HEALTH CARE BRIEFING: At-Home Covid Test Makers Want More Access

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A coalition of companies that make at-home Covid-19 tests hired a lobbying firm to influence Medicare’s reimbursement policy around their tests.

Abbott Laboratories, Becton Dickinson, eMed Labs, Quidel, and Visby Medical have jointly hired McDermott+Consulting to lobby on their behalf, starting late in 2021. The companies, which all produce rapid Covid-19 tests, formed the At-home COVID Testing (ACT) Coalition, according to a federal lobbying disclosure posted on Monday. The group wants Medicare to cover at-home tests, Eric Zimmerman, a partner with McDermott, said.

The formation of the group comes as the Biden administration is dealing with a historic rise in Covid-19 cases across the U.S. The White House vowed to buy 500 million at-home Covid-19 tests and mail them to any Americans who want them. The Biden White House in early December also announced it would require private insurers to cover the costs of at-home Covid tests. That policy doesn’t apply to public programs such as Medicare and Medicaid.

Medicare by law must cover at no cost PCR SARS-CoV-2 tests, the kind that people get at laboratories, hospitals, and other testing sites. Results from these tests can take several days to return when labs are stressed. Medicare has the power to pay for at-home tests for its beneficiaries, Zimmerman said, Alex Ruoff reports.

Separately, Walmart and Kroger are both raising the price of a popular at-home Covid-19 test after a deal with the White House to sell the kits at cost expired. The price of BinaxNOW tests at Walmart is increasing to $19.88 this week from $14, the company said in an email yesterday. Kroger said it reinstated “retail pricing” after completing the three-month commitment to President Joe Biden’s administration, Brendan Case reports.

Meanwhile, Biden said long lines for Covid-19 tests should start to ease as the federal government increases capacity. Biden told reporters at the White House yesterday that U.S. has opened new testing sites around the country and that drug stores are restocking home test kits. The U.S. had faced a shortage of tests, leaving many unable to make appointments, especially before the holidays. “Believe me, it’s frustrating to me,” Biden said of the testing shortages.

The testing crunch could even be seen at the U.S. Capitol. Yesterday, a day after the attending physician of the Capitol said there had been an “explosive” growth of infections in the complex, lines were more than 90 minutes deep midday. Staffers returning to work after the Christmas recess queued up, as far less testing staff than usual were on hand. Read more from Josh Wingrove.

And as emergency rooms struggle to keep up with omicron, they’re also contending with a stream of frustrated people looking for Covid tests. With retailers short of at-home tests and queues at many urgent care centers and doctor’s offices stretching for hours, those with mild or even non-existent symptoms have slammed ERs looking for anywhere that might have a test. Read more from Kristen V. Brown.

More on the Pandemic

CDC Sticks to New Covid-19 Isolation Guidance: The Centers for Disease Control and Prevention clarified the rationale behind its decision to shorten recommended isolation and quarantine guidance, and not support more testing to resume normal activities, following criticism that its shift was not driven by current science. In a posting on its website yesterday, the federal public-health agency said that it had opted to change its guidelines based on emerging scientific evidence concerning when and for how long a person is most likely to transmit the highly infectious omicron variant. Read more from Fiona Rutherford.

CDC Recommends Pfizer Booster After 5 Months: The Centers for Disease Control and Prevention recommended that people get a booster dose of the Pfizer-BioNTech vaccine five months after their first two shots, shortening the interval from the earlier six-month regimen. The new recommendation comes one day after the Food and Drug Administration changed its emergency authorization for the shot to reflect a shorter dosing interval for the booster.

Today, a panel of vaccine experts who advise the CDC are expected to weigh recommending boosters for 12-to-15-year-olds with the Pfizer shot. The committee is expected to vote on recommendations, but voting language hasn’t yet been made public. After the vote, CDC Director Rochelle Walensky will decide whether to sign off on their recommendation. Then doctors, drugstores and other sites could begin giving shots to the age group. Robert Langreth has more.

But lingering vaccine hesitancy is complicating the administration’s goal to keep kids in schools, even with clearance of Pfizer’s booster shot for 12- to 15-year-olds, health policy analysts say. The Food and Drug Administration kicked off 2022 by authorizing Pfizer’s boosters for young teens, widening access to additional doses as parents seek to protect their children from the omicron variant. Boosters’ ability to help scale back infections in schools may be limited if only half of U.S. parents are getting their children vaccinated. Read more from Ian Lopez and Celine Castronuovo.

‘Up-to-Date’ Shots Replacing Term ‘Fully Vaccinated,’ Fauci Says: The language around what constitutes fully vaccinated against Covid-19 is being replaced, in the strongest indication by White House chief medical adviser Anthony S. Fauci that two shots of a messenger RNA vaccine fall short of protection amid the highly transmissible omicron variant. “We’re using the terminology now ‘keeping your vaccinations up to date,’ rather than what ‘fully vaccinated’ means,” Fauci said during a National Institutes of Health lecture yesterday. “Right now, optimal protection is with a third shot of an mRNA or a second shot of a J&J.” Read more from Jeannie Baumann.

State Lawyers Take SCOTUS Lectern in Vaccine Hearings: Six lawyers will argue in special Supreme Court sessions Jan. 7 over Biden’s Covid-19 vaccine rules, including several current or former state solicitors general. The unusual hearings will feature a mix of first-time and repeat players at the high court, according to the court’s list of the lawyers arguing, published yesterday. Kicking off the rare day is veteran lawyer Scott Keller, a former solicitor general for Texas who’s representing business groups against the employer mandate. Read more from Jordan S. Rubin.

