On January 10, 2022, the U.S. Department of Health & Human Services, Department of Labor, and the Treasury (“Tri-Agencies”) published guidance about how health plans and health insurance issuers must reimburse OTC COVID-19 tests. , the Biden Administration explained that health plans and health insurance issuers (meaning the commercial insurance market) would be required to reimburse individuals who purchase OTC COVID-19 tests during the public health emergency. The Administration directed the Tri-Agencies to issue guidance by January 15, 2022 detailing how to effectuate this expanded coverage of COVID-19 diagnostic testing. Yesterday, the Tri-Agencies published FAQ 51 which requires health plans and health insurance issuers to cover no less than 8 tests per 30-day period per individual beneficiary beginning January 15, 2022.
The guidance relies on the existing authority under FFCRA § 6001 (as amended by CARES Act § 3201) to require health plans and health insurance issuers to cover consumer-purchased, at-home COVID-19 diagnostic testing. That law broadly requires coverage of any COVID-19 diagnostic testing that has been approved, cleared, or authorized by FDA or for which the developer has requested emergency use authorization and tests authorized and used by a state to diagnose patients. This coverage mandate prohibits the application of cost sharing, prior authorization, or other medical management requirements. Cares Act Section 3202 generally requires plans and...
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