Tuesday Tidbits

David Ermer–CDC, Medical / Rx research, Mental health care, NIH, Rx coverage, SCOTUS, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC —

  • The U.S. Supreme Court released three more opinions this morning. The Wall Street Journal reports
    • “The Supreme Court rejected a bid by Norfolk Southern to limit its state-court liability in states where it does relatively little business, ruling Tuesday that states can require companies to submit to their courts’ jurisdiction as a condition of doing business within their borders.
    • “While the case involved a long-pending workplace lawsuit filed by a retired railway employee from Virginia, Justice Neil Gorsuch, writing for a 5-4 majority of the justices, linked the issue to a Norfolk Southern train’s Feb. 3 derailment in East Palestine, Ohio.”
  • The Supreme Court has pending seven more decisions from its October 2022 term. The next decision day will be Thursday morning.
  • Beckers Hospital Review tells us,
    • “The Federal Trade Commission has proposed changes to the premerger notification form in addition to premerger notification rules implementing the Hart-Scott-Rodino Act, which requires organizations to report large transactions to the FTC and Justice Department for antitrust review.
    • “The HSR Act and its implementing rules related to mergers and acquisitions involve completing HSR Forms and waiting a specified period of time before completing the transaction.
    • “The proposed HSR changes would help the agencies to more effectively screen transactions for potential competition issues within the waiting period, which is generally 30 days. The FTC said that this competition review is important to identify deals that require in-depth investigations to determine whether they would violate antitrust laws and, if so, to seek to block the proposed transaction.”
  • HHS Inspector General announced posting
    • “its final rule implementing information blocking penalties. The final rule establishes the statutory penalties created by the 21st Century Cures Act. If OIG determines that an individual or entity has committed information blocking, they may be subject up to a $1 million penalty per violation.
    • “The final rule does not impose new information blocking requirements. OIG incorporated regulations published by the Office of the National Coordinator for Health Information Technology (ONC) as the basis for enforcing information blocking penalties. For more information on ONC’s information blocking regulations see: Information Blocking.
    • “To report complaints about information blocking, please visit the ONC Information Blocking Portal or the OIG Hotline.”
  • HR Dive points out the steps that covered employers to take to comply with the Pregnant Workers Fairness Act, which took effect today.

From the public health front —

  • The Washington Post reports,
    • “For the first time in two decades, malaria infections have been confirmed in people who did not travel outside the United States, leading federal health authorities to warn about the potential for transmission of the mosquito-born disease within the nation’s borders.
    • “Four people in Sarasota County, Fla., and one in Cameron County, Tex., were confirmed as having been infected between late May and late June through local transmission. All have gotten treatment and are recovering as health officials watch for additional cases, the Centers for Disease Control and Prevention said.
    • “Although the potentially fatal disease was once endemic, it was declared eliminated in the United States in 1951. About 2,000 people are diagnosed with malaria in the nation each year, but those cases have involved trips abroad. For a handful who came down with the disease in recent months, that was not the case.
    • “The risk of getting malaria in the United States “remains extremely low,” the CDC said. Still, experts said Americans should be aware of the possibility and take steps to prevent mosquito bites.”
  • The CDC discusses a recent study examining the health impact of widening the age range eligible for cost-free in-network diabetes type 2 testing.
  • The Health and Human Services Department “released a report showcasing evidence-based interventions to support physical activity among adults ages 65 years and older. By the year 2030, 1 in every 5 Americans will be age 65 or over. More than 85 percent of older adults currently have at least 1 chronic health condition. The growing population of older adults can gain substantial health benefits and prevent or manage chronic disease by engaging in physical activity.”

