Midweek update

OPM

Midweek update

David Ermer–Congress, FDA, Federal employment benefits, Medical / Rx research, OPM, U.S. Healthcare–

From Washington, DC

  • Roll Call reports,
    • “The House took a major step toward providing funding for immigration enforcement agencies by adopting a Senate-backed budget resolution Wednesday evening.
    • “Now that both chambers have adopted the budget blueprint, lawmakers can move forward with a filibuster-proof reconciliation bill to provide around $70 billion in immigration enforcement funding. That money is designed to sustain the Immigration and Customs Enforcement and Customs and Border Protection agencies for the remainder of President Donald Trump’s term.
    • “The vote on the GOP-written resolution was 215-211, falling strictly along party lines. Rep. Kevin Kiley of California, a Republican-turned-independent from a swing district, voted “present.”
  • The Government Accountability Office released a report today finding
    • he Federal Employees Health Benefits program is the largest employer-sponsored health insurance program in the United States. The Office of Personnel Management is responsible for managing fraud risks in the program.
    • But OPM’s process for verifying whether health care providers were eligible to provide care under the program isn’t always working. For example, our data analyses identified claims from providers who were deceased or excluded from other federal programs for certain violations.
    • Our [fifteen] recommendations would improve OPM’s process for verifying health care provider eligibility and reduce risks to the program.
  • Fedweek relates,
    • In a memo issued on April 28, 2026, Office of Personnel Management (OPM) Director Scott Kupor advised federal agencies to exclude all employees in Schedule C and Schedule G General Schedule (GS) positions from the performance appraisal requirements under Subchapter I of Chapter 43 of Title 5, including requirements for performance standards, progress reviews, and annual ratings of record.
    • “This directive simplifies personnel management for these excepted-service political appointments, which are now treated as “at-will” roles where retention and removal do not hinge on formal performance ratings. 
    • “The memo clarifies that these employees operate outside the structured appraisal frameworks that apply to most competitive-service GS employees. They are excluded due to the confidential, policy-determining, policy-making, or policy-advocating nature of their positions.
    • “This latest memo is not a surprise, as it is a step in implementing [Schedule F] policies that have already been formulated.”
  • The Hill tells us,
    • “The Trump administration is no longer allowing federal funds to be used for purchasing or distributing test strips that can determine if street drugs have been mixed or cut with fentanyl or other contaminants, a reversal that comes amid the administration’s broader opposition to harm reduction practices. 
    • “In an open letter to federal grantees, the Substance Abuse and Mental Health Services Administration said it was ending the practice, which it has championed since 2021, because the strips are “intended for use by people using drugs.” 
    • “However, the notice emphasized that federal funds can still be used for test strips to be used by public health officials, law enforcement, medical workers and others in professional settings.  
    • “Test strips cost about $1 each and can detect drugs like fentanyl or animal tranquilizers like xylazine and medetomidine. Many states have legalized test strips in an effort to slow the number of overdose deaths.” 
  • The American Hospital Association News informs us,
    • “The Agency for Healthcare Research and Quality has issued a request for nominations for candidates to serve on the U.S. Preventive Services Task Force. While all nominees will be considered, AHRQ said it encourages nominations of physician specialists in anesthesiology/pain management, cardiology, endocrinology, family medicine, gastroenterology, hematology/oncology, internal medicine, obstetrics and gynecology, pediatrics, preventive medicine and radiology, as well as experts in health economics. The agency said it will also consider applications from physicians in specialties including but not limited to surgery, laboratory medicine/molecular pathology and clinical genetics. AHRQ is also seeking wide geographic representation and experience in diverse settings, including individuals with expertise in rural medicine. Nominations must be received by AHRQ electronically by May 23 to be considered for appointment beginning in June.”
  • Bloomberg Law adds,
    • “The Trump administration is appealing a federal district court order that temporarily blocked US Health Secretary Robert F. Kennedy Jr.’s changes to the nation’s childhood vaccine schedule.
    • “The US Department of Justice filed a notice Wednesday to appeal an order issued March 16 by Judge Brian Murphy of the US District Court for the District of Massachusetts that halted decisions made by a vaccine advisory panel earlier this year to drastically reduce the number of recommended shots for kids. 
    • “The appeal to the US Court of Appeals for the First Circuit challenges the judge’s decision to temporarily block Kennedy’s appointments of 13 members to the panel, the Advisory Committee on Immunization Practices, which helps determine which vaccines are covered by insurance and provided for free for some children.
    • “The committee was scheduled to convene on March 18-19 at the US Centers for Disease Control and Prevention headquarters, but the court ruled it can’t meet and the meeting was subsequently postponed.”

From the Food and Drug Administration front,

  • The Wall Street Journal reports,
    • “The Food and Drug Administration on Wednesday released the results of a major study examining the safety of infant formula sold in the U.S., finding that most products contained low or undetectable levels of contaminants including heavy metals.
    • “The findings come amid “Operation Stork Speed,” the Trump administration’s sweeping review of U.S. infant formula ingredients. Federal officials said the results reinforce that the nation’s infant formula supply is safe, while adding that the FDA will continue additional testing as part of its continuing monitoring and oversight efforts.
    • “We tested more infant formula than ever before, and the results are clear: most products meet a high safety standard—but even small exposures matter for newborns,” Health and Human Services Secretary Robert F. Kennedy Jr. said in a statement.” * * *
    • “Although the results didn’t break down findings by specific companies, leading manufacturers welcomed the report.”
  • MedTech Dive relates,
    • “Medtronic received Food and Drug Administration approval for its next-generation mitral valve and has launched the device in the U.S., the company said Wednesday.
    • “Called Mosaic Neo, the bioprosthetic valve is designed to be implanted through sternotomy, which requires separating the breastbone to reach the heart, or through minimally invasive surgery.
    • “In addition, the first concomitant procedure was performed where the Mosaic valve was implanted alongside Medtronic’s Penditure left atrial appendage exclusion device, the company said. The Penditure clip is designed to close the left atrial appendage to help prevent clots from entering the bloodstream.”
  • Cardiovascular News informs us,
    • “The U.S. Food and Drug Administration (FDA) is warning the public about a potential safety issue with certain Relay Pro Thoracic Stent Grafts from Terumo Aortic. 
    • “These devices are used by interventional cardiologists and vascular surgeons to repair damaged or weakened sections of a patient’s thoracic aorta. However, Terumo Aortic has received multiple reports of the stent being unable to unclasp from the delivery system. When this happens, it can lead to significant risks, including death. As of April 23, in fact, three deaths have been directly linked to this issue.
    • “Difficulties in releasing the stent graft may result in delay of procedure, stent graft displacement, and an inability to release the stent graft,” according to the FDA’s warning. “This may require conversion to open surgical repair to release the clasp and can result in patient death. Please be advised that this failure mode can occur without prior warning and no device-based bailout method has been identified for this specific scenario.”
  • and
    • “Abbott has received U.S. Food and Drug Administration (FDA) clearance and CE mark approval for Ultreon 3.0, its next-generation coronary imaging platform.
    • “Ultreon 3.0, an update of the company’s Ultreon 2.0 technology, uses advanced artificial intelligence (AI) algorithms to capture and evaluate optical coherence tomography (OCT) images, delivering real-time guidance during percutaneous coronary intervention (PCI) procedures. OCT is a critical modality for the diagnosis, treatment and management of coronary disease. This platform was built to give clinicians detailed OCT images from inside the blood vessels. It then uses those images to assess the blockage being treated and make recommendations to the PCI operator on the selection and placement any stents.
    • “Ultreon 3.0 represents a pivotal step forward in how we treat and ultimately care for our patients,” Evan Shlofmitz, DO, director of interventional cardiology at St. Francis Hospital and Health Center in Roslyn, New York, said in a statement. “This next-generation platform, combining imaging and AI, doesn’t just improve upon existing technology—it leapfrogs it. By delivering greater clarity, speed, and clinical insight, Ultreon 3.0 accelerates the path to more confident clinician decision making and transformative patient care.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “Marriage is linked to a lower risk of developing cancer, recent research found.
    • “A study of more than 4 million cancer cases in the U.S. found that cancer rates were about 68% higher among men who have never married compared with those who have. For never-married women, the relationship was even more pronounced, with cancer rates roughly 83% higher, according to research published recently in the journal Cancer Research Communications.
    • “Married people tend to have greater economic stability and better support systems, and they are more likely to stick with treatment, said Paulo Pinheiro, professor of cancer epidemiology at the University of Miami School of Medicine’s Sylvester Comprehensive Cancer Center and co-author of the findings. 
    • “Previous studies have found that married people who have cancer tend to get diagnosed earlier and have better survival rates. 
    • ‘The recent study looked at data collected between 2015 and 2022 encompassing more than 100 million people aged 30 or older from across 12 states. About 20% were unmarried.” 
  • Healio informs us,
    • “A large measles outbreak in South Carolina has ended after nearly 1,000 cases.
    • “More than 8,000 measles vaccinations were administered during the outbreak, which began in October.”
  • Health Day relates,
    • “Mail-in colon cancer kits can extend easy, affordable cancer screening to low-income folks, study shows
    • “People preferred returning test kits that look for cancer-related DNA
    • “That might be because the kits had more comprehensive support from their manufacturer, researchers said.”
  • Medpage Today tells us,
    • “Over 15 years, a moderately protein-restricted diet was tied to a lower risk of starting dialysis in patients with stages 3 or 4 chronic kidney disease.
    • “Associations with a 50% eGFR decline and all-cause mortality approached, but did not achieve, statistical significance.
    • “Findings support guideline-based care while emphasizing practicality, the researchers noted.”
  • Per an Institute for Clinical and Economic Review (ICER) news release,
    • “The Institute for Clinical and Economic Review (ICER) today posted its revised Evidence Report assessing the comparative clinical effectiveness and value of oveporexton (Takeda Pharmaceutical Co., Ltd.) for narcolepsy type 1.
    • “Current treatments for narcolepsy do not address the underlying cause of the condition, and many patients report incomplete relief from narcolepsy symptoms despite multiple medications,” said ICER’s Senior Vice President of Research, Foluso Agboola, MBBS, MPH.  “ICER’s analyses found that oveporexton, the first medication for narcolepsy type 1 that directly addresses the underlying cause of the condition, is effective in promoting wakefulness, improving quality of life, and appears to offer better health benefits than current options. Pricing choices that balance innovation rewards while addressing long-term value and patient access will be important topics at the public meeting.”
    • “This Evidence Report will be reviewed at a virtual public meeting of the Midwest CEPAC on May 14, 2026. The Midwest CEPAC is one of ICER’s three independent evidence appraisal committees comprising medical evidence experts, practicing clinicians, methodologists, and leaders in patient engagement and advocacy.
    • “Register here to watch the live webcast of the virtual meeting.” * * *
    • “Oveporexton has not yet been approved by the FDA for narcolepsy type 1. The manufacturers have not yet announced a US price for the therapy if approved. ICER calculated a health benefit price benchmark (HBPB) between $50,400 and $59,400 per year.”

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

  • The Wall Street Journal reports,
    • “Humana reported lower first-quarter profit, with shares down 7.4% in premarket trading, due to lower 2026 Medicare Advantage Star Ratings.
    • “The company reiterated its full-year adjusted-earnings guidance but cut its nonadjusted earnings outlook to at least $8.36 a share.
    • “Humana incurred charges for a multiyear transformation program and faced higher medical costs, particularly from older people using services.”
  • Beckers Payer Issues relates
    • “Blue Cross NC recorded a net loss of $497.3 million in 2025, according to regulatory filings.
    • “The insurer posted a net income of $68.5 million in 2024 and $133 million in 2023.” * * *
    • ‘The company reported total assets of $7.2 billion as of year-end 2025, with capital and surplus of $3 billion. Medicaid was the company’s largest line of business by direct premiums written at $3.5 billion, followed by Medicare at $2.2 billion, the Federal Employees Health Benefits program at $1.8 billion, Medicare supplement at $397.4 million, and dental at $101.3 million.”
  • and
    • “BlueCross BlueShield of Tennessee recorded a net income of $168.4 million in 2025, a 62% decline from $446.8 million in 2024, according to regulatory filings.
    • “In its 2025 impact report, the insurer said 89 cents of every premium dollar collected last year was used to pay member claims, and medical and pharmacy claims payments have increased 25% over the past five years.
    • “The company reported total assets of $6.7 billion as of year-end 2025, with capital and surplus of $5.4 billion. Medicare was the company’s largest line of business by direct premiums written at $2.5 billion, followed by the Federal Employees Health Benefits program at $1.1 billion, dental at $172.6 million, Medicare supplement at $153.5 million, and vision at $37.4 million.”
  • Fierce Healthcare tells us,
    • “Teladoc Health reported a 2% decline in revenue in the first quarter, but the telehealth giant touted “meaningful progress” in scaling insurance coverage for its BetterHelp mental health business as a catalyst for future growth.
    • “The virtual care company reported Q1 revenue of $613.8 million compared to $629 million a year ago. Access fees revenue decreased 8% to $484.7 million.
    • “U.S. revenue dropped 6% to $491.5 million while revenue from international markets rose 17% to $122.3 million. The company’s integrated care segment revenue inched up 2% to $395.4 million and its BetterHelp segment saw revenue fall 9% to $218.4 million. Aside from access fee revenue, Teladoc Health reported “other revenue” jumped 25% to $129.2 million during the quarter.
    • “The company reported adjusted EBITDA of $58.2 million, essentially flat year-over-year, and the company narrowed its losses from a loss of $93 million in Q1 2025 to a net loss of $63.8 million, or $0.36 per share, in the most recent quarter.”
  • Beckers Hospital Review discusses “three barriers to GLP-1 adherence — and how systems are overcoming them.”
  • Health CIO informs us,
    • “Nearly 80% of provider-payer partnerships recognized in KLAS Research’s 2026 Points of Light report centered on value-based care workflows. That figure stood at 48% the year before. The shift signals that interoperability has graduated from differentiator to baseline expectation. Success in provider-payer collaboration will now hinge on whether shared data drives measurable financial and clinical outcomes.
    • “The report, released in April 2026 and produced through KLAS’s K2 Collaborative, profiles 24 award-winning partnerships. KLAS validated each through structured interviews conducted between September 2025 and February 2026. Of those 24 collaborations, 23 involved interoperability or clinical data exchange in some form. Federal mandates such as CMS-0057-F are accelerating adoption of FHIR-based APIs and HL7 Da Vinci implementation guides. As a result, payers and providers are moving toward standardized exchange that supports patient access, payer-to-payer transfers, and electronic prior authorization.”
  • BioPharma Dive points out,
    • “Teva Pharmaceutical is wagering up to $900 million on a biotechnology company built around a potential treatment for Tourette syndrome.
    • “Through an acquisition announced Wednesday, Teva will take control of privately held Emalex Biosciences and its drug ecopipam, which is in late-stage clinical testing. Ecopipam is meant to inhibit “D1,” a kind of dopamine-regulating protein that research suggests may play a role in the involuntary movements, or tics, associated with Tourette’s. The antipsychotics often used to treat this disorder target a different but related protein, D2.
    • “The companies expect their deal to close sometime between July and the end of September. Terms hold that Teva will pay $700 million up front and possibly as much as $200 million more if ecopipam hits certain commercial goals. Emalex shareholders will be eligible to receive sales-based royalties as well.”

Weekend update

David Ermer–Congress, Federal employment benefits, Medical / Rx research, OPM, U.S. Healthcare–

From Washington, DC

  • The House Ways and Means Committee will hold a hearing with health system CEOs on April 28, 2026, at 10 am ET.
  • Roll Call offers more details on this week’s activities on Capitol Hill.
  • Federal News Network interviews NARFE Staff Vice President John Hatton about OPM’s ill-advised health claims data warehouse and the Postal Service’s decision to suspend making contributions toward their employee’s retirement benefits due to its cash woes.

From the public health and medical / Rx research front,

  • Health Exec reports,
    • “The more you maintain good physical fitness from your mid-40s to your mid-60s, the likelier you are to add years to your life and life to your later years. 
    • “So conclude researchers at Texas Tech University Health Sciences Center who tracked cardiorespiratory health in around 25,000 adults from midlife through elder stages. 
    • “The team, led by Clare Meernik, PhD, MPH, assessed participants’ fitness using a treadmill test until age 65. From that point on, the researchers used Medicare data to watch for and record the onset of 11 major chronic conditions such as heart disease, diabetes, kidney disease and cancer.
    • “The Journal of the American College of Cardiology published the results April 21.”
  • The FEHBlog noted on Friday that tick bites are increasing in the U.S. The Washington Post offers relevant advice. “Experts explained what to do if you find a tick attached to your skin, including how to remove it and document it, and when to seek medical advice.”
  • Building on another FEHBlog post from Friday, the Wall Street Journal explains what heart valve patients need to know before treatment.
  • Cardiovascular Business adds,
    • “New-onset postoperative atrial fibrillation (POAF) remains the most common complication following cardiac surgery, typically developing within four days of treatment. While it often resolves on its own, POAF is also associated with longer hospitalizations, higher healthcare costs and an increased risk of poor clinical outcomes, including long-term mortality.
    • “How can care teams work to minimize a patient’s risk of developing POAF? What is the best way to manage POAF once it develops? To answer those very questions, the Society of Thoracic Surgeons (STS) gathered a committee of cardiac surgeons, cardiologists, anesthesiologists and intensivists who specialize in POAF. The group reviewed years of data, including randomized trials and contemporary treatment guidelines, and landed on a total of 15 recommendations for reducing the risk of POAF after cardiac surgery. This included eight preventive strategies, three intraoperative techniques and four postoperative treatments.
    • “The committee’s report, first presented at the STS annual meeting in New Orleans, is now published in full in The Annals of Thoracic Surgery.

From the U.S. healthcare business front

  • Health Exec kindly offers five reasons not to (solely) blame insurance companies for what ails US healthcare.
    • High health insurance premiums are largely driven by high underlying healthcare costs. 
    • Health insurers don’t raise premiums to be mean, greedy or otherwise uncaring. 
    • As a share of premium revenues, health insurers’ profit margins are generally modest.
    • Prior authorization: A necessary ‘evil’ without which things would be worse. 
    • There’s enough blame to go around. 
  • Health Exec reports,
    • “TV viewers of a certain age have a hard time avoiding commercials hawking pharmaceutical and medical products. That category is the second-most heavily advertised on TV. Only entertainment is ahead of it. 
    • “And that’s just TV. Across all media, pharmaceutical companies are spending close to $10 billion per year on direct-to-consumer advertising in the U.S., MediaRadar reports. Only the entertainment industry spends more. 
    • “This kind of drug-pushing is legal, of course. But is it good for the health status of Americans?
    • “There are two schools of thought on that question. One defends a soft yes, the other a hard no. Both get a hearing in a slice of investigative journalism from KFF Health News in partnership with The New York Times.”
  • MedCity News notes
    • “Regeneron Pharmaceuticals’ Otarmeni is now approved for treating hearing loss from an ultra-rare genetic mutation found in an estimated 50 newborns per year. While Regeneron will offer this gene therapy for free, the approval came with a rare pediatric disease priority review voucher that the company can sell for hundreds of millions of dollars.”

