Happy New Year!

FDA

Happy New Year!

David Ermer–CDC, FDA, Medical / Rx research, NIH, U.S. Healthcare–
Photo by Natalie Kinnear on Unsplash

Happy New Year, FEHBlog readers, and greetings to the Postal Service Health Benefits Program which launched today.

The New York Times offers “10 Ways to Keep Your Mind Healthy in 2025” and “12 Ways to Get Fitter in 2025.”

The Wall Street Journal advises “Want to Lose Weight This Year? Start With What You Drink. Sugary drinks are sneakier than equally high-calorie foods—and even diet soda can affect your metabolism.” Stick with water.

From the public health and medical research front,

  • Per an NIH news release,
    • “Since 1996, HPAI H5N1 influenza viruses have circulated in at least 23 countries. In late 2021, HPAI H5N1 spread from Europe to North America causing sporadic infections among wild birds and poultry farms. In 2022, the virus spread to South America where it devastated birds and marine mammals. In March 2024, USDA scientists identified HPAI H5N1 in U.S. dairy cows, and it subsequently reached herds in 16 states. The virus has been detected in dairy herds in three states over the past 30 days, according to USDA/APHIS. In 2024, the virus has caused 66 confirmed and 7 probable cases of influenza in people in the U.S. and one case in Canada. These human cases have been caused by either the H5N1 type circulating in birds (D1.1) or the type circulating in dairy cows (B3.13).
    • “Against this backdrop, Drs. Marrazzo and Ison say there are four keys to controlling the current outbreak. The first imperative is timely, effective collaborations among investigators in human and veterinary medicine, public health, health care, and occupational workers, such as dairy and poultry workers.
    • “This involves cultivating trust not only between numerous entities, but with people seeking care for symptoms of concern, including conjunctivitis, the authors write. Fortunately, so far most U.S. cases of HPAI H5N1 have been mild and resolved on their own without the need for treatment.
    • “Their second key is a focus on the Canadian HPAI H5N1 patient, who developed respiratory failure and required life-saving medical intervention and treatment before recovering. The authors write that mutations found in the virus in this patient highlight an urgent need for vigilant disease surveillance to identify and assess viral changes to evaluate the risk for person-to-person transmission. Effective surveillance, they say, requires that complete genomic sequencing data from animals and people are made rapidly and readily available.
    • Without information pertaining to where and when isolates were collected, the data cannot be linked phylogenetically to other reported sequences, limiting insight into how the virus is spreading, they write. These data would also provide opportunity for early detection of mutations that might portend avidity for human respiratory epithelium, which may require as little as one mutation in the virus.
    • “Third, researchers must continue to develop and test medical countermeasures—such as vaccines and therapies that eliminate or alleviate disease—against H5N1 and other influenza viruses. Fortunately, current vaccine candidates neutralize the circulating strains, which so far are susceptible to antivirals that could mitigate transmission and severity of illness, they write.
    • “Lastly, Drs. Marrazzo and Ison encourage people to take precautions to prevent exposure to the virus and minimize the risk of infection. For example, people who work with poultry and cows should use personal protective equipment and educate themselves about occupational risks when working with birds and mammals, as CDC and USDA have repeatedly recommended.
    • “Ideally, following these four steps will help scientists and public health officials investigating HPAI H5N1 to answer the many remaining questions more quickly about how the virus is spreading, evolving, and affecting people, other mammals, and birds.”
  • MedPage Today adds,
    • “A 13-year-old Canadian girl recovered after being hospitalized in critical condition with H5N1 avian influenza, researchers reported.
    • “The girl was hospitalized on Nov. 7 and transferred to BC Children’s Hospital the next day, where she was intubated and put on extracorporeal membrane oxygenation (ECMO) and treated with three different antivirals, David Goldfarb, MD, of BC Children’s Hospital in Vancouver, and colleagues reported in the New England Journal of Medicine (NEJM).”
  • Precision Vaccinations lets us know,
    • “A recent study found that 73% of adult Portuguese patients with urinary tract infections (UTIs) reported a reduction in symptom severity or duration of illness after treatment with Uromune™ (MV140). This inactivated oral spray serves as a novel sublingual mucosal-based bacterial vaccine.
    • “This prospective observational study, which involved 125 patients with complicated and uncomplicated recurrent UTIs, was published in the journal MDPI Vaccines (12(12), 1426) on December 18, 2024. In addition to the primary outcome of symptom reduction, the study assessed overall patient satisfaction, adverse events, and the effectiveness of Uromune in subgroups with specific UTI risk factors.
    • “During the 12 months following the start of treatment, 38% of patients were free of UTIs. Meanwhile, 34% reported experiencing one or two episodes, while the remaining 28% had three or more recurrent UTIs.”
  • Beckers Hospital Review informs us,
    • “The FDA approved a subcutaneous injection version of Bristol Myers Squibb nivolumab and hyaluronidase-nvhy for the treatment of several cancers including melanoma, non-small cell lung cancer and renal cell carcinoma. 
    • “The approval covers both monotherapy and combination therapy options, including use of chemotherapy and combination therapy options including use with chemotherapy or cabozantinib, according to a Dec. 27 news release from the agency. “
  • Here’s a link to the December NIH Office of Reseach on Women’s Health Pulse newsletter.
  • Per Medscape,
    • “Researchers are gaining new insight into the relationship between the human cytomegalovirus (HCMV), a common herpes virus found in the gut, and the immune response associated with CD83 antibody in some individuals with Alzheimer’s disease (AD).
    • ‘Using tissue samples from deceased donors with AD, the study showed CD83-positive (CD83+) microglia in the superior frontal gyrus (SFG) are significantly associated with elevated immunoglobulin gamma 4 (IgG4) and HCMV in the transverse colon (TC), increased anti-HCMV IgG4 in the cerebrospinal fluid (CSF), and both HCMV and IgG4 in the SFG and vagus nerve.
    • “Our results indicate a complex, cross-tissue interaction between HCMV and the host adaptive immune response associated with CD83+ microglia in persons with AD,” the investigators including Benjamin P. Readhead, MBBS, research associate professor, ASU-Banner Neurodegenerative Disease Research Center, Arizona State University, Tempe, Arizona, noted.
    • “The results suggest antiviral therapy in patients with biomarker evidence of HCMV, IgG4, or CD83+ microglia might ward off dementia.
    • “We’re preparing to conduct a clinical trial to evaluate whether careful use of existing antivirals might be clinically helpful in preventing or slowing progression of CD83+ associated Alzheimer’s disease,” Readhead told Medscape Medical News.”

From the U.S. healthcare business front,

  • STAT News asked “Four digital health unicorns on what they expect in 2025.” For example,
    • “Sean Duffy, the CEO of Omada Health, jokes that 2024 was “the year of Gs” when GLP-1s and GPT were all anybody talked about. While the description could have just as easily applied to 2023, Omada’s most important move this year was all about GLP-1s: a deal with Cigna subsidiary Evernorth to offer its digital behavior change program as a key piece of EncircleRx, which helps employers manage the growing boom in interest for the weight loss drugs. In October, Cigna reported that it had 8 million covered lives in the program. 
    • “Looking ahead to 2025, Duffy said that by the end of the year, Omada hopes to have data that show the company’s lifestyle programs have a meaningful impact on the success of GLP-1s.
    • “Glen Tullman, the CEO of Transcarent, is elated that next year Apple, a company that’s legendarily fastidious about design, will be one of the first users of Transcarent’s new WayFinding tech. The AI chat interface answers questions about care and benefits and represents a sophisticated real-world example of patient-facing generative AI. 
    • “Transcarent already has plans to launch the tool to 1 million people, and Tullman said that ambitiously, he’d like to roll it out to 5 million members by the end of 2025. Tullman thinks of Transcarent as a more sophisticated health care benefit for self-insured employers. Over the last few years, he said the company has poured over $100 million into developing AI for its app that serves as the focal point for the company’s services including virtual care, pharmacy benefits, as well as specialized services for mental health, cancer, surgery and more.” 
    • “Maven Clinic has grown to be a vanguard in the women’s health space by taking a broad approach to fertility benefits, which includes access to additional family planning resources, menopause care, and support for men.
    • “CEO and founder Kate Ryder says in 2024, she’s proud the company launched a comprehensive fertility benefit offering that integrates care coordination, coaching, virtual care, and financial support. One stat the company often cites is that 30% of members in its fertility program conceive without IVF — which Ryder points out can save tens of thousands of dollars per family. * * *
    • “Looking ahead, Ryder said she believes the company can lean on artificial intelligence to create a more personalized experience for members.  “We know what great personalization looks like in other areas of consumer tech, but we haven’t seen that in health care yet,” she said.”
  • The Healthcare Management Financial Association tells us,
    • “Accelerating hospital-focused expenditures helped spur a 2023 increase in national health spending, according to newly released actuarial data.
    • ‘Spending on hospital services surged by 10.4% for the year, up from a 3.2% increase in 2022 and 3.4% for the three-year period spanning 2020-22. The 2023 increase was the biggest seen since a 10.8% jump in 1990.
    • “Partially as a result, total healthcare spending (including clinical research and public health activities) jumped by 7.5% to reach $4.9 trillion, or 17.6% of GDP. In 2022, spending had risen by 4.6% and amounted to 17.4% of GDP. The 2023 share of GDP still was lower than in the peak pandemic years of 2020-21 and roughly the same as it was in 2019.
    • “The spending increase dropped from 7.5% to 4.4% when accounting for healthcare price inflation, up from 1.4% using that adjustment in 2022. Spending per capita reached $14,570.”
  • Modern Healthcare reports,
    • “Elevance Health completed its acquisition of Indiana University Health Plans, according to a Tuesday news release from the insurance company’s subsidiary Anthem Blue Cross and Blue Shield.
    • “IU Health Plans — which will operate under Anthem Blue Cross and Blue Shield in Indiana — offers Medicare Advantage plans in 36 Indiana counties, with 19,000 members. It also offers fully insured commercial plans to employers, covering approximately 9,600 members.”
  • Per MedPage Today, “IV fluid shortage [created by Hurricane Helene is] likely to extend Into early 2025. Major supplier damaged by Hurricane Helene continues to bring production lines back online.”
  • Beckers Hospital Review reports,
    • “Several major pharmaceutical companies, including Pfizer, Bristol Myers Squibb and Sanofi, are set to raise prices on more than 250 branded medications in the U.S. starting Jan. 1, 2025, according to a Reuter’s exclusive report. 
    • “Data analyzed by healthcare research firm 3 Axis Advisors showed the price increases will affect a range of drugs, including Pfizer’s COVID-19 treatment Paxlovid, Bristol Myer Squibb’s cancer therapies and vaccines from Sanofi. 
    • “Most of the price hikes are below 10%, with the median increase across affected drugs at 4.5%. This aligns with the median price increase for 2024, as drugmakers have scaled back large price hikes over the years following public scrutiny. 
    • “The price adjustments apply to list prices, which do not include rebates or discounts negotiated with pharmacy benefit managers.”

FEHBlog Extra

David Ermer–ACA, CMS, FDA, Federal employment benefits, HIPAA Privacy and Security Rules, HSA, OPM, U.S. Healthcare–

From Washington, DC,

  • Federal News Network reports,
    • “President-elect Donald Trump has announced plans to nominate a new leader for the Office of Personnel Management.
    • “On Sunday evening, Trump’s team shared in a press email that Scott Kupor, currently a managing partner at venture capital firm Andreessen Horowitz, is the planned pick for OPM director in Trump’s second term.
    • “Scott will bring much needed reform to our federal workforce,” Trump said in a statement on Sunday.
    • “Prior to his current role at Andreessen Horowitz, Kupor served as chairman of the National Venture Capital Association from 2014 to 2018, according to his LinkedIn profile. Kupor has also worked as vice president and general manager of technology company Hewlett-Packard (HP) and held various other executive management roles in the private sector. * * *
    • “Kupor graduated Phi Beta Kappa from Stanford University with a bachelor’s degree in public policy with honors and distinction. He also holds a law degree with distinction from Stanford University and is a member of the State Bar of California.”
  • and
    • “President Joe Biden has finalized a 2% federal pay raise for the General Schedule, but the increases federal employees across the country will see when they open their first paycheck of 2025 will look a little different.
    • “That’s because the 2% federal pay raise is an average — it will vary slightly depending on where federal employees work and their locality pay area.
    • “Biden’s 2% raise includes a 1.7% across-the-board boost that most civilian employees on the General Schedule will get, as well as an average of a 0.3% locality pay adjustment. The 0.3% portion of the raise accounts for the variations in next year’s federal pay raise. Starting in January, some feds’ raises will be slightly above the 2% average raise, while others will see slightly less than the average.
    • “For 2025, the spread of raises ranges from a high of 2.35% in the San Francisco-San Jose-Oakland locality pay area, and a low of 1.88% in the Cleveland locality pay area, according to the General Schedule pay tables the Office of Personnel Management published Monday afternoon. Federal employees working in the national capital region will get a 2.22% raise next year.”
  • Bloomberg reports,
    • “The Biden administration on Monday withdrew a proposed rule that, if finalized, would have expanded access to birth control coverage offered under the Affordable Care Act.
    • “The ACA guarantees coverage of women’s preventive services, like birth control and contraceptive counseling, at no cost for women enrolled in group health plans or individual health insurance coverage. In 2018, new regulations expanded exemptions for religious beliefs and moral convictions that allow private health plans and insurers to deny coverage of contraceptive services.
    • “The [February 2, 2023] proposal—from the departments of Health and Human Services (RIN: 0938-AU94), Labor (RIN: 1210-AC13), and Treasury (RIN: 1545-BQ35)—would have removed the moral exemption waiver, but retained the current religious exemption, the Centers for Medicare & Medicaid Services said previously.”

In judicial news,

  • Reuters lets us know,
    • “A federal judge in Texas ruled that Democratic President Joe Biden’s administration likely exceeded its authority by issuing a rule strengthening privacy protections for women seeking abortions and for patients who receive gender transition treatments.
    • “U.S. District Judge Matthew Kacsmaryk in Amarillo on Sunday [December 22] agreed to block the U.S. Department of Health and Human Services from enforcing the rule against a Texas doctor who through lawyers at a conservative Christian legal group challenged the regulation as unlawful.
    • “The ruling by Kacsmaryk, who was appointed by Republican President-elect Donald Trump in his first term, issued the preliminary injunction a day before a Monday deadline for the doctor, Carmen Purl and her business to comply with the rule.”
    • FEHBlog observation: As noted in the article, the preliminary injunction applies only to the plaintiff.

