FAQ Part 51: Coverage Updates: COVID-19 Tests, Colonoscopies, and Contraception

The Departments of Labor, Health and Human Services (HHS), and the Treasury (collectively, the Departments) have issued Part 51 of its FAQs dealing with three areas of concern for health plans and health insurance issuers.  The FAQs address:

• Coverage of over-the-counter (OTC) COVID-19 tests.
• Coverage of colonoscopies as preventive care.
• Coverage of contraceptives.

(1) Coverage of OTC COVID-19 Tests

Beginning January 15, 2022, health plans and health insurance issuers (collectively, Plans) must cover certain OTC COVID-19 tests without cost-sharing, prior authorization, or other medical management requirements.  This applies to tests that may be purchased by individuals without a prescription or individualized clinical assessment from a health care provider.

• Plans may require participants to submit a claim for reimbursement,  but are strongly encouraged to provide direct coverage by reimbursing sellers directly without requiring participants to incur any upfront costs.
• If a Plan does not have a network of providers, the Plan must reimburse for the actual cost the test.
• Plans that do have a network may not limit coverage to tests purchased through its network of preferred providers or retailers, but may limit payment to out-of-network providers to $12 per test.
• Some OTC COVID-19 tests are sold in packages containing more than one test.  If a Plan limits reimbursement for OTC COVID-19 tests from non-preferred sellers, pharmacies, or retailers to $12 per test, the Plan must calculate the reimbursement based on the number of tests in a package.
• Plans may limit the number of OTC COVID-19 tests covered for each covered person to no less than 8 tests per 30-day period (or per calendar month).  Each test in a package containing multiple tests counts as one test.
• Plans are not required to cover tests that are required for employment purposes.

Although Plans may not impose medical management limits on the purchase of tests, it may act to prevent fraud and abuse provided that those steps do not create significant barriers for participants.

• For example, a Plan or issuer could require an attestation, such as a signature on a brief attestation document, that the OTC COVID-19 test was purchased for the personal use of a covered person, not for employment purposes, has not been (and will not be) reimbursed by another source, and is not for resale.
• In contrast, a Plan could not require an individual to submit multiple documents or involve numerous steps that unduly delay a participant’s access to, or reimbursement for, OTC COVID-19 tests.
• Likewise, a Plan may require reasonable documentation of proof of purchase with a claim for reimbursement for the cost of an OTC COVID-19 test.  Examples of such documentation could include the UPC code for the OTC COVID-19 test to verify that the item is one for which coverage is required and/or a receipt from the seller of the test, documenting the date of purchase and the price of the OTC COVID-19 test.

Previous guidance regarding notice of modification of the Plan’s terms continues to apply.  This means that a Plan would not have to give notice of Plan changes though an amended summary of benefits and coverage 60 days prior to the effective date, provided that it gives notice as soon as reasonably practicable.

(2) Coverage of Preventive Services

Non-grandfathered health plans and issuers are required to cover certain preventive services without imposition of cost-sharing requirements.  This includes those services that have in effect a rating of “A” or “B” in the current recommendations of the United States Preventive Services Task Force (USPSTF) with respect to the individual involved.  This includes colonoscopies for adults within specified age ranges.

The FAQ provides that the requirement to cover colonoscopies includes those performed after positive non-invasive stool-based screening test or direct visualization screening test for colorectal cancer.

This requirement is effective for plan years beginning on of after May 31, 2022.

(3) Coverage of Contraceptive Products

Health plans and issuers are required to cover the full range of FDA-approved contraceptive methods including, but not limited to, barrier methods, hormonal methods, and implanted devices, as well as patient education and counseling, as prescribed by a health care provider.  (Plans maintained by employers with religious or moral objections to contraceptive methods may not have to comply with this requirement.)

The FAQ notes that the Departments have received numerous complaints about practices that may violate the contraceptive coverage rules.  The FAQ notes several practices that are problematic:

• Denying coverage for all or particular brand name contraceptives, even after the individual’s attending provider determines and communicates to the Plan that a particular service or FDA-approved, cleared, or granted contraceptive product is medically necessary with respect to that individual.
• Requiring individuals to fail first using numerous other services or FDA-approved, cleared, or granted contraceptive products within the same method of contraception before the plan or issuer will approve coverage for the service or FDA-approved, cleared, or granted contraceptive product that is medically appropriate for the individual, as determined by the individual’s attending health care provider.
• Requiring individuals to fail first using other services or FDA-approved, cleared, or granted contraceptive products in other contraceptive methods before the Plan will approve coverage for a service or FDA-approved, cleared, or granted contraceptive product in the contraceptive method that is medically appropriate for the individual, as determined by the individual’s attending health care provider.
• Failing to provide an easily accessible, transparent, and sufficiently expedient exception process that is not unduly burdensome (for example, requiring individuals to appeal an adverse benefit determination using the Plan’s internal claims and appeals process as the means to obtain an exception).

The Departments note they are actively investigating complaints regarding these types of practices and may take enforcement or other corrective actions.