Friday Factoids

Medicare

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.”

Monday Roundup

David Ermer–CDC, COVID-19, FDA, Medical / Rx research, Medicare, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC,

  • Per an HHS press release,
    • “The U.S. Department of Health and Human Services (HHS), through the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (hereafter ASTP), today published the final 2024-2030 Federal Health IT Strategic Plan – PDF in accordance with the Health Information Technology for Economic and Clinical Health (HITECH Act.) The Strategic Plan presents federal health information technology (health IT) goals and objectives to achieve a future state where health IT and electronic health information are used to:
      • Promote health and wellness;
      • Enhance the delivery and experience of care;
      • Accelerate research and innovation; and
      • Connect the health system with health data.
    • “The draft Strategic Plan was published by ASTP in March 2024 following a comprehensive and collaborative effort with more than 25 federal agencies that are central to the advancement of health IT. These federal agencies regulate, purchase, develop, fund, research, and use health IT to improve patient care and health outcomes. The Strategic Plan was subsequently updated and finalized following a 60-day public comment period, which produced comments from a variety of organizations including health care systems, associations and specialty societies, electronic health record developers, patient advocates, and others.”
  • In related news, the Sequoia Project made the following announcement,
    • “TEFCA RCE Webinar on TEFCA Exchange for Public Health
    • “Friday, October 11 | 11:00 a.m. – 12:00 p.m. ET
      • “Access to health information is an important tool for Public Health Authorities (PHAs) and their Delegates to support core public health services including, but not limited to, assessing and monitoring population health and investigating, diagnosing, and addressing health hazards and root causes. Use cases described in the recently released Public Health Exchange Purposes Implementation SOP, allow PHAs to identify disease trends, track and monitor outbreaks, and prevent and control future outbreaks.
      • “Join experts from the Trusted Exchange Framework and Common Agreement™(TEFCA™) Recognized Coordinating Entity® (RCE™) and the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (ASTP/ONC) for an informative webinar, where we’ll cover the essentials of TEFCA Exchange and dive into the details of the Public Health Exchange Purposes Implementation SOP.” * * *
      • “Don’t Miss Out – Register Now!
  • The American Hospital Association News lets us know,
    • “Johnson & Johnson Sept. 30 notified the Health Resources and Services Administration that it is ceasing implementation of its proposed 340B rebate model. The decision comes after HRSA Sept. 27 said it would terminate J&J’s Pharmaceutical Pricing Agreement and/or impose civil monetary penalties if J&J didn’t halt implementation of the program.” * * *
    • “The AHA is pleased that Johnson & Johnson has decided to cease implementation of its 340B rebate proposal, which would have harmed patients and 340B providers,” said Rick Pollack, AHA president and CEO. “We are especially appreciative of HRSA’s efforts to convince J&J to put an end to this unlawful proposal and those members of Congress who demonstrated their firm support of the 340B program.” 
  • Per another HHS press releases,
    • “The U.S. Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), today announced that some Medicare enrollees will pay less for 54 drugs available through Medicare Part B. The drugs will have a lowered Part B coinsurance rate from October 1, 2024 – December 31, 2024, since drug companies raised prices for each of these 54 drugs faster than the rate of inflation. Over 822,000 people with Medicare use these drugs annually to treat conditions such as cancer, osteoporosis, and pneumonia. Since April 1, 2023, people with Medicare have seen savings on over 100 drugs thanks to Inflation Reduction Act’s Medicare Prescription Drug Inflation Rebate Program.” * * *
    • “For more information on the Medicare Prescription Drug Inflation Rebate Program visit, https://www.cms.gov/inflation-reduction-act-and-medicare/inflation-rebates-medicare.
    • “To view the fact sheet on the 54 Part B drugs with a coinsurance reduction for the quarter October 1, 2024 – December 31, 2024, visit, https://www.cms.gov/files/document/reduced-coinsurance-certain-part-b-rebatable-drugs-october-1-december-31-2024.pdf – PDF“
  • ICD10 Monitor identifies eleven key takeaways from ICD-10 changes that code changes that will go into effect for hospital discharges on Oct. 1, 2024.
  • HR Dive informs us,
    • Federal enforcement of new workplace protections for pregnant workers is picking up steam, just as regulations implementing those requirements reach 100 days on the books.
    • The U.S. Equal Employment Opportunity Commission filed its first lawsuit alleging violations of the Pregnant Workers Fairness Act earlier this month and followed it up with two more Wednesday [September 25].

