“Simplicity is a great virtue but it requires hard work to achieve it and education to appreciate it. And to make matters worse: complexity sells better.”
– Edsger W. Dijkstra

From Washington, DC,

• Beckers Hospital Review reports,
  • “CMS proposed a sweeping deregulation rule Nov. 5 that would remove hospital staff training requirements tied to Biden-era obstetric standards. It would also roll back several nursing home requirements, rescind a Medicaid payment transparency rule and exempt certain critical access hospitals from distance requirements.
  • “The proposed rule follows a CMS review of the conditions of participation for all 21 provider and supplier types. Providers must meet these baseline standards to bill Medicare and Medicaid.
  • “CMS said the rule is meant to eliminate obsolete or excessively burdensome requirements so healthcare organizations can devote more time and resources to improving patient care.
  • “The agency estimates the proposals would save $320 million a year and return more than 3.26 million hours of staff time to providers. Nursing homes would see the largest share at $142.6 million a year. Hospitals would save $123.2 million, CAHs $16.6 million and intermediate care facilities for individuals with intellectual disabilities $6.6 million. Rescinding a Medicaid payment reporting requirement accounts for another $30.4 million.”
• and
  • “CMS has finalized a rule that sets ongoing policies for the Medicare Drug Price Negotiation Program, starting with negotiated prices that take effect in 2029.
  • “The agency said the rule is designed to give drugmakers in the program a clearer, more predictable process going forward, according to a Nov. 5 news release.
  • “CMS plans to pick up to 20 additional Part D or Part B drugs for the program’s fourth negotiation cycle by Feb. 1, 2027. It may also select previously negotiated drugs for renegotiation.
  • “This rule provides additional tools to help CMS negotiate better deals, achieve greater savings for taxpayers and beneficiaries, and improve health outcomes for seniors who rely on the Medicare Prescription Drug Program,” CMS Administrator Mehmet Oz, MD, said in the release.”
• and
  • “HHS’ Administration for Strategic Preparedness and Response, the Commerce Department’s Bureau of Industry and Security and the Department of War’s health affairs office are assessing the U.S. industrial base for pharmaceutical key starting materials. The materials are the chemical precursors and intermediates used to make active pharmaceutical ingredients.
  • “The assessment will examine the upstream supply chain behind U.S. drug manufacturing, including limited domestic production capacity and reliance on foreign or single sources of critical materials, according to a Nov. 3 news release. BIS is surveying U.S. manufacturers, chemical suppliers, distributors, procurers and customers under Section 705 of the Defense Production Act. The one-time survey collects information on production capabilities, sourcing practices, customers, supply chain disruptions, workforce and research and development.
  • “The findings will be compiled into a report on U.S. production capacity, supply chain vulnerabilities and emergency response capabilities, with recommendations to improve resilience and public health emergency preparedness. The government plans to use the findings to develop funding strategies for the availability, quality and security of the materials.”

• STAT News adds,
  • “Medicare will finalize a controversial proposal that will prevent providers, such as hospitals, from using third parties to deliver remote patient monitoring services, brushing away widespread opposition to the idea. However, Medicare will delay implementing the rule for two years to give providers enough time to hire and train staff to deliver the services. (I pulled the RPM section of the fee schedule here.)
  • “A common use case for RPM is using a connected blood pressure cuff to monitor a patient’s response to hypertension drugs and helping them manage the condition. Despite evidence RPM can be helpful for patients, use of the services has soared, and Medicare is worried about fraud in RPM billing.” 

• Per a Health and Human Services Department news release,
  • “Women with higher blood levels of two common per- and polyfluoroalkyl substances, also familiarly known as PFAS, were more likely to develop estrogen receptor-negative, or ER-negative, breast cancer, according to a new study by the National Institutes of Health (NIH), part of the U.S. Department of Health and Human Services (HHS). PFAS are a large group of chemicals used in common consumer products. Often referred to as “forever chemicals,” PFAS do not break down easily in the environment and can remain in the body for years.
  • “The study found that women with higher blood plasma levels of two of these substances, perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS), were associated with a higher incidence of ER-negative breast cancer. No clear association was observed between the two chemicals and breast cancer risk overall.
  • “Women deserve clear answers about how chemicals in their environment may affect their health,” said HHS Secretary Robert F. Kennedy, Jr. “This NIH study links two forever chemicals to a higher risk of ER-negative breast cancer and demands further investigation. Under President Trump’s leadership, we will pursue the evidence, confront environmental health risks, and give women the information they need to protect their health.”

