Medicare's PET scan proposal

The agency late Monday proposed ending restrictions on how many PET scans patients can receive to detect amyloid plaques in their brains, a key change that could ease access to new dementia drugs like Leqembi.

CMS has normally restricted coverage to a single scan for patients who participated in clinical studies. Advocates had warned that could cause issues related to a new class of Alzheimer's drugs designed to clear those plaques, my co-writer Rachel Cohrs reports.

This new coverage policy could allow physicians to more easily test patients to see if they qualify for Leqembi, made by Eisai and Biogen, and also to monitor how quickly the plaques are cleared by the medicine.

And yet: Lawmakers are still pushing Medicare for broader Alzheimer's disease drug access. CMS hasn't been transparent enough about national coverage determinations and is dragging its feet on proposed changes, 40 House Republicans argued in a Friday letter to HHS Secretary Xavier Becerra and CMS Administrator Chiquita Brooks LaSure.

While the letter was aimed at broad changes, E&C Committee Chair Cathy McMorris Rodgers and others didn't miss a chance to implore CMS once again to reconsider its recent Alzheimer's drug coverage decision, which "illustrates the fundamental problems with the vast agency discretion and political uncertainty." They asked for answers from the agency by July 28.

CONGRESS

House committee plots new hospital transparency path

With just two weeks until summer recess, Ways and Means Committee leaders are drafting their own transparency legislation, all but assuring that an existing pack of requirements for hospitals and PBMs, and a so-called "site-neutral" pay policy for drugs administered in doctors' offices, won't get a vote soon, Rachel scooped last night.

The House E&C committee already marked up and passed the original pack of bills, teeing them up for relatively clear sailing. But four lobbyists tell Rachel that W&M is working on its own version — and it's unclear how much it may diverge. Because the two panels share jurisdiction over these issues, that could spell a slowdown for all the legislation. Details from Rachel.

eye on 2024

A peek into 2024 campaign figures

First things first: Vivek Ramaswamy, the former biotech exec and entrepreneur, has met the 40,000 donor threshold set by the Republican National Committee to appear in the first debate, according to campaign disclosures filed with the FEC this weekend. (Donald Trump, Ron DeSantis, Tim Scott, Nikki Haley and Chris Christie all have too, but notably, Mike Pence hasn't yet).

While Ramaswamy has poured more than $10 million into his own campaign, he counts hundreds of individual contributors. Among those that gave the $6,600 maximum: Stephen May Travis, co-founder and director of health tech Datavant Group; Ed Hyman, chairman of Evercore ISI; and Henry Perot Jr, Ross Perot's son.

Turning to congressional races, Sen. Mike. Crapo (R-Idaho), ranking member of the Senate Finance Committee, received a combined $11,000 from PhRMA and the pharmaceutical companies Takeda and Jazz last month. PCMA also put money towards two primary races, $1,000 apiece for Rep. Virginia Foxx (R-N.C.) and Jay Obernolte (R-Calif.).

ADVOCACY

Anti-PBM group spends big on lobbying

The Council for Citizens Against Government Waste spent a record $1.1 million on lobbying last quarter, at least in part on efforts to oppose PBM reform, Rachel reports. The sum is 22 times the $50,000 CCAGW spent in the same quarter last year. The group only employs a single lobbyist.

The group called the Senate health committee's PBM reform package "burdensome" and "anticompetitive," and said it amounted to "inserting government into private healthcare" — even though it passed on a bipartisan basis. Read more on the group's tactics.

future of ai

Tech giants battle health tech regs

From Google to Amazon, big businesses poised to profit from artificial intelligence in health care are pushing back against newly proposed federal rules aimed at increased oversight of AI's use in the sector, reports STAT's Casey Ross.

The Office of the National Coordinator for Health Information Technology wants to require developers of electronic health records and other health software to provide users with details about the training and testing of predictive models that draw data from their systems, or are hosted within them. It also wants developers to assess and publicly disclose potential risks and create a way for clinicians and other users to report problems.

By last week, the proposal was awash from public comments from tech companies, insurers, and medical software companies arguing the transparency requirements would diminish innovation and give some competitors an advantage. Elsewhere, scholars and AI-control advocates said the draft rule doesn't go far enough. Some of Google's individual scientists have even raised alarms about the rising dangers posed by modern AI systems. Dive into the controversy with Casey here.

drug shortages

Medicare's drug shortage plan could meet trouble

Medicare has a new proposal to pay hospitals more to stockpile essential drugs. But experts caution the policy could cause the very shortages that government officials are trying to avoid, John writes.

The new idea: paying hospitals to create a "buffer stock" of 86 medicines that HHS deems critical. Medicare would not pay hospitals for the drugs, but pay for the cost of managing a three-month inventory. It published the proposal in a rule last week; it's seeking comment now before it will weigh whether to finalize the policy.

What has experts concerned? Many factories are already at capacity, and a rush of hospital orders could further throw stress on a system that sees even small manufacturing glitches trigger shortages. More from John.

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