Tuesday Tidbits

CDC

Tuesday Tidbits

David Ermer–ACA, CDC, FDA, Federal employment benefits, Medical / Rx research, NIH, OPM, Rx coverage, SCOTUS, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • Yesterday, the Supreme Court invited the Solicitor General to submit a brief expressing her views on the 10th Circuit’s decision in PCMA v. Mulready which is favorable to ERISA and Medicare preemption of state PBM reform laws.
  • The Solicitor General typically submits a brief favoring Supreme Court review no later than December so that the Court can hear the case in its current term. If the Solicitor General opposes Supreme Court review, her brief likely will be submitted next April.
  • The FEHBlog hopes that the Solicitor General files an April 2025 brief.
  • Also yesterday, the Defense Department announced a one-year pilot program to provide no-cost supplemental health support services to DoD civilian employees serving in Japan after a yearlong effort to identify and address concerns regarding access to medical care.
    • “This pilot is called the Pilot Health Insurance Enhancement for DoD Civilian Employees in Japan and will assist [11,000] eligible civilian employees with health care navigation and upfront costs associated with accessing Japan’s healthcare system.
    • “To be eligible, the employee must be enrolled in a participating health plan through the Federal Employees Health Benefits (FEHB) program. The enrollment window for eligible employees will be the Federal Benefits Open Season, which runs this year Nov. 11 through Dec. 9. Federal Benefits Open Season allows federal civilians to enroll in or change health care options.
    • “The services provided under this pilot will begin Jan. 1, 2025, when participants can use the services and access support through a call center. The call center will be open 24/7 and staffed with bilingual service representatives who will assist callers with identifying their needs, make appointments with provider offices, and issue payment guarantees up front. Dependents are not eligible for services during the pilot, which runs through Sept. 29, 2025. * * *
    • “The Office of the Assistant Secretary of Defense for Health Affairs will oversee the pilot program and has awarded a $4.2 million contract to International SOS Government Services Inc., which is also the prime contractor for the TRICARE Overseas Program. The contract for this pilot is being funded by the military departments, defense agencies and DoD field activities that have civilian employees working in Japan.
    • “Active-duty service members and TRICARE Prime beneficiaries have prioritized access to health care in military hospitals and clinics based on current federal law and DoD policy. DoD civilians who are not TRICARE beneficiaries may use military health facilities on a space-available basis. [This unfortunate 2023 policy change led to this pilot.]
    • “Agreements with FEHB insurance carriers who currently provide coverage for DoD civilian employees in Japan will be established to provide direct billing agreements. Non-appropriated Fund (NAF) employees are eligible for this program if enrolled in an Aetna International plan.”
  • The FEHBlog finds it odd that the DOD pilot does not cover eligible family members.
  • Health Affairs Forefront provides even more details on the lengthy proposed 2026 Notice of Benefit and Payment Parameters for the ACA marketplace released last Friday.
  • Federal News Network tells us,
    • “After making improvements for two months, the Office of Personnel Management retirement backlog saw a decline in claims received and processed claims for the month of September.
    • “OPM received 5,618 claims in September, 1,465 less than the month of August’s claims received. OPM processed 6,302 claims in September, 1,400 less than in August.”
    • That appears to be a wash to the FEHBlog.

From the public health and medical research front,

  • American Hospital News informs us,
    • “The Centers for Disease Control and Prevention last week confirmed the first two human cases of H5 bird flu in California. The individuals were workers who had contact with infected dairy cows, CDC said. There have been 16 total human cases of H5 bird flu reported in humans across the country this year, with six being linked to exposure to sick or infected dairy cows, nine with exposure to infected poultry, and one case in Missouri with an origin that has yet to be determined. The CDC’s risk assessment of a bird flu outbreak for the general public remains low.”
  • Per BioPharma Dive,
    • “Vaccine maker GSK unveiled new data Tuesday showing its respiratory syncytial virus vaccine Arexvy protected older adults over three seasons against disease caused by infection.
    • “Across the entire time period, one dose of Arexvy was 63% effective against RSV broadly, and 67% effective against severe disease, GSK said. However, the shot’s efficacy waned, falling to an estimated 48% in the third season alone.
    • “Currently, the Centers for Disease Control and Prevention doesn’t recommend a second RSV vaccine dose. While GSK described the three-season data as evidence of the shot’s “significant health impact,” it said that “over time, revaccination is expected to be required to maintain an optimal level of protection.”
  • CNN reports,
    • “A new study found that having your arm in the wrong position during blood pressure checks — either at home or the doctor’s office — can result in readings “markedly higher” than when your arm is in the recommended position: appropriately supported on a table with the middle of the cuff positioned at heart level.
    • “This suggests that not consistently having your arm positioned and supported appropriately during a blood pressure reading might result in a misdiagnosis of high blood pressure, which some experts worry could possibly lead to unnecessary treatment.
    • “The study, published Monday in the journal JAMA Internal Medicine, found that having your arm resting in the lap during a blood pressure reading can lead to an overestimated systolic blood pressure measurement by 3.9 mm Hg and overestimated diastolic reading by 4 mm Hg. And having your arm hang by your side can lead to an overestimated systolic reading by 6.5 mm Hg and overestimated diastolic reading by 4.4 mm Hg.”
  • Per Healio,
    • “A blood test for men at the time of a metastatic prostate cancer diagnosis may predict treatment response and survival, according to study results.
    • “The test could help oncologists decide which patients should receive standard treatment and who might derive more benefit from a clinical trial, researchers concluded.”
  • The Washington Post lets us know,
    • “Children should spend up to two hours a day outside to reduce their risk of myopia, or nearsightedness, according to a new consensus report from the National Academies of Sciences, Engineering and Medicine. At least one of those hours should take place during the school day, the report says.
    • “Myopia is a condition in which distant objects are blurry but close-up objects look clear. The National Academies report cites research indicating a significant rise in myopia worldwide.”
  • The National Institutes of Health posted the latest issue of “Women’s Health In Focus at NIH, Volume 7, Issue 3, 2024.” This is a quarterly publication of NIH’s Office of Research on Women’s Health.
  • The International Foundation of Employee Benefit Plans offers flu season advice to employers.

