Friday Report

Congress

Friday Report

David Ermer–CDC, CMS, Congress, COVID-19, FDA, Generative AI, Medical / Rx research, Medicare, SCOTUS, Telehealth, U.S. Healthcare–
Photo by JOSHUA COLEMAN on Unsplash

From Washington, DC

  • Govexec tells us,
    • “A 50-page document, compiled by GOP members of the House Budget Committee and first reported by Politico, outlines a list of provisions that could be included in the [budget reconciliation] package, which would not be subject to the Senate’s 60-vote filibuster threshold, includes a litany of proposals increasing federal workers’ contribution to their retirement and health care benefits, in exchange for worse payouts.” * * *
    • “On health care benefits, the House GOP proposes replacing the current system, by which the federal government pays for a percentage of health care premiums through the Federal Employees Health Benefits Program and the new Postal Service Health Benefits program, with a “voucher model.”
    • “Under this option, the FEHB and PSHB programs would be reformed by replacing the current premium-sharing structure with a voucher, which would not be subject to income and payroll taxes,” the document states.
    • “And the document calls for enactment of a bill introduced last year to require the Office of Personnel Management to audit FEHBP for improper enrollments. But OPM has said that under the current “decentralized” nature of the program, the agency does not have the capabilities to conduct such an audit.
    • “Prior to the presidential transition, then-President Biden’s OPM sent Congress a legislative proposal, drawn on lessons learned in launching the PSHB program this year, to revamp how it administers FEHBP so that it can conduct better oversight.”
    • FEHBlog observation — Better oversight starts with giving FEHBP and FEDVIP carriers the HIPAA 820 enrollment roster transactions that would allow them to reconcile individual enrollees with premiums paid.
  • MedPage reports,
    • “Legislation providing more scrutiny for pharmacy benefit managers (PBMs) that failed to make it through Congress in the waning days of 2024 seems to still be viable for passage this year, according to a House staff member.
    • “I think there’s plenty of political will there; that’s what I’ve seen from members,” Preston Bell, a professional staff member on the House Ways & Means Committee, said Thursday at an event sponsored by the American Enterprise Institute (AEI) on the future of the Medicare prescription drug benefit. “I do think there are disparate ideas across Congress as to how much intervention within the PBM market is appropriate. What you’ve seen come through Congress in the [massive continuing resolution] package [released and rejected in December 2024] is probably the litmus test, or maximum, of what is feasible for that type of reform.”
  • Healthcare Dive informs us,
    • “Sara Brenner, a Food and Drug Administration official in the agency’s medical device division, has been named the FDA’s acting commissioner, according to an update made online to the regulator’s leadership biography page. * * *
    • “Brenner will lead the agency until a permanent commissioner is installed. President Donald Trump has nominated Johns Hopkins surgeon Marty Makary as FDA commissioner, but he has not yet been confirmed by the Senate. Confirmation hearings for Robert F. Kennedy Jr., who, as Trump’s pick to run the Department of Health and Human Services, would be Makary’s boss, are scheduled for Jan. 29 and Jan. 30.
    • “Brenner worked in the FDA’s medical devices branch, most recently as chief medical officer for in vitro diagnostics and associate director for medical affairs. A preventive medicine physician, Brenner has been at the agency since 2019, according to her LinkedIn page, and helped coordinate diagnostic standards and policy as part of HHS’ COVID-19 response. 
    • “Brenner was previously a senior policy advisor at the White House Office of Science and Technology Policy under the first Trump administration.”
  • The Hill lets us know,
    • “The Food and Drug Administration (FDA) has withdrawn a rule that would have banned menthol cigarettes and flavored cigars, putting a formal end to a policy that had been indefinitely delayed under the Biden administration. 
    • “A regulatory filing showed the rule had been “withdrawn” on Jan. 21, President Trump’s second day in office. The move is a significant blow to public health groups who said banning menthol had the potential to save hundreds of thousands of lives, particularly among Black smokers.”
  • The IRS released its 2024 tax return edition of Publication 969 which concerns health savings accounts and other tax favored health plans.

From the judicial front,

  • Bloomberg Law reports,
    • “A former Johnson & Johnson executive’s allegations that the drug company overpaid for prescription drug benefits are “speculative and hypothetical,” and injuries she did suffer cannot be resolved by the court, a New Jersey federal judge ruled.
    • “The decision Friday dismissed most of Ann Lewandowski’s high-profile class action that argued the pharmaceutical giant violated its fiduciary duties under the Employee Retirement Income Security Act by not negotiating better drug prices with its pharmacy benefit manager, Express Scripts, or switching to a different PBM. 
    • “The lawsuit is one of several recent [actually it was the first] attempts to hold employers responsible through ERISA for monitoring and reducing health-care costs. The claims against J&J reveal that not even large drug companies are immune to complaints over high drug prices.
    • “Judge Zahid N. Quraishi in the US District Court for the District of New Jersey concluded that Lewandowski lacked standing to sue in dismissing two of her three claims. Lewandowski’s argument that J&J’s plan forced her to pay higher premiums and cost her higher wages was speculative “at best,” he said.
    • “And while Lewandowski did show that her copays for some drugs exceeded prices offered by other health plans, the court could not fulfill a key requirement for standing by making her whole, the judge said. Any amount refunded to her would have to go through the health plan for money it spent after she hit her out-of-pocket limit, Quraishi said.
    • “In straightforward terms, a favorable decision would not be able to compensate Plaintiff for the money she already paid,” he wrote.
    • “The judge did find that Lewandowski has standing to pursue her claim against J&J for not providing more information she requested around the plan’s drug prices, including the contract with Express Scripts, which was not a party to the suit. Quraishi invited Lewandowski to amend her complaint.”
  • The Wall Street Journal points out,
    • “Enforcement of the Corporate Transparency Act, which requires millions of companies to disclose their true ownership, remains on hold despite a U.S. Supreme Court ruling in favor of the Treasury Department. 
    • “The Supreme Court on Thursday overturned a lower court order that was blocking enforcement of the CTA. However, a separate national injunction issued earlier this month by a federal judge apparently remains in place and continues to block the law’s implementation.
    • “The Treasury’s Financial Crimes Enforcement Network, which is overseeing the law’s implementation, issued an alert Friday confirming compliance with the CTA isn’t mandatory while the injunction remains in force.” 
  • Fierce Healthcare relates,
    • “The Centers for Medicare & Medicaid Services has changed course on plans to appeal a court ruling that determined it must recalculate UnitedHealthcare’s Medicare Advantage star ratings.
    • “The agency submitted a filing in Texas district court earlier this week saying it intended to file an appeal to the Fifth Circuit Court. In new court documents filed Friday, CMS has withdrawn its notice of appeal.”

From the public health and medical research front,

  • The Center for Disease Control and Prevention announced today,
    • Seasonal influenza activity remains elevated across the country and is increasing in most areas. COVID-19 activity is elevated in many areas of the country. RSV activity has peaked in many areas of the country.
    • COVID-19
      • COVID-19 activity is elevated in many areas of the country, though wastewater levels are moderate, emergency department visits are at low levels, and laboratory percent positivity has declined in the last week. Emergency department visits and hospitalizations are highest in older adults and emergency department visits are also elevated in young children.
      • There is still time to benefit from getting your recommended immunizations to reduce your risk of illness this season, especially severe illness and hospitalization.
      • CDC expects the 2024-2025 COVID-19 vaccine to work well for currently circulating variants. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.
    • Influenza
      • Seasonal influenza activity remains elevated across the country and is increasing in many areas.
    • RSV
      • RSV activity has peaked in many areas of the country. Emergency department visits and hospitalizations are highest in children and hospitalizations are elevated among older adults in some areas.
    • Vaccination
      • Vaccination coverage with influenza and COVID-19 vaccines are low among U.S. adults and children. COVID-19 vaccine coverage in older adults has increased compared with the 2023-2024 season. Vaccination coverage with RSV vaccines remains low among U.S. adults. Many children and adults lack protection from respiratory virus infections provided by vaccines.
  • BioPharma Dive relates,
    • “An experimental obesity drug from Novo Nordisk helped people lose an average of up to 22% of their body weight over 36 weeks in an early-stage trial, results that, if reproduced in further testing, could rival medicines Eli Lilly has on the market and in development.  
    • ‘Novo said Friday it is planning “further clinical development” of the drug, called amycretin, but didn’t specify the design of additional trials or when they might begin. Amycretin affects the same two targets as a Novo drug called cagrisema that recently missed expectations in a Phase 3 trial but does so in a single molecule rather than a two-drug combination.”
       
  • Per Healio,
    • “Integrating lifestyle care into low back pain management resulted in greater improvements in disability, weight loss and physical quality of life vs. just guideline-recommended care, a randomized study showed.
    • “The findings, published in JAMA Network Open, “could influence future updates to back pain guidelines,” Emma Mudd, PhD, senior research officer at the University of Sydney in Australia and the analysis’ lead author, said in a press release. “Patients valued the holistic support, and the outcomes speak for themselves.”
  • Earlier this week, the CVS Health Foundation announced $4 million in grants related to its health aging initiative.

From the U.S. healthcare business front,

  • Beckers Hospital Review notes,
    • “Mayo Clinic’s chief executive said at the World Economic Forum’s annual meeting in Davos, Switzerland, that he is fully committed to the adoption of artificial intelligence in healthcare, the Rochester (Minn.) Post Bulletin reported.
    • “I personally would not want to have my healthcare, in some specialties, without AI because I firmly believe I will get a better outcome,” said Gianrico Farrugia, MD, president and CEO of the Rochester-based health system, according to the newspaper’s coverage of the event Jan. 22.
    • “Mayo Clinic has been at the forefront of developing and deploying healthcare AI, with 320 algorithms in use, the news outlet reported.”
  • Beckers Payer Issues adds,
    • Insurers do not have to own every part of the healthcare system to improve connection, according to Jim Boyman, vice president of GuideWell Health. 
    • GuideWell is the parent company of Florida Blue. In December, the company launched an initiative to manage cancer care for Florida Blue ACA members. Through a partnership with Cerritos, Calif.-based The Oncology Institute and primary care organization Sanitas, Florida Blue members diagnosed with cancer will be connected with an oncology team to manage a personalized treatment plan. 
    • “Everyone talks about how fragmented healthcare is,” Mr. Boyman told Becker’s. “This shows how you don’t necessarily have to own all parts of the system to reduce that fragmentation. You can use technology and relationships to collaborate and overcome fragmentation through programs like this.” 
  • Fierce BioTech reports,
    • “Neomorph is building out its supply of Big Pharma partnerships, this time stamping down an option-to-license pact with AbbVie that centers around the biotech’s molecular glue platform.
    • “AbbVie will pay the San Diego biotech an undisclosed upfront sum and offer up to $1.64 billion in option fees and milestones, plus royalties, according to a Jan. 23 release.
    • “The new partners will look to develop molecular glue degraders—a novel class of small molecules designed to selectively degrade proteins that drive disease—for multiple targets across oncology and immunology.
    • “Protein degraders represent a groundbreaking advancement in the field of drug discovery and at AbbVie we are committed to advancing this technology forward,” Steven Elmore, Ph.D., AbbVie’s vice president of small molecule therapeutics and platform technologies, said in the release. “We are excited to collaborate with Neomorph to develop novel molecular glue degraders that could pave the way for new, effective therapies in the treatment of immune disorders and cancer.”
    • “Neomorph emerged in 2020 and quickly garnered a neuro deal worth up to $1.45 billion in biobucks with Biogen, plus a partnership with Novo Nordisk that offers up to $1.46 billion.” 
  • Per Fierce Healthcare,
    • “Self-funded employer health plan Centivo is announcing Centivo Care, a tech-forward virtual primary care platform integrated with behavioral health specialists.
    • “Centivo’s virtual offerings, which will be available in states where the company operates, are increasingly desired by its clients’ members, said Wayne Jenkins, M.D., chief medical officer for Centivo and president of Centivo Care, in an interview with Fierce Healthcare.
    • “He said at first, just 5% to 10% of people preferred the virtual option, but now it’s closer to 20%. For some employers, they see an even higher adoption rate. One of its clients, JetBlue Airlines, sees high utilization since their employees travel so often and can more easily text with a physician or schedule a video call than attend an appointment in person.
    • “Centivo Care is one of few primary care practices to earn a Patient-Centered Medical Home accreditation from the National Committee for Quality Assurance, the company said in a news release. These virtual appointments are free, and members receive personalized care plans, after-visit summaries, preventive care reminders and more.”
  • Per Beckers Hospital Review,
    • Telehealth utilization grew across most U.S. regions in October 2024, with the Midwest as the sole exception, according to FAIR Health’s monthly telehealth regional tracker.
    • Nationally, telehealth claim lines increased from 4.80% of medical claim lines in September to 4.89% in October, marking a 2% rise. Regional increases varied, with the West seeing the largest growth at 2.8%, while the Midwest experienced a 3.7% decrease.
    • Here are four things to know about telehealth utilization, according to FAIR Health’s tracker:
      • Psychiatric nurses moved up to the second-most common telehealth specialty nationally in October, overtaking family practice, which fell to fourth place.
      • Mental health conditions remained the leading telehealth diagnostic category nationally and regionally. 
      • The tracker revealed modest differences in telehealth costs compared to office visits. For instance, the median cost for a nutritional therapy reassessment was typically $1 to $2 lower via telehealth than in-office, except in the West, where telehealth costs were slightly higher.
      • Telehealth usage was highest among patients aged 31–40, followed by those aged 19–30, a pattern consistent across all regions.

