September 12, 2023

On tap today: DEA's telemedicine listening session

The Drug Enforcement Administration — responsible for promulgating rules surrounding virtual prescribing for controlled substances without an in-person visit — is convening a public listening session on the topic today and Wednesday. We'll be monitoring the discussions for perspectives from psychiatry professional groups, patients and tech companies that have built a business facilitating these types of prescriptions during the pandemic's early stages.

As they wade through 38,000 public comments on a proposal to restrict some virtual prescribing — which garnered censure from doctors and Democratic lawmakers concerned about limits on substance use disorder treatment and a potential spike in opioid-related deaths, — DEA and the Health and Human Services Department have temporarily extended pandemic-era flexibilities allowing virtual prescribing for some controlled substances without an in-person visit.

But patients — including those being treated for substance use disorder — could abruptly lose access to life-saving medication if the flexibilities are reversed, patient advocacy organizations and psychiatry industry groups have warned.

Also coming up today: Apple's consumer tech showcase, with rumored iPhone 15 and Apple Watch announcements. It's not clear if we'll see anything about the company's creep into health care — like the electrocardiogram feature it's been building out for the past few years, or reported blood pressure monitoring capabilities — but we'll have updates in Thursday's edition if so.

Big tech

Where's Amazon headed in health care?

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Also on Big Tech's plans for health: Last week my colleague Katie Palmer spoke with four of the retail giant's chief medical officers — from Amazon Health Services, One Medical, Amazon Pharmacy and Amazon Clinic — about the company's future. Since we've watched several of its previous attempts to shake up the market falter, including Haven and Halo, Katie's keeping close tabs on whether its latest suite of services can coalesce into a viable, scalable end-to-end health care business.

"We have learned a lot in the years that we've been dabbling in health care," Sunita Mishra, chief medical officer for Amazon Health Services, told Katie. "And it's now made us more confident that we're on the right track."

"I think there's this expectation that Amazon is going to come in and displace, versus complement and try to fix what's not working," Vin Gupta, chief medical officer for Amazon Pharmacy, said. "And you don't have to displace to fix what's not working. Read more from Katie here.

big box

Report: Walmart in talks to buy stake in ChenMed

WalMart is considering buying a majority stake in senior-focused primary care chain ChenMed, Bloomberg reported late last week. Still, the deal, which values ChenMed at several billion dollars, isn't finalized and could still fall through, that report said.

If it does go through, the deal could set WalMart up to take on other retailers and pharmacy chain competitors snapping up primary care tech companies, like CVS, which acquired Oak Street Health in May in a deal valued at more than $10 billion.

Devices

Years late, FDA moves on a flawed approval pathway

The Food and Drug Administration is finally moving on a plan to improve a medical device approval program that critics warn has overlooked risky devices, Lizzy Lawrence reports.

In general, medical device manufacturers don't have to test products on people to score FDA clearance; instead, they must demonstrate that their products are "substantially equivalent" to devices already on the market, termed "predicates." That process is known as the 510(k) pathway, accounts for the vast majority of new medical devices launched on the market each year, including x-ray machines and wheelchairs.

Critics have warned, however, that the pathway doesn't appropriately account for the fact that clinical data for predicates might be out of date. So five years after promising to fix the 510(k) program, the agency published some guidelines late last week explaining how it now plans to evaluate devices — including by asking manufacturers to avoid previously marketed devices that were recalled for design issues or safety concerns, and to submit flow charts explaining why they chose to submit those devices if they do.

It might not work, experts told Lizzy.

"It's likely that these will lead to small improvements in terms of patient safety, but none of the proposed suggestions solve the fundamental issue with 510k," said Alex Everhart, a health economist at Washington University. "Sometimes the FDA is going to make mistakes." Read more from Lizzy here.

Telehealth

Study: Spanish speakers face telehealth challenges

A secret shopper study led by RAND's Lori Uscher-Pines suggests that Spanish speakers face more challenges than other patients when scheduling telehealth appointments. Over a few hundred calls to California safety net clinics, nearly a fifth of calls in Spanish ended with the scheduler hanging up on the patient or telling them no one could assist them in Spanish, the study found. Callers told schedulers they were new patients looking for depression medication.

Findings suggest that language guidance at clinics may not be adequate — especially if it focuses on patient-clinician communication instead of on patients' interactions with schedulers, authors wrote.

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What we're reading

A16z-backed HealthIQ files for bankruptcy, Forbes
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New obesity drugs are in the works to challenge Wegovy and Mounjaro. STAT

Thanks for reading! More on Thursday - Mohana

Mohana Ravindranath is a Bay Area correspondent covering health tech at STAT and has made it her mission to separate out hype from reality in health care.