From the U.S. healthcare business front,

  • The KFF-Peterson Health Tracker shares a “chart collection explores how health spending is expected to grow in coming years, based on National Health Expenditure (NHE) projections from federal actuaries. A related chart collection explores how U.S. health spending has changed over time using historical data, and an interactive tool allows users to explore health spending changes over time.”
  • Modern Healthcare reports,
    • “Four large nonprofit health systems created a new company to use as a testing ground for boosting access to drugs, improved care coordination for Medicare Advantage patients and streamlined billing processes.
    • “Baylor Scott & White Health, Memorial Hermann Health System, Novant Health and Providence are the founding members of Longitude Health. Each health system has made an undisclosed financial commitment to fund Longitude, which is a Delaware-based holding company owned and managed by its founders.
    • “The health system-led, for-profit entity plans to form three operating companies that will essentially act as startups on pharmaceutical development, care coordination and billing. Chief executive officers of the participating systems make up the Longitude board, along with Longitude CEO Paul Mango, former chief of staff at the Centers for Medicare and Medicaid Services.
    • “Executives hope to create additional operating companies and attract more health systems and investors over the next year.”
  • Beckers Hospital Review adds, “The U.S. spent $99 billion on both oral and clinician-administered cancer therapies in 2023, according to a report published in April by analytics firm IQVIA. As cancer drug prices continue to increase, spending is projected to grow.”
  • Per Fierce Pharma,
    • “As the eastern U.S. braces for another storm in the form of Hurricane Milton, at least one major drugmaker is stepping up to support Florida locals and preserve access to critical medical supplies and drugs.
    • “Pfizer—which opened a global hub in Tampa, Florida, in 2021—is setting out to bolster emergency services, pool donations and ease medical supply needs as Milton touches down this week, the company’s CEO, Albert Bourla, Ph.D., said in a post on X (formerly Twitter) Tuesday.
    • “Like many people, I have watched with a heavy heart as the scale of the damage caused by Hurricane Helene has become fully evident,” the chief executive said. “Now it seems Hurricane Milton is heading toward the Tampa area, where we have a major Pfizer facility.”
    • “In light of the impending natural disaster, Bourla said Pfizer is pledging all it can to support the community during this trying time.”
  • Per MedTech Dive,
    • “Baxter said Monday it has made progress restoring a North Carolina manufacturing plant damaged by Hurricane Helene. 
    • “Rain and storm surge from Hurricane Helene flooded the plant and damaged access bridges. So far, Baxter has not identified any structural damage to the facility. The Marion, North Carolina, site is the company’s largest manufacturing facility and produces dialysis solutions and IV fluids.
    • “Baxter is resuming shipments of dialysis products to hospitals and patients after a temporary hold last week.”
  • and
    • “Mercury Medical has recalled 1,300 emergency breathing support devices in response to a problem that can affect ventilation of the patient.
    • “The Food and Drug Administration, which published an alert about the problem Monday, categorized the action as a Class I recall. Mercury asked customers to stop the use and distribution of the affected devices.
    • “No reported injuries or deaths have been associated with the issue, but the FDA said affected products could cause serious adverse health consequences.”
  • Beckers Hospital Review points out,
    • “A group representing companies that produce copycat versions of Eli Lilly weight loss medications has filed a lawsuit against the FDA following the agency’s recent decision to remove the drugs from its shortage list, Bloomberg reported Oct. 7. 
    • “The Outsourcing Facilities Association, along with compounding pharmacy FarmaKeio Superior Custom Compounding, alleged the FDA acted arbitrarily and failed to provide prior notice regarding its decision. 
    • “The plaintiffs asserted that the shortage of Lilly’s drugs is not truly over and argued that the FDA’s action limits patient access to essential medications. The lawsuit seeks to overturn the FDA’s removal of Lilly’s weight loss drugs from the shortage list. 
    • “With the FDA announcement, many patients who relied on compounded versions of the medications now face the choice of switching to higher priced brand-name medications or seeking alternatives from Novo Nordisk.” 
  • Per SHRM, Mercer Consulting predicts
    • “Employers may be cautious about pay due to economic concerns, but they are planning to stay consistent with salaries next year—at least for now.
    • “On average, U.S. employers are budgeting for 3.3% merit increases and 3.6% increases for their total salary budgets for nonunionized employees, according to new data from consulting firm Mercer, which surveyed more than 1,100 employers to gauge what pay will look like in 2025. These numbers are the same as the actual pay increases that employers delivered in 2024.
    • “Mercer’s analysis also found that, in addition to remaining consistent with salary increases, employers are planning to promote just under 10% of their employees in 2025. For companies with a separate promotion budget, the average promotion increase budget for 2025 is 1%, down slightly from 1.1% in 2024.
    • “There are variations in compensation projections across industries, Mercer found. For example, technology and life sciences reported above-average compensation budgets, with merit and total increase budgets at 3.5% and 3.9%, respectively. On the other end of the spectrum, retail and wholesale reported merit and total increase budgets of 3.1% and 3.3%, respectively.”

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.”

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.”

Friday Factoids

David Ermer–CDC, FDA, Medical / Rx research, U.S. Healthcare–

From Washington, DC,

  • Healthcare Dive lets us know,
    • The Federal Trade Commission has filed suit against the three largest pharmacy benefit managers in the country for anticompetitive business practices that artificially inflated the price of life-saving insulin drugs.
    • The agency’s administrative complaint alleges CVS’ Caremark, Cigna’s Express Scripts and UnitedHealth’s Optum Rx steered patients toward higher priced insulin in order to bring in larger rebates from pharmaceutical manufacturers.
    • As a result, patients who weren’t eligible for the lower discounted price faced higher costs, the FTC alleges. Caremark, Express Scripts and Optum Rx together control about 80% of U.S. prescriptions.
  • The FTC has decided to try the case in the FTC’s administrative court, instead of a federal district court. Any appeal would be taken to a federal circuit court of appeals, typically the D.C. Circuit.
  • Modern Healthcare adds,
    • “CVS Caremark in a statement said it had worked to drive down insulin prices by creating new formulary options and negotiating discounts on behalf of clients. It pointed to a program available to patients at its network pharmacies offering lower-cost insulin.
    • “Any action that limits the use of these PBM negotiating tools would reward the pharmaceutical industry and return the market to a broken state, leaving American businesses and patients at the mercy of the prices drugmakers set,” a spokesperson said in the statement.
    • “Cigna Chief Legal Officer Andrea Nelson refuted the FTC’s allegations and reiterated the role PBMs such as Express Scripts play in the healthcare system. She said the case could lead to higher drug prices.
    • “Express Scripts intends to vigorously defend itself to protect our ability to lower drug costs for the thousands of clients and the millions of Americans we serve,” Nelson said in a statement.
    • “An OptumRx spokesperson said in a statement its negotiations with drugmakers and other actions have led to lower insulin costs for members.
    • “This baseless action demonstrates a profound misunderstanding of how drug pricing works,” the spokesperson said.”
  • CMS posted the presentation from the agency’s September 10 webinar about group health plan Section 111 reporting.
  • Fierce Healthcare tells us,
    • “The Medicaid unwinding is coming to a close, and a new analysis from KFF finds that while many people have lost coverage during this period, enrollment remains above pre-pandemic levels.
    • “The report estimates that more than 25 million people were disenrolled as part of the Medicaid redeterminations, while more than 56 million renewed coverage successfully. However, while millions have lost coverage, there are about 10 million more people enrolled in Medicaid and the Children’s Health Insurance Program (CHIP) compared to the start of the COVID-19 pandemic.
    • “KFF found that most states completed the redeterminations with higher enrollment than they reported in February 2020. In seven states, enrollment was 30% above pre-pandemic levels.
    • “Also playing a role is the fact that five states—Missouri, Nebraska, North Carolina, Oklahoma, and South Dakota—expanded their Medicaid programs since the pandemic began, COVID-19 said.
    • “There have always been people eligible for Medicaid but not enrolled, as well as people who get dropped from Medicaid for failing to complete regular renewal processes,” the researchers wrote. “During the unwinding period, many states took steps to improve their renewal systems, leading to fewer people getting dropped even though they remain eligible.”