Thursday Report

David Ermer–Congress, Federal employment benefits, Government Contracting, Medical / Rx research, Mental health care, OPM, SCOTUS, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC

  • Per a Senate press release,
    • “U.S. Senate Democratic Whip Dick Durbin (D-IL) today delivered a speech on the Senate floor highlighting his Drug-price Transparency for Consumers (DTC) Act, a bill he is introducing with Senator Chuck Grassley (R-IA) that would require price disclosures on advertisements for prescription drugs in order to empower patients and reduce Americans’ colossal spending on medications. The Government Accountability Office (GAO) has found that prescription drugs advertised directly to consumers accounted for 58 percent of Medicare’s spending on drugs between 2016 and 2018, while a 2023 study in the Journal of the American Medical Association found that two-thirds of advertised drugs offered “low therapeutic value.” By requiring direct-to-consumer (DTC) advertisements for prescription drugs to include a disclosure of the list price, patients can make informed choices when inundated with drug commercials and pharmaceutical companies may reconsider their pricing and advertising tactics.  In recent years, the pharmaceutical industry has sued to keep the prices of their drugs out of their TV advertisements.”
  • Politico reports,
    • Republican funding leaders have made an opening offer to Democrats as the two parties launch negotiations toward a deal to fund the government before the mid-March shutdown deadline.
    • Congress’ top appropriators gathered privately Thursday evening in the Capitol for an hour-long “four corners” meeting — the first concrete step toward a bipartisan funding agreement as Republican leaders begin to embrace the idea of a cross-party accord that funds the government and raises the debt limit, while also potentially boosting disaster aid and border security funding. The beginning of negotiations follows months of inaction on a bipartisan government funding plan, after lawmakers first punted beyond the October start of the fiscal year and then again resorted to a stopgap measure in December, pushing the spending cliff into the first months of the new Trump administration.
  • Federal News Network tells us,
    • “Agencies have until the end of the day Friday to revise their telework policies and begin ordering federal employees to work onsite full-time, according to a return-to-office memo from the Office of Personnel Management Wednesday evening.
    • “OPM is recommending agencies target a 30-day deadline to be in full compliance with the return-to-office directive President Donald Trump signed on his first day in office. Trump’s executive order told agencies to return their federal employees to work at the office “as soon as practicable.” The order also called for agencies to end “remote work arrangements” and require employees to work in person full-time, while leaving room for some exemptions.”
  • FedSmith lets federal and postal employees know the best dates to retire in 2025.
  • Per an OFCCP news release,
    • On January 21, 2025, the White House and President Donald Trump issued an Executive Order: “Ending Illegal Discrimination and Restoring Merit-Based Opportunity”, which revoked Executive Order 11246. For 90 days from the date of this order, Federal contractors may continue to comply with the regulatory scheme in effect on January 20, 2025.  
    • The Office of Federal Contract Compliance Programs shall immediately cease:
      • Promoting “diversity”.
      • Holding Federal contractors and subcontractors responsible for taking “affirmative action”; and
      • Allowing or encouraging Federal contractors and subcontractors to engage in workforce balancing based on race, color, sex, sexual preference, religion, or national origin.
    • It is important to note that requirements under Section 503 of the Rehabilitation Act, 29 U.S.C. 793, and the Vietnam Era Veterans’ Readjustment Assistance Act (VEVRAA), 38 U.S.C. 4212, both enforced by OFCCP, are statutory and remain in effect.

From the judicial front,

  • MedPage Today informs us,
    • “Members of the family who own Purdue Pharma, the maker of oxycodone hydrochloride (OxyContin), and the company itself, agreed to pay up to $7.4 billion in a new settlement to lawsuits over the toll of the powerful prescription painkiller, New York Attorney General Letitia James announced Thursday.
    • “The deal, agreed to by Purdue Pharma, the Sackler family members who own the company, and lawyers representing state and local governments and thousands of victims of the opioid crisis, represents an increase of more than $1 billion over a previous settlement deal that was rejected last year by the U.S. Supreme Court.
    • “The Sacklers agreed to pay up to $6.5 billion, Purdue to pay $900 million, for a total of $7.4 billion.
    • “It’s among the largest settlements reached over the past several years in a series of lawsuits by local, state, Native American tribal governments, and others seeking to hold companies responsible for a deadly epidemic. Aside from the Purdue deal, others worth around $50 billion have been announced — and most of the money is required to be used to stem the crisis.
    • “The deal still needs court approval, and some of the details are yet to be ironed out. An arm of the Department of Justice opposed the previous settlement, even after every state got on board, and took the battle to the U.S. Supreme Court. But under President Donald Trump, the federal government is not expected to oppose the new deal.”
  • The Washington Post reports,
    • The Supreme Court cleared the way Thursday for a major corporate transparency law that requires millions of businesses to make new ownership disclosures in an effort to combat financial crimes.
    • The high court lifted a block on the enforcement of the Corporate Transparency Act while a federal Circuit Court of Appeals based in New Orleans weighs the law’s constitutionality.
    • “The act, which passed in 2021, requires most U.S. businesses to disclose which of its owners control more than 25 percent of the stock or hold a similar stake in equity. The law aims to expose bad actors who create shell companies to disguise their identities while carrying out money laundering, tax fraud, drug trafficking or the financing of terrorism. It would affect more than 32 million businesses.”
  • Per Fierce Healthcare,
    • “An arbitrator has determined Prime Therapeutics violated federal and state antitrust laws against the AIDS Healthcare Foundation (AHF) and independent pharmacies.
    • “In a ruling (PDF) handed down Jan. 17, the AHF was awarded more than $10 million and injunctive relief after Prime Therapeutics was found to engage in horizontal price-fixing with Cigna’s pharmacy benefit manager (PBM), Express Scripts.
    • “Prime is a PBM owned by Blue Cross Blue Shield state plans. It has more than 20 million patients in its network affected by the collaboration.
    • “Prime was told to end its reimbursement structure for drugs under a long-standing collaboration with Express Scripts and to reimburse underpayments since June 30. The cozy relationship between Prime and Express Scripts allowed Prime to reimburse drugs and services the AHF provides to health plans, where Prime is the PBM, at a lower rate.”

From the public health and medical research front,

  • The New York Times reports,
    • “A study of more than 30,000 British adults diagnosed with attention deficit hyperactivity disorder, or A.D.H.D., found that, on average, they were dying earlier than their counterparts in the general population — around seven years earlier for men, and around nine for women.
    • “The study, which was published Thursday in The British Journal of Psychiatry, is believed to be the first to use all-cause mortality data to estimate life expectancy in people with A.D.H.D. Previous studies have pointed to an array of risks associated with the condition, among them poverty, mental health disorders, smoking and substance abuse.
    • “The authors cautioned that A.D.H.D. is substantially underdiagnosed and that the people in their study — most of them diagnosed as young adults — might be among the more severely affected. Still, they described their findings as “extremely concerning,” highlighting unmet needs that “require urgent attention.”
    • “It’s a big number, and it is worrying,” said Joshua Stott, a professor of aging and clinical psychology at University College London and an author of the study. “I see it as likely to be more about health inequality than anything else. But it’s quite a big health inequality.”
  • The American Hospital Association News notes,
    • “Perinatal mental health disorders affect countless mothers during pregnancy and postpartum, yet access to comprehensive care remains a challenge. Hospitals are stepping up to fill this gap, creating innovative programs that address the unique mental health needs of mothers during this critical period. A recent panel hosted by the AHA and the Policy Center for Maternal Mental Health highlighted the efforts of two trailblazing hospitals: Woman’s Hospital in Baton Rouge, La., and the University of Colorado Hospital Anschutz Medical Campus. READ MORE.” 
  • Per MedPage Today,
    • “Early Alzheimer’s pathology was not consistently linked to depressive symptoms in people without clinical dementia, cross-sectional data suggested.
    • “In people with normal cognition, depressive symptoms and amyloid pathology were not associated with each other (OR 1.13, 95% CI 0.90-1.40, P=0.29), reported Julie Oomens, PhD, of Maastricht University in the Netherlands, and co-authors.
    • “However, in people with mild cognitive impairment, the presence of depressive symptoms was tied to a lower likelihood of amyloid pathology (OR 0.73, 95% CI 0.61-0.89, P=0.001), Oomens and colleagues said in JAMA Psychiatry.
    • “The findings suggest that other mechanisms may underlie the previously seen associations between depressive symptoms and cognitive decline in late life, Oomens and colleagues observed.
    • “This large-scale study including data from 49 cohorts included in the Amyloid Biomarker Study shows that depressive symptoms were not consistently associated with a higher frequency of amyloid pathology in persons without dementia,” Oomens told MedPage Today. “This means that the earlier identified association between depressive symptoms and cognitive decline is likely not explained by Alzheimer’s disease pathology.”
  • and
    • Considering a risk score generated from multiple genetic variants linked to chronic obstructive pulmonary disease (COPD) caught undiagnosed cases of the disease better than conventional risk factors and respiratory symptoms alone, a study showed.
    • Adding the COPD polygenic risk score (PRS) to the Lung Function Questionnaire clinical risk score significantly improved the area under the curve by 0.03 to 0.06, suggesting a 3 to 6 percentage point increase in accuracy in identifying spirometry-defined, moderate to severe COPD, as researchers led by Matthew Moll, MD, MPH, of Brigham and Women’s Hospital and Harvard Medical School in Boston, reported in JAMA.
  • and
    • “Intermittent explosive disorder (IED), characterized by impulsive aggression and poorly regulated emotional control, was associated with multiple classes of comorbidities, an analysis of 117.7 million healthcare records showed.
    • “Of 30,000 individuals with an IED diagnosis during their lifetime, 95.7% had at least one other psychiatric diagnosis, reported Yanli Zhang-James, MD, PhD, of SUNY Upstate Medical University in Syracuse, and co-authors in JAMA Psychiatry.
    • “All psychiatric subcategories and 92% of psychiatric diagnoses were significantly associated with IED, with hazard ratios (HRs) ranging from 2.1 for substance use disorder to 76.6 for disorders of adult personality and behavior.”
  • Per tctMD,
    • “Patients who have hypertension while lying down, even if their blood pressure is normal while sitting up, have greater CVD and mortality risks in the decades to come, according to an analysis of the Atherosclerosis Risk in Communities (ARIC) study.
    • “Through more than 25 years of follow-up, supine hypertension was associated with greater risks of fatal and nonfatal coronary heart disease, heart failure, stroke, and all-cause death, lead author Duc Giao, MD (Harvard Medical School, Boston, MA), and colleagues report in a study published online Wednesday in JAMA Cardiology.
    • “The results didn’t differ based on whether patients were taking antihypertensive medications or whether they also had seated hypertension. Although risks of adverse outcomes were greatest in patients with both seated and supine hypertension, those with high supine BP alone carried greater hazards compared with those with elevations only when seated.
    • “Our conclusion was that not only is supine blood pressure an important risk factor for cardiovascular disease, but also it’s possible we could be missing a high-risk state by simply focusing on the seated position,” senior author Stephen Juraschek, MD, PhD (Beth Israel Deaconess Medical Center and Harvard Medical School), told TCTMD. “There might be more information to be gathered when we lie people flat and measure their blood pressure in the lying position.”

From the U.S. healthcare business front,

  • STAT News reports,
    • “UnitedHealth Group has named Tim Noel as the next CEO of UnitedHealthcare, replacing Brian Thompson, who was killed in New York City in December.
    • “Noel has been at the health care conglomerate since 2007 and most recently led UnitedHealthcare’s Medicare division — one of the company’s most important and profitable lines of health insurance. Its Medicare Advantage and Medigap supplemental plans made up almost half of UnitedHealthcare’s $300 billion of revenue last year.”
  • Per Healthcare Dive,
    • “Elevance’s profits took a serious hit in the fourth quarter of 2024, falling to $418 million — down more than half from $856 million in the prior-year period — amid higher medical costs in the safety-net Medicaid program, according to financial results released Thursday morning.
    • “Yet the insurer’s earnings were in line with analyst expectations after a hard year. Investors also found reason for optimism in revenue growth, with Elevance’s topline of $45 billion up about 6% year over year. Elevance’s stock, and shares in managed care peers, rose in Thursday morning trading following the results.
    • “Still, Elevance’s guidance for 2025 implies the insurer expects spending to remain elevated this year, and some market watchers are concerned about the health of Elevance’s growth outlook for privatized Medicare plans — another source of shrinking margins.”
  • On a related note, Kaufmann Hall discusses the “Next Phase of Inorganic Payer Growth.”
  • Modern Healthcare adds,
    • “The number of Chapter 11 bankruptcy filings in healthcare dropped significantly in 2024 from the previous year, though filings still hit historically high levels.
    • “Fifty-seven healthcare companies with more than $10 million in liabilities filed for bankruptcy protection in 2024, the second-highest level since 2019, according to a report released Thursday from Gibbins Advisors. But the 2024 total is still down from 79 filings in 2023.
    • “Pharmaceutical companies topped the list with 14 bankruptcy filings, followed by 11 senior care companies and 10 clinics and physician practices. Bankruptcy filings for clinics and physician practices hit the highest level in the past six years, according to the report.
    • “Five hospital groups filed for bankruptcy protection in 2024, compared with 12 groups in 2023. However, one of those groups, Steward Health Care, involved more than 30 hospitals and marked the largest bankruptcy in the hospital sector in decades, the report noted.”