From the public health and medical research front,

  • Beckers Clinical Leadership tells us,
    • “After its detection in 28 countries, the CDC began tracking the proportions of COVID-19 variant XEC. 
    • “Currently accounting for 6% of U.S. cases, XEC is the fifth most dominant variant in the nation. Other leading variants include KP.3.1.1 (58.7%), KP.2.3 (9.4%), LB.1 (7.9%) and KP.3 (7.1%). 
    • “As of Sept. 19, the XEC lineage has been detected in 633 COVID-19 cases after first appearing June 28, according to Scripps Research’s Outbreak.info. Twenty-four states have at least one XEC case. In early September, XEC was seen in 12 states and 15 countries. 
    • “It is too early to determine whether the variant is more transmissible or more severe than current strains, experts told NBC News in a Sept. 27 article.”
  • The Centers for Disease Control and Prevention (CDC) informs us,
    • “CDC reported one new flu-related death in a child last week, bringing the total number of U.S. pediatric deaths for the 2023-2024 season to 200. This number of pediatric deaths exceeds the previous high reported for a regular (non-pandemic) flu season. The previous high of 199 deaths was reported during the 2019-2020 season. Consistent with other seasons, of children who were eligible for a flu vaccine and for whom vaccination status was known, about 80 percent were not fully vaccinated.
    • “Getting your child a flu vaccine is the most effective step to reduce the risk of flu illness and flu-related doctor’s visits and missed school days; flu vaccination also reduces the risk of flu-related hospitalization and death. In the 2023-2024 season, estimates indicated that flu vaccination reduced the risk of flu related medical visits by approximately two-thirds and halved the risk of flu-related hospitalization for vaccinated children. September and October are the best times for most children to receive flu vaccine. CDC recommends everyone 6 months and older get an annual flu vaccine, especially children at higher risk for serious flu complications.”
  • The Washington Post reports,
    • “Nearly 90 percent of adults over 65 took prescription medication in the previous 12 months in 2021 and 2022, according to a recent report by the Centers for Disease Control and Prevention.
    • “Drawing on data from the 2021 and 2022 National Health Interview Survey, the report focused on 17,706 adults 65 and older. According to the analysis, 88.6 percent of older adults took prescription medications in the previous 12 months.
    • “Use was similar for men and women, but higher for those 75 and above than those 65 to 74. White older adults were also more likely than Black, Hispanic and Asian adults to take prescription medication. The study also found that 82.7 percent of older adults had prescription drug coverage, and that coverage was higher among men, White adults and those with higher incomes.”
  • Consumer Reports, writing in the Washington Post, offer tips about “how to deal with heel pain. Plantar fasciitis, Achilles’ problems and other issues can cause the tenderness. Stretches, the right footwear and shifting your activities can help.”
  • Healio notes,
    • “Hospitalized older adults are more likely to die from RSV than influenza B, though the risk is similar for influenza A.
    • “Improved testing strategies and outreach could lower the risk for death.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “CVS Health is conducting a strategic review of options for the company, including a possible breakup of the industry giant, according to people with knowledge of the matter. 
    • “The company’s board of directors has retained bankers to facilitate the review, which has been ongoing for weeks, the people said. 
    • “No decision by CVS is imminent, and it is possible there won’t be any major changes in the business as a result, they added. 
    • “The review includes different options, including various forms a potential breakup could take, some of the people said.”
  • Per Beckers Hospital Review,
    • “Dana Filmore, a grandmother from Columbus, Ohio, is among thousands of plaintiffs filing a federal lawsuit against pharmaceutical companies Novo Nordisk and Eli Lilly, alleging Ozempic and Mounjaro caused gastroparesis, USA Today reported Sept. 27. 
    • “Gastroparesis, a condition characterized by stomach paralysis that severely impacts digestion, caused Filmore, who turned to the medication to control her blood sugar to have persistent nausea and bowel issues. 
    • “The lawsuit alleges that the drug manufacturers failed to adequately warn patients about the risks associated with the medications and central to the lawsuit were claims of gastroparesis, according to the USA Today report.”
  • Per MedTech Dive,
    • “Establishment Labs received Food and Drug Administration approval for its Motiva breast implants for primary and revision breast augmentation.
    • “Motiva is the first new breast implant to receive U.S. premarket approval since 2013, according to Establishment Labs’ Thursday announcement. Since then, the market has been reshaped by safety problems that led to the withdrawal of Allergan’s Biocell textured breast implant.
    • “Motiva devices have a surface designed to enhance biocompatibility and promote low inflammation, according to the company. Establishment Labs won approval on the strength of three-year clinical data.”