Thursday report

David Ermer–ACA, CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, Medicare, No Surprises Act, OPM, Patient safety, U.S. Healthcare–

From Washington, DC

  • The American Hospital Association News reports,
    • “The Senate April 23 adopted a budget resolution by a 50-48 vote, paving the way for a narrow reconciliation bill focused on immigration enforcement funding. Congressional Republicans are seeking to use the reconciliation process primarily to end the partial shutdown of the Department of Homeland Security. The resolution instructs the Senate Homeland Security and Governmental Affairs Committee, the Senate Judiciary Committee, and the House Homeland Security and Judiciary committees to write legislation by May 15 that provides up to $70 billion in funding.  
    • “The vote followed a lengthy “vote-a-rama” session overnight that consisted of multiple proposed amendments from Democrats that failed to pass. Both chambers must pass a common budget resolution to move forward with the reconciliation process. Legislative action is expected in the House as early as next week.”  
  • STAT News reports,
    • “President Donald Trump’s acting attorney general on Thursday signed an order reclassifying state-licensed medical marijuana as a less-dangerous drug, a major policy shift long sought by advocates who said cannabis should never have been treated like heroin by the federal government.
    • “The order signed by Todd Blanche does not legalize marijuana for medical or recreational use under federal law. But it does change the way it’s regulated, shifting licensed medical marijuana from Schedule I — reserved for drugs without medical use and with high potential for abuse — to the less strictly regulated Schedule III. It also gives licensed medical marijuana operators a major tax break and eases some barriers to researching cannabis.
    • “The Trump administration also said it was jump-starting the process for reclassifying marijuana more broadly, setting a hearing to begin in late June.”
  • The Wall Street Journal tells us “What to Know About the Health Risks of Marijuana.”
    • “Studies show the drug can exacerbate anxiety and teen use poses risks for developing brains.”
  • STAT News adds,
    • “President Trump heralded a drug pricing agreement with Regeneron on Thursday, closing the last of 17 deals initially sought by the White House last year.
    • “Regeneron, as part of the private deal, will reduce prices on drugs to Medicaid, provide cholesterol medicine Praluent on TrumpRx for $225, and invest $27 billion in drug development in the United States.”
  • Tammy Flanagan, writing in Govexec, lets us know,
    • “I was planning to write about the number of TSP millionaires for this week’s column — until I started getting messages from former federal employees, all who retired on September 30, 2025, and are still waiting for their retirement benefit from the Office of Personnel Management (OPM) to be finalized.
    • “It is not completely surprising that retirement processing has slowed down, and for some former employees, they continue to wait for their retirement benefits to be finalized. But for the employees who have reached out for assistance, many have not received any money since their last paycheck was received in October 2025.
    • “It has been almost six months with very little or, in some cases, no money and little communication to help them understand how long they will have to continue to wait.” * * *
    • “In my experience, retirement processing is less like flipping a switch and more like closing out a file with dozens of tabs. One missing document or unresolved question can stop forward progress.
    • “Common culprits include late or incomplete payroll certifications, missing service history, unposted deposits or redeposits for prior service, unresolved military service credit, periods of leave without pay that need to be documented, name discrepancies, incomplete beneficiary or survivor elections, or court orders that require special handling.
    • “None of these problems are rare, and when thousands of cases arrive at once, the odds go up that more people land in the exception pile.”
    • Tammy then make suggestion on steps to take.

From the Food and Drug Administration front,

  • Healthcare Dive reports,
    • “The CMS and the Food and Drug Administration have unveiled a new pathway to speed up Medicare coverage for certain breakthrough medical devices.
    • “The pathway, called the Regulatory Alignment for Predictable and Immediate Device, or RAPID, allows the two health agencies to work together, and with companies, during the device review process to speed up Medicare coverage for certain FDA-designated Class II and Class III breakthrough medical devices.
    • “The approach could enable Medicare national coverage and payment as soon as two months after a device has received market authorization, compared with approximately one year or more under the current system, according to the Thursday announcement.”
  • The Wall Street Journal relates,
    • “Children born deaf because of a rare condition can now take a drug to restore their hearing after a gene therapy was approved in the U.S., ushering in a new era for the treatment of an inherited form of hearing loss. 
    • “The Food and Drug Administration approved Regeneron Pharmaceuticals’drug Otarmeni for children born with a faulty gene that plays a role in hearing. It targets a rare condition affecting an estimated 20 to 50 newborns in the U.S. each year and could eventually be expanded to an even wider population if additional studies succeed.
    • “In my wildest dreams I never thought we’d be here in my lifetime,” said Lawrence Lustig, a hearing specialist at Columbia University Irving Medical Center who helped lead the trial.
    • “Regeneron said it would offer the drug free to people in the U.S.”
  • MedTech Dive tells us,
    • “Tandem Diabetes Care issued an urgent medical device correction for a software problem with its Mobi insulin pumps.
    • “The malfunction may cause insulin delivery to stop, causing high blood sugar if not addressed, the Food and Drug Administration said in a Wednesday recall notice. 
    • “Tandem sent a letter to customers in October notifying them of the fault and instructing them to update their pump software as soon as possible. Tandem had reported four serious injuries related to the problem as of Nov. 4.”

From the judicial front,

  • Modern Healthcare reports,
    • “The Federal Trade Commission has reached an agreement in principle with U.S. Anesthesia Partners to settle the government’s 2023 lawsuit. 
    • “The terms of the preliminary settlement are confidential so USAP can carry out the negotiations necessary to fulfill them, the FTC said in a Thursday news release.
    • “The agency in its original complaint claimed the anesthesiology group allegedly violated antitrust laws and reduced competition for anesthesia services in Texas. The preliminary settlement resolves the charges, the FTC said Thursday.” 
  • The New York Times points out “A $440,000 Breast Reduction: How Doctors Cashed In on a Consumer Protection Law.”
    • A law meant to end surprise medical billing accidentally created a multibillion-dollar industry that is making doctors richer.”
  • FEHBlog observation – This is happening. Why can’t Congress and the regulators fix the problem?

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “Novo Nordisk will seek regulatory approval for its semaglutide pill to treat Type 2 diabetes in children and adolescents after a late-stage trial showed it significantly reduced blood sugar in 10- to 17-year-olds.
    • “The once-daily semaglutide pill is currently marketed as Rybelsus in the EU and U.S. to treat diabetes in adults and will be available in the U.S. as Ozempic pill later in the second quarter. It is not currently approved for use in children or adolescents.
    • “The Danish drugmaker said Thursday that oral semaglutide has the potential to be the first oral GLP-1 to demonstrate a superior reduction in blood sugar levels compared with a placebo in children and adolescents with Type 2 diabetes, while maintaining the well-tolerated safety profile seen across other semaglutide trials.
    • “Over the past two decades, the prevalence of Type 2 diabetes among children and adolescents has increased substantially, yet treatment options for this population remain limited, underscoring a significant unmet need,” said Martin Holst Lange, Novo Nordisk’s chief scientific officer and head of research & development.”
  • MedPage Today relates,
    • “An investigational benzamide antipsychotic significantly improved symptoms in hospitalized adults with acute schizophrenia in a phase II trial.
    • “The drug, N-methyl amisulpride, is similar to its predecessor, amisulpride, but has some key differences in dosing and side effects.
    • “Because of the 4-week trial duration, long-term treatment durability wasn’t evaluated.”
  • Genetic Engineering and Biotechnology News tells us,
    • “Diabetes affects over half a billion people globally. Along with direct consequences to those with the disease, it also contributes to and predisposes affected individuals to a host of other conditions. Specifically, it is a known contributing factor in the development of vascular disease, including peripheral artery disease. While therapies exist, they are not very effective, and peripheral artery disease can lead to restricted blood flow in peripheral limbs, which sometimes leads to amputation. Understanding the mechanism driving the connection at the tissue and cellular level has the potential to improve therapy options and the development of new treatments.
    • “Normal function of the peripheral vasculature requires communication and cooperation between the vascular endothelium and macrophages. “Monocytes patrol the vascular endothelium and remove damaged cells, and intimal-resident macrophages maintain a nonthrombogenic endothelial state,” wrote the authors of a study led by Zhen Chen, PhD, at City of Hope. They explained that under stress, macrophages can modulate vascular remodeling and in certain conditions, like cancer, they “can secrete inflammatory mediators to disrupt endothelial cell tight junctions and increase endothelial cell permeability.”
    • “The team decided to explore the cellular cross-talk between macrophages and endothelial cells, as well as the resulting vascular function, to better understand the mechanisms behind peripheral artery disease induced by diabetes.
    • “They published their work in a paper titled “Diabetes-induced TREM2–endothelial cell signaling impairs ischemic vascular repair” in Science Translational Medicine.“
  • Healio tells us,
    • “Influenza vaccination continues to protect children from influenza-related outpatient visits and hospitalizations, according to post-pandemic data published in Pediatrics.
    • “We have had really severe recent seasons for flu, particularly in children,” Samantha M. Olson, MPH, an epidemiologist in the CDC’s influenza division, told Healio in an interview. “This study really adds to the growing body of evidence showing how protective flu vaccines can be for infants, children and adolescents, and this includes even the most severe outcomes.”
  • and
    • “People taking GLP-1s had reduced risk for atrial fibrillation, regardless of whether they lost weight or how much they lost, according to findings presented at Heart Rhythm 2026.
    • “We were prompted to undertake this study by some encouraging data that … GLP-1 receptor agonists seem to have a favorable effect on reducing the incidence of atrial fibrillation, particularly in patients with metabolic risk factors,” Kenneth C. Bilchick, MD, MS, professor of cardiovascular medicine at the University of Virginia School of Medicine, who presented the findings, told Healio. “I think the results were expected, but they were even better than we thought they would be.”
  • Health Day informs us,
    • For many women, a sudden sneeze or a hearty laugh bring an unwelcome consequence: A small leak of urine. 
      Often dismissed as a normal part of aging or motherhood, new research suggests the real culprit may lie deep within the abdomen.
      A study from the Federal University of São Carlos (UFSCar) in Brazil found that hidden fat stored between internal organs is a major driver of stress-induced urinary incontinence.
      The research — published recently in the European Journal of Obstetrics & Gynecology and Reproductive Biology — suggests that where a woman carries her weight matters far more than the number on the scale.
      Stress urinary incontinence occurs when everyday actions like coughing, lifting or exercising put too much pressure on the bladder, causing urine to leak.
      “It’s that urinary leakage that occurs when pressure inside the abdomen increases and the pelvic floor can’t hold it in,” Patricia Driusso said in a news release. She’s a professor of physical therapy at UFSCar.

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

  • Healthcare Dive reports,
    • “Molina benefited from better controlled Medicaid spending in the first quarter, though steeper membership losses than expected raise questions about whether the insurer can keep costs in hand for the remainder of 2026.
    • “Molina posted better-than-expected first quarter earnings on Wednesday afternoon, sending the insurer’s stock up more than 10% in Thursday morning’s trade.
    • “Yet, unlike its peers UnitedHealth and Elevance, which both raised 2026 guidance after keeping medical spending in check, Molina elected to reaffirm its outlook.
    • “Executives said retaining the current 2026 guidance is prudent given it’s early in the year and the cost environment remains challenging. Still, they hinted Molina might update the outlook after the second quarter.”
  • Fierce Healthcare relates,
    • “Elevance Health’s top brass told investors Wednesday that the insurer is on pace to end the second quarter of 2026 with about 1.2 million members in its individual market plans.
    • “CEO Gail Boudreaux said on the company’s earnings call that the company saw “moderately stronger retention” in the Affordable Care Act segment through Q1, and that it was one of the contributing factors to its better-than-expected results in the quarter.
    • “The membership growth in the individual market plans reflected a shift toward bronze tier coverage following the expiration of enhanced premium tax credits at the beginning of this year, said Chief Financial Officer Mark Kaye. Part of why this trend contributed to lower medical costs is that utilization in these plans is frequently backloaded, he said.” * * *
    • “Kaye said that the company feels good about its position in the ACA market, and the shift to bronze tier plans has been positive in certain markets. However, the company is still taking a prudent approach to forecasting around the ACA market.”
  • Beckers Hospital Review identifies “eight health systems that recently had their outlooks upgraded by Fitch Ratings or Moody’s Investors Service in 2026.”
  • MedTech Dive tells us,
    • “Boston Scientific slashed its 2026 sales growth and earnings guidance on Wednesday as key businesses are facing challenges and setbacks.
    • “The medtech company expects full-year sales growth in a range of 7% to 8.5%, down from a range of 10.5% to 11.5% given in February. Boston Scientific also lowered its adjusted earnings per share guidance from a range of $3.43 to $3.49 to a range of $3.34 to $3.41.
    • “CEO Mike Mahoney told investors on an earnings call that the lowered guidance reflects challenges in several prominent businesses, including electrophysiology and the company’s Watchman franchise.
    • “This was a guide down that we, quite frankly, are not proud of, but we think it’s the right thing to do, and best reflects the current environment,” Mahoney said.”
  • Beckers Health IT informs us,
    • “OpenAI has introduced ChatGPT for Clinicians, offering free use of the tool to all verified U.S. physicians, nurse practitioners, physician assistants and pharmacists.
    • Here are [four] things to know from an April 22 news release and past Becker’s reporting:
      • “1. The AI developer said the solution can help clinicians with tasks like documentation, writing and medical research, freeing up time for patient care.
      • “2. OpenAI has previously launched ChatGPT for Healthcare, an enterprise solution for health systems, and ChatGPT for Health, a tool for users to ask health-related questions.
      • “3. The company also debuted HealthBench Professional⁠, a benchmarking application for three use cases: care consultation, documentation and writing, and medical research.
      • “4. OpenAI said its physician advisors review the AI’s healthcare responses “every few minutes” and before releasing ChatGPT for Clinicians tested nearly 7,000 conversations in their daily work, rating 99.6% of responses as accurate and safe.”
  • Healthcare Dive adds,
    • “The American Medical Association is urging Congress to create safety guardrails for artificial chatbots in mental healthcare, as Americans increasingly turn to the technology for health information and advice. 
    • “In letters sent Wednesday to the chairs of three congressional committees on digital health and AI, the major physician lobby said “well-designed, purpose-built” tools could help patients who would otherwise struggle to access mental healthcare, but that the lack of safety protocols poses serious risks.
    • “Privacy concerns, risks of emotional dependency on AI and reports the tools could encourage self-harm signal that “immediate attention is required to ensure these tools do not inadvertently harm individuals seeking mental health support or companionship,” AMA CEO Dr. John Whyte wrote.”

Monday report

David Ermer–CMS, Congress, COVID-19 vaccine, HIPAA Privacy and Security Rules, Medical / Rx research, Medicare, Mental health care, OPM, Rx coverage, U.S. Healthcare–

From Washington, DC,

  • Tomorrow at 11 am ET, the House Appropriations Committee will consider its subcommittee’s print of the appropriations bill for financial services and general government, including the Office of Personnel Management for the fiscal year ending September 30, 2027.
  • The subcommittee’s print includes the standard appropriations provisions exempting FEHB and PSHB carriers from full Cost Accounting Standards coverage (Sec. 611) and limiting abortion coverage to cases when carrying the fetus to term would endanger the mother’s life or the pregnancy results from rape or incest (the Hyde amendment, Secs. 613, 614). The bill (Sec. 761) also states “None of the funds made available by this Act, or in any previous appropriation, may be provided for in insurance plans in the Federal Employees Health Benefits program to cover the cost of surgical procedures or puberty blockers or hormone therapy for the purpose of gender affirming care.” The bill no longer includes the contraception mandate that OPM treated as overridden by the ACA’s contraception mandate. 
  • Federal News Network reports,
    • “The Office of Personnel Management and the General Services Administration — the federal government’s human resources office and landlord, respectively — are embarking on plans to move under one roof.
    • “GSA will temporarily relocate to OPM’s headquarters, the Theodore Roosevelt Federal Building, starting in July, while GSA’s 1800 F St. headquarters goes through a renovation.
    • “In December 2028, GSA will move back into its renovated headquarters, along with OPM. Once consolidation is complete, GSA says it will initiate an “accelerated disposal” of OPM’s old headquarters building.” * * *
      “The first Trump administration proposed merging OPM and GSA into a single agency, but ultimately walked away from those plans. In addition to managing a governmentwide real estate portfolio, GSA provides contracting and IT support to other federal agencies.
    • “OPM Director Scott Kupor said there are no talks of a possible merger of the two agencies.”
  • and
    • “House and Senate Democrats are urging the Office of Personnel Management to halt its plans for collecting detailed medical data on potentially millions of enrollees in the government’s health insurance programs.
    • “Citing “significant legal, ethical and security concerns,” two recent letters sent to Trump administration officials identified potential legal violations and the possibility of targeting enrollees across the Federal Employees Health Benefits (FEHB) and Postal Service Health Benefits (PSHB) programs.
    • “The collection of broad, personally identifiable data regarding medical care and treatment raises concerns that OPM could target certain federal employees seeking vital health care services that the administration disagrees with on political grounds,” House Democrats on the Oversight and Government Reform Committee wrote in an April 17 letter, addressed to OPM and the Office of Management and Budget.
    • “This proposal is another step in the stated goal of traumatizing the federal workforce,” Senate Democrats, led by Sens. Adam Schiff (D-Calif.) and Mark Warner (D-Va.), wrote in a separate April 19 letter to OPM Director Scott Kupor. “We are deeply concerned this information will be used in employment actions, including actions related to hiring, suitability determinations, appeals, reductions in force, disability accommodation requests, labor-management relations and performance reviews.”
  • Roll Call adds,
    • “Senate Republicans plan to release their budget resolution and take a procedural vote as early as Tuesday, kicking off the cumbersome process for a reconciliation bill designed to help end the partial shutdown of the Department of Homeland Security.
    • “Senate Majority Leader John Thune, R.S.D., said Monday he hopes to confine the bill to the narrow mission of funding Immigration and Customs Enforcement and the Border Patrol. “
  • HR DIve relates,
    • “Secretary of Labor Lori Chavez-DeRemer resigned on Monday, she confirmed in a post to her official X account, ending her tenure after just over one full year leading the U.S. Department of Labor.
    • “Chavez-DeRemer’s departure followed recent reports that the agency’s inspector general had launched an investigation into her potential misconduct, including contact between her family and department staff. Similar previous inquiries reportedly led to the departure of employees including Chavez-DeRemer’s chief of staff and deputy chief of staff.
    • “Chavez-DeRemer said in her post Monday that under her watch, DOL “created new pathways to mortgage-paying jobs, prepared workers to excel in the age of AI, took steps to lower prescription drug costs, promoted retirement security, and so much more.” A White House spokesperson did not immediately respond to a request for comment.”
  • The American Hospital Association News tells us
    • “Centers for Medicare & Medicaid Services Administrator Mehmet Oz, M.D., and CMS Deputy Administrator and Director of Medicaid and CHIP Dan Brillman sat down with Bill Gassen, president and CEO of Sanford Health and AHA chair-elect, for a discussion about the changes that have occurred in CMS in the past year, as well as how they intend to move forward.  
    • Oz described the agency’s focus this year on working with insurers to reduce the need for prior authorizations. In addition, both Oz and Brillman spoke on the agency’s drive to reduce unnecessary spending; Oz estimated that 5% of CMS’ budget, or about $100 billion, is lost to fraud, waste and abuse.  
    • “Brillman spoke on the new community engagement standards that require most Medicaid recipients to perform a certain number of employment or volunteer hours to maintain their eligibility for benefits, which Brillman said provides “paths to prosperity” for beneficiaries, saying, “if we get someone a higher income so they no longer need services, that’s a win for all Americans.” 
    • “Technology, especially the use of artificial intelligence, was also acknowledged as an important advancement, with Oz saying that current technology offers “a generational opportunity to fix health care,” noting that “I do not see a way to make health care as great as it could be without AI.”  
    • “Oz spoke on last year’s Rural Health Transformation Fund, saying that the infusion of $50 billion over five years will have nationwide effects. “The learnings will accrue to urban centers,” he said. “[The fund] is creating a sandbox in rural areas, and what you learn will benefit all of you.” 

