS assign contractor pricing to these procedures. We agree with the RUC and we are proposing contractor pricing for all four codes in the family, CPT codes 53XX1 (Periurethral transperineal adjustable balloon continence device; bilateral insertion, including cystourethroscopy and imaging guidance), 53XX2 (Periurethral transperineal adjustable balloon continence device; unilateral insertion, including cystourethroscopy and imaging guidance), 53XX3 (Periurethral transperineal adjustable balloon continence device; removal, each balloon) and 53XX4 (Periurethral transperineal adjustable balloon continence device; percutaneous adjustment of balloon(s) fluid volume).

(15) Intracranial Laser Interstitial Thermal Therapy (LITT) (CPT Codes 617X1 and 617X2)

In October 2020, the CPT Editorial Panel approved the addition of two codes to report laser interstitial thermal therapy (LITT) of lesion, intracranial, including burr hole(s), with magnetic resonance (MR) imaging guidance for a single trajectory for 1 simple lesion and multiple trajectories for multiple or complex lesion(s). LITT is a novel procedure that involves multiple steps and movements of the patient through the hospital for different stages of the procedure. The typical facility does not have an interoperative MRI suite (a small minority of academic medical centers may), so patient transport is necessary.

The RUC recommended a work RVU of 20.00 for CPT code 617X1 (Laser interstitial thermal therapy (LITT) of lesion, intracranial, including burr hole(s), with magnetic resonance imaging guidance, when performed; single trajectory for 1 simple lesion) based on the survey median response. CPT code 617X1 was surveyed with having one subsequent hospital visit, CPT code 99232 (sbsq hospital care/day 25 minutes) and 40 minutes of immediate postservice time. The RUC noted that although the survey median immediate postservice time was 40 minutes, for 617X1, the CMS 23-Hour Stay Outpatient Surgical Services with Subsequent Hospital Visits Policy was applied which resulted in the 99232 visit being removed and its 20 minutes of intraservice time being applied to the 40 minutes of immediate postservice time resulting in 60 minutes of immediate postservice time. See the 2011 PFS final rule (75 FR 73226) for an in-depth explanation of the 23-hour policy. We believe the RUC partially applied the 23-hr policy when it applied the policy to the immediate post service time but not to the work RVU. We believe the 23-hour policy in its entirety should be applied to 671X1, which includes the work RVUs along with the immediate postservice time.

Following the valuation methodology we established for 23-hour stay services in the CY 2011 PFS final rule, 617X1 would have a work RVU of 19.06.

The steps are as follows:

  • Step (1): CPT code 617X1 does not have a hospital discharge day management service; therefore, we would skip this step.
  • Step (2): 20 − 1.39** = 18.61.
  • Step (3): 18.61 + (20 minutes × 0.0224)*** = 19.06 RVUs.

* Value associated with 1/2 hospital discharge day management service.

** Value associated with an inpatient hospital visit, CPT code 99232.

*** Value associated with the reallocated intraservice time multiplied by the postservice intensity of the 23-hour stay code.

Therefore, for CY 2022 we are proposing a work RVU of 19.06 for CPT code 671X1.

In reviewing the RUC-recommended direct PE inputs for 671X1 we noticed the RUC proposed the standard 090-day preservice times for the following clinical labor activities:

  • Complete preservice diagnostic and referral forms (CA001) 5 minutes.
  • Coordinate pre-surgery services (including test results) (CA002) 20 minutes.
  • Schedule space and equipment in facility (CA003) 8 minutes.
  • Provide preservice education/obtain consent (CA004) 20 minutes.

Complete pre-procedure phone calls and prescription (CA005) 7 minutes.

We note that the RUC recommended 090-day preservice times despite surveying the service as a 000-day service. We disagree with the RUC-recommended 090-day times as we believe this is a 000-day service and should have times consistent with 000-day services. However, we recognize there is time needed to coordinate this service. Therefore, for CY 2022 we are proposing the following standard clinical labor times for a 000-day extensive:

  • Complete preservice diagnostic and referral forms (CA001) 5 minutes.
  • Coordinate pre-surgery services (including test results) (CA002) 10 minutes.
  • Schedule space and equipment in facility (CA003) 5 minutes.
  • Provide preservice education/obtain consent (CA004) 7 minutes.
  • Complete pre-procedure phone calls and prescription (CA005) 3 minutes.

For CPT code 617X2 (Laser interstitial thermal therapy (LITT) of lesion, intracranial, including burr hole(s), with magnetic resonance imaging guidance, when performed; multiple trajectories for multiple or complex lesion(s)), the RUC recommended a work RVU of 24.00 which is the survey median. The RUC's recommendation also included 40 minutes of immediate postservice time and one hospital visit, CPT code 99233 (sbsq hospital care/day visit 35 minutes). We believe it would be appropriate to apply the 23-hr policy to CPT code 617X2 as well.Start Printed Page 39162

The steps are as follows:

  • Step (1): CPT code 617X2 does not have a hospital discharge day management service. Therefore, we would skip this step.
  • Step (2): 24 − 2** = 22
  • Step (3): 22 + (30 minutes × 0.0224)*** = 22.67 RVUs

* Value associated with 1/2 hospital discharge day management service.

** Value associated with an inpatient hospital visit, CPT code 99233.

*** Value associated with the reallocated intraservice time multiplied by the postservice intensity of the 23-hour stay code.

This results in a work RVU of 22.67, and an immediate post service time of 70 minutes. Therefore, for CY 2022 we a proposing a work RVU of 22.67 and 70 minutes of immediate postservice time for CPT code 617X2.

For the direct PE, the RUC proposed identical preservice times for CPT codes 617X1 and 617X2. For the reasons stated above concerning the direct PE inputs for CPT code 671X1, we are proposing the standard clinical labor times associated with a 000-day extensive for CPT code 617X2 for CY 2022.

(16) Arthrodesis Decompression (CPT Codes 630XX and 630X1)

For CPT codes 630XX (Laminectomy, facetectomy, or foraminotomy (unilateral or bilateral with decompression of spinal cord, cauda equina and/or nerve root[s] [eg, spinal or lateral recess stenosis]), during posterior interbody arthrodesis, lumbar; single vertebral segment (List separately in addition to code for primary procedure)) and 630X1 (Laminectomy, facetectomy, or foraminotomy (unilateral or bilateral with decompression of spinal cord, cauda equina and/or nerve root[s] [eg, spinal or lateral recess stenosis]), during posterior interbody arthrodesis, lumbar; each additional segment (List separately in addition to code for primary procedure)), we disagree with the RUC-recommended work RVUs of 5.55 and 4.44, respectively, because these values are anomalously high in comparison to other similar add-on codes that have longer intraservice times, and we are proposing a work RVU of 3.08 for CPT code 630XX and a work RVU of 2.31 for CPT code 630X1.

CPT codes 630XX and 630X1 are new add-on codes to report decompression when performed in conjunction with posterior interbody arthrodesis at the same interspace. The proposed work RVU for CPT code 630XX is based on an intraservice time ratio between the proposed 40 minutes of intraservice time for CPT code 630XX and the 45 minutes of intraservice time for CPT code 63048 (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; each additional segment, cervical, thoracic, or lumbar (List separately in addition to code for primary procedure)). We believe that CPT code 63048 is a stronger reference code for CPT code 630XX than the RUC-recommended reference CPT codes 33924 (Ligation and takedown of a systemic-to-pulmonary artery shunt, performed in conjunction with a congenital heart procedure (List separately in addition to code for primary procedure)) and 22614 (Arthrodesis, posterior or posterolateral technique, single level; each additional vertebral segment (List separately in addition to code for primary procedure)) because of the similarities in the long descriptors, physician time, and intensity of intraservice work for CPT codes 630XX and 63048. The intraservice time ratio between CPT codes 63048 and 630XX equals a work RVU of 3.08 for CPT code 630XX ((40 minutes/45 minutes) * 3.47 = 3.08). Therefore, we are proposing a work RVU of 3.08 for CPT code 630XX. The intraservice time ratio between CPT codes 63048 and 630XX was selected to value CPT code 630XX because of the similarities in the descriptions of intraservice work provided in the RUC's summary of recommendations for CPT code 630XX and the RUC Database for CPT code 63048. We are proposing a work RVU of 2.31 for CPT code 630X1 based on an intraservice time ratio between the proposed 30 minutes of intraservice time for CPT code 630X1 and the proposed 40 minutes of intraservice time for CPT code 630XX ((30 minutes/40 minutes) * 3.08 = 2.31), given that the RUC contends that there are some efficiencies in providing an additional level of decompression, evidenced by the 10 minutes less of intraservice time for CPT code 630X1 compared to CPT code 630XX. These work RVU proposals are further supported by brackets of other 30 and 40 minute ZZZ codes.

We note that the proposed work RVU for CPT code 630XX falls between CPT code 19294 (Preparation of tumor cavity, with placement of a radiation therapy applicator for intraoperative radiation therapy (IORT) concurrent with partial mastectomy (List separately in addition to code for primary procedure)), which has a work RVU of 3.00, and CPT code 37185 (Primary percutaneous transluminal mechanical thrombectomy, noncoronary, non-intracranial, arterial or arterial bypass graft, including fluoroscopic guidance and intraprocedural pharmacological thrombolytic injection(s); second and all subsequent vessel(s) within the same vascular family (List separately in addition to code for primary mechanical thrombectomy procedure)), which has a work RVU of 3.28. Both of these bracketing reference codes have identical intraservice times as CPT code 630XX. The proposed work RVU for CPT code 630X1 falls between CPT code 43273 (Endoscopic cannulation of papilla with direct visualization of pancreatic/common bile duct(s) (List separately in addition to code(s) for primary procedure)), which has a work RVU of 2.24, and CPT code 22870 (Insertion of interlaminar/interspinous process stabilization/distraction device, without open decompression or fusion, including image guidance when performed, lumbar; second level (List separately in addition to code for primary procedure)), which has a work RVU of 2.34. Both of these bracketing reference codes have identical intraservice times as CPT code 630X1. When we compared the RUC-recommended work RVU of 5.55 for CPT code 630XX and 4.44 for CPT code 630X1 to other spinal add-on codes in the 63000 CPT code series in the RUC database, we found that CPT code 630XX would have the highest work RVU and the second shortest intraservice time (with CPT code 630X1 having the shortest intraservice time), and CPT code 630X1 would have the third highest work RVU and shortest intraservice time compared to the 10 other nationally-priced spinal add-on codes in the 63000 CPT code series. We do not agree that decompression when performed in conjunction with posterior interbody arthrodesis at the same interspace should have an anomalously high work value in comparison to other similar add-on codes that have longer intraservice times. We believe that our proposed work RVUs of 3.08 for CPT code 630XX and 2.31 for CPT code 630X1 better serve the interests of relativity. We note that the specialty societies did not survey the two new add-on codes with the base codes, which is a standard to provide assurance that the respondents followed instruction to only consider the work of the add-on codes. CPT codes 630XX and 630X1 were reviewed again with their base codes at the April 2021 RUC meeting. There were also revisions to the base codes' definitions, guidelines, and parenthetical instructions, which Start Printed Page 39163were approved by the CPT Editorial Panel for CY 2022.

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

(17) Hypoglossal Nerve Stimulator Services (CPT Codes 645X1, 645X2, and 645X3)

In October 2020, the CPT Editorial Panel added three new CPT Category I codes to report open implantation, revision or replacement, and removal of hypoglossal nerve stimulator array. These new CPT codes replaced three CPT Category III codes which were reported with CPT codes 64568 (Incision for implantation of cranial nerve (eg, vagus nerve) neurostimulator electrode array and pulse generator), 64569 (Revision or replacement of cranial nerve (eg, vagus nerve) neurostimulator electrode array, including connection to existing pulse generator) and 64570 (Removal of cranial nerve (eg, vagus nerve) neurostimulator electrode array and pulse generator).

CPT code 645X1 (Open implantation of hypoglossal nerve neruostimulator array, pulse generator, and distal respiratory sensor electrode or electrode array) was previously reported using the now deleted Category III CPT code 0466T (Insertion of chest wall respiratory sensor electrode or electrode array, including connection to pulse generator (List separately in addition to code for primary procedure)) along with CPT code 64568. We are not proposing the RUC-recommendation to use the survey median work RVU of 16.00 for CPT code 645X1. We are proposing a work RVU of 14.00 based on the intraservice time ratio of CPT code 64568 compared to the RUC-recommended intraservice time for CPT code 645X1. CPT code 64568 has a work RVU of 9.00, intraservice time of 90 minutes and total time of 275 minutes. CPT code 645X1 has a RUC-recommended work RVU of 16.00, intraservice time of 140 minutes and total time of 294 minutes. Additionally, when we reviewed CPT code 645X1, we found that the RUC-recommended work RVU was higher than other global 90-day codes with similar time values. We do not agree that it would be typical to value this code so much higher than services with similar work time values. Additionally, we note that the proposed work RVU of 14.00 is also the survey 25th percentile. Therefore, as previously stated, we believe 14.00 is a more appropriate value overall than 16.00 when compared to the range of codes with similar work times.

We are not proposing the RUC-recommended work value of 16.50 for CPT code 645X2 (Revision or replacement of hypoglossal nerve neruostimulator array and distal respiratory sensor electrode or electrode array, including connection to an existing pulse generator), rather we are proposing a work RVU of 14.50. Although we disagree with the RUC-recommended work RVU, we concur that the relative difference in work between CPT codes 645X1 and 645X2 is equivalent to the recommended increment of 0.50 RVUs. Therefore, we are proposing a work RVU of 14.50 for CPT code 645X2 based on the recommended increment of 0.50 additional RVUs above our proposed work RVU of 14.00 for CPT code 645X1. 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 codes where it is important to maintain an appropriate intra-family relativity. Additionally, we note that the proposed work RVU of 14.50 is also nearly identical to the 25th percentile survey value for CPT code 645X2 of 14.63. Therefore, as previously stated, we believe 14.50 is a more appropriate value than 16.50 to maintain an appropriate intra-family relativity.

We are not proposing the RUC-recommended work value of 14.00 for CPT code 645X3 (Removal of hypoglossal nerve neruostimulator array, pulse generator, and distal respiratory sensor electrode or electrode array), rather we are proposing a work RVU of 12.00. Although we disagree with the RUC-recommended work RVU, we concur that the relative difference in work between CPT codes 645X1 and 645X3 is equivalent to the recommended increment of −2.0 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 codes where it is important to maintain an appropriate intra-family relativity. Therefore, we are proposing a work RVU of 12.00 for CPT code 645X3 based on the recommended increment of 2.0 RVUs below our proposed work RVU of 14.00 for CPT code 645X1. Additionally, we note that the proposed work RVU of 12.00 is also the RUC 25th percentile survey value for CPT code 645X3.

We are proposing the RUC-recommended direct PE inputs without refinements for CPT codes 645X1, 645X2 and 645X3.

(18) Destruction by Neurolytic Agent (CPT Codes 64633, 64634, 64635, and 64636)

In September 2014, the Relativity Assessment Workgroup identified a work neutrality issue for CPT codes 64633 (Destruction by neurolytic agent, paravertebral facet joint nerve(s), with imaging guidance (fluoroscopy or CT); cervical or thoracic, single facet joint), 64634 (Destruction by neurolytic agent, paravertebral facet joint nerve(s), with imaging guidance (fluoroscopy or CT); cervical or thoracic, each additional facet joint (List separately in addition to code for primary procedure)), 64635 (Destruction by neurolytic agent, paravertebral facet joint nerve(s), with imaging guidance (fluoroscopy or CT); lumbar or sacral, single facet joint), and 64636 (Destruction by neurolytic agent, paravertebral facet joint nerve(s), with imaging guidance (fluoroscopy or CT); lumbar or sacral, each additional facet joint (List separately in addition to code for primary procedure)) related to incorrect coding relative to how the services were originally valued. In May 2015, the CPT Editorial Panel revised the parenthetical instructions for the five codes describing paravertebral facet joint nerve destruction to clarify that these codes are reported per joint, not nerve. Due to the extensive growth and original incorrect assumptions about distribution of reporting, the RUC recommended that CPT codes 64633-64636 be surveyed. We are proposing the RUC-recommended work RVU of 1.32 for CPT code 64634 and the RUC-recommended work RVU of 1.16 for CPT code 64636.

For CPT codes 64633 and 64635, we are not proposing the RUC-recommended work RVU of 3.42 for both codes, as we believe this value understates the decrease in physician work time for these codes. An analysis of all 010-day global period codes indicates that these proposed values would place these codes among the highest valued for codes with similar time values. We are instead using a total-time ratio methodology to propose work RVUs of 3.31 for CPT code 64633 and 3.32 for CPT code 64635. We support these values by noting that they fall between CPT codes 54164 (Frenulotomy of penis), with a work RVU of 2.82, and CPT code 68371 (Harvesting conjunctival allograft, living donor), with a work RVU of 5.09; these reference codes have total time values that are similar to, and intraservice time values that are identical to those recommended for CPT codes 64633 and 64635.Start Printed Page 39164

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

(19) Destruction of Intraosseous Basivertebral Nerve (CPT Codes 646X0 and 646X1)

In October 2020, the CPT Editorial Panel added two Category I codes to report thermal destruction of intraosseous basivertebral nerve, inclusive of all imaging guidance for the first two vertebral bodies (lumbar or sacral) and for each additional vertebral body (lumbar or sacral).

We are not proposing the RUC-recommended work value of 8.25 for CPT code 646X0 (Thermal destruction of intraosseous basivertebral nerve, inclusive of all imaging guidance; first two vertebral bodies, lumbar or sacral). When we reviewed CPT code 646X0, we found that the RUC-recommended work RVU was higher than codes with the same 10-day global period, same intraservice time and similar total times. The RUC-recommended work RVU of 8.25 would value CPT code 646X0 at the 90th percentile of comparable 10-day globals and we do not agree that it would be typical to value this code so much higher than services with similar work time values. We believe it would be more accurate to propose a work RVU of 7.15 based on a crosswalk to CPT code 63650 (Percutaneous implantation of neurostimulator electrode array, epidural) with a work RVU of 7.15, identical intraservice time of 60, and similar total time of 170. We believe the crosswalk to CPT code 63650 serves as a more accurate valuation for CPT code 646X0.

We also are not proposing the RUC-recommended work value of 4.87 for CPT code 646X1 (Thermal destruction of intraosseous basivertebral nerve, inclusive of all imaging guidance; each additional vertebral body, lumbar or sacral (List separately in addition to code for primary procedure)). Although we disagree with the RUC-recommended work RVU, we concur that the relative difference in work between CPT codes 646X0 and 646X1 is equivalent to the recommended increment of −3.38 RVUs. However, since the recommended work RVU of code 646X0 was higher than other codes with the same 10-day global period, same intraservice time, and similar total times, we refined the work RVU for code 646X1 to preserve the incremental difference between the two codes. We believe that these refinements maintain the relationship between the two codes in the family while better preserving relativity with other similar 10-day global codes on the wider PFS. 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 codes where it is important to maintain an appropriate intra-family relativity. Therefore, we are proposing a work RVU of 3.77 for CPT code 646X1 based on the recommended increment of 3.38 RVUs below our proposed work RVU of 7.15 for CPT code 646X0.

We are proposing the RUC-recommended direct PE inputs without refinements for CPT code 646X0. CPT code 646X1 is an add-on code and does not have any direct PE inputs.

(20) Dilation of Aqueous Outflow Canal (CPT Codes 66174 and 66175)

These services were identified through the New Technology/New Services List. In January 2020, the specialty societies submitted an action plan and the RUC recommended referral to the CPT Editorial Panel in 2020 to possibly revise the descriptor and add exclusionary parentheticals for CPT code 66174 (Transluminal dilation of aqueous outflow canal; without retention of device or stent). In October 2020, the CPT Editorial Panel revised this code to add a parenthetical to restrict reporting this code in conjunction with CPT code 65820 (Goniotomy).

We are not proposing the RUC-recommended work RVUs of 8.53 for CPT code 66174 and 10.25 for CPT code 66175 (Transluminal dilation of aqueous outflow canal; with retention of device or stent), as we believe these values do not adequately reflect the surveyed reductions in physician time. These RVUs would rank these codes among the highest valued 090-day global period codes of similar time values. We are proposing a work RVU of 9.34 for CPT code 66175 using a reverse building block methodology. We then subtract the incremental difference between the two RUC-recommended work RVUs, an increment of 1.72, from our proposed work RVU of 9.34 for CPT code 66175 to propose a work RVU of 7.62 for CPT code 66174. We believe this approach is consistent with the RUC's assumption that the intensity and complexity of CPT code 66174 is the same as that of CPT code 66175, the only difference between the two procedures being the additional intraservice time associated with placement of the stent. As further support for these values, we note that they fall between CPT code 66984 (Extracapsular cataract removal with insertion of intraocular lens prosthesis (1 stage procedure), manual or mechanical technique (eg, irrigation and aspiration or phacoemulsification); without endoscopic cyclophotocoagulation), with 7.35 work RVUs, and CPT code 15150 (Tissue cultured skin autograft, trunk, arms, legs; first 25 sq cm or less), with 9.39 work RVUs.

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

(21) Cataract Removal With Drainage Device Insertion (CPT Codes 669X1, 669X2, 66982, 66984, 66987, 66988, and 0X12T)

The RUC identified CPT code 0191T (Insertion of anterior segment aqueous drainage device, without extraocular reservoir, internal approach, into the trabecular meshwork; initial insertion) via the Category III codes with High Utilization screen (2018 estimated Medicare utilization over 1,000). In January 2020, the RUC recommended that the specialty societies develop a coding application for Category I status for CPT code 0191T and CPT code 0376T (each additional device insertion (List separately in addition to code for primary procedure). In October 2020, the CPT Editorial Panel replaced two Category III codes (CPT codes 0191T and 0376T) with two new codes, CPT codes 669X1 and 669X2, to report extracapsular cataract removal with insertion of intraocular lens prosthesis and one Category III code to report insertion of anterior segment aqueous drainage device without concomitant cataract removal.

The RUC recommended a work RVU of 12.13 for CPT code 669X1 (Extracapsular cataract removal with insertion of intraocular lens prosthesis (1-stage procedure), manual or mechanical technique (eg, irrigation and aspiration or phacoemulsification), complex, requiring devices or techniques not generally used in routine cataract surgery (eg, iris expansion device, suture support for intraocular lens, or primary posterior capsulorrhexis) or performed on patients in the amblyogenic developmental stage; with insertion of intraocular (eg, trabecular meshwork, supraciliary, suprachoroidal) anterior segment aqueous drainage device, without extraocular reservoir, internal approach, one or more) based on the survey 25th percentile.

In its recommendation, the RUC noted that the recommended intraservice time of 28 minutes for CPT code 669X1 is 2 minutes less than the intraservice time of 30 minutes associated with CPT code 66982 (Extracapsular cataract removal with insertion of intraocular lens prosthesis (1-stage procedure), manual Start Printed Page 39165or mechanical technique (eg, irrigation and aspiration or phacoemulsification), complex, requiring devices or techniques not generally used in routine cataract surgery (eg, iris expansion device, suture support for intraocular lens, or primary posterior capsulorrhexis) or performed on patients in the amblyogenic developmental stage; without endoscopic cyclophotocoagulation). The RUC further noted this should not be the case, as the insertion of the intraocular lens prosthesis should take the same amount of time and be represented by the same relative work for both procedures and that it is counterintuitive that the intraservice time for CPT code 669X1 would be lower than the intraservice time for CPT code 66982, as CPT code 669X1 includes both complex cataract surgery and the insertion of the intraocular anterior segment aqueous drainage device. The specialty society that surveyed the codes explained that this is likely because the early adopters of this new technology service are highly skilled surgeons who would likely perform these procedures quickly. They stated that as this procedure diffuses into the wider population of ophthalmologic surgeons over the next few years, the intraservice time will likely rise above the intraservice time associated with CPT codes 66982 and 66984 and will come in line for both CPT codes 669X1 and 669X2.

CPT code 69982 has a work RVU of 10.25, 125 minutes of total time and 30 minutes of intraservice time. CPT code 669X1 has a RUC-recommended work RVU of 12.13, 176 minutes of total time and 28 minutes of intraservice time. We agree with the RUC assessment that both procedures, CPT code 66982 and CPT code 669X1, are almost identical in time and intensity. However, we disagree with the RUC-recommended work RVU of 12.13 for CPT code 669X1 noting that CPT code 66982 has a work RUV of 10.25. We are proposing a work RVU of 10.31 based on the current total time ratio of CPT code 66982 compared to the RUC-recommended total time for CPT code 669X1.

For CPT code 669X2, the RUC recommended a work RVU of 9.23. The RUC determined that it would be appropriate to use the increment between the 25th percentile work RVU value for CPT code 669X1 and the current RUC-reviewed work RVU value for CPT code 66982 to build a work RVU recommendation for CPT code 669X2. The RUC determined that the increment between the 25th percentile work RVU value for CPT code 669X1 (work RVU = 12.13) and the current RUC-reviewed work RVU value for CPT code 66982 (work RVU = 10.25) would yield an increment between those two codes of 1.88. The RUC added the 1.88 increment to 7.35, the current work RVU for 66984, which yields a RUC-recommended work RVU value of 9.23. This comparison results in a work RVU recommendation of 9.23 for CPT code 669X2. We are proposing a work RVU of 7.41, which is the increment between the current RUC-reviewed work RVU value for CPT code 66982 and CPT code 66984. The increment between CPT code 66982 (work RVU = 10.25) and CPT code 66984 (work RVU = 7.35) yields a work RUV of 2.90. We subtracted this 2.90 increment from 10.31, to determine our proposed work RVU of 7.41 for CPT code 669X1.

We are proposing the RUC-recommended indirect PE values for CPT codes 669X1 and 669X2.

We are not proposing any new valuations but reaffirming the work RVUs and direct PE inputs that we previously finalized for CPT codes 66982 (Extracapsular cataract removal with insertion of intraocular lens prosthesis (1-stage procedure), manual or mechanical technique (eg, irrigation and aspiration or phacoemulsification), complex, requiring devices or techniques not generally used in routine cataract surgery (eg, iris expansion device, suture support for intraocular lens, or primary posterior capsulorrhexis) or performed on patients in the amblyogenic developmental stage; without endoscopic cyclophotocoagulation) and 66984 (Extracapsular cataract removal with insertion of intraocular lens prosthesis (1 stage procedure), manual or mechanical technique (eg, irrigation and aspiration or phacoemulsification); without endoscopic cyclophotocoagulation). For CPT codes 66987 (Extracapsular cataract removal with insertion of intraocular lens prosthesis (1-stage procedure), manual or mechanical technique (eg, irrigation and aspiration or phacoemulsification), complex, requiring devices or techniques not generally used in routine cataract surgery (eg, iris expansion device, suture support for intraocular lens, or primary posterior capsulorrhexis) or performed on patients in the amblyogenic developmental stage; with endoscopic cyclophotocoagulation) and 66988 (Extracapsular cataract removal with insertion of intraocular lens prosthesis (1 stage procedure), manual or mechanical technique (eg, irrigation and aspiration or phacoemulsification); with endoscopic cyclophotocoagulation) we continue to believe these services should be contractor priced.

(22) Retinal Detachment Prophylaxis (CPT Codes 67141 and 67145)

CPT code 67145 (Prophylaxis of retinal detachment (eg, retinal break, lattice degeneration) without drainage, 1 or more sessions; photocoagulation (laser or xenon arc)) was identified in October 2019 as a Harvard Valued service with utilization over 30,000. In January 2020, the RUC agreed with the specialty societies that surveyed the service and recommended that CPT code 67145, as well as its parent CPT code 67141 (Prophylaxis of retinal detachment (eg, retinal break, lattice degeneration) without drainage, 1 or more sessions; cryotherapy, diathermy), be referred to the CPT Editorial Panel for a descriptor and global period change. The codes were edited to remove the reference to “1 or more sessions” so that the services may be valued as a 010-day procedure versus the current 090-day global. At the May 2020 CPT Editorial Panel meeting, the Panel approved revision of the two codes to remove “1 or more sessions” from the descriptors and deletion of the Eye and Ocular Adnexa Prophylaxis guidelines.

