Following is newly issued guidance on requirements for coverage by Federal Employees Health Benefits program carriers for Coronavirus testing, vaccines and therapeutics.
On January 10, 2022, the Departments of Labor, Health and Human Services, and the Treasury (collectively, the Departments) issued Frequently Asked Questions (FAQs) Part 51, which provides clarifying guidance about requirements for coverage of COVID-19 tests available over-the-counter (OTC) under section 6001 of the Families First Coronavirus Response Act (FFCRA) for individualized diagnosis or treatment. OPM is directing Carriers to follow the Departments’ guidance in providing coverage of OTC COVID-19 tests through FEHB plans. Specifically, Carriers must cover OTC COVID-19 tests that meet the statutory criteria under section 6001(a)(1) of the FFCRA, including tests that have been authorized, cleared, or approved for use without the involvement of a health care provider. Consistent with section 6001 of the FFCRA, this coverage must be provided without imposing any cost-sharing requirements, prior authorization, or other medical management requirements. It remains the case that FEHB plans are not required to provide coverage of testing (including an OTC COVID-19 test) that is for employment purposes.
OPM recognizes that FEHB covered individuals may benefit from education, as well as other forms of consumer support, in order to access and use OTC COVID-19 tests as intended. Carriers must provide education and information resources to support FEHB covered individuals seeking OTC COVID-19 testing, including how to obtain OTC COVID-19 tests directly from their FEHB plan or designated sellers. This should include efforts such as prominently posting pertinent information to their websites, or direct communication by email or other means generally used by the Carrier to reach covered individuals.
Consistent with FEHB Carrier Letters 2020-08 and 2020-19, Carriers must immediately cover, without cost sharing, any COVID-19 vaccine once the U.S. Food and Drug Administration (FDA) authorizes it under an Emergency Use Authorization (EUA) or approves it under a Biological License Application (BLA). Likewise, once a COVID-19 vaccine’s EUA or BLA is amended, Carriers must immediately cover any expanded scope including administration of an additional dose to certain individuals; administration of booster doses; or the expansion of the age demographic for whom the vaccine is authorized or approved. This aligns with the answer to Question 1 in FAQs Part 50, jointly issued by the Departments on October 4, 2021.
A. Rapid Coverage of Therapeutics
The range of COVID-19 therapeutics available for treatment, pre-exposure prevention and post exposure prophylaxis continues to expand as drugs in the clinical pipeline are approved or authorized by the FDA. Consistent with Carrier Letters 2021-02 and 2020-02, OPM expects that if applicable, Carriers will rapidly review and approve COVID-19 therapeutics, including any monoclonal antibody therapeutics or oral antiviral medications that are authorized or approved by the FDA.
B. Pharmacy Access to Therapeutics
On September 14, 2021, HHS issued a Ninth Amendment to Declaration Under the Public Readiness and Emergency Preparedness (PREP) Act for Medical Countermeasures Against COVID-19 (“Ninth Amendment”). The Ninth Amendment provides liability immunity to and expands the scope of authority for:
1. Licensed pharmacists to order and administer select COVID-19 therapeutics, including subcutaneous monoclonal antibodies, and
2. Qualified pharmacy technicians and licensed or registered pharmacy interns to administer those select COVID-19 therapeutics.
3. The Ninth Amendment addresses select COVID-19 therapeutics given orally, subcutaneously, or intramuscularly, that are approved, authorized, or licensed by the FDA.
4. OPM expects Carriers to provide reimbursement for the assessment and administration of select COVID-19 therapeutics by qualified medical providers including licensed pharmacists, qualified pharmacy technicians and licensed or registered pharmacy interns, where the criteria of the Ninth Amendment are met.