Health reforms tossed from spending package

A number of health care policy reforms have fallen by the wayside as Congress scrambles to stave off the latest shutdown looming this week. Lawmakers abandoned their attempt to include reforms to how pharmacy middlemen operate, Rachel Cohrs and John Wilkerson scooped. They also dropped a controversial policy to equalize certain Medicare payments to hospitals and physicians' offices, Rachel reported.

Congress could revive negotiations on the issues in the future, but this funding package could be a major missed opportunity. It also throws other health care reforms into question, as the PBM legislation was a potential offset for costs tied to a separate effort to renew expiring funding for safety-net hospitals, community health centers, and other public health programs. Negotiations over a final deal to extend those programs are ongoing.

This leaves both Senate and House versions of various PBM and site-neutral reforms in limbo for now. More on the various PBM proposals and the unusual coalitions around site-neutral.

drug price reform

The call to abandon march-in is coming from inside the House

President Biden's effort to broaden federal agencies' power to march-in on pharmaceutical and tech patents hasn't received a rosy reception from universities, companies, or former officials. Now, even some congressional Democrats are questioning the plan.

The proposal, which would let officials consider "reasonable prices" as a reason to license patents based on federally funded research to other manufacturers, would have "serious unintended consequences," lawmakers led by Sens. Chris Coons (D-Del.) and Thom Tillis (R-N.C.) wrote in a letter first shared with STAT. Twenty-eight senators and representatives including nine Democrats signed onto the letter. They argued that besides potentially paralyzing public-private collaboration on new drugs and technology, the move would hardly have an effect on existing pharmaceutical prices.

But Biden has his supporters too. Seventy-five Democrats led by Sen. Elizabeth Warren (D-Mass.) and House Ways & Means Health subcommittee ranking member Rep. Lloyd Doggett (D-Tex.) telegraphed their support for stronger provisions in the guidance earlier this month. That letter echoed calls for an even more aggressive patent approach from Sen. Bernie Sanders (I-Vt.), one of its signees. More on march-in, here.

health tech

What the cyberattack fallout says about the system

Change Healthcare's recent cyberattack has hospitals, doctors' offices, and pharmacies across the country reeling as they struggle to process claims and bill patients. Change's massive reach as one of the country's biggest claims hubs exacerbated the impact of the attack — and exposed glaring risks to health care consolidation, experts told STAT's dynamic biz trio, Brittany Trang, Tara Bannow and Bob Herman.

It's worth nothing, the U.S. Justice Department tried to stop UnitedHealth's $13 billion Change acquisition, arguing in a lawsuit that the deal would stifle competition in two markets: health insurance and the technologies insurers use to process claims. But a federal judge tossed the case.

More details about the cyberattack are expected, particularly because of a new SEC rule that requires companies to notify investors of any cybersecurity incidents they deem to be material. Dive into the ongoing chaos here.

abortion wars

Go deep on mifepristone

A lawsuit against the FDA's decades-old abortion pill approval hinges on the argument that the agency approved the drug despite serious risks, as evidenced by restrictions installed around mifepristone. But legal experts and former FDA officials argue those protocols, a precursor to what we now know as the REMS program, show just how cautious the agency was, my colleague Olivia Goldhill reports.

The Supreme Court will hear these and other arguments around mifepristone's 2000 approval and later modifications next month. A decision even just partially reversing FDA's decisions could ripple through its other authorities, especially the REMS programs it's established around several dozen medicines since the program began in 2007.

While REMS have become common for certain classes of drugs, mifepristone's prescribing limits were constructed seven years earlier, under an umbrella known as Subpart H, after a lengthy review process for its approval. Olivia spoke to experts about what that means and why it's become central to the case.

eye on fda

FDA makes first accelerated approval reversal

The FDA is rescinding its approval of a blood cancer treatment from the Swedish firm Oncopeptides, the agency's first exercise of a new authority that allows regulators to more quickly withdraw drugs that have not lived up to their promise, STAT's Damian Garde wrote in our Readout newsletter.

The move comes amid increased scrutiny of the FDA's accelerated approval program, which allows novel drugs to reach the market based on preliminary signs of efficacy while larger trials continue. Public health advocates have argued that drug companies abuse the system, pointing out that it takes nearly four years for ineffective drugs to have their accelerated approvals withdrawn. Subscribe to The Readout for more from Damian.

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