Tuesday Tidbits

OPM

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.”

Monday Roundup

David Ermer–ACA, COVID-19 testing, FDA, Generative AI, Medical / Rx research, OPM, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC,

  • Federal News Network tells us,
    • “Close to 15,000 blue-collar federal employees working in trade, craft and manual labor jobs are likely to see their federal pay rates increase by as much as 12%, once a new proposed rule from the Office of Personnel Management becomes finalized.
    • “The proposed regulations, which OPM released on Monday, aim to improve overall pay parity for roughly 168,000 blue-collar federal workers who are paid hourly through the Federal Wage System (FWS). In practice, OPM’s proposal would align the map of FWS wage areas more closely with the General Schedule’s locality pay map.
    • “This would lead to greater equity across federal pay systems, with FWS workers’ pay more aligned with GS workers who work in the same geographic area,” OPM wrote in a press release Monday.
    • ‘As a result of the proposed re-mapping, around 15,000 blue-collar federal employees would begin receiving higher pay rates once OPM’s regulations become final — as long as there are no major changes to how the proposed regulations are currently written.”
  • and
    • “The Postal Service, more than three years into a 10-year reform plan, is seeking a higher borrowing limit with the Treasury Department to sustain its infrastructure upgrades.
    • ‘USPS, in an update to its “Delivering for America” plan last week, said its current $15 billion debt limit with Treasury was set in the 1970s, and has not been adjusted for inflation in decades.
    • “We continue to lack access to capital and credit markets that most in the private sector rely on in transformative situations like ours,” USPS wrote in a report last week.
    • “USPS is also calling on the Office of Personnel Management to reassess what it pays into the Civil Service Retirement System, the pension system for federal employees who began government service before 1987.”
  • Gallagher timely reminds us about ACA FAQ 63 which told us
  • The American Hospital Association News informs us,
    • “AHA President and CEO Rick Pollack Oct. 7 sent a letter to President Biden urging the Administration to take immediate actions to increase the supply of IV solutions for hospitals and other health care providers that are struggling with shortages following the closure of a Baxter manufacturing plant as a result of Hurricane Helene.  
    • “Our members are already reporting substantial shortages of these lifesaving and life-supporting products,” Pollack wrote. “Patients across America are already feeling this impact, which will only deepen in the coming days and weeks unless much more is done to alleviate the situation and minimize the impact on patient care.”  
    • “The letter includes a number of specific actions the AHA is asking the Administration to take to support hospitals’ ability to care for patients and communities. In addition, the AHA invited the White House and agency experts to join the association in a forum to communicate directly with hospitals and health systems to “inform each other in real time on the status of the situation while we work together to mitigate the impact on patients.” 
  • Fierce Healthcare offers a summary of HHS’s proposed 2026 notice of benefit and payment parameters for the ACA marketplace. The public comment deadline is November 12, 2024.

From the Food and Drug Administration front,

  • Per an FDA press release,
    • “Today [October 7], the U.S. Food and Drug Administration granted marketing authorization for the Healgen Rapid Check COVID-19/Flu A&B Antigen Test. The test, authorized for use without a prescription, is for use by individuals experiencing respiratory symptoms and uses a nasal swab sample to deliver at-home results in approximately 15 minutes for COVID-19 and influenza (flu). The test detects proteins from both SARS-CoV-2 (the virus that causes COVID-19) and influenza A and B (the viruses that causes flu).  
    • “This is the first over the counter (OTC) test that can detect influenza to be granted marketing authorization using a traditional premarket review pathway, which enables the test to be marketed in the absence of an applicable emergency use declaration. Other OTC flu/COVID tests are currently available under emergency use authorization.” 
  • Per MedTech Dive,
    • The Food and Drug Administration approved Exact Sciences’ Cologuard Plus colorectal cancer test, the company said Friday [October 4]. 
    • The product is an updated version of Exact Sciences’ existing stool-based cancer test. The company expects to launch the test, which has higher specificity than its predecessor, with Medicare coverage and guideline inclusion in 2025.
    • Exact Sciences recently failed to land a Medicare price premium for Cologuard Plus, but Leerink Partners and William Blair analysts expect one of the company’s subsequent attempts to succeed.

