Friday report

Employee Wellness Programs

Friday report

David Ermer–CDC, CMS, Congress, COVID-19, Employee Wellness Programs, FDA, Generative AI, HIPAA Privacy and Security Rules, Medical / Rx research, OPM, U.S. Healthcare, Wellness–

From Washington, DC,

  • The Washington Post reports,
    • “House Republicans unveiled a new health care proposal Friday as they aim to address concerns about rising health insurance costs just weeks before enhanced Affordable Care Act subsidies expire.
    • “The legislation would codify and expand health plans for small businesses, fund reductions of premiums for low-income people in the individual health insurance market and increase transparency in prescription drug pricing, according to House Republican leadership aides.
    • “The proposal would also allow for a separate vote on an extension of the premium ACA tax credits, which subsidize health insurance for most of the 24 million Americans who buy their coverage from the Obamacare Marketplace — the central demand Democrats and moderate Republicans have made in the recent health care debate.
    • “The House is expected to vote on the proposal next week before leaving Washington for a two-week holiday break. If passed, it is unclear if the proposal could succeed in the Senate, where it would require 60 votes to overcome a filibuster.”
  • FEHBlog observation — This week, the Democrat leadship in the Senate offered a three year extension extension of the Biden subsidies while the Republican leadership offered a new approach with no transistion period. Both offerings were doomed to fail. The FEHBlog hopes that cooler heads prevail over the next week.
  • Govexec relates,
    • “The House voted 231-195 on Thursday to pass legislation that would nullify President Trump’s efforts to strip more than 1 million federal workers of their collective bargaining rights, sending the measure over to the Senate, where its prospects are less rosy.
    • “Twenty Republican lawmakers broke ranks to support the Protect America’s Workforce Act (H.R. 2550) on the floor. Introduced by Reps. Jared Golden, D-Maine, and Brian Fitzpatrick, R-Pa., the measure effectively nullifies Trump’s March executive order barring unions at more than 40 federal agencies under the guise of national security and bars federal agencies from terminating any union contracts that were in place prior to the edict’s signature.”
  • The American Hospital Association News lets us know,
    • “The Centers for Medicare & Medicaid Services Dec. 11 announced the launch of the Make America Healthy Again: Enhancing Lifestyle and Evaluating Value-based Approaches Through Evidence Model, a voluntary payment model that will fund up to 30 chronic disease prevention and health promotion proposals. The proposals must include evidence-based functional or lifestyle medicine interventions not covered by Original Medicare. Under the MAHA ELEVATE Model, CMS said it will evaluate necessary data on the cost and quality of such interventions to inform future decisions on the feasibility of including them in Original Medicare. The agency will release a funding notice in early 2026 for the first cohort, which will begin Sept. 1, 2026. The second cohort will begin one year later.”
  • The U.S. Office of Personnel Management announced today that it is seeking public comments on its plan to resurrect its FEHB and now also PSHB health claims data warehouse.
    • “OPM is collecting service use and cost data from FEHB and PSHB Carriers, including medical claims, pharmacy claims, encounter data, and provider data. This data will enable OPM to oversee health benefits programs and ensure they provide competitive, quality, and affordable plans. OPM requires Carriers to report necessary information and permit audits and examinations to manage the FEHB Program effectively. The Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule permits covered entities, including carriers, to disclose protected health information (PHI), including service use and cost data, to health oversight agencies, such as OPM, for oversight activities authorized under 45 CFR 165.512(d)(1).”
    • This is a legally flawed analysis. The FEHB Act, 5 U.S.C. Sec. 8910(b), states
      • “(b) Each contract entered into under section 8902 of this title shall contain provisions requiring carriers to—
      • “(1) furnish such reasonable reports as the Office determines to be necessary to enable it to carry out its functions under this chapter; and
      • “(2) permit the Office and representatives of the Government Accountability Office to examine records of the carriers as may be necessary to carry out the purposes of this chapter.”
    • Furnishing all claims data to OPM is a not a reasonable report in any sense of the English language, and the HIPAA Privacy Rule does not give health oversight agencies new data access rights. See Fed. Reg. 82,462, 82,528 (Dec. 28, 2000). OPM should head back to the drawing board for consultations with carriers.
    • The public comment deadline is February 10, 2026.
  • On a related note, per a CMS news release,
    • “The Centers for Medicare & Medicaid Services (CMS) is pleased to announce the 2026 CMS Burden Reduction Conference taking place February 25, 2026, from 9:00 a.m. to 1:00 p.m. ET. This year’s conference will be a hybrid event, with in-person programming at the Hubert H. Humphrey (HHH) Building in Washington, DC, and a fully supported virtual option for remote attendees. In-person attendance will be limited due to space.”
  • OPM should hold a similar event for overburdened FEHB and PSHB carriers.

From the Food and Drug Adminstration front,

  • Per Fierce Pharma,
    • “Amid a swell of regulatory successes in the myasthenia gravis arena this decade, Amgen is wading into the fray with a new indication for its monoclonal antibody Uplizna.
    • “Thursday, the FDA greenlighted Uplizna (inebilizumab) to treat generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) and anti-muscle specific tyrosine kinase (MuSK) antibody positive. After two loading doses, Uplizna for gMG is administered just twice a year, Amgen noted in a Dec. 11 press release.”
  • and
    • “After a three-decade drought of new antibiotics to treat gonorrhea, the FDA has signed off on two first-in-class oral treatments for the sexually transmitted infection (STI), which affects more than 80 million people around the world each year. 
    • “On Friday, the U.S. regulator green lit Innoviva’s Nuzolvence (zoliflodacin) for uncomplicated urogenital gonorrhea. The nod comes less than 24 hours after the agency granted an approval in the same indication to GSK’s Blujepa, which was already on the market for uncomplicated urinary tract infections following its approval in March.
    • “The endorsements are similar in that both therapies are indicated for those ages 12 and older where standard of care treatment is contraindicated or where patients are intolerant or unwilling to use the first line of treatment.”
  • Cardiovascular Business tells us,
    • “The U.S. Food and Drug Administration (FDA) has granted 510(k) market clearance to the enVast mechanical thrombectomy system from Texas-based Vesalio.
    • “The company said the system offers a new approach to clot capture and the removal of large thrombus burden (LTB) in patients undergoing primary percutaneous coronary intervention (PCI). Thrombectomy is used in the coronary arteries to quickly remove clots to restore blood flow following a heart attack to minimizing myocardial damage.
    • “With FDA clearance and the upcoming U.S. launch of enVast, we are proud to introduce a device that we truly believe redefines coronary thrombectomy,” Steve Rybka, CEO of Vesalio, said in a statement. “Clinical experience internationally has consistently demonstrated its safety and effectiveness in managing complex LTB situations.”

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “RSV activity is increasing in the Southeastern, Southern, and Mid-Atlantic areas of the country with emergency department visits and hospitalizations increasing among children 0-4 years old. Seasonal influenza activity continues to increase in most areas of the country. COVID-19 activity is low nationally.
    • “COVID-19
      • “COVID-19 activity is low nationally.
    • “Influenza
    • “RSV
      • “RSV activity is increasing in the Southeastern, Southern, and Mid-Atlantic areas of the country with emergency department visits and hospitalizations increasing among children 0-4 years old.
    • “Vaccination
      • “It is not too late to get vaccinated ahead of the holidays. Talk to your doctor or trusted healthcare provider about what vaccines are recommended for you and your family.”
  • The American Hospital Association News adds,
    • “The Centers for Disease Control and Prevention Dec. 11 released a report that found last year’s version of the COVID-19 vaccine was 76% effective in preventing emergency department or urgent care visits for children ages 9 months to 4 years. It was 56% effective for those ages 5-17 years old. “These findings suggest that vaccination with a 2024–2025 COVID-19 vaccine dose provided children with additional protection against COVID-19–associated ED/UC encounters compared with no 2024–2025 dose,” the CDC wrote.”
  • The New York Times reports,
    • “To treat their pain, anxiety and sleep problems, millions of Americans turn to cannabis, which is now legal in 40 states for medical use. But a new review of 15 years of research concludes that the evidence of its benefits is often weak or inconclusive, and that nearly 30 percent of medical cannabis patients meet criteria for cannabis use disorder.
    • “The evidence does not support the use of cannabis or cannabinoids at this point for most of the indications that folks are using it for,” said Dr. Michael Hsu, an addiction psychiatrist and clinical instructor at the University of California, Los Angeles, and the lead author of the review, which was published last month in the medical journal JAMA. (Cannabis refers to the entire plant; cannabinoids are its many compounds.)”
  • The AP informs us,
    • “The U.S. suicide rate dropped slightly last year from some of the highest levels ever reported, preliminary data suggests. Experts say it’s hard to know exactly why, or whether the decline will continue.
    • “A little over 48,800 suicide deaths were reported in 2024, according to provisional data from the Centers for Disease Control and Prevention, roughly 500 fewer than the year before.
    • “The overall suicide rate fell to 13.7 per 100,000 people.”
  • The Washington Post relates,
    • “Solving a technical challenge that has stymied science for 40 years, researchers have built a robot with an onboard computer, sensors and a motor, the whole assembly less than 1 millimeter in size — smaller than a grain of salt.
    • “The feat, accomplished by a partnership of researchers at the University of Pennsylvania and University of Michigan, advances medicine toward a future that might see tiny robots sent into the human body to rewire damaged nerves, deliver medicines to precise areas, and determine the health of a patient’s cells without surgery.”
  • Per Healio,
    • “GLP-1 receptor agonists are not associated with increased risks for dry age-related macular degeneration or cataract development, according to two recently published studies.
    • “The data instead showed significantly reduced risk for cataracts, as well as lower risk for dry AMD, linked with the use of GLP-1s, according to Abhimanyu Ahuja, MD, an ophthalmology resident at the Oregon Health & Science University Casey Eye Institute, and colleagues.
    • “Other studies have demonstrated that these medications have anti-inflammatory and neuroprotective properties,” Ahuja told Healio. “We wondered whether they might influence the risk of conditions like macular degeneration or cataracts in older adults.”
  • Per MedTech Dive,
    • “AtriCure, whose devices are used to treat atrial fibrillation and related conditions, said Thursday the first procedures were performed in patients with its new dual energy platform.
    • “The system integrates pulsed field ablation with a radiofrequency ablation approach using the company’s cardiac clamp technology. Surgeons can use either method independently or in combination.
    • “The platform is not yet approved for use in any market. AtriCure said it expects to initiate a clinical trial in the coming year.”
  • Per Biopharma Dive,
    • “Arcus Biosciences will terminate work on a TIGIT-targeting cancer drug following a decision to cancel a Phase 3 trial because it didn’t appear likely to improve patients’ survival, the company said in a statement Friday.
    • “Called domvanalimab, the drug was being tested in combination with the immunotherapy zimberelimab and chemotherapy against Bristol Myers Squibb’s Opdivo and chemo in gastric and esophageal cancers that haven’t been treated before. Arcus said an independent data committee recommended ending the trial because the domvanalimab combination wasn’t likely to help patients live longer.
    • “The domvanalimab-based combination was the centerpiece of a partnership with Gilead Sciences that led the bigger company to buy a 33% stake in Arcus and pay $900 million just to secure rights.”

