Friday Report

FDA

Friday Report

David Ermer–CDC, Congress, COVID-19, FDA, Medical / Rx research, NIH, Rx coverage, U.S. Healthcare–
Photo by Josh Mills on Unsplash

Public service notice — January 3 is the statute of limitations for wishing another person Happy New Year, according to Larry David.

From Washington, DC,

  • The Wall Street Journal reports,
    • “Incumbent Mike Johnson won re-election as speaker of the House on the first ballot, after President-elect Donald Trump pressured GOP holdouts to change their votes, handing the Louisiana Republican the narrow majority needed to claim the gavel.
    • “Johnson’s dramatic victory clears the way for Republicans to charge headlong into Trump’s second term, taking on an ambitious agenda of tax cuts and border security. While Johnson avoided a repeat of the GOP’s calamitous January 2023 speaker vote, the tally underscored how little room he has to maneuver with the party’s razor-thin margin. It also showed the power of any small group of dissidents to derail the party’s plans.
    • “Working together, we have the potential to be one of the most consequential congresses in the history of this great nation,” Johnson said.
    • “The chain of events previewed how Trump and Johnson will need to move in lockstep to get legislation across the finish line and tamp down dissent, even though the party controls both chambers of Congress and the White House.”
  • Roll Call adds,
    • “A last-minute insertion into House Republicans’ rules package for the 119th Congress substantially raises the bar for voting on legislation under suspension of the rules late in the week or over the weekend, in a concession to conservatives upset about recent deals with Democrats on big-ticket spending bills.
    • “The change requires the House to adopt a special rule to consider bills under suspension of the rules — which bars amendments but requires the support of two-thirds of members present and voting for passage — on any days other than Mondays, Tuesdays or Wednesdays.” * **
    • The House adopted the new rules package on a 215-209 vote late Friday.
  • The Wall Street Journal tells us,
    • “The U.S. surgeon general said alcoholic beverages should carry cancer warnings to increase awareness that the drinks are a leading cause of preventable cancers.
    • “An act of Congress would be required to change the existing warning labels on bottles of beer, wine and liquor. Today, federal rules require only a warning against drunken driving and drinking while pregnant, as well as a general warning that alcohol “may cause health problems.”
    • “Alcohol is a well-established, preventable cause of cancer responsible for about 100,000 cases of cancer and 20,000 cancer deaths annually in the United States,” Dr. Vivek Murthy said in his advisory issued Friday. “Yet the majority of Americans are unaware of this risk.”
  • Per a Health and Human Services Department press release,
    • “Today, the U.S. Department of Health and Human Services (HHS) announced it would award $306 million dollars to continue its H5N1 Avian Flu response. While CDC’s assessment of the risk of avian influenza to the general public remains low, USDA and HHS continue to closely collaborate with Federal, State, local, industry and other stakeholders to protect human health, animal health, and food safety.
    • “While the risk to humans remains low, we are always preparing for any possible scenario that could arise. These investments are critical to continuing our disease surveillance, laboratory testing, and monitoring efforts alongside our partners at USDA,” said Secretary Xavier Becerra. “Preparedness is the key to keeping Americans healthy and our country safe. We will continue to ensure our response is strong, well equipped, and ready for whatever is needed.”
  • MedTech Dive informs us that the “FDA closed 2024 with string of early alerts on device safety risks. Olympus advised providers to stop using an endoscope accessory due to an infection risk linked to 120 injuries and one death.”

From the judicial front,

  • Fierce Healthcare lets us know,
    • “Aetna is taking legal action against Pfizer, Novartis, Teva Pharmaceuticals and others, saying the list of drugmakers conspired to overcharge the insurer, consumers and the federal government for generic drugs.
    • “The complaint, filed Dec. 31, claims the drugmakers communicated secretly at trade conferences or through phone calls, beginning in 2012, to determine the market share, prices and bids of certain drugs. If communication was in writing, they destroyed the evidence, Aetna claimed.
    • “They effectuated their market allocation by either refusing to bid for particular customers or providing outrageously high cover bids,” the complaint said. “This created an artificial equilibrium that enabled the conspirators to then collectively raise and/or maintain prices for a particular generic drug.”
    • “Aetna said that drug purchasers, predominantly insurers, suffered as a result of these actions. Insurers place generic drugs on their formularies to lower costs but instead were paying unfairly high prices for these products.”

