Midweek Update

CMS

Midweek Update

David Ermer–ACA, CDC, CMS, FDA, Federal employment benefits, Medical / Rx research, Medicare, NIH, OPM, U.S. Healthcare–

From Washington, DC,

  • The New York Times reports,
    • “Healthcare facilities across the west coast of Florida, from clinics to nursing homes, are temporarily shutting their doors and evacuating patients in preparation for Hurricane Milton’s potentially devastating landfall.
    • “Mandatory evacuation orders in Pinellas County, which includes Clearwater and St. Petersburg, affect about 6,600 patients at six hospitals, 25 nursing homes and 44 assisted living facilities, according to the order. Scores of medical clinics and dialysis centers across the region have also closed, including dozens of outpatient facilities operated by the BayCare, a health care network.
    • “The region’s only Level 1 trauma center, Tampa General Hospital, has deployed a temporary flood barricade that officials hope will stave off the storm surge. Most of the hospitals in the region that are still open have suspended elective operations or have stopped accepting new patients.
    • “University of Florida Health, which operates about a dozen hospitals across the state, had enough food, water and fuel to keep its facilities operating for 96 hours, according to Peyton Wesner, a spokesman.”
  • and
    • “U.S. officials approved airlifts of IV fluids from overseas manufacturing plants on Wednesday to ease shortages caused by Hurricane Helene that have forced hospitals to begin postponing surgeries as a way to ration supplies for the most fragile patients.
    • “The current shortage occurred when flooding coursed through western North Carolina and damaged a Baxter plant, which is now closed for cleaning. The plant makes about 60 percent of the United States’ supply of fluids used in IVs, for in-home dialysis and for people who rely on IV nutrition. They include premature babies in intensive care and patients who rely on tube feeding to survive.
    • “The situation could become even more dire now that Hurricane Milton is hitting Florida. On Tuesday, workers at B. Braun, makers of a fourth of the nation’s IV fluids, loaded trucks at the company’s plant in Daytona Beach with the medical bags and drove them north through the night to what they hoped would be a safer location.
    • “The Baxter plant, in Marion, N.C., and the B. Braun site in Daytona Beach manufacture about 85 percent of the nation’s supply of IV fluids. Experts on shortages have long pointed out the risk of such over-concentration of critical supplies, citing exposure to disasters like those now at hand. Even before the latest storm, supplies were tight and reflected a longstanding problem of how few companies are willing to produce crucial but low-cost and low-profit medical products.”
  • Here’s a link to an HHS Secretary letter to healthcare leaders about the IV fluid shortage, and Beckers Payer Issues offers five notes on insurer response to Hurricane Milton.
  • Kevin Moss, writing in Govexec, takes a closer look at 2025 FEHB premiums.
  • CMS has issued a memorandum with payment parameters guidance for the 2026 plan year
    • The 2025 maximum limit on cost sharing for FEHB and other group plans is $10.150 for self only coverage and $20,300 for other than self only coverage. These limits represent approximately a 10.3% increase over the 2025 maximum limits of $9,200 for self only coverage and $18,400 for other than self only coverage.
  • “The International Foundation of Employee Benefit Plans shares links to the final 1094-B, 1095-B, 1094-C, and 1095-C forms [and instructions] that employers, plan sponsors and group health insurers will use to report 2024 health coverage to plan members, and the IRS as required by the Affordable Care Act (ACA).” 
  • STAT News tells us,
    • “A new report from congressional budget experts this week estimated that it would cost Medicare an additional $35 billion over nine years if the program began covering GLP-1 drugs for obesity. But the report also noted that half of seniors who would qualify for obesity coverage already have access to the drugs for other conditions.”
  • The American Hospital Association News notes,
    • “The Centers for Medicare & Medicaid Services Oct. 9 released a request for information and a sample list of prescription drugs it intends to include under a proposed Medicare $2 Drug List Model. Under the model, people enrolled in a Part D plan would have access to these drugs for a low, fixed copayment no higher than $2 for a month’s supply per drug. The model would provide individuals more certainty about out-of-pocket costs for these generic covered drugs that would target common conditions such as high cholesterol and high blood pressure. The Center for Medicare and Medicaid Innovation’s model aims to test whether a simplified approach to offering low-cost, clinically important generic drugs can improve medication adherence, lead to better health outcomes and improve satisfaction with the Part D prescription drug benefit among Medicare beneficiaries and prescribers. It is also aligned with Executive Order 14087, “Lowering Prescription Drug Costs for Americans,” which directed the creation of new payment models to lower drug costs and promote access. Comments are due Dec. 9 through a CMS survey.”
  • KFF provides us with “A Current [Detailed] Snapshot of the Medicare Part D Prescription Drug Benefit.”
  • The Wall Street Journal reports,
    • “CVS Health filed a motion seeking to disqualify top Federal Trade Commission officials from participating in a case regarding some of its businesses over alleged bias against pharmacy benefit managers.
    • “The healthcare company said Chair Lina Khan, Commissioner Rebecca Kelly Slaughter and Commissioner Alvaro Bedoya through public statements show they have prejudged the matter at hand and that their participation would violate the due process rights of respondents Caremark Rx and Zinc Health Services.
    • “CVS specified that past statements made false assertions that are critical to the merits of the case, including that pharmacy benefit managers “control” drug pricing and patient access to drugs including insulin.
    • “Cigna Group, on behalf of Express Scripts and other of its businesses, also filed a motion seeking to disqualify Khan, Slaughter and Bedoya.
    • “UnitedHealth Group, who reportedly filed a similar motion, didn’t immediately respond to a request for comment.”

From the public health and medical research front,

  • STAT News points out,
    • “A trio of scientists who opened new doors in our understanding of the structure of proteins — the fundamental building blocks of biology — and even came up with ways to create new proteins won the Nobel Prize in chemistry Wednesday.
    • “The prize went to David Baker of the University of Washington, and to Demis Hassabis and John Jumper, who work at Google DeepMind in London. Baker will receive half the 11 million Swedish kronor (just over $1 million) prize, while Hassabis and Jumper will split the other half.” * * *
    • “Baker said he was sleeping when he received the Nobel call early Wednesday morning, as is often the case for laureates in the U.S. When he was told he had won the prize, his wife started yelling, drowning out the person on the phone. He had to go to another room so he could hear the rest of the call, he said. 
    • “Asked by one journalist to pick his favorite protein, Baker demurred, saying he didn’t want to identify just one. But he did highlight one that he and his colleagues had crafted that could potentially block the coronavirus behind Covid-19 from infecting cells, hinting at one of the applications of his discoveries that researchers are now pursuing. 
    • “I’ve been very excited about the idea of a nasal spray of little designed proteins that would protect against all possible pandemic viruses,” he said.”
  • Kudos to the recipients.
  • The American Medical Association tells us what doctors wish their patients knew about microplastics.
  • The National Cancer Institute shares its Cancer Information Highlights about “Breast Cancer | Jaw Necrosis | Leiomyosarcoma.”
  • Per National Institutes of Health press release,
    • “The National Institutes of Health has launched a nationwide consortium to address the dramatic rise in youth diagnosed with type 2 diabetes over the past two decades, a trend that is expected to continue. The effort aims to advance understanding of the biologic, social, and environmental drivers of youth-onset type 2 diabetes, with the goals of determining which children are at highest risk for developing the disease and how to better prevent, screen for, and manage type 2 diabetes in young people.
    • “Our children who are overweight or have obesity are at risk, but we don’t know how best to identify the children who will progress to type 2 diabetes,” said Rose Gubitosi-Klug, M.D., Ph.D., study lead, and chief of pediatric endocrinology at Case Western Reserve University/Rainbow Babies and Children’s Hospital, Cleveland. “This study will bring us closer to our goal of prevention of type 2 diabetes in future generations of youth.” * * *
    • “For more information about the study, known as DISCOVERY of Risk Factors for Type 2 Diabetes in Youth, please visit discovery.bsc.gwu.edu.”

From the U.S. healthcare business front,

  • The American Hospital Association News lets us know,
    • “The average annual premium for employer-sponsored family health coverage rose 7% in 2024 to $25,572, according to the latest KFF annual survey. It is the second consecutive year with a 7% increase. For workers who have an annual deductible for single coverage, the 2024 average is $1,787, similar to last year’s $1,735 and up 8% from 2019. The survey found that the amount workers’ pay toward annual premiums has increased less than 5% since 2019, which may be due to a tight labor market.”
  • Per Beckers Hospital CFO Report,
    • “Chicago-based CommonSpirit is “investing significantly in high-growth markets,” such as Arizona and Colorado, to ensure the long-term sustainability of the health system, CFO Dan Morissette said during the company’s investor call on Oct. 4.
    • “Last year, Centennial, Colo.-based Centura Health folded into CommonSpirit, which manages 20 hospitals and more than 240 care sites in Colorado, Kansas and Utah that were previously managed by Centura. 
    • “The news came shortly after CommonSpirit and Altamonte Springs, Fla.-based AdventHealth said they would end their Centura Health joint venture after 27 years, with each system directly managing their respective care sites in Kansas and Colorado. 
    • “Much of our focus in this market is on transition alignment and ambulatory care sites, as well as future inpatient growth to meet the rapidly expanding demand,” Mr. Morissette said. “We also announced a partnership with Kaiser in this market, which is an important new collaboration for us.Intentional capital deployment means taking a system-level approach to reviewing and 
    • “CommonSpirit is also diversifying its service line in these high-growth markets. Areas of focus include behavioral health, cancer care and outpatient care.”
  • Per Fierce Pharma,
    • “GSK has agreed to pay up to $2.2 billion to resolve approximately 80,000 lawsuits brought by users of Zantac who claimed the heartburn drug caused their cancer.
    • “The agreement frees the British pharma giant from litigating 93% of the state court cases it faced in the U.S., most of which had been consolidated in Delaware. The settlement was reached with 10 plaintiff firms with the agreement that GSK does not admit liability, the company said.
    • “With the deal, lawyers representing the plaintiffs are unanimously recommending that clients accept terms of the settlement, which is expected to be complete by the end of the first half of 2025, GSK said.
    • “The agreement is in line with a similar settlement Sanofi reportedly made earlier this year. The French pharma consented to pay $100 million to resolve roughly 4,000 Zantac claims, Bloomberg reported in April. That deal paid plaintiffs roughly $25,000 each. The GSK settlement comes to approximately $27,500 per claimant.
    • ‘In May of this year, Pfizer also settled approximately 10,000 Zantac lawsuits for an undisclosed figure. Pfizer had the rights to sell the antacid from 1998 to 2006.
    • “In addition to the $2.2 billion deal, GSK also said on Wednesday that it will pay $70 million to resolve a qui tam complaint filed by Connecticut-based laboratory Valisure, which first raised alarm bells about Zantac’s risks in 2019 during routine batch testing.”
  • Per MedTech Dive,
    • “The number of medical devices with artificial intelligence technology has risen sharply in the past decade. 
    • “The Food and Drug Administration has authorized 950 AI or machine learning-enabled devices as of Aug. 7, 2024, according to the agency’s database. While the FDA authorized the first AI-enabled device in 1995, the number of submissions has spiked in recent years.
    • “In 2015, the FDA authorized six AI medical devices. In 2023, the agency authorized 221 devices, according to data reviewed by MedTech Dive.
    • “The trend has been driven by more connected devices, more investment into AI and machine learning and growing familiarity with how software is regulated as a medical device, experts said in interviews.
    • “We’re definitely seeing huge increases in investment. There’s no doubt about that,” said Jennifer Goldsack, CEO of the Digital Medicine Society, an industry group for digital health.”

Friday Factoids

David Ermer–CDC, CMS, Congress, COVID-19, Federal employment benefits, Medical / Rx research, Medicare, Obesity, OPM, U.S. Healthcare–

From Washington DC

  • Federal News Network points out
    • “The Office of Personnel Management is still facing several long-standing management challenges, but one challenge in particular has been knocked off the latest list from OPM’s inspector general office.
    • “Due to “continued improvements,” the federal retirement claims processing backlog at OPM is no longer a top management challenge for the agency, OPM IG Krista Boyd wrote in an Oct. 1 report.”
  • Here are some of the FEHBlog’s long-standing management challenges which are not mentioned in the IG’s report
    • OPM and Congress should place a moratorium a new FEHB benefit mandates in order to allow competition in the FEHB to flourish.
    • OPM should at long last implement a statute added to the FEHB Act in 1989, 5 U.S.C. Section 8910(d), requiring OPM in cooperation with CMS to offer FEHB carriers a Medicare coordination of benefits database.
    • OPM should share with carriers much more information from its study of the FEHB Program called for by 5 USC Section 8910(a).
    • OPM should follow the path created by all other large employers in the U.S. by providing carriers with a HIPAA 820 electronic enrollment roster that would allow carriers to reconcile enrollment and premiums at the individual enrollee level.
  • The Congressional Budget Office released a report about “Alternative Approaches to Reducing Prescription Drug Prices.”
  • Bloomberg reports,
    • “Proposed guidelines for operating Obamacare insurance exchanges in 2026 call for tightening protections against unauthorized actions by agents and brokers who help consumers enroll in coverage. 
    • ‘The proposal, released Friday by the Centers for Medicare & Medicaid Services, sets standards for health insurers and ACA marketplaces, as well as requirements for agents, brokers, and others who help consumers enroll in marketplace coverage. It also includes policies that affect Medicaid, the Children’s Health Insurance Program, and the Basic Health Program.
    • “The 2026 Benefit and Payment Parameters proposed rule (RIN 0938-AV41) includes a number of proposals, including ways to prevent unauthorized marketplace activity by agents and brokers; standards for allowable “Silver Loading,” the raising of premiums for silver plans to offset the cost of providing cost-sharing reductions; and advancing health equity and mitigating health disparities.
    • “Our goal with these proposed requirements is providing quality, affordable coverage to consumers while minimizing administrative burden and ensuring program integrity,” the proposed rule’s preamble said.”
  • Fierce Healthcare informs us,
    • “Last month, Rep. Debbie Dingell, D-Michigan, introduced a new bill in the House to profoundly expand dental coverage for millions of Americans through The Comprehensive Dental Care Reform Act of 2024 [HR 9622].
    • “The bill is a clean companion to similar legislation brought forward by Senator Bernie Sanders, D-Vermont, which would expand coverage for individuals in Medicare, Medicaid, the individual market and the Department of Veterans Affairs.
    • “A lack of dental care can worsen other serious medical conditions, but without adequate coverage, millions of Americans go without the critical oral care they need,” said Dingell in a statement. “This comprehensive legislation will make it easier for Americans to get the dental care they deserve, by expanding coverage and increasing care providers, especially in rural and underserved communities.”

