CMS Announces Changes in 2021 Physician Fee Schedule Final Regulation

An elderly person wearing a medical device on her wrist

On Dec. 2, 2020, the Centers for Medicare & Medicaid Services (CMS) released the Medicare Physician Fee Schedule Final Regulation for Calendar Year (CY) 2021. This regulation included numerous changes to connected health policy, including on telehealth and remote physiologic monitoring (RPM) reimbursement. In addition, CMS finalized several policies for the Quality Payment Program (QPP) and other payment-related policy changes.  

HIMSS worked with the Personal Connected Health Alliance (PCHAlliance) to respond to the Proposed Regulation’s Public Comment Period in September 2020.

Over the last 11 months, CMS received extensive waiver authority around connected health under the COVID-19 Public Health Emergency (PHE) declaration, albeit on a temporary basis. While CMS made many changes in the Physician Fee Schedule Final Regulation, the agency is still largely limited by statute as to what it can and cannot make permanent, particularly around telehealth. Ensuring that patients and providers continue to have access to the broad range services utilized during the COVID-19 pandemic after the PHE ends will require Congressional action. 

The 2021 Physician Fee Schedule Final Regulation includes the following changes.

Telehealth and other Communication Technologies Highlights

  • Adds nine new codes to the Category 1 telehealth services list, including group psychotherapy, home visits for an established patient, and cognitive assessment and care planning services, among others.
  • Creates new Category 3 telehealth services list. Coverage and reimbursement for these services is temporary and will expire at the end of the year when the COVID-19 PHE Declaration expires. This new category will provide healthcare providers time to collect evidence and share whether these services should be added permanently. CMS included over 60 codes on the Category 3 list.
  • Establishes new communication technology-based services (CTBS) codes that allow allied health professionals (such as physical therapists, occupational therapists, and speech-language pathologists) to furnish brief online assessments, virtual check-ins, and remote evaluation services. These services are not reimbursed at the same level as telehealth, since CMS does not have authority over the types of providers that furnish telehealth without an act of Congress.
  • Allows direct supervision to be provided using telehealth through the end of 2021.
  • Reduces frequency limitation for subsequent nursing facility visits furnished via telehealth to one visit every 14 days, from once every 30 days.
  • There will be no separate audio-only service reimbursement after the PHE expires. However, for CY 2021, CMS is creating a new code for virtual check-in services for synchronous, audio-only medical discussion lasting 11-20 minutes to determine the need for an in-person visit. This service will not be reimbursed at the same rate as a telehealth visit, however it is a step in the right direction.

Care Management and RPM Services Highlights

  • Clarifies that any device used for RPM must meet the Food and Drug Administration’s definition of a medical device, and must digitally collect and transmit a patient’s physiologic data rather than be self-reported.
  • Makes the change permanent that RPM can be used for patients with both acute and chronic conditions, and that consent can be obtained at the time the services are furnished.
  • Allows auxiliary personnel, including contracted employees, the ability to provide two services (CPT codes 9453 and 99454 – for patient education and initial set up, device supply, and data collection) under physician supervision.
  • Requires an established relationship between a physician and patient to furnish RPM after the COVID-19 PHE ends.
  • Limits billing of RPM services to once per patient per month.
  • Reverts back to the 16-day minimum requirement for physiologic data collection and transmission from a device to a provider after the COVID-19 PHE ends. This requirement had been reduced to a two-day minimum during the course of PHE.
  • Prohibits federally qualified health centers and rural health clinics from separately billing for RPM services.
  • While the community awaits confirmation from CMS, the requirements for 20 minutes of time per month for codes 99457 and 99458 appears to include both interactive communication using synchronous, two-way interactions with the patient or caregiver, as well as time furnishing care management services. CMS initially proposed requiring 20 minutes of interactive communication with the patient or caregiver, but now appears to be including care management services as part of that time requirement.

