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The path forward for Medicare Advantage audits, Biden calls emergency's end, FDA grapples with accelerated approval

January 31, 2023
Reporter, D.C. Diagnosis Writer

Happy Tuesday, D.C. Diagnosis readers! Always a health-care angle? The Kansas City Chiefs are heading to the Super Bowl after their quarterback pushed through a much-analyzed and meme'd ankle sprain. I tried! Send news, tips, and Super Bowl and Puppy Bowl predictions to sarah.owermohle@statnews.com.

Medicare

'Blood on their hands': The battle over Medicare Advantage payments hits its boiling point

A decade-long fight over how Medicare Advantage plans should be audited and how to best claw back overpayments to those plans hit an inflection point with a new CMS rule out Monday. 

The agency's plan is to aggressively audit insurers, likely resulting in billions of dollars of repayments to the program, report Bob Herman and Tara Bannow. Bob delved into the longtime battle ahead of the rule, with experts telling him that this is just the start of another brawl that will almost certainly head to court and delay changes for years.

Billions of dollars are on the line, almost all of which would get redirected back into Medicare's trust fund to benefit taxpayers and Medicare enrollees. That sizable sum is a large part of why reform attempts have virtually stalled for years, as insurers hellbent on keeping auditors out of profitable plans go up against an under-resourced federal oversight system, Bob writes.

A little extra: HHS Secretary Xavier Becerra told me last week at his 65th birthday party that he's enrolling in Medicare Part A for now, since he's still got benefits through his federal job. Read more about his celebrations with a giant Medicare card and Spanish choir.


The Pandemic

Emergency's end on the horizon

President Joe Biden told Congress Monday that he'll end the Covid-19 emergency declarations on May 11, more than three years after the pandemic triggered global shutdowns.

As the Associated Press first reported, the long-anticipated change would officially end a number of pandemic measures and protections. My colleague Rachel Cohrs has laid out a lot of those thorny issues around test and treatment payments, insurance and other health system infrastructures. But Congress has also already moved to unfurl some emergency protections, like ending freezes on Medicaid rolls this April.

Biden's announcement comes as House Republicans plan to bring a resolution to end the emergency immediately. 


drug regulation 

FDA signals how it'll wield new accelerated approval powers

Jacqueline Corrigan-Curay, an official in FDA's drug center, said during a Monday event that there might be cases in which the agency lets companies start trials after approval. 

That new power is part of reforms to the Food and Drug Administration's accelerated approval path that Congress recently passed, STAT's John Wilkerson reports. While there are arguments to speed approval especially for life-savings medicine, FDA cancer drug regulators also recently wrote that it typically took three and a half years longer to withdraw drugs that didn't work out when confirmatory trials were not already underway at the time the agency approved the drug.

Industry is anxious to know whether FDA will make exceptions to pre-approval enrollment of post-approval trials. Commissioner Robert Califf recently suggested at a STAT event that the agency wants trials to start as early as possible.



around the agencies

New hires and old jobs

The FDA tapped Troy Tazbaz, recently a senior vice president at Oracle, to head its Digital Health Center of Excellence, STAT's Lizzy Lawrence first reported Monday. He'll take over for Brendan O'Leary, who has been acting director since the previous FDA digital health head, Bakul Patel, left for a digital health strategy role at Google in May.

Tazbaz, who worked on Oracle's cloud computing business, is the latest person to go through the revolving door between the FDA and tech: Commissioner Robert Califf came to the agency from Verily, where former deputy commissioner Amy Abernethy also headed after her tenure. Patel left for a digital health strategy role at Google in May.

Meanwhile, former White House science adviser Eric Lander will resume his position at the Broad Institute of MIT and his tenured faculty positions at MIT and Harvard, after nearly a year of public silence following his ouster from the government over bullying allegations, my colleague Megan Molteni reports.

Lander, the institute's original founding director, won't return to the top role he held from 2003 to 2021, but will resume running his genetics lab and "do what he does best: elevate Broadies' science by helping us imagine what might be possible," current director Todd Golub wrote in an announcement to staff Friday.


More around STAT
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What we're reading

  • Federal panel approves plans to safeguard lab-made virus research, STAT
  • 'A classic case': A legal expert explains why lawsuits challenging abortion pill restrictions may succeed, STAT
  • Trump hits DeSantis on the campaign trail, accusing him of being a Covid skeptic phony, Politico
  • WHO extends public health emergency over Covid but signals end could come soon, STAT

Thanks for reading! More on Thursday,


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