For CY 2022, we are proposing the RUC-recommended work RVU of 2.53 for CPT codes 67141 and 67145. We are also proposing the RUC-recommended direct PE inputs without refinements.

(23) Strabismus Surgery (CPT Codes 67311, 67312, 67314, 67316, 67318, 67320, 67331, 67332, 67334, 67335, and 67340)

In April 2020, The RUC recommend that add-on CPT codes 67320, 67331, 67332, 67334, 67335, and 67340 be surveyed along with the base codes in which these services are typically reported (CPT codes 67311, 67312, 67314, 67316 and 67318). When AMA staff compiled a list of 010-day and 090-day services for increases in physician work and time during the surgical global period, they noticed that several low volume codes that were converted to ZZZ global periods in 1999 still included office visits (specifically CPT codes 67320, 67331, 67332, 67334, 67340). It appeared that these office visits may not be appropriate for these services. This issue was deferred until October 2020.

We are proposing the RUC-recommended work RVUs for all base codes within this family. This includes a work RVU of 5.93 for CPT code 67311 (Strabismus surgery, recession or resection procedure; 1 horizontal muscle), 9.50 for CPT code 67312 Start Printed Page 39166(Strabismus surgery, recession or resection procedure; 2 horizontal muscles), 5.93 for CPT code 67314 (Strabismus surgery, recession or resection procedure; 1 vertical muscle (excluding superior oblique), 10.31 for CPT code 67316 (Strabismus surgery, recession or resection procedure; 2 or more vertical muscles (excluding superior oblique)), and 9.80 for CPT code 67318 (Strabismus surgery, any procedure, superior oblique muscle).

We are also proposing the RUC-recommend work RVUs for all of the add-on codes within this family. This includes a work RVU of 3.00 for CPT code 67320 (Transposition procedure (eg, for paretic extraocular muscle), any extraocular muscle (specify) (List separately in addition to code)), 2.00 for CPT code 67331 (Strabismus surgery on patient with previous eye surgery or injury that did not involve the extraocular muscles (List separately in addition to code for primary procedure)), 3.50 for CPT code 67332 (Strabismus surgery on patient with scarring of extraocular muscles (eg, prior ocular injury, strabismus or retinal detachment surgery) or restrictive myopathy (eg, dysthyroid opthalmopathy) (List separately in addition to code for primary procedure)), 2.06 for CPT code 67334 (Strabismus surgery by posterior fixation suture technique, with or without muscle recession (List separately in addition to code for primary procedure)), 3.23 for CPT code 67335 (Strabismus surgery by posterior fixation suture technique, with or without muscle recession (List separately in addition to code for primary procedure)), and 5.00 for CPT code 67340 (Strabismus surgery by posterior fixation suture technique, with or without muscle recession (List separately in addition to code for primary procedure)).

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

(24) Lacrimal Canaliculus Drug Eluding Implant Insertion (CPT Codes 68XXX)

CPT code 68XXX (Insertion of drug-eluting implant, including punctal dilation, when performed, into lacrimal canaliculus, each) was recommended for RUC review in October 2020 since the CPT Editorial Panel replaced CPT Category III (temporary) code 0356T with a new CPT Category I code to report the insertion of a drug eluting implant into the lacrimal canaliculus. We are proposing the RUC-recommended work RVU of 0.49 for CPT code 68XXX.

For the direct PE inputs, we are proposing to refine the equipment time for the “lane, screening (oph)” (EL006) from the RUC-recommended 9 minutes of equipment time to the 5 minute equipment standard for CPT code 68XXX. Five minutes is the standard equipment time associated with EL006 for this procedure. The recommended materials for this code family from the RUC state that the screening lane is used for the duration of setup, procedure, cleaning, and counselling post procedure and that the standard formulas are applied. We believe that the RUC inadvertently failed to update the equipment time associated with this procedure when CPT code 68XXX was reviewed. The recommended materials for CPT code 68XXX state the standard equipment time formula would be typical for this service, which would be 5 minutes in this case (the CA013 and CA024 equipment times are included but not the CA035 equipment time). We are proposing to refine the equipment time for the equipment item lane, screening (oph) (EL006) from 9 minutes to 5 minutes to match this change in equipment time and are seeking additional comment from stakeholders regarding the RUC-recommended non-standard equipment time of 9 minutes. We do not agree that it would be typical for CPT code 68XXX to require an additional 4 minutes of equipment time totaling 9 minutes.

(25) Transcutaneous Passive Implant-Temporal Bone (CPT Codes 69714, 69717, 69X50, 69X51, 69X52, and 69X53)

In October 2020, the CPT Editorial Panel deleted two codes used for mastoidectomy and replaced them with four new codes for magnetic transcutaneous attachment to external speech processor. The CPT Editorial Panel made additional revisions to differentiate implantation, removal, and replacement of the implants.

We are proposing the RUC-recommended work RVU for all six of the codes in this family. We are proposing a work RVU of 8.69 for CPT code 69714 (Implantation, osseointegrated implant, skull; with percutaneous attachment to external speech processor), a work RVU of 9.77 for CPT code 69X50 (Implantation, osseointegrated implant, skull; with magnetic transcutaneous attachment to external speech processor), a work RVU of 8.80 for CPT code 69717 (Revision/replacement (including removal of existing device), osseointegrated implant, skull; with percutaneous attachment to external speech processor), a work RVU of 9.77 for CPT code 69X51 (Revision/replacement (including removal of existing device), osseointegrated implant, skull; with magnetic transcutaneous attachment to external speech processor), a work RVU of 5.93 for CPT code 69X52 (Removal, osseointegrated implant, skull; with percutaneous attachment to external speech processor), and a work RVU of 7.13 for CPT code 69X53 (Removal, osseointegrated implant, skull; with magnetic transcutaneous attachment to external speech processor).

For the direct PE inputs, we are proposing to refine the clinical labor time for the “Post-operative visits (total time)” (CA039) activity from the RUC-recommended 108 minutes to 99 minutes for CPT codes 69714 and 69717. 99 minutes is the clinical labor time associated with one Level 2 postoperative office visit and two Level 3 postoperative office visits; we believe that the RUC inadvertently failed to update the clinical labor time associated with these postoperative office visits when CPT codes 69714 and 69717 were reviewed. We are also proposing to refine the equipment time for all equipment items other than the basic instrument pack (EQ137) from 108 minutes to 99 minutes to match this change in clinical labor time.

(26) X-Rays at Surgery Add-On (CPT Code 74301)

The RUC recommended that CPT code 74301 (Cholangiography and/or pancreatography; additional set intraoperative, radiological supervision and interpretation (List separately in addition to code for primary procedure)) be deleted for October 2020. The specialty societies that typically bill for this service submitted a code change application to delete CPT code 74301 at the February 2020 CPT meeting. However, the specialty societies withdrew the deletion request after receiving feedback from the dominant provider of CPT code 74301 (general surgery), indicating the code is still necessary and should not be deleted. The RUC recommended to maintain the work RVU of 0.21 for CPT code 74301. The specialty societies did not resurvey CPT code 74301 due to its low utilization (2019 Medicare utilization = 63) and the difficulty of obtaining 30 survey responses from providers with experience in the past 12 months. Since there was no survey done, there is no new information and the RUC recommended to maintain the current value. The work RVU suggested by the RUC is a reaffirmation of the current value.

We are proposing the RUC-recommended work RVU of 0.21 for Start Printed Page 39167CPT code 74301. This is an add-on code with no direct PE inputs.

(27) Trabecular Bone Score (TBS) (CPT Codes 77X01, 77X02, 77X03, and 77X04)

We are proposing the RUC-recommended work RVUs of 0.20 for CPT codes 77X01 (Trabecular bone score (TBS), structural condition of the bone microarchitecture; using dual X-ray absorptiometry (DXA) or other imaging data on gray-scale variogram, calculation, with interpretation and report on fracture risk) and 77X04 (Trabecular bone score (TBS), structural condition of the bone microarchitecture; using dual X-ray absorptiometry (DXA) or other imaging data on gray-scale variogram, calculation, with interpretation and report on fracture risk interpretation and report on fracture risk only, by other qualified health care professional). CPT codes 77X02 (Trabecular bone score (TBS), structural condition of the bone microarchitecture; technical preparation and transmission of data for analysis to be performed elsewhere) and 77X03 (Trabecular bone score (TBS), structural condition of the bone microarchitecture; technical calculation only) are PE only codes; the RUC did not recommend and we are not proposing a work RVU for these codes.

The RUC PE recommendations for CPT codes 77X01 and 77X03 include a new “TBS iNsight Software” supply input. The submitted invoice for this supply indicates that it is a licensing fee associated with the use of the software, which is not typically considered to be a form of direct PE under our methodology. Historically, we have considered most computer software and associated licensing fees to be indirect costs tied to associated costs for hardware considered to be medical equipment. However, as we noted in section II.B. of this proposed rule (the PE section), stakeholders have routinely expressed concerns with this policy, especially for evolving technologies that rely primarily on software and licensing fees with minimal costs in equipment or hardware. Most of the recommended resource costs for CPT codes 77X01 and 77X03 are for this analysis fee and these costs are not well accommodated by the PE methodology since these sorts of technological applications did not exist when the data that underlie the PE allocation was last collected in 2007 through 2008.

We are therefore proposing to value the PE for CPT codes 77X01 and 77X03 through the use of a crosswalk to a comparable service, CPT code 71101 (Radiologic examination, ribs, unilateral; including posteroanterior chest, minimum of 3 views), which, for CY 2021, had a PE RVU of 0.94. We are proposing that the PE RVU for CPT code 77X03 equals the PE RVU from code 77X01 minus the PE RVU from codes 77X02 and 77X04 so that the three codes sum to the valuation of code 77X01. (CPT code 77X01 is the global code in this family and CPT codes 77X02, 77X03, and 77X04 must sum together to equal the value of 77X01.) CPT code 71101 is another type of bone imaging procedure that we believe reflects codes 77X01 and 77X03 similar direct PE resource costs as CPT codes 77X01 and 77X03. We recognize that the services being performed in this crosswalk code are not the same as the services in CPT codes 77X01 and 77X03, however we believe that the direct resource costs would typically be analogous across these codes. We believe that this is the most accurate way to incorporate the costs of the software employed in CPT codes 77X01 and 77X03 which would not typically be considered direct PE under our current methodology. We are soliciting comments, both on the specific proposal for the Trabecular Bone Score codes as well as our broader discussion of this topic in section II.B. of this proposed rule.

(28) Pathology Clinical Consult (CPT Codes 80XX0, 80XX1, 80XX2, and 80XX3)

The Relativity Assessment Workgroup identified CPT code 80500 (Clinical pathology consultation; limited, without review of patient's history and medical records) via the CMS/Other source codes with the Medicare utilization over 20,000 screen. In October 2019, the RUC referred this issue to the CPT Editorial Panel to define this service more specifically as the current descriptor is vague. In October 2020, the CPT Editorial Panel replaced CPT codes 80500 and 80502 (Clinical pathology consultation; comprehensive, for a complex diagnostic problem, with review of patient's history and medical records) with four new codes, CPT codes 80XX0 (Pathology clinical consultation; for a clinical problem with limited review of patient's history and medical records and straightforward medical decision making. When using time for code selection, 5-20 minutes of total time is spent on the date of the consultation. (For consultations involving the examination and evaluation of the patient, see 99241, 99242, 99243, 99244, 99245, 99251, 99252, 99253, 99254, 99255)), 80XX1 (for a moderately complex clinical problem, with review of patient's history and medical records and moderate level of medical decision making. When using time for code selection, 21-40 minutes of total time is spent on the date of the consultation), 80XX2 (for a highly complex clinical problem, with comprehensive review of patient's history and medical records and high level of medical decision making. When using time for code selection, 41-60 minutes of total time is spent on the date of the consultation), and 80XX3 (prolonged service, each additional 30 minutes (List separately in addition to code for primary procedure) (Use 80XX3 in conjunction with 80XX2) (Do not report 80XX0, 80XX1, 80XX2, 80XX3 in conjunction with 88321, 88323, 88325) (Prolonged pathology clinical consultation service of less than 15 additional minutes is not reported separately) (For consultations involving the examination and evaluation of the patient, see 99241-99255)) to report pathology clinical consultation and creation of guidelines to select and document the appropriate level of service.

The RUC recommended a work RVU of 0.50 for CPT code 80XX0 based on the 25th percentile of the survey. The RUC-recommended 15 minutes of intraservice and total times for CPT code 80XX0 are 2 minutes above the current instraservice and total times for CPT code 80500. This represents a 15 percent increase in the respective times. However, the RUC-recommended work RVU of 0.50 is 35 percent higher than the current work RVU of 0.37 for CPT code 80500. We believe that the increase or decrease in times should be commensurate with the increase or decrease in the work RVU. Therefore, we are proposing a work RVU of 0.43. This represents the ratio of total time between the current total time of CPT code 80500 and the proposed total time of CPT code 80XX0 (0.15) applied to the current value of CPT code 80500 (0.37 × 0.15 = 0.43).

We are proposing the RUC-recommended work RVU of 0.91 without refinements for CPT code 80XX1.

The RUC recommended a work RVU of 1.80 for CPT code 80XX2 based on the 25th percentile of the survey. The current intraservice and total times for CPT code 80502 are 42 minutes. The RUC-recommended times for CPT code 80XX2 are 54 minutes. Similar to the scenario described above for CPT code 80XX0, the intraservice and total times for CPT code 80XX2 increased 28.6 percent while the work RVU increased 35 percent. As stated above, we believe the increase or decrease in time should be commensurate with the increase or Start Printed Page 39168decrease in the work RVU. Therefore, for CPT code 80XX2 we are proposing a work RVU of 1.71, which is the current total time ratio of CPT code 80502 compared to the RUC-recommended total time for CPT code 80XX2.

We are proposing the RUC-recommended work RVU of 0.80 for CPT code 80XX3 without refinement.

For the direct PE inputs of CPT codes 80XX0, 80XX1, and 80XX2, we are proposing to refine the time associated with the clinical labor activity PA001 (Accession and enter information) from the RUC-recommended time of 4 minutes to 0 minutes as we believe the time is duplicative with clinical labor activity PA008 (File specimen, supplies, and other materials).

The RUC recommended 15, 30, 54, and 30 minutes of equipment time for EP024 (microscope, compound) for CPT codes 80XX0, 80XX1, 80XX2, and 80XX3, respectively. We note that there is no indication from the code descriptors that the pathologist is reviewing physical slides. The code descriptor and description of work indicate that the pathologist is reviewing paper records and/or EHR and therefore we are proposing to remove the equipment time associated with EP024 (microscope, compound) from CPT codes 80XX0, 80XX1, 80XX2, and 80XX3.

Additionally, the proposed Levels of Decision Making for Table for Pathology Clinical Consult codes includes “Assessment requiring an independent historian(s)” as an element of “Amount and/or Complexity of Data to be Reviewed and Analyzed *—Each unique test, order, or document contributes to the combination of 2 or combination of 3 in Category 1 below.” Neither the code descriptors nor the descriptions of work indicate that this type of assessment is typical in a pathology clinical consult as was discussed for the office visit Levels of Decision Making table. For these reasons, CMS proposes that this element not be included as an element that CMS would recognize as an element of medical decision making. We note that CMS will monitor the use of these replacement codes per our usual practice to ensure appropriate billing and inform future rulemaking as needed. We are also seeking comment on how these replacement codes would most typically be billed relative to use of existing pathology coding. Such information would also inform future rulemaking as needed.

(29) Revaluing End Stage Renal Disease (ESRD) Monthly Capitation Payment Services (MCP) (CPT Code 90954)

In the CY 2021 PFS final rule (85 FR 84551 through 84554), we revalued most, but not all, of the ESRD MCP services. We finalized an increase in valuations for those ESRD MCP codes with values tied to the values of Outpatient/Office Evaluation and Management (O/O E/M) codes. We did not revalue CPT code 90954 (End-stage renal disease (ESRD) related services monthly, for patients 2-11 years of age to include monitoring for the adequacy of nutrition, assessment of growth and development, and counseling of parents; with 4 or more face-to-face visits by a physician or other qualified health care professional per month) because it was originally valued by a crosswalk.

Stakeholders stated that CPT code 90954 was different from the other ESRD MCP codes. Rather than using an O/O E/M code building block methodology as had been used originally to value the other ESRD MCP codes, CPT code 90954 was valued based upon a crosswalk to CPT code 99293 (Inpatient pediatric critical care provided for children age 29 days through 24 months old, per day). When CPT code 99293 was deleted, the value of CPT code 90954 was crosswalked to a replacement code, CPT code 99471 (Initial inpatient pediatric critical care, per day, for the evaluation and management of a critically ill infant or young child, 29 days through 24 months of age). By crosswalking CPT code 90954 to CPT code 99471, the rank order across the ESRD MCP code family at that time was preserved.

Since we finalized the revalued ESRD MCP values for CY 2021, stakeholders have requested that we revalue CPT code 90954 because by not updating it, we created a rank order anomaly for work RVUs and time within the ESRD MCP code family. A stakeholder suggested that we address the rank order anomaly by revaluing CPT code 90954 based upon a new crosswalk to CPT code 33977 (Removal of a ventricular assist device; extracorporeal, single ventricle). The stakeholder stated that CPT code 33977 more appropriately represented the time and effort of the service provided over one month than the existing crosswalk to CPT code 99471 relative to the revalued services within the MCP code family.

In response to stakeholder requests to update the value of CPT code 90954, we are proposing to increase the value of CPT code 90954, a global code with a current work RVU of 15.98, by crosswalking it to CPT code 33977, a 090-day procedural code with a work RVU of 20.86 to preserve relativity within the ESRD MCP family. We are also seeking comment on our proposal to increase the value of CPT code 90954.

(30) Colon Capsule Endoscopy (CPT Codes 91110, 91111, and 9111X)

In October 2020, the CPT Editorial Panel replaced Category III code 0355T (Gastrointestinal tract imaging, intraluminal (eg, capsule endoscopy), colon, with interpretation and report) with a new Category I code 9111X (Gastrointestinal tract imaging, intraluminal (eg, capsule endoscopy), colon, with interpretation and report) to report gastrointestinal tract imaging. CPT codes 91110 (Gastrointestinal tract imaging, intraluminal (eg, capsule endoscopy), esophagus through ileum, with interpretation and report) and 91111 (Gastrointestinal tract imaging, intraluminal (eg, capsule endoscopy), esophagus with interpretation and report) were added as part of the family and surveyed for the January 2021 RUC meeting.

We are proposing the RUC-recommended work RVU for two of the codes in this family. We are proposing a work RVU of 2.24 for CPT code 91110 and a work RVU of 2.41 for CPT code 9111X as recommended by the RUC in both cases. For CPT code 91111, we disagree with the RUC-recommended work RVU of 1.00 and we are proposing a work RVU of 0.90 based on a crosswalk to CPT code 95923 (Testing of autonomic nervous system function; sudomotor, including 1 or more of the following: Quantitative sudomotor axon reflex test (QSART), silastic sweat imprint, thermoregulatory sweat test, and changes in sympathetic skin potential). CPT code 95923 is an autonomic nervous system testing procedure that shares the identical intraservice work time of 15 minutes with CPT code 91111 and has 5 additional minutes of immediate postservice work time. When we reviewed CPT code 91111, we noted that the surveyed intraservice work time had decreased by 3 minutes, from 18 minutes to 15 minutes, while the RUC recommended maintaining the current work RVU of 1.00. 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, decreases in time should typically be reflected in decreases to work RVUs. In the case of CPT code 91111, we believe that it would be more accurate to propose a work RVU of 0.90 based on a crosswalk Start Printed Page 39169to CPT code 95923 to account for these decreases in the surveyed work time.

For the direct PE inputs, we are proposing to refine the clinical labor time for the “Prepare, set-up and start IV, initial positioning and monitoring of patient” (CA016) activity from the RUC-recommended 9 minutes to 6 minutes for CPT code 91111. The recommended materials for this code family state that the 6 minutes for the CA016 activity are used to connect the equipment, fit belt to patient, put data recorder on patient, and sync capsule to each sensor on belt. This description of this clinical labor activity is identical for CPT codes 91110 and 9111X and each code has the same recommended time of 6 minutes. However, the recommended materials for CPT code 91111 state that 6 minutes are used to connect the equipment, fit belt, put data recorder on patient, sync capsule to each sensor and then an additional 3 minutes are used to position the patient (assist patient onto table lying down on right side and then into a sitting position after the capsule is swallowed). We do not agree that it would be typical for CPT code 91111 to require an additional 3 minutes for positioning as compared with the other codes in the family, particularly in light of the clinical similarities between these services. We are refining the clinical labor time to 6 minutes for CPT code 91111 to maintain relativity within the family.

We are also proposing to refine the equipment time for the capsule endoscopy recorder kit (EQ146) from 64 minutes to 61 minutes and the exam table (EF023) from 44 minutes to 41 minutes to match this change in clinical labor time for CPT code 91111.

(31) External Cardiovascular Device Monitoring (CPT Codes 93228 and 93229)

For 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), we disagree with the RUC-recommended work RVU of 0.52, and we are proposing a work RVU of 0.43. The proposed work RVU is based on an intraservice time ratio between the current and RUC-recommended intraservice times for CPT code 93228 ((10 minutes/12 minutes)*0.52), yielding a work RVU of 0.43. This proposed work RVU reflects the decrease in total time and is a direct work RVU crosswalk to CPT code 93290 (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; implantable cardiovascular physiologic monitor system, including analysis of 1 or more recorded physiologic cardiovascular data elements from all internal and external sensors). CPT code 93290 has the same pre-, intra-, and postservice times as the survey times for CPT code 93228 and was reviewed in October 2016. While we recognize that the number of ECG tracings and daily reports have increased because of the increase in average wear time from 14 days to 20 days, the specialty societies and the RUC contend that this is offset by technology advancements, integrations with EHRs, and online portals that make it easier to manage and review the data in a chronological and efficient manner. Therefore, we are recommending a work RVU that accounts for decrease in total time to provide this service, given that the increased tracings and daily reports are offset by the efficiencies gained by technological advancements.

The RUC recommended 10 minutes for “Provide education/obtain consent” (CA011) for CPT code 93228, based on a direct crosswalk and duplication of CPT code 93229 (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). We disagree with the RUC-recommended duplication of clinical labor to provide education that the patient will hear for a second time from the IDTF technician. While we understand that the duplication is by design, we do not agree with a direct crosswalk from CPT code 93229, because the provider of CPT code 93229 will likely have more in-depth education, specific to the patient, including materials and instructions for the patient to review. Therefore, we are proposing the standard 2 minutes for CA011 in the non-facility for CPT code 93228.

The RUC recommended the addition of 24 minutes for quality assurance “overread” done by a second, senior technician, Clinical Activity Code CA021, Line 67 on the RUC-recommended PE Spreadsheet, for CPT code 93229. This is a new clinical activity for CPT code 93228, and we are seeking public comment about the typicality of a second senior technician. We are requesting additional information about the IDTF's current quality assurance measures and parameters within the ECG recording program that should act as some degree of quality assurance. We are also seeking additional information from IDTFs about the current error rate for improperly transmitted tracings to the physician that would indicate that it is typical for a second, senior technician to perform “overread.” We are proposing 0 minutes for Clinical Activity Code CA021, Line 67 on the RUC-recommended PE Spreadsheet, unless commenters can provide compelling information that a second, senior technician typically performs quality assurance measures. Otherwise, we agree with the RUC-recommended direct PE inputs and are proposing the refinements as recommended.

In addition to the proposed work RVU and direct PE input refinements, we are requesting additional information about the acquisition costs for equipment item EQ340 Patient Worn Telemetry System. Due to the proprietary nature of this equipment, invoices were unattainable to update this equipment item. Substantial technological improvements have been made to these devices since the last update in 2008, but they are proprietary devices, owned and manufactured for each IDTF. We are seeking public comment on the manufacturing costs and other information to help update the equipment item for CY 2022. Second, we are requesting additional information about the useful lifetime of EQ340. CMS currently assigns 3 years of useful life to EQ340, but the RUC notes that this is the only equipment item and CPT code 93228 is the only CPT code with an equipment item that has more than 500 minutes of equipment time and a useful life of 3 years or less. We are seeking public comment to help update the useful life of EQ340, as it has not been updated since 2008, and the device has experienced significant technological changes.

(32) Electrophysiologic Evaluation (CPT Code 93621)

In October 2019, the RUC identified CPT code 93621 (Comprehensive electrophysiologic evaluation including insertion and repositioning of multiple electrode catheters with induction or attempted induction of arrhythmia; with left atrial pacing and recording from coronary sinus or left atrium (List separately in addition to code for Start Printed Page 39170primary procedure) as a high-growth service. It is an add-on code that can be used with several different procedures—base codes or other add-on codes, diagnostic as well as therapeutic. CPT code 93621 is furnished in the facility only and thus has no direct PE inputs.

We disagree with the RUC-recommended work RVU of 1.75 based on a crosswalk to CPT code 36483 (Endovenous ablation therapy of incompetent vein, extremity, by transcatheter delivery of a chemical adhesive (eg, cyanoacrylate) remote from the access site, inclusive of all imaging guidance and monitoring, percutaneous; subsequent vein(s) treated in a single extremity, each through separate access sites (List separately in addition to code for primary procedure). We are proposing a work RVU of 1.50 based on a crosswalk to CPT code 16036 (Escharotomy; each additional incision). CPT code 16036 is also an add-on code for a surgical incision that shares both an identical intraservice work time and a total time of 20 minutes with CPT code 93621. While the RUC's recommended crosswalk code also has 20 minutes of intraservice and total time, CPT code 36483 is more intense than CPT code 93621, whereas CPT code 16036 has a similar level of intensity as CPT code 93621.

The RUC did not recommend and we are not proposing any direct PE inputs for CPT code 93621.

(33) Cardiac Ablation Services Bundling (CPT Codes 93653, 93654, 93655, 93656, and 93657)

The technologies and clinical practices associated with Cardiac Ablation Services have changed enough over the past decade (since 2011 when they were first developed) that the specialty societies recommended referring theses codes to CPT Editorial Panel to have the code descriptors for Cardiac Ablation Services updated to create new and more complete descriptors reflecting the fact that many of these services are commonly performed together and should be incorporated and bundled. In October 2020, the CPT Editorial Panel revised the three existing cardiac ablation codes to be bundled with 3D mapping and to include “induction or attempted induction of an arrhythmia with right atrial pacing and recording, and catheter ablation of arrhythmogenic focus,” and “left atrial pacing and recording from coronary sinus or left atrium” and “intracardiac echocardiography including imaging supervision and interpretation” into their descriptors.

A survey of the Cardiac Ablation Services was sent out using the newly revised CPT code descriptors asking cardiac electrophysiologists about the revised language in the existing CPT codes. From the survey results, the RUC advisory committee believes that many of the survey respondents may not have realized that the code descriptors had been substantially revised and that they may not have read the updated code descriptors thoroughly enough to understand that services that are separately billed, were now combined into the existing codes (since CPT did not issue new codes for the revised descriptors). The RUC recommended that these services be valued as interim to allow for re-survey and subsequent review at the April 2021 RUC meeting.

CPT code 93653 (Comprehensive electrophysiologic evaluation with insertion and repositioning of multiple electrode catheters, induction or attempted induction of an arrhythmia with right atrial pacing and recording, and catheter ablation of arrhythmogenic focus, including intracardiac electrophysiologic 3-dimensional mapping, right ventricular pacing and recording, left atrial pacing and recording from coronary sinus or left atrium, and His bundle recording, when performed; treatment of supraventricular tachycardia by ablation of fast or slow atrioventricular pathway, accessory atrioventricular connection, cavo-tricuspid isthmus or other single atrial focus or source of atrial re-entry) (previous work RVU of 14.75 with 000-day global) is now bundled with the add-on CPT codes 93613 (Intracardiac electrophysiologic 3-dimensional mapping (List separately in addition to code for primary procedure))(work RVU of 5.23 with 90 minutes of intraservice time) and the add-on CPT code 93621 (Comprehensive electrophysiologic evaluation including insertion and repositioning of multiple electrode catheters with induction or attempted induction of arrhythmia; with left atrial pacing and recording from coronary sinus or left atrium (List separately in addition to code for primary procedure))(work RVU of 2.10 with 30 minutes of intraservice time). The RUC-recommended work RVU for CPT code 93653 is 18.49, with 40 minutes of preservice evaluation, 3 minutes of preservice positioning, 15 minutes of preservice scrub/dress/wait time, 125 minutes of intraservice time and 30 minutes of immediate postservice time.