Texas Governor Greg Abbott (R) also sued Biden’s White House over its effort to impose a vaccine mandate on National Guard troops, saying it violates state sovereignty to require the shots when the troops aren’t on active federal duty. Under U.S. law, National Guard units answer to the states where they are domiciled unless they are called into active duty by the federal government. Abbott’s suit also cites Texas’s constitution, saying its governor serves as the guard’s commander-in-chief except when the troops are called into federal service. Christian Berthelsen has more.

Pfizer-U.S. Pill Pact Hits 20 Million: Pfizer said the federal government has agreed to buy an additional 10 million courses of its Covid-19 pill, adding to the country’s stash of virus-fighting tools as infections continue to rise. The company said in a statement yesterday that the U.S. agreed to buy the additional supply of the drug, known as “Paxlovid,” on top of 10 million courses it had previously agreed to purchase. Around 10 million courses have been accelerated for delivery by the end of June, Pfizer said, with the remaining tranche to be delivered by the end of September. Read more from Riley Griffin and Josh Wingrove.

Biden at the White House yesterday said the U.S. may need additional orders of Pfizer’s Paxlovid, which was cleared for emergency use by the FDA last month for people at high-risk of developing severe disease and has been shown in trials to sharply reduce hospitalizations and deaths from Covid-19. The new pills are a “game changer” that are going to decrease hospitalizations and deaths from Covid-19, Biden said, Megan Howard and Josh Wingrove report.

U.S. Hits Record 1 Million Cases in 1 Day: The U.S. set a new global daily record of coronavirus cases, with more than 1 million people diagnosed with Covid-19 on Monday as omicron sweeps across the country. That’s more than any country has ever seen since the pandemic began and comes after the recent record of around 590,000 cases was itself a doubling from the prior week. The stratospheric numbers come even as many Americans rely on tests they take at home, with results that are not reported to authorities. That means that the record is likely a significant under-estimate. Read more from Jinshan Hong.

Omicron is accounting for the lion’s share of new coronavirus cases, according to estimates from federal health officials. The variant made up 95% of all sequenced Covid-19 cases in the U.S. in the week ending on Jan. 1, up from a revised 77% in the previous week, according to a model by the CDC. Previously, the CDC estimated that the variant accounted for 58.6% of cases in the week ending Dec. 25, Fiona Rutherford reports.
Still, U.S. hospitals are so far seeing significantly fewer severe outcomes from the omicron wave than they saw in past Covid spikes, mirroring the experience of South Africa and the U.K. The U.S. is reporting a weekly average of 485,363 cases, roughly twice the peak of last winter, and true prevalence is projected to be far higher. But U.S. hospitals have just 64% of the Covid-19 patients in adult intensive-care beds as they did at last winter’s peak, and hospital deaths are around 52% of last winter’s worst period. Read more from Jonathan Levin.

More Headlines:

What Else to Know Today

Nominations on the Hill: The Biden administration sent to the Senate yesterday a list of nominations, re-upping several that didn’t reach confirmation in the chamber last year. The list included Robert Califf for commissioner of the U.S. Food and Drug Administration and John Nkengasong for ambassador-at-large and coordinator of U.S. government activities to combat AIDS.

Meanwhile, the Senate Health, Education, Labor, and Pensions Committee set Jan. 12 as the new date to consider Califf’s nomination for a hearing originally scheduled for today.

Biden Agenda Stuck as Manchin Reports ‘No Negotiation’: Sen. Joe Manchin (D-W.Va.) said yesterday he’s not in talks with the White House or Democrats on reviving Biden’s $2 trillion tax and spending agenda, leaving the administration’s signature domestic initiative stalled. Manchin signaled he may be open to future talks on some of Biden’s proposals, including some clean energy proposals. He has had problems with the legislation’s paid family leave and Medicare expansion provisions. Read more from Erik Wasson and Laura Litvan.

Texas Abortion Fight Heads Back to High Court: Texas abortion providers are back at the Supreme Court, this time asking the justices to expedite the litigation in the lower courts, as the six-week abortion ban remains in place. The Supreme Court Dec. 10 remanded the case back to the New Orleans-based Fifth Circuit, with a narrow path for providers to challenge the law in federal court. Before sending the case back to the trial court to consider that narrow path, the Fifth Circuit scheduled oral argument Jan. 7 on whether the case should first go to Texas state courts. Read more from Kimberly Strawbridge Robinson.

Meanwhile, long-term care industry trade groups are asking the U.S. Supreme Court to grant review of a Seventh Circuit verdict giving residents of publicly operated nursing facilities the right to sue for alleged rights violations. The case presents “an excellent vehicle” for determining if people can sue government-operated nursing facilities for allegedly violating rights conferred by spending clause legislation, the American Health Care Association and Indiana Health Care Association argued in a friend of the court brief. Read more from Mary Anne Pazanowski.

More Headlines:

To contact the reporter on this story: Michaela Ross in Washington at mross@bgov.com

To contact the editors responsible for this story: Zachary Sherwood at zsherwood@bgov.com; Giuseppe Macri at gmacri@bgov.com; Brandon Lee at blee@bgov.com

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