From the U.S. Office of Personnel Management front,

• FedSmith advises,
  • “Protect Your FEHB Benefits: Who Qualifies, What to Verify and How to Keep Coverage.”
    • “Review your family’s FEHB eligibility before Open Season. Learn who qualifies, what documents may be required and how to avoid losing coverage for eligible family members.”

• Tammy Flanagan, writing in Govexec, suggests,
  • “Make these health coverage decisions before you retire
    • “From FEHB eligibility rules to Medicare enrollment deadlines, the right steps before your last day can protect coverage for you and your spouse.”

From the U.S. Food and Drug Administration front,

• Cardiovascular Business reports,
  • “The U.S. Food and Drug Administration (FDA) has confirmed that a safety issue with certain accessories used to implant the Sapien M3 transcatheter mitral valve replacement (TMVR) system has been ruled a Class I recall. 
  • “This is the agency’s most severe recall classification. It means using the devices in question could cause “serious adverse health consequences or death.”
  • “This Class I recall only covers four specific lots of these devices: 67718561, 67804014, 67887043 and 67887044. Delivery systems distributed as part of those four lots should not be used to treat any patients going forward. However, all other delivery systems sold with the Sapien M3 TMVR system can be used as normal. 
  • “The FDA first released information about this recall in October while the issue was still under investigation. As the agency explained at the time, four lots of the Commander M delivery systems sold with the Sapien M3 TMVR systems were being recalled due to an increased risk of the balloons bursting during inflation. Four serious injuries and one death were linked to the issue.” 

• Per an FDA news release,
  • “The U.S. Food and Drug Administration today granted accelerated approval to Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) for the treatment of adults with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) whose disease has progressed on or after platinum-based chemotherapy and immunotherapy. HNSCC is an aggressive, life-threatening disease for which there is a high unmet need for effective therapies.
  • “Rybrevant Faspro is not indicated as a treatment for patients with oropharyngeal squamous cell carcinoma that is associated with human papillomavirus (HPV). 
  • “Approval was based on trial results showing that more than double the percentage of patients responded to the drug compared to currently approved therapies. This is the first approval in 10 years of a drug for patients with recurrent or metastatic HNSCC who had received prior platinum-based chemotherapy.” 

• The Acting FDA Director writes about “Delivering Answers and Hope for Rare Disease Families.”

From the judicial front,

• Per a Human Rights Campaign news release,
  • [On November 4,] the Human Rights Campaign Foundation and the law firm Correia & Puth filed an application for a preliminary injunction in their federal lawsuit to block the Office of Personnel Management’s (OPM) prohibition on health insurance coverage for transgender medical care under the Federal Employee Health Benefits (FEHB) and Postal Service Health Benefits (PSHB) plans. Implemented this year, OPM’s mandate has subjected federal employees and their families to even higher barriers to access potentially life-saving medical care, forcing many to leave their jobs, take on heavier financial burdens or go without care altogether. As Open Season for enrollment in these healthcare plans ends on December 14, a preliminary injunction is crucial to prevent imminent harm to federal employees who need continuing gender-affirming care.”

• The Wall Street Journal reports,
  • “Elevance Health sued autism-therapy provider the Perfect Child, alleging that it paid the company $160 million due to misleading claims over the last five years.
  • “The lawsuit, filed in New York state court on Wednesday, cites a Wall Street Journal article that detailed the Perfect Child’s practices of charging insurers rates that could exceed $30,000 a day and attempting to collect directly from families when they balked at the bills, despite promises they would face little or no out-of-pocket costs.”

• Beckers Hospital Review relates,
  • “A federal judge has lifted CMS’ freeze on new ACA marketplace broker registrations, clearing the way for approximately 19,000 licensed agents and brokers to assist consumers with 2027 coverage.
  • “The U.S. District Court for the District of Maryland ruled Nov. 5 in favor of the National Association of Benefits and Insurance Professionals, which challenged the moratorium in an Oct. 15 lawsuit. The ruling immediately lifts the registration restrictions, with training for newly eligible agents and brokers set to begin Nov. 6, according to the association.
  • “CMS implemented the moratorium Sept. 22, blocking agents and brokers who had not registered with the federally facilitated Marketplace for the 2026 plan year from completing registration for 2027. The freeze was originally set to remain in effect through Feb. 1, 2027.”