From the public health and medical research front,

  • The Centers for Disease Control and Prevention announced today,
    • “COVID-19 activity is increasing in most areas of the country. Seasonal influenza activity continues to increase and is elevated across most of the country. RSV activity is very high in many areas of the country, particularly in young children.
    • “COVID-19
      • “COVID-19 activity is increasing in most areas of the country, with high COVID-19 wastewater levels and increasing emergency department visits and laboratory percent positivity. Based on CDC modeled estimates of epidemic growth, we predict COVID-19 illness will continue 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 very high in many areas of the country, particularly in young children. Emergency department visits and hospitalizations are highest in children and hospitalizations are elevated among older adults in some areas.
    • “Vaccination
      • “Vaccination coverage with influenza and COVID-19 vaccines are low among U.S. adults and children. COVID-19 vaccine coverage in older adults has increased compared with the 2023-2024 season. Vaccination coverage with RSV vaccines remains low among U.S. adults. Many children and adults lack protection from respiratory virus infections provided by vaccines.”
  • Following up on the Surgeon General’s advisory, the Wall Street Journal considers,
    • “How much drinking is bad for you?
    • “Though more people are calling themselves sober-curious or are trying zero-proof replacements for alcohol, drinking is a regular part of social life for most of us. A coupe of champagne can add fun to a celebration. A cocktail can take the edge off a tough day. And a cold beer can liven up a sports game. 
    • “Yet scientists’ warnings about the potential health problems of even small amounts of alcohol are growing more dire. For moderate drinkers, it can be hard to know what’s actually OK to consume: Is two a day that much worse than one? Are two drinks over a week the same as two in a day? 
    • “Averaging no more than about one drink a day is relatively low risk, according to scientists who study alcohol. They warn the risk of cancer rises significantly when you exceed that. Studies have suggested that alcohol contributes to about half a dozen types of cancers, including breast and colorectal, as well as heart and liver disease, among other conditions.” 
  • Per MedTech Dive,
    • “The Food and Drug Administration said a literature review found no safety concerns associated with tampon use and contaminant exposure.
    • “FDA officials commissioned the independent review in September in response to a study that found tampons may expose users to metals. After seeing the findings, the agency continues to recommend FDA-cleared tampons as a safe option for use as a menstrual product.
    • “The FDA is still running an internal bench laboratory study designed to show if metals from tampon materials are released or absorbed in the body. That study will better enable the FDA to complete a risk assessment, the agency said in a Dec. 23 statement.”
  • The Wall Street Journal notes,
    • Researchers have identified a focal point for the forces they suspect of driving up cancer cases in young people: the gut. They are searching people’s bodies and childhood histories for culprits.
    • Rates of gastrointestinal cancers among people under 50 are increasing across the globe. In the U.S., colorectal cancer is the leading cause of cancer death in men under 50 and second for women behind breast cancer. Each generation born since the 1950s has had higher risk than the one before. 
    • “Everything you can think of that has been introduced in our society since really the 1960s, the post-World War II era, is a potential culprit,” said Dr. Marios Giannakis, a gastrointestinal oncologist at the Dana-Farber Cancer Institute in Boston.
    • “Robert F. Kennedy Jr., President-elect Donald Trump’s pick for Health and Human Services secretary, has pointed to ultra-processed foods and chemicals in medicines and the environment. Cancer doctors share some of his suspicionsabout diet and exposure to contaminants such as microplastics, shards that make their way from packaging or clothing into our bodies through water and food. They are scrutinizing those and other potential hazards including “forever chemicals” and even light.   
    • “We’re all concerned and want to do something quickly and act quickly, but we want to do so based on sound science,” said Dr. Andrew Chan, director of epidemiology at Mass General Cancer Center in Boston.” 
  • Per HealthDay,
    • “Not sure what’s causing your child’s asthma?
    • “A new quick-and-easy nasal swab test for kids can diagnose the specific immune system drivers behind their asthma, potentially opening the door to better treatments, researchers say.
    • “The test diagnoses a child’s asthma subtype, also called an endotype.
    • “Because asthma is a highly variable disease with different endotypes, which are driven by different immune cells and respond differently to treatments, the first step toward better therapies is accurate diagnosis of endotype,” senior researcher Dr. Juan Celedon, chief of pulmonary medicine at the UPMC Children’s Hospital of Pittsburgh, said in a news release from the hospital.”
  • A National Institutes of Health news release points out,
    • “A novel class of antibodies that binds to a previously untargeted portion of the malaria parasite could lead to new prevention methods, according to a study from researchers at the National Institutes of Health (NIH) published today in Science. The most potent of the new antibodies was found to provide protection against malaria parasites in an animal model. The researchers say antibodies in this class are particularly promising because they bind to regions of the malaria parasite not included in current malaria vaccines, providing a potential new tool for fighting this dangerous disease.
    • Malaria is a life-threatening disease caused by Plasmodium parasites, which are spread through the bites of infected mosquitoes. Although malaria is not common in the United States, its global impact is devastating, with 263 million cases and 597,000 deaths estimated by the World Health Organization in 2023. Of the five species of Plasmodium that cause malaria, Plasmodium falciparum is the most common in African countries where the burden of malaria is largest and where young children account for the majority of malaria deaths. Safe, effective countermeasures are critical for reducing the immense burden of this disease. * * *
    • “Findings from the study will inform future strategies for the prevention of malaria and may facilitate the development of new antibodies and vaccines against the disease, the researchers indicate. The scientists also note that more research is needed to examine the activity and effectiveness of the newly identified antibody class and epitope, according to their paper. The approach used in this study could also aid the development of a new generation of countermeasures against other pathogens, in addition to malaria.”  

