COVID-19 AT-HOME/OTC DIAGNOSTIC TESTS

COVID-19 At-Home/OTC Diagnostic Tests

On January 10, 2022, federal regulators issued regulatory guidance in FAQs (Part 51) regarding mandatory coverage of at home or over-the-counter COVID-19 diagnostic testing purchased on or after January 15, 2022, during the public health emergency.

Coverage Of Diagnostic COVID-19 At Home or Over-The-Counter Tests Without a Physician Order
Group health plans and insurers (collectively, “plans”)¹ must provide coverage without cost-sharing, prior authorization or other medical management requirements of over-the-counter diagnostic COVID-19 tests that meet statutory criteria² (OTC COVID-19 tests) without an order or individualized clinical assessment by a health care provider when purchased on or after January 15, 2022 during the public health emergency. This does not require plans to cover testing for employment purposes.

No Direct Coverage Required
The guidance and the statutory mandate does not require the plan to reimburse sellers of OTC COVID-19 tests directly (referred to as “direct coverage”). Instead, the plan may require participants, who purchases an OTC COVID-19 test, to submit a claim for reimbursement to the plan.

If Plan Provides Direct Coverage, Plan Can Limit Out-of-Network Reimbursement to $12 per Test
Under a safe harbor explained below, Plans cannot limit coverage to only tests that are provided through preferred pharmacies or other retailers; however, a plan can limit reimbursement.
Plans can arrange and provide coverage of OTC COVID-19 tests purchased by participants during the public health emergency by arranging for direct coverage of such tests purchased through:

1. its pharmacy network and
2. a direct-to-consumer shipping program (mail order), and
3. limit reimbursement for OTC COVID-19 tests from non-preferred pharmacies or other retailers to no less than the actual price or $12 per test (whichever is lower).

Under this safe harbor, the direct-to-consumer shipping program may be provided through one or more in-network provider(s) or another entity designated by the plan.

Direct coverage means the participant is not required to seek reimbursement post-purchase; instead, the plan processes payment to the pharmacy network or retailer directly with no upfront out-of-pocket payment by the participant. Plans may not impose any prior authorization or medical management requirements. The plan has to take reasonable steps to ensure that participants have adequate access to OTC COVID-19 tests through an adequate number of retail locations (including in-person and online locations), and are made aware of key information such as dates of availability of the direct coverage program and participating retailers or other locations.

This safe-harbor applies only to coverage of OTC COVID-19 tests that are administered without a provider’s involvement or prescription; plans must continue to provide coverage for COVID-19 tests administered with a provider’s involvement or prescription as required by law, even when relying on this safe harbor.

Plans Can Limit Number or Frequency of OTC COVID-19 Tests to 8 Tests Per 30 days or Calendar Month
A Plan can limit the number or frequency of OTC COVID-19 tests covered for each participant to no less than 8 tests per 30-day period or calendar month. It cannot limit participants to a smaller number of such tests over a shorter period i.e. 4 tests per 15-day period. Such limit only applies to OTC COVID-19 tests, and not tests involving a provider or a prescription.

Permissible Activities if Plan Suspects Fraud or Abuse
Although medical management of coverage for COVID-19 diagnostic testing is prohibited, plans may act to prevent, detect, and address fraud and abuse as follows:

1. A plan can require an attestation, such as a signature or a brief attestation documenting that the OTC COVID-19 test was purchased by the participant for personal use, not for employment purposes, has not been (and will not be) reimbursed by another source, and is not for resale. However, plans are prohibited from requiring an individual to submit multiple documents or take numerous steps that unduly delay a participant’s access to or reimbursement for OTC COVID-19 tests.
2. A plan may require reasonable documentation of proof of purchase with a claim for reimbursement. 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 by statute, and/or a receipt from the seller, documenting the date of purchase and the price of the OTC COVID-19 test.

Amending Plan Documents to Address The Guidance
Previously issued FAQs Part 42, Q9 which permitted plans to amend the terms of a plan document to add benefits or reduce or eliminate cost sharing, for the diagnosis and treatment of COVID-19 prior to satisfying any applicable notice-of-modification requirements and without regard to otherwise restrictions on mid-year changes, continue to apply with respect to changes made to comply with the guidance regarding OTC COVID-19 tests.

How Plans Can Facilitate Access to, Effective Use of OTC COVID-19 Tests
Plans may provide education and information to support participants seeking OTC COVID-19 testing as long as such resources make clear that the plan provides coverage for, including reimbursement of all OTC COVID-19 tests that meet statutory criteria (subject to the safe harbors listed above) and such information is consistent with the test’s emergency use authorization (EUA), including:

1. Guidance to support efforts to access and effectively use OTC COVID-19 tests and information explaining the different between such tests and tests performed or ordered by a health care provider and/or processed in a lab (including when different types of COVID-19 tests are appropriate based on guidance from scientific entities like the FDA, the National Institutes of Health, and the Centers for Disease Control and Prevention (CDC);
2. Quality information (including shelf life and expiration dates) for specific OTC COVID-19 testing products, or information about reliability of OTC COVID-19 test results, such as information from the test’s labeling or EUA summary about the expected test performance (i.e. rates of false positives/negatives) of specific tests and active recalls of FDA-authorized, cleared or approved OTC COVID-19 tests;
3. How to obtain OTC COVID-19 tests directly from the plan or designated sellers; and
4. How to submit a claim for reimbursement and the documentation that must be included.

¹ Group health plans (includes self-funded ERISA and non-ERISA plans), and a health insurer offering group or individual health insurance coverage (including a grandfathered health plan); excludes group health plans that do not cover at least two employees who are current employees (i.e. retiree-only plans) and excepted benefit plans.
² Section 6001(a)(1) of the Families First Coronavirus Response Act (FFCRA) as amended by the section 3201 of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), describes in vitro diagnostic tests for the detention of SARS-Co-V-2 or the diagnosis of COVID-19 that (A) are approved, cleared, or authorized under the section 510(k), 513, 414, or 564 of the Federal Food, Drug and Cosmetic Act (FFDCA); (B) the developer has requested or intends to request, emergency use authorization under Section 564 of the FFDCA, unless and until the emergency use authorization request under such Section 564 has been denied or the developer of such test does not submit a request under such section within a reasonable timeframe; (C) are developed in and authorized by a state that has notified the Secretary of HHS of its intention to review tests intended to diagnose COVID-19; or (D) are other tests that the Secretary of HHS determines appropriate in guidance.