From the public health and medical / Rx research front,

  • Health Day reports,
    • “Reaching for the salt shaker could have long-lasting implications for your memory and brain health, a new study says.
    • “Higher sodium intake appears to affect episodic memory, the type of memory used to recall personal experiences and specific events from your past, researchers report in the June issue of the journal Neurobiology of Aging.
    • “This effect – which could cause one to forget anything from where they parked the car to their first day of school – occurred mainly among men, researchers found.
    • “No such associations were observed among women in the study, researchers said.”
  • The American Medical Association lets us know seven things patients should know about protein maxxing.
  • Healio relates,
    • “Prescriptions for direct-acting antivirals to treat hepatitis C virus in the U.S. have declined substantially since 2015 and remain well below the approximately 260,000 annual treatment courses needed to meet the target for elimination.
    • “Results of a national cross-sectional analysis showed annual treatment volume trending alongside HCV infection rate, rather than surpassing it.
    • “We’re roughly treating the same number of people each year as there are new infections,” Sanjay Kishore, MD, assistant professor at University of Virginia School of Medicine, told Healio. “We’re essentially just holding steady and not actually making any progress.” * * *
    • “I think we need to think creatively about using things like mobile clinics to take care of people. We need to really lean into telehealth on this issue, and we need to expand screening to places where people are getting addiction treatment. Maybe instead of a hospital, it’s a rehab facility or a syringe exchange. We need to make it easier to connect with clinicians and get treatment to meet people where they are.”
  • MedPage Today tells us,
    • “Adults whose type 2 diabetes was treated with GLP-1 receptor agonists were more than likely to develop cognitive impairment over 10 years than their counterparts not treated with GLP-1 agents, a propensity-matched retrospective study of nearly 65,000 patients suggested.”
  • and
    • “Lower hemoglobin levels were linked with higher dementia risk over 9 years of follow-up.
    • “Anemia was associated with elevated Alzheimer’s blood biomarkers including p-tau217 and neurofilament light chain.
    • “Dementia risk was highest when anemia coexisted with abnormal Alzheimer’s biomarkers.”
  • BioPharma Dive offers news from the annual meeting of the American Association for Cancer Research and informs us,
    • “An experimental autoimmune drug from Nektar Therapeutics helped people with alopecia areata who’d already responded to the treatment in a Phase 2 trial grow more hair as time went on, the company said Monday.
    • “The data released Monday measured hair regrowth after 52 weeks of treatment with the therapy, known as rezpegaldesleukin. Nektar disclosed last year that the therapy failed to show a statistically significant benefit over a placebo after 36 weeks. The company, though, blamed that result on the inclusion of four patients that shouldn’t have been eligible and said the findings supported additional development.”
  • Fierce Pharma points out,
    • “Sanofi’s protein-based vaccine Nuvaxovid has conquered Moderna’s next-generation messenger RNA shot mNexspike in a head-to-head trial assessing the tolerability of the two COVID vaccines.
    • “In the phase 4 double-blind, real-world study, which included 1,000 adult participants in the United States, Nuvaxovid showed statistically significant fewer side effects across all pre-specified endpoints.
    • “Symptomatic reactions with Nuvaxovid were both milder and shorter than with mNexspike. Additionally, less than 10% of those who received Nuvaxovid experienced severe side effects—such as fatigue, headache or fever which prevented them from conducting their daily activities—compared to 20% of those who got mNexspike. As for injection site symptoms such as pain, redness and swelling, they were more than 75% more frequent for those who received Moderna’s shot.”

From the U.S. healthcare business front,

  • ‘Per a Lockton news release,
    • “Lockton’s eighth annual survey of over 1,700 U.S. employers helps employers compare their benefit strategies with those of other employers -providing benchmark data, highlighting trends, and illuminating new ideas.
    • “As healthcare costs rise and economic pressures mount, cost is a defining reality for employers. The 2026 Lockton National Benefits Survey shows a rapid acceleration of a shift that first took hold last year – cost management decidedly the top priority vs the next ranked priority – attracting and retaining talent. The data shows how employers are searching for an answer to their need for cost containment solutions.
    • “To gain further insights into the 2026 survey findings, you can access the executive summary here.”
  • The Peterson / KFF Health System Trackers identifies recent trends in employer-based health coverage.
    • “Key takeaways include:
      • “In March 2025, 60.0% of the non-elderly, or about 165.6 million people, had employer sponsored insurance or ESI. 
      • “About four in five (80.4%) adult non-elderly workers worked for an employer that offered ESI to at least some employees, a share that has been consistent over recent years. 
      • “The share of workers eligible for ESI at their job declined slightly over the past few years, from 75.3% in March 2023 to 74.6% in March 2025. 
      • “Most eligible workers who do not take up ESI offered at work cite other coverage (63.0%) and cost (30.2%) as the reason.”  
  • Beckers Hospital Review tells us,
    • “As more care shifts outside hospital walls, health system leaders are rethinking how they plan, staff and structure their workforces to support a rapidly expanding ambulatory footprint.
    • “Outpatient services accounted for 57% of hospital revenues in 2024, up from 52% in 2020, according to the American Hospital Association. The AHA’s Sg2 forecasting model projects outpatient volumes will grow another 17% over the next decade. At the same time, many health systems are accelerating ambulatory investments in 2026 to support financial sustainability and expand access closer to home.”
  • MedCity News notes that “Expanding the CJR Model Is a Logical Step in Value Based Care, but Implementation Challenges Remain.”
    • “CMS is proposing to make its joint replacement bundled payment model mandatory nationwide. Experts say it is a logical step, but warn that mandatory participation could be challenging for hospitals to implement.”
  • Healthcare Dive relates,
    • “Physician burnout continues to decline across the U.S., a bright spot for an occupation plagued by heavy workloads, pervasive stress and high stakes. But the improvement is not equal across medical specialties, according to new data from the American Medical Association.
    • “The AMA surveyed thousands of physicians and found that 41.9% reported experiencing a burnout symptom in 2025, down from 43.2% in 2024 and 48.2% in 2023. The decline likely reflects employer efforts to reduce burnout, including by increasing job satisfaction, the medical association said.
    • “However, burnout rates vary significantly across specialties, and tend to be higher among doctors employed by hospitals, suggesting health systems could be doing more to ameliorate the phenomenon.”
  • Fierce Healthcare informs us,
    • “UnitedHealthcare is building on its work to support rural hospitals and will now exempt these facilities from most prior authorizations.
    • “The insurance giant said in an announcement on Monday that the shift will apply across all lines of business. In addition, UHC will accelerate payments by up to 50% for about 1,500 rural hospitals and all critical access hospitals across the country.”
  • and
    • “Just over two years ago, Highmark joined forces with Spring Health to launch a new mental well-being platform that made it far easier for members to access critical services.
    • “Now, the partners are offering a look at how that program has worked for members. In a paper published last month, researchers at Highmark reported that patients waited less than two days on average in 2025 to access an appointment.
    • “Spring’s platform is embedded directly into Highmark’s member app, and that integration was a key part of what made the program work, according to the analysis. Members can easily find mental well-being tools and complete a self-assessment upon connecting for the first time, which allows Spring to build a personalized approach.”
  • The Wall Street Journal points out,
    • “Eli Lilly struck a deal to acquire Kelonia Therapeutics for $3.25 billion upfront and up to $7 billion if certain milestones are reached. 
    • “Kelonia is developing a next-generation CAR-T therapy for multiple myeloma, which promises to transform treatment without chemotherapy.
    • “The acquisition positions Eli Lilly to enter a lucrative segment of the global cancer-drug market and bolster its cancer offerings.”
  • MedTech Dive adds,
    • “Medtronic said Monday it has closed the acquisition of CathWorks, a deal worth $585 million with potential undisclosed earn-out payments.
    • “The transaction, agreed to in February, continues a strategy of increasing acquisitions to strengthen the company’s leadership in its core businesses, Medtronic said.
    • “CathWorks’ FFRangio system uses artificial intelligence and computational science to assess the entire coronary tree from routine angiograms that image the blood vessels.”

Midweek update

David Ermer–ACA, CMS, FDA, HIPAA Privacy and Security Rules, Medical / Rx research, Mental health care, OPM, U.S. Healthcare–

From Washington, DC,

  • OPM Director Scott Kupor added another post to his excellent Secrets of OPM blog today. This one is titled “Simplicity is a Virtue.” In the FEHBlog’s opinion, OPM should focus on simplifying its administration of the FEHB and PSHB programs.
  • The FEHBlog noticed on the following rulemakings currently under Office of Management and Budget review:
  • The FEHBlog is concerned about the OPM rule because OPM has not implemented the HIPAA 820 electronic enrollment roster transaction that would allow carriers to reconcile individual enrollees with their premiums. What is the sense of having a pristine family member list without knowing whether the enrollee is paying the correct premium. The HIPAA 820 also would give carriers earlier notice about enrollees who have left federal employment and annuitants who have passed away.
  • Per an HHS news release,
    • “The U.S. Department of Health and Human Services (HHS) today announced the 2026 KidneyX EMPOWER Prize Challenge, a $4 million national competition to accelerate innovation supporting living kidney donors and patients who depend on them. To further enhance nephrology care, HHS will also support data standardization and health information technology improvements across the kidney care ecosystem. The challenge will be run through the Kidney Innovation Accelerator (KidneyX).”
  • The Wall Street Journal reports,
    • “One in seven people who signed up for Affordable Care Act plans this year failed to pay after premium costs rose sharply, according to an analysis that provides the first comprehensive look at the impact of expiring federal subsidies. 
    • “Nationally, around 14% of those who enrolled in ACA plans this year didn’t pay their first monthly bill for January coverage. In some states, the share was a quarter or more, according to a new analysis from the actuarial firm Wakely Consulting Group, provided exclusively to The Wall Street Journal.
    • “It’s a big drop,” said Michelle Anderson, a Wakely consulting actuary. 
    • “Normally, the rate of falloff in ACA plan membership early in the year is in the midsingle-digit range.”

From the Food and Drug Administration front,

  • The Washington Post reports,
    • “The Food and Drug Administration is taking the first step toward potentially allowing compounding pharmacies to produce seven peptides that are currently restricted because of the agency’s previous warning over safety concerns.
    • “The agency’s expert advisory panel on pharmacy compounding is scheduled to discuss whether the peptides should be used in compounding for purposes for ulcerative colitis, wound healing, inflammatory conditions, obesity, insomnia and more, according to a Federal Register notice posted Wednesday announcing a late-July meeting.”

From the judicial front,

  • Bloomberg Law reports,
    • “A federal appeals court vacated an order rejecting a request to block a Maryland drug discount law, remanding the decision for review, in a victory for AbbVie Inc., Novartis AG, AstraZeneca Plc, and PhRMA.
    • “The US Court of Appeals for the Fourth Circuit ruled that a lower court “erred” when it denied the drugmakers’ motion for a preliminary injunction against Maryland’s H.B. 1056.
    • “The decision was driven by a recent order from the Fourth Circuit that upheld a block on West Virginia’s version of the contract pharmacy law, with the majority opinion stating that “West Virginia passed a materially similar statute, which this Court recently held is likely preempted”.

From the public health and medical / Rx research front,

  • The New York Times reports,
    • “Many scientists have contended that humans have evolved very little over the past 10,000 years.
    • A few hundred generations was just a blink of the evolutionary eye, it seemed. Besides, our cultural evolution — our technology, agriculture and the rest — must have overwhelmed our biological evolution by now.
    • “A vast study, published on Wednesday in the journal Nature, suggests the opposite. Examining DNA from 15,836 ancient human remains, scientists found 479 genetic variants that appeared to have been favored by natural selection in just the past 10,000 years.
    • “The researchers also concluded that thousands of additional genetic variants have probably experienced natural selection. Before the new study, scientists had identified only a few dozen variants.
    • “There are so many of them that it’s hard to wrap one’s mind around them,” said David Reich, a geneticist at Harvard Medical School and an author of the new study.” * * *
    • “Nandita Garud, a geneticist at the University of California, Los Angeles, who was not involved in the new study, said that unearthing natural selection over the past 10,000 years could do more than just illuminate our deep history.
    • “Scientists still don’t know much about how genetic variations influence our health. When they find a link between a genetic variant and a disease, Dr. Garud said, it will be important to see whether it has been favored by natural selection.
    • “That might give you a clue that this is important,” she said.”
  • The Wall Street Journal relates,
    • “Vertigo and dizziness, often caused by dislodged inner-ear crystals (BPPV), are common age-related problems increasing fall risk.
    • “Emergency-room visits for vertigo commonly result in unnecessary diagnostic tests and sedative medications, potentially worsening patient outcomes.
    • “Researchers are investigating links between BPPV and migraines, low vitamin D, and osteoporosis, while developing new rehabilitation treatments.”
  • Fierce Healthcare tells us,
    • “Behavioral health utilization increased substantially from 2018 to 2024, with anxiety disorder care fueling much of that growth, according to Trilliant Health. 
    • “The health data analytics and market research firm’s latest report outlines a 62.6% jump in behavioral health utilization, based on any visit associated with a behavioral health diagnosis code.
    • “Between 2008 and 2024, the prevalence of mental illness increased by almost 6 percentage points. About a quarter of adults had any mental illness in 2024, Trilliant found, though in adults 18-25 exhibit the highest prevalence both in terms of any mental illness (33%) and serious mental illness (16%). 
    • “Anxiety disorders accounted for the highest visit volume and experienced the fastest growth, up 89% from 2018 to 2024. Anxiety disorders in women aged 18-44 were also the highest utilization category in 2024. 
    • “It’s possible those figures are increasing because more screening is happening, acknowledged Trilliant Health Chief Research Officer Allison Oakes, Ph.D.”
  • Medscape adds,
    • “Utah’s pilot program using AI for psychiatric medication refills raises safety and compliance concerns. Critics argue it lacks transparency, proper research, and may violate FDA laws, emphasizing the need for licensed physician oversight.”
  • Genetic Engineering and Biotechnology News informs us,
    • “Studying mice, researchers at Toronto’s Sinai Health have found that semaglutide—the active ingredient in popular weight loss drugs that mimic the gut hormone GLP-1—acts directly on a subset of liver cells to improve organ function, and does so independently of weight loss. The finding challenges long-held assumptions about how GLP-1 medicines work in the liver and could reshape how physicians treat metabolic liver disease.
    • “Headed by Daniel Drucker, MD, a senior investigator at the Lunenfeld-Tanenbaum Research Institute, the team reported on their findings in Cell Metabolism, in a paper titled “The weight-loss-independent hepatoprotective benefits of semaglutide are orchestrated by intrahepatic sinusoidal endothelial GLP-1 receptors.”\
  • Per Multiple Sclerosis News,
    • “People with diabetes are significantly more likely — with nearly 60% higher odds — to develop multiple sclerosis (MS) than those without the metabolic disease, which is marked by high blood sugar levels, according to a new systematic review and meta-analysis.
    • “A significant association was also observed specifically between type 2 diabetes, the most common form of the condition, and MS risk.
    • “The analysis did not, however, find clear evidence that MS increases the likelihood of developing diabetes.
    • “Current evidence indicates that [diabetes mellitus], specifically [type 2 diabetes], increases the risk of developing MS,” the researchers wrote. “However, a reverse association remains unconfirmed.”
  • Per MedPage Today,
    • “Primary care patients educated about Alzheimer’s disease blood-based biomarkers were generally willing to undergo tests and supported their use, survey data showed.
    • “After patients received a brief explanation of Alzheimer’s blood tests, 94.5% supported offering them to patients with memory complaints, and 85% said they were willing to complete a test if their clinician recommended it, reported Andrea Russell, PhD, of Northwestern University Feinberg School of Medicine in Chicago, and co-authors.
    • “Patients endorsed Alzheimer’s blood tests when they informed medical care (94.2%), were covered by insurance (93.4%), if comprehensive education was received prior to testing (88.5%), and if testing was easy or convenient (88.1%), Russell and colleagues wrote in Alzheimer’s & Dementiaopens in a new tab or window.”
  • Healio adds,
    • “High vitamin D levels in mid-life were associated with lower levels of tau protein in the brain more than a decade later, suggesting a possible modifiable risk factor for Alzheimer’s disease, according to findings in Neurology Open Access.
    • “Previously, it was known that low circulating vitamin D in later life is associated with an increased risk of cognitive impairment and clinical dementia,” Martin D. Mulligan, MBBCh, BAO, a researcher at the University of Galway in Ireland, told Healio.
    • “Most prior studies evaluating the association between vitamin D and cognitive function typically measured circulating vitamin D in older adults,” he continued. What our study adds is a focus on early mid-life.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “The increasing cost of medical care is driving more workers to forgo needed care or stop taking medications, ADP found in a recently released employee benefits survey. 
    • “Twenty-six percent of respondents said they’d skipped needed medical care for themselves or a family member due to out-of-pocket costs (compared to 21% in 2020), 22% have stopped taking or taken less medication (compared to 17% in 2020), and 15% declined vision or dental insurance so they could afford medical insurance. 
    • “The finding “points to the need for simpler plan design, clearer education and flexible options that reflect different budget preferences,” ADP observed. “Employers can play a stronger role in helping employees make cost-conscious choices without compromising care.”
  • Fierce Healthcare relates,
    • “Average physician pay rose about 3% between 2024 and 2025, from $374,000 to $386,000—outpacing the 2.7% U.S. core inflation rate that rounded out the year, a new annual report from Medscape found.
    • “Medscape’s 2026 Physician Compensation Report surveyed 5,916 physicians across more than 29 specialties. Total compensation numbers reflect base salary and incentive bonuses, plus other income sources like profit-sharing contributions, as reported by full-time physicians.
    • “Matthew Wells, Ph.D, a senior director at AGMA Consulting, called 2025 a “return to normalization” for physician compensation in the report and expects “consistency with increases” in the future. Driving factors cited by Wells include physician productivity in seeing more patients and improved technology-driven efficiency. 
    • “Fifty-three percent of all physicians report feeling fairly compensated, as opposed to last year’s report in which only 48% reported fair compensation—what the report notes was the “most dispirited response” it had seen in a decade of posing the question.” 
  • Beckers Hospital Review offers a non-exhaustive list of “32 health systems with strong operational metrics and solid financial positions, according to reports from credit rating agencies Fitch Ratings and Moody’s Investors Service released in 2026.”
  • and lets us know,
    • “The Illinois Health Facilities and Services Review Board approved Ontario, Calif.-based Prime Healthcare’s acquisition of Franciscan Health Olympia Fields (Ill.). 
    • “The 214-bed hospital is expected to transition to Prime on May 1, according to an April 14 news release shared with Becker’s. 
    • “Prime Healthcare entered an agreement in January to acquire the hospital and and Specialty Physicians of Illinois from Mishawaka, Ind.-based Franciscan Alliance. Prime said it plans to offer jobs to “substantially all employees” at Olympia Fields. 
    • “Olympia Fields is set to become Prime’s ninth Illinois hospital and 55th overall. In March 2025, the health system acquired eight Illinois facilities from St. Louis-based Ascension. Prime said that in the first year of ownership, it invested more than $104 million in the eight hospitals to enhance clinical care and operations, modernize infrastructure and expand service lines.” 
  • BioPharma Dive informs us,
    • “Beeline Medicines emerged from stealth Wednesday with plans to develop “precision therapies” for immune diseases, nearly a year after its backer Bain Capital teamed up with Bristol Myers Squibb to give five of the pharma’s experimental medicines a new home.
    • “Beeline’s pipeline is led by the licensed drug afimetoran, a daily oral treatment for systemic lupus erythematosus, a form of lupus, that targets a pair of receptor proteins which are responsible for regulating the immune system. At Bristol Myers, the drug had already been tested in a Phase 1b trial in a different form of lupus. A Phase 2 study is underway and is expected to be completed in the second half of this year, after which Beeline plans to launch “a pivotal development program.”
  • MedTech Dive adds,
    • “Avanos Medical has accepted a $1.27 billion go-private offer from American Industrial Partners, the company said Tuesday. 
    • “AIP agreed to pay a 72.1% premium to Avanos’ closing stock price on Monday. Avanos CEO Dave Pacitti told customers that AIP will back his company to strengthen its competitive position.  
    • “Avanos competes with businesses including Boston Scientific and Cook Medical for the specialty nutrition market, and rivals such as Medtronic and Stryker in the pain management space.”

