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The Health 202

A newsletter briefing on the health-care policy debate in Washington.

At-home coronavirus tests are still elusive -- and here's why

The Health 202

A newsletter briefing on the health-care policy debate in Washington.

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Hi, it's your Health 202 researcher, Alex. If you like this newsletter, check out the other one I work on, The Climate 202. Also, a bit of housekeeping: We'll be off Monday but back Tuesday.

Dueling drug pricing reports came out this morning and hospitals are suing over surprise billing. But first:

The Biden administration's testing promises aren't panning out yet

President Biden framed testing as a key part of his pandemic response.

Indeed, in the last few months, his administration has shown renewed focus on testing, announcing a $3 billion investment in rapid tests, an expedited regulatory pathway for test approval, and a plan to make private insurers reimburse the cost of tests (although that has come under fire from critics who say it’s overly complicated).

But Americans are still paying a pretty penny for at-home coronavirus tests, which run around $25 for a pack of two — if they can even find one. In contrast, stores in Germany and India sell tests for a few dollars. The United Kingdom provides seven free tests per day to anyone who wants them. Singapore mailed tests to every household.

Tensions over the issue were apparent at the White House earlier this week, when press secretary Jen Psaki responded sarcastically to a question about giving rapid tests to every American – and was met with backlash. “Should we just send one to every American?” she asked. (As our colleague Aaron Blake notes, that's close to what other countries have done.)

Boston Globe reporter Matt Karolian:

Experts point to several reasons behind the U.S. testing challenges, including limited government investment, a stricter regulatory environment compared to other countries and a lack of clear public health messaging. Let's dive in a little deeper:

1. A lack of spending

The United States has failed to invest in and prioritize rapid, at-home tests across two U.S. administrations, according to a Washington Post investigation published yesterday. 

Government subsidies and large purchasing agreements drove testing availability in other countries, a senior administration official told our colleagues.

But the United States got off to a slow start as the Trump administration failed to appreciate the role widespread testing could play in identifying asymptomatic or pre-symptomatic spreaders and disrupting chains of transmission. Later, the Biden administration focused on vaccinations rather than testing as the key to defeating the coronavirus.

Last spring, a group of health officials urged the White House to purchase millions of rapid tests, but the White House never followed up on the proposal, our colleagues Yasmeen Abutaleb, Lena H. Sun, Laurie McGinley, Dan Diamond and Tyler Pager report.

The lack of investment took a toll: As coronavirus cases dropped over the summer, test manufacturer Abbott laid off thousands of workers and destroyed excess test cards, as the New York Times first reported

Biden administration officials defend their approach, pointing to a growth in testing supply and noting over-the-counter tests are just one part of the nation’s testing infrastructure.

2. The regulatory environment

Some public health experts told The Health 202 that the regulatory environment has also contributed to fewer at-home tests in the United States compared with other countries. 

In Europe, at least 46 rapid, at-home antigen tests have been approved. The United States, for its part, has granted emergency use authorization for just 14 tests from 10 manufacturers, according to a database from Arizona State University.

A recent ProPublica investigation found that companies seeking regulatory approval in the United States often faced months-long delays. The report also said that while many European countries adopt similar benchmarks to the United States for tests, they have more flexibility around how trials are conducted.

But an FDA official attributed the discrepancy in testing availability in part to the fact that Europe relies on a self-certification model — a model, the official warned, which could allow low-performing tests on the market. 

The official also disputed that the regulatory environment was a primary reason for the lack of tests, pointing instead to government investment as the main driver. “What matters is the number of tests, not the number of different types of tests,” the official told The Health 202.

3. Federal messaging  

Health officials have been slow to communicate a vision of how to use at-home tests, offering “limited guidance on the role of home or routine testing, as a public health tool,” according to a Kaiser Family Foundation report from last month.

The Centers for Disease Control and Prevention (CDC) released additional guidelines for at-home testing this week, recommending the use of tests before gatherings. Some public health experts say more is needed.

“We should be mailing fistfuls of free tests to every household in the country,” David Paltiel, a health policy professor at Yale School of Public Health, told The Health 202. 

Paltiel’s vision is unlikely to become reality anytime soon.

On Tuesday, White House coronavirus response coordinator Jeff Zients confirmed that mailing out tests to every American was not on the table: “Our approach is not to send everyone a test … independent of their need or desire to get tested,” he said.


Federal regulators authorized booster shots for 16- and 17-year-olds

The FDA authorized booster shots of Pfizer-BioNTech’s coronavirus vaccine for 16- and 17-year-olds amid surging infections from the delta variant in parts of the country and concerns about the emerging threat from omicron, The Post’s Laurie McGinley, Katie Shepherd and Lena H. Sun report.