From the public health and medical research front,

  • The Centers for Disease Control and Prevention announced,
    • “Seasonal influenza and RSV activity are low nationally and COVID-19 activity is decreasing in most areas.
    • “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 2.8% of adults 18 years and older reporting receipt of the updated 2024-25 COVID-19 vaccine and 6.8% reporting receipt of an influenza vaccine. Among adults 75 years and older, 33.1% reported ever receiving an RSV vaccine. RSV, influenza, and COVID-19 vaccines are available to provide protection during the 2024-25 respiratory illness season.
  • In Covid news, The University of Minnesota’s CIDRAP adds,
    • “Test positivity for COVID was 13.5% last week, down from 14.9% the week before.
    • “Hospitalizations continue to decline but remain highest in seniors, followed by adults ages 50 to 64 and children younger than age 4 years. 
    • “Emergency department visits dropped about 19% compared to the previous week and are now at low levels across much of the country. 
    • “Deaths held steady, and provisional data show that the CDC received reports of 563 COVID deaths for the week ending September 14.
    • “Detections of SARS-CoV-2 in wastewater are still high nationally, according to CDC tacking. The highest levels remain in the West, followed by the Midwest and the South. However, all regions show downward trends.
    • ‘The latest data from WastewaterSCAN, a national wastewater monitoring system based at Stanford University in partnership with Emory University, show that detections are still high nationally and, in the Midwest, with no significant up or down trend over the past 3 weeks.”
  • NBC News informs us,
    • “The U.S. is experiencing more than four times as many whooping cough cases compared with last year — a spike that some experts attribute to post-pandemic vaccine fatigue. 
    • “With the increase in vaccine hesitancy that has been going on since the Covid-19 pandemic, we’re seeing outbreaks occurring in kids who are not vaccinated,” said Dr. Tina Tan, president-elect of the Infectious Diseases Society of America.
    • “Babies are given the DTaP vaccine, which helps protect against three diseases: pertussis, diphtheria and tetanus. The vaccine works well against diphtheria and tetanus, but is less effective over time for pertussis. 
    • “Advisors to the Food and Drug Administration met Friday to discuss the need for more robust and longer-lasting versions of the whooping cough vaccine. 
    • “Until next generation vaccines are developed, boosters are recommended about every 10 years, starting in the tween years, as kids start middle school. 
    • “It’s the tweens and teens whose immunity against whooping cough has waned that are driving outbreaks in many states, experts say.”
    • “On Thursday, the CDC reported that 14,569 cases of whooping cough had been confirmed so far in 2024. That’s a significant increase over last year’s total of 3,475 cases.”
  • The New York Times reports,
    • “The Food and Drug Administration on Friday authorized at-home use of FluMist, opening the door for needle-shy people to have easy access to a nasal spray vaccine that is potentially lifesaving.
    • “The approval will allow, for the first time, an alternative to the annual flu shot that parents and caregivers can give to children and that adults can use on their own outside of a health-care setting. It would still require a prescription and is expected to be available from an online pharmacy next fall.
    • “AstraZeneca, which makes the treatment, said it would start a FluMist Home website, where people can fill out a questionnaire that will be reviewed by a pharmacist before the treatment is shipped to a person’s home. The mist will remain available from prescribers as an in-office treatment. The current out-of-pocket cost for a dose is about $35 to $45 but may be less depending on insurance coverage.
    • “Today’s approval of the first influenza vaccine for self- or caregiver-administration provides a new option for receiving a safe and effective seasonal influenza vaccine potentially with greater convenience, flexibility and accessibility for individuals and families,” said Dr. Peter Marks, director of the F.D.A.’s vaccine center, which authorized the at-home option.”
  • The American Hospital Association News points out,
    • Drug overdose deaths have dropped by 10% this year compared to last, according to data from the Centers for Disease Control and Prevention. This year also marked an annual decline in overdose deaths for the first time in five years. On Aug. 31, federal agencies awarded an additional $416 million to respond to the overdose crisis and support substance use treatment and recovery services. The AHA remains focused on supporting hospitals and health systems in reducing drug overdose deaths, including by providing resources to enhance opioid stewardship. Learn more from AHA’s Opioid Stewardship Hub.” 
  • Per an FDA press release,
    • “Today, the U.S. Food and Drug Administration approved Miplyffa (arimoclomol), an oral medication for the treatment of Neimann-Pick disease, type C (NPC). Miplyffa, in combination with the enzyme inhibitor miglustat, is approved to treat neurological symptoms associated with NPC in adults and children 2 years of age and older.
    • “Miplyffa is the first drug approved by the FDA to treat NPC. NPC is a rare genetic disease that results in progressive neurological symptoms and organ dysfunction. It is caused by changes in either the NPC1 or NPC2 gene, affecting the necessary transport of cholesterol and other lipids within a cell. As a result, these cells do not function as they should, ultimately causing organ damage. On average, individuals affected by this devastating disease only live for about 13 years.
    • “NPC is a serious disease that leads to enormous adverse impacts on patients and families. Despite extensive research efforts, there have not been approved treatments to meet the significant needs of patients,” said Janet Maynard, M.D., M.H.S., director of the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine (ORPURM), in the FDA’s Center for Drug Evaluation and Research. “The first-ever approval of a safe and effective drug option for NPC will undoubtedly support the essential medical needs of those suffering.”
  • STAT News lets us know,
    • “A next-generation obesity drug candidate from Novo Nordisk produced modest weight loss, along with a higher rate of some psychiatric side effects like anxiety and sleep disturbances — results that pose a challenge to the pharma giant’s efforts to find novel obesity drugs that could extend its success from its blockbuster Wegovy.
    • “A Phase 2a trial tested monlunabant, a pill that inhibits CB1 receptors that Novo got through its acquisition of Inversago Pharma last year. Those on the lowest dose of 10 mg lost on average 6.4% of their weight at 16 weeks, compared with 0.6% in the placebo group, Novo said Friday. The study also tested higher doses of 20 mg and 50 mg, but Novo said “limited additional weight loss” was seen at these higher doses and did not disclose specific data.”

From the U.S. healthcare business front,

  • Beckers Hospital Review Becker’s has compiled “a list of 189 hospitals with a CMS five-star rating for care transitions” and identified the “top ranked hospitals for coronary bypass in the U.S., according to the WebMD Choice Awards.
  • The Wall Street Journal reports,
    • “A price battle has broken out in the hot market for weight-loss drugs.
    • “Eli Lilly and Novo Nordisk, the pharmaceutical heavyweights selling the popular injections, are each dangling discounts to gain an edge and to induce health plans to pay up. The concessions are slashing as much as half off the price tags of the $1,000-plus-a-month medicines.
    • For people who pay out of pocket, Lilly recently introduced vials of its drug Zepbound that cost as little as $399 a month.
    • Price concessions are a new, major development in the burgeoning market for weight-loss drugs, after high prices and limited supplies led many health plans to refuse coverage and prompted some patients to turn to lower-priced but unapproved custom-made version.
  • MedTech Dive notes,
    • “GE Healthcare has received 510(k) clearance for a tool designed to help clinicians assess people who may have Alzheimer’s disease, the company said Tuesday.
    • “The clearance adds a Centiloid scale tool to GE Healthcare’s Mim software to enable clinicians to determine the density of amyloid plaque in a patient’s brain from PET scans. Amyloid is a protein that, in Alzheimer’s, can clump up into toxic plaques in the brain. Scientists have linked the formation of those plaques to symptoms such as memory loss.
    • “Researchers developed the Centiloid scale, which Eisai and Eli Lilly used during the development of their recently approved Alzheimer’s drugs, to standardize amyloid imaging measures.
  • and
    • “Abbott ramps up Libre 3 production amid shortages. Some people are facing delays in filling prescriptions for the glucose sensor. Abbott expects to resolve the problem soon.” * * *
    • “Some people who use a Freestyle Libre 3 glucose sensor are facing delays getting their prescriptions filled.
    • “Abbott spokesperson Lindsy Delco said the delays are driven by strong demand for the Libre 3 sensors. The company is ramping up production, adding capacity to an existing manufacturing facility this month, and opening a new manufacturing facility later this year, she wrote in an email.” * * *
    • “If people are unable to get Libre 3 sensors through their pharmacy or mail order company, Delco recommended checking back in a few days to see if they have new supply.
    • “If there are prolonged delays, another option is to talk to a healthcare provider about switching to a prescription for Freestyle Libre 3 Plus, Delco said. The Food and Drug Administration cleared the newer version of the sensor last year. It has a 15-day wear time, instead of 14 days for the Libre 3. The Libre 3 Plus has supply at both pharmacies and mail-order companies, according to Abbott.”

