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.: