Monday Report

OPM

Monday Report

David Ermer–ACA, CDC, CMS, Congress, FDA, HSA, Medical / Rx research, Obesity, OPM, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC

  • The Hill reports,
    • “Top Republicans are signaling progress in government funding talks as leaders look to clinch a deal ahead of a looming Friday deadline. 
    • “House Appropriations Chair Tom Cole (R-Okla.) told reporters Monday that the “differences are narrowing” between all sides as they try to hash out the last significant funding deal in the divided Congress.
    • “It’s both between the House and the Senate and Republicans and Democrats. So, they’re both institutional differences, and there are partisan differences,” Cole said. But he added “there are a lot fewer of them than there were 24 hours ago.” * * *
    • “Pressed about the status of health care as leaders look to tie up loose ends in the CR, House Majority Leader Steve Scalise (R-La.) said Monday there are “big discussions on all of the remaining items.”
    • “But we’re trying to get it wrapped up,” he said. 
    • “According to a source familiar, a package of key health policies is expected to be attached to the stopgap funding bill. It will likely include a two-year extension of telehealth flexibilities for Medicare, as well as an overhaul of pharmacy benefit managers’ business practices.” 
  • Fierce Healthcare adds,
    • “Pharmacy benefit manager reform is included in a larger-than-anticipated healthcare package, but the PBM lobby is fighting the legislation at the eleventh hour.
    • “Lawmakers appear to have agreed to a lame-duck healthcare package which, in addition to PBM reform, will include key program extensions.
    • “As of last weekend, the package included an increase to the Medicare physician fee schedule of 2.5% for one year, bonuses to alternative payment models and a reauthorization of the SUPPORT Act for dealing with the opioid crisis.
    • “PBM policies will be used as budgetary offsets. The legislation would ban spread pricing in Medicaid, ensure Part D plan sponsors delink PBM fees from the price of a drug and includes other transparency requirements.
    • “The end-of-year health care package accompanying the Continuing Resolution has morphed into a massive 400-page bill that includes provisions that would undermine the role that PBMs play in lowering costs and providing choices for employers in the prescription drug marketplace,” said the PBM trade lobby, the Pharmaceutical Care Management Association (PCMA), in a statement Dec. 16. “The health care provisions included in the latest draft, as reported in the media, risk increasing costs for health plan sponsors, like employers and labor unions, patients, and families, and hiking up premiums for seniors.”
  • One Digital informs us that “Congress passed the Paperwork Reduction Act and the Employer Reporting Improvement Act, each of which modify the ACA’s provisions on 1094 and 1095 tax form reporting. President Biden is expected to sign both acts into law, significantly altering ACA reporting requirements.”
    • “The Paperwork Reduction Act amends the ACA by no longer requiring employers and health insurance providers to send tax forms to the covered individuals under their health plan. Previously employers and/or insurance providers had to send 1095-B/1095-C tax form to each covered individual showing proof of minimum essential coverage. Now, those forms must only be sent when requested by the covered individual. If a covered individual requests a form, the form must be provided by January 31 or 30 days after the date of the request, whichever is later. Employers and insurance providers must inform covered individuals of their right to request a form.”
    • “The Employer Reporting Improvement Act codifies IRS regulations that allow for an individual’s date of birth to be substituted if the individual’s Tax Identification Number is not available. The Act also amends the ACA to incorporate IRS regulations allowing employers and insurance providers to offer 1095-B and 1095-C tax forms to individuals electronically.
    • Additionally, and more importantly to employers, the Act requires the IRS to give large employers at least 90 days to respond to 226-J letters that issue a proposed employer shared responsibility payment. Previously, employers had only 30 days to respond. Finally, the Act establishes a six-year statute of limitations for collecting these payments.”
       
  • The Plan Sponsor Council of America tells us,
    • “The ERISA Advisory Council (EAC) voted on and approved 12 recommendations for the Department of Labor (DOL) to improve health insurance claim denials and related appeals. These reforms range from better oversight of AI determinations to requiring payouts for prior approvals.
    • “Lisa Gomez, head of the Employee Benefit Security Administration (EBSA), described these proposed reforms today as “strangely and somewhat tragically timely, with the events of last week,” in reference to the killing of UnitedHealthcare CEO Brian Thompson in Manhattan on Dec. 4.”
    • Due to the Affordable Care Act, ERISA appeal procedure changes embedded in regulations typically apply to FEHB carriers.
  • The American Hospital Association News tells us,
    • “The Department of Health and Human Services Dec. 16 published a final rule implementing certain provisions related to information blocking exceptions. The rule revises defined terms related to protecting access to care for purposes of the information blocking regulations.
    • “The agency adopted select provisions first proposed in August as part of the much larger Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability (HTI-2) rule. The adopted provisions are designed to address concerns from patients, health care providers and other stakeholders regarding patient privacy, access to care, preferences for electronic health information sharing, and methods for achieving a balance between certainty and flexibility for entities involved in enhancing EHI interoperability and exchange.
    • “The finalized “Protecting Care Access Exception” would allow entities to restrict EHI sharing under certain conditions to mitigate the risk of legal repercussions for patients, providers or care facilitators involved in lawful reproductive health services. The provisions will be effective immediately when published Dec. 17 in the Federal Register.
    • “This is the second rule in less than a week containing policies originally included in the proposed HTI-2 rule. As such, additional provisions of the HTI-2 rule, including prior authorization application programming interfaces, United States Core Data for Interoperability Version 4 standards and public health interoperability requirements — which are currently under review by the White House Office of Management and Budget — could be published soon.”
  • and
    • “The Centers for Medicare & Medicaid Services Dec. 15 announced an extension to Dec. 18 for enrollment in federally facilitated marketplace coverage that begins Jan. 1. This applies to the 31 states that use HealthCare.gov for signups. Those consumers previously had until Dec. 15 to enroll for a full year of coverage. Individuals who enroll for 2025 coverage after Dec. 18 will have their plans begin Feb. 1. Individuals in Washington, D.C., and the 19 states that operate their own state-based marketplaces are advised to visit their state website for deadlines and effective dates for their coverage.”
  • and
    • “The Health Resources and Services Administration last week directed Sanofi to cease implementation of its 340B rebate proposal immediately and to inform HRSA of its plans no later than Dec. 20 in order to provide adequate notice to covered entities.
    • “By way of this correspondence, HRSA provides warning that this unapproved credit proposal violates Sanofi’s obligations under the 340B statute, and HRSA expects Sanofi to cease implementation of it,” wrote HRSA Administrator Carole Johnson.
    • “The letter says that the proposal, if implemented, would violate Sanofi’s obligations under the 340B statute and subject Sanofi to potential consequences, such as termination of Sanofi’s Pharmaceutical Pricing Agreement and civil monetary penalties.
    • “In its Nov. 22 letter to 340B covered entities, Sanofi said it would be effectuating 340B discounts via the new credit model as of Jan. 6, 2025, for disproportionate share hospitals, critical access hospitals, rural referral centers and sole community hospitals.”
  • Govexec points out,
    • “The Office of Personnel Management is set to publish a final rule Tuesday that would finally implement provisions of a seven-year-old law aimed at reducing agencies’ ability to put federal workers accused of misconduct on prolonged stints of administrative leave.
    • “In 2016, Congress enacted the Administrative Leave Act as part of the 2017 National Defense Authorization Act. The law tries to reduce agencies’ reliance on placing federal workers who are under investigation into employment limbo—paid but unable to work—for long stretches of time. It also updated the government’s policies on weather and safety leave.
    • “Though OPM proposed regulations to implement all of the law’s provisions in 2017, only the provisions governing weather and safety leave actually made it across the finish line. But earlier this year, the environmental advocacy group Public Employees for Environmental Responsibility sued the HR agency seeking to force it to act.
    • “In a final rule set for publication Tuesday in the Federal Register, OPM formally implemented the 2016 law’s restrictions on administrative leave. While the new rule will be effective Jan. 17, 2025, agencies have until October to comply with the new restrictions on administrative leave.”

In Food and Drug Administration news,

  • MedTech Dive relates
    • Zimmer Biomet received Food and Drug Administration clearance for a new stemless shoulder implant, called Osseofit.
    • The implant is shaped to match the anatomy of patients’ humerus, or upper shoulder bone, while preserving as much of their healthy bone as possible in total shoulder replacement procedures. Zimmer announced the clearance on Friday.
    • CEO Ivan Tornos highlighted stemless shoulder implants as a meaningful growth driver for the orthopedics company in an Oct. 30 investor call.
  • Per Fierce Pharma
    • “The FDA has blessed two previously approved medicines—one a cream and the other an injection—to treat atopic dermatitis (AD). Both products now will be available to a significantly larger patient population as roughly 26 million in the U.S. have the disorder, which is also known as eczema.
    • “Organon’s Vtama, a topical cream originally approved for plaque psoriasis in 2022, is now cleared to treat AD, the company said early Monday. The nod came three months after New Jersey-based Organon acquired the product in a $1.2 billion takeover of Dermavant. 
    • “Similarly, the FDA gave a thumbs-up to Galderma’s Nemluvio to treat AD. The drug, a monthly subcutaneous injection, was previously endorsed by the U.S. regulator for prurigo nodularis.” 
  • and
    • “After seven decades with no advances in the treatment of the genetic disorder classic congenital adrenal hyperplasia (CAH), Neurocrine Biosciences has scored FDA approval for its first-in-class, twice-daily oral medicine Crenessity (crinecerfont).
    • “The blessing came nearly two weeks before its FDA target date and is termed as “paradigm shifting” by the San Diego-based company. The selective oral corticotropin-releasing factor type 1 receptor (CRF) antagonist can be used by CAH patients ages 4 and older.
    • “Serving as an add-on to glucocorticoid replacement therapies, Crenessity reduces excess adrenocorticotropic hormone (ACTH) and downstream adrenal androgen production, allowing for glucocorticoid dose reduction.”
  • Cardiovascular Business alerts us,
    • “The U.S. Food and Drug Administration (FDA) and Boston Scientific today sent an urgent alert to patients and healthcare providers about the potential need for early device replacement of some Accolade pacemakers.
    • The company announced a recall for a subset of its Accolade devices because of an increased risk of permanently entering the safety mode. This has limited functionality, making the device unable to properly regulate the heart’s rhythm and rate. Most of the activations have occurred during follow-up office or hospital visits when the devices are interrogated for data.
    • There have been two reported patient deaths in pacemaker dependent patients after the devices went into safety mode in an ambulatory outpatient medical setting. Boston Scientific said about 70% of safety mode events occurred during in-office interrogations from a Latitude programmer, and the remaining incidents took place in an ambulatory setting.
    • “The risk of harm may be greater when safety mode occurs in an ambulatory setting, as patients are not in a monitored clinical environment,” the company said in its recall notice.
  • Beckers Hospital Review adds,
    • “The FDA has recalled more than 233,000 bottles of antidepressant duloxetine, sold by Rising Pharmaceuticals, due to a potential cancer risk. 
    • “The recall, issued Dec. 5, was prompted by the discovery of a nitrosamine impurity, N-nitroso-duloxetine in the capsules which exceeds the FDA’s safety threshold. 
    • ‘The FDA has classified the recall as a Class II risk, its second most severe classification. The recall affects 233,000 bottles of duloxetine, which is used to treat conditions such as depression and generalized anxiety disorder. 
    • “The FDA also recalled 7,107 bottles of duloxetine capsules distributed by Towa Pharmaceutical Europe in October for similar concerns about nitrosamine impurities.” 

