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
    • “Nationally, seasonal influenza activity remains low. Additional information about current influenza activity can be found at: Weekly U.S. Influenza Surveillance Report | CDC.
  • “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.”