Since the two add-on codes are combined with the primary CPT code 93653, one would expect the intraservice time to have increased or remained similar to the current 180 minutes. Instead, the RUC-recommended intraservice time has decreased to 125 minutes. Accounting for changes in technologies and clinical practices from over 10 years since this code family's last review, we would expect better efficiencies and reductions in work times, but with the addition of two add-on codes whose work is mostly, if not all, added to the intraservice time, one would not expect a net decrease in minutes. This is not what the collected responses from this survey show and it is a concern. Some of CPT code 93653 add-on service times may have shifted over to the increases in preservice times, but there does appear to be a collective misunderstanding in the survey's work RVUs and physician work time responses.

In light of the RUC's intention to resurvey and re-review CPT code 93653 (and this family of codes) at the April 2021 RUC meeting, and to resolve any flaws from the initial survey, such as survey respondents probably not realizing that a new descriptor describing the inclusion of services is now bundled to the existing CPT code (and not a newly issued CPT code), we are proposing to maintain the current physician times and current work RVU of 14.75, until the AMA RUC returns with a more definitive and accurate valuation.

For CPT code 93654 (Comprehensive electrophysiologic evaluation with insertion and repositioning of multiple electrode catheters, induction or attempted induction of an arrhythmia with right atrial pacing and recording, and catheter ablation of arrhythmogenic focus, including intracardiac electrophysiologic 3-dimensional mapping, right ventricular pacing and recording, left atrial pacing and recording from coronary sinus or left atrium, and His bundle recording, when performed; with treatment of ventricular tachycardia or focus of ventricular ectopy including left ventricular pacing and recording, when performed) (work RVU of 19.75), the RUC recommends 40 minutes of preservice evaluation, 3 minutes of preservice positioning, 20 minutes of preservice scrub/dress/wait time, 240 minutes of intraservice time and 33 minutes of immediate postservice time for a total of 336 minutes, an increase to the code's current 309 total minutes. Unlike CPT codes 93653 and 93656, CPT code 93654 already accounts for the work RVUs and physician times for 3-dimensional mapping of add-on CPT code 93613. The RUC recommended maintaining the current work RVU Start Printed Page 39171value of 19.75. We are proposing the RUC-recommended updates to the physician times (net increase in total minutes) and to maintain the same work RVUs for CPT code 93654 for CY 2022.

CPT code 93655 (Intracardiac catheter ablation of a discrete mechanism of arrhythmia which is distinct from the primary ablated mechanism, including repeat diagnostic maneuvers, to treat a spontaneous or induced arrhythmia (List separately in addition to code for primary procedure)) has a current work RVU of 7.50 with a physician intraservice time of 90 minutes. The RUC recommended a revised intraservice time of 60 minutes and 6.50 work RVUs. The primary change to CPT code 93655 is the reduction of the intraservice time of about 67 percent, which we use as a guide to determine a work RVU. We compare add-on CPT code 22854 (Insertion of intervertebral biomechanical device(s) (e.g., synthetic cage, mesh) with integral anterior instrumentation for device anchoring (e.g., screws, flanges), when performed, to vertebral corpectomy(ies) (vertebral body resection, partial or complete) defect, in conjunction with interbody arthrodesis, each contiguous defect (List separately in addition to code for primary procedure)) also with 60 minutes of intraservice and total time and a work RVU of 5.50 to CPT code 93655 and we believe that this is a more accurate valuation than the RUC's work RVU crosswalk to CPT code 34709 (Placement of extension prosthesis(es) distal to the common iliac artery(ies) or proximal to the renal artery(ies) for endovascular repair of infrarenal abdominal aortic or iliac aneurysm, false aneurysm, dissection, penetrating ulcer, including pre-procedure sizing and device selection, all nonselective catheterization(s), all associated radiological supervision and interpretation, and treatment zone angioplasty/stenting, when performed, per vessel treated (List separately in addition to code for primary procedure)) with a work RVU of 6.50 and an intraservice and total time of 60 minutes because the proportional reduction in physician time should also reflect a similar proportional reduction in work RVUs. We are proposing the RUC-recommended 60 minutes of intraservice and total time, but instead propose a work RVU of 5.50 for CPT code 93655.

CPT code 93656 (Comprehensive electrophysiologic evaluation including transseptal catheterizations, insertion and repositioning of multiple electrode catheters with intracardiac catheter ablation of atrial fibrillation by pulmonary vein isolation, including intracardiac electrophysiologic 3-dimensional mapping, intracardiac echocardiography including imaging supervision and interpretation, induction or attempted induction of an arrhythmia including left or right atrial pacing/recording, right ventricular pacing/recording, and His bundle recording, when performed) is now bundled with the add-on CPT codes 93613 (Intracardiac electrophysiologic 3-dimensional mapping (List separately in addition to code for primary procedure)) (work RVU of 5.23 with 90 minutes of intraservice time) and the add-on CPT code 93662 (Intracardiac echocardiography during therapeutic/diagnostic intervention, including imaging supervision and interpretation (List separately in addition to code for primary procedure) (work RVU currently carrier-priced with 25 minutes of intraservice time) which previously were separately reported add-on services, similar to above CPT code 93653 and its add-on codes.

The RUC-recommended work RVU for CPT code 93656 is 20.00, with 40 minutes of preservice evaluation, 3 minutes of preservice positioning, 20 minutes of preservice scrub/dress/wait time, 210 minutes of intraservice time and 33 minutes of immediate postservice time, for a total of 306 minutes. The current physician times for CPT code 93656 are 23 minutes of preservice evaluation, 1 minutes of preservice positioning, 5 minutes of preservice scrub/dress/wait time, 240 minutes of intraservice time, and 40 minutes of immediate postservice time, for a total of 309 minutes, which is a net difference of 3 minutes less in the total proposed minutes, and the RUC is recommending a work RVU of 20.00, which is 0.23 more work RVUs than the current work RVU of 19.77.

In light of the RUC's intention to resurvey and review CPT code 93653 (and this family of codes) with its new bundling at their April 2021 RUC meeting to resolve any flaws from the initial survey, where many of the survey respondents may not have realized that the code descriptors had been substantially revised and that they may not have read the updated code descriptors thoroughly enough to respond correctly, we believe CPT code 93656 is in the same situation with its new bundling thus, we are proposing the RUC-recommended updates to the physician times (a net decrease of 3 minutes in total time) and to maintain the current work RVU of 19.77.

From the survey of CPT code 93657 (Additional linear or focal intracardiac catheter ablation of the left or right atrium for treatment of atrial fibrillation remaining after completion of pulmonary vein isolation (List separately in addition to code for primary procedure)), a value of 8.00 work RVUs was obtained at the 25th percentile for this add-on code. The RUC recommended a work RVU of 6.50, for the 60 minutes of intraservice and total physician time. The current work RVU is 7.50, for 90 minutes of intraservice and total physician time.

We compare add-on CPT code 22854 (Insertion of intervertebral biomechanical device(s) (e.g., synthetic cage, mesh) with integral anterior instrumentation for device anchoring (e.g., screws, flanges), when performed, to vertebral corpectomy(ies) (vertebral body resection, partial or complete) defect, in conjunction with interbody arthrodesis, each contiguous defect (List separately in addition to code for primary procedure)) with 60 minutes of intraservice and total time and 5.50 work RVUs to CPT code 93657 and we believe that this is a more accurate valuation, since the primary change to CPT code 93657 is the reduction of the intraservice time of about 67 percent, which we use as a guide to determining a work RVU. The RUC-recommended work RVU is crosswalked from CPT code 34709 (Placement of extension prosthesis(es) distal to the common iliac artery(ies) or proximal to the renal artery(ies) for endovascular repair of infrarenal abdominal aortic or iliac aneurysm, false aneurysm, dissection, penetrating ulcer, including pre-procedure sizing and device selection, all nonselective catheterization(s), all associated radiological supervision and interpretation, and treatment zone angioplasty/stenting, when performed, per vessel treated (List separately in addition to code for primary procedure)) with a work RVU of 6.50 and an intraservice and total time of 60 minutes, does not reflect the proportional reductions to the intraservice time and work. For CPT code 93657, we are proposing the RUC-recommended 60 minutes of intraservice and total time, and a work RVU of 5.50, crosswalked from CPT code 22854. There are no direct PE inputs for these facility-only CPT codes.

(34) 3D Imaging of Cardiac Structures (CPT Codes 933X0)

In May 2020, the CPT Editorial Panel created one new add-on code to describe the 3D echocardiographic imaging and postprocessing during transesophageal or transthoracic echocardiography for congenital cardiac anomalies for the assessment of cardiac Start Printed Page 39172structure(s). The 3D imaging could be performed as a follow-up to a 2D transthoracic echocardiogram.

We are proposing the RUC-recommended work RVU of 0.50 for CPT code 93XX0 (3D echocardiographic imaging and postprocessing during transesophageal echocardiography, or during transthoracic echocardiography for congenital cardiac anomalies, for the assessment of cardiac structure(s) (eg, cardiac chambers and valves, left atrial appendage, interatrial septum, interventricular septum) and function, when performed (List separately in addition to code for echocardiographic imaging).

While we are proposing no refinements to the direct PE inputs, we are requesting additional information about the 3D echocardiography probe equipment item. The RUC recommended that a 3D probe was required in addition to the base echocardiography machine. We received an invoice for $31,754.30 for this equipment item. It was unclear if the invoice reflected both the 3D probe and the base echocardiography machine or only the probe itself. We are seeking additional information to know if this equipment item reflected both the 3D probe and the base echocardiography machine or only the probe.

(35) Cardiac Catheterization for Congenital Defects (CPT Codes 93X1X, 93X2X, 93X3X, 93X4X, 93X5X, and 93X6X)

In May 2020, the CPT Editorial Panel replaced a family of four cardiac catheterization codes with five new codes (CPT codes 93X1X-93X5X) to describe cardiac catheterization for congenital cardiac defect(s). The CPT Editorial Panel also replaced two cardiac output measurement codes with one new add-on code (CPT code 93X6X) to report cardiac output measurement(s), performed during cardiac catheterization for congenital cardiac defects.

We are proposing the RUC-recommended work RVU for two of the codes in this family. We are proposing a work RVU of 3.99 for CPT code 93X1X (Right heart catheterization for congenital heart defect(s) including imaging guidance by the proceduralist to advance the catheter to the target zone; normal native connections) and a work RVU of 6.10 for CPT code 93X2X (Right heart catheterization for congenital heart defect(s) including imaging guidance by the proceduralist to advance the catheter to the target zone; abnormal native connections) as recommended by the RUC in both cases.

For CPT code 93X3X (Left heart catheterization for congenital heart defect(s) including imaging guidance by the proceduralist to advance the catheter to the target zone, normal or abnormal native connections), we disagree with the RUC-recommended work RVU of 6.00 and we are instead proposing a work RVU of 5.50 based on a crosswalk to CPT code 32607 (Thoracoscopy; with diagnostic biopsy(ies) of lung infiltrate(s) (eg, wedge, incisional), unilateral). CPT code 32607 is a thorascopy procedure with three fewer minutes of intraservice work time (45 minutes) than CPT code 93X3X but a higher total work time of 178 minutes. CPT code 93X3X has similar surveyed work time to CPT code 93X1X but the RUC recommended a work RVU of 3.99 for the first code in the family as compared to 6.00 for CPT code 93X3X. While we agree that CPT code 93X3X is a more intensive procedure, we do not agree that it should be valued more than two full RVUs higher as compared to the first code in the family. We believe that it would be more accurate to propose a work RVU of 5.50 based on the aforementioned crosswalk to CPT code 32607. We note that the intensity of CPT code 93X3X remains higher than the first two codes in the family at the proposed work RVU of 5.50.

For CPT code 93X4X (Right and left heart catheterization for congenital heart defect(s) including imaging guidance by the proceduralist to advance the catheter to the target zone(s); normal native connections), we disagree with the RUC-recommended work RVU of 7.91 and we are instead proposing a work RVU of 6.84 based on a crosswalk to CPT code 32608 (Thoracoscopy; with diagnostic biopsy(ies) of lung nodule(s) or mass(es) (eg, wedge, incisional), unilateral). CPT code 32608 is another thorascopy procedure from the same family as CPT code 32607, with the same 60 minutes of intraservice work time as CPT code 93X4X and a higher total work time of 195 minutes. In the same fashion as the previous code, CPT code 93X4X has similar surveyed work time to CPT code 93X2X but the RUC recommended a work RVU of 6.10 for the second code in the family as compared to 7.91 for CPT code 93X4X. While we agree that CPT code 93X4X is a more intensive procedure, we do not agree that it should be valued almost two full RVUs higher as compared to the second code in the family. We believe that it would be more accurate to propose a work RVU of 6.84 based on the aforementioned crosswalk to CPT code 32608. We note that the intensity of CPT code 93X4X remains the highest among the first four codes in the family at the proposed work RVU of 6.84. We believe that our proposed RVUs for CPT codes 93X3X and 93X4X better preserve relativity both within the family and also with other services on the PFS.

For CPT code 93X5X (Right and left heart catheterization for congenital heart defect(s) including imaging guidance by the proceduralist to advance the catheter to the target zone(s); abnormal native connections), we disagree with the RUC-recommended work RVU of 9.99 and we are instead proposing a work RVU of 8.88 based on the median work RVU from the survey. The RUC's recommendation of a work RVU of 9.99, based on maintaining the prior work RVU of deleted CPT code 93532 (Combined right heart catheterization and transseptal left heart catheterization through intact septum with or without retrograde left heart catheterization, for congenital cardiac anomalies), was nearly equal to the 75th percentile work RVU from the survey at 10.00. Since the RUC recommended the survey median work RVU for the other four non-measurement codes in the family, we do not understand the recommendation of a value for CPT code 93X5X that sits within 0.01 RVUs of the survey 75th percentile. The survey for CPT code 93X5X also revealed that it typically requires far less work time to perform as compared with predecessor code 93532 (83 minutes of intraservice work time as compared to 175 minutes for the predecessor code). Although we agree that CPT code 93X5X is a more intensive procedure than its predecessor code, we do not believe that the work RVU should remain unchanged given the greatly reduced work time in the new procedure. Since the two components of work are time and intensity, we believe that decreases in time should typically be reflected in decreases to work RVUs. We are therefore proposing a work RVU of 8.88 for CPT code 93X5X based on the survey median outcome. We believe that our proposed RVU more accurately accounts for these changes in surveyed work time and better preserves relativity with the rest of the family.

For CPT code 93X6X (Cardiac output measurement(s), thermodilution or other indicator dilution method, performed during cardiac catheterization for the evaluation of congenital heart defects), we disagree with the RUC-recommended work RVU of 1.75 and we are instead proposing a work RVU of 1.44 based on a crosswalk Start Printed Page 39173to CPT code 37253 (Intravascular ultrasound (noncoronary vessel) during diagnostic evaluation and/or therapeutic intervention, including radiological supervision and interpretation; each additional noncoronary vessel). CPT code 37253 is an intravascular ultrasound procedure that shares the same intraservice work time of 20 minutes as CPT code 93X6X and has 1 additional minute of immediate postservice time. We note that the intensity of CPT code 93X6X as recommended by the RUC at a work RVU of 1.75 would be the second-highest in the family, higher than CPT code 93X5X for example. We do not agree that this cardiac output measurement code would typically be more intensive to perform than the two types of heart catheterization taking place in CPT code 93X5X.

We also note that the recommended work RVU for CPT code 93X6X was higher than the sum of its two predecessor codes. Former CPT codes 93561 (Indicator dilution studies such as dye or thermodilution, including arterial and/or venous catheterization; with cardiac output measurement) and 93562 (Indicator dilution studies such as dye or thermodilution, including arterial and/or venous catheterization; subsequent measurement of cardiac output) had CY 2021 work RVUs of 0.95 and 0.77 respectively. These two codes sum together to a work RVU of 1.72 which would be lower than the RUC's recommendation of 1.75 for CPT code 93X6X. The RUC's recommendation suggests that there would be no efficiencies gained or savings created in the process of creating CPT code 93X6X; we believe that the survey for the new code indicates otherwise, as the predecessor codes had work times of 15 minutes and 12 minutes respectively (27 minutes total) as compared to 20 minutes of surveyed work time for the new code. This lower work time suggests that the creation of CPT code 93X6X has led to greater efficiencies in the service which, under the resource-based nature of the RVU system, lends further support for a reduction in the work RVU as compared to a sum of the predecessor codes. We therefore believe that it would be more accurate to propose a work RVU of 1.44 based on the aforementioned crosswalk to CPT code 37253.

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

(36) Outpatient Pulmonary Rehabilitation Services (CPT Codes 946X1 and 946X2)

CPT code 946X1 (Physician or other qualified health care professional services for outpatient pulmonary rehabilitation; without continuous oximetry monitoring (per session)) and CPT code 946X2 (Physician or other qualified health care professional services for outpatient pulmonary rehabilitation; with continuous oximetry monitoring (per session) (Do not report 946X1, 946X2 in conjunction with 94760, 94761)) are two new codes created by the CPT Editorial Panel to take the place of the HCPCS G-code G0424 (Pulmonary rehabilitation, including exercise (includes monitoring), one hour, per session, up to two sessions per day) which was created in 2010. The RUC recommended work RVUs for CPT codes 946X1 and 946X2 of 0.55 and 0.69 respectively. We disagree with the RUC-recommended work RVUs for both CPT code 946X1 and 946X2. Although the pulmonary rehab service as described by these new codes have not changed, the RUC recommendation included an increase in intraservice and total time for the services. As the survey time increased for the pulmonary rehabilitation codes, an increase in work value may be appropriate.

Based on a comparison of intraservice time for the current code relative the recommended values, we are proposing a work RVU of 0.36 for CPT code 946X1 and a work RVU of 0.56 for CPT code 946X2, which is an increase to the work RVU from the HCPCS G-code G0424 that these two codes are replacing and reflects a commensurate increase in work relative to the increase in intraservice time.

For the direct PE inputs, we are proposing to refine the clinical labor time for the “Provide education/obtain consent” (CA011) activity from the RUC-recommended 15 minutes to 2 minutes for both CPT codes 946X1 and 946X2. The recommended materials for this code family state that the 15 minutes for the CA011 activity are used for education which is an integral component of pulmonary rehabilitation programs. There is education provided at each separate session following a curriculum outlined in the guideline and covers both educational topics concerning self-management and educational topics concerning advance care planning which is different at every session.

We do not agree that it would be typical for CPT codes 946X1 and 946X2 to require an additional 13 minutes for education and consent given the patient is seen two to three times a week for pulmonary rehabilitation and the education can be covered during those sessions. We are refining the clinical labor time to 2 minutes for both CPT codes 946X1 and 946X2 to maintain relativity, particularly in light of the clinical similarities between these services. The education would be done during the “Perform procedure/service—NOT directly related to physician work time” (CA021), as stated above, as the patient is seen two to three times a week for pulmonary rehabilitation.

We are also proposing to refine the equipment time and lower the pulse oximeter w-printer (EQ211) and exercise equipment (treadmill, bike, stepper, UBE, pulleys, balance board) (EQ118) equipment times from 93 minutes to 80 minutes to match this change in clinical labor time for CPT codes 946X1 and 946X2.

Additionally, we are proposing to revise the utilization that we would use to set rates for CPT code 946X2 to reflect our understanding that pulmonary rehabilitation is always done with pulse oximetry. Thus, we are proposing to update our analytic crosswalk to reflect our belief that 100 percent of the utilization for the pulmonary rehabilitation services currently billed using HCPCS code G0424 will now be billed using CPT code 946X2. We believe that it is unlikely that these services would typically be billed using CPT code 946X1 since it is our understanding that pulmonary rehabilitation is typically provided with pulse oximetry, and therefore, we expect little to no utilization for CPT code 946X1. We are seeking comment from stakeholders on our understanding and proposal to revise the utilization as stated.

(37) Remote Therapeutic Monitoring (CPT Codes 989X1, 989X2, 989X3, 989X4, and 989X5)

Remote Therapeutic Monitoring (RTM) is a family of five codes created by the CPT Editorial Panel in October 2020 and valued by the RUC at its January 2021 meeting. The RTM family includes three PE-only codes and two codes that include professional work.

In recent years, we have finalized seven codes in the Remote Physiological Monitoring (RPM) family that include services similar to the new RTM codes. (See the CY 2021 PFS final rule at 85 FR 84542 through 84546 for more information.) Based upon our analysis, the services and code structure of RTM resemble those of RPM. For example, the RTM codes reflect similar staff and Start Printed Page 39174physician work, although the specific equipment used is different.

While there are notable similarities between the two sets of code descriptors, there are two primary differences. One difference is that according to RUC documents, primary billers of RTM codes are projected to be nurses and physical therapists. Stakeholders have suggested that the new RTM coding was created to allow practitioners who cannot bill RPM codes to furnish and bill for services that look similar to those of RPM. RPM services are considered to be E/M services and physical therapists, for example, are practitioners who cannot bill E/M services. The RTM codes, instead, are general medicine codes.

In our review of the new codes, we identified an issue that disallows physical therapists and other practitioners, who are not physicians or NPPs, to bill the RTM codes. By modeling the new RTM codes on the RPM codes, “incident to” services became part of the three direct practice expense-only (PE-only) codes (that is, CPT codes 989X1, 989X2, and 989X3) as well as the two professional work codes (that is, CPT codes 989X4 and 989X5). As a result, the RTM codes as constructed currently cannot be billed by, for example, physical therapists. We describe “incident to” services in the CMS Medicare Benefit Policy Manual, Chapter 15, beginning at section 60 and note that only physicians and certain other practitioners are authorized to furnish and bill “incident to” services. Incident to services are:

  • An integral, although incidental, part of the physician's professional service (see § 60.1);
  • Commonly rendered without charge or included in the physician's bill (see § 60.1A);
  • Of a type that are commonly furnished in physician's offices or clinics (see § 60.1A); and
  • Furnished by the physician or by auxiliary personnel under the physician's direct supervision (see § 60.1B).

Additionally, we designated the treatment management RPM codes (that is, CPT codes 99457 and 99458) as care management services (84 FR 62697 through 62698), which allow general supervision rather than direct supervision for incident to services. The treatment management RTM codes (CPT codes 989X4 and 989X5), because they are not E/M codes, cannot be designated as care management services. As a result, we are seeking comment on how we might remedy the issues related to the RTM code construction in order to permit practitioners who are not physicians or NPPs to bill the RTM codes.

The second primary difference between the RTM and RPM codes is the nature of the data to be collected and how it is collected. According to the code descriptors, RTM codes monitor health conditions, including musculoskeletal system status, respiratory system status, therapy (medication) adherence, and therapy (medication) response, and as such, allow non-physiologic data to be collected. Reportedly, data also can be self-reported as well as digitally uploaded. RPM requires that data be physiologic and be digitally uploaded. We note that, for both sets of codes, the device used must meet the FDA definition of a medical device as described in section 201(h) of the Federal Food, Drug and Cosmetic Act (FFDCA). We are seeking comment on the typical type of device(s) and associated costs of the device(s) that might be used to collect the various kinds of data included in the code descriptors (for example, respiratory system status, musculoskeletal status, medication adherence, pain) for the RTM services.

For CY 2022, we are proposing the RUC-recommended work RVU of 0.62 for CPT code 989X4 (Remote therapeutic monitoring treatment management services, physician/other qualified health care professional time in a calendar month requiring at least one interactive communication with the patient/caregiver during the calendar month; first 20 minutes) and the RUC-recommended work RVU of 0.61 for its add-on code, CPT code 989X5 (Remote therapeutic monitoring treatment management services, physician/other qualified health care professional time in a calendar month requiring at least one interactive communication with the patient/caregiver during the calendar month; each additional 20 minutes (List separately in addition to code for primary procedure)) as a means of maintaining parity with the two RPM treatment management codes (CPT codes 99457 and 99458) upon which the two RTM codes are based. We also are proposing the RUC-recommended direct PE inputs for the two treatment management codes, CPT codes 989X4 and 989X5, without refinement.

We are proposing to refine the direct PE inputs for the three PE-only codes: CPT code 989X1 (Remote therapeutic monitoring (e.g., respiratory system status, musculoskeletal system status, therapy adherence, therapy response); initial set-up and patient education on use of equipment), CPT code 989X2 (Remote therapeutic monitoring (e.g., respiratory system status, musculoskeletal system status, therapy adherence, therapy response); device(s) supply with scheduled (e.g., daily) recording(s) and/or programmed alert(s) transmission to monitor respiratory system, each 30 days), and CPT code 989X3 (Remote therapeutic monitoring (e.g., respiratory system status, musculoskeletal system status, therapy adherence, therapy response); device(s) supply with scheduled (e.g., daily) recording(s) and/or programmed alert(s) transmission to monitor musculoskeletal system, each 30 days). We are proposing to value the PE for CPT code 989X1 by crosswalking to the PE RVU for RPM code 99453 upon which the new RTM code was based. We also are proposing to value the PE for CPT codes 989X2 and 989X3 by crosswalking to the PE RVU for comparable RPM code 99454, a code that includes payment for the medical device used to collect and transmit data. We note that the only input to CPT code 989X2 is a monthly fee of $25, which would not be paid as a direct cost under the PFS. Historically, we have considered most computer software and associated licensing fees to be indirect costs. However, as we noted in section II.B. of this proposed rule (the PE section), stakeholders have routinely expressed concerns with this policy, especially for evolving technologies that rely primarily on software and licensing fees with minimal costs in equipment or hardware.

(38) Principal Care Management and Chronic Care Management (CPT Codes 99490, 99439, 99491, 99X21, 99487, 99489, 99X22, 99X23, 99X24, and 99X25)

In recent years, we have engaged in efforts to update and improve the relative value of care management and coordination services within the PFS by identifying gaps in payment and coding. One of those PFS services is Chronic Care Management (CCM). CCM services, which include management and support services provided by clinical staff under the supervision of a physician or NPP or services provided personally by a physician or NPP, have received ongoing refinements related to payment and coding since CY 2013.

Beginning in the CY 2014 PFS final rule (78 FR 74414 through 74427), we noted that physicians and NPPs who furnish care to patients with multiple chronic conditions require greater resources than are required to support patient care in a typical E/M service. In response, we finalized a separately payable HCPCS code, GXXX1 (Chronic Care Management (CCM) services Start Printed Page 39175furnished to patients with multiple (2 or more) chronic condition expected to last at least 12 months, or until the death of the patient; 20 minutes or more per in 30 days of chronic care management services provided by clinical staff and directed by a physician or other qualified health care practitioner). For CY 2015 (79 FR 67715 through 67730), we refined aspects of the existing CCM policies and adopted separate payment for CCM services under CPT code 99490 (Chronic care management services (CCM), at least 20 minutes of clinical staff time directed by a physician or other qualified health professional, per calendar month, with the following required elements: Multiple (two or more) chronic conditions expected to last at least 12 months, or until the death of the patient; Chronic conditions place the patient at significant risk of death, acute exacerbation/decompensation, or functional decline; Comprehensive care plan established, implemented, revised, or monitored). For CY 2017 (81 FR 80244), we adopted CPT codes 99487 (Complex chronic care management (CCCM) services with the following required elements: Multiple (two or more) chronic conditions expected to last at least 12 months, or until the death of the patient, chronic conditions place the patient at significant risk of death, acute exacerbation/decompensation, or functional decline, comprehensive care plan established, implemented, revised, or monitored, moderate or high complexity medical decision making; first 60 minutes of clinical staff time directed by a physician or other qualified health care professional, per calendar month) and 99489 (Complex chronic care management (CCCM) services with the following required elements: Multiple (two or more) chronic conditions expected to last at least 12 months, or until the death of the patient, chronic conditions place the patient at significant risk of death, acute exacerbation/decompensation, or functional decline, comprehensive care plan established, implemented, revised, or monitored, moderate or high complexity medical decision making; each additional 30 minutes of clinical staff time directed by a physician or other qualified health care professional, per calendar month (List separately in addition to code for primary procedure)). Then, in the CY 2019 PFS final rule (83 FR 59577), we adopted a new CPT code, 99491 (Chronic care management services, provided personally by a physician or other qualified health care professional, at least 30 minutes of physician or other qualified health care professional time, per calendar month, with the following required elements: Multiple (two or more) chronic conditions expected to last at least 12 months, or until the death of the patient; chronic conditions place the patient at significant risk of death, acute exacerbation/decompensation, or functional decline; comprehensive care plan established, implemented, revised, or monitored), to describe at least 30 minutes of CCM services performed personally by a physician or NPP. In the CY 2020 PFS final rule (84 FR 62690), we established payment for an add-on code to CPT code 99490 by creating 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). We also created two new HCPCS G codes, G2064 and G2065 (84 FR 62692 through 62694), representing comprehensive services for a single high-risk disease (that is, principal care management). In the CY 2021 PFS final rule (85 FR 84639), we finalized a RUC-recommended replacement code for HCPCS code G2058, CPT code 99439, which was given the same valuation and the identical descriptor as G2058.