In Food and Drug Administration news,

  • Per an FDA press release,
    • “Today [December 23], the U.S. Food and Drug Administration approved the first generic referencing Victoza (liraglutide injection) 18 milligram/3 milliliter, a glucagon-like peptide-1 (GLP-1) receptor agonist indicated to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes as an adjunct to diet and exercise.
    • “The FDA approved the first generic in this class of medications last month with the approval of a generic referencing Byetta (exenatide).
    • “Liraglutide injection and certain other GLP-1 medications are currently in shortage. The FDA prioritizes assessment of generic drug applications for drugs in shortage to help improve patient access to these medications.
    • “The FDA supports development of complex generic drugs, such as GLP-1s, by funding research and informing industry through guidance as part of our ongoing efforts to increase access to needed medications,” said Iilun Murphy, M.D., director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research. “Generic drugs provide additional treatment options which are generally more affordable for patients. Today’s approval underscores the FDA’s continued commitment to advancing patient access to safe, effective and high-quality generic drug products.”
  • STAT News reports,
    • “The FDA just approved Alyftrek, a once-daily medicine for a small slice of cystic fibrosis patients that carry certain mutations, including F508del. It’s a triple combination CFTR modulator that works across 31 other mutations, and outperformed Trikafta — another popular Vertex drug for cystic fibrosis — in its ability to reduce sweat chloride levels. This is the company’s fifth CFTR modulator to win U.S. approval.
    • “Vertex said that the drug offers simpler dosing for existing patients taking its drugs — but will be beneficial for an additional 150 U.S. patients with the disease, whose mutations are now treatable.”
  • Per Fierce Pharma,
    • “Undeterred by last year’s rejection and the recent approval of a close rival from Pfizer, Novo Nordisk has pushed its once-daily hemophilia injection across the regulatory finish line days before we hit 2025. 
    • “Late last week, Novo revealed that the FDA approved its tissue factor pathway inhibitor (TFPI) antagonist concizumab as a once-a-day treatment to prevent or curb the frequency of bleeding episodes in patients ages 12 and older who have hemophilia A or B with inhibitors.
    • “The prophylactic, which comes in prefilled, premixed pens for subcutaneous injection, will be marketed under the commercial title Alhemo, Novo said in a release.”

From the public health and medical research front,

  • Beckers Clinical Leadership offer five updates on the respiratory illness surge and six developments on bird flu as we head into the new year.
  • The American Medical Association fills us in on what doctors wish their patients knew about pneumonia.
  • Consumer Reports, writing in the Washington Post, relates “Things to do, and not to do, when you have a cut. Don’t “air it out.” Put down the hydrogen peroxide. Don’t bother with the antibiotic ointment. But do wash it and cover it.”

From the U.S. healthcare business front

  • Per Fierce Healthcare,
    • “Despite significant headwinds coming to bear over the past several years, healthcare executives are expecting a favorable 2025, according to a new survey from Deloitte.
    • “Deloitte’s Center for Health Solutions polled 80 C-level leaders at healthcare organizations, including 40 from health systems and 40 from health plans. Close to 60% said they believe the outlook for the coming year is favorable, increasing from 52% in last year’s survey.
    • “A majority (69%) said they believe revenues will grow in 2025, and 71% said they expect greater profitability.
    • “Two major themes emerged from executives in both sectors, according to Deloitte: growth and consumer affordability. In addition, insurance executives said they were gearing up for a year of regulatory change and new technological advancements, while health system leaders said they expect continued workforce challenges and enhancements to core business technologies.
  • Bloomberg reports,
    • “Republicans have a new chance to expand health savings accounts offered by employer plans when Congress reconvenes in 2025, revisiting a divisive policy that some Democrats support even as others denounce it as a tax break for the wealthy.
    • “Health savings accounts let high-deductible health plan enrollees use tax-free dollars on certain medical expenses. The money rolls over annually and can be invested tax-free for higher returns. Twenty-two percent of employers surveyed by the Kaiser Family Foundation offered HSA-eligible plans in 2024.
    • “Advocates see the tax-advantaged accounts as a vehicle to increase both health care access and conscious spending for high-deductible plan members, who pay more out-of-pocket before insurance kicks in. Lawmakers from both parties have proposed bills to allow patients to use HSAs for everything from gym memberships and menstrual products to funeral expenses and veterinary bills.” * * *
    • “Labeling HSAs as tools for the wealthy is a “mischaracterization,” said Johns Hopkins University accounting and health policy professor Ge Bai, pointing to data that show the majority of HSA holders live in zip codes where the median income is below $100,000. Loosening requirements around the accounts could be particularly useful for gig workers who lack insurance, she said.”
  • Beckers Hospital Review shares Mark Cuban’s plans for the new year.

Weekend Update

David Ermer–Congress, FDA, Medical / Rx research, Mental health care–

Jingle bells! The FEHBlog will be on a holiday break until next Thursday December 26.

From Washington, DC

  • The President signed into law yesterday the skinny continuing resolution (H.R. 10545) funding the federal government through March 14, 2025, and creating funding for disaster relief and farmers. No shutdown. No PBM “reform.”
  • Healthcare Finance adds,
    • “Acute hospital-care-at-home and telehealth temporary waivers were continued but were not given the long-term extensions that were included in a Dec. 18 bipartisan resolution. Both received short-term extensions until March 31.
    • “The original bill extended telehealth for two years and acute hospital care at home by five years.
    • “Stripped out of the bill is a provision to prevent the Medicare pay cut to physicians. This means physicians get a 2.8% Medicare payment cut on January 1, 2025. 
    • Also excluded from the CR is a provision extending the ability of high deductible health plans to cover telemedicine services before the deductible beyond December 31, 2024.
  • The Senate also passed the Social Security Fairness Act on Saturday which benefits federal, state, and local government employees who receive Social Security retirement income. That bill now goes to the President for his signature. 
  • The 118th Congress has completed its work. The 119th Congress will be gaveled in on January 3, 2024.

In Food and Drug Administration News,

  • The New York Times shares the story of a woman “fighting to avoid her mother’s fate [early onset dementia], for her daughters’ sake. A mutant gene is coming to steal Linde Jacobs’s mind. Can she find a way to stop it?” Fascinating.
  • Per FDA press releases,
    • “The U.S. Food and Drug Administration approved Symvess [December 20], the first acellular tissue engineered vessel indicated for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization (restoration of blood flow) is needed to avoid imminent limb loss, and autologous vein graft is not feasible.
    • “Vascular trauma occurs when a blood vessel is injured such as a rupture of an artery in the extremities, which can lead to serious, life-threatening complications such as hemorrhage or blood clotting. When damage to an artery in the extremity occurs, urgent surgical repair is needed to restore normal blood flow. The current standard of care for patients with extremity vascular injuries can include procedures such as autologous vein grafting (surgical repair using the patient’s own blood vessels) or implantation of a synthetic graft. These treatments are not suitable or available for every patient.
    • “Today’s approval provides an important additional treatment option for individuals with vascular trauma, produced using advanced tissue engineering technology,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research (CBER). “The FDA remains committed to facilitating the development of innovative products that offer potentially life-saving benefits for patients with severe injuries.” 
  • and
    • “Today, the U.S. Food and Drug Administration approved Ryoncil (remestemcel-L-rknd), an allogeneic (donor) bone marrow-derived mesenchymal stromal cell (MSC) therapy indicated for the treatment of steroid-refractory acute graft-versus-host disease (SR-aGVHD) in pediatric patients 2 months of age and older.
    • “Ryoncil is the first FDA-approved MSC therapy. It contains MSCs, which are a type of cell that can have various roles in the body and can differentiate into multiple other types of cells. These MSCs are isolated from the bone marrow of healthy adult human donors. 
    • “Today’s decision marks an important milestone in the use of innovative cell-based therapies to treat life-threatening diseases with devastating impacts on patients, including children,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research (CBER). “This first mesenchymal stromal cell therapy approval demonstrates the FDA’s commitment to supporting the development of safe and effective products that could improve the quality of life for patients with symptoms that are unresponsive to other therapies.”

From the public health and medical research front,

  • Fortune Well tells us,
    • “A drug already FDA-approved for people with a rare form of breast cancer has now been shown to improve patients’ long-term survival, new clinical trial data suggest.
    • “Lynparza (olaparib), a product of Fortune 500 pharmaceutical firm Merck and Fortune 500 Europe company AstraZeneca, exhibited clinically meaningful improvements in overall survival, among other promising findings, in people with germline BRCA-mutated (gBRCAm), HER2-negative high-risk early breast cancer. About 87.5% of patients treated with the drug were alive after six years, compared to 83.2% who received a placebo. Long-term results of the OlympiA phase 3 trial were presented Dec. 11 at the San Antonio Breast Cancer Symposium.
    • “The durable long-term efficacy seen in the OlympiA study reinforces Lynparza as an important treatment option for those living with this truly challenging, very aggressive form of breast cancer,” Dr. Eliav Barr, senior vice president, head of global clinical development, and chief medical officer of Merck Research Laboratories, said in a news release about the findings.”
  • A mother, writes in the Washington Post, about having a stroke soon after giving birth. According to the article, “postpartum strokes happen more often than you’d think.”
  • The Wall Street Journal lets us know,
    • Dabbing has emerged in recent years as a popular way to consume marijuana, especially among youths. But it is dangerous. Like other new forms of marijuana use that have proliferated in recent years, dabbing involves highly potent concentrates of cannabis.
    • Health authorities are sounding the alarm, warning that dabbing could addict users and is sending teenagers to emergency rooms with seizures, cyclical vomiting or psychosis. Some users and doctors call a cannabis overdose, with the accompanying sweaty nausea and disorientation, a “green out,” a term believed to be a play on “black out.” 
    • “People are consuming extremely high doses of THC,” the psychoactive component of cannabis, said Dr. Nora Volkow, director of the National Institute on Drug Abuse. “People can become psychotic.”
  • and
    • “California OnTrack uses a skills-based therapy program called coordinated specialty care, which is offered through at least 381 programs in all 50 states. The program substantially reduces symptoms of psychosis, as well as hospitalizations and homelessness compared with traditional treatment, according to published studies.
    • “The premise of the treatment is simple: Teach people with psychosis to live with their imagined voices, hallucinations and false memories. With practice, such symptoms can be managed or ignored. The techniques taught in the program, in conjunction with medication, diminish symptoms over time and keep new ones at bay.
    • “People who enroll in the treatment within two years of their first psychotic episode fare the best, studies found. People with longer-term psychosis also improved but to a lesser degree.
    • “It’s not like a switch where all the symptoms subside. It’s like a dimmer switch,” said Carlos Larrauri, who completed a similar treatment in Florida after being diagnosed with schizophrenia in 2011 at age 24. He has since finished law school, trained as a nurse practitioner, married and now works as a lawyer.
    • “For more than a decade, the federal government and the American Psychiatric Association have identified coordinated specialty care as the gold standard to treat early psychosis. Yet few people know about it, and fewer still have a chance to benefit from it. Three of the largest private insurers only recently began covering the treatment, which has largely been limited to Medicaid patients. California OnTrack is one of the few providers in the U.S. that has secured coverage from private insurance.” 

Friday Report

David Ermer–CDC, CMS, Congress, COVID-19, FDA, Medical / Rx research, Medicare, U.S. Healthcare–

From Washington, DC

  • The Wall Street Journal reports,
    • “The Republican-led House approved stopgap spending legislation to avert a government shutdown and provide more than $100 billion in disaster and farm aid, sending the measure to the Senate just hours ahead of the midnight deadline.
    • “Lawmakers voted 366 to 34 to approve the proposal, well above the two-thirds threshold needed under special fast-track procedures. 
    • “The bill marked House Speaker Mike Johnson’s third attempt to combine a three-month funding extension with emergency aid this week, after wrestling with competing demands from President-elect Donald Trump, his billionaire efficiency czar Elon Musk, internal GOP critics and Democrats.”
  • Govexec adds,
    • “The continuing resolution now heads to the Senate and Senate Majority Leader Chuck Schumer, D-N.Y., has indicated he is supportive of the bill. The White House has told lawmakers President Biden will sign it. Incoming Senate Majority Leader John Thune, R-S.D., said he expected his chamber could move the bill before the midnight deadline.” 
  • Fierce Healthcare lets us know,
    • “The Centers for Medicare and Medicaid Services announced Friday that 64 Part B drugs will have a reduced price for Medicare patients at the pharmacy counter in the first quarter of 2025.
    • “CMS said patients may save between $1 and $10,818 per day on co-insurance costs for the Part B drugs included on the list.
    • “As part of the Inflation Reduction Act, drug manufacturers must give rebates to the federal government for single source drugs and biological products, including certain biosimilar biological products, whose price increased more than the rate of inflation. The list of discounted drugs changes each quarter.
    • “The 64 drugs (PDF) with reduced co-insurance costs for Medicare patients include Kepivance, which treats mouth sores caused by chemotherapy, Talvey, used to treat patients with multiple myeloma, and Yescarta for recurrent or treatment-resistant blood cancer.”
  • Per HHS press releases,
    • “Today, the U.S. Department of Health and Human Services’ (HHS) launched the Let’s Get Real campaign to cut through the noise of misinformation and give parents the balanced information they need about childhood vaccines. The campaign provides verifiable facts so parents can get the information they want to make informed vaccine decisions, and it shares stories from doctors and peers on why most of us rely on vaccines to protect our children. Let’s Get Real also offers tools for health care professionals with pediatric patients.”
  • and
    • “Today, the U.S. Department of Health and Human Services (HHS), through the Office of Global Affair’s (OGA) U.S. Section of the U.S. – Mexico Border Health Commission (Commission), released Healthy Border 2030 – PDF.
    • “This framework includes an assessment of health data and priority issues that affect the health of the population on the U.S. side of the border as well as high-level strategic recommendations for federal, state and local governments, and community-based stakeholders on how to take action to address them. Building on previous reports in 2010 and 2020, the recommendations in the 2030 framework focus on the U.S. context and consider, when feasible, the importance of a binational approach in improving the health and well-being for populations along the U.S. southern border.”

In Food and Drug Administration News,

  • The New York Times reports,
    • “The Food and Drug Administration on Friday approved the weight loss drug Zepbound to treat obstructive sleep apnea. It is the first prescription medication approved to treat the common sleep disorder.
    • ‘The drug’s maker, Eli Lilly, announced that the agency authorized Zepbound for people with obesity and moderate to severe obstructive sleep apnea. Millions of Americans have the condition, and many of them also have obesity. The company said that the drug should be used with a reduced-calorie diet and increased physical activity. 
    • “When people have obstructive sleep apnea, they struggle to breathe properly during sleep and can wake up gasping for air. If untreated, obstructive sleep apnea raises the risk for a range of health issues, including cardiovascular problems, diabetes, stroke and dementia.
    • “In June, two studies found that people who took the drug saw a greater improvement in sleep apnea symptoms, including fewer interruptions in sleep, than those who took a placebo. Eli Lilly funded both studies.”