From the U.S. healthcare business and artificial intelligence front,

  • Healthcare Dive reports,
    • “Hospitals are managing series of cost, workforce and reimbursement challenges as they navigate uncertainty at the close of 2025 and beyond, according to a new report from Kaufman Hall.
    • “Health systems are attempting to mitigate the impact of tariffs and increasingly expensive supplies, according to Kaufman Hall’s 2025 Health System Performance Outlook report. At the same time, hospitals are trying to retain clinical staff and outsource other functions, according to the report.
    • “Only 30% of hospital leaders surveyed expect balance sheets to improve in 2026, while 30% expect them to lower and 40% projected little change. The split highlights how uncertain health systems feel about the future, especially from recent regulatory changes in the “Big Beautiful Bill” and the likely expiration of Affordable Care Act subsidies.”
  • Beckers Hospital Review relates,
    • “Dallas-based Tenet Healthcare reached a record high stock price of $218 on Nov. 25, capping off a transformative year that highlights investor confidence in the system’s ongoing shift toward specialty and outpatient care.
    • “As of Dec. 12, Tenet stock remained elevated at $199, up nearly 60% from $125 on Jan. 2. The spike reflects investor optimism around Tenet’s long-term strategy to transform into a value-based care enterprise anchored by its ambulatory business, United Surgical Partners International.
    • “In 2024, Tenet sold 14 hospitals for a combined $4.8 billion as part of a sweeping overhaul. The system now operates 50 acute-care hospitals while aggressively expanding its ambulatory surgery center footprint through USPI.”
  • Beckers Payer Issues tells us about 14 payer AI moves this year and “Turquoise Health has detailed its first comprehensive payer price transparency scores in its 2025 impact report, evaluating machine-readable file quality across 97 payers.” 

Tuesday report

David Ermer–CMS, Congress, COVID-19 vaccine, Employee Wellness Programs, FDA, Medical / Rx research, Obesity, OPM, U.S. Healthcare–

From Washington, DC

  • The Wall Street Journal reports,
    • “The Trump administration released its ‘Make America Healthy Again’ strategy to improve children’s health.
    • “The strategy includes a vaccine framework, lenient approach to pesticides, and focus on processed foods and dyes.
    • “The FDA will modernize infant-formula nutrient requirements and increase testing for heavy metals and other contaminants.”
  • and
    • “President Trump signed an executive order to increase federal enforcement of pharmaceutical advertisements.
    • “The FDA is sending thousands of enforcement letters to drugmakers regarding misleading advertisements on multiple platforms.
    • “HHS wants to amend FDA guidance, closing a loophole allowing abbreviated descriptions of drug side effects in TV ads.”
  • Per a Congressional news release,
    • “U.S. Senator Bill Cassidy, M.D. (R-LA), chair of the Senate Health, Education, Labor, and Pensions (HELP) Committee, announced that the HELP Committee will hold a hearing next week on delivering President Trump’s mission to restore radical transparency at the Centers for Disease Control and Prevention (CDC). This is crucial to protecting the health of American children.
    • “At the hearing, the HELP Committee will hear from former CDC officials Susan Monarez, PhD, and Debra Houry, M.D., about the recent high-profile departures from the agency. The Committee is also planning to invite current officials at the Department of Health and Human Services to respond by speaking with Committee members at a future hearing.”
  • STAT News tells us,
    • “More than 160 U.S. lawmakers have urged the Trump administration to abandon a newly announced pilot program that would allow pharmaceutical companies to offer rebates for a small number of therapies to hospitals that participate in a federal drug discount program.
    • “At issue is the 340B discount program, which was created to help hospitals and clinics care for low-income and rural patients. Drug companies that want to take part in Medicare or Medicaid must offer their medicines at a discount — typically, 25% to 50%, but sometimes higher — to participating hospitals and clinics. Right now, drug companies generally provide the discounts at the time of purchase.” * * *
    • “The latest controversy has been over double discounts, an issue that can be traced, in part, to the Inflation Reduction Act, which allows Medicare to negotiate the prices of some drugs. The concern is a significant issue for drugmakers, since certain medicines, including big-selling heart and cancer treatments, have been selected by Medicare for price negotiations.
    • “The Inflation Reduction Act imposes a maximum fair price on drugs paid for by Medicare and obligates the companies to pay added inflation rebates in Medicare. But the requirement overlaps with 340B, because drugmakers must offer hospitals the lower of the maximum fair price or 340B price, and pay inflation rebates only on drugs not sold at the 340B price.”
  • The American Hospital Association is opposed to the rebate pilot.
    • “The AHA Sept. 8 urged the Federal Trade Commission and Antitrust Division of the Department of Justice to investigate several drug companies’ concerted efforts to impose rebate models within the 340B Drug Pricing Program, saying the actions may violate antitrust laws. 
    • “These drug companies sought to switch from providing ‘upfront discounts’ on 340B drugs to a model in which 340B hospitals must purchase even the costliest drugs at full price and then submit for a rebate,” AHA wrote. “If successful, this concerted effort would essentially obligate America’s safety-net hospitals to advance interest-free loans to the world’s largest and most profitable drug companies. This new ‘rebate model’ would inflict untold harm on hospitals, patients and communities. And for your purposes, the publicly available information suggests potential anticompetitive activity.”  
    • “The AHA letter details a timeline of many actions taken by several drug companies over a six-month period highlighting a potential antitrust conspiracy to limit 340B discounts.”
  • STAT News also informs us,
    • “Medicare is delaying implementation of a Biden-era rule that would have made Medicare Advantage plans notify members about their unused supplemental benefits — services such as vision and dental. 
    • “Medicare didn’t say how long it’s delaying implementation but disclosed in a notice late Monday that insurers had asked questions and sought technical guidance on the rule. The agency said it’s delaying implementation “for contract year 2026 and beyond” because of “logistical concerns.” 
  • Per a Government Accountability Office news release,
    • “When Medicare beneficiaries need medical devices or health care services, they can choose from among the items and services that Medicare has decided to cover. 
    • “Medicare sets time frames for determining coverage and meets its goals more than 80% of the time. However, the agency doesn’t systematically identify the reasons why some decisions are delayed, which may make it harder to improve timeliness.
    • ‘There are also concerns that Medicare isn’t transparent about how it prioritizes reviews of new coverage requests. Making this information available could improve the quality of requests.
    • “Our recommendations address these issues.”
    • Here is a link to the full report.
  • Federal News Network points out,
    • “Federal employees, on average, are waiting longer to see their retirement applications processed. New data from the Office of Personnel Management for August shows it takes an average of 70 days to process a claim from a retiring fed. But if retirement claims are coming to OPM in less than 60 days, those cases take on average 45 days to complete. At the same time, OPM received more than 9,400 retirement claims last month. OPM’s backlog of retirement claims dropped by 2,000 to 24,300.” 
  • Per MedTech Dive,
    • “Microbot Medical has received 510(k) clearance for its Liberty Endovascular Robotic System, the company said Monday.
    • “The Food and Drug Administration clearance positions Microbot to start marketing the single use, remotely operated robotic system for peripheral endovascular procedures.
    • “Siemens Healthineers launched a robotic system for peripheral vascular interventions in 2021 but withdrew from the market to focus on neurovascular procedures two years later.”

From the public health and medical/Rx research front,

  • The Washington Post reports,
    • “‘Kissing bug’ disease is now endemic in the [southern] U.S., CDC says. What is it?
    • “The U.S. is seeing a rise in Chagas disease, which is a life-threatening illness transmitted through “kissing bugs” known to bite human faces. Pets can be carriers.”
  • MedPage Today tells us,
    • “The monoclonal antibody romosozumab (Evenity) increased bone mineral density (BMD) in premenopausal women with idiopathic osteoporosis, according to a small, phase II open-label study.
    • “Among the 29 women enrolled, treatment with romosozumab was associated with a 15% gain in BMD in the lumbar spine, a 5.3% increase at the total hip, and a 5.4% increase at the femoral neck as measured by dual-energy x-ray absorptiometry at 1 year (all P<0.001), reported Lauren Lynch, MD, PhD, of Columbia University Irving Medical Center in New York City.”
    • “Increases in BMD at all three spots were significant by month 6 of treatment, she said at the American Society for Bone and Mineral Researchopens in a new tab or window annual meeting.
    • “Treatment with romosozumab was also tied to a 3.4% gain in trabecular bone score at 1 year (P<0.001).
    • “These promising data provide support for future randomized controlled trials that test romosozumab as a therapeutic option for premenopausal idiopathic osteoporosis,” said Lynch.”
  • Per Healio,
    • “Body composition measurements may be better predictors of colorectal cancer incidence than BMI.
    • “An evaluation of more than 9,000 postmenopausal women who had dual-energy X-ray absorptiometry-determined adiposity found those with higher visceral adipose tissue and android fat had greater risk for developing the malignancy. Those with increased subcutaneous adipose tissue, more closely related to BMI, did not.”
  • and
    • “The prevalence of mild, moderate and severe obstructive sleep apnea in U.S. adults are each expected to rise by 2050, according to results published in The Lancet Respiratory Medicine.
    • “By projecting a rise in OSA prevalence, the research helps fill a critical gap in public health planning and ensures that health systems, payers and policymakers can prepare for rising demand,” Carlos M. Nunez, MD, chief medical officer at Resmed, told Healio.”
  • The International Foundation of Employee Benefit Plans lets us know,
    • “Many people could benefit from a nudge to help them exercise more, improve their finances or get a recommended health screening.
    • “A recent report from the International Foundation of Employee Benefit Plans suggests that organizations that provide motivation in the form of incentives tend to have better participation in their wellness programs, likely leading to improvement in several workforce measures.
    • “Workplace Wellness and Financial Education: 2025 Survey Report uncovers insights into the types of wellness incentives organizations offer and their impact on program participation as well as overall worker wellness and organizational goals.
    • “More than four in ten (44%) survey respondents said they offer an incentive for at least one of their wellness initiatives. In addition, 19% said incentives are offered through a vendor or health care provider. Thirty-eight percent said they do not offer incentives.” 
  • Beckers Hospital Review identifies the states that vaccinate their populations the most and those that vaccinate their populations the least based on a Wallet Hub report published Sept. 9.