For CY 2022, the RUC resurveyed the CCM code family, including Complex Chronic Care Management (CCCM) and Principal Care Management (PCM), and added five new CPT codes: 99X21 (Chronic care management services each additional 30 minutes by a physician or other qualified health care professional, per calendar month (List separately in addition to code for primary procedure)), 99X22 (Principal care management services for a single high-risk disease first 30 minutes provided personally by a physician or other qualified health care professional, per calendar month), 99X23 (Principal care management services for a single high-risk disease each additional 30 minutes provided personally by a physician or other qualified health care professional, per calendar month (List separately in addition to code for primary procedure), 99X24 (Principal care management services, for a single high-risk disease first 30 minutes of clinical staff time directed by physician or other qualified health care professional, per calendar month), and 99X25 (Principal care management services, for a single high-risk disease each additional 30 minutes of clinical staff time directed by a physician or other qualified health care professional, per calendar month (List separately in addition to code for primary procedure)). The CCM/CCCM/PCM code family now includes five sets of codes, each set with a base code and an add-on code. The sets vary by the degree of complexity of care (that is, CCM, CCCM, or PCM), who furnishes the care (that is, clinical staff or the physician or NPP), and the time allocated for the services. The RUC-recommended values for work RVUs and direct PE inputs for CY 2022 derive from the recent RUC specialty society survey (see Table 12).

We reviewed the RUC-recommended values for the 10 codes in the CCM family and are proposing to accept the recommended work values for the codes. We are proposing the RUC-recommended direct PE inputs without refinements. We believe that proposing to accept these updated values is consistent with our goals of ensuring continued and consistent access to these crucial care management services and acknowledges our longstanding concern about undervaluation of care management under the PFS. We are seeking comment, however, on whether keeping professional PCM and CCM at the same value creates an incentive to bill CCM instead of billing PCM when appropriate.

In addition to the proposals on the values for CCM codes, we are interested in understanding more about the standard practice used by practitioners to obtain beneficiary consent for these services. We have received questions from stakeholders regarding the consent requirements for CCM services. We believe that these questions have arisen because of the many flexibilities allowed in response to the PHE for COVID-19. In particular, during the PHE for COVID-19, we allowed stakeholders to obtain beneficiary consent for certain services under general supervision (85 FR 19230, April 6, 2020). Before the PHE for COVID-19, we required that beneficiary consent be obtained either by or under the direct supervision of the primary care practitioner. This requirement is consistent with the conditions of payment for this service under the PFS. As we consider what policies implemented during the PHE for COVID-19 should remain in effect beyond the PHE, we are interested in understanding how billing practitioners furnishing CCM at different service sites (for example, physician office settings, RHCs, FQHCs) have been obtaining beneficiary consent over the past year and how different levels of supervision impact this activity. We welcome public comment on the issue, specifically on what levels of supervision are necessary to obtain beneficiary consent when furnishing CCM services and will Start Printed Page 39176consider such comments in future rulemaking.

We also are proposing to adopt CPT codes 99X22 (PCM First 30 minutes provided personally by a physician or other qualified health care professional, per calendar month) and 99X24 (PCM First 30 minutes of clinical staff time directed by physician or other qualified health care professional, per calendar month) to replace HCPCS codes G2064 and G2065 in the calculation of the rate for HCPCS code G0511 for General Care Management services billed by RHCs and FQHCs. The payment rate for HCPCS code G0511 is calculated based on the average of the national non-facility PFS payment rate for care management and general behavioral health integration codes (CPT codes 99484, 99487, 99490, and 99491) as well as HCPCS codes G2064 and G2065 which describe PCM services billed under the PFS. The payment rate for HCPCS code G0511 is updated annually based on the PFS amounts for these codes.

(39) Moderate Sedation (HCPCS Code G0500)

Following the publication of the CY 2021 PFS final rule, a stakeholder contacted us regarding what they believed to be an error in the intraservice work time for HCPCS code G0500 (Moderate sedation services provided by the same physician or other qualified health care professional performing a gastrointestinal endoscopic service that sedation supports, requiring the presence of an independent trained observer to assist in the monitoring of the patient's level of consciousness and physiological status; initial 15 minutes of intra-service time; patient age 5 years or older (additional time may be reported with 99153, as appropriate)). We established HCPCS code G0500 in CY 2017 to more accurately capture the work of administering moderate sedation for gastrointestinal endoscopic procedures for patients 5 years of age or older. We based the physician work and time for HCPCS code G0500 on data from the 100 gastroenterologists who completed the survey of CPT code 99152 (Moderate sedation services provided by the same physician or other qualified health care professional performing the diagnostic or therapeutic service that the sedation supports, requiring the presence of an independent trained observer to assist in the monitoring of the patient's level of consciousness and physiological status; initial 15 minutes of intraservice time, patient age 5 years or older) presented at the October 2015 RUC meeting. The survey data for CPT code 99152 showed a significant bimodal distribution with data from gastroenterologists performing endoscopic procedures demonstrating a markedly different and lesser amount of physician work for moderate sedation compared to other specialties. The stakeholder stated that the finalization of 12 minutes of intraservice work time for HCPCS G0500 appeared to be an error and asked CMS to correct it to reflect the 5 minutes of intraservice work time indicated by survey data when gastroenterologists performed endoscopic procedures.

While we appreciate the feedback from the stakeholder, we disagree that the finalization of 12 minutes of intraservice work time for HCPCS code G0500 (matching CPT code 99152) was an error. The work time for HCPCS code G0500 was proposed and finalized at 12 minutes in CY 2017, with the intention that it would match the work time for CPT code 99152. This was the rationale behind the descriptor for HCPCS code G0500 listing that the code was intended for the initial 15 minutes of intraservice time. Furthermore, several commenters questioned the work time for HCPCS code G0500 in the CY 2017 PFS final rule (81 FR 80341) and we stated in response that we expected that practitioners would report the appropriate CPT or HCPCS code that most accurately described the services performed during a patient encounter, including those services performed concurrently and in support of a procedural service consistent with CPT guidance. We noted that the commenters referred to the time for moderate sedation in the survey data, while the time thresholds for the moderate sedation codes were intended to match the intraservice time of the procedure itself. For a full discussion of this topic, we refer readers to the CY Start Printed Page 391772017 PFS final rule (81 FR 80339 through 80349).

Although we are not proposing a change in the work time for HCPCS code G0500, we are soliciting comments on this issue in the interest of gaining additional information about the typical use of this procedure.

(40) Payment for Synthetic Skin Substitutes (HCPCS Codes GXXAB, GXXAC, GXXAD, GXXAE, GXXAF, GXXAG, GXXAH, and GXXAI)

On July 1, 2020, Medicare implemented HCPCS code C1849 (Skin substitute, synthetic, resorbable, per square centimeter) and made it payable under the OPPS. In the CY 2021 OPPS final rule (85 FR 86064 through 86067) Medicare finalized payment for C1849—and the associated synthetic skin substitute products—allowing it to be billed with graft skin substitute procedure CPT codes 15271 through 15278. We note that under the OPPS, payment for C1849 is packaged into the payment for the graft skin substitute procedure, and its costs are reflected in the development of the payment rates for those services. The creation of the C-code and the CY 2021 OPPS rulemaking addressed the need for a mechanism to pay for graft skin substitute application services performed with synthetic graft substitute products in the outpatient hospital setting, which is comparable to how Medicare pays for graft skin substitute application services performed with graft skin substitutes that are regulated by the Food and Drug Administration (FDA) under its regulatory framework at section 361 of the Public Health Service (PHS) Act for human cells, tissues, and cellular and tissue-based products (HCT/Ps). We want to clarify that the availability of a HCPCS code for a particular HCT/P does not mean that the product is appropriately regulated solely under section 361 of the PHS Act and the FDA regulations in 21 CFR part 1271. Manufacturers of HCT/Ps should consult with the FDA Tissue Reference Group (TRG) or obtain a determination through a Request for Designation (RFD) on whether their HCT/Ps are appropriately regulated solely under section 361 of the PHS Act and the regulations in 21 CFR part 1271 (85 FR 86058). We note that in a response to the CY 2021 OPPS proposal, a commenter noted that the use of a C-code meant that synthetic graft skin substitute products would only be payable under the OPPS, and would not be able to be reported for graft skin substitute services using a synthetic product in the physician office setting (85 FR 86066).

Currently, graft skin substitute application services are paid separately from the (HCT/Ps) skin substitutes under the PFS. Specifically, when a physician or NPP furnishes a surgical service to apply a (HCT/Ps) skin substitute in a non-facility setting, they may bill Medicare for the surgical service (as described by CPT codes 15271 through 15278), and separately bill for the (HCT/Ps) skin substitute. For CY 2022, in order to reconcile the gap in payment for synthetic products in the physician office setting, we are proposing to create eight HCPCS codes (parallel to the aforementioned existing surgical codes) that would include the synthetic graft skin substitute product as a supply cost in determining the PFS rate. We believe that it would be appropriate to consider these products as incident to supplies in the office setting, and as such they should be built in as a supply cost in calculating the PFS rate. Therefore, we are proposing to consider these products as incident to supplies in the office setting.

The codes and long descriptors for the proposed synthetic graft skin substitute services are:

  • HCPCS Code GXXAB: Application of synthetic skin substitute graft to trunk, arms, legs, total wound surface area up to 100 sq cm, including provision of synthetic skin substitute; first 25 sq cm or less wound surface area.
  • HCPCS Code GXXAC: Application of synthetic skin substitute graft to trunk, arms, legs, total wound surface area up to 100 sq cm, including provision of synthetic skin substitute; each additional 25 sq cm wound surface area, or part thereof (List separately in addition to code for primary procedure).
  • HCPCS Code GXXAD: Application of synthetic skin substitute graft to trunk, arms, legs, total wound surface area greater than or equal to 100 sq cm, including provision of synthetic skin substitute; first 100 sq cm wound surface area, or 1% of body area of infants and children.
  • HCPCS Code GXXAE: Application of synthetic skin substitute graft to trunk, arms, legs, total wound surface area greater than or equal to 100 sq cm, including provision of synthetic skin substitute; each additional 100 sq cm wound surface area, or part thereof, or each additional 1% of body area of infants and children, or part thereof (List separately in addition to code for primary procedure).
  • HCPCS Code GXXAF: Application of synthetic skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits, total wound surface area up to 100 sq cm, including provision of synthetic skin substitute; first 25 sq cm or less wound surface area.
  • HCPCS Code GXXAG: Application of synthetic skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits, total wound surface area up to 100 sq cm, including provision of synthetic skin substitute; each additional 25 sq cm wound surface area, or part thereof (List separately in addition to code for primary procedure).
  • HCPCS Code GXXAH: Application of synthetic skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits, total wound surface area greater than or equal to 100 sq cm, including provision of synthetic skin substitute; first 100 sq cm wound surface area, or 1% of body area of infants and children.
  • HCPCS Code GXXAI: Application of synthetic skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits, total wound surface area greater than or equal to 100 sq cm, including provision of synthetic skin substitute; each additional 100 sq cm wound surface area, or part thereof, or each additional 1% of body area of infants and children, or part thereof (List separately in addition to code for primary procedure).

We are proposing contractor pricing for these codes for CY 2022; we note that there is limited data available on the cost of synthetic skin substitute products in physician offices, so we are also seeking comment and documentation regarding the appropriate values for these services for consideration of national pricing in future rulemaking.

Though we are proposing contractor pricing in the interim, we also considered an alternative approach that would use crosswalks to value these services in the physician office setting in a way that is commensurate with the rates paid under the OPPS. Though limited data exists on the cost of graft synthetic skin substitute products in physician offices, hospitals began reporting costs associated with synthetic skin substitute products in CY 2020 after C1849 became effective and payable under the OPPS starting in July, 2020. We analyzed CY 2020 OPPS claims data and estimate hospital outpatient department costs for graft synthetic skin substitute products averaged $1,500. We note that under the OPPS, outpatient departments are paid separately for the primary surgical application codes (CPT codes 15271, 15273, 15275, 15277), and the costs associated with the synthetic products Start Printed Page 39178as well as the add-on services (described by CPT codes 15272, 15274, 15276, 15278) are packaged into the payment for the primary procedure.

Under this alternative, we considered following an approach similar to that under the OPPS where the cost of the supply would be included in the primary codes (described by HCPCS GXXAB, GXXAD, GXXAF, and GXXAH) and not the add-on codes (described by HCPCS GXXAC, GXXAE, GXXAG, and GXXAI), though the add-on would continue to be reported and paid separately. Specifically, we would use direct crosswalks for the work RVUs, MP RVUs, and facility PE RVUs from the current surgical application codes (that is, CPT codes 15271 through 15278) as we believe that these payment components for the synthetic graft skin substitute services, described by the aforementioned HCPCS codes, would be similar.

However, with regards to the non-facility PE RVUs, we recognize that there are significant supply costs associated with synthetic skin substitute products. As described previously, we estimate that hospitals face average costs associated with synthetic skin substitute products of $1,500. We note that the PE methodology, which relies on the allocation of indirect costs based on the magnitude of direct costs, may not be appropriate for these types of services because the specialists that typically furnish these types of services do not typically have significant supply costs within the methodology. As such, we used the hospital reported costs and we looked to other codes where specialists frequently have similarly high supply costs in order to crosswalk the non-facility PE RVUs. We considered services that have a significant proportion of supply costs and are furnished by specialists who typically have higher supply costs as potential crosswalks for the non-facility PE RVUs. For example, we considered a crosswalk to CPT code 21461 (Open treatment of mandibular fracture; without interdental fixation) for HCPCS codes GXXAB and GXXAF, and a crosswalk to CPT code 21462 (Open treatment of mandibular fracture; with interdental fixation) for HCPCS codes GXXAD and GXXAH. As an estimate of non-facility PE, we believe these would be appropriate codes for crosswalking non-facility PE RVUs. As previously discussed, for the purposes of the work RVUs, MP RVUs, and facility PE RVUs, we believe direct crosswalks to the current surgical application codes would be appropriate as those values would generally not be impacted by the addition of a synthetic skin substitute product. We realize this alternative considered would follow a similar coding and payment approach established under the OPPS, and that potential adoption of this alternative would mean that the cost of the products is included in the primary codes and not included in the add-on codes. We welcome feedback on our proposal to treat synthetic skin substitute products as incident to supplies in the physician office, the proposal to have contractor pricing for these codes, and other ways we could obtain detailed and reliable cost information on synthetic skin substitutes that are furnished in the non-facility setting. We are also seeking comment on the alternative approach that we considered (using crosswalks to value these services in the physician office setting). Additionally, we are seeking comment on potential ways to reconcile these coding and payment differences across settings to yield a more consistent and rational payment approach for synthetic and HCT/P graft skin substitutes.

(41) External Extended ECG Monitoring (CPT Codes 93241, 93242, 93243, 93244, 93245, 93246, 93247, and 93248)

In the CY 2021 PFS proposed rule (85 FR 50164), we proposed to adopt the RUC recommendations for CPT codes 93241 (External electrocardiographic recording for more than 48 hours up to 7 days by continuous rhythm recording and storage; includes recording, scanning analysis with report, review and interpretation), 93242 (External electrocardiographic recording for more than 48 hours up to 7 days by continuous rhythm recording and storage; recording (includes connection and initial recording)), 93243 (External electrocardiographic recording for more than 48 hours up to 7 days by continuous rhythm recording and storage; scanning analysis with report), 93244 (External electrocardiographic recording for more than 48 hours up to 7 days by continuous rhythm recording and storage; review and interpretation), 93245 (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), 93246 (External electrocardiographic recording for more than 7 days up to 15 days by continuous rhythm recording and storage; recording (includes connection and initial recording)), 93247 (External electrocardiographic recording for more than 7 days up to 15 days by continuous rhythm recording and storage; scanning analysis with report), and 93248 (External electrocardiographic recording for more than 7 days up to 15 days by continuous rhythm recording and storage; review and interpretation).

We noted that 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 we received 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 health care 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, which we rejected as we typically require an invoice representative of commercial market pricing to establish a national price for a new supply or equipment item.

After consideration of the information, we proposed to employ a crosswalk to an existing supply for use as a proxy price until we received pricing information to use for the “extended external ECG patch, medical magnetic tape recorder” item. We proposed to use the “kit, percutaneous neuro test stimulation” (SA022) supply as our proxy item at a price of $413.24. We believed the kit to be the closest match from a pricing perspective to employ as a proxy until we would be able to arrive at an invoice that is representative of commercial market pricing. We welcomed the submission of invoices or other additional information for use in pricing the “extended external ECG patch, medical magnetic tape recorder” supply. In response to our proposal, we received conflicting information from commenters and in the CY 2021 PFS final rule (85 FR 84631), we ultimately finalized contractor pricing for CY 2021 for the four codes that include this supply input (CPT codes 93241, 93243, 93245, and 93247) to allow additional time to receive more pricing information.

We note that stakeholders have continued to engage with CMS and the MACs on payment for this service. We remain concerned that we continue to hear that the supply costs as initially considered in our CY 2021 PFS proposal are much higher than they should be. At the same time we also have heard that Start Printed Page 39179the resource costs, as reflected in the contractor based payments do not adequately cover the incurred cost for the SD339 supply that is used to furnish these services. In consideration of continued access to these services for Medicare beneficiaries, we are once again seeking public comment and information to support CMS' future rulemaking to establish a uniform national payment that appropriately reflects the PE that are used to furnish these services. As previously stated, invoices or other additional information, including for example, which proxy supply items could be used to establish cost for the SD339 supply, information on use/application and potential alternatives (as appropriate) to the supply items, would be ideal for us to use in establishing fair and stable pricing for these services. We note that in the absence of such additional and actionable information (that is, information that provides further context to information that has already been considered) we are proposing to maintain contractor pricing for these services.

(42) Comment Solicitation for Impact of Infectious Disease on Codes and Ratesetting

During the PHE for COVID-19, several stakeholders have contacted CMS with concerns about the additional costs borne by physician and NPPs due to the pandemic that may impact the professional services furnished to Medicare beneficiaries. For example, we have heard from stakeholders about higher costs due to additional supplies, such as personal protective equipment, and increased time that physicians, NPPs and their clinical staff may spend with patients to mitigate further spread of infection when, for example, stakeholders are working to rule out a COVID-19 infection, or furnishing other services to a patient with a confirmed COVID-19 infection. While costs such as these may diffuse into Medicare payment rates over a period of time, our payment systems, including the PFS, are not generally designed to accommodate more acute increases in resource costs, even if they are widespread. We acknowledge the circumstances stakeholders have identified that may lead to additional costs borne by physicians and NPPs during the PHE, and we have developed and implemented policies, as appropriate and where possible, to maintain beneficiary access to necessary services during the PHE. CMS is continuing to think broadly about the concerns raised, and specifically about the types of resource costs that may not be fully reflected in payment rates for existing services, or costs that could be accounted for by establishing new payment rates for new services. We are interested in feedback from stakeholders about additional strategies to account for PHE-related costs, including feedback on the specific types of services and costs that may benefit from further review, such as infectious disease control measures, research-related activities and services, or PHE-related preventive or therapeutic counseling services. We are interested in detailed feedback from stakeholders to help inform whether we should consider making changes to payments for services or develop separate payments for such services in future rulemaking.

(43) Comment Solicitation on Separate PFS Coding and Payment for Chronic Pain Management

Adequate treatment of pain is a significant public health challenge. Centers for Disease Control and Prevention (CDC) data indicate 50 million adults in the United States have chronic daily pain, with nearly 20 million experiencing high impact pain that interferes with daily life or work. Pain is the most common reason individuals seek medical care, and more than 20 percent of office visits are associated with pain.[4] In the United States, 42.6 percent of adults report having pain on some days in the past 6 months,[5] and chronic pain and high-impact chronic pain are experienced by 20.4 percent and 8 percent of adults, respectively.[6] The high prevalence of pain exacts a substantial economic toll: Medical expenditures and lost productivity related to pain result in a cost to the United States estimated at up to $635 billion.[7]

In 2010, HHS, through the National Institutes of Health (NIH), contracted with the Institute of Medicine to make recommendations “to increase the recognition of pain as a significant public health problem in the United States.” In its 2011 report entitled Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research, the Institute of Medicine, through a study mandated by Congress, recommended significant improvements in pain prevention, care, education, and research and development of a population health-level strategy to address pain care.[8] The report described that the unique experience of pain requires a combination of person-centered therapies and coping techniques influenced by genes, cultural attitudes, stress, depression, ability to understand health information, and other behavioral, cultural, and emotional factors. It noted that individualized care can require adequate extra time to counsel patients and caregivers, promote self-management, and consult with other providers, but current reimbursement systems are not designed to efficiently pay for this approach. HHS subsequently convened an expert committee to oversee creation of the National Pain Strategy (NPS), issued in 2016.[9] The NPS addressed six key areas of care: Population research, prevention and care, disparities, service delivery and payment, professional education and training, and public education/communication. In this report, NPS' vision is to “decrease the prevalence of pain across its continuum from acute to high-impact chronic pain and its associated morbidity and disability across the lifespan,” and aim “to reduce the burden of pain for individuals, their families, and society as a whole.”

This work was followed by HHS's 2019 release of its Pain Management Best Practices Inter-Agency Task Force Report: Updates, Gaps, Inconsistencies, and Recommendations (PMTF Report).[10] The PMTF Report focuses on the development of patient-centered pain treatment plans to establish diagnosis and set measurable outcomes such as improvements in quality of life, function, and activities of daily living. It emphasized multi-modal, multi-disciplinary approaches that include various modalities for acute and chronic pain. The PMTF Report also identified five broad treatment categories: Medications including opioids and non-opioids, restorative therapies, interventional approaches, behavioral approaches, and complementary and integrative health. It stressed the importance of special populations including older adults and persons with Start Printed Page 39180relapsing conditions, Veterans, and people who receive palliative care. The PMTF Report recognized the importance of proper opioid stewardship for individuals who need opioids to effectively manage their pain. As the Task Force noted, there are ongoing concerns regarding suicide and suicidal ideation due to pain, and a lack of access to pain treatment, including appropriate access to opioid medications. The PMTF Report noted that management of pain conditions often requires multidisciplinary coordination among health care professionals, and that the experience of pain can intensify other health issues such as delayed recovery from surgery, or exacerbate behavioral health conditions. Many health care professionals, including primary care providers, have opted out entirely in treating pain, worsening an existing shortage of pain specialists and making chronic pain care hard to access, including for people who frequently experience disparities in pain care such as rural dwellers, racial/ethnic minorities, and people with disabilities. The COVID-19 Public Health Emergency has also had an impact on the ability of many older adults and people with disabilities' access to care, although telehealth modalities have shown promise in broadening access to services and supports.

At the same time individuals are experiencing difficulties finding pain care, the country is also coping with a worsening opioid and SUD crisis. The current environment involves shifting “waves” of overdose deaths associated with heroin, synthetic opioids, and prescription drugs, and intensifying stimulant and polysubstance use. Preliminary Centers for Disease Control and Prevention data released in April 2021 show a 29 percent rise in overdose deaths from October 2019 through September 2020—the most recent data available—compared with the previous 12-month period.[11] Illicitly manufactured fentanyl and other synthetic opioids were the primary drivers, although many fatal overdoses have also involved stimulant drugs, particularly methamphetamine. In December 2020, the Substance Abuse and Mental Health Services Administration (SAMHSA) released a preliminary report from its Drug Abuse Warning Network, which captures data on emergency department (ED) visits related to recent substance use and misuse such as alcohol use, illicit drug use, suicide attempts, and nonmedical use of pharmaceuticals. Most commonly associated with ED visits in the participating hospitals are illicit substances and central nervous system agents. Among illicit drugs, stimulants (including methamphetamine and illicit amphetamine) are the most common, followed by cannabinoids (including marijuana and synthetic cannabinoids).[12]

The PMTF Report urged clinicians to use a comprehensive, individualized, person-centered approach to the diagnosis and treatment of pain featuring multiple therapeutic modalities. The uptake of this approach is an urgent concern as growing numbers of older adults are enrolling in Medicare. Some estimates indicate about half of older adults have pain that interferes with function. Primary care clinicians and specialists are already facing challenges in treating pain and associated chronic disease in the Medicare population, where conditions such as arthritis, bone/joint disorders, back and neck pain, cancer and other conditions that inform and at times inhibit employing the full spectrum of pain management therapies are common. We believe untreated and inappropriately treated pain may translate to increased costs to the Medicare program as more beneficiaries experience functional decline, incapacitation, and frailty. Additional risks in untreated pain include individuals using illicit drugs such as cannabis; inadequate treatment of mental disorders such as depression and anxiety, misuse of prescription drugs, alcohol and other drug use disorder, and increased suicide risk and suicide.

In 2019 HHS issued the Guide for Clinicians on the Appropriate Dosage Reduction or Discontinuation of Long-Term Opioid Analgesics (the Guide) to support the thoughtful, deliberative, and measured discontinuation of long-term opioid analgesics, and mitigate harm and risk to patients who are working with their clinicians to undergo appropriate tapering or discontinuation.[13] The Guide notes that decisions to continue or reduce opioid medications for pain should be collaborative and based on the individual patient's goals and circumstances and clinicians should consider, for example, whether opioid medications continue to support patients meeting treatment goals; if opioids are exposing the person to an increased risk for serious adverse events or an opioid use disorder; and whether benefits continue to outweigh risks of opioids. Whether or not opioids are used in treatment, safe and effective non-opioid treatments can be integrated into patients' pain management plans based on an individualized assessment of benefits and risks, and considering the patient's diagnosis, goals and circumstances.[14] Unique needs and coordination across the health care team is critical and clinicians and care teams have a responsibility to provide, or arrange for, coordinated management of patients' pain including any medication-related issues. The system of care should not ultimately result in patient abandonment. The FDA issued a safety announcement in 2019, advising that health care professionals should not abruptly discontinue opioids in patients who are physically dependent and that patient-specific plans should be created to gradually taper off opioids, in part due to the risk of adverse events including abrupt withdrawal symptoms, increased pain, mood changes, mental health impact, psychosocial impact, and importantly, suicide risk.[15]

In 2020 the National Academy of Medicine, as part of its “Action Collaborative to Countering the U.S. Opioid Epidemic,” began an effort to understand more about the state of chronic pain management, and to bring greater awareness to any intended and unintended consequences of opioid prescribing metrics as they pertain to the delivery, access, and coordination of chronic pain management and care. CMS is one of the sponsors of this work. The aim of this project is to visually illustrate the chronic pain management journey and accelerate the uptake of a range of pain treatments by outlining approaches to effective communication that leads to strong clinical relationships and optimal quality of life for people with pain.[16]

The SUPPORT Act (Pub. L. 115-271, October 24, 2018) outlines national strategies to help address America's opioid and substance use disorders (SUD) crisis, and advances policies to improve the treatment of pain and SUD. The SUPPORT Act recognizes the importance of opioid-related medication management, as well as the overall need to identify SUD in the Medicare Start Printed Page 39181beneficiary population. Sections 2002 and 6086 of the SUPPORT Act are of particular importance regarding pain management. For beneficiaries with chronic pain, section 2002 of the SUPPORT Act amended sections 1861(ww) and (hhh)(2) of the Act to include a review of any current opioid prescriptions in conjunction with the initial preventive physical examination (the “Welcome to Medicare” visit) and annual wellness visit (AWV). The opioid prescription review is to include a review of the potential risk factors to the individual for opioid use disorder, an evaluation of the individual's pain severity and current treatment plan, the provision of information on non-opioid treatment options, and referral to a specialist, if appropriate. Section 2002 also amended sections 1861(ww) and (hhh)(2) of the Act to add a screening for potential SUDs to the Welcome to Medicare visit and the AWV, and to add referral to a specialist, as appropriate, to the AWV.