Midweek Report

David Ermer–CMS, Congress, Government Contracting, Medical / Rx research, Obesity, Rx coverage, U.S. Healthcare–
Photo by Juliane Liebermann on Unsplash
  • From a Senate news release,
    • “U.S. Senate Finance Committee Chairman Mike Crapo (R-Idaho) will hold a nomination hearing on Wednesday, January 29, at 10:00AM to consider Robert F. Kennedy Jr. to be Secretary of the U.S. Department of Health and Human Services.” 
  • In the meantime, Dorothy Fink is serving as acting HHS Secretary.
  • FedWeek shares “the key portions of the guidance from OPM on the federal hiring freeze issued by the new Trump administration that addresses issues including general and special exceptions, movement and promotions of current employees and a prohibition on using contractors to fill vacated positions.”
  • The President issued an executive order revoking the affirmative action requirements of E.O. 11246 which President Lyndon Johnson signed in 1965. This action relieves federal government contractors and subcontractors with a contract valued at $100,000 or more and 50 employees or more of the burden to develop and implement a detailed affirmative action program. These businesses remain subject to federal and state laws prohibiting discrimination in employment, e.g., Title VII of the 1964 Equal Employment Opportunity Act.
  • The American Hospital Association News reports,
    • “The Department of Health and Human Services Health Resources and Services Administration is accepting applications until April 22 for its four-year Rural Maternity and Obstetrics Management Strategies Program. HRSA will award up to three cooperative agreements for up to $1 million per year for establishing rural obstetric networks to improve maternity care and access in rural communities. The program runs from Sept. 30, 2025, through Sept. 29, 2029.”

From the judicial front,

  • Per Fierce Healthcare,
    • “The feds intend to appeal a judge’s decision that would force them to recalculate UnitedHealthcare’s Medicare Advantage (MA) star ratings.
    • “The Centers for Medicare & Medicaid Services (CMS) submitted a filing Tuesday in Texas district court saying that it would appeal the November ruling to the Fifth Circuit Court of Appeals. Further details were not included in the court filing.
    • “Judge Jeremy Kernodle of Texas’ Eastern District Court ruled on Nov. 22 that the CMS would have to recalculate UnitedHealth’s MA scores. 
    • “At the center of the case is a single foreign language test phone call that was made to one of UnitedHealthcare’s call centers. The CMS categorized the call as “unsuccessful” because it was disconnected before the test caller could fully engage with a customer service agent, according to UnitedHealth’s lawsuit, which was filed in early October.“
  • The Groom Law Group discusses pending ERISA litigation.

From the public health and medical research front,

  • USA Today reports,
    • “The beer, spirits and wine industries were already prepared for a continued lull in sales for 2025, then came the U.S. surgeon general’s call for cancer warning labels on alcoholic beverages.
    • “Add that buzz kill to a flight of other challenges facing the booze business: Dry January – and its sober-curious companion in fall, Sober October – along with the thriving year-round embrace of lower-alcohol and non-alcohol options, especially by younger consumers.
    • “Suddenly, moderation is sweeping the nation. Nearly half of Americans (49%) say they plan to drink less in 2025 – up from 41% who said that was their plan in 2024, according to a new survey, released Tuesday, commissioned by advertising and sales measurement technology firm NCSolutions.”
  • STAT News tells us,
    • “Immune checkpoint inhibitors, drugs that can help make the immune system recognize and destroy cancer more aggressively, are one of the most important medicines in cancer treatment today. Merck’s Keytruda has been used against dozens of different cancers in millions of patients, making it the top-selling drug in the world, with over $25 billion in revenue in 2023. Opdivo, from Bristol Myers Squibb, earned $10 billion in 2023.
    • “Now, a new class of drugs may be emerging to challenge the dominance of these first-generation checkpoint inhibitors. Experts said a certain type of bispecific antibody seems to have hit upon a crucial combination of two cancer targets: the proteins VEGF and either PD-1 or PD-L1. “It’s exactly that,” said Özlem Türeci, the CMO and co-founder of BioNTech. “I think that the anti-PD-1 or PD-L1 and VEGF concept can be a very broad, pan-tumor platform: the next-generation checkpoint modulator.”
  • MedPage Today informs us,
    • “Beneficial pediatric obesity treatment response was associated with a reduced risk of obesity-related events in young adults, a nationwide prospective cohort study in Sweden showed.
    • “Compared with poor response, good response to obesity treatment was associated with lower risk of type 2 diabetes (adjusted HR [aHR] 0.42, 95% CI 0.23-0.77), dyslipidemia (aHR 0.31, 95% CI 0.13-0.75), and bariatric surgery (aHR 0.42, 95% CI 0.30-0.58), reported Emilia Hagman, PhD, of the Karolinska Institute in Sweden, and colleagues.”
    • “Obesity remission showed similar reduced risks, as well as reduced risk of hypertension (aHR 0.40, 95% CI 0.24-0.65). Good response in obesity treatment or obesity remission was associated with a reduced risk of mortality (aHR 0.12, 95% CI 0.03-0.46), though treatment response was not associated with reduced risk for depression or anxiety, they noted in JAMA Pediatrics.
    • “The long-term effects of treating obesity in childhood were largely unknown,” Hagman told MedPage Today in an email. “Many people believe that because maintaining weight loss is so challenging, early treatment might not make a real difference in reducing the risk of serious health problems like type 2 diabetes, high blood pressure, or heart disease later in life. Our research helps answer this critical question and shows the importance of addressing obesity early.”
  • HCPLive adds,
    • “Patient factors, including sociodemographic, healthcare, and clinical elements, were linked to the initiation of semaglutide, a glucagon-like peptide-1 receptor agonist (GLP-1 RA), in a population with obesity without type 2 diabetes (T2D).1
    • “Among more than 97,000 commercially insured adults in a recent cohort study, approximately 2.0% began semaglutide treatment within 6 months of an obesity diagnosis, with sex, insurance plan, and medication use found to be relevant factors for medication initiation.
    • “The association of these factors with semaglutide initiation were quantified using multivariable logistic regression, and use of common medications, insurance plan structure, employer industry type, and sex were all significantly associated with semaglutide initiation,” wrote the investigative team, led by Andrew C. Stokes, PhD, department of global health, school of public health, Boston University.”

From the U.S. healthcare business front,

  • Healthcare Dive relates,
    • “Johnson & Johnson on Wednesday reported modestly higher-than-expected earnings for the fourth quarter, while cautioning that unfavorable currency exchange rates would temper sales growth this year.
    • “Adjusted earnings per share reached $2.04 in the fourth quarter, higher than the Wall Street consensus of $2.01 and Leerink Partners’ estimate of $1.96, Leerink analyst David Risinger wrote in a note to clients. The company’s sales rose 5.3% to $22.5 billion during the quarter, in line with estimates
    • “Full-year 2024 revenue increased to $88.8 billion from $85.2 billion in 2023. For this year, J&J expects revenue to climb to between $89.2 billion and $90 billion, with a mid-point of $89.6 billion, less than the consensus estimate of $91.1 billion. Shares of the company dropped about 3% in early trading Wednesday, even as the overall market rose.”
  • BioPharma Dive adds,
    • “Johnson & Johnson expects changes in Medicare’s prescription drug benefit will negatively impact its sales by about $2 billion this year, a modest headwind for a pharmaceuticals division the company anticipates will otherwise continue growing.
    • “The changes are the result of a redesign under the Inflation Reduction Act to Medicare’s Part D benefit, which covers outpatient drug treatment. The 2022 law capped annual out-of-pocket spending by people enrolled in Part D to $2,000 beginning this year, and required drugmakers provide additional discounts within certain phases of coverage, among other tweaks.
    • “J&J provided its estimate of the redesign’s financial impact Wednesday alongside earnings for the fourth quarter. In doing so, the company follows Pfizer, which late last year forecast the changes would have a $1 billion net negative impact on 2025 revenue.
    • “The Part D redesign brought on by the Inflation Reduction Act is proving consequential to drugmakers’ business even as the law’s provisions allowing Medicare to negotiate certain drug prices get more attention. Three drugs marketed in whole or in part by J&J were picked by the Biden administration for the first round of negotiations that wrapped up last summer.”
  • The American Hospital Association News points out,
    • “Baxter notified customers on Jan. 22 that allocations for two sodium chloride IV solutions have been increased to 100%. According to Baxter, the products will have a one- to two-week lag time while they progress through the full distribution network after implementing changes. AHA members have notified the association of two- to three-week lag times in some cases following previous allocation updates.”
  • Per Fierce Healthcare,
    • “Credit downgrades for nonprofit hospitals again outpaced upgrades across 2024, though the difference between the two narrowed compared to the year before, according to a review of three credit agencies’ rating actions published Wednesday.
    • “Moody’s, S&P and Fitch collectively issued 95 downgrades and 37 upgrades in 2024, as opposed to 116 and 33 in 2023, wrote Kaufman Hall Managing Director Lisa Goldstein.
    • “She and her firm expect the trend to continue into 2025 “given a growing reliance on government payers, labor challenges and a competitive environment.”
    • “Policy and funding changes will also cast uncertainty into the mix in 2025 and may cause credit deterioration in future years,” she wrote on Kaufman Hall’s website.”
  • Healthcare Dive adds, “Providers to target efficiency, supply chain resilience in 2025. Health systems will work to expand their supply chains and ink nontraditional partnerships in 2025, while trimming excessive AI programs and nonclinical staff.”
  • Meanwhile MedTech Dive notes, “AI in medtech is taking off. Here are 4 trends to watch in 2025. New documents clarify how the FDA plans to regulate AI-enabled devices, experts say, but several important questions remain around insurance coverage and generative AI.”
  • Per a news release,
    • The Institute for Clinical and Economic Review (ICER) today announced a new analysis it plans to release on an annual basis titled the “Launch Price and Access Report” which will examine launch pricing for FDA-approved treatments. This report will review the affordability and access of the treatments and their value to the overall health system.
    • “There is no better time to provide an independent analysis on trends in launch pricing – both list and net – and patient access,” stated ICER’s Vice President of Research Foluso Agboola, MBBS, MPH. “ICER typically evaluates promising treatments that pose potential affordability challenges for the U.S. health system. Through this work, ICER will continue to work towards a health system where the pricing of innovative treatments are tied to value, while still ensuring affordability and access for patients.”  * * *
    • “The report is expected to be released in the fourth quarter of 2025.”
  • Alan Fein, in his Drug Channels blog, discusses “The Big Three PBMs’ 2025 Formulary Exclusions: Humira, Stelara, Private Labels, and the Shaky Future for Pharmacy Biosimilars.”

Tuesday Report

David Ermer–CDC, Congress, COVID treatment, FDA, Medical / Rx research, Mental health care, U.S. Healthcare–

From Washington, DC,

  • The Hill reports, “Senate Republicans hit their full 53-member majority on Tuesday as Sens. John Husted (R-Ohio) and Ashley Moody (R-Fla.) were sworn into office by Vice President Vance.” 
  • Fierce Healthcare reviews how yesterday’s executive orders and other actions impact healthcare.
  • The U.S. Preventive Services Task Force highlights its most recent final recommendations.
  • Fierce Pharma tells us,
    • “Already on its way to becoming a blockbuster drug, Johnson & Johnson’s Spravato has received another potential boost as the FDA has blessed the nasal spray to be used as a monotherapy for major depressive disorder (MDD).
    • “Spravato was originally approved in 2019 to be used along with an oral antidepressant for patients who have not seen results with other antidepressant medications.
    • “In 2020, the U.S. regulator tacked on another nod for Spravato to be used by patients with MDD who experience acute suicidal thoughts or behavior.
    • “The standalone endorsement allows patients to use Spravato without taking oral antidepressants. Spravato can work as quickly as 24 hours, Bill Martin, Ph.D., who heads up J&J neuroscience, said in a release.
    • “Treatment-resistant depression can be very complicated, especially for patients who do not respond to oral antidepressants or cannot tolerate them,” Martin added. “For too long, healthcare providers have had few options to offer patients much-needed symptom improvement.”
  • and
    • “After hitting a regulatory roadblock in 2022, Sanofi’s consumer healthcare business Opella has secured the FDA’s blessing to move forward with its ambition to convert its erectile dysfunction med Cialis into an over-the-counter product.
    • “The agency previously placed a clinical hold on the company’s planned actual use trial (AUT) for the conversion, citing problems with protocol design. AUTs are a key step in the FDA’s process for switching drugs from prescription to OTC products and are meant to prove that consumers can adequately diagnose and treat themselves without the help of a healthcare provider.
    • “Now, after a review, the FDA’s green light marks a “significant step forward in Opella’s data-driven efforts to switch a PDE-5 inhibitor like Cialis,” Opella’s chief science officer Josephina Fubera, Ph.D., said in a company release.
    • “We look forward to continuing our work to bring safe and expanded access to the many consumers who will benefit from nonprescription Cialis,” Fubera added.”