From the public health and medical research front,

  • The Centers for Disease Control and Prevention announced today,
    • “COVID-19 activity is increasing from low levels in some areas of the nation. Seasonal influenza activity is moderate and continues to increase across the country. RSV activity is high and continues to increase in most areas of the United States, particularly in young children.
    • “COVID-19
      • “COVID-19 activity, including wastewater levels, emergency department visits, and laboratory percent positivity, is increasing from low levels in some areas of the nation. Based on CDC modeled estimates of epidemic growth, we predict COVID-19 illness to increase in the coming weeks as it usually does in the winter.
      • “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
    • “RSV
      • “RSV activity is high and continues to increase in most areas of the United States, particularly in young children. Emergency department visits and hospitalizations are increasing in children and hospitalizations are increasing among older adults in some areas.
    • “Vaccination
      • “Vaccination coverage with influenza and COVID-19 vaccines are low among U.S. adults and children. Vaccination coverage with RSV vaccines remains low among U.S. adults. Many children and adults lack protection from respiratory virus infections provided by vaccines.
    • “Season Outlook
      • “As of December 19, CDC continues to expect the fall and winter virus season will have a similar or lower peak number of combined hospitalizations from COVID-19, influenza, and RSV compared to last year. However, peak hospitalizations from all respiratory viruses remain likely to be much higher than they were before the emergence of COVID-19.
      • “CDC has updated the outlook this week. This update uses historical data and COVID-19 scenario modeling to assess when peak hospital demand may occur nationally and regionally. Additional updates will occur if there are big changes in how COVID-19, flu, or RSV are spreading. Read the entire 2024-2025 Respiratory Season Outlook- December Update. (12/20/2024).”
  • The University of Minnesota’ CIDRAP tells us based on two new studies that “6% of US adults have long COVID, and many have reduced quality of life.”
  • Per Health Day,
    • “The sicker a senior becomes, the more likely they’re going to develop kidney problems on top of their other health challenges.
    • “A new study published Dec. 17 in Journal of the American Geriatrics Society (JAGS) shows that as a person’s number of chronic illnesses increases, a decline in their kidney function becomes both more likely and steeper.
    • “This is particularly true of people with many heart problems, and people with a large number of chronic illnesses that require lots of medication and treatments.
    • “Our findings emphasize the importance of a comprehensive assessment that considers not only the overall chronic disease burden, but also the complex interplay between diseases when evaluating the risk of kidney function decline in older adults,” said lead researcher Giorgi Beridze, a doctoral student in geriatric epidemiology with the Karolinska Institute.”
  • and
    • “Knee arthritis could become easier to detect and diagnose thanks to a new test involving the lubricating fluid inside the joint.
    • “A new study shows that arthritis of the knee often is diagnosed in its late stages, after cartilage has degraded and bones are rubbing against each other in the joint.
    • “At that point, it’s tough to tell whether knee arthritis has been caused by natural wear and tear, or if an inflammatory disease is behind a person’s joint problems, the researchers noted in a new study published Dec. 18 in the Journal of Orthopaedic Research.
    • “But a new test involving two markers found in the synovial fluid of patients’ joints might be able to help docs suss all this out more promptly.
    • “The test “addresses an unmet need for objective diagnosis of osteoarthritis to improve clinical decision-making and patient outcomes,” researcher Daniel Keter with CD Diagnostics, a division of Zimmer Biomet, said in a journal news release.”

From the U.S. healthcare business front,

  • HCPLAN shares summaries of reports presented at its recent summit.
  • Kaufmann Hall points out four trends to help health systems accelerate their 2025 strategies.
  • The Wall Street Journal reports,
    • “Novo Nordisk’s big bet to improve on the success of its weight-loss drug franchise hit a stumbling block Friday, wiping out nearly $100 billion of the drugmaker’s stock-market value.
    • “The Danish company—which had become Europe’s biggest by market capitalization on booming sales of Ozempic and Wegovy—reported disappointing results of a closely watched clinical trial testing an experimental anti-obesity treatment that the company hoped would be its next big weight-loss product.
    • ‘The two-drug combination, dubbed CagriSema, helped study volunteers lose a significant amount of weight, some 22.7% on average after more than a year’s treatment. And the drug might still make it to market. But the magnitude of weight loss it induced in the study fell short of the company’s and investors’ expectations.”
  • The American Hospital News informs us,
    • “After incurring damage from Hurricane Helene on Sept. 27, Baxter reports that as of Dec. 19, nearly all of its manufacturing lines in its North Cove, N.C., facility have been restarted. The producer of IV and peritoneal dialysis solutions says that the lines represent 85% of the site’s total pre-hurricane capacity.  
    • “Baxter officials say they expect production across the plant to rise to pre-hurricane levels early in the first quarter of 2025. “Note that it will take some time for product to flow through the distribution channels,” according to the Baxter website.”

Thursday Report

David Ermer–CDC, CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, Medicare, NIH, No Surprises Act, OPM, U.S. Healthcare, Uncategorized–

From Washington, DC,

  • This evening, the House of Representatives turned down the President-elect approved, 121-page long version of the Continuing Resolution this evening. The Wall Street Journal adds that “Talk circulated among lawmakers about a possible weeklong funding extension, which would push the shutdown deadline past Christmas. But that too would need bipartisan support to get through the Senate.” The current CR funding the federal government expires at 12:01 AM on December 21.
  • Govexec informs us,
    • “The House passed a compendium of veterans care proposals, packaged into a single bill, on Monday, sending it to the president’s desk in the waning days of the congressional session. 
    • “The Senator Elizabeth Dole 21st Century Veterans Healthcare and Benefits Improvement Act (S.141) — which provides the Veterans Affairs Department with everything from community care improvements to expanded home care and educational assistance benefits — cleared the chamber in a 382-12 vote Monday night after previously passing the Senate by unanimous consent on Dec. 12.
    • “The legislation serves as an omnibus package of previous House and Senate bills designed to improve VA community care offerings, quality care standards and other programs, while offering benefit increases for veterans and some providers. 
    • “We worked hard to craft this legislation to put veterans – not government bureaucracy – at the core of it,” said House Veterans Affairs Committee Chairman Mike Bost, R-Ill., in a statement. “The Dole Act will do that by expanding economic opportunities, simplifying the disability claims process, reforming services for aging veterans, opening more doors for mental health support and a lot more.”
  • Federal News Network lets us know,
    • “Federal agencies will be closed on Tuesday, Dec. 24, President Joe Biden announced, giving federal employees an extra day off the day before Christmas.
    • “The president made the announcement via an executive order that he signed Thursday.
    • “All executive departments and agencies of the Federal Government shall be closed and their employees excused from duty on Tuesday, December 24, 2024, the day before Christmas Day,” the executive order states.”
  • Modern Healthcare reports,
    • “A mandatory hospital payment model finalized this year by the Centers for Medicare and Medicaid Services could make earnings uncertain for providers, researchers said.
    • “Under the Transforming Episode Accountability Model, or TEAM, hospitals could lose out on an average of $500 per episode of care covered in the model, according to a December report from the Institute for Accountable Care. But the forecast results vary widely: Hospitals in the Minneapolis-St. Paul region could gain an average of $900 per episode of included care, the report said, while Denver providers stand to lose $1,300 per episode, on average. 
    • Beginning in 2026, TEAM sets 30-day episode-based payments for lower-extremity joint replacements, femur fracture surgeries, spinal fusions, coronary artery bypass grafts and major bowel procedures. CMS will set bundled payments for these services based on regional benchmarks. In other words, hospitals will need to reduce spending for select care to a threshold set by their neighbors, or risk having to make up the difference.  
    • “It creates a really strong incentive” to manage costs, said Rob Mechanic, executive director of the Institute for Accountable Care, an independent nonprofit initially funded by the National Association of ACOs. On the flip side, he said, the regional benchmarks mean hospitals can significantly reduce their costs but still lose money.
    • The government selected 741 hospitals to participate in the five-year model, which gives safety-net hospitals extra time to prepare before taking on downside risk. Since the model is mandatory, hospitals can’t opt out. Ambulatory surgical centers are not included. According to the IAC report, the covered services represent about 15% of Medicare revenue, on average, for participating hospitals.

From the judicial front,

  • The Wall Street Journal reports,
    • “Federal prosecutors charged ex-Ivy Leaguer Luigi Mangione with murder and stalking Thursday for the Dec. 4 shooting of UnitedHealth executive Brian Thompson, alleging he was arrested with a notebook stating an intent to “wack” the CEO of an insurance company.” * * *
    • “The latest charges, brought by the Manhattan U.S. attorney’s office, mean federal prosecutors could pursue a death-penalty case against him.” * * *
    • The new federal charges capped a whirlwind day that began in Pennsylvania, where Mangione agreed at a hearing to waive his right to contest his transfer to New York. He had been detained in Pennsylvania since his arrest last week.”

In Food and Drug Administration News,

  • Healthcare Dive relates,
    • “The Food and Drug Administration on Thursday reaffirmed its assessment that Mounjaro and Zepbound, popular drugs for diabetes and obesity, are no longer in shortage,
    • “The agency’s decision will largely prevent so-called compounding pharmacies from making off-brand copies of the drug, closing a lucrative market niche that had opened as Eli Lilly, the drug’s maker, found itself unable to meet skyrocketing demand.
    • “However, the FDA won’t take enforcement action against compounding pharmacies until early next year, a grace period the agency said is to “avoid unnecessary disruption to patient treatment.”
  • Per STAT News,
    • “Ionis Pharmaceuticals on Thursday won Food and Drug Administration approval for a therapy that treats patients with a rare and deadly genetic disease that impedes the body’s ability to break down fats, setting the stage for the company to kick off the first solo drug launch in its 35-year history.
    • “The treatment, Tryngolza, also known by its scientific name of olezarsen, was approved for patients with familial chylomicronemia syndrome, or FCS, on the basis of late-stage trial results showing the therapy lowered triglyceride levels and was generally safe. Patients on the drug were less likely to develop an inflamed pancreas, an excruciating and sometimes life-threatening complication.
    • “Ionis executives believe the drug could also help patients with more common forms of sky-high triglycerides and have ongoing trials aiming to show that. If the drug is approved for more common conditions, market analysts have forecasted that Tryngolza could bring in $1.8 to $2 billion in peak sales.”
  • and
    • “Spinal cord injuries dramatically reduce a person’s mobility and independence, but a new device could aid rehabilitation efforts.
    • “Onward Medical received Food and Drug Administration clearance on Thursday for its non-invasive spinal cord stimulator, the ARC-EX. In a recent trial, the stimulator boosted hand sensation and strength in 72% of participants. While the treatment cannot replace rehabilitative therapy, device users rave about its effects.
    • “They tell patients the golden window of recovery is that first year or two,” said Sherown Campbell, one of the trial participants who signed up after he broke his neck wrestling in 2014. “I’ve made significant progress since then. I didn’t think that I would be able to move as much as I do, or I guess, as close to normal as I am.”
  • Per an FDA press release,
    • “Today, the U.S. Food and Drug Administration is announcing a final rule to update the definition of the nutrient content claim “healthy.” There is an ever-growing crisis of preventable, diet-related chronic diseases in the U.S. that requires immediate action. The updated “healthy” claim marks an important step in fulfilling the FDA’s nutrition priorities, which are part of a whole-of-government approach to address this crisis. This rule will help ensure that consumers have access to more complete, accurate, and up-to-date nutrition information on food labels.
    • “The “healthy” claim has been updated to help consumers find foods that are the foundation of a healthy dietary pattern and could also result in the development of healthier foods. Manufacturers can voluntarily use the “healthy” claim on a food package if a product meets the updated definition.”
  • The Wall Street Journal adds,
    • “Under the updated claim, eggs, nuts and seeds, olive oil and higher-fat fish such as salmon will now qualify to use the “healthy” claim. Examples of products that qualified as healthy under the original claim but not the updated one include fortified white bread, highly sweetened yogurt, and highly sweetened cereals.
    • The agency said it would work with interested parties to support use of the updated claim, adding it had entered a partnership with grocery-delivery company Instacart to help shoppers find products.
    • Both the original and updated claims have limits on saturated fat and sodium. The updated claim has a limit on added sugars, while ending the limit on total fat.

From the public health and medical research front,

  • The American Hospital News lets us know,
    • “Life expectancy in the U.S. grew an average of 10.8 months in 2023, to 75.8 years for men and 81.1 years for women, according to a report by the Centers for Disease Control and Prevention. The overall death rate declined by 6%.  
    • “The 10 leading causes of death were unchanged from 2022, with heart disease, cancer and unintentional injuries remaining the top three. COVID-19 dropped from fourth to 10th, which moved stroke up to fourth, followed by chronic lower respiratory diseases, Alzheimer’s disease, diabetes, kidney disease, and chronic liver disease and cirrhosis.”
  • Per Healio,
    • “As many as 15 million adults in the United States have a 10% or greater risk for heart failure, results of a research letter published in Annals of Internal Medicine showed.
    • “The majority of those at higher risk for heart failure (HF) had uncontrolled modifiable risk factors for the condition, including obesity and hypertension, according to the researchers.
    • “Identifying populations at such a risk, along with implementing prevention strategies, “has the potential for dramatic public health impact,” the researchers wrote.”
  • The National Institutes of Health Director, Dr. Monica Bertagnolli, writes in her blog,
    • “Clinical trials are essential for advancing new treatments that improve patient care and lives. But far too many clinical trials face challenges in identifying and enrolling eligible trial participants. Now, an NIH-led team has introduced an artificial intelligence (AI) tool that promises to speed up the process of matching patients to clinical trials to help boost enrollment. They call it TrialGPT.
    • “As reported in Nature Communications, TrialGPT takes advantage of large language models, a type of AI that can generate human-like responses to questions and explanations familiar to users of ChatGPT. The research team adapted it for matching patients to thousands of possible clinical trials in a data-efficient and transparent way. While earlier studies have shown the potential for using this type of AI for answering clinical questions, designing clinical trials, and retrieving initial lists of potential trials, TrialGPT is the first end-to-end solution, generating a list of potential trials before more precisely matching and ranking them. The team’s preliminary testing of this tool suggests TrialGPT can achieve a high degree of accuracy while cutting the time required of clinicians for screening patients. * * *
    • “In a pilot user study conducted at NCI, the researchers compared patient-trial evaluations based on short summaries about six patients made by one medical expert with TrialGPT and another who made the same evaluation manually without TrialGPT. Both experts conducted evaluations with and without AI to account for any differences in their speed or skill. The study found that clinicians using TrialGPT could generate similarly accurate lists of trial options in 40% less time.
    • “More study is needed to assess TrialGPT’s practical application in real-world settings across diverse groups of patients. But these findings already show the remarkable potential of AI technology for connecting patients to relevant trial opportunities, with tremendous potential for speeding trial recruitment and treatment advances while giving clinicians more time for other tasks only humans can do, including caring for their patients.”
  • The National Heart, Lung and Blood Institute offers an update featuring the “latest research on hypertension, educational resources on blood donation, and more.”
  • The Wall Street Journal reports,
    • “Roche said a Parkinson’s disease experimental drug missed its primary goal in a mid-stage trial, the second setback this week for candidate treatments for the neurodegenerative condition.
    • “The update from the Swiss pharmaceutical giant came after Belgian peer said a similar drug candidate for Parkinson’s developed jointly with Novartis failed to meet key goals in a clinical trial.
    • “Roche said Thursday that its drug candidate, prasinezumab, didn’t delay progression of motor symptoms in the trial, which included early-stage Parkinson’s patients, to an extent considered statistically significant.
    • “However, the company said the drug did show potential clinical efficacy, as well as positive trends on several other goals of the trial and was well tolerated. Roche will continue to evaluate the data and work together with health authorities to decide on next steps, it said.”
  • Per BioPharma Dive,
    • “Merck & Co. has long been dominant in cancer immunotherapy, with its drug Keytruda earning 40 approvals en route to becoming the world’s best-selling medicine. But the New Jersey-based drugmaker has had difficulty finding a successor, and a Monday announcement is the latest evidence.
    • “In a statement, Merck said it will end development of two experimental cancer drugs that are currently in late-stage testing. One, called vibostolimab, is aimed at a target called TIGIT. The other, favezelimab, homes in a protein named LAG-3. Both were being evaluated in combinations with Keytruda and have been touted by Merck as a way to extend Keytruda’s market advantage beyond 2028, when its main U.S. patent will expire.”

