Evidence behind breakthrough devices

Since launching the breakthrough devices program in 2016, the Food and Drug Administration has granted more than 1,000 products the label, and at least 127 of these have come to market. Now, device makers are pushing for automatic Medicare reimbursement for these devices.

As STAT's Katie Palmer reports, new research analyzing the first crop of FDA-authorized breakthrough devices, published in JAMA Internal Medicine, could help make the case for more caution before rushing to cover devices. While the program is keeping its promise of faster review times, the researchers also found shortcomings in the evidence supporting devices. Notably, eight devices came to market without any clinical testing.

policy

Senate to vote on spending bill with health tech changes

The Senate is expected to vote imminently on the spending bill passed by the House last month. To be honest, by the time you read this, things may have changed. But as of when I'm writing this, there are a few items especially relevant to you, health tech readers:

Senators over the weekend added a provision that would establish a permanent rule allowing employers to offer first-dollar telehealth coverage to workers on HSA-eligible high-deductible health plans. The rule was adopted during the pandemic and had usually been extended along with other temporary telehealth rules. It fell off in the scramble to pass a stop-gap spending bill at the end of last year.
A controversial 10-year moratorium on enforcing state bills around artificial intelligence appears to be in jeopardy. Earlier in negotiations it appeared a shorter, more limited moratorium might make it into the Senate package. We wrote last month about the potential implications of a ban for health AI bills.

medical devices

CGM update in Medicare home health payment rule

CMS released its proposal for updates to payment rates and policies for home health agencies. A notable change would allow Medicare beneficiaries to upgrade continuous glucose monitors and insulin pumps as often as every 30 to 90 days. Rather than purchasing the products for beneficiaries once every five years, CMS proposes to switch to a rental model. The proposed rule argues that the technology is changing quickly, cites cybersecurity concerns with outmoded equipment, and points out that under a rental model agencies would be required to help beneficiaries with the devices.

CGMs are a favored technology among associates of health secretary Robert F. Kennedy Jr. and in his comments before a House committee last week he touted the potential of the devices to help people manage diabetes and lose weight, and he suggested the health department was exploring ways to expand payment for the devices.

Is this a handout to CGM manufacturers or suppliers? On first read, it appears that CMS wants to cap CGM rental prices at a rate that would add up to what it currently costs Medicare to buy a device every five years while replenishing necessary supplies. Tell me if I've got that wrong. We'll see what people say in the comments about this one.

artificial inteligence

Europe approves an LLM-based clinical device

STAT's Brittany Trang writes: Earlier this year, a generative AI clinical decision support tool was approved as a class IIb medical device under Europe's CE marking. Called Prof. Valmed (short for "validated medical information"), the tool uses GPT-4o to generate medical answers from a restricted database of clinical guidelines, regulatory documents, quality handbooks, patient handbooks, Cochrane reviews, and publicly available PubMed documents.

The testing for the regulatory approval included 900 questions across different specialties, with the first endpoint for a "safety" index and the secondary endpoint for a response quality index, or how satisfied users were with the answer. The tool is approved for use by medical workers such as nurses and as a medical education tool (Prof. Valmed CEO Vera Rödel mentioned that the company was sponsored by a pharma company who planned to use the tool for its employees' medical education), but is also supposed to support clinical diagnosis and treatment.

Rödel and her co-founder, Heinz Wiendl, a doctor, appeared on a webinar this morning to talk about the tool. Questions about how the team tested for hallucinations, controlled for automation bias, and how it compares to tools like OpenEvidence were not answered. And just last fall, the FDA took a very conservative approach to the idea of approving generative AI devices, with an advisory committee cautioning that the technology is very different than traditional medical devices and would perhaps require totally different approaches to regulation.

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The medical device that's become a MAHA fixation, The Atlantic
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