CMS has released the CY 2021 Medicare Physician Fee Schedule (“MPFS”) Final Rule that will take effect on January 1, 2021.  This detailed final rule contains important updates to telehealth regulations during the COVID-19 public health emergency (“PHE”) and beyond. Additionally, it impacts payments for outpatient evaluation and management visits, which have been examined separately by Advis.  A summary of additional key impacts included within the rule follows below.

1. Remote Physiologic Monitoring (“RPM”) Services

CMS has recently established payment protocols for seven RPM codes and created flexibilities on some of these codes during the COVID-19 PHE (i.e., CPT codes 99453, 99454, 99091, 99457, and 99458).  In response to stakeholder questions, the final rule clarifies that CMS will again require an established patient-physician relationship before RPM services can be furnished at the conclusion of the COVID-19 PHE.  More specifically, 16 days of data for each block of 30 days must be collected and transmitted to meet the requirements to bill for RPM services after the COVID-19 PHE, while CMS continues to allow data collection and transmission to be less during the PHE.Similarly, CMS finalized that RPM services must utilize an FDA-approved medical device per Section 201(h) of the Food, Drug, and Cosmetic Act.  In addition, the medical device used for RPM services must be capable of automatically uploading patient physiologic data. The data cannot be patient self-recorded or self-reported.Further, CMS confirms there must be the ability to participate in “interactive communications”. As explained by CMS, interactive communications must occur in real-time and include synchronous, two-way interactions for 20-minutes of time to fulfill the requirements of CPT codes 99457 and 99458.  The time spent can include documented time the provider spent rendering care management services to the patient.CMS also finalized a permanent policy that mandates providers obtain consent at the time the RPM services are furnished and that auxiliary personnel may furnish CPT codes 99453 and 99454 services under a physician’s supervision (including contracted employees).

1. Direct Supervision Policies Expanded through COVID-19 PHE

CMS confirmed the earlier proposed rule to allow for the direct supervision to be provided using real-time audio and video technology through the duration of the COVID-19 PHE.  Originally, CMS had proposed to only allow for direct supervision through the end of December 31, 2020, but elected to expand on this deadline after significant stakeholder engagement with the proposed rule. The use of telephone supervision without real-time video streaming will continue to be excluded. 

    3.  Policies Regarding Professional Scope of Practice, and Related Issues

Five points are made:

• • CMS confirmed that nurse practitioners, clinical nurse specialists, physician assistants, certified registered nurse anesthetists and certified nurse-midwives may continue to supervise the performance of diagnostic tests in addition to physicians beyond the duration of the COVID-19 PHE so long as they operate within the scope of their practice and abide all state laws.
  • This MPFS Final Rule reiterated that pharmacists providing services incident to physicians’ services fall within the regulatory definition of auxiliary personnel under “incident to” regulations. So long as pharmacists operate under appropriate supervision of a billing or non-physician practitioner and payment is not made under Medicare Part D, pharmacists may provide services incident to the services.
  • Under Medicare Part B for maintenance therapy services, physical and occupational therapists are allowed to delegate maintenance therapy to physical and occupational therapy assistants with similar discretion used for the delegation of rehabilitative services. This policy is a confirmation and extension of a rule created during the COVID-19 PHE and will continue after the PHE.
  • In accordance with the CY 2020 MPFS Final Rule, CMS clarified that physicians and non-physician practitioners (including therapists) can review and verify documentation entered into medical records by members of the medical team for their own services that are paid under the MPFS. Therapy students and students of other qualifying disciplines may also document in the record so long as the documentation is reviewed and verified by the billing physician, practitioner, or therapist.
  • CMS has finalized their proposed policies to satisfy residency requirements during the public health emergency to allow the use of interactive, real-time audio/video for residents outside of a metropolitan statistical area not engaging in surgical or high-risk procedures. CMS has also permanently expanded the settings that residents may “moonlight” to include services not related to their approved GME programs so long as the medical record shows the resident furnished identifiable physician services that meet conditions of payments prescribed in §415.102(a).

