Regulation

CMS Releases Proposed Changes to Telehealth, Merit-based Value Pathways and Certification in Physician Fee Schedule Rule

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On Aug. 3, the Centers for Medicare & Medicaid Services (CMS) released its proposed changes to the Physician Fee Schedule for Calendar Year (CY) 2021.

This proposed rule has significant implications for telehealth and remote physiologic monitoring, Merit-based Value Pathways and Health IT Certification.

The deadline to submit public comments is Oct. 5.

Connected Health

In response to COVID-19, CMS moved swiftly to expand access to telehealth to allow for social distancing, improve access to care and expand the workforce. HIMSS supports making permanent the advancements made on Medicare telehealth services beyond the COVID-19 public health emergency (PHE), however many of the changes will require an act of Congress.

Along with CMS’s proposed rule, President Donald Trump issued an Executive Order on Improving Rural and Telehealth Access on Aug. 3, which focuses on improving healthcare access through telehealth. This Order includes:

  1. Announcing a new payment model for rural healthcare providers to allow for flexibilities from existing Medicare rules
  2. Developing and implementing a strategy to improve the physical and communications infrastructure to improve access to healthcare in rural communities;
  3. Submitting a report on upcoming initiatives to improve the availability of clinicians in rural communities
  4. Proposing a rule to extend telehealth Medicare flexibilities put in place during the PHE beyond the PHE.

In the proposed rule, CMS proposed to allow some of the 135 added services during COVID-19 to be made permanent. CMS is proposing to add nine codes to the Category 1 list, which indicates a strong evidence base for both in-person and virtual care for these services. CMS also proposed creating a third category (Category 3), adding 13 telehealth codes on a temporary basis that were added during the PHE. These services would expire at the end of the calendar year that the PHE expires, if they are not added permanently. CMS plans to remove 74 codes from coverage once the PHE ends, as they believe there is not a strong clinical benefit.

CMS also proposes to eliminate audio-only telehealth when the PHE ends, due to statutory restrictions. However, the agency is seeking comment on whether it should develop coding and payment for a service similar to the virtual check-in but for a longer unit of time and subsequently with a higher value. CMS is also proposing to allow non-physician practitioners, including physical therapists, occupational therapists, speech-language pathologists, clinical psychologists and licensed clinical social workers, to furnish communication-technology based services (CTBS) such as online assessments, virtual check-ins and remote evaluation services.   

In addition to telehealth, CMS is clarifying and proposing a number of changes to its policies for remote physiologic monitoring services (RPM). These include:

  1. Clarifying the requirement that an established clinician-patient relationship must exist for the furnishing of RPM services after the PHE ends
  2. Clarifying that practitioners may serve patients through RPM with both acute as well as chronic conditions
  3. Proposing that consent can be obtained at the time of RPM services
  4. Proposing that RPM services are considered to be evaluation and management (E/M) services.

CMS has also given guidance on what medical devices can be used to furnish RPM. CMS is clarifying that the device must meet the Food and Drug Administration’s definition of a medical device as described in Section 201(h) of the FD&C Act, and the data must be digitally collected and transmitted rather than self-reported.

Merit-Based Incentive Payment System Program (MIPS) Value Pathways (MVPs)

CMS had intended to begin implementing the MVPs Program in the 2021 Performance Period, but given how hard clinicians are working to address the spread of COVID-19 within their practices and communities, the agency is delaying the initial MVPs until at least the 2022 Performance Period. 

MVPs allow for a more cohesive participation experience by connecting activities and measures from the four MIPS performance categories that are relevant to a specialty, medical condition or a particular population cared for by the clinician. The MVPs use the Promoting Interoperability Performance Category as a foundational element and incorporate population health claims-based measures as feasible along with relevant measures and activities for the quality, cost and improvement activities performance categories.

Health information exchanges (HIEs) allow for information sharing and improved interoperability, care coordination and access to data in a timely manner between clinicians, health systems and public health agencies. Evidence suggests that use of an HIE has a significant impact on patient outcomes. Therefore, CMS proposed to add an optional HIE bi-directional measure to the MIPS Promoting Interoperability performance category. This means the clinician’s EHR, via an HIE, would be able to both query and share patient information. Despite the significant investment in HIEs across the country, there are usage gaps to fill and this proposal would further incentivize clinicians to participate in HIEs, improving care coordination as well as patient care. The HIE measure would be an optional alternative to two existing measures: the Support Electronic Referral Loops by Sending Health Information measure and the Support Electronic Referral Loops by Receiving and Incorporating Health Information measure. The HIE measure would be worth 40 points.

Health IT Certification

CMS is proposing that healthcare providers participating in the Promoting Interoperability Programs or the Quality Payment Program (QPP) would be required to only use technology that is considered certified under the ONC Health IT Certification Program according to the timelines finalized in the Office of the National Coordinator for Health IT’s (ONC's) Final Interoperability Regulation. CMS’s proposed policy would also incorporate the enforcement discretion that ONC announced in response to the PHE that would allow providers more flexibility in terms of the implementation timelines for adopting the Final Interoperability Regulations from ONC and CMS. 

If CMS’s proposal is finalized, healthcare providers would only be able to use certified EHR technology (CEHRT) that has been certified to the 2015 Edition Cures Update in order for a measure action to count in the numerator during a performance period after Aug. 2, 2022 (which reflects the 24-month compliance deadlines finalized in the 21st Century Cures Act final rule, and the additional 3-month period of enforcement discretion described by ONC). On or prior to Aug. 2, 2022, healthcare providers participating in the Medicare Promoting Interoperability Program and QPP would be able to continue to use technology meeting existing 2015 Edition criteria to meet the CEHRT definition and to support program participation.

During this period, CMS expects that healthcare providers could work with their health IT developers to plan for implementing CEHRT that meets the 2015 Edition Cures Update as soon as health IT developers make updated technology available. CMS expects that this approach to updating the current 2015 Edition would allow healthcare providers and health IT developers adequate time to implement updates and plan for an effective transition, including planning ahead for reporting measure results to CMS for program participation.

Look to HIMSS for additional information on the CY 2021 Proposed Physician Fee Schedule and the development of a public comment letter. 

HIMSS Government Relations

The HIMSS policy team works closely with the U.S. Congress, federal decision makers, state legislatures and governments, and other organizations to recommend policy, and legislative and regulatory solutions to improve health through information and technology.

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