From the public health and medical research front,

  • MedPage Today reports,
    • “CDC could not confirm what was suspected to have been the first H5N1 bird flu case linked to raw milk.
    • “The patient, a child in Marin County, California, experienced fever and vomiting after drinking raw milk, as reported last week. The child initially tested positive for influenza A, with the local lab unable to find evidence of person-to person transmission between the child and her family members.
    • “The State Laboratory and the CDC conducted additional testing, “but due to low levels of viral RNA, they were unable to confirm whether the influenza A virus present was H5N1 (avian influenza) or seasonal influenza,” according to the Marin County public health department.”
  • The Washington Post tells us,
    • “Nearly a quarter of U.S. adults reported living with chronic pain in 2023, according to a recent report from the Centers for Disease Control and Prevention.
    • “Just over 24 percent (24.3 percent) of survey respondents said they experienced chronic pain either most days or every day, the CDC said, and nearly 9 percent of adults had “high-impact chronic pain” in the previous three months, meaning their pain frequently limited their life or work activities.” * * *
    • “Chronic pain and pain that often restricts life or work activities, referred to in this report as high-impact chronic pain are the most common reasons adults seek medical care, and are associated with decreased quality of life, opioid misuse, increased anxiety and depression, and unmet mental health needs,” co-authors Jacqueline W. Lucas and Inderbir Sohi wrote in a data brief on the numbers.”
  • Beckers Hospital Review adds,
    • “In 2023, the United States saw a slight decrease in obesity prevalence among adults, according to research findings published Dec. 13 in JAMA. 
    • “Amid projections of increasing obesity rates over the next decade, researchers from Boston Children’s Hospital and Optum Life Sciences analyzed body mass index data from 2013 to 2023. The dataset included nearly 48 million BMI measurements from 16.7 million nonpregnant adults. 
    • “Between 2013 and 2022, mean population BMI and obesity rates rose annually. Both figures slightly declined in 2023, the study found. 
    • “The researchers suggested this change could be due to weight loss GLP-1s such as semaglutide (Wegovy) and “pandemic-associated demographic and behavior changes.”
  • A recent National Health Statistics Reports shares characteristics of older Americans who fulfilled physical activity guidelines in 2022.
  • The American Medical Association lets us know what doctors wish their patients knew about hand, foot, and mouth disease.
  • MedPage Today notes,
    • “Diets higher in inflammatory foods were tied to an increased incidence of dementia in older adults, longitudinal data from the Framingham Heart Study Offspring cohort showed.
    • “Over 13 years of follow-up, higher Dietary Inflammatory Index (DII) scores averaged across three time points were linearly associated with an increased incidence of all-cause dementia (HR 1.21, 95% CI 1.10-1.33, P<0.001), reported Debora Melo van Lent, PhD, of UT Health San Antonio in Texas, and co-authors.
    • “Similarly, higher DII scores were linearly associated with an increase in Alzheimer’s disease dementia (HR 1.20, 95% CI 1.07-1.34, P=0.002), the researchers reported in Alzheimer’s & Dementia. Findings were adjusted for demographic, lifestyle, and clinical covariates.
    • “Although these promising findings need to be replicated and further validated, our results suggest that diets that correlate with low DII scores may prevent late-life dementia,” van Lent and colleagues noted.”
  • To that end, Consumer Reports, writing in the Washington Post, discusses “four ways to reduce inflammation for better health. It’s thought to be an underlying cause of diabetes, heart disease and more. Diet and lifestyle can help you control it.”
  • Per a press release,
    • “The Institute for Clinical and Economic Review (ICER) today released a Final Evidence Report assessing the comparative clinical effectiveness of tabelecleucel (“tab-cel”®, Pierre Fabre) for the treatment of Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD).
    • “ICER’s report on this therapy was the subject of the November 2024 public meeting of the New England CEPAC, one of ICER’s three independent evidence appraisal committees. 
    • “Downloads: Final Evidence Report | Report-at-a-Glance | Policy Recommendations 
  • STAT News reports,
    • “Just over a year ago the PREVENT calculator to predict cardiovascular risk was released by the American Heart Association. It was acclaimed for improving on a 2013 model that didn’t take into account companion conditions such as kidney disease or type 2 diabetes, or include people from more diverse backgrounds.
    • “PREVENT soon drew attention for its potential to reduce the number of Americans eligible to receive widely prescribed cholesterol-lowering statins, projected in two analyses published in June and July. 
    • “A less noted change was the addition of heart failure to conditions estimated by the risk calculator, alongside the traditional targets of heart attack and stroke. Heart failure is a serious illness that means the heart can no longer pump blood through the body as well as it should. It’s different from diseases that narrow blood vessels that feed the heart or brain.
    • “Heart failure has no cure, making it more urgent to identify who’s at risk. PREVENT allows that risk to be estimated using information typically collected in a regular primary care visit.”

From the U.S. healthcare business front,

  • Reuters reports,
    • “Powerful weight-loss drugs are expanding use of U.S. health care as patients starting prescriptions are diagnosed with obesity-related conditions or take the drugs to become eligible for other services, health records and discussions with doctors show.
    • “An exclusive analysis of hundreds of thousands of electronic patient records by health data firm Truveta found slight, but measurable, increases in first-time diagnoses of sleep apnea, cardiovascular disease, and type 2 diabetes within 15 days of an initial prescription for a GLP-1 weight-loss drug between 2020 and 2024.
    • “In addition to obesity-related conditions, some patients are being prescribed the drugs to lose weight and become eligible for services, including organ transplants, fertility treatments or knee replacements, according to interviews with seven doctors and five other health experts.
    • “This is a population that previously felt stigmatized by health care providers and often didn’t return. But now that they’re actually seeing themselves get healthier, asking clinicians questions and engaging more, I do think we’re seeing new patients,” said Dr. Rekha Kumar, a New York endocrinologist and obesity medicine specialist.”
  • McKinsey and Company explore how the healthcare industry can weather current challenges.
    • “The healthcare industry has been buffeted by a growing number of challenges over the past few years. This turbulence struck provider organizations in 2022, while payers were initially sheltered from the storm (Exhibit 1). But conditions became more difficult for payers in 2023, which has continued into this year, and there’s limited respite on the horizon. Unlike the widespread challenges the provider and payer sectors have faced, the picture for pharmacy services has been more nuanced. Some organizations have been propelled by tailwinds from pharmaceutical innovation and new delivery models, while others have battled headwinds from increased regulatory scrutiny. The healthcare services and technology (HST) sector, in contrast, has benefited from continued demand for data, analytics, and software. Along with pressures on earnings, the healthcare sector has also faced challenges in the capital markets, with deal activity in 2024 lower than 2023, according to McKinsey analysis.”
  • Per the American Hospital Association News,
  • Healthcare IT News tells us “74% of hospital leaders say virtual nursing will become integral to acute care. A nurse expert [in the article] discusses the results of a new survey from AvaSure showing that, while virtual nursing has yet to gain traction in acute inpatient care, it holds much promise – and already is showing results that benefit both nurses and the bottom line.”
  • A recent National Health Statistics Report examines under age 65 enrollment in high deductible and consumer driven health plans in the U.S.
  • Per HR Brew,
    • “Despite a softening job market, US employers are expected to grant merit increases of 3.3% to non-unionized employees in 2025—the same rate as this year, according to a report by Mercer.
    • “It’s not surprising to us to see employers really kind of keeping up with the part of what they had done in the prior year,” said Jack Jones, principal consultant at Mercer. “I think what it shows is employers are still prioritizing the investment in their talent.”
    • “Next year, employers are expected to increase their total salary budgets—which includes money for promotions and adjustments to reach equity—to 3.7%, excluding unionized workers. The increase was 3.6% for this year. About one-tenth (9.3%) of employees are expected to receive promotions next year, compared to 8% in 2024.
    • “However, Jones noted the numbers could change because only 20% of the more than 850 organizations surveyed had finalized their budgets. Still, most organizations (69%) don’t expect to adjust their initial projections.”

Weekend update

David Ermer–Congress, NIH, OPM, U.S. Healthcare–
  • Fedsmith reports that the President’s 2025 Pay Agent report creates no new locality pay areas for 2025.
  • Govexec lets us know that
    • The Office of Personnel Management this week quietly released its report analyzing the results of the 2024 Federal Employee Viewpoint Survey alongside agency-by-agency data from the annual census of federal workers’ job sentiment.
    • The report affirms preliminary data released in October, which found that employee engagement ticked up one point to tie a record high of 73 out of 100, while the governmentwide global satisfaction index, a tool used to measure federal worker morale, followed suit, increasing from 64 out of 100 last year to 65 in 2024. And the response rate crept up two points over 2023 to 41%.
  • HR Dive informs us,
  • The Washington Post points out,
    • “Want to know the latest about research funded by the National Institutes of Health on topics including menopause, polycystic ovary syndrome and other conditions affecting women’s health? Discover Women’s Health Research (DiscoverWHR), a recently launched website on federally funded women’s health research across the lifespan, offers answers.
    • “The portal is a resource from NIH in support of the White House Initiative on Women’s Health Research, which is focused on closing research gaps and improving prevention, detection and treatment of health issues affecting girls and women.”
  • STAT News relates,
    • “Novo Holdings, the parent company of Novo Nordisk, can proceed with its planned $16.5 billion acquisition of Catalent, a leading contract drug manufacturer, after U.S. regulators declined to challenge the deal following months of scrutiny.
    • “The companies expect to close the transaction in the next several days, after a deadline passed for the U.S. Federal Trade Commission to raise objections and other regulatory conditions were fulfilled, according to statements issued by Novo Nordisk and Catalent. We asked the FTC for comment and will update you accordingly. Last week, the European Commission approved the transaction.
    • “The deal had generated enormous interest over concerns that competition in the pharmaceutical industry could be harmed. Indeed, the move was prompted by sporadic shortages of one of the world’s hottest-selling medications — Novo Nordisk’s weight loss treatment Wegovy — and designed, in part, to solve what has been a critical and seemingly intractable problem for Novo Nordisk.
    • “This made Catalent an attractive buyout target for Novo Holdings, which owns 77% of the voting shares in Novo Nordisk, because it is already a subcontractor that helps manufacture Wegovy. But one part of the plan sparked complaints because Novo Holdings said it would sell three Catalent facilities to Novo Nordisk for $11.7 billion after completing the deal.”

Weekend update

David Ermer–CDC, Congress, Federal employment benefits, Medical / Rx research, Obesity, OPM, U.S. Healthcare, Uncategorized–
  • The Wall Street Journal reports
    • “Days after a hooded and masked man fatally shot a UnitedHealthcare executive in Manhattan, investigators have learned key details about the gunman’s stay in the city and how he planned his crime.
    • “Investigators are looking at the possibility that the shooter might be a disgruntled ex-employee of Brian Thompson’s insurance company or an angry client, according to NYPD Chief of Detectives Joseph Kenny. Investigators have been in touch with Thompson’s family, but there is no indication the shooting involved his private life, police said.
    • “New York Mayor Eric Adams told reporters Saturday that police have a name for the suspect but declined to disclose it pending the investigation. “The net is tightening,” the mayor said outside a Police Athletic League event in Harlem, according to footage from MSNBC. A New York police spokesman late Saturday said he couldn’t confirm that the department has the name of a suspect.
    • “The shooter might have used a large handgun, or possibly a veterinary gun, a firearm used to put down animals that doesn’t make a lot of noise, police said.
    • “The assailant likely left New York on a bus early Wednesday, not long after he fatally shot Thompson outside a hotel in Midtown Manhattan, investigators said. But he left behind a critical piece of evidence: the backpack he wore during the shooting and apparently abandoned in Central Park. Police found a bag there Friday afternoon.

From Washington, DC,

  • OPM reminds us,
    • “OPM has extended Open Season for the Postal Service Health Benefits Program through Friday, December 13th at 11:59 pm EST. This extension is only for the PSHBP. This does not extend to FEHB or other benefits programs. The deadline for FEHB remains 11:59 pm, in the location of your electronic enrollment system, on Monday, December 9th.”
  • Federal News Network tells us,
    • “Office of Personnel Management Acting Director Rob Shriver sees several areas of opportunity to build on the forward momentum to reform federal hiring and retention.
    • “During the Biden administration, the President’s Management Agenda focused one of its key priorities on strengthening and empowering the federal workforce. Though the efforts of the PMA are now coming to a close, administration officials pointed to promising signs of an improving federal hiring process.
    • “For example, the Biden administration has taken steps to keep the ball rolling on a push toward skills-based hiring. In April, the White House announced plans to transition the government’s primary job series for federal IT specialists away from college degree requirements over the next year.
    • “This really picked up on an initiative from the prior administration, and we’ve been grinding through the implementation of that,” Shriver said in an interview with Federal News Network at a Dec. 4 White House event. “But there are also a lot of challenges to implementing true skills-based hiring.”

