Thursday Miscellany

David Ermer–Congress, End of the PHE, NE, FDA, Medical / Rx research, OPM, SCOTUS, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC, Roll Call reports

“Lawmakers from both parties suggested negotiators were making progress Thursday toward a bipartisan deal that would raise the $31.4 trillion debt limit, though days of talks still lie ahead.

“Scrambling to avert a debt limit breach that Treasury Secretary Janet L. Yellen said could hit as early as June 1, negotiators are attempting to reach a framework for a deal by Sunday, when President Joe Biden returns from a trip to the G-7 summit in Japan.

“Speaker Kevin McCarthy, who is negotiating with Biden through proxies, said he is hopeful that a deal could come as soon as this weekend. In a sign of progress, the two parties have begun to exchange offers, said House Rules Chairman Tom Cole, R-Okla.

“We’ve made good progress this week, but the work continues,” said Senate Majority Leader Charles E. Schumer. “ No one will get everything they want.”

“If a deal is reached by Monday, the House would vote next week, with 72 hours notice after the text is posted. While the Senate is scheduled to be in recess next week, Schumer said his chamber would be prepared to reconvene with 24 hours’ notice to schedule a vote.”

Per STAT News

“Pharmacy benefit managers would be subject to new transparency rules under a bill that cleared a key House subcommittee, Modern Healthcare says. The Transparent PRICE Act of 2023, which received a unanimous vote in the House Energy and Commerce Committee’s Health Subcommittee, would require pharmacy benefit managers to annually provide employers with detailed data on drug spending, including acquisition costs, out-of-pocket spending, formulary-placement rationale, and aggregate rebate information. The bill also would order the Government Accountability Office to report on group health plan pharmacy networks, including those owned by health insurers.”

Fierce Healthcare discusses other healthcare actions taken by this subcommittee yesterday.

BioPharma Dive tells us

“The U.S. Supreme Court on Thursday ruled against Amgen in its decade-long battle with Sanofi and Regeneron, affirming a lower court’s decision that Amgen’s rivals did not infringe on patents the biotechnology company held on a cholesterol-lowering medicine.

“In a unanimous decision authored by Justice Neil Gorsuch, the court said two Amgen patents on its PCSK9 inhibitor Repatha fell short of a legal standard known as enablement, which requires the claimed invention be described well enough to allow a skilled person in the field to use it. * * *

“The court’s ruling could open the door for challenges to older classes of antibody therapies, [University of Illinois law professor Jacob]Sherkow said. “This decision is probably going to give challengers solace. They’re going to have good options when working with the enablement requirements to challenge competitors’ patents out there.”

From the public health front —

  • The Robert Wood Johnson Foundation released its 2023 U.S. county health rankings while the UnitedHealthFoundation issued its 2023 Seniors Report from its America’s Health Rankings Services.
  • MedPage Today informs us
    • “The CDC encouraged populations at risk of contracting mpox, formerly known as monkeypox, to get fully vaccinated against the disease as part of preparations for summer during a briefing Thursday morning.
    • “Demetre Daskalakis, MD, the White House National Mpox Response Deputy Coordinator, noted that with summer gatherings on the horizon, mpox vaccination should be considered, as should overall sexual health and wellness.
    • “Getting ‘summer ready’ means mpox vaccination, but that’s not all it means — it also means to be up to date on all of your sexual health, and that includes HIV and STIs [sexually transmitted infections] like syphilis, gonorrhea, and chlamydia,” he said.”
  • The Department of Health and Human Services posted a fact sheet with “Resources on Ways Communities Can Stay Protected from Mpox in Advance of Summer Months.”
  • The Wall Street Journal points out the important medical tests that Americans should consider undergoing over the decades of life.
  • The U.S. Preventive Services Task Force notified the public about a draft research plan concerning “Weight Loss to Prevent Obesity-Related Morbidity and Mortality in Adults: Interventions” that is open for comment until June 14, 2023.

From the Food and Drug Administration front, the Wall Street Journal reports

“The Food and Drug Administration for the first time cleared a test to gauge a mother’s risk of severe preeclampsia, a leading cause of pregnancy-related illness and death in the U.S.  

“Thermo Fisher Scientific said Thursday that the blood test it already sells in Europe could be available in the U.S. soon. Its introduction could transform prenatal care in the U.S., doctors and maternal-health advocates said.”

Bravo.

From the U.S. healthcare business front —

  • Beckers Hospital Review notes five new details about Kaiser Permanente’s Risant Health deal.
  • Fierce Healthcare discusses provider objections to what appears to the FEHBlog to be a reasonable new prior authorization program that UnitedHealthcare is introducing. No good deed goes unpunished.

From the miscellany department —

  • STAT News relates that
    • “A multibillion-dollar science agency tasked with slashing through research bureaucracy will start its work with a plan to help people regenerate bone.
    • “The Advanced Research Projects Agency for Health, launched a little more than a year ago, announced Thursday that its first official program would target bone and joint damage from osteoarthritis, a condition affecting more than 32 million Americans.”
  • Govexec discusses FEHB coverage of Covid tests and vaccines following the end of the PHE.
  • The Equal Employment Opportunity Commission weighs in on the Title VII compliance implications of employer use of artificial intelligence to make employment decisions.