From the U.S. public health and medical research front,

  • The Centers for Disease Control and Prevention announced today,
    • “Summary
      • “COVID-19 activity is declining in most areas. Seasonal influenza is low nationally. Signs of increased RSV activity have been detected in the southeastern U.S. including Florida, particularly in young children.
    • “COVID-19
      • “Nationally, COVID-19 activity has continued declining in most areas. COVID-19-associated ED visits and hospitalizations are decreasing overall. Laboratory percent positivity is 9.2%. ED visits for COVID-19 are highest among infants and older adults. Hospitalizations for COVID-19 are highest among older adults. Provisional trends in deaths associated with COVID-19 have remained stable at 2.0% of all deaths nationally.
      • “A new variant, XEC, has been detected and is estimated to comprise 2-13% of circulating viruses in the U.S. as of September 28, 2024. Because XEC is recombined from two JN.1 lineage viruses, the 2024-2025 COVID-19 vaccines that already include JN.1 strains are still expected to provide protection.
      • Similarly, there are no impacts currently expected on tests, treatments, or symptoms at this time. For additional information, please see CDC COVID Data Tracker: Variant Proportions. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.
    • “Influenza
    • “RSV
      • “Nationally, RSV activity remains low. However, signs of increased RSV activity have been detected in the southeastern U.S. including Florida, particularly in young children.
    • “Vaccination
      • “Vaccinations to prevent fall respiratory virus have started for the 2024-25 respiratory illness season. RSV, influenza, and COVID-19 vaccines are available to provide protection during the 2024-25 respiratory illness season.”
  • The University of Minnesota’s CIDRAP adds that “wastewater levels—still highest in the West [for Covid] —now are at moderate levels.”
  • CBS News reports,
    • “The effectiveness of this year’s influenza vaccine was lower in South America than last season, the Centers for Disease Control and Prevention reported Thursday, which might be a clue to how much protection the shots could offer people in the U.S. this winter.
    • “Vaccine effectiveness was 34.5% against hospitalization, according to interim estimates from a new article published by the CDC’s Morbidity and Mortality Weekly Report, among high-risk groups like young children, people with preexisting conditions and older adults. That means, vaccinated people in those groups were 34.5% less likely than unvaccinated people to get sick enough to go to the hospital.
    • “Last year, the CDC’s report had estimated vaccine effectiveness in South America was 51.9% against hospitalization among at-risk groups. A study by the same group looking at data from 2013 to 2017 estimated effectiveness was around 43% for fully vaccinated young children and 41% for older adults.
    • “These data come from a research network coordinated by the Pan American Health Organization, including Argentina, Brazil, Chile, Paraguay and Uruguay.” 
  • STAT News notes, “After a rocky debut for new RSV tools [in 2023], hopes are high as a new season approaches. The fall’s rollout of a vaccine and an antibody shot is expected to be smoother.”
    • “Anyone who works in the pediatric field understands that if we can immunize children against RSV, whether it’s through maternal vaccination or through nirsevimab, that’s really going to be life changing as far as admissions to the hospital,” Peacock, director of the immunization services division in the Centers for Disease Control and Prevention’s National Center on Immunization and Respiratory Diseases, told STAT in a recent interview.
    • “The good news is that many people who work in this field believe this year’s rollout of the new medical tools will run a lot smoother than last year’s rocky debut outing. They warned, though, that some hurdles will remain.
    • “I expect it will be better. I can’t say how much better,” said Sean O’Leary, professor of pediatrics at the University of Colorado School of Medicine, and a pediatric infectious diseases specialist at Children’s Hospital Colorado.” * * *
    • “Despite the potential for lingering challenges, [Dr. Joseph] Domachowske, from SUNY Upstate Medical University, is hopeful the societal benefit of protecting babies from RSV will soon be apparent. “It’s working,” he said, pointing to a study the CDC published in early March that showed the effectiveness of Beyfortus in preventing RSV hospitalization in infants was 90% from October 2023 to February 2024. “We just need to improve our distribution and make sure we increase the number of babies that are eligible who are getting it.”
  • The University of Minnesota’s CIDRAP tells us,
    • “California health officials yesterday announced the state’s second H5N1 avian flu infection in a dairy farm worker who had no known connection to its first case, as federal health officials announced new steps to boost the supply of H5N1 vaccines, if needed.
    • “In related developments, federal officials today shared updates about the investigation into a recent Missouri H5N1 case with no clear exposure source and what other federal agencies are doing to manage the threat to people and animals.
    • “California’s second patient also had conjunctivitis
    • “Hours after California announced its first H5N1 case in a farm worker yesterday, officials announced a second similar case in a worker at a second farm impacted by recent outbreaks in cows. Both patients worked on farms in the Central Valley, where the virus has now been detected in 56 dairy farms since September.
    • “The California Department of Public Health said, as in the first case, the second patient had mild symptoms, including conjunctivitis. Neither reported respiratory symptoms or was hospitalized.”
  • Fierce Pharma adds,
    • “CSL Seqirus, Sanofi and GSK have collectively secured $72 million in funding from the U.S. health department to boost the country’s supply of bird flu vaccines.
    • “The grant comes from the Department of Health and Human Services’ Center for Biomedical Advanced Research and Development Authority (BARDA) under a national preparedness initiative, the Administration for Strategic Preparedness and Response said Friday.
    • “The three companies will fill and finish additional doses of their influenza A(H5) vaccines, turning bulk materials into ready-to-use vials or syringes that can be immediately distributed if needed.”
  • NBC News informs us,
    • “After the recommended age to start screening for colorectal cancer was lowered to 45, there was a small but significant increase in screenings among younger people, according to a study published in the journal JAMA Network Open. 
    • “The lower screening age was put into place in 2021 by the U.S. Preventive Services Task Force, which previously recommended starting screenings at age 50. 
    • “Colorectal cancer cases have been rising in people younger than 50 over the last two decades. The U.S. Preventive Services Task Force isn’t the first group to suggest lowering the screening age. In 2018, the American Cancer Society also recommended to start getting checked at 45.” 
  • Per Healio,
    • “Tirzepatide and semaglutide confer greater weight loss than other FDA-approved obesity medications with no significantly higher risk for adverse events, according to findings from a network meta-analysis published in Obesity.
    • “Over the years, we’ve had all these drugs that were approved by FDA,” Priyanka Majety, MD, assistant professor of internal medicine and adult outpatient diabetes director in the division of endocrinology, diabetes and metabolism at Virginia Commonwealth University Health System, told Healio. “Recently, the GLP-1s and tirzepatide have had such huge success, so we wanted to compare all of the FDA-approved medications for obesity and see if we can provide some guidance to physicians and patients to see which one would be the most beneficial.”
  • Per an FDA press release,
    • “On Thursday, the FDA Office of Women’s Health (OWH) released its updated Women’s Health Research Roadmap. The Roadmap, provides a science-based framework to address women’s health research questions and to build women’s health science into the FDA’s research activities and outlines priority areas in which new or further research is needed and serves as a catalyst for research collaborations both internal and external to the FDA. 
    • “The updated roadmap serves as a guide to drive research that will address the health needs of women and bridge knowledge gaps to improve health outcomes.,” said Kaveeta Vasisht, M.D., Pharm.D., FDA’s Associate Commissioner for Women’s Health and Director, Office of Women’s Health.”

From the U.S. healthcare business front,

  • Beckers Payer Issues offer sixteen expert opinions about the headwinds facing payers.
  • Modern Healthcare reports,
    • “VillageMD’s tumultuous year continues as Dr. Rishi Sikka, president of Village Medical primary care operations, is leaving the role after one year.
    • “Effective Oct. 21, Sikka will succeed Dale Maxwell as CEO at Presbyterian Healthcare Services, a nine-hospital nonprofit system based in Albuquerque, New Mexico. Maxwell is retiring after 23 years at Presbyterian, according to a Thursday news release.”
  • and
    • “There’s a new morning ritual in Pinedale, Wyoming, a town of about 2,000 nestled against the Wind River Mountains.
    • “Friends and neighbors in the oil- and gas-rich community “take their morning coffee and pull up” to watch workers building the county’s first hospital, said Kari DeWitt, the project’s public relations director.
    • “I think it’s just gratitude,” DeWitt said.
    • “Sublette County is the only one in Wyoming — where counties span thousands of square miles — without a hospital. The 10-bed, 40,000-square-foot hospital, with a similarly sized attached long-term care facility, is slated to open by the summer of 2025.”
  • Kaufmann Hall lets us know,
    • “Hospital financial performance remained relatively stable during the month of August, and despite higher patient volume, revenue and expenses declined on a volume-adjusted basis.
    • “The median Kaufman Hall Calendar Year-To-Date Operating Margin Index reflecting actual margins for the month of August was 4.2%.
    • “The most recent National Hospital Flash Report with August 2024 metrics covers these and other key performance metrics.”
  • Beckers Health IT notes,
    • “Cleveland Clinic expanded its Care at Home program to Weston (Fla.) Hospital, a 258-bed nonprofit facility. 
    • “The program was launched in April 2023 at Cleveland Clinic Indian River Hospital and has since expanded to two other locations. The program reduced hospital readmissions and helped 1,800 patients recover successfully in the first 18 months.
    • “The Care at Home patients are digitally connected to physicians and nurses who continuously monitor them and are available for immediate connection if the patient pushes a button. The program serves patients with congestive heart failure, kidney infections and pneumonia, among other ailments.”
  • Per Healthcare Dive,
    • “Iredell Health System announced this week it completed a deal to purchase two North Carolina-based hospitals from Community Health Systems.
    • “The hospitals include Davis Regional Psychiatric Hospital and Davis Regional Medical Center in Statesville, North Carolina. Terms of the deal were not disclosed. 
    • “The acquisition comes five months after CHS’ previous deal to sell struggling Davis Regional Psychiatric to Novant Health fell apart amid a challenge from the Federal Trade Commission.” 
  • Per BioPharma Dive,
    • “Over the past decade, the medicine Enjaymo has been passed around no less than five times by developers large and small. Now it’s trading hands again, through a deal announced Friday.
    • “Sanofi is selling global rights to Enjaymo to the Italy-based drugmaker Recordati, in exchange for an upfront payment of $825 million. And if the medicine hits certain sales goals, Sanofi could take home up to $250 million more.
    • “For Recordati, which specializes in rare diseases, the deal adds a ninth marketed product to the company’s portfolio. Enjaymo is approved in the U.S., Europe and Japan as a treatment for an uncommon type of anemia. In this condition, known as cold agglutinin disease or CAD, the body’s immune system mistakenly attacks and destroys some red blood cells. Enjaymo is designed to tamp down that immune response and spare the cells, thereby decreasing the need for red blood cell transfusions.”

Thursday Miscellany

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

From Washington, DC

  • The Wall Street Journal reports,
    • “Eli Lilly has finally made enough supply of its popular medicine tirzepatide to meet soaring demand, which should help the company widen its share of the booming weight-loss drug market.
    • “The Food and Drug Administration said late Wednesday that Lilly had resolved the shortage. It had started in 2022, just months after the drug was introduced with the brand Mounjaro for diabetes. Tirzepatide was approved as Zepbound in late 2023 as a weight-loss treatment.
    • ‘The milestone means that compounding pharmacies that make knockoff versions of tirzepatide will likely face new restrictions on what they can produce.
    • “The compounding pharmacies had legal cover to sell knockoff tirzepatide as long as it was on the FDA shortage list, and many patients turned to these products as a cheaper alternative. Yet in announcing the end of the shortage, the FDA said federal law bars compounders from making copies of drugs that aren’t on the shortage list, though they may make certain amounts.
    • “This essentially precludes compounded tirzepatide from being produced commercially,” BMO Capital Markets analysts said.” * * *
    • “Lilly’s rival, Novo Nordisk, also has been expanding its production capacity to resolve shortages of a similar drug, semaglutide, sold as Ozempic for diabetes and Wegovy for weight loss. The lowest dose of Wegovy is currently in shortage, while higher Wegovy doses and all Ozempic doses are available, according to the FDA shortage list.”

  • Per Healthcare Dive,
    • “A bipartisan group of two dozen lawmakers is urging the Biden administration to extend telehealth prescribing flexibilities for opioid use disorder treatment. 
    • “The representatives, led by Reps. Annie Kuster, D-N.H., and Carol Miller, R-W.Va., argued flexibilities allowing telehealth prescriptions of buprenorphine without an in-person visit has increased access to treatment and reduced overdoses.
    • “But those flexibilities are set to expire at the end of the year. Lawmakers also raised concerns that the Drug Enforcement Administration could propose more stringent requirements for telehealth prescriptions of buprenorphine, a medication that be used to treat opioid use disorder, limiting its use just as overdose deaths have begun to decline.” 
  • STAT News reports,
    • “A key aspect of the Democrat-passed law to lower drug prices is significantly more expensive to the government than expected, according to nonpartisan budget experts in Congress.
    • “The redesign of the Medicare Part D drug benefit will cost $10 billion to $20 billion more next year than the Congressional Budget Office initially projected. That office estimates that a separate recently announced program to pay insurers to lower drug premiums will cost $5 billion.”
  • Per Fierce Healthcare,
    • The Biden administration could stand to take a firmer hand on hospital price transparency, especially when it is unclear whether the price data being published are even accurate, the Government Accountability Office (GAO) wrote in a Wednesday report.
      The Centers for Medicare & Medicaid Services (CMS) has required hospitals to post the prices for numerous services annually and this past summer raised the bar by ensuring hospitals were doing so using a standardized file format.
    • Numerous reports from stakeholders criticized hospitals’ compliance along the way, with hospitals themselves often saying that the requirements were burdensome and often too vague.
    • On instruction from Congress, the GAO conducted a review of the requirements, the CMS’ enforcement and whether the agency’s policy was successfully serving patients, payers and researchers.
    • The GAO interviewed 16 stakeholder groups—representing those three groups—who described difficulties making effective comparisons and compiling the data for large-scale use. These hurdles were tied to inconsistent file formats, pricing complexities that came across poorly in the machine-readable format and what they perceived to be incomplete and inaccurate data sets.
    • “While the use of hospital price transparency data has been limited so far, many stakeholders we interviewed noted that they expect use to increase over time if the data usability challenges are overcome or addressed,” the GAO wrote in the report. “Further, some stakeholders also noted that it will take health plans and employers time to figure out how to effectively use the pricing data as part of their price negotiations and their efforts to develop networks of health care providers.”
  • The GAO also issued a healthcare capsule report on treatment for drug misuse.
  • Per an HHS press release,
    • “As part of the Biden-Harris administration’s efforts to ensure Americans access to affordable medicines and strengthen American medical supply chains, the Administration for Strategic Preparedness and Response (ASPR) today announced a $12.3 million agreement with California-based Amyris to expand U.S.-based manufacturing of key starting materials and active pharmaceutical ingredients needed to make essential medicines.” 
  • Tammy Flanagan, writing in Govexec, discusses end of year retirement planning for federal couples.
  • Per an OPM press release,
    • “The U.S. Office of Personnel Management (OPM) has authorized the use of an emergency leave transfer program (ELTP) for federal employees and their families adversely impacted by Tropical Cyclone, Tropical Storm, and Hurricane Helene.    
    • “After coordinating with federal agencies to assess the impact on employees by Tropical Cyclone, Tropical Storm, and Hurricane Helene and its aftermath, OPM, in consultation with the Office of Management and Budget (OMB), has determined that the establishment of an ELTP is warranted. The establishment of an ELTP permits employees in the executive and judicial branches, or agency leave banks established under 5 U.S.C. 6363 to donate unused leave for transfer to employees within their agency or at other agencies who are severely adversely affected or have family members who are severely adversely affected by a major disaster or emergency as declared by the President and who need additional time off from work without having to use their own paid leave. This ELTP will assist federal employees in the declared disaster areas in Alabama, Florida, Georgia, North Carolina, South Carolina, Tennessee, and Virginia. Furthermore, if President Biden approves other disaster declarations because of Helene, federal employees in those areas will also become eligible for ELTP donations.”    
  • Federal News Network tells us,
    • “The Merit Systems Protection Board has brought a historic backlog of federal employee adverse action cases down to nearly zero.
    • “By the end of September, MSPB reported that it had issued decisions on 94% of the thousands of federal employee appeal cases that had been sitting stagnant during the record five-year period without a quorum. Between 2017 and 2022, vacant board seats left the agency unable to issue case decisions, and thousands of federal employees without answers on their pending appeals.
    • “As an agency, MSPB aims to protect federal employees against prohibited personnel practices, like whistleblower retaliation, by adjudicating adverse action appeals from employees. But during more than five years without a quorum — which requires at least two of the three board seats to be occupied — MSPB amassed nearly 3,800 pending cases from federal employees looking to appeal a decision on an adverse action.
    • “The process of shrinking the significant case backlog has so far taken about 2.5 years for the current MSPB members. During fiscal 2025, the board expects to fully eliminate the remaining pending cases that built up during the lack of quorum. The agency will likely take the “inherited inventory” down to zero by the end of December, according to an MSPB spokesperson.”