From the U.S. healthcare business front,

  • The Wall Street Journal explores the question “Why Are Americans Paying So Much More for Healthcare Than They Used To?”
    • “National healthcare spending increased 7.5% year over year in 2023 to $4.867 trillion, or $14,570 per person, according to data released Wednesday by the Centers for Medicare and Medicaid Services. 
    • “Total spending on healthcare goods and services, everything from prescription drugs to back surgeries, accounted for 17.6% of gross domestic product, a measure of goods and services produced by the U.S. economy.
    • “The 7.5% rise represented a much faster pace of growth than the 4.6% increase in 2022. It came as pandemic federal funding for the healthcare sector expired and private health insurance enrollment increased. More people with insurance led to increased demand for medical procedures, and spending on hospital care grew at the fastest pace since 1990. Spending on drugs also rose, including for medications to treat diabetes and obesity.  
    • “A full 92.5% of Americans were covered by insurance last year, and 175.6 million, or just over half the population, got it through their employer, according to the government’s new annual data. 
    • “Over 65 million Americans are on Medicare, a government health-insurance program mainly for people ages 65 and older, and nearly 92 million are on Medicaid, a state-federal program for the low-income and disabled.”
  • STAT News relates,
    • “Most of the formularies run by some of the largest health plans in the U.S. generally provide “fair access” to 11 treatments for several serious diseases, although transparent coverage information is often lacking for some medicines, a new analysis has found.
    • “Almost uniformly, the 11 formularies made the drugs available fairly when judged on three criteria: eligibility based on clinical data, restrictions placed on prescribers, and step therapy, which requires patients to try other medicines before insurers approve a prescription. The formularies are run by health plans, pharmacy benefit managers, and the U.S. Department of Veterans Affairs.
    • “But only 81% of the formularies scored well on a fourth criterion: cost-sharing, which is the portion of expenses paid by insured individuals. Although there is a caveat: This particular metric was based on a subset of just three drugs that were deemed to be fairly priced based on a cost-effectiveness assessment — the Mounjaro type 2 diabetes treatment, and the Wegovy and Qsymia obesity drugs.
    • “Meanwhile, transparency into coverage information for three gene therapies — Zynteglo for combating beta thalassemia, the Hemgenix hemophilia B treatment, and Roctavian for treating hemophilia A — remains less than optimal. Of the six formularies covering the therapies, 83% provided clinical criteria, cost-sharing information was only available in two or three, and none provided site of care information.”
  • Per Fierce Healthcare,
    • “Tech platform Uno Health is rolling out a self-service guide that shows users financial savings they could be eligible to obtain.
    • “The tool boasts of its ability to save the average user $4,500 a year after asking just a few questions. It is designed to improve accessibility and simplify the application process for everything ranging from federal and state health programs, heating bills, phone and internet services and the Supplemental Nutritional Assistance Program.
    • ‘These programs and benefits can be difficult for individuals to sift through, potentially leaving hundreds, or thousands, of dollars on the table if they do not enroll. Uno Health CEO Anna de Paula Hanika, formerly at Clover Health and Google, says the tool is an encapsulation of the company’s broader offerings.
    • “She said at least 50% of Medicare members are eligible for, but not enrolled in, other financial assistance programs. That figure increases to nearly 90% for Medicaid members. Unused benefits strain health programs and insurers.”

Midweek update

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

From Washington, DC,

  • The Wall Street Journal reports,
    • “President-elect Donald Trump said he opposes the bipartisan deal struck by congressional leaders to avoid a partial government shutdown this weekend, insisting that lawmakers tear up the agreement and pass a narrower bill.
    • “Trump’s comments upended efforts to pass a stopgap spending bill to keep the government funded through mid-March, while also providing more than $100 billion in disaster and farm aid. Trump said Congress should craft a new deal that keeps the aid but leaves out other measures, and couple that with immediately raising the federal debt ceiling, ahead of a deadline on the nation’s borrowing limit looming next year.” * * *
    • “To keep the government funded, a bill must pass both chambers of Congress and be signed into law by President Biden before Friday’s midnight deadline.” 
  • Politico identifies the winners and losers in Tuesday night’s CR, FYI.
  • Federal News Network tells us,
    • “The Senate passed a defense bill Wednesday that authorizes significant pay raises for junior enlisted service members, aims to counter China’s growing power and boosts overall military spending to $895 billion while also stripping coverage of transgender medical treatments for children of military members.
    • “The annual defense authorization bill usually gains strong bipartisan support and has not failed to pass Congress in nearly six decades, but the Pentagon policy measure in recent years has become a battleground for cultural issues. Republicans this year sought to tack on to the legislation priorities for social conservatives, contributing to a months-long negotiation over the bill and a falloff in support from Democrats.
    • “Still, the bill passed comfortably 85-14, sending it to President Joe Biden. Eleven senators who caucus with Democrats, as well as three Republicans, voted against the legislation.”
  • Modern Healthcare informs us,
    • “The House Bipartisan Task Force on Artificial Intelligence [AI] has issued a comprehensive report outlining policy recommendations for AI’s in healthcare.
    • “AI development in healthcare has outpaced regulation of the technology, leaving the industry to create its own guidelines. Congressional leaders from both the Senate and House of Representatives have conducted hearings to learn how insurers and providers use AI, but they have not passed significant legislation to regulate it. 
    • “A bipartisan group of 12 Republican and 12 Democratic lawmakers led by co-chairs Rep. Ted Lieu (D-Calif.) and Rep. Jay Obernolte (R-Calif.) authored the report. The task force, formed in February, looked at AI in healthcare along with several other industries.”
  • The American Hospital News lets us know
    • “The Centers for Medicare & Medicaid Services today announced Michigan, New York, Oklahoma and South Carolina state Medicaid agencies were selected to participate in its state-based Innovation in Behavioral Health Model. The eight-year IBH Model is intended to improve care quality and behavioral and physical health outcomes for Medicare- and Medicaid-enrolled adults with moderate to severe mental health conditions and substance use disorders. The pre-implementation period will begin Jan. 1, 2025, when states will begin to conduct outreach and recruit specialty behavioral health practices to participate in the model.”
  • Modern Healthcare points out,
    • “The U.S. spent $4.9 trillion on healthcare in 2023, a 7.5% increase from the prior year, according to a report the Centers for Medicare and Medicaid Services Office of the Actuary published in the journal Health Affairs on Wednesday.
    • “National health expenditures, including the public and private sectors, constituted 17.6% of gross domestic product last year. That’s slightly higher than 17.4% in 2022 and 17.5% in 2019 — prior to the COVID-19 pandemic — but lower than 19.5% in 2020 and 18.3% in 2021 amid the public health crisis.
    • “The Office of the Actuary, which is independent from CMS leadership, mainly attributes the growth in 2023 to greater utilization and intensity. Hospital care, physician and clinical services, and retail prescription drugs were the three biggest categories of higher spending.
    • ‘Expenditures increased at a greater rate last year than during the prior two years, when pandemic-era funding flexibilities began to expire, according to the actuaries. Healthcare expenditures rose 4.6% in 2022 and 4.2% in 2021 after spiking 10.4% in 2020 because of COVID-19.”

In Food and Drug Association News,

  • Per Cardiovascular Business,
    • “The U.S. Food and Drug Administration (FDA) has announced that Boston Scientific is recalling the catheters associated with its POLARx Cryoablation System due to a heightened risk of esophageal injury. The issue has been linked to seven patient injuries and four deaths.
    • “The POLARx Cryoablation System is designed to treat recurrent, symptomatic atrial fibrillation that does not respond to treatment from medical therapy alone. It gained FDA approval back in August 2023.
    • ‘The FDA has ruled that this is a Class I recall, which means it is associated with the highest possible risk level. However, this recall does not involve removing the devices from the market. Instead, Boston Scientific has updated the instructions for use and is urging customers to follow these updated instructions moving forward. 
    • “The recall includes both the POLARx and POLARx FIT cryoablation catheters.”
  • Per MedTech Dive,
    • “Boston Scientific has recalled a group of Accolade pacemakers because of a malfunction that can permanently put devices in safety mode, limiting functionality and preventing devices from properly treating patients. The Food and Drug Administration said devices that permanently enter safety mode must be replaced.
    • “The recall has been tied to two deaths. Boston Scientific did not specify the number of injuries in its December recall notice. The FDA posted an alert for the recall on Monday.
    • “The subset of affected Accolade devices includes Accolade, Proponent, Essentio and Altrua 2 standard life and extended life pacemakers, as well as Visionist and Valitude cardiac resynchronization therapy pacemakers, according to the FDA’s notice.”

From the public health and medical research front,

  • The Washington Post reports,
    • “An individual in Louisiana has the first severe illness caused by bird flu in the United States, federal health officials said Wednesday.
    • “The patient, who is hospitalized, had been in contact with sick and dead birds in backyard flocks on their property, the Centers for Disease Control and Prevention said. It’s the first case of H5N1 bird flu in the United States that has been linked to exposure to a backyard flock, and news of the infection comes the same day California officials declared a state of emergency to confront the outbreak spreading among dairy cows.” * * *
    • “Emma Herrock, a spokeswoman for the Louisiana Health Department, said in an emailed statement Wednesday the patient is over 65 and has underlying medical conditions. She declined to describe the person’s symptoms or severity of illness. Citing patient confidentiality, she said there would be no updates about the patient’s condition at this time.”
  • The New York Times adds,
    • “The virus, H5N1, cannot yet spread easily among people, and it still poses little danger to the average American. Pasteurized dairy products are still safe to consume.
    • “But the past few weeks have brought a steady drumbeat of cases in people, dairy cattle, birds and other animals. Each infection gives the virus a chance to take on a form that could cause a pandemic, experts warned.
    • “All these infections in so many species around us is paving a bigger and bigger runway for the virus to potentially evolve to infect humans better and transmit between humans,” said Dr. Nahid Bhadelia, the director of the Boston University Center on Emerging Infectious Diseases.
    • “That represents an escalation in the situation, even if risk to general population remains low,” she said.
    • “California has borne the brunt of the outbreak in cattle.
    • “The first herds in the nation infected with the bird flu virus, H5N1, were identified in March. California identified its first infected herd in late August.
    • “But since then, the state’s agriculture department has found the virus in 645 dairies, about half of them in the past 30 days alone.
    • “California has also recalled raw milk products from two companies after the virus was detected in samples.”
  • STAT News informs us,
    • “A major report on alcohol’s health effects — which will inform the 2025 Dietary Guidelines for Americans — found moderate drinkers had lower all-cause mortality, and a lower risk of death from cardiovascular disease, than those who never drank. The findings are sure to cause a stir, especially once a separate panel of experts releases its own alcohol report in coming weeks. 
    • “For years, researchers and public health officials have been taking a harder stance on alcohol as evidence has emerged of its associations with various diseases, including certain cancers and liver disease. The head of the National Institute on Alcohol Abuse and Alcoholism, George Koob, has said there are “no health benefits to alcohol.” The new 230-page report, released Tuesday by the National Academies of Sciences, Engineering, and Medicine, seems to undermine those assertions. 
    • “The “Review of Evidence on Alcohol and Health” from NASEM does not make recommendations. Instead, it summarizes the available evidence published in the past five to 15 years on how moderate alcohol consumption is linked to lactation, weight, cancer, cardiovascular disease, neurocognition and all-cause mortality. Moderate drinking is defined as two drinks per day for men, or one drink per day for women. The committee’s conclusions are based on associations, so the report doesn’t explain whether alcohol consumption is directly responsible for the outcomes. 
    • “Recommendations will be made by the main dietary guidelines committee next year, using NASEM’s review and another, from a separate panel in the Department of Health and Human Services. That report has not been released yet but is expected by next month.” 

From the U.S. healthcare business front,

  • Beckers Payer Issues names the “four health insurers earned a spot on the latest list of the 250 best-managed companies, as ranked by the Drucker Institute.”
  • BioPharma Dive reports,
    • “Merck & Co. has made its first big move in obesity treatment, announcing Wednesday it is paying Hansoh Pharma $112 million for rights outside China to a preclinical pill that works similarly to the popular injection Wegovy.
    • “Per deal terms, China-based Hansoh could receive up to $1.9 billion in additional payouts based on reaching clinical, regulatory and commercial milestones. Hansoh has an option to co-promote or solely commercialize the pill, code-named HS-10535, in China.
    • “Merck was one of the few big U.S. drugmakers that didn’t have an experimental obesity drug in development, and investors were therefore closely watching whether it would make a deal.”
  • Beckers Hospital Review ranks weight loss drugs by recent price changes for us.
  • Also, per BioPharma Dive,
    • “Almost 15 years ago, in the midst of an opioid epidemic that would kill more than half a million people in the U.S., a startup formed with the aim of creating new, non-addictive pain drugs.
    • “This goal could have been seen as noble. But for most investors, it was far too risky. Pain research was known to be exceedingly difficult and, even if successful, any resulting products would have to compete in a healthcare system that opioid makers had already gamed.
    • “The startup, SiteOne Therapeutics, has stayed afloat in the years since mostly through small grant funds. Yet, in a major reversal of fortune, it recently began to receive a huge influx of investment. The company on Wednesday announced the closing of a $100 million fundraising round,and plans to put the cash toward human studies designed to show its drugs work as intended.
    • “Pain has really been out of favor in the industry up until very recently,” said John Mulcahy, SiteOne’s cofounder and CEO. “Now is the time to add additional resources to really ramp things up.
    • “SiteOne’s research focuses on a kind of protein that’s embedded, by the thousands, in the perimeter of cells. Aptly named “ion channels,” these microscopic tunnels allow cells to communicate with one another through the rush of electrically charged particles. They are essential. Without them, our bodies wouldn’t be able to move muscles, sense surroundings or fight against germs.
    • “These functions also make ion channels attractive targets for drug researchers, who have already found ways to use them to combat seizures, infections, and problems with the heart and blood pressure. And over the past couple decades, technological advances have led to a better understanding of these proteins, such that some pharmaceutical companies now believe the field will, before too long, produce new treatments for pain, epilepsy, depression and many more neurological conditions.”

