Home Visit Scheme; FDA Faces Pressure on Psychedelics; Hospital Stifled Debate?

Welcome to the latest edition of Investigative Roundup, highlighting some of the best investigative reporting on healthcare each week.

$15B From One-Hour Nurse Visits

Insurers send nurses into the homes of Medicare beneficiaries millions of times each year to gather new diagnoses that allow Medicare Advantage plans to collect additional money from the federal government, the Wall Street Journal reported.

Insurers urged nurses to perform screening tests and add unusual diagnoses, turning hour-long visits into an extra $1,818, on average, from 2019 to 2021, WSJ reported, citing its own investigation of home visits. The payments added up to about $15 billion during this period, according to its analysis of Medicare data.

Recently, WSJ also reported that insurers received nearly $50 billion in payments from 2019 to 2021 due to diagnoses they added and that no doctor or hospital treated. Diagnoses after home visits account for approximately 30% of this total, WSJ reported. More than 700,000 peripheral artery disease cases diagnosed solely during home visits added $1.8 billion in payments, WSJ reported.

Insurers, including UnitedHealth and CVS Health, told WSJ that home visits help patients, including by catching diseases early and making sure people are properly taking their medications. They also said they relay home visit findings to primary care physicians.

A CMS spokesperson told WSJ that the agency recently ramped up audits to verify diagnoses, and that it is eliminating some diagnoses — including peripheral artery disease — from those that qualify for extra payments.

Psychedelic Advocates Turn Up Heat on FDA

Jack Bergman (R-Mich.), a 77-year-old retired Marine Corps general, has “emerged as an unlikely advocate” for treating veterans with post-traumatic stress disorder (PTSD) with the psychedelic drug ecstasy, Politico reported.

Bergman, who flew helicopters in Vietnam and earned 3 stars, “sees promise in psychedelics that a group of mostly psychiatry professors who advise the FDA didn’t when they recommended the nation’s drug regulator turn down a pharmaceutical company’s application to offer MDMA along with therapy as a PTSD treatment,” Politico reported.

That pharmaceutical company is Lykos Therapeutics, and the FDA is expected to make a decision on its treatment by August 11.

Bergman co-founded the Congressional Psychedelics Advancing Therapies Caucus with Rep. Lou Correa (D-Calif.), and its members include Rep. Jimmy Panetta (D-Calif.), a former Navy intelligence officer whose father is a former head of the Defense Department, and Morgan Luttrell (R-Texas), a retired Navy SEAL who has used psychedelics to treat trauma due to a training accident.

Bergman also led a bipartisan group of 80 legislators in sending letters to President Joe Biden and FDA Commissioner Robert Califf, MD, pushing for fast-track approval of the treatment.

“The strategy here is to put pressure in a positive way so that the bureaucracy feels it’s OK to assume some risk,” Bergman told the outlet.

Other psychedelic advocates — including Elon Musk, doctors, investors, and drug legalization advocates — have called on FDA to approve the therapy. The agency declined to comment since the company’s application is still under review.

Mount Sinai Stifled Debate?

The Mount Sinai hospital network in New York City moved to “blunt the fallout” over a research project in which brain biopsies are taken from patients having deep brain stimulation (DBS), STAT reported.

This has included “not only enlisting its own patients to defend the research but also seeking to stop a professional society of neurosurgeons from issuing a statement that could have jeopardized the research,” STAT reported.

The campaign reportedly ensued after a previous STAT investigation disclosed that an FDA review found researchers at Mount Sinai were misleading patients and using a false justification to obtain biopsies, the outlet stated. (As part of its investigation, STAT also published a piece detailing Mount Sinai’s responses to its questions about the research project.)

Regarding outreach to patients, a spokesperson for Mount Sinai told STAT the following: “As caregivers, it is our obligation to follow-up with our patients to ensure their well-being.”

As for reported attempts to quiet fallout at the biennial meeting of the American Society for Stereotactic and Functional Neurosurgery (ASSFN), the spokesperson said in part that, “We question how you arrived at … any of these statements regarding the ASSFN meeting given that it is a closed meeting and its content confidential.”

STAT said its investigation has “set off a debate within the neurosurgical community about patient consent, and how to ethically pursue sensitive brain research that provides no therapeutic benefit,” and that it has also “prompted concern that the controversy itself could chill further research, which must already meet a high bar for approval.”

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