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “The U.S.’s largest maker of intravenous fluids will slash shipments to hospitals after Hurricane Helene took down one of its manufacturing plants in North Carolina. 
    • “Baxter sent letters to hospitals telling them that future shipments of IV fluids would be about 40% of what they normally receive after the storm flooded its facility in Marion, N.C., Dr. Paul Biddinger, chief preparedness and continuity officer at Mass General Brigham in Boston said during a conference call Thursday. 
    • “Mass General Brigham, a prestigious hospital system, said it is continuing to treat patients normally, but is conserving its fluid supplies. This includes switching to oral hydration—Gatorade or water—for patients who are healthy enough for it, and not discarding partially used IV fluid bags when patients are moved to a different part of the hospital, Biddinger said. The organization uses hundreds of thousands of liters of IV fluids each month, and a majority of patients admitted to a hospital receive fluids at some point, Biddinger said.
    • “Right now we’re continuing all of our clinical care as we normally do,” Biddinger said. “Our intent is to preserve clinical care in the face of this shortage as long as we possibly can.” 
  • Beckers Hospital Review identifies the 73 drugs and intravenous fluids made at the flooded Baxter facility.
  • The Washington Post explains “Why fears of human-to-human bird flu spread in Missouri are overblown. Hospital workers reported respiratory symptoms after encountering a Missouri patient with H5N1 who had not been exposed to farm animals. Officials say bird flu transmission is unlikely.”
  • The NIH Director, writing in her blog, tells us,
    • “In recent years, medical researchers have been looking for ways to use artificial intelligence (AI) technology for diagnosing cancer. So far, most AI models have been developed to perform specific tasks in cancer diagnosis, such as detecting cancer presence or predicting a tumor’s genetic profile in certain cancer types. But what if an AI system could be more flexible, like a large language model such as ChatGPT, performing a variety of diagnostic tasks across multiple cancer types?
    • “As reported in the journal Nature, researchers have developed an AI system that can perform a wide range of cancer evaluation tasks and outperforms current AI methods in tasks like cancer cell detection and tumor origin identification. It was tested on 19 cancer types, leading the researchers to refer to it as “ChatGPT-like” in its flexibility. According to the research team, whose work is supported in part by NIH, this is also the first AI model based on analyzing slide images to not only accurately predict if a cancer is likely to respond to treatment, but also to validate these predictions across multiple patient groups around the world.” * * *
    • “This is all good news, but there’s much more work ahead before an AI model like this could be used in the clinic. Next steps for the researchers include training the model on images of tissues from rare cancers, as well as from pre-cancerous and non-cancerous conditions. With continued development and validation, the researchers aim to enable the system to identify cancers most likely to benefit from targeted or experimental therapies in hopes of improving outcomes for more people with cancer in diverse clinical settings around the world.”
  • Healio informs us,
    • “The addition of HPV vaccination into routine postpartum care may increase vaccination rates, which can reduce patient costs, prevent HPV-related cancers and vaccinate vulnerable populations, researchers reported in Obstetrics & Gynecology. 
    • “The postpartum period has been identified as a missed opportunity for HPV vaccination counseling and administration,” Sara E. Brenner, MD, MPH, third-year resident in the department of gynecology and obstetrics at Emory University School of Medicine, and colleagues wrote. “Many vaccinations are already given routinely in the postpartum period such as the Tdap and the measles-mumps-rubella vaccines. These are often incorporated into perinatal workflows so that patients are routinely educated on their options for vaccination during their prenatal visits and postpartum patients can receive them before leaving the hospital.”
  • The American Hospital Association News informs us about “refreshed webpages dedicated to maternal and child health. The redesigned platform offers three distinct subpages focused on Better Health for Mothers and Babies, child and adolescent health, and advocacy and policy. Hospitals and health systems are encouraged to explore the tools and resources, such as case studies, podcasts, infographics and action plans to drive their own improvement in maternal and child health.”
  • Per STAT News,
    • “Apple Watch may help keep people with Parkinson’s disease out of the hospital. That’s according to early data from a Kaiser Permanente pilot program.
    • “Since late 2023, Kaiser Permanente has been giving some of its Parkinson’s patients in California an Apple Watch app called StrivePD, developed by Rune Labs. The app uses the onboard sensors in the device to track tremors associated with the disease; dyskinesia, a side effect of medication; activity; sleep; and falls. Using Rune’s software, people can also track medication intake and other data.” * * *
    • “Kaiser and Rune presented data from 138 patients enrolled in the program at the International Congress of Parkinson’s Disease and Movement Disorders in late September. In a limited run, the program reduced patient visits to the emergency department by 42% and reduced visits to movement disorder specialists by 18%. Three-quarters of people in the program reported that they found StrivePD helpful for staying on top of medications.
    • “It’s important to note that the data is only a snapshot from the first 100 days that people are in the program. It is not a randomized control that researchers would want to see to establish the benefits of a treatment program. And the data has not been published in a peer-reviewed publication.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports this evening,
    • “U.S. dockworkers agreed to return to work after port operators sweetened their contract offer, ending a three-day strike that threatened to disrupt the American economy.
    • “The breakthrough Thursday came after port employers offered a 62% increase in wages over six years, according to people familiar with the matter.
    • “The agreement ends a strike that had closed container ports from Maine to Texas and threatened to disrupt everything from the supply of bananas in supermarkets to the flow of cars through America’s factories.”
  • Per Fierce Healthcare,
    • “Another significant legal headache related to star ratings is on the table of the federal government just days before open enrollment begins.
    • “UnitedHealthcare companies in various states are suing the Centers for Medicare & Medicaid Services (CMS) for decreasing the insurer’s star ratings unfairly. They are looking for an injunction and corrected ratings before Oct. 15.
    • “The plaintiffs allege one metric, call center customer service performance, was downgraded based on an “arbitrary and capricious assessment” of one phone call [by a CMS test caller] that lasted eight minutes. It caused the insurer to earn a four-star rating on the call center measure instead of a five-star rating.”
    • UnitedHealthcare said the star ratings downgrade would “misinform millions of current and potential customers” from choosing their plans, the insurer said in the lawsuit.
  • Per BioPharma Dive,
    • “Eli Lilly on Wednesday announced plans to spend $4.5 billion on a new facility that will use advancements in technology for research and manufacturing.
    • “Dubbed the Lilly Medicine Foundry, the new site will be located in the “LEAP Research and Innovation District” in Lebanon, Indiana. The latest infusion of cash brings Lilly’s investment in the LEAP district to more than $13 billion.
    • “The facility will allow Lilly to produce medicines for clinical trials while also researching new methods of manufacturing, the company said. Technologies developed at the foundry can then be deployed at other production sites around the world.”

Midweek Update

David Ermer–CMS, COVID-19 vaccine, Federal employment benefits, Medical / Rx research, Medicare, NIH, OPM, Rx coverage, U.S. Healthcare–

From Washington, DC,

  • Per an HHS press release,
    • “As part of the continued implementation of the Biden-Harris Administration’s historic prescription drug law, the Inflation Reduction Act, the U.S. Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), released final guidance – PDF
       today outlining the process for the second cycle of negotiations under the Medicare Drug Price Negotiation Program. The guidance also explains how CMS will help ensure people with Medicare can access drugs at the negotiated prices from the first and second cycles when those prices become effective beginning in 2026 and 2027, respectively.” * * *
    • “For the fact sheet on the Medicare Drug Price Negotiation Program Final Guidance for Initial Price Applicability Year 2027 and Manufacturer Effectuation of the Maximum Fair Price in 2026 and 2027, visit https://www.cms.gov/files/document/fact-sheet-medicare-drug-price-negotiation-program-ipay-2027-final-guidance-and-mfp-effectuation.pdf – PDF“
      .
  • Modern Healthcare lets us know,
    • “Getting top quality scores will continue to be a challenge for Medicare Advantage insurers that had grown accustomed to high star ratings and lucrative bonus payments.
    • “That’s because the Centers for Medicare and Medicaid Services is elevating most of the “cut points” used to calculate 2025 Medicare Advantage star ratings, according to financial analysts and consultants who previewed the agency’s guidelines before the highly anticipated release of the latest ratings later this month. Cut points are the upper and lower thresholds for each measure that collectively generates a plan’s overall score on a one-to-five scale.
    • “Higher cut points will make it more difficult for plans to score better or even retain current ratings for individual metrics, said Alexis Levy, senior partner at HealthScape Advisors, which is part of the consultancy Chartis Group.
    • “If you’re a health plan and your performance stay the same, but the cut points move, you could lose a star rating on a given measure because you didn’t keep up with the overall market,” Levy said.”
  • The Wall Street Journal adds,
    • “Humana shares slid more than 10% Wednesday after the health insurer warned that a steep drop in the federal government’s quality ratings of its Medicare plans could hit its results in 2026.
    • “Humana said it has about 25% of its members currently enrolled in plans rated four stars and above for 2025 based on preliminary 2025 Medicare Advantage ratings data from the Centers for Medicare and Medicaid Services, down from 94% this year. 
    • ‘The quality ratings, on a scale of one to five stars, are tied to bonuses paid to insurers. The downgrade could have a huge revenue impact in 2026, with analysts suggesting a range of figures, from less than $2 billion to far higher.
    • “The scale of the drop is a shock,” said Sarah James, an analyst with Cantor Fitzgerald, who projected the shift in stars could affect nearly $3 billion in 2026 revenue if Humana isn’t able to alleviate it.”
  • FedWeek offers a generic comparison of 2025 FEHB and PSHB plans.
  • Fedsmith delves into the recent FEHB / PSHB premium increase.

From the public health and medical research front,

  • STAT News reports,
    • “U.S. health officials have run into obstacles in their efforts to determine whether a Missouri person infected with H5N1 bird flu passed the virus on to others, causing a delay that will likely fuel concerns about the possibility that there has been human-to-human transmission.
    • “The Centers for Disease Control and Prevention has blood samples from several health workers and a household contact of the Missouri case that it plans to test for antibodies that would indicate whether they too had been infected with the virus, an agency official told STAT.
    • “But the CDC has had to develop a new test to look for those antibodies because key genetic changes to the main protein on the exterior of the virus found in the Missouri case meant the agency’s existing tests might not have been reliable, Demetre Daskalakis, director of the CDC’s National Center on Immunization and Respiratory Diseases, said in an interview. He suggested it will be mid-October before the work can be completed.
    • “The antibodies that would grow in the person exposed to that virus would then be different then the antibodies that would grow in a person who had a virus without those mutations,” Daskalakis said.
    • “Developing the new test has been challenging because the sample from the patient contained so little viral material that the CDC was not able to grow whole viruses from it. Instead, its scientists have had to reverse engineer H5N1 viruses that contain the changes to use them as the basis for the new serology test, he said.”
  • Healio informs us,
    • “Adults who more frequently consumed several flavonoid-rich foods, like berries and tea, had a significantly lower risk for dementia, according to an analysis published in JAMA Network Open.
    • “Certain individuals, like those with depressive symptoms or hypertension, benefited even more from higher adherence to a flavonoid-rich diet, the researchers found.
    • “Flavonoids and flavonoid-rich foods have been previously tied to reduced risk for several diseases and health outcomes, including type 2 diabetes and mortality in those with colorectal cancer.”
  • Health Day adds,
    • “Folks who received the three doses of a COVID vaccine got heart protection, too
    • “The protection translated to reduced risk of serious heart problems stemming from a COVID infection
    • “However, the short-term risk of a serious heart complication owing to the vaccine was real but rare.”
  • Per an NIH press release,
    • “A scientific team supported by the National Institutes of Health (NIH) unveiled the first complete map of the neural connections of the common fruit fly brain. The map provides a wiring diagram, known as a connectome, and is the largest and most complete connectome of an adult animal ever created. This work offers critical information about how brains are wired and the signals that underlie healthy brain functions. The study, which details over 50 million connections between more than 130,000 neurons, appears as part of a package of nine papers in the journal Nature.  
    • “The diminutive fruit fly is surprisingly sophisticated and has long served as a powerful model for understanding the biological underpinnings of behavior,” said John Ngai, Ph.D., director of NIH’s Brain Research Through Advancing Innovative Neurotechnologies Initiative®, or The BRAIN Initiative®. “This milestone not only provides researchers a new set of tools for understanding how the circuits in the brain drive behavior, but importantly serves as a forerunner to ongoing BRAIN-funded efforts to map the connections of larger mammalian and human brains.”
  • The American Hospital Association News notes,
    • “As health care environments shift, hospitals and health systems can experience challenges in adjusting their infection and prevention control practices to accommodate the changes. AHA examined these challenges in partnership with member hospitals and Upstream Thinking and determined that using human-centered design can help identify ways to improve upon current practice. READ MORE “

