Friday Factoids

David Ermer–CMS, FDA, Federal employment benefits, Generative AI, Medicare, SDOH, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From the FDA front —

  • MedPage Today tells us
    • “Lecanemab (Leqembi) showed clinical benefit in early Alzheimer’s disease in its confirmatory trial, paving the way for traditional approval of the drug, an FDA advisory committee said Friday.
    • “In a 6-0 vote, the agency’s Peripheral and Central Nervous System Drugs Advisory Committee fully backed the evidence supporting the anti-amyloid monoclonal antibody. * * *
    • “The agency is expected to make its final decision about lecanemab by July 6.
  • KFF provides a cost perspective in anticipation of FDA approval of this drug, which action is expected to trigger CMS approval for Medicare Part B coverage.

From the FEHB front, Tammy Flanagan writing in Govexec delves into FEHB and Medicare Part B coverage.

From the litigation front —

  • The Wall Street Journal reports
    • “Pharmaceutical industry giants completed a deal to pay $19 billion to states that accused them of fueling the opioid crisis, infusing more money into communities still struggling with how to address the scourge of drug use.”
    • “Most states agreed to the deal to settle agreements with manufacturers Teva and Allergan as well as pharmacy chains CVS and Walgreens. The agreement is in addition to a $26 billion so-called global settlement with drug distributors McKesson, Cardinal Health and AmerisourceBergen and manufacturer Johnson & Johnson. The latest settlements close lawsuits against most of the major players and brings the total income from opioid litigation that states will have to spend to about $50 billion. 
    • “The legal fight stretches back nearly a decade, when more than 3,000 lawsuits from states, Native American tribes and counties alleged the drugmakers, pharmacies and distributors played down the risk of painkillers and didn’t stem their flow. Misuse of prescription painkillers sparked a health crisis that was supercharged as fentanyl infiltrated the illicit drug supply and now claims more than 100,000 lives in the U.S. each year. 
    • “Money from the recent settlements will begin to flow to states this year. More than $3 billion from the global settlementhas already been dispersed. The funds are distributed to states based on population adjusted to account for the burden of the opioid epidemic based on deaths and people using drugs. The agreements require most of the money to be spent on abating the opioid crisis, but the parameters are broad and officials are using different strategies to spend it.”
  • KFF has created a tracker to follow the distribution of the opioid litigation settlement funds.

From the CMS front —

  • Healthcare Dive informs us,
    • “CMS is exploring programs that would pay social or community health workers to address patients’ social needs in a bid to invest more heavily in food, housing, transportation and other social determinants of health, according to agency officials.
    • “We are looking at that. For example, in maternal health, thinking about the role of doula and community health workers,” Liz Fowler, director of the Center for Medicare and Medicaid Innovation, said on Thursday during the CMS’ inaugural health equity conference.”
  • and
    • “CMS announced a new model that aims to strengthen and improve primary care, including by ensuring small and rural organizations are able to enter into value-based care arrangements. 
    • “The Making Care Primary Model will run for more than 10 years in eight states — in Colorado, Massachusetts, Minnesota, New Jersey, New Mexico, New York, North Carolina and Washington.
    • “Research shows primary care is key to improving health outcomes and lowering costs. The CMS noted Medicare and Medicaid patients are often diagnosed with multiple chronic conditions, and primary care providers are charged with prevention, screening and management. But, because many patients will see multiple specialists, coordinating care can be challenging.”
  • Fierce Healthcare relates,
    • “The Department of Health and Human Services (HHS) has released a 43-drug list of the Medicare Part B prescription treatments that must repay the program for raising prices above the rate of inflation.
    • “The second quarterly list takes effect in July and is an expansion over the 20 price-capped drugs from April through June. According to HHS, the rebates could save Medicare beneficiaries taking the treatments anywhere from $1 to $449 per average dose in out-of-pocket costs.
    • “The Medicare Prescription Drug Inflation Rebate Program is a critical way to address long-term price increases by drug companies, and [the Centers for Medicare and Medicaid Services (CMS)] is continuing our work to make prescription drugs more affordable for people with Medicare,” CMS Administrator Chiquita Brooks-LaSure said in a release.
    • “The full list of prescription drugs and biological products with adjusted coinsurance amounts for July 1 to Sept. 30 is available here (PDF).
    • “Of note, CMS said the list could be adjusted before or after July 1 based on public feedback notifying the agency of any potential discrepancies, as was the case during the program’s inaugural quarter when a highly publicized list of 27 drugs was later trimmed down to 20.”

From the U.S. healthcare business front —

  • Beckers Hospital Review reports
    • “In the first quarter of 2023, 17 healthcare companies with more than $10 million in liabilities filed for Chapter 11 bankruptcy, a sharp rise compared to seven bankruptcies in the first quarter of 2022, Bloomberg Law reported June 9.
    • “High-profile bankruptcies from Envision, Invacare Corp. and Sorrento Therapeutics contributed to the numbers. The first three months of 2023 saw a slight slump in bankruptcies but remain higher than the same period a year ago.
    • “Despite the year-over-year increase, the first quarter of 2023 still had fewer healthcare bankruptcies than the fourth quarter of 2022.
    • “Once the government money ran out, once all the stimulus dollars around healthcare ran out, there was essentially going to be this backwash,” Timothy Dragelin, a healthcare director at FTI Consulting, told Bloomberg. “The fact that labor costs increased substantially—you also had the issues with supply chain and supply chain caused some disruptions.”
  • Fierce Healthcare tells us
    • “Walgreens Boots Alliance sold its remaining stake in post-acute care and infusion services company Option Care Health for $330 million.
    • “The drugstore chain announced Thursday it sold 10.8 million shares of Option Care Health and plans to use the proceeds primarily for debt paydown, continued support of the company’s strategic priorities and to help fund its healthcare-focused business initiatives, according to a press release.
    • “The transaction is another decisive action WBA is taking to unlock value and further simplify the company’s portfolio,” the company said.
    • “Back in March, Walgreens cut its stake in Option Care Health when it sold 15.5 million shares at $30.75 per share. The transaction reduced Walgreen’s ownership in the company, formerly known as Walgreens Infusion Services, from 14% to 6%, according to a Walgreens news release. “

From the generative AI front —

  • Beckers Hospital CFO Report points out the steps the Google and Microsoft are taking to integrate generative AI in healthcare systems.
  • HR Dive discusses the impact of generative AI on employers and the workplace.