Section 6086 of the SUPPORT Act, the Dr. Todd Graham Pain Management Study, will provide HHS and CMS with key information about services delivered to Medicare beneficiaries with acute or chronic pain, help in understanding the current landscape of pain relief options for Medicare beneficiaries, and inform decisions around payment and coverage for pain management interventions, including those that minimize the risk of SUD. CMS has worked with the Agency for Healthcare Research and Quality, which has undertaken three topic briefs and two systematic reviews to inform Medicare coverage for the treatment of acute and chronic pain. CMS has also worked with HHS's Office of the Secretary for Planning and Evaluation to write a Report on the Study, which will be submitted to Congress. CMS will post a completed copy of the Report on our website. The Report will address questions regarding coverage and payment for evidence-based interventions for acute and chronic pain in Medicare, barriers to access, costs and benefits of expanding or revising benefits not currently covered, and legislative and administrative options to improve pain interventions.

We believe it is important to highlight the role of a person-centered approach to pain care. The National Quality Forum, which as its core work defines measures and health care practices as the best, evidence-based approaches to improving care, has defined person-centered planning as “a facilitated, individual-directed, positive approach to the planning and coordination of a person's services and supports based on individual aspirations, needs, preferences, and values,” and stated that the “goal of person-centered planning is to create a plan that would optimize the person's self-defined quality of life, choice, and control, and self-determination through meaningful exploration and discovery of unique preferences and needs and wants in areas including, but not limited to, health and well-being, relationships, safety, communication, residence, technology, community, resources, and assistance.” [17] These general principles should also apply in the treatment of individuals with pain, where clinicians confirm and affirm the individual's recovery and/or maintenance goals, and focus on those, where treatment is a means to an end.[18] For example, one goal might be to not rely on aiming to reduce a simple pain score, such as a numeric or visual score, but to evaluate function for example, through a tool such as the Defense and Veterans Pain Rating scale,[19] which integrates functional status, and then aim to optimize physical function and mental function in the beneficiary with chronic pain.

We recognize that there are no existing codes that specifically describe the work of the clinician involved in performing the tasks necessary to perform pain management care. We believe there are complexities in treating pain management patients that could include lifestyle discussion, ongoing medication management (such as opioid tapering or discontinuation, when appropriate), behavioral health care, preparation and updating of a care plan, consideration of federal and other opioid prescribing limits and guidelines, Prescription Drug Monitoring Program checks, electronic prescribing requirements, special licensing requirements (controlled substance licenses; buprenorphine “X-waivers”), interdisciplinary interactions, prescription drug coverage, CMS high-prescriber oversight, consideration of out-of-pocket costs, and other issues. As one example, decreasing or discontinuing opioid treatment requires careful, person-centered consideration of all of these aspects of providing care. These unique challenges often adversely impact the delivery of care, and subsequent access to care, for beneficiaries with chronic pain. Current Medicare payment methodologies such as Chronic Care Management (CCM) support chronic disease management, though may not provide adequate payment to health care providers or systems to holistically care for beneficiaries with chronic pain; we believe the complexity and resources required for safe and effective pain management may not be adequately captured and paid through these codes.

We believe that creating separate or add-on payment for care and management for people with pain might provide opportunities to better leverage services furnished using telecommunications technology and non face-to-face care while expanding access to treatment for pain. Such an additional payment could potentially be effective in preventing or reducing the need for acute services such as fall avoidance, and reduce the need for treatment for mental disorders such as depression, anxiety, and sleep disorders which may occur in some individuals with pain. There is also reason to believe that addressing chronic pain (for example, pain that lasts more than 3 months) early in its course may result in averting the development of “high-impact” chronic pain in some individuals, where they experience at least one major activity restriction (for example, unable to work, go to school, perform household chores). These individuals report more severe pain, more difficulty with self-care, and higher health care use than others with chronic pain. From a social determinants of health perspective, Blacks, Native Americans, persons of Asian/Indian descent, older adults, and people with less education, and single individuals report more high impact chronic pain.[20]

In 2019, 12.2 million individuals were enrolled in both Medicaid and Medicare, including people age 65 and older and younger beneficiaries with disabilities. Many have multiple chronic conditions, physical disabilities, behavioral health conditions, and cognitive impairments and on average, use more services and supports than those enrolled in only Medicaid or Medicare, with higher per capita costs. Dually eligible beneficiaries often have multiple social risk factors such as housing insecurity and homelessness, food insecurity, inadequate access to transportation, and low health literacy. A 2019 study [21] on dually eligible beneficiaries using “high dose” opioids to treat pain between 2006 through 2015 Start Printed Page 39182indicated that the common conditions in beneficiaries studied were chronic pain, migraine, rheumatoid arthritis, osteoporosis, HIV/AIDS, viral hepatitis, and SUD.[22]

We are soliciting comment on whether we should consider creating separate coding and payment for medically necessary activities involved with chronic pain management and achieving safe and effective dose reduction of opioid medications when appropriate, or whether the resources involved in furnishing these services are appropriately recognized in current coding and payment. These activities could include, but are not limited to the following:

  • Diagnosis;
  • Assessment and monitoring;
  • Administration of a validated rating scale(s);
  • Development and maintenance of a person-centered care plan;
  • Overall treatment management;
  • Facilitation and coordination of any needed behavioral health treatment;
  • Medication management;
  • Patient education and self-management;
  • Crisis care;
  • Specialty care coordination such as complementary and integrative pain care, and SUD care; and
  • Other aspects of pain and/or behavioral health services, including care rendered through telehealth modalities.

We are interested in feedback regarding whether the resource costs involved in furnishing these activities would be best captured through an add-on code to be billed with an E/M visit or a standalone code. To price such a code, we could consider using a crosswalk to the valuation and inputs for reference codes such as CPT code 99483 (Assessment of and care planning for a patient with cognitive impairment), HCPCS code G2064 (Comprehensive care management services for a single high-risk disease, e.g., principal care management, at least 30 minutes of physician or other qualified health care professional time per calendar month), HCPCS code G0108 (Diabetes outpatient self-management training services, individual, per 30 minutes), or other services paid under the PFS with similar resource costs.

We also seek information on which healthcare settings and stages in treatment these transitions from opioid dependence are occurring, as well as what types of practitioners furnish these services. We are soliciting comments on whether the specific activities we identify above are appropriate, and whether there are other activities that should be included. We are interested in stakeholder feedback regarding how we could define and value separate coding or an E/M add-on code. We also seek comment on whether any components of the service could be provided “incident to” the services of the billing physician who is managing the beneficiary's overall care similar to the structure of the Behavioral Health Integration (BHI) codes, which can include BHI services that are not delivered personally by the billing practitioner and delivered by other members of the care team (except the beneficiary), under the direction of the billing practitioner on an incident to basis (as an integral part of services delivered by the billing practitioner), subject to applicable state law, licensure, and scope of practice. The other care team members are either employees or working under contract to the practitioner who bills for BHI services.

We welcome feedback from stakeholders and the public on potential separate coding or an E/M add-on code for chronic pain management for our consideration for CY 2022 or for future rulemaking.

Start Printed Page 39183

Start Printed Page 39184

Start Printed Page 39185

Start Printed Page 39186

Start Printed Page 39187

Start Printed Page 39188

Start Printed Page 39189

Start Printed Page 39190

Start Printed Page 39191

Start Printed Page 39192

Start Printed Page 39193

Start Printed Page 39194

Start Printed Page 39195

Start Printed Page 39196

Start Printed Page 39197

Start Printed Page 39198

Start Printed Page 39199

Start Printed Page 39200

Start Printed Page 39201

Start Printed Page 39202

Start Printed Page 39203

F. Evaluation and Management (E/M) Visits

Over the past several years, CMS has engaged with the AMA and other stakeholders in a process to update coding and payment for office/outpatient evaluation and management (E/M) visits, with recent changes taking effect January 1, 2021 (see 85 FR 84548 through 84574). In light of these changes, we are engaged in an ongoing review of other E/M visit code sets and are proposing a number of refinements to our current policies. The following section will discuss proposed policies regarding split (or shared) visits, critical care services, and teaching physician visits.

1. Split (or Shared) Visits

a. Background

A split (or shared) visit refers to an E/M visit that is performed (“split” or “shared”) by both a physician and a NPP who are in the same group. Because the Medicare statute provides a higher PFS payment rate for services furnished by physicians than services furnished by NPPs, we need to address whether and when the physician can bill for split (or shared) visits. For visits in the non-facility (for example, office) setting for which the physician and NPP each perform portions of the visit, the physician can bill for the visit rather than the NPP as long as the visit meets the conditions of payment in our regulations at § 410.26(b)(1) for services furnished “incident to” a physician's professional services. However, for visits furnished under similar circumstances in facility settings (for example, in a hospital), our current regulations provide for payment only to the physician or NPP who personally performs all elements of the service, and no payment is made for services furnished “incident to” the billing professional's services.

As stated in our regulation at § 410.26(b)(1), Medicare Part B pays for services and supplies furnished “incident to” a physician's (or other practitioner's) professional services if those services and supplies are furnished in a noninstitutional setting to noninstitutional patients. In certain institutional (or “facility”) settings, our longstanding split (or shared) billing Start Printed Page 39204policy allows a physician to bill for an E/M visit when both the billing physician and an NPP in their group each perform portions of the visit, but only if the physician performs a substantive portion of the visit. When the physician bills for such a split (or shared) visit, in accordance with section 1833(a)(1)(N) of the Act, the Medicare Part B payment is equal to 80 percent of the payment basis under the PFS which, under section 1848(a)(1) of the Act, is the lesser of the actual charge or the fee schedule amount for the service. In contrast, if the physician does not perform a substantive portion of such a split (or shared) visit and the NPP bills for it, in accordance with section 1833(a)(1)(O) of the Act, the Medicare Part B payment is equal to 80 percent of the lesser of the actual charge or 85 percent of the fee schedule rate.

Previously, our policy for billing these split (or shared) visits was reflected in several provisions of our Medicare Claims Policy Manual (sections 30.6.1(B), 30.6.12, and 30.6.13(H)) which were withdrawn effective May 9, 2021, in response to a petition under the Department's Good Guidance regulations at 45 CFR 1.5 (see Transmittal 10742 available on the CMS website at https://www.cms.gov/​Regulations-and-Guidance/​Guidance/​Transmittals/​Transmittals/​r10742cp). In the absence of these manual provisions, the Medicare statute and various broadly applicable regulations continue to apply. In addition to withdrawing the manual provisions, we issued our response to the petition and an accompanying enforcement instruction on May 26, 2021, available on the CMS website at https://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​PhysicianFeeSched/​Evaluation-and-Management-Visits). In those documents, we indicated that we intend to address split (or shared) visits and critical care services (addressed below) through rulemaking; and that until we do, we will limit review to the applicable statutory and regulatory requirements for purposes of assessing payment compliance.

The list of applicable statutory and regulatory requirements includes the CY 2021 PFS final rule (85 FR 84549), where CMS generally adopted new CPT prefatory language and code descriptors for office/outpatient E/M visits. The new CPT guidelines for E/M services introduced a CPT definition of a split (or shared) visit for the first time, effective January 1, 2021. This new CPT definition was part of CPT's new guidelines indicating how to select the visit level based on time, which can be done for all office/outpatient E/M visits starting in 2021. The CPT guidelines that we are referring to are published in the CPT Codebook, in a section titled “Evaluation and Management Services (E/M) Guidelines.” [23] In this section of our proposed rule, we use the term “CPT E/M Guidelines” to refer to this material.

In the CY 2021 PFS final rule (85 FR 84549), we stated that we are generally adopting the CPT E/M Guidelines for the new office/outpatient E/M visit codes. However, the CPT E/M Guidelines do not address many issues that arise in the context of PFS payment for split (or shared) visits, such as which practitioner should report the visit when elements of the visit are performed by different practitioners; whether a substantive portion of the visit must be performed by the billing practitioner; whether practitioners must be in the same group to bill for a split (or shared) visit; or the settings of care where split (or shared) visits may be furnished and billed. The CPT E/M Guidelines simply state, “A split or shared visit is defined as a visit in which a physician and other qualified health care professional(s) jointly provide the face-to-face and non-face-to-face work related to the visit. When time is being used to select the appropriate level of services for which time-based reporting of shared or split visits is allowed, the time personally spent by the physicians and other qualified health care professional(s) assessing and managing the patient on the date of the encounter is summed to define total time. Only distinct time should be summed for split or shared visits (that is, when two or more individuals jointly meet with or discuss the patient, only the time of one individual should be counted).” [24]

In contrast, to ensure appropriate PFS payment, our policy for split (or shared) visits, as expressed in the recently withdrawn manual provisions, is that the physician may bill for a split (or shared) visit only if they perform a substantive portion of the visit, and the practitioners must be in the same group and furnishing the visit in specified settings in order to bill for a split (or shared) visit. Our manual also limited billing for split (or shared) visits to services furnished to established patients. In this proposed rule, we are making a number of proposals to address the recently withdrawn manual sections and improve transparency and clarity regarding our policies on billing for split (or shared) visits, to update them to account for recent revisions to E/M visit coding and payment, and to revise our regulations to reflect these policies.

b. Definition of Split (or Shared) Visits

We are proposing to define a split (or shared) visit as an E/M visit in the facility setting that is performed in part by both a physician and an NPP who are in the same group, in accordance with applicable laws and regulations. We propose to add this definition to a new section of our regulations at § 415.140.

Additionally, we propose to define split (or shared) visits as those that:

  • Are furnished in a facility setting by a physician and an NPP in the same group, where the facility setting is defined as an institutional setting in which payment for services and supplies furnished incident to a physician or practitioner's professional services is prohibited under our regulation at § 410.26(b)(1).
  • Are furnished in accordance with applicable law and regulations, including conditions of coverage and payment, such that the E/M visit could be billed by either the physician or the NPP if it were furnished independently by only one of them in the facility setting (rather than as a split (or shared) visit).

We are proposing to revise our regulations at § 415.140 to codify this definition.

We believe that limiting the definition of split (or shared) visits to include only E/M visits in institutional settings, for which “incident to” payment is not available, will allow for improved clarity, and clearly distinguish, the policies applicable to split (or shared) visits, from the policies applicable to services furnished incident to the professional services of a physician. We do not see a need for split (or shared) visit billing in the office setting, because the “incident to” regulations govern situations where an NPP works with a physician who bills for the visit, rather than billing under the NPP's own provider number.

We are also proposing to modify our policy to allow physicians and NPPs to bill for split (or shared) visits for both new and established patients, and for critical care and certain Skilled Nursing Facility/Nursing Facility (SNF/NF) E/M visits. We are proposing these modifications to the current policy and conditions of payment for split (or shared) visits, discussed below, to account for changes that have occurred in medical practice patterns, including Start Printed Page 39205the evolving role of NPPs as part of the medical team.

c. Definition of Substantive Portion

(1) More Than Half of the Total Time

As stated earlier, only the physician or NPP who performs the substantive portion of the split (or shared) visit would bill for the visit. We are proposing to define “substantive portion” as more than half of the total time spent by the physician and non-physician practitioner performing the visit. We note that our withdrawn manual instructions contained a few definitions of “substantive portion.” For example, one section defined substantive portion as any face-to-face portion of the visit, while another section defined it as one of the three key components of an E/M visit—either the history of present illness (HPI), physical exam, and/or medical decision-making (MDM). Given recent changes in the CPT E/M Guidelines, HPI and physical exam are no longer necessarily included in all E/M visits, because as noted above, for office/outpatient E/M visits, the visit level can now be selected based on either MDM or time, and history and exam are performed only as medically appropriate. Accordingly, defining “substantive portion” as one of these three key components is no longer a viable approach. Similarly, MDM is not easily attributed to a single physician or NPP when the work is shared, because MDM is not necessarily quantifiable and can depend on patient characteristics (for example, risk). We believe that time is a more precise factor than MDM to use as a basis for deciding which practitioner performs the substantive portion of the visit.

We also do not believe it would be appropriate to consider the performance of any portion of the visit—with or without direct patient contact—as a substantive portion. For instance, we do not believe it would be appropriate to consider a brief or minor interaction, with or without direct patient contact, such as where the physician merely “pokes their head” into the room, to be a substantive portion of the visit. Therefore, we are proposing to define “substantive portion” as more than half of the total time spent by the physician and NPP performing the split (or shared) visit. We are proposing to revise our regulation at § 415.140 to codify this definition.

We recognize that the billing practitioner, who would be the practitioner providing the substantive portion of the visit, could select the level for the split (or shared) visit based on MDM, but we nonetheless propose to base the definition of substantive portion on the amount of time spent by the physician and NPP providing the visit. We recognize that this policy would necessitate the practitioners' tracking and documenting the time they spent for these visits. However, we believe that practitioners are likely to increasingly time their visits for purposes of visit level selection independent of our split (or shared) visit policies, given recent changes to the CPT E/M Guidelines, and the fact that critical care visits are already timed. Accordingly, we do not believe this would comprise a substantial new burden.

(2) Distinct Time

We propose that the distinct time of service spent by each physician or NPP furnishing a split (or shared) visit would be summed to determine total time and who provided the substantive portion (and therefore bills for the visit). This would be consistent with the CPT E/M Guidelines stating that, for split (or shared) visits, when two or more individuals jointly meet with or discuss the patient, only the time of one individual should be counted).[25] For example, if the NPP first spent 10 minutes with the patient and the physician then spent another 15 minutes, their individual time spent would be summed to equal a total of 25 minutes. The physician would bill for this visit since they spent more than half of the total time (15 of 25 total minutes). If, in the same situation, the physician and NPP met together for five additional minutes (beyond the 25 minutes) to discuss the patient's treatment plan, that overlapping time could only be counted once for purposes of establishing total time and who provided the substantive portion of the visit. The total time would be 30 minutes, and the physician would bill for the visit since they spent more than half of the total time (20 of 30 total minutes).

(3) Qualifying Time

Drawing on the CPT E/M Guidelines, we are proposing a listing of activities that could count toward total time for purposes of determining the substantive portion. For visits that are not critical care services, we are proposing the same listing of activities that can count when time is used to select E/M visit level, specifically the following activities, when performed and regardless of whether or not they involve direct patient contact:

  • Preparing to see the patient (for example, review of tests).
  • Obtaining and/or reviewing separately obtained history.
  • Performing a medically appropriate examination and/or evaluation.
  • Counseling and educating the patient/family/caregiver.
  • Ordering medications, tests, or procedures.
  • Referring and communicating with other health care professionals (when not separately reported).
  • Documenting clinical information in the electronic or other health record.
  • Independently interpreting results (not separately reported) and communicating results to the patient/family/caregiver.
  • Care coordination (not separately reported).

Practitioners would not count time spent on the following:

  • The performance of other services that are reported separately.
  • Travel.
  • Teaching that is general and not limited to discussion that is required for the management of a specific patient.[26]

Since critical care services can include additional activities that are bundled into the critical care visit code(s), we are proposing a different listing of qualifying activities, discussed in our section below on split (or shared) critical care services. Additionally, we are seeking public comment on whether there should be a different listing of qualifying activities for purposes of determining the total time and substantive portion of split (or shared) emergency department visits, since those visits also have a unique construct.

(4) Application to Prolonged Services

For office/outpatient E/M visits, as discussed in our CY 2021 PFS final rule (85 FR 84572), HCPCS code G2212 can be used to report prolonged services in 15-minute increments of time beyond the maximum time for a level 5 office/outpatient E/M visit. For all other E/M visits (except critical care and emergency department visits), CPT codes 99354-9 can be used to report prolonged time with or without direct patient contact, when required time increments above the typical time is spent (see CY 2017 PFS final rule, 81 FR 80228-80230 and the Medicare Claims Processing Manual (Pub. 100-02), chapter 12, section 30.6.15 available on our website at https://www.cms.gov/​Start Printed Page 39206Regulations-and-Guidance/​Guidance/​Manuals/​Downloads/​clm104c12.pdf).

Our withdrawn manual provisions instructed that practitioners cannot bill prolonged services as a split (or shared) visit. Having reviewed this policy, we believe that codes that are billed as add-on codes for prolonged service time for an E/M visit, which could be furnished and billed as a split (or shared) visit under our proposed policy, should be considered to be part of that E/M visit. Therefore, we are proposing to change our policy to allow a practitioner to bill for a prolonged E/M visit as a split (or shared) visit. Specifically, the physician or practitioner who spent more than half the total time (that is, performed the substantive portion described above) would bill for the primary E/M visit and the prolonged service code(s) when the service is furnished as a split (or shared) visit, if all other requirements to bill for the services were met. The physician and NPP would sum their time together, and whomever furnished more than half of the total time, including prolonged time, (that is, the substantive portion) would report both the primary service code and the prolonged services add-on code(s), assuming the time threshold for reporting prolonged services is met. We note that for critical care visits, the practitioner would not bill prolonged E/M services because the practitioners would instead aggregate their time, as proposed below, to report additional units of critical care services.

d. New and Established Patients, and Initial and Subsequent Visits

Our withdrawn manual provisions stated that when an E/M service is furnished as a split or shared encounter, between a physician and an NPP (that is, an NP, PA, CNS or CNM), the service is considered to have been performed “incident to” if the requirements for “incident to” are met and the patient is an established patient. This provision was generally interpreted to mean that split (or shared) visits cannot be billed for new patients. The withdrawn manual provisions also did not specify whether the practitioner who bills for the split or shared visit could bill for initial, versus subsequent, split (or shared) visits in the facility setting. After conducting an internal review, including consulting our medical officers, we believe that the practice of medicine has evolved toward a more team-based approach to care, and greater integration in the practice of physicians and NPPs, particularly when care is furnished by practitioners in the same group in the facility setting. Given this evolution in medical practice, the concerns that may have been present when we issued the manual instructions may no longer be as relevant. We understand that there have been changes in the practice of medicine over the past several years, some facilitated by the advent of electronic health records (EHRs) and other systems, toward a more team-based approach to care. There has also been an increase in alternative payment models that employ a more team-based approach to care. After considering and reevaluating our policy, we see no reason to preclude the physician or NPP from billing for split (or shared) visits for a new patient, in addition to an established patient, or for initial and subsequent split (or shared) visits. Therefore, we are proposing to permit the physician or NPP to bill for split (or shared) visits for both new and established patients, as well as for initial and subsequent visits. We believe this approach is also consistent with the CPT E/M Guidelines for split (or shared) visits, which does not exclude these types of visits from being billed when furnished as split (or shared) services.

e. Settings of Care

The concept of split (or shared) visits was developed as an analog in the facility setting to payment policies for services and supplies furnished incident to a physician's or an NPP's professional services in the non-institutional setting. Section 410.26(a)(6) of our regulations defines the non-institutional setting as all settings other than a hospital or SNF. We are proposing to allow billing of split (or shared) visits, including critical care visits, when they are performed in any institutional setting and are proposing to codify the definition of facility setting in the regulation at § 415.140. We discuss our proposals regarding billing for critical care split (or shared) E/M services below (see section II.F. of this proposed rule).

Our withdrawn manual provisions did not allow practitioners to bill for split (or shared) visits that are critical care services or SNF/NF visits. The manual stated that the split (or shared) E/M policy did not apply to critical care services or procedures, and that a split (or shared) E/M service performed by a physician and a qualified NPP of the same group (or employed by the same employer) cannot be reported as a critical care service. It also stated that a split (or shared) E/M visit cannot be reported in the SNF/NF setting. We propose to define split (or shared) visits to be limited to services furnished in institutional settings, as discussed above. As discussed below, we do not see any reason to preclude billing for split (or shared) visits for critical care services, although we are seeking public comment on this issue in particular. We understand that there have been changes in the practice of medicine over the past several years, some facilitated by the advent of EHRs and other systems, toward a more team-based approach to care. There has also been an increase in alternative payment models that employ a more team-based approach to care. Where a physician and NPP in the same group take a team approach to furnishing care, as would be the case for split (or shared) visits, even for new patients, initial visits, critical care visits, or SNF/NF visits, we are less concerned about potential disruptions in continuity of care than we might once have been. Rather, we believe that when a visit is shared between a physician and an NPP in the same group, there would be close coordination and an element of collaboration in providing care to the beneficiary.

We do not see any reason to preclude billing for split (or shared) visits for the subset of SNF/NF visits that are not required by our regulations to be performed in their entirety by a physician. Under our current policy, no E/M services can be furnished and billed as split (or shared) visits in the SNF setting. We refer readers to our Conditions of Participation in 42 CFR 483.30 for information regarding the SNF/NF visits that are required to be performed in their entirety by a physician. That regulation requires that certain SNF/NF visits must be furnished directly and solely by a physician. If finalized, our proposal would not apply to the SNF/NF visits that are required to be performed in their entirety by a physician; any SNF/NF visit that is required to be performed in its entirety by a physician cannot and would not be able to be billed as a split (or shared) visit. However, for other visits to which the regulation at § 483.30 does not apply, there is no requirement for a physician to directly and solely perform the visit. We propose that those visits could be furnished and billed as split (or shared) visits.

f. Same Group

In accordance with the current policy outlined in the withdrawn manual provisions, we are proposing that a physician and NPP must be in the same group in order for the physician and NPP to bill for a split (or shared) visit. We believe that in circumstances when a split or (shared) visit is appropriately billed, a physician and NPP are working jointly to furnish all of the work related to the visit with the patient. However, if a physician and NPP are in different groups, we would expect the physician Start Printed Page 39207and NPP to bill independently, and only for the services they specifically and fully furnish. Further, consistent with our withdrawn manual guidance, we note that Medicare does not pay for partial physician's visits, so CPT modifier −52 (reduced services) could not be used to report split (or shared) visits. Thus, if a physician and an NPP who are in different groups each furnish part of an E/M service, but not all of it, then we would not consider either service to be a billable service. Similarly, if two physicians, each in their own private practice, both saw the same patient in the hospital, but neither one fully furnished a billable service—there would be no basis on which to combine their efforts or minutes of service into one billable E/M visit.

We are seeking public comment on whether we should further define “group” for purposes of split (or shared) visit billing. While we are not proposing a definition in this proposed rule, we have considered several options, such as requiring that the physician and NPP must be in the same clinical specialty, in which case we would use the approach outlined in the CPT E/M Guidelines; that is the NPP is considered to be in the same specialty and subspecialty as the physician with whom they are working.[27] We are also considering an approach under which we would align the definition of “group” with the definition of “physician organization” at § 411.351. The term “physician organization” is defined at § 411.351 for purposes of section 1877 of the Act and our regulations in 42 CFR part 411, subpart J (collectively, the physician self-referral law), and explained further in frequently asked questions available on the CMS website at https://www.cms.gov/​Medicare/​Fraud-and-Abuse/​PhysicianSelfReferral/​Downloads/​FAQs-Physician-Self-Referral-Law.pdf. Another approach would be to consider practitioners with the same billing tax identification number as being in the same group. We are concerned that this particular approach may be too broad in multi-specialty groups or health care systems that include many practitioners who do not typically work together to furnish care to patients in the facility setting. We note that some of these approaches may not align with the definition of “group” used for purposes of Medicare enrollment.

g. Medical Record Documentation

To ensure program integrity and quality of care, we are proposing that documentation in the medical record must identify the two individual practitioners who performed the visit. The individual who performed the substantive portion (and therefore bills the visit) would be required to sign and date the medical record. We are proposing to revise our regulation at § 415.140 to reflect the conditions of payment for split (or shared) visits as discussed in this section.

h. Claim Identification

We are proposing to create a modifier to describe split (or shared) visits, and we are proposing to require that the modifier must be appended to claims for split (or shared) visits, whether the physician or NPP bills for the visit. Currently, we cannot identify through claims that a visit was performed as a split (or shared) visit, which means that we could know that a visit was performed as a split (or shared) visit only through medical record review. We believe it is important for program integrity and quality considerations to have a way to identify who is providing which E/M services, and how often we are paying at the physician rate for services provided in part by NPPs. (Please see the documentation section below for additional information). The proposed modifier, if finalized, would give CMS insight, directly through our claims data instead of only through medical record review, into the specific circumstances under which these split (or shared) visits are furnished. Such information would be helpful to CMS for program integrity purposes, and could be instructive in considering whether we may need to offer additional clarification to the public, or further revise the policy for these E/M visits in future rulemaking.