From the U.S. healthcare business front,

  • KFF finds,
    • “One or two health systems controlled the entire market for inpatient hospital care in nearly half (47%) of metropolitan areas in 2022.
    • “In more than four of five metropolitan areas (82%), one or two health systems controlled more than 75 percent of the market.
    • ‘Nearly all (97% of) metropolitan areas had highly concentrated markets for inpatient hospital care when applying HHI thresholds from antitrust guidelines to MSAs.”
  • Modern Healthcare reports,
    • “Independent lab companies have continued their transaction spree in 2024, either by forming partnerships with hospitals and health systems or by outright acquiring some of their lab assets.
    • “Quest Diagnostics has announced seven acquisitions this year, including its recent purchase of select lab assets from Minneapolis-based Allina Health. Slated to close later this year are deals with OhioHealth in Columbus and University Hospitals in Cleveland.
    • ‘Meanwhile, Labcorp has closed three acquisitions this year, with Springfield, Massachusetts-based Baystate Health, Renton, Washington-based Providence Health and Services and Naples, Florida-based NCH Healthcare System. It recently announced plans to acquire the lab assets of Johnson City, Tennessee-based Ballad Health in a deal expected to close in December.”
  • The American Hospital Association News points out,
    • “The Department of Health and Human Services Sept. 30 released a statement on the dockworker strike at ports along the East and Gulf coasts, saying that immediate impacts to medicines, medical devices and other goods should be limited. HHS, the Food and Drug Administration and the Administration for Strategic Preparedness and Response are working with trade associations, distributors and manufacturers to limit impacts on consumers and assess vulnerabilities. The AHA is monitoring the situation.  
    • “According to Healthcare Ready, a nonprofit organization that works with the government, providers, and supply chain organizations to enhance the resiliency of communities before, during and after disasters, a substantial number of pharmaceuticals commonly used in the care of patients come through the ports every day. Given the shortages that already exist for many medications, and the disruption in the supply of IV solutions caused by the flooding of the Baxter plant in North Carolina, AHA will be alert for potential shortages of vital pharmaceuticals related to the strike.”
  • Per Healthcare Dive,
    • A major California health plan has struck a novel deal directly with a drug manufacturer for a cheaper version of Humira, cutting out pharmacy benefit managers — controversial middlemen in the drug supply chain that typically control access to medication — entirely.
    • As a result of the deal, Blue Shield of California will purchase a Humira biosimilar for $525 per monthly dose, significantly below the drug’s net price of $2,100.
    • The biosimilar will be available for most of BSCA’s commercial members at $0 co-pay starting Jan. 1, 2025, according to the insurer, which announced the deal Tuesday.

Happy New Federal Fiscal Year!

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

From Washington, DC,

  • The FEHBlog was in college when Congress moved the beginning of the federal fiscal year from July 1 to October 1 to give Congress more time to decide on appropriations.
  • Congratulations to former President Jimmy Carter who turned 100 years old today. Mr. Carter is the first former President to reach the century mark. The FEHBlog heard on the radio today that October 1, 1924, was only 98 and 1/4 years after July 4, 1826, the date when Presidents John Adams and Thomas Jefferson passed away.
  • Blue Cross FEP has posted its 2025 benefits information on the internet.
  • CMS has turned on its 2025 Medicare open enrollment decision making tool, and Fierce Healthcare discusses the various Medicare Advantage offerings. The Medicare open enrollment period begins on October 15 and ends on December 7, 2024.
  • The Department of Labor launched an online tool that “provides access to more than 700 accommodation ideas for workers with disabilities and their employers.”
  • BioPharma Dive points out five FDA decisions to watch in the fourth quarter of 2024. “Over the next three months, the agency could approve a rival to a fast-selling Pfizer heart drug, a much-debated lung cancer medicine and an addition to Vertex’s dominant cystic fibrosis business.”
  • The American Hospital Association News lets us know,
    • “The Centers for Medicare & Medicaid Services Sept. 30 released a report on the hospital-at-home program, which found that patients and caregivers overall had positive experiences in the program. Patients in the H@H program were more likely to be white, urban-living and less likely to receive Medicaid or low-income subsidies. The report does not provide insight into the criteria participating hospitals use to identify patients suitable for H@H care but does note that hospitals used evidence and an awareness of their own capacity to support care in the home to establish their criteria. Patients were most commonly treated for respiratory, circulatory and renal conditions, as well as infectious diseases. The study also found that H@H patients had a lower mortality rate than those in brick-and-mortar facilities but had a slightly longer length of stay.”

From the public health and medical research front,

  • The New York Times reports,
    • “Rates of breast cancer — the second leading cause of cancer deaths in U.S. women — climbed by 1 percent a year from 2012 to 2021, and even more sharply among women under age 50 and among Asian American/Pacific Islander women of all ages, according to an American Cancer Society report published on Tuesday.
    • “The biennial report is among the most comprehensive and detailed studies of breast cancer occurrence over recent years. One in 50 U.S. women will develop invasive breast cancer by the age of 50, the authors said, based on National Cancer Institute calculations.
    • “The sharpest increases in young adults by age during the decade were among women in their 20s, whose rate increased by about 2.2 percent a year, though their absolute risk remains very low, at about 6.5 per 100,000 women. 
    • “Among Asian American/Pacific Islander women, who historically also have had a low prevalence of the disease, rates increased by 2.7 percent a year among those under 50, and by 2.5 percent a year among older women.”
  • STAT News informs us,
    • “Across all kinds of cancer, Black Americans have higher rates of mortality and, often, more aggressive forms of the disease. A growing body of research suggests the reasons may not have to do with African ancestry as much as social and environmental factors like racism, housing discrimination, and — according to a new study — exposure to pollution.
    • “The study, published in Nature Communications, found that in several types of cancer, Black patients had more cancers with extra copies of genes. But the team found that these genetic duplications, which can make cancers more aggressive, didn’t seem to be linked to anything ancestral. Rather, the team reported genetic duplications were more likely in cells exposed to pollutants.
    • “What this paper hints at, is that we’re seeing something which looks like a genetic difference, but the source of that might actually not be genetic — it’s more environmental,” said Kanika Arora, a computational biologist at Memorial Sloan Kettering who was not involved with the new study.” * * *
    • “[T]he study highlights the need to reduce people’s exposure to pollutants and the importance of prioritizing genetic screening to understand a person’s individual cancer risk, according to Melissa Davis, the head of the Institute of Genomic Medicine at Morehouse School of Medicine. Davis also notes if pollutants are driving disparate cancer rates, cancer treatment and prevention methods need to change accordingly.”  
  • MedPage Today tells us,
    • “Nearly 11% of older adults with an injurious fall were diagnosed with dementia 1 year later.
    • “Compared with other traumatic injuries, falls were tied to a 21% increased risk of a subsequent dementia diagnosis.
    • “Findings support cognitive screening for older adults who have a fall that involves an ED visit or hospital admission.”
  • McKinsey & Co. interview “Marcus Schindler, executive vice president for R&D and chief scientific officer at Novo Nordisk. They discuss how Novo Nordisk is expanding its external innovation capabilities and moving into new therapeutic areas. They also explore his efforts to embed AI throughout the R&D organization, establish Novo Nordisk as a leader of AI ecosystems (in Boston and beyond), and eventually advance from treating diseases to curing them, with help from AI.

From the U.S. healthcare business front,

  • Healthcare Dive reports
    • “CVS plans to lay off 2,900 workers amid swirling reports that the healthcare behemoth is undergoing a strategic review, including a potential breakup of its businesses.
    • “The layoffs, which were confirmed by a CVS spokesperson, will affect about 1% of CVS’ 300,000 employees.
    • “CVS unveiled a plan to cut $2 billion in costs this summer in a bid to bolster flagging operational performance amid rising costs for its health insurance arm Aetna and shaky reimbursement at its pharmacies.”
  • Per Fierce Healthcare,
    • “On the same day that Johnson & Johnson confirmed layoffs at its home base in New Jersey, the company made waves with a major manufacturing announcement in Wilson, North Carolina. 
    • “J&J is planning to build a state-of-the-art biologics plant to provide supplies for treatments across the oncology, immunology and neuroscience treatment areas, J&J said in a Tuesday press release. Construction is slated to begin in the first half of 2025, and the site will have a workforce of 420 once fully operational. 
    • “The company’s total investment in the site is expected to reach “more than $2 billion,” according to J&J’s release.”
  • Beckers Payer Issues tells us five things to know about United Healthcare’s prior authorization gold card which launched today.
  • Beckers Hospital Review notes,
    • “Dallas-based Tenet Healthcare has completed the sale of its 70% majority ownership interest in Birmingham, Ala.-based Brookwood Baptist Health to Orlando (Fla.) Health,” and offers six things to know about the transaction.
  • and
    • Detroit-based Henry Ford Health and Ascension Michigan have officially launched their joint venture to improve healthcare access, experience and outcomes and offers seven things to know about this joint venture.
  • The Wall Street Journal explores the future of dental care.
    • “Imagine a world where you could regenerate a missing tooth with a single drug, and microrobots clean your teeth every night.
    • “That future is getting closer, scientists say. “We are really looking for disruptive technology,” says Dr. Hyun (Michel) Koo, co-founding director of the Center for Innovation & Precision Dentistry at the University of Pennsylvania.”

Friday Factoids

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

From Washington, DC,

  • Per a CMS press release,
    • “Today, the Centers for Medicare & Medicaid Services (CMS) announced that average premiums, benefits, and plan choices for Medicare Advantage (MA) and the Medicare Part D prescription drug program will remain stable in 2025. Average premiums are projected to decline in both the MA and Part D programs from 2024 to 2025. Enhancements adopted in the 2025 MA and Part D Final Rule, as well as payment policy updates in the 2025 MA and Part D Rate Announcement, support this stability and increase enrollee protections and access to care for people with Medicare. In addition, the Inflation Reduction Act is reducing prescription drug costs and delivering more comprehensive benefits than ever before, including an annual $2,000 cap on out-of-pocket drug costs. CMS is committed to ensuring these programs work for people with Medicare, that they have access to strong and stable choices, and that they have the information they need to make informed choices about what is best for them. 
    • “CMS is releasing this key information, including 2025 premiums, benefits, and access to plan options for MA and Medicare Part D prescription drug plans, ahead of the upcoming Medicare Open Enrollment, which runs from October 15, 2024, to December 7, 2024, to help people with Medicare determine the best Medicare coverage option for their health care needs. * * *
    • “For more information on MA and Medicare Part D offerings for 2025, view the fact sheet. 
    • “To view the premiums and costs of 2025 Medicare Advantage and Part D plans, please visit https://www.cms.gov/medicare/coverage/prescription-drug-coverage. Select the 2025 landscape source file in the downloads section of the webpage. This year, CMS has combined the Landscape files into one file, instead of five individual files as was the case historically, and made additional enhancements to improve the end-user experience and simplify the format. The accompanying readme file at the link above provides important notes about the format and file columns.    
    • “For state-by-state information, important dates, and enrollment resources for Medicare Advantage and Part D in 2025, please visit: https://www.cms.gov/files/document/2025-ma-part-d-landscape-state-state-fact-sheet.pdf.
    • “For information on the Medicare Advantage Value-Based Insurance Design Model, including plan participation in 2025, please visit: https://www.cms.gov/newsroom/fact-sheets/medicare-advantage-value-based-insurance-design-model-calendar-year-2025-model-participation.” 
  • Beckers Payer Issues offers ten notes on the CMS press release.
  • The American Hospital Association News lets us know,
    • “The Health Resources and Services Administration Sept. 27 sent a final warning letter to Johnson & Johnson urging the company to inform the agency by Monday, Sept. 30 that it would halt its proposed 340B rebate model scheduled to go into effect next month. 
    • “As outlined in HRSA’s September 17, 2024, letter, if J&J proceeds with implementing its rebate proposal without Secretarial approval, it will violate section 340B(a)(1) of the Public Health Service Act,” HRSA wrote today. “If J&J has not notified HRSA that it is ceasing implementation of its rebate proposal by September 30, 2024, HRSA will begin the process outlined in J&J’s Pharmaceutical Pricing Agreement related to terminating the agreement. In addition, if J&J moves forward with implementation of its rebate proposal, HRSA will initiate a referral to the HHS Office of Inspector General pursuant to 42 U.S.C. § 256b(d)(1)(B)(vi).” 
  • Federal. News Network informs us,
    • “Postmaster General Louis DeJoy is telling lawmakers the Postal Service is ready to handle a high volume of mail-in ballots ahead of Election Day.
    • “DeJoy told members of the House Appropriations Committee on Thursday that USPS has a “track record of success” delivering ballots.
    • “In 2020, at the height of the COVID-19 pandemic, USPS delivered 99.89% of ballots from voters to election officials within seven days.
    • “That year, when USPS delivered a “historically high number of ballots,” DeJoy said they accounted for just 0.1% of its annual mail volume.
    • “We will be even better prepared for 2024,” DeJoy said. “Our network is designed to readily handle a surge in mail volume, just like we do every election and holiday season.”
    • “DeJoy recommends voters mail their ballots early, at least seven days before their state’s election deadline.”