From the public health and medical research front,

  • The University of Minnesota’s CIDRAP lets us know today,
    • “Over the past few days, the US Department of Agriculture (USDA) confirmed more H5N1 avian flu outbreaks in poultry from eight states, including the first at a commercial farm in Georgia.
    • “Meanwhile, the Food and Drug Administration (FDA) and the USDA on January 17 announced new steps to step up the safety of raw pet food, following recent reports of H5N1 infections in household cats.”
  • and
    • “A new real-world study published in PLOS Medicine that looked at outcomes of 703,647 patients with COVID-19 seen at 34 US clinics in 2022 and 2023 found that Paxlovid use was correlated with lower rates of hospitalization and death, particularly among older patients. 
    • “Both vaccinated and unvaccinated patients benefitted from Paxlovid when administered within 5 days of COVID-19 infection confirmation, the authors said. But researchers observed lower rates of use among Black and Hispanic patients than among White patients. 
    • “The study was based on the National COVID Cohort Collaborative’s (N3C) electronic health record database. While clinical trials showed as high as an 88.9% reduction in the risk of COVID-related hospitalization or death among those who received Paxlovid compared to those who received placebos, limited real-world data has been gathered in the post-Omicron era on Paxlovid efficacy.”
  • Consumer Reports, writing in the Washington Post, discusses “What to look for — and what to avoid — in an energy bar. Many are little more than candy bars and don’t deliver the health benefits you might expect.”

From the U.S. healthcare business front,

  • RAND opines,
    • “The typical cost of developing new medications may not be as high as generally believed, with a few ultra-costly medications skewing public discussions about the cost of pharmaceutical research and development, according to a new RAND study.
    • “Using a novel method to assess spending on research and development for 38 drugs that were recently approved by the U.S. Food and Drug Administration, researchers found that the mean, or average, cost of developing a new drug was much higher than the mid-point (median) cost of development.
    • “Researchers estimated a median direct research and development cost of $150 million compared to a mean of $369 million.
    • “Costs were higher after adjusting for earnings drug developers could have made if they had invested these amounts in other activities and for drugs that never made it to the market. With these adjustments, researchers estimated a median research and development cost of $708 million across the 38 drugs examined, with the average cost rising to $1.3 billion driven by a small number of high-cost outliers.
    • “The average cost of developing a new drug was 26 percent lower when excluding just two drugs, dropping from $1.3 billion to $950 million. The findings are published in the journal JAMA Network Open.”
  • Employee Benefit News explains why “costly gene therapy is top of mind for benefits administrators.” Check it out.
  • Per Fierce Healthcare,
    • “Healthcare technology company Innovaccer announced its acquisition of Humbi AI, an actuarial software, services and analytics company used by providers, payers and life sciences companies.
    • “Innovaccer’s cloud powers a slew of healthcare AI features like an AI-assisted care management system, contract management, ambient documentation, pre-visit summary and AI-suggested differential diagnoses.
    • “Financial details of the deal were not disclosed.
    • “The Humbi AI acquisition will help build out Innovaccer’s data analytics capabilities. The Nashville-based company combines healthcare data analytics and actuarial consulting to help healthcare organizations improve value-based contracts, manage risk and design benefits.
    • “Humbi AI’s actuarial capabilities will be an integral component of Innovaccer’s cloud platform, and the company plans to launch its own actuarial copilot, executives said in a press release.”
  • Modern Healthcare adds,
    • “Digital health companies at last week’s J.P. Morgan Healthcare Conference weren’t just looking for investors. They were looking for dance partners.
    • “The desire of digital health companies to scale through mergers and acquisitions or partnerships was one of the most buzzed-about topics at the conference. Marissa Moore, principal at venture capital firm Omers Ventures, said potential buyers and sellers were trying to size up prospects during the event.
    • “People were soliciting us, ‘Hey, we’re trying to spin off this asset, do you know any good buyers?’ Every conversation we were having [at JPM] was an M&A conversation,” Moore said. “We were approached by corporate development executives from big tech companies…you could tell they were trying to get a pulse on what was struggling and what might fit into their growing portfolios, and where there might be an opportunity to partner.”
    • “That search was particularly active for companies selling digital health solutions to employers, a market that has become challenged as employers grapple with the rising cost of healthcare and low usage rates of their offerings. Employers are looking to reduce the number of companies they contract with to reduce costs and simplify the experience for their employees, said Jim Winkler, chief strategy officer at Business Group on Health, an industry group that represents large employers.”

Happy Martin Luther King, Jr., Day

David Ermer–Congress, Medical / Rx research, OPM, U.S. Healthcare–
Photo by Tim Mossholder on Unsplash

The National Part Service reminds us, “Dr. Martin Luther King Jr. was a tireless advocate for racial equality, working classes, and the oppressed around the world. Commonly called Martin Luther King, Jr. Day or MLK Day, the third Monday of January is a federal holiday to honor his life and legacy.”  RIP

Donald J. Trump was sworn into office as the 47th President of the United States at noon today.

The Wall Street Journal reports, “President Trump signed an executive order creating the Elon Musk-led Department of Government Efficiency. “That’s a big one,” he exclaimed. Trump said Musk would get an office for about 20 staffers.” * * *

“Trump’s executive order calls on agencies to set up DOGE teams of at least four employees, which will include a team leader, an engineer, a human resources specialist and an attorney. Under the new structure, the United States Digital Service, which provides information technology services to federal agencies, will be renamed the United States DOGE Service with an administrator who will report to the White House chief of staff, Susie Wiles.”

President Trump also signed the following additional executive orders of relevance to federal employment and the FEHB Program —

The President formally nominated Scott Kupor of California to be OPM Director.

Rescission of the January 3 memorandum is understandable because the President named an OPM IT executive Charles Ezell to be acting OPM Director. Here is a link to Director Ezell’s first formal action in that role.

The House of Representatives and the Senate are in session this week for Committee business and floor voting. The Senate unanimously confirmed now former Senator Marco Rubio to be Secretary of State this evening.

The Senate committees will be holding confirmation hearings and meetings while committees in both Houses will be engaged in organizational activities. The Senate Homeland Security and Governmental Affairs held a business meeting this evening on whether to confirm the President’s nominee to Director of the Office of Management and Budget, Russell Vought. The Senate Budget Committee will hold a hearing on Mr. Vought’s nomination tomorrow. In the meantime, OMB Assistant Directors for Legislative Reference Matthew Vaeth is the acting OMB Director.

STAT News reports,

  • “A next-generation form of chemotherapy from AstraZeneca and Daiichi Sankyo has won Food and Drug Administration authorization for a form of breast cancer, the first U.S. approval for a drug for which the companies have high expectations. 
  • “The FDA on Friday announced it had approved the drug, to be marketed as Datroway, for certain advanced breast cancer patients. Datroway, also called datopotamab deruxtecan, or Dato-DXd, was approved in Japan for a form of breast cancer last month, its first regulatory green light.
  • “The U.S. list price for Datroway is roughly $4,900 per 100 milligram vial and the recommended dose of the drug is 6 milligrams per kilogram of patient weight every three weeks. 
  • “Datroway is what’s known as an antibody-drug conjugate, an emerging type of therapy that aims to deliver the powerful cancer-killing ability of chemotherapy directly to tumor cells, staving off the toxic side effects of standard chemo. AstraZeneca and Daiichi are also partnered on a top-selling ADC called Enhertu.”

MedPage Today lets us know

  • An observational study of 175 health outcomes using Veterans Affairs (VA) data for nearly 2 million individuals uncovered new insights about possible risks and benefits of GLP-1 receptor agonists.
  • “Over a median of 3.68 years, adults with type 2 diabetes who added a GLP-1 agent to their treatment plan had significantly decreased risks for 42 diverse outcomes, increased risks for 19 outcomes, and no association with 114 outcomes compared with usual care, reported Ziyad Al-Aly, MD, of Washington University in St. Louis, and colleagues.
  • “The results may be useful for informing clinical care, enhancing pharmacovigilance, and guiding the development of mechanistic and clinical research to evaluate the broad pleiotropic effects of GLP-1 receptor agonists,” the researchers wrote in Nature Medicine.
  • “GLP-1 agents “have an intricate web of various effects,” Al-Aly said in a press briefing. For example, the analysis showed that use of GLP-1 agonists was associated with a 5% risk reduction in neurocognitive disorders, driven by an 8% decreased risk of dementia and 12% lower risk for Alzheimer’s disease.
  • “It’s weak, but it’s not null,” Al-Aly said about the Alzheimer’s relationship, adding that this finding “is still welcome” given the limited number of treatments for the disease.”

Thursday Report

David Ermer–AHRQ, CDC, CMS, Congress, FDA, Medical / Rx research, NIH, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC,

  • The American Hospital Association News tells us,
    • “The Medicare Payment Advisory Commission today voted to recommend that Congress update Medicare payment rates for hospital inpatient and outpatient services by the current law amount plus 1% for 2026 and reiterated its recommendation to distribute an additional $4 billion to safety-net hospitals by transitioning to a Medicare safety-net index policy. The AHA last week urged the committee for higher updates.  
    • “In other action, MedPAC recommended that Congress update 2026 Medicare payments for physicians and other health professional services by the Medicare Economic Index minus one percentage and enact a non-budget-neutral add-on payment under the physician fee schedule to services provided to low-income Medicare beneficiaries. The commission also recommended reducing the 2026 payment rates for home health agencies by 7%, skilled nursing facilities by 3% and inpatient rehabilitation facilities by 7%. 
    • “In addition, MedPAC voted to recommend eliminating the 190-day lifetime limit in freestanding inpatient psychiatric facilities and the reduction of the number of covered inpatient psychiatric days. The commission also presented status reports for the Part D program and ambulatory surgical centers.”  
  • Federal News Network informs us,
    • “If Russell Vought’s confirmation hearing to run the Office of Management and Budget was a boxing match, the judges would’ve given him the win on points. Democrats on the Senate Homeland Security and Governmental Affairs Committee didn’t land any knockout questions and Vought bobbed and weaved enough to avoid any self-inflicted knock downs.
    • “Vought offered some insights around hot management topics like telework and remote work. He stayed away from getting Democrat jabs about Schedule F. And he ducked questions about how he would address the Impoundment Control Act, the 1974 law that restricts presidential authority to impound funds enacted by law. Vought and other incoming Trump administration supporters have said they believe the Impoundment Control Act is illegal and plan to challenge the law.
    • “Nothing in the almost two-hour hearing seems to indicate Vought will not win enough Republican support to get through the committee vote, and likely the full Senate.”
  • OPM has unveiled a new public website.
  • Per an FDA press release,
    • “Today, the U.S. Food and Drug Administration authorized the marketing of 20 ZYN nicotine pouch products through the premarket tobacco product application (PMTA) pathway following an extensive scientific review. This is the first time the agency has authorized products commonly referred to as nicotine pouches, which are small synthetic fiber pouches containing nicotine designed to be placed between a person’s gum and lip.  
    • “The FDA determined that the specific products receiving marketing authorization met the public health standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act. This standard considers the risks and benefits of products to the population as a whole.” 

From the judicial front,

  • Fierce Healthcare points out,
    • “Teva Pharmaceuticals is suing the Centers for Medicare & Medicaid Services (CMS) for its implementation of the drug price negotiation program under the Inflation Reduction Act (IRA).
    • “Teva claims the program is a “fiction” and “upsets the delicate balance between innovation and affordability,” in its lawsuit (PDF). The company argues CMS guidance contradicts key elements of the IRA, which dictate drugs are only eligible for the program if they’ve been marketed for a specified amount of time or declares they are exempt when non-branded competitors enter the market.
    • “Another source of contention is the agency’s definition of a qualifying single source drug, or a drug eligible for negotiation.
    • “Under CMS’ made-up definition, the agency can decide that two or more drugs approved under distinct FDA applications held by the same entity should be treated as one Qualifying Single Source Drug because they have the same active moiety—that is, the same active molecule,” the lawsuit reads.”