Midweek update

David Ermer–CDC, Congress, COVID-19, Federal employment benefits, Medical / Rx research, NIH, OPM, Rx coverage, SCOTUS, Telehealth, U.S. Healthcare, Uncategorized–
Photo by Tomasz Filipek on Unsplash

From Washington, DC,

  • NBC News informs us,
    • “House Republicans on Wednesday defeated their own plan to avert a government shutdown at the end of the month, with the party divided over the length of a short-term funding bill and what, if anything, should be attached to it.
    • “It was an embarrassing blow to Speaker Mike Johnson, R-La., who had yanked the same funding package off the floor last week amid growing GOP defections, only to watch it collapse on Wednesday in a vote that seemed doomed from the start.
    • “The vote was 202-220 with two members voting present. In all, fourteen Republicans voted against the package and three Democrats voted for it.
    • “Thirteen days before money runs out for the federal government, there is still no bipartisan plan to stave off a shutdown. While the GOP-led House could try again, the focus now likely shifts to the Senate, where leaders in both parties agree a shutdown would be disastrous weeks before the election.”
  • Govexec adds,
    • “Legislation to cover a $3 billion shortfall in veterans’ benefits through the end of the month passed the House Tuesday, three days before benefits could be disrupted.  
    • “Lawmakers passed the Veterans Benefits Continuity and Accountability Supplemental Appropriations Act by voice vote Tuesday evening, sending it to the Senate ahead of a Friday deadline to ensure the Veterans Affairs Department can process benefit payments for 7 million veterans. * * *
    • “Senate Veterans’ Affairs Committee Chairman Jon Tester, D-Mont., said in a statement Tuesday that it was critical that the Senate move with haste to pass the legislation.”
  • STAT News reports,
    • “A House committee on Wednesday advanced legislation that would extend Medicare telehealth flexibilities, and a home hospital program adopted during the pandemic, the final step before the bills face a vote by the full House of Representatives.
    • “Congress in 2022 extended pandemic-era flexibilities about where and what kinds of care Medicare enrollees could receive over telehealth. The two-year telehealth extension unanimously passed on Wednesday by the House Energy & Commerce Committee is very similar to bills advanced in May by Commerce’s health subcommittee and the House Ways & Means Committee. 
    • “The two bills set up the House position heading into negotiations with the Senate on extending the telehealth policies, which expire at the end of December.” 
  • Per Federal News Network,
    • “House Democrats are pushing harder to try to help federal employees more easily access IVF treatments. A new bill, called the Right to IVF Act, rolls together four previous bills all aiming to broaden fertility coverage nationwide. Part of the legislation would require carriers in the Federal Employees Health Benefits Program to increase their coverage of IVF for FEHB enrollees. The Democrats who introduced the bill are calling for a House floor vote, but so far, the legislation has no Republican co-sponsors.(Right to IVF Act – Reps. Gerry Connolly (D-Va.), Susan Wild (D-Pa.), Rick Larsen (D-Wash.) and Rosa DeLauro (D-Conn.))”
  • and
    • “Federal benefits for health and retirement are a major recruitment and retention influence for employees, especially for early-career talent.
    • “Women as well as individuals in younger generations ranked the importance of federal benefits more highly than older or male employees, according to the results of the 2023 Federal Employee Benefits Survey (FEBS) from the Office of Personnel Management, obtained exclusively by Federal News Network.
    • “The benefits stemming from the Federal Employees Health Benefits (FEHB) program and the paid parental leave program are particularly important to younger generations of employees, OPM’s survey showed. Specifically, 94% of millennial and Gen Z respondents said the FEHB was either “important” or “extremely important” to them, compared with 84% of baby boomers and older generations who gave the same response.
    • “It is clear that these major benefit programs have an impact on both recruiting and retaining talent in the federal government, making it critical to continuously improve these benefits to meet employee needs,” OPM wrote in the survey results.”
  • A commentator writing in Real Clear Health commends the FEHB Program for being a catalyst for change in women’s health care and suggests three improvements:
    • Provide solutions for perimenopause and menopause
    • Provide a safety net for caregivers, and
    • Provide enhanced family planning and maternal care.
  • Mercer Consulting offers FAQs on the Supreme Court’s recent Loper Bright decision.
    • “The US Supreme Court overturned a 40-year-old principle of administrative law known as the Chevron deference doctrine (Loper Bright Enterprises et al. v. Raimondo, Secretary of Commerce, et al.). That doctrine required courts to defer to administrative agencies’ reasonable interpretation of a federal law that is silent or ambiguous. Now, federal courts must exercise independent judgment when determining the best interpretation of a statute and cannot simply defer to agency interpretations, even when they are reasonable. This will likely increase courts’ scrutiny of federal agency regulations that are subject to legal challenges. These FAQs provide high-level information about the case and its potential impact on employee benefit plans and their sponsors. Also, this Mercer US Health News 15-minute video highlights the practical implications of this opinion on employer-sponsored health plans.”

From the public health and medical research front,

  • MedPage Today lets us know,
    • “The new COVID-19 variant XEC may overtake others in circulation to become dominant in the coming months, experts said but will not prompt a meaningful change in symptoms or vaccine response.” * * *
    • “XEC represents a fairly minor evolution relative to the SARS-CoV-2 diversity currently in circulation, and is not a highly derived novel variant such as those that were granted Greek letters,” like Alpha, Delta, and Omicron, Francois Balloux, PhD, a computational biologist at University College London and director of the UCL Genetics Institute, said in a Science Media Centre statement.
    • “Experts noted that while XEC may have a small advantage in transmission, available vaccines are still likely to provide protection from serious illness.
    • “XEC is a “recombinant variant of some of the other Omicron lineages that have been around for a while, and it does appear to be more immune evasive, giving it a transmissibility advantage in the population with the immunity that it has,” Amesh Adalja, MD, of the Johns Hopkins Center for Health Security in Baltimore, told MedPage Today. “But it doesn’t really change anything, just like the last variant didn’t change anything, or the one before that, one before that, or the one before that.”
  • NBC New points out,
    • “Black women are more likely than white women to die from even the most treatable types of breast cancer, a study published Tuesday in the Journal of Clinical Oncology found.
    • “The findings, experts say, underscore that it’s racial disparities, not biology, driving the biggest differences in death rates between Black and white women. While Black women and white women are diagnosed with breast cancer at similar rates, Black women are 40% more likely to die from the disease.” * * *
    • “If you look at breast cancer data from 40 years ago, there really weren’t differences in mortality for breast cancer between Black and white women. We weren’t very good at treating and diagnosing it. But as we’ve gotten better, the gap between white and Black women has grown,” [lead author Dr. Erica] Warner said. “That is problematic, but that also tells us we have our foot on the pedal for these differences. If we can create them, we can eliminate them.” 
  • STAT News reports,
    • “A long-running race to develop a gene therapy for the most common cause of age-related blindness is heating up.
    • “On Wednesday, 4D Molecular Therapeutics announced new data from its program for the disease, known as wet age-related macular degeneration, or wet-AMD. In one 30-person Phase 2 study, patients’ need for standard-of-care injections fell by 89% after receiving gene therapy, and 73% did not need another standard-of-care shot for at least 32 weeks. 
    • “Notably, only two of 71 patients who received a high dose of therapy have shown signs of ocular inflammation, 4D said. In 2021, another leading contender, Adverum, was set back after a patient with a related disease went blind in one eye. 
    • “I think it’s very positive and there’s a good chance they’ll be able to move toward approval,” said Ron Crystal, chair of genetic medicine at Weill Cornell Medical Hospital, who has served as a scientific adviser to and has stock in Adverum.”
  • The New York Times notes,
    • “Adults under age 50 have been developing breast cancer and colorectal cancer at increasingly higher rates over the last few decades, and alcohol use may be one factor driving the trend, according to a scientific report published on Wednesday.
    • “The report, by the American Association for Cancer Research, highlights scientific breakthroughs that have led to new anticancer drugs and improved overall survival.
    • “But the authors also described a troubling pattern: Even as cancer death rates have declined, the overall incidence of several cancers has been rising inexplicably, with an especially alarming increase among younger adults in cancers of the gastrointestinal system, like colorectal cancer.
    • “The report estimates that 40 percent of all cancer cases are associated with modifiable risk factors. It recommends reducing alcohol consumption, along with making lifestyle changes such as avoiding tobacco, maintaining a healthy diet and weight, exercising, avoiding ultraviolet radiation and minimizing exposure to pollutants.”
  • Per NIH press releases,
    • “Results from a large study supported by the National Institutes of Health show that protein analyses taken during the first trimester of pregnancy did not improve predictions for identifying people at risk for experiencing conditions related to having high blood pressure during pregnancy. Since there is an urgent need to better predict people at risk for developing conditions related to having high blood pressure during pregnancy, also called hypertensive disorders of pregnancy, researchers have been studying if proteins taken from blood or urine samples could provide this insight. This study provides the largest data to date based on using protein analyses from blood samples during early pregnancy.”
  • and
    • “Researchers at the National Institutes of Health (NIH) and their collaborators have identified a protein, known as RNF114, that reverses cataracts, a clouding of the eye’s lens that occurs commonly in people as they age. The study, which was conducted in the 13-lined ground squirrel and rats, may represent a possible surgery-free strategy for managing cataracts, a common cause of vision loss.  The study published in the Journal of Clinical Investigation.
    • “Scientists have long searched for an alternative to cataract surgery, which is effective, but not without risk. Lack of access to cataract surgery is a barrier to care in some parts of the world, causing untreated cataracts to be a leading cause of blindness worldwide,” said Xingchao Shentu, M.D., a cataract surgeon and the co-lead investigator from Zhejiang University, China.” * * *
    • “According to the scientific team, these findings are proof-of-principle that it is possible to induce cataract clearance in animals. In future studies, the process will need to be fine-tuned so scientists can stimulate specific protein degradation to see how to precisely regulate protein stability and turnover. This mechanism is also an important factor in many neurodegenerative diseases, they said.”
  • and
    • “A clinical trial supported by the National Institutes of Health (NIH) was stopped early after researchers found sufficient evidence that a drug used to treat bone marrow cancer and Kaposi sarcoma is safe and effective in treating hereditary hemorrhagic telangiectasia (HHT), a rare bleeding disorder that affects 1 in 5,000 people worldwide. The trial results, which are published in the New England Journal of Medicine, detail how patients with HHT given the drug, called pomalidomide, experienced a significant reduction in the severity of nosebleeds, needed fewer of the blood transfusions and iron infusions that HHT often demands, and showed improved quality of life.
    • “Finding a therapeutic agent that works in a rare disorder is highly uncommon, so this is a real success story,” said Andrei Kindzelski, M.D., Ph.D., of NIH’s National Heart, Lung, and Blood Institute. “Before our trial, there was no reliable therapeutic to treat people with HHT. This discovery will give people who suffer with this disease a positive outlook and better quality of life.”

