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Administration Posed to Expand COVID Testing Insurance Coverage Mandate

The Biden Administration recently announced plans to require commercial insurers to cover over-the-counter and at-home COVID-19 tests. Commercial insurers are currently required to cover in vitro diagnostic (IVD) products that test for COVID-19. Most often, this has taken the form of clinical laboratory testing wherein the lab or other provider submits a claim to the insurer for reimbursement. However, many providers have encountered pushback from insurers, usually based on the unclear criteria of the current mandate. More guidance is due to be released on January 15, 2022.

Currently, commercial insurers are required by the Families First Coronavirus Response Act (FFCRA) and the CARES Act to cover, without cost-sharing requirements, IVD products for the detection of SARS–CoV–2 or the diagnosis of the virus that causes COVID–19 that are approved by the Food and Drug Administration or otherwise authorized. The implementation of this coverage mandate is governed by guidance jointly released by the Departments of Health and Human Services (HHS), Labor (DOL), and Transportation (DOT).

In general, this guidance requires that the test be covered where it is medically appropriate for the individual, as determined by the individual’s attending healthcare provider in an “individualized clinical assessment,” consulting CDC guidelines as appropriate and in accordance with accepted standards of current medical practice. The provider need not be the patient’s attending provider as long as they are authorized and acting within the scope of their license. The insurer is then required to cover the test without prior authorization, the presence of symptoms, or other medical management criteria. Where the patient seeks a test from a licensed or authorized provider, insurers are generally required to assume that the test reflects an “individualized clinical assessment” and cover the test. On the other hand, under the mandate, insurers are not required to cover testing for back to work/school purposes or for general screening. Testing for travel-relating purposes may be covered under the mandate, depending on the circumstances, but is often a matter of contentious debate that thus far has not been resolved by federal guidance.

When Congress enacted the coverage mandate, it did not provide funding and left it to the insurers to bear the cost of covering these COVID-19 test. Clinical labs who have billed insurers have received uneven responses, with some insurers accepting the new mandate and paying claims under it and others attempting to defeat coverage, often by using the unclear criteria of an “individualized clinical assessment” or the interaction with state law.

Under the expansion of the coverage mandate to over-the-counter and at-home COVID-19 tests, individual patients will be required to seek reimbursement from insurers themselves.  Patients may encounter many of the same difficulties in securing reimbursement as providers have encountered. Guidance on the expansion of the coverage mandate is due to be released January 15, 2022. It is unclear if the January 15, 2022 guidance will address or resolve any of the issues currently facing providers.

For over 35 years, Wachler & Associates has represented healthcare providers and suppliers nationwide in a variety of health law matters, and our attorneys can assist providers and suppliers in understanding the COVID-19 testing coverage mandate. If you or your healthcare entity has any questions pertaining to healthcare compliance, please contact an experienced healthcare attorney at 248-544-0888 or

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