Tuesday Report

David Ermer–AHRQ, CDC, CMS, Congress, FDA, Medical / Rx research, Medicare, OPM, Rx coverage, U.S. Healthcare–
Photo by Andy Feliciotti on Unsplash

From Washington, DC

  • The Wall Street Journal reports,
    • “Congressional leaders closed in on a deal Tuesday to keep the government funded through mid-March and provide relief to disaster victims and farmers, but the sprawling nature of the package and delays in finalizing an agreement angered some House Republicans.
    • “House Speaker Mike Johnson (R., La.) and Senate Majority Leader Chuck Schumer (D., N.Y.) said a stopgap deal was near, ahead of Friday night’s deadline to avoid a partial government shutdown. The package is expected to include about $10 billion for farmers and tens of billions more to help residents and businesses rebuild from recent Hurricanes Helene and Milton.
    • “The emerging bipartisan proposal would extend current government funding until March 14, punting until the next Congress decides how much money to allocate to each federal agency for the remainder of the fiscal year, which runs until Sept. 30. Republicans will control both chambers of Congress as well as the White House in the new year, when they are expected to pursue ambitious proposals related to border spending, energy policy and tax cuts.
    • “The text of the agreement was initially expected over this past weekend but slipped into the week. By Tuesday, Johnson was saying the legislation, called a continuing resolution or CR, was coming later in the day, and made clear he was aware of the grumbling from his GOP colleagues about the various measures attached to it.”
  • Indeed, the text of the continuing resolution was released this evening. Worth noting
    • TITLE IX—LOWERING PRESCRIPTION DRUG COSTS (p. 833)
      • Sec. 901. Oversight of pharmacy benefit management services. 
      • Sec. 902. Full rebate pass through to plan; exception for innocent plan fiduciaries. 
      • Sec. 903. Increasing transparency in generic drug applications. 
      • Sec. 904. Title 35 amendments. 
    • TITLE X—MISCELLANEOUS 
      • Sec. 1001. Two-year extension of safe harbor for absence of deductible for telehealth. 
      • Sec. 1002. Eligibility for FEHBP enrollment for Members of Congress. (p. 938)
    • Congress wants the option to rejoin the FEHBP!!
  • Federal News Network tells us,
    • “A bipartisan bill to reform the way federal agencies recruit and hire their employees is heading to President Joe Biden’s desk for a signature.
    • “Congress has passed the Chance to Compete Act, a bill that will codify skills-based hiring practices for the federal workforce. The House cleared the bill Monday evening by voice vote, following shortly after the Senate’s passage of the companion legislation late last week.
    • “Once enacted, the Chance to Compete Act will require agencies to conduct technical and skills-based assessments of federal job candidates, rather than the current and common practice of candidate self-evaluations.
    • “By asking job applicants to rank themselves on their own skill levels, federal hiring managers frequently struggle to find a truly qualified candidate for an open position. More often than not, self-assessments lead to dead ends in federal hiring, according to Jenny Mattingley, vice president of government affairs at the Partnership for Public Service.”
  • Fierce Healthcare informs us,
    • “The Centers for Medicare & Medicaid Services (CMS) is discontinuing the Medicare Advantage (MA) Value-Based Insurance Design model at the end of 2025.
    • “The CMS said the model was too costly because of “increased risk score growth and Part D expenditures” among participating plans.
    • “In calendar years 2021 and 2022, the model cost the Medicare Trust Fund a combined $4.5 billion. That level of costs was “unprecedented,” and there were no “viable policy modifications” to make the model more sustainable.”
  • Modern Healthcare lets us know,
    • “Federal regulators’ decision to remove longstanding antitrust guidance could deter some provider-led joint ventures.
    • “The Federal Trade Commission voted 3-2 Wednesday to withdraw guidelines issued in 2000 that helped hospitals and other providers gauge whether regulators would investigate affiliations between competitors.
    • “The guidelines were outdated and missing key information on recent court rulings, updated regulatory guidance, how technology like artificial intelligence could impact competition and current consolidation strategies such as vertical integration, the FTC and Justice Department said in a joint statement. In addition, the guidelines included safe harbors that have “no basis in federal antitrust statutes,” the statement said.
    • “Regulators did not indicate whether they plan on replacing the guidelines. However, a new administration under President-elect Donald Trump may choose to reinstate or rework the guidance, which pertains to all economic sectors.
  • The U.S. Preventive Services Task Force proposed the following Grade D recommendations, which adhere to the existing 2018 recommendations”
    • “Population: Postmenopausal women and men aged 60 years or older
      • “The USPSTF recommends against supplementation with vitamin D with or without calcium for the primary prevention of fractures in community-dwelling postmenopausal women and men aged 60 years or older.
      • “Postmenopausal women and men aged 60 years or older The USPSTF recommends against supplementation with vitamin D for the prevention of falls in community-dwelling postmenopausal women and men aged 60 years or older.”
    • The comment period ends on January 21, 2025.

From the judicial front,

  • Healthcare Dive relates,
    • “Sanofi is suing the Biden administration in a bid to push through a controversial policy changing how the drugmaker pays hospitals discounts for medications in a federal drug savings program.
    • “Sanofi filed a complaint Monday in a D.C. district court days after regulators threatened the manufacturer’s invaluable contract with Medicare and Medicaid over its plan to pay hospitals rebates instead of upfront discounts on eligible drugs in the program, called 340B.
    • “The lawsuit, which mirrors litigation filed by drugmakers Johnson & Johnson and Eli Lilly earlier this fall over their own 340B rebate plans, wants a judge to find the credit model legal and stop the government from punishing Sanofi for implementing it.”
  • Per the American Hospital Association News,
    • “The Centers for Medicare & Medicaid Services announced that the 8th U.S. Circuit Court of Appeals Dec. 16 issued a temporary stay of a preliminary injunction granted in Kansas v. United States of America. The decision now permits Deferred Action for Childhood Arrivals recipients to enroll in a qualified health plan through the Health Insurance Marketplace in all states, including the 19 involved in the lawsuit. CMS said it would notify consumers if future court decisions impact their coverage.”
  • The Wall Street Journal reports,
    • “UnitedHealth suspect Luigi Mangione has been indicted on new charges, including a first-degree murder offense that prosecutors said was committed to further an act of terrorism.
    • “This was a frightening, well-planned, targeted murder that was intended to cause shock and attention and intimidation,” Manhattan District Attorney Alvin Bragg said at a news conference Tuesday.” * * *
    • “Mangione has a court hearing in Pennsylvania [where he was arrested] on Thursday, which could pave the way for him to come to New York to face the murder charges. He faces a maximum penalty of life in prison without parole for the New York charges, Bragg said.”

From the public health and medical research front,

  • The New York Times reports,
    • “A 53-year-old Alabama woman with kidney failure who waited eight years for an organ transplant has received a kidney harvested from a genetically modified pig, NYU Langone Health surgeons announced on Tuesday.
    • “The patient, Towana Looney, went into surgery just before Thanksgiving. She was in better health than others who have received porcine organs to date and left the hospital 11 days after the procedure.
    • “But Ms. Looney returned on Friday for a series of intravenous infusion treatments. Even before the transplant, she had high levels of antibodies that made it difficult to find a compatible human donor kidney.
    • “The case will be closely watched by the transplant community, as success could speed initiation of a clinical trial, bringing pig transplants closer to reality and helping to solve the organ-supply shortage.”
  • Per MedPage Today,
    • “Teen drug use hasn’t rebounded from its drop during the early years of the COVID-19 pandemic, according to the results from a large annual national survey released Tuesday.
    • “About two-thirds of 12th graders this year said they hadn’t used alcohol, marijuana, cigarettes, or e-cigarettes in the previous 30 days. That’s the largest proportion abstaining since the annual survey started measuring abstinence in 2017.
    • “Among 10th graders, 80% said they hadn’t used any of those substances recently, another record. Among 8th graders, 90% didn’t use any of them, the same as was reported in the previous survey.
    • “The only significant increase occurred in nicotine pouches. About 6% of 12th graders saying they’d used them in the previous year, up from about 3% in 2023.
    • “Whether that has the makings of a new public health problem is unclear. The University of Michigan’s Richard Miech, PhD, who leads the survey, said: “It’s hard to know if we’re seeing the start of something, or not.”
  • The Washington Post lets us know,
    • During a virtual meeting last week, the Pan American Health Organization warned that the Americas are facing their largest dengue epidemic since 1980, when officials started documenting infections. More than 12.6 million people have contracted the mosquito-borne illness this year, nearly three times more than in 2023, a record year. Of those, more than 7,700 people have died.
    • “Global health professionals say travelers can still visit places with dengue outbreaks — but should come prepared.” * * *
    • “The CDC recommends bringing an Environmental Protection Agency-registered insect repellent. Use a sweat-resistant spray or lotion with at least 25 percent DEET or 20 percent Picaridin, and pair it with loose-fitting, light-colored pants and long-sleeve shirts. For more streamlined protection, seek out clothing treated with repellent or douse your items in permethrin. Another twofer: sunscreen and repellent in one bottle.
    • “If you have health concerns, ask your hotel whether it employs mosquito eradication practices, such as spraying the grounds. Seek out lodgings, restaurants and attractions with screened windows or air conditioning. Unfurl a mosquito net when sleeping.”
  • STAT News reports,
    • “Driving a taxi isn’t the healthiest profession. The sedentary job and long hours can lead to joint and back pain as well as heart issues. 
    • “But in at least one area, taxi drivers do quite well. A new study, released today in The BMJ, shows that taxi drivers die at lower rates from Alzheimer’s disease than people in other professions — potentially because the job involves exercising the parts of the brain that are responsible for navigation day in and day out. * * *
    • “Taxi drivers have been teaching neuroscientists about the brain for years. Over 20 years ago, a landmark paper showed that compared to other people, London cabbies have a bigger hippocampus, a small, seahorse-shaped part of the brain responsible for learning, memory, and navigating. London cabbies have to take an intensive test called “The Knowledge,” which requires them to memorize the thousands of streets in the city. 
    • The hippocampus is one of the first areas of the brain to break down in Alzheimer’s disease. That’s why one of the earliest signs of the disease in many patients is subtle issues with memory or navigation, said Scott Small, director of the Alzheimer’s Disease Research Center at Columbia University who studies Alzheimer’s and the hippocampus but was not part of the new study.
    • “An interesting next step for researchers could be to “image drivers as they age, or with and without early stages of Alzheimer’s,” he added.”
  • The Wall Street Journal tells us,
    • “Bayer said its eye treatment aflibercept at high doses showed positive results in a late-stage trial, including improved vision gains for people suffering from some retinal diseases.
    • “Patients received 8 milligrams of the drug every eight weeks and achieved visual acuity gains after 36 weeks. The treatment led to rapid, robust reduction of fluid in the retina in patients with macular edema following retinal vein occlusion, Bayer said.
    • “The high-dose drug has the potential to become a new standard of care in the treatment of exudative retinal diseases, said Richard Gale, clinical director at York Teaching Hospital, U.K. and part of the trial.
    • “The standard of care for the same drug so far is a 2 milligram-dosage every 4 weeks, Bayer said.
    • “For patients this means less frequent injections at comparable efficacy and safety, Bayer’s Head of Research and Development Christian Rommel said.
    • “Bayer said the drug candidate was well tolerated by patients with a safety profile in line with previous clinical trials.”
  • Per BioPharma Dive,
    • “In experimental drug co-developed by Teva and Sanofi met its main objectives in a mid-stage clinical trial in inflammatory bowel disease, showing what the partners claimed to be “best-in-class potential.”
    • “Around half of people with ulcerative colitis who received a high dose of the drug, duvakitug, in a Phase 2 trial had their symptoms resolve after 14 weeks, versus just over 20% of those on placebo. A similar, roughly 48% of Crohn’s disease patients given a high dose of duvakitug experienced meaningful improvement on a measure of disease severity, compared to 13% of people on placebo, Sanofi and Teva said Tuesday.
    • “The companies didn’t provide details, which will be presented at a medical meeting next year. Still, they said the drug’s effects were consistent across subgroups and rates of treatment-related side effects were similar between both study groups. The partners intend to start late-stage development, pending discussions with regulators.”

In Food and Drug Administration news,

  • MedPage Today alerts us that “The FDA slapped a boxed warning on fezolinetant (Veozah), a hormone-free pill for moderate to severe hot flashes caused by menopause, highlighting the known risk of rare but serious liver injury associated with use of the drug, the agency announced.”
  • Per FiercePharma,
    • “Johnson & Johnson has received coal in its stocking from the FDA as manufacturing issues have tripped up the company’s attempt to gain approval of its subcutaneous version of lung cancer drug Rybrevant (amivantamab).
    • “The U.S. regulator sent J&J a complete response letter (CRL) rejecting its application to clear Rybrevant’s injected formulation for patients with non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations.
    • “The FDA also has sent a CRL to AstraZeneca, swatting its request for full approval of Andexxa, which reverses the anticoagulant effect of blood thinners. The thumbs down was not a surprise as it came three weeks after an FDA advisory panel questioned Andexxa’s safety profile.”

From the U.S. healthcare business front,

  • Beckers Hospital Review reports,
    • “The Leapfrog Group has published its annual list of top hospitals for quality and patient safety, recognizing 134 U.S. hospitals for their performance in 2024. 
    • “Top hospitals are identified using data from the watchdog organization’s annual hospital survey, with selection based on excellence in various quality and patient safety measures, including infection rates, maternity care, surgical safety, error prevention, ethical billing and ensuring patients provide informed consent for procedures. The awards are divided into four categories: children’s hospitals (8), general hospitals (36), rural hospitals (15) and teaching hospitals (75). Read more about the methodologies for each category here. 
    • “The Top Hospital Award is given to all hospitals that meet standards outlined in Leapfrog’s methodologies for each category, rather than to a fixed number of hospitals. Hospitals must have received an ‘A’ in Leapfrog’s latest scoring round of its safety grades program to be eligible for the award. Institutions that received the award represent less than 6% of all eligible hospitals. This year, two more hospitals earned the recognition compared to last. “
  • Beckers Hospital Review also lists “Amazon’s top 10 healthcare moves in ’24.”
  • Per BioPharma Dive,
    • “Pfizer on Tuesday said it anticipates bringing in between $61 billion and $64 billion in revenue next year, matching this year’s expected sum and within range of Wall Street forecasts.
    • “The pharmaceutical company boosted its 2024 guidance two months ago to account for $1.2 billion in non-recurring revenue related to its COVID-19 antiviral Paxlovid. Excluding this impact, Pfizer estimates revenue in 2024 will be between $59.8 billion and $62.8 billion, which would make 2025’s forecast an increase of as much as 5% versus the midpoint of this year’s range.
    • “Pfizer shares rose by over 4% in Tuesday morning trading. The drugmaker has been under pressure to improve its performance, sustaining a challenge from activist investor Starboard Value. The company’s stock is down by more than 12% this year.”
  • and
    • “AbbVie will pay $200 million to acquire privately held Nimble Therapeutics and its pipeline of oral peptide drugs for immune diseases like psoriasis and inflammatory bowel disease, the pharmaceutical company said Friday.
    • “Chief among that pipeline is an oral therapy designed to inhibit a protein called IL-23, the same target of AbbVie’s blockbuster injection Skyrizi. That drug is in preclinical testing, as are two other candidates Nimble has disclosed for generalized myasthenia gravis and IBD.
    • “In addition to Nimble’s pipeline, AbbVie also noted that the acquisition will give it access to the Madison, Wisconsin-based company’s technology for synthesizing, screening and optimizing peptide-based drug candidates.”
  • Beckers Hospital Review points out,
    • “Historically viewed as cost centers, hospitals and health systems are increasingly identifying their pharmacy departments as “revenue engines,” according to Vizient. 
    • “As pharmaceutical costs rise, Vizient emphasized the importance of integrating finance leaders and other C-suite members into pharmacy discussions about medication quality, cost and reimbursement. In its 2025 trends report, the organization also encouraged leaders to develop interdisciplinary teams to analyze appropriate use, equitable access and optimal reimbursement practices for medicines costing more than $500,000.”
  • Fierce Heathcare updates us on Thyme Care, a value-based cancer care navigation startup, while Medical Economics gives us the lowdown on ZocDoc, an online health care marketplace enabling patients to find and book [in network] care online.
  • The Healthcare Financial Management Association observes “As transparency rules enter their fifth year, advanced uses gain traction. Employers increasingly are putting price information to work in shaping their healthcare networks.:

Monday Report

David Ermer–ACA, CDC, CMS, Congress, FDA, HSA, Medical / Rx research, Obesity, OPM, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC

  • The Hill reports,
    • “Top Republicans are signaling progress in government funding talks as leaders look to clinch a deal ahead of a looming Friday deadline. 
    • “House Appropriations Chair Tom Cole (R-Okla.) told reporters Monday that the “differences are narrowing” between all sides as they try to hash out the last significant funding deal in the divided Congress.
    • “It’s both between the House and the Senate and Republicans and Democrats. So, they’re both institutional differences, and there are partisan differences,” Cole said. But he added “there are a lot fewer of them than there were 24 hours ago.” * * *
    • “Pressed about the status of health care as leaders look to tie up loose ends in the CR, House Majority Leader Steve Scalise (R-La.) said Monday there are “big discussions on all of the remaining items.”
    • “But we’re trying to get it wrapped up,” he said. 
    • “According to a source familiar, a package of key health policies is expected to be attached to the stopgap funding bill. It will likely include a two-year extension of telehealth flexibilities for Medicare, as well as an overhaul of pharmacy benefit managers’ business practices.” 
  • Fierce Healthcare adds,
    • “Pharmacy benefit manager reform is included in a larger-than-anticipated healthcare package, but the PBM lobby is fighting the legislation at the eleventh hour.
    • “Lawmakers appear to have agreed to a lame-duck healthcare package which, in addition to PBM reform, will include key program extensions.
    • “As of last weekend, the package included an increase to the Medicare physician fee schedule of 2.5% for one year, bonuses to alternative payment models and a reauthorization of the SUPPORT Act for dealing with the opioid crisis.
    • “PBM policies will be used as budgetary offsets. The legislation would ban spread pricing in Medicaid, ensure Part D plan sponsors delink PBM fees from the price of a drug and includes other transparency requirements.
    • “The end-of-year health care package accompanying the Continuing Resolution has morphed into a massive 400-page bill that includes provisions that would undermine the role that PBMs play in lowering costs and providing choices for employers in the prescription drug marketplace,” said the PBM trade lobby, the Pharmaceutical Care Management Association (PCMA), in a statement Dec. 16. “The health care provisions included in the latest draft, as reported in the media, risk increasing costs for health plan sponsors, like employers and labor unions, patients, and families, and hiking up premiums for seniors.”
  • One Digital informs us that “Congress passed the Paperwork Reduction Act and the Employer Reporting Improvement Act, each of which modify the ACA’s provisions on 1094 and 1095 tax form reporting. President Biden is expected to sign both acts into law, significantly altering ACA reporting requirements.”
    • “The Paperwork Reduction Act amends the ACA by no longer requiring employers and health insurance providers to send tax forms to the covered individuals under their health plan. Previously employers and/or insurance providers had to send 1095-B/1095-C tax form to each covered individual showing proof of minimum essential coverage. Now, those forms must only be sent when requested by the covered individual. If a covered individual requests a form, the form must be provided by January 31 or 30 days after the date of the request, whichever is later. Employers and insurance providers must inform covered individuals of their right to request a form.”
    • “The Employer Reporting Improvement Act codifies IRS regulations that allow for an individual’s date of birth to be substituted if the individual’s Tax Identification Number is not available. The Act also amends the ACA to incorporate IRS regulations allowing employers and insurance providers to offer 1095-B and 1095-C tax forms to individuals electronically.
    • Additionally, and more importantly to employers, the Act requires the IRS to give large employers at least 90 days to respond to 226-J letters that issue a proposed employer shared responsibility payment. Previously, employers had only 30 days to respond. Finally, the Act establishes a six-year statute of limitations for collecting these payments.”
       
  • The Plan Sponsor Council of America tells us,
    • “The ERISA Advisory Council (EAC) voted on and approved 12 recommendations for the Department of Labor (DOL) to improve health insurance claim denials and related appeals. These reforms range from better oversight of AI determinations to requiring payouts for prior approvals.
    • “Lisa Gomez, head of the Employee Benefit Security Administration (EBSA), described these proposed reforms today as “strangely and somewhat tragically timely, with the events of last week,” in reference to the killing of UnitedHealthcare CEO Brian Thompson in Manhattan on Dec. 4.”
    • Due to the Affordable Care Act, ERISA appeal procedure changes embedded in regulations typically apply to FEHB carriers.
  • The American Hospital Association News tells us,
    • “The Department of Health and Human Services Dec. 16 published a final rule implementing certain provisions related to information blocking exceptions. The rule revises defined terms related to protecting access to care for purposes of the information blocking regulations.
    • “The agency adopted select provisions first proposed in August as part of the much larger Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability (HTI-2) rule. The adopted provisions are designed to address concerns from patients, health care providers and other stakeholders regarding patient privacy, access to care, preferences for electronic health information sharing, and methods for achieving a balance between certainty and flexibility for entities involved in enhancing EHI interoperability and exchange.
    • “The finalized “Protecting Care Access Exception” would allow entities to restrict EHI sharing under certain conditions to mitigate the risk of legal repercussions for patients, providers or care facilitators involved in lawful reproductive health services. The provisions will be effective immediately when published Dec. 17 in the Federal Register.
    • “This is the second rule in less than a week containing policies originally included in the proposed HTI-2 rule. As such, additional provisions of the HTI-2 rule, including prior authorization application programming interfaces, United States Core Data for Interoperability Version 4 standards and public health interoperability requirements — which are currently under review by the White House Office of Management and Budget — could be published soon.”
  • and
    • “The Centers for Medicare & Medicaid Services Dec. 15 announced an extension to Dec. 18 for enrollment in federally facilitated marketplace coverage that begins Jan. 1. This applies to the 31 states that use HealthCare.gov for signups. Those consumers previously had until Dec. 15 to enroll for a full year of coverage. Individuals who enroll for 2025 coverage after Dec. 18 will have their plans begin Feb. 1. Individuals in Washington, D.C., and the 19 states that operate their own state-based marketplaces are advised to visit their state website for deadlines and effective dates for their coverage.”
  • and
    • “The Health Resources and Services Administration last week directed Sanofi to cease implementation of its 340B rebate proposal immediately and to inform HRSA of its plans no later than Dec. 20 in order to provide adequate notice to covered entities.
    • “By way of this correspondence, HRSA provides warning that this unapproved credit proposal violates Sanofi’s obligations under the 340B statute, and HRSA expects Sanofi to cease implementation of it,” wrote HRSA Administrator Carole Johnson.
    • “The letter says that the proposal, if implemented, would violate Sanofi’s obligations under the 340B statute and subject Sanofi to potential consequences, such as termination of Sanofi’s Pharmaceutical Pricing Agreement and civil monetary penalties.
    • “In its Nov. 22 letter to 340B covered entities, Sanofi said it would be effectuating 340B discounts via the new credit model as of Jan. 6, 2025, for disproportionate share hospitals, critical access hospitals, rural referral centers and sole community hospitals.”
  • Govexec points out,
    • “The Office of Personnel Management is set to publish a final rule Tuesday that would finally implement provisions of a seven-year-old law aimed at reducing agencies’ ability to put federal workers accused of misconduct on prolonged stints of administrative leave.
    • “In 2016, Congress enacted the Administrative Leave Act as part of the 2017 National Defense Authorization Act. The law tries to reduce agencies’ reliance on placing federal workers who are under investigation into employment limbo—paid but unable to work—for long stretches of time. It also updated the government’s policies on weather and safety leave.
    • “Though OPM proposed regulations to implement all of the law’s provisions in 2017, only the provisions governing weather and safety leave actually made it across the finish line. But earlier this year, the environmental advocacy group Public Employees for Environmental Responsibility sued the HR agency seeking to force it to act.
    • “In a final rule set for publication Tuesday in the Federal Register, OPM formally implemented the 2016 law’s restrictions on administrative leave. While the new rule will be effective Jan. 17, 2025, agencies have until October to comply with the new restrictions on administrative leave.”

In Food and Drug Administration news,

  • MedTech Dive relates
    • Zimmer Biomet received Food and Drug Administration clearance for a new stemless shoulder implant, called Osseofit.
    • The implant is shaped to match the anatomy of patients’ humerus, or upper shoulder bone, while preserving as much of their healthy bone as possible in total shoulder replacement procedures. Zimmer announced the clearance on Friday.
    • CEO Ivan Tornos highlighted stemless shoulder implants as a meaningful growth driver for the orthopedics company in an Oct. 30 investor call.
  • Per Fierce Pharma
    • “The FDA has blessed two previously approved medicines—one a cream and the other an injection—to treat atopic dermatitis (AD). Both products now will be available to a significantly larger patient population as roughly 26 million in the U.S. have the disorder, which is also known as eczema.
    • “Organon’s Vtama, a topical cream originally approved for plaque psoriasis in 2022, is now cleared to treat AD, the company said early Monday. The nod came three months after New Jersey-based Organon acquired the product in a $1.2 billion takeover of Dermavant. 
    • “Similarly, the FDA gave a thumbs-up to Galderma’s Nemluvio to treat AD. The drug, a monthly subcutaneous injection, was previously endorsed by the U.S. regulator for prurigo nodularis.” 
  • and
    • “After seven decades with no advances in the treatment of the genetic disorder classic congenital adrenal hyperplasia (CAH), Neurocrine Biosciences has scored FDA approval for its first-in-class, twice-daily oral medicine Crenessity (crinecerfont).
    • “The blessing came nearly two weeks before its FDA target date and is termed as “paradigm shifting” by the San Diego-based company. The selective oral corticotropin-releasing factor type 1 receptor (CRF) antagonist can be used by CAH patients ages 4 and older.
    • “Serving as an add-on to glucocorticoid replacement therapies, Crenessity reduces excess adrenocorticotropic hormone (ACTH) and downstream adrenal androgen production, allowing for glucocorticoid dose reduction.”
  • Cardiovascular Business alerts us,
    • “The U.S. Food and Drug Administration (FDA) and Boston Scientific today sent an urgent alert to patients and healthcare providers about the potential need for early device replacement of some Accolade pacemakers.
    • The company announced a recall for a subset of its Accolade devices because of an increased risk of permanently entering the safety mode. This has limited functionality, making the device unable to properly regulate the heart’s rhythm and rate. Most of the activations have occurred during follow-up office or hospital visits when the devices are interrogated for data.
    • There have been two reported patient deaths in pacemaker dependent patients after the devices went into safety mode in an ambulatory outpatient medical setting. Boston Scientific said about 70% of safety mode events occurred during in-office interrogations from a Latitude programmer, and the remaining incidents took place in an ambulatory setting.
    • “The risk of harm may be greater when safety mode occurs in an ambulatory setting, as patients are not in a monitored clinical environment,” the company said in its recall notice.
  • Beckers Hospital Review adds,
    • “The FDA has recalled more than 233,000 bottles of antidepressant duloxetine, sold by Rising Pharmaceuticals, due to a potential cancer risk. 
    • “The recall, issued Dec. 5, was prompted by the discovery of a nitrosamine impurity, N-nitroso-duloxetine in the capsules which exceeds the FDA’s safety threshold. 
    • ‘The FDA has classified the recall as a Class II risk, its second most severe classification. The recall affects 233,000 bottles of duloxetine, which is used to treat conditions such as depression and generalized anxiety disorder. 
    • “The FDA also recalled 7,107 bottles of duloxetine capsules distributed by Towa Pharmaceutical Europe in October for similar concerns about nitrosamine impurities.” 

From the public health and medical research front,

  • MedPage Today reports,
    • “CDC could not confirm what was suspected to have been the first H5N1 bird flu case linked to raw milk.
    • “The patient, a child in Marin County, California, experienced fever and vomiting after drinking raw milk, as reported last week. The child initially tested positive for influenza A, with the local lab unable to find evidence of person-to person transmission between the child and her family members.
    • “The State Laboratory and the CDC conducted additional testing, “but due to low levels of viral RNA, they were unable to confirm whether the influenza A virus present was H5N1 (avian influenza) or seasonal influenza,” according to the Marin County public health department.”
  • The Washington Post tells us,
    • “Nearly a quarter of U.S. adults reported living with chronic pain in 2023, according to a recent report from the Centers for Disease Control and Prevention.
    • “Just over 24 percent (24.3 percent) of survey respondents said they experienced chronic pain either most days or every day, the CDC said, and nearly 9 percent of adults had “high-impact chronic pain” in the previous three months, meaning their pain frequently limited their life or work activities.” * * *
    • “Chronic pain and pain that often restricts life or work activities, referred to in this report as high-impact chronic pain are the most common reasons adults seek medical care, and are associated with decreased quality of life, opioid misuse, increased anxiety and depression, and unmet mental health needs,” co-authors Jacqueline W. Lucas and Inderbir Sohi wrote in a data brief on the numbers.”
  • Beckers Hospital Review adds,
    • “In 2023, the United States saw a slight decrease in obesity prevalence among adults, according to research findings published Dec. 13 in JAMA. 
    • “Amid projections of increasing obesity rates over the next decade, researchers from Boston Children’s Hospital and Optum Life Sciences analyzed body mass index data from 2013 to 2023. The dataset included nearly 48 million BMI measurements from 16.7 million nonpregnant adults. 
    • “Between 2013 and 2022, mean population BMI and obesity rates rose annually. Both figures slightly declined in 2023, the study found. 
    • “The researchers suggested this change could be due to weight loss GLP-1s such as semaglutide (Wegovy) and “pandemic-associated demographic and behavior changes.”
  • A recent National Health Statistics Reports shares characteristics of older Americans who fulfilled physical activity guidelines in 2022.
  • The American Medical Association lets us know what doctors wish their patients knew about hand, foot, and mouth disease.
  • MedPage Today notes,
    • “Diets higher in inflammatory foods were tied to an increased incidence of dementia in older adults, longitudinal data from the Framingham Heart Study Offspring cohort showed.
    • “Over 13 years of follow-up, higher Dietary Inflammatory Index (DII) scores averaged across three time points were linearly associated with an increased incidence of all-cause dementia (HR 1.21, 95% CI 1.10-1.33, P<0.001), reported Debora Melo van Lent, PhD, of UT Health San Antonio in Texas, and co-authors.
    • “Similarly, higher DII scores were linearly associated with an increase in Alzheimer’s disease dementia (HR 1.20, 95% CI 1.07-1.34, P=0.002), the researchers reported in Alzheimer’s & Dementia. Findings were adjusted for demographic, lifestyle, and clinical covariates.
    • “Although these promising findings need to be replicated and further validated, our results suggest that diets that correlate with low DII scores may prevent late-life dementia,” van Lent and colleagues noted.”
  • To that end, Consumer Reports, writing in the Washington Post, discusses “four ways to reduce inflammation for better health. It’s thought to be an underlying cause of diabetes, heart disease and more. Diet and lifestyle can help you control it.”
  • Per a press release,
    • “The Institute for Clinical and Economic Review (ICER) today released a Final Evidence Report assessing the comparative clinical effectiveness of tabelecleucel (“tab-cel”®, Pierre Fabre) for the treatment of Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD).
    • “ICER’s report on this therapy was the subject of the November 2024 public meeting of the New England CEPAC, one of ICER’s three independent evidence appraisal committees. 
    • “Downloads: Final Evidence Report | Report-at-a-Glance | Policy Recommendations 
  • STAT News reports,
    • “Just over a year ago the PREVENT calculator to predict cardiovascular risk was released by the American Heart Association. It was acclaimed for improving on a 2013 model that didn’t take into account companion conditions such as kidney disease or type 2 diabetes, or include people from more diverse backgrounds.
    • “PREVENT soon drew attention for its potential to reduce the number of Americans eligible to receive widely prescribed cholesterol-lowering statins, projected in two analyses published in June and July. 
    • “A less noted change was the addition of heart failure to conditions estimated by the risk calculator, alongside the traditional targets of heart attack and stroke. Heart failure is a serious illness that means the heart can no longer pump blood through the body as well as it should. It’s different from diseases that narrow blood vessels that feed the heart or brain.
    • “Heart failure has no cure, making it more urgent to identify who’s at risk. PREVENT allows that risk to be estimated using information typically collected in a regular primary care visit.”