Tuesday report

David Ermer–CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, Medicare, No Surprises Act, OPM, Telehealth, U.S. Healthcare–

From Washington, DC,

  • Fierce Healthcare reports,
    • “A prominent physician voice in the House of Representatives has introduced a new bill that would compel insurers to apply the cost for drugs purchased from direct-to-consumer platforms to deductibles and out-of-pocket maximums.
    • “North Carolina Republican Greg Murphy, M.D., on Tuesday unveiled the Every Dollar Counts Act, a bill that aims to lower patients’ out-of-pocket costs for pharmaceuticals. Murphy, a consistent critic of insurers and pharmacy benefit managers, notes in an announcement that consumers have increasingly embraced DTC offerings as costs rise.
    • “Using these platforms, patients can often find prices that cost far less out-of-pocket, especially for branded drugs, per Murphy’s office.”
  • The American Hospital Association News adds,
    • “The AHA and dozens of other organizations April 14 sent a letter of support to Reps. Suzan DelBene, D-Wash., and Mike Kelly, R-Pa., for their introduction of the Chronic Care Management Improvement Act. The bill would waive beneficiary cost-sharing requirements for Medicare beneficiaries receiving chronic care management services. Beneficiaries are currently required to pay a 20% coinsurance fee to receive such services. “This cost-sharing requirement creates a barrier to care, as beneficiaries are being billed for services that do not always include interfacing with their provider, thus creating confusion for patients,” the organizations wrote. “Also, many of these beneficiaries consider any additional out-of-pocket expense for healthcare services untenable.”
  • CMS has posted MMSEA Section 111 GHP User Guide Version 7.8 – April 13, 2026 (PDF)
    • “The GHP User Guide * * * is your primary source for Section 111 GHP reporting requirements.”
  • OPM Director Scott Kupor has added a new post titled “Merit Matters” to his Secrets of OPM blog.
    • “If we want the best talent in the federal government – which I think we do – we should not refuse to hire college dropouts, unless dropping out of college is somehow representative of their ability to work successfully on behalf of the American people. And, if they are in fact world-class engineers, then we should pay them at the level at which they are performing versus force-fitting them into a lower pay level because they have no prior work experience.
    • “Once again, merit matters.”
  • Per an OPM news release,
    • “US Office of Personnel Management (OPM) Director Scott Kupor joined Fox News’ Saturday in America with host Kayleigh McEnany to highlight the launch of EarlyCareers.gov, a new initiative to recruit more early career Americans into federal service and strengthen the government’s talent pipeline.”

From the Food and Drug Administration front,

  • Fierce Pharma reports,
    • “Even as Eli Lilly gets underway with its next major obesity launch in Foundayo, an FDA document related to the oral treatment shows lingering reservations about multiple “unexpected serious” risks potentially related to the drug.
    • “In the FDA’s approval letter (PDF) for GLP-1 pill Foundayo, the agency tasks Eli Lilly with obtaining more information about the med’s potential link to major adverse cardiovascular events and drug-induced liver injury. In addition, the agency wants to gain more info about delayed gastric emptying associated with the drug and its potential effects in lactating women.
    • “In its assessment of the medicine’s data, the FDA “determined that only a clinical trial (rather than a nonclinical or observational study) will be sufficient to assess a signal of a serious risk of retained gastric contents and to identify an unexpected serious risk for major adverse cardiovascular events (MACE), drug-induced liver injury (DILI), and exposure to [Foundayo] during lactation,” the letter says.”
  • STAT News adds,
    • “In a bid toward greater transparency, the Food and Drug Administration sent reminder letters to more than 2,200 companies and researchers that they are required to report clinical trial results to a federal government database or they may face fines.
    • “FDA officials disclosed that an internal analysis found results were not submitted for nearly 30% of studies that were “highly likely” to fall under mandatory reporting requirements. The agency also noted that the letters were sent to companies and researchers associated with more than 3,000 registered trials, some of which were publicly funded.
    • “In explaining its move, the regulator acknowledged a long-standing complaint from researchers who have argued that without access to specific data, trial results cannot be easily duplicated, and this inhibits greater understanding of how medicines might work. They also contend this can adversely affect treatment decisions and health care costs.”
  • MedTech Dive relates,
    • “Medline is removing certain angiographic syringes from the market due to problems with the devices becoming loose or disconnected.
    • “Medline began the recall in February, and it was posted to the Food and Drug Administration’s website last week. The problem was the subject of a warning letter that Medline received in March, also recently posted to the FDA’s website.” 
  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today issued a draft guidance for sponsors seeking approval of human gene therapy products involving genome editing technologies. When finalized, this guidance will provide recommendations for standardized methods for comprehensively assessing the safety of genome editing therapies to bring effective treatments to patients sooner.
    • “Genome editing holds extraordinary promise for treating previously incurable genetic diseases, and today’s announcement represents the FDA’s forward approach to drive innovation and advance the development of genome editing therapies,” said FDA Commissioner Marty Makary, M.D., M.P.H. “This guidance provides sponsors with clear, scientifically-grounded recommendations for evaluating off-target editing risks using state-of-the-art sequencing technologies. We are serious about moving this ball forward.”  
    • “The draft guidance, issued by the Center for Biologics Evaluation and Research, supports the FDA’s framework for accelerating development of individualized therapies for ultra-rare diseases launched in February. The framework revolutionizes how the FDA engages with industry and promotes a path for transformative rare disease treatments.
    • “The “Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing” guidance provides specific recommendations on sequencing strategies, sample selection, analysis parameters, and reporting.”

From the judicial front,

  • Healthcare Dive reports,
    • “A federal [magistrate] judge has tossed an Elevance subsidiary’s lawsuit against billing intermediary HaloMD and several California-based providers alleging they’re abusing the out-of-network billing dispute process set up by the No Surprises Act.
    • “[Magistrate] Judge Karen Scott of the Central District of California dismissed the suit on Monday, finding that Anthem Blue Cross, Elevance’s California subsidiary, failed to prove that the companies were gaming the law’s independent dispute resolution, or IDR, in order to inflate their reimbursement.
    • “It’s a major win for HaloMD, which is facing similar lawsuits from Elevance in three other states and has found itself in hot water over its status as the No. 1 submitter of IDR disputes. The Texas-based company cheered the court’s decision, while Elevance said it plans to appeal.”
    • Yesterday, Anthem Blue Cross did appeal the court’s decision to the U.S. Court of Appeals for the Ninth Circuit.
  • Bloomberg Law reports,
    • “A Delaware judge threw out lawsuits seeking to link the heartburn drug Zantac to cancer, freeing makers of the product from facing trials in the state over the cases.
    • “Superior Court Judge Francis “Pete” Jones concluded Monday lawyers for ex-Zantac users couldn’t produce legitimate evidence backing up claims the over-the-counter product caused cancer. Zantac is currently made by French drugmaker Sanofi.” * * *
    • Because former Zantac owners GSK Plc, Pfizer Inc., Sanofi and Boehringer Ingelheim Pharmaceuticals already have settled thousands of Zantac suits over the last several years, it’s unclear how many Delaware cases will be dismissed by Jones’ order. GSK paid more than $2 billion in 2024 to resolve what it said was more than 90% of its pending cases.

From the public health and medical / Rx research front,

  • Fierce Healthcare reports,
    • “Seven in 10 U.S. adults gamble, according to a survey from the National Council on Problem Gambling (NCPG). Commercial gaming revenue broke records at $78.7 billion in 2025, with over $18 billion in tax revenue going into state and local coffers. All gaming segments, from casinos to sports betting to online games (iGaming), are growing. Throw in prediction markets, which allow users to speculate on the outcome of real-world events but are not legally considered gambling platforms, and the betting buffet becomes basically limitless. 
    • “This menu of options is creating an addiction crisis yet to be widely recognized by the public, policymakers and the healthcare sector, experts caution. Current national problem gambling prevalence is unknown due to a lack of research and funding dedicated to the issue. States that measure and publish their own prevalence rates see anywhere from 1% to 6%. Those most at risk include young adults, men and online gamblers. Gambling-related harms can be dire, from financial stress to co-occurring behavioral health conditions to suicide, which a fifth of individuals with gambling addiction attempt.
    • “To understand problem gambling, what’s driving it and efforts underway to address it, Fierce Healthcare talked to two dozen providers, researchers, advocates and regulators. This story is also based on a review of research, as well as exclusive data from Komodo Health analyzed on Fierce Healthcare’s behalf.
    • “It’s a small but mighty group of us that have been in this field, treating,” said Jody Bechtold, L.C.S.W., president of the International Problem Gambling and Gaming Certification Organization (IPGGC). “We call it the next opioid epidemic.” 
  • Healio tells us,
    • “The risk for subsequent fractures is similar for older adults, regardless of whether they had an initial major osteoporotic fracture or nonmajor osteoporotic fracture, researchers reported.
    • “In findings published in Journal of Bone and Mineral Research, researchers found that sustaining a major or nonmajor osteoporotic fracture raises the risk for subsequent fractures and mortality.”
  • Infectious Disease Advisor informs us,
    • “Rhinovirus and enterovirus are associated with severe clinical outcomes among hospitalized patients, including mechanical ventilation and death, highlighting the need for expanded respiratory virus surveillance among high-risk patient populations.”
  • MedPage Today points out,
    • “A dual deprescribing intervention for proton pump inhibitors (PPIs) targeting patients and their primary care doctors proved effective in reducing potentially inappropriate use, a cluster-randomized trial in France found.
    • “At 1 year, the combined approach — where patients got educational material about reducing PPI use mailed to them and their physicians received a letter detailing a deprescribing algorithm — resulted in twice as many patients cutting their PPI use in half (14.9%) versus usual care (7%) or physician-targeted intervention alone (7.7%, P<0.001 for both).
    • “The results underscore “the value of prioritizing patient-facing deprescribing strategies,” wrote researchers led by Jean-Pascal Fournier, MD, PhD, of Nantes Université in France, in JAMA Internal Medicineopens in a new tab or window. Furthermore, the interventions were not associated with a resurgence in gastroesophageal reflux disease (GERD) symptoms.
    • “PPIs in the U.S. are frequently prescribed for inappropriate indications and sometimes prescribed indefinitely, according to Fournier and colleagues.” * * * Potentially unnecessary PPI spending — reimbursements in 2015 hit $12 billion in the U.S.

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

  • Modern Healthcare reports,
    • “The Purchaser Business Group on Health, which represents large companies, launched a project to combine federally required data with claims data culled from its biggest members to provide insight into costs and quality in employer-sponsored health plans.
    • “This has the potential to supply employers with unprecedented access to healthcare pricing data that could help curb escalating employee health benefit costs, said Purchaser Business Group on Health President and CEO Elizabeth Mitchell.
    • “There is employer demand for this information that is unmet in the market,” Mitchell said during a Purchaser Business Group on Health webinar on healthcare transparency in February.
    • “The Purchaser Business Group on Health has found that normal market forces that should be expected to link prices to quality don’t function in healthcare. Prices often fluctuate wildly based more on the size and market power of health systems or insurers than on the quality of services rendered.
    • “For instance, its data reveal prices at hospitals in the same markets do not correlate with scores from the Leapfrog Group, which assesses hospital quality and safety. Often, low-rated hospitals charge more. Or the same hospital charges vastly different prices for the same procedures depending on the insurance plans, not any differences in the service.” 
  • and
    • “Health systems are increasing their investments in concierge medicine to meet patient demand and keep burned-out doctors practicing.
    • “Though typically a small percentage of a health system’s operations, concierge medicine — where patients pay thousands of dollars in membership fees for increased access to primary care physicians — helps diversify revenue and creates growth opportunities in new and existing markets.
    • “Still, it’s a controversial model that raises questions about equal access to care because it historically has appealed to wealthier, often older individuals looking for more personalized primary care. Health systems say patient demand has expanded beyond that demographic.”
  • Fierce Healthcare relates,
    • “Anthem and Mount Sinai have reached a new multi-year contract agreement, restoring coverage for thousands after the system went out-of-network last month.
    • “Anthem Blue Cross and Blue Shield of New York said in a statement Monday that the three-year deal returns Mount Sinai’s hospitals, physicians and other providers to its network. The health plan said that the contract “reflects both organizations’ commitment to delivering quality care while helping control healthcare costs for New York workers, families, employers and taxpayers.”
    • “The contract also includes updated reimbursement models that aim to reward quality and outcomes, while continuing to support accurate billing and payment.”
  • The Wall Street Journal lets us know ,
    • Healthcare giant Johnson & Johnson JNJ reported nearly 10% revenue growth for the latest quarter on strong cancer drug sales that offset a steep decline from one of its bestselling drugs, Stelara.
    • J&J said its first-quarter sales rose to $24.06 billion, topping the mean estimate of $23.62 billion from analysts surveyed by FactSet. Adjusted quarterly earnings also beat Wall Street expectations.
    • On the back of those results, the drug and medical-device maker boosted its full-year financial forecast. So far, disruptions from the war in Iran haven’t materially hurt J&J.
    • “There’s a lot of macro uncertainty out there,” J&J Chief Financial Officer Joseph Wolk said in an interview. “We think the fact that we’re not only maintaining but raising” the forecast is a sign of the company’s strength, he added.
    • J&J has been working to ensure consistent growth after losing patent protection for Stelara, a treatment for skin and digestive conditions. Competitors introduced lower-cost alternatives last year, leading to a 60% drop in first-quarter sales of the brand-name version of the drug.
    • Strong sales of J&J cancer medications like multiple-myeloma treatment Darzalex helped make up for those declines. The company’s cancer-drug sales rose more than 22% for the quarter. J&J is in a stronger position than some of its peers, which face even bigger patent cliffs in coming years.
  • BioPharma Dive tells us,
    • “Eli Lilly is again turning to dealmaking to boost its oncology portfolio, reaching a deal Tuesday to acquire a biotechnology company, CrossBridge Bio, that’s developing newer types of targeted cancer medicines.
    • “Lilly will pay up to $300 million in cash for CrossBridge, a Houston-based startup making antibody-drug conjugates for cancer. That total includes an unspecified upfront payout and subsequent payment tied to a development milestone, CrossBridge said in a statement.
    • “The deal hands Lilly technological capabilities that have become increasingly desirable to major pharmaceutical firms. Antibody-drug conjugates, or ADCs, are now a pillar of cancer care, a method of precisely delivering a toxic blow to malignant cells. Over 20 ADCs are currently available to treat tumors of the breast, lung, bladder and more. Many are working their way into earlier treatment lines, in some cases supplanting decades-old chemotherapy approaches.”
  • MobiHealth informs us,
    • “New York-based virtual women’s health provider Maven Clinic announced a strategic collaboration with care concierge company Wellthy to combine clinical care and caregiving support for employees.
    • “Maven Clinic is a digital reproductive health and family platform that offers fertility and family planning services, pregnancy and postpartum care, parenting and pediatric support, and menopause-related care.
    • ‘Wellthy offers a care concierge service that connects employees with care teams to help them navigate the healthcare system, including finding in-home support, understanding benefits, accessing legal resources and obtaining financial assistance.
    • “The company also offers Backup Care services to help employees find emergency care for family members, including daycares, on-site childcare facilities and other community-based programs.    
    • “The aim of Maven and Wellthy’s partnership is to help employees in the “sandwich generation, – those in the period of starting a family and caring for an older loved one – navigate the process from fertility, growing a family and overseeing eldercare.
    • “This partnership is about building a system that reflects how people live, with clinical care and caregiving support together in one place. When technology makes that support intuitive, you don’t just improve outcomes – you make it possible for people to ask for help in the first place,” Kate Ryder, founder and CEO of Maven Clinic, said in a statement.”
  • The Wall Street Journal informs us,
    • “Novo Nordisk NOVO.B said it would work with ChatGPT maker OpenAI on how to leverage artificial intelligence to discover new drugs, the latest AI partnership in the medical field as healthcare companies seek to harness the technology to get ahead of the competition.
    • “The Danish drugmaker said it would integrate OpenAI’s models across its operations to help its workforce analyze complex datasets and reduce the time it takes to move from research to delivering treatments to patients.
    • “The group said the partnership would boost efficiency across manufacturing, distribution, the supply chain and corporate, with pilot programs initially launching in research and development, manufacturing and commercial operations ahead of a full AI integration by the end of the year.” * * *
    • “Drugmakers are turning to AI companies and their increasingly powerful models to improve operations and cut repetitive tasks for employees, giving them more time to focus on R&D in a bet that advancements in the technology will help them identify promising new drugs and treatments.”
  • Modern Healthcare adds,
    • “Health systems and payers are making big investments in artificial intelligence to improve their operations by reducing administrative burden, beefing up clinical prediction capabilities and increasing access to care. 
    • “A case in point: This year alone, UnitedHealth Group is investing $1.6 billion into its AI efforts. Companies also are realigning executive roles by adding chief AI officers or adding AI responsibilities to C-suite executives overseeing data and innovation.” * * *
    • “Mike Baker, chief operating officer, UnitedHealthcare
    • “UnitedHealth Group, our parent, has embedded the use of AI across our business to simplify healthcare and improve how people access care, information and support. UnitedHealth Group is investing $1.6 billion this year with the aim of making experiences more personalized, reducing administrative friction for clinicians, increasing transparency around cost and coverage, and supporting better care decisions.” 