From the public health and medical / Rx research front,

• Beckers Clinical Leadership reports,
  • “An infant in Wisconsin has died of measles, the state’s first measles death since 1990, the Wisconsin Department of Health Services said Nov. 5.
  • “The coroner listed measles as the immediate cause of death. The department is withholding further details to protect the family’s privacy.
  • “Any death of a child is a tragedy and even more so when it is related to a vaccine-preventable disease,” DHS Secretary Kirsten Johnson said in the news release.
  • “As of Nov. 3, Wisconsin had reported 431 measles cases in 2026, the state’s highest count in more than 35 years. Nine patients have been hospitalized with severe symptoms. The department said official counts likely understate the outbreak’s reach because not every sick person seeks care or gets tested.”

• Health Day relates,
  • “More than 6 in 10 American drivers admit they’ve driven while dangerously sleepy.
  • “A new National Sleep Foundation report estimates 145 million adults have driven drowsy, including nearly 35 million who do so at least monthly.
  • “And about 40% don’t recognize warning signs like frequent blinking, head-nodding or drifting out of their lane.
  • “Drowsy driving is responsible for 1 in 5 deadly crashes, according to data cited in the report.
  • “Every signal in this year’s report points the same way: Drowsy driving is common, it’s under-recognized and the public is ready for solutions,” said Joseph Dzierzewski, senior vice president of research and scientific affairs at the foundation. “When 4 in 10 drivers can’t identify even the most basic of warning signs, too many people don’t realize they’re impaired and shouldn’t be behind the wheel.”
  • “The researchers say drowsy driving deserves the same serious attention as drunken driving.”
• and
  • “Cutting-edge weight-loss drugs like Ozempic and Zepbound are helping people reverse prediabetes and avoid heart attack and stroke more effectively than standard diabetes medications, a new study says.
  • “People with prediabetes had 53% better odds of getting their blood sugar levels back to normal if they were taking a GLP-1 drug rather than the diabetes drug metformin, researchers are slated to report Monday at the annual meeting of the American Heart Association (AHA) in Chicago.
  • “They also were less likely to develop type 2 diabetes or suffer life-threatening heart problems on a GLP-1, researchers said.
  • “The great news with prediabetes is that it’s still possible to reverse the progression of the disease,” investigator Dr. Vinicius de Sousa Barzon Serra said in a news release. He is a research fellow in the department of cardiovascular medicine at the Mayo Clinic in Scottsdale, Arizona. 
  • “This research may add to the case for considering GLP-1 medications earlier for certain patients, rather than waiting until they develop Type 2 diabetes,” he said.”

• Healio adds,
  • “Bariatric surgery can offer long-term cancer-protective effects for people with obesity regardless of their sex or age, findings of a population-based cohort study suggest.
  • “An analysis of registry data from nearly 800,000 people showed those who underwent the procedure exhibited an overall significantly lower risk for 10 obesity-related malignancies.
  • “The magnitude of risk reduction remained consistent between younger and older adults, and analyses that focused on cancer types that affect both sexes showed comparable benefits for men and women.”
    
• MedPage Today tells us,
  • “The share of newborns who missed routine vitamin K shots rose to 6.8% in 2025.
  • “Infants who didn’t receive vitamin K shots faced a 47% higher bleeding risk in their first 6 months of life.
  • “Newborns without vitamin K shots also had doubled intracranial hemorrhage and bleeding-related death risks.”

• STAT News informs us,
  • “When statins aren’t enough, other cholesterol-lowering drugs come into play. But which one is most effective?
  • “Cardiologists looking to help their patients reduce the amount of LDL, or “bad,” cholesterol threatening to clog their coronary arteries often consider two long-approved drugs, each acting through a different mechanism delivered by a different route. A new trial based on real-world evidence pitted the injectable PCSK9 inhibitor evolocumab, sold by Amgen as Repatha, against the oral cholesterol absorption inhibitor ezetimibe, now generic but previously sold by Merck as Zetia.
  • “Repatha was the winner.” 
• and
  • “Novartis has acknowledged seven previously unknown instances in which tumors were found in children who were treated with its spinal muscular atrophy therapy, a surprising development that has raised concerns among families, physicians, and patient advocacy groups.
  • “The cases, which for the moment are being seen as only a potential safety signal, were publicized on Thursday by an advocacy group and on a Facebook page after Novartis earlier this week disclosed the information to neurologists. One advocacy group, SMA Europe, issued a statement saying that regulatory authorities are now examining the cases.
  • “The drugmaker issued its own statement saying that since its treatment — called Zolgensma — was approved in 2019, it has received nine reports of tumors in previously treated patients. Of those, two cases to date showed evidence that the tumors may be linked to the treatment itself.” 
    