From the U.S. healthcare business front,

  • Per Beckers Hospital Review,
    • “St.-Louis-based Ascension reported a $79 million operating loss (-0.3% margin) for the 10 months ending April 30, a substantial improvement on the $1.2 billion operating loss in the previous 10-month period. 
    • “The results include $402 million in one-time, non-cash write-downs and non-recurring losses.
    • “In May and June 2024, operations were hampered by the May ransomware attack, resulting in reduced revenues from the associated business interruption along with costs incurred to address the issues and other business-related expenses.
    • “Despite this incident, Ascension drove a $1.2 billion operational improvement year over year for the 10 months ending April 30. The 136-hospital system’s economic improvement plans focused on volume growth, rates and pricing, and cost levers. 
    • “The results are a notable improvement on the $3 billion operating loss (-5.5% margin) reported in fiscal year 2023. Including the cyberattack, Ascension reported a $1.8 billion (-4.9% margin) loss in FY 2024. 
    • “Ascension is also reorganizing its portfolio with several transactions in multiple markets.”
  • Healthcare Dive tells us,
    • “Community Health Systems’ Northwest Urgent Care has signed a definitive agreement to purchase 10 Arizona urgent care centers from Carbon Health for an undisclosed price, according to a press release this week.
    • “The acquisition, which is expected to close in the fourth quarter, will grow CHS’ integrated health network to more than 80 care sites in the Tucson, Arizona region, according to CHS.
    • “The acquisition is a reversal from CHS’ recent string of hospital divestitures, which have been integral to helping the operator deleverage its portfolio.”
  • Per BioPharma Dive,
    • “Organon has agreed to buy Roivant’s dermatology subsidiary Dermavant for $175 million upfront plus more than $1 billion in potential additional payments if certain milestones are hit.
    • “With the acquisition, Organon will gain Dermavant’s cream called Vtama, which was approved in 2022 to treat plaque psoriasis. The medicine is also awaiting action from the Food and Drug Administration that could expand its use to include atopic dermatitis, commonly known as eczema.
    • “Approval in eczema, expected in the fourth quarter, would trigger a $75 million payment, Organon said Wednesday. The deal also includes $950 million in potential commercial milestone payments as well as tiered royalties on net sales to Dermavant shareholders. Roivant owns the majority of Dermavant.”
  • Fierce Healthcare points out,
    • “If a patient receives a continuous glucose monitor device through their medical benefit, they may be more adherent and may have lower costs, according to a new analysis.
    • “Researchers at CCS, which offers clinical services and home delivery for medical supplies for people with chronic conditions, published the peer-reviewed study this week in the Journal of Medical Internet Research Diabetes (JMIR) and found that patients who secured the monitors through their medical coverage had 23% higher rates of adherence.
    • “The study included data on 2,356 people, with 1,178 in the pharmacy benefit group and 1,178 in the durable medical equipment cohort. In addition to greater adherence, the study found that people who received the devices through their medical benefit had 35% lower average annual total costs of care.
    • “And, for patients who were not adherent to their devices, there was a higher rate of reinitiation (22%) for those in the medical benefit compared to those who received the glucose monitors through their pharmacy benefit (11%).”
  • Per MedTech Dive,
    • “Zimmer Biomet will phase out sales of its CPT Hip System by December due to concerns about the risk of thigh bone fractures, the Food and Drug Administration said in a Tuesday notice. 
    • “Despite plans to pull the device, the FDA said it is still concerned about the hip system being implanted in new patients, and it is “working with the manufacturer to address these concerns.” 
    • “Earlier this month, the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) flagged a higher risk of thigh bone fracture after surgery with the CPT Hip System, compared with similar hip replacement devices. While the analysis is currently unpublished, the British Hip Society and the British Orthopaedic Association advised against using the implant for elective surgery unless in exceptional circumstances.”

Friday Factoids

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

From Washington, DC,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Thursday Miscellany

David Ermer–CDC, Congress, FDA, Federal employment benefits, Medical / Rx research, OPM, Patient safety, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC,

