HEALTH CARE BRIEFING: U.S. Opens Covid Test Orders Before Launch

The Biden administration’s program to send free Covid-19 tests to U.S. households informally launched yesterday to prepare for its official rollout today.

The site to request tests, CovidTests.gov, is operating at limited capacity to take orders. The early launch is standard practice to troubleshoot, White House Press Secretary Jen Psaki said yesterday. “As you know, every website launch in our view comes with risks. We can’t guarantee there won’t be a bug or two,” Psaki said. “But the best tech teams across the administration and the Postal Service are working hard to make this a success.”

Households that place orders through the website or a phone line will each receive four kits, the administration said last week. The U.S. Postal Service will deliver the tests and expects the initial requests to be delivered in seven to 12 days.

Some issues began surfacing yesterday. Some users reported the ability to add Box #1, to an address, apparently infinitely, to order more than four tests. Others say the system is flagging some residential addresses as business addresses and denying requests.

The tests in the program are from the 500-million-test order approved by President Joe Biden in December. Last week, Biden said the administration is acquiring an additional 500 million tests. The moves came as the fast-spreading omicron variant has caused demand for testing kits to surge, leaving many Americans facing long lines at testing centers and empty shelves at stores selling at-home kits, Jennifer Epstein and Josh Wingrove report.

• On the Hill, lawmakers are calling on the White House to provide full reimbursement to Medicare recipients who buy at-home test kits. Their letter comes after the Biden administration required commercial insurers to cover the cost of at-home tests.“We write today to urge you to take immediate action to ensure that those covered by Medicare have the same ready, cost free access to COVID-19 diagnostic tests,” they said. Read their letter here.
• The Biden administration is preparing to release 400 million non-surgical N95 masks from the Strategic National Stockpile with plans for Americans to be able to pick them up from tens of thousands of sites across the country beginning late next week, the White House said today. The masks will be sent to the same venues where Americans have been vaccinated against Covid-19, including tens of thousands of pharmacies and thousands of community health centers, a White House official said on the condition of anonymity to preview the announcement. Read more from Jennifer Epstein.

Happening on the Hill

Budget & Pandemics: Lawmakers should exempt pandemic preparedness funding from the usual top-line funding discussions, Robert Kadlec, former assistant secretary for preparedness and response at the Department of Health and Human Services, will tell lawmakers on the House Rules Committee this morning. Kadlec, who served during the Trump administration, will testify at a House Rules subcommittee hearing on budgeting for pandemic preparedness and other disasters, Jack Fitzpatrick reports.

Wyden Queries Bristol-Myers Squibb on Taxes: Senate Finance Chairman Ron Wyden (D-Ore.) asked Bristol-Myers Squibb for information in response to reports that the firm used offshore subsidiaries in Ireland as part of a “sophisticated tax avoidance strategy.” The query is part of an ongoing investigation into major pharmaceutical firms’ tax practices and how tax-code loopholes let multinational firms avoid paying U.S. taxes on drug sales, Wyden said. He called on CEO Giovanni Caforio to explain a 2012 transaction that resulted in its tax rate falling to -6.9% that year from 24.7% a year prior. Laura Davison has more.

Democrats Urge CMS Not to Increase Premiums: Rep. Angie Craig (D-Minn.) and over 30 other Democrats called on the Centers for Medicare & Medicaid Services to reconsider a 14.5% increase in Medicare Part B premiums this year. The agency last year announced that Medicare’s Part B monthly premium for 2022 would increase by $21.60—”an increase largely driven by the exorbitant launch price of a newly approved Alzheimer’s drug called Aduhlem,” according to a statement from Craig’s office, referring to the controversial treatment from Biogen, which has since reduced its list price by half. Read their letter here.

What Else to Know Today

CEO Aided Illegal Opioid Sales, U.S. Says: The former head of a major generic drug distributor directed U.S. sales of opioids to pharmacies despite “serious red flags” that the powerful medications were being illegally diverted to street dealers and addicts, a prosecutor told jurors at the start of a criminal trial in Manhattan. Laurence F. Doud III, who spent 25 years as Rochester Drug Co-Operative CEO, is alleged to have plotted with other executives to distribute oxycodone and fentanyl to pharmacies that had been flagged for questionable practices. Read more from Bob Van Voris and Chris Domletsch.

SCOTUS Wants U.S. View on Hospice Kickback Suit: The U.S. Supreme Court said yesterday it wants the U.S. solicitor general to file a brief expressing the views of the federal government about whistleblowers’ claims that Bethany Hospice and Palliative Care violated the False Claims Act by engaging in a kickback scheme under which it paid doctors in exchange for patient referrals. The Eleventh Circuit ruled that whistleblowers failed to adequately allege Bethany Hospice actually billed Medicare for services. Their petition argued the whistleblowers’ knowledge of billing practices was enough for the case to continue. Daniel Seiden has more.

Antitrust Cops Eye Tougher Merger Rules: Federal antitrust enforcers announced an effort to toughen merger reviews, saying a new framework is needed to battle a surge in deals that threatens to worsen already high concentration across industries. The heads of the Department of Justice’s antitrust division and the Federal Trade Commission said yesterday that the merger guidelines they use to assess whether a deal violates antitrust laws need to be revamped to protect competition. David McLaughlin has more.

More in Industry & Regulations:

• High Court Passes On Dispute Over Insurance for Transgender Care
• Denial of Medicare Telehealth Payment to Overseas Doctors Upheld
• Women’s Health Data Gets Focus in FDA’s Device Research Initiative
• Antares’s Adrenal Crisis Drug Gets Fast Track Designation From FDA
• Allergan Keeps N.J. Breast Implant Suit in Federal Court
• Deaf Patient’s Claim for Hospital’s Lack of Interpreter Advances

Two J&J Shots Offer Least Protection Against Omicron: Combining two Johnson & Johnson shots offers the least amount of antibody protection against omicron, according to an NIH study on how well mix-and-match boosters work against the highly contagious variant. The study comes as the omicron strain now accounts for 98% of cases of Covid-19 in the U.S. Public health leaders have stressed the importance of boosters, but most of the data showing the additional doses increase antibody levels stems from the Pfizer-BioNTech or Moderna vaccine. Read more from Jeannie Baumann.

More on the Covid-19 Pandemic:

• Schools in Virginia Prepare for Mask Clash With Gov. Youngkin
• Omicron May Cut Future Severity of Coronavirus, Study Shows
• Vaccine’s Rocky Journey Shows Why Fast End to Covid-19 Threatened
• Gates and Wellcome Take Aim at Covid-19 Variants and Future Threats

With assistance from Jack Fitzpatrick and Alex Ruoff

To contact the reporter on this story: Brandon Lee in Washington at blee@bgov.com

To contact the editors responsible for this story: Zachary Sherwood at zsherwood@bgov.com; Giuseppe Macri at gmacri@bgov.com; Michaela Ross at mross@bgov.com