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.”

Thursday Miscellany

David Ermer–Congress, FDA, Federal employment benefits, Medical / Rx research, Medicare, Mental health care, NIH, OPM, U.S. Healthcare–

From Washington, DC

  • Per a White House press release,
    • “On Thursday, September 26, 2024, the President signed into law:
    • “H.R. 9747, the ”Continuing Appropriations and Extensions Act, 2025,” which provides fiscal year 2025 appropriations to Federal agencies through December 20, 2024, for continuing projects and activities of the Federal Government.”
  • Bye, bye Congress. See you in November.
  • MedTech Dive adds,
    • “Congress has again deferred Medicare reimbursement cuts of up to 15% for clinical laboratory tests with the passage Wednesday of a short-term government funding bill.
    • “The appropriations bill pushes back by one year the implementation of Medicare payment rates scheduled to take effect in January for about 800 lab services.
    • “We are pleased that Congress has delayed pending reductions, recognizing the harm repeated Medicare reductions would have on the nation’s health care system that relies on clinical laboratory testing every day to inform patient care,” Susan Van Meter, president of the American Clinical Laboratory Association, said in a Wednesday statement.”
  • Here are links on yesterday’s OPM’s 2025 FEHBP/FEDVIP premium announcement from Govexec, Fedweek and FedSmith. Govexec also reports, “Biden administration officials said that two nationwide insurers in the federal government’s employer-sponsored health care program [Blue Cross FEP and GEHA] will offer $25,000 worth of in vitro fertilization and other fertility treatments.
  • Per an HHS press release,
    • “Today, the U.S. Department of Health and Human Services (HHS) through the Advanced Research Projects Agency for Health (ARPA-H) announced funding for the Transforming Antibiotic R&D with Generative AI to stop Emerging Threats (TARGET) project, which will use AI to speed the discovery and development of new classes of antibiotics. This program is another action to support the United States’ longstanding commitment to combating antimicrobial resistance (AMR), from groundbreaking innovation to international collaboration. The U.S. is a global leader in the fight against AMR and has a demonstrated track record of progress in protecting people, animals, and the environment from the threat of AMR domestically and globally.”

