The FEHBlog will be on hiatus following today until next December 27 Cybersecurity Saturday. Merry Christmas and Jingle Bells to all.

From Washington, DC,

• Federal News Network reports,
  • “There’s an old adage that tells someone to “put your money where your mouth is.” Well, Don Bauer is going all in at the Office of Personnel Management.
  • “Bauer wrote a column for Federal News Network criticizing OPM’s plans to consolidate and modernize human resources systems across the government. In his Oct. 30 column, Bauer wrote that OPM’s initial plan was “not modernization; it’s madness.”
  • “Now Bauer is in charge of that madness. Federal News Network has learned Bauer will join OPM on Jan. 12 as its new deputy associate director for workforce standards and data center (WSDC) in the HR Solutions (HRS) office. He will be leading the HR Line of Business, the quality service management office (QSMO) and human capital management core modernization effort.”
• Good luck, Mr. Bauer.

• Mercer tells us,
  • “In Notice 2026-5, IRS and the Treasury Department provide key details about health savings account (HSA) enhancements passed as part of the One Big Beautiful Bill Act (OBBBA) (Pub. L. No. 119-21), clearing the way for employers to continue offering telehealth and to begin offering direct primary care service arrangements (DPCSAs) to otherwise HSA-eligible employees.
  • “Effective for the 2025 plan year, OBBBA reinstated and made permanent COVID-19-era telehealth relief allowing HSA-compatible high-deductible health plans (HDHPs) to cover telehealth and other remote care services before the statutory minimum deductible is satisfied.
  • “Beginning Jan. 1, 2026, OBBBA also allows individuals enrolled in DPCSAs to remain eligible to make or receive HSA contributions and treats certain bronze and catastrophic plans as HDHPs.
  • “This article summarizes the Notice 2026-5 question-and-answer guidance, addressing significant topics such as which services the IRS will treat as “telehealth and other remote care services;” whether a DPCSA can separately bill for primary care services or offer services beyond primary care; and whether a bronze or catastrophic plan can be an HDHP if purchased using an employer-sponsored individual coverage health reimbursement account (ICHRA).
  • ‘Comments about the guidance are due March 6, 2026.”

• Per a CMS news release,
  • “The Centers for Medicare & Medicaid Services (CMS) announced today a new voluntary test of a model that is designed to enable Medicare Part D plans and state Medicaid agencies to cover GLP-1 medications used for weight management and metabolic health improvement, while helping control costs for patients and taxpayers.
  • “The Better Approaches to Lifestyle and Nutrition for Comprehensive hEalth (BALANCE) Model builds on emerging evidence that combines access to GLP-1 medications with access to evidence-based lifestyle supports to achieve better long-term health outcomes. The model represents a major step toward potential expanded access and affordability for millions of Americans. 
  • “Today’s announcement builds upon our historic Most Favored Nations drug pricing deals’ goal of democratizing access to weight-loss medication, which has been out of reach for so many in need,” said CMS Administrator Dr. Mehmet Oz. “These actions further the administration’s bold plan to reform our country’s health systems and Make America Healthy Again. With the BALANCE Model, we’re pairing breakthrough science with healthy living to cut costs while empowering Americans to take control of their health.”
  • “Under the model, CMS negotiates directly with pharmaceutical manufacturers of GLP-1 drugs for lower net prices and standardized coverage terms. Negotiation areas include: 
    • “Guaranteed net pricing and potential out-of-pocket limits for beneficiaries;
    • “Standardized coverage criteria; and
    • “Evidence-based lifestyle support offerings.”
  • “To learn more about the BALANCE Model, visit: https://www.cms.gov/priorities/innovation/innovation-models/balance. 
  • “Prior to the launch of the BALANCE model, CMS also plans to implement a new Medicare GLP-1 payment demonstration beginning in July 2026, which will serve as a short-term bridge to the model. This additional payment demonstration means that Medicare beneficiaries can start accessing these important medications at prices negotiated by the Administration as soon as possible.
  • “The GLP-1 payment demonstration will operate outside of the Medicare Part D benefit’s coverage and payment flow, which means that Part D Plan Sponsors will not carry risk for eligible GLP-1 products furnished under the demonstration. Beneficiaries enrolled in Medicare Part D who meet the negotiated access criteria will have access to these drugs. Under the demonstration eligible Medicare beneficiaries will pay $50 for a month of GLP-1 medications.
  • “CMS will provide additional information on the design and implementation of the GLP-1 payment demonstration in early 2026.

