UPDATE: Dec. 22, 2021: President Joe Biden on Tuesday laid out his plan to increase the availability of COVID-19 diagnostics, including distributing 500 million free at-home testing kits to Americans, as a surge in omicron cases has continued to put additional stress on an already strained U.S. supply of tests. 

Biden said omicron "spreads easily" and that "it's critically important that we know who's infected" which is why the country urgently needs more testing. "We have to do more. We have to do better — and we will," the president said. "We also need to do better with at-home testing." 

In a shift in strategy, the Biden administration plans to buy 500 million rapid COVID-19 tests and start mailing them next month to those Americans who sign up online for home delivery.

While Biden touted his administration's efforts to bolster the supply of coronavirus tests, including use of the Korean War-era Defense Production Act that allows the president to order private companies to manufacture certain products during national emergencies, he acknowledged "it's not enough." Biden said his administration will continue to use the DPA "to make sure we're producing as many tests and as quickly as possible."

AdvaMed in a written statement on Tuesday said the Biden administration's plan to purchase 500 million COVID-19 tests and make them available for free is an "encouraging next step" but added that more must be done to ensure the availability of diagnostics.

"A consistent, reliable supply of rapid Covid tests is critical to getting our country through to the other side of this pandemic," said AdvaMed CEO Scott Whitaker. "This guaranteed-purchase approach is one of several we have urged this Administration to take."

AdvaMedDx, the AdvaMed division that represents diagnostics manufacturers, along with the American Clinical Laboratory Association sent a letter in September to the White House advocating for a number of policy recommendations for enhancing COVID-19 testing including a "formalized and permanent forum for frequent, real time and meaningful communication and collaboration between the Administration and the diagnostics manufacturers and laboratories."

While Whitaker's statement on Tuesday did not specifically call out Biden's use of the Defense Production Act, the CEO made the case that the federal government "can and should play the pivotal role of guaranteeing the market for these Covid tests going forward, so that our testing supply remains where it needs to be and diagnostics companies know how best to meet demand."

Dive Brief:

• President Joe Biden plans to announce that the federal government will purchase 500 million rapid COVID-19 tests and ship them free to Americans starting in January.
• The White House said the diagnostics procurement is one of a slate of new actions meant to get "ahead of the winter" and prepare for rising coronavirus cases driven by the omicron variant, which is now the dominant strain in the U.S. The Biden administration's plan is to "ensure Americans have access to free testing, including convenient, at-home tests" and to create a website where people can have test kits mailed to them.
• Biden earlier this month announced plans to require private health insurance companies cover the cost of home COVID-19 tests as part of a push to improve access to testing. However, the administration has been under fire for the lack of availability of tests and from health policy experts who questioned why the U.S. wasn't purchasing COVID-19 tests on behalf of all Americans and providing them at little to no cost, as in Europe.

Dive Insight:

Growing U.S. demand for rapid COVID-19 home testing kits is far outpacing supply as coronavirus cases are again surging due to the spread of the highly transmissible omicron variant. Accessing affordable at-home tests has been a challenge since the start of the pandemic, but it's a problem that has only gotten worse in recent weeks due to heightened demand leading up to the holidays.

Biden came into office vowing to make testing cheap and accessible. However, matching supply with demand has been a persistent challenge despite the administration setting 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.

With prices ranging from $7 to $50 per test, Americans have been struggling to access inexpensive kits. While Biden's plan to require private insurance companies to reimburse people for the tests was seen as a step in the right direction, it was criticized for putting the burden on consumers to submit receipts for reimbursement.

Politico reported earlier this month that Biden administration officials concluded it would be too costly and inefficient to send the tests to all Americans for free. Asked during a media briefing why the administration wasn't making free tests widely available, White House press secretary Jen Psaki mocked the idea. "Should we just send one to every American?"

Now, in an apparent reversal, the White House appears to be adopting a more European-style approach to testing with plans to buy half a billion at-home COVID test kits and mail them to people who want them. No dollar figure for the procurement was provided by the administration or which test manufacturers might be involved.

In a speech set for Tuesday, Biden will lay out his plan to increase the availability of free and more convenient test options, including standing up new federal testing sites around the country. The first is slated for New York City, where over the weekend people stood in long lines in the cold for hours to get tested.

Biden is also expected to reaffirm in his speech the administration's commitment to using the Defense Production Act to ensure the U.S. can produce as many COVID-19 tests as quickly as possible.

The White House contends that "just in the last week, the Administration used DPA to ensure that two testing manufacturers have the raw materials and equipment they need to produce as many tests as they can — enabling one company to double its production of lab-based tests, and another to rapidly to scale up production of new over-the-counter and point-of-care tests."