From the public health and medical research front,

  • Per an FDA press release,
    • “Today, the U.S. Food and Drug Administration approved [Bristol, Myers, Squibb’s] Cobenfy (xanomeline and trospium chloride) capsules for oral use for the treatment of schizophrenia in adults. It is the first antipsychotic drug approved to treat schizophrenia that targets cholinergic receptors as opposed to dopamine receptors, which has long been the standard of care.
    • “Schizophrenia is a leading cause of disability worldwide. It is a severe, chronic mental illness that is often damaging to a person’s quality of life,” said Tiffany Farchione, M.D., director of the Division of Psychiatry, Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research. “This drug takes the first new approach to schizophrenia treatment in decades. This approval offers a new alternative to the antipsychotic medications people with schizophrenia have previously been prescribed.”
  • BioPharma Dive offers an excellent explanation of the various factors affecting sales of this drug.
  • KFF Health News points out that “Deadly High Blood Pressure During Pregnancy Is on the Rise.”
  • The Washington Post reports,
    • “A New York resident has died amid a nationwide listeria outbreak tied to Boar’s Head deli meat, the Centers for Disease Control and Prevention announced Wednesday, bringing the death toll to 10 in the largest outbreak of the foodborne illness since 2011.
    • “The agency also reported two new hospitalizations associated with the outbreak. In total, 59 people have been hospitalized in 19 states since late May.
    • “Deaths have occurred in Illinois, New Jersey, New York, Virginia, Florida, Tennessee, New Mexico and South Carolina. In its latest update, the CDC noted that illnesses have started to decrease. The number of sick people is probably higher than the official case count, the agency said, since those who do not seek medical care are not tested for listeria.
    • “Boar’s Head identified the production process for liverwurst at its plant in Jarratt, Va., as the culprit for contaminating the meat. This month, the company announced it would indefinitely close the southern Virginia plant and permanently discontinue liverwurst.”
  • The NIH Director writes in her blog,
    • “Genetic mutations affect nearly all human diseases. Some genetic disorders such as cystic fibrosis are caused by mutations in a single gene that a person inherits from their parents. Other diseases can be caused by changes in multiple genes or from a combination of gene mutations and environmental factors. We still have a lot to learn about the complex ways that variations in our genes affect health and disease.
    • “Researchers investigating genetic disorders have primarily studied mutations that cause our cells to alter the makeup of proteins, like the most common mutations that cause cystic fibrosis. Less research has been done on alterations called synonymous mutations, which have been called “silent” because they don’t alter the makeup of proteins, leading scientists to long assume that these kinds of mutations don’t produce any noticeable differences in our biology or health. However, recent research has shown that synonymous mutations can lead to significant changes in a cell’s ability to survive and grow. A new NIH-supported study reported in Proceedings of the National Academy of Sciences sheds additional light on the impact of synonymous mutations and their effect on the way proteins are made.” * * *
    • “The researchers behind this study, at the University of Notre Dame in Notre Dame, IN, wanted to understand how synonymous mutations may affect how much protein is made and whether proteins are folded correctly in cells. Misfolded proteins are known to play roles in numerous diseases, including cystic fibrosis, Alzheimer’s disease, and some cancers. The study team, led by Patricia L. Clark, who received an NIH Director’s Pioneer Award in 2021 for this work, has shown that synonymous mutations in a particular gene in Escherichia coli (E. coli) bacteria can alter how the encoded protein folds as it is being made, by altering the rate at which cells produce each copy of the protein. The new research goes a step further and shows that silent mutations in one gene can affect the amount of protein produced from a separate, neighboring gene.” * * *
    • “This discovery in E. coli may have important implications for understanding the bacteria’s biology and evolution. Clark’s team continues to study this system to learn more. Their findings may also prove to have broader implications for biology, including for some genetic disorders. It’s an area that warrants more study and attention, to better understand the roles that synonymous mutations may be playing in genes and their effects on human health.”
  • Per an NIH press release,
    • “Scientists at the National Institutes of Health (NIH) and their colleagues have identified a gene responsible for some inherited retinal diseases (IRDs), which are a group of disorders that damage the eye’s light-sensing retina and threatens vision. Though IRDs affect more than 2 million people worldwide, each individual disease is rare, complicating efforts to identify enough people to study and conduct clinical trials to develop treatment. The study’s findings published today in JAMA Ophthalmology.
    • “In a small study of six unrelated participants, researchers linked the gene UBAP1L to different forms of retinal dystrophies, with issues affecting the macula, the part of the eye used for central vision such as for reading (maculopathy), issues affecting the cone cells that enable color vision (cone dystrophy) or a disorder that also affects the rod cells that enable night vision (cone-rod dystrophy). The patients had symptoms of retinal dystrophy starting in early adulthood, progressing to severe vision loss by late adulthood.
    • “The patients in this study showed symptoms and features similar to other IRDs, but the cause of their condition was uncertain,” said Bin Guan, Ph.D., chief of the Ophthalmic Genomics Laboratory at NIH’s National Eye Institute (NEI) and a senior author of the report. “Now that we’ve identified the causative gene, we can study how the gene defect causes disease and, hopefully, develop treatment.”
    • “Identifying the UBAP1L gene’s involvement adds to the list of more than 280 genes responsible for this heterogeneous disease.”
  • The U.S. Preventive Services Task Force posted a “Final Research Plan for Enhanced Risk Assessment for Cardiovascular Disease: Coronary Artery Calcium Scoring.”