We are proposing to revise our regulation at § 415.140 to reflect the conditions of payment for split (or shared) visits as discussed in this section.

Consistent with our current policy, Medicare does not pay for partial E/M visits for which all elements of the service are not furnished. Therefore, we are proposing that the modifier identified by CPT for purposes of reporting partial services (modifier −52 (reduced services)) could not be used to report partial E/M visits, including any partial services furnished as split (or shared) visits. We are also considering whether it is necessary to amend our regulations to explicitly state that Medicare does not pay for partial E/M visits and are interested in public comments on this issue.

2. Critical Care Services (CPT Codes 99291-99292)

As stated previously, in light of updates that we previously finalized for coding and payment for office/outpatient E/M visits, we are proposing a number of refinements to other E/M code sets. Historically, our policy for billing critical care services was reflected in several provisions of the Medicare Claims Processing Manual (sections 30.6.1(B), 30.6.12, and 30.6.13(H)) which were withdrawn effective May 9, 2021, in response to a petition under the Department's Good Guidance regulation at 45 CFR 1.5 (see Transmittal 10742 available on the CMS website at https://www.cms.gov/​Regulations-and-Guidance/​Guidance/​Transmittals/​Transmittals/​r10742cp). In the absence of these manual provisions, the Medicare statute and various broadly applicable regulations continue to apply. In addition to withdrawing the manual provisions, we issued our response to the petition and accompanying enforcement instruction issued on May 26, 2021, available on the CMS website at https://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​PhysicianFeeSched/​Evaluation-and-Management-Visits. In those documents, we indicated that we intend to address split (or shared) visits (addressed above) and critical care services (addressed below) through rulemaking; and that until we do, we will limit review to the applicable statutory and regulatory requirements for purposes of assessing payment compliance. The list of applicable statutory and regulatory requirements includes the CY 2021 PFS final rule (85 FR 84549), where CMS generally adopted new CPT prefatory language and code descriptors for office/outpatient E/M visits. Therefore, in this section of the proposed rule, we are proposing to update our critical care E/M visit policies to improve transparency and clarity, and to account for recent revisions to E/M visit coding and payment.

The CPT 2021® Professional Codebook (hereafter, CPT Codebook) provides guidelines for critical care services in the CPT E/M Guidelines on pp. 5-9 and in prefatory language, code descriptors, and parentheticals on pp. 31-33. We are proposing to adopt the CPT prefatory language for critical care services as currently described in the CPT Codebook, except as otherwise specified in this section of the proposed rule. Should CPT make changes to the guidance for critical care services in a Start Printed Page 39208subsequent edition of the CPT Codebook, we could revisit these policies in future rulemaking.

We are also proposing to clarify our definition of critical care visits, and the requirements governing how critical care visits are reported when more than one practitioner or specialty is involved in furnishing critical care services to a patient. Further, we are proposing to prohibit a practitioner that reports critical care services furnished to a patient from also reporting any other E/M visit for that same patient on the same calendar day that the critical care services are furnished to that patient, and vice versa. Additionally, we are proposing to prohibit practitioners from reporting critical care visits during the same time-period as a procedure with a global surgical period.

a. Definition of Critical Care

Critical care visits are described by CPT codes 99291 (Critical care, evaluation and management of the critically ill or critically injured patient; first 30-74 minutes) and 99292 (each additional 30 minutes (List separately in addition to code for primary service). As stated above, the CPT Codebook defines critical care services in prefatory language on pp. 31-33.

Critical care services were defined in the withdrawn provisions of the Medicare Claims Processing Manual, and that definition tracked closely with the CPT prefatory language regarding critical care services. To improve transparency and clarity, we are proposing to adopt the CPT prefatory language as the definition of critical care services. The CPT prefatory language states that critical care is the direct delivery by a physician(s) or other qualified healthcare professional (QHP) of medical care for a critically ill/injured patient in which there is acute impairment of one or more vital organ systems, such that there is a probability of imminent or life-threatening deterioration of the patient's condition.[28] It involves high complexity decision-making to treat single or multiple vital organ system failure and/or to prevent further life-threatening deterioration of the patient's condition. We continue to believe that the CPT Codebook appropriately delineates coding and definitions for critical care services in order to distinguish them as more intense services that are valued relatively higher than other E/M services. Thus, we are proposing to adopt the CPT prefatory language as the definition of critical care services, and refer readers to the CPT Codebook for additional details.

Under current Medicare policy, a QHP is an individual who is qualified by education, training, licensure/regulation (when applicable), facility privileging (when applicable), and the applicable Medicare benefit category to perform a professional service within their scope of practice and independently report that service (see, for example, 80 FR 70957; 85 FR 84543, 84593). Because the CPT Codebook provides that critical care services can be delivered by a physician or QHP, we are proposing that critical care services may be reported by a physician or NPP who is a QHP as explained above.

The CPT prefatory language specifies that critical care may be furnished on multiple days, and is typically furnished in a critical care area, which can include an intensive care unit or emergency care facility. CPT prefatory language also states that critical care requires the full attention of the physician or NPP, and therefore, for any given time-period spent providing critical care services, the practitioner cannot provide services to any other patient during the same period of time. We are proposing to adopt this CPT prefatory language to improve transparency and clarity of our policy for this service for Medicare billing purposes.

CPT prefatory language and billing and coding guidance bundles several services into critical care visits furnished by a given practitioner when performed during the critical period by the practitioners providing critical care. We are proposing to adopt CPT's listing of bundled services that are part of critical care visits to improve transparency and clarity of our policy for this service. Therefore, we are proposing that the following services would be bundled into critical care visits: Interpretation of cardiac output measurements (93561, 93562), chest X rays (71045, 71046), pulse oximetry (94760, 94761, 94762), blood gases, and collection and interpretation of physiologic data (for example, ECGs, blood pressures, hematologic data); gastric intubation (43752, 43753); temporary transcutaneous pacing (92953); ventilator management (94002-94004, 94660, 94662); and vascular access procedures. As a result, these codes would not be separately billable by a practitioner during the time-period when the practitioner is providing critical care for a given patient. We are also proposing to adopt the CPT prefatory language stating that time spent performing separately reportable procedures or services should be reported separately and should not be included in the time reported as critical care time.

b. Critical Care by a Single Physician or NPP

Our withdrawn manual provisions and the prefatory language in the CPT Codebook cited above both describe the time duration for the correct reporting of critical care services by a single physician or NPP. To improve transparency and clarity of our policy for this service, we are proposing to adopt the CPT prefatory language. Under our proposal, the physician or NPP would report CPT code 99291 for the first 30-74 minutes of critical care services provided to a patient on a given date. Thereafter, they would report CPT code 99292 for additional 30-minute time increments provided to the same patient. We refer readers to the CPT Codebook for examples of the total duration of critical care visits.[29] The prefatory language states that CPT codes 99291 and 99292 are used to report the total duration of time spent by the physician or QHP providing critical care services to a critically ill or critically injured patient, even if the time spent by the practitioner on that date is not continuous; and that non-continuous time for medically necessary critical care services may be aggregated. The CPT Codebook indicates that CPT code 99291 is used to report the first 30-74 minutes of critical care on a given date, and that the code should be used only once per date even if the time spent by the practitioner is not continuous on that date. We are proposing to adopt this rule for critical care services furnished by a single physician or NPP. We note that the prefatory language does not indicate how practitioners should report critical care when a service lasts beyond midnight. We are seeking comment about how practitioners should report CPT codes 99291 and 99292 when a service extends beyond midnight to the following calendar day.

c. Critical Care Services Furnished Concurrently by Different Specialties

The CPT Codebook does not provide any special instructions regarding how to report critical care furnished by more than one physician or practitioner, whether in a split (or shared) visit context or other contexts that might be relevant given the unique nature of critical care and the long timeframes over which patients may receive these services. The CPT E/M Guidelines state broadly that concurrent care is the provision of similar services (for Start Printed Page 39209example, hospital visits) to the same patient by more than one physician or other QHP on the same day. The CPT E/M Guidelines state that when concurrent care is provided, no special reporting is required.[30] The CPT E/M Guidelines also state broadly that when time is being used to select the appropriate level of services for which time-based reporting of split (or shared) visits is allowed, the time personally spent by the physician and other QHP(s) assessing and managing the patient on the date of the encounter is summed to define total time; and that only distinct time should be summed for split (or shared) visits (that is, when two or more individuals jointly meet with or discuss the patient, only the time of one individual should be counted).[31]

In the context of critical care services, our withdrawn manual provisions provided guidance on concurrent care, and stated that there are situations where physicians or NPPs within a group provide coverage or follow-on care for one another on a single day. The manual also stated that critically ill or injured patients may require the care of more than one practitioner from more than one specialty (regardless of group affiliation), and this work could transpire simultaneously or overlap. Consistent with our current policy, and to improve transparency and clarity of our policy for critical care services, we are proposing that concurrent care occurs where more than one physician or qualified NPP furnishes services to the same patient on the same day. In general, concurrent care is covered when the services of each practitioner are medically necessary, and not duplicative. For example, concurrent care may be medically necessary because of the existence of more than one medical condition requiring diverse specialized medical services, that is, more than one specialty (which can include a qualified NPP as a specialty). In the context of critical care services, a critically ill patient may have more than one medical condition requiring diverse specialized medical services and thus requiring more than one practitioner having different specialties to play an active role in the patient's treatment. Thus, we are proposing that critical care services may be furnished as concurrent care (or concurrently) to the same patient on the same day by more than one practitioner in more than one specialty (for example, an internist and a surgeon, allergist and a cardiologist, neurosurgeon and NPP), regardless of group affiliation, if the service meets the definition of critical care and is not duplicative of other services. However, as for most Medicare-covered services, these critical care services would need to be medically reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member. We are seeking comment on this proposal to better understand current clinical practice for critical care, and when it would be appropriate for more than one physician or NPP of the same or different specialties, and within the same or a different group, to provide critical care services.

d. Critical Care Furnished Concurrently by Practitioners in the Same Specialty and Same Group (Follow-Up Care)

Physician(s) or NPP(s) in the same specialty and in the same group may provide concurrent follow-up care, such as a critical care visit subsequent to another practitioner's critical care visit. This may be as part of continuous staff coverage or follow-up care to critical care services furnished earlier in the day on the same calendar date. According to CPT coding and billing conventions that we generally acknowledge, a practitioner who furnishes a timed service such as critical care would typically need to report the primary service or procedure code before reporting an add-on code. However, we are proposing that when critical care is furnished concurrently by two or more practitioners in the same specialty and in the same group to the same patient on the same day, the individual physician(s) or NPP(s) providing the follow-up or subsequent care would report their time using the code for subsequent time intervals (CPT code 99292), and would not report the primary service code (CPT code 99291). CPT code 99291 would not be reported more than once for the same patient on the same day by these practitioners. This proposal recognizes that multiple practitioners in the same specialty and the same group can maintain continuity of care by providing follow-up care for the same patient on the same day, and is consistent with our current policy as described in the withdrawn manual provisions. Because practitioners in the same specialty and same group cover for one another to provide concurrent critical care services, we believe the total time for critical care services furnished to a patient on the same day by the practitioners in the same group with the same specialty should be reflected as if it were a single set of critical care services furnished to the patient. The practitioner furnishing the initial critical care service would report CPT code 99291, and the practitioner(s) reporting subsequent critical care service time would report CPT code 99292.

Under our current policy, the initial critical care service must be performed by a single physician or qualified NPP. In considering and reevaluating this policy, we believe it would better reflect current medical practice to allow critical care service time spent by more than one practitioner in the same group with the same specialty to be added together for the purposes of meeting the time requirement to bill for the initial critical care service using CPT code 99291. We are proposing this policy for two main reasons. First, we believe this proposal would appropriately recognize that multiple practitioners in the same specialty and group can concurrently furnish critical care services to a patient on a single day. Second, this proposal would conform our policy for the initial critical care service with our proposal described above for multiple practitioners in the same specialty and same group to report CPT code 99292 for their cumulative critical care service time. Thus, we are proposing that where one practitioner begins furnishing the initial critical care service but does not meet the time required to report CPT code 99291, and another practitioner in the same specialty and group continues to deliver critical care to the same patient on the same day, the time spent by those practitioners could be aggregated to meet the time requirement to bill CPT code 99291. Under our proposal, once the cumulative required critical care service time is met to report CPT code 99291, CPT code 99292 would not be reported by the practitioner or another practitioner in the same specialty and group unless and until an additional 30 minutes of critical care services are furnished to the same patient on the same day (114 total minutes). Finally, consistent with our current policy, we are proposing that the aggregated time spent on critical care visits must be medically necessary and each visit must meet the definition of critical care in order to add the times for purposes of meeting the time requirement to bill CPT code 99291. We are seeking comment on this proposal to better understand current clinical practice for critical care, and when it would be appropriate for more than one physician or NPP of the same or different specialties, and within the same or a different group, to provide Start Printed Page 39210critical care services to a patient on a single day.

e. Split (or Shared) Critical Care Services

Under current CMS policy, critical care services cannot be billed as split (or shared) E/M services. As previously discussed in section II.F.1. of this proposed rule for split (or shared) visits, we believe the practice of medicine has evolved toward a more team-based approach to care, and greater integration in the practice of physicians and NPPs, particularly when care is furnished by clinicians in the same group in the facility setting. Given this evolution in medical practice, the concerns that may have been present when we issued current policy may no longer be as relevant. We understand that there have been changes in the practice of medicine over the past several years, some facilitated by the advent of EHRs and other systems, toward a more team-based approach to care. There has also been an increase in alternative payment models that employ a more team-based approach to care. In considering and reevaluating this policy, we believe it would be appropriate to revise our policy to allow critical care services to be reported when furnished as split (or shared) services. Therefore, we are proposing that critical care visits may be furnished as split (or shared) visits. The proposals described in section II.F.1. of this proposed rule for split (or shared) visits would apply (with one exception discussed below), and service time would be counted for CPT code 99292 in the same way as for prolonged E/M services. In other words, we are proposing that the total critical care service time provided by a physician and NPP in the same group on a given calendar date to a patient would be summed, and the practitioner who furnishes the substantive portion of the cumulative critical care time would report the critical care service(s).

In section II.F.1. of this proposed rule, drawing on the CPT E/M Guidelines, we proposed a list of activities that could count toward total time for purposes of determining the substantive portion. We stated that since critical care services can include additional activities that are bundled into the critical care visits code(s), we are proposing a different listing of qualifying activities for split (or shared) critical care. These qualifying activities are described in prefatory language on pp. 31-32 of the CPT Codebook. Thus, when critical care services are furnished as a split (or shared) visit, we are proposing to define the substantive portion as more than half the cumulative total time in qualifying activities that are included in CPT codes 99291 and 99292. Additionally, the billing practitioner would first report CPT code 99291 and, if 75 or more cumulative total minutes were spent providing critical care, one or more units of CPT code 99292. We would require practitioners to include the proposed split (or shared) visit modifier on the claim, and we are proposing that the documentation and other rules proposed in section II.F.1. of this proposed rule for split (or shared) visits would apply to split critical care services. We note that, in contrast to our proposals regarding concurrent critical care services above, we are proposing that when a critical care service is furnished as a split (or shared) visit, when two or more practitioners spend time jointly meeting with or discussing the patient, the time may be counted only once for purposes of reporting the split (or shared) critical care visit. This proposed policy accords with our proposed policy for all split (or shared) visits. It also accords with the CPT E/M Guidelines stating that, for split (or shared) visits, when two or more individuals jointly meet with or discuss the patient, only the time of one individual should be counted).[32]

We are seeking comment on these proposals to ensure they reflect a clinically appropriate approach, and intend to assess whether we should instead require that an individual physician or NPP directly perform the entirety of each critical care visit. We are seeking comment on this proposal to better understand current clinical practice for critical care, and when it would be appropriate for more than one physician or NPP of the same or different specialties, and within the same or a different group, to provide critical care to a patient.

f. Critical Care Visits and Same-Day Emergency Department, Inpatient or Office/Outpatient Visits

The CPT Codebook states that critical care and other E/M services may be provided to the same patient on the same date by the same individual. However, our general policy as described in the Medicare Claims Processing Manual states that physicians in the same group who are in the same specialty must bill and be paid for services under the PFS as though they were a single physician. If more than one E/M visit is provided on the same day to the same patient by the same physician, or by more than one physician in the same specialty in the same group, only one E/M service may be reported unless the E/M services are for unrelated problems. Instead of billing separately, the physicians should select a level of service representative of the combined visits and submit the appropriate code for that level.[33] This policy is intended to ensure that multiple E/M visits for a patient on a single day are medically necessary and not duplicative. With respect to office/outpatient E/M visits specifically, our current manual instructs, “As for all other E/M services except where specifically noted, the Medicare Administrative Contractors (MACs) may not pay two E/M office visits billed by a physician (or physician of the same specialty from the same group) for the same beneficiary on the same day unless the physician documents that the visits were for unrelated problems in the office, off campus-outpatient hospital, or on campus-outpatient hospital setting which could not be provided during the same encounter.” [34] With respect to hospital visits, hospital ED visits, and critical care services furnished on the same day, the Medicare Claims Processing Manual states, “When a hospital inpatient or office/outpatient E/M service are furnished on a calendar date at which time the patient does not require critical care and the patient subsequently requires critical care both the critical care services (CPT codes 99291 and 99292) and the previous E/M service may be paid on the same date of service. Hospital ED services are not paid for the same date as critical care services when provided by the same physician to the same patient.” [35]

We are concerned that adopting the CPT rule that critical care and other E/M visits may be furnished to the same patient on the same date by the same practitioner could have unintended consequences for the Medicare program. We have previously expressed concerns that multiple E/M visits by the same practitioner, or by practitioners in the same specialty within a group, on the same day as another E/M service ordinarily would not be medically necessary (83 FR 59639). It is possible that adopting the CPT rule allowing billing for critical care and other E/M Start Printed Page 39211visits on the same day, by practitioners in the same group and of the same specialty, could lead to duplicative payment, particularly given the frequently long duration of critical care services, the CPT prefatory language indicating that time spent furnishing critical care may be non-continuous, and the relatively higher valuation of critical care services compared to other E/M services. Thus, we are proposing that no other E/M visit can be billed for the same patient on the same date as a critical care service when the services are furnished by the same practitioner, or by practitioners in the same specialty in the same group.

There are possible alternative approaches to address our concerns about medical necessity and duplicative payment for E/M services furnished to a patient on the same day by the same practitioner or a practitioner in the same group. We have previously considered a Multiple Procedure Payment Reduction (MPPR) for standalone office/outpatient E/M visits that occur on the same day as a procedure to address efficiencies (for example, in preservice and postservice clinician work and PE) that are not accounted for in the current payment rates (83 FR 59639). These visits could be identified on the claim with modifier −25 (significant, separately identifiable E/M service by the same physician on the same day of the procedure or other service) and CMS could assign a reduced payment rate to one of the visits. CMS could also use documentation requirements to support the medical necessity and non-duplicative nature of a claim for critical care services on the same calendar date as another E/M visit provided to a patient by the same practitioner or practitioner of the same specialty in a group. We also recognize that our proposal not to allow an E/M visit to be billed for the same patient on the same date as a critical care service when the services are furnished by the same practitioner, or by practitioners in the same specialty within a group, may be appropriate only in certain clinical situations. For example, it may be possible that a patient would not require critical care services at the time of an ED visit, but then be admitted to the hospital on the same calendar date as the ED visit and require care that meets the definition of critical care services. It may also be possible that the practitioner who furnished the ED visit later provided critical care services to the same patient on the same calendar date. Thus, we are seeking comment on this proposal to better understand clinical practice for critical care, whether and how CMS could pay for E/M services furnished on the same date as critical care services when provided by the same practitioner, or practitioners in the same specialty within a group, while also reducing the potential for duplicative payment.

g. Critical Care Visits and Global Surgery

Critical care services may be needed on the on the same calendar date as a procedure code with a global surgical period. In many cases, preoperative and postoperative critical care visits are included in procedure codes that have a global surgical period. In the CY 2015 PFS final rule, we discussed the challenges of accurately accounting for the number of visits included in the valuation of 10- and 90-day global packages (79 FR 67548, 67582). The 10- and 90-day global packages can include critical care visits. We finalized a policy to change all global periods to 0-day global periods, and to allow separate payment for post-operative E/M visits. Our concerns were based on a number of key points including: The lack of sufficient data on the number of visits typically furnished during the global periods, questions about whether we will be able to adjust values on a regular basis to reflect changes in the practice of medicine and health care delivery, and concerns about how our global payment policies could affect the services that are actually furnished. Section 1848(c)(8)(B) of the Act, which was added by section 523(a) of the Medicare Access and CHIP Reauthorization Act (MACRA), required us to collect data to value surgical services. Because critical care visits are included in some 10- and 90-day global packages, we are proposing to bundle critical care visits with procedure codes that have a global surgical period. We note that this proposal contrasts with the current policy as described in the Medicare Claims Processing Manual which states that critical care visits are unbundled from procedures with a global surgical period as long as the critical care service was unrelated to the procedure.[36] As we have made clear in previous rulemaking, we are continuing to assess values for global surgery procedures (84 FR 2452), including in particular the number and level of preoperative and postoperative visits, which can include critical care services. Because this work is still ongoing, we are proposing to bundle critical care visits with procedure codes that have a global surgical period.

h. Documentation Requirements

Because critical care is a time-based service, we are proposing to require practitioners to document in the medical record the total time that critical care services were provided by each reporting practitioner (not necessarily start and stop times). The documentation would also need to indicate that the services furnished to the patient, including any concurrent care by the practitioners, were medically reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member. To support coverage and payment determinations regarding concurrent care, services would need to be sufficiently documented to allow a medical reviewer to determine the role each practitioner played in the patient's care (that is, the condition or conditions for which the practitioner treated the patient). To support coverage and payment determinations regarding split (or shared) critical care services, the documentation requirements proposed above for all split (or shared) E/M visits would also apply to critical care visits (see section II.F. of this proposed rule).

3. Payment for the Services of Teaching Physicians

As part of the CPT office/outpatient E/M visit coding framework that we finalized beginning for CY 2021 (85 FR 84548 through 84574), practitioners can select the office/outpatient E/M visit level to bill, based either on the total time personally spent by the reporting practitioner or MDM. Stakeholders have asked us how teaching physicians who involve residents in furnishing care should consider time spent by the resident in selecting the office/outpatient E/M visit level.

For teaching physicians, section 1842(b) 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 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 Start Printed Page 39212who 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. Medicare separately pays for the time spent by the resident through direct graduate medical education (GME) under Medicare Part A.

a. General Policy for Evaluation and Management Visits

Under our regulation at § 415.172 and absent a public health emergency (PHE), if a resident participates in a service furnished in a teaching setting, a teaching physician can bill for the service only if they are present for the key or critical portion of the service. For residency training sites that are located outside a metropolitan statistical area, PFS payment may also be made if a teaching physician is present through audio/video real-time communications technology (that is, “virtual presence”). In the case of E/M services, the teaching physician must be present during the portion of the service that determines the level of service billed.

We are proposing that when total time is used to determine the office/outpatient E/M visit level, only the time that the teaching physician was present can be included. We believe it is appropriate to include only the time of the teaching physician because the Medicare program makes separate payment for the program's share of the resident's graduate medical training program, which includes time spent by a resident furnishing services with a teaching physician, under Medicare Part A. During the PHE, the time of the teaching physician when they are present through audio/video real-time communications technology may also be included in the total time considered for visit level selection. We note that, outside the circumstances of the COVID-19 PHE, the teaching physician presence requirement can be met virtually, through audio/video real-time communications technology, only in residency training sites that are located outside of a metropolitan statistical area.

This proposal is consistent with our previously finalized policy that practitioners can use total time personally spent by the reporting practitioner to select office/outpatient E/M visit level. It is also consistent with our regulation at § 415.172 that states that PFS payment is made when a teaching physician involves a resident in providing care only if the teaching physician is present for the key or critical portions of the service, including the portion that is used to select the visit level.

b. Primary Care Exception Policy

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 primary care 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. We expanded the list of services that residents could furnish without the physical presence of the teaching physician for the duration of the PHE to include all levels of an office/outpatient E/M visit, among other services. Upon the conclusion of the PHE, levels 4-5 office/outpatient E/M visits will no longer be included in the primary care exception (85 FR 84585 through 84590).

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.

We are proposing that under the primary care exception, only MDM can be used to select office/outpatient E/M visit level. 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 to permit 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. In the context of teaching hospital primary care centers that are staffed by residents and teaching physicians, we believe that MDM would be a more accurate indicator of the complexity of the visit as opposed to time. Because residents are in training, they may need more time than is reflected in the code descriptor to furnish a visit that has a low-level of medical decision making. For example, CPT code 99213 (Office or other outpatient visit for the evaluation and management of an established patient, which requires a medically appropriate history and/or examination and low level of medical decision making. When using time for code selection, 20-29 minutes of total time is spent on the date of the encounter) involves a low level of MDM and between 20-29 minutes of total time. If time was used for level selection instead of MDM, it is possible that residents may need more than 20-29 minutes of time, including any conferring with the teaching physician, to furnish CPT code 99213. Thus, residents may be less efficient relative to a teaching physician in furnishing care.

Office/outpatient E/M visits requiring 30 or more minutes of total time are described by visit levels 4-5. After the expiration of the COVID-19 PHE, office/outpatient levels 4-5 will no longer be included in the primary care exception. In the CY 2021 PFS final rule, we expressed concern 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 noted 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 (85 FR 84586). Thus, to guard against the possibility of residents furnishing visits that are of more than lower and mid-level complexity, we are proposing that only MDM may be used for office/outpatient E/M visit level selection for services furnished by residents under the primary care exception.

We acknowledge that under the new CPT office/outpatient E/M visit coding framework, it is possible that time is an accurate indicator of the complexity of the visit. Thus, we are seeking comment on this proposal, including our assumption that MDM is a more accurate indicator of the appropriate level of the visit relative to time in the context of the primary care exception for services furnished by residents and billed by teaching physicians in primary care centers. We are also seeking comment on whether time is an accurate indicator of the complexity of the visit and how teaching physicians might select office/outpatient E/M visit level using time when directing the care of a patient that is being furnished by a resident in the context of the primary care exception.Start Printed Page 39213

G. Billing for Physician Assistant (PA) Services

Under the respective Medicare statutory benefit categories for services of Physician assistants (PAs), nurse practitioners (NPs), and clinical nurse specialists (CNSs), these practitioners are authorized to furnish services that would be physicians' services if they were furnished by a physician, and which they are legally authorized to perform by the state in which the services are furnished; and such services that are furnished incident to the practitioners' professional services (but only if no facility or other provider charges or is paid any amount for the services). Additionally, the payment amount for the services of PAs, NPs, and CNSs, as specified under section 1833(a)(1)(O) of the Act, is equal to 80 percent of the lesser of the practitioner's actual charge or 85 percent of the amount that would be paid to a physician under the PFS. However, while NPs and CNSs are authorized to bill the Medicare program and be paid directly for their professional services, section 1842(b)(6)(C)(i) of the Act has required since the inception of the PA benefit (with a narrow exception not relevant here) that payment for PA services must be made to the PA's employer. Accordingly, our regulation at § 410.74(a)(2)(v) specifies that PA services are covered under Medicare Part B only when billed by the PA's employer. Our regulation that addresses to whom Medicare Part B payment is made, at § 410.150(b)(15), further provides that payment is made to the qualified employer of a PA, and specifies that the PA could furnish services under a W-2 employment relationship, an employer-employee relationship, or as an independent contractor through a 1099 employment relationship. The regulation also specifies that a group of PAs that incorporate to bill for their services is not a qualified employer. Given the statutory requirement that we make payment to the PA's employer, PAs are precluded from directly billing the Medicare program and receiving payment for their services, and do not have the ability to reassign Medicare payment rights for their services to any employer, facility, or billing agent.