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Ardent Health has acquired 18 facilities from urgent care provider NextCare, following through on its plan to expand its urgent and ambulatory care presence.
    • “The for-profit health system, which went public in July, said Friday it acquired six facilities in New Mexico and 12 in Oklahoma. Financial details and terms of the agreement were not disclosed.
    • “An Ardent spokesperson said the deal was part of a larger growth strategy and the system planned to acquire more ambulatory facilities.”
  • Beckers Payer Issues relates,
    • UnitedHealth Group is the world’s largest insurer by net premiums written for a 10th year in a row, according to AM Best’s annual ranking published Jan. 2.
    • In 2025, UnitedHealth expects revenues of up to $455 billion and adjusted net earnings of $29.50 to $30.00 per share.
    • Top four insurers ranked by 2023 NPW:
      • UnitedHealth Group
      • Centene
      • Elevance Health
      • Kaiser Permanente
  • Per Beckers Hospital Review,
    • “The Women’s Choice Award has recognized 457 hospitals on its annual list of the Best Hospitals for Patient Safety.
    • “To compile the ranking, the organization analyzed hospitals’ performance on 13 surgical complication and infection measures from CMS, including central-line associated bloodstream infections, sepsis and serious blood clots after surgery. Hospitals had to report on at least six measures to be included in the analysis and could not rank worse than the national average on any measure.  
    • “Hospitals on the patient safety list were among the top 10% of organizations nationwide with the lowest incidence of adverse medical events and infections. See the full list of winners here.” 

Thursday Report

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

From Washington, DC,

  • According to the House of Representatives and Senate press galleries, each body will assemble before noon to adjourn the 118th Congress sine die and at noon will convene for the start of the 119th Congress.
  • Govexec tells us,
    • “Current federal employees, retirees and others impacted by widespread breach of personal data maintained by the Office of Personnel Management took advantage of only a small portion of the money made available in a settlement agreement following the 2015 hack. 
    • “Plaintiffs in the class action lawsuit reached a settlement in 2022 with the government that made $63 million available for those who could demonstrate financial hardship as a result of the breach. A federal judge closed out the case last month after OPM and the Treasury Department doled out just $4.8 million to just more than 5,000 individuals. The remaining $58.2 million is set to go back to the Treasury on Thursday, according to court documents last month.” 

