Health IT regulator changes coming?

Buried in a leaked draft budget from the Trump administration is an ask that may alarm (or elate?) health tech watchers. The administration is proposing to create a new office of the chief technology officer within the federal health department that would house the Assistant Secretary for Technology Policy, the department's health IT regulator, and an "Office of Chief Information." Under the proposal, ASTP would be funded with $9 million, compared to the $66 million appropriated in the 2023 budget.

While this funding document is preliminary and likely to be ignored by Congress (as lawmakers have routinely done in the past), it's notable in light of whispers that a shakeup may be coming to ASTP.

Read more about the budget here and get in touch if you know more.

policy

Radiology network scoops up AI company

RadNet, which runs a network of nearly 400 radiology imaging centers, this week announced a deal to acquire iCAD, a developer of an AI breast cancer screen, for $103 million. RadNet has made a series of acquisitions over the last few years as it seeks to beef up its AI capabilities.

RadNet's willingness to bet big on AI is notable given a tepid response in the market so far. Radiology products account for more than three-quarters of the AI devices cleared by the Food and Drug Administration, but as STAT's Katie Palmer reports, adoption by providers can be bumpy for standalone developers. Reimbursement isn't assured and even then, the economics can be tricky for practices wanting to adopt. An AI used alongside a technician's read needs to make you money, make your practice more efficient, or significantly improve outcomes. Given it's new technology, the evidence of benefits is still emerging.

medical devices

Test maker used by UnitedHealth may settle with DOJ

Semler Scientific has offered to pay the Department of Justice nearly $30 million to settle federal health care fraud claims related to its peripheral artery disease test, QuantaFlo. Semler revealed the preliminary agreement in an SEC filing Tuesday. The deal would resolve an investigation into whether federal health programs paid out improper claims based on the use of QuantaFlo, which would violate the False Claims Act.

A STAT investigation last year revealed that UnitedHealth Group, which owns the country's largest Medicare Advantage insurer, boosted Medicare reimbursements by using QuantaFlo to screen patients for vascular disease.

research

Spending on remote monitoring is on the rise

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The Peterson Center on Healthcare this week released a report examining remote monitoring technologies, including some new claims data. The chart above shows growing use of remote physiologic monitoring codes, which providers use to bill for setting patients up with devices like blood pressure cuffs and for reviewing the data and communicating with patients about it. RPM spending in traditional Medicare alone has grown from $6.8 million in 2019 to $194 million in 2023.

The center finds there are use cases where remote monitoring has a high clinical impact, like in helping people stabilize high blood pressure. However, the report notes that many of the benefits of monitoring are achieved within a few months and a third of enrollees using RPM are monitored for 7 months or more. The report suggests duration limits for monitoring and limiting payment to conditions where monitoring shows value. Last fall, a federal health department watchdog issued a report warning of the potential for fraud by providers offering remote monitoring to patients.

research

Telehealth program saves 68 steaks worth of carbon

In a new paper in NEJM Catalyst, researchers from the Department of Veterans Affairs estimate that a telehealth-based diabetes care program that enrolled 576 patients "prevented over 200,000 miles of driving, saving around $20,000 in gasoline costs for patients and 82 metric tons of carbon dioxide emission compared with equivalent in-person care." Elsewhere, the researchers estimate that the carbon dioxide reduction for each veteran "would be equal to the carbon emissions associated with the production of more than 68 beef steaks for human consumption."

I'm too hungry to check the math.

digital therapeutics

So how will Click market its migraine therapeutic?

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As I noted briefly on Tuesday, Click Therapeutics this week received FDA clearance for CT-132, a new smartphone-based digital treatment (an app) that aims to reduce the number of days people experience migraines.

The data: In a randomized control trial, people who received the treatment app reported a reduction of about three days without migraines per month compared to control group that used a sham app, which saw a reduction of about two days.
The problem for CT-132 is similar to the problem for Rejoyn, the depression treatment jointly developed by Otsuka and Click that was c leared by FDA last year: It's very hard to make money off these clinical apps when they are marketed like drugs. Insurance reimbursement is non-existent, and there's little evidence a critical mass of people will pay out of pocket.
In an email, Rich DeNunzio, Click's chief commercial officer, pointed to data showing that the app delivers benefits for patients who continue to suffer from migraines despite taking CGRP therapy, which he said opens the door to "integrated solutions with CGRP manufacturers" that take advantage of draft FDA guidance around prescription drug use-related software.

industry news

Verily's new partners and a Lilly ML deal

Verily, Alphabet's health tech company, today announced that NashBio, University of Oxford, and the NIH Intramural Center for Alzheimer's and Related Dementias are new customers using its Workbench product to help store and analyze data.
BigHat Biosciences, which is using machine learning to hunt for new antibodies, announced that it's working with Eli Lilly on up to two candidates for chronic disease, as well as advancing an internal antibody-drug conjugate for GI cancers with Lilly's support. As part of the partnership, Lilly is investing in BigHat, together with Merck and Samsung Ventures, bringing the startup's Series B funding to more than $120 million.