From Washington, DC,
- The White House posted a fact sheet on the steps that the Administration is taking to lower health and prescription drug costs.
- Following up on yesterday’s post, BioPharma Dive adds
- The White House on Thursday took steps to pressure pharmaceutical companies to lower the price of drugs developed with federal funding, backing a plan that would enable the government to sidestep patent protections for those medicines.
- New draft guidelines published by the National Institutes of Standards and Technology permit government agencies to consider “reasonableness of the price” when evaluating whether to invoke so-called march-in rights, which permit the government to suspend patents when federally funded inventions aren’t made available to the public.
- The newly published framework gives agencies the power to act “if it appears that the price is extreme, unjustified, and exploitative of a health or safety need.” One example is a “sudden, steep price increase in response to a disaster,” although the initial cost of a drug when it’s launch can also be considered, the guidance said.
- The agency is seeking further comment on its guidance — the product of an interagency review that began early this year — before publishing a final version.
- The Senate Finance Committee leadership announced that “the Committee has reported legislation that was marked up in the committee in November. The “Better Mental Health Care, Lower-Cost Drugs, and Extenders Act” addresses a number of important health care priorities in the committee’s jurisdiction.”
- American Hospital News tells us,
- “The House Energy and Commerce Committee Dec. 6 advanced 19 health care bills, including legislation (H.R. 6364) that would prevent Medicare from publicizing a telehealth provider’s home address when the provider delivers telehealth services from their home. AHA has additionally urged Congress to remove a requirement that these telehealth providers report their home address on Medicare enrollment and claims forms effective Jan. 1, 2025.
- “The committee also advanced H.R. 6545, as amended, which included provisions that were part of two other bills that had previously moved through the health subcommittee: H.R. 6366, to extend for one year the Geographic Practice Cost Index floor for physician work under the Medicare Physician Fee Schedule; and H.R. 6369, to extend the 3.5% incentive payment for eligible Advanced Alternative Payment Model participants for the calendar year 2026 period. AHA supports the extension, but would prefer Congress to restore the incentive payment to 5% and remove the legislation’s payment reductions for longstanding participants.”
- MedPage Today offers insights into a December 5 Senate Finance Committee hearing on drug shortages.
- The Government Accountability Office issued a report on “improper payments and fraud: how they are related but different.” OPM has focused FEHB carrier attention on this topic in 2023.
In federal benefit news,
- FedWeek discusses how FEHB premiums compare for retirees versus employees.
- Govexec reports,
- “For the third time this year, the federal government’s backlog of pending retirement claims filed by departing federal workers hit a six-year low, as the Office of Personnel Management continues its focus on improving a process that has long pestered agencies and retirees alike.
- “OPM reported Tuesday that its retirement backlog fell to 15,826 pending cases at the end of November. That’s the second time the inventory fell below 16,000 this year, and the third time this year that the backlog reached a six-year record low, dating back to when it briefly felt to around 14,000 in 2017. OPM’s goal is a “steady state” of 13,000 pending claims at any given time.
- “In 2023, the retirement backlog has fallen in seven out of 11 months. Last month, the average processing time fell across multiple metrics. Measured on a monthly basis, the average processing time of a retirement claim fell from 73 days in October to 66 last month. And the average processing time so far this fiscal year—or since Oct. 1—fell from 73 at the end of last month to 69 days.”
From the public health and medical research front,
- The Washington Post offers helpful advice on wounds that aren’t healing properly.
- JAMA Network posts observations on GLP-1 drugs from last October’s Obesity Week meetings. Of note,
- “Jacinda Nicklas, MD, MPH, gave a talk at the conference showing that females often respond better to newer antiobesity medications than males.
- “Something that we’re gradually becoming more aware of over time is that GLP-1s, in general, seem to work better in females,” Nicklas, an associate professor of internal medicine at CU School of Medicine who specializes in obesity and women’s health, said in an interview with JAMA.
- “Nicklas did not present new research, but instead combed through past studies of GLP-1 agonists. She said sex differences haven’t often been separated out in studies and that the majority of participants in the clinical trials are females.
- “Digging into the data from the STEP trials of semaglutide, she said females had greater weight reduction than males. The same was true in a phase 2 clinical trial of retatrutide for treatment of obesity without type 2 diabetes. Participants who received the highest dose lost an average of 24% of their body weight but females lost much more: about 29% compared with about 20% for males.”
- MedPage Today tells us that an “Alzheimer’s Blood Test Predicts Who Might Benefit Most From Anti-Amyloid Drugs — Novel two-cutoff approach may reduce need for confirmatory PET scans.”
From the U.S. healthcare business front,
- Beckers Hospital Review points out that “U.S. News and World Report released a list December 5 recognizing hundreds of hospitals for maternity care.” Becker’s article includes that list.
- Beckers Health IT notes,
- “CVS is planning to release a new mobile healthcare app designed to function as a central hub for its healthcare services.
- “The app, teased in a video at the company’s Dec. 5 investor meeting, can help consumers manage their prescriptions while providing access to informative health tips.
- “Some of the app’s other features include an augmented reality store navigation and a function that allows consumers to schedule appointments at CVS MinuteClinics and CVS-owned Oak Street Health.
- “An AI-powered chatbot will also be integrated into the app so consumers can get their questions answered.
- “CVS did not detail when the app would be released.”
- The Wall Street Journal reports,
- “Merck & Co. is ending a late-stage study of the combination of Keytruda and Lynparza in certain lung cancer patients due to an expected failure of the trial.
- “The Rahway, N.J., drugmaker, which was evaluating Keytruda in combination with maintenance Lynparza in a Phase 3 study in patients with metastatic squamous non-small cell lung cancer, said it is stopping the trial for futility based on the recommendation of an independent data monitoring committee.”