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Does the shutdown actually stall price negotiations?

There are a slew of government health programs and thousands of federal staff that could see work stalled by the budget deadline Friday. But is Biden’s signature drug pricing program on the outs too?

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HHS Secretary Xavier Becerra warned reporters Friday that “a lot” of the work negotiation staff are doing right now — compiling information, corresponding with manufacturers — “takes people who would be impacted by a shutdown.”

Except … the Inflation Reduction Act provisioned $3 billion for the negotiation program to get up and running. Unless Medicare has already hoovered up that money, despite slowing staffing up the 95-person office, it seems like the funds should still be there to keep the fledgling department open.

HHS did not answer specific questions about how the shutdown would impact the new Medicare negotiation team. A staffer reiterated that “core” CMS staff would stay on during a shutdown, but support and career staff would be furloughed. That’s true of every health agency in a budget shutdown, but IRA already provisioned funds to the negotiation office.

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Even if the drug negotiation office is safe, roughly 58% of HHS staff across government programs will be furloughed if lawmakers don’t reach a deal by Oct. 1. While pandemic-related activities, emergency response and “those whose work is necessary for the safety of human life” will be exempted, the shutdown’s impact will vary dramatically across agencies.

Are you a government employee or contractor whose work will be impacted by an impending shutdown? Reach out to me and DCD co-writer [email protected] about what is worrying you.

Could pharma lose its biggest Dem ally?

New Jersey Sen. Bob Menendez’s future in Washington is in limbo after he was hit last week with an indictment over hundreds of thousands of dollars he and his wife allegedly accepted to influence military aid. It’s not the first time we’ve been here: He was previously indicted on similar allegations related to Medicare payments, but that case ended in a hung jury.

This time around, New Jersey Democrats — and at least one Senate caucus member, Pennsylvania neighbor John Fetterman — are demanding his resignation. Menendez is holding firm, but his case is far from settled. That means a hazy future for one of the pharmaceutical industry’s biggest (and maybe only) allies in the Democratic Party.

As STAT’s reported, top drugmakers (including several headquartered in his state) flooded Menendez with cash in early 2021, right as drug price negotiation discussions in his party heated up. As Nick Florko pointed out then, it was pretty exceptional: None of the eight CEOs who donated to him had spent money on other senators, Democrat or Republican, that cycle.

Also worth noting: Menendez is the lead Senate Democrat on the international HIV/AIDS program PEPFAR, which is up for reauthorization this month.

Dairy farmers milk last battle against soy, oat rivals

There are few issues in food world that seem to cause as much debate as names for nut, soy and other plant-based alternatives to milk. But almond milk and its peers seem here to stay, STAT’s Nick Florko reports.

Dairy farmers and their advocates for years have tried everything to convince regulators companies like Silk and Oatly shouldn’t be able to slap “the m word” on their products, enlisting Hollywood stars and drafting state bills nationwide. For them the argument is simple: As former FDA Commissioner Scott Gottleib once said, “an almond doesn’t lactate.”

But Gottlieb’s former agency released a draft policy earlier this year allowing plant-based companies to use “milk.” Regulators said consumers aren’t actually confused by these products, ultimately narrowing the window for milk advocates to push change. Now, dairy farmers have one last resort: ask Congress to override the FDA. Read more on the fascinating milk fight from Nick.

A new effort to improve care for dual-eligible Americans

Just 15% of CMS enrollees are eligible for both Medicare and Medicaid, a fraction of enrollees that nevertheless account for a third of the two programs’ spending. The agency spends roughly $440 billion a year on these patients but senators increasingly argue that isn’t leading to better care — in large part because patients are getting snared in a confusing two-part system, Simar Bijaj reports.

Sen. Bill Cassidy (R-La.) has spearheaded a bipartisan Senate Finance group to reform certain insurance plans for the population. The fruit of those efforts, a bill to better integrate care between Medicare and Medicaid, is expected later this year but likely won’t see a vehicle until at least 2025.

Still, the time could be ripe for reform. These patients are particularly vulnerable but also, to insurers, seemingly profitable. That’s prompted dozens of “look-alike” insurance programs that don’t actually ensure dual-program coordination. More from Simar.

What we’re reading

BrainStorm’s case for ALS approval relies on ‘grossly deficient’ data, FDA finds, STAT

New poll shows just how much GOP voters have diverged from everyone else on vaccines, Politico

Treating Rural America: The last doctor in town, STAT

Covid boosters aren’t reaching people who want them, The Wall Street Journal

Correction: An earlier version of this story mistaklenly identified Menendez as the lead sponsor for the reauthorization of the Pandemic and All-Hazards Preparedness Act.