As stated in our blog post of January 11, 2022 and alert, the Department of Labour, Department of Health and Human Services, and Treasury (the “Agencies”) issued Part 51 of the FAQs on January 10, 2022, requiring group health plans to cover COVID over-the-counter (“OTC”) -19 tests at no cost to participants, without prior authorization or medical coverage. In response to stakeholder feedback on FAQ 51, agencies have published FAQ 52 on February 4, 2022. The new guidelines provide additional flexibility to comply with Safe Harbor that allows plans offering direct coverage for tests obtained from network pharmacies and a direct-to-consumer program to limit reimbursement of tests purchased from non-preferred pharmacies or retailers at $12 per test (“$12 Safe Harbor”), and responds to other questions from stakeholders regarding mandatory OTC COVID-19 test coverage.
$12 Safe Harbor Tips
Effective February 4, 2022, the $12 safe harbor has been clarified as follows:
- To comply with the Safe Harbor requirement that the direct coverage program provide adequate access (based on facts and circumstances), OTC COVID-19 tests must generally be made available through “at least one direct-to-consumer shipping mechanism and at least one in-person mechanism. The Agencies have recognized, however, that there may be limited circumstances in which a direct program could provide adequate access without providing both a direct-to-client mechanism and an in-person mechanism.
- A “direct-to-consumer shipping mechanism” includes programs that provide direct testing coverage without requiring plan members to obtain the OTC COVID-19 test in person. Examples include ordering online or over the phone, and may be provided through a pharmacy or retailer, the plan or health insurance issuer directly, or any other entity on behalf of the plan. .
- Reasonable shipping costs related to OTC COVID-19 testing should be covered by the plan or issuer. Shipping costs are included in the $12 refund limit.
- An insurance plan or issuer is bound to comply with the $12 safe harbor if it is temporarily unable to provide adequate access to OTC COVID-19 testing through its direct coverage program due to of a supply shortage.
- The plan or issuer is not required to cover all FDA-approved OTC COVID-19 tests under its direct coverage program to satisfy the adequate access requirement.
The directives of February 4, 2022 also provided the following clarifications:
- The requirement to provide OTC testing without participant cost sharing, prior authorization or medical management, described in FAQs Part 51 and Part 52, does not apply to OTC COVID-19 home testing that requires a laboratory or another health care provider to treat the results.
- An insurance plan or issuer may prohibit reimbursement for tests purchased from individuals or online auctions, limit reimbursement to established retailers who typically sell COVID-19 tests over-the-counter, and establish other reasonable policies to prevent fraud and problematic behavior that could limit access to trials.
- A participant cannot double up if the medical plan reimburses the participant for OTC COVID-19 testing and be reimbursed from a Health Flexible Spending Account (FSA), Health Savings Account (HSA), or Health Reimbursement Account (HRA). If a participant is reimbursed by both the medical plan and an FSA or HRA, the participant should contact the plan administrator regarding corrective procedures.