In the midst of a health crisis a few years ago, patient advocate Samantha Bonsack learned a startling fact: The thyroid-stimulating hormone test — one of the most commonly ordered laboratory blood tests in the country — is not standardized. Depending on which company’s analyzer processes the blood, the same sample can yield results differing from 20% to 40%.

“What makes this failure especially frustrating is that the scientific solution already exists,” Bonsack writes in a new First Opinion essay. The CDC, along with an international clinical chemistry group, created a validated protocol to streamline the results from different companies. But the FDA has never required manufacturers to recalibrate, and the CDC lacks enforcement power. Read more on what Bonsack says should be a straightforward fix to this long-ignored problem.

FDA to Moderna: Never mind

That didn’t take long. Moderna said this morning that the FDA will now review its experimental mRNA flu vaccine, reversing its decision denying a review because of a dispute over the vaccine’s clinical trial design.

Expect attention now to turn toward Vinay Prasad, the FDA’s top vaccine regulator, who overruled his own staff recommendation to block the Moderna vaccine review. Now, it seems, Prasad has been overruled.

“We appreciate the FDA’s engagement in a constructive … meeting and its agreement to advance our application for review,” said Stéphane Bancel, Moderna’s chief executive officer of Moderna, in a statement.

from AXIOS:

Low CMS rates blunt digital health hopes

Illustration: Sarah Grillo/Axios

Digital health insiders are underwhelmed by the reimbursement rates CMS just set for a tech-focused pilot program that pays Medicare providers a fixed amount to manage patients’ chronic issues. Why it matters: The industry hoped for a major health tech boost from the ACCESS program, but the $7 per-member, per-month rate is a far cry from the $30-$50 figure industry experts anticipated, Erin Brodwin wrote first on Pro. What they’re saying: The figures “are so low that it will require some real breakthroughs in technology-enabled care to make the math work,” says Venrock partner Bob Kocher. “This is not enough money to support clinicians engaging in care,” Kocher adds. How it works: CMS’ initial reimbursement figures range from roughly $180-$360 per year, depending on the specialty. The agency then withholds half until outcomes are proven at the end of a 12-month care period. Case in point: For musculoskeletal conditions, for example, the agency will reimburse $180 per year. With $90 withheld, that leads to roughly $7.50 in monthly cash flow per patient. The other side: The model is better suited for companies making intensive use of AI — letting them operate with less staff and on slimmer margins, several industry experts say.