From the U.S. healthcare business front,

  • The American Hospital Association reports
    • A JAMA internal medicine study published Sept. 8 found that since the COVID-19 pandemic, Medicare Advantage beneficiaries have been experiencing longer hospital stays than those under Traditional Medicare. The study examined more than 89 million hospitalizations from 2017 to 2023 and found the average length of stay for MA admissions during that period increased from 6 to 7.1 days, while Traditional Medicare admissions grew from 5.8 to 6.3 days. The researchers noted that these trends “may reflect insurance-related discharge barriers” and that the results “are consistent with hospital industry reports.” They point to prior authorization or limited post-acute care networks as possible causes. 
  • The Wall Street Journal informs us,
    • Novartis agreed to buy Tourmaline Bio in a roughly $1.4 billion-dollar deal that boosts its cardiovascular drug pipeline with access to the targeted therapy drug pacibekitug.
    • The Swiss pharmaceutical company said Tuesday that it would offer Tourmaline Bio shareholders $48 a share, valuing the company at approximately $1.4 billion on a fully diluted basis. Tourmaline’s board has approved the deal.
    • Tourmaline Bio [which is based in Massachusetts] is a clinical-stage biopharmaceutical company developing pacibekitug which is a treatment option for atherosclerotic cardiovascular disease.
  • Per STAT News,
    • “Eli Lilly has developed artificial intelligence models that can help predict the behavior of potential drug candidates, based on the data the drugmaker has collected over the last two decades and at the cost of more than a billion dollars. Now, it’s opening up some of those models to biotech companies that want to use them to jumpstart their science.
    • “The only catch? Lilly wants to use data from those other companies to improve its models.”
  • Modern Healthcare tells us,
    • “The vast majority of UnitedHealthcare Medicare Advantage members will be enrolled in policies with high quality scores next year, parent company UnitedHealth Group announced Tuesday.
    • “UnitedHealthcare anticipates that 78% of its Medicare Advantage enrollees in 2026 will have plans in contracts that earned at least four out of five stars under the Star Ratings quality measurement program. That compares with 71% this year.
    • “The performance is consistent with expectations. UnitedHealth Group wrote in a filing to the Securities and Exchange Commission. The company also reaffirmed its full-year adjusted earnings outlook of at least $16 per share on revenues of $445.5 billion-$448 billion.”
  • Per Healthcare Dive,
    • “Mayo Clinic plans to close six of its clinics in Minnesota by Dec. 10 and reduce services at its Albert Lea hospital, the nonprofit provider said Monday.
    • “The health system will shutter clinics in Belle Plaine, Caledonia, Montgomery, North Mankato, St. Peter, and Wells and stop offering elective surgeries and procedures in ophthalmology, gynecology, endoscopy, orthopedics and podiatry at the hospital and clinic in Albert Lea.
    • “Mayo said it is consolidating services in part to address lower patient volumes and staffing shortages. Consolidating services will help the system “strengthen rural health care delivery and ensure safe, high-quality and sustainable care for generations to come,” Mayo said.”
  • Fierce Pharma reports,
    • “Amid a yearslong wave of enthusiasm and uptake for Eli Lilly and Novo Nordisk’s blockbuster obesity medicines, the drugs have scored a strong endorsement from an independent U.S. cost watchdog.
    • “In a draft report (PDF), the Institute for Clinical and Economic Review (ICER) determined the drugs are “highly cost-effective” because of their ability to help patients lose weight, reduce metabolic risk factors and address obesity-related health complications. The group specifically looked at Novo’s injectable semaglutide at the 2.4-mg dose, Novo’s investigational oral semaglutide 25-mg dose and Lilly’s injectable 15-mg dose of tirzepatide.
    • “After reviewing the health benefits of the medicines, the cost watchdog said the drugs met the mark on “commonly used cost-effectiveness thresholds.”
    • “Because treatment with all three drugs results in substantial weight loss and improvement in metabolic risk factors, we have high certainty that all three drugs have substantial net health benefit over lifestyle modifications alone,” ICER reviewers said in the report.”
  • Per Fierce Healthcare,
    • “Hospitals’ operating margins continued to soften through July as volumes remained strong, but spending on supplies and drugs inched upward, according to Kaufman Hall’s latest monthly performance report.
    • “The firm’s operating margin index of nationwide hospitals was a median 1.7% across seven months when including health system allocations for the cost of shared services and 5.3% when excluding those. That’s a low point for 2025 but still above hospitals’ performance during the same period in 2024.
    • “Looking at July alone, the index showed a 2.6% median operating margin with health system allocations and 6.2% without. In June, those were 3.4% and 7%, respectively.
    • “While performance has generally been strong this year, profitability has decreased slightly over the past few months,” Erik Swanson, managing director and data and analytics group leader with Kaufman Hall, said in a release.”
  • and
    • “Telehealth GLP-1 company Remedy Meds, founded in 2024, announced its intent to acquire health tech unicorn Thirty Madison for $500 million in an all-stock deal. 
    • “The deal will create a larger, multibrand platform across women’s, men’s and metabolic health, executives said. The deal also positions Remedy Meds as a more competitive player in the direct-to-consumer health space, up against Hims & Hers and Ro. 
    • “Thirty Madison was valued at $1 billion in June 2021, launching it to unicorn status. In the years since, the company has completed several mergers and acquisitions, including with women’s-health-focused company Nurx. 
    • “Remedy Meds is a relative newcomer compared with the company it plans to buy, having only been founded in January 2024. Its founder Haris Memon founded and sold a home goods company called Miracle Brands in July 2023 before entering the healthcare market.”
  • Per MedTech Dive,
    • “Senseonics has struck a deal to retake control of the commercialization and distribution of its implantable continuous glucose monitors, the company said Wednesday.
    • “Ascensia Diabetes Care is currently the exclusive worldwide distributor of the Eversense devices. That will change at the start of 2026, when Senseonics will resume responsibility.
    • “BTIG analysts said in a note to investors that the move shows “Senseonics is doubling down on its view that the one-year sensor will finally enable an inflection in patient demand for the implantable glucose monitor.”

Friday report

David Ermer–AHRQ, CDC, Congress, COVID-19, Employee Wellness Programs, FDA, Medical / Rx research, Mental health care, OPM, Patient safety, Rx coverage, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC

  • The American Hospital Association (AHA) News reports,
    • “Sens. Chuck Schumer, D-N.Y., Susan Collins, R-Maine, and Andy Kim, D-N.J., June 5 reintroduced the SEPSIS Act, legislation which would task the Centers for Disease Control and Prevention with continuing its efforts addressing sepsis care. The agency’s work would include an education campaign about addressing sepsis in hospitals, improving pediatric sepsis data collection, sharing information with the Department of Health and Human Services on data collection, and developing and implementing a sepsis outcome measure.
    • “The bill would also require a report on a sepsis outcome measure and a congressional briefing on the CDC’s sepsis activities. Additionally, the legislation includes a voluntary recognition program for hospitals that maintain effective sepsis programs or improve their programs over time.”
  • and
    • “The House June 4 passed the AHA-supported SUPPORT Act (H.R. 2483) by a 366-57 vote. The legislation reauthorizes key prevention, treatment and recovery programs for patients with substance use disorder, including programs to support the behavioral health workforce.”
  • Federal News Network tells us,
    • “More federal employees filed retirement papers with the Office of Personnel Management in May than in the last three months. OPM said it received more than 15,000 claims last month, driving the backlog up over 21,000. The processing time for these retirement claims remain consistent at 49 days on average in May and 52 days on average for the entire 2025. The increase in applications comes as OPM is requiring agencies to send retirement paperwork only in digital formats by July 15. OPM launched two new tools this week to improve the retirement services process. One is a new platform for agency HR and payroll providers and another to modernize the Electronic Official Personnel Folder (eOPF) platform.”
  • CMS shared “Federal Independent Dispute Resolution (IDR) Technical Assistance for Certified IDR Entities and Disputing Parties –June 2025 — Topic: Errors Identified After Dispute Closure.”
  • BenefitFocus discusses “Health Care Transparency 2.0 – What Might We See in Forthcoming Transparency Regulations.”

From the Food and Drug Administration front,

  • Per BioPharma Dive, “FDA meeting gives window into gene therapy field’s angst. Gene therapy experts and advocates warning of the sector’s many challenges found a receptive audience in FDA leadership at a regulatory forum Thursday.”
  • Per MedTech Dive,
    • “Medtronic is recalling certain tracheostomy tubes because of the risk that the devices could dislodge, causing an emergency where the patient cannot breathe or their airway is blocked, according to a Thursday Class I recall notice from the Food and Drug Administration. 
    • “The company sent a notice to customers on Feb. 26 asking them to quarantine and return all unused tubes from the affected lot. The recall applies to the Shiley adult flexible tracheostomy tube with taperguard cuff reusable inner cannula.
    • “Medtronic began the recall after receiving reports from customers that the flange used to secure the device may become disconnected. Patient harm was reported in some cases, but no deaths have been reported to date, a company spokesperson wrote in an email Thursday.”
  • BioPharma Dive relates,
    • “Vera Therapeutics lost nearly a third of its market value Friday after Otsuka Pharmaceutical presented late-stage study data on a rival drug it’s developing for the kidney disease IgA nephropathy. At a medical meeting, Otsuka said its therapy, sibeprenlimab, led to a 51% reduction in proteinuria, a key marker of kidney health, after nine months of treatment. Though cross-trial comparisons can be misleading, Vera’s therapy led to a 42% reduction in proteinuria compared to placebo at a similar timepoint in its own Phase 3 study, causing investors to sell off company shares. Still, some analysts defended Vera. Jefferies’ Farzin Haque cautioned not to “overinterpret the data” and argued the two datasets “are not clinically or statistically different for commercial uptake.” The Food and Drug Administration could approve Otsuka’s drug by Nov. 28. On Monday, Vera said it intends to file an accelerated approval application in the fourth quarter.”

From the judicial front,

  • Beckers Hospital Review informs us,
    • “The CEO of a healthcare software company was convicted by a federal jury for his role in operating a platform that generated fraudulent physicians’ orders to defraud Medicare and other payers out of more than $1 billion.
    • “Gary Cox, 79, of Maricopa County, Ariz., was the CEO of Power Mobility Doctor Rx (DMERx), an internet-based platform that generated fraudulent orders for unnecessary orthotic braces, pain creams and other items, according to a June 3 Justice Department news release.”