From the public health and medical research front,

  • The Centers for Disease Control and Prevention announced today,
    • “Seasonal influenza and RSV activity are low nationally, but COVID-19 activity is elevated.
    • “COVID-19
      • “There are continued signs of declines in COVID-19 activity in many areas. COVID-19 test positivity, emergency department visits, and rates of COVID-19–associated hospitalizations are decreasing. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.
    • “Influenza
    • “RSV
      • “Nationally, RSV activity remains low.
    • “Vaccination
      • “Vaccinations to prevent fall respiratory virus have started for the 2024-25 respiratory illness season with 4.5% of adults 18 years and older reporting receipt of the updated 2024-25 COVID-19 vaccine and 9.6% reporting receipt of an influenza vaccine. Among adults 75 years and older, 34.0% reported ever receiving an RSV vaccine. RSV, influenza, and COVID-19 vaccines are available to provide protection during the 2024-25 respiratory illness season.”
  • The University of Minnesota CIDRAP informs us,
    • Wastewater levels for COVID-19 remain high but low for RSV and influenza. Of flu cases identified through specimens testing, the H1N1 strain accounts for 53.5% of cases, H3N2 for 46.5%, and influenza B for 1.2%. Influenza test positivity for the week ending on September 21 was 0.6%.
  • and
    • “A new study on COVID-19’s effects on US infants notes that the proportion of hospitalized babies of mothers vaccinated during pregnancy plunged from 18% in October 2023 to 4% in April 2024, underscoring the need for increased vaccine uptake.
    • “And another report estimates that unexpected infant deaths jumped as much as 14% in 2021 relative to pre-pandemic totals.”
  • and
    • “A pair of new studies on COVID-19 antiviral drugs suggest that resistance mutations that emerge after treatment with nirmatrelvir-ritonavir (Paxlovid) or remdesivir (Veklury) are rare and that almost a third of US adults have never heard of Paxlovid.”
  • The American Hospital Association News points out,
    • “The National Foundation for Infectious Diseases Sept. 25 released a survey showing that less than one in five U.S. adults are concerned about themselves or a family member getting a respiratory virus infection this fall and winter. The survey, conducted in August, found that 20% are concerned about COVID-19, 17% are concerned about flu, 17% are concerned about pneumococcal disease and 16% are concerned about respiratory syncytial virus. Additionally, it found that while 67% of adults agree that an annual flu vaccination is the most effective way to prevent flu-related hospitalizations and deaths, 45% said they do not plan to or are unsure if they will receive a flu vaccine this season, and 38% said they definitely plan to. Regarding COVID-19, 26% of adults said they will definitely get an updated vaccine. Among those for whom a vaccine is recommended, only 21% said they will definitely get an RSV vaccine and 24% said they would definitely receive one against pneumococcal disease.”
  • The New York Times reports,
    • “A possible cluster of bird-flu infections in Missouri has grown to include eight people, in what may be the first examples of person-to-person transmission in the United States, the Centers for Disease Control and Prevention reported on Friday.
    • “If confirmed, the cases in Missouri could indicate that the virus may have acquired the ability to infect people more easily. Worldwide, clusters of bird flu among people are extremely rare. Most cases have resulted from close contact with infected birds.
    • “Health officials in Missouri initially identified a patient with bird flu who was hospitalized last month with unusual symptoms. The patient may have infected one household member and six health care workers, all of whom developed symptoms, according to the C.D.C.
    • “Investigators have not yet confirmed whether any of those seven individuals were infected with the virus, called H5N1, leaving open the possibility that they had Covid or some other illness with flulike symptoms.”
  • and
    • “Major heart defects are more common — but still rare — in babies conceived through certain fertility treatments, including in vitro fertilization, researchers reported on Thursday in the largest study of its kind.
    • “The research, which included medical records of more than seven million Nordic children, also bolstered evidence that I.V.F. is associated with a small but significant uptick in birth abnormalities.
    • “It’s an increased risk, but the absolute risk is very small,” said Dr. Ulla-Britt Wennerholm, the senior author of the paper and a professor of obstetrics and gynecology at the University of Gothenburg in Sweden.
    • “I think that’s a reassuring finding, actually.”
    • “The study focused on children born between 1984 and 2015 in Denmark, Sweden, Norway and Finland as a result of a class of fertility treatments called assisted reproductive technology, the most common of which is I.V.F.”
  • STAT News tells us,
    • “Prostate cancer presents a tricky screening challenge. Catching it early could mean dodging a painful journey with advanced cancer. Yet a sizable majority of prostate cancers are “indolent” — slow growing tumors that most likely would never metastasize during the patient’s lifetime, and whose treatment  would do more harm than good.
    • “Experts have long clashed over these considerations, with some arguing that the harms of PSA testing outstrip the benefits and others adamant that lives are saved with screening. The balance may now be shifting as researchers and physicians find methods that reduce the harms of screening, in particular with the use of MRI. A new study published in the New England Journal of Medicine on Wednesday showed using MRI scans can reduce unnecessary diagnosis and treatment of screen-detected prostate cancer by more than half.
    • “That result should be a reason for experts to rethink prostate cancer screening guidelines with MRI in mind, according to Jonas Hugosson, a professor of urology at the University of Gothenburg in Sweden and the study’s lead author. “In my opinion, this is the last piece of the puzzle to have real evidence that the benefits of prostate screening exceed the harms on a population level,” he said. “This paper is the message to healthcare authorities around the world to look over recommendations for men.”
    • “That may be easier said than done, other experts said. There may not be enough MRI infrastructure to support a prostate screening program requiring the scans.” 
  • STAT News also calls attention to the fact that the “Sickle cell community scrambles to find safe plan after a drug is pulled from the market. Pfizer’s abrupt decision left many feeling they had no guidance on what to do next.”
    • “The vast majority of Americans with the disease are Black, its research long neglected, its care long suffused with racism and stigma. “There’s a lot of people in the sickle cell warrior community where they felt like, historically, they’ve been guinea pigs,” said Habib.
    • “This week, the feeling can cut two ways, in the sense that some patients may have been prescribed a medication that may have been dangerous, and in the sense that some are losing something helpful with no warning. It wasn’t just the news about a drug that some people had been taking daily for years; it was how it was rolled out, with little warning or guidance. One patient advocate said she was too devastated to comment. Another was so shocked she didn’t believe it at first. 
    • “You know I’m just worried about everyone’s safety. I want to make sure no one is having extreme side effects,” said Quannecia McCruse, president and CEO of the Sickle Cell Association of Houston, who had considered quitting her Oxbryta cold turkey this week because she’s done so before and had no issues. Yet she also found the whole thing weirdly precipitous, and wondered if the drug might still end up in the medicine cabinet — perhaps for a more specific group. “Not one sickle cell person is like another.”
  • The New York Times identifies five common signs of dementia other than memory loss
    • Financial problems,
    • Sleep issues,
    • Personality changes,
    • Driving difficulties, and
    • Loss of smell.
  • The New York Times also notes,
    • “Women are increasingly using guns to die by suicide in the United States, challenging long-held assumptions that they will usually resort to less lethal means, according to data released on Thursday by the Centers for Disease Control and Prevention.
    • “Gun-related suicide is most often associated with men, largely because men are more likely than women to purchase guns and to die by suicide. But in 2020, gun-related suicides surpassed poisoning and suffocation for the first time among women and have continued to rise since then.
    • “Suicide attempts with guns are far more lethal than those by other means, and firearm injuries now account for more than half of all suicide deaths.
    • “The findings, drawn from federal health data, showed that in 2022, 20 out of every million women used a gun to die by suicide, up from 14 women in 2002. This marks a 43 percent increase. The report also found that suicide rates have risen among women over the past two decades.”

From the U.S. healthcare business front,

  • The Institute for Clinical and Economic Research follows up on yesterday’s FEHBlog post,
    • “The FDA approved Karuna Therapeutics’ xanomeline tartrate/trospium chloride (also known as KarXT) for schizophrenia yesterday.
    • “ICER released a Final Evidence Report assessing the comparative clinical effectiveness and value of KarXT this year. At ICER’s public meeting, the independent appraisal committee voted that current evidence is not adequate to demonstrate superior net health benefits for KarXT compared to generically available aripiprazole. If long-term data confirm KarXT’s benefits and lack of weight gain, KarXT would achieve common thresholds for cost-effectiveness if priced between $16,000 to $20,000 per year. Karuna Therapeutics [ a subsidiary of Bristol, Myers, Squibb] priced the therapy close to the upper bound of ICER’s recommended range, at $22,500 per year.
    • “ICER’s Chief Medical Officer David Rind, MD, MSc stated:
      • “Schizophrenia is a serious mental illness that affects how a person thinks, feels, and behaves. Among the important side effects of current treatments is weight gain leading to metabolic syndrome. This, in turn, places patients at risk for cardiovascular events and death. KarXT has a novel mechanism of action and, at least in the short run, does not seem to cause weight gain. This may lead to major health benefits compared with existing treatments, however current evidence on benefits and harms is limited.” 
  • Fierce Healthcare lets us know,
    • “As employers face rising costs, many are looking to rethink plan designs rather than emphasize shifting expenses to workers, according to a new WTW report.
      WTW released its 2024 Best Practices in Healthcare Survey on Thursday, which polled 417 employers representing 6 million workers. It found that these firms are expecting costs to balloon by 7.7% in 2025, compared to an increase of 6.9% in 2024 and 6.5% for 2023.
    • “Despite the increase, however, only 34% told WTW that they intend to shift those costs to employees by raising premiums. Twenty percent said they will push high-deductible health plans or account-based coverage to address costs.
    • “Instead, 52% said they intend to roll out programs that reduce total costs, and 51% said they would use plan designs and network models to steer workers to lower-cost and higher-quality providers.”

OPM Publishes 2025 FEHB and FEDVIP Premiums

David Ermer–CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, Medicare, Mental health care, Obesity, OPM, U.S. Healthcare–
OPM Headquarters a/k/a the Theodore Roosevelt Building

From the FEHB / FEDVIP front,

  • Federal News Network tells us,
    • “Enrollees in the Federal Employees Health Benefits (FEHB) program are about to see the largest annual increase in their health insurance costs in at least a decade.
    • “Beginning in January, federal employees and annuitants enrolled in FEHB will pay 13.5% more, on average, toward their health care premiums, according to data the Office of Personnel Management released Wednesday.
    • “The significant premium increase for FEHB plan year 2025 follows a 7.7% jump for 2024, and an 8.7% increase in 2023. OPM said the increase reflects changes in the market over the last year, and generally aligns with other programs in the commercial market.
    • “The premium increases are due to the impact of price increases by providers and suppliers, increased utilization of certain prescription drugs and behavioral health spending,” OPM said. “Industry-wide cost pressures affect FEHB and PSHB rates similarly.” * * *
    • “Across the 42 health carriers for 2025, FEHB participants will see 64 plans and a total of 130 plan options.
    • “PSHB participants will, by contrast, have 69 plan options offered across 30 health carriers. That includes seven fee-for-service carriers and 23 health maintenance organizations (HMOs) available through the PSHB.”
  • Here is a link to OPM’s 2025 FEHB/PSHBP premiums website.
    • Federal Employees Health Benefits (FEHB)
      • “The 2025 biweekly maximum government contribution for most employees and annuitants (72% of the weighted average) is $298.08 for Self Only, $650.00 for Self Plus One, and $714.23 for Self and Family. The monthly maximum government contribution (72% of the weighted average) is $645.84 for Self Only, $1,408.33 for Self Plus One and $1,547.50 for Self and Family.
      • “For 2025, the biweekly program-wide weighted average premiums for Self Only, Self Plus One, and Self and Family enrollments with a government contribution are $414.00, $902.78, and $991.99, respectively. The monthly program-wide weighted average premiums for Self Only, Self Plus One, and Self and Family enrollments with a government contribution are $897.00, $1,956.02, and $2,149.31, respectively.”
    • Postal Service Health Benefits (PSHB)
      • “The 2025 biweekly maximum government contribution for most employees and annuitants (72% of the weighted average) is $286.09 for Self Only, $618.40 for Self Plus One, and $672.95 for Self and Family. The monthly maximum government contribution (72% of the weighted average) is $619.86 for Self Only, $1,339.87 for Self Plus One and $1,458.06 for Self and Family.
      • “For 2025, the biweekly program-wide weighted average premiums for Self Only, Self Plus One, and Self and Family enrollment with a government contribution are $397.35, $858.89, and $934.65, respectively. The monthly program-wide weighted average premiums for Self Only, Self Plus One, and Self and Family enrollments with a government contribution are $860.93, $1,860.93, and $2,025.08, respectively.”
  • Federal News Network adds,
    • “In contrast to the large increases for FEHB and PSHB premiums, the average premium rate increases for the Federal Employees Dental and Vision Insurance Program (FEDVIP) will be relatively small in 2025.
    • “Premiums will rise for FEDVIP dental plans by 2.97% on average, while vision plans will go up by 0.87%, OPM said.
    • “FEHB and PSHB participants will both be able to select from seven dental carriers offering 14 nationwide plan options for 2025. There will also be 10 nationwide vision plans available nationwide across five different carriers next year.”
  • Here is a link to the OPM website with 2025 FEDVIP premiums.

From Washington, DC,

  • The Washington Post reports,
    • “Congress passed legislation on Wednesday to fund the government into December and send more than $230 million in emergency funding to the Secret Service.
    • “Lawmakers had a deadline of Monday to pass new financing bills and avoid a government shutdown. The new legislation extends that deadline to Dec. 20 and funds the government at current levels until then.
    • “House Speaker Mike Johnson (R-La.) relied on support from Democrats — rather than just his own GOP majority — to approve the funding. The House earlier rejected a measure Johnson preferred that would have extended the deadline into March and included a new requirement to prove citizenship when registering to vote in federal elections. The Senate passed it very quickly later Wednesday evening on a bipartisan basis.
    • “The short-term spending bill, also known as a continuing resolution or CR, will set up a frenzied year-end period to pass annual spending bills before the next president takes office.”
  • The Washington Post adds,
    • “Democrats on Wednesday launched a legislative push to extend federal subsidies that defray the cost of health insurance for millions of Americans. The effort tees up another Affordable Care Act fight that could stretch into next year — and perhaps challenge the next president.
    • “Sens. Jeanne Shaheen (D-N.H.) and Tammy Baldwin (D-Wis.) introduced legislation to make permanent tax credits that lower the cost of plans sold through the Affordable Care Act. Rep. Lauren Underwood (D-Ill.), who helped craft the initial legislation to create the expanded tax credits almost four years ago, introduced companion legislation in the House. Senate Majority Leader Charles E. Schumer (D-N.Y.) and House Minority Whip Katherine Clark (D-Mass.) joined Shaheen and Underwood at a news conference to unveil the legislation Wednesday.
    • “Congress must “take swift action at the first legislative opportunity to make the tax credits permanent,” Underwood said in an interview.”
  • and
    • “The Senate voted unanimously Wednesday to hold Steward Health Care CEO Ralph de la Torre in contempt of Congress, asking the Justice Department to pursue criminal charges against the hospital executive for failing to comply with a congressional subpoena.
    • “It is the first time since 1971 that the Senate has asked the Justice Department to pursue criminal contempt charges against an individual, lawmakers said. Steward, a for-profit company that owns about two dozen hospitals across the country, is engaged in bankruptcy proceedings and has been seeking to sell its hospitals.
    • “Community leaders and health workers in states served by Steward’s facilities have blamed the company’s leaders for extravagant paydays even as hospitals struggled to meet mortgage payments and cover other expenses. The Justice Department also has been investigating the company regarding allegations of fraud.”
  • Healthcare Dive lets us know,
    • “Regulators need to boost oversight over remote patient monitoring in Medicare to avoid fraud, according to a report by the HHS’ Office of Inspector General. 
    • “About 43% of Medicare beneficiaries who received remote patient monitoring didn’t get all three components of the service, including the monitoring device, education and setup, and treatment management.
    • “Medicare doesn’t have critical information about the remote monitoring it pays for —  like what data is being monitored, what types of devices beneficiaries use and which provider ordered the service — complicating oversight efforts, according to the OIG.”
  • and
    • “The Biden administration has finalized a rule targeting fraudulent billing in Medicare’s largest value-based care program, after concerning reports of spiking spending on urinary catheters.
    • “The anomalous billing had the potential to hurt accountable care organizations, or ACOs, in the Medicare Shared Savings Program by impairing their ability to capture shared savings. ACOs are groups of providers that assume responsibility — and occasionally, financial risk — to care for a group of patients.
    • “However, the CMS’ rule finalized Tuesday shields ACOs by excluding payments for suspect catheter billing codes from the 2023 performance year.”
  • Per Modern Healthcare,
    • “Medicare will begin compensating hospitals for providing quality data to support “age-friendly” medical care as the government seeks to bolster private sector efforts to adapt to the aging population.
    • “Starting in January, hospitals will report on a slew of measures to assess whether they are improving care for older patients in emergency departments, operating rooms and other settings. The Centers for Medicare and Medicaid Services laid out the new policy in the Medicare Inpatient Prospective Payment System final rule for fiscal 2025, which it published last month.”
  • Per an HHS press release,
    • “Today, the 988 Suicide & Crisis Lifeline announced that the process to start routing cellular phone calls to 988 contact centers based on the caller’s approximate location, versus by area code — known as “georouting” — began last week with two major U.S. wireless carriers that combined make up about half of all wireless calls to 988. The U.S. Department of Health and Human Services’ (HHS) Substance Abuse and Mental Health Services Administration (SAMHSA) and the 988 Network Administrator, Vibrant Emotional Health, have been working with all of the major U.S. cell phone carriers for more than a year to improve call routing to 988 so that callers on a cell phone can be connected more locally to centers that are better equipped to provide nearby resources and services.”