From the U.S. healthcare business front,

  • Reuters reports,
    • “Powerful weight-loss drugs are expanding use of U.S. health care as patients starting prescriptions are diagnosed with obesity-related conditions or take the drugs to become eligible for other services, health records and discussions with doctors show.
    • “An exclusive analysis of hundreds of thousands of electronic patient records by health data firm Truveta found slight, but measurable, increases in first-time diagnoses of sleep apnea, cardiovascular disease, and type 2 diabetes within 15 days of an initial prescription for a GLP-1 weight-loss drug between 2020 and 2024.
    • “In addition to obesity-related conditions, some patients are being prescribed the drugs to lose weight and become eligible for services, including organ transplants, fertility treatments or knee replacements, according to interviews with seven doctors and five other health experts.
    • “This is a population that previously felt stigmatized by health care providers and often didn’t return. But now that they’re actually seeing themselves get healthier, asking clinicians questions and engaging more, I do think we’re seeing new patients,” said Dr. Rekha Kumar, a New York endocrinologist and obesity medicine specialist.”
  • McKinsey and Company explore how the healthcare industry can weather current challenges.
    • “The healthcare industry has been buffeted by a growing number of challenges over the past few years. This turbulence struck provider organizations in 2022, while payers were initially sheltered from the storm (Exhibit 1). But conditions became more difficult for payers in 2023, which has continued into this year, and there’s limited respite on the horizon. Unlike the widespread challenges the provider and payer sectors have faced, the picture for pharmacy services has been more nuanced. Some organizations have been propelled by tailwinds from pharmaceutical innovation and new delivery models, while others have battled headwinds from increased regulatory scrutiny. The healthcare services and technology (HST) sector, in contrast, has benefited from continued demand for data, analytics, and software. Along with pressures on earnings, the healthcare sector has also faced challenges in the capital markets, with deal activity in 2024 lower than 2023, according to McKinsey analysis.”
  • Per the American Hospital Association News,
  • Healthcare IT News tells us “74% of hospital leaders say virtual nursing will become integral to acute care. A nurse expert [in the article] discusses the results of a new survey from AvaSure showing that, while virtual nursing has yet to gain traction in acute inpatient care, it holds much promise – and already is showing results that benefit both nurses and the bottom line.”
  • A recent National Health Statistics Report examines under age 65 enrollment in high deductible and consumer driven health plans in the U.S.
  • Per HR Brew,
    • “Despite a softening job market, US employers are expected to grant merit increases of 3.3% to non-unionized employees in 2025—the same rate as this year, according to a report by Mercer.
    • “It’s not surprising to us to see employers really kind of keeping up with the part of what they had done in the prior year,” said Jack Jones, principal consultant at Mercer. “I think what it shows is employers are still prioritizing the investment in their talent.”
    • “Next year, employers are expected to increase their total salary budgets—which includes money for promotions and adjustments to reach equity—to 3.7%, excluding unionized workers. The increase was 3.6% for this year. About one-tenth (9.3%) of employees are expected to receive promotions next year, compared to 8% in 2024.
    • “However, Jones noted the numbers could change because only 20% of the more than 850 organizations surveyed had finalized their budgets. Still, most organizations (69%) don’t expect to adjust their initial projections.”

Thursday Report

David Ermer–Congress, FDA, Federal employment benefits, Medical / Rx research, Mental health care, NIH, Obesity, Rx coverage, U.S. Healthcare, Uncategorized–
Photo by Josh Mills on Unsplash

From Washington, DC

  • Govexec tells us,
    • “Senate Majority Leader Chuck Schumer told unions and federal employee groups Wednesday that he will schedule a vote on the Senate floor on legislation to repeal two controversial tax provisions that reduce some public servants’ retirement benefits just weeks before the end of the congressional session and Democrats’ control of the chamber.
    • “Schumer’s remarks came at a rain-soaked rally, organized by lawmakers and organized labor on Capitol Hill in support of the Social Security Fairness Act (H.R. 82), which passed the House by a 327-75 vote last month.” * * *
    • “If enacted, the legislation would repeal Social Security’s windfall elimination provision and government pension offset. The windfall elimination provision reduces the Social Security benefits of retired federal employees who spent a portion of their careers in the private sector in addition to a federal, state or local government job where Social Security is not intended as an element of their retirement income, such as the Civil Service Retirement System. And the government pension offset reduces spousal and survivor Social Security benefits in families with retired government workers.”
  • FedSmith adds,
    • “The OPM retirement backlog has dropped to levels not seen since 2016. As of the end of November 2024, the total outstanding retirement claims at the Office of Personnel Management is 13,844. The last time it was at or below that level was June 2016 when it was 13,529.
    • “OPM received 6,808 new retirement claims in November and processed 7,872. It took an average of 55 days to process claims.
    • “So far in 2024, the average level of the OPM retirement backlog is 16,083. The average number of retirement claims submitted by federal employees to OPM each month has been 7,558, and the average number processed each month is 7,599.
    • “The end of a year is the peak time for federal employees to retire, so it’s good news for federal employees who plan to retire soon that the number of pending retirement claims at OPM has fallen as the end of 2024 approaches.
    • “However, even though most federal employees retire at the end of a calendar year, the impact on the processing doesn’t hit until January. The peak time at OPM for processing retirement claims is January through March, and January is typically the month with the largest spike in the retirement backlog based on past data. For example, the OPM retirement backlog grew by 46% last January.”
  • BioPharma Dive lets us know,
    • “When the Food and Drug Administration took Eli Lilly’s Zepbound and Mounjaro off of its drug shortage list in October, companies making cheap “compounded” versions found themselves in a bind.
    • “By ending compounders’ ability to manufacture and sell their off-brand versions in bulk, the FDA’s decision also left some patients wondering how they would be able to access the popular obesity and diabetes drugs at an affordable price. About 12% of American adults have taken a GLP-1 medication, according to a May poll from KFF Health. And compounded versions may account for as much as 20% of all GLP-1 prescriptions, CNN reported.
    • “But when the FDA backed down, letting compound pharmacies resume their activities for the time being, the industry was left in something of a limbo. * * *
    • “The FDA said it will issue another update Dec. 19, although it’s possible it will be another extension of the review. The agency said in a late November joint status update to a court hearing the compounders’ challenge that it had not yet made a determination, according to Beaver.
    • “In the interim period, FDA has indicated it does not intend to take enforcement action against the continued compounding of tirzepatide,” Beaver said.
    • “With a new presidential administration set to take over next month, the FDA may simply wait.”
  • STAT News adds,
    • “Eli Lilly, which has been directing patients to various telehealth sites as it sells its blockbuster obesity medication Zepbound, is broadening its reach, announcing a partnership Wednesday with major telehealth platform Ro.
    • “Under the new agreement, Ro patients who are prescribed Zepbound will be able to get vials of the drug through its app. Previously, Lilly had only made these vials, which are priced lower than its injectable pens, available to patients who filled prescriptions through an online portal created by Lilly, called LillyDirect.”
  • MedTech Dive offers “four takeaways from the FDA’s first digital health advisory committee. Industry and patient representatives debated how the FDA should regulate generative AI in medical devices and address new challenges with the technology.”

From the judicial front,

  • Reuters informs us,
    • “The U.S. Department of Health and Human Services overstepped its authority when it boosted Medicare reimbursements to hospitals in low-wage areas to help them recruit and retain staff, a divided federal appeals court ruled on Wednesday.
    • “A 2-1 panel of the San Francisco-based 9th U.S. Circuit Court of Appeals found that HHS’s 2020 policy shift ran afoul of the law governing Medicare, the federal health insurance program for seniors and some people with disabilities.
    • “The decision was a victory for a group of 53 California hospitals that sued HHS in 2020 in Los Angeles federal court, saying their Medicare reimbursements were cut by a total of about $3.8 million to make up for the increased payments to hospitals in low-wage areas.
    • “HHS said earlier this year that it would not continue the policy in 2025, meaning that Wednesday’s decision will affect only reimbursements for past years going back to 2020.”

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “When a woman learns she has breast cancer, her reaction is often: take it out. Now doctors say that might not always be necessary.
    • “Some women with the earliest stages of breast cancer could be carefully monitored, undergoing surgery and radiation only if the disease advances, new data suggests.
    • “The strategy is akin to one already used in early prostate cancer, as doctors are increasingly looking at whether they can pull back on some cancer therapies, to spare patients side effects and costs.
    • “This is really the first study to confirm our suspicions that there’s a subset of low-risk patients that could do just as well without surgery,” said Dr. Nancy Chan, a breast-cancer specialist at NYU Langone’s Perlmutter Cancer Center, who wasn’t involved in the study. “It’s really encouraging.” * * *
    • “It was a data-free zone because we already treated it like a cancer,” said Dr. E. Shelley Hwang, a breast-cancer surgeon at Duke Cancer Institute, who led the trial. “We didn’t know what we could dial back on.”
    • Hwang and her colleagues recruited some 950 women ages 40 and older with a type of low-risk DCIS that is sensitive to hormones. The women were split into two groups: One was recommended standard care—surgery with or without radiation—while the other was recommended mammograms every six months. The monitoring group could opt for surgery at any time and had to get surgery if the disease progressed.
    • Most women in both groups took hormone therapy to help keep cancer growth in check. Some 17% of women in the monitoring group ended up getting surgery, and some assigned to the treatment group declined to get an operation.
    • Two years later, the rates of women who developed invasive breast cancer were similar between the groups, less than 10%, the researchers found. The women also reported comparable rates of anxiety, a concern when doctors are considering dialing-back treatment.
    • Women who got standard care reported more arm problems and breast pain, but that resolved over time. The results were published in the academic journals JAMA and JAMA Oncology and presented at the San Antonio Breast Cancer Symposium on Thursday.
  • STAT News points out,
    • “Pfizer said Thursday its drug Ibrance showed efficacy in a group of breast cancer patients who do not currently have access to the medicine, potentially expanding its use.
    • “Ibrance, which generates annual sales of $4.3 billion, is currently used for patients whose tumors are positive for the estrogen receptor (ER) and negative for a second biomarker, called HER2. That population represents 70% of women with breast cancer. But the new results are in patients whose tumors test positive for both the estrogen receptor and HER2, a population that represents 10% of breast cancer patients.”
  • The New York Times relates,
    • “Over the last 20 years, clinicians have increasingly recognized that A.D.H.D. symptoms, which begin in childhood, can linger into adulthood, and that some groups — like women and people of color— are more likely to be underdiagnosed early in life. Now, with the rise of telemedicine, increased awareness of A.D.H.D. and changing attitudes about mental health treatment, new A.D.H.D. diagnoses are surging among older Americans.
    • “An analysis by Truveta, a health care data and analytics company, shows that the rate of first-time A.D.H.D. diagnoses has been on the rise since 2021, but the increase has occurred only among people 30 and older. From January 2021 to October 2024, the rate of first-time diagnoses rose about 61 percent among those ages 30 to 44 and 64 percent among those ages 45 to 64.
    • “As a result, about 31 percent of first-time diagnoses are now among people ages 30 to 44, the largest proportion of any age group. (In 2018, younger adults took the top spot.)
    • “The analysis, which was done at the request of The New York Times, drew on Truveta’s database of 30 health systems, which included more than one million people who had received first-time A.D.H.D. diagnoses.”
  • The National Institutes of Health Director, Dr. Monica Bertagnolli, writes,
    • “In people with brain tumors known as diffuse gliomas, cancerous cells often spread and invade nearby tissue to mix with healthy cells. As a result, it can be challenging for neurosurgeons to differentiate cancerous from healthy tissue during surgery as is required to safely remove as much of the cancer as possible. Many patients with glioma are found to have residual tumor after surgery, which can mean additional surgeries, earlier recurrence, and decreased survival. But research is showing that artificial intelligence (AI) tools could enable doctors to not only predict if a cancer will respond to treatment, but also to differentiate cancerous from healthy tissue rapidly enough to guide more brain surgeries in real time.
    • “In one promising example of this, an NIH-supported study in Nature  recently reported the development of an open-source, AI-based diagnostic system that can determine in just 10 seconds if part of a cancerous brain tumor that could be removed still remains. The new system, called FastGlioma, combines rapid, user-friendly, optical microscopy with AI models trained on diverse data, including over 11,000 surgical specimens and 4 million microscopy images, to give surgeons needed answers very quickly.
    • “Today, neurosurgical teams locate residual tumor during surgery guided by MRI or fluorescent imaging. The research team for this study—led by Todd Hollon , University of Michigan Health, Ann Arbor, and Shawn Hervey-Jumper , University of California, San Francisco—reports that the new system significantly outperforms current methods for identifying tumor remains, working faster and more accurately.” * * *
    • “The presence of residual tumor tissue following surgery is a significant and costly public health problem in the U.S. and around the world, for brain cancers and other solid cancers alike. The research team reports that FastGlioma can already accurately detect residual tumor in many other brain cancer types, including both adult and childhood brain cancers, suggesting it has potential to one day serve as a general-purpose tool for guiding brain tumor surgeries. The researchers also plan to explore the system’s application to other cancers, including lung, prostate, breast, and head and neck cancers. Through this kind of work, the researchers hope this tool and others like it can help unlock the potential of AI for improving cancer care in the years ahead.”
  • Per MedPage Today,
    • “Postmarketing data on obeticholic acid (Ocaliva) identified a risk for serious liver injury in primary biliary cholangitis (PBC) patients without cirrhosis, the FDA said in a safety communication on Thursday.
    • “The agency’s review of a mandated clinical trial “found that some cases of liver injury in patients without cirrhosis resulted in liver transplant. This risk was notably higher for patients taking Ocaliva compared with a placebo,” the FDA said.”
  • Per Beckers Hospital Review,
    • “The FDA has placed a hold on all clinical studies of vaccines for respiratory syncytial virus in infants due to safety concerns following a trial involving two mRNA-based vaccine candidates from Moderna. 
    • “A briefing document released by the FDA ahead of the Vaccine and Related Biological Products Advisory Committee revealed that a phase 1 trial evaluating two RSV vaccines in infants aged 5 to 8 months was paused in July after five severe cases of RSV-related illness were reported among infants receiving the vaccine candidates.” * * *
    • “VRBPAC will review the safety data and discuss implications for the future development of RSV vaccines for infants Dec. 12.” 

