Biden's big bet on testing races against demand

By Sarah Owermohle and Adam Cancryn

With Alice Miranda Ollstein

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— Biden is going big on Covid-19 tests, but experts and former health officials worry it won’t be enough as communities brace for fall and winter demands.

— Senators can’t reach an agreement on drug pricing, in large part because they don’t know what Sen. Kyrsten Sinema wants.

— A global discussion on kratom begins this week after U.S. health officials have repeatedly tried to limit its use.

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A message from Surgical Care Coalition:

The Surgical Care Coalition is urging Congress to stop impending Medicare cuts of nearly 9% that will threaten patient access to quality surgical care. These cuts are even more concerning considering the ongoing COVID-19 pandemic. Learn more about the Surgical Care Coalition , representing more than 150,000 surgeons across the country, and how you can take action against these devastating cuts.

BIDEN RACES THE CLOCK ON COVID TESTS — The Biden administration plans to triple the nation’s supply of at-home Covid-19 tests by early November, but public health experts say that welcome increase likely won’t be enough to meet surging demand.

The White House announced last week it would spend $1 billion to increase home test access, with the ultimate goal of making 200 million available each month by year’s end. But that amount may not be enough to stem soaring demand fueled by the Delta variant, holiday travel, school screening and the administration’s pending regulations requiring companies with more than 100 workers to ensure any unvaccinated employees undergo weekly tests, POLITICO’s David Lim writes.

What if supplies fall short? Commercial labs may have to plug some of the gap, along with health professionals who can administer other types of tests, like point-of-care antigen tests that have quick turnarounds.

The administration’s recent testing efforts include new contracts with OraSure, Quidel, Abbott and Intrivo to boost the at-home test supply. But those expansion efforts will take months to materialize fully, industry and public health experts said.

Several of those experts question why President Joe Biden — who campaigned on expanding access to Covid-19 testing — didn’t make larger investments sooner to help the country’s testing system grow more quickly.

“They really believed that they were going to declare victory over Covid and move on. And so they took their eye off the testing ball for most of this year because they thought that vaccines were going to save the day,” said Jerome Adams, the country’s surgeon general during the Trump administration. “I think that was very much a real issue with our lack of ability to provide testing.”

SINEMA NOT SOLD ON A DRUG PLAN, STILL — Senate Democrats still haven’t agreed on a key component of President Joe Biden’s sweeping social spending package — drug pricing reform.

The holdup: Sen. Kyrsten Sinema (D-Ariz.) hasn’t decided what she wants. The moderate hasn’t wavered from her stance of nearly a month ago opposing the current drug price reforms up for debate, Rep. Scott Peters (D-Calif.), a pharmaceutical industry ally pushing a narrower plan, told POLITICO’s Alice Miranda Ollstein and Laura Barrón-López.

“Senator Sinema is not yet for any proposal to deal with prescription drugs,” Peters said in an interview. “And I'm trying to get her to come my way because I think, frankly, it would just be good to put this issue to rest.”

Sinema's spokesperson, John LaBombard, refuted Peters’ characterization of the senator’s’ position, saying Sinema is "carefully reviewing various proposals around this issue" in her “direct negotiations” over the $3.5 trillion package. Sinema generally supports the idea of lowering drug prices but has declined to say what, if any, proposals she would back.

Democratic leaders are banking on the original plan — projected to save more than $450 billion over a decade — to fund major expansions of Medicare, Medicaid, Obamacare and home health care.

White House puts on the pressure. The administration for months largely deferred to leaders on Capitol Hill to iron out those disagreements but is now actively reaching out to House and Senate moderates to press for support. Peters said the White House has more directly engaged him on drug pricing recently and “we understand where each other is better.”

Officials have also noticed the unlikely agreement between Sens. Bernie Sanders (I-Vt.) and Joe Manchin (D-W.Va.) on allowing Medicare to negotiate drug prices, said a source familiar with the administration’s thinking. Lowering prescription drug costs is one of the more popular elements of Biden’s plan. Many Democrats see it as key to their success in the 2022 midterms and beyond — particularly because other well-liked proposals, like lowering the Medicare eligibility age, have been dropped.

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MERCK FILES FOR ANTIVIRAL USE — Merck on Monday announced it asked the Food and Drug Administration to authorize emergency use of an experimental antiviral pill that appears to halve the risk of hospitalization or death from Covid-19 in some people.

The company and its partner Ridgeback Biotherapeutics said the request covered adults with mild-to-moderate Covid-19 who are at risk for progressing to severe Covid-19 or hospitalization. Merck said it expects to produce 10 million courses of treatment, called molnupiravir, by the end of 2021, with more courses expected to be produced in 2022.

The drug is taken twice a day for five days at home, in contrast to antiviral treatments like remdesivir or monoclonal antibodies that have to be infused or injected in a clinic. That's raised hopes it could help reduce the risk of severe illness and ease the burden on health systems by reducing future surges of infection.

