FDA misses pulse oximeter target date

For months, FDA officials have said they'd release new guidelines to encourage device firms to make pulse oximeters more equitable for patients with darker skin by Sept. 30. But the day has come and gone, and the recommendations still aren't here, my colleagues Usha Lee McFarling and Lizzy Lawrence report.

FDA spokesperson Carly Kempler said the agency is working to get the guidance out as "expeditiously" as possible, but physicians who rely on the devices are frustrated.

The delay could be costly for patients, as evidence has shown that inaccurate readings for patients with darker skin can make them less likely to receive the supplemental oxygen they need, which can lead to death and organ failure. STAT has pioneered coverage on this issue, so you can bet Usha and Lizzy will keep on it.

congress

House Democrat leads challenge to Biden administration on opioid addiction treatment

Rep. Annie Kuster (D-N.H.) is leading the charge to call on the Biden administration to preserve health providers' ability to prescribe a highly effective opioid addiction treatment via telehealth, STAT's Lev Facher scooped yesterday.

Currently, a pandemic-era emergency waiver issued by DEA to allow buprenorphine products to be prescribed via telehealth expires at the end of 2024. A bipartisan group of 17 members of Congress signed on to the letter.

The pressure from House Democrats comes as the telehealth and addiction medicine worlds anxiously await the DEA's final decision on whether to roll back some of the telehealth flexibilities, which it proposed doing in 2023. It's the home stretch for regulatory decisions by the Biden administration, so the coming weeks will be crucial.

insurance

Humana's stars are shooting… downward

Humana's Medicare business has gone from bad to worse, my colleague Bob Herman reports, following news that more of its Medicare Advantage members are enrolled in plans with lower star ratings.

Plans that have higher star ratings, which are supposed to be a proxy for quality, get bonus payments from the federal government. The proportion of Humana's enrollees in plans that have high star ratings plummeted from 94% this year to 25% for next year, and Humana's stock dropped with the news on Wednesday.

Star ratings will officially be announced a week from today. The announcement will be yet another headwind for the company, which is seeing its enrollees using more health care services than it expected and is planning to cut benefits.

drug pricing

Senators press FTC to investigate new PBM subsidiaries

Two Democratic senators are asking FTC Chair Lina Khan to investigate whether CVS Health and Cigna's new business units might unfairly steer patients toward more costly medicines, my colleague Ed Silverman writes.

The new subsidiaries, which sign "co-manufacturing deals" with companies that make biologic medicines and biosimilars, may be a bid to control more parts of the prescription drug supply chain, Sens. Ron Wyden (D-Ore.) and Sherrod Brown (D-Ohio) write.

The units add yet another layer of complication to the competition for biosimilar versions of drugs to gain market share. Read more from Ed on PBMs' cutting-edge tactics to expand their influence.

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