Monday report

David Ermer–CMS, Congress, FDA, Generative AI, HSA, Medicare, NIH, OPM, Rx coverage, U.S. Healthcare–

From Washington, DC,

  • The Washington Post lets us know,
    • “The White House will make the case Monday to Congress — and to voters — that it has developed a strategy to address frequent frustrations involving U.S. medical care, such as too few physicians and too much paperwork.
    • “The Trump administration casts its physician-focused agenda as a fix for a strained health care system — pointing to a $50 billion funding program for rural health it contends will boost the number of doctors in remote areas, efforts to reduce payment distortions that favor hospitals rather than doctors, and regulatory changes intended to speed insurance approvals for tests and follow-up care.
    • “Together, these reforms will enable faster, more affordable, and higher-quality physician services for Americans,” the White House writes in the Economic Report of the President [WhiteHouse.gov link], an annual document previewed with The Washington Post and set to be transmitted to Congress on Monday.
    • “The economic report, which does not offer new proposals, is best understood as a distillation of White House economists’ thinking ahead of this year’s midterm elections, in which voters’ frustrations regarding health care costs and access are set to play a central role. Past administrations have often used the report, which is written by the president’s Council of Economic Advisers, as a messaging document to rally support for their initiatives. This year’s report addresses health care affordability, a key focus for President Donald Trump and his advisers, and says it is working to “unleash” more competition in health care markets to lower costs and improve quality.”
  • Bloomberg Law informs us,
    • “Senate Republicans aren’t planning to include Medicare and Medicaid changes in the next partisan spending package—instead focusing it largely on ending the partial government shutdown.
    • “Top Republicans plan to use a bill that advances through the simple-majority budget reconciliation process to fund immigration enforcement and US Border Patrol and would not require Democrats’ support.
    • “Though some Republicans have been pushing for including Medicare and Medicaid policies in the package, the narrow focus does not leave room for other priorities, Senate Majority Leader John Thune (R-S.D.) said Monday. He said budget instructions will not be sent to the Senate Finance Committee.” * * *
    • “But he didn’t rule out returning to other health care policies. For instance, he mentioned a provision blocking federal Medicaid payments from going to Planned Parenthood, which was included in the 2025 tax-and-spending law and sunsets in July, as a possible candidate for inclusion.”
  • Beckers Hospital Review reports,
    • “CMS on April 10 proposed a 2.4% pay increase for hospitals under the fiscal 2027 Inpatient Prospective Payment System, but hospitals are concerned that the update does not keep pace with the mounting financial challenges.
    • “CMS has proposed another inadequate update to inpatient payment rates, another extremely high productivity cut, and reductions to disproportionate share payments — in the face of rising need for care and higher uninsured rates,” Ashley Thompson, the American Hospital Association’s vice president of public policy analysis and development, said in an April 10 statement. 
    • “Beth Feldpush, America’s Essential Hospitals’ senior vice president of policy and advocacy told Becker’s in an April 11 statement that the proposed DSH payment cuts “fails to acknowledge the growing number of uninsured individuals due to recent Congressional actions.” 
    • ‘Charlene McDonald, president and CEO of the Federation of American Hospitals, said in an April 10 statement that CMS’ proposal is a step in the right direction, but added it “does not negate the compounding effects of rising inflation, record levels of uncompensated care and a growing uninsured population.”
    • “National hospital group leaders also raised concerns about another aspect of the proposal: the introduction of the first mandatory nationwide episode-based payment model.”
  • Fierce Healthcare informs us,
    • “The Centers for Medicare and Medicaid Services picked 150 digital health companies and healthcare providers to participate in the launch of its tech-enabled chronic care model.
    • “The Center for Medicare and Medicaid Innovation (CMMI) announced in December the Advancing Chronic Care with Effective Scalable Solutions (ACCESS) Model as a 10-year payment program to encourage the use of technology to treat chronic diseases. CMS aims for the ACCESS Model to provide stable, recurring payments for technology used to treat diabetes, hypertension, chronic kidney disease, obesity, depression and anxiety. The model will help pay for telehealth software, wearables and wellness apps that address the conditions.
    • “The CMMI plans to use outcome-aligned payments to cover the cost of technology for Medicare providers if a patient with a qualifying chronic condition achieves clinically significant outcomes, such as lowering their blood pressure.” 
  • Citeline points out,
    • An April 1, 2026, proposal [Federal Register link] from the US Treasury Department would allow whistleblowers who alert the government to certain financial crimes to collect 10%-30% of any monetary penalties collected, creating a new risk for healthcare firms – especially those with overseas business partners. The public comment period ends on June 1, 2026.

From the Food and Drug Administration front,

  • Fierce Pharma reports,
    • “For the first time, the FDA has approved generics for AstraZeneca’s Type 2 diabetes blockbuster Farxiga. The U.S. regulator has given thumbs up to 14 companies, including Teva, Sandoz and a host of Indian drugmakers including Aurobindo, Biocon, Cipla, Lupin and Zydus to produce 5 mg and 10 mg tablets of dapagliflozin.
    • “The treatment is indicated for glycemic control and to reduce the risk of hospitalization for heart failure for those with Type 2 diabetes who also have established cardiovascular disease or multiple cardiovascular risk factors.Farxiga generated sales of $8.5 billion last year, including $1.7 billion in the U.S.
    • “The FDA originally approved the SGLT2 inhibitor in 2014. Generic versions of Farxiga became available (PDF) in the U.K. and Japan in the second half of last year.”
  • and
    • “From a negative phase 3 readout and a seemingly tightening regulatory climate to a grueling three-month review extension, the path for Travere Therapeutics in its first-in-disease bid was anything but certain. Yet, the company has defied the odds, securing Filspari a landmark FDA approval in focal segmental glomerulosclerosis (FSGS) and delivering the first treatment for the rare kidney disease.
    • “Monday’s FDA approval makes Filspari the first therapy specifically indicated for FSGS, a condition that represents a $1 billion-plus sales opportunity, according to Leerink Partners analysts. The drug was originally approved in 2023 for the treatment of IgA nephropathy, another kidney disease.
    • “FSGS is estimated to affect more than 40,000 patients in the U.S. The disorder is characterized by scarring in the kidney’s filtering units as protein keeps leaking into the urine, often leading to further disease progression and kidney failure, sometimes quite rapidly.” 
  • Cardiovascular Business relates,
    • “Anumana, a Massachusetts-based artificial intelligence (AI) company co-founded by nference and Mayo Clinic, has received U.S. Food and Drug Administration (FDA) clearance for a new algorithm designed to detect signs of cardiac amyloidosis (CA). This represents Anumana’s second FDA clearance in just two weeks, highlighting the company’s growing impact in the world of cardiovascular care. 
    • “CA is a life-threatening condition that often leads to heart failure complications, but it remains critically underdiagnosed. Anumana sees this clearance as a way to help care teams identify CA early so patients can receive timely treatment.
    • “The newly cleared algorithm, which previously received the FDA’s breakthrough device designation, was designed to evaluate standard 12-lead electrocardiograms (ECGs) and flag patients at increased risk of CA. 
    • “Each of our FDA-cleared algorithms addresses a specific and frequently missed cardiovascular condition, and cardiac amyloidosis represents an important addition to that portfolio,” Maulik Nanavaty, CEO of Anumana, said in a prepared statement. “The more conditions we can identify from a single ECG, the more valuable the test becomes in clinical practice. That’s what Anumana is working toward with each new clearance as we continue to advance our rigorous clinical evidence approach.”

From the census front,

  • The Wall Street Journal reports,
    • “The first of the youth-obsessed baby boomers turn 80 this year, including President Trump, and they want to shake up old age.
    • “Having reached octogenarian levels, a generation that shaped much of our past is shaping the future of aging for themselves and those who follow. They want better healthcare and housing, cures for dementia and a say in when to die. New professions and products will appear. Their massive spending will shift and innovators will follow.
    • “They are reinventing old age,” says Joseph Coughlin, director of the Massachusetts Institute of Technology AgeLab. Unlike the patient Silent Generation, boomers had high expectations and used their sheer numbers as well as financial and political clout to make them happen, which isn’t necessarily a bad thing.
    • “If you don’t have expectations of getting better, then you simply become satisfied with what is,” says Coughlin.”

From the public health and medical / Rx research front,

  • NBC News reports,
    • “Protein-hungry shoppers are buying more meat with their health top of mind. Health experts, however, wish they’d think beyond the butcher counter.” * * *
    • “Meat is indeed packed with protein, but it comes with some well-established health drawbacks.
    • “Saturated fat we’ve known about for decades,” said Dr. Sarah C. Hull, a cardiologist at Yale Medicine. It’s common in red meat and contributes to increasing LDL cholesterol levels, hardening the blood vessels and, in turn, raising the risk of heart attack or stroke.” * * *
    • “Hull said that many common plant-based proteins are particularly high in fiber, which 95% of Americans don’t get enough of, and they’re generally associated with better overall health outcomes than animal proteins. Her research suggests that increased consumption of certain plant-derived nutrients may help counter some negative effects of red meat and ultra-processed foods.”
  • Health Day relates,
    • “Influenza vaccination may offer cardiovascular protection even when it does not prevent infection, according to a study published online April 2 in Eurosurveillance.” * * *
    • “Hospital admissions for heart attack and stroke were more frequent in the first week after testing positive for influenza than during any other period in the year before and after their test,” the authors write. “This increased risk was about half as high among people who tested positive for influenza but had received the influenza vaccine that season.”
  • and
    • “Children with ADHD are more apt to have a bright future if they’re diagnosed in their early elementary years rather than as high schoolers, a new study says.
    • “Kids diagnosed with ADHD at an earlier age are more likely to have better grades and go on to college, researchers reported April 8 in JAMA Psychiatry. They’re also less likely to drop out of school.
    • “ADHD diagnosis during the first years of school was associated with better school performance, more academic track choices and lower probability of school dropout,” concluded the research team led by Lotta Volotinen, a doctoral researcher at the University of Helsinki in Finland.
    • “The findings support the recommendations for earlier diagnosis, and screening for ADHD before age 12 years should be considered,” the team wrote.”
  • The American Medical Association lets us know “what doctors wish patients knew about managing food allergies.”
    • Once a food allergy is diagnosed, learning how to avoid triggers, recognize warning signs and when to seek medical care are key. Two physicians share more.
  • Per Cardiology Advisor,
    • “Maternal stroke is associated with significantly higher rates of maternal mortality and severe delivery complications, including cardiac arrest and acute renal failure.”
  • Per Pulmonology Advisor,
    • “The increased risk for asthma attacks among those using marijuana was consistent regardless of whether individuals vaped or smoked cannabis or did both.”
  • Per an Oregon State University news release,
    • “Researchers at Oregon Health & Science University have uncovered a key reason why immunotherapy has largely failed in pancreatic cancer — and identified a promising strategy to overcome that resistance. 
    • “The study, published in the journal Immunity, shows that pancreatic tumors actively reshape their immune environment by co‑opting regulatory immune cells that normally shut down tumor-killing cells. By reprogramming those cells, the research reveals a potential pathway to make immunotherapy effective against one of the deadliest and most treatment‑resistant cancers. 
    • “Pancreatic cancer is incredibly resistant to most therapies,” said the study’s senior author, Katelyn Byrne, Ph.D., assistant professor of cell, developmental and cancer biology in the OHSU School of Medicine and member of the OHSU Brenden‑Colson Center for Pancreatic Care. “Even when we know the immune system is capable of long‑lasting protection, it’s been very difficult to get that response to work in this disease.” 
    • “In the new study, Byrne and team tested an experimental immunotherapy in mouse models known as agonistic CD40, which works differently from standard checkpoint inhibitors. Rather than targeting a single immune signal, the therapy broadly activates the immune response upstream. 
    • “Byrne said the researchers were surprised to find out that activating the immune system this way didn’t just stimulate tumor‑killing cells — it also reprogrammed regulatory T cells, converting them from immune suppressors into cells that support anti‑tumor activity. 
    • “We didn’t expect this,” Byrne said. “The therapy doesn’t directly target Tregs, but as a secondary effect of turning on the immune response, those Tregs changed their behavior. Cells that were shutting down the immune reaction suddenly started supporting tumor killing.” 
    • “The team’s findings help explain one reason why many immunotherapies haven’t worked in pancreatic cancer and point to a possible solution: Treatments may need to both turn on the immune system and overcome the tumor’s own ability to shut it down.” 
  • Per an NIH news release,
    • “A National Institutes of Health (NIH)-funded research team has discovered an enhanced CRISPR gene-editing system that could enable targeted delivery inside the human body — a key step toward broader clinical use. Researchers identified a naturally occurring enzyme, Al3Cas12f, that is small enough to fit into adeno-associated virus vectors, a leading targeted delivery method for gene therapies. They then engineered an enhanced version that dramatically improved gene-editing performance in human cells. 
    • “The advance addresses a major limitation in CRISPR technology. Commonly used gene-editing proteins are too large for targeted delivery systems, restricting clinical applications to cells modified outside the body, such as blood and bone marrow. 
    • “Smart delivery of gene editing systems is a powerful notion with broad clinical implications, and this basic science finding takes us a significant step toward that future,” said Erica Brown, Ph.D., acting director of NIH’s National Institute of General Medical Sciences (NIGMS).” 
  • BioPharma Dive adds,
    • “Revolution Medicines said Monday its experimental pancreatic cancer drug hit every goal at an early checkpoint in a Phase 3 trial, helping people who got it live nearly twice as long as those who got standard chemotherapy.
    • “Enrollees who got daraxonrasib lived a median of 13.2 months after treatment, compared with 6.7 months for those who got chemo, a finding that equates to a 60% reduction in the risk of death among those who got the experimental drug. Daraxonrasib achieved its other objectives at an interim look at the results, findings so striking that the company ended the trial early. Revolution enrolled people whose metastatic pancreatic cancer had returned after an earlier treatment.
    • “The Food and Drug Administration has already awarded daraxonrasib a “national priority” voucher that could help Revolution gain an approval within weeks of an official submission. Revolution shares rose nearly 40% in early trading, adding $7 billion to the company’s already hefty valuation.”
  • BioPharma Dive also informs us,
    • “An experimental therapy from Allogene helped eliminate signs of cancer better than standard treatment in a Phase 3 trial in first-line large B-cell lymphoma, results suggesting the biotechnology company may have found a role to use donor-derived cell therapy against the deadly blood cancer.  
    • “After 45 days of treatment, seven of the 12 patients given Allogene’s therapy in the study were negative for “minimal residual disease,” meaning that diagnostic tests could no longer detect signs of cancer. By comparison, only 2 of 12 placebo recipients hit that mark, a roughly 42-percentage-point difference that clears an important bar published literature has suggested is crucial for delaying a relapse. 
    • “The results come from an early “futility” analysis. Allogene is enrolling 220 people in the study and expects to report in 2027 results showing whether treatment staved off cancer’s return.
  • and
    • “In experimental drug from Spyre Therapeutics helped lower signs of disease activity and improve remission rates in a Phase 2 study of people with ulcerative colitis. 
    • After 12 weeks of treatment, patients who received “SPY001” in the trial had a statistically significant, 9.2-point reduction on a scoring system that assesses the severity of their disease, meeting the study’s primary objective. Notably, treatment was also associated with a 40% remission rate and a 51% improvement on endoscopic imaging. One severe adverse event was reported — chest pain in a 68-year-old male with a history of cardiovascular disease — but was deemed unrelated to treatment.
    • Spyre said the findings were “clinically meaningful” and support SPY001’s “best-in-class profile.” The drug is one of multiple therapies the company is evaluating in Phase 2 trials in inflammatory bowel disease. Proof-of-concept data for two other therapies in the trial are expected later this year. Data from a placebo-controlled portion of the study are on track for 2027.” 
  • Per Fierce Pharma,
    • “Eli Lilly has chalked up another victory in the chronic lymphocytic leukemia (CLL) space, as its BTK inhibitor Jaypirca delivered its fourth positive phase 3 readout in the blood cancer. 
    • “Monday, Lilly said its phase 3 Bruin CLL-322 trial in patients with previously treated CLL or small lymphocytic lymphoma (SLL) has met its primary endpoint. In an industry first, the study showed that adding Jaypirca to a fixed-duration regimen of venetoclax and rituximab significantly extended progression-free survival (PFS) compared with the standard combo alone. 
    • “As Lilly pointed out, Bruin CLL-322 is the first phase 3 in CLL to utilize and outperform a venetoclax-based regimen. Roche and AbbVie sell venetoclax, an oral BCL-2 inhibitor, under the brand name Venclexta.” 