From the public health and medical research front,

  • Cardiovascular Business informs us,
    • “Heart surgeons with the WVU Heart and Vascular Institute have made a bit of history, performing the world’s first combined robotic aortic valve replacement (AVR) and coronary artery bypass grafting (CABG) procedure—all through one small incision. Patients requiring these procedures typically undergo open-heart surgery. 
    • “The patient in question, 73-year-old Poppy McGee, presented with a history of stroke, brain surgery and ongoing weight loss. She was referred to Vinay Badhwar, MD, executive chair of the WVU Heart and Vascular Institute and chair of WVU’s department of cardiovascular and thoracic surgery, who initially recommended open-heart surgery. However, when McGee and her family heard that the odds of dying exceeded 10%, they inquired about less invasive treatment options. 
    • “Badhwar, a known pioneer of robotic aortic valve replacement (RAVR) and other robotic surgical techniques, said his team had developed a new technique for combining AVR and CABG—but it had not yet been tested on a patient. After a long discussion with McGee and her family about the risks, she agreed to the new-look surgical treatment.
    • “The combined surgery occurred on Oct. 31, 2024. Both the AVR and the CABG were performed using the same small incision on the far right of McGee’s chest. The surgery was a success, and a detailed account is expected to publish in The Annals of Thoracic Surgery.” ***
    • “Goya Raikar, MD, a member of Badhwar’s robotics team and an assistant professor a WVU, highlighted the progress this successful procedure represents for their work on advancing robotic surgical techniques.
    • “Until now, the main exclusion for us to perform a robotic approach has been the coexistence of valve and coronary artery disease,” he said. “Building on our experience with robotic aortic valve surgery, this new approach may help us extend robotic surgery options to many more patients.”  
  • The Hill lets us know,
    • “A more potent form of fentanyl is contributing to the thousands of overdose deaths that happen every year, health officials warn.
    • “An extremely powerful derivative of fentanyl, called carfentanil, was detected in 513 overdose deaths between 2021 and early 2024, according to a report from the Centers for Disease Control and Prevention (CDC). 
    • “Carfentanil was designed to tranquilize large animals and is estimated to be 10,000 times stronger than morphine and 100 times stronger than fentanyl.  
    • “Just 2 milligrams is needed to tranquilize an elephant; that same amount is powerful enough to kill 50 people, according to a Department of Veteran Affairs report.
    • “Drug overdose deaths overall have been declining since 2023, according to the CDC. But they remain high in the United States, and the majority are connected to illegally manufactured fentanyls (IMFs).
    • “Carfentanil-related overdose deaths are becoming less rare, highlighting the “ever-changing illegal drug supply” that threatens the progress made in reducing overdose deaths, according to the report.” * * *
    • “Carfentanil-related deaths continued to rise this year, with a total of 238 people dying from the drug by June — a roughly 720 percent increase from the first half of 2023 to the first half of 2024.”
  • Per Medscape,
    • “Vaccines for treating and preventing cancer have long been considered a holy grail in oncology.
    • “But aside from a few notable exceptions — including the human papillomavirus (HPV) vaccine, which has dramatically reduced the incidence of HPV-related cancers, and a Bacillus Calmette-Guerin vaccine, which helps prevent early-stage bladder cancer recurrence — most have failed to deliver.
    • “Following a string of disappointments over the past decade, recent advances in the immunotherapy space are bringing renewed hope for progress.
    • “In an American Association for Cancer Research (AACR) series earlier this year, Catherine J. Wu, MD, predicted big strides for cancer vaccines, especially for personalized vaccines that target patient-specific neoantigens — the proteins that form on cancer cells — as well as vaccines that can treat diverse tumor types.
    • “A focus on neoantigens that arise from driver mutations in different tumor types could allow us to make progress in creating off-the-shelf vaccines,” said Wu, the Lavine Family Chair of Preventative Cancer Therapies at Dana-Farber Cancer Institute and a professor of medicine at Harvard Medical School, both in Boston.”
  • Fortune Well points out five symptoms that men over 40 should never ignore.
    • “Unexplained fatigue
    • “Chest discomfort
    • “Swelling in lower extremities
    • “Changes in exercise tolerance, and
    • “Loss of morning erections.”
  • NPR Shots reminds us,
    • “[I]nstead of chilling out in front of the TV after you polish off a scrumptious dessert, consider venturing out for a walk. It’s one of the easiest things you can do to boost your health after a meal, and even a short stroll can yield big benefits.
    • “The concept of post-meal walks has been around for centuries, notes Loretta DiPietro, a professor of exercise and nutrition science at the George Washington University Milken Institute School of Public Health.”

From the U.S. healthcare business front,

  • BioPharma Dive relates,
    • “BioAge Labs said it is terminating a mid-stage study of its obesity drug candidate azelaprag in combination with Eli Lilly’s tirzepatide due to safety concerns, causing its share price to slide by three-quarters in after-hours trading Friday.
    • “Eleven people who received azelaprag in STRIDES, BioAge’s Phase 2 study, showed elevated levels of liver enzymes that can warn of potential organ damage. As a result, the company is discontinuing dosing and halting further enrollment.
    • “The San Francisco Bay Area company raised $170 million in February and banked a $198 million initial public offering in September to fund its ambitious foray into metabolic drugs, not long after it pivoted from making treatments for age-related diseases.”
  • MedTech Dive adds,
    • “Edwards Lifesciences predicted Wednesday that an expanded indication in transcatheter aortic valve replacement (TAVR) and rapid growth in its newer mitral and tricuspid heart valve technologies will accelerate total company sales in 2026 and beyond.
    • “Edwards anticipates mid-2025 approval for TAVR in people with asymptomatic severe aortic stenosis, the company said during an investor day event.
    • “The Sapien TAVR system is Edwards’ biggest product but has seen growth slow this year as hospital heart teams dealt with capacity constraints. Hospitals, however, are investing to increase capacity and avoid delays in patient treatment, which will support prioritization of aortic stenosis cases long term, Edwards said in its presentation.” 
  • The Journal of Accountancy lets us know,
    • “A federal district court, finding that the Corporate Transparency Act (CTA) is likely unconstitutional, issued an order Tuesday prohibiting the enforcement of the CTA and the beneficial ownership information (BOI) reporting rule in the CTA’s accompanying regulations.
    • “The injunction, which according to the court should apply nationally, was issued in Texas Top Cop Shop, Inc. vs. Garland, No. 4:24-CV-478 (E.D. Texas 12/3/24).
    • “Under the injunction, the CTA and the BOI reporting rule cannot be enforced, and reporting companies need not comply with the CTA’s Jan. 1, 2025, BOI reporting deadline pending a further order of the court.
    • “The Financial Crimes Enforcement Network (FinCEN), which enforces the CTA, is reviewing the order, a spokesperson said Wednesday, pointing out that other courts have denied similar requests. The Justice Department (DOJ) filed a notice of appeal on Thursday night.
    • “An AICPA statement, released before the DOJ notice of appeal, acknowledged the potential effects of the injunction and urged CPAs assisting clients with BOI reporting to be prepared.
    • “Under the injunction, FinCEN is barred from enforcing BOI filing requirements while the case is pending,” the statement said. “Best practices dictate that at a minimum those assisting clients with BOI report filings gather the required information from the clients and are prepared to file the BOI report if the injunction is lifted. While it is unlikely that the injunction will be lifted prior to the final outcome of the proceedings, we advise being prepared in the event that there is a reversal.”

Thursday Report

David Ermer–ACA, CDC, Congress, FDA, Federal employment benefits, Medical / Rx research, NIH, Obesity, OPM, Telehealth, U.S. Healthcare–

Healthcare Dive shares observations and news about yesterday’s murder of United Healthcare’s CEO Brian Thompson.

Yahoo News delves into the investigation of Mr. Thompson murder by the New York City Police Department. The FEHBlog has the utmost confidence that this investigation will end with at least one arrest.

From Washington, DC

  • Federal News Network informs us,
    • “Enrollees in the new Postal Service Health Benefits program will have a few extra days of Open Season to review their plan options and make changes to their benefits for plan year 2025.
    • “The Office of Personnel Management officially extended Open Season for PSHB participants until Dec. 13, Federal News Network has learned. Participants in the Federal Employees Health Benefits program and other federal benefits programs will still see Open Season end on the original Dec. 9 deadline.
    • “OPM said the transition to the new PSHB program is “a big change” for enrollees, and it’s extending Open Season by four days to give Postal employees, annuitants and their family members additional time to look at plans and make changes as they see fit.
    • “We feel it is important to extend Open Season for customers of the PSHB program to give them ample time to shop for plans and change their elections if they want to,” OPM said.
  • Tammy Flanagan, writing in Govexec, discusses Open Season and tax savings.
  • Politico reports,
    • “The House is losing several health policy leaders after this Congress, and they’ll likely want to make their mark in their last two months on Capitol Hill.
    • “While Congress negotiates its end-of-year legislative package, some key departing lawmakers are rallying to pass projects before their terms end — although expectations for a health care package are low. Historically, Congress has sometimes shown a willingness to give outgoing lawmakers a win.”
    • Politico shares the legacy goals of the retiring House members.
  • Among the bills for possible inclusion in the lame duck health care package is S. 1339, Pharmacy Benefit Manager Reform Act. The Congressional Budget Office issued a report on this bill today.
  • The Washington Post informs us,
    • “A bipartisan group of senators grilled Food and Drug Administration officials Thursday on the agency’s failure to more tightly regulate ultra-processed foods and food dyes, highlighting a key part of the health agenda promoted by Robert F. Kennedy Jr.
    • “Kennedy, President-elect Donald Trump’s controversial pick to lead the sprawling Department of Health and Human Services, which oversees the FDA, has blamed the nation’s surge of chronic disease and declining life expectancy on ultra-processed foods — a position that aligns with Sen. Bernie Sanders (I-Vermont), who convened the hearing as chairman of the Senate health committee.
    • “Congress and the FDA have allowed large corporations to make huge profits by enticing children and adults to consume ultra-processed food and beverages loaded up with sugar, salt and saturated fat,” Sanders said Thursday, pointing to the billions of dollars the food-and-beverage industry spends on advertising.”
  • Govexec notes,
    • “The leaders of President-elect Trump’s new advisory panel aiming to slash government spending, Elon Musk and Vivek Ramaswamy, met with Republican lawmakers at the Capitol on Thursday in what leaders pitched as an informational session to share ideas. 
    • “Congressional Republicans and a handful of Democrats have embraced Trump’s Department of Government Efficiency, which will function as a non-governmental commission, and on Thursday were eager to share their ideas for identifying areas for cuts. Some Republicans cautioned, however, that the advisory panel must work through the appropriate channels and win congressional support for their initiatives. 
    • “Nearly every House and Senate member that emerged from the various meetings called them productive and suggested a unifying idea supported by both lawmakers and Trump’s designated efficiency czars: recalling teleworking employees back to the office.”  
  • Per Department of Health and Human Services press releases,
  • and
    • “Today, the U.S. Department of Health & Human Services (HHS), Office for Civil Rights (OCR), issued a “Dear Colleague” letter – PDF to help federally funded health care providers, plan grantees, and others better understand their civil rights obligations under the new final rule on Section 1557 of the Affordable Care Act (“Section 1557”).  
    • “Section 1557 provides nondiscrimination protections by requiring covered entities (e.g., recipients of Federal financial assistance, programs administered by HHS, and entities established under Title I of the Affordable Care Act (ACA)) to provide language assistance to individuals with limited English proficiency (LEP) or disability.”
  • Modern Healthcare reports,
    • “Hospitals have expanded their legal push for the federal government to boost Medicare reimbursement.
    • “More than 500 hospitals last week sued the Health and Human Services Department for allegedly miscalculating a 40-year-old Inpatient Prospective Payment System base reimbursement rate that providers say has lowered years of subsequent Medicare payments to hospitals. The lawsuit is the latest in a series of similar complaints that allege the Health and Human Services Department must increase Medicare inpatient pay.
    • “Each lawsuit challenges different batches of denied requests to amend reimbursement rates, but the arguments are largely the same. Hundreds of millions of dollars are at stake, providers allege. If the federal government changes the inpatient base pay rate, hospitals stand to not only recoup money from prior fiscal years but also increase future reimbursement rates.”
  • The American Hospital Association News tells us,
    • “A $2.8 billion settlement from Blue Cross Blue Shield to health care providers resolving a 12-year antitrust lawsuit received preliminary approval yesterday from the U.S. District Court for the Northern District of Alabama. The settlement will also “significantly improve how Providers will interact with the Blues, bringing more transparency and efficiency to their dealings, and increase Blue Plan accountability,” according to the court filing. 
    • “The lawsuit alleged that BCBS member companies violated antitrust laws by agreeing to allocate markets via exclusive service areas and fixing prices paid to health care providers through the organization’s BlueCard Program.”
  • and
    • “Approximately 988,000 consumers who currently do not have health insurance coverage through the individual marketplace have signed up for a 2025 health plan through the federally facilitated Health Insurance Marketplace, the Centers for Medicare & Medicaid Services announced yesterday. Nearly 4.4 million returning consumers have selected 2025 plans. The open enrollment period began Nov. 1 and continues through Jan. 15.”
    • The deadline for January 1, 2025, enrollments is December 15, 2024. Later enrollments will begin on February 1, 2025.
  • and
    • “The Food and Drug Administration yesterday released recommendations for streamlining the approval process for medical devices that use artificial intelligence. The guidance recommends information to include in a predetermined change control plan as part of a marketing submission for a medical device using AI. The PCCP should include a description of the device’s planned modifications; methods to develop, validate and implement the modifications; and an assessment of the modification’s impacts. FDA will then review the PCCP within the submission to ensure the device’s safety and effectiveness without needing additional marketing submissions for each modification.” 