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “The Nobel Prize in medicine was awarded to Victor Ambros and Gary Ruvkun for the discovery of microRNA, molecules that help control how genes are expressed.
    • “Their findings unlocked new areas of research into the roles these molecules play in human health. Researchers are exploring microRNA treatments for cancer, heart disease and dementia.”
    • “Ruvkun and Ambros were giddy with excitement on Monday after learning of their Nobel honors.”
    • Kudos to the recipients.
  • and, on a different topic,
    • “Inflammaging, a chronic low-grade inflammation, is associated with an increased risk of heart attack, cancer, Alzheimer’s and other conditions. It occurs as we age, but some people develop it more than others.
    • “Chronic inflammation can be caused by cellular senescence, where damaged aging cells secrete inflammatory proteins. 
    • “Prevention and treatment measures include lifestyle changes such as exercise, healthy diet and adequate sleep.”
  • The American Medical Association lets us know eight things that doctors wish their patient knew about the flu vaccine.
  • Consumer Reports, writing in the Washington Post, fills us in on how to choose the right multivitamin for your body’s needs.
  • Per BioPharma Dive,
    • “An experimental, muscle-preserving therapy from Scholar Rock succeeded in a Phase 3 trial in spinal muscular atrophy, positioning the biotechnology company to seek approvals in the U.S. and Europe early next year.
    • “A regimen of Scholar Rock’s drug, apitegromab, and a standard SMA therapy significantly improved motor function after one year versus treatment with a typical SMA medicine and a placebo, the company said Monday. Specifically, a prespecified, pooled analysis showed children between 2 and 12 years old who received one of two tested doses had an average difference versus placebo of about a 1.8-point change from baseline on a scale used to evaluate their physical abilities.
    • “Motor function benefits were also observed in a smaller, exploratory group of 13- to 21-year-olds, according to the company. No new safety findings were reported, and no one dropped out of the trial due to side effects. “We believe these data collectively show that apitegromab has the potential to become part of a new standard of care,” CEO Jay Backstrom said on a conference call. Shares more than quadrupled in value Monday.”

From the U.S. healthcare business front,

  • Per Fierce Healthcare,
    • “The healthcare industry is making the push toward greater adoption of value-based care, yet it’s not a secret that progress has been slow-moving.
    • “With that backdrop, UnitedHealth Group has released its latest “A Path Forward” report, which is a biennial look at progress in the shift to value. The paper includes dozens of policy recommendations that the team believes can accelerate that transformation.
    • “Wyatt Decker, M.D., UnitedHealth Group executive vice president and chief physician who’s leading the charge at the company on value-based care and innovation, told Fierce Healthcare in an interview that the U.S. healthcare system is extremely effective at addressing crises, complex patient conditions and end-stage needs. But it’s in prevention where “we really fall down,” he said.
    • “We don’t, by and large, have a system that focuses on keeping people healthy and well,” Decker said. “Most people wonder why their physician or their assistants don’t reach out when it’s time to get a screening and why they have so much trouble scheduling appointments, finding doctors, and, of course, figuring out how much it’s all going to cost.” 
  • and
    • “GenAI experimentation, research and potential use cases proliferate by the day. Like other industries, healthcare is hurrying to jump on the opportunity. A growing number of companies are creating genAI products to help organizations streamline their administrative workflows, simplify physician notetaking or respond to basic patient questions. But publicly available tools, like ChatGPT, are popular, easy to access and simple to use. If consumers are using them, are doctors, too?
    • “The answer, Fierce Healthcare finds, is yes. In the first in-depth look of its kind into physician use of public genAI tools, Fierce Healthcare spoke with nearly two dozen doctors, students, AI experts and regulators, and helped conduct a survey of more than 100 physicians. The reporting confirms that some doctors are turning to tools intended for non-clinical uses to make clinical decisions. With no standardized guidelines, lagging physician training and regulators racing to try to keep up with rapidly changing technology, guardrails to protect patients appear to be years behind current rates of utilization.
    • “You have an uncertain regulatory environment, you’ve got a march of technology and at the same time, you have an uptake by both consumers and healthcare professionals. And the consequences of that are very much uncertain,” Peter Bonis, M.D., chief medical officer at Wolters Kluwer, an information services company, told Fierce Healthcare.”

  • The FEHBlog learned a new use for the work “hallucination” today at the Texas Bar Association’s Health Law Conference. A generative AI mistake is a hallucination.
  • McKinsey and Company discuss “Advancing inclusive care pathways for people with disabilities. Across disease types, patients with disabilities experience inequities all along the care pathway—with consequently worse outcomes. Inclusive pathway designs and targeted interventions could help.”

