This alert — updated since its first release April 6, 2020 — is part of a series discussing the comprehensive actions taken by the Centers for Medicare & Medicaid Services (CMS) that are most important to healthcare providers. For related alerts, see "CMS Issues Updated Guidance on Medicare Flexibility
Measures for Laboratories" (May 6), "CMS Updates Guidance on Medicare Flexibility Measures for Long-Term Care Facilities" (May 7), "CMS Continues to Increase Flexibility in Quality Reporting Requirements" (May 8) and "COVID-19 – New Regulatory Flexibilities for Durable Medical Equipment Suppliers" (May 13)
In response to the extraordinary circumstances of the novel coronavirus pandemic, on March 30, 2020, CMS announced multiple temporary regulatory waivers and new rules to provide temporary relief from many paperwork, reporting and audit requirements so providers can focus on providing care to patients affected by COVID-19. CMS announced that these temporary changes and regulations will apply, effective immediately, across the entire U.S. healthcare system for the duration of the emergency declaration.
This article summarizes how CMS has increased flexibility for plans and providers under Medicare Parts C and D, incorporating information from updated guidance published April 29, 2020, and including important points for Medicare plans and providers.
Flexibility to Provide Expanded Benefits. CMS allowed Medicare Advantage plans to expand telehealth services and make other midyear benefit enhancements beyond those included in their approved 2020 benefits when such enhancements are provided in connection with the COVID-19 outbreak, are beneficial to enrollees and are provided uniformly to all similarly situated enrollees.
Prior Authorization for Part D Drugs. Part D sponsors may waive prior authorization (PA) requirements that would apply to Part D drugs used to treat or prevent COVID-19, if or when such drugs are identified. Part D sponsors may also waive or relax PA requirements for other formulary drugs to facilitate access and reduce the burden on beneficiaries, plans and providers.
Part D “Refill-Too-Soon” Edits and Maximum Day Supply. Medicare Part D plan sponsors now must permit enrollees to obtain the total supply prescribed for a covered Part D drug, up to a 90-day supply in one fill or refill, if: (1) requested by the enrollee; (2) PA or step therapy requirements have been satisfied; and (3) no safety edits limit the quantity or days’ supply. In addition, Plan D sponsors must relax their “refill-too-soon” policies, which restrict coverage for a prescription that is being refilled early, if circumstances are reasonably expected to result in a disruption in access to drugs. CMS clarified that Part D sponsors must not permit enrollees to obtain a single fill or refill that is inconsistent with a safety edit.
Home or Mail Delivery of Part D Drugs. If enrollees experience difficulties commuting to or are actually prohibited from going to a retail pharmacy (e.g., as a result of quarantine), Part D sponsors may relax policies that discourage certain methods of delivery, such as mail or home delivery, for retail pharmacies that choose to offer these delivery services.
Audit Reviews. CMS is pausing many of its standard medical review activities, including prior authorization and other reviews that require documentation from providers. In addition, CMS is reprioritizing scheduled program audits and contract-level Risk Adjustment Data Validation (RADV) audits. For example, CMS is suspending RADV activity related to the 2015 payment year audit and will not initiate any additional contract-level audits until after the public health emergency has ended. As part of the suspension, CMS directed Medicare Advantage organizations to immediately suspend soliciting RADV-related medical records from providers. CMS will continue reviewing medical records that already have been submitted, including submissions for the 2014 audit. CMS will announce when normal audit activities will resume after the public health emergency has ended.
Coverage of Testing and Testing-Related Services for COVID-19. The Families First Coronavirus Response Act and the CARES Act prohibit Medicare Advantage organizations from charging enrollees for clinical laboratory tests to detect or diagnose the virus that causes COVID-19, or for the administration of such tests and related services, from March 18, 2020, through the end of the public health emergency. In addition, Medicare Advantage organizations may not impose any PA or other utilization management requirements with respect to the coverage and administration of such tests and related services.
Medicare Advantage (Part C) and Part D Star Ratings — Temporary Relief From Data Collection Requirements
CMS provided temporary relief from several reporting requirements to take some of the administrative burden off healthcare facilities that are overwhelmed with patients.
For the 2020 Star Ratings, CMS is removing the requirement for submission of Healthcare Effectiveness Data and Information Set (HEDIS) for the 2019 measurement year for the Medicare program, and will instead use the HEDIS data based on care delivered in 2018.
CMS also will no longer require the submission of Consumer Assessment of Healthcare Providers & Systems (CAHPS) survey data for 2020, and Part C and D plans can use any CAHPS data collected for their internal quality improvement efforts.
2021 Star Ratings
For the 2021 Star Ratings, CMS will use the HEDIS measures scores and the CAHPS survey data from the 2020 Star Ratings.
For all other measures, the data and measurement period will not change what was finalized in the April 2018 final rule unless the COVID-19 outbreak prevents CMS from having validated data or from calculating the 2021 Star Ratings, in which case CMS would use the Star Ratings from 2020 for 2021.
For new contracts in which the 2021 Star Ratings would be the first year the plans would receive a Star Rating, CMS will treat them as new for an additional year, and they will receive their first rating in 2022.
2022 Star Ratings
For the 2022 Star Ratings, CMS expects Medicare Advantage contracts to submit HEDIS data in June 2021, and Medicare Advantage and Part D contracts to collect CAHPS survey data in 2021.
In response to concerns about overall performance in 2020, CMS is also expanding the “hold harmless rule” for the 2022 Star Ratings to include all contracts at the overall and summary rating levels.
CMS authorized Medicare Administrative Contractors and Qualified Independent Contractors in the fee-for-service program, Medicare Advantage plans and Part D plans, as well as the Part C and Part D Independent Review Entities, to provide additional flexibility with respect to Medicare appeals. For example, these entities are now allowed to grant extensions to file an appeal, waive requirements for timeliness in response to requests for additional information to adjudicate appeals, process appeals with incomplete Appointment of Representation forms, permit Independent Review Entities to process requests for appeal that don’t meet the required elements using information that is available and “to utilize all flexibilities available in the appeal process as if good-cause requirements are satisfied.”
Please contact the authors or any of the McGuireWoods COVID-19 Response Team members for additional information on each of the rule changes listed. CMS is expected to announce supplemental guidance on these regulatory changes, and McGuireWoods will continue to monitor the progress of COVID-19-related legislation and provide updates. McGuireWoods has published additional thought leadership on how companies across various industries can navigate urgent and evolving challenges arising from the COVID-19 pandemic on the McGuireWoods COVID-19: Impact and Insight webpage.
In a series of video alerts, McGuireWoods’ healthcare lawyers address
issues providers face and overcoming COVID-19 challenges.