• The Wall Street Journal points out,
  • “About half of 20 million Americans with FSA [healthcare flexible spending] accounts let some of their money expire each year.
  • “The average forfeited amount per individual is over $400, and unused FSA money generally returns to employers.
  • “FSAs offer tax savings; a worker in the 22% tax bracket contributing $1,500 could save as much as around $500 in taxes.”

• Per an AHIP news release from December 18,
  • “AHIP’s Board of Directors has elected Jim Rechtin, President and CEO of Humana, as Board Chair effective January 1, 2026. Rechtin succeeds Pat Geraghty, who announced his retirement after 14 years leading GuideWell and Florida Blue effective December 31, 2025.
  • “I was proud to be part of AHIP’s work this year to unite our industry around voluntary commitments to simplify prior authorization – an important ongoing effort that shows what’s possible when health plans work together to deliver for patients. As Board Chair, I look forward to taking the same cooperative approach to helping health consumers navigate the system and access high-quality, affordable care,” Rechtin said.

From the Food and Drug Administration front,

• MedPage Today tells us,
  • “The FDA has expanded the indication of ferric maltol (Accrufer) capsules for the treatment of iron deficiency to include adolescents.
  • “The approval makes the drug the first prescription oral medicine for iron deficiency in pediatric patients ages 10 and older. It was first approved in 2019 for adults with iron deficiency.
  • “The expanded indication was supported by the phase III FORTIS trialopens in a new tab or window in which 24 patients ages 10-17 received age-based dosing of ferric maltol twice daily, and showed a clinically meaningful average increase in hemoglobin of 1.1 g/dL at 12 weeks. This would be the expected average increase in hemoglobin with one blood transfusion, the agency noted.”

• MedTech Dive reports,
  • “Edwards has received Food and Drug Administration approval for its Sapien M3 mitral valve replacement system, the company said Tuesday.
  • “The device is intended for people with moderate to severe mitral regurgitation, a heart condition where the valve between the left heart chambers doesn’t fully close, allowing blood to leak back through. Sapien M3 is indicated for people who are deemed unsuitable for surgery or transcatheter edge-to-edge repair therapy, a minimally invasive procedure to fix a valve by clipping its leaflets together.”
• and
  • “The Food and Drug Administration said Monday it has issued a Class I recall notice regarding Medtronic’s removal of heart vent catheters.
  • “Medtronic previously asked customers to quarantine lots of its DLP Left Heart Vent Catheters in response to an issue linked to three serious injuries. The FDA published an early alert about the recall in August.
  • “The agency updated its notice this week to inform the public that it has classified the issue as a Class I recall.” 

From the public health and medical / Rx research front,

• MedPage Today reports,
  • “Infants given the monoclonal antibody nirsevimab, which provides temporary immunity to respiratory syncytial virus (RSV), had lower risks of related hospitalizations and severe outcomes than those whose mothers got the RSVpreF vaccine, according to a population-based study.
  • “The study may be the first to compare the two interventions in a real-world setting in a national population.
  • “The study and two others reported alongside it join a growing body of real-world evidence demonstrating the effectiveness of RSV products in protecting against severe outcomes related to RSV in the youngest kids.”

• Health Day informs us,
  • “People on the verge of type 2 diabetescan cut their risk of death from heart disease by more than 50% if they bring their blood sugar levels back to normal, a new study says.
  • “Patients with prediabetes reduced their heart risk by up to 58% when they successfully lowered their blood sugar, researchers reported in The Lancet Diabetes & Endocrinology.
  • “This is an important finding, given that recent studies have concluded people with prediabetes can’t lower heart disease risk through lifestyle changes like exercise, weight loss and a healthy diet, researchers said.
  • “Essentially, reversing prediabetes by lowering blood sugar matters more to your heart than any healthy habits you adopt, researchers said.
  • “This study challenges one of the biggest assumptions in modern preventative medicine,” said lead researcher Dr. Andreas Birkenfeld, a reader in diabetes at King’s College London.

