NEW YORK – The Centers for Medicare and Medicaid Services and the US Departments of Labor and the Treasury on Saturday issued guidance requiring private health insurance to cover, at no cost, diagnostic testing for SARS-CoV-2, the coronavirus that causes COVID-19.
The guidance covers molecular-based testing, as well as serology tests.
Under the guidance, group health plans and group and individual health insurers must cover diagnostic testing and "certain related items and services" during a medical visit without any cost sharing.
It is unclear if the guidance covers testing for patients who are uninsured.
Urgent care visits, emergency room visits, and in-person and telehealth visits to a doctor's office resulting in a coronavirus test are covered as part of the guidance, which includes all FDA-authorized coronavirus tests, tests that developers have requested authorization for on an emergency basis, and diagnostic tests developed in and authorized by states.
Notably, the guidance includes coverage for antibody-based coronavirus serology tests. While questions remain about the use of such tests for diagnosing disease, they can provide information about who has been exposed to SARS-CoV-2, even if an individual never develops any symptoms, and assessing how widespread the coronavirus is.
To date, only one SARS-CoV-2 immunoassay test, from Cellex, has received Emergency Use Authorization from the US Food and Drug Administration.
The CMS said in a statement on Saturday that once an antibody-based test for the coronavirus is broadly available, it "could become a key element in fighting the pandemic by providing a more accurate measure of how many people have been infected and potentially enabling Americans to get back to work more quickly."
On Friday, the US National Institutes of Health announced it has begun recruiting volunteers for a study to determine how many Americans have antibodies to the coronavirus. The study will use serology tests.