Dive Brief:

• The Biden administration announced Thursday it is set to require private health insurance companies to cover the cost of at-home COVID-19 tests as part of a push to improve access to testing.
• The Departments of Health and Human Services, Labor and Treasury will issue guidance by Jan. 15 to clarify that the 150 million Americans with private health insurance can seek reimbursement for coronavirus tests they buy over the counter. Test makers such as Abbott Laboratories, Becton Dickinson and Quidel could see demand increase as costs for consumers become reimbursable. The White House is also doubling distribution of free at-home COVID-19 tests to uninsured and underserved communities. 
• The actions follow reports about the difficulty of finding inexpensive at-home coronavirus tests in the U.S., which was slower to make rapid antigen kits widely available than European countries. AdvaMed in a statement commended the Biden administration for increasing access to the diagnostics. However, some health policy experts have questioned why the U.S. does not purchase COVID-19 tests on behalf of all Americans and provide them at little to no cost, as in Europe. 

Dive Insight:

President Joe Biden has put improved access to rapid antigen tests at the heart of his COVID-19 strategy, marking a shift from the approach of the Trump Administration. The White House set aside $2 billion for purchases of rapid antigen tests for U.S. schools, health centers and food banks, as well as an additional $1 billion to procure at-home tests. Yet, consumers are still struggling to access cheap kits, with prices reportedly ranging from $7 to $50 per test.

Speaking at the National Institutes of Health on Thursday, Biden outlined the changes since he took office, noting that the number of at-home tests has risen from zero to eight, while acknowledging that problems remain. 

"It still isn't good enough, in my view. That's why I am announcing that health insurers must cover the cost of at-home testing. Now, for those not covered by private insurance, we're going to make available free tests at thousands of convenient locations — locations for folks to pick them up and take a test kit home. The bottom line: This winter, you'll be able to test for free in the comfort of your home and have some peace of mind," Biden said.

As Biden explained, the initiative has two components. People with private insurance will be able to claim OTC, at-home COVID-19 kits on their insurance, as they already can with no cost sharing for tests covered in physician offices, pharmacies and clinics. 

Details of exactly how the system will work will emerge when HHS, Labor and the Treasury issue guidance on the topic, which is set to happen by Jan 15. For now, the only other information provided by the White House is that workplace screening will remain consistent with current guidance.

The second piece of the strategy targets people without private insurance. Biden previously vowed to distribute 25 million free tests to neighborhood sites such as health centers. The President has now upped that commitment to 50 million tests and expanded the program to cover rural clinics. The White House will work with "trusted community providers" to get the kits to where they are needed. 

The U.S. is stepping up access to free rapid antigen tests at a time when other countries are ending similar programs. While tests remain available for free in the U.K., Germany stopped subsidizing free antigen tests last month because all citizens had been offered vaccines. It is unclear whether the rise of omicron, which may render vaccines less effective, will lead Germany to rethink its decision.

Demand for rapid tests rose significantly, particularly in the U.S. as the delta variant spread. The Biden administration's latest testing plan comes amid reports that the new omicron variant has been identified in multiple states.

FDA this week said it expects polymerase chain reaction and rapid antigen tests used in the U.S. to be able to detect the omicron variant but is continuing to monitor the situation after completing a preliminary review. Test makers including Abbott, BD, Hologic, Quidel and Thermo Fisher Scientific have all expressed confidence that their diagnostics will be able to detect omicron.