"On January 10, 2022, the Departments issued [FAQs Part 51, which] clarified that the requirement to cover COVID-19 diagnostic tests under section 6001 of the FFCRA applies with respect to over-the-counter (OTC) COVID-19 tests available without a prescription or individualized clinical assessment from a health care provider. Plans and issuers must provide coverage for such tests without cost-sharing requirements, prior authorization, or other medical management requirements in accordance with section 6001 of the FFCRA with respect to such tests purchased on or after January 15, 2022, during the public health emergency.

"FAQs Part 51 also established two safe harbors intended to facilitate consumer access without cost sharing to OTC COVID-19 tests available without an order or individualized clinical assessment by a health care provider that meet the statutory criteria under section 6001(a)(1) of the FFCRA....

"The Departments have received a number of questions from stakeholders regarding FAQs Part 51. These FAQs Part 52 modify the safe harbor in FAQs Part 51, Q2 in certain respects and further clarify the coverage requirements during the public health emergency related to coverage of OTC COVID-19 tests available without an order or individualized clinical assessment by a health care provider in response to those questions....

• Q1: Do plans and issuers have flexibility in how they establish a direct-to-consumer shipping program and direct coverage through an in-person network in order to qualify for the safe harbor established in FAQs Part 51, Q2?....
• Q2: Will the Departments take enforcement action against a plan or issuer that is temporarily unable to provide adequate access to OTC COVID-19 tests through its direct coverage program due to a supply shortage?....
• Q3: Is a plan or issuer permitted to address suspected fraud and abuse related to the reimbursement of OTC COVID-19 tests purchased by a participant, beneficiary, or enrollee from a private individual or via online auctions, resale marketplaces, or resellers?....
• Q4: Do the coverage requirements specified in FAQs Part 51 apply to COVID-19 tests that use a self-collected sample but require processing by a laboratory or other health care provider to return results (such as home-collection PCR tests that can be purchased directly by consumers)?....
• Q5: How does a plan's or issuer's coverage of OTC COVID-19 tests impact health flexible spending arrangements and similar account-based plans?"

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