From the U.S. healthcare business front,

  • The FEHBlog was surprised to read in Beckers Hospital Review that
    • Johnson & Johnson will discontinue upfront 340B drug rebates for certain hospitals, raising concerns among healthcare providers and advocacy groups. The proposed policy, set to take effect Oct. 15, would prevent certain hospitals from accessing 340B discounts for Stelara, used to treat plaque psoriasis, psoriatic arthritis and other conditions; and Xarelto, a blood thinner.
  • Per Fierce Healthcare,
    • “While consumers give telehealth high marks for convenience, overall experience is fairly mixed, according to a new report.
    • “J.D. Power released its annual Telehealth Satisfaction Study on Thursday, and found patients overall gave a score of 730 out of 1,000 for direct-to-consumer telehealth platforms. Payer-provided telehealth earned a lower score of 708, which suggests patients encounter differences in quality and ease of access between providers.
    • “The study also found the highest satisfaction scores for people enrolled in Medicaid, those living in urban areas, millennials and Gen Zers. The lowest scores were among people enrolled in Medicare or commercial coverage, those living in suburban regions and members of the Boomer generation or older.”
  • McKinsey and Company explore “Reimagining healthcare industry service operations in the age of AI.”
  • KFF offers “A Snapshot of Sources of Coverage Among Medicare Beneficiaries” and tells us “Nearly 7 in 10 Medicare Beneficiaries Did Not Compare Plans During Medicare’s Open Enrollment Period.”

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–Federal employment benefits, Medical / Rx research, Medicare, Mental health care, NCQA, OPM, U.S. Healthcare–

This morning, while driving from Plano, TX, to our home in Dripping Springs, TX, the FEHBlog listened to this week’s Econtalk episode in which the host Russ Roberts interviewed Dr. Marty Makary about his new book “Blind Spots: When Medicine Gets It Wrong, and What It Means for Our Health.” I encourage folks to listen to the podcast or read the transcript, either of which is eye opening.  

From Washington, DC,

  • OPM has shared its supplemental Postal Service Health Benefits Program final rule with the Office of Management and Budget’s Office of Information and Regulatory Affairs for its review before publication in the Federal Register.
  • This is the rulemaking in which OPM laid out its plan to deprive Medicare Part D eligible members of their PSHB plan’s prescription drug benefits if they opt out of the Plan’s Part D EGWP. OPM does not reduce the premium in the event of an opt out.
  • OPM settled on this approach based on its finding that the statute is ambiguous, thereby triggering the since then discredited Chevron doctrine. In any case, the statute is not ambiguous. PSHB plans must offer a Part D EGWP, and members can choose whether or not to join the Part D EGWP.
  • As the FEHBlog has explained, the new and improved Part D program, with a $2000 out of pocket maximum, coupled with the Medicare Prescription Payment Plan, should sell itself to FEHB Part D eligible members.
  • NCQA “announced its 2024 Health Plan Ratings, an annual list that evaluates commercial, Medicare and Medicaid health plans based on assessments of patient experience and clinical quality. The 2024 Health Plan Ratings are based on data from calendar year 2023, when approximately 227 million people were enrolled in health plans that reported Healthcare Effectiveness Data and Information Set (HEDIS®) results to NCQA.”
  • Beckers Payer Issues identifies the plans with the top NCQA ratings.
  • The American Hospital Association News informs us,
    • “The Centers for Medicare & Medicaid Services has issued a request for information that seeks information on artificial intelligence use from health care providers, companies and others that can improve health care outcomes and care delivery. CMS plans to select organizations on a rolling basis to give 15-minute demonstrations of their AI products and services to the agency during quarterly CMS AI Demo Days which begin in October. The presentations will inform future CMS actions on AI. The deadline for questions is Sept. 27 and responses are due by Oct. 7.”