Weekend Update

David Ermer–Congress, Federal employment benefits, OPM, SCOTUS–
  • Congress remains on the campaign trail until November 12 according to Govexec.
  • Last Friday, the Supreme Court issued its list of petitions granted its review at its September 30 conference. Oklahoma’s petition seeking review of the 10th Circuit’s ERISA preemption opinion involving Oklahoma’s PBM reform law (No. 23-1213) was not on the list. Tomorrow the Court will release other orders that conference.
  • The Social Security Administration is expected to announce its new Social Security cost of living adjustment on Thursday according to CBS News. “The 2025 cost-of-living adjustment is forecast to come in at about 2.5%, according to the Senior Citizens League (TSCL), an advocacy group for older Americans.”  
  • Fedweek has collected projections on the federal employee pension program (CSRS and FERS) COLAs which will be announced later this month.
  • This month, OPM is reconciling carrier and government data to identify all of the Postal Service Health Benefit Program enrollees effective January 1, 2025. OPM will be auto enrolling those folks in the appropriate PSHB plan. OPM will be mailing out auto-enrollment notices to each PSHB enrollee before Open Season begins on November 11, 2024. Here is a link to OPM’s website on the auto enrollment program.
  • The FEHBlog will be attending the Texas Bar Association’s Health Law Conference tomorrow and Tuesday in Austin.

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.”

Midweek Update

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

From Washington, DC,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Thursday Miscellany

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

From Washington, DC

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

OPM Publishes 2025 FEHB and FEDVIP Premiums

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

From the FEHB / FEDVIP front,

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

From Washington, DC,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Thursday Miscellany

David Ermer–Congress, Obesity, OPM, U.S. Healthcare, Uncategorized–
Photo by Josh Mills on Unsplash

From Washington, DC,

  • Federal News Network lets us know,
    • “The Senate passed a $3 billion supplemental funding bill, allowing the Department of Veterans Affairs to pay veterans’ benefits without delay.
    • “The Senate unanimously passed the supplemental funding bill in a voice vote Thursday. This bill now heads to President Joe Biden’s desk to be signed into law.
    • “VA Secretary Denis McDonough tweeted Thursday that the supplemental funding “will go directly to earned benefits” for about 7 million veterans and their families.”
  • Roll Call reports,
    • “The House is gearing up to go first on a bipartisan stopgap funding package early next week after nailing down the particulars this weekend, lawmakers said Thursday.
    • “The measure would extend current funding levels, with some “anomalies” allowing for higher rates, likely through Dec. 13, a source familiar with the talks said. The plan is to be ready to go with text of the package over the weekend so members can have time to review it before voting early next week.
    • “Rep. Mike Simpson, R-Idaho, a senior Appropriations Committee member, said he expects the continuing resolution to hit the floor around “the first of the week.” The deadline to get a bill through both chambers without triggering a partial government shutdown is Sept. 30, though it is more like Friday, Sept. 27, since that’s the last scheduled day in session.
    • “Simpson said there was some discussion of going an extra week beyond Dec. 13, but that there was basic agreement not to interfere with the holidays. “I’d like to have it done before [Dec. 31] so we can actually have our appropriations staff have a Christmas,” he said.
    • “Senate Majority Leader Charles E. Schumer, D-N.Y., earlier Thursday teed up a separate legislative vehicle in his chamber that could be used to carry a bipartisan deal in case of any House holdups. 
    • “But it appeared that by Thursday afternoon, House Republicans were on board with avoiding a shutdown, even if it meant making tough concessions to the other side.”
  • Healthcare Dive tells us,
    • “On Thursday, a powerful Senate committee voted unanimously to advance two resolutions holding Steward Health Care CEO Ralph de la Torre in contempt for refusing to testify before the committee last week.” * * *
    • “The Senate will consider whether to adopt the measures — civil enforcement, which instructs Senate Legal Counsel to bring a civil suit against de la Torre in the District Court for the District of Columbia; or a criminal contempt resolution, which would refer the matter to the U.S. Attorney for the District of Columbia for criminal prosecution.”
  • Per HHS press releases,
    • Today, the Health Resources and Services Administration (HRSA), an agency within the U.S. Department of Health and Human Services (HHS), announced $240 million in awards to launch and expand mental health and substance use disorder services in more than 400 community health centers across the country that care for more than 10 million people. Health centers are trusted community providers and a primary source of care for individuals across the country who are uninsured, underinsured, or enrolled in Medicaid – making them well-positioned to respond to the urgent need for behavioral health services that are high quality, stigma-free, culturally competent and readily accessible.  These grants will help expand access to needed care to help tackle the nation’s mental health and opioid crises – two pillars of the Biden-Harris Administration’s Unity Agenda for the nation.
  • and
    • Today, the Health Resources and Services Administration (HRSA) at the Department of Health and Hunan Services (HHS) announced the first ever multi-vendor contract awards to modernize the nation’s organ transplant system to improve transparency, performance, governance, and efficiency of the organ donation and transplantation system for the more than 100,000 people on the organ transplant waitlist.
    • The Organ Procurement and Transplantation Network (OPTN) has long faced critiques about lack of transparency, potential for conflicts of interest, IT reliability issues and other structural challenges. As part of the Administration’s transformation of the OPTN, for the first time in 40 years, multiple contractors will provide their expertise and proven experience to improve the national organ transplant system. This transition from a single vendor to multiple vendors to support OPTN operations is a critical step in advancing innovation in the transplant system to better serve patients and their families and implements the bipartisan Securing the U.S. Organ Procurement and Transplantation Network Act signed by the President in September 2023.
  • The U.S. Office of Personnel Management announced the availability of new online resources about the Postal Service Health Benefits Program.
    • Resources include a new landing page with details for PSHB enrollees; information about auto-enrollment where Postal employees will be automatically transitioned from their current plan to a comparable plan in the new PSHB program; and a page providing information on cost savings for enrollees who are also signed up for Medicare Part B or Medicare Advantage through PSHB. 
  • Tammy Flanagan, writing in Govexec, poses a Medicare quiz for federal annuitants.
  • Fedweek offers tips to federal retirees on whom to notify when you move residences.