From the public health and medical research front,

  • The Washington Post reports, “More children are getting kidney stones. Experts think it’s their diet.”
    • “Some research suggests that genetic predisposition may play a role, but experts say the increase more likely reflects dietary habits and lifestyle.
    • “A North Carolina doctor detected a potential culprit: salt-laden diets. Sodium intake has increased significantly among children in the past few decades.
    • “There is so much added salt to the American diet today, and when the kidney is excreting the sodium, it pulls calcium with it and increases the risk of calcium-based stones,” John S. Wiener, a pediatric urologist at Duke Health, said.”
  • The American Medical Association discusses “Raw milk: Questions patients may have and how to answer.” Econtalk host Russ Roberts chats with Brown University economist Emily Oster about raw milk and similar public health issues in his latest podcast.
  • HealthDay lets us know,
    •  “Alzheimer’s disease experts have updated their diagnosis guidelines for the first time in more than 20 years, laying out how family doctors and brain specialists can best detect dementia.
    • “The guidelines call for the use of three general criteria to assess a person’s brain health, according to a report published Dec. 23, 2024, in the journal Alzheimer’s & Dementia:
      • “The patient’s overall level of cognitive impairment
      • “Specific symptoms they’re suffering, which can involve memory, reasoning, language or mood
      • “Brain diseases most likely to be causing these symptoms
    • “These three areas of diagnosis were intentionally left broad, so that new tests can be incorporated into the guidelines as researchers learn more about dementia and Alzheimer’s, Dr. Alireza Atri, a lecturer on neurology at Harvard Medical School, said in a news release from the Alzheimer’s Association.”
  • Per National Institutes of Health news releases,
    • “Based on new brain mapping research funded by the National Institutes of Health (NIH), scientists have discovered that not all cell types in the brain age in the same way. They found that some cells, such as a small group of hormone-controlling cells, may undergo more age-related changes in genetic activity than others. The results, published in Nature, support the idea that some cells are more sensitive to the aging process and aging brain disorders than others.
    • “Aging is the most important risk factor for Alzheimer’s disease and many other devastating brain disorders. These results provide a highly detailed map for which brain cells may be most affected by aging,” said Richard J. Hodes, M.D., director of NIH’s National Institute on Aging. “This new map may fundamentally alter the way scientists think about how aging affects the brain and also provide a guide for developing new treatments for aging-related brain diseases.”
    • “Scientists used advanced genetic analysis tools to study individual cells in the brains of 2-month-old “young” and 18-month-old “aged” mice. For each age, researchers analyzed the genetic activity of a variety of cell types located in 16 different broad regions — constituting 35% of the total volume of a mouse brain.”
  • and
    • ‘In a small clinical trial, a CAR T-cell therapy—a type of immunotherapy that uses a patient’s own immune cells to fight cancer—shrank tumors in several children and young adults with diffuse midline gliomas. This fast-growing form of brain and spinal cord cancer typically causes death within a year of diagnosis.
    • “In the trial, several participants were still alive 2 years or more after receiving the treatment.” * * *
    • “This study breaks new ground,” said study co-investigator Crystal L. Mackall, M.D., of Stanford Medicine. “It demonstrates that CAR T cells can have real, meaningful benefit for solid cancers, something that many people have not believed [was possible].”  
    • “In the trial, 9 of 11 patients who received the GD2 CAR T-cell therapy had neurological improvement. Of those, 7 had tumor shrinkage and in some cases the effects were quite dramatic. As patients’ tumors shrank, their symptoms improved and many regained physical functions they had lost from the disease, such as hearing, walking, and taste sensation. 
    • “Participants lived a median of nearly 2 years after treatment, with two patients still alive past the study’s 2.5-year follow-up period. One of these patients had a complete disappearance of his tumor and remains cancer free 4 years after his diagnosis. 
    • “It’s really remarkable,” said Rosandra N. Kaplan, M.D., of NCI’s Center for Cancer Research, who is also running a GD2 CAR T-cell therapy clinical trial but was not involved in this study. “This is a tumor for which nothing has ever worked. I think this is the start of a revolution in understanding how to treat these patients.”   
  • The Hill reported yesterday
    • “Broccoli sold at Walmart stores in 20 states has been recalled.
    • “Braga Fresh last week issued a voluntary and precautionary advisory for 12-ounce bags of Marketside Broccoli Florets that may be contaminated with Listeria monocytogenes.” * * *
    • “According to the U.S. Food and Drug Administration (FDA), which posted the advisory Tuesday, the pathogen can cause “serious and sometimes fatal infections” in young children, elderly people and others with weakened immune systems.” * * *