CDC Director Rochelle Walensky endorsed the move, which came a day after the vaccine makers released new data suggesting boosters could play a key role in protecting against the omicron variant by raising the level of virus-fighting antibodies.

Another booster dose? Albert Bourla, Pfizer’s chief executive, told CNBC’s “Squawk Box” that people may need a fourth shot, possibly one targeting the omicron variant, sooner than expected. Bourla had previously projected that a fourth dose might be needed 12 months after the third shot.

On the Hill

Averted: The Senate adopted a bipartisan deal staving off several Medicare cuts amid a push from physician groups over recent weeks. Earlier Thursday, 14 Republicans helped advance the measure, which also paves the way for lawmakers to raise the debt ceiling, our colleague Tony Romm reports.

Out this morning: Dueling drug pricing reports

The drug industry relies on pricing practices that are “unsustainable, unjustified and unfair,” according to findings from a nearly three-year investigation by House Oversight Committee Democrats. The companies the committees studied raised prices of common brand-name drugs over the past five years by nearly four times the rate of inflation.

  • “The report seeks to debunk industry contentions that companies’ price strategy is needed to plow money back into researching and developing new medicines, finding that revenue is substantially greater than those investments,” our colleague Amy Goldstein writes.

The panel’s Republicans released their own drug-industry report based on a less exhaustive look at pharmaceutical benefit managers.

  • The middlemen “use their market leverage to increase their profits, not reduce costs for consumers,” the 19-page GOP report contends.

First in The Health 202: Two top Democrats seek action to ensure birth control is free.

The move comes from Senate HELP Committee Chair Patty Murray (D-Wash.) and Senate Finance Committee Chair Ron Wyden (D-Ore.). The pair say they’ve heard “alarming reports” that insurers aren’t abiding by the Affordable Care Act’s contraceptive coverage protections — and in a letter to the Biden administration, urged three federal departments to issue new guidance for payers providing free coverage of birth control. They’re also urging action against any insurer flouting the rules. 

  • In letters shared with The Health 202, several insurers wrote that patients needed to try to fail other birth control options before they’d cover the method the person was seeking.
  • Despite Obamacare’s guarantee of free birth control, there are gaps. Insurers don’t have to cover every single contraceptive, and new ones aren’t automatically put on the federal list that guides plans’ coverage decisions, Kaiser Health News reported this summer.

Agency alert

Tabak was named acting NIH director

Lawrence Tabak, the second-in-command at the National Institutes of Health, will assume the role on Dec. 20 as longtime director Francis Collins steps down from his post. 

Tabak has served as NIH’s principal deputy director and deputy ethics counselor since 2010. Before that, he served as the director of the National Institute of Dental and Craniofacial Research. The appointment was announced by Health and Human Services Secretary Xavier Becerra, who said the department would be “in capable hands” during the search for Collins’s successor. 

Reproductive wars

A new Texas abortion ruling: The enforcement mechanism for Texas’s abortion ban, which is the most restrictive in the nation, violates the state constitution, a state judge ruled yesterday, our colleagues Meryl Kornfield and Reis Thebault write.

It’s a victory for abortion rights advocates. However, the ruling by District Judge David Peeples doesn’t include an injunction against the law, which charges private citizens with enforcing it. 

Meanwhile, the Supreme Court heard arguments about the Texas law last month, but hasn’t yet made a decision. The high court seemed willing to allow a challenge by abortion providers to a ban on most abortions after six weeks. 

In the courts

The surprise billing wars continue: The major hospital and doctor lobbies are suing the administration over its surprise billing rules less than a month before the regulations are set to go into effect. 

The move is another salvo in the years-long lobbying war over how to resolve payment disputes among providers and insurers, since neither industry wants to pick up the bulk of the cost. 

What happened: The American Medical Association and the American Hospital Association contend the administration didn’t adhere to Congress’ intent when drafting the law’s regulations. 

  • Meditators help resolve payment disputes when providers and insurers can’t agree.
  • The rule generally pegged the winning amount to the plan’s median in-network rate for a similar service in that geographic area — and that’s the aspect of the rule providers are challenging.
  • The trade groups said the lawsuit shouldn’t prevent surprise bill protections from kicking in Jan. 1.

Meanwhile … over 60 organizations — such as unions, employer and patient groups — have urged the Biden administration to implement the new law as is. Complicating matters, some lawmakers drafting the surprise billing laws, which passed last year, said the administration’s rule adhered to Congress’ intent, while others said it didn’t. 

Quote of the week

In other health news

How Nursing Homes’ Worst Offenses Are Hidden From the Public (The New York Times | Robert Gebeloff, Katie Thomas and Jessica Silver-Greenberg)

Long covid is destroying careers, leaving economic distress in its wake (Christopher Rowland)

Sugar rush

Thanks for reading! See y'all tomorrow.