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

  • Beckers Payer Issues reports,
    • “Houston-based Memorial Hermann Health System and BCBS Texas agreed on a contract April 11, bringing the health system back in network.
    • “The agreement ensures “access to quality care at cost-effective prices,” BCBS Texas said in an April 13 statement shared with Becker’s. It covers both commercial and Medicare Advantage members. The previous contract expired April 1, affecting commercial members. The health system had beenout of network for Medicare Advantage plans since Jan. 1.”
  • Fierce Healthcare offers a look at how Evernorth’s new Delaware specialty pharmacy facility highlights a broader care coordination approach.
  • Beckers Hospital Reports ranks 83 health systems by their most recent revenue.
    • “Revenue growth continued across the hospital industry in 2025, with many of the nation’s largest health systems posting mid- to high-single-digit gains fueled by stronger patient volumes, improved payment rates and the expansion of ambulatory and pharmacy operations. 
    • “But the gains were far from uniform. Some systems grew revenue by double digits through mergers, acquisitions and new payer arrangements, while others saw declines as they shed hospitals and restructured their portfolios.”
  • and tells us,
    • “The world’s two main GLP-1 drug manufacturers, Eli Lilly and Novo Nordisk, are taking different approaches with rolling out their recently approved GLP-1 pills for weight loss. 
    • “Two oral GLP-1s, two very different commercial strategies. Health systems operating metabolic programs or making formulary decisions need to understand both.
    • “While both companies offer their recently approved GLP-1 pills through pharmacies and direct-to-consumer platforms that circumvent pharmacy benefit managers, they are diverging in other routes. 
    • “Eli Lilly is betting on retail and digital access, as it’s offering its weight loss GLP-1 pill through GoodRx, telehealth firm Ro and same-day delivery with Amazon Pharmacy. 
    • “By contrast, Novo Nordisk launched a Wegovy subscription program through WeightWatchers, LifeMD, Ro and Hims & Hers — with which the drugmaker previously had a strained relationship. With the 12-month subscription plan, Novo Nordisk said patients can save up to $600 per year on the Wegovy pill.” 
  • and informs us,
    • “Large language models may help identify drug safety signals in clinical notes, though their performance remains below thresholds required for clinical decision support.
    • “Researchers evaluated three models — GPT-3.5, GPT-4 and GPT-4o — using clinical notes from 100 patients at Nashville, Tenn.-based Vanderbilt Health, 70 patients at the University of California—San Francisco and 272 patients from seven Roche-sponsored trials, according to an April 6 Vanderbilt news release.
    • “For detecting immune-related adverse events at the patient level, GPT-4o achieved F1 scores of 56%, 66% and 62% across the respective datasets. The F1 score reflects how well a model balances correctly identifying real safety issues while avoiding false alarms. At the individual note level, the model reached an average F1 score of 57% across 667 notes.
    • “An F1 score of 90% or more is considered excellent, while 80% or higher may support clinical decision-making.”
  • STAT News points out,
    • “Every day, more than 40 million people ask ChatGPT about health care, according to OpenAI. They’re asking questions about diet, exercise, insurance — and in some cases, serious symptoms that would typically get discussed on a 911 call or in a doctor’s office.
    • “For some health systems, that’s creating an imperative. A small number of hospitals are trying to recapture some of those clinical conversations from commercial large language models like ChatGPT, Claude, and Gemini. They’re implementing their own patient-facing chatbots, ones that draw directly from their existing medical records and can funnel patients toward care in their own system. 
    • “Hartford HealthCare this week will launch PatientGPT, a chatbot engineered by clinical AI company K Health, to its patients in Connecticut. Two health systems — California-based Sutter Health and Reid Health, serving Indiana and Ohio — have announced pilot versions of Emmie, the chatbot built by medical record mammoth Epic. The list is likely to grow rapidly.
    • “Health systems need to do this, either through a vendor or building it themselves,” said Mount Sinai chief AI officer Girish Nadkarni, the senior author of a recent study that found ChatGPT Health missed high-risk emergencies when used to triage patients.”
  • The Wall Street Journal cautions,
    • “The artificial intelligence gold rush is rapidly drying up the supply of computing power, leading to product issues and reliability problems.
    • “Anthropic experiences frequent outages and limits user token usage, while OpenAI scrapped its Sora app to free up compute.
    • “CoreWeave raised prices over 20% and extended contracts, as spot-market Nvidia GPU rental costs rose 48% in two months.” * * *
    • “All of it points to a classic problem that has popped up in technology booms throughout history, from the 19th-century railroad expansion to the telecom and internet explosion of the early 2000s. Demand is growing far faster than companies are able to access resources and build out infrastructure. Historically, price increases have been among the only ways to address a supply crunch, but such a move could be perilous for frontier AI companies, which are in a ferocious competition to gain users.”
  • Per MedTech Dive,
    • “Stryker said Monday that it has agreed to buy intravascular lithotripsy firm Amplitude Vascular Systems. The companies did not disclose the terms of the acquisition. 
    • “Intravascular lithotripsy is a procedure to treat artery disease. Boston-based Amplitude Vascular Systems, or AVS, uses pressure waves generated by carbon dioxide through a balloon catheter to break up calcified plaque.
    • “The acquisition is expected to bolster Stryker’s peripheral vascular portfolio once AVS’ device is cleared in key markets.”
  • and
    • “GE HealthCare has provided an update on the integration of its bkActiv intraoperative ultrasound technology with Medtronic’s Stealth AXiS surgical navigation system.
    • “The integrated product is now available commercially, GE HealthCare said Thursday. Medtronic said it had integrated bkActiv into Stealth AXiS when the surgical system received regulatory clearance last month.
    • “Integrating the technologies gives surgeons real-time ultrasound images, helping them to assess mid-procedure anatomy changes that could affect the preoperative plan.”

Friday report

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

From Washington, DC,

  • Federal News Network offers an interview with Tammy Flanagan about how “health‑coverage decisions in retirement can shape when and how federal retirees tap their money.”
  • Govexec reports,
    • “The percentage of federal employees who are classified as “thriving” decreased by 10 points between 2024 and 2025, according to a recent report from Gallup, which sheds light on how civil servants are reacting to cuts and other reforms that President Donald Trump has made to agencies since the start of his second term. 
    • “By taking the average of responses from quarterly surveys conducted respectively in both years, the analytics firm found that the percentage of “thriving” feds dropped from 58% in 2024 to 48% in 2025.” * * *
    • “While the “thriving” rate for federal employees held steady at around 60% from 2022 to 2024, the latest data puts them on par with the average for U.S. workers in general, which also stood at 48% in 2025. That broader group, however, saw a smaller decline, going from 51% in 2024.”
  • OPM has brought the Director’s Secrets of OPM blog posts up to date on the agency’s website, which may be more easily accessible than Substack.
  • Per a CMS email,
  • This reporting requirement applies to FEHB and PSHB plans.
  • The American Hospital Association News informs us,
    • “The Centers for Medicare & Medicaid Services April 9 held a demonstration showcasing the first series of products intended to push the health care industry toward a more connected ecosystem. The event highlighted tools and applications from more than 50 companies supporting the Medicare App Library that was initially announced in February. Tools intended to promote digital data access and eliminate manual check-in forms were featured, along with personalized health apps providing tailored guidance for nutrition, wellness and chronic disease management.” 
  • Fierce Healthcare reports,
    • “The Centers for Medicare & Medicaid Services has proposed a 2.4% payment rate bump for inpatient services for fiscal year 2027 as well as the first mandatory, nationwide test of an episode-based payment model. 
    • “The plans were outlined Friday in the annual release of CMS’ Inpatient Prospective Payment Systems (IPPS) and Long-Term Care Hospital (LTCH) Prospective Payment System proposed rule. 
    • “Other planned changes, according to a fact sheet from the agency and the proposed rule’s summary, include various measure additions or modifications to measures in the Hospital Inpatient Quality Reporting Program; adjustments to the Transforming Episode Accountability Model (TEAM) alternative payment model controversially finalized in last year’s rule; and changes to graduate medical education payments to implement discrimination requirements aligned with the administration’s view of diversity, equity and inclusion practices.” 
  • A CMS news release adds,
    • “Medicare beneficiaries undergoing knee, hip, and ankle replacements, among the most frequent surgeries for people with Medicare, could soon experience more coordinated care and lower costs under a new Centers for Medicare & Medicaid Services (CMS) proposal. CMS is looking to implement these improvements by expanding the Comprehensive Care for Joint Replacement (CJR) Model nationwide through the Fiscal Year (FY) 2027 Hospital Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital Prospective Payment System (LTCH PPS) proposed rule.
    • “Every year, Medicare funds thousands of knee, hip, and ankle replacements that help seniors keep up with their speedy little grandkids,” said CMS Administrator Dr. Mehmet Oz. “This proposed expansion of our successful joint replacement pilot program would better align financial incentives with improved health outcomes—protecting taxpayer dollars while ensuring patients get the care they need before, during, and after surgery.” * * *
    • “To learn more about the CJR-X Model, including independent evaluation reports, visit: https://www.cms.gov/priorities/innovation/innovation-models/cjr-x“
    • “The FY 2027 IPPS and LTCH PPS proposed rule can viewed on the Federal Register at: https://www.federalregister.gov/public-inspection/current. 
    • “For a fact sheet on FY 2027 IPPS and LTCH PPS proposed rule, visit: https://www.cms.gov/newsroom/fact-sheets/fy-2027-hospital-inpatient-prospective-payment-system-ipps-long-term-care-hospital-prospective.”
  • Fierce Healthcare relates,
    • “The Trump administration has issued a proposed rule that aims to significantly overhaul prior authorization for pharmaceuticals.
    • “Through the Interoperability Standards and Prior Authorization for Drugs rule, the Centers for Medicare & Medicaid Services said it would establish deadlines for payers in government insurance plans, setting the timeline at 24 hours for urgent requests and 72 hours for standard determinations.
    • “In addition, the rule would require insurers to publicly report certain metrics around prior authorization, including approval and denial rates; outcomes for appeals; and decision timeframes, according to an announcement from the agency.”
    • “The rule also builds on a 2024 regulation that took aim at prior authorization for non-drug services as well as payers’ 2025 pledge to significantly overhaul their approach to prior auth, an agreement brokered in part by CMS officials.” * * *
    • “CMS would also push to adopt Fast Healthcare Interoperability Resources (FHIR)-based standards for the small number of plans still using older models, making it easier for real-time electronic workflows to thrive.”
  • and
    • “Despite encountering a legal roadblock last month in his effort to rework the U.S. vaccine infrastructure, HHS secretary Robert F. Kennedy Jr. is continuing to reshape the Centers for Disease Control and Prevention’s vaccine advisory panel in a way that’s setting off alarm bells for some experts.
    • “In the new charter for the Advisory Committee on Immunization Practices (ACIP), the focus of the group—which helps advise the CDC on vaccine schedules and recommendations—seems to be shifting more toward concerns around vaccine safety and side effects. 
    • “In particular, the panel will now work on identifying “gaps in vaccine safety research, including adverse effects following vaccination.” The language is new in the updated charter and will likely appease the vaccine skeptic crowd, which has long used the potential for vaccine injuries and erroneous links to the development of neurological disorders like autism to further their cause.
    • “The group will also now specifically be tasked with reviewing new vaccine platforms such as mRNA shots, which have become a frequent bugbear in anti-vaccine rhetoric following the COVID-19 pandemic.”

From the Food and Drug Administration front,

  • BioPharma Dive reports,
    • “The Food and Drug Administration has, for the second time, turned back a medicine for a tough-to-treat skin cancer in a decision that marks a major setback for the therapy and its developer, biotechnology company Replimune.
    • “The agency on Friday rejected the treatment, vusolimogene oderparepvec or “RP1,” which had been under review for people whose advanced melanoma progresses despite treatment with a widely used cancer immunotherapy. In a letter made public Friday, the agency claimed that the review team, as well as multiple agency leaders and subject matter experts, determined the data are “insufficient to conclude substantial evidence of effectiveness.”
    • “The decision comes eight months after U.S. regulators spurned RP1, arguing that the company’s findings couldn’t be “adequately interpreted.” Replimune claimed to have been blindsided by the rejection and afterwards provided the FDA with additional information and analyses to boost its case. The agency, though, argued in its letter that its feedback to Replimune has remained consistent through years of communications and that its issues weren’t addressed.”
  • The Wall Street Journal relates,
    • “GSK withdrew its application for a drug touted last year by President Trump as a potential treatment for autism symptoms, just months after the company submitted it at the request of health officials.
    • “The U.K. drugmaker asked the Food and Drug Administration to pull its application for the drug leucovorin calcium because it doesn’t market the medicine, according to a regulatory filing posted Thursday. 
    • “The FDA had just approved leucovorin last month. Generic forms of the medicine will still be available. * * *
    • “GSK hadn’t sold the drug since 1999. At the request of the Food and Drug Administration, GSK said in September it would submit its application for patients with cerebral folate transport deficiency—a rare genetic condition with similarities to autism—in a move that allowed the agency to update the label for the drug and its generic counterparts. 
    • “FDA officials last month announced they had approved the drug for that condition based on a review of existing studies, but said in a call with reporters that they hadn’t found enough evidence to merit OK’ing the drug’s use to treat autism more broadly.
    • “Senior FDA officials said they examined scientific studies to see whether they could approve leucovorin to treat autism, but didn’t come up with enough strong scientific evidence to do so.
    • “A spokesman for HHS said GSK’s withdrawal on Thursday doesn’t affect generic versions of the drug, which already have updated labels for the genetic condition.”
  • Cardiovascular Business tells us,
    • :The U.S. Food and Drug Administration (FDA) is warning the public that certain sizing catheters from Indiana-based Cook Medical should no longer be used due to an increased risk of cracking or breaking.
    • “The agency’s warning covers specific lots of Cook Medical’s Centimeter Sizing Catheters, Aurous Centimeter Sizing Catheters and Beacon Tip Centimeter Sizing Catheters. These devices are used for a variety of angiographic procedures, aortic interventions, peripheral interventions and vascular interventions. They are made in a variety of sizes and multiple configurations.
    • “Potential adverse events that could result include increased procedural time, harms associated with device fragmentation/separation and vessel injury,” according to the FDA. “In a worst-case scenario, device fragmentation and separation could cause life-threatening harm or death.”
    • “At this time, the FDA noted, no serious injuries or deaths have been linked to this issue. The agency is still reviewing the situation.
    • “The FDA’s early alert can be read in full here. It also includes a full list of all affected product lots.”

From the public health and medical / Rx research front,

  • The University of Minnesota’s CIDRAP reports,
    • “Even as the US respiratory illness season continues to ebb, it remains deadly, with the Centers for Disease Control and Prevention (CDC) documenting 12 more pediatric deaths in its FluView update today. 
    • “So far this season, 139 children have died from the virus, and about 85% with a known vaccination status were unvaccinated. While the CDC has classified this flu season as moderate for adults, it’s been high-severity for children.
    • “For comparison, in the previous three flu seasons the CDC logged 187, 210, and 296 flu-related deaths for the complete season. The 289 pediatric deaths in 2024-25 was the most since the 2009-10 H1N1 flu pandemic.
    • “Only four jurisdictions were reporting moderate flu activity last week, and none saw high activity. Flu accounted for 8.2% of viral respiratory diseases, down from 9.8% the previous week. A total of 2,589 people were hospitalized, compared with 3,050 the week before. The proportion of outpatient visits for flu declined to 2.4% from 2.6% the previous week.” * * *
    • “The level of acute respiratory illness causing people to seek medical attention is very low. Rates of respiratory syncytial virus (RSV) remain elevated, but the virus is past peak in many areas of the country, the CDC said in its weekly respiratory virus activity update today.
    • “COVID-19 levels are low in most parts of the country, and viral wastewater concentrations are low for RSV and very low for COVID-19 and influenza A.” 
  • The American Hospital Association adds,
    • “The Utah measles outbreak has increased to 583 cases, the state’s Department of Health and Human Services reported April 7. Of those, 386 cases have been diagnosed this year. Nationwide, there have been 1,714 confirmed measles cases so far in 2026, according to the latest data from the Centers for Disease Control and Prevention. Of those, 94% of cases are outbreak-associated and 6% of cases have been hospitalized. The vaccination status of 92% of cases is unvaccinated or unknown.” 
  • Harvard Professor of Pediatrics Dr. David S. Ludwig opines in STAT News
    • “Targeting ultra-processed foods would make packaged foods less tasty and appealing, but no less fattening.
    • “Ironically, many products now emblematic of ultra-processed foods were developed in response to calls from nutrition scientists and government to replace dietary fat with carbohydrates, a misguided campaign that did more harm than good. We can’t afford another sweeping restructuring of the food supply based on imprecise interventions and uncertain science.
    • “Instead, focusing on processed carbohydrates offers a more precise and pragmatic solution, one that could invite collaboration with, rather than opposition from, the food industry.
    • “Delicious, calorie-rich food — whether home-prepared or packaged — isn’t the problem. What matters is how long we stay satisfied (satiety) relative to calories consumed. A 100-calorie snack or a sugary beverage isn’t better for our waistline than 200 calories from nuts if the lower-calorie option leaves us hungry and craving more soon after.
    • “By targeting the dietary drivers of weight gain, rather than misleading notions about food palatability and pleasure, we can have our (low-carb) cake and eat it, too.”
  • STAT News also tells us,
    • “With thousands of illegal e-cigarettes for sale in the U.S., both the Trump and Biden administrations have vowed to crack down on the illicit fruit- and candy-flavoredvapes that hold particular appeal to minors. But a new government report suggests law enforcement efforts by the Department of Justice lag far behind the scope of the problem. 
    • “Most DOJ enforcement actions between fiscal year 2022 and fiscal year 2025 — 50 out of a total of 88 — were to add the names of remote e-cigarette sellers to a list of unauthorized businesses, according to the report from the Government Accountability Office. The second-most common type of enforcement actions (20 out of 88) noted in the report were injunctions to stop legal violations. 
    • “The GAO report was focused on actions that involved the DOJ, so those tallies do not take into account enforcement actions like the seizure of more than 6 million illegal products by the Food and Drug Administration and U.S. Customs and Border Protection between 2024 and 2025. To put those seizures in context, a large seizure of $76 million worth of products in 2024 — 3 million vapes — equated to about 4% of China’s e-cigarette exports to the U.S. in a single month, said Steven Xu, an adjunct assistant professor at the University of Waterloo who studies e-cigarettes.
    • “Sen. Dick Durbin (D-Ill.), who requested the report, said it shows that much more work needs to be done to combat the public health threat posed by illegal vapes.”
  • Health Day informs us,
    • “Standard cognitive tests may fail to capture early brain changes in women 
    • “Women’s brains often show a steeper and more widespread decline than men’s when moving from mild impairment to Alzheimer’s
    • “Sex-specific standards may be needed to interpret brain scans and screening results accurately.”
  • and
    • “Cardiovascular health may impact fracture risk in women after menopause, according to a study published online March 27 in The Lancet Regional Health-Americas.” * * *
    • “Many of the same factors that protect your heart — regular physical activity, a balanced diet rich in calcium and vitamin D, not smoking and managing conditions like diabetes and high blood pressure — also help protect your bones,” Hossain said in a statement. “If you’ve been told you have intermediate or high cardiovascular risk, particularly if you are a postmenopausal woman, it may be worthwhile to talk to your doctor about bone health screening, given the many effective treatments available that reduce fracture risk.”