• Beckers Hospital Review points out,
  • “Active U.S. drug shortages stood at 225 at the end of the third quarter, similar to the past three quarters, according to the American Society of Health-System Pharmacists. The 87 new shortages reported through September nearly equal the 89 reported for all of 2025, and chemotherapy shortages in particular have outlasted drugmakers’ resupply estimates. The FDA’s databasecontinues to reflect new discontinuations weekly.
  • [The article identifies] 11 recent shortage and discontinuation listings, according to the FDA database.”

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

• The Wall Street Journal reports,
  • “Cigna Group CI lifted its outlook and reported higher sales in the recent quarter, driven by growth in both its healthcare and pharmacy-benefit businesses.
  • “The healthcare company on Thursday reported a third-quarter profit of $1.44 billion, or $5.47 a share, compared with $1.87 billion, or $6.98 a share, a year earlier.
  • “Stripping out certain one-time items, earnings were $7.98 a share. Analysts polled by FactSet expected adjusted earnings of $7.52 a share.
  • “Total revenues climbed 5.6% to $73.68 billion, ahead of Wall Street models for $72.64 billion. The company attributed the growth to gains across both its namesake healthcare business and Evernorth Health Services.”
• and
  • “Inside CVS Health, a small group of top executives spent months engaged in a strategic review that developed into a secret plan: a decision to split up the $400 billion healthcare giant, hiving off its ubiquitous pharmacies. 
  • “It was an unlikely and radical step. The stores, with CVS’s signature red-letter logo, weren’t only how Americans thought of CVS but also the heart of its identity as a healthcare giant. Chief Executive David Joyner, a longtime veteran at the company, publicly rejected a split when he landed the top job in 2024. 
  • “This year, the C-suite’s annual planning exercise delivered a different verdict. The company should break off its drugstores from the Aetna health-insurance unit and Caremark pharmacy-benefit manager. The breakup, revealed Tuesday, will put Aetna and Caremark into one company, and the approximately 9,000 retail pharmacies into another.
  • “The logic: Its balance sheet was strong enough to support the two resulting companies, and the breakup would create more agile, focused firms. “It basically gives you confidence and strength about how each of the businesses are going to perform,” Joyner said in an interview. 
  • “The board supported the move. CVS wanted to get ahead of dynamics reshaping the healthcare market. Regulators appeared increasingly hostile to healthcare conglomerates.”

• Beckers Payer Issues adds,
  • “Oscar Health reported $167.3 million in profit for third-quarter 2026, compared to a net loss of $137.5 million in the same period last year.
  • “The company reported its third-quarter earnings Nov. 5. Oscar brought in $5.1 billion in revenue, a 72% year-over-year increase. That includes a $250 million benefit from updated risk adjustment estimates.
  • “Earnings from operations reached $178 million, up from a $129.3 million loss in the third quarter of 2025.
  • ‘The company’s medical loss ratio fell from 88.5% in third-quarter 2025 to 84%.
  • “Oscar’s membership grew about 27% year over year, nearing 2.7 million effectuated members as of Sept. 30.”

• Fierce Healthcare relates,
  • “Clover Health is continuing to see strong traction in its Medicare Advantage plan, with membership growing 49% year-over-year in the third quarter to approximately 157,000 members.
  • “Alongside continued membership growth, executives touted the company’s star ratings from the Centers for Medicare & Medicaid Services for payment year 2028.
  • “We are incredibly proud that our flagship PPO plan achieved five stars for payment year 2028, making it the largest five-star PPO contract in the country,” Andrew Toy, Clover Health CEO, said during Wednesday’s earnings call. “Additionally, our HMO plan achieved four and a half stars, meaning 100% of Clover members are enrolled in plans rated at least four and a half stars for payment year 2028.” 
  • “Toy said the ratings give Clover “continued flexibility to invest” in benefits and affordable care access for members, adding that the company’s HEDIS quality performance remains “industry leading.”

