Telehealth extension bill takes shape

Yesterday, by a vote of 41-0, the House Ways & Means Committee favorably referred legislation that would extend telehealth flexibilities for two years, to the full House of Representatives. While it's an exciting moment for many proponents, this is merely the first step toward the legislation potentially becoming law.

During the Covid-19 pandemic, Congress expanded where and how Medicare enrollees could receive many kinds of care, but those rules are set to expire at the end of this year.

While roughly a dozen different bills had been proposed to permanently enshrine the popular rules, the new bill, which was first released earlier this week, basically just moves the end date on flexibilities. As we previously reported, extension is seen as the most likely short term path forward because it is easier to pay for.

In the markup hearing, Rep. Lloyd Doggett (D-TX) registered the sternest objection, saying that while he would support the legislation, it did not go far enough to prevent fraud. In addition to telehealth flexibilities, the proposed legislation would also extend t he Acute Hospital at Home Waiver program for five years.

Read more about the brewing telehealth policy landscape here

Artificial intelligence

AlphaFold 3 is here. Are we there yet?

Google this week released AlphaFold 3, the latest version of its AI system for aiding in structural biology research and drug discovery. The model, whose initial breakthrough was to predict protein structure, is now capable of accurately mapping the interaction of a much wider universe of biomolecules, including RNA, DNA, ions and residues.

Biologists anticipating the model's release said its new capabilities represent a fundamental advance in the plodding work of untangling the mechanisms of disease. But it remains to be seen whether it will significantly advance the precision of drug research, or lower the sky high failure rates of late-stage clinical trials.

Most new drugs consist of small molecules designed to bind to a protein involved in disease. Casey Ross reports that AlphaFold 3 opens broader avenues of exploration, allowing scientists to rapidly examine complex interactions with other molecules that may highlight new disease targets — and different ways of attacking them.

Telehealth

Amazon Clinic leader departs

ALEX HOGAN/STAT

Nworah Ayogu, the general manager at Amazon Clinic, the company's store for virtual care appointments, is leaving the company to join investment firm Thrive Capital.

Ayogu originally joined Amazon as the medical director PillPac k, which eventually morphed into Amazon Pharmacy. In an interview with my colleague Katie Palmer last summer, he described how the idea to create a way to connect users to outside telehealth vendors came from the observation that many people had health concerns that didn't necessarily demand medication as an answer.

"If we're going to do it, let's make sure we're leveraging things that Amazon does really well, which is connecting buyers and sellers," he told Katie.

Ayogu's move comes as many large players are reconsidering their virtual care offerings, especially around urgent care services that are hard to distinguish from one another. In some ways, Amazon Clinic is the ultimate expression of how such care is commodified: when you go to Amazon Clinic and select a particular concern, the service presents you with several different vendors that can provide you with an appointment.

Amazon's health care strategy has itself seen several swerves in recent years, including the shutdown of its homegrown virtual care service, Amazon Care, and the company's acquisition of OneMedical. It's fun to speculate about what different moves mean for Amazon's future in health care, but the reality is that it's incredibly difficult to predict.

In a farewell post, Ayogu affirmed his ongoing confidence in Amazon's health care future.

Wearables

Apple's A-fib History feature gets fresh FDA nod

The Apple Watch secured a new qualification from the Food and Drug Administration that could make the smartwatch an appealing tool for medical device companies hoping to illustrate the benefits of a common heart procedure.

The Apple Watch's Atrial Fibrillation History feature has now became the first digital tool qualified under the FDA's Medical Device Development Tools (MDDT) program. Released in 2022, the feature estimates a user's A-fib burden, or how much time they spend in atrial fibrillation. The qualification means that FDA has determined in advance that sponsors can use the feature as a secondary endpoint in clinical trials for cardiac ablation devices without having to do additional work.

Earnings

Will the VA shape up as a digital health market?

For a while now, I've been following pharmaceutical company Orexo's stumbling course in digital health. And recently, it's been banking on the Department of Veterans Affairs as a possible source of sales.

To review: Orexo, which makes almost all of its money from a drug used to treat opioid dependence, made an aggressive move to develop digital treatments during the pandemic. The market for both direct-to-consumer sales and insurance reimbursement turned out to be much smaller than the company anticipated. It slashed its investments and has basically said it intends to wait and see how the market develops.

Within its "cost-conscious approach to commercialization" Orexo is hopeful that the VA will blossom into a real market. The company's apps designed to help people with problem drinking and opioid addiction have been reimbursed within the VA Federal Supply Schedule as of January 1st. On the earnings call this week, Orexo CEO Nikolaj Sørensen said the company is now working with an external vendor to see if they can set up some pilot programs within that.

Orexo is hardly the first digital health company I've heard say they want to target the VA or the military. Many innovative mental health treatments I've covered at STAT were born out of research that was funded to help treat the mental health issues of soldiers. I've been interested to learn how the VA has come to embrace the potential of virtual reality based treatments. But I'm honestly very curious to see whether the VA ends up being a big enough market to sustain digital health companies.

lizzy's device digest

FDA recalls and warnings

STAT's medical devices ace Lizzy Lawrence writes in to tell us us about two FDA actions of note.

At least 224 diabetes patients have been harmed by a software error causing their insulin pumps to spontaneously shut down, FDA announced in a recall notice on Wednesday. The product is made by Tandem Diabetes Care, which sells touchscreen insulin pumps and an accompanying app to help dose the medicine. Read Lizzy's story on the recall here.
In other news, FDA is warning health care providers about using Swedish company Getinge's balloon devices that are implanted in the chest to help the heart pump more blood. The company has recalled devices 12 times since January 2023, eight of which the FDA considered the most serious type of recall. The agency has received almost 3,000 reports of complications, 15 of which resulted in serious injury or death.

The European Union's device regulatory body temporarily removed its clearance from the Getinge device in March. The FDA notice makes it clear that Getinge is in big trouble with the U.S. regulator as well.