From the U.S. healthcare business front,

  • Per a press release,
    • The Institute for Clinical and Economic Review (ICER) today published its latest report on Unsupported Price Increases (UPI) of prescription drugs in the United States, highlighting the top 10 drugs with substantial net price increases in 2023. ICER determined that five of those drugs lacked adequate evidence to support any price increase, which resulted in a total of $815 million incremental added costs to US payers in 2023. The five drugs with unsupported price increases are Biktarvy, Darzalex, Entresto, Cabometyx, and Xeljanz.
    • Downloads: Final Report
    • “We continue to see list price increases that are far above the rate of inflation for many of the costliest drugs,” stated Foluso Agboola, MBBS, MPH, ICER’s Vice President of Research. “These price hikes resulted in over $800 million in excess costs to the US health care system in just one year alone. This impacts everyone in the country, especially patients and their families. Over the past few years, ICER has played a role in highlighting substantial price increases. Since launching this report in 2019, we have noticed a decrease in the number of drugs that have significant price hikes without any new clinical evidence. In this report, half of the drugs we assessed had price increases in the setting of new evidence of additional benefits or reduced harm, while the other half lacked such evidence to support their higher price tag.”
  • STAT News discusses “AI versus AI: The emerging arms race over health insurance denials. New startups are harnessing artificial intelligence to appeal denials by health insurers.
    • “Like many Americans, Holden Karau said she was fed up with health insurance. * * *
    • Karau’s company, FightHealthInsurance.com, is one of many upstart businesses seeking to harness the power of artificial intelligence to combat denials by health insurers that block access to medical services.
    • “There’s a lot of technology on the insurance side to automate denials,” Karau said. “I think it’s time to build the tools for patients and providers.”
    • “Her company, and its companions in the market, are just getting off the ground. But they promise to help automate appeals for providers and patients, making it much faster and easier to contest denials that often go unchallenged.”
  • Beckers Hospital Review shares weight loss drug fills by states.
    • “Alaska recorded the highest percentage of medication fills for weight loss drugs this year, according to data from GoodRx. 
    • “To assess state-level trends, GoodRx examined fill rates for all medications, excluding vaccines, from a nationally representative sample between Jan. 1 and Oct. 31. The figures below reflect the percentage of total medication fills for GIP and GLP-1 drugs prescribed for either diabetes or weight loss indications. Medications for Type 2 diabetes included Ozempic, Mounjaro, Victoza and liraglutide, while medications prescribed for weight loss included Wegovy, Zepbound, Saxenda, Qsymia and phentermine.
    • “Regionally, states in the South had higher fill rates for medications prescribed for diabetes while states in the Northeast had the highest fill rates for medications prescribed for weight loss.” 
  • and points out “US News’ 118 maternity care access hospitals.”
    • “On Dec. 10, U.S. News & World Report released its annual Best Hospitals for Maternity Care ratings, which also recognize hospitals providing services to underserved communities.
    • “U.S. News identified 118 hospitals as Maternity Care Access Hospitals for providing maternity services in areas that would otherwise lack access to such care.
    • “To qualify, these hospitals met specific geographic and quality criteria. They were eligible if they were the only hospital providing maternity care within their county, and the county had fewer than 60 obstetric providers per 10,000 births. Alternatively, hospitals qualified if they were the only facility within a 15-mile radius and were located in a county with fewer than 128 obstetric providers per 10,000 births.”
  • Per Fierce Healthcare,
    • “Centene released its earnings guidance for 2025 as a part of its investor day on Thursday.
    • “The health insurer expects to bring in between $166.5 billion and $169.5 billion in revenue for the year, including between $154 billion and $156 billion in premium and service revenue, according to the announcement. It also estimates earnings per share of at least $7.25 in 2025.
    • “The company is bracing for elevated utilization trends to continue as well, according to the announcement. It projects a medical loss ratio of between 88.4% and 89%.”

Midweek Update

David Ermer–ACA, CDC, Congress, Electronic health records, FDA, Medical / Rx research, NIH, U.S. Healthcare–

From Washington, DC

  • The Wall Street Journal reported this morning
    • “A bipartisan group of lawmakers introduced legislation to break up pharmacy-benefit managers, the drug middlemen that have now faced yearslong scrutiny from Congress and the Federal Trade Commission.
    • “A Senate bill, sponsored by Sens. Elizabeth Warren (D., Mass.) and Josh Hawley (R., Mo.), would force the companies that own health insurers or pharmacy-benefit managers to divest their pharmacy businesses within three years.
    • “A companion bill, which sponsors say draws on a history of government prohibitions on joint ownership within industries, was also introduced in the House on Wednesday.
    • “If passed, the legislation would be the most far-reaching intervention yet into the operations of pharmacy-benefit managers, known as PBMs, and their parent companies, cutting off a major source of revenue for the companies and frustration for patients.”
  • STAT News added this afternoon,
    • “A proposed Senate bill that would prohibit companies that control health insurers or pharmacy benefit managers from owning pharmacies rattled investors on Wednesday, but some Wall Street analysts believe the legislation is unlikely to gain much traction, at least for now.
    • “The bipartisan bill, which would require divestiture within three years, is aimed at what the lawmakers call an “inherent conflict of interest” that has forced Americans to pay more for medicines and hastened the demise of independent pharmacies. A companion bill, that refers to a history of government prohibitions on joint ownership within industries, is scheduled to be introduced in the House.” * * *
    • Wall Street watchers believe the lower stock prices are an overreaction. Although the insurers are a juicy target, various factors suggest the bill is far from a sure bet, given the upcoming change in administrations. Securities analysts believe other legislative priorities will get more attention, despite a focus on health care matters more broadly.”
  • The Wall Street Journal also lets us know,
    • “The House voted Wednesday to approve a nearly $900 billion annual defense policy bill that includes a controversial provision that would block some transgender medical care for minors covered by the military’s healthcare program.
    • “The package, which sets national defense standards and priorities for the 2025 fiscal year, notably calls for a 14.5% pay raise for junior enlisted service members, dwarfing the 4.5% pay raise included for all other members of the armed forces. The package passed 281-140, with most Republicans voting for the bill but more than half of Democrats voting no.
    • “The 1,800-page National Defense Authorization Act would increase the national security budget to $895 billion, about a 1% increase from last year’s total, less than inflation. * * *
    • “The NDAA authorizes appropriations but doesn’t provide budget authority, making it a guide to what military spending is ultimately passed separately by Congress. It is set to be the 64th consecutive NDAA successfully passed through Congress—a rarity in what has increasingly become a divided and chaotic legislature. 
    • “The bill is now expected to be fast-tracked in the Senate, where the chamber will likely pass it before Congress leaves at the end of next week. From there, it would go to President Biden’s desk, where he is expected to sign it.”
  • Federal News Network tells us,
    • “With just a few weeks left in the year for President Joe Biden to finalize the 2025 federal pay raise, House and Senate Democrats are calling for a larger pay boost than the currently planned raise for civilian federal employees on the General Schedule.
    • “In a letter sent to Biden Wednesday morning, a group of 22 Democrats pushed for what they said should be “pay parity” between civilian and military federal employees. Currently, civilian and military personnel are slated for likely different pay raises for 2025.
    • “We believe it is imperative you revise your budget to align military and civilian employee pay raises,” the lawmakers, led by Sens. Tim Kaine (D-Va.) and Mark Warner (D-Va.), and Rep. Steny Hoyer (D-Md.), wrote in the letter, shared with Federal News Network.
    • “Currently, most civilian employees are on track to receive a 2% federal pay raise beginning in January, according to the alternative pay plan Biden sent to congressional leaders in August. In contrast, military personnel are expected to likely receive a 4.5% raise for 2025. Although the raise amounts appear to be heading in those two directions, neither raise amount is final just yet. Unless Congress or Biden opts for a different pay plan, the 2% raise is expected to become final through signing an executive order by the end of December.”
  • The American Hospital Association News informs us,
    • The Senate Dec. 10 unanimously passed legislation reauthorizing the Emergency Medical Services for Children Program (H.R. 6960) for an additional five years. The program provides funding for equipment and training to help hospitals and paramedics treat pediatric emergencies. The program was authorized at $24.3 million per year from 2025-2029. The bill was passed by the House in May.”
  • and
    • “The Department of Health and Human Services Dec. 11 published a final rule implementing provisions related to the Trusted Exchange Framework and Common Agreement. The rule is intended to advance equity, innovation and interoperability by promoting the use and exchange of electronically captured health information as specified in certain provisions of the Health Information Technology for Economic and Clinical Health Act of 2009.  
    • “The provisions today’s final rule adopts were first proposed in August as part of a much larger rule and will be effective 30 days after it is officially published in the Federal Register.”
  • The New York Times relates,
    • “In the final days of the Biden administration, the Food and Drug Administration is seeking White House approval to propose a drastic reduction in the amount of nicotine in cigarettes, a longstanding goal of public health experts that has faced stiff opposition from the powerful tobacco lobby.
    • “The F.D.A. submitted the proposal to the Office of Management and Budget only on Tuesday, a sign that the move was perhaps more wishful and symbolic than realistic for a White House juggling many late-term agenda items. And traditionally, the budget office’s review of agency proposals can take months.”
  • Per Fierce Pharma,
    • “As Donald J. Trump gradually fills out his cabinet, the President-elect’s latest pick could bode well for biopharma business development over the next four years.
    • “Trump on Tuesday nominated Andrew Ferguson to lead the U.S. Federal Trade Commission (FTC). Ferguson is one of two Senate-confirmed Republican FTC commissioners appointed by President Joe Biden, Reuters notes.
    • “At the same time, Trump said in a post on Truth Social that he plans to nominate Mark Meador, a partner at the law firm Kressin Meador Powers, to become an FTC commissioner. Should he be confirmed for the job, Meador will take over the spot currently filled by FTC chair Lina Khan, whose term at the antitrust agency has expired, the news agency said.”

From the public health and medical research front,

  • Per MedPage Today,
    • “A possible case of H5N1 bird flu virus in a California child has been linked to raw milk consumption and is under investigation by state health officials and the CDC.
    • “The patient experienced fever and vomiting after drinking raw milk and has since recovered, according to an announcement by Marin County Public Health. Officials said that the risk to the public remains low, as there was no evidence of person-to person transmission between the child and her family members.
    • “The case stands out for being outside the usual farm work setting.”
  • The New York Times adds,
    • “Domestic cats could provide an unexpected new route for the bird flu virus H5N1 to evolve into a more dangerous form, according to a new study published on Monday.
    • “In the year since the virus began circulating in dairy cattle, it has killed many cats, primarily on farms with affected herds. It has also sickened at least 60 people, most of whom had close contact with infected dairy cows or poultry.
    • “So far, H5N1 does not spread easily among people, although studies have suggested that just one or two key mutations could allow the virus to make that leap.
    • “There is no evidence that cats have spread H5N1 to people and they may not represent a major avenue for the evolution of bird flu, experts said. Still, if a cat were simultaneously infected with H5N1 and a seasonal flu virus, the H5N1 virus could potentially acquire the mutations it needed to spread efficiently among people.”
  • ABC News reports,
    • “The rates of late-stage breast cancer at diagnosis have risen among women in all racial and ethnic groups, but Black women have been hit the hardest, according to a new study published in the journal Radiology.
    • “The study, which looked at data from 2004 to 2021, found that advanced breast cancer rates have risen among women of all ages, with the sharpest increases in young women aged 20 to 39, and women over 75.
    • “Black women experience advanced diagnoses 55% more often than white women and are more likely to die from the disease, the study found.
    • “While mammography does save lives by catching cancer earlier, fewer than 70% of eligible women are up to date on their screenings, the study found.
    • “This trend is particularly alarming because early detection significantly improves survival. Five-year survival rates drop drastically from 99% for early-stage breast cancer to just 31% when the cancer is more advanced and has already spread to other parts of the body, the study found.”
  • BioPharma Dive adds,
    • “An experimental breast cancer drug developed by Eli Lilly met its main goal in a Phase 3 study, helping people with a form of HER2-negative, ER-positive disease stay alive and progression free for longer than standard hormone-suppressing therapies, according to data disclosed Wednesday.
    • “When combined with Lilly’s approved medicine Verezenio, the experimental drug, called imlunestrant, also helped women stay alive and progression free longer than treatment with imlunestrant alone regardless of their mutation status, according to results of the EMBER-3 trial presented at the San Antonio Breast Cancer Symposium. The data were also published in The New England Journal of Medicine.”
  • Per a National Institutes of Health press release,
    • “National Institute of Health (NIH) scientists have made a significant breakthrough in understanding how “bad” cholesterol, known as low-density lipoprotein-cholesterol or LDL-C, builds up in the body. The researchers were able to show for the first time how the main structural protein of LDL binds to its receptor – a process that starts the clearing of LDL from the blood – and what happens when that process gets impaired.
    • “The findings, published in Nature, further the understanding of how LDL contributes to heart disease, the world’s leading cause of death, and could open the door to personalizing LDL-lowering treatments like statins to make them even more effective.
    • “LDL is one of the main drivers of cardiovascular disease which kills one person every 33 seconds, so if you want to understand your enemy, you want to know what it looks like,” said Alan Remaley, M.D., Ph.D., co-senior author on the study who runs the Lipoprotein Metabolism Laboratory at NIH’s National Heart, Lung, and Blood Institute.” * * *
    • “The study findings could open new avenues to develop targeted therapies aimed at correcting these kinds of dysfunctional interactions caused by mutations. But, as importantly, the researchers said, they could also help people who do not have genetic mutations, but who have high cholesterol and are on statins, which lower LDL by increasing LDLR in cells. By knowing precisely where and how LDLR binds to LDL, the researchers say they may now be able to target those connection points to design new drugs for lowering LDL from the blood.” 
  • STAT News points out,
    • “Gilead said Tuesday that it will soon begin Phase 3 testing for a drug it believes could prevent HIV infection with just a single shot every year.
    • “Such a medicine, if proven effective, would be the closest thing to a vaccine the HIV field has produced in four decades of research. The company plans to begin the trial next year, with an eye toward regulatory filings in late 2027.”

From the U.S. healthcare business report,

  • Health Affairs reports,
    • “Numerous studies show that employer plans pay providers significantly more than Medicare, but less is known about prices in nongroup plans sold both on and off the Marketplaces established by the Affordable Care Act (ACA), where narrow networks and low-cost insurers are more prevalent.
    • “We estimated prices for three market segments (Marketplace nongroup, off-Marketplace nongroup, and employer small group) and three types of services (professional, outpatient hospital, and inpatient hospital) relative to a Medicare benchmark.
    • “We used 2021 claims data covering virtually all enrollment in ACA risk-adjusted plans. In aggregate, in 2021, Marketplace prices were 152 percent of Medicare prices, whereas the prices paid in small-group employer plans were 179 percent of Medicare prices.
    • “Comparing across market segments, relative to employer small-group plans, Marketplace professional prices were 6.9 percent lower, inpatient prices were 13.3 percent lower, and outpatient prices were 26.3 percent lower. Off-Marketplace prices fell between Marketplace and employer small-group prices.
    • “The finding that nongroup prices were significantly lower than prices paid by employer small-group plans—more so than indicated by prior research—is important for understanding federal subsidies and affordability for nongroup coverage and evaluating policies such as a nongroup public option with prices capped at a percentage of Medicare prices.”
  • Per Healthcare Dive,
    • “For the first time in 27 months, Fitch Ratings is revising its credit outlook for the nonprofit hospital sector — lifting it from deteriorating to neutral in its 2025 outlook report and adding that hospitals have made “enough meaningful strides” to warrant the revision.
    • “Hospitals have seen “steady improvement” on operating margins, according to the Monday report. The trend is attributable to providers’ success controlling labor expense growth, as well as stronger cash flows and equity returns.
    • “Fitch predicts margins will continue to improve, with operators reporting median operating figures between 1% and 2% in 2025. However, if President-elect Donald Trump announces cuts to Medicaid or supplemental Medicaid funds, margins could be adversely impacted and the sector’s outlook may be reverted to deteriorating.”
  • Modern Healthcare informs us,
    • “Labcorp has completed its acquisition of select non-hospital lab assets from Ballad Health, the independent laboratory company said Wednesday. A purchase price was not immediately available.
    • “Johnson City, Tennessee-based Ballad Health will retain operations of its inpatient and emergency department laboratory services, as well as lab services for hospital-based practices, according to a news release.” * * *
    • “The latest deal continues a trend of health systems selling off parts of their laboratory business to save on costs and focus on other areas of their operations. Independent lab companies often can provide a higher volume of tests at a lower cost compared with hospitals performing tests at their own facilities.”