From the public health and medical research front,

  • The New York Times reports,
    • “This year’s [prestigious] Lasker-DeBakey Clinical Medical Research Award went to three scientists for their work on GLP-1, the hormone that led to drugs like Wegovy (the same compound is the basis for Ozempic), which have transformed the treatment of obesity. They are Dr. Joel Habener, Svetlana Mojsov and Lotte Bjerre Knudsen.
    • “Each of the three honorees played a role at a key moment: finding the new hormone; finding the biologically active shorter form of GLP-1; and, finally, showing that the shorter form elicits weight loss.
    • “Of course, as almost always happens in science, many others also played key roles, and the Lasker Foundation mentioned some as part of its citation. And one of the honorees, Dr. Mojsov, is receiving what many deem a long overdue recognition.”
  • Per Beckers Hospital Review,
    • “Cancer survivors with overweight and obesity showed a 13.9% increased risk of developing a second cancer and a 33.2% increased risk of developing a second cancer related to obesity, according to a study published Sept. 17 in JAMA Open Network. 
    • “Researchers from the American Cancer Society analyzed data from 26,894 cancer survivors in the Cancer Prevention Study II Nutrition study. Participants were surveyed starting in 1992 with follow-up occurring through 2017. Of all participants, 42% were overweight and 17.2% were obese at the time of their first cancer diagnosis.”

From the U.S. healthcare business front,

  • The International Foundation of Employee Benefit Plans informs us,
    • “High-dollar claimants continue to concern employer-sponsored health plans in the U.S. Those that self-fund and purchase medical stop-loss coverage have seen premiums continuing to rise over 10% annually, as reported by the 2024 Aegis Risk Medical Stop-Loss Premium Survey, cosponsored by the International Society of Certified Employee Benefit Specialists. In its 18th edition, this year the survey measured over $1 billion in annual premium across more than 1,100 stop-loss policies and covering more than 1.1 million employees.
    • “When asked about the type of catastrophic health claimants that are their top two or three concerns in the next year, responding plan sponsors cited cancer and specialty pharmacy as the two most prominent. Top claimant concerns include:
      • “Cancer/neoplasms, including leukemia—83%
      • “Specialty pharmacy—50%
      • “Gene and cell therapies—29%
      • “Heart/cardiovascular—27%
      • “Newborn/infant care—24%
      • “Lengthy inpatient hospital stays—23%.
  • Per Beckers Hospital Review,
    • “Five years ago, Dallas-based Tenet Healthcare embarked on a new chapter in the health system’s journey, reducing its debt profile and having its ambulatory surgery center business drive a greater portion of the company’s performance, according to CEO and Chair Saum Sutaria, MD. 
    • “Tenet committed to deleveraging the company, realizing the fair value of assets through divestitures and growing its ambulatory business, United Surgical Partners International, by capitalizing on the shift to outpatient procedures at lower costs.
    • “The proceeds from asset sales reflect their high quality, helping us reduce leverage, which now provides strategic and financial flexibility for future growth,” Dr. Sutaria said Sept. 9 during the Wells Fargo Healthcare Conference. “Our ability to deleverage the company with the types of proceeds we’ve generated … has been very good. We are seeing the company at a place where the leverage generates not only a degree of strategic and financial flexibility, but stability for the organization’s ability to invest in growth over the next few years.”
    • “Tenet, now a 52-hospital system, significantly improved its leverage position this year, selling nine hospitals in high-growth markets in California and South Carolina for a total of $3.9 billion. It also plans to sell its majority stake in five more Alabama hospitals for $910 million this fall. 
    • “Proceeds from these hospital sales are being used to reduce the health system’s debt and expand its outpatient footprint through strategic ASC acquisitions and de novo developments.” 

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.”

Monday Roundup

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

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

From Washington, DC,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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