From the public health and medical research front,

  • The Washington Post reports,
    • “Scientists from the Scripps Research Institute are reporting that it would take just a single mutation in the version of bird flu that has swept through U.S. dairy herds to produce a virus adept at latching on to human cells, a much simpler step than previously imagined.
    • “To date, there have been no documented cases of one human passing avian influenza to another, the Scripps scientists wrote in their paper, which was published Thursday in the journal Science. The mutation they identified would allow the virus to attach to our cells by hitching itself to a protein on their surface, known as the receptor.
    • “William Schaffner, a professor of infectious diseases at Vanderbilt University Medical Center who did not participate in the study, called the research “sobering,” adding, “I had not known it would take just one mutation in the virus for it to attach itself to the receptors on human cells.
    • “However, he stressed that the H5N1 virus has been active for 20 years and “has multiplied billions upon billions upon billions of times and the spontaneous mutation that the authors describe,” has not been found, despite intense surveillance.
    • “Yoshihiro Kawaoka, a professor of virology at the University of Wisconsin, who was not involved in the latest research but has studied bird flu extensively, said that statistically, the mutation probably already exists in H5N1-infected cows and humans, given that 1 in 10,000 infectious particles of the influenza virus is a mutant.
    • “James C. Paulson, one of the paper’s authors, and several other top scientists agreed that it is statistically likely the mutation has occurred in the H5N1 virus but stressed that it has yet to be detected, and other barriers remain before the virus could be transmitted from one person to another. Paulson is a professor in the Department of Molecular Medicine at Scripps.”
  • The National Institutes of Health Director, Dr. Monica Bertagnolli, writes in her blog,
    • “Your memories of life experiences are encoded in collections of neurons in the brain that were active at the time the event took place. Later, those same patterns of neural activity are replayed in your mind to help stabilize your memories of past events. But new research suggests those memories aren’t fixed. An NIH-supported study in male mice reveals how an older memory can be “refreshed” and altered by association with newer events.
    • “The findings, reported in Nature , show that a memory of a recent negative event can become linked to the memory of a neutral event that took place days earlier, changing the way it’s remembered. This provides important insight into what we know about how the brain updates and reorganizes memories based on new information. These findings could also have implications for our understanding of neurobiological processes that might occur in the brain in memory-related mental health conditions like post-traumatic stress disorder (PTSD), when people feel stress or fear even in situations that present no danger.” *. * *
    • “Although these findings were obtained in a mouse model, according to the researchers, the study results suggest that our brains may integrate memories to form a cohesive understanding of real-world experiences in ways that offer stability and flexibility. These insights suggest that memories of the past are constantly updated and refreshed by new experiences in ways that may help us function in a world marked by constant change.
    • “The findings also suggest that negative experiences can lead us to fear seemingly unrelated places or events in ways that are detrimental. This may help to explain why for people with PTSD, exposure therapy—in which people work to overcome fears through gradual exposures to them in a safe environment—can stop being effective. The hope is that findings like these might shed light on potential new ways to treat PTSD and related disorders.”
  • Per an NIH press release,
    • “Improvements in cancer prevention and screening have averted more deaths from five cancer types combined over the past 45 years than treatment advances, according to a modeling study led by researchers at the National Institutes of Health (NIH). The study, published Dec. 5, 2024, in JAMA Oncology, looked at deaths from breast, cervical, colorectal, lung, and prostate cancer that were averted by the combination of prevention, screening, and treatment advances. The researchers focused on these five cancers because they are among the most common causes of cancer deaths and strategies exist for their prevention, early detection, and/or treatment. In recent years, these five cancers have made up nearly half of all new cancer diagnoses and deaths.
    • “Although many people may believe that treatment advances are the major driver of reductions in mortality from these five cancers combined, the surprise here is how much prevention and screening contribute to reductions in mortality,” said co-lead investigator Katrina A. B. Goddard, Ph.D., director of NCI’s Division of Cancer Control and Population Sciences. “Eight out of 10 deaths from these five cancers that were averted over the past 45 years were due to advances in prevention and screening.”
    • “A single prevention intervention, smoking cessation, contributed the lion’s share of the deaths averted: 3.45 million from lung cancer alone. When considering each cancer site individually, prevention and screening accounted for most deaths averted for cervical, colorectal, lung, and prostate cancer, whereas treatment advances accounted for most deaths averted from breast cancer.
    • “To reduce cancer death rates, it’s critical that we combine effective strategies in prevention and screening with advances in treatment,” said W. Kimryn Rathmell, M.D., Ph.D., director of NCI. “This study will help us understand which strategies have been most effective in reducing cancer deaths so that we can continue building on this momentum and hopefully increase the use of these strategies across the United States.”
  • The AP adds,
    • “Many moms-to-be opt for blood tests during pregnancy to check for fetal disorders such as Down syndrome. In rare instances, these tests can reveal something unexpected — hints of a hidden cancer in the woman.
    • “In a study of 107 pregnant women whose test results were unusual, 52 were ultimately diagnosed with cancer. Most of them were treated and are now in remission, although seven with advanced cancers died.
    • “They looked like healthy, young women and they reported themselves as being healthy,” said Dr. Diana Bianchi, the senior author of the government study published Wednesday in the New England Journal of Medicine.
    • “Of the discovered cancers, lymphoma blood cancers were the most common, followed by colon and breast cancers.
    • “The blood test is called cell-free DNA sequencing. It looks for fetal problems in DNA fragments shed from the placenta into the mother’s bloodstream. It also can pick up DNA fragments shed by cancer cells.”
  • NBC News relates,
    • “Prescription fills for blockbuster weight loss medications in the U.S. more than doubled in 2024, even with limited insurance coverage and high out-of-pocket costs for the treatments.
    • “That’s according to new data from drug savings company GoodRx, which examined fill trends and spending patterns for weight loss drugs such as Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound.
    • “It offers more evidence of the insatiable demand for a buzzy class of medications called GLP-1 and GIP agonists, which have hefty list prices of roughly $1,000 per month before insurance or savings cards.”
  • More on prevention from Physicians’ Weekly,
    • “People with type 2 diabetes mellitus (T2DM) face a high risk of cardiovascular disease (CVD), but the timing of this elevated risk before diagnosis is not well understood.  
    • “Researchers conducted a retrospective study to examine CVD occurrence up to 30 years before and 5 years after a diagnosis of type 2 diabetes.  
    • ‘They included individuals diagnosed with type 2 diabetes in Denmark (2010 and 2015) n=127,092 and matched comparisons n=381,023. Conditional logistic regression was used to compute ORs for the prevalence of CVD in the 30 years before diagnosis, and Cox proportional hazards regression models to calculate HRs for 5-year CVD incidence after diagnosis.  
    • ‘The results showed that, in the 30 years before diagnosis, 14,179 (11.2%) individuals with type 2 diabetes and 17,871 (4.7%) comparisons experienced CVD. The odds of CVD were higher for individuals with type 2 diabetes, ranging from 2.18 (95% CI: 1.91-2.48) in the earliest period (25-30 years before diagnosis) to 2.96 (95% CI: 2.85-3.08) in the latest period (less than 5 years before diagnosis). After diagnosis, the 5-year CVD incidence was higher for individuals with type 2 diabetes (HR: 2.20; 95% CI: 2.12-2.27).  
    • “They concluded that individuals with type 2 diabetes experienced twice the number of CVD events compared to matched controls, starting up to 30 years before diagnosis, suggesting that early preventive strategies may be necessary.”  

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Eli Lilly said it would invest $3 billion to expand a recently acquired manufacturing facility to meet growing demand for its diabetes and weight-loss medicines.
    • “The drugmaker said the Kenosha County, Wis., plant expansion would extend the reach of its injectable-product manufacturing and add 750 jobs. The facility already employs around 100 people.
    • “Overall, the expanded facility would focus on manufacturing injectable medicines, device assembly and packaging for medicines across multiple therapeutic areas, the Indianapolis company said.
    • “The decision comes months after Lilly resolved shortages for its weight-loss and diabetes drugs, Zepbound and Mounjaro. Lilly’s rival, Novo Nordisk, has been expanding its production capacity to resolve shortages.”
  • Per Fierce Healthcare,
    • “Amazon has added digital musculoskeletal care company Hinge Health to its health conditions program, a service it rolled out in January to help connect customers with virtual care benefits.
    • “Hinge Health is the first digital musclosketal platform to join Amazon Health Services’ offering that aims to help people discover and enroll in digital health programs available through their employer or health plan at no additional cost.
    • “It marks the fourth company to join Amazon Health Services’ digital health benefits program, following Omada Health, as its first launch partner, Talkspace and behavioral health company Rula Health.”
  • Per Fierce Pharma,
    • “AstraZeneca has picked off another label expansion for its cancer blockbuster Imfinzi (durvalumab) as the FDA has blessed the PD-L1 inhibitor for limited-stage small cell lung cancer (LS-SCLC) patients who have not had disease progression after concurrent chemotherapy and radiation treatments.
    • “With the nod, Imfinzi becomes the first immunotherapy for LS-SCLC, an aggressive form of the disorder with a survival rate between 15% and 30% after diagnosis. The subtype includes roughly 30% of all SCLC cases. It often recurs and progresses rapidly despite initial response to standard-of-care chemo and radiation treatment.
    • “The approval is backed by results from the ADRIATIC trial which showed that, compared to placebo, Imfinzi extended patients’ lives by 27% among those who had not progressed following chemoradiotherapy. The estimated median overall survival was 55.9 months for Imfinzi versus 33.4 months for placebo.”
  • BioPharma Dive points out,
    • “Inside every human cell are thousands of snippets of genetic code that serve as the directions for creating proteins. And over the past four years, a small biotechnology company has been trying to prove that, by looking closely enough at this assembly of instructions, it can find new ways to treat diseases like Alzheimer’s, Parkinson’s and multiple sclerosis.
    • “The company, Muna Therapeutics, now has a nod of confidence from one of the world’s largest drugmakers, as it announced on Thursday a collaboration with GSK that could ultimately be worth hundreds of millions of dollars.
    • “Per deal terms, Muna will analyze brain tissue samples from a variety of sources, from healthy individuals to Alzheimer’s patients to centenarians with and without cognitive impairment. The company will then use different technologies to determine where protein instructions are (or aren’t) in those tissues, with the goal being to identify and validate new targets for Alzheimer’s drugs.”
  • RAND Healthcare shares its key findings on telehealth policy.

Tuesday Tidbits

David Ermer–ACA, CDC, Congress, FDA, Medical / Rx research, Obesity, OPM, Rx coverage, U.S. Healthcare, Uncategorized–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • Govexec let us know,
    • “The top House Republicans for veterans’ issues are pushing a new measure to codify and expand privatized health care on the taxpayer dime, reigniting a controversial issue that is likely to come back to the fore under President-elect Trump. 
    • “The Complete the Mission Act would serve as a followup to the 2018 Mission Act that Trump signed into law, which streamlined and expanded veterans’ access to private sector care paid for by the Veterans Affairs Department. Congress passed the Mission Act on a bipartisan basis to follow a 2014 law with similar goals, but lawmakers have since disagreed over its implementation. 
    • “The new bill, introduced by House Veterans Affairs Committee Chairman Mike Bost, R-Ill., would ensure existing access standards for private sector “community care” are codified in law. Those rules allow veterans living more than a 30-minute drive on average from the nearest VA facility to access the community care network for services such as primary care, mental health and some extended care. For specialized care, veterans must live more than a one-hour drive from the nearest VA facility. They can also access private care when a close VA facility does not provide the service they are seeking, or when their VA doctor recommends it. 
    • “Bost’s measure would expand extended care options in the private sector and bar VA from considering telehealth availability when calculating community care eligibility. It would also require VA to consider veterans’ preference of where to seek treatment. The bill would create a three-year pilot in which patients could enroll in non-VA outpatient mental health or substance use treatment without requiring.”
  • Federal News Network informs us,
    • “Agency leaders in charge of combatting fraud are highlighting the importance of workforce training and data sharing, as the White House touts a deep decline in the governmentwide rate of improper payments.
    • “The Office of Management and Budget last week reported the governmentwide rate improper payment rate had fallen to 3.97%, the lowest since 2014. The rate has dropped by nearly 50% since fiscal 2021, when improper payments and fraud soared amid emergency COVID relief spending.
    • “The total amount of improper and unknown payments in fiscal 2024 was $161.5 billion, compared to just under $236 billion in fiscal 2023, according to data posted on PaymentAccuracy.gov.
    • “The White House said the past year’s progress was driven by “a government-wide approach focused on improving up-front controls, prioritizing fraud prevention, and driving increased collaboration between agencies and their inspectors general.”
  • The Internal Revenue Service announced that “The applicable dollar amount that must be used to calculate the [PCORI] fee imposed by sections 4375 and 4376 for policy years and plan years that end on or after October 1, 2024, and before October 1, 2025, is $3.47.
  • The Office of Personnel Management’s Inspector General released her latest semi-annual report to Congress.
  • Adam Fein, writing in his Drug Channels blog, shares four revelations about Minnesota’s first 340B program transparency report.

From the public health and medical research front,

  • STAT News reports,
    • “At the annual meeting of the Menopause Society earlier this fall, researchers presented new evidence that hormone therapy can be beneficial to menopausal women’s heart health, reducing insulin resistance and other cardiovascular biomarkers. It was the latest in a long line of research showing the benefits of hormone therapy for women in menopause, which also includes alleviating symptoms like hot flashes, sleep disturbances, vaginal dryness, and pain during sex.
    • “But despite this evidence, hormone therapy’s use has plummeted over the past few decades. In 1999, almost 27% of menopausal women in the U.S. used estrogen. By 2020, less than 5% did. 
    • “So why aren’t more women in menopause taking advantage of treatments known to be effective? Misconceptions about the risks of hormone therapy are one reason, according to experts. So is the lingering cultural taboo around discussing menopause, which has created “a perfect storm for under-treatment,” said Theodoros Kapetanakis, an OB-GYN at Mount Auburn Hospital’s Endometriosis Center in Waltham, Mass.” 
  • Healio tells us.
    • “The beneficial impact of physical activity on mortality risk remained consistent across the adult lifespan, even growing stronger later in life, according to study results published in JAMA Open Network.
    • “In contrast, other modifiable health factors saw their effects on the risk for mortality decrease with increasing age.
  • RAND offers a report titled “Improving the Detection of Cognitive Impairment and the Pathway to Treatment.”‘
    • “Low cognitive ability, functional limitations, and poor physical health are strong predictors of dementia as many as 20 years before its onset. Lifestyle factors, such as never drinking alcohol or drinking excessively, never exercising, and low engagement in hobbies, are associated with cognitive impairment and dementia.
    • “Early detection of cognitive impairment helps people take mitigating actions to prepare for future loss of their financial and physical independence.
    • “Older adults’ take-up of cognitive testing is low, and many who do get tested exit the clinical care pathway before being diagnosed and receiving treatment. Take-up of cognitive tests would increase if tests were free and readily accessible. Treatments would be more palatable if they had fewer side effects and helped patients maintain independence longer.
    • “More engagement of primary care practitioners and team-based care in the clinical care pathway and the use of new technologies, such as blood-based biomarkers, could ease health care system capacity constraints on dementia specialists and reduce wait times for patients.”
  • McKinsey & Company offers ideas about “How to address healthcare inequities for people with disabilities.”
    • “Globally, people with disabilities have a mortality rate that is 2.24 times higher than those without disabilities. And although people with disabilities often have greater healthcare needs, they also experience more and higher barriers to care. McKinsey’s Dr. Mona Hammami and coauthors write that in the patient care pathway, people with disabilities are more likely to report:
      • “skipping or delaying care because of cost
      • “having difficulty securing transportation to a health facility
      • “encountering inaccessible facilities
      • “meeting workers with inadequate skills or flexibility to provide quality care
    • “This International Day of Persons with Disabilities (IDPD), examine inequities in the patient care pathway, potential interventions to overcome them, and a three-step approach to reducing inequities across communicable and non-communicable disease types.”
  • The New York Times reports
    • “Health officials have closed their investigations into an E. coli outbreak linked to raw onions on McDonald’s Quarter Pounder hamburgers that sickened more than a hundred people, the Food and Drug Administration (FDA) announced Tuesday.
    • “In total, 104 people from 14 states were sickened from the contaminated food and 34 were hospitalized. One older person in Colorado died.
    • “Officials said there did not appear to be a “continued food safety concern,” because McDonald’s had not served slivered onions — which investigators determined to be the “likely source of contamination”— on the Quarter Pounders for more than a month. The onions were recalled. And in many states, Quarter Pounders were removed from the menu altogether for several weeks.
    • “There have not been any new illnesses since McDonald’s decided to remove the onions from its menu on Oct. 22, according to the Centers for Disease Control and Prevention.”
  • Per an FDA announcement,
    • “On Monday, the FDA updated the outbreak advisory for Salmonella Typhimurium infections linked to cucumbers. As of November 26, 2024, a total of 68 people infected with the outbreak strain of Salmonella have been reported from 19 states. Of the 50 people for whom information is available, 18 have been hospitalized. No deaths have been reported. Of the 33 people interviewed, 27 (82%) reported eating cucumbers.
    • “On November 27, 2024, SunFed Produce, LLC initiated a voluntary recall of all sizes of American/slicer cucumbers that were grown by Agrotato, S.A. de C.V. in Sonora, Mexico. On November 29, 2024, Baloian Farms of Arizona Co., Inc. initiated a voluntary recall of all sizes of American/slicer cucumbers that were grown by Agrotato, S.A. de C.V. On December 1, 2024, Russ Davis Wholesale initiated a voluntary recall of American/slicer cucumbers and multiple products containing recalled cucumbers.
    • “The FDA is working with the recalling firms and their direct customers to determine if additional downstream customer recalls are necessary. The FDA’s investigation is ongoing.”

From the U.S. healthcare business front,

  • Modern Healthcare relates,
    • “Kaiser Permanente-backed Risant Health acquired Cone Health on Sunday, making it the second health system to join Risant in less than a year.
    • “Cone is following in the footsteps of Geisinger Health, which was folded into the newly-formed Risant in March. Kaiser created Washington, D.C.-based Risant earlier this year as a nonprofit entity to buy systems and form a national network for value-based care.” * * *
    • “Having two of these close in one year has made for a pretty busy year,” said Dr. Jaewon Ryu, CEO at Risant. “It’s great to get on the other side of the regulatory approvals and finalize welcoming [Cone] into Risant Health.”
  • Beckers Hospital Review notes,
    • “California was CommonSpirit’s top-performing market in terms of margins in the first quarter of fiscal year 2025 (the three months ending Sept. 30) but the Chicago-based system’s South region, which includes Texas and Kentucky, “remains challenged,” Benjie Loanzon, senior vice president and corporate controller, said during the company’s Dec. 2 earnings call. 
    • “We are taking a range of actions in this region, focusing on our ambulatory strategy,” Mr. Loanzon said. “We are encouraged by recent performance improvements, though a significant amount of work will be needed to reach an acceptable level [of] performance.”
    • “CFO Dan Morissette said the health system continues to look at ways to improve the South region’s performance. Key focus areas include contracting, efficiency, growth and cost containment. 
    • “Although Texas didn’t perform well in Q1, we are encouraged by other achievements in terms of the volume and cost containment,” Mr. Loanzon said. “Kentucky is the most improved market in terms of the financial performance. In terms of the volume and cost containment, it has a positive EBIDTA compared to the past.”
  • Per BioPharma Dive,
    • “Shares of Janux Therapeutics surged to record highs following the release of study results for a drug that, if ultimately successful in testing, would represent a new type of therapy for prostate cancer. 
    • “The findings come from an early-stage study testing the biotechnology company’s therapy, dubbed JANX007, in 16 people with a form of advanced prostate cancer. Data Janux first disclosed earlier this year vaulted the company’s market value past $2 billion. While early and from a small clinical trial, the new results announced Monday afternoon pushed Janux’s shares nearly 75% higher, changing hands Tuesday morning at more than $70 apiece.”‘
  • Beckers Payer Issues tells us how much health plans are paying for GLP-1 drugs.
    • The prices for some GLP-1s have dropped significantly in recent years for individuals covered by Medicare and commercial insurance, according to a new report from HHS,
    • In 2024, the U.S. list prices for a one-month supply for most GLP-1s are stable or increasing, but after payer negotiations and rebates, net prices for many GLP-1s have decreased since 2022. Net prices for GLP-1s are between 24% and 73% lower than list prices, indicating that most insurers are paying less than the manufacturer’s list price.
    • “In the net prices, we see evidence of the impact of competition as new drugs in the class enter the market,” HHS wrote. “While list prices are consistently stable or increasing, for many of these drugs, including Ozempic, Rybelsus, Saxenda, and Victoza, net prices fell.”
  • Healthcare Dive explains “Healthcare organizations must carefully vet AI tools, address patient concerns and keep an eye on standards and regulation, according to industry experts who spoke at a Healthcare Dive virtual event.”

Weekend Update

David Ermer–Congress, Federal employment benefits, Obesity, OPM, U.S. Healthcare–

From Washington, DC,

  • The deadline for Congress to take action on Fiscal Year 2025 appropriations is Friday December 20.
  • FedWeek lets us know,
    • “Rep. James Comer, R-Ky., is due to remain chairman of the Oversight and Accountability Committee for the 2025-2026 Congress.” * * *
    • “On the Senate side, another Kentucky Republican, Sen. Rand Paul, is set to become chairman of the Homeland Security and Governmental Affairs when the GOP takes control of that chamber.” * * *
    • “There has been no indication of a nominee for OPM director, but one potential candidate would be Michael Rigas, who was deputy director late in the first term and then acting director from March 2020 when the second of the directors confirmed in that administration resigned after disputes over the White House’s intent to move OPM’s policy functions directly under OMB. Rigas was not then nominated to become director, however.”
  • The Medicare open enrollment period ends this Saturday December 7, while the Federal Employees Benefits Open Season is scheduled to end the following Monday, December 9. It remains to be seen whether OPM will extend the first open season for the Postal Service Health Benefits Program as some have urged.
  • The FEHBlog urges OPM and PSHBP carriers to share with Postal Service annuitants over age 65 the substance of this Washington Post article about “How to take advantage of Medicare’s expanded drug benefit in 2025. “It will be easier to spread out Part D drug costs over the year, while the total annual cost of medicines will be capped at $2,000.” The new Medicare Part D features make Part D a viable alternative to folks who currently rely on manufacturer coupons.
  • The U.S. Attorney’s Office for the Southern District of Texas announced last Wednesday,
    • “A 53-year-old Sugar Land [Texas] man has agreed to pay $2,095,946 to resolve allegations he submitted false claims for the placement of electro-acupuncture devices, announced U.S. Attorney Alamdar S. Hamdani.
    • “Dr. Rajesh Bindal used the entity Texas Spine & Neurosurgery Center P.A. to conduct his medical practice. From March 16, 2021, to April 22, 2022, Bindal billed Medicare and the Federal Employees Health Benefits Program (FEHBP) for the surgical implantation of neurostimulator electrodes. 
    • “These are invasive procedures usually requiring use of an operating room. As a result, Medicare and the FEHBP pay thousands of dollars per procedure. 
    • “However, neither Bindal nor his staff performed these surgical procedures, according to the allegations. 
    • “Instead, patients allegedly received devices used for electro-acupuncture, which only involved inserting monofilament wire a few millimeters into patients’ ears and taping the device behind the ear with an adhesive. In some instances, a device sales representative or a physician assistant allegedly performed these placements, which were then billed as surgeries. All device placements took place in Bindal’s clinic, not a hospital or surgical center, and no incision was made on a patient. Most patients claimed the adhesive came loose and the device fell off on its own accord within a few days.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Many of the manufacturing jobs that are being moved overseas, replaced by automation or phased out of the American economy were mostly filled by men. As a result, other occupations traditionally dominated by women are now gaining a larger share of men, including elementary and middle-school teachers and customer-service representatives. 
    • “Still, nursing is a relative outperformer in the proportion of men joining what has long been considered a “pink collar” sector. The number of male registered nurses has increased from about 140,000 in 2000 to about 400,000 in 2023. This means that about 14% of nurses are now men, up from about 9% roughly two decades ago. 
    • “Economists at the Washington Center for Equitable Growth found that men who were becoming registered nurses tended to do so in their late 20s or early 30s rather than as their first job.”
  • and
    • “The obesity duopoly has been pierced as Amgen positions itself to have a drug on the market in a few years. While this adds competition to a market currently controlled by Eli Lilly and Novo Nordisk, it also reinforces the dominance of the makers of Wegovy and Zepbound.
    • “Amgen reported on Tuesday that its highly anticipated obesity-drug candidate, MariTide, helped patients shed around 20% of their body weight, though side effects such as nausea and vomiting were common. The company didn’t disclose detailed data, which is expected at a medical conference next year. If all goes well in a larger late-stage study, Amgen could have a drug on the market within a few years. 
    • “But what we already know suggests that Lilly and Novo Nordisk’s market leadership isn’t about to be upended. Not only did MariTide fail to outperform Lilly’s Zepbound, but both Lilly and Novo also have next-generation medications under development, with promising data showing even more impressive weight loss results.”
  • HR Dive tells us
    • “What employers should know now that the 2024 [Fair Labor Standards Act] overtime rule is vacated.
    • “One attorney cautioned against dropping workers’ recently changed nonexempt status too quickly or without careful consideration.”

Friday Factoids

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

From Washington, DC

  • Federal News Network points out three reasons why federal and postal employees and annuitants should consider their FEHB plan options before Open Season ends on December 9.
  • FedWeek updates its Open Season FAQs for the benefit of Postal employees and annuitants.
  • The Government Accountability Office released a report comparing employer sponsored plans against Affordable Care Act marketplace plans.
    • “In 2023, about 165 million individuals in the U.S. got their health coverage through an employer and about 16 million got coverage through Affordable Care Act Marketplaces.
    • “Comparing the costs of these plans isn’t straightforward. For example, people with employer-sponsored plans pay their premiums with pre-tax dollars. People with Marketplace plans pay their premiums with after-tax dollars. Other factors (e.g., geographic area, level of coverage) can also affect costs.
    • “We estimated that people with employer-sponsored plans had lower average premiums, but their average contributions to those premiums were higher than those in Marketplace plans.”
  • Beckers Payer Issues informs us,
    • “Some insurers are sounding the alarm that Medicare coverage of weight loss drugs could increase premiums. 
    • “On Nov. 26, CMS issued its proposed rule for Medicare Advantage plans in 2026. The rule included a proposal to allow the program to pay for weight loss drugs for individuals with obesity. 
    • “The coverage would also extend to Medicaid beneficiaries. The White House estimated more than 7 million people would be eligible for weight loss drugs if coverage is expanded. 
    • Ceci Connolly, president of the Alliance of Community Health Plans, called the proposal “irresponsible, without further analysis and stakeholder engagement.” 
    • “We are deeply concerned with the proposed coverage expansion of weight-loss drugs in Medicare and Medicaid,” Ms. Connolly said. “The excessive prices drugmakers command for GLP-1s have enormous cost consequences for consumers, taxpayers and employers.” 
    • “The organization represents 30 nonprofit health plans.”
  • STAT News reports,
    • “Bristol Myers Squibb has filed a lawsuit accusing the Biden administration of unlawfully preventing the company from using rebates to pay hospitals that participate in a federal drug discount program, the fourth large pharmaceutical company to attempt a change in payment terms in recent weeks.
    • “The drugmaker sought that move for its widely prescribed Eliquis blood thinner, but the U.S. Department of Health and Human Services maintained such a switch would violate federal law. The agency recently made the same determination in rejecting moves by Johnson & Johnson and Eli Lilly to change payment terms, both of which filed lawsuits. Sanofi also wants to change payment terms but has not filed a lawsuit.
    • ‘In its lawsuit, Bristol argued that the 340B Drug Discount Program is rife with waste and abuse. The program was created three decades ago 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.
    • “However, Bristol had an additional motive for filing its suit. Eliquis was selected by Medicare for price negotiations. And the agency wants manufacturers to ensure the 340B discount and maximum fair price under the Inflation Reduction Act are not applied to the same drug. By offering rebates instead of discounts, the company is trying to avoid this conundrum. J&J stated the same concern in its lawsuit.”

From the public health and medical research front,

  • The Wall Street Journal tells us,
    • “More than 1 in 4 people over age 65 fall each year. Earlier this month, the veteran TV host and comedian Jay Leno was one of them. Leno, 74, left his hotel near Pittsburgh looking for a bite to eat. It would have been a long walk to the restaurant, so he took a shortcut down a grassy hill. A tumble on the slope left him with a broken wrist and significant bruises to his face and entire left side. 
    • “Leno still managed to do his comedy act that night. He was luckier than many fall victims. Every year falls among older Americans result in about 3.6 million emergency room visits and 1.2 million hospital stays, at a cost of roughly $80 billion. Nationwide, 41,000 senior citizens die from falls annually, according to the Centers for Disease Control and Prevention. In recent years, prominent figures such as comedian Bob Saget, former Connecticut Sen. Joe Lieberman and Ivana Trump died after a fall.
    • “And despite progress in care and prevention techniques, a University of Michigan study found that the number of falls goes up about 1.5% every year. “It could be that efforts aren’t working—or that they are, by mitigating even worse potential injury risk in the population,” said Geoffrey Hoffman, a gerontologist at the University of Michigan. “Either way, more investment in prevention and funding for fall education and prevention programs would help.” 
    • “The CDC operates a program known as STEADI (Stopping Elderly Accidents, Deaths and Injuries) to assist healthcare providers in screening older patients for fall risk factors, such as a history of falls, vision problems, inadequate vitamin D intake and foot problems. In one common test, the patient must get up from a chair, walk 10 feet, turn around, walk back and sit down. If this takes more than 12 seconds, they are deemed to be at risk for a fall.
    • “Earlier this year, Rep. Carol Miller of West Virginia, a Republican, introduced legislation to make fall-risk assessment part of Medicare’s annual wellness benefit for all seniors. The bill, known as the SAFE Act, would also direct the Department of Health and Human Services to report annual statistics about falls to Congress.”
  • Medscape discusses new data supporting the most promising treatments for long Covid.
  • Per an NIH press release,
    • “Children of mothers who took certain antiseizure medications while pregnant do not have worse neurodevelopmental outcomes at age 6, according to a long-running study funded by the National Institutes of Health (NIH). The study was published in JAMA Neurology.
    • “Controlling seizures during pregnancy is an important part of prenatal care for women with epilepsy, but for years, the effects of newer antiseizure medications on their children was unknown,” said Adam Hartman, M.D., program director at NIH’s National Institute of Neurological Disorders and Stroke (NINDS). “One major component of this study was correlating the cognitive abilities of children with maternal blood levels of the drugs. This opens the door to future work and might inform better dosing strategies.”
    • “Treating epilepsy during pregnancy is challenging, as some antiseizure medications, primarily older drugs such as valproate, are known to cause serious birth defects and cognitive problems in children, including lower IQ and autism spectrum disorders. Newer antiseizure drugs that are widely used today are generally considered safe, but little is known about whether they affect cognition in children after fetal exposure.”
  • The Washington Post reports,
    • “A farm that supplies organic, pasture-raised eggs for Costco has issued a recall for more than 10,000 products sent to 25 retail locations in five southern states.
    • “Handsome Brook Farms said the eggs, which were sold in packs of 24 under the label of Kirkland Signature, could be contaminated with salmonella. The recalled eggs were sent to Costco stores in Alabama, Georgia, North Carolina, South Carolina and Tennessee, the farm said. The affected products were sent beginning Nov. 22 and bear the UPC 9661910680, along with the code 327 and a “use by” date of Jan. 5, 2025, printed on the side.
    • “Handsome Brook Farms, which is working with the Food and Drug Administration on the recall, said no one has reported being sickened by the eggs. Salmonella is a bacteria that can cause diarrhea, fever and abdominal cramps, according to the FDA. More severe cases can be fatal, and children, elderly people and those with weakened immune systems are more vulnerable to more acute infections.”
  • NBC News adds,
    • “An Arizona produce company is recalling all sizes of its whole, fresh American cucumbers in 26 states and parts of Canada because they could be contaminated with salmonella, it said.
    • “SunFed said in an announcement posted online Thursday by the Food and Drug Administration that cucumbers it sold from Oct. 12 to Nov. 26 were recalled because of the potential contamination, which can cause serious and sometimes fatal infections in young children, frail or elderly people and others with weakened immune systems.
    • “The recalled cucumbers were packaged in bulk cardboard containers marked with the SunFed label or in generic white boxes or black plastic crates with stickers naming the grower, according to the company.
    • “The produce was distributed in 26 states: Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Idaho, Illinois, Indiana, Kansas, Maryland, Massachusetts, Minnesota, Missouri, New Jersey, New York, North Carolina, Oklahoma, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin.”
  • The CDC notes that “Due to the Thanksgiving holiday, the weekly respiratory virus data and summaries will not update on Friday, November 29, 2024. Data updates will resume on Monday, December 2, 2024.”  Lo siento.

From the U.S. healthcare business front,

  • Health Affairs Scholar lets us know,
    • As policymakers continue to grapple with rising health care costs and prices, understanding trends and variations in inpatient prices among hospital characteristics is an important benchmark to allow policymakers to craft targeted policies. In this study, we provide descriptive trends on variation in inpatient prices paid by commercial health plans stratified by hospital characteristics using data from Health Care Cost Institute’s employer-sponsored insured claims data.
    • Our analyses found evidence of considerable variation among inpatient price levels and growth among system affiliation and profitability. Prices among system-affiliated hospitals grew from $14,281.74 in 2012 to $20,731.95 in 2021, corresponding to a 45.2% increase during this period. On the other hand, prices among independent hospitals grew more slowly, from $13,460.50 in 2012 to $18,196.90 in 2021, corresponding to a 35.2% increase.
    • We did not observe a similar trend in growth rates among case mix index by hospital characteristics, implying that differential inpatient price growth is not driven by changes in case mix by hospital characteristics. Heterogeneity in hospital prices and price growth by type of hospital suggests that public and private policymakers aiming to rein in health spending should consider policies that address this variation.
  • Per BioPharma Dive
    • “For drug companies, predicting how much money a product will make is a risky endeavor. If the estimate ends up being far off, then investors may question how well a developer understands its own business or the markets in which it operates. That’s especially true when the prediction is too high.
    • “Analysts on Wall Street were therefore surprised last month to hear Intra-Cellular Therapies, which never much entertained this guessing game, say that its brain-rebalancing drug Caplyta would reach $5 billion in annual sales sometime in the next decade. This year alone, the New Jersey-based company expects $665 million to $685 million in net product sales from Caplyta. * * *
    • “Known scientifically as lumateperone, Caplyta is already approved to treat schizophrenia and bipolar depression and could be cleared for major depressive disorder as early as next year. Intra-Cellular licensedthe drug from Bristol Myers Squibb in 2005, just a few years after the company formed and right as big pharma really started backing away from neuroscience and psychiatry. Now, the company has about 530 sales reps and plans to expand again in preparation for the move into major depression.”
    • In the article, BioPharma Dive interviews Sharon Mates, Intra-Cellular’s founder and CEO.
  • Modern Healthcare reports,
    • “Tim Barry, the CEO of VillageMD, has left the company following a rocky few years mired by its failure to help execute on a healthcare push launched by majority-owner Walgreens Boots Alliance.
    • “It’s unclear exactly when Barry left the Chicago-based company, but VillageMD Chief Operations Officer Jim Murray replaced him “effective immediately,” assuming all day-to-day leadership responsibilities, spokeswoman Molly Lynch said in a statement to Crain’s today.
    • “VillageMD reaffirms its commitment to providing high-quality, accessible healthcare services for individuals and communities across the United States,” Lynch said. She declined to provide additional information about the transition.
    • “Barry co-founded VillageMD in 2013 as a primary care company focused on value-based care, growing to hundreds of locations across the country.”

Happy Thanksgiving!

David Ermer–CDC, CMS, FDA, Medical / Rx research, Medicare, NIH, Obesity, OPM, Patient safety, U.S. Healthcare–

The FEHBlog will be back on Friday.

From Washington, DC,

Transition News

  • Govexec tells us,
    • “President-elect Trump has reached an agreement with the Biden administration that will allow his teams to deploy throughout federal government, ending a standoff that had blocked official presidential transition efforts taking place. 
    • “Transition staff assigned to each agency, known as landing teams or agency review teams, will now physically enter headquarters offices throughout government. Once there, they will meet with assigned career senior executive staff, receive already drafted briefings on agency activities and begin the process of exchanging information about existing projects and future priorities.”
  • STAT News reports,
    • “President-elect Trump has chosen Stanford University professor Jay Bhattacharya to lead the National Institutes of Health, his transition announced Tuesday.
    • “If confirmed by the Senate, Bhattacharya would be in charge of implementing the incoming Trump administration’s bold goals to reform the agency. 
  • The Wall Street Journal adds,
    • “Bhattacharya is both a doctor and economist who became known during the Covid-19 pandemic as a co-author of the Great Barrington Declaration, a document that called for ending lockdowns and isolating the vulnerable so that young, healthy people could get infected and build up immunity in the population. 
    • “Other doctors and public-health researchers, including then-infectious disease chief Dr. Anthony Fauci, criticized the document and said its approach was flawed and would lead to unnecessary deaths.”
  • The Hill notes,
    • “President-elect Trump’s choice for deputy secretary of Health and Human Services is Jim O’Neill, an investor and historically close associate of billionaire Peter Thiel, the president-elect said Tuesday.”

Medicare / GLP-1 Drug News

  • The American Hospital Association News informs us,
    • “The Department of Health and Human Services Nov. 26 issued a final rule that expands access to kidney and liver transplants for individuals with HIV by removing clinical research requirements. Specifically, the rule implements a stipulation under the HIV Organ Policy Equity Act, eliminating the need for approval from the clinical research and institutional review board for kidney and liver transplants between donors with HIV and recipients with HIV. The change was based on research showing the safety and effectiveness of such transplants, HHS said. The final rule is effective Nov. 27.
    • “In tandem with the final rule, the National Institutes of Health published a notice seeking public comment on a proposed revision to its research criteria for HOPE Act transplants of other organs, such as heart, lung and pancreas, with a 15-day comment period.”
  • and
    • “The Centers for Medicare & Medicaid Services Nov. 26 proposed changes to the Medicare Advantage and prescription drug programs for contract year 2026. Those changes would permit coverage of anti-obesity medications in the Medicare and Medicaid programs; fortify existing limitations on insurer use of internal coverage criteria and requirements for MA plans to provide coverage for all reasonable and necessary Medicare Part A and B benefits; and apply additional guardrails to insurer use of artificial intelligence to ensure it does not result in inequitable treatment or access to care. CMS also proposes to update MA and Part D plan medical loss ratio reporting requirements to improve oversight, align reporting with commercial and Medicaid reporting, and request additional information on MLR and vertical integration. 
    • “Among other provisions, the proposed rule would require MA plans to make provider directory information more widely available through the Medicare Plan Finder tool; limit enrollee cost sharing for behavioral health services to an amount that is no greater than Traditional Medicare; enhance CMS oversight of MA agent and broker marketing and communication materials; increase insurer reporting requirements related to insurer use of prior authorization and potential health equity implications; and add new requirements governing MA plan use of debit cards to administer enrollee supplemental benefits. Finally, the proposed rule would also codify several provisions in the Inflation Reduction Act, such as capping certain out-of-pocket costs in Medicare Part D, and other pharmacy-related provisions, such as new requirements for Part D sponsors on formulary inclusion and placement of generic drugs and biosimilars.” 
  • Here is a link to the CMS fact sheet about the Medicare Advantage and Part D proposed changes for 2026.
  • KFF already has issued a policy watch about CMS’s proposal to cover GLP-1 drugs for obesity under Medicare Part D and Medicaid beginning in 2026. The FEHBlog is surprised that CMS made this decision knowing that the Inflation Reduction Act has placed financial pressure on standalone Medicare Part D plans.
  • The Wall Street Journal notes,
    • The [GLP-1 drug] proposal, which would have to be finalized by the Trump administration, faces uncertain prospects.
  • In this regard, Beckers Hospital Review shares the recent comments of President-elect Trump’s nominee for HHS Secretary Robert F. Kennedy, Jr., concerning GLP-1 drugs.
  • The Wall Street Journal adds,
    • “Meantime, Mehmet Oz, the choice to run the Centers for Medicare and Medicaid Services, has said on X that the drugs “can be a big help. We need to make it as easy as possible for people to meet their health goals, period.” * * *
  • On a related note, MedCity News discusses “The Promise and Challenge of GLP-1 Medications: Ensuring ROI in Obesity Care.”

Federal Employment Tidbits

  • Federal News Network reports
    • “Federal Executive Boards are looking to expand their offerings to even more federal employees working outside of the Washington, D.C., region.
    • “After reporting successful training sessions, recruitment events and cost savings in the last fiscal year, the Office of Personnel Management sees an opportunity to extend FEBs’ reach to more than double the number of feds who can access the program’s resources.
    • “The expansion would now be possible, after the FEB program went a restructuring, as well as recently developing a new funding model, OPM said.
    • “This transformation is designed to enhance the FEBs’ effectiveness in fostering interagency collaboration, better serve the 85% of federal employees located outside Washington, D.C., and expand FEBs’ reach to areas with significant federal activity but no FEB presence,” OPM wrote in its fiscal 2023 FEB annual report, published earlier this month.”
  • FedWeek lets us know,
    • “Availability of telework has had a positive impact on recruitment and retention, a sampling of four agencies told GAO, but its effect on customer service and other agency operations is hard to gauge—and three of the four have done little to even try.
    • “The effect on productivity has become a major focus in the ongoing debate over agency telework levels that, although well below the peak of the pandemic period, remain high by historic measures. The GAO report, while not conclusive, adds information to a debate that may result in moves to restrict telework starting in January by the new Congress, the Trump administration, or both.”

FDA News

  • Per Fierce Pharma,
    • “In 2001, a Time Magazine cover story touted Novartis’ targeted leukemia treatment Gleevec (imatinib) as a new kind of “ammunition in the war against cancer.” Along with a picture of the Gleevec pills, Time exclaimed: “These are the bullets.”
    • “Twenty-three years later, patients no longer need to take a “bullet” to reap the benefits of imatinib as Shorla Oncology has scored an FDA approval for its strawberry-flavored drink version of the treatment. Dubbed Imkeldi, it becomes the first oral liquid form of imatinib, Shorla said in a press release.
    • “The therapy can help patients combat myelodysplastic syndrome/myeloproliferative disease (MDS/MPD), gastrointestinal tumors (GIST) and cancers such as chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL).”
  • Per MedTech Dive,
    • “Zimmer Biomet said Monday that it received approval for a cementless partial knee replacement implant in the U.S.
    • “The Oxford Cementless Partial Knee launched in England in 2004. The device is established in Europe, where the company said it has a 60% market share, but will be the first product of its type available in the U.S. The orthopedic company plans to launch the implant in the first quarter of 2025.
    • “Zimmer has identified the device as a good fit for ambulatory surgical centers (ASC) and CEO Ivan Tornos has forecast the product will be one of the top three knee growth drivers in the U.S.”

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “A highly anticipated obesity-drug candidate from biotech Amgen helped patients shed a significant amount of weight in a mid-stage study but fell short of the loftier expectations of some investors. 
    • “Subjects taking Amgen’s MariTide lost 20% of their body weight compared with those who received placebos, Amgen said Tuesday. Analysts had generally expected the drug to achieve weight reduction of 20% or more.
    • “About 11% of subjects dropped out of the study because of side effects, the most common of which included nausea and vomiting.”
  • BioPharma Dive offers a tracker for obesity drug trials.
  • Beckers Hospital Review relates,
    • “A new study on asthma medication Singulair has raised concerns about its potential mental health side effects, USA Today reported Nov. 24. 
    • “The study, presented by the FDA at the American College of Toxicology meeting in Austin, Texas, found that the drug binds to multiple brain receptors linked to mood, cognition, sleep and impulse control. While the research does not confirm if this binding causes harmful side effects, experts warned it could be a significant concern. 
    • “Singulair, commonly prescribed for asthma and allergy symptoms, has been linked to severe neuropsychiatric issues, including anxiety, depression, hallucinations, irritability and suicidal thoughts, USA Today reported.
    • ‘In 2020, the FDA added a boxed warning to the drug, highlighting the risk of severe mental health side effects. Since its introduction in 1998, Singulair has been associated with dozens of suicides and other psychiatric disorders, with reports of adverse effects continuing into recent years. 
    • “Despite the new findings, the FDA said it will not immediately update the drug’s label. The agency also emphasized that more research is needed to fully understand the extent of the drug’s impact on the brain, according to the report.”
  • The National Institutes of Health shares news about “Sleep and heart healing | Liver-brain communication | Characterizing sensory nerves.”
  • Beckers Hospital Review offers a “‘straight-A’ hospital’s safety playbook.”

From the U.S. healthcare business front,

  • Fierce Healthcare points out,
    • “Pittsburgh-based health insurer and provider Highmark Health has brought in $529 million in net income through the first three quarters of the year, according to its latest financial details released Tuesday.
    • “That’s on $22.1 billion in revenue through the first nine months of 2024, along with $273 million in operating gain.
    • “Highmark said that its financial performance is driven by its health plans along with increased volumes at its Allegheny Health Network (AHN). As of Sept. 30, the AHN saw a 3% increase in inpatient discharges and observations as well as 7% more outpatient registrations compared to the same time last year.
    • “In addition, the AHN logged a 5% increase in physician visits and a 6% increase in visits to the emergency room.”
  • Modern Healthcare reports,
    • “Community Health Systems scrapped a $120 million deal to sell three Pennsylvania hospitals and related facilities to WoodBridge Healthcare.
    • “CHS and WoodBridge mutually decided to dissolve the agreement Friday due to WoodBridge’s inability to satisfy funding requirements, according to a Tuesday news release. Investment banking firm Zeigler was unable to sell the bonds needed to fund the acquisition, despite earlier indications of confidence in the bond sales, WoodBridge said in a separate release.”
  • Chief Healthcare Executive (11/22, Southwick) reported, “The majority of hospital and health care facility reviews on Yelp are negative, according to a new study.” Investigators found that “in March 2020, 54.3% of reviews on Yelp were positive, but that number has dropped to 47.9%” Chief Healthcare Executive adds, “Since the second half of 2021, positive reviews haven’t surpassed 50%.” The research was published in JAMA Network Open. Thanks, Covid.