• Beckers Hospital Review tells us,
  • “Indianapolis-based Indiana University Health reported an operating income of $110 million (4% margin) in the third quarter, up from $6.4 million (0.3% margin) in the third quarter of 2025, according to its most recent financial report. 
  • “IU Health’s operating expenses were $2.6 billion for the three months ended Sept. 30, 2026, up from $2.4 billion the previous year. Total revenue was $2.7 billion in the third quarter of 2026, up from $2.4 billion in the third quarter of 2025.
  • “The system’s long-term debt was $3.3 billion as of Sept. 30, 2026.”

• Beckers ASC Review informs us,
  • “McAllen, Texas-based UT Health RGV Surgery Center has joined the ASC network of Phoenix-based Atlas Healthcare Partners, marking Atlas’ expansion into Texas, according to a Nov. 5 news release shared with Becker’s.
  • “The center is part of a new collaboration between Atlas and the University of Texas Rio Grande Valley. It has four ORs and one procedure room and offers orthopedics, gastroenterology, surgical oncology, general surgery, podiatry, gynecology and ENT.
  • “Atlas partners with nonprofit health systems, including Banner Health, Corewell Health, ChristianaCare and Prisma Health, to operate 47 ASCs across eight states. The company performs more than 110,000 procedures a year and generates about $400 million in annual revenue.”
• and
  • “Palm Harbor, Fla.-based American Vascular Associates has formed a strategic partnership with New England Endovascular Center, a West Springfield, Mass.-based provider of minimally invasive vascular and endovascular care, the organizations announced Nov. 4 in a news release shared with Becker’s.
  • “AVA is a vascular management and growth organization. It supports office-based labs and ASCs with operations, revenue cycle management, finance, IT, compliance, marketing, physician recruitment and growth strategy.
  • “NEEC was the first interventional and endovascular medical center in Western New England. It serves patients across the Pioneer Valley, the Greater Springfield region, the Berkshires and Northern Connecticut.”

• STAT News points out,
  • “The commercial debut of Revolution Medicines’ pancreatic cancer drug Rasonquewas eye-popping and jaw-dropping: $198 million in sales in just five weeks following the U.S. approval of the groundbreaking pan-RAS inhibitor. More than 5,000 patients have already been treated with the drug, the company said Wednesday evening. 
  • “The U.S. launch of Rasonque is off to a strong start,” said Revolution Chief Commercial Officer Anthony Mancini, on the company’s earnings call — perhaps the understatement of the year in commercial biotech.”

• Per Healthcare Dive,
  • “Mayo Clinic’s health tech innovation arm, Mayo Clinic Platform, has launched an artificial intelligence tool to bring patients’ medical information and relevant clinical evidence together during patient interactions, the health system said Tuesday.
  • “The solution offers clinicians specific guidance for more than 35 specialties, helping answer clinical questions, explore diagnoses and assess care options. The tool aims to reduce the time clinicians spend finding the information they need across different resources and to focus more on patient care. 
  • “The tool is available to clinicians at the Mayo Clinic and others who work for organizations that participate in Mayo Clinic Platform’s provider programs.”

• Per MedTech Dive,
  • “Study results supporting Edwards Lifesciences’ transcatheter aortic valve replacement in patients with less severe disease were a highlight of the Transcatheter Cardiovascular Therapeutics conference.
  • “Also notable were findings on Medtronic’s renal denervation system in a broader patient population and the performance of Abbott’s Amulet 360 left atrial appendage closure device one year after implant.
  • “The TCT conference, which wrapped up in San Diego this week, is the Cardiovascular Research Foundation’s annual scientific symposium.”
• and
  • “Edwards Lifesciences’ third-quarter sales exceeded its expectations, prompting the heart valve maker to raise its full-year forecast for the third time this year.
  • “Executives on Wednesday’s earnings call pointed to several catalysts for the business going forward, including data supporting expanded use of transcatheter aortic valve replacement to treat aortic stenosis.
  • “In the PROGRESS trial, presented this week at the Transcatheter Cardiovascular Therapeutics conference, Edwards’ Sapien 3 TAVR device demonstrated superiority to standard-of-care clinical surveillance in people with moderate aortic stenosis and at-risk features.”