From the public health and medical research front,

  • The Centers for Disease Control and Prevention announced today,
    • Seasonal influenza, COVID-19, and RSV activity is low.
    • COVID-19
      • COVID-19 wastewater activity is low and emergency department visits and laboratory percent positivity are at very low levels.
    • Influenza
    • RSV
      • RSV activity has declined to low levels.
  • The AHA News lets us know,
    • “There have been 1,168 confirmed cases of measles across 33 states as of June 6 this year, according to the latest data from the Centers for Disease Control and Prevention. This year’s figure is more than four times higher than the 2024 total of 285 cases. There have been 17 outbreaks this year, and 89% of confirmed cases (1,040 of 1,168) are outbreak-associated. The vaccination status of 95% of all cases is classified as “unvaccinated or unknown.” 
  • Of note, Health Day warns us,
    • “An afternoon snooze might seem appealing to middle-aged folks and seniors, but these naps could carry a high cost.
    • “People with certain types of napping patterns have a greater risk of an early death, researchers are slated to report at an upcoming meeting of the American Academy of Sleep Medicine (AASM).
    • “People who slept longer during the day, had irregular daytime sleep patterns, or slept more around midday and early afternoon were at greater risk, even after accounting for health and lifestyle factors,” lead researcher Chenlu Gao, a postdoctoral research fellow at Massachusetts General Hospital in Boston, said in a news release.
    • “The findings call into question the whole concept of the “power nap.”
  • HHS’s AHRQ posted a report about “Management of Suicidal Thoughts and Behaviors in Youth: A Systematic Review.”
  • Per HR Dive,
    • “Work can either fuel employee well-being or become a source of strain for employees already stressed out by economic volatility and political tension, according to a May 12 survey of employee mental health by Inmar Intelligence.
    • “Of the 1,000 U.S. full- and part-time employees who responded to the May 12 survey, 34% said their job positively impacts their mental health, while 33% reported a negative impact, Inmar found.
    • “This near-even split reinforces the importance of thoughtful leadership and inclusive workplace design to support the full spectrum of employee needs,” the business technology firm stated in a May 29 post.”
  • Cardiovascular Business reports,
    • “Heart surgeons with the WVU Heart and Vascular Institute have made a bit of history, performing the world’s first robotic explant of a transcatheter aortic valve replacement (TAVR) device and subsequent aortic valve replacement.
    • “The group already has plenty of experience breaking new ground in the field of robotic-assisted surgery. They developed a robotic aortic valve replacement (RAVR) technique that is now being used all over the world and performed the world’s first robotic aortic valve replacement and coronary artery bypass (RAVCAB) procedure in 2024.
    • “This latest breakthrough started when Thelma Hyer, a 67-year-old female patient, presented with a failing TAVR valve in addition a leaky mitral valve. She had received her TAVR valve just four years prior, but premature structural valve degeneration had already made a full replacement necessary.
    • “Vinay Badhwar, MD, executive chair of the WVU Heart and Vascular Institute, initially recommended open-heart surgery to remove the failing TAVR valve and then replace her aortic and mitral valves. However, Hyer and her family had hesitations due to her history of scoliosis and arthritis. Badhwar then proposed using robotics as an alternative. 
    • “The technology had never been used in this exact way before, but Badhwar was confident in the abilities of both his team and the robotic surgery platform. The group developed a plan, talked it over with the patient, and went forward with the robotic procedure in late May. 
    • “The operation—including the TAVR explant and the replacement of both heart valves—appears to have been a success. Hyer was discharged after less than a full week of observation.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Omada Health shares jumped after the company made its public-market debut, propelled by Americans’ renewed focus on how weight affects physical health.
    • “Shares of the virtual healthcare platform climbed 35% to $25 on Friday, at one point hitting a high of $28, above the initial offering price of $19. The price gives it a market valuation of around $1.4 billion.
    • “The gains are a sign investors are willing to invest in newly public companies after a volatile stock market pushed some companies like payments platform Klarna to delay its IPO filing. Stablecoin issuer Circle opened on Thursday at $69, more than double its offering price, and was recently trading at $119.15. Hinge Health HNGE 0.83%increase; green up pointing triangle, another digital health company, opened in May at $39 after offering a $32 price.
    • “Omada is trading publicly after 14 years of providing support to patients with weight-related chronic illnesses. Leadership sees the current moment as the perfect time for an IPO, as GLP-1 drugs such as Ozempic, Wegovy and Mounjaro have sparked renewed focus on health problems that can stem from obesity, President Wei-Li Shao said.
    • “We’re entering this unique moment in time where there’s a convergence between what we’ve been working on for over a decade, and then also what society is increasingly caring about,” Shao said.”
  • Becker Hospital Review discusses ten key transactions that created Ascension 2.0.
    • “Over the last 16 months, St. Louis-based Ascension has sold or consolidated about 35 hospitals across the country as it revamps its hospital portfolio, operating model and overall financial performance.
    • “Despite reporting a $466 million operating loss (a -2.4% margin) for the nine months ending March 31, 2025, the Catholic nonprofit system has made notable strides in improving its liquidity position. That progress is largely attributed to the successful collection of accounts receivable that had temporarily spiked due to two major cybersecurity incidents — the May 2024 ransomware attack and the February 2024 Change Healthcare cyberattack.
    • “Since the fourth quarter of fiscal 2024 — the three months ending June 30, 2024 — Ascension has improved recurring operating performance by $1.4 billion, while increasing patient volumes and same-facility revenue.”
  • Beckers Health IT tells us,
    • “California-based Stanford Health Care is piloting an internally developed, AI-backed software designed to revolutionize clinician interaction with the EHR.
    • “Nigam Shah, MBBS, PhD, chief data science officer at Stanford Health Care, is leading the development team for ChatEHR, which allows clinicians to ask questions, request summaries and pull specific information from a patient’s medical record. ChatEHR is built directly into Stanford’s EHR to maximize clinical workflow.
    • “The pilot is available to a small cohort of 33 physicians, nurses and physician assistants. The technology is secure and designed for information gathering; not medical advice.
    • “ChatEHR, which has been in development since 2023, facilitates a more streamlined and efficient way for clinicians to interact with patient records.
    • “This is a unique instance of integrating [large language model] capabilities directly into clinicians’ practice and workflow,” said Michael Pfeffer, MD, chief information and digital officer at Stanford Health Care and School of Medicine, in a news release. “We’re thrilled to bring this to the workforce at Stanford Health Care.”
  • Drug Store News informs us,
    • “Walmart has become the first retailer to scale its drone delivery to five states with its recently announced service expansion in Atlanta, Charlotte, Houston, Orlando and Tampa. The new service will launch at 100 stores throughout Arkansas, Florida, Georgia, North Carolina and Texas, in addition to current operations in Northwest Arkansas and the Dallas-Fort Worth area.
    • “As we look ahead, drone delivery will remain a key part of our commitment to redefining retail,” said Greg Cathey, SVP, Walmart U.S. transformation and innovation. “We’re pushing the boundaries of convenience to better serve our customers, making shopping faster and easier than ever before.”
    • “Continued Cathey: “This expansion of our drone delivery service marks a significant milestone in that journey. As the first retailer to scale drone delivery, Walmart is once again demonstrating its commitment to leveraging technology to enhance our delivery offerings with a focus on speed.” 

Weekend Update

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

From Washington, DC,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Friday Factoids

David Ermer–AHRQ, CDC, Congress, Employee Wellness Programs, Medical / Rx research, Telehealth, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC,

  • STAT News reports,
    • “A House panel is exploring holding a vote on scaled-back versions of two major health care bills that would expand Medicare’s coverage of cancer screening tests and hugely popular weight loss drugs, five sources familiar with the planning told STAT. * * *
    • The two pieces of legislation are the Treat and Reduce Obesity Act, which would allow Medicare to cover obesity drugs and enable more health care providers to provide intensive behavioral therapy for obesity to Medicare patients, and the Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act, which would allow Medicare to cover multi-cancer blood tests to screen healthy people for cancer. * * *
    • “Full Medicare coverage for both items has broad bipartisan support, but the expansion has been hampered by the likely exorbitant price tags to the federal government. If the House Ways and Means Committee is able to scale back the measures to a more palatable price point, it could increase their chance of passage.
    • “It is unclear how the bills could be limited to decrease their cost, and whether such pared-down proposals could achieve the bipartisan support that would be necessary to make the bills candidates for inclusion in a health care package that’s expected at the end of the year.”
  • BioPharma Dive informs us,
    • “Peter Marks is again at the center of a controversial Food and Drug Administration decision on a gene therapy for Duchenne muscular dystrophy. Twice now, the high-ranking FDA leader has pushed aside objections from agency reviewers to grant an approval to Sarepta Therapeutics’ treatment for the muscle-wasting condition.
    • “On Thursday, the FDA substantially broadened use of that treatment, called Elevidys. The decision makes Elevidys available to approximately 80% of people in the U.S. with Duchenne, which has limited treatment options and no cure. The agency also converted Elevidys’ accelerated approval to full, securing its place on the market. Previously, Elevidys was only approved for a specific group of boys 4 or 5 years of age.
    • “[D]ocuments published by the FDA expose a rift within the agency over Elevidys. Three FDA review teams and two top officials recommended Sarepta’s application be rejected due to insufficient and conflicting clinical data. They were overruled by Marks, head of the FDA center that reviews gene therapies, who found the results supportive enough to broaden Elevidys’ label. It’s now cleared for Duchenne patients over the age of 4 with mutations to a specific gene, regardless of whether they can still walk.
    • “I come to a different conclusion regarding the overall interpretation of the data,” Marks wrote in a memo. * * *
    • “The lasting impact of the approval will likely shape the FDA and gene therapy space for some time,” wrote Tim Lugo, an analyst at the investment bank William Blair, in an investor note Thursday. “We believe a more patient focused and less adversarial FDA review process is likely to continue across several areas in the agency, especially for heterogenous and deadly diseases with few good treatment options.”
  • This morning, the 5th Circuit issued in its opinion in a case challenging the authority of the U.S. Preventive Services Task Force (USPSTF) to make binding preventive services recommendations under the Affordable Care Act. The Court agreed with the lower court that USPSTF members are principal officers of the U.S. due to the binding nature of their recommendations. (HHS argued unsuccessfully that they were inferior officers.). Under the Constitution, the President must appoint principal officers with the advice and consent of the Senate. 
  • The Court granted relief to the individual plaintiffs but rejected the district court’s grant of universal injunction against enforcement of USPSTF recommendations since ACA enactment. The Court remanded the case to the district court for further proceedings.
  • The political ball is in the Biden Administration’s court.

From the public health and medical research front,

  • The Centers for Disease Control tells us,
    • “Seasonal influenza and RSV activity are low nationally, but COVID-19 activity is increasing in some areas.
    • “COVID-19
      • “COVID-19 test positivity has increased to 6.6% from 5.4% in the previous week. Emergency department visits for COVID-19 are also increasing nationally. Wastewater viral activity is showing increases in some states. We also estimate that COVID-19 infections are growing or likely growing in 39 states and territories, declining or likely declining in 0 states or territories, and are stable or uncertain in 10 states and territories, based on CDC modeled estimates of epidemic growth. KP.3 and LB.1 are projected to continue increasing as proportions of the variants that cause COVID-19 (CDC COVID Data Tracker: Variant Proportions).
    • “Influenza
    • “RSV
      • “Nationally, RSV activity remains low.
    • “Vaccination
  • Health Day lets us know,
    • “A medication used to manage type 2 diabetes has been found effective in treating sleep apnea.
    • “The worldwide clinical trial demonstrates that tirzepatide significantly lowers breathing interruptions during sleep, a key indicator of the severity of a patient’s obstructive sleep apnea (OSA).
    • “Tirzepatide is one of the class of blockbuster GLP-1 medicines, sold as Mounjaro to fight diabetes and as Zepbound to help with weight loss.
    • “This study marks a significant milestone in the treatment of OSA, offering a promising new therapeutic option that addresses both respiratory and metabolic complications,” said study leader Dr. Atul Malhotra, director of sleep medicine at UC San Diego Health. * * *
    • “The findings, published June 21 in the New England Journal of Medicine, add to evidence that a drug targeting both apnea and obesity is better than treating either condition on its own. Researchers said the drug therapy improved other aspects related to OSA, such as improving weight. Some patients, however, had mild stomach issues.”
  • Medscape notes, “Individuals on an intermittent-fasting and protein-pacing (IF-P) diet had fewer gastrointestinal symptoms and increased diversity in gut microbiota than those on a calorie-restricted (CR) Mediterranean-style diet in a small, randomized trial.”
  • The Assistant Secretary of Labor for Employee Benefit Security writes in her blog that “For Men, Taking Care of Your Family Means Taking Care of Yourself.”