From the public health and medical research front,

  • NBC News reports,
    • “Nearly 1 in 3 Americans may have an undiagnosed iron deficiency, a problem that can lead to fatigue, brain fog and difficulty concentrating, a new study suggests. 
    • “An analysis of data from more than 8,000 adults in the U.S. revealed that 14% had low iron blood levels, a condition known as absolute iron deficiency, while 15% had the right iron levels but their bodies couldn’t use the essential mineral properly, known as functional iron deficiency, according to the report published Tuesday in JAMA Network Open.
    • “Doctors don’t typically screen adults for iron deficiency, which is why the condition has been overlooked in many people.
    • “The researchers weren’t surprised at the results, however. There had been hints in other studies suggesting iron deficiency might be more widespread than doctors assume.” 
  • Per The Washington Post,
    • “You might think that people would be lining up to get a highly effective vaccine for a relatively common disease that can cause such pain, but that’s not the case. The CDC recommends two doses of Shingrix for everyone 50 and older, yet only 18.6 percent of people in the United States in this age group have received at least one dose, according to CDC data from 2021.
    • “Jonathan Lowe says many people don’t understand how bad shingles can be.
    • “A television reporter and anchor in Charlotte, Lowe was diagnosed with shingles in March, and it took five months for him to fully recover and start anchoring a newscast again.”
  • The Wall Street Journal reports,
    • “Pfizer said it is voluntarily withdrawing all lots of its sickle-cell drug Oxbryta in all markets where it is approved, two years after acquiring its parent company Global Blood Therapeutic in a $5.4 billion deal.
    • “The drugmaker said Wednesday the decision is based on clinical data that now indicate the overall benefit of Oxbryta no longer outweighs the risk in the approved sickle-cell patient population.
    • “Pfizer also said it has notified regulatory authorities about its latest findings about Oxbryta.”
  • Per an NIH press release,
    • “Adults with opioid use disorder who receive a higher daily dose of the opioid addiction treatment medication buprenorphine may have a lower risk of subsequent emergency department visits or use of inpatient services related to behavioral health (such as for mental health and substance use disorders) than adults receiving the recommended dose, according to an analysis funded by the National Institutes of Health (NIH). These findings suggest that higher buprenorphine doses could be more effective in managing opioid use disorder, which may be particularly relevant for improving treatment for those who use fentanyl, a major driver of the overdose crisis.” * * *
    • “These findings build upon accumulating evidence of the safety and efficacy of higher doses of buprenorphine. Studies have shown that more than 16 mg of buprenorphine is safe and well tolerated in people with opioid use disorder in emergency department and outpatient treatment settings, and that higher buprenorphine doses are associated with improved retention in treatment for opioid use disorder.”
  • The National Cancer Institute posted its Cancer Information Highlights on “GI Problems | Whole-Body Effects of Cancer | Potential Drug Targets.”

From the U.S. healthcare business front,

  • Per BioPharma Dive,
    • “Wall Street analysts greeted research announcements from Amgen about two immunology medicines with skepticism, saying the results suggest the drugs won’t pose a major challenge to market leaders. 
    • “Amgen shared the top-line results from two Phase 3 trials during an investor presentation Tuesday. In the first, Amgen’s experimental rocatinlimab showed statistically significant improvement versus placebo for patients with atopic dermatitis, a form of eczema. In the second study, the drug Uplizna succeeded in treating generalized myasthenia gravis.
    • “But in research notes published following the presentation, analysts called the rocatinlimab results disappointing, saying the drug needed to show an especially high efficacy profile to counter safety concerns. The Uplizna findings, meanwhile, suggest Amgen has a viable second-line contender to treat myasthenia gravis but likely won’t threaten Argenx’s Vyvgart as a first-line choice, analysts said.”
  • Per MedTech Dive,
    • “Medtronic and Siemens Healthineers have partnered to expand accessto pre- and post-operative imaging technologies for spine surgery, the companies said Wednesday at the North American Spine Society annual meeting. 
    • “The firms will co-market Siemens Healthineers’ Multitom Rax X-ray imaging system and integrate it into Medtronic’s AiBLE suite of products for spine surgery. 
    • “Skip Kiil, Medtronic’s president of cranial and spinal technologies, said in a statement the partnership should reduce variability and improve patient outcomes.”
  • and
    • “Roche launched the first test using the company’s technology to simultaneously detect up to 12 respiratory viruses.
    • “The launch, announced Tuesday, enables users of Roche’s Cobas 5800, 6800 and 8800 molecular diagnostic analyzers to test for pathogens including influenza A and B, RSV and the COVID-19 virus.
    • “The test is available for labs in countries that accept CE marks. Roche plans to file for 510(k) clearance in the U.S. in the fourth quarter. The company is targeting a respiratory molecular diagnostics market that it has predicted will be worth 1.7 billion Swiss francs by 2027, the equivalent of about $2 billion according to Wednesday’s exchange rate.”
  • Beckers Hospital Review identifies the 25 most expensive inpatient drugs, and tells us,
    • “A recent study from Harvard Medical School introduced TxGNN, an innovative AI tool designed to identify potential drug candidates for over 17,000 rare and neglected diseases. 
    • “The research, published in Natural Medicine Sept. 25, found that TxGNN is nearly 50% more effective at identifying drug candidates and 35% more accurate in predicting contraindications than existing methods. 
    • “The model links conditions to existing drugs, both FDA-approved and experimental, by leveraging data on DNA, clinical notes and gene activity. The model also offers insights into potential side effects, potentially speeding up the lengthy drug discovery process. 
    • “TxGNN has been made available for free, encouraging its adoption by clinician-scientists in the search for new therapies.” 
  • The New York Times reports that “Health care systems have been putting therapists’ progress reports online, much to the surprise (and anger) of some patients.”
    • “Starting in 2021, the federal government required all U.S. health care systems to share clinicians’ visit notes electronically, often referred to as open notes, as part of the 21st Century Cures Act. This includes therapy progress notes, which typically provide information about the client’s appearance and mood, a diagnosis, the treatment plan and any progress the client has made toward therapy goals.” * * *
    • “The 21st Century Cures Act allows clinicians to block notes in certain circumstances — for example if there’s a chance that the patient could become suicidal or homicidal after reading it.
    • “Steve O’Neill, a licensed clinical social worker and the director of behavioral health for OpenNotes, the organization at Beth Israel that has pushed for transparency between clinicians and patients, said that he temporarily blocked his notes from a patient who initially became psychotic and holed up in her apartment after reading them.
    • “There needs to be more research, Dr. Blease said, examining whether patients with severe mental illness could experience emotional harm or even self-injury after reading open notes.
    • “Dr. O’Neill has observed that some patients benefit from reading the notes alongside a clinician or in group therapy. It’s important that the patient not feel “ambushed,” he added.

Monday Roundup

David Ermer–CMS, Congress, Electronic health records, FDA, Medical / Rx research, Mental health care, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC

  • The House of Representatives and the Senate are in session this week for Committee business and floor voting. The members of Congress hit the campaign trail next week until they return to Capitol Hill in November following the national election for a lame duck session.
  • Per an HHS press release,
    • “In its ongoing commitment to support women’s health, the U.S. Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), today launched an innovative grant program to provide almost $9 million to improve women’s health coverage and access to critical health benefits. These funds may be used to develop activities and launch educational campaigns to address disparities in access to reproductive health care and maternal health outcomes – many of which often result from challenges women face when trying to access information about available benefits or coverage, including for contraception and other family planning services. The Expanding Access to Women’s Health program grantees include the District of Columbia and the following 14 states: Arkansas, Colorado, Hawaii, Massachusetts, Maine, Mississippi, Nebraska, New Hampshire, New Jersey, New Mexico, Pennsylvania, Vermont, Washington, and Wisconsin.”
  • Modern Healthcare reports,
    • “Fewer hospitals will face high readmissions penalties in 2025 as rates of reimbursement cuts stabilize for providers.
    • “It is the third consecutive year in which the percentage of hospitals assessed penalties of 1% or more moderated, according to preliminary data released Friday by the Centers for Medicare and Medicaid Services. Penalties reduce the Medicare fee-for-service payments CMS makes to hospitals.
    • “For fiscal 2025, the number of hospitals included in the agency’s Hospital Readmissions Reduction Program is the lowest it has been in five years, with 100 fewer facilities participating than in fiscal 2021.
    • “The hospital readmissions performance period for fiscal 2025 pulls in claims from July 2020 through June 2023. The report is based on a rolling three-year time period, so the most recent one is the first to only include data generated after the start of the COVID-19 pandemic.”
  • FiercePharma tells us,
    • “For trade group the Pharmaceutical Research and Manufacturers of America (PhRMA), the fight against pricing provisions in the Inflation Reduction Act isn’t over yet.
    • “Late last week, the U.S. Court of Appeals for the Fifth Circuit reversed (PDF) a previous dismissal of PhRMA’s Inflation Reduction Act (IRA) lawsuit from February [2024 for lack of standing and proper venue], punting the complaint back to a lower Texas court.
  • and
    • “Less than a year after snagging its first FDA approval in psoriasis, UCB’s blockbuster hopeful Bimzelx has picked up three more indications to add to its growing resume of inflammatory disease treatment.
    • “The FDA cleared Bimzelx to treat adults with active psoriatic arthritis (PsA), active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation, and active ankylosing spondylitis (AS). The med is the first IL-17A/F inhibitor approved to treat the three indications, UCB noted in a press release.”

From the public health and medical research front,

  • The Washington Post informs us,
    • “About 37 percent of Gen Z men in the United States do not have an established primary care provider, according to a recent survey from the Cleveland Clinic. The survey, conducted this summer, involved 1,000 American men 18 or older living in the continental United States.
    • “Researchers assessed how different generations of men responded to questions about their health and health care, including whether they obtain yearly physicals, get screened based on doctors’ recommendations, and avoid smoking or vaping.
    • “The 37 percent of adult Gen Z men (born from 1997 through 2005) without a regular primary care provider compared with 27 percent of millennials (born from 1981 through 1996), 17 percent of Gen X respondents (1965 to 1980) and 7 percent of baby boomers and older (born before 1965).
    • “Nearly all the respondents said living a healthy lifestyle was a top priority, and 87 percent were concerned about how their current health habits would affect their future health. Millennials and adult Gen Zers were more likely to take care of their mental health (59 percent) than Gen X and boomers (53 percent), according to the survey.”
  • Consumer Reports, writing in The Washington Posts, offers tips on how to alleviate hip pain.
  • STAT News informs us,
    • “Of the roughly 15 million Americans who tried to quit smoking in 2022, 5 in 6 failed. It’s a jarring statistic — and an indictment of the treatment options for an addiction that kills 480,000 people in the U.S. each year.
    • “The smoking-cessation drugs on the market don’t work well for the majority of people, and they come with side effects and reputations that keep some smokers from ever trying them. Despite this, there hasn’t been a new class of drug approved for the condition in nearly two decades.” * * * 
    • “Chantix increases smokers’ success at quitting when compared to a placebo — but for every 100 people who use it, just 21 to 25 successfully stop, a recent meta-analysis found. It’s also associated with a raft of side effects, ranging from nausea to vivid dreams. Chantix, also known by its chemical name, varenicline, went generic in 2021 and can be purchased without insurance for roughly $68 for a one month supply, according to GoodRx.”  * * *
    • “In 2019, GlaxoSmithKline wrote to the FDA urging the agency to take several steps that would align its approach toward regulating NRT products with other nations’. Specifically, the drugmaker requested that the agency embrace a “Reduce to Quit” approach, whereby smokers are encouraged to use products like nicotine gum as they gradually reduce their cigarette consumption. 
    • “While the FDA has said it is open to this approach, which is used in countries like Germany, Canada, and the United Kingdom, the agency issued a guidance last year instructing drugmakers they would need to conduct a trial to evaluate the proposed regimen. GSK has warned that the need for another study “will make it less likely for innovator companies to pursue this indication in the U.S.”
  • Per KFF,
    • “A new KFF analysis examines the recent decline in opioid overdose deaths, with a focus on how trends vary by age, race, gender and state.
    • “Provisional data from the Centers for Disease Control and Prevention show a 20% decline in deaths during the latter half of 2023 compared to the same period from the previous year.
    • “In the second half of 2023, White people saw the largest decline (-14%) in opioid overdose deaths while declines among Black people were about half that (-6%), compared to the same period the year before.
    • “All age groups experienced declines in opioid overdose deaths except one. Among people 65 and older, opioid deaths rose by 9% percent in late 2023, with factors such as low detection of substance use concerns potentially playing a role.
    • “In three-quarters of states, opioid deaths declined in the last six months of 2023 compared to the same period in 2022. In 2023, opioid death rates were the highest in West Virginia, Washington D.C. and Delaware, while states with the lowest opioid death rates included Nebraska, South Dakota and Iowa.
    • “Newer provisional and partial data for the first quarter of 2024, which is not included in this analysis, point to a continuation of the overall downward trend in opioid overdose deaths through early 2024.”