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “The face of cancer in the U.S. is getting younger—and more feminine. 
    • “Cancer rates for women in the U.S. have risen over the past half-century, particularly among women under age 65 diagnosed with breast cancer, the American Cancer Society said Thursday. Men, meanwhile, have experienced a decline in cancer rates compared with prior decades. 
    • “If you’re a woman under the age of 65, you’re now more likely to develop cancer than a man” in that same age group, said Dr. William Dahut, the American Cancer Society’s chief scientific officer.
    • “For decades, the cancer burden in the U.S. was higher for men, who started smoking en masse in the 20th century. Their rates of lung-cancer cases and deaths soared. Lung cancer remains the biggest cancer killer for men in the U.S., but case and death rates have dropped, after smoking rates declined. 
    • “Women started smoking heavily later than men and have been slower to quit, so their lung-cancer decline started later and hasn’t been as steep. 
    • “That has had a significant impact: Lung cancer incidence among women under 65 was greater than among men for the first time in 2021. Women are also more likely to get diagnosed with lung cancer as nonsmokers.” 
  • STAT News lets us know,
    • “The field of Huntington’s disease research has been undergoing a radical reshaping of how the brain-ravaging disease — and what drives it — is understood. After decades focused on the notion that Huntington’s is caused by the slow, lifelong accumulation of toxic proteins produced by a mutant gene, more and more scientists are now turning to the dynamics of the gene itself.  
    • “The HTT gene, which produces a protein called huntingtin, is littered with a sort of genetic stutter — repeats of a sequence of three DNA letters: “C-A-G.” A hallmark of Huntington’s disease is that the number of CAG repeats a person has determines when in life symptoms start, if ever. 
    • “Forty or more generally result in the arrival of Huntington’s symptoms, including involuntary movements, loss of coordination, cognitive decline, irritability, and compulsive behavior, in the person’s mid-to-late 30s. All are due to neuronal death in the movement-controlling striatum as well as the cerebral cortex. More than 60 repeats can bring symptoms as early as adolescence. And the more CAG repeats there are, the more unstable the gene becomes, causing it to continue to grow over time. This “somatic expansion,” as it’s known, is what an increasing number of scientists believe is to blame for the death of brain cells.” * * *
    • “Even more striking, the study, which was published Thursday by a team from Harvard Medical School, the Broad Institute of MIT and Harvard, and McLean Hospital, showed that only once a medium spiny neuron’s DNA expansion reaches a threshold number of CAGs — roughly 150 repeats — does the cell rapidly deteriorate and die. This process is happening at different rates in different neurons. For some, it could take years, for some, decades. But only once enough of them have died do symptoms of Huntington’s disease appear.” 
  • and
    • “Last week, Sana Biotechnology, a once-mysterious and still-buzzy biotech startup, released clinical trial results showing that it had managed to implant insulin-producing cells in the arm muscle of a patient with type 1 diabetes without provoking immune rejection.
    • “Beyond the fact that there were only results available for a single patient, researchers had only one month’s worth of follow-up data at a very low dose. At first blush, the results might have prompted a shrug.
    • “It’s actually very exciting,” said Jay Skyler, an endocrinologist at the University of Miami, even as he acknowledged the caveats. Even if the results hold up, Sana would have to develop a different formulation of the treatment then put it through many stages of safety and efficacy testing before the company could submit it for regulatory approval or consider it — the ultimate goal — a cure fortype 1 diabetes, which typically develops in childhood.
    • “But the results, Skyler said, were a big step forward. “I think it’s much closer today than yesterday. It is an exciting result, a real exciting result,” he said.
    • “The data represent one of those moments in medical science where it is clear a company is moving forward quickly through dense fog — but where the shore cannot be seen and it is not clear exactly how much farther there is to go.”
  • The American Hospital Association News notes,
    • “The Centers for Disease Control and Prevention today released an advisory recommending clinicians expedite subtyping of type A influenza samples from hospitalized patients, particularly individuals in an intensive care unit. The CDC recommends that this subtyping occur as soon as possible following admission — ideally within 24 hours — to determine whether the virus is a seasonal influenza A subtype (i.e. A[H1] and A[H3]) or a novel influenza A virus, such as avian influenza A H5N1. The agency said these efforts can help prevent delays in identifying human H5N1 bird flu infections and support timely infection control and investigation.  
    • “The CDC still considers bird flu a low risk to the public. The agency said while seasonal flu levels are high nationally, nearly all individuals currently hospitalized with type A flu infections are likely experiencing a seasonal strain.” 
  • Medscape relates,
    • “The latest glucagon-like peptide 1 (GLP-1) receptor agonists have been heralded for their potential to not only boost weight loss and glucose control but also improve cardiovascular, gastric, hepatic, and renal values.
    • “Throughout 2024, research has also indicated GLP-1 drugs may reduce risks for obesity-related cancer as well.
    • “In a US study of more than 1.6 million patients with type 2 diabetes, cancer researchers found that patients who took a GLP-1 drug had significant risk reductions for 10 of 13 obesity-associated cancers, as compared with patients who only took insulin.
    • “The research team found a reduction in esophageal, colorectal, endometrial, gallbladder, kidney, liver, ovarian, and pancreatic cancers, as well as meningioma and multiple myeloma. They also saw a declining risk for stomach cancer, though it wasn’t considered statistically significant, but not a reduced risk for postmenopausal breast cancer or thyroid cancer.
    • “The associations make sense, particularly because GLP-1 drugs have unexpected effects on modulating immune functions linked to obesity-associated cancers.”
  • Per an NIH press release,
    • “In a follow up study funded by the National Institutes of Health (NIH), researchers found that children who wore special contact lenses to slow progression of nearsightedness, known as myopia, maintained the treatment benefit after they stopped wearing the contacts as older teens. Controlling myopia progression in childhood can help to potentially decrease the risks of vision-threatening myopia complications later in life, such as retinal detachment and glaucoma. Rates of myopia have been increasing in recent years with some implications that higher use of personal devices plays a role.”
  • Endocrinology Advisor shares an interesting study result — “A layperson-delivered telephone-based empathetic engagement was associated with improved glycemic control among patients with diabetes.”

From the U.S. healthcare business front,

  • Healthcare Dive reports
    • “UnitedHealth brought in a record $400.3 billion in revenue in 2024 despite a string of crises for the nation’s largest healthcare company, including a massive cyberattack, heavy congressional and regulatory scrutiny and the shooting of its top insurance executive.
    • “However, UnitedHealth’s annual net income plummeted to $14.4 billion — its smallest profit since 2019 — as the company spent billions to recover from the cyberattack on claims processing subsidiary Change Healthcare and made less from offering Medicare and Medicaid plans, according to financial results released Thursday morning.
    • Still, when excluding the cyberattack costs (and other factors UnitedHealth believes aren’t representative of its overall business performance in the year), the Minnesota healthcare behemoth reported adjusted profit of $25.7 billion — an all-time record.” * * *
    • “Amid Washington’s focus on PBM reform, Optum Rx plans to phase out all models that allow it to retain savings from negotiations with drugmakers over the next three years, Witty said.
    • “The CEO noted that Optum Rx already passes through 98% of rebate discounts, but the remaining fraction it retains gives critics leverage to argue PBMs are profiteering from their middleman status in the drug supply chain.
    • “We’re committed to fading out those remaining arrangements so that 100% of rebates will go to customers by 2028 at the latest,” Witty said. “This will help make more transparent who is really responsible for drug pricing in this country: the drug companies themselves.”
  • Reuters adds,
    • “UnitedHealth (UNH.N), opens new tab CEO Andrew Witty said on Thursday that healthcare in the U.S. needs to be “less confusing, less complex and less costly” during the company’s first earnings call since the murder of Brian Thompson, the head of its insurance unit.
    • “Thompson’s killing outside a hotel where the company was to hold its investor day meeting was met with shock across the industry as well as a social media outpouring of anger from Americans frustrated over their dealings with health insurers, citing medical care denials and high costs.
    • “Witty said the company would work with policymakers to reduce the frequency of prior authorization approvals required before a patient can access medical treatment in its Medicare business for people aged 65 and older or with disabilities.
    • “Some of this work we can do on our own and we are doing it, but we are encouraged by industry and policymaker interest in solving for this particular friction in the system,” said Witty, who was previously CEO of British drugmaker GlaxoSmithKline.”
  • BioPharma Dive sums up this week’s JP Morgan Healthcare conference, and reports that “A fast-improving pipeline of drugs invented in China is attracting pharma dealmakers, putting pressure on U.S. biotechs and the VC firms that back them.”
  • McKnight’s Long-Term Care News lets us know,
    • “Many older adults use various types of digital health technology, but patient portals top the list, a new survey finds.
    • “Investigators used data from the internet and phone calls conducted in 2021 that were completed through the National Poll on Healthy Aging. A total of 2,110 participants were between 50 and 80 years old at the time of the interview, according to the report published Wednesday in JAMA Network Open.
    • “The team measured older adults’ use of patient portals, telehealth visits and mobile applications on computers, smartphones, smartwatches, tablets and fitness trackers. Among 81.4% of those using technology, 64.5% used patient portals, 49.1% utilized telehealth and 44% used mobile applications.
    • “The data showed that an older adult’s physical and cognitive needs can affect their technology use. Still, older adults tend to follow the same predicting factors as younger folks that drive technology usage (education level, income, etc.)”

Tuesday Report

David Ermer–ACA, AHRQ, CDC, Congress, FDA, Generative AI, Medical / Rx research, NIH, No Surprises Act, Obesity, OPM, Rx coverage, Telehealth, U.S. Healthcare–
OPM Headquarters a/k/a the Theodore Roosevelt Building

From Washington, DC

  • Today, the U.S. Office of Personnel Management released a list of its accomplishments during the Biden-Harris administration.
  • Here is a link to Andreessen Horowitz bio of Scott Kupor who is President elect Trump’s designee for OPM Director.
  • The Washington Post is maintaining a website outside its paywall providing comprehensive news on Mr. Trump’s nominations.
  • The Wall Street Journal reports,
    • “Two vaccine skeptics who had been advising Robert F. Kennedy, Jr. as he prepares to become health secretary have been sidelined by Trump transition officials, people familiar with the matter said, underscoring a split over immunizations in the “Make America Healthy Again” movement.
    • “Adviser Stefanie Spear and lawyer Aaron Siri had asked prospective administration hires about their beliefs around vaccines even if they were interviewing for posts that had little to do with immunizations, people familiar with the interviews said. Kennedy, whose hearings to lead the Department of Health and Human Services could start on Capitol Hill as early as next week, also lobbed questions related to inoculation, the people said.
    • “The questions were different from those asked in separate meetings with President-elect Donald Trump’s staff, according to some of the people. Trump’s team asked about topics traditionally important to conservatives, such as the size of government and deregulation.
    • “Siri is no longer advising the presidential transition, a transition spokeswoman confirmed, and people familiar with the matter said his vaccine stances played a role. Spear, who had told others she would be Kennedy’s chief of staff, was passed over for that post in favor of a veteran of the first Trump administration—in part because of her vaccine priorities and in part because of her lack of experience, according to people familiar with the matter.”
  • The No Surprises Act regulators, which group includes OPM, released FAQ 69 which concerns an important opinion from the U.S. Court of Appeals for the Fifth Circuit handed down October 30, 2024. The Court has not issued its mandate in the case while it considers the Texas Medical Association’s motion for rehearing and rehearing en banc. The FAQ also includes compliance advice about the No Surprises Act anti-gag clause.
  • Per a Federal Trade Commission news release,
    • “The Federal Trade Commission today published a second interim staff report on the prescription drug middleman industry, which focuses on pharmacy benefit managers’ (PBMs) influence over specialty generic drugs, including significant price markups by PBMs for cancer, HIV, and a variety of other critical drugs.
    • “Staff’s latest report found that the ‘Big 3 PBMs’—Caremark Rx, LLC (CVS), Express Scripts, Inc. (ESI), and OptumRx, Inc. (OptumRx)—marked up numerous specialty generic drugs dispensed at their affiliated pharmacies by thousands of percent, and many others by hundreds of percent. Such significant markups allowed the Big 3 PBMs and their affiliated specialty pharmacies to generate more than $7.3 billion in revenue from dispensing drugs in excess of the drugs’ estimated acquisition costs from 2017-2022. The Big 3 PBMs netted such significant revenues all while patient, employer, and other health care plan sponsor payments for drugs steadily increased annually, according to the staff report.” 
  • STAT News adds,
    • “In response to the latest report, a CVS spokesperson wrote that “any proposed policy regulating PBMs should face a simple test: will this increase or decrease drug costs? Nearly all recently proposed ‘anti-PBM’ policies would ultimately increase U.S. drug costs and serve as a handout to the pharmaceutical industry. Instead of focusing on the impact to consumers and organizations that pay for prescription drugs, the FTC has prioritized comments from the conflicted pharmaceutical and pharmacy industries that would profit from a weakened PBM guardrail.”
    • “The company also argued it is “inappropriate and misleading to draw broad conclusions from cherry-picked” generic drugs. Between 2017-2022, specialty generic products have represented less than 1.5% of total spending on medicines by health plans contracted with CVS. In contrast, branded specialty products represent more than 50% of total spending.
    • “A spokeswoman for Cigna, which owns Express Scripts, wrote to say “this is another set of misleading conclusions based on a subset of medications that represent less than 2% of what our health plans spend on medications in a year — much like their first interim report that the FTC itself has already said is ‘limited’ and ‘tentative’. Nothing in the FTC’s report addresses the underlying cause of increasing drug prices, or helps employers, unions, and municipalities keep prescription benefits affordable for their members. We look forward to continuing to address the blatant inaccuracies in the Commission’s reports.”
    • “One Wall Street analyst maintained the FCC report does not tell the complete PBM story. TD Cowen analyst Charles Rhyee wrote in an investor note that “the fundamental issue with the FTC’s claims… is that they use only data on specialty generics, a small subset of the overall drug market – 0.9% of total drug spending – and is not representative of the value that the PBM industry delivers as a whole.”
  • Per a Food and Drug Administration press release,
    • “Today, the U.S. Food and Drug Administration is announcing an important step to provide nutrition information to consumers by proposing to require a front-of-package (FOP) nutrition label for most packaged foods. This proposal plays a key role in the agency’s nutrition priorities, which are part of a government-wide effort in combatting the nation’s chronic disease crisis. If finalized, the proposal would give consumers readily visible information about a food’s saturated fat, sodium and added sugars content—three nutrients directly linked with chronic diseases when consumed in excess.  
    • “The proposed FOP nutrition label, also referred to as the “Nutrition Info box,” provides information on saturated fat, sodium and added sugars content in a simple format showing whether the food has “Low,” “Med” or “High” levels of these nutrients. It complements the FDA’s iconic Nutrition Facts label, which gives consumers more detailed information about the nutrients in their food.” * * *
    • “Comments on the proposed rule can be submitted electronically to http://www.regulations.gov by May 16, 2025.”
       