From the U.S. healthcare business front,

  • Beckers Hospital Review reports,
    • “Risant Health, a nonprofit formed under Oakland, Calif.-based Kaiser Permanente, has signed a definitive agreement to acquire Greensboro, N.C.-based Cone Health.
    • “The news comes less than three months after Risant acquired its first health system, Danville, Pa.-based Geisinger Health. 
    • “If the transaction closes, Cone Health will operate independently as a regional and community-based health system under Risant, which supports organizations with technology and services to improve outcomes and lower care costs in diverse business models.
    • “Cone Health’s impressive work for decades in moving value-based care forward aligns so well with Risant Health’s vision for the future of healthcare. Their longstanding success and deep commitment to providing high-quality care to North Carolina communities make them an ideal fit to become a part of Risant Health,” CEO, Jaewon Ryu, MD, said in a June 21 news release. “We will work together to share our industry-leading expertise and innovation to expand access to value-based care to more people in the communities we serve.” 
    • “Cone Health includes four acute-care hospitals, a behavioral health facility, three ambulatory surgery centers, eight urgent care centers and more than 120 physician practices, according to its website. It has more than 13,000 employees and over 700 physicians, along with 1,800 partner physicians.” 
  • Per Healthcare Dive,
    • “Steward Health Care this week pushed back the auction timeline for the sale of its physician group and about half of its hospitals — less than a week before bids were due.
    • “The delay impacts the sale of Arizona and Massachusetts hospitals as well as the St. Joseph Medical Center in Texas. The new deadline for bids is July 15, with an auction following July 18 and a proposed sales hearing on July 31. Steward did not change the timeline for the sale of its other assets.
    • “One expert told Healthcare Dive it was “very possible” Steward would delay the sale timeline again if creditors agreed it was the best business move — especially since the company just re-upped its debtor-in-possession financing, which provides cash to fund operations through restructuring.”
  • and
    • “Telehealth use declined across most sociodemographic groups from 2021 to 2022, according to a survey published Thursday by the National Center for Health Statistics.
    • “Thirty-seven percent of adults reported using telemedicine in the past 12 months in 2021, compared with just over 30% in 2022.
    • “Researchers noted the decline across nearly all groups studied, including sex, family income, education and region. Women, adults with at least a college degree and people living in more urban areas were more likely to use telehealth in 2022.” 
  • Per Fierce Healthcare,
    • “An innovation council brought together some of the nation’s largest health plans to raise issues and look for ways to improve complex processes, including credentialing and provider data management.
    • “It’s one of the first times payers have sat down together to solve these pain points, CAQH CEO Sarah Ahmad told Fierce Healthcare in an interview. The health plan representatives met in-person just one day before AHIP 2024 kicked off in Las Vegas last week.
    • “You don’t see that in healthcare these days,” said Ahmad, whose company assembled the leaders.
    • “CAQH is a provider data management company that works on the provider side to credential and handle directory management, and on the member side to handle coordination of benefits.”
  • HR Dive offers five stories on the rise of wellness benefits.

Friday Factoids

David Ermer–CDC, Congress, COVID-19 vaccine, Employee Wellness Programs, FDA, Generative AI, Medical / Rx research, Obesity, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC

  • Govexec reports,
    • “In the face of mounting pressure from lawmakers of all political stripes, watchdogs, stakeholders and even members of its own governing board, as well as another financial quarter in the red, leadership of the U.S. Postal Service is doubling down on its controversial plan to overhaul the agency. 
    • “USPS posted a net loss of $1.5 billion in the second quarter of fiscal 2024, though management noted that was trimmed to a $300 million loss after dispensing with costs outside of its control. USPS leaders boasted they have turned a $200 million profit in the first half of the fiscal year using that same metric, which marked a $600 million turnaround compared to the first six months of fiscal 2023.
    • “While First-Class mail volume has continued its longstanding decline, revenue grew in the quarter by nearly $500 million due in large part to the dramatic price increases USPS has instituted. The Postal Service has cut $100 million in costs, driven largely by a reduction in transportation expenses and slashing 9 million work hours. 
    • “On-time delivery of mail, however, has plummeted as USPS has instituted significant reforms to its network as laid out in Postmaster General Louis DeJoy’s 10-year Delivering for America plan.” 
  • HHS posted a fact sheet on new government efforts to reduce the impact of spread of avian flu H5N1
  • Senators John Fetterman (D PA) and Tina Smith (D MN) announced a bill, “the United States Senate Commission on Mental Health Act of 2024. The bill would establish a U.S. Senate Commission on Mental Health tasked with providing Congress and the president independent, expert policy recommendations to improve access to and affordability of mental health care services. * * * Full text of the bill can be found here.“

From the public health and medical research front,

  • The Centers for Disease Control tells us today,
    • “The amount of respiratory illness (fever plus cough or sore throat) causing people to seek healthcare continues to decrease across most areas of the country. This week, no jurisdictions experienced moderate, high, or very high activity.
    • “Nationally, emergency department visits with diagnosed influenza are decreasing. Emergency department visits with COVID-19 and RSV remain stable at low levels.
    • “Nationally, influenza and RSV test positivity decreased compared to the previous week. COVID-19 test positivity remained stable at low levels.
    • “Nationally, the COVID-19 wastewater viral activity level, which reflects both symptomatic and asymptomatic infections, is minimal.”
  • STAT News reports “Harvard scientists unveil the most detailed map of the brain ever: ‘It’s an alien world inside your own head’”.
    • “On Thursday, [Dr. Jeffrey’ Lichtman and his partners unveiled the results of their [decade long] efforts in the prestigious journal Science, and also posted to the internet renderings of the human brain unlike any ever seen. They came complete with a program that allows viewers to move through a microscopic alien landscape so detailed Lichtman can’t resist waxing poetic when he talks about it.
    • “It’s an alien world inside your own head,” he said. “Neurons themselves are truly awe inspiringly beautiful. There’s no two ways about it.”
    • “True, the insights gleaned from the tiny sample have not yet unraveled the mysteries of autism, schizophrenia, or depression. They can’t yet explain the mechanics of human learning, memory, and personality on the cellular level. But they represent an important first step in that direction, and provide a tantalizing preview of the kind of insights we might see in the decades ahead.”
  • The Wall Street Journal reports,
    • “Bristol Myers Squibb said on Friday that its trial evaluating a combination of cancer treatments failed to meet its primary endpoint.
    • “The company’s trial was evaluating the cancer-drug Opdivo and concurrent chemoradiotherapy, followed by Opdivo plus Yervoy, the brand name for a monoclonal antibody, in treating unresectable, locally advanced non-small cell lung cancer. The trial’s primary endpoint was progression-free survival.
    • “Bristol Myers Squibb said it would fully evaluate the data and work with investigators to share results with the scientific community.
    • “Opdivo and certain combinations with Opdivo are approved treatments for eligible patients with non-small cell lung cancer.”
  • Per Fierce Healthcare,
    • “Cancer diagnoses are on the rise among younger adults, and a new guidebook seeks to arm employers with the tools necessary to tackle this issue.
    • “The Northeast Business Group on Health’s new toolkit highlights actions employers can take to proactively address growing rates for five types of cancer in their workforce: breast cancer, colorectal cancer, head and neck cancer, cancer of the reproductive organs and skin cancer.
    • “There’s a clear business case for putting a focus on cancer, as the cost of therapies continues to increase and patients often require treatment for the long haul, NEBGH Medical Director Mark Cunningham-Hill, M.D., told Fierce Healthcare.
    • “He said that many employers, especially larger firms, have established sophisticated and comprehensive wellness and health programs for their workers. But they can do more to “connect the dots” between those offerings and critical preventive care around cancer and conditions that increase risk factors, like obesity.”
  • USA Data relates,
    • One out of every 42 babies born in the United States in 2021 was conceived using IVF or other assisted reproductive technologies.  
    • Parents who started treatments in 2021 gave birth to 97,128 babies, a 49% increase from 2012. In 2021, 238,126 patients initiated 413,776 IVF or similar treatment cycles, up 135% from 2012. 
    • IVF was most common in Washington, DC, with 5.8% of babies conceived via IVF, Massachusetts (5.4%), and New Jersey (5.0%). Less than one percent of infants born in Puerto Rico were conceived via IVF (0.4%). Alabama (0.6%) and Arkansas (0.7%) also had low rates.  

From the U.S. healthcare business front,

  • The Kaiser Family Foundation released a “KFF Health Tracking Poll May 2024: The Public’s Use and Views of GLP-1 Drugs.” Here are the key finding from the poll:
    • “The latest KFF Health Tracking Poll finds that about one in eight adults (12%) say they have ever taken a GLP-1 agonist – an increasingly popular class of prescription drugs used for weight loss and to treat diabetes or prevent heart attacks or strokes for adults with heart disease – including 6% who say they are currently taking such a drug. The share who report ever taking these drugs rises to four in ten (43%) among adults who have been told by a doctor that they have diabetes, a quarter who have been told they have heart disease, and one in five (22%) who have been told by a doctor that they are overweight or obese in the past five years1. Public awareness of GLP-1 drugs has increased in the past year, with about one-third (32%) of adults now saying they have heard “a lot” about these drugs, up from 19% in July 2023.
    • “Most adults who have taken GLP-1 drugs say they took them to treat a chronic condition including diabetes or heart disease (62%), while about four in ten say they took them primarily to lose weight.
    • “About half (54%) of all adults who have taken GLP-1 drugs say it was difficult to afford the cost, including one in five (22%) who say it was “very difficult.” While most insured adults who have taken these drugs say their insurance covered at least part of the cost, even among insured adults about half (53%) say the cost was difficult to afford2.
    • “While 8% of adults ages 65 and older say they have taken a GLP-1 medication for a chronic condition, just 1% say they have ever taken a GLP-1 drug to lose weight, which may reflect Medicare’s lack of coverage for prescription drugs used for weight loss. Nearly four in ten (37%) adults ages 65 and older report being told by a doctor they are overweight or obese in the past five years.
    • “With Medicare currently prohibited by law from covering prescription drugs used for weight loss, six in ten adults say they think Medicare should cover the cost of these drugs when prescribed for weight loss for people who are overweight, including more than half of Democrats, independents and Republicans. Similar shares of the public continue to support Medicare coverage of these drugs for weight loss even after hearing arguments for and against this proposal.”
  • Per BioPharma Dive,
    • “Sanofi will pay vaccine maker Novavax $500 million and take a small equity stake in the Maryland-based company as part of a broad COVID-19 shot alliance, the companies announced Friday.
    • “Through the deal, Sanofi will gain rights to co-market Novavax’s protein-based COVID vaccine globally, excepting certain countries, and a license to combine it with Sanofi’s existing influenza shots. Sanofi will also hold a non-exclusive right to use Novavax’s soap bark tree-derived adjuvant in other products it develops.
    • “Starting next year, Sanofi will book sales of Novavax’s COVID shot and pay Novavax double-digit percentage royalties. The French pharmaceutical company will also support certain R&D, regulatory and commercial expenses.”
  • Per MedTech Dive,
    • “Tandem Diabetes Care is recalling a version of its t:connect app for iPhone because of a fault that could drain insulin pump batteries, the Food and Drug Administration said Wednesday.”Tandem Diabetes Care is recalling a version of its t:connect app for iPhone because of a fault that could drain insulin pump batteries, the Food and Drug Administration said Wednesday.
    • “After updating the app in February, Tandem received 224 injury reports in about two months. The reports related to an issue that caused the app to crash and relaunch, resulting in excessive use of Bluetooth and potentially draining the battery of the connected insulin pump.
    • “The FDA categorized the event as a Class I recall because of the life-threatening potential for pumps to deliver too little insulin. Tandem corrected the fault in an app update in March.”
  • The Wall Street Journal explains why “Getting Alzheimer’s treatment to those who need it poses particular challenges.” For example
    • “The problem isn’t this drug. Sure. It has risks, et cetera,” said Jason Karlawish, co-director, of the Penn Memory Center at the University of Pennsylvania. “But the problem was the drug and the system — namely with a system of care for its delivery.”
    • “Karlawish said his memory center infused its first patient with Leqembi on November 16. He said that in the six months since, the number of patients who have received the drug there has climbed into the double-digits, reaching roughly 50 people. That, he said, required setting up an infrastructure that “either didn’t exist or existed in bits that had to be put together.”
  • MedCity new points out,
    • “Navigation challenges are the top reason consumers stop seeing healthcare providers, while experience issues are the main reason consumers leave their health insurer, a new survey found.
    • “The Accenture report, released last week, surveyed more than 9,700 insured consumers and 8,000 consumers who sought or received care in the prior year. The survey is a follow-up to a 2021 report, which examined why people are loyal or not loyal to their payer or provider.
    • “We wanted to leverage our patient and member experience surveys to continue to track the state of consumerism in health care, assessing how providers and health insurers perform across a number of key touchpoints that drive selection, loyalty, value and ease of use,” said Sarah Sinha, a managing director in Accenture’s health business, in an email.”
  • Insurance Business tells us,
    • “Offering support across a variety of functions including customer service, claims processing, underwriting, and fraud detection, the capability of AI to analyze large datasets and process information will continue to revolutionize insurance.
    • “Nirmal Ranganathan, vice president of engineering, AI, at Rackspace Technology, spoke with Insurance Business on how insurance companies can take advantage of AI to generate cost savings across their businesses.”
    • Check it out.