From the U.S. healthcare business front,

  • Beckers Payer Issues shares a boatload of Blue Cross Blue Shield updates.
  • Healthcare Dive reports,
    • “Menopause has come out of the shadows and into the public spotlight in recent years. Celebrities have become more eager to dish about hot flashes and night sweats, and a flurry of telehealth start-ups promising relief from a broad constellation of symptoms have given rise to a $17 billion menopause market.
    • “But demand for treatments still far outpaces the science, as persistent structural barriers confound the women’s health space. 
    • “People have taken up the charge and are trying to make an impact in a specific area,” said Kim Dalla Torre, an EY Global and Americas Health leader.” * * *
    • “More also needs to be done to raise women’s awareness that menopausal symptoms shouldn’t be something they need to tolerate in silence, Dalla Torre said. Some 80% of women experiencing these symptoms don’t reach out to their doctors for help, according to the Mayo Clinic. Drugmakers also need to play a role.” 
       
  • Cigna, writing in LinkedIn, tells us,
    • “Mental fitness is essential for stress management, resilience, and workplace productivity, helping employees achieve work/life harmony.
    • “When organizations truly care about mental fitness, employees feel more supported and valued—which leads to higher engagement, fewer days missed from work, and meaningful reductions in healthcare costs for everyone.
    • “By thoughtfully weaving together mental and physical wellness programs, organizations can nurture a more vibrant and supportive workforce—leading to lasting success, greater employee retention, and the ability to attract exceptional talent.”
  • Healthcare Innovation points out,
    • “Sentara Health’s navigators are trained professionals with expertise in behavioral health, community resources, and motivational interviewing, working closely with ED teams and patients.
    • “The program started with pilot phases at select hospitals, expanding to 10 sites over a year, with ongoing data collection to measure impact and guide future improvements.
    • “Early results indicate significant reductions in readmission rates, demonstrating the program’s effectiveness in connecting patients to appropriate community-based care.”
  • Radiology Business informs us,
    • “In a bid to offer more services outside of Manhattan, Weill Cornell Medicine is planning to build a $57 million new radiology clinic in Brooklyn.
    • “The New York City academic system officially applied for the necessary state Department of Health approvals on Monday. Located in South Brooklyn’s Bay Ridge neighborhood on 86th Street, the clinic is expected to include three MRI machines, a CT scanner and ultrasound and mammography offerings, Crain’s New York Business reported. 
    • “The outpatient radiology clinic will be housed inside the NewYork-Presbyterian Bay Ridge Primary Multispecialty center and marks a significant expansion for the hospital system outside of Manhattan.
    • “While it’s premature to talk about the services of this location, we are always striving to meet the healthcare needs of New Yorkers in their own neighborhood,” Robert J. Min, MD, radiology chair and president and CEO of the Weill Cornell Physician Organization, told Radiology Business by email April 9. “We are still in the planning stages and will share details in the coming months.”
    • “Weill Cornell hopes the new center will help alleviate demand for radiology services in Brooklyn and the surrounding communities, according to the state application. The project is part of a bigger push by Weill Cornell and NewYork Presbyterian to expand their outpatient footprint across the city, local news outlet Hoodline reported Thursday.” 

Midweek report

David Ermer–CDC, CMS, COVID-19, Federal employment benefits, Medical / Rx research, Mental health care, NIH, Obesity, OPM, U.S. Healthcare–

From Washington, DC,

  • Govexec writes about OPM’s March 31 call letter for 2027 FEHB and PSHB benefit and rate proposals.
    • “John Hatton, staff vice president for policy and programs at the National Active and Retired Federal Employees Association, said it’s not unusual for administrations to promote their health policy priorities—or to seek cost savings—via FEHBP. While the letter likely won’t lead to huge shifts in how insurers cover federal workers—or how doctors approach their patients—it does mark a noteworthy shift away from traditional medical interventions.
    • “There isn’t one thing that really stands out by itself as noteworthy, but combined the letter reflects a trend toward alternative treatments and expanding and encouraging the treatment of underlying causes rather than symptoms,” he said. “But it’s not like providers don’t already try to do that to begin with. This is a MAHA set of policies . . . but if you were expecting them to say ‘we’re banning vaccines,’ the letter is not doing that. But it does change the incentives.”
  • FEHBlog observation — What’s typical, and is occurring again, is that the new Administration’s initiatives build on top of prior Administration initiatives. As a result, carriers are caught in a spider web of federal and OPM mandates which makes it difficult to lower costs.
  • KFF Health News shares public comments on OPM’s health claims data warehouse initiative.
    • FEHBlog observation: The most secure approach would be for OPM to make aggregated data requests to FEHB plan and PSHB plan “edge servers.” This is how CMS gets health information from qualified health plans in the federal exchange.
  • Federal News Network tells us,
    • “Department of Homeland Security employees who have gone unpaid through nearly two months of a partial government shutdown will start receiving paychecks this week.
    • “In a message to all DHS employees on Monday, the office of the under secretary for management said furloughed and excepted employees would receive full salaries covering the start of the shutdown on Feb. 14 through April 4, the end of the last full pay period.
    • “Employees should start receiving paychecks as early as April 10 and no later than April 16, depending on their financial institution, according to the message.
    • “The update comes after President Donald Trump’s directive to pay all DHS employees last week.”
  • Per an HHS news release,
    • “U.S. Department of Health and Human Services Secretary Robert F. Kennedy, Jr. traveled to Arizona this week as part of his “Take Back Your Health” tour, meeting with leaders across health care, independent living, and recovery to drive a prevention-focused agenda.
    • “Arizona is putting prevention at the center of American health care,” said Secretary Kennedy. “By prioritizing recovery, nutrition, physical fitness, and personal empowerment, providers across this state are driving a shift from a reactive sick-care system to a true health care system that delivers better outcomes for the American people.”
  • Fierce Pharma informs us,
    • “After more than a decade in charge of the most influential organization representing the U.S. pharmaceutical industry, the Pharmaceutical Research and Manufacturers of America (PhRMA), Steve Ubl will step down as its CEO at the end of the year.
    • “PhRMA’s board of directors announced the departure of Ubl on Wednesday and said it will begin a search for his successor. To ensure a smooth transition, Ubl will remain on board until a new CEO is identified, PhRMA said.
    • “Ubl is leaving during a turbulent time for the industry as President Donald Trump pursues several initiatives related to drug pricing and domestic manufacturing, and as leaders at the Department of Health and Human Services and the FDA have embraced certain controversial policies and decisions.”

From the judicial front,

  • Yesterday, the U.S. Court of Appeals for the Sixth Circuit affirmed a federal district court ruling that ERISA, which governs private sector employer sponsored health plans, preempts Tennessee’s any willing pharmacy law. This outcome supports FEHB Act preemption of the same state law.
    • FEHBlog observation — If OPM wants to lower FEHB and PSHB costs, the agency should inform state governments about FEHB Act preemption in these situations.
  • Beckers Hospital Review reports,
    • “A federal judge has declined to block the mailing of mifepristone prescriptions nationwide while directing the FDA to complete its ongoing review of the drug.
    • “U.S. District Judge David Joseph denied a request from Louisiana Attorney General Liz Murrill to pause 2023 FDA rules allowing the drug to be dispensed by mail. He instead granted a request to temporarily pause the case and said the agency must provide an update on its review within six months.
    • “The ruling allows current access to continue as legal challenges proceed, though the judge said he could revisit the issue depending on the FDA’s findings.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “Some people, frustratingly, don’t lose as much weight as others on popular weight-loss drugs like Wegovy. A new study suggests the answer may be in their genes.
    • “Researchers from consumer gene-testing service 23andMe, which has one of the world’s biggest DNA databases derived from saliva samples, analyzed genetic data from 27,885 customers who have taken drugs like Wegovy and Zepbound to see if any genes or variants were correlated with how much weight people lost or how bad their side effects were.
    • “The findings, published online Wednesday by the journal Nature, showed people with a common gene variant lost more weight on GLP-1 weight-loss drugs than those without it. Researchers also found people with specific genetic variants were more likely to have side effects like nausea and vomiting from the drugs.
    • “This warrants further study,” said Dr. Noura Abul-Husn, chief medical officer at the 23andMe Research Institute. “Right now the alternative is really nothing to guide any type of personalization around how to manage expectations around GLP-1 use.”
    • “23andMe filed for bankruptcy protection last year after struggling to find a profitable business model. Testing for predictive genes could be a way for the company to salvage its business.”
  • Per a National Institutes of Health news release,
    • “A clinical trial funded by the National Institutes of Health (NIH) found that a scalable, team-based intervention strategy in federally qualified health centers (FQHCs) was able to significantly reduce systolic blood pressure for low-income participants. Scientists deployed team-based care, which included intensive blood-pressure management, blood pressure tracking and feedback to providers, health coaching on lifestyle changes and medication adherence, and home blood-pressure monitoring.  
    • “Uncontrolled high blood pressure, known as hypertension, is a major preventable risk factor for cardiovascular disease and death worldwide. According to the Centers for Disease Control and Prevention, only 1 in 4 adults with high blood pressure has their blood pressure under control. 37 million U.S. adults with uncontrolled high blood pressure have a blood pressure of 140/90 mmHg or higher. Lower income Americans experience high prevalence of hypertension and low control rates, contributing to an increased disease burden. 
    •  “Evidence-based strategies to treat uncontrolled hypertension among low-income Americans are severely lacking, even though we know this condition is a huge risk factor for more serious heart complications,” said NIH Director Jay Bhattacharya, M.D., Ph.D. “This study shows us that we can deploy an affordable, tested program to help reduce the burden of heart disease in this population.” 
  • Healio relates,
    • “People who had severe COVID-19 infections exhibited a 24% higher risk for lung cancer, retrospective data showed.
    • ‘The risk persisted throughout the 4-year follow-up period.” * * *
    • “The findings — derived from work in murine models and retrospective analyses of data from humans — underscore the importance of increased lung cancer surveillance among high-risk individuals, researchers concluded.”
  • MedPage Today points out,
    • The number of U.S. individuals on long-term opioid therapy fell from 5.6 million in 2015 to 4.2 million in 2023.
    • Co-prescribing opioids with gabapentinoids increased, however, reaching 58.7% in 2023.
    • Meanwhile, the mean age of long-term opioid therapy patients rose from 52.5 years in 2015 to 60.5 in 2023. * * *
    • “Our main finding is that while long-term opioid therapy has declined, it remains common among Americans. Also, co-prescribing with gabapentinoids rose between 2015 and 2023,” Thuy Nguyen, PhD, of the University of Michigan School of Public Health in Ann Arbor, told MedPage Today. “This is concerning because the FDA warns that concurrent gabapentin and opioid use may lead to respiratory depression.”
  • and
    • “High-flow nasal oxygen therapy has been increasingly used for noninvasive respiratory support after cardiac surgery.
    • “In the large randomized NOTACS trial, high-flow nasal oxygen therapy didn’t improve survival with maintenance of functional independence after cardiac surgery in high-pulmonary-risk patients as compared with standard oxygen.
    • “The findings suggest no need for routine provision of high-flow oxygen in this setting, although use for selected patients was not ruled out.”
  • and
    • “A national analysis of claims data found that only 1.6% of at-risk youth filled a prescription for HIV preexposure prophylaxis (PrEP) from 2018 to 2022.
    • “Minors, young women, and those living in the South faced larger disparities.
    • “Tailored and more effective interventions are needed to improve PrEP access and use in this population, the researchers argued.”
  • The American Journal of Managed Care notes,
    • “A Pediatrics review found no serious adverse events attributable to neonatal hepatitis B virus (HBV) vaccination and no evidence supporting delayed initiation of the series. 
    • “ACIP/CDC now permit optional birth dosing for infants of HBsAg-negative mothers, while maintaining mandatory vaccine plus HBIG within 12 hours for positive/unknown status. 
      • ‘Perinatal infection carries ~90% chronicity in the first year of life; timely birth dosing prevents transmission and full-series completion yields ~98% durable immunity. 
      • ‘Population-level impacts include a 99% reduction in pediatric HBV infections, with modeled reversals likely if universal birth-dose norms erode and coverage declines permanently. 
    • “Pharmacists can mitigate implementation risk by reinforcing prenatal test limitations, countering misinformation, streamlining same-day vaccination, documenting immunizations, and driving series completion follow-up.”
  • Per Fierce Pharma,
    • “For the second time in a span of four months, Insmed’s Brinsupri has come up short in a mid-stage trial designed to expand its use into a new indication. 
    • “The New Jersey biotech revealed that a phase 2b study of Brinsupri in adults with moderate to severe hidradenitis suppurativa (HS) has failed to achieve its primary or secondary endpoints for either of its 10 mg or 40 mg once-daily treatment arms. With the result, the company will terminate the program. 
    • “The flop comes after Insmed reported the misfire of another Brinsupri trial, testing the first-in-class dipeptidyl peptidase 1 (DPP1) inhibitor in patients with chronic rhinosinusitis without nasal polyps (CRSsNP).”
  • Per BioPharma Dive,
    • “An experimental, dual-acting drug from Sanofi succeeded in two studies in different respiratory conditions but missed its mark in an eczema trial, the French drugmaker said Tuesday.
    • “Known as lunsekimig, the therapy met its main and key secondary goals in Phase 2 studies evaluating the treatment in moderate-to-severe asthma and chronic rhinitis with nasal polyps. In asthma, treatment led to a “statistically significant and clinically meaningful” reduction in symptom flare-ups and helped improve lung function. Lunsekimig reduced the size and severity of nasal polyps, as well as related congestion, in the other trial, Sanofi said.
    • “Lunsekimig didn’t meet its main objective in a separate trial in atopic dermatitis, failing to meet a certain threshold of skin clearance compared to a placebo. The drug was “generally well tolerated” across the trials, with serious adverse events and discontinuation rates comparable between treatment and placebo recipients. Two Phase 3 trials are underway in chronic obstructive pulmonary disease, another lung condition.” 