  • The Wall Street Journal reports,
    • “Two U.S. senators are aiming to crack down on deceptive or misleading online promotion of weight-loss and other prescription drugs by telehealth firms and social-media influencers who profit from their posts.
    • “New bipartisan legislation proposed by Sens. Dick Durbin (D., Ill.) and Mike Braun (R., Ind.) would authorize the Food and Drug Administration to warn and potentially impose costly fines on those who post false information online about medicines or omit important information about a drug’s safety risks.
    • “One impetus for the bill, according to a Senate aide, is the 2024 reporting by The Wall Street Journal about how social media has fueled demand for Ozempic and Wegovy from Novo Nordisk as well as other drugs used for weight loss. The Journal found that posts on platforms such as TikTok, YouTube and Instagram often omit information about difficult side effects, and that some influencers and companies profit from the posts.”
  • Healthcare Dive informs us,
    • “Top executives at major pharmacy benefit managers are standing behind recent testimony on the Hill that put them in hot water with the chair of the powerful House Oversight Committee.
    • “Chair James Comer, R-Ky., accused Patrick Conway, the CEO of UnitedHealth’s Optum Rx; Adam Kautzner, the president of Cigna’s Express Scripts; and David Joyner, the president of CVS’ Caremark, of lying during a July hearing, and gave them until Wednesday to correct their statements or face potential fines or jail time.
    • “Optum Rx, Caremark and Express Scripts have responded to Comer and declined to change any testimony, the companies confirmed. The House Oversight Committee is “reviewing the PBMs’ written responses as well as the additional documents and information they provided,” according to a spokesperson.”
  • Per Fierce Healthcare,
    • “Steward Health Care CEO Ralph de la Torre, M.D., defied a subpoena to testify before Congress Thursday morning, leading heads of the investigating committee to promise civil enforcement and criminal charges for the executive.
    • “During the summer, the Senate Committee on Health, Education, Labor and Pensions (HELP) had voted to issue its first subpoena in over 40 years. Chairman Bernie Sanders, D-Vermont, said at the time that de la Torre needed to “explain to Congress the financial chicanery that made him extremely wealthy while the hospitals he managed went bankrupt.”
    • “Sanders and Committee Ranking Member Bill Cassidy, M.D., R-Louisiana, said Thursday that de la Torre’s legal team suggested he would be in attendance until they received a letter eight days ago. The letter informed the committee that he would not be attending out of concern that his testimony could harm the company’s ongoing bankruptcy proceedings. His legal counsel also suggested that the senators planned to turn their hearing into a “pseudo-criminal proceeding.”
    • “The committee overruled the letter a day later and told de la Torre to show up anyway. He did not.”
  • American Hospital Association News tells us,
    • “The Centers for Disease Control and Prevention Sept. 12 released a rural health strategic plan which includes the agency’s key priorities, objectives and outcomes in rural health for the next five years. The CDC’s priorities include advancing results-based engagement with partners and communities to address rural health challenges, strengthening rural health infrastructure and the workforce, advancing rural health science and improving rural health preparedness and response capacity. As part of the fiscal year 2023 Congressional appropriations, CDC created an Office of Rural Health to coordinate its growing rural health portfolio across the agency.”
  • Per HHS press releases,
    • “Today, the Department of Health and Human Services (HHS), through the Office of the Assistant Secretary for Health (OASH) and the Health Resources and Services Administration (HRSA), announce a Notice of Proposed Rulemaking (NPRM) to amend the regulations implementing the National Organ Transplant Act of 1984. * * *
    • “The proposed rule change, if finalized, would remove clinical research and institutional review board (IRB) requirements for transplantation of kidney and livers from donors with human immunodeficiency virus (HIV) to recipients with HIV. The proposed rule, Organ Procurement and Transplantation: Implementation of the HIV Organ Policy Equity (HOPE) Act, is based on rigorous analysis of clinical data.
    • “If the proposed rule is finalized, HHS expects this rule will allow a larger number of transplant centers to conduct HOPE Act kidney and liver transplants and will help reduce the stigma and health disparities associated with HIV. 
    • “Public comments on the NPRM are due 30 days after publication of the NPRM in the Federal Register on October 15, 2024, at 11:59 PM ET. The NPRM may be viewed or downloaded at: Federal Register: Public Inspection: Organ Procurement and Transplantation: Implementation of the HIV Organ Policy Equity Act.”
  • and
    • “Today, the U.S. Department of Health and Human Services, through the Office of Research Integrity (ORI), finalized the 2024 Public Health Service (PHS) Policies on Research Misconduct. This rule updates the 2005 regulation and clarifies requirements for addressing research misconduct in PHS-funded research.” * * *
    • “The research landscape has changed over the past 20 years with new technology, scientific advances, and globalization, which increases the need for ORI to remain nimble and collaborative. ORI is committed to keeping up with the needs of the research community,” said ORI Director Sheila Garrity. “The Final Rule aims to adapt to our current time, support our colleagues in the research community, and fortify ORI’s role in fostering research integrity and preserving public trust in science for future generations.”
    • “The Final Rule takes effect January 1, 2025, and becomes applicable on January 1, 2026. In the coming months, ORI plans to release sample policies and guidance to help prepare PHS-funded entities. The Final Rule can be found here https://www.federalregister.gov/public-inspection/2024-20814/public-health-service-policies-on-research-misconduct.”
  • FedWeek discusses the all-important Five-Year Rule which generally is a prerequisite for continuing FEHB and FEGLI coverage into federal retirement.

From the public health and medical research front,

  • STAT News reports,
    • “Disease investigators have not been able to determine how a person in Missouri with no known exposures to animals or poultry became infected with an H5 bird flu virus, the principal deputy director of the Centers for Disease Control and Prevention said Thursday.
    • “But Nirav Shah said the ongoing investigation has turned up no evidence of onward spread of the virus, suggesting this case may turn out to be a one-off infection that defies explanation.
    • “Here’s the bottom line: Our influenza surveillance system is designed to find needles in haystacks,” Shah said at a news briefing. “Here in this case, we found such a needle, but we don’t know how it got there. Our investigation continues, and we will keep everyone updated as we learn more.”
  • and
    • “Gilead said Thursday that its twice-yearly antiviral reduced the risk of HIV infections by 96% compared to an expected rate of infection in a second pivotal trial, paving the way for the likely approval of the drug for pre-exposure prophylaxis, or PrEP.
    • “The study, which enrolled cisgender men, transgender women, transgender men, and gender nonbinary individuals who have sex with partners assigned male at birth, also showed that the antiviral, called lenacapavir, was 89% more effective than a daily pill called Truvada.
    • “Specifically, two out of the 2,180 participants taking lenacapavir contracted HIV, while nine out of the 1,087 individuals in the Truvada group did.
  • The New York Times reports,
    • One dozen of 36 cinnamon products tested by a consumer group contained elevated levels of lead, according to a study released on Thursday that reinforced concerns about metals in foods after tainted cinnamon applesauce poisoned dozens of children last year.
    • The study, by Consumer Reports, documented levels that were far lower than the amounts discovered last year.
    • The Consumer Reports team tested the spice and found high levels in lead in 12 items sold at discount stores and ethnic markets, with lead levels reaching 3.5 parts per million. New York, the only state with tough lead standards in spices, recalls spices — among them curry powder, chili powder, cumin and five-spice powder — with more than one part per million of lead. Consumer Reports advised that people throw out items with that amount.
  • The American Hospital Association News lets us know,
    • “The AHA Sept. 12 released a new report that found hospital and health system performance on key patient safety and quality measures was better in the first quarter of 2024 than it was prior to the COVID-19 pandemic, and that hospitals made these improvements while caring for patients with more significant health care needs.  
    • “Hospitals and health systems are continuously working to advance patient safety and quality — which is always the hospital field’s top priority,” said AHA President and CEO Rick Pollack. “This report shows hospitals have made significant improvements on pre-pandemic performance in key patient safety outcomes. Hospitals’ commitment to improving patient outcomes and enhancing the patient experience continues to drive these efforts forward.”  
       
  • Beckers Hospital Review points out,
    • “Among 95 patients who are overweight or obese, an experimental daily pill from Novo Nordisk reduced their mean body weight by 13.1%, NBC News reported Sept. 10. 
    • “Novo Nordisk, the manufacturer of Ozempic, Wegovy, and other popular GLP-1 drugs, shared the phase 1 trial results at the European Association for the Study of Diabetes annual meeting. 
    • “The Denmark-based company recruited 124 patients and randomly assigned them either a placebo or its daily pill candidate, amycretin, to take for 12 weeks. Amycretin is a GLP-1 and protein-based unimolecular amylin, according to an abstract on the association’s website. 
    • “The trial’s primary endpoint was the number of treatment-emergent adverse events — which were found to be mild to moderate — and body weight changes were a key exploratory endpoint. The weight reduction results are “remarkable,” according to the abstract.
  • Per MedPage Today,
    • “The FDA warned that fezolinetant (Veozah), a hormone-free pill for moderate to severe hot flashes caused by menopause, could cause rare but serious liver injury.
    • “If women experience any signs or symptoms suggesting liver injury, they should stop fezolinetant, the agency said. Symptoms include new-onset fatigue, nausea, vomiting, pruritus, jaundice, pale feces, dark urine, or right upper quadrant pain.
    • “Treatment discontinuation may prevent worsening liver injury and may potentially return liver function to normal, the FDA explained.”
  • Per an NIH press release,
    • “National Institutes of Health (NIH) researchers and collaborators have found that being a carrier for sickle cell disease, known as having sickle cell trait, increases the risk of blood clots, a risk that is the same among diverse human populations that may not traditionally be associated with sickle cell disease. The study provides estimated clinical risks for people with sickle cell trait, which can inform clinical practice guidelines. Researchers examined the largest and most diverse set of people with sickle cell trait to date, which includes data from over 19,000 people of various ancestral backgrounds with sickle cell trait.  
    • The study, published in Blood Advances was led by researchers at National Human Genome Research Institute (NHGRI), part of NIH, The Johns Hopkins University School of Medicine, Baltimore, and the company 23andMe, South San Francisco, California.  * * *
    • “This study, therefore, provides important insights about patterns of venous blood clots and suggests a unique mechanism of blood clotting in people with sickle cell trait,” said Rakhi Naik, M.D., clinical director for the Division of Hematology at Johns Hopkins University, Baltimore, who co-led the study. “Knowing the risks of blood clots in people with sickle cell trait is important for situations such as surgeries or hospitalizations, which add to the risk of developing serious blood clots.” 
    • Over 2 million people in the United States have sickle cell trait. People with sickle cell trait have one copy of the genomic variant that causes sickle cell disease, a genetic condition that causes red blood cells to become rigid and sticky, which blocks blood flow. While people with sickle cell trait typically do not have any associated health complications, they are carriers for sickle cell disease. In rare cases, sickle cell trait has been found to be a risk factor for health complications such as muscle breakdown, presence of blood in the urine and kidney disease.  
  • Per Healio,
    • “Nearly one in 20 adults in the U.S. are estimated to have atrial fibrillation, many more than previous studies had indicated, according to new data out of the University of California, San Francisco.
    • “Atrial fibrillation doubles the risk of mortality, is one of the most common causes of stroke, increases risks of heart failure, myocardial infarction, chronic kidney disease and dementia, and results in lower quality of life,” Jean Jacques Noubiap, MD, PhD, postdoctoral scholar at University of California, San Francisco, said in a press release. “Fortunately, atrial fibrillation is preventable, and early detection and appropriate treatment can substantially reduce its adverse outcomes.”
  • The Institute for Clinical and Economic Review announced the release of a Draft Evidence Report on Treatment for Epstein-Barr Virus Positive Post-Transplant Lymphoproliferative Disease. The Public comment period now open until October 8, 2024; Requests to make oral comment during public meeting also being accepted.