Midweek Update

David Ermer–CMS, Congress, COVID-19, Cybersecurity, Employee Wellness Programs, FDA, Generative AI, Medical / Rx research, Mental health care, Obesity, OPM, Rx coverage, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC,

  • Roll Call reports,
    • “Speaker Mike Johnson, R-La., and his top lieutenants on Wednesday morning moved to quell reservations among their conference about the emerging $1.2 trillion-plus final spending package headed for a vote likely on Friday, while their Democratic counterparts did likewise in a separate meeting.
    • “Appropriators were scrambling under a tight timeline to finish drafting the measure, which is taking longer than expected due to a last-minute decision to write a full-year Homeland Security bill. But Johnson told reporters after a GOP conference meeting that text is expected as soon as Wednesday afternoon.
    • “Other sources expected the bill drop to slip to Thursday, with the standard “reading out” of the DHS title, to catch any errors before posting, not even expected to begin until later Wednesday. But no matter: Lawmakers said they expect the chamber to vote as soon as Friday, regardless of a 72-hour review rule. * * *
    • “Final passage wouldn’t come until this weekend at the earliest, and senators are working to accommodate Sen. Susan Collins, R-Maine, who has never missed a vote but will be attending her mother’s funeral on Saturday. That could push votes off until Sunday or Monday, though few are worried at this point about the effects of such a brief funding lapse. 
    • “I don’t think we’ll do a [continuing resolution],” Johnson said.”
  • The American Hospital Association (AHA) News informs us,
    • “The House Energy and Commerce Committee March 20 unanimously passed AHA-supported legislation to reauthorize through 2029 the Dr. Lorna Breen Health Care Provider Protection Act (H.R. 7153), which provides grants to help health care organizations offer behavioral health services for front-line health care workers. The bill also would reauthorize a national campaign that provides hospital leaders with evidence-based solutions to support worker well-being. Without congressional action, the law will expire at the end of this year.”
  • and
    • “Congress should address any statutory constraints that prevent the Centers for Medicare & Medicaid Services and Department of Health and Human Services from adequately helping hospitals and other health care providers impacted by the Change Healthcare cyberattack, AHA said a letter submitted to the House Ways and Means Committee for a hearing March 20 with HHS Secretary Xavier Becerra on fiscal year 2025 funding for HHS.”
  • Govexec tells us,
    • “The top senator with direct oversight of the U.S. Postal Service is calling on its leadership to pause its overhaul of the agency’s mailing network due to potential impacts they are having on delivery, rejecting USPS assertions that is has provided transparency. 
    • “USPS should not continue its nationwide operational reforms until it can prove the changes will not negatively impact mail service, Sen. Gary Peters, D-Mich., who chairs the Senate Homeland Security and Governmental Affairs Committee, said in a letter to Postmaster General Louis DeJoy. Agency leadership said in response to the letter it has offered volumes of documents and many staff-level briefings to Congress, though Peters said USPS ignored many of his requests for additional information on its efforts and left Congress uncertain about the fallout that could befall postal customers.”
  • On March 18, 2024, the Office of Management and Budget’s Office of Information and Regulatory Affairs received for final regulatory review an OPM proposed rule with additional requirements and clarifications for the Postal Service Health Benefits Program (RIN 3206-AO59).
  • The AHA News tells us,
    • “U.S. health care organizations should immediately transition away from using certain unauthorized plastic syringes made in China by Jiangsu Caina Medical Co. and Jiangsu Shenli Medical Production Co., and should only use other plastic syringes made in China until they can transition to alternatives, the Food and Drug Administration announced March 19, citing potential quality and performance issues. The recommendations do not apply to glass syringes, pre-filled syringes, or syringes used for oral or topical purposes, FDA said. The agency advises health care providers to confirm the manufacturing location by reviewing the labeling, outer packaging, or contacting the supplier or group purchasing organization.”
  • The Assistant Secretary of Labor for Employee Benefit Security, Lisa M. Gomez, posted on her blog about “Health and Money Smarts for Women.”
  • Fierce Healthcare lets us know,
    • “The Employee Retirement Income Security Act, or ERISA, is turning 50 this year and lawmakers are curious to hear about how the law could be updated to increase coverage affordability and care access.
    • “Payers and providers, it turns out, have very different ideas on where Congress should focus its efforts.
    • “In response to the House Committee on Education and the Workforce’s January request for information, lobbying groups representing both sides of the industry weighed in on the act that outlines federal guidelines for employee benefit plans, including employer-sponsored group health plans.”
    • The article delves into these comments.
  • Newfront offers insights about 2024 RxDC reporting considerations. The reports are due June 1, 2025.
  • The Congressional Budget Office released a presentation about “The Federal Perspective on Coverage of medications to treat obesity. Assuming Congress allows Medicare to cover anti-obesity medications (AOM),
  • “The future price trajectory of AOMs is highly uncertain.
    • “CBO expects semaglutide to be selected for price negotiation by the Secretary of Health and Human Services within the next few years, which would lower its price (and potentially the prices of other drugs in the AOM class).
    • “CBO expects generic competition for semaglutide and tirzepatide to start in earnest in the second decade of a policy allowing Medicare Part D to cover AOMs.
    • “New AOMs are expected to become available. The new drugs might be more effective, have fewer side effects, or be taken less frequently or more easily than current medications. Those improvements could translate to higher prices, on average, even if prices decline for drugs that exist today.”
  • See also the Beckers Hospital Review article below on the next generation of AMOs.
  • Healthcare Dive tells us,
    • “The Medicare Advisory Payment Commission, which advises Congress on Medicare policy, is recommending boosting hospital payment rates by 1.5% in 2025 and base physician payment rates by 1.3% above current law, according to its annual report released Friday. 
    • “MedPAC suggested tying the rate of physician payment increasesmoving forward to the Medicare Economic Index, an annual measure of practice cost inflation. MedPAC suggested payments increase “by the amount specified in current law plus 50% of the projected increase in the MEI.”
    • “Provider groups, including the Medical Group Management Association and American Medical Association, have said the proposed payment increases are inadequate.”

From the public health and medical research front,

  • The Washington Post reports,
    • “More than two-thirds of young children in Chicago could be exposed to lead-contaminated water, according to an estimate by the Johns Hopkins Bloomberg School of Public Health and the Stanford University School of Medicine.
    • “The research, published Monday in the journal JAMA Pediatrics, estimated that 68 percent of children under the age of 6 in Chicago are exposed to lead-contaminated drinking water. Of that group, 19 percent primarily use unfiltered tap water, which was associated with a greater increase in blood lead levels.
    • “The extent of lead contamination of tap water in Chicago is disheartening — it’s not something we should be seeing in 2024,” lead author Benjamin Huynh, assistant professor of environmental health and engineering at the Johns Hopkins Bloomberg School of Public Health, said in a news release.”
  • The Wall Street Journal relates,
    • “Debi Lucas had a tremor in her arm. Her feet froze when she tried to walk and she fell into her coffee table, busting her lip. 
    • “She went to a neurologist who thought she had Parkinson’s disease. Doctors normally diagnose the neurodegenerative condition by symptoms. Lucas, 59, had them. 
    • “But the neurologist, Dr. Jason Crowell, couldn’t be sure. The symptoms might be related to a traumatic brain injury Lucas suffered in a car accident decades earlier, he thought. Or they might be from her medications. 
    • “To find an answer, Crowell turned to a new test: a skin biopsy that can detect an abnormal protein people with Parkinson’s have inside their nerves. He took samples of skin near her ankle, knee and shoulder and sent them to a lab. 
    • “The results confirmed that Lucas has Parkinson’s. The diagnosis was scary, but Lucas finally knew what was causing her symptoms. “I was glad to have a name on it,” she said. 
    • “The test sped her diagnosis, said Crowell, a movement-disorders neurologist at the Norton Neuroscience Institute in Louisville, Ky. “It just gives me more confidence,” he said. 
    • “The skin test is an important part of progress researchers are making against Parkinson’s, the second-most common age-related neurodegenerative condition, which is on the rise and a major driver of disability, dementia and death. The test Lucas received, made by CND Life Sciences, a medical technology company in Scottsdale, Ariz., is one of a few in use or development to allow doctors to diagnose Parkinson’s based on biology rather than symptoms that can take years to appear“.
  • Medscape explains “why a new lung cancer treatment is so promising.”
  • MedPage Today notes,
    • “The FDA has approved aprocitentan (Tryvio), making it the first endothelin receptor antagonist for the treatment of high blood pressure (BP), Idorsia Pharmaceuticals announced on Wednesday.
    • “The once-daily oral medication is indicated in combination with other antihypertensive drugs to lower BP in adult patients who do not have their BP controlled with other therapies.
    • “It is believed that some people may respond better to the drug’s novel mechanism, as aprocitentan is a dual endothelin receptor antagonist that works differently than conventional diuretics, renin-angiotensin-aldosterone system antagonists, calcium channel blockers, and beta-blockers used to lower BP.”
  • Beckers Hospital Review considers the three generations of weight loss drugs.
    • “Anita Courcoulas, MD, defines GLP-1s as “generation one;” dual GLP-1 and GIPs as the second; and a triple threat of GLP-1, GIP and GCGRs as the third generation of weight loss drugs. 
    • “Dr. Courcoulas is chief of Pittsburgh-based UPMC’s minimally invasive bariatric and general surgery program. She told Becker’s the next class of anti-obesity medications are finally reaching weight loss outcomes seen from gastric sleeve and bypass procedures, the two most common surgeries for trimming pounds. * * *
    • “Dr. Courcoulas said the biggest unknown is long-term durability of these medications, a concern other bariatric experts have raised. 
    • “She expects GLP-GIP-GCGR medications to gain approval and enter the U.S. market next year. 
    • “I think it’s very exciting to realize there are medications that are under investigation now that could come to market that could have even better weight loss results than the two drug [classes] we’re seeing now,” Dr. Courcoulas said.”
  • The National Institutes of Health announced,
    • “SARS-CoV-2, the virus that causes COVID-19, can damage the heart even without directly infecting the heart tissue, a National Institutes of Health-supported study has found. The research, published in the journal Circulation, specifically looked at damage to the hearts of people with SARS-CoV2-associated acute respiratory distress syndrome (ARDS), a serious lung condition that can be fatal. But researchers said the findings could have relevance to organs beyond the heart and also to viruses other than SARS-CoV-2.
    • “Scientists have long known that COVID-19 increases the risk of heart attack, stroke, and Long COVID, and prior imaging research has shown that over 50% of people who get COVID-19 experience some inflammation or damage to the heart. What scientists did not know is whether the damage occurs because the virus infects the heart tissue itself, or because of systemic inflammation triggered by the body’s well-known immune response to the virus.
    • “This was a critical question and finding the answer opens up a whole new understanding of the link between this serious lung injury and the kind of inflammation that can lead to cardiovascular complications,” said Michelle Olive, Ph.D., associate director of the Basic and Early Translational Research Program at the National Heart, Lung, and Blood Institute (NHLBI), part of NIH. “The research also suggests that suppressing the inflammation through treatments might help minimize these complications.”
  • and
    • “An investigational gene therapy for a rare neurodegenerative disease that begins in early childhood, known as giant axonal neuropathy (GAN), was well tolerated and showed signs of therapeutic benefit in a clinical trial led by the National Institutes of Health (NIH). Currently, there is no treatment for GAN and the disease is usually fatal by 30 years of age. Fourteen children with GAN, ages 6 to 14 years, were treated with gene transfer therapy at the NIH Clinical Center and then followed for about six years to assess safety. Results of the early-stage clinical trial appear in the New England Journal of Medicine. 
    • “The gene therapy uses a modified virus to deliver functional copies of the defective GAN gene to nerve cells in the body. It is the first time a gene therapy has been administered directly into the spinal fluid, allowing it to target the motor and sensory neurons affected in GAN. At some dose levels, the treatment appeared to slow the rate of motor function decline. The findings also suggest regeneration of sensory nerves may be possible in some patients. The trial results are an early indication that the therapy may have favorable safety and tolerability and could help people with the rapidly progressive disease.
    • “One striking finding in the study was that the sensory nerves, which are affected earliest in GAN, started ‘waking up’ again in some of the patients,” said Carsten G. Bonnemann, M.D., senior author and chief of the Neuromuscular and Neurogenetic Disorders of Childhood Section at the National Institute of Neurological Disorders and Stroke (NINDS), part of NIH. “I think it marks the first time it has been shown that a sensory nerve affected in a genetic degenerative disease can actually be rescued with a gene therapy such as this.”
  • Lifesciences Intelligence reports,
    • “Recently, JAMA Network Open published a study analyzing the association between a healthy diet, sleep duration, and type 2 diabetes (T2D) risk. The study data revealed that habitual short sleep duration was linked to an increased probability of T2D by as much as 41%.
    • “Using data on 247,867 individuals from the UK biobank, researchers divided patients into groups based on their sleeping habits. The stratified groups included normal (7–8 hours per night), mildly short (6 hours per night), moderately short (5 hours per night), and extremely short (3–4 hours per night).
    • “Across all study participants, only 3.2% were diagnosed with T2D; however, the adjusted hazard ratios revealed that the prevalence of T2D was higher among shorter sleep groups. More specifically, the increased probability of T2D was identified in those who slept 5 hours or less per night. Those in the moderate short sleep group were 16% more likely to have a T2D diagnosis. Additionally, those in the extremely short sleep group had a 41% greater likelihood of being diagnosed with T2D.”