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

  • Paragon Health Institute offers an interesting analysis of the Medicare cost shift.
    • “Although the usual narrative of cost shift is a myth, it is true that government can and does artificially increase costs for private payers.”
  • Fierce Healthcare delves into the Worthy healthcare reform project initiated by Ascendiun CEO Paul Markovich and tells us,
    • “Despite artificial intelligence becoming an increasing source of health information, 85% of U.S. adults still get information from providers “at least sometimes,” a new survey finds.
    • “Researchers at the Pew Research Center surveyed 5,111 U.S. adults from Oct. 20 to Oct. 26 for the report. Aside from providers, researchers identified six other main sources of health information:
      • “People with similar health issues: 66% 
      • “Major health information websites: 60% 
      • “News organizations: 46%
      • “Government health agencies: 45%
      • “Social media: 36%
      • “AI chatbots: 22%
  • Beckers Hospital Review lets us know,
    • “The availability and affordability of healthcare tops the list of American’s concerns about key issues, according to a March 31 Gallup article.
    • “The findings are based on telephone interviews conducted March 2-18 with 1,000 U.S. adults.”
  • Health Day reports,
    • “More pregnant women have to drive long distances to get the maternity care they need, a new study says.
    • “U.S. counties that lost all hospital-based obstetric services have been hardest hit, researchers recently reported in the American Journal of Preventive Medicine.
    • “In those counties, the number of women of childbearing age who live within a half-hour drive of obstetric care fell from more than 90% in 2010 to about 60% in 2021, researchers siad.
    • “Access to maternity care is critical for the health of both the birthing person and babies,” said lead investigator Brittany Ranchoff, a research fellow at Harvard Pilgrim Health Care Institute in Boston.” * * *
    • “The National Rural Health Association has more on rural access to obstetric services.”
  • Modern Healthcare adds,
    • “Health systems struggling to fill gaps in mental healthcare are hiring staff and redeploying capital to try to keep pace with rising demand.
    • “Systems including Hartford Healthcare, Sentara Health and Northern Light Health are expanding their mental health networks and ramping up care coordination teams. Still, health system leaders fear they will not be able to move quickly enough to patch an eroding safety net for mental health patients.
    • “Nearly 23% of Americans 12 and older received mental health treatment in 2024, up from 20.6% in 2023, according to the latest national data from the federal Substance Abuse and Mental Health Services Administration. Meanwhile, 137 million people lived in areas last year where there was a shortage of mental health professionals, up 12% from 122 million in 2024, Health Resources and Services Administration data show.
    • “Avoidable behavioral health inpatient admissions are often made because there is no place to discharge to,” said Tracey Izzard-Everett, vice president of behavioral health at Norfolk, Virginia-based Sentara Health. “That leads to repeat emergency department visits.”
  • Fierce Healthcare informs us,
    • “Orlando Health is acquiring Northeast Alabama’s RMC Health System, further fleshing out the Florida-based provider’s push into its neighboring state. 
    • “Unveiled Tuesday, the deal brings five years of “significant” investment into RMC’s facilities, equipment and technology, the organizations said in their announcements. These are expected to improve patients’ access to care, including specialty services, and boost physician recruitment. 
    • “The City of Anniston, Alabama, which owns RMC, said that the transaction has been approved by its city council and the system’s board of directors. It is expected to be completed this fall, pending regulatory approvals. Financial terms were not disclosed.”
  • Per Beckers Hospital Review,
    • “New York City-based NYC Health + Hospitals has opened a 104-bed Outposted Therapeutic Housing Unit at NYC Health + Hospitals/Bellevue.
    • “The unit is designed to treat people in custody with complex medical needs by relocating clinically vulnerable detainees from Rikers Island prison to a therapeutic setting with greater access to specialty care. It marks the first of three planned units across the city, according to an April 7 news release from Mayor Zohran Mamdani’s office. 
    • “At Bellevue, patients will have access to speciality care, including oncology, cardiology and neurology, according to the release. Correctional Health Services will deliver care on site, while the city’s Department of Correction will oversee security and custody management.”
  • and
    • “Searcy, Ark.-based Unity Health on April 15 will permanently close the emergency department and medical unit at its acute care hospital in Jacksonville, Ark., a spokesperson for the health system confirmed to Becker’s. 
    • “The closure comes just three years after the hospital opened in March 2023. Unity Health plans to convert the facility into a freestanding psychiatric hospital.
    • “Unity Health-Jacksonville currently operates a 13-bed emergency department and 24-bed behavioral health unit, and provides a range of services including inpatient and observation care, imaging and inpatient cardiopulmonary services.”
  • Per BioPharma Dive,
    • “Gilead Sciences was an industry pioneer in infectious disease, bringing to market treatments that have helped turn HIV into a manageable condition and effectively cure hepatitis C. But it has struggled to branch out elsewhere — a foray into heart disease didn’t turn out well, for instance, and a long-running push into cancer hasn’t yet yielded the kind of dividends the company had hoped.
    • “Those struggles haven’t discouraged Gilead from using deals to bolster other parts of its portfolio. The company’s pipeline now includes more experimental medicines for cancer and inflammatory conditions than infectious diseases. And three acquisitions struck in quick succession in early 2026 have shown the company remains committed to growing beyond its roots in HIV. 
    • “On a conference call with analysts Tuesday, Gilead CEO Dan O’Day claimed these dealmaking moves have made the company’s portfolio the “most robust and diverse” it’s ever been.” 
  • Per Beckers Payer Issues,
    • “Thirty-six percent of providers believe payers reliably deliver on promises, according to an inaugural Aetna provider survey released April 8.
    • “The survey will run quarterly, polling representatives of U.S. healthcare providers. This round fielded responses from 827 hospital system executives, physicians, nurses, pharmacists and health IT leaders over the first quarter of 2026. Global decision intelligence company Morning Consult conducted the survey.”

Monday report

David Ermer–CMS, FDA, Federal employment benefits, Medical / Rx research, Medicare, OPM, U.S. Healthcare–

From Washington, DC,

  • The Wall Street Journal reports,
    • “The Trump administration will raise payments to Medicare insurers by 2.48% next year, a dramatic increase after a preliminary proposal holding the line on payments drew fierce criticism from the industry and torpedoed shares of the largest companies.
    • “The final 2027 rates for Medicare Advantage, the private-insurer version of the federal program for seniors and the disabled, came in above some analysts’ expectations. Several had suggested a rate increase would likely be finalized at around 1% or slightly higher, with a “bull” case closer to 2% to 3%. 
    • “The final increase represents about $13 billion in additional payments to the insurers.
    • “The announcement marks a stunning turnaround for an industry that has been battered by a series of financial setbacks across multiple lines of business, particularly in the Medicare plans that had long been a major engine of growth.” * * *
    • “Chris Klomp, the Medicare program director, said in an interview with The Wall Street Journal that the Centers for Medicare and Medicaid Services is trying to balance the interests of enrollees and taxpayers. 
    • “We have to be wise stewards of the tax dollar,” said Klomp, who is also now a top official at the Department of Health and Human Services. But “we need to make sure that plans aren’t pulling out of markets, that they’re not cutting benefits that beneficiaries are relying on.”
    • “Trends in Medicare plans’ billing will raise the overall 2027 payment increase to 4.98% with the final rate changes added in, the agency said.”
  • AHIP adds,
    • “AHIP issued the following statement after the Centers for Medicare and Medicaid Services (CMS) issued the final 2027 Medicare Advantage (MA) and Part D rate notice.
    • “More than 35 million seniors and Americans living with disabilities choose Medicare Advantage because it provides them with better care at lower costs than fee-for-service. As health plans incorporate the policies released in recent days, they will continue to focus on keeping coverage and care as affordable as possible during this time of sharply rising medical costs.” – Chris Bond, AHIP spokesperson.”
  • and
    • “A new report by The Wall Street Journal examines why “Americans spend more on health care than anyone else in the world,” underscoring “the high prices Americans pay for surgeries and drugs” compared to consumers in other nations. Some key excerpts: 
    • “Americans spend more on healthcare than anyone else in the world. Just insuring a family here costs nearly $27,000 a year, enough to buy a car. The main cause: Prices are far higher in the U.S. for the same medical products and services, from surgeries to drugs.”
    • “Big hospitals can charge higher rates because of consolidation … Many cities and communities are now dominated by a single hospital system, partly because hospitals have been merging in recent years. The consolidation has given hospital systems leverage to command higher rates during negotiations with health insurers. The insurers would lose business if powerful hospitals shut them out.”
    • “Of note, an analysis  by KFF provides some additional context on the significance of pricing: “The U.S.’s higher spending on providers is driven more by higher prices than higher utilization of care. Patients in the U.S. have shorter average hospital stays and fewer physician visits per capita, while many hospital procedures have been shown to have higher prices in the U.S.” 
  • On a related note, MedPage Today offers an interview with “William Schpero, PhD, a healthcare economist at Weill Cornell Medicine in New York City, explains — among other things — why he thinks consumer-focused price transparency in healthcare won’t work, but putting the onus on physicians might.”
  • Modern Healthcare informs us,
    • “The Federation of American Hospitals’ new President and CEO, Charlene MacDonald, has her work cut out. 
    • “MacDonald, who succeeded longtime CEO Chip Kahn in January, is charged with steering a trade group that supports more than 1,000 for-profit hospitals and health systems as they navigate steep funding cuts and a rapidly evolving care delivery landscape.
    • “MacDonald joined the federation in 2023 as executive vice president of public affairs and oversaw government affairs, advocacy, communications, finance and operations. 
    • “In an interview, MacDonald said the changes coming in the next two years are dire for hospitals, and members can play a critical role in shaping policy. The interview has been edited for length and clarity. 
    • “What are your top priorities for 2026 and beyond?
    • “The first is affordability. That’s not just premiums, but out-of-pocket costs and whether coverage translates into access. The second is stability in coverage programs. Medicaid financing is obviously critical, but so is the stability of the individual market. The third is transparency and accountability on how premium dollars are being used.
    • “Our role is to bring that on-the-ground perspective to the policy conversation and ensure the conversations we’re having are not just academic but are reflective of the patient experience.”
  • Govexec and Federal News Network discuss OPM’s March 31, 2026, call letter for 2026 benefit and rate proposals from FEHB and Postal Service Health Benefits carriers. It is unfortunate that OPM continues to pile new benefit mandates on top of the many older ones.

From the Food and Drug Administration front,

  • MedTech Dive reports,
    • “VDyne said the Food and Drug Administration approved an investigational device exemption for a pivotal clinical trial of its transcatheter tricuspid valve replacement system. The approval, announced last week, moves VDyne a step closer to competing with Edwards Lifesciences’ Evoque tricuspid valve replacement device.
    • “The TRIVITA trial will evaluate the safety and efficacy of the VDyne device to treat symptomatic severe tricuspid regurgitation, where the valve fails to close properly and leaks, making the heart work harder to pump blood. The artificial valve is intended to restore normal blood flow.
    • “VDyne said there is a significant unmet need for minimally invasive tricuspid regurgitation treatments, noting most of the 1.5 million patients in the U.S. with the condition are too frail for open heart surgery. Tricuspid valve surgery is associated with high mortality and poor outcomes, the company added.”
  • Fierce Pharma relates,
    • “In response to a warning letter from the FDA that accused the company of making “false or misleading” claims about its bladder cancer drug Anktiva, ImmunityBio is implementing enhanced measures aimed at ensuring that all promotional communications relating to the drug are “accurate, balanced and compliant with FDA regulations,” the company said in a release.
    • “Among the measures ImmunityBio has implemented are “expanded promotional review protocols,” executive training and external regulatory oversight, the company said. The moves follow a “comprehensive review of all promotional materials and external communications” with its legal and regulatory teams, ImmunityBio explained.
    • “ImmunityBio added that it has removed from its corporate website a podcast identified by the U.S. regulator in its March warning letter. The company has also requested the removal of the podcast from all third-party platforms, it said.” 

From the public health, medical and Rx research front,

  • HealthDay reports,
    • “Many folks think it’s OK to belt back a few extra rounds on Saturday night if they stay mostly sober during the week.
    • “But saving up your drinks for a single sitting could be a recipe for liver problems, new research suggests.
    • “A team at the University of Southern California’s Keck School of Medicine linked occasional heavy drinking to triple the risk of advanced liver fibrosis — a dangerous type of scarring that can lead to liver failure. 
    • “Their findings — published April 2 in Clinical Gastroenterology and Hepatology — indicate that the way you drink may be just as important as how much.
    • “Occasional binge drinking could be changing liver tissue in profound ways.
    • “This study is a huge wake-up call because traditionally, physicians have tended to look at the total amount of alcohol consumed, not how it is consumed, when determining the risk to the liver,” lead author Dr. Brian Lee, a hepatologist at Keck Medicine, said in a news release.”
  • The American Medical Association lets us know “what doctors wish patients knew about rheumatoid arthritis.”
    • “Among chronic conditions, one stands out for its enigmatic nature and debilitating impact: rheumatoid arthritis (RA). 
    • “This condition presents an array of challenges and wreaks havoc on the lives of those who live with it. And while there are effective treatments that can prevent or slow the progression of rheumatoid arthritis, many questions remain unanswered, leaving patients and their families searching for better strategies to manage this life-altering condition.”
  • Drug Topics relates,
    • A growing body of evidence suggests that the choice of glucose-lowering therapy may play a critical role in colorectal cancer prevention.
    • For pharmacists managing the complex needs of patients with type 2 diabetes (T2D), a growing body of evidence suggests that the choice of glucose-lowering therapy may play a critical role in colorectal cancer prevention. A trial emulation published in Diabetology and Metabolic Syndrome reveals that dual therapy combining sodium-glucose cotransporter-2 (SGLT2) inhibitors with glucagon-like peptide-1 (GLP-1) receptor agonists is associated with a 21% lower risk of colon cancer in high-risk patients with a history of polypectomy. This finding, derived from a large-scale analysis of over 57,000 patients, suggests that the combination of these 2 drug classes may offer additive chemopreventive effects that surpass the benefits of monotherapy alone.
  • MedPage Today adds,
    • “Commonly prescribed antibiotics and non-antibiotic drugs were associated with significantly increased odds of Clostridioides difficile infection in a case-control study.
    • “Non-antibiotic drugs with the greatest observed risks for C. difficile infection were antidiarrheals, analgesics, and corticosteroids.
    • Considering how frequently these medications are used, prudent prescribing decisions are needed, researchers said.
  • Healio notes,
    • “Approximately half of patients with the highest-risk brain metastases did not receive palliative care consultations, according to results of a study of nearly 500 patients.
    • “Those who received palliative care had significantly higher rates of advance directive completion and hospice enrollment, without any compromise in overall survival.
    • “Palliative care consultation is not end-of-life consultation,” Rohit Singh, MD, medical oncologist and assistant professor at University of Vermont Larner College of Medicine, told Healio. “It should be a part of patients’ multidisciplinary team.”
  • Genetic Engineering and BioTechnology News tells us,
    • “Biomedical researchers headed by a team at the Lampe Joint Department of Biomedical Engineering, University of North Carolina at Chapel Hill/North Carolina State University, have developed an injectable microgel to help reduce bleeding in infants who require surgical care. Tests in an animal model showed that the hemostatic microgels, known as B-knob-triggered microgels (BK-TriGs), reduced bleeding by at least 50%.
    • “Research lead Ashley Brown, PhD, who is the Lampe Distinguished Professor of Biomedical Engineering, is co-corresponding author of the team’s published paper in Science Advances, titled “Hemostatic B-knob-triggered microgels (BK-TriGs) to address bleeding in neonates.” In their paper the team concluded “This study highlights the potential of BK-TriGs, designed for neonatal-specific clotting mechanisms, to address the heightened bleeding and thrombosis risks in neonates, who face 4.4 times higher postsurgery mortality … Our findings support BK-TriGs as a promising approach for improving hemostasis in neonates, offering a tailored, effective solution for this vulnerable patient population.”
  • BioPharma Dive informs us,
    • “Amgen said an injectable version of its blockbuster eye disease drug Tepezza hit both goals in a key late-stage trial that could help the company fend off competition from an emerging rival. 
    • “According to Amgen, a form of the thyroid eye disease drug Tepezza that’s delivered via an on-body injector instead of an intravenous infusion met its main objective as well as a key secondary endpoint in the study. Notably, the newer version, Tepezza OBI, appeared comparable to the marketed medicine, displaying “IV-like efficacy,” said research chief Jay Bradner, in the statement.”  

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

  • Healthcare Dive reports,
    • “Centene has created two new executive leadership positions to consolidate oversight of its Medicaid, Medicare and Affordable Care Act businesses as the insurer copes with rising costs and looming policy challenges.
    • “Centene has hired longtime health insurance executive Daniel Finke as its inaugural group president of markets and commercial, the company announced Monday. Centene also named Michael Carson, the CEO of its Medicare business, as group president of Medicare and specialty.
    • “Both executives will report to Centene CEO Sarah London. Centene did not respond to a request for comment about when the appointments are effective.”
  • Per a recent Health Care Cost Institute issues brief,
    • “Imaging services made up 24% of outpatient visits and were the second largest category of outpatient spending (17%) in 2022. The most common imaging services were for screening mammography and chest x-rays, which are used for routine screening and diagnosing certain conditions. Other imaging services such as CT scans of the abdomen, echocardiography (ultrasound for the heart), and MRI of the brain occurred less often but had higher costs, making them some of the highest spending imaging services.
    • “One way to better understand prices in employer-sponsored insurance is to compare negotiated rates paid in ESI to Medicare payments for the same services. On average the commercial prices of x-rays were 314% of Medicare, MRIs were 307% of Medicare, CT scans were 257% of Medicare, and Ultrasounds were 245% of Medicare. HCCI estimated that, if commercial prices were equal to Medicare prices, ESI spending would be $6B lower for MRIs, $3.1B lower for CT scans, $2.7B lower for ultrasounds, $1.5B lower for nuclear imaging, and $1.2B lower for x-rays.”
  • MedCity News relates,
    • A new report is providing some much needed validation for those in the women’s health industry.
    • Women’s health has long been under-represented, under-researched and under-funded. About 5% of total healthcare R&D and investment funding goes towards women’s health. But a shift is taking place as research shows that increasing investor dollars are starting to flow into women’s health, and not just reproductive health, according to a report released this month from consulting firm PwC. Which means a wholesale modification of the very categories that define women’s health — traditionally thought of only as reproductive health and women specific-conditions such as menopause or endometriosis — is in order.
    • The traditional definition of women’s health only represents a $195-205 billion market, according to PwC. But there are medical conditions that affect women differently — like asthma, cardiovascular diseases, diabetes and mental health. Then there are conditions that affect women disproportionately, including Alzheimer’s, autoimmune diseases and migraines.
    • “When this broader definition is considered that includes a woman’s entire life cycle through all its varied stages, the women’s health industry represents a $430-440 billion global market across pharmaceuticals, devices and diagnostics, providers, payers and consumer health solutions, according to PwC. 
    • “And this is projected to reach $600 billion by 2030, and that’s “if we do nothing,” according to Glenn Hunzinger, PwC’s health industries leader.
    • “If we continue to have a focus, I could see those opportunities getting much wider and much bigger,” he said in an interview.
    • “Investors, advocates and entrepreneurs were encouraged by the report’s call to action.”
  • MedTech Dive tells us,
    • “Boston Scientific has closed its acquisition of incontinence device maker Valencia Technologies, the company said on LinkedIn last week.
    • “The buyout gives Boston Scientific control of eCoin, a tibial nerve stimulator that competes with Medtronic’s Altaviva for the urge urinary incontinence market. Boston Scientific announced the deal in January.
    • “RBC Capital Markets analysts welcomed the deal in a note to investors in January, explaining that the takeover moves Boston Scientific into a high-growth area.”
  • Fierce Pharma informs us,
    • “Neurocrine Biosciences, forever a possible M&A target in the biopharma industry, is making a major acquisition itself.
    • “Neurocine has reached a deal to acquire Soleno Therapeutics for $2.9 billion, bagging recently FDA-approved Vykat XR (diazoxide choline), the first therapy for hyperphagia in patients with the rare genetic neurodevelopment disorder Prader-Willi syndrome (PWS).
    • “Hyperphagia is an insatiable hunger, which can lead to co-morbidities such as obesity and other cardiometabolic diseases and death.
    • “The announcement of the Soleno deal comes a few months after Neurocrine unveiled an obesity pipeline led by a preclinical CRF2 agonist.” 
  • Fierce BioTech points out,
    • “AI powerhouse Anthropic is continuing its push into the healthcare arena with the acquisition of previously stealth AI biotech startup Coefficient Bio in a $400 million stock deal, according to reporting from The Information and Eric Newcomer.
    • “TechCrunch also confirmed the acquisition through sources close to the deal, and Coefficient’s PitchBook page reflects the $400 million transaction as well. Anthropic and Coefficient have not yet responded to Fierce Biotech’s requests for confirmation.”
  • MedCity News adds “Uma Veerappan of Flare Capital Partners thinks the healthcare AI startups that will come out on top will be companies that integrate seamlessly into workflows, build proprietary datasets and quickly determine how to sell their technology.”