From the U.S. healthcare business front,

  • Managed Healthcare Executive points out,
    • “Employers expect prescription drug costs to increase an average of 8% in 2025, making prices the highest they’ve been in 15 years, according to a news release published yesterday. Data was taken from the results of the 2025 Segal Health Plan Cost Trend Survey, an annual survey of managed care organizations, health insurers, prescription drug benefit managers (PBMs) and third party administrators (TPAs). Price inflation is the biggest factor on medical costs.
    • “Respondents predict that the highest rates will be reflected in all outpatient prescription drugs with an 11.4% increase, up from last year’s projected rate of 9.9%, calculated before PBM rebates. Outpatient prescription drugs trends are affected by factors such as drug price inflation, direct-to-consumer advertising and a changing drug mix.
    • “The increased use of drugs with the glucagon-like peptide 1 (GLP-1s) is a driving force in drug prices, due to their effectiveness in treating both type 2 diabetes and obesity, the survey reports. In 2023, obesity management was the top medical condition driving costs at 255.3%, followed by migraines at 31.4%.”
  • Per Fierce Healthcare,
    • “What began as a dispute between two health tech companies over healthcare data exchange practices has now led to a federal lawsuit alleging antitrust violations.
    • “Venture-backed health tech company Particle Health filed an antitrust lawsuit against Epic in the Southern District of New York alleging that the electronic health records (EHR) giant is trying to muscle out competition in the payer platform market.
    • “The 81-page lawsuit (PDF), filed today [in the U.S. District Court for the Southern District of New York], alleges Epic engaged in monopolistic, anti-competitive practices, using its “power over EHRs to expand its dominance into the fledgling market for payer platforms,” according to the lawsuit, which was reviewed by Fierce Healthcare.
    • “Particle Health argues in its federal complaint that Epic has not only engaged in anticompetitive behavior but has purposefully blocked the exchange of patient information.
    • “In an emailed response to Fierce Healthcare, an Epic spokesperson said Particle’s claims are baseless.”
  • MedTech Dive lets us know,
    • “Stryker has struck its fourth takeover in as many months, acquiring Nico Corporation to add minimally invasive solutions for brain tumor removal and stroke care to its portfolio.
    • “Nico sells devices for navigating through the brain, visualizing the organ, removing tumors and clots and collecting tissue. The company received clearance for a device that allows visualization of the surgical field during brain surgery in 2012 and has since expanded its portfolio.
    • “Stryker will slot the products into a neurocranial business that reported U.S. organic sales growth of almost 11% in the second quarter. Specifically, the devices will form part of a neurosurgical unit that Stryker called out as a growth driver in the fourth quarter of 2023. Stryker did not disclose the terms of the deal.”

Friday Factoids

David Ermer–CDC, CMS, Congress, COVID-19, FDA, Federal employment benefits, Medical / Rx research, Medicare, NIH, Obesity, Rx coverage, U.S. Healthcare–

From Washington, DC,

  • The American Hospital Association (AHA) News tells us,
    • “Sens. Chuck Schumer, D-N.Y., Susan Collins, R-Maine, and Bob Casey, D-Pa., Sept. 11 introduced the SEPSIS Act, legislation which would task the Centers for Disease Control and Prevention with building on its current efforts addressing sepsis care. New efforts would include an education campaign about addressing sepsis in hospitals, improving pediatric sepsis data collection, sharing information with the Department of Health and Human Services on data collection, including the Centers for Medicare & Medicaid Services on sepsis quality measures, and the development and implementation of a sepsis outcome measure. The bill also includes a voluntary recognition program for hospitals which maintain effective sepsis programs or improve their programs over time.”  
  • The University of Minnesota’s CIDRAP lets us know,
    • “A National Academies of Sciences, Engineering and Medicine report recommends five actions to transition the National Wastewater Surveillance System (NWSS)—developed as a response to the COVID-19 pandemic—to a forward-looking version for both endemic and emerging pathogens.
    • “The paper, released yesterday, is the second and final report by the Academies’ Committee on Community Wastewater-Based Infectious Disease Surveillance done at the behest of the Centers for Disease Control and Prevention (CDC).
    • “The CDC launched the NWSS with the US Department of Health and Human Services to centralize the detection and quantification of pathogen biomarkers that people shed into the sewer system.
    • “Whereas clinical laboratory testing tracks individual cases of infection, sampling and analysis at the wastewater treatment plant level (termed community-level wastewater surveillance) provide aggregate data from the homes, businesses, and other institutions that share a common sewer system,” the committee wrote.”
  • CMS has launched a public facing website and posted a consumer fact sheet about the Medicare Prescription Payment Plan which will take effect January 1, 2025.
  • Healthline offers a projection of 2025 IRMAA brackets applicable to Medicare Parts B and D coverage for higher income beneficiaries.
  • Tammy Flanagan, writing in Govexec, offers thirteen things to know about long-term care planning.

From the public health and medical research front,

  • The Centers for Disease Control and Prevention posted their weekly summary concerning respiratory illnesses in the U.S. today.
    • “Seasonal influenza and RSV activity are low nationally, but COVID-19 activity is elevated in most areas.
    • “COVID-19
      • “COVID-19 activity remains elevated nationally, but there are continued signs of decline in many areas. COVID-19 test positivity, emergency department visits, and rates of COVID-19–associated hospitalizations remain elevated, particularly among adults 65+ and children under 2 years. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.
    • “Influenza
    • RSV
      • “Nationally, RSV activity remains low.
    • Vaccination
      • “National vaccination coverage for COVID-19, influenza, and RSV vaccines was low for children and adults for the 2023-24 respiratory illness season. RSV, influenza, and COVID-19 vaccines are available to provide protection during the 2024-25 respiratory illness season.”
  • Ruh roh. The New York Times reports,
    • “Someone who lived with a Missouri resident infected with bird flu also became ill on the same day, the Centers for Disease Control and Prevention reported on Friday.
    • “The disclosure raises the possibility that the virus, H5N1, spread from one person to another, experts said, in what would be the first known instance in the United States.
    • “On Friday night, C.D.C. officials said that there was “no epidemiological evidence at this time to support person-to-person transmission of H5N1,” but that additional research was needed.
    • “The coincidental timing of the illnesses, especially outside flu season, concerned independent experts. H5N1 has been known to spread between close contacts, including those living in the same household.
    • “And neither the initial patient nor the household contact had any known exposure to the virus via animals or raw milk.
    • “Neither patient has been identified, and details are scant. The household contact was not tested, so officials cannot be sure that the individual actually was infected with the bird flu virus.”
  • More ruh roh. Health Day points out,
    • “U.S. obesity rates keep rising, with 1 in every 5 people in every state reported to be obese in 2023
    • “In 23 states, 35% or more of the population is now obese
    • “Tackling unhealthy weight gain as early as childhood may be key to turning these numbers around.”
  • The NIH Director cheers us up by writing in her blog,
    • In Parkinson’s disease, neurons in parts of the brain gradually weaken and die, leading people to experience worsening problems with movement and other symptoms. While the causes of this disease aren’t fully known, studies have suggested the Parkinson’s brain lacks fuel to power dopamine-producing neurons that are essential for movement. When too many of those neurons are lost, Parkinson’s disease symptoms appear. But what if there was a way to boost energy levels in the brain and stop the neurodegenerative process in its tracks?
    • While the findings are preliminary, an NIH-supported study reported in Science Advances takes an encouraging step toward this goal. The key element, according to the new work, is an energy-producing enzyme known as phosphoglycerate kinase (PGK1). In fact, these latest preclinical findings in models of the disease suggest that boosting this enzyme in the brain even slightly may be enough to restore energy and afford some protection against Parkinson’s disease.
    • The team, led by Timothy Ryan and Alexandros Kokotos , Weill Cornell Medicine, New York City, was inspired by recent discoveries suggesting an unexpectedly important role for PGK1 in protecting the normal function of neurons. They knew PGK1 plays an essential role in the pathway through which cells use glucose to generate and store energy in the form of adenosine 5′-triphosphate (ATP) molecules. The surprise came when studies showed the drug terazosin, which is used to treat high blood pressure and enlarged prostate, has an unexpected side effect: it enhances PGK1 activity, although perhaps weakly. * * *
    • “For the approximately one million Americans with Parkinson’s disease today, current treatments help to relieve symptoms but don’t stop the disease from progressing. These new findings raise the possibility that terazosin or drugs that enhance PGK1 activity even more may fuel the brain, helping to protect essential dopamine-producing neurons to treat or even prevent Parkinson’s disease, as well as other neurodegenerative conditions where PGK1 may play a role.”
  • Per an NIH press release,
    • “The National Institutes of Health (NIH) has established a pandemic preparedness research network to conduct research on high-priority pathogens most likely to threaten human health with the goal of developing effective vaccines and monoclonal antibodies. Currently, many of the diseases caused by these pathogens have no available vaccines or therapeutics, and investing in this research is key to preparing for potential public health crises—both in the United States and around the world. NIH’s National Institute of Allergy and Infectious Diseases (NIAID) expects to commit approximately $100 million per year to fund the program, pending the availability of funds.
    • “The Research and Development of Vaccines and Monoclonal Antibodies for Pandemic Preparedness network—called ReVAMPP—will focus its research efforts on “prototype pathogens,” representative pathogens from virus families known to infect humans, and high-priority pathogens that have the potential to cause deadly diseases. By studying specific prototype pathogens, scientists will build a knowledge base that could be applied to other related viruses. For example, NIAID’s earlier work on the Middle East respiratory syndrome coronavirus (MERS-CoV) played a crucial role in understanding and developing safe and effective treatments and vaccines for SARS-CoV-2, the virus that caused the COVID-19 pandemic. The ReVAMPP network will study viruses from virus families that have caused human disease for millennia—many of which have the potential to become pandemic threats in the future.
    • “In the wake of the COVID-19 pandemic and ongoing outbreaks of emerging infectious diseases, the need for robust pandemic preparedness is evident,” said NIAID Director Jeanne M. Marrazzo, M.D., M.P.H. “The ReVAMPP network will enable researchers to fill key knowledge gaps and identify strategies to develop safe and effective medical countermeasures for targeted virus families before the need becomes critical.”
  • STAT News reports,
    • “A new drug — approved by regulators last month — has shown it can delay tumor progression, meaning patients could get more years to work and travel and be with their families before subjecting themselves to the rigors of the more pernicious treatments, which can lead to a range of health and cognitive problems. It is one of the first major brain tumor breakthroughs in decades.
    • “It gives you more time to do the things you love to do and lets you live a more normal life,” said [a patient], who enrolled in the trial that led to the approval of the drug, called Voranigo and developed by the privately held French firm Servier.
    • “Taken as a daily pill, Voranigo, or vorasidenib, is a signal to researchers and other pharmaceutical companies that success in this field is possible. It’s also the first targeted therapy designed specifically for this brain cancer, homing in on a genetic mutation that drives tumor formation and bringing the type of the success seen in lung and breast cancers to among the most difficult-to-treat tumors. 
    • “The drug, which has a list price of nearly $480,000 a year, is approved for patients with specific types of brain tumors — gliomas and astrocytomas — that are categorized as grade 2, a few thousand of which are diagnosed every year in the U.S. (Brain tumors are graded on a scale of 1 to 4, with higher grades indicating tumors that are more aggressive.) It’s also only meant for people who have particular mutations in one of two related genes, known as IDH1 or IDH2, who account for the large majority of low-grade glioma patients. Now, researchers are starting to test it in combination with other treatments in more advanced brain cancers. 
    • “I was in the field for 38 years, and when you can count the number of approved drugs on one hand, you know you’ve got a difficult disease to treat,” said Mark Gilbert, who recently retired as chief of the National Cancer Institute’s neuro-oncology branch.” 

From the U.S. healthcare business front,

  • The New York Times reports,
    • Boar’s Head announced on Friday that it would indefinitely shut down the troubled Virginia deli meat plant that it acknowledged had caused a deadly listeria outbreak, killing nine people and sickening dozens more in 18 states.
    • The company also said it had identified liverwurst processing as the source of contamination and would permanently discontinue the product.
    • “Given the seriousness of the outbreak, and the fact that it originated at Jarratt, we have made the difficult decision to indefinitely close this location,” the company said in a statement posted on its website Friday. The shutdown affects about 500 workers in Jarratt, Va., a small rural town whose economic livelihood largely depended on the plant’s business.
  • Per Fierce Healthcare,
    • “Employers are bracing for a third straight year with health benefit costs increasing more than 5%, according to a new report from Mercer.
    • “The organization released preliminary findings from its annual National Survey of Employer-Sponsored Health Plans and found that the total health benefit cost for individual employees is expected to increase by 5.8% in 2025. This accounts for any cost-reduction initiatives that employers may take on.
    • “The survey, based on responses from 1,800 employers across the country, estimates that with no cost-reduction efforts, expenses would increase by 7% per worker.”
  • and
    • “Elevance Health has entered into a deal to acquire Indiana University Health Plans, the company’s Anthem Blue Cross unit announced this week.
    • “Should the deal close, IU Health Plans will operate as part of Anthem in the Hoosier State, according to the press release. Financial terms of the sale were not disclosed.
    • “IU Health Plans provides Medicare Advantage plans to 19,000 people across 36 counties and has a 4.5-star rating from the Centers for Medicare & Medicaid Services. It also has 12,000 fully insured commercial plan members, according to the release.” * * *
    • “The parties expect the deal to close at the end of 2024.”
  • Per Beckers Hospital Review,
    • “Oakland, Calif.-based Kaiser Permanente received approval from the San Jose (Calif.) planning commission during a Sept. 11 meeting to move forward with plans to demolish its existing San Jose Medical Center and build a new hospital.
    • “Kaiser Permanente San Jose is excited about this new facility, which will provide greater access to high-quality care and medical services to our members and patients in the greater San Jose community,” a spokesperson for Kaiser shared with Becker’s in a Sept. 12 statement. 
    • “The project, which the health system shared initial plans for in February, would demolish the current 250,000-square-foot hospital and develop a new 685,000-square-foot hospital, central utility plant and a five-level parking garage, resulting in the addition of around 800 new employees.
    • “It would also increase bed count from 247 to 303, according to project highlights during the meeting.” 
  • Per Healthcare Dive,
    • “Steward Health Care exited a federal bankruptcy court hearing on Wednesday absolved of billions of dollars in outstanding lease agreements and with a plan to keep the majority of its remaining hospitals open.
    • “Under the deal, Steward’s landlord, Medical Properties Trust, will forgive approximately $7.5 billion in outstanding obligations and allow Steward to receive $395 million in proceeds from a recent hospital sale in Florida in order to pay its lenders and unsecured creditors, according to testimony from the health system’s chief restructuring advisor, John Castellano.
    • “In exchange, Steward will waive its rights to pursue lawsuits against the real estate investment trust.”
  • Per Fierce Pharma,
    • “When Roche’s Genentech gained approval for Ocrevus in 2017, the first-in-class infused drug quickly became the best-selling treatment in a crowded multiple sclerosis (MS) market. Three years later, Novartis’ next-in-class Kesimpta stole some of Ocrevus’ thunder, offering a convenience edge with its once-monthly, at-home prefilled injection. 
    • “Now, Genentech has responded with a new formulation as the FDA has endorsed a subcutaneous version of Ocrevus. While it can’t match the at-home convenience of Kesimpta, subcutaneous Ocrevus Zunovo, with its twice-a-year, under-the-skin dosing regimen, provides an attractive option.
    • “This is something than can be provided in clinics and doesn’t require people to go to an infusion center,” David Jones, Genentech’s medical director for MS, said in an interview. “This will expand access to individuals who may not be able to access Ocrevus now, especially for reasons like geography or rural setting, individuals that might have challenges with their healthcare provider.”
    • “Ocrevus Zunovo can be injected in 10 minutes, compared to the two-plus hours needed for an infusion of the drug. For patients who experience side effects, the intravenous infusion can take up to four hours.” 
  • and
    • “It’s better late than never for an FDA approval for the first subcutaneous PD-L1 inhibitor, which was doled out to Roche’s Tecentriq Hybreza after manufacturing delays derailed the company’s initial launch plans last year.
    • “The agency was originally slated to issue its verdict on Tecentriq in its under-the-skin formulation last September but the drug’s manufacturing processes needed updating, Roche’s delivery technology partner Halozyme Therapeutics said in a filing at the time. The tweaks, which a Roche spokesperson said were made in response to the FDA’s evolving requirements, were expected to wrap up in 2023 to support a 2024 launch. The world-first approval for the formulation came in the U.K. last year. 
    • “Now, the therapy has been cleared for use in the U.S. in all of the Tecentriq adult formulation’s indications, including types of lung, liver, skin and soft tissue cancers. The new version uses Halozyme’s Enhanze drug delivery tech to subcutaneously inject the product over seven minutes, compared to the 30 to 60 minutes needed for an IV infusion.
    • “By enabling subcutaneous administration for a cancer immunotherapy, Tecentriq Hybreza now offers patients with multiple cancer types and their physicians greater flexibility and choice of treatment administration,” Roche’s chief medical officer and head of global product development Levi Garraway, M.D., Ph.D., said in a press release.”

