Midweek Update

David Ermer–ACA, Congress, FDA, Federal employment benefits, Medical / Rx research, SDOH, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC

  • Beckers Payer Issues reports,
    • “Making expanded ACA subsidies permanent would add $335 billion to the national deficit between 2025 and 2034, the Congressional Budget Office estimated. 
    • “Premium tax credits have spurred record enrollment in ACA marketplace plans. These subsidies, implemented in 2021, are set to expire at the end of 2025 unless Congress votes to extend them. 
    • “In a June 24 letter to the chairs of the House ways and means and budget committees, the CBO estimated making subsidies permanent would cost $415 billion overall — the result of a $250 billion increase in spending and a $164 billion decrease in tax revenue. 
    • “These costs would partially be offset by a decline in offers of employment-based insurance, the CBO estimated, resulting in a total add of $335 billion to the budget.  * * *
    • “Payer executives have told investors they are optimistic Congress will cut a deal to extend the subsidies or make them permanent.”
  • Fierce Healthcare tells us,
    • “A leading Democrat and health legislator is urging the Centers for Medicare & Medicaid Services (CMS) to better enforce Medicare Part D program requirements for pharmacy benefit managers.
    • “By evading such requirements, PBMs are threatening the financial health of the country’s smaller pharmacies, Senate Finance Committee Chair Ron Wyden, D-Oregon, wrote to the agency in a letter (PDF).
    • “I am alarmed to hear reports that PBM contracting practices are straining the finances of pharmacies and directly contributing to their closures,” he said. “Specifically, I am concerned PBMs are not adhering to the new rule reining in direct and indirect remuneration (DIR) fees that took effect on January 1 and undermining Medicare’s pharmacy access standards as intended by Congress.”
  • The National Academies of Sciences, Engineering, and Medicine released a report titled “Ending Unequal Treatment: Strategies to Achieve Equitable Health Care and Optimal Health for All” which follows up on a well-known 2003 report on social determinants of health.
  • Per an FDA press release,
    • “Today, the U.S. Food and Drug Administration issued a draft guidance, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies,” to assist medical product sponsors in submitting Diversity Action Plans to support certain clinical studies. Diversity Action Plans are intended to increase clinical study enrollment of participants of historically underrepresented populations to help improve the data the agency receives about the patients who may potentially use the medical product. * * *
    • “Comments on the draft guidance should be submitted within 90 days after publication in the Federal Register to Regulations.gov. All written comments should be identified with the docket number and with the title of the guidance document.”
  • Federal News Network informs us,
    • “For more than a week, federal employees enrolled in FSAFEDS have not been receiving payments for approved reimbursement claims made in their Flexible Spending Accounts.
    • “The program suspended all reimbursement payments beginning June 16 as an effort to further strengthen anti-fraud and security measures, Federal News Network confirmed with a government source who explained the issue on the condition of anonymity.
    • “At this time, the FSAFEDS is holding all claims payments out of an abundance of caution,” FSAFEDS wrote Tuesday in a post on X. “FSAFEDS has taken this action due to recently discovered fraudulent claims activity. We are working to resolve and restore all claims payment activities as soon as possible.”
    • “The pause on reimbursement payments, however, has been lifted and payments to employees should resume soon, Federal News Network has learned. FSAFEDS plans to process all reimbursements currently on hold by the end of the week.