From the public health and medical research front,

  • Healio makes one of Dr. Makary’s points when it informs us that “Hormone therapy use among menopausal women has fallen to just 1.8% as of 2023, data show, despite evidence and clinical guidance suggesting HT is safe and effective for most women for bothersome menopausal symptoms.”
  • The New York Times reports,
    • “Research is revealing intriguing clues about how pregnancy changes the brain. 
    • “Studies scanning women’s brains before and after pregnancy have found that certain brain networks, especially those involved in social and emotional processing, shrink during pregnancy, possibly undergoing a fine-tuning process in preparation for parenting. Such changes correspond with surges in pregnancy hormones, especially estrogen, and some last at least two years after childbirth, researchers have found.
    • “A new study, published Monday in the journal Nature Neuroscience, adds to the picture by documenting with M.R.I.s brain changes throughout one woman’s pregnancy. It confirms previous results and adds detail, including that white matter fibers showed greater ability to efficiently transmit signals between brain cells, a change that evaporated once the baby was born.
    • “What’s very interesting about this current study is that it provides such a detailed mapping,” said Elseline Hoekzema, a neuroscientist who heads the Pregnancy and the Brain Lab at Amsterdam University Medical Center and has helped lead studies analyzing brain scans of more than 100 women before and after pregnancy.
    • “Dr. Hoekzema, who was not involved in the new study, said it showed that along with previously documented “longer-lasting changes in brain structure and function, more subtle, transient changes also occur.”
  • Consumer Reports, writing in the Washington Post, explains how to track your health at home.

From the U.S. healthcare business front,

  • Per MedCity News,
    • “A new Mercer report predicts there will be a national surplus of about 30,000 nurses by 2028. Though an overall surplus is projected nationally, there will still be significant shortages of nursing labor in a handful of states, as well as most of the country’s rural areas. To solve this issue, providers need to recruit from wider labor pools, minimize nurses’ nonclinical tasks and prioritize creating a more supportive work environment.”
  • Beckers Hospital Review discusses the threats looming over hospital revenue cycles.
  • Per MedTech Dive,
    • “Smiths Medical recalled tracheostomy kits because of a manufacturing defect that could cause the balloon to separate from the inflation line. 
    • “The recall, which includes the Portex Bluselect, Blugriggs and Bluperc kits, comprises more than 850,000 units, according to Food and Drug Administration database entries posted Wednesday. In a June letter to customers, Smiths said it received more than 10 reports of serious injuries related to the problem. 
    • “So far this year, Smiths has had seven Class I recalls, a designation the FDA uses for recalls with a risk of potential serious injury or death.”

Weekend Update

David Ermer–Congress, Employee Wellness Programs, Generative AI, Medical / Rx research, Medicare, U.S. Healthcare–

From Washington, DC,

  • The Hill reports,
    • “Rep. Andy Harris (R-Md.) predicted on Friday [September 13] that a government shutdown will be avoided as one looms.
    • “Do you believe that Republicans will be able to avoid a government shutdown?” NewsNation’s Blake Burman asked Harris on “The Hill.” “And do you think shutdowns are useful tools, or not?”
    • “There will not be a government shutdown, you know, one month before an election, that I can tell you,” Harris responded. 
    • “Lawmakers are racing to avoid a shutdown before the end-of-the-month deadline.”
  • Sen. Tim Kaine (D VA) has signed onto a bill as a co-sponsor to mandate FEHB coverage of IVF procedures. The Senate Majority Leader reportedly plans to bring up an IVF mandate bill this coming week.  
  • The American Medical Association’s public website explains various Medicare payment reform laws for its members.

