April 6, 2023

Telehealth

The gray area of telehealth's weight loss ads

Companies including Ro and Calibrate have capitalized on new weight loss drugs by launching telehealth services dedicated to prescribing Wegovy and Ozempic. In Ro's case, the company has launched with prominent subway ads that feature close-up pictures of people injecting themselves and simple pitches like "Wegovy to lose weight."

Experts say that the promotions run into a regulatory gray area of direct-to-consumer drug advertising. There are long-standing boundaries for drugmakers who must list side effects and risks, but less clarity for telehealth companies that have cropped up to prescribe their medicines. The FDA told STAT it may have oversight over prescription drug ads if a telehealth company ships medicines — which Ro said it doesn't — but in other situations, doesn't have regulatory authority.

"Enforcement advertising regulations, FDA, FTC simply have not caught up with this new world, and we think it's a wild one," Thomas Moore of Johns Hopkins told Mohana. Read her full story here.

medical devices

Boston Scientific is latest to tackle obesity

The obesity treatment landscape has evolved tremendously over the past few years, particularly with the emergence of weight loss drugs like Wegovy. Device makers want in on the conversation — starting with Boston Scientific, which yesterday closed on its deal to acquire Apollo Endosurgery.

Apollo specializes in minimally invasive surgeries in the GI tract, selling two flagship weight loss devices. Boston Scientific's core focus is also minimally invasive surgery, but Apollo represents its first foray into bariatric surgery. "We've been calling it a measured entry into the bariatric space," Brian Dunkin, who oversees Boston Scientific's endoscopy division, told me. "We want to get our experience using a technology that has clinical data to support its use."

I sat down with Dunkin to learn more about the acquisition, and whether there's room for device-based treatments in the obesity treatment whirlwind. Read more here.

medicare advantage

Biden cracks down on using algorithms to deny care

The Biden administration is moving forward with proposals that would crack down on Medicare Advantage insurers that deny care inappropriately — including if companies use algorithms to turn down coverage.

A recent STAT investigation found Medicare Advantage companies increasingly have used unregulated algorithms to determine when they can cut off patients' care. Many of those people are in nursing homes, rehab facilities, and other post-acute settings, and judges often rule that the algorithms run afoul of Medicare law and should have covered the care.

Starting next year, Medicare Advantage plans cannot reject coverage of procedures, prescription drugs, tests, or supplies that would otherwise be covered if someone were enrolled in traditional Medicare, according to final regulations issued Wednesday. Medicare Advantage, the privatized version of the original Medicare program, covers more than 31 million older adults and people with disabilities in insurance plans. The federal government also specifically called out the use of algorithms being used to reject care.

sleep tech

Snoo, the smart bassinet, gets FDA clearance

The Food and Drug Administration has granted Happiest Baby a clearance it can use to market its $1,700 Snoo smart bassinet more aggressively to parents anxious about sudden infant deaths. It wasted no time taking advantage of the clearance, billboarding the "FDA De Novo approval" on its website and blasting parents with an email alert touting the FDA's "approval" of its "ability to keep babies safely sleeping on their backs."

Read closely, the marketing authorization is somewhat unusual. Happiest Baby has pioneered a new FDA device classification called an "infant supine sleep system." Babies are locked into the bassinet using a special swaddle that physically prevents them from rolling over. As the FDA notes, babies who sleep on their backs are "at lower risk of sudden infant death syndrome or sudden unexpected infant death."

But though the device has shown in a single-arm observational study to promote a recommended safe sleep practice, Happiest Baby concedes in the press release that "Snoo has not directly demonstrated a reduction in the incidence of SIDS/SUID." Of 3.6 million births in 2020, there were 3,356 reports of SUID in 2020, according to the CDC. It's likely that the tragic outcome is so rare that a study to detect Snoo's impact would need to be prohibitively large.

data leak

Alcohol recovery startup Monument leaks patient data

Monument, an online alcohol counseling startup, has been sharing patient data with advertisers for years. In a data breach notification issued last week, the company confirmed it used tracking technology that scooped up personal data and shared it with big tech companies like Google and Facebook. This personal information may have included names, birthdates, and appointment-related information.

Monument is one of dozens of telehealth startups that have shared sensitive health data with big tech companies, STAT and The Markup found in December. Monument is also one of the companies called out in February by a bipartisan group of senators who cited STAT and The Markup's investigation as evidence for Monument's shady data practices. "This data is extremely personal, and it can be used to target advertisements for services that may be unnecessary or potentially harmful physically, psychologically, or emotionally," the senators wrote.

opioids

Former Magellan execs allegedly sold faulty lead tests

Federal prosecutors have charged three former executives at Magellan Diagnostics with selling defective lead testing machines that generated inaccurate results for tens of thousands of children nationwide, as well as clients of at least one international relief organization.

Prosecutors said the executives knew the devices — including Magellan's Leadclear II product, which was used for half of all tests conducted in the United States in 2017 — had a manufacturing flaw that generated false negatives, giving parents the mistaken impression their children were safe. "We allege that these defendants deceived customers and the FDA about the reliability of medical tests that detected lead levels. By doing so, we assert that they endangered the health and lives of incredibly vulnerable victims," Rollins said in a statement. "According to the CDC, there is no safe level of lead in the blood." Read more here.

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What we're reading

Why don't we screen healthy people to catch diseases early?, Out of Pocket
Developing better digital health measures of Parkinson's disease using free living data and a crowdsourced data analysis challenge, PLOS Digital Health
Often overlooked, a common infection during pregnancy kickstarts a conversation about newborn screening, STAT