From the Rx coverage front —

  • Health Affairs lets us know that
    • “Using Medicare claims, we documented US prescribing patterns for originator biologic trastuzumab (Herceptin), a targeted cancer therapy, and five biosimilar entrants since 2019. The first biosimilar captured a dominant share, but over time, average sales prices of all products declined, and later entrants became dominant in some states. Despite strong brand loyalty to the first biosimilar, competitive pressure increased with subsequent entrants.”
  • Beckers Hospital Review relates
    • “With about a dozen cancer drugs on back order and no clear end to the shortages, the American Society of Clinical Oncology and the Society of Gynecologic Oncology recently advised clinicians to ration chemotherapy supplies. 
    • “The updated guidelines recommend curbing or halting pharmaceutical treatment for patients with “recurrent, agent-resistant cancers” — which means saving therapies for patients with a better chance of surviving. 
    • “The national cancer care group also recommended extending the time between treatments when appropriate; lessening waste by “optimizing vial size, dose rounding and using multi-use vials”; and providing support services to patients and clinicians experiencing “shortage-related distress.”
    • “Two cancer drugs in shortage that treat multiple cancers and cost about $20 per vial, cisplatin and carboplatin, have been in shortage for months. One of the main suppliers for the drugs ended operations in late 2022 after FDA investigators found numerous quality infractions and ruined reporting documents. In another inspection, the agency found more quality issues, which could further delay expected recovery. 
    • “The FDA allowed a China-based drug company to produce and import cisplatin, and the agency is working to boost carboplatin supplies.”

From the studies front —

  • The National Institutes of Health announced
    • “In people with Alzheimer’s disease, the underlying changes in the brain associated with dementia typically begin many years—or even decades—before a diagnosis. While pinpointing the exact causes of Alzheimer’s remains a major research challenge, they likely involve a combination of genetic, environmental, and lifestyle factors. Now an NIH-funded study elucidates the role of another likely culprit that you may not have considered: the human gut microbiome, the trillions of diverse bacteria and other microbes that live primarily in our intestines.
    • “Earlier studies had showed that the gut microbiomes of people with symptomatic Alzheimer’s disease differ from those of healthy people with normal cognition [2]. What this new work advances is that these differences arise early on in people who will develop Alzheimer’s, even before any obvious symptoms appear.
    • “The science still has a ways to go before we’ll know if specific dietary changes can alter the gut microbiome and modify its influence on the brain in the right ways. But what’s exciting about this finding is it raises the possibility that doctors one day could test a patient’s stool sample to determine if what’s present from their gut microbiome correlates with greater early risk for Alzheimer’s dementia. Such a test would help doctors detect Alzheimer’s earlier and intervene sooner to slow or ideally even halt its advance.”
  • Fierce Healthcare informs us
    • “Medicare Advantage (MA) beneficiaries given home-delivered meals in the four weeks after being discharged from a hospital were not only less likely to be readmitted within 30 days, they were also less likely to die, according to a study in JAMA Health Forum.
    • “The 2018 Chronic Care Act gave MA plans greater leverage to address the social determinants of healthcare. In addition to giving insurers an impetus for launching dietary programs, the act also covers transportation for beneficiaries and other at-home services.
    • “The study states that “nearly three-quarters of MA plans offered meals as a supplemental benefit in 2022, mostly driven by expectations of downstream cost savings based on findings from earlier observational studies of community-based nutrition programs, and desires to maintain market parity in an increasingly competitive MA space.
    • “Beginning in January 2021, Kaiser Permanente Southern California (KPSC) began offering home-delivered meals to eligible MA enrollees. The comparative cohort study in JAMA Health Forum examines data from 4,032 KPSC MA enrollees who’d been hospitalized for heart failure and 7,944 who’d been hospitalized for other reasons after they’d been discharged from Jan. 1, 2021, to Jan. 31, 2022. The data come from 15 hospitals in the KPSC network.”

In U.S. healthcare business news —

  • Healthcare Dive reports
    • “Walgreens missed Wall Street earnings expectations in its third fiscal quarter and cut its 2023 outlook, citing macro factors including a weak respiratory season and falling demand for COVID-19 tests and vaccines.
    • “The pharmacy chain did beat the Street’s revenue expectations with a topline of $35.4 billion, up 9% year over year, thanks in part to its expanding U.S. Healthcare segment, which includes value-based medical group VillageMD.”