From the U.S. healthcare business front,

  • BioPharma Dive relates,
    • “Orchard Therapeutics said Wednesday it will offer a new gene therapy to children with a rare, devastating disease at a record-setting wholesale price of $4.25 million. 
    • “The therapy, Lenmeldy, won Food and Drug Administration approval on Monday to treat patients with early-onset metachromatic leukodystrophy, or MLD. The disease, which most often attacks infants between six months and two years of age, robs patients of the ability to walk, talk and function in the world, killing most of its earliest victims within five years of onset.
    • “Lenmeldy’s price tag will leapfrog those of the two most expensive gene therapies available in the U.S. Sarepta Therapeutics sells its Elevidys treatment for Duchenne muscular dystrophy for $3.2 million, while CSL and UniQure’s hemophilia treatment Hemgenix costs $3.5 million.”
  • MedPage Today lets us know,
    • “Despite being a growing percentage of the physician workforce, women physicians continued to be paid less than their male colleagues, a strong body of evidence shows.
    • “While the gender pay gap decreased by 2% from 2021 to 2022 — from 28% to 26% — the gap was still significant, according to online networking service Doximity’s 2023 physician compensation reportopens in a new tab or window.
    • “Women doctors in 2022 earned nearly $110,000 less per year than men physicians, on average, after adjusting for specialty, location, and years of experience. Data from individual states have backed up this figure, too. For instance, in 2022, the Maryland State Medical Society conducted a survey and found that women doctors in Maryland are paid about $100,000 less annually than men.”
  • Beckers Hospital Review lists ten common issues in pharmacies.
  • United Healthcare updated its Change Healthcare cyberattack response website today.
  • HR Daily Advisor explains how companies are exploring the limitations of employee assistance plans amid the country’s mental health crisis.
  • Forbes reports,
    • “Medical diagnosis and procedure codes are so numerous and varied that Debbie Beall, manager of coding at Houston Methodist in Texas, needs a 49-person team to translate the medical notes written by the system’s 1,600 clinicians into the codes needed to bill insurers.
    • “There is a medical code for every imaginable scenario – from “burn due to water-skis on fire” to “spacecraft collision injuring occupant” — and their specificity determines how much the insurance companies pay. Each team member processes anywhere from 70 to 250 claims per day, depending on the complexity, she said. That’s why Beall is so excited about the possibility of using artificial intelligence to speed up the job.
    • “There’s no way I’m ever going to replace coders completely with an AI system,” Beall told Forbes. But for run-of-the-mill procedures performed multiple times a day in a hospital, like X-rays and EKGs? “Yes, an AI engine can do that.”
    • “Beall was one of the first dozen or so people to test a prototype of an AI-powered medical coding tool from electronic health records giant Epic Systems, which had $4.6 billion in revenue in 2022. Based on GPT-4, the large language model that powers the viral chatbot ChatGPT, Epic’s coding assistant prototype ingests and summarizes clinician notes and then tees up the “most likely” diagnosis codes and procedures codes, along with suggestions of “other potential codes,” according to mock ups viewed by Forbes that did not include real patient information. * * *
    • “While Epic has so far focused on using generative AI in back office functions, it has also been working on a patient-facing application that wouldn’t require human review. Krause told Forbes a tool that would help explain the patient’s bill, including their deductible and outstanding balance, could be rolled out by November. “We feel like that’s a fairly benign place to start. It’s not about healthcare at that point, but it’s really about their billing,” he said. “That’s not going to harm a patient in any way.”

   

Thursday Miscellany

David Ermer–ACA, CMS, Employee Wellness Programs, Mental health care, OPM, SDOH, U.S. Healthcare, Wellness–

As you may be able to tell, it’s a late FEHBlog post because the FEHBlog was returning home to Dripping Springs, TX, last night from our Nation’s capital.

In case, here are some highlights from Washington DC.

  • The GAO released a troubling report on our country’s fiscal health this week. Here’s a link to a Wall Street Journal Opinion Watch podcast about the report. The podcast is about 20 minutes long, and it may make your hair stand on edge.
  • Mercer Consulting discusses changes to the RxDC reports due annually on June 1.
    • “CMS released instructions for the third prescription drug data collection (RxDC) reports due June 1, 2024 – and they may cause plan sponsors to reconsider whether they need to make “plan level” submissions, instead of relying on their vendors to make “aggregate” submissions on their behalf. The good news is that the instructions largely mirror prior versions, so plan sponsors should be able to build off prior RxDC reporting efforts. However, for the first time, CMS plans to enforce the “aggregation restriction”—a provision in the 2021 regulations that CMS suspended for the first two reporting cycles. As explained [in the article], the reinstated aggregation restriction may cause headaches for some plan sponsors, who find that they can no longer rely on their PBM’s aggregate submission of pharmacy data but must instead submit plan level data. Other plan sponsors may welcome the opportunity to do a plan level submission so they can obtain otherwise unavailable prescription drug data.”
  • Per Govexec,
    • “With federal budget talks still unresolved less than a month away from Congress’ latest deadline, the Office of Personnel Management said Friday that the decade-long pay freeze for senior political appointees like Vice President Kamala Harris and others will remain in effect.
    • “In a Feb. 9 post, OPM Director Kiran Ahuja said that under January’s continuing resolution that extended federal funding to agencies until March 1 and 8, certain senior political appointees will continue to see their payable pay rates remain at current levels at least through the latter budget deadline, when Congress will have to decide whether it will continue to fund the federal government. 
    • “Future Congressional action will determine whether the pay freeze continues beyond March 8, 2024,” Ahuja said. “Until such time, the OPM guidance issued on Dec. 21, 2023, regarding the pay freeze for certain senior political officials continues to be generally applicable in applying the pay freeze in 2024.”

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “There isn’t a silver bullet to maintaining mental acuity or warding off dementia [as we age], scientists of aging say. But a combination of genetics, healthy lifestyle habits and factors such as cleaner air and good education have been linked to prolonged mental agility.  * * *
    • “Genetics is thought to play a role in brain maintenance, as does diet, exercise and a person’s risk of vascular disease. More education, mental stimulation and social connectivity have been associated with improved cognitive reserve.
    • “Better brain maintenance and cognitive reserve might help keep symptoms of dementia at bay. Almost 50% of people 40 and older think they will likely develop dementia, according to a 2021 AARP survey. The actual number of U.S. adults 65 and older with dementia is closer to 10%, a 2022 study found. * * *
    • “Sleeping too little—or too much—can also lead to cognitive problems. Activities including yoga and tai chi, the Chinese martial art, could help improve cognitive function, research suggests. 
    • “Hearing loss is a risk factor for dementia, too. Lost hearing might cause the brain to atrophy more quickly and can make people more isolated, said Dr. Dung Trinh, chief medical officer of the Healthy Brain Clinic. Hearing aids can help preserve mental fitness.”
  • AHA News adds,
    • “About half of U.S. health care workers have witnessed racial discrimination against patients and say discrimination against patients is a crisis or major problem, according to a survey released Feb. 15 by the Commonwealth Fund and African American Research Collaborative. Younger workers and workers of color were more likely than their older or white counterparts to say they witnessed discrimination, as were workers at facilities with more patients of color. About six in 10 Black health care workers and four in 10 Latino, Asian American and Pacific Islander workers say they have been discriminated against because of their race or ethnicity. 
    • “While most health care workers see positive efforts from employers to address discrimination, a majority of Black, Latino, and AAPI workers worry about retaliation if they raise discrimination concerns. When asked about potential solutions, more than two-thirds of health care workers thought the following could help: providing an easy way to anonymously report situations involving racism or discrimination; creating opportunities to listen to patients and health care professionals of color; examining treatment of non-English-speaking patients; and training health care staff to spot discrimination.” 
  • Employee Benefit News offers three suggestions on how employers can help employees hold cancer at bay with preventive screenings.
    • “A new report from healthcare platform Color Health shows that although 80% of employers are concerned by rising cancer costs and 96% of benefits leaders agree early detection is the best solution, the majority of focus is devoted to post-diagnosis treatment, rather than evidence-based screenings. 
    • “According to the report, three out of four employers say they are placing more emphasis on screening, early detection and risk prevention efforts, but they are going to have to go beyond their current benefits setup: Only a quarter believe their current health plans meet the screening needs of their workforce, and three-quarters say employees are not being adequately screened by their primary care provider. Leaders report that 40% of employees are not compliant with screenings in general, and for the most deadly forms of cancer — lung and bronchus — the American Lung Association reports that only 6% of people eligible get screened. 
    • “The assumption [has been that] if we cover mammograms and colonoscopies and lung CTs, then people will actually get them, and that’s turned out to be false,” says Othman Laraki, Color Health’s CEO. “The big driver for that is that for non-acute care services, availability is not the same thing as access.” 

