Coronavirus antibody testing must be covered free of charge, feds say
Washington — Tests to detect antibodies in people who have previously been infected by the coronavirus must be covered free of charge under health insurance plans and Medicaid, according to new guidance quietly issued by the Trump administration.
In a document dated April 11 explaining the implementation of two pieces of legislation signed into law last month, the Departments of Labor, Health and Human Services and Treasury said the Food and Drug Administration has determined that serology testing for antibodies should be considered an "in vitro diagnostic test" and treated the same as tests to detect the virus itself.
"FDA has advised the Departments that serological tests for COVID-19 meet the definition of an in vitro diagnostic product for the detection of SARS-CoV-2," the departments said, using the coronavirus' scientific name. "Therefore, plans and issuers must provide coverage for a serological test for COVID-19 that otherwise meets the requirements of" the Families First Coronavirus Response Act (FFCRA) and the CARES Act, both of which established free diagnostic testing. The FDA did not immediately respond to a request for comment on Monday.
Antibodies are proteins produced by white blood cells to fight viral infections and remain detectable once a patient has successfully beaten the virus. Many people who are infected with the coronavirus never develop symptoms but can still transmit it to others, a factor that has contributed to the virus' rapid spread around the world.
While research about the antibodies is still in its infancy, public health experts say serology tests will be crucial for understanding how extensively the virus has spread among the population. Patients who have recovered from the virus also likely have some level of immunity from reinfection, at least for a period of time. Identifying who is immune could be key to gradually lifting lockdowns and stay-at-home orders, as those who have had the virus could safely begin returning to work or school.
In order to do that, however, widespread access to antibody testing would be needed. The two bills passed by Congress and signed into law in March said diagnostic testing for the coronavirus itself must be covered free of charge, but didn't explicitly say the same regarding serology tests, leading to uncertainty among insurers, providers and patients.
The new federal guidance says the relevant sections of the FFCRA and the CARES Act that waive cost-sharing for diagnostic testing — copays, coinsurance and deductibles, in or out of network — also apply to antibody tests.
Even before the laws passed, the nation's largest health insurance companies committed to waiving cost-sharing for testing and some did the same for treatment, but whether they would cover serology tests was uncertain. Spokespeople from several insurers were unable to tell CBS News whether they would cover claims for serology testing in full before the new guidance required them to do so.
The laws established that those without health insurance can get tested for free under Medicaid, and the Trump administration has said it will tap into a $100 billion fund established by the CARES Act to reimburse hospitals and providers that treat the uninsured.
The development of reliable antibody testing is still in the early stages, and the White House has called on private companies to accelerate their efforts.
The FDA loosened restrictions on certain tests in March to make them available to patients without prior approval, and said last week that more than 70 manufacturers have notified the agency that they have tests available. However, the FDA warned that some companies "are falsely claiming that their serological tests are FDA approved or authorized, or falsely claiming that they can diagnose COVID-19."
The agency has only approved one test for emergency use, green-lighting a test two weeks ago that takes about 10 minutes to return results. President Trump said on Friday that the administration is working to get new tests "approved very quickly."
"The NIH, CDC, and FDA are currently validating these antibody tests to ensure that they are accurate, and they're doing that at breakneck speed," the president said at the White House on Friday. "When validated, we're confident that the production will scale up to tens of millions of tests very quickly."