January 31, 2023
Public Health Emergency Ending Puts CMS Coverage of At-Home COVID-19 Tests in Jeopardy
The announcement last night from the Biden Administration that the COVID-19 Public Health Emergency (PHE) will end on May 11, 2023, brings into sharp focus the need for the Centers for Medicare and Medicaid Services (CMS) to extend the program that covers at-home COVID-19 diagnostic tests for Medicare beneficiaries. CMS previously indicated they intend to end coverage for at-home tests with the conclusion of the PHE.
On April 4, 2022, the Biden-Harris Administration announced that Americans with Medicare Part B, including those enrolled in a Medicare Advantage plan, would have access to Food and Drug Administration (FDA) approved, authorized, or cleared over-the-counter COVID-19 tests at no cost.
CMS established this program using authority available to the agency through 42 U.S. Code § 1395b–1, which authorizes the agency to, among other things, develop and implement projects to test new Medicare payment methods. This authority does not expire at the end of the PHE, but CMS has indicated that it intends to end the demonstration program when the PHE concludes. However, the need for affordable, accessible at-home diagnostic tests will not end on May 11. Currently, the Medicare program offers no alternative coverage for at-home COVID-19 tests.
“CMS’s demonstration program provides a valuable benefit to Medicare beneficiaries that many are utilizing,” said Amy Kelbick, a lobbyist working on the issue. “If CMS decides to end this program, older Americans will have to pay the full cost of at-home tests out-of-pocket.” An analysis of Medicare claims data by McDermott+Consulting shows that 10.6 million at-home COVID-19 tests were distributed to 1.4 million Medicare beneficiaries from April through June of 2022.
Key stakeholders have already weighed in with CMS, asking the Administration to confirm plans and authority to continue the demonstration program beyond the PHE. Congresswoman Anna Eshoo, Ranking Member of the House Energy and Commerce Health Subcommittee, and AARP both sent letters to CMS expressing their support for the program and asking for details on CMS’s authority and plans to continue to make free at-home tests available to Medicare beneficiaries beyond the PHE. A copy of those letters can be found here and here.