From the U.S. healthcare business front,

  • Per an FDA press release,
    • “Today, the U.S. Food and Drug Administration authorized the first over-the-counter (OTC) hearing aid software device, Hearing Aid Feature, intended to be used with compatible versions of the Apple AirPods Pro headphones.
    • Once installed and customized to the user’s hearing needs, the Hearing Aid Feature enables compatible versions of the AirPods Pro to serve as an OTC hearing aid, intended to amplify sounds for individuals 18 years or older with perceived mild to moderate hearing impairment.” 
  • McKinsey and Company explain why the U.S. physician shortage isn’t going anywhere.
  • STAT News reports,
    • “A new [medical debt relief model] pioneered in North Carolina shows how hospitals could make money off of a larger national program.
    • “In North Carolina, hospitals are set to collect billions in federal money to cancel patients’ medical debt and implement new policies to help prevent debt from accumulating in the first place. The funding comes as part of the state’s Medicaid expansion.
    • “Hospitals have significant political power to work federal programs to their advantage, and the template opens the door to other creative ways to use taxpayer funds to pay providers for medical debt. Read the full case study here.”
  • Beckers Payer Issues notes,
    • “Anthem Blue Cross Blue Shield is requesting payments from some providers it alleges falsified patients’ medical records when prescribing Ozempic, Bloomberg reported Sept. 12. 
    • “A spokesperson for Elevance Health, which owns Anthem BCBS, told Bloomberg it contacted a small number of providers about repayments for Ozempic prescribed to their patients. In some cases, the amount of repayment requested was more than $1 million. 
    • “Representatives for Elevance told Bloomberg that Anthem BCBS only covers Ozempic for patients with Type 2 diabetes. The drug is not approved by the FDA for weight loss, but is often prescribed off-label for that purpose.” 
  • Per Becker’s Hospital Review,
    • “A Wilmington, Del.-based physician has agreed to pay more than $1 million to settle allegations he violated the False Claims Act by ordering medically unnecessary durable medical equipment for Medicare and Federal Employees Health Benefits Program patients. 
    • “Vishal Patel, MD, referred patients for more than 1,750 orthotic devices between February 2018 and April 2019, according to a Sept. 11 Justice Department news release. The department alleged that Dr. Patel had no medical relationship with these patients and the referrals were based on brief reviews of their medical charts. 
    • “Medicare and the Federal Employees Health Benefits Program paid more than $400 on average for each device, according to the release. The patient files were provided to Dr. Patel by RediDoc, a telemedicine company whose owners pleaded guilty in 2022 to their roles in a $64 million fraud scheme. 
    • “The claims resolved by Dr. Patel’s settlement are only allegations and there has been no determination of liability, according to the release.”  

Tuesday’s Tidbits

David Ermer–CDC, Congress, COVID-19, Federal employment benefits, Medical / Rx research, Medicare, Obesity, OPM, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC

  • BioPharma Dive reports
    • The U.S. House of Representatives voted Monday to approve legislation that would restrict U.S. companies from working with five China-based biotechnology firms on clinical development, research and manufacturing, in an attempt to secure the pharmaceutical supply chain.
    • The Biosecure Act passed 306-81 under a procedure used to pass relatively noncontroversial legislation. It was left out of a large Department of Defense bill that cleared the House in June, but may yet need to be included in a Senate version of that defense bill for it win support in that chamber.
    • The legislation would prohibit the federal government from contracting with the five “companies of concern” or any biotech that has a contract with those companies. Drugmakers with current contracts would have until 2032 to allow those deals to expire before being subject to the law.
  • Roll Call and Govexec bring us up to date on FY 2025 appropriations measures under consideration on Capitol Hill.
  • Govexec tells us,
    • “A bipartisan pair of lawmakers on Tuesday filed a discharge petition seeking to force a vote on the House floor on a measure that would eliminate a pair of controversial tax rules that reduce the retirement benefits of some ex-government workers.
    • “Reps. Abigail Spanberger, D-Va., and Garret Graves, R-La., are the lead sponsors of the Social Security Fairness Act (H.R. 82), a measure introduced last year that would eliminate Social Security’s windfall elimination provision and government pension offset.” * * *
    • “Though the bill has widespread support in Congress among both parties—with more than 300 cosponsors in the House alone—the chamber’s leadership has balked at allowing the bill to receive a floor vote. If Spanberger and Graves can secure at least 218 signatures among House lawmakers, they can then force such a vote to take place.”
  • FedWeek reminds us,
    • “September 30 is the end of the “special enrollment period” in which Postal Service retirees eligible for Medicare Part B but not currently enrolled in it may elect that coverage without the standard penalty for enrolling more than three months beyond first eligibility, which typically is on turning age 65.” * * *
    • “Further information on the special enrollment period is here.
    • “Meanwhile, the announcement of plans, coverage terms and premium rates in both the FEHB and the PSHB for 2025 is just ahead. That announcement commonly comes in late September or early October, with fuller information provided just ahead of the open season for enrolling or changing current enrollments, which this year will run November 11-December 9.”
  • Newfront poses a Q&A,
    • “Question: What steps do employers need to take to ensure their coverage meets the ACA affordability standard in 2025?
    • “Short Answer: The 2025 ACA affordability threshold increases to 9.02%. The easiest way to ensure affordability in 2025 is to meet the federal poverty line affordability safe harbor by offering at least one medical plan option (that provides minimum value) for which the monthly employee-share of the premium for employee-only coverage does not exceed $113.20. Otherwise, employers will need to calculate the applicable affordability threshold under one of the other safe harbor approaches, which are based on employee compensation levels.”
  • Per an HHS press release,
    • “The U.S. Department of Health and Human Services (HHS), through the Substance Abuse and Mental Health Services Administration (SAMHSA), recently awarded $68 million in grants for suicide prevention and mental health care programs. Addressing the U.S. mental health crisis and preventing suicide are top priorities of the Biden-Harris Administration and part of President Biden’s Unity Agenda.
    • “Every September we recognize Suicide Prevention Month as a time to raise awareness—to remind those struggling that they are not alone and that there is hope. Many people who have experienced suicidal thoughts are alive today because they got help,” said HHS Secretary Xavier Becerra, “The Biden-Harris Administration is deeply committed to expanding and improving suicide prevention in order to save lives. That is why we launched the 988 Suicide & Crisis Lifeline two years ago and why we continue to invest in suicide prevention programs that help save lives across this country.”
  • The Census Bureau posted its report with 2023 statistics on health insurance coverage in the United States based on information collected in the Current Population Survey Annual Social and Economic Supplement (CPS ASEC).
    • “Of the subtypes of health insurance coverage, employment-based insurance was the most common, covering 53.7 percent of the population for some or all of the calendar year, followed by Medicaid (18.9 percent), Medicare (18.9 percent), direct-purchase coverage (10.2 percent), TRICARE (2.6 percent), and VA and CHAMPVA coverage (1.0 percent).
    • “While the private coverage rate was statistically unchanged between 2022 and 2023, the employment-based coverage rate declined by 0.7 percentage points to 53.7 percent in 2023. At the same time, the rate of direct-purchase coverage increased by 0.3 percentage points to 10.2 percent in 2023.”