Delaying the Introduction of the Merit-based Incentive Payment System (MIPS) Value Pathways (MVP) Program

CMS had previously finalized that QPP participation through MVPs would begin with the 2021 performance period.  However, the agency recognized stakeholder concerns about this timeline, even more so now that clinicians are working hard to address the spread of COVID-19 within their practices and communities. Therefore, CMS decided not to introduce any MVPs into the program for the 2021 Performance Period. Instead, it is finalizing additions to the framework’s guiding principles and development criteria to support stakeholder engagement in collaborating with CMS to develop MVPs and establishing a clear path for MVPs candidates to be recommended through future rulemaking.

In our HIMSS and PCHAlliance Proposed Regulation comment letter, we supported a delay in the timeline for starting the implementation of the MVP Program to at least the 2022 Performance Period. Fundamentally, we expressed support for the MVP Program concept connecting quality, cost, and improvement activity measures around specific chronic conditions or specialty cohorts.  We believe that more constrained measurement for each specialty and chronic care condition would reduce variability and reliability of measures and create more effective benchmarking mechanisms for driving care quality and performance transparency for patients.

HIMSS and PCHAlliance encouraged this change primarily due to the lack of information available about the development of the MVP Program.  HIMSS has consistently recommended that any measures reported to CMS should be fully-tested (including field testing) with actual patient data to produce meaningful, clinically-appropriate measures of care quality, which can be reported with minimal burden.

Clarifying the Compliance Dates for Certain 2015 Edition Certification Criteria

In the Proposed Regulation, CMS included the requirement that technology used to meet the certified electronic health record (EHR) technology (CEHRT) definitions must be certified in accordance with the updated certification criteria in the Office of the National Coordinator for Health Information Technology (ONC) 21st Century Cures Act Final Regulation.  The agency proposed that eligible clinicians (ECs) must adopt and use 2015 Cures Edition Update CEHRT criteria after August 2, 2022, to meet Promoting Interoperability and Quality performance category requirements of the MIPS program as well as other QPP components. 

CMS used the Final Regulation to clarify that health IT developers have until December 31, 2022, to make technology certified to the updated criteria available to their customers—after this date, technology that has not been updated in accordance with the 2015 Edition Cures Update will no longer be considered certified by ONC. ONC’s Final Regulation provided that developers of certified health IT have 24 months from the publication date of the Final Regulation to make technology certified to new or updated criteria available and ONC subsequently extended the timeline until December 31, 2022. ONC stated that in order to reduce confusion, it has aligned these dates to the calendar year where they impact CMS program participants as aligning these compliance dates to the calendar year, also aligns them to the CMS program annual cycle.

ONC expects and requires that developers will notify customers when technology certified to the updated criteria is available, and that developers will introduce these updates into certified health IT products in the manner most appropriate for their customers, such as through the course of normal maintenance. 

Aligning the Reporting Requirements Under the Shared Savings Program

CMS finalized its proposed revisions to the quality reporting requirements under the Shared Savings Program effective for the 2021 Performance Year and subsequent performance years. The revisions align the Shared Savings Program quality reporting requirements with the requirements that will apply under the Alternative Payment Model (APM) Performance Pathway (APP) in QPP. The Final Regulation also includes a requirement that Shared Savings Program Accountable Care Organizations (ACOs) will report quality data for purposes of the Shared Savings Program via APP. In order to meet the quality reporting requirements under the Shared Savings Program, ACOs must meet certain program requirements.

HIMSS supported these changes in this Proposed Regulation as they would ensure greater alignment and integration between QPP and the Shared Savings Program, including revising the quality performance standard. The idea of APP replacing the Shared Savings Program quality measure set would reduce reporting burden, create new scoring opportunities for participants in MIPS APMs, encourage more participation in APMs, and serve as a suitable complementary path to the MVP Program. 

HIMSS will provide further information about the 2021 Physician Fee Schedule.

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