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A PBM sprint, a potential drug negotiation pause, and an energy drink crusade

July 13, 2023
Reporter, D.C. Diagnosis Writer
Good morning and happy Thursday, D.C. Diagnosis readers! If you're a Twitter denizen who has migrated to Threads, you can find me @rachelcohrsreporter. There are a few health policy folks who have made their way over, so I'm going to be sharing all about the awesome work the STAT team is doing there. But never fear, you can always reach me the old-fashioned way at rachel.cohrs@statnews.com.

drug costs

The Finance Committee's PBM sprint

As both the House and Senate scramble to figure out a path forward on PBM reforms, leaders of the Senate Finance Committee are finally advancing their proposals to change how PBMs work, announcing a markup for Wednesday, July 26 — just two days before August recess is scheduled to begin.

The panel didn't release the full legislation, but two members (and committee leaders) put out yet another bill on Wednesday that may be included. It's a transparency measure that would require PBMs to report to Medicare price and rebate information that impacts patient premiums and copays. 

An interesting tidbit: ahead of this key three-week stretch, PhRMA CEOs are in town for their annual planning meeting, and are headed to the Hill for some bipartisan meetings, three industry lobbyists told me. The organization has pushed heavily for substantive PBM reform legislation.


litigation

Trying to press pause on drug price negotiation

In a significant development in the pharmaceutical industry's litigation against the Inflation Reduction Act, the U.S. Chamber of Commerce on Wednesday afternoon requested a preliminary injunction to stop Medicare's drug price negotiation program from going into effect. 

This is the first such motion, and could speed up the impact of the lawsuits significantly, as the Chamber requested a ruling by Oct. 1, which is the date when the first group of drugmakers selected for the program would have to sign contracts with Medicare. 

"We're seeking timely relief before the government can further implement its illegal and arbitrary price control scheme. If allowed to go into effect, the scheme would harm not only U.S. businesses but U.S. patients — limiting access to medicine, deterring needed investment, and stifling innovation," said Andrew Varcoe, deputy chief counsel at the Chamber's litigation center.


fda

Is the energy drink Chuck Schumer's criticizing actually hurting kids?

GettyImages-1531399540-1600x900Brandon Bell/Getty Images

Senate Majority Leader Chuck Schumer has launched a crusade against an energy drink made by a company co-founded by social media star and professional wrestler Logan Paul for advertising to children. 

But my colleague Nicholas Florko found that the FDA hasn't received a single adverse event report related to Prime, he writes in a new story out this morning. 

In fact, the drink isn't even the strongest one on the market, and others are marketed to children, too. So it remains to be seen whether FDA would have grounds to single out Prime, as the agency only really has the power to crack down on a specific product when people are clearly being harmed, or that product is widely out of step with other legal products on the market.



capitol hill

A wrench in the House?

While a hospital and PBM transparency bill sailed through the House Energy & Commerce Committee earlier this year, it remains to be seen whether the Ways & Means Committee, its well-known rival on health care issues, will assert its jurisdiction. The panel has held health care hearings on competition and affordability but hasn't marked up a competing legislative package.

Republicans on the panel are meeting today to discuss health care issues, three hospital lobbyists told me, after which it could become clear whether the committee will throw a wrench into E&C's plans to get its package to a floor vote quickly. Sound like surprise billing to anyone else?


supply chain

Where is Congress on drug shortages?

The House Energy and Commerce Committee marks up today pandemic-preparedness legislation that is well-suited to drug shortage reforms, but my colleague John Wilkerson reports that Congress might let that opportunity pass it by.

Everyone agrees drug shortages have reached a crisis point. In the Senate, neither party is proposing drug shortage reforms in the reauthorization of the Pandemic All-Hazards Preparedness Act. In the House, Democrats want to give the FDA more authority over the drug supply chain. House Republicans are wary of giving the agency more power, and the FDA has yet to take advantage of authorities that Congress provided three years ago, but it's unclear exactly how Republicans want to fix the problem.

"What we're seeing is disagreement on what the right vehicle and timeline for addressing shortages is," said Soumi Saha, senior vice president of government affairs at Premier, a group purchasing organization.


alzheimer's

The unanswered question about Leqembi coverage

Medicare coverage expanded for the new Alzheimer's drug Leqembi last week when the FDA gave the drug full, traditional approval — but there's still a big lingering question out there. 

Medicare is still weighing how it's going to cover PET scans that help physicians see whether patients have the amyloid plaques in their brains that the medication is supposed to clear. But right now Medicare only covers one of them in a patient's lifetime, which is sufficient to determine the presence of the plaques, but wouldn't allow physicians to see whether the drug is actually working. Neurologists I spoke with about the rollout were anxious to learn more about the coverage policy.

Medicare was supposed to issue a proposed coverage policy in December, but they've blown through that deadline. A CMS spokesperson said the agency would be issuing a proposed decision "soon." Out-of-pocket costs for the scans can run more than $5,000. Stay tuned!


local politics

A bellwether hospital defeat

As hospitals face down potential transparency measures and payment reforms in Congress, New York lawmakers Chuck Schumer and Hakeem Jeffries will be key decision-makers about whether any of that gets across the finish line. Schumer, in particular, is well-known as a friend of the industry

However, transparency advocates recently won a policy fight in New York City over the protests of the state's powerful hospital lobby. Mayor Eric Adams signed a hospital price transparency measure that also created an Office of Health Care Accountability to examine pricing practices, which will post prices for procedures online.


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What we're reading

  • Superbugs, antibiotic resistance get renewed scrutiny in Congress, STAT
  • Most patients using weight-loss drugs like Wegovy stop within a year, data show, Reuters
  • Takeda withdraws application for dengue vaccine from FDA, STAT
  • Alzheimer's drug trials target older Californians. Do they understand what they're signing up for?, Los Angeles Times

Thanks for reading! More next week,


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