• Medscape points out,
  • “A trio of large observational studies reported at the San Antonio Breast Cancer Symposium (SABCS) 2025 suggest that GLP-1 receptor agonists may improve outcomes in some women with breast cancer.
  • “Two studies reported an overall survival benefit of GLP-1 use in certain patients with breast cancer, including those with ductal carcinoma in situ (DCIS) and invasive hormone receptor (HR)-positive nonmetastatic disease, and a third found improvements in a range of toxicities among patients receiving chemotherapy.
  • “These studies, presented during a poster session, add to other emerging research indicating that GLP-1 drugs could have implications across the breast cancer trajectory, including prevention, active therapy, and posttreatment survivorship, explained study discussant Jasmine S. Sukumar, MD, with University of Texas MD Anderson Cancer Center in Houston.”

• Fierce Pharma relates,
  • “Just days after an upbeat R&D event, Neurocrine Biosciences has found itself having to report a phase 3 failure.
  • “The company’s Ingrezza (valbenazine), approved to treat certain uncontrolled movement conditions, failed to make a significant difference in a phase 3 trial for patients with dyskinesia due to cerebral palsy (CP), Neurocrine announced Monday.
  • “Ingrezza didn’t outperform placebo on improving involuntary, jerky movements of the body after 14 weeks of treatment, causing the phase 3 trial to miss its primary endpoint. The study, dubbed Kinect-DCP, also did not meet key secondary endpoints, according to Neurocrine.”
• and
  • “A patient in an open label extension study of Pfizer’s hemophilia treatment Hympavzi has died, the company and several hemophilia advocacy groups confirmed this week.
  • “Pfizer is now working with its trial investigator and independent data monitoring committee to accrue more information and better understand the circumstances behind the incident, the New York drugmaker wrote in a letter to the hemophilia community, which was posted online (PDF) by the World Federation of Hemophilia (WFH) on Dec. 22.”

• STAT News reports,
  • “Oncologists have been moving away from the notoriously unpopular neutropenic diet. It requires nearly all food to be cooked to high temperatures — or, as some have described it, “boiled to death” — to reduce the risk of food-borne illnesses. But since evidence in recent years suggested the diet didn’t actually help ward off infections, doctors started leaning away from a strict neutropenic diet.
  • “Now, a new study published last week in the Journal of Clinical Oncology is giving some physicians pause about fresh fruits and vegetables for patients whose treatment involves heavy suppression of the immune system, particularly neutrophils, white blood cells that are key to preventing infection. Contrary to research in the past, the trial found that certain blood cancer patients who were allowed a less restrictive or liberalized diet had 11% more infections than patients who were prescribed the neutropenic diet.”

From the U.S. healthcare business front,

• Modern Healthcare reports,
  • “Analysts expect health insurance companies to be better positioned for 2026 after adjusting their offerings.
  • “Medicare Advantage offers the sector the largest potential for improvement because companies will receive a significant increase in federal pay. 
  • “Federal changes to Medicaid and the exchanges will pressure health insurance companies’ finances.”

• Ernst & Young informs us,
  • “A changing healthcare landscape is shifting economic returns, leading organizations to rethink their value chain position.
  • “Expansion in lower-acuity care and opportunistic mergers and acquisitions can accelerate long-term growth.
  • “Implementing new benefit cost containment strategies and investing in innovative AI solutions can elevate efficiency and performance.”

• Per a Harvard Business Review article,
  • “U.S. employers are grappling with surging healthcare costs as healthcare prices and service volumes rise. Provider consolidation, high drug prices, labor shortages, and growing chronic disease are fueling the cost increases. Employer have largely responded by shifting expenses to workers. Their track record in pursuing aggressive options—including collective purchasing, tiered plans, value-based care, and advocating for changes in government policies—is poor. The big question is whether they have the will to become more aggressive in pursuing remedies. The outlook is not promising. The reasons include the complexity of the problem, employee resistance to some solutions, and the fact that most employers just don’t have sufficient “skin in the game” to take on the disruption and risk that would be required to bend the healthcare cost curve significantly or sustainably.”
• The FEHBlog has more confidence in employers.

FEHBlog response to public comment

• A commenter called into question the statistices upon which AHIP relied in this recent news release which the FEHBlog quoted. In response the FEHBlog notes that the AHIP news release was generated in response to the Affordable Care Act marketplace subsidy controversy and 2020 was an outlier year for all health insurers as it was the first year of the Covid pandemic. Health plans did make MLR rebates in that year according to CMS.