policy
How much Pfizer and Lilly paid telehealth companies
As pharma companies continue to build bridges with the telehealth companies that can get their drugs prescribed, a new report reveals that some drugmakers are paying hundreds of thousands, if not millions, for their telehealth contracts.
In the last nine months, four senators have peppered Pfizer, Eli Lilly, and five of their telehealth partners with questions about their contracts, hoping to suss out whether they are inappropriately influencing clinicians' prescriptions. Their report published today reveals new details about those eyebrow-raising deals, along with some of the telehealth companies' prescribing behaviors and industry payments outside the contracts.
Read more from Katie Palmer here
telehealth
CMS doesn't heed RPM warnings
As I discussed on Tuesday, Medicare regulators this week proposed to cover more remote patient monitoring. If the rules are finalized, doctors will now be able to bill in circumstances in which they collect less data and spend less time interacting with patients.
What Medicare did not do was propose any guardrails to prevent abuse despite a growing chorus of policy experts warning that Medicare may be paying for low-value services. Medicare started covering RPM in 2019, and paid over $300 million for RPM in 2022. There was a feeling on both sides of the debate that Medicare might institute new rules, but it did not.
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Regulation
FDA, Whoop, and the fuzziness of regulation
The Food and Drug Administration warned wearable maker Whoop this week about its new Blood Pressure Insights feature, which the agency believes is a medical device subject to its regulatory review, because "the product is intended to provide a measurement or estimation of a user's blood pressure, which is inherently associated with the diagnosis of hypo- and hypertension." The agency points to the company's statements, like "Higher blood pressure may be an indicator of poor sleep," as evidence.
Whoop launched Blood Pressure Insights in early May, and it has been extremely deliberate in framing it as a wellness feature that is not intended to diagnose or treat disease. The FDA appears to be saying it must review any technology that offers users measurements of blood pressure.
The episode is emblematic of how fuzzy regulation can be around wellness and medical devices. In his response, CEO Will Ahmed pointed to the importance of the "intended use" of a technology. In other cases, FDA lets companies get away with claiming a device that could be regulated is for wellness purposes. For now, Ahmed wrote, "we won't let regulatory overreach dictate how people access their own health data." The company has 15 business days to tell FDA how it has remedied the situation. Popcorn out!
A couple of interesting pieces of context. First, it's interesting to see FDA warning a company in an anti-regulation administration, especially as Ahmed recently met with health secretary Robert F. Kennedy Jr. and Whoop executive Kristen Holmes just testified before a House committee. Clearly, whatever strings Whoop is pulling in Washington isn't helping with FDA — yet.
The warning letter came just six days after FDA cleared a cuffless wearable from Aktiia that monitors blood pressure, and it's been reported that Apple has been working on a blood pressure feature for many years. It's conceivable there were complaints about Whoop's feature when others are going through the FDA process.
Whoop's feature doesn't directly measure blood pressure — it uses PPG, a non-invasive optical technique, to estimate it. The company claims its algorithms are based on "32,000 sleep sessions from 11,000+ members, then validated the results against clinical readings." Would that stand up to FDA scrutiny? We don't know.
Let me know your thoughts!
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