December 07, 2022
Hello there, Vitals readers. Today's newsletter is 1,024 words or a 4-minute read.
☝️Don't forget! Join Axios' Caitlin Owens and me in Washington, D.C., today at 8am ET for an event looking at the top priorities, issues and challenges shaping the post-midterm health care policy landscape.
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1 big thing: COVID could be DeSantis' secret weapon in 2024
Florida Gov. Ron DeSantis — should he run for the GOP's 2024 presidential nomination — has an opening to attack former President Trump's COVID response from the right, Axios' Caitlin Owens writes.
The big picture: The federal COVID response has become a red-meat issue for the party's base, and DeSantis' 2020 actions are much more aligned with the GOP's tone today.
- "DeSantis is a conservative rock star in large part because of how he handled COVID in Florida," said GOP strategist Alex Conant, who worked on Sen. Marco Rubio's campaign in 2016. "He'll certainly make the implicit contrast with Trump."
DeSantis' hands-off approach to the pandemic — reopening schools for in-person learning earlier than other states, fighting vaccine mandates and refusing to reimpose restrictions during case spikes — was a key to developing his political brand.
- "DeSantis made some decisions early on that the federal response didn’t make any sense as applied to Florida," said Joe Grogan, director of the Domestic Policy Council under Trump and a member of Trump's coronavirus task force. "So DeSantis was set up as a foil for the federal government's response."
Flashback: As much as Democrats have criticized Trump's COVID response, there's an opening to attack it from the right, too.
- Trump announced a 15-day national shutdown in mid-March of 2020, which was promptly extended after the virus continued to spread.
- He appeared on television regularly with NIAID director Anthony Fauci, who remained a member of Trump's COVID response even as the right grew increasingly frustrated with him.
"He introduced the country to Dr. Fauci, and the far right is not going to forget that," said Brendan Buck, a former adviser to Paul Ryan.
What they're saying: "After China unleashed this deadly virus onto the rest of the world, President Trump and his administration worked tirelessly to secure medical equipment to save the lives of Americans who were infected," said Trump campaign spokesperson Steven Cheung.
- Spokespeople for DeSantis declined to comment.
2. Formula shortage part of bigger FDA problems
The FDA's food programs are plagued by structural and cultural problems such as a lack of clear leadership and "a culture of indecisiveness," a report released Tuesday by the Reagan-Udall Foundation found.
Why it matters: The independent report was commissioned in July by FDA commissioner Robert Califf.
- The panel, chaired by former FDA commissioner Jane Henney, addressed this year's widely criticized response to infant illness and unsafe conditions at an Abbott formula plant, and its subsequent shutdown that led to the prolonged infant formula shortages. It also took up what hampers the response to more common food safety concerns.
What they're saying: "The lack of a clear overarching leader of the Human Foods Program has contributed to a culture of indecisiveness and inaction and created disincentives for collaboration," the report read.
- Specifically, a review of the infant formula shortage spurred by a foodborne illness outbreak indicated "lack of communication and engagement across the agency accounted, in part, for missteps," the report said.
- "There was little motivation, and apparently no requirement, to share information and interact across the agency to facilitate critical thinking and proactive decision-making," the report said.
The bottom line: Leadership and structural changes, as well as additional oversight authority and funding from Congress, are needed to ensure the agency can safeguard the food system, they said.
3. MA prior authorization rule drops
Medicare Advantage plans and other government-funded insurers would have to overhaul the electronic process they use to approve medical services and prescriptions under a rule proposed by the Biden administration on Tuesday, Axios' Maya Goldman writes.
Why it matters: Prior authorization is a top concern of physicians, who say it imposes excessive administrative burdens and have pressed Congress to make changes in the lame-duck session. The rule could dramatically reduce the cost of a Medicare Advantage prior authorization fix.
- Prior authorization requirements were "very or extremely burdensome" for nearly 82% of respondents to a Medical Group Management Association survey conducted earlier this year. More than half of respondents to an American Medical Association survey said the requirements often or always lead to patient care delays.
- But insurers say prior authorization is a necessary tool to control costs and make sure care is effective and efficient. AHIP, a major trade organization for health plans, supports electronic prior authorization as a way to improve the system.
Flashback: CMS initially proposed to improve electronic data exchange among health care payers, providers and patients in the final days of the Trump administration. But the original rule just applied to Medicaid, CHIP and Qualified Health Plans. CMS never finalized the policy.
4. FDA fast-tracks review of OTC Narcan
A nasal spray for reversing opioid overdoses could become available over-the-counter as early as next March after the FDA gave it priority review, Axios' Sabrina Moreno writes.
Why it matters: Advocacy groups, medical associations and federal agencies have said expanding the availability of naloxone is critical to addressing the addiction epidemic that killed more than 100,000 Americans last year.
- Making naloxone easier to obtain could also reduce the stigma of asking for a prescription, per a 2021 report from Integrated Pharmacy Research and Practice.
Driving the news: The FDA fast-tracked the application from Emergent BioSolutions — the maker of Narcan — for a non-prescription version of naloxone, the company announced on Tuesday.
- If approved, the spray would become the first naloxone product on the market that wouldn't require a doctor's sign-off, though most states already have access laws to bypass the requirement.
Yes, but: At roughly $160, the cost can be prohibitive and insurers vary in their coverage of naloxone.
- Community health organizations and public health departments have absorbed some of the cost to distribute the drug free-of-cost.
- Other free vending machines have popped up across the country in New York City and Los Angeles County to dispense doses.
5. Catch up quick
👉 Demonstrations that rocked many Chinese cities last week succeeded in getting China's leaders to rework the zero-COVID policy. (Axios)
👀 The U.S. won't agree to waive intellectual-property protections for COVID-19 treatments and tests this year. (Bloomberg)
💰 More than 350 labs billed Medicare at questionable levels for COVID-19 tests, federal watchdog finds. (Becker's Hospital Review)
🍄 Psychedelic therapy could be part of a health benefit in the future. (Axios)
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