A LOOMING FIGHT OVER KRATOM — A World Health Organization meeting this week could determine the future of kratom, a widely available herbal supplement some tout as an alternative to opioid painkillers.

Kratom advocates say the substance is a promising replacement for opioids that could help wean people addicted to those drugs, which killed nearly 70,000 people in the U.S. in 2020. But those claims have yet to be fully vetted by scientists, POLITICO’s Lauren Gardner writes. Meanwhile, the U.S. government has twice tried to restrict kratom's use by classifying it as a controlled substance, though public outcry and pushback from Congress thwarted those efforts.

Now, kratom advocates suggest Washington is behind the WHO’s interest in an attempt to end-run the federal regulatory process by taking the international route to finish what it couldn’t accomplish domestically.

The debate divided Trump officials. Former FDA commissioner Scott Gottlieb has asserted that kratom is just as dangerous as opioids, tweeting in May that he’s “convinced it’s fueling the opioid addiction crisis.”

But those comments prompted a swift rebuke from Brett Giroir, Trump’s assistant secretary for health and acting FDA commissioner after Gottlieb left. Giroir, in a 2018 memo, rescinded the HHS recommendation to outlaw kratom and called for more study and public comment.

After spending "hundreds of hours" reviewing the data, Giroir told POLITICO on Friday he determined that listing kratom as a Schedule I drug would stymie research and potentially steer users toward deadlier options like heroin and fentanyl.

SCOTUS TAKES UP A NARROWER ABORTION QUESTION — The Supreme Court will hear an under-the-radar case Tuesday focusing on which state officials can defend abortion bans in court, Alice reports.

The case, the first on abortion to be fully argued before the court’s new 6–3 conservative supermajority, concerns the Kentucky attorney general’s bid to intervene in a lawsuit over a state abortion ban the governor refused to defend.

If the justices side with Kentucky AG Daniel Cameron, it could open the door for more state officials to defend abortion laws when their governors choose not to do so.

The justices are set to hear a much more high-profile and influential abortion case in December — a lawsuit over Mississippi’s 15-week abortion ban that directly challenges Roe v. Wade. Lawsuits against Texas’ six-week abortion ban could also come back to the court either on an emergency basis or through the regular channels.

FAUCI: DON’T ‘DECLARE VICTORY’ YET — Covid-19 cases are trending in the “right direction,” but people should be careful to not “declare victory,” Biden’s top medical adviser said Sunday.

Cases dipped below 100,000 in the most recent seven-day period, while hospitalizations were below 10,000 and deaths below 2,000 during that time.

“If you look at the history of the surges and the diminutions in cases over a period of time, they can bounce back,” Director of the National Institute of Allergy and Infectious Diseases Anthony Fauci said on CNN’s “State of the Union.” Plus, he mentioned roughly 68 million people eligible for vaccination haven’t gotten it.

Plus: The holidays are coming. Halloween is around the corner, kids are in school and the colder months are ahead. Also, 68 million eligible people still haven’t gotten the shot. With upcoming holidays like Thanksgiving and Christmas, Fauci cautioned not to “just throw your hands up and say it's all over.”

TEXAS GUBERNATORIAL CANDIDATE HOSPITALIZED WITH COVID — Tea party candidate Allen West was hospitalized with Covid-19 Sunday but said he’s “doing great.”

“No complaints. I’m just relaxing,” West told The Associated Press during a brief phone interview from a hospital in the Dallas suburb of Plano. He said he got a good night’s rest and was awaiting the results of an early morning chest X-ray.

West and his wife, Angela West, were diagnosed with the virus after attending a “packed house” fundraising event. Both received monoclonal antibody treatments for Covid-19, and Angela, who was vaccinated against the virus, was released to go home. The unvaccinated Republican candidate said doctors were worried Saturday about the lowered oxygen saturation level in his blood.

Ashley Wilson is joining Catholics for Choice as director of comms and strategy. She previously was grasstops advocacy manager at the Friends Committee on National Legislation.

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Community clinics nationwide are awaiting payments for millions of Covid-19 shots administered since January, causing cash flow problems that could impact operations, Kaiser Health News’ Rachana Pradhan and Rachel Bluth report.

How COVAX failed so far : The “naively ambitious” plan has contributed less than 5 percent of coronavirus vaccines administered worldwide and is struggling to meet 2021 goals, Olivia Goldhill and Rosa Furneaux write in Stat News.

A message from Surgical Care Coalition:

A nearly 9% cut to Medicare could threaten patients’ access to quality surgical care. The Surgical Care Coalition, representing more than 150,000 surgeons across the country, are advocating Congress to stop these harmful cuts to protect patients and ensure access to the care they deserve, especially considering the ongoing COVID-19 pandemic.

Health care systems and providers across the country continue to be strained. And COVID-19 has forced patients to delay routine, preventative care leading to delays in a diagnosis and treatment. The proposed Medicare cuts will weaken the system even further and jeopardize access to care for the most vulnerable.

Learn more about the Surgical Care Coalition and how you can protect patient care by stopping these impending Medicare cuts.

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