Section 403 of the Consolidated Appropriations Act, 2021 (CAA) (Pub. L. 116-260, December 27, 2020), amends section 1842(b)(6)(C)(i) of the Act to remove the requirement to make payment for PA services only to the employer of a PA effective January 1, 2022. With the removal of this requirement, PAs will be authorized to bill the Medicare program and be paid directly for their services in the same way that NPs and CNSs do. Effective with this amendment, PAs also may reassign their rights to payment for their services, and may choose to incorporate as a group comprised solely of practitioners in their specialty and bill the Medicare program, in the same way that NPs and CNSs may do. We note that the amendment made by section 403 of the CAA changed only the statutory billing construct for PA services. It neither changed the statutory benefit category for PA services, including the requirement that PA services are performed under physician supervision, at section 1861(s)(2)(K)(i) of the Act, nor did it change the statutory payment percentage applicable to PA services specified in section 1833(a)(1)(O) of the Act.

We are proposing to amend pertinent sections of our regulations to reflect the amendment made by section 403 of the CAA. Specifically, we are proposing to amend § 410.74(a)(2)(v) to specify that the current requirement that PA services must be billed by the PA's employer in order to be covered under Medicare Part B is effective only until January 1, 2022. We are also proposing to amend § 410.150(b) to redesignate the current requirements in paragraph (b)(15) as § 410.150(b)(15)(i), and to amend that paragraph to provide that Medicare payment is made for PA services to the qualified employer of the PA for services furnished prior to January 1, 2022. In § 410.150, we further propose to add a new paragraph (b)(15)(ii) to state that, effective for services furnished on or after January 1, 2022, payment is made to a PA for their professional services, including services and supplies furnished incident to their services. We would conform this new paragraph with the regulation at § 410.150(b)(16) regarding to whom payment is made for NP or CNS services. As such, the proposed new paragraph at § 410.150(b)(15)(ii) would provide that payment will be made to a PA for professional services furnished by a PA in all settings in both rural and non-rural areas; and that payment is made only if no facility or other provider charges or is paid any amount for services furnished by a PA. We also intend to update our program manual instructions to reflect the statutory change made by section 403 of the CAA and the changes to our regulations.

H. Therapy Services

We are implementing the third and final part of the amendments made by section 53107 of the Bipartisan Budget Act (BBA of 2018) (Pub. L. 115-123, February 9, 2018). The BBA of 2018 added a new section 1834(v) of the Act. Section 1834(v)(1) of the Act requires CMS to make a reduced payment for physical therapy and occupational therapy services furnished in whole or in part by physical therapist assistants (PTAs) and occupational therapy assistants (OTAs) at 85 percent of the otherwise applicable Part B payment for the service, effective January 1, 2022.

Section 1834(v)(2) of the Act requires that: (1) By January 1, 2019, CMS must establish a modifier to indicate that a therapy service was furnished in whole or in part by a PTA or OTA; and, (2) beginning January 1, 2020, each claim for a therapy service furnished in whole or in part by a PTA or an OTA must include the modifier. Section 1834(v)(3) of the Act requires CMS to implement these amendments through notice and comment rulemaking.

In the CY 2019 PFS final rule (83 FR 59654 through 59660), we established the CQ and CO modifiers that were required to be used by the billing practitioner or therapy provider to identify therapy services provided in whole or in part by PTAs and OTAs, respectively, beginning January 1, 2020. We require these payment modifiers to be appended on claims for therapy services, alongside the GP and GO therapy modifiers which are used to indicate the services are furnished under a physical therapy or occupational therapy plan of care, respectively. The payment modifiers are defined as follows:

  • CQ modifier: Physical therapy services furnished in whole or in part by PTAs.
  • CO modifier: Occupational therapy services furnished in whole or in part by OTAs. In the CY 2019 PFS final rule (83 FR 59654 through 59660), we did not finalize our proposed definition of “furnished in whole or in part by a PTA or OTA” as a service for which any minute of a therapeutic service is furnished by a PTA or OTA. Instead, in response to public comments, we finalized a de minimis standard under which a service is considered to be furnished in whole or in part by a PTA or OTA when more than 10 percent of the service is furnished by the PTA or OTA.

In the CY 2019 PFS proposed and final rules (83 FR 35850 through 35852, and 83 FR 59654 through 59660, respectively), we explained that the CQ and CO modifiers would not apply to claims for outpatient therapy services that are furnished by, or incident to, the services of, physicians or NPPs including NPs, PAs, and CNSs. This is because our outpatient physical and Start Printed Page 39214occupational therapy services regulations require that the individual who performs outpatient therapy services incident to the services of a physician or NPP must meet the qualifications and standards for a therapist (other than state licensure). As such, only therapists, and not therapy assistants, can perform outpatient therapy services incident to the services of a physician or NPP (83 FR 59655 through 59656); and the modifiers to describe services furnished in whole or in part by a PTA or OTA are not applicable to the claim for a therapy service billed by a physician or NPP incident to their professional services. We indicated that we would add this distinction in the provision of the Medicare Benefit Policy Manual (MBPM) Chapter 15 that discusses therapy services furnished incident to the physician's or NPP's services at section 230.5, as well as the sections that discuss PTA and OTA services at sections 230.1 and 230.2, respectively.

In the CY 2020 PFS proposed and final rules (84 FR 40558 through 40564 and 62702 through 62708, respectively), we explained that the CQ/CO modifiers and the de minimis policy would apply to both untimed and timed codes. The untimed codes are evaluation and reevaluation codes, group therapy and supervised modalities, and when these are billed, only one unit is reflected in the “units” portion of the claim. When the PTA/OTA provides more than 10 percent of the service, the code is billed with a CQ/CO modifier. For timed codes, that is, those codes defined in 15-minute increments, the services are typically performed in multiple units of the same and/or different codes for a patient on one treatment day. We explained that under our policy, the therapist or therapy assistant needs to find the total time of all these 15-minute timed codes in order to determine the number of units that can be billed for that day. For example, if the PT/OT and/or the PTA/OTA, as appropriate, furnished between 8 minutes through 22 minutes, one unit can be billed; if 23 minutes through 37 minutes are provided, 2 units can be billed; if 38 minutes through 52 minutes are furnished, 3 units can be billed. Once the total number of units to bill is determined, the qualified professional (therapist or assistant) then needs to decide whether the CQ/CO modifier is applicable.

In the CY 2020 PFS proposed rule (84 FR 40558 through 40564), we proposed that the time the PTA/OTA spent together with the PT/OT in performing a service, as well as the time the PTA/OTA spent independent of the PT/OT treating the patient, is considered time for which the service is furnished in whole or in part by the PTA/OTA. As explained in the CY 2020 PFS final rule (84 FR 62702 through 62708), many commenters objected to our proposal to include as time that the therapy service is furnished “in whole or in part” by the PTA/OTA both the minutes spent by the PTA/OTA concurrently with and separately from the therapist. These commenters also expressed concerns that this policy would unfairly discount services that are fully furnished by therapists, and in which the therapy assistant supports them while they provide a service. We were persuaded by commenters to finalize a policy to not include as minutes furnished in whole or in part by a PTA/OTA the minutes in which the PTA/OTA worked concurrently with the PT/OT. We agreed with the commenters that when a therapy assistant and therapist furnish care to a patient at the same time, the patient requires both professionals, and this reflects a clinical scenario where the assistant is helping the therapist to provide a highly skilled procedure or one in which both professionals are needed for safety reasons. We modified our proposed regulation text at §§ 410.59 (outpatient occupational therapy), 410.60 (physical therapy), and 410.105 (for PT and OT CORF services) accordingly.

For purposes of deciding whether the 10 percent de minimis standard is exceeded, we offered two different ways to compute this.

  • The simple method: Divide the total of the PTA/OTA + PT/OT minutes by 10, round to the nearest integer then add 1 minute to get the number of minutes needed to exceed the de minimis standard at and above which the CQ/CO modifier applies.
  • The percentage method: Divide the PTA/OTA minutes by the sum of the PTA/OTA and therapist minutes and then multiply this number by 100 to calculate the percentage of the service that involves the PTA/OTA, if this number is greater than 10 percent the CQ/CO modifier applies.

Hypothetical examples of each of these methods are included later in this section. In response to our proposal that all the units of one service needed to be considered when determining if the de minimis is applied, commenters requested that we consider each 15-minute unit instead—noting that they would be able to apply the CQ/CO modifier on one claim line for a service that was provided by the PTA/OTA and report another claim line without the CQ/CO for the service provided by the PT/OT. We were persuaded by stakeholders, and finalized a policy under which the de minimis standard is applied for each 15-minute unit of a service. This allows the separate reporting, on two different claim lines, of the number of 15-minute units of a code to which the therapy assistant modifiers do not apply, and the number of 15-minute units of a code to which the therapy assistant modifiers do apply. However, we neglected to modify the text of our regulations to reflect this final policy for applying the de minimis standard; therefore, we are proposing to revise our regulation text to specify that the de minimis rule is applied to each 15-minute unit of a service, rather than to all the units of a service at §§ 410.59(a)(4)(iii)(B), 410.60(a)(4)(iii)(B), and 410.105(d)(3)(ii). The specific proposed revisions are discussed below.

To recap, we finalized a de minimis standard to identify when the CQ/CO modifiers apply and when they do not apply as follows:

  • Portions of a service furnished by the PTA/OTA independent of the physical therapist/occupational therapist, as applicable, that do not exceed 10 percent of the total service (or 15-minute unit of a service) are not considered to be furnished in whole or in part by a PTA/OTA, so are not subject to the payment reduction;
  • Portions of a service that exceed 10 percent of the total service (or 15-minute unit of a service) when furnished by the PTA/OTA independent of the therapist must be reported with the CQ/CO modifier, alongside of the corresponding GP/GO therapy modifier; are considered to be furnished in whole or in part by a PTA/OTA, and are subject to the payment reduction; and
  • Portions of a service provided by the PTA/OTA together with the physical therapist/occupational therapist are considered for this purpose to be services provided by the therapist.

In the CY 2020 PFS proposed rule (84 FR 40558 through 40564), we proposed to adopt a documentation requirement that a short phrase or statement must be added to the daily treatment note to explain whether the therapy assistant modifier was or was not appended for each therapy service furnished. We also sought comment on whether it would be appropriate to also require documentation of the minutes spent by the therapist or therapy assistant along with the CQ/CO modifier explanation as a means to avoid possible additional burden associated with a contractor's medical review process conducted for these services. Many commenters stated that: (1) The statute does not require documentation to explain why a Start Printed Page 39215modifier was or was not applied for each code; (2) the proposed documentation requirements are exceedingly burdensome and conflict with the agency's “Patients over Paperwork Initiative”; (3) the proposed documentation requirement that calls for a narrative phrase in the treatment note and requires documentation of the minutes is duplicative of current requirements that requires adding the total timed code minutes and total treatment time (includes timed and untimed codes) to the daily treatment note; and, (4) the Medicare Benefit Policy Manual (MBPM) already includes extensive documentation requirements. In response to the feedback, we did not finalize the proposed documentation requirement; nor did we finalize a requirement that the therapist and therapy assistant minutes be included in the documentation. Instead, we reminded therapists and therapy providers that correct billing requires sufficient documentation in the medical record to support the codes and units reported on the claim, including those reported with and without an assistant modifier. Further, in agreement with many commenters, we clarified that we would expect the documentation in the medical record to be sufficient to know whether a specific service was furnished independently by a therapist or a therapist assistant, or was furnished “in part” by a therapist assistant, in sufficient detail to permit the determination of whether the 10 percent standard was exceeded.

In the CY 2020 PFS proposed rule, we also provided multiple typical clinical billing scenarios to illustrate when the CQ/CO modifier would and would not be applicable. Because these clinical scenarios did not convey our finalized policies as modified in response to public comments, we indicated in the CY 2020 PFS final rule that we would provide further detail regarding the clinical scenario examples to illustrate how to use the therapy assistant modifiers through information we would post on the cms.gov website. We clarified that our revised finalized policy applied generally in the same way as illustrated in those examples, except for the difference in the minutes of time that are counted toward the 10 percent standard (not counting the minutes furnished together by a therapist and therapy assistant), the application of the 10 percent standard to each billed unit of a timed code rather than to all billed units of a timed code, and the billing on two separate claim lines of the units of a timed code to which the therapy assistant modifiers do and do not apply.

In early March 2021, we posted on our Therapy Services website at https://www.cms.gov/​Medicare/​Billing/​TherapyServices general guidance on how to assign the CQ/CO modifiers for multiple billing scenarios. In the guidance, we provided general examples for 8 different billing scenarios in which multiple units of 15-minute codes are provided by PTs/OTs and PTAs/OTAs and one billing example that used the untimed code for group therapy performed for equal minutes by a PT and a PTA.

We noted that prior to applying our rules to determine appropriate application of the CQ/CO modifiers, the PTA/OTA or PT/OT first needs to determine how many 15-minute units can be billed in a single treatment day for a patient. For information on this topic, we referred readers to the chart in section 20.2.C of Chapter 5 of the Medicare Claims Processing Manual (MCPM) that describes how to count minutes for timed codes defined by 15-minute units, since the therapist or assistant should use the same counting rule, commonly known as the “8-minute rule,” that they have used previously.

Once the therapist or therapy assistant has identified the number of 15-minute units that can be billed for a patient on a single treatment day, we provided the following information to clarify how to apply our policy for application of the CQ and CO modifiers, as follows:

Step 1. Identify the Timed HCPCS Codes Furnished for 15 Minutes or More: List the code numbers of each of the services furnished along with the number of minutes in total done by the PT, PTA, OT, or OTA. When a PT, PTA, OT, or OTA provides at least 15 minutes and less than 30 minutes of a service on a single treatment day, assign 1 unit; when multiples of 15 minutes are furnished, for example, 30 minutes (assign 2 units) and 45 minutes (assign 3 units), etc. This needs to be the first step whenever it is applicable to the billing scenario. When any of these services, that is, full 15-minute increments, are provided by a PTA/OTA, the CQ/CO modifiers apply.

Step 2. Identify Services for Which the PT/OT and PTA/OTA Provide Minutes of the Same HCPCS Code: After applying Step 1, where applicable, identify any minutes (including remaining minutes from Step 1) performed by a PT/OT and PTA/OTA for the same service/code. Add the minutes furnished by the PT/OT and the PTA/OTA together, then divide the total by 10 and round to the nearest integer—this is the 10 percent de minimis time standard. Then add 1 minute to get the fewest number of minutes performed by the PTA/OTA that would exceed the 10 percent time standard for that service—if the PTA/OTA minutes meet or exceed this number, the CQ/CO modifier would be appended. This is the “simple” method for calculating the de minimis number of minutes.

Step 3. Identify Services Where the PT/OT and PTA/OTA Furnish Services of Two Different Timed HCPCS Codes: After applying Step 1 for each service, compare the remaining minutes furnished by the PT/OT for one service with the remaining minutes furnished by the PTA/OTA for a different service. Assign the CQ/CO modifier to the service provided by the PTA/OTA when the time they spent is greater than the time spent by the PT/OT performing the different service. The CQ/CO modifier does not apply when the minutes spent delivering a service by the PT/OT are greater than the minutes spent by the PTA/OTA delivering a different service.

Step 4. Identify the Different HCPCS Codes Where the PT/OT and the PTA/OTA Each Independently Furnish the Same Number of Minutes: Once Step 1 is completed for each service (when applicable), and when the remaining minutes for each service—one provided by the PT/OT and the other provided by the PTA/OTA—are the same, either service may be billed. If the service provided by the PT/OT is billed, the CQ/CO modifier does not apply. However, if the service provided by the PTA/OTA is billed, the CQ/CO modifier does apply.

The below two examples are taken from our guidance on the CMS website. These are examples of when the PT and PTA provide minutes of the same service:

Example #1

PTA—23 minutes 97110

PT—13 minutes 97110

PT—30 minutes 97140

Total = 66 minutes—qualifies for billing 4 units (53 minutes through 67 minutes).

Billing Explanation:

  • First Step: Assign units to services based on those that have at least 15 minutes or codes that were provided in multiples of 15 minutes. For 97110, assign one unit of 97110 with the CQ modifier because the PTA furnished at least 15 minutes of 97110 (therapeutic exercise). Then, assign two units of 97140 without the modifier, because the PT furnished the full 30 minutes of manual therapy.
  • Second Step: Determine if the PTA furnished more than 10 percent of the remaining minutes of the 97110 service. To do this via the simple method: Add Start Printed Page 39216the PTA's 8 remaining minutes to the PT's 13 minutes for a total time of 21 minutes. Divide the total by 10 to get 2.1 minutes and round to the nearest integer, which is 2 minutes (the 10 percent time standard for this service). Add 1 minute to find the threshold number of minutes that would exceed the de minimis standard, which in this example is 3 minutes. Using the percentage method, divide the PTA's remaining 8 minutes by the total 21 minutes of the service (8 PTA + 13 PT = 21 minutes) to get 0.38, then multiply the result × 100 = 38 percent.

Final Step: Because 8 minutes meets or exceeds the 3-minute threshold, and 38 percent is greater than 10 percent, a second unit of 97110 is billed with the CQ modifier.

Example #2

PTA—19 minutes of 97110

PT—10 minutes of 97110

Total = 29 minutes—two units of 97110 can be billed (23 minutes through 37 minutes).

Billing Explanation:

  • First Step: Bill one unit of 97110 with the CQ modifier because a full 15 minutes was provided by the PTA, with 4 minutes remaining.
  • Second Step: Determine if the PTA's 4 remaining minutes exceed the 10 percent de minimis standard. Simple method: Add together the PTA's 4 remaining minutes and the 10 PT minutes to get the total time of 14 minutes and divide by ten to get 1.4 minutes and round to the nearest integer = 1 minute to get the 10 percent de minimis standard. Then add 1 minute to get a threshold minimum of 2 minutes for PTA time. If the PTA minutes are at or above the threshold, the CQ modifier applies. Percentage method: Divide the PTA's 4 remaining minutes by the total time of 14 to get 0.29 then multiply by 100 = 29 percent. If the resulting percentage is greater than 10 percent, the PTA modifier applies.
  • Final Step: Bill another unit of 97110 with the CQ modifier since 4 minutes is greater than the 2-minute threshold minimum and 29 percent is greater than 10 percent.

After reviewing the information posted on the CMS Therapy Services web page, therapy stakeholders reached out to CMS to express concern that certain aspects of the billing scenarios described in the guidance contradict their interpretation of our de minimis policy, especially as it applies to a final unit of a multiple-unit timed service. The therapy stakeholders suggested that the guidance we offered would lead to confusion for the same-service billing scenarios (including examples #1 and #2 above). We consider the unit of measure for a timed therapy service code to be 15 minutes. In billing scenarios with multiple units, we would consider the combined time for same or different services in 15-minute unit increments.

The stakeholders agree that the de minimis standard is applied to the last unit of a timed therapy service code in two separate cases. The first case happens when the PTA/OTA and the PT/OT each furnish less than 8 minutes for that final unit of a service. For example, if the PTA/OTA provided 7 minutes and the PT/OT furnished 5 minutes—using the simple method: 12 minutes divided by 10 equals 1.2, rounded to the nearest integer is 1, plus 1 equals 2—if the PTA/OTA provides 2 or more minutes, the CQ/CO modifier is applied. The second case occurs when the PTA/OTA provides 8 or more minutes and the PT/OT furnishes less than 8 minutes—in which event, the de minimis standard is exceeded and the CQ/CO modifier is applied.

We note that the therapy stakeholders' interpretation of when the de minimis policy applies for a final 15-minute unit of a multiple unit timed service is based on what is commonly termed the “8-minute rule” which recognizes a unit of a 15-minute timed therapy service code as 8 minutes (more than the midpoint of the service or 7.5 minutes), but only when it applies to the final unit billed. Applied to the above two examples, the stakeholders informed us that they believe the second unit of CPT code 97110 in both examples should not be billed with an assistant modifier because the therapist provided enough minutes of the service on their own, that is, 8 minutes or more, to bill for the last unit without the assistant's additional minutes. The stakeholders indicated that the therapist would have a financial incentive to not have the PTA/OTA provide the additional minutes at all if the CQ or CO modifier would apply. We note that, in addition to the two cases discussed above, there is another billing scenario to address in the context of our de minimis policy—specifically, where the PT/OT and PTA/OTA each furnish between 9 and 14 minutes of a 15-minute timed service when the total time of therapy services furnished in combination by the PTA/OTA and PT/OT is at least 23 but no more than 28 minutes, and there are two remaining units left to be billed. These “two remaining unit” cases with time ranges between 9 and 14 minutes include the following PTA/OTA:PT/OT (or vice versa) time splits: 9:14, 10:13, 11:12, 12:12, 12:13, 12:14, 13:13; 13:14; and 14:14.

We believe that the stakeholder's interpretation of the de minimis standard is not consistent with the de minimis policy we finalized in the CY 2020 PFS final rule (84 FR 62702 through 62708). However, in working through the billing scenarios with the stakeholders, we identified where we could make refinements to our policy to address some of the confusion and concerns expressed by stakeholders and to address the “two remaining unit” cases noted above. These refinements may also avoid implementing a payment policy that could be perceived to penalize the provision of additional care by a therapy assistant when those minutes of service would lead to a reduced payment for a unit of a service. The stakeholders criticized the finalized de minimis policy because they believed it provides an inherent financial incentive for the therapist to ensure that PTAs/OTAs provide services in exactly 15-minute intervals—to avoid any leftover PTA/OTA minutes that could necessitate application of the CQ/CO modifier, and reduced payment, for the service that the therapist is also providing—without regard to the clinical needs of the individual patient. The stakeholders suggested that if we were to recognize their “8-minute rule” and recommended policy, we would remove the incentive for the therapist to avoid providing appropriate minutes of therapy services performed by the PTA/OTA.

To address the concerns expressed by the stakeholders and the “two remaining unit” cases we identified in our review, we propose to modify our existing policy, specifically for billing scenarios when only one unit of a timed therapy service remains to be billed (the majority of all billing scenarios) and the “two remaining unit” cases described above. As shown in Table 19, this proposal would require application of the CQ/CO modifier when the PTA/OTA provides at least 8 minutes or more and the PT/OT provides less than 8 minutes of the service; or, when both the PT/OT and the PTA/OTA provide less than 8 minutes of the same service.

Start Printed Page 39217

Under this proposed modification, the CQ/CO modifier would not apply when the PT/OT furnishes 8 minutes or more, or both the PT/OT and the PTA/OTA furnish 8 minutes or more, of a timed service. This proposed “midpoint rule” policy was suggested to us by the therapy stakeholders. We agree that since, in this circumstance, the PT/OT provided enough minutes of the service on their own to bill the last unit of the service, the additional minutes of service performed by the PTA/OTA are not material, and thus, should be disregarded, as shown in the examples in Table 20.

With these proposed policy adjustments, the CQ/CO modifiers apply when the PTA/OTA provides all the minutes of a timed service, and to some services (as illustrated in Table 19) when the PTA/OTA and PT/OT each, independent of the other, furnish portions of the same timed service. The CQ/CO modifiers also apply if the portion of an untimed code furnished by the PTA/OTA exceeds the de minimis standard. The CQ/CO modifiers do not apply when the PTA/OTA and the PT/OT furnish different services. Time spent by the PT/OT and PTA/OTA providing services together is considered time spent by the PT/OT for purposes of applying the de minimis standard. Finally, we propose to modify our policy so that the CQ/CO modifiers would not apply when the PT/OT provides enough minutes of the service on their own to bill for the last unit of a timed service, (more minutes than the midpoint or 8 minutes of a 15-minute timed code) regardless of any additional minutes for the service provided by the PTA/OTA.

Examples of Billing Scenarios using the CQ/CO modifiers when the de minimis standard applies, and the proposed policy for the last billed unit of a service:

Example #A:

PTA—10 minutes of 97110

PT—5 minutes of 97110

Total = 15 minutes—qualifies to bill one 15-minute unit (8 minute to 22 minutes).

Analysis: Bill one unit of 97110 with the CQ modifier because the PTA provided 8 minutes or more and the PT provided less than 8 minutes. The de minimis standard applies in these cases.

Example #B:

PTA—5 minutes of 97110

PT—6 minutes of 97110

Total = 11 minutes—qualifies to bill one 15-minute unit (8 minute through 22 minutes).

Analysis: Bill one unit of 97110 with the CQ modifier because the PTA and the PT both provided less than 8 minutes. In this case, the PT provided 6 minutes and the PTA furnished 5 minutes independent of each other. The de minimis standard applies in these cases.

Example #C:

PTA-22 minutes of 97110

PT—23 minutes of 97110

Total = 45 minutes—qualifies to bill three 15-minute units (38 minutes through 52 minutes).

Analysis:

  • Apply Step One of the general policy rules and bill one unit of 97110 with the CQ modifier because the PTA provided 15 full minutes with 7 minutes remaining.
  • Apply Step One to the PT's 23 minutes and bill one unit without the assistant modifier with 8 minutes remaining.
  • The third unit of 97110 is billed without the assistant modifier because the therapist provided enough minutes (8 or more minutes) without the PTAs minutes to bill the final unit.Start Printed Page 39218

Example #D—also see the below regulatory proposal using this `two remaining unit' example.

PT—12 minutes of 97110

PTA—14 minutes of 97110

PT—20 minutes of 97140

Total = 46 minutes—qualifies to bill three units (38 minutes through 52 minutes).

Analysis:

  • Apply Step One of the general policy rules and bill one unit of 97140 without the CQ modifier because the PT provided 15 full minutes of one unit with 5 minutes remaining.
  • Two units remain to be billed and the PT and the PTA each provided between 9 and 14 minutes independent of one another with a total time between 23 and 28 minutes—in these “two remaining unit” scenarios, one unit is billed with the CQ modifier for the PTA and the other unit is billed without it for the PT.
  • The PT's 5 remaining minutes of 97140 are counted towards the total timed minutes but are not billable in this scenario.

Example #E

OTA—11 minutes of 97535

OT—11 minutes of 97530

Total = 22 minutes—qualifies to bill one (1) unit (8 minutes through 22 minutes).

Billing Analysis:

Since two different services were furnished for an equal number of minutes—the “tie-breaker” scenario applies. Either code 97530 by the OT or code 97535 by the OTA can be billed in accordance with a billing example in the MCPM, Chapter 5, section 20.2.C. Either one unit of 97530 is billed without the CO modifier or one unit of 97535 is billed with the CO modifier.

Example #F: Untimed code—1 unit is billed for all untimed codes including evaluations, reevaluations, supervised modalities, and group therapy.

OTA—20 minutes 97150 independent of the OT

OT—20 minutes 97150 independent of the OTA

Total = 40 minutes of Group Therapy = 1 unit of 97150 is billed for each group member.

Billing Analysis: One unit of group therapy 97150 is billed with the CO modifier because the OTA provided more than the 10 percent time standard in this example. Either method can be used to determine if the OTA's time exceeded the 10 percent time standard for this clinical scenario, see below:

  • The simple method: First add the OTA's 20 minutes to the OT's 20 minutes to get 40, then divide by 10 to get 4.0 and add 1 to equal 5 minutes. The OTA's 20 minutes is equal to or greater than 5 minutes so the CO modifier is required on the claim.
  • The percentage method: Divide the number of minutes that an OTA independently furnished a service by the total number of minutes the service was furnished as a whole—20 divided by 40 equals 0.50. Then multiple by 100 to get 50 percent, which is greater than 10 percent. The CO modifier is applied to 97150.
  • Tie breaker: The tie breaker does not apply in this scenario because the example does not contain two different timed codes described in 15-minute intervals. For “tie breaker” see Example #F above.

