| | | |   | Hello, D.C. Diagnosis readers. Congress is back in session and there’s already lots of drama flying around. If your Monday was thrown into a panic by a hypothetical deal on reconciliation — that turned out to reference a relatively random March tweet — you’re not alone. Send rumors to nicholas.florko@statnews.com. Bonus points if they’re true! | | | The case of the missing user fee agreement The Senate HELP Committee is supposed to formally markup its must-pass user fee package this Wednesday at 10 a.m. There’s just one problem: Lawmakers were expected to release a new version of that package – commonly known as a manager’s amendment – yesterday morning. But by Monday night, no one had heard a peep from the committee. That’s significant because generally, manager’s amendments are made public at least 48 hours before a markup so that senators can draft amendments and file them well before the actual hearing, according to two former Senate HELP staffers. It’s unclear whether there’s a big delay holding up the package, or if there will be a manager’s amendment after all. Staff for the HELP Committee did not respond to STAT’s request for comment. But there’s hints of drama behind the scenes: Drug lobbyists were on high alert on Monday over rumors that Sen. Bernie Sanders (I-Vt.) was pushing to include a drug importation amendment in the package. The committee’s top Republican has also hinted that he wanted to delay the package over the FDA’s ongoing infant formula fiasco. Whenever the markup does happen, however, it’s bound to be a good one – at least if you’re really into seeing policy get made in real time. After all, there’s several major policy riders that were still being debated as of Monday night. | The other potential UFA fireworks We at D.C. Diagnosis are particularly eager to see how the ongoing spat over the future of dietary supplements shakes out during Wednesday’s user fee marketup. The Council for Responsible Nutrition, one of the main supplement lobbying groups in Washington, came out against the bill’s supplement provisions — despite being an extremely vocal backer of reform. The group, it turns out, believes the bill does not protect manufacturers’ confidential information and could allow the FDA to unfairly keep supplements off the market. If these objections seem familiar, that’s because other supplement lobby groups in Washington have been raising these exact concerns for weeks. It's unclear, however, whether CRN's change of heart will prompt lawmakers to rethink their approach. CRN said in a statement: “It’s premature to speculate what will be included or to try and theorize why those items were not included in the first round of the bill.” Lawmakers are also within striking distance of giving the FDA greater power to regulate so-called laboratory developed tests, but the laboratory lobby, the American Clinical Laboratory Association, has a slate of changes it wants made to the bill before it’s passed. The changes mostly revolve around when a test is “grandfathered in” and thus not subject to FDA review, and timeline for making certain tests subject to FDA oversight. They're wonky issues, but they're apparently very important to them. The group wrote in its comments that these issues “must be addressed.” And then, of course, there’s the fact that as of right now, the House bill includes exactly zero of these riders. That will have to change if even a single one of them is to become law. | ACLU to prisons: explain your paltry Paxlovid prescribing STAT scooped in March that the federal Bureau of Prisons was receiving a miniscule allocation of Covid-19 drugs, like Paxlovid and remdesivir, despite the outsized impact the virus has had on the prison population. In May we reported on additional documents that showed the prison system was prescribing even fewer doses than previously known. In fact, some prisons with massive outbreaks hadn’t prescribed a single dose of the drugs. Now the ACLU is demanding answers from Attorney General Merrick Garland. In a May letter shared with STAT, the group urged the BOP to “mandate that everyone with any medical vulnerability to Covid-19 who reports any symptom of Covid-19 receives a test within 24 hours, and that within 48 hours of receiving that test, they receive results and have an appointment with a medical provider to evaluate their eligibility for Paxlovid or other therapeutic medications.” The letter, interestingly enough, came just days before the White House ordered the Attorney General to largely revamp the BOP’s approach toward testing. For more information on that order, check out my new story here. | Healthcare distributors create between $33 and $53 billion in cost savings each year. Here’s how. Distributors' central role in the healthcare supply chain means that they have a deep understanding of the unique needs of upstream manufacturers and downstream providers. By providing logistics expertise and innovative solutions that drive cost efficiencies, healthcare distributors create between $33 and $53 billion in healthcare cost savings each year, streamlining a complex healthcare ecosystem. Learn more. | The Supreme Court deals a blow to Medicaid patients Monday saw the release of a Supreme Court health care opinion — though not the opinion everyone’s waiting for. (Or even the other ruling, if you’re a drug pricing wonk.) This 7-2 ruling says Florida’s Medicaid program can seize a patient’s personal injury settlement to reimburse the state for the care it already provided because of that accident, even when the settlement is earmarked for “future care.” If that sounds abstract and wonky, let me put it this way: The Supreme Court ruled Monday that Florida can take $300,000 from a 13-year-old who was left in a permanent vegetative state after being hit by a pickup truck while getting off the school bus, even though only a fraction of that money was supposed to be used to pay her past medical expenses.
Medicaid is supposed to seek “reimbursement” for care when there is another payer — in this case, a personal injury settlement — but the case really shines a spotlight on the ugly side of the U.S. health care system. And states weren’t doing themselves any favors either: The National Conference of State Legislatures argued in its brief to the Supreme Court that it should be able to take this money because Medicaid programs are broke.
“The heavy financial burden that states bear under Medicaid means that every option the States have for recouping costs is important,” the group wrote. Read the opinion here. | What we're reading -
The FDA’s Pazdur on accelerated approval, single-arm studies, and his own future, STAT -
Francis Collins: Concern about independence of new moonshot science agency ARPA-H are ‘overblown’, STAT -
The U.S. has wasted over 82million Covid vaccine doses, NBC -
If Roe is overturned, the ripples could affect IVF and genetic testing of embryos, experts warn, STAT -
AARP’s billion-dollar bounty, Kaiser Health News | Thanks for reading! More Thursday,  | | | |
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