    • “It was distributed to stores in Alaska, Arkansas, Arizona, California, Colorado, Idaho, Illinois, Indiana, Kentucky, Louisiana, Michigan, Montana, Nevada, Ohio, Oklahoma, Oregon, Texas, Utah, Washington and Wyoming.
    • “No illnesses have yet been reported in connection with the product, the advisory said.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Sanford Health closed its merger with Marshfield Clinic Health System on Wednesday.
    • “The combined system, led by Sanford President and CEO Bill Gassen, has more than $10 billion in revenue and operates 56 hospitals across seven states, in addition to two health plans with roughly 425,000 members. It has almost 56,000 employees, including about 13,000 employees from Marshfield, according to a Thursday news release.“
  • and
    • “CareSource has completed its acquisition of Common Ground Healthcare Cooperative, the nonprofit health insurers announced in a news release Thursday.
    • “Privately held CareSource, which has 2 million Medicare, Medicaid and health insurance exchange members, gains 54,000 marketplace customers in Wisconsin through the deal. Common Ground CEO Cathy Mahaffey remains as chief executive of Common Ground Healthcare Cooperative and was named CareSource market president for the Badger State.”
    • “Common Ground had been one of three remaining member-owned cooperative health insurers supported with funding from the Affordable Care Act of 2010.” * * *\
    • “Of the 23 co-ops that debuted on the exchanges in 2013, only Community Health Options in Maine and Mountain Health CO-OP in Idaho, Montana and Wyoming are still in operation.”
  • Beckers Hospital Review lists “the hospitals patients are most likely to recommend in every state using Hospital Consumer Assessment of Healthcare Providers and Systems data from CMS.”
  • Beckers Payer Issues identifies the fifteen insurers exiting Medicare Advantage markets in 2025.
  • BioPharma Dive points out “ten clinical trials to watch in the first half of 2025. Expected readouts in diabetes, cancer and depression headline a series of study results that could help the biotechnology sector regain its footing after a shaky year.”
  • Forbes reports,
    • “The anti-obesity drug Zepbound made by Eli Lilly & Co. could be one of the biggest cost drivers for health insurers, employers and government health programs that cover it this year.
    • “Already, GLP-1 weight loss prescriptions Wegovy, Rybelsus and Saxenda—along with Ozempic—are the “single biggest driver” of employer health costs, adding 1% to the total premium expense for 2025, data released last fall from the benefits consultancy Aon said.
    • ‘These GLP-1 drugs are adding to general healthcare inflation that is projected to increase employer-sponsored health insurance coverage by 9%, eclipsing $16,000 per employee in 2025. The spike in premiums, which is higher than the 6.4% increase employers faced in 2024 and in 2023, comes before any “cost savings strategies” are implemented, Aon said.
    • “But a new report from GlobalData indicates Zepbound is poised to overtake other GLP-1 drugs.
    • “Zepbound’s superior efficacy and strategic market expansion suggest that the drug will dominate the obesity market, surpassing Novo Nordisk’s Wegovy (semaglutide),” GlobalData said in a report the market research firm released Tuesday.”
  • Per BioPharma Dive,
    • “Neumora Therapeutics, a well-funded biotechnology company, lost more than 80% of its value Thursday because its most advanced drug failed a major test.
    • “After seeing positive signs in a smaller study in 2023, Neumora pushed the drug into a trio of late-stage clinical trials to evaluate it as a treatment for the most common type of depression. The company just released data from the first of those trials, which found the drug no better than a placebo at alleviating depression.
  • and
    • “Pfizer won’t move forward with asking regulators to approve a gene therapy for hemophilia A and instead will hand back rights to development partner Sangamo Therapeutics in a blow to the California-based biotechnology company. In a Dec. 30 statement, Sangamo CEO Sandy Macrae said his company was “surprised and extremely disappointed” by Pfizer’s decision, which comes some five months after the treatment met its goal in a Phase 3 study of people with the inherited bleeding disorder. Sangamo plans to search for an “optimal path” forward, which could include partnering with another company. Pfizer has steadily retreated from gene therapy, although it sells a hemophilia B gene therapy called Beqvez that it obtained from Spark Therapeutics.”
  • and
    • “After many years of effort, Novartis has obtained positive results from a Phase 3 study for a form of its spinal muscular atrophy gene therapy Zolgensma that’s delivered via spinal injection rather than intravenous infusion. Data from the study, called Steer, showed treatment improved motor abilities in people with the neuromuscular disease who were two years of age or older and could still sit but had never walked independently. U.S. regulators suspended testing of the intrathecal formulation in late 2019 over safety concerns, but in August 2021 permitted Novartis to begin the Steer study. Novartis plans to share the new data with health authorities to support approval of the gene therapy in a broader range of people with spinal muscular atrophy.”

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.”