Weekend Update

David Ermer–CDC, CMS, Congress, FDA, Generative AI, Medicare, OPM, U.S. Healthcare–

From Washington, DC,

  • The House of Representatives and the Senate are on District / State work breaks from Capitol Hill this week due to the Thanksgiving holiday.
  • The Hill offers backgrounds on the Food and Drug Administration commissioner, Centers for Disease Control director, and Surgeon General nominees that President-elect Trump announced Friday evening.
  • STAT News reports
    • “A conservative federal judge in Texas has ruled in favor of UnitedHealth Group, saying the federal government unlawfully factored in a “disputed” phone call to lower UnitedHealth’s Medicare Advantage ratings. 
    • “The Centers for Medicare and Medicaid Services will now have to revise UnitedHealth’s 2025 Medicare Advantage ratings by taking out the call center metric, and “immediately publish the recalculated star ratings in the Medicare Plan Finder,” Judge Jeremy Kernodle wrote in his ruling.”
    • Congrats UHG.
    • “Four other large Medicare Advantage insurers — Humana, Elevance Health, Centene, and Blue Cross Blue Shield of Louisiana — have also sued Medicare for downgrading their 2025-star ratings. The lawsuits from Humana and Centene similarly involve the government’s evaluation of their call centers.”
  • Federal News Network tells us,
    • “The Office of Personnel Management has a new leader to focus specifically on federal employees working in HR. Jeff Bardwell will be the first-ever senior executive to serve as the advisor for human resources workforce programs at OPM. In the new position, Bardwell will be tasked with developing and managing the direction of the HR workforce governmentwide. His work will likely include defining HR career paths and improving HR training and professional development opportunities. Bardwell previously spent 15 years working at the Department of Homeland Security.”

From the public health and medical research front,

  • The New York Times discusses how healthcare can unnecessarily take time away from senior citizens.
    • “[S]lowing the health care treadmill — an approach Dr. Montori has called “minimally disruptive medicine” — is possible.
    • “If doctors and clinics and health care systems paid attention to ways to lessen the burden, we’d all be better off,” Dr. Ganguli said. “And some are fairly simple.”
    • “One strategy: reducing what experts call “low-value care.” Her research has confirmed what critics have pointed out for years: Older people receive too many services of dubious worth, including prostate cancer screening in men over 70 and unneeded tests before surgery.”
  • Fortune Well shares “Tips and habits for getting a good night’s rest and boosting your health.”
  • The Wall Street Journal offers an obituary for “Janelle Goetcheus, the ‘Mother Teresa of Washington, D.C.,’ dies at 84. She felt a pull to practice medicine and a call to serve God—the two were always intertwined.
    • “Goetcheus [and her husband, a Methodist minister] spent the [last] half-century treating the unhoused in Washington, D.C. She helped open clinics, organizations and warm buildings to support and care for them. She also visited patients on park benches and in the street—treating people where they are was central to her mission.
    • “Sometimes called the “Mother Teresa of Washington, D.C.,” Goetcheus was best known for co-founding Christ House with a group that included her husband, the Rev. Allen Goetcheus. A “medical respite,” Christ House is a place where men who are no longer sick enough to be in a hospital, but don’t have an appropriate place to convalesce, can live while they recover. It was also the home where the couple raised their three children and where she died, Oct. 26, at the age of 84.” * * *
    • “We wanted to learn to be with people and not just to do for people,” Goetcheus said in the oral-history interview.”
    • RIP Dr. Goetcheus.

From the U.S. healthcare business front,

  • The Washington Post reports,
    • “A growing number of companies have begun to offer employees access to menopause-related benefits in their health insurance, including paid time off, access to health providers knowledgeable about menopause, coverage of medication for menopause symptoms, and even altered work schedules and relaxed dress code options. These benefits are meant to help employees cope with symptoms such as hot flashes, depression and other physical discomforts.
    • “The benefits are designed to meet the needs of people dealing with menopause and of their employers, who are adding such coverage to help retain employees, many who have decades of experience, are in management and senior leadership positions or are in line for those posts.
    • “Among the companies offering a variety of menopause-related benefits are Microsoft, Genentech, Adobe and insurer Healthfirst.”
  • BioPharma Dive reports,
    • “The Food and Drug Administration has approved a new medicine for a deadly genetic heart condition, boosting its developer, BridgeBio Pharma, and teeing up a battle for control of a lucrative market targeted by several drugmakers.
    • “The agency on Friday cleared Attruby, known scientifically as acoramidis, for people with a cardiac form of transthyretin amyloidosis, a progressive disease that leads to heart failure and death.
    • “In testing, Attruby helped keep people alive and out of the hospital longer than those who’d received a placebo. Treatment was also associated with improvements in quality of life as well as markers of heart health.
    • “Notably, the drug is approved to prevent hospitalization or death resulting from heart complications of transthyretin amyloidosis with cardiomyopathy. Investors had been skeptical BridgeBio would earn such a distinction from regulators, leading to doubts about Attruby’scommercial prospects. 
    • “BridgeBio priced Attruby at just under $19,000 for a 28-day supply, translating to an annual list cost of about $244,000.”
  • McKinsey & Company considers what’s next for AI and healthcare.
    • In healthcare—with patient well-being and lives at stake—the advancement of AI seems particularly momentous. In an industry battling staffing shortages and increasing costs, health system leaders need to consider all possible solutions, including AI technologies. “Organizations are eager to use generative AI to help enhance how healthcare stakeholders work and operate,” write McKinsey’s Jessica Lamb and coauthors, “but some are still adopting a wait-and-see approach.” Where do you stand? Explore these insights to get up to date on AI and healthcare topics including: 
      • Adding artificial intelligence to nurses’ toolbox
      • Making coverage and cost information more understandable
      • AI impact on the payment integrity (PI) value chain
      • AI use cases in claims processing, enrollment, and underwriting.
  • HR Dive provides “a roundup of numbers from the last week of HR news — including the percentage of employers covering GLP-1s for obesity treatment [44%].”

Midweek Update

David Ermer–AHRQ, Congress, FDA, Federal employment benefits, Medical / Rx research, Mental health care, OPM, U.S. Healthcare, Uncategorized–
Photo by Tomasz Filipek on Unsplash

From Washington, DC

  • This afternoon the FEHBlog was listening to an OPM meeting about the PSHBP when someone mentioned a benefit administration letter. The FEHBlog realized that he was overdue in posting the 2025 FEHB and PSHBP Significant Plan Changes notices which appear under on OPM’s benefit administration letters page.
  • Kevin Moss, writing in Govexec, pitches the many advantages available to annuitants over age 65 who enroll in an FEHB or PSHB plan’s Medicare Part D EGWP for 2025. Mr. Moss warns readers about the income adjusted Part D premiums (IRMAA) and the Medicare bar against using manufacturer coupons. In the FEHBlog’s opinion, the combination of the Medicare Part D’s new features for 2025 — a $2000 out of pocket maximum and the Medicare Prescription Payment Plan — outclass manufacturer coupons and diminish the impact of IRMAA which in any case is much lower for Part D compared to Part B.
  • HUB International reminds us,
    • “Back in 2020, the Coronavirus Aid, Relief, and Economic Security (CARES) Act first allowed HDHPs to cover telehealth and other remote care services on a first dollar basis through the end of 2021. This was initially designed to make medical care accessible during the COVID-19 pandemic, when it may not have been for many in need.
    • “Congress first resurrected this relief in April 2022 after a three-month hiatus. This relief was scheduled to end on December 31, 2022, until Congress extended it once again. This second extension is now coming to an end for plan years beginning on or after January 1, 2025.”
  • The lame duck session of Congress could pass a law extending this benefit beyond 2024.
  • The U.S. Preventive Services Taskforce presented its 14th annual report to Congress on “High-Priority Evidence Gaps Across the Lifespan, in All Communities” today.

From the public health and medical research front,

  • MedPage Today tells us,
    • “Among adults with outpatient respiratory syncytial virus (RSV) infections across six RSV seasons, roughly one in 20 were hospitalized within 28 days, according to a large cohort study that used data from three health record databases.
    • “In the cohort of over 67,000 patients with outpatient medically attended RSV infections, hospitalization rates were 4.5% to 6.2%, and 6.5% to 8.5% in a high-risk subgroup, across the three databases, reported Joshua T. Swan, PharmD, MPH, of Pfizer in New York City, and colleagues in JAMA Network Open.
    • “High-risk features included age 65 and older, asthma, chronic obstructive pulmonary disease (COPD), and congestive heart failure (CHF). Across the patients in the three databases, comorbidity prevalence were 20% to 30.5% for COPD, 14.6% to 24.4% for CHF, 14.6% to 24.4% for asthma, and 14% to 54.5% for age 65 and over.
    • “Infection rates for RSV have been underestimated, partly due to underutilization of testing for the viruses, Swan and team noted. Although there are three available vaccines against RSV, there are few approved treatments for it.”
  • and
    • “Diagnoses of postpartum depression (PPD) increased significantly across all racial and ethnic groups and prepregnancy body mass index (BMI) categories over the past decade, according to a California-based cross-sectional study.
    • “An analysis of more than 400,000 pregnancies found that prevalence of PPD doubled from 2010 to 2021 (9.4% vs 19%), according to Darios Getahun, MD, PhD, MPH, of Kaiser Permanente Southern California in Pasadena, and co-authors.
    • “While rates increased across all groups, the largest increases were seen in those who identified as Asian and Pacific Islander (280% increase) and non-Hispanic Black (140% increase), they reported in JAMA Network Open.”
  • The National Cancer Institute released cancer information highlights about “B-Cell Lymphoma | Advanced Cancer | Skin Cancer and Darker Skin.”
  • Per Fierce Pharma,
    • “It was only last October that UCB’s up-and-coming immunology powerhouse Bimzelx first crossed the FDA finish line in psoriasis after an initial delay. Now with a new nod in hidradenitis suppurativa (HS), the drug seems to be carving the path to blockbuster land with five approved indications.
    • “Bimzelx, which is the first to selectively inhibit IL-17F as well as IL-17A, was cleared to treat adults with moderate to severe forms of the disease after proving it could help patients significantly reduce signs and symptoms of the condition. HS is characterized by chronic and recurring painful nodules, abscesses and pus-discharging fistulas that can have a major impact on quality of life.
    • “UCB is “thrilled” with the milestone, head of patient impact and chief commercial officer Emmanuel Caeymaex said in a company press release.”

From the U.S. healthcare business front,

  • Fierce Healthcare informs us,
    • “More than half of health system and health plan executives say AI is an immediate priority, and 73% are increasing their investments in the technology, a new C-suite survey finds.
    • “Many healthcare organizations are moving past early pilot successes to enterprise scaled solutions, but are balancing AI enthusiasm against pragmatism, according to the survey from Define Ventures of C-suite and senior executive leaders from more than 60 providers and payers.
    • “Define Ventures, a venture capital firm focused on early-stage health tech companies, conducted surveys and meetings with executives from 10 of the top 20 providers and three of the top 10 payers to check the industry’s pulse on AI adoption and investment. The survey took place from August through early November.”
  • Per BioPharma Dive,
    • “Pfizer on Wednesday said it will promote Chris Boshoff to chief scientific officer and president of research and development as the giant drugmaker struggles to win back the faith of investors.
    • “Boshoff will assume his new post on Jan. 1, succeeding Mikael Dolsten, who oversaw research at Pfizer for 15 years. The company announced Dolsten’s departure in July.
    • “Boshoff currently serves as chief oncology officer and is credited with delivering 24 approved new medicines and biosimilars during his 11-year tenure at the company. Boshoff has also worked as Pfizer’s head of development in Japan and as chief development officer for oncology and rare disease.”
  • Kauffman Hall discusses the misadventures of primary care.
  • Modern Healthcare reports,
    • “Three lawsuits filed against data analytics firm MultiPlan alleging antitrust law violations for reducing pay for out-of-network providers have been consolidated into one suit seeking class action status.
    • “The American Medical Association and the Illinois State Medical Society filed suit against the company in October in federal court in Illinois. Advanced Orthopedic Center, a medical practice in Poway, California filed its suit in June in federal court in New York. Orthopedic provider Dr. Curtis Robinson filed his suit in federal court in California.
    • “The complaints, all now in the U.S. District Court for the Northern District of Illinois, allege MultiPlan has contracts with 700 large insurers, which allows them to have unfair control of market rates for provider pay.” * * *
    • “A spokesperson for MultiPlan said the company intends to fight the allegations.