From the public health and medical research front,

  • MedPage Today tells us,
    • “All adults ages 75 years and older should receive a single dose of any respiratory syncytial virus (RSV) vaccine, and adults ages 60 to 74 years who are at increased risk of severe RSV disease should receive a vaccine, according to a unanimous 11-0 vote by the CDC’s Advisory Committee on Immunization Practices (ACIP).
    • “Also, people who have already received the RSV vaccine are not recommended to receive a booster, based on data that showed another dose did not improve outcomes.
    • “These recommendations supplant the current recommendation that adults ages 60 and older may receive RSV vaccination after engaging in shared clinical decision-making with their healthcare provider.
    • “There are currently three RSV vaccines available for use in older adults — GSK’s adjuvanted RSV prefusion F protein-based vaccine (Arexvy) Pfizer’s unadjuvanted, bivalent RSV prefusion F protein vaccine (Abrysvo), and Moderna’s mRNA-1345 vaccine (mRESVIA).
  • The American Hospital Association News notes,
    • “The Administration for Strategic Preparedness and Response June 25 announced a flu pandemic preparedness and response strategy in response to the threat of H5N1 bird flu in humans. The strategy, released through ASPR’s Biomedical Advanced Research and Development Authority, has four objectives: strategic implementation and deployment of the national pre-pandemic influenza vaccine stockpile; enhanced protection through novel vaccines; leverage therapeutics through deployment, early availability and development of novel products; and ensure rapid and effective diagnostics tools to inform rapid antiviral prescription and treatment.” 
  • BioPharma Dive calls attention to the fact “Women with a common hormonal disorder have few good treatment options. Could GLP-1 drugs help? There are no drugs specifically for polycystic ovary syndrome, a chronic condition that can cause infertility. One study is testing whether Wegovy might be beneficial.”
  • Per Fierce Pharma,
    • “[Verona Pharma’s] Ohtuvayre [which the FDA approved for marketing today] becomes the first novel treatment advance in more than a decade for COPD, an inflammatory condition which restricts airflow from the lungs and leaves patients struggling to breathe. Ohtuvayre is approved as an add-on medicine with current therapies.
    • “As a selective dual inhibitor of the phosphodiesterase 3 (PDE3) and phosphodiesterase 4 (PDE4) enzymes, Ohtuvayre combines two properties in one medicine, setting it apart in COPD for its ability to both open the airways of patients and reduce their inflammation.
    • “It’s really the first novel mechanism as an inhaled therapy in over 20 years for COPD,” David Zaccardelli, Verona’s CEO said in an interview with Fierce Pharma. “We believe its bronchodilator and non-steroidal anti-inflammatory activity has the potential to change the treatment paradigm.”
  • The Washington Post reports,
    • “A few of your favorite ice cream products might no longer be in the freezer this summer after a prominent supplier to brands such as Hershey’s and Friendly’s issued a recall notice over a potential listeria contamination.
    • “Maryland-based Totally Cool recalled products from 13 brands distributed nationwide in retail locations and through direct delivery after sampling by the Food and Drug Administration discovered the presence of Listeria monocytogenes, the bacterium that causes listeria infections, the agency said Monday.
    • “The brands involved were Abilyn’s Frozen Bakery, Amafruits, Chipwich, Cumberland Farms, Dolcezza Gelato, Friendly’s, Hershey’s Ice Cream, Jeni’s, LaSalle, Marco, Taharka Brothers, the Frozen Farmer and Yelloh. More than 65 products were recalled, including ice cream cakes and sandwiches, as well as sorbets, according to a list published by the FDA that includes expiration dates.”

From the U.S. healthcare business front,

  • Kaufmann Hall discusses the state of play in healthcare antitrust enforcement.
  • The Wall Street Journal predicts “The War Over Cheaper Ozempic Won’t End Well for Some Investors. Once Eli Lilly and Novo Nordisk increase supply of weight-loss medications, companies such as Hims & Hers may find it trickier to sell compounded versions of the drugs [due to the nuances of FDA law.]”
  • MedTech Dive points out “Abbott and Dexcom are launching the first over-the-counter CGMs. Here are 7 questions on the new tech. Experts expect the release of new over-the-counter glucose monitors in the U.S. to fuel more widespread use of the devices.”
  • Per Fierce Healthcare,
    • “Blue Shield of California is making it easier for members to access their personal health data through its new Member Health Record.
    • “The platform will combine health data both from claims as well as from providers in one place and is available both online and through Blue Shield’s app so members can connect virtually. The Member Health Record will first launch for a “select group” of Medicare Advantage members and will be rolled out to all of its members by the end of the year.
    • “The health record will include information on lab results, immunizations, diagnoses and conditions alongside historical health data that have been shared with the plan, including details tallied before the member joined Blue Shield.”