  • The Wall Street Journal adds,
    • “It is unclear how the incoming Trump administration will view the rule. Robert F. Kennedy Jr., the prospective next head of U.S. health policy, is a critic of processed foods and has been outspoken about his view that U.S. food companies are partly to blame for sickening Americans.
    • “Consumer advocacy groups and public health organizations cheered the rule, though some said they hoped the Trump administration would consider labels similar to those adopted in other countries that bear more pointed warnings.
    • “Industry groups have warned the FDA that they could sue to challenge mandatory front-of-package labels. Such labels, they said, could threaten First Amendment rights—because companies could consider them a form of forced speech—and only Congress has the authority to require them.” 
  • The New York Times reports,
    • “Among both men and women, drinking just one alcoholic beverage a day increases the risk of liver cirrhosis, esophageal cancer, oral cancer and various types of injuries, according to a federal analysis of alcohol’s health effects issued on Tuesday.
    • “Women face a higher risk of developing liver cancer at this level of drinking, but a lower risk of diabetes. And while one alcoholic drink daily also reduces the likelihood of strokes caused by blood clots among both men and women, the report found, even occasional heavy drinking negates the benefits.
    • “The report, prepared by an outside scientific review panel under the auspices of the Department of Health and Human Services, is one of two competing assessments that will be used to shape the influential U.S. Dietary Guidelines, which are to be updated this year.”
  • Monica M. Bertagnolli, M.D., issued a statement on ending her tenure as NIH director January 17, 2025. The FEHBlog has enjoyed her Director’s blog entries.

From the public health and medical research front,

  • The U.S. Preventive Services Task Force today gave B grades to the following recommended preventive services:
    • “The USPSTF recommends screening for osteoporosis to prevent osteoporotic fractures in women 65 years or older.”
    • “The USPSTF recommends screening for osteoporosis to prevent osteoporotic fractures in postmenopausal women younger than 65 years who are at increased risk for an osteoporotic fracture as estimated by clinical risk assessment.”
  • and an inconclusive grade to the following preventive service
    • “The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for osteoporosis to prevent osteoporotic fractures in men.”
  • The USPSTF notes,
    • “This recommendation updates the 2018 USPSTF recommendation on screening for osteoporosis. In 2018, the USPSTF recommended screening for osteoporosis with bone measurement testing to prevent osteoporotic fractures in women 65 years or older and in postmenopausal women younger than 65 years who are at increased risk of osteoporosis, as determined by a formal clinical risk assessment tool.45 For the current recommendation, the USPSTF has noted that screening can include DXA BMD, with or without fracture risk assessment. The current recommendation is otherwise generally consistent with the 2018 recommendation.”
  • The Journal of the American Medical Association expands on this USPSTF note in an editorial comment.
    • “At first glance, the updated US Preventive Services Task Force (USPSTF) Recommendation Statement on osteoporosis screening1 appears nearly identical to the previous 2018 statement, especially regarding the recommendation for universal screening in women 65 years or older and insufficient evidence to support a recommendation for or against screening in men. However, subtle revisions to the 2018 recommendation2 may result in substantive changes in screening of younger postmenopausal women in clinical practice. While a B recommendation for higher-risk postmenopausal women younger than 65 years is common to both statements, the 2018 statement recommended assessing risk of osteoporosis in these women using a formal clinical risk assessment tool, whereas the 2024 Recommendation Statement1 recommends screening those at increased risk for an osteoporotic fracture as estimated by clinical risk assessment. Additionally, the screening test for both younger and older postmenopausal women in the 2018 recommendation is specified broadly as bone measurement testing. By contrast, the 2024 statement is more specific and defines screening as central (hip or lumbar spine) dual-energy x-ray absorptiometry (DXA) bone mineral density (BMD) testing with or without fracture risk assessment.
    • “In postmenopausal women younger than 65 years, osteoporosis screening presents several challenges. While time is often limited and resources scarce in the overstretched primary care practice environment, the USPSTF recommends a 2-step process to identify women in this age group who warrant screening. The clinician first determines whether traditional osteoporosis risk factors such as low body weight or tobacco use are present. For women with 1 or more risk factors, the USPSTF then advises risk assessment with a clinical risk assessment tool (eg, the Osteoporosis Self-Assessment Tool [OST], the Osteoporosis Risk Assessment Instrument [ORAI], or the Fracture Risk Assessment Tool [FRAX]) calculated without BMD information to further select women who warrant BMD testing. Primary care clinicians should be aware that the OST and ORAI were designed to identify osteoporosis (BMD T score ≤−2.5), while FRAX was developed to estimate 10-year absolute probabilities of hip and major osteoporotic fracture. Use of the OST or ORAI entails a simple calculation with few inputs (e.g., the OST is based on age and weight alone), whereas use of FRAX requires entering information on 11 clinical risk factors into a web-based algorithm. Table 2 in the Recommendation Statement1 provides “frequently used thresholds for increased osteoporosis risk” for OST (score <2) and ORAI (score ≥9), indicating that these thresholds identify women for whom central DXA BMD testing is suggested. In contrast to the 2011 and 2018 recommendations, the 2024 USPSTF Recommendation Statement1 does not suggest a specific FRAX threshold to define increased osteoporosis risk.
  • Per a National Cancer Institute news release,
    • “Feeding fructose to lab animals with cancer made their tumors grow faster, a new study has shown. But the tumors didn’t directly consume fructose, the researchers found. Instead, the liver converted it into a type of fat that cancer cells gobbled up.
    • “Studies have suggested that diets containing excess fructose—which is found in high-fructose corn syrup and table sugar—can help tumors grow. But how this common dietary sweetener might do so has been a bit of a mystery. The researchers believe their study provides some important answers. 
    • “The NIH-funded study, published December 4 in Nature, showed that several types of cancer cells lacked the enzyme needed to use fructose directly. However, liver cells have the necessary enzyme, called KHK, and used it to convert fructose into fats called lipids. 
    • “The findings could open up a new avenue for potential cancer treatments, said the study’s senior researcher, Gary Patti, Ph.D., of Washington University in St. Louis. A drug that blocks the KHK enzyme slowed fructose-fueled tumor growth in mice, the scientists showed.”
  • The National Institutes of Health released an NIH research matters bulletin concerning “Cancer prevention and screening | Improving flu vaccines | LDL structure.”
  • AP reports,
    • “A group of global experts is proposing a new way to define and diagnose obesity, reducing the emphasis on the controversial body mass index and hoping to better identify people who need treatment for the disease caused by excess body fat. 
    • “Under recommendations released Tuesday night, obesity would no longer be defined solely by BMI, a calculation of height and weight, but combined with other measurements, such as waist circumference, plus evidence of health problems tied to extra pounds. 
    • “Obesity is estimated to affect more than 1 billion people worldwide. In the U.S., about 40% of adults have obesity, according to the U.S. Centers for Disease Control and Prevention. 
    • “The whole goal of this is to get a more precise definition so that we are targeting the people who actually need the help most,” said Dr. David Cummings, an obesity expert at the University of Washington and one of the 58 authors of the report published in The Lancet Diabetes & Endocrinology journal.”
  • Per MedPage Today,
    • “Integrating smoking cessation into a lung cancer screening program had the biggest benefit for patients who wanted to quit, a randomized trial showed.
    • “Self-reported tobacco abstinence was greater at both 3 and 6 months with higher levels of integration of smoking cessation assistance in the lung cancer screening program, reported Paul Cinciripini, PhD, of the University of Texas MD Anderson Cancer Center in Houston, and colleagues in JAMA Internal Medicine.”
  • and
    • “Antiviral drugs commonly used to treat non-severe influenza appeared to have little or no effect on key clinical outcomes, except for baloxavir (Xofluza), according to a systematic review and meta-analysis of 73 randomized trials.”

From the U.S. public health front,

  • STAT News adds,
    • “Since society rebounded from the pandemic, Teladoc Health has gone from a soaring rocket ship considered an emblem of the potential of health tech to a cautionary tale about overblown hype. Its telehealth services are now viewed by many as an interchangeable commodity in a crowded market.
    • “In his first prominent public appearance as CEO of the virtual care giant, Chuck Divita showed up [at the JPM Conference] and played the part — promising growth and stability and reminding investors of the company’s strong foundation.”
  • Beckers Hospital Review points out,
    • Eli Lilly is leading a push with other pharmaceutical companies to request a pause in the Biden administration’s drug pricing negotiations, even as officials prepare to release a new list of medications to be targeted for price reductions, Bloomberg reported Jan. 13. 
    • Speaking at the JPMorgan HealthCare Conference in San Francisco, Eli Lilly CEO Dave Ricks emphasized the need for changes to the Inflation Reduction Act before additional drugs are included in the program. 
  • MedCity News relates, “Nvidia announced four new partnerships focused on scaling AI models across the healthcare industry. The company is teaming up with Mayo Clinic, Illumina, IQVIA and Arc Institute” at JPM Conference.
  • BioPharma Dive lets us know,
    • “Eli Lilly on Tuesday said the company’s revenue in 2024 totaled about $45 billion, a 32% jump on 2023’s total but less than what it had estimated in October.
    • “Third quarter sales of Mounjaro and Zepbound, its GLP-1 drugs for diabetes and obesity, were below Wall Street analysts’ expectations at $3.5 billion and $1.9 billion, respectively. CEO David Ricks said GLP-1 market growth was slower than the company anticipated.
    • “Shares of the Indianapolis-based company fell by as much as 8% in morning trading, shaving tens of billions of dollars from its market valuation. Since hitting a high of $960 apiece in late August, shares have tumbled in value by about one-fifth as Zepbound sales have fallen short of forecasts.”
  • McKinsey & Company explains “How healthcare entities can use M&A to build and scale new businesses.”

Weekend update

David Ermer–Congress, Medical / Rx research, U.S. Healthcare–

From Washington, DC,

  • Govexec tells us,
    • “Rep. Gerry Connolly, D-Va., the new top Democrat on the House Oversight and Accountability Committee, says he’s open to working with Elon Musk and Vivek Ramaswamy’s Department of Government Efficiency in some areas.
    • “That may make for strange bedfellows. But the lawmaker — who recently beat Rep. Alexandria Ocasio-Cortez, D-N.Y., to be the committee’s ranking member — has long focused on the government’s often-aged technology, a shared interest for both Ramaswamy and Musk. In recent months, Musk has posted about federal IT several times, referencing 2023 congressional testimony on legacy tech from the Government Accountability Office.
    • “By the way, that was the GAO report I requested,” Connolly pointed out during an interview with Nextgov/FCW. The report also lists former representatives Elijah Cummings, Mark Meadows, Will Hurd and current Reps. Robin Kelly, D-Ill., and Jim Jordan, R-Ohio, as requesters.”
  • Federal News Network lets us know,
    • “President-elect Donald Trump is preparing more than 100 executive orders starting Day One of the new White House, in what amounts to a shock-and-awe campaign on border security, deportations and a rush of other policy priorities.
    • “Trump told Republican senators about the onslaught ahead during a private meeting on Capitol Hill. Many of the actions are expected to launch on Inauguration Day, Jan. 20, when he takes office. Trump top adviser Stephen Miller outlined for the GOP senators the border security and immigration enforcement measures that are likely to launch soonest. Axios first reported on Trump and his team’s presentation.
    • “There will be a substantial number,” said Sen. John Hoeven, R-N.D.
    • “Allies of the president-elect have been preparing a stack of executive orders that Trump could sign quickly on a wide range of topics – from the U.S.-Mexico border clampdown to energy development to federal Schedule F workforce rules, school gender policies and vaccine mandates, among other day-one promises made during his campaign.”