Thursday Miscellany

David Ermer–AHRQ, CMS, FDA, Medical / Rx research, Medicare, Mental health care, NIH, Obesity, Telehealth, U.S. Healthcare–

From Washington, DC,

  • Per an HHS press release,
    • “Today, leaders from the U.S. Department of Health and Human Services (HHS), the Office of National Drug Control Policy (ONDCP), and the Substance Abuse and Mental Health Services Administration (SAMHSA) joined recovery advocates to kick off observance of the 35th National Recovery Month at the second annual SAMHSA Walk for Recovery. The National Walk for Recovery supports and celebrates recovery from substance use and/or mental health conditions while reducing stigma.
    • “In addition to hosting the walk, SAMHSA published the Gallery of Hope which features over 250 visual art entries submitted to the Art of Recovery project. The gallery highlights the transformative impact of art on mental health and substance use recovery. * * *
    • “Recovery Month, observed every September since 1989, promotes evidence-based substance use disorder and mental health treatment and recovery support practices and serves as an opportunity to celebrate the achievements of tens of millions of people in recovery and reduce stigma surrounding substance use and mental health issues. Over 65 million people consider themselves in recovery from substance use and/or mental health issues according to the 2023 National Survey on Drug Use and Health (NSDUH), among adults 18 or older in America. SAMHSA’s National Recovery Month Toolkit is available online and features recovery resources, social media assets, and weekly themes and messaging.”
  • American Hospital Association News lets us know,
    • “The Centers for Medicare & Medicaid Services Sept. 5 published a list of participants for the Transforming Episode Accountability Model. TEAM is a mandatory payment model that will bundle payment to acute care hospitals for five types of surgical episodes. The AHA June 10 urged CMS to make the model voluntary, however the mandatory model was finalized in the CY 2025 Inpatient Prospective Payment System Final Rule.”
  • Per Fierce Pharma,
    • “A year after missing on a trial endpoint, Travere Therapeutics can breathe a sigh a relief. The FDA has converted Filspari’s conditional nod in the kidney disease IgA nephropathy (IgAN) into a full approval.
    • “As part of the conversion Thursday, the FDA has removed a specific urine protein level requirement from Filspari’s label. Now, the only condition for treatment with Filspari is that patients be at risk of disease progression.
    • The adjustment will allow Filspari to reach more patients who’re at lower risk of progression, Travere CEO Eric Dube, Ph.D., said in a recent interview. The company will be able to promote Filspari’s ability to preserve kidney function, and the full approval could give more doctors confidence to start using the drug, he added.
    • During a drug launch, “those later adopters oftentimes look for things like guidelines, support or advocacy from their peers, or in this case, also full approval,” Dube said. “So we do expect that there’s going to be a broader set of nephrologists prescribing.”
  • Federal News Network informs us,
    • “The Postal Service is bringing back a holiday surcharge for some of its package services, as the agency prepares for its busy year-end peak season.
    • “The new prices will take effect on Oct. 6, 2024, and will last through Jan. 19, 2025. USPS announced the return of the holiday surcharge in a press release Thursday.
    • “USPS waived the surcharge last year, in the hopes that that lower prices would help the agency capture a bigger share of the lucrative holiday package business from private-sector competitors like UPS, FedEx and Amazon.
    • “USPS said in a press release Thursday that the temporary price adjustment will “help cover extra handling costs to ensure a successful peak season.”

From the public health and medical research front,

  • The American Hospital Association News tells us,
    • “The California Department of Food and Agriculture Aug. 30 reported cows in three dairy herds tested positive for bird flu. No human cases were confirmed in association with this incident. Both the California Department of Health and the Centers for Disease Control and Prevention consider the risk of bird flu to the general public as low. As of yesterday, there have been 13 total positive cases of H5 bird flu in humans, according to the CDC.” 
  • The New York Times reports,
    • “The number of teenagers who reported using e-cigarettes in 2024 has tumbled from a worrisome peak reached five years ago, raising hopes among public health officials for a sustained reversal in vaping trends among adolescents.
    • “In an annual survey conducted from January through May in schools across the nation, fewer than 8 percent of high school students reported using e-cigarettes in the past month, the lowest level in a decade.
    • “That’s far lower than the apex, in 2019, when more than 27 percent of high school students who took the survey reported that they vaped — and an estimated 500,000 fewer adolescents than last year.
    • “The data is from the National Youth Tobacco Survey, a questionnaire filled out by thousands of middle and high school students that is administered each year by the Food and Drug Administration and the Centers for Disease Control and Prevention.”
  • The Washington Post points out,
    • “A new study adds to a growing body of evidence that Parkinson’s disease, long believed to have its origins in the brain, may begin in the gut.
    • “Gastrointestinal problems are common in patients with neurodegenerative disorders, to the point where a condition known as “institutional colon” was once thought to afflict those who lived in mental health institutions. In Parkinson’s disease, the entire gastrointestinal tract is affected, causing complications such as constipation, drooling, trouble swallowing and delayed emptying of the stomach. These symptoms often appear up to two decades before motor symptoms such as rigidity or tremor.
    • “People have, for the longest time, described Parkinson’s disease as a top-down disease — so, it starts in the brain and then percolates down to the gut, and that’s why patients have issues with their gastrointestinal tract,” said study author Subhash Kulkarni, an assistant professor at Beth Israel Deaconess Medical Center. “Another hypothesis suggests that, in many patients, it may be a bottom-up approach, where it starts in the gut and goes all the way up to the brain.”
    • “Kulkarni and his colleagues found that people with upper gastrointestinal conditions — in particular, ulcers or other types of damage to the lining of the esophagus, stomach, or upper part of the small intestine — were far more likely to develop Parkinson’s disease later in life. The study was published online Thursday in JAMA Network Open.”
  • The NIH Director writes in her blog,
    • “Each year in the U.S. there are about 18,000 new spinal cord injuries, which damage the bundle of nerves and nerve fibers that send signals from the brain to other parts of the body and can affect feeling, movement, strength, and function below the injured site. A severe spinal cord injury can lead to immediate and permanent paralysis, as our spinal cords lack the capacity to regenerate the damaged tissues and heal.
    • “So far, even the most groundbreaking regenerative therapies have yielded only modest improvements after spinal cord injuries. Now, an NIH-supported study reported in Nature Communications offers some new clues that may one day lead to ways to encourage healing of spinal cord injuries in people. The researchers uncovered these clues through detailed single-cell analysis in what might seem an unlikely place: the zebrafish spinal cord.
    • “Why zebrafish? Unlike mammals, zebrafish have a natural ability to spontaneously heal and recover after spinal cord injuries, even when the injuries are severe. Remarkably, after a complete spinal cord injury, a zebrafish can reverse the paralysis and start swimming again within six to eight weeks. Earlier studies in zebrafish after spinal cord injury found that this regenerative response involves many types of cells, including immune cells, progenitor cells, neurons, and supportive glial cells, all of which work together to successfully repair damage. * * *
    • “In future work, the researchers plan to conduct similar studies in the many other cell types known to play some role in spinal cord healing in zebrafish, including supportive glia and immune cells. They’re also continuing to explore how the activities they see in the zebrafish spinal cord compare to what happens in mice and humans. With much more study, these kinds of findings in zebrafish may lead to promising new ideas and even treatments that encourage neural protection, flexibility, and recovery in the human nervous system after spinal cord injuries.”
  • The “Institute for Clinical and Economic Review publishes Evidence Report on treatments for Transthyretin Amyloid Cardiomyopathy — Current evidence suggests that tafamidis and acoramidis provide a net health benefit when compared to no disease-specific therapy; these treatments would achieve common thresholds for cost-effectiveness if priced between $13,600 to $39,000 per year.” * * * “This Evidence Report will be reviewed at a virtual public meeting of the Midwest CEPAC on September 20, 2024.”
  • The U.S. Preventive Services Task Force posted a final research plan for “Early Allergen Introduction to Prevent Food Allergies in Infants: Counseling.
  • Per Reuters,
    • “There is no link between mobile phone use and an increased risk of brain cancer, according to a new World Health Organization-commissioned review of available published evidence worldwide.
    • “Despite the huge rise in the use of wireless technology, there has not been a corresponding increase in the incidence of brain cancers, the review, published on Tuesday, found. That applies even to people who make long phone calls or those who have used mobile phones for more than a decade.”
  • FEHBlog comment: Whew!
  • Per MedPage Today,
    • “Having a medical condition was associated with an increased risk of suicide in a dose-response-like manner, such that the higher the burden of disability, the higher the risk of suicide, according to an observational study in Denmark.
    • “An analysis of more than 6.6 million people found that nine medical condition categories including 31 specific conditions were associated with a statistically significant increased risk of suicide, with the exception of endocrine disorders, reported Søren Dinesen Østergaard, MD, PhD, of Aarhus University Hospital, and co-authors.
    • “The associations were most pronounced for gastrointestinal conditions (incidence rate ratio [IRR] 1.7, 95% CI 1.5-1.8), cancers (IRR 1.5, 95% CI 1.4-1.6), and hematological conditions (IRR 1.5, 95% CI 1.3-1.6), they wrote in JAMA Psychiatry.
    • “The risk was highest in the first 6 months following diagnosis and subsequently faded over time, although the risk after certain medical conditions remained elevated up to 15 years after onset.”

From the U.S. healthcare business front,

  • Beckers Payer Issues provides context to Modern Healthcare’s story in yesterday’s post about HCSC offering a no deductible plan design. It’s a trend.
  • Modern Healthcare adds today,
    • “Cigna Group CEO David Cordani underscored the booming state of the company’s health services business and outlined the unit’s potential growth opportunities during Morgan Stanley’s annual Global Healthcare Conference on Thursday.
    • “Cordani said the company sees opportunities to capitalize on the $400 billion specialty pharmacy market and to drive more business for its pharmacy benefit manager, Express Scripts.
    • “Cigna has been charting strong growth this year for its Evernorth Health Services business as it pulls out of the lucrative Medicare Advantage market, and it’s already seeing positive returns. Evernorth, which houses Cigna’s specialty pharmacy and pharmacy benefits businesses, generated more than 80% of its total revenue in the second quarter ended June 30.
    • “Cordani highlighted Evernorth’s successes as the segment announced another low-cost biosimilar product. Early next year, eligible members will have access to a biosimilar for Johnson & Johnson’s Stelara arthritis drug with no out-of-pocket cost at its specialty pharmacy. Cordani said the new offering could save each member $4,000 annually.”
  • Per Fierce Healthcare,
    • “Over the past several years, Humana has made significant strides in growing its senior-focused primary care business, and a new study highlights areas where it’s seeing success in this model.
    • “The study, conducted by the Humana Healthcare Research team along with Harvard researcher J. Michael McWilliams, M.D., Ph.D., digs into data from six senior-focused primary care organizations on more than 421,000 patients who were enrolled in Medicare Advantage coverage in 2021.
    • “It found that patients in these organizations had 17% more primary care visits across the board. This included 39% more visits among Black patients and 21% more among low-income patients, which can address disparities faced by these populations.
    • “The study also suggests that patients who are engaged with a senior-focused primary care model see better outcomes on multiple quality measures including cancer screenings, medication adherence and controlled blood pressure. The researchers did note that future analysis is necessary to refine these findings.”
  • Modern Healthcare notes,
    • “Ochsner Health is expanding its digital medicine program to offer weight management, the health system said Wednesday.
    • “Some [program] patients will have access to popular weight loss medications including glucagon-like peptide agonists, Ochsner said in a release. The digital medicine program has previously focused on patients with hypertension, Type 2 diabetes and hyperlipidemia.” * * * 
    • “Ochsner is the latest organization seeking to leverage the popularity of GLP-1 medications such as Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound. GLP-1s have led many organizations to offer virtual weight management services, including Mayo Clinic. The Rochester, Minnesota-based organization said in January it’s testing a telehealth weight loss offering through its diet program.”  
  • Per Healthcare Dive,
    • “Henry Ford Health and Ascension will launch their joint venture in Michigan at the start of October, moving eight Ascension and Genesys hospitals and an addiction treatment center under the Henry Ford brand, the companies said on Wednesday.
    • “Detroit-based Henry Ford will double in size once the joint venture launches, growing its acute care footprint from five to 14 hospitals.
    • “The no-cash deal, announced nearly a year ago, is expected to create an organization with more than $10.5 billion in annual operating revenue. Henry Ford CEO Bob Riney will serve as the CEO of the new entity.”
  • and
    • “Female physicians and doctors who work in nonrural practices deliver more care via telehealth, according to a study published this week in Health Affairs. 
    • “The research also found differences in virtual care utilization by specialty. For example, 23% of psychiatrists delivered all or nearly all of their visits through telehealth, compared with fewer than 1% for physicians in all other specialties. 
    • “The findings offer insight into long-term patterns of telehealth utilization in the U.S. and help show how virtual care might be affecting care access and outcomes, the study authors wrote.”
  • Per Kauffman Hall,
    • Hospital financial performance remains strong this year, with continued stabilization in the month of July. Outpatient revenue and average lengths of stay showed signs of improvement.
    • The median Kaufman Hall Calendar Year-To-Date Operating Margin Index reflecting actual margins for July was 4.1%.
    • The recent [/July] issue of the National Hospital Flash Report covers these and other key performance metrics.
  • Per MedTech Dive,
    • “Abbott is working to integrate its newest continuous glucose monitor (CGM) with Beta Bionics’ automated insulin delivery (AID) system.
    • “The companies plan to connect Beta Bionics’ iLet Bionic Pancreas to Abbott’s Freestyle Libre 3 Plus CGM, according to the Wednesday announcement. Readings from the CGM will help iLet calculate insulin doses for automated delivery.
    • “Beta Bionics said the integration, which is scheduled to launch in the fourth quarter, will be the first of its kind for Freestyle Libre 3 Plus in the U.S. Abbott also has AID partnerships with Insulet and Medtronic.”