From the public health and medical research front,

  • Modern Healthcare reports,
    • “Cost, wait times, transportation problems and negative interactions with healthcare professionals are driving U.S. women to delay medical care or skip it altogether, according to a recent Deloitte survey.
    • “Half of the approximately 1,000 women who responded to the consultancy’s 2024 Health Care Consumer Survey said they had forgone care in the past year, compared with 37% of men, Deloitte said in a report Tuesday.
    • “Deloitte paired the results of its survey — which asked a representative sample of roughly 2,000 people in February 2024 about how everyone in the country could have quality medical care — with an analysis of claims data. It found that although women require on average almost 10% more health services than men, they’re about 35% more likely to say they’ve skipped or delayed care.”
  • JD Supra offers “5 Tips for Employers to Prepare for Cold, Flu, and COVID Season.”
  • The Centers for Disease Control and Prevention suggest five actions that communities can take to reduce suicides.
  • Per National Institutes of Health press releases,
    • “A scientific team supported by the National Institutes of Health (NIH) has created a preclinical blood test to identify adults most likely to develop severe respiratory conditions, including chronic obstructive pulmonary disease (COPD). The blood test analyzes 32 proteins that scientists determined accurately predicted an adult with an increased likelihood for requiring medical care for or dying from severe respiratory illness. The risk score was based on lung health data collected from nearly 2,500 U.S. adults over a 30-year period. The findings were published in the American Journal of Respiratory and Critical Care Medicine(link is external).
    • “We are still not ready for this test to be used in practice, but it’s a promising advance,” said James P. Kiley, Ph.D., director of the Division of Lung Diseases at NIH’s National Heart, Lung, and Blood Institute (NHLBI), which funded the study. “It consolidates insights from decades of breathing tests and medical evaluations into a single tool that has the potential to identify patients at risk for severe disease and complications.”
  • and
    • “Providing optional syphilis tests to most people seeking care at a large emergency department led to a dramatic increase in syphilis screening and diagnosis, according to a National Institutes of Health (NIH)-supported study of nearly 300,000 emergency department encounters in Chicago. Most people diagnosed had no symptoms, which suggests that symptom-based testing strategies alone could miss opportunities to diagnose and treat people with syphilis. The results were published today in the journal Open Forum Infectious Diseases.
    • “The Centers for Disease Control and Prevention (CDC) estimates that adult and congenital syphilis cases increased by 80% and 183% respectively between 2018 and 2022. Improved syphilis diagnosis strategies will be essential for reaching populations such as pregnant women and people with limited access to health care. The optimal model for syphilis screening has not been identified, particularly for preventing congenital syphilis. Previous literature supports targeted emergency department syphilis screenings based on clinical factors such as active symptoms or pregnancy. However, the screening criteria used in those models would not capture most people whose syphilis is asymptomatic.”
  • Here is a link to NIH’s Research Matters report covering “Deep brain stimulation for Parkinson’s | Brain-computer interface for speech | Glucose metabolism and Alzheimer’s disease.”
  • Per STAT News,
    • “The first late-stage trial of a GLP-1 drug in young children with obesity showed the treatment helped lower body mass index. But the findings also raise questions about whether obesity medications, some of which are currently approved for teenagers, should also be given to children at such a young age.”
  • Per Medscape
    • “Sustained participation in a community-based structured exercise program is linked to a reduced risk for all-cause hospitalization among older adults, but the benefits varied by gender {favoring women], according to a new study.”
  • Ruh roh. Bloomberg Prognosis lets us know,
    • “I [the reporter] was exposed to Covid at a family get-together in upstate New York last month. Two days later, I woke up feeling awful — sniffles, fatigue and fever. So I swabbed both nostrils with the last Covid test in our cabinet. 
    • “To my great surprise, it was negative, and I went back to sleep. When I tested again two days later, it turned positive in seconds. I started to wonder: Are home Covid tests bad at detecting the latest variants?
    • “The short answer is no, the doctors I spoke with told me. But that answer comes with a big caveat. It turns out the way the immune system interacts with the virus these days means home tests may not turn positive until several days after you get sick.”
  • More ruh roh. The New York Times reports,
    • “Two years before a deadly listeria outbreak [earlier this year], U.S. inspectors warned that conditions at a Boar’s Head plant posed an “imminent threat” to public health, citing extensive rust, deli meats exposed to wet ceilings, green mold and holes in the walls.
    • ‘But the U.S. Agriculture Department did not impose strict measures on the plant, in Jarratt, Va., which could have ranged from a warning letter to a suspension of operations.
    • “Since then, other inspections found that many of the problems persisted, but again, the plant continued to process tons of beef and pork products, including liverwurst.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “More providers are opting out of contracts with Medicare Advantage plans as national insurers reconfigure their networks, leaving patients in limbo.
    • “Medicare Advantage enrollment and profitability surged in recent years as a growing number of seniors sought plans with minimal copays and extra benefits not offered in traditional Medicare. However, Medicare Advantage enrollment growth has slowed and insurance companies’ earnings per member have declined over the past year as insurers grapple with stiffer competition, higher medical costs and utilization, lower reimbursement rates and stricter regulatory oversight.” * * *
    • “This is just the start of insurers’ squeeze on Medicare Advantage markets and provider contracts, the effects of which will grow as Medicare Advantage enrollment is expected to account for about 60% of all Medicare membership by 2030, consultants, analysts and policy experts said.
    • “This is the first year that MA plans have really hammered hospitals, and I think it will get uglier,” industry consultant Paul Keckley said.
    • “Health systems have walked away from in-network agreements or looked to scale up as a buffer and negotiating tool.”
  • and
    • “The American Medical Association released its updated list of Current Procedural Terminology codes for 2025, adding 270 new universal codes used for billing healthcare services and reimbursing providers.
    • “The organization announced 420 updates to its list Tuesday, with several revisions and additions for genetic testing, digital health services like remote patient monitoring and care involving artificial intelligence.”
  • Even more ruh roh. The American Hospital Association News complains,
    • “Hospitals and health systems are seeing significant increases in administrative costs, including due to burdensome practices by commercial insurers that often delay and deny care for patients, according to a new report released Sept. 10 by the AHA. 
    • “Many hospitals and health systems are forced to dedicate staff and clinical resources to appeal and overturn inappropriate denials, which alone can cost billions of dollars every year,” the report notes. 
    • “Among other findings, the report highlights recent data from Strata Decision Technology showing that administrative costs alone account for more than 40% of total expenses hospitals incur in delivering care to patients. In addition, between 2022 and 2023, care denials increased an average of 20.2% and 55.7% for commercial and Medicare Advantage claims, respectively.” 
  • Per Fierce Healthcare,
    • “UnitedHealth Group’s Optum Rx will join its peers in the big three pharmacy benefit managers by pulling Humira from some of its preferred formularies, according to a report from Reuters.
    • “Instead, it will recommend a cheaper biosimilar as the preferred option beginning Jan. 1, 2025, according to the article. Amgen’s Amjevita biosimilar will be among the options.
    • “CVS Health’s Caremark announced similar steps in April, and Cigna’s Express Scripts unit followed suit in August. Prescriptions for Sandoz’s Hyrimoz biosimilar spiked after CVS removed Humira from its major commercial formularies, according to a report in Stat.
    • “Reuters reported that UnitedHealth will continue to offer Humira coverage until the biosimilars are awarded an interchangeable designation from the Food and Drug Administration, which is expected in 2025.”