From the public health and medical research front,

  • MedPage Today tells us,
    • ‘The detection of the first clade I mpox case in the U.S. this November, followed by a subsequent case in Canada, is far more than a fleeting headline. It is a stark reminder of the interconnectedness of global health. Clade I mpox, a public health emergency of international concern concentrated in Central and Eastern Africa, has already caused more than 57,000 suspected cases and more than 1,200 deaths in 2024 alone. Travel-associated cases have now extended to Europe, Asia, and North America, with the first U.S. case linked to travel from an endemic region.
    • “This development underscores the urgent need for sustained, coordinated action to prevent clade I mpox from following the trajectory of clade II. The latter has resulted in the continued global circulation of over 100,000 cases across 122 countries, including 115 nations where mpox was not previously reported.
    • The emerging threat of clade I mpox presents the incoming Trump administration with a unique opportunity to demonstrate leadership, bolster global health, and underscore the value of preparedness. Proactively addressing this challenge can protect the U.S. from future outbreaks while reaffirming its commitment to global health security and collaboration.
  • Per Healio,
    • Researchers developed a computer-based tool [known as TBorNotTB] to evaluate hospitalized patients for suspected tuberculosis that correctly identified 100% of cases, which could help prevent spread to other patients, they said.
    • “Infection prevention and control programs are tasked with implementing appropriate isolation of patients in health care facilities with suspected or confirmed communicable diseases to reduce the risk of health care-associated infections to patients and mitigate occupational risks to health care personnel,” Caitlin Dugdale, MD, MSc, an infectious disease physician at Massachusetts General Hospital, told Healio.
  • Fortune Well informs us,
    • “New research makes a strong case for morning joe, indicating that the timing may impact your longevity. In a study published in the European Heart Journal, researchers looked at two patterns of coffee timing: people who drank their coffee in the morning, and people who were all-day drinkers. After adjusting for other potential factors, researchers found that morning coffee drinkers were 16% less likely to die of any cause during the study period, and 31% less likely to die of cardiovascular disease, compared to people who didn’t drink coffee. However, there was no reduction in risk for all-day coffee drinkers compared to non-coffee drinkers. 
    • “The authors speculate that drinking caffeinated coffee later in the day could disrupt circadian rhythm and melatonin levels, leading to inflammation and sleep disturbances. A second potential explanation is that inflammation is at its highest in the morning, and the natural anti-inflammatory properties of coffee may have a greater impact when consumed earlier in the day.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Mercy Health — Toledo plans to acquire 10 urgent care centers in Ohio and Michigan from Greater Midwest Urgent Cares.
    • “The nonprofit, faith-based system, part of Cincinnati-based Bon Secours Mercy Health, said Friday it plans to assume ownership April 1. Financial details of the transaction, which would be through an asset purchase agreement, were not disclosed.
    • “Our intent is to keep those Greater Midwest Urgent Care employees who’ve done an amazing job providing patient centric care,” said Bob Baxter, president of Mercy Health — Toledo.”
  • HR Dive points out “five compensation and benefits trends to buy into in 2025. To attract and retain workers, employers will focus on competitive salaries and flexible benefits, experts say.”

Thursday Report

David Ermer–CDC, CMS, Congress, FDA, Generative AI, Medical / Rx research, Obesity, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC

  • Tammy Flanagan, writing in Govexec, discusses, “The Social Security Fairness Act: What we know so far.  It may take time to implement this new law — here’s what you should know for now.”
    • “It will undoubtedly take time to implement this new law as it impacts about two million beneficiaries who have their earned Social Security benefits reduced because of the WEP, and close to 750,000 individuals who have had spousal and widow’s benefits payable based on the Social Security work record of their current, former or deceased spouse.  
    • “The repeal of the WEP and GPO will increase the Social Security benefit entitlements of the government worker or retiree who is receiving a pension from work not covered by Social Security. For most of you reading today’s column, this would be the CSRS employees and retirees who are married or were married to a spouse who paid Social Security taxes and the CSRS employee or retiree who earned their own Social Security retirement benefit in addition to receiving a CSRS retirement benefit.  
    • “The WEP can also affect CSRS Offset employees and retirees as well as some employees or retirees who transferred to FERS after more than five years of creditable service under CSRS.”
  • The American Hospital Association News tells us,
    • The Centers for Medicare & Medicaid Services will host a webinar Jan. 16 at 1 p.m. ET to provide an update on the No Surprises Act Good Faith Estimate requirements for uninsured and self-pay patients. Experts will discuss the recent GFE FAQs with a focus on implications for providers and facilities. REGISTER NOW” 

From the public health and medical research front,

  • Per Medical Economics,
    • Screening for physical inactivity during routine medical visits can play a pivotal role in the identification of patients at risk for chronic diseases, according to a study published in Preventing Chronic Disease, a journal of the U.S. Centers for Disease Control and Prevention (CDC). Using the Exercise Vital Sign (EVS), researchers found that patients screened for physical activity had healthier profiles and fewer comorbid conditions than those who were not screened.
  • WTW Consulting informs us,
    • More and more evidence show that GLP-1 medications are good for losing weight and reducing the amount of metabolic disease in people with obesity. But only about 52% of employers currently cover these drugs for obesity, and these employers are facing rising costs.
    • Previous research has shown that the cost of these drugs will exceed any medical cost savings, as is true for most medical interventions. For example, medical plans don’t save money by treating cancer or providing dialysis for patients with kidney failure.
    • JAMA Network Open recently published a study that showed that healthcare spending could decrease based on the type of weight loss seen with use of GLP-1 medications. However, the study demonstrates once again that even with their impressive impacts on patient weight and health, an employer-sponsored health insurance plan should not expect net medical savings from these medications.
    • The researchers looked at medical claims from over 13,000 commercially insured adults from the Medical Panel Expenditure Survey from 2001 to 2020 and found that medical spending was lower in those who weighed less. Therefore, cost effectiveness of an effective weight loss drug would be much higher in those with higher BMIs, especially in those with diabetes. 
    • However, the study didn’t evaluate people who had lost weight, but rather examined differences in costs based on BMI. Those who lose weight won’t necessarily have the same lower level of expense as those who weren’t previously obese. Even if their estimate of cost “savings” is correct, the net cost of semaglutide or tirzepatide is around $9,000 annually, which is more than the delta in costs for a person with diabetes who loses 25% of their body weight.
    • Implications for employers: 
      • An employer-sponsored health insurance plan should not expect net medical savings from these medications, even with their impressive impacts on patient weight and health.
      • The decision to cover these medications should be based on the benefit they offer, and not the hope of lower medical expenses. Lower prices would allow more people to benefit from these medications.
  • The Wall Street Journal warns us,
    • Wildfires in California aren’t all wild anymore. They often burn in urban areas, creating a toxic soup of smoke, ash and noxious substances that can be dangerous, even deadly. 
    • In Los Angeles this week, wildfires have burned buildings and roadways. Incinerating the plastics, metals and other materials that these structures are built from releases hazardous chemicals and gases into the air, doctors and public-health experts say. 
    • Wildfires which tear through urban landscapes release chemicals from human-made fuels, construction materials, household products and generate emissions which are chemically different from wildland fires, according to a 2022 report from the National Academies of Sciences, Engineering and Medicine. About 70,000 communities and 43 million homes are at risk from fires that could burn through both wild and urban landscapes, the report stated.
    • “The combination of wildfire smoke in conjunction with human elements might be even more dangerous,” said Dr. Sanjay Rajagopalan, chief of cardiovascular medicine at University Hospitals Harrington Heart & Vascular Institute in Cleveland. “When you burn plastic, for instance, or you burn rubber, you get some pretty nasty stuff.”
    • Smoke from the Los Angeles wildfires could have far-reaching effects. Depending on weather patterns and geographic conditions, smoke can travel vast distances. Tens of thousands of Los Angeles County residents have already been ordered to evacuate.
  • BioPharma Dive points out,
    • “An experimental menopause drug from Bayer succeeded in a late-stage trial in women taking drugs to treat or prevent breast cancer, the company said Thursday.
    • “Bayer said the drug, elinzanetant, significantly reduced the frequency of hot flashes and improved sleep for women with breast cancer, or who are at high risk of developing it, and whose symptoms are caused by hormone therapy. The study randomized 474 women to receive treatment or a placebo and measured the effects after four and 12 weeks.
    • “The announcement represents the fourth positive late-stage study result for elinzanetant, but the first that isn’t in menopausal women. Bayer has already submitted the drug for U.S. approval in postmenopausal women, and the Food and Drug Administration accepted its application in October. If cleared by regulators, the drug would compete with Astellas Pharma’s Veozah.”
  • Per Fierce Pharma,
    • “Trailing Johnson & Johnson’s powerhouse Darzalex by roughly five years in its development timeline has made it challenging for Sanofi’s Sarclisa—the only other CD38 antibody on the market for multiple myeloma—to compete in the indication.
    • “But with an on-body delivery system (OBDS) to deliver its subcutaneous (SC) formulation of Sarclisa, Sanofi may be finding the edge it needs.
    • “The company has taken a major step in the development of its OBDS as a phase 3 trial has met its primary co-endpoints, showing non-inferiority to intravenous (IV) Sarclisa. The company reported the trial result in a press release Thursday.”

From the U.S. healthcare business front,

  • Health Dive relates,
    • “Blue Shield of California, one of the largest plans in the state, has revamped its corporate structure and named its first-ever female CEO.
    • “Blue Shield created a parent company called Ascendiun to oversee the insurer, along with its managed Medicaid subsidiary and clinical services firm Altais, starting Jan. 1, the company announced Wednesday. Ascendiun also includes a newly created health services business called Stellarus, which aims to scale and sell Blue Shield’s pharmacy and technology offerings to other insurers.
    • “Lois Quam, who has been Blue Shield’s president since last year, will step up as chief executive of the insurer. Quam will be the first woman to serve as Blue Shield’s CEO in the organization’s 86 years of operation. Paul Markovich, Blue Shield’s CEO for over a decade, will become president of Ascendiun and will also lead Stellarus on an interim basis.”
  • and
    • “Amwell is selling its virtual psychiatric care business to fellow telehealth provider Avel eCare for about $21 million in cash, the company said Thursday. 
    • “The divestiture, which includes an additional earn-out payment for Amwell if the business meets financial targets, includes the psychiatric care segment’s technology and personnel along with Asana, a clinical network that employs and contracts with the unit’s clinicians. 
    • “Amwell CEO Ido Schoenberg said in a statement the sale strengthens the telehealth firm’s balance sheet and “fortifies our confidence” to reach positive cash flow in 2026.”
  • The American Hospital Association announced,
    • “The AHA today released its 2025-2027 Strategic Plan, approved by the AHA Board of Trustees in November. The plan is rooted in four core disciplines — advocacy and representation, thought leadership, knowledge exchange, and agents of change. It also includes nine principles that serve as the foundation of the AHA’s work and strategies to help the field make progress on its mission of advancing health in America. View the 2025-2027 Strategic Plan for more information.”
  • Modern Healthcare notes,
    • Oakland, California-based Kaiser Permanente led a $275 million Series F funding round for Innovaccer, a company that sells technology to unify patient data across health systems.
    • Innovaccer said the round will help it introduce new artificial intelligence and cloud capabilities. The company also said the new capital will help it to continue scaling a developer ecosystem that can allow health systems to implement AI tools with other third-party vendors.
  • NCQA suggests “Health Care Trends to Watch in 2025.”
  • Per Fierce Healthcare,
    • “A new report from Press Ganey highlights the close relationship between patient experience and health plan star ratings.
    • “Researchers polled 450,000 people across 200 plans and combined those survey results with its database of 5.5 million patient encounters. It found that people who gave poor scores for safety and privacy in surveys following a visit to their primary care providers also frequently awarded their health plan one star on quality and access to needed care on Medicare consumer services.
    • “The report noted these are critical data for plans to consider, as they have traditionally focused on making improvements to customer service, benefit design and patient engagement. It suggests they should also be considering ways to address safety.
    • “In addition, the survey found that patients expect easy access to primary care, but their ability to reach specialists is a key differentiator. Plans that earned four or more stars connected a higher proportion of their members with specialty care.”
  • MedTech Dive points out “five medtech trends to watch in 2025. After a busy 2024, experts called out competition in soft tissue robotics, uncertainty from a Trump White House and continued success for pulsed field ablation as trends to watch this year.”

Midweek Report

David Ermer–CMS, Congress, FDA, Generative AI, Medical / Rx research, NIH, U.S. Healthcare–

From Washington, DC

  • FedScoop informs us,
    • “President Joe Biden on Saturday signed into law the Government Service Delivery Improvement Act, legislation that targets improving customer service interactions with the government.
    • “The bill (H.R. 5887) was first introduced by Reps. Ro Khanna, D-Calif., Byron Donalds, R-Fla., Barry Loudermilk, R-Ga., and William Timmons, R-S.C., in October 2023. Now as law, it requires the Office of Management and Budget to choose a senior official as a “Federal Government Service Delivery Lead” to coordinate government service delivery improvement within agencies. 
    • “That service delivery lead would also work with new agency-appointed senior officials, who must be named within a year of the bill’s enactment, to oversee their organizations’ delivery improvements.”
  • Per an HHS press releases,
    • “Today, U.S. Department of Health and Human Services Secretary Xavier Becerra announced he would delegate the authority vested in the HHS under the Dr. Emmanuel Bilirakis and Honorable Jennifer Wexton National Plan to End Parkinson’s Act to the National Institutes of Health, with support from the HHS Office of the Assistant Secretary for Health.”
  • and
    • “Today, the White House Initiative on Asian Americans, Native Hawaiians, and Pacific Islanders (WHIAANHPI) unveiled Rising Together, its final report to President Joe Biden. The report showcases how the Biden-Harris Administration has leveraged the full force of the federal government to make real the promise of America for Asian American, Native Hawaiian, and Pacific Islander (AA and NHPI) communities. Read the full report at wh.gov/whiaanhpireport2025 – PDF“
  • and
    • “Today, the U.S. Department of Health and Human Services (HHS) announced seven winners of the KidneyX Sustainability Prize, designed to incentivize development of solutions to reduce water or power usage during dialysis care.” * * *
    • “HHS congratulates the winners of the KidneyX Sustainability Prize, who will each receive an equal share of the $7.25 million prize purse:  
      • “Kuleana Technology Inc. Advancing Hemodialysis Sustainability: Dialysate Regeneration via Uremic Toxin Photo-Oxidation. “Kuleana Technology’s Dialysate Regeneration Module enables hemodialysis with just 2 liters of water per treatment, making dialysis portable and accessible while saving 300 billion liters of water per year worldwide.”
      • “Micro Nano Technologies Inc. Handheld Water-Free and Battery-Powered Renal Replacement System. “The proposed technology mimics kidney filtration, eliminating the need for water and operating on a laptop-sized battery for 8 hours, ensuring dialysis access during disasters without traditional infrastructure.”
      • “Particle4X. SMART-PD: Sustainable Home Dialysis Revolution. “SMART-PD is an advanced home dialysis system that produces sterile PD fluid from tap water, reclaims effluent, and employs AI-powered monitoring to enhance sustainability and patient safety.”
      • “Qidni Labs Inc. Qidni/D: A Novel Sorbent Platform for Dialysis. “The Qidni/D is a portable and nearly waterless hemodialysis system that can offer accessible and sustainable access to care anywhere.”
      • “Stephen Ash. Sorbent Regeneration of Dialysate with Improved Ammonium Capacity. “We have developed a sorbent with high capacity for NH4+ (from urea) and minimal binding of Ca++ and Mg++, which should make regeneration of dialysate simpler, smaller and more practical.”
      • “University of Minnesota. Decentralized Dialysis Fluid Production: Enhancing the Sustainability of Dialysis Care. “Our innovation enables decentralized production of peritoneal dialysis fluids, reducing dialysis energy and water consumption by 48% and 66%, respectively, increasing supply chain resilience, and improving patient outcomes worldwide.”
      • “Wearable Artificial Organs Inc. Green dialysis on batteries using only 300ml of water. “A 2 lb. miniaturized Wearable Artificial Kidney (WAK) powered by rechargeable batteries, continuously regenerates dialysate water and delivers continuous dialysis 24 hours a day, 7 days a week.”
    • Kudos to the prize winners.
  • The American Hospital Association News tells us,
    • “The Centers for Medicare & Medicaid Services Jan. 8 announced 23.6 million consumers have signed up for a 2025 Health Insurance Marketplace plan. Of that total, approximately 3.2 million are new consumers. Open enrollment continues until Jan. 15 for the 31 states that use HealthCare.gov and most state-based marketplaces for coverage beginning Feb. 1.” 
  • Kevin Moss, writing in Federal News Network, answers the question “If someone is on Federal Health Benefits, what happens when they turn 65 and become eligible for Medicare, and what happens when their spouse turns 65 and is also eligible for Medicare?” It’s worth adding that OPM regulations grant special FSHB/PSHB open enrollment period to employees and annuitants who turn 65:
    • On becoming eligible for Medicare. An employee [or an annuitant] may change the enrollment from one plan or option to another at any time beginning on the 30th day before becoming eligible for coverage under title XVIII of the Social Security Act (Medicare). A change of enrollment based on becoming eligible for Medicare may be made only once. 5 CFR Secs 890.301(k), 890.306(p)
  • Stars and Stripes gives us an update on the “pilot program aimed at helping Department of Defense civilian employees [based in Japan] find health care from Japanese providers is up and running, according to the DOD. The program, which aims to connect the civilians with local health care providers without paying large, upfront service fees, among other advantages, began Jan. 1, according to a fact sheet emailed to employees Wednesday by the U.S. Army Civilian Human Resources Agency. The program complements existing health insurance coverage for eligible DOD employees.”

From the judicial front,

  • Bloomberg Law reports,
    • “A trade group representing consumer credit reporting companies and a Texas-based credit union association sued to block the Consumer Financial Protection Bureau’s new rule barring most medical debt from credit reports.
    • “The CFPB overstepped its authority in eliminating medical debt from credit reports and banning creditors from considering medical debt in lending decisions, the Consumer Data Industry Association and the Cornerstone Credit Union League said in a complaint filed Tuesday in the US District Court for the Eastern District of Texas.
    • “Only Congress has the power to determine whether information can or can’t be included in credit reports, the complaint said.
    • “The ban will make it harder for lenders, employers, and rental housing providers to make informed decisions about the creditworthiness of borrowers, the industry groups said. 
    • “Knowing whether a consumer has debt is an important element of underwriting, and unilaterally eliminating consideration of coded medical debt information erodes the predictive nature, and therefore the value, of consumer reports,” the complaint said.
    • “The suit came on the same day the CFPB finalized its medical debt rule.”

From the Food and Drug Administration front,

  • Fierce Pharma lets us know,
    • “The FDA will require GSK and Pfizer to include on the label of their respiratory syncytial virus (RSV) vaccines a warning about the risk of developing Guillain-Barré syndrome (GBS), a rare neurological condition that can cause paralysis.
    • “The ruling will affect GSK’s Arexvy and Pfizer’s Abrysvo, both of which were approved by the agency in May of 2023 for adults 60 years or older and realized booming sales in their first year on the market.
    • “Seven months ago, however, the sales potential for both shots declined significantly when the Centers for Disease Control and Prevention (CDC) recommended that they only be used by adults aged 75 and older and those 60 and older who have a high risk of severe disease due to underlying medical conditions.
    • “In narrowing the population with its revised recommendation, the CDC cited the potential link between the vaccines and GBS.
    • “On Tuesday, the FDA explained that its new guidelines come after the agency conducted a post marketing observational study and evaluated the results of clinical trials and reports to its Vaccine Adverse Event Reporting System (VAERS).”
  • Per Healthcare Dive,
    • “The Food and Drug Administration’s device center clarified how manufacturers should approach artificial intelligence in a draft guidance issued on Monday.
    • “The document outlines recommendations for design, development and maintenance to ensure AI-enabled devices are safe and effective. In particular, the guidance outlines how device makers should address transparency and bias and when post market monitoring is needed. 
    • “Troy Tazbaz, director of the FDA’s Digital Health Center of Excellence, said the agency has authorized more than 1,000 AI-enabled devices to date. 
    • “As we continue to see exciting developments in this field, it’s important to recognize that there are specific considerations unique to AI-enabled devices,” Tazbaz said in a statement.”
  • Per MedTech Dive,
    • “Johnson & Johnson said Wednesday it paused all U.S. Varipulse caseswhile the company investigates the cause of four reported neurovascular events.
    • “J&J said the cases were part of an external evaluation in the U.S. The pause was initiated on Jan. 5. J&J completed more than 130 cases across 14 sites as of Jan. 3.
    • “An external evaluation is a limited rollout intended to collect physician feedback on a new technology before a full release, a J&J spokesperson said in an email to MedTech Dive.
    • “Because the evaluation used a unique platform configuration, the pause does not affect the rollout of Varipulse outside of the U.S., where more than 3,000 commercial cases have been completed, J&J said.
    • “The pause of U.S. cases comes two months after J&J received Food and Drug Administration approval for Varipulse, becoming the third device company to offer a PFA system in the U.S.”

From the public health and medical research front,

  • The National Cancer Institute released its Cancer Information Highlights concerning “Targeted Therapy for Head and Neck Cancer & CAR T-Cell Therapy for Brain Cancer.”
  • MedPage Today informs us,
    • A study of older adults showed that 6% had depression, with higher prevalences in certain groups, including women, those who were unmarried, and those with chronic medical conditions. (Journal of the American Geriatrics Society)
    • A single 25-mg dose of synthetic psilocybin significantly improved depressive symptoms by week 3 among participants with severe treatment resistance in a small single-arm open-label trial. (American Journal of Psychiatry)
    • Older adults with major depressive disorder displayed riskier driving compared with those without depression, according to a prospective longitudinal cohort study. (JAMA Network Open).
  • MedPage Today adds, “Two types of Wicklow Gold cheddar cheese sold in five states were recalled due to potential contamination with Listeria monocytogenes, Abbey Specialty Foods said [last Friday].”

From the U.S. healthcare business front,

  • Healthcare Dive expects that “Health insurers will step off the roller coaster in 2025. After a turbulent year, things should calm for payers with the advent of a business-friendly Trump administration — though challenges will persist.”
  • MedCity News discusses
    • How Can Employers Manage Rising Healthcare Costs in 2025? Multiple reports indicate that employers can expect rising healthcare costs in 2025. To address these costs, employers are holding their vendor partners accountable and evaluating their health plan and PBM partners.
  • and
    • “Biopharma in 2025: Outlook for Obesity Meds, Drug Prices, Regulation & More. Metabolic medicines dominated life sciences headlines in 2024, a trend expected to continue into the new year. Other things to look for include more widespread adoption of artificial intelligence technologies and the IPO market’s return to normal levels.”
  • STAT News reports
    • “Next week brings the return of the J.P. Morgan Healthcare Conference, and with it another fabled opportunity for companies in the industry to court possible mergers, acquisitions, and licensing deals. This year, there will be even greater pressure to make a good match, as the pharmaceutical industry, which drives more than $1 trillion in economic activity and thousands of jobs, faces one of the largest patent cliffs in recent history. 
    • “Between now and 2033, the patents on dozens of brand-name medications will expire, allowing generic drugmakers to begin selling cheaper versions. Drug companies stand to lose more than $400 billion in revenue as patents expire for Keytruda, Eliquis, Jardiance, Opdivo, and other blockbuster therapies. (By comparison, the last major patent cliff that hit the industry, in 2011, jeopardized around $250 billion in drug revenue.) 
    • “One of the few tried-and-tested methods for navigating a patent cliff is to acquire startups and new drugs — and lots of them. As a result, many experts anticipate pharma ramping up M&A activity in 2025, starting at the J.P. Morgan conference. 
    • “We always have a handful of deals announced around JPM. But the real work is the meetings that happen at JPM, that start the discussions.… I think people need to buckle up, because it’s already twice as frothy and could get even more,” said Charles Ruck, an attorney at Latham Watkins who specializes in M&A.”
  • Per Fierce Healthcare,
    • “Two-thirds of insured Americans say they would trust a health insurer’s artificial intelligence copilot to accurately inform them about a health plan’s benefits, a survey conducted by virtual care navigation platform Pager Health and market research firm The Harris Poll reveals.
    • “Of the respondents, 66% believe AI can correctly personalize digital healthcare with the goals and needs of the member. Even more respondents think AI can find doctors accepting new members and schedule appointments.
    • “The survey, shared exclusively with Fierce Healthcare, provide insights into how members want insurers to offer a better customer experience, sometimes through AI. However, health plans do not fully capitalize on this opportunity.
    • “Only 41% of people say they receive personalized messages, while 17% don’t receive health plan recommendations at all. About one-third of respondents say an insurer’s wellness programs would be more enticing if they received progress alerts, biometric information or claims data.
    • “Only health plans that fully leverage the power of AI to analyze the wealth of health data available will be able to meet this demand and, in the process, boost member engagement and satisfaction,” said Rita Sharma, chief product officer at Pager Health, in a news release.”
  • The Wall Street Journal reports,
    • “Novo Nordisk expanded a deal with Valo Health, a U.S. company, to discover and develop treatments for obesity, type 2 diabetes and cardiovascular disease using human data and artificial intelligence.
    • “The deal extends an agreement signed in 2023 and will see Valo become eligible for increased payments and funding.
    • “Under the original deal, the companies agreed to develop up to 11 drug programs, primarily focused on cardiovascular disease, with Valo eligible to receive up to $2.7 billion in milestone payments, plus research and development funding and potential royalty payments.
    • “The new agreement set out Wednesday expands the scope to put a stronger focus on obesity and type 2 diabetes and includes near-term payments to Valo of up to $190 million.
    • “A further $4.6 billion in potential milestone payments will be made for up to nine new drug programs and Valo will also be eligible for more research and development funding and potential royalty payments.
    • “The companies will continue to use Valo’s drug discovery and development platform that uses patient data and AI to generate new insights and translate them into potential therapeutics.”
  • Per Healthcare Dive,
    • “Transcarent, a healthcare platform for self-insured employers, will acquire benefits navigator Accolade for about $621 million, the companies announced Wednesday. 
    • “The deal will combine Transcarent’s offerings — including an artificial intelligence-backed information and navigation service, health benefits guidance and virtual care — with Accolade’s services, like providing virtual primary care and specialist consultations, as well as patient advocates and care navigation. 
    • “The acquisition will net Accolade stockholders $7.03 per share in cash, an approximately 110% premium over the company’s closing stock price on Tuesday. Transcarent’s CEO, noted entrepreneur and investor Glen Tullman, will head up the combined organization, according to a spokesperson.”