4. Other CMS Notable MPFS Updates:

• • Immunization Services: CMS will maintain the payment rates for immunization administration services in an effort to stabilize payment levels for stakeholders during the public health emergency. (CPT Codes 90460, 90461, 90471, 90472, 90473, & 90474; HCPCS Codes G0008, G0009, & G0010).

• • Medicare Coverage for Opioid Use Disorder Treatment Services Furnished by Opioid Treatment Programs (“OTPs”): The SUPPORT Act, Section 2005 established a new Medicare Part B benefit category for Opioid Use Disorder treatment services furnished by OTPs during an episode of care and expanded on the OUD definition to include opioid antagonist medications (naloxone) that are approved through proper FDA channels.  Additionally, CMS is in the process of finalizing two add-on codes for the frequency and use of naloxone.
  • SUPPORT Act
    • Section 2002: CMS has fully implemented this section of the Act that requires initial preventive physical examination (“IPPE”) and annual wellness visits (“AWV”) during screenings of potential substance use disorders. CMS will also require a review of any current opioid prescriptions during these screenings in an effort to promote early detection of high-risk patients.
    • Section 2003: In an effort to smoothly implement this section of the Act, CMS is requiring that prescribers use the National Council for Prescription Drug Programs SCRIPT 2017071 standard for the electronic prescribing of controlled substances (the same standard that Part D plans are required to support).  Providers must be fully compliant with these standards by January 1, 2022.

• • Clinical Laboratory Fee Schedule: Revised Data Reporting Period and Phase-in of Payment Reductions: CMS has implemented the changes to the data reporting and payment requirements within 42 CFR 414(G) to reflect revisions of the data reporting period and phase-in payment reductions enacted in the Further Consolidated Appropriations Act of 2020 and the CARES Act. Specifically, after the data reporting period in 2022 (which is based upon 2019 data), there is a three-year data reporting cycle for clinical diagnostic laboratory tests that are not advanced diagnostic laboratory tests (e.g., 2025, 2028, and so on).

• • Principal Care Management Services in Rural Health Clinics (“RHCs”) and Federally Qualified Health Centers (“FQHCs”): The CY 2020 MPFS Final Rule added a separate payment methodology for principal case management services paid under the PFS through two new HCPCS codes (G2064, G2065), and CMS is finalizing the use of these codes to the HCPCS general care management code (G0511) furnished in RHCs and FQHCs starting January 1, 2021.
  • Rebase and Revise the FQHC Market Basket: CMS rebased and revised the FQHC market basket to reflect the 2017 base year of 2.4 percent.  Accordingly, the multifactor productivity adjustment for CY 2021 is 0.7 percent and the final CY 2021 FQHC payment update is 1.7 percent.

• • Medicare Shared Savings Program (“MSSP”): The proposed changes to the MSSP quality performance standard and reporting requirements were finalized for performance years beginning on January 1, 2021. CMS hopes that these changes will further align with Meaningful Measures, reduce reporting burden, and focus on patient outcomes.  Specifically, CMS is still finalizing the use of automatic full credit for CAHPS patient experience of care surveys for performance year 2020.

• • Part B Drug Payment for Drugs Approved under Section 505(b)(2) of the Food, Drug, and Cosmetic Act: CMS is not finalizing their proposal to continue assigning certain drug products to existing multiple source drug sets (Federal Food, Drug, and Cosmetic Act, Section 505(b)(2)) when the drugs meet the requirements of sharing similar labeling and uses with generic drugs.
  • Removal of Outdated National Coverage Determinations (“NCDs”): Six outdated and obsolete National Coverage Determinations were removed. As such, MACs will no longer require providers to follow these outdated coverage policies.  CMS hopes that this will allow for flexibility for contractors to determine coverage for beneficiaries in their geographic areas based on more recent evidence and information.

For any questions regarding the Medicare Physician Fee Schedule Proposed Rule, the potential impact on providers, or any other health care regulatory and/or operational matters, please contact Advis or call 708.478.7030.

Published: December 4, 2020