Monday Roundup

David Ermer–CDC, Congress, COVID-19, Electronic health records, Employee Wellness Programs, Federal employment benefits, Medical / Rx research, Mental health care, OPM, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC,

  • STAT News informs us,
    • “The Senate health care committee will consider a sweeping bill next week meant to combat the opioid epidemic, according to four lobbyists and a congressional aide familiar with the legislation. 
    • “The proposal would reauthorize a number of programs first created by the SUPPORT Act, an addiction-focused bill that Congress first passed in 2018. Many of those programs’ authorizations expired earlier this year, however, leading addiction treatment advocates to fret that lawmakers — and specifically the committee’s chairman, Sen. Bernie Sanders (I-Vt.) — no longer view the issue as a priority.    
    • “If passed, the legislation would mark Capitol Hill’s first major action this year on the addiction crisis. Current data shows that roughly 110,000 Americans are dying of drug overdoses each year. Roughly 85,000 of those overdoses involve opioids.” 
  • The Department of Health and Human Services announced,
    • “Today, United States Surgeon General Dr. Vivek Murthy is launching the 5-for-5 Connection Challenge, calling on Americans to take five actions over five days to build more connection in their lives. Dr. Murthy recently issued this challenge to students across the country on his “We Are Made to Connect” College Tour, which concluded just last week. Now, as we enter the holiday season, the 5-for-5 Connection Challenge aims to inspire people of all ages to build, strengthen, and prioritize their relationships.
    • “For the next two weeks, from December 4th – December 15th, the Surgeon General will encourage people to take five actions over five days that express gratitude, offer support to, or ask for help from people in their lives. These types of actions are outlined in the Surgeon General’s Advisory on Our Epidemic of Loneliness – PDF as some of the ways that people can catalyze social connection. As outlined in the Advisory, social connection can advance physical, mental, and cognitive health, and it is even associated with a decreased risk of mortality.”
  • MedTech Dive tells us,
    • “The Food and Drug Administration is evaluating the potential for plastic syringes made in China to suffer problems such as leaks and breakages.
    • “Officials began the investigation after receiving information about quality issues associated with “several Chinese manufacturers of syringes” that made them concerned that some devices “may not provide consistent and adequate quality or performance.”
    • “The FDA is advising consumers and healthcare providers to check where syringes are made and “consider using syringes not manufactured in China, if possible.” The advice applies to plastic syringes used for injecting fluids into, or withdrawing fluids from, the body.”

In FEHB Open Season news, Govexec offers helpful, last-minute advice from Kevin Moss.

From the public health and medicare research front,

  • U.S. News and World Report points out,
    • “After a period of limited change, COVID-19 activity is increasing again especially in the Midwest and Mid-Atlantic regions,” the CDC said in a report published Friday.
    • “Federal health officials are likely watching the increase given that they expect a “moderate” winter wave of coronavirus and this could be the start of it. Holiday gatherings and travel are also typically followed by an increase in coronavirus cases and hospitalizations.
    • “COVID-19 vaccination rates, meanwhile, have been disappointing for many.
    • “CDC Director Mandy Cohen told Congress this week that about 16% of Americans have gotten the updated COVID-19 vaccine.
    • “That’s not enough,” Cohen said.”
  • Beckers Hospital Review notes,
    • “So far this year, the CDC estimates there have been at least 1.8 million illnesses, 17,000 hospitalizations, and 1,100 deaths from flu in the U.S. 
    • “Influenza A continues to be the dominant strain in circulation, making up around 82% of cases, while influenza B is only accounting for around 18%. 
    • “Louisiana and South Carolina are still reporting the highest levels of flu activity in the country. 
    • “Nine states are experiencing high activity levels, but less than the two states above, including: California, New Mexico, Texas, Mississippi, Alabama, Georgia, Colorado, Florida and Tennessee. 
    • “Cases are also high in New York City and Puerto Rico.”
  • The Journal of the American Medical Association presented the following study results:
    • “Question  Is smoking still decreasing among US adults and do the trends vary by age, income, and race and ethnicity?
    • “Findings  In this cross-sectional study of 353 555 adults responding to the 2011 to 2022 National Health Interview Surveys, adults younger than 40 years had dramatic declines in smoking prevalence during the last decade, especially among those with higher incomes. In contrast, relatively slow declines were observed among adults aged 40 to 64 years, with no decrease in smoking among those 65 years or older.
    • “Meaning  These findings suggest that the precipitous decline in smoking among younger adults should be maintained, but that additional efforts are required to further reduce smoking in older adults.”
  • The American Medical Association explains “What doctors wish patients knew to improve their mental health.”
  • Per Endocrinology Advisor, “Decreased mortality risk is associated with concomitant reductions in glycated hemoglobin (HbA1c) and body weight among patients with type 2 diabetes, according to study results published in Diabetes Obesity and Metabolism.”

From the U.S. healthcare business front,

  • Fierce Healthcare profiles ten women of influence in U.S. healthcare. Check it out.
  • BioPharma Dive reports
    • “Roche on Monday agreed to acquire biotechnology company Carmot Therapeutics in a deal that bulks up the Swiss pharmaceutical giant’s pipeline with a group of weight loss drugs in early clinical testing.
    • “Roche will pay $2.7 billion upfront for the Berkeley, California-based Carmot. Roche could owe as much as $400 million more in future payments to Carmot shareholders, among them The Column Group and RA Capital, if certain milestones are met. The companies expect the acquisition to close next year.
    • “The deal hands Roche a trio of drugs in human testing for obesity, an area of pharmaceutical research that has been catalyzed by the success of weight loss medicines like Wegovy and Zepbound. Their progress has fueled a gold rush among large drugmakers, a number of which are either advancing in-house medicines or inking deals to acquire new prospects.”
  • and
    • “The Food and Drug Administration granted conditional approval to Eli Lilly’s oral cancer drug Jaypirca in two types of blood cancer, expanding its use from a rare type of lymphoma to people with leukemia and lymphoma patients who have previously received two other treatments, the company said Friday.
    • “Jaypirca is the fourth of a group of drugs called BTK inhibitors, a class that includes AbbVie and Johnson & Johnson’s Imbruvica and AstraZeneca’s Calquence. It gained approval earlier this year and posted $42 million in sales through Sept. 30.
    • “With this approval, Jaypirca can now be used in chronic lymphocytic leukemia or small lymphocytic lymphoma after patients have been treated with AbbVie and Roche’s Venclexta and another BTK inhibitor. Lilly said a Phase 3 trial meant to confirm Jaypirca’s accelerated approval has already met its primary goal.”
  • HR Dive discusses “Why EAPs go unused despite growing mental health awareness; Many factors contribute to the historic underutilization of employee assistance programs, despite their value as an access point to quality care.”
  • Medscape offers an infographic on how doctors grade their EHR systems while MedCity News explains how improved coding quality by healthcare providers can prevent denials and improve cash flow.
  • Health Payer Intelligence adds,
    • “Payers are investing in healthcare IT resources to support cost optimization and improve member experience, according to a study from EY-Parthenon and KLAS Research.
    • “As payers face operational and financial pressures, they are turning to healthcare IT solutions for help. Researchers sought to understand what strategies payers prioritize, how much they spend on healthcare IT resources, and what future investments look like.
    • “The study findings reflect responses from over 100 executives across payer entities serving commercial, Medicare, and Medicaid populations. Around 70 percent of respondents were traditional payers; the remaining were provider-sponsored, third-party administrators, and management services organizations.”
  • According to Healthcare Dive,
    • “A merger between major health insurers Cigna and Humana would go through the wringer of an intense antitrust review, but could come out finalized, experts say.
    • “Though, to receive the regulatory green light, a combined company would probably have to emerge looking different from the Cigna and Humana of today. * * *
    • “Gaining regulatory approval — especially if a challenge further ties up the process in the courts — could set a deal’s finalization back by a year or more. But, due to a lack of direct competition between the two, Cigna and Humana could be allowed to combine, creating a healthcare powerhouse with roughly $300 billion in annual revenue.”
  • and
    • “For-profit hospital chain HCA Healthcare’s Houston affiliate announced last week it completed its acquisition of 11 free-standing emergency departments from SignatureCare Emergency Centers. 
    • “HCA Houston Healthcare, which operates a network of 13 hospitals and nine outpatient surgery centers, now has 26 free-standing emergency departments in the area in addition to hospital-based emergency rooms, according to a Friday press release.
    • “The SignatureCare centers will be re-branded to HCA Houston ER 24/7. Financial terms of the deal were not disclosed.
  • and
    • “Rural hospital chain Lifepoint Health and Ascension Saint Thomas announced a joint venture last week to co-own Highpoint Health, a four-hospital system in Tennessee currently operated by Brentwood, Tennessee-based Lifepoint.
    • “The hospitals and care sites will be co-branded with Ascension Saint Thomas, but will be majority-owned and operated by Lifepoint, according to the release. The companies declined to comment on the cost of the buy-in.
    • “The health systems have partnered before. Ascension Saint Thomas partnered with Kindred Rehabilitation Services, a Lifepoint business unit, in 2022 to jointly own Ascension Saint Thomas Rehabilitation Hospital in Nashville.” 

Weekend update

David Ermer–Congress, Employee Wellness Programs, Generative AI, Mental health care, U.S. Healthcare–
Photo by Michele Orallo on Unsplash

From Washington, DC —

From the mental health coverage front —

  • Fierce Healthcare tells us,
    • “The United Health Foundation, the company’s philanthropic arm, each year releases America’s Health Rankings, which dive into major healthcare trends across the country. The latest analysis of that data examines how different populations are experiencing the rising tide of mental health concerns.
    • “For example, adults with disabilities were 3.5 times more likely to report frequent mental distress and 3.5 times more likely to have had a major depressive episode in the last year.
    • “This data is highlighting the need to take a closer look,” said Yusra Benhalim, M.D., senior national medical director at Optum Behavioral Health Solutions, in an interview. “I think we need to kind of lean in a little bit more and understand what the experience is like for individuals with disabilities.”
  • Health Affairs Forefront considers whether the private sector lead in addressing this mental health equity crisis. The FEHBlog thinks it can.

From the generative AI front —

  • The Wall Street Journal reports,
    • “Hundreds of doctors across the U.S. have entrusted recordings of their private talks with patients to a startup promising to turn the conversations into usable medical records through artificial intelligence.
    • “The technology makes multiple errors while producing the reports, such as failing to use correct medical terminology and adding medicines a patient isn’t taking, according to current and former workers.
    • “To fix those errors, health-tech startup DeepScribe relies on 200 human contractors to listen to the medical conversations and revise the records, the company’s founders said. The workers also use Google searches to find billing codes.”
  • This reminds the FEHBlog of a situation that occurred nearly thirty years ago. A client decided to use then new scanning technology to feed paper claims into its claims system for auto-processing. The client wound up needing at least a hundred people to correct errors in the scans. Over time the technology improved, and human assistance dropped off to reasonable levels. The FEHBlog is certain that, in due time, generative AI will be able to create these reports without human assistance.

From the U.S. healthcare business front, NPR warns providers have begun to bill patients and their health plans for responding to messages posted on the provider’s patient portal. Before long, generative AI will be able to reply on the doctor’s behalf.

From the wellness front, Fortune Well shares expert advice on four habits that aging folks need to adopt, besides exercise, to stay fit.

Check out last Monday’s Econtalk episode in which Russ Roberts interviews Lydia Dugdale about her book, the Lost Art of Dying.