As noted above and illustrated in Example #D, there are a finite number of cases where there are two 15-minute units left to bill. In these “two remaining unit” cases, the PTA/OTA and the PT/OT each provide between 9 and 14 minutes with a total time of at least 23 minutes through 28 minutes. Under our proposed policy, one unit of the service would be billed with the CQ/CO modifier for the minutes furnished by the PTA/OTA (who furnished between 9 and 14 minutes of the service), and one unit would be billed without the CQ/CO modifier for the service provided by the PT/OT (who also furnished between 9 and 14 minutes of the same service). This is because the PTA/OTA and the PT/OT each independently furnished part of each unit of the same service, and these cases are not addressed by the proposed midpoint rule that would apply when there is only one single unit left to bill. We are proposing to amend our regulation to address the scenario where there are two remaining 15-minute units of the same service for which the PTA/OTA and the PT/OT each provided between 9 and 14 minutes with a total time of at least 23 minutes and no more than 28 minutes. In this scenario, we propose that one unit of the service would be billed with the CQ/CO modifier and the other unit of the service would be billed without the assistant modifier. We are proposing to add this policy to our regulations at §§ 410.59(a)(4)(v) and 410.60(a)(4)(v) for outpatient occupational therapy and physical therapy services, respectively and at § 410.105(d)(3)(iv) for Comprehensive Outpatient Rehabilitation Facility (CORF) services.

As noted above, when we finalized the policy to consider each 15-minute unit of a service for purposes of determining whether the de minimis standard applies, we neglected to revise our regulations at §§ 410.59, 410.60 and 410.105 to reflect this change. As such, we are proposing to amend the regulations at §§ 410.59(a)(4)(iii)(B) and 410.60(a)(4)(iii)(B) for outpatient occupational therapy and physical therapy services, respectively, and at § 410.105(d)(3)(ii) for CORF services to specify that we consider a service to be furnished in part by a PTA or an OTA when the PTA/OTA furnishes a portion of a service, or in the case of a 15-minute timed code, a portion of a unit of a service, separately from the portion of the service or unit of service furnished by the therapist such that the minutes for that portion of a service or a unit of a service furnished by the PTA/OTA exceed 10 percent of the total minutes for that service or unit of a service.

To accommodate the proposed refinement of the de minimis policy, we are proposing to amend the same regulations at §§ 410.59(a)(4)(iv) and 410.60(a)(4)(iv) for outpatient occupational therapy and physical therapy services, respectively, and at § 410.105(d)(3)(iii) for CORF services to provide that, for the final 15-minute unit billed for a patient for a date of service, when the PT/OT provides more than the midpoint (at least 8 minutes) of a service such that they could bill for the service without any additional minutes being furnished by the PTA/OTA, the service may be billed without a CQ or CO modifier, and any remaining minutes of service furnished by the PTA/OTA are considered immaterial.

Beginning January 1, 2022, therapy services furnished in whole or in part by a PTA or OTA will be identified based on the inclusion by the billing therapy services provider (whether a therapist in private practice or therapy provider) of the CQ or CO modifier, respectively, on claim lines for therapy services, and the payment for those services will be adjusted as required by section 1834(v)(1) of the Act. Per our usual system update process, we plan to issue instructions in a change request to prepare our shared systems and Medicare Administrative Contractors (MACs) to pay the reduced amount for therapy services furnished in whole or in part by a PTA or OTA. We will issue an MLN article once the CR is released, after the CY 2022 PFS final rule is issued.

We are seeking comment on all of our proposals.

I. Changes to Beneficiary Coinsurance for Additional Procedures Furnished During the Same Clinical Encounter as Certain Colorectal Cancer Screening Tests

Section 122 of the Consolidated Appropriations Act (CAA) of 2021, Waiving Medicare Coinsurance for Start Printed Page 39219Certain Colorectal Cancer Screening Tests, amends section 1833(a) of the Act to offer a special coinsurance rule for screening flexible sigmoidoscopies and screening colonoscopies, regardless of the code that is billed for the establishment of a diagnosis as a result of the test, or for the removal of tissue or other matter or other procedure, that is furnished in connection with, as a result of, and in the same clinical encounter as the colorectal cancer screening test. The reduced coinsurance will be phased-in beginning January 1, 2022. Currently, the addition of any procedure beyond a planned colorectal cancer screening test (for which there is no coinsurance), results in the beneficiary having to pay coinsurance.

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

Under these statutory provisions, we have issued regulations governing payment for colorectal cancer screening tests at § 410.152(l)(5). We pay 100 percent of the Medicare payment amount established under the applicable payment methodology for the setting for providers and suppliers, and beneficiaries are not required to pay Part B coinsurance for colorectal cancer screening tests (except for barium enemas, which are not recommended by the USPSTF with a grade of A or B).[37]

In addition to colorectal cancer screening tests, which typically are furnished to patients in the absence of signs or symptoms of illness or injury, Medicare also covers various diagnostic tests (see § 410.32). In general, diagnostic tests must be ordered by the physician or practitioner who is treating the beneficiary and who uses the results of the diagnostic test in the management of the patient's specific medical condition. Under Part B, Medicare may cover flexible sigmoidoscopies and colonoscopies as diagnostic tests when those tests are reasonable and necessary as specified in section 1862(a)(1)(A) of the Act. When these services are furnished as diagnostic tests rather than as screening tests, patients are responsible for the Part B coinsurance (20 or 25 percent depending upon the setting) associated with these services.

We define colorectal cancer screening tests in our regulation at § 410.37(a)(1) to include “flexible screening sigmoidoscopies” and “screening colonoscopies, including anesthesia furnished in conjunction with the service.” Under our current regulations, we exclude from the definition of colorectal screening services, colonoscopies and sigmoidoscopies that begin as screening services, but where a polyp or other growth is found and removed as part of the procedure. The exclusion of these services from the definition of colorectal cancer screening tests is based upon longstanding provisions under sections 1834(d)(2)(D) and (d)(3)(D) of the Act dealing with the detection of lesions or growths during procedures (see CY 1998 PFS final rule at 62 FR 59048, 59082 for a more detailed explanation).

Prior to the enactment of section 122 of the CAA, section 1834(d)(2)(D) of the Act provided that if, during the course of a screening flexible sigmoidoscopy, a lesion or growth is detected which results in a biopsy or removal of the lesion or growth, payment under Medicare Part B shall not be made for the screening flexible sigmoidoscopy, but shall be made for the procedure classified as a flexible sigmoidoscopy with such biopsy or removal. Similarly, prior to the recent legislative change, section 1834(d)(3)(D) of the Act provided that if, during the course of a screening colonoscopy, a lesion or growth is detected that results in a biopsy or removal of the lesion or growth, payment under Medicare Part B shall not be made for the screening colonoscopy but shall be made for the procedure classified as a colonoscopy with such biopsy or removal. In these situations, Medicare pays for the flexible sigmoidoscopy and colonoscopy tests as diagnostic tests rather than as screening tests and the 100 percent payment rate for recommended preventive services under section 1833(a)(1)(Y) of the Act, as codified in our regulation at § 410.152(l)(5), has not applied. As such, beneficiaries currently are responsible for the usual coinsurance that applies to the services (20 or 25 percent of the cost of the services depending upon the setting).

Under section 1833(b) of the Act, before making payment under Medicare Part B for expenses incurred by a beneficiary for covered Part B services, beneficiaries must first meet the applicable deductible for the year. Section 4104 of the Affordable Care Act (that is, the Patient Protection and Affordable Care Act (Pub L. 111-148, March 23, 2010), and the Health Care and Education Reconciliation Act of 2010 (Pub. L. 111-152, March 30, 2010), collectively referred to as the “Affordable Care Act”) amended section 1833(b)(1) of the Act to make the deductible inapplicable to expenses incurred for certain preventive services that are recommended with a grade of A or B by the USPSTF, including colorectal cancer screening tests as defined in section 1861(pp) of the Act. Section 4104 of the Affordable Care Act also added a sentence at the end of section 1833(b)(1) of the Act specifying that the exception to the deductible shall apply with respect to a colorectal cancer screening test regardless of the code that is billed for the establishment of a diagnosis as a result of the test, or for the removal of tissue or other matter or other procedure that is furnished in connection with, as a result of, and in the same clinical encounter as the screening test. Although amendments made by the Affordable Care Act addressed the applicability of the deductible in the case of a colorectal cancer screening test that involves biopsy or tissue removal, they did not alter the coinsurance provision in section 1833(a) of the Act for such procedures. Public commenters encouraged the agency to eliminate the coinsurance in these circumstances; Start Printed Page 39220however, the agency found that statute did not provide for elimination of the coinsurance (75 FR 73170 at 73431).

Beneficiaries have continued to contact us noting their concern that a coinsurance percentage applies (20 or 25 percent depending upon the setting) under circumstances where they expected to receive only a colorectal screening test to which coinsurance does not apply. Instead, these beneficiaries received what Medicare considers to be a diagnostic procedure because, for example, polyps were discovered and removed during the procedure. Similarly, physicians have expressed concern about the reactions of beneficiaries when they are informed that they will be responsible for coinsurance if polyps are discovered and removed during a procedure that they had expected to be a screening procedure to which coinsurance does not apply.

Section 122 of the CAA addresses this coinsurance issue by successively reducing, over a period of years, the percentage amount of coinsurance for which the beneficiary is responsible. Ultimately, for services furnished on or after January 1, 2030, the coinsurance will be zero.

To implement the amendments made by section 122 of the CAA, we are proposing to modify our regulations to reflect the changes to Medicare statute. As amended, the statute effectively provides that, for services furnished on or after January 1, 2022, a flexible sigmoidoscopy or a colonoscopy can be considered a screening flexible sigmoidoscopy or a screening colonoscopy test even if an additional procedure is furnished to remove tissue or other matter during the screening test. Specifically, section 122(a)(3) of the CAA added a sentence to the end of section 1833(a) of the Act to include as colorectal screening tests described in section 1833(a)(1)(Y) of the Act, a colorectal cancer screening test, regardless of the code that is billed for the establishment of a diagnosis as a result of the test, or for the removal of tissue or other matter or other procedure that is furnished in connection with, as a result of, and in the same clinical encounter as the screening test. We note that only flexible screening sigmoidoscopies and screening colonoscopies are recognized currently as colorectal cancer screening tests that might involve removal of tissue or other matter. This new sentence added under section 1833(a) of the Act uses the same language that was used to amend the statute at section 1833(b)(1) of the Act and to broaden the scope of colorectal cancer screening tests to which a deductible does not apply. Section 122(b)(1) of the CAA then limits application of the 100 percent Medicare payment rate (that is, no beneficiary coinsurance) under section 1833(a)(1)(Y) of the Act for the additional colorectal cancer screening tests (those that are not screening tests “but for” the new sentence at the end of section 1833(a) of the Act) by making payment for them subject to a new section 1833(dd) of the Act. Section 1833(dd) of the Act provides for a series of increases in the Medicare payment rate percentage for those services over successive periods of years through CY 2029. Thereafter, section 1833(dd) of the Act has no effect, so payment for all colorectal cancer screening tests would be made at 100 percent under section 1833(a)(1)(Y) of the Act.

To codify the amendments made by section 122 of the CAA in our regulations, we are proposing to make two modifications to current regulations.

At § 410.37, we propose to modify our regulation where we define conditions for and limitations on coverage for colorectal cancer screening tests by adding a new paragraph (j). That paragraph would provide that, effective January 1, 2022, when a planned colorectal cancer screening test, that is, screening flexible sigmoidoscopy or screening colonoscopy test, requires a related procedure, including removal of tissue or other matter, furnished in connection with, as a result of, and in the same clinical encounter as the screening test, it is considered to be a colorectal cancer screening test.

At § 410.152(l)(5), we also propose to modify our regulation. Here we describe payment for colorectal cancer screening tests. Effective January 1, 2022, we propose to provide for an increase in the Medicare payment percentage that is phased in over time. As the Medicare payment percentage increases, the beneficiary coinsurance percentage decreases. We propose to revise § 410.152(l)(5) to provide that Medicare payment in a specified year is equal to a specified percent of the lesser of the actual charge for the service or the amount determined under the fee schedule that applies to the test. The phased in Medicare payment percentages for colorectal cancer screening services described in the proposed regulation at § 410.37(j) (and the corresponding reduction in coinsurance) are as follows:

  • 80 percent payment for services furnished during CY 2022 (with coinsurance equal to 20 percent);
  • 85 percent payment for services furnished during CY 2023 through CY 2026 (with coinsurance equal to 15 percent);
  • 90 percent payment for services furnished during CY 2027 through CY 2029 (with coinsurance equal to 10 percent); and
  • 100 percent payment for services furnished from CY 2030 onward (with coinsurance equal to zero percent).

Thus, between CYs 2022 and 2030, the coinsurance required of Medicare beneficiaries for planned colorectal cancer screening tests that result in additional procedures furnished in the same clinical encounter will be reduced over time from the current 20 or 25 percent to zero percent in CY 2030 and will remain at zero percent for these services furnished beginning in CY 2030 and thereafter.

J. Vaccine Administration Services: Comment Solicitation: Medicare Payments for Administering Preventive Vaccines

On January 31, 2020, under section 319 of the Public Health Service (PHS) Act (42 U.S.C. 247d), the Secretary of the Department of Health and Human Services (the Secretary) determined that a public health emergency (PHE) as a result of confirmed cases of 2019 Novel Coronavirus exists nationwide and has existed since January 27, 2020 (hereafter referred to as the PHE for COVID-19). The Secretary has since renewed this declaration for successive 90-day periods, the latest on April 15, 2021.

The PHE for COVID-19 has reinforced the important and positive impact that preventive vaccines can have on the health of Medicare beneficiaries and the broader public. At the time of publishing this proposed rule, the PHE for COVID-19 declaration is still in effect and the United States is in the middle of a national effort to vaccinate as many people against COVID-19 as quickly as possible. This national effort has at least temporarily altered the landscape for vaccines and vaccine administration by, for example, encouraging existing providers and suppliers to dramatically expand their vaccination capabilities and by encouraging new (and new types) of providers and suppliers to furnish vaccines.

Over the past several years, stakeholders have expressed concerns about the reduction in Medicare payment rates for the service to administer preventive vaccines covered by Medicare Part B under section 1861(s)(10) of the Act, including the influenza, pneumococcal, and hepatitis B virus (HBV) vaccines. In the last two PFS rulemaking cycles (that is, for CY 2020 and CY 2021), we have attempted Start Printed Page 39221to address some of these concerns and these efforts are discussed in more detail below. However, CY 2021 payment rates for administration of these vaccines by suppliers including physicians, NPPs, and mass immunizers remain the same as in CY 2019: A national average rate of $16.94, which is geographically adjusted. In this section, we are seeking feedback on how we should update the payment rate for administration of these preventive vaccines under Medicare Part B.

1. Medicare Part B Payment for Vaccines

Under section 1861(s)(10) of the Act, Medicare Part B covers both the vaccine and its administration for the preventive vaccines specified—the influenza, pneumococcal, HBV, and COVID-19 vaccines. Under sections 1833(a)(1)(B) and (b)(1) of the Act, there is no applicable beneficiary coinsurance, and the annual Part B deductible does not apply for these vaccinations or the services to administer them. In CY 2021, payment for these vaccines is based on 95 percent of the Average Wholesale Price (AWP) for a particular vaccine product except where furnished in the settings for which payment is based on reasonable cost, such as a hospital outpatient department, rural health clinic (RHC), or federally qualified health center (FQHC). For example, for the 2020-2021 influenza season, payment limits for adult influenza vaccine products range from about $19 to $61 per adult dose. We note that most other preventive vaccines not specified for Medicare Part B coverage under section 1861(s)(10) of the Act, such as the shingles vaccine, are covered and paid for under Medicare Part D.

Section 3713 of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) (Pub. L. 116-136) added the COVID-19 vaccine and its administration to section 1861(s)(10)(A) of the Act in the same subparagraph as the influenza and pneumococcal vaccines and their administration. To implement this section, we issued an interim final rule with comment period (November 4th COVID-19 IFC (85 FR 71145 through 71150)) which established that payments for COVID-19 vaccines and vaccine administration would be made in the same manner as payments for the influenza and pneumococcal vaccines. The IFC specifically amended §§ 414.707(a)(2)(iii) and 414.904(e)(1) to include the COVID-19 vaccine in the list of vaccines with payment limits calculated using 95 percent of the AWP (85 FR 71147). We note that Medicare does not pay providers and suppliers for the vaccine product when the federal government purchases it and gives it to the provider or suppliers for free, as has been the case for all COVID-19 vaccines as of the publication of this proposed rule.

We note that the vaccine administration services described under 1861(s)(10) of the Act are not technically valued or paid under the PFS, as they are not included within the statutory definition of physicians' services in section 1848(j)(3) of the Act. Despite this, we have historically based payment rates for the administration of these preventive vaccines by suppliers such as physicians, NPPs, and mass immunizers on an evaluation of the resource costs involved in furnishing the service, which is similar to the methodology that we use to establish payment rates for the PFS. We note further that we also assign a payment rate for administering these preventive vaccines under the Outpatient Prospective Payment System (OPPS), and those payment rates are for hospitals and home health agencies for preventive vaccine administration. Certain other types of providers and suppliers, such as RHCs, FQHCs and critical access hospitals (CAHs), are paid based on reasonable cost for vaccine administration. We also note that these payments are geographically adjusted based on the provider's wage index.

As discussed in the CY 2021 PFS proposed rule (85 CFR 50162), many stakeholders raised concerns about the reductions in payment rates for the preventive vaccine administration services that had occurred over the past several years. We generally have established payment rates for the three Healthcare Common Procedural Coding System (HCPCS) codes G0008, G0009, and G0010—which describe the services to administer an influenza, pneumococcal and HBV vaccines, respectively, based on a direct crosswalk to the PFS payment rate for 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, the payment rate for the vaccine administration codes was concurrently reduced. Further, because the reduction in RVUs for CPT code 96372 was significant enough to be required to be phased in over several years under section 1848(c)(7) of the Act, the reductions in overall valuation for the vaccine administration codes were likewise subject to reductions over several years. As noted in Table 21, the national payment rate for administering these preventive vaccines has declined more than 30 percent since 2015.

Start Printed Page 39222

We have attempted to address the reduction in payment rates for these vaccine administration HCPCS codes in the last two PFS rulemaking cycles. In the CY 2020 PFS final rule, we acknowledged that it is in the public interest to ensure appropriate resource costs are reflected in the valuation of the immunization administration services that are used to deliver these 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, G0009 and G0010.

In the CY 2021 PFS proposed rule, we proposed to crosswalk G0008, G0009 and G0010 to CPT code 36000 (Introduction of needle or intracatheter, vein) (85 FR 50163). In the proposed rule, we noted that CPT code 36000 is a service with a similar clinical vignette, and that the additional clinical labor, supply, and equipment resources associated with furnishing CPT code 36000 were similar to costs associated with these vaccine administration codes. We also noted that this crosswalk would have resulted in payment rates for vaccine administration services at a rate that is approximately the same as the CY 2017 rate (as noted in Table 21) that was in place prior to the revaluation of CPT code 96372 (the original crosswalk code). In the CY 2021 PFS final rule, we did not finalize the proposed policy, and instead finalized a policy to maintain the CY 2019 payment amount for G0008, G0009 and G0010 (85 FR 84628). In the final rule, we also noted that we continued to seek additional information that specifically identifies the resource costs and inputs that should be considered to establish payment for vaccine administration services on a long-term basis.

As noted above, section 3713 of the CARES Act added the COVID-19 vaccine and its administration to the preventive vaccines covered under Medicare Part B under section 1861(s)(10)(A) of the Act in the same subparagraph as the influenza and pneumococcal vaccines and their administration. Section 3713 of the CARES Act allows us to implement the amendments made by that section through “program instruction or otherwise.” In the November 4th COVID-19 IFC (85 FR 71147) implementing section 3713 of the CARES Act, we indicated that we would establish specific coding and payment rates for the COVID-19 vaccine and vaccine administration through technical direction to Medicare Administrative Contractors (MACs) and information posted publicly on CMS' website.

In December 2020, we publicly posted the applicable CPT codes for the Pfizer-BioNTech and Moderna COVID-19 vaccines and initial Medicare payment rates for administration of these vaccines upon the FDA's authorization of these vaccines. We announced an initial Medicare payment rate for COVID-19 vaccine administration of $28.39 to administer single-dose vaccines. For a COVID-19 vaccine requiring a series of two or more doses—for example, for both the Pfizer-BioNTech and Moderna products—we announced a payment rate for administration of the initial dose(s) of $16.94, which was based on the Medicare payment rate for administering the other preventive vaccines under section 1861(s)(10) of the Act. We also announced a payment rate for administering the second dose of $28.39, which was based on the payment rate that was proposed, but not finalized, for administration of the other preventive vaccines under section 1861(s)(10) of the Act in the CY 2021 PFS proposed rule, discussed in more detail above.

On March 15, 2021, we announced an increase in the payment rate for administering a COVID-19 vaccine to $40 per dose, effective for doses administered on or after March 15, 2021, which means the payment rate is $40 to administer a single dose product, and $40 each to administer the first and second dose in a two-dose regime ($80 total).

Start Printed Page 39223

As discussed above, payment rates for suppliers such as physicians, NPPs, and mass immunizers for administering the Part B covered preventive vaccines have generally been based on a direct crosswalk to CPT code 96372 (Therapeutic, prophylactic, or diagnostic injection (specify substance or drug); subcutaneous or intramuscular). This crosswalk code is paid under the PFS, and Medicare's process to value codes under the PFS relies in part on recommended resource inputs provided by the AMA RUC and steps to translate those recommended inputs into national RVUs.

In 2020, the RUC resubmitted its 2009 valuation recommendation for vaccine administration services described by CPT codes, including CPT codes 90460 (Administration of first vaccine or toxoid component through 18 years of age with counseling), 90471 (Administration of 1 vaccine), and 90473 (Administration of 1 nasal or oral vaccine). The AMA RUC also recently provided valuation recommendations for the CPT codes that describe the service to administer the COVID-19 vaccines.

As noted earlier, we also assign a payment rate for administering preventive vaccines under the OPPS by assigning an ambulatory payment classification (APC) to each service based on clinical and resource cost similarity to other services assigned to the APC. Geometric mean costs, which are generally used in establishing the prospective OPPS payments for each APC, are calculated using historical claims and cost report information. In CY 2021, CMS assigned HCPCS codes G0008, G0009 and G0010 to APC 5691 (level 1 drug administration), which has a national payment rate of $40 for CY 2021.

Our practice of setting payment rates for preventive vaccine administration services described by HCPCS codes G0008, G0009 and G0010 for physicians, NPPs, and mass immunizers by using the PFS approach (for example, a crosswalk to an existing CPT code) means that costs incorporated into the rate primarily reflect costs of furnishing the service in a physician office setting. It also means that the payment rate can be affected by other aspects of the PFS rate-setting methodology, such as the allocation of indirect PE, and broader changes to PFS codes and rates, including the multi-year phase-in of significant reductions in RVUs discussed earlier. We note that we have not historically collected or used information from other providers and suppliers, including pharmacies which are commonly enrolled as mass immunizers to furnish vaccines and vaccine administration services, for purposes of establishing a rate for these codes.

We are requesting feedback from stakeholders that would support the development of an accurate and stable payment rate for administration of the preventive vaccines described in section 1861(s)(10) of the Act for physicians, NPPs, mass immunizers and certain other providers and suppliers. We are interested in detailed feedback on the following questions, which we believe would assist us in establishing payment rates for these services that could be appropriate for use on a long-term basis.

  • What are the different types of providers and suppliers that furnish preventive vaccines, and have these types of providers/suppliers changed as a result of the PHE for COVID-19? (We note that our claims data reflect the type of Medicare enrollment for those billing for the vaccine administration, but we are particularly interested in understanding additional, specific characteristics of the providers and suppliers that may not be distinguishable under the more general Medicare enrollment data.) We are also interested in whether different providers and suppliers furnish different aspects of the vaccine administration for the same beneficiary.
  • What are the differences in incurred costs of furnishing flu, pneumonia and HBV vaccines compared to furnishing COVID-19 vaccines? Are there differences in the costs (per dose or otherwise) of furnishing a one-dose vaccine product vs. a two-dose vaccine product? Also, are there differences in cost of administering preventive vaccines furnished under the Part D benefit, such as the shingles vaccines, compared to those furnished under Part B?
  • What are the resource costs that physicians, NPPs, mass immunizers and certain other suppliers incur when furnishing vaccines safely and effectively? We are interested in specific information on costs related to staffing/labor, infrastructure, patient onboarding/enrollment, vaccine storage and handling, vaccine procurement and coordination, supplies, CDC and state reporting requirements, patient counseling about safety and efficacy, and other costs we may not have considered. We are also interested in specific resource costs per vaccine dose within each cost category, if that is available.
  • What are the impacts of the PHE for COVID-19 on resource costs incurred by vaccination providers, and do stakeholders envision that these impacts will continue after the PHE has ended? Following the end of the PHE, do you expect that the same types of vaccination providers and suppliers will continue to administer vaccines, or do you envision that this will change (if so, how, and what would be the primary factors driving the change)?
  • As described previously, Medicare has generally relied on the PFS methodology for setting payment rates for HCPCS codes G0008, G0009 and Start Printed Page 39224G0010. How should Medicare assess costs associated with furnishing these preventive vaccines outside of the physician office setting, such as in pharmacies, mass immunization sites, mobile vaccine clinics or other locations? In addition, we understand that there could be administrative burden associated with the routine collection of cost data to support more accurate rate-setting for suppliers that are vaccinating patients. Are there other ways to update and validate costs for a broader range of entities using existing data?
  • Payment rates for vaccine administration currently vary by setting. For HCPCS codes G0008, G0009 and G0010, the CY 2021 national average payment rate for physicians, practitioners and other suppliers is $16.94, which is geographically adjusted, while for hospital outpatient departments it is $40. However, for COVID-19 vaccine administration, Medicare now pays $40 per administration in all settings, unless the vaccine in administered under certain circumstances in the beneficiary's home or residence (as discussed in more detail below). Should Medicare continue to pay differently for non-COVID-19 preventive vaccines furnished in certain settings or under certain conditions? If not, what factors contribute to higher costs for administration of non-COVID-19 vaccines that are not currently reflected in the Medicare payment rates?
  • Should CMS use a different process to update the payment rates for administration of the preventive vaccines described in section 1861(s)(10) of the Act on an annual basis?
  • In the last few years we have also crosswalked vaccine administration CPT codes 90460 (Administration of first vaccine or toxoid component through 18 years of age with counseling), 90461 (Administration of vaccine or toxoid component through 18 years of age with counseling), 90471 (Administration of 1 vaccine), 90472 (Administration of vaccine), 90473 (Administration of 1 nasal or oral vaccine), and 90474 (Administration of nasal or oral vaccine) to the same rate used by G0008, G0009 and G0010. How should Medicare address payment rates for these CPT codes under the PFS?
  • Are there major differences between what Medicare pays physicians, NPPs and mass immunizers for non-COVID-19 preventive vaccine administration and what commercial insurers pay? To the extent possible we are also interested in feedback on specific rates used by other insurers.

2. Payment for COVID-19 Vaccine Administration in the Home

Effective June 8, 2021, we announced a new add-on payment with a national rate of $35.50 when a COVID-19 vaccine is administered in the beneficiary's home.[38] Under this new policy, providers and suppliers that administer a COVID-19 vaccine in a beneficiary's home under certain circumstances can bill Medicare for one of the existing COVID-19 vaccine administration CPT codes (0001A, 0002A, 0011A, 0012A, 0031A) along with HCPCS code M0201 (COVID-19 vaccine administration inside a patient's home; reported only once per individual home per date of service when only COVID-19 vaccine administration is performed at the patient's home). Providers and suppliers administering a COVID-19 vaccine in the home will be paid a national average payment $75.50 dollars per dose ($40 for COVID-19 vaccine administration and $35.50 for the additional payment for administration in the home, and both payments are geographically adjusted).

In establishing the additional payment for COVID-19 vaccine admini