From the public health and medical research front,

  • The AMA points out the top preventive health tips that your internist wants you to know.
  • The New York Times identifies “Three Medical Practices That Older Patients Should Question. Some treatments and procedures become routine despite lacking strong evidence to show that they’re beneficial. Recent studies have called a few into question.”
  • The Washington Post reports,
    • “More than 5 percent of women who get their tubes tied later become pregnant, a new analysis suggests — and researchers say the failure of tubal sterilization procedures, which are widely considered permanent, “may be considerably more common than many expect.”
    • “The study, published in NEJM Evidence, used data from the National Survey of Family Growth, which looks at contraception use, pregnancy and birth outcomes among a representative sample of U.S. women aged 15 to 44. The data was assembled during four waves of data collection from about 4,000 women who had tubal ligations between 2002 and 2015. * * *
    • “When choosing what birth control will work best for them, people consider many different things, including safety, convenience, and how fast they can start to use the method,” says Eleanor Bimla Schwarz, chief of the UCSF Division of General Internal Medicine at Zuckerberg San Francisco General and the study’s first author, in a news release.
    • “This study shows that tubal surgery cannot be considered the best way to prevent pregnancy. People using a contraceptive arm implant, or an IUD are less likely to become pregnant than those who have their tubes tied.”
    • “The researchers call for more inquiry into the “real-world effectiveness” of different forms of contraception.”
  • STAT News informs us from a Barcelona, Spain, oncology conference held this weekend,
    • “An AstraZeneca immunotherapy, given both before and after surgery, improved survival rates in patients with bladder cancer, results that could reshape how muscle-invasive bladder tumors are treated. 
    • “The regimen using Imfinzi, the company’s anti-PD-L1 checkpoint inhibitor, cut the risk of death by 25% compared to treating patients before surgery with chemotherapy alone, researchers reported Sunday. It also lowered the risk of disease recurrence by about a third. 
    • “It really is offering a curative-intent regimen and improving the cure rate in the disease,” Susan Galbraith, AstraZeneca’s head of oncology R&D, told STAT at the European Society for Medical Oncology meeting in Barcelona, using the word “transformative” several times. The results of the Phase 3 NIAGARA trial were presented in a presidential session at the conference and simultaneously published in the New England Journal of Medicine.
    • “Galbraith said the company would talk with regulators about the data, but experts will be watching to see if an ongoing debate about clinical trial design could pose a problem in this case.”
  • and
    • “Patients with advanced cancers often develop a secondary condition that causes them to shed weight, making it even harder to tolerate their cancer treatments. Called cachexia, it’s an under-recognized syndrome that researchers are still trying to tease out, and one that’s attracting more interest from drugmakers.
    • “On Saturday, Pfizer reported that an experimental antibody not only helped cancer patients with cachexia regain some weight versus placebo, but that it also seemed to increase their muscle mass and activity levels, signaling that the added weight translated into meaningful benefits.”
  • and
    • “A targeted immunotherapy being developed by the biotech iTeos Therapeutics and GSK delivered promising response rates in patients with a type of lung cancer, propelling the treatment into a pivotal Phase 3 trial and adding fuel to a broader debate about the validity of the target.
    • “The companies reported on Saturday that their combination of a TIGIT-targeting antibody and GSK’s Jemperli increased the percentage of patients who saw their tumors shrink versus those who received Jemperli alone, meeting the goals of the Phase 2 trial and the expectations that analysts had set for the study to be considered a success.”

From the U.S. healthcare business front,

  • Healthcare Dive tells us,
    • “Health systems are a large market for artificial intelligence startups, but companies selling to insurers or life sciences firms create value more quickly, according to an analysis by venture capital firm Flare Capital Partners.
    • “Most AI startups selling their products to health systems haven’t progressed past early-stage investment rounds. Just over 5% of those companies have reached a Series C raise or later, compared with nearly 10% of startups in life sciences and about 16% of companies selling to health plans. 
    • “The gap suggests AI startups in the life sciences and health plan markets have been able to create more value for their customers, according to Flare. But those sectors also have higher operating margins and can likely devote more resources — and time — to scale AI products.”\