Tuesday report

Federal employment benefits

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.” 

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.” 

Thursday report

David Ermer–CDC, Electronic health records, FDA, Federal employment benefits, Medical / Rx research, Mental health care, Obesity, Rx coverage, U.S. Healthcare–

From Washington, DC

  • Federal News Network reports,
    • “The Postal Service is temporarily suspending payments to a governmentwide pension plan, after warning Congress that it’s less than a year away from running out of cash.
    • “USPS told the Office of Personnel Management on Thursday that it will hold off paying its contributions to the Federal Employees Retirement System (FERS), a move that’s expected to conserve cash in the near term.
    • “The mail agency, which has posted billion-dollar net losses almost every year since 2007, has relied on these extraordinary measures before to conserve cash.”
  • and
    • “The Postal Service received approval to add a temporary surcharge to most of its standard package shipping options. The Postal Regulatory Commission approved an 8% across-the-board price increase for its core package and shipping services. The surcharge will go into effect on April 26 and will remain in place until Jan. 17, 2027. USPS said the surcharge is necessary to keep up with higher fuel and transportation costs. Before this, USPS only added a package surcharge during its busy holiday peak season, which runs from October through December.”
  • OPM Director Scott Kupor explains how to chart your HR career path in his latest Secrets of OPM blog post which is available on Substack.
  • Tammy Flanagan writing in Govexec discusses “How to ensure your federal retirement benefit is correct.”
    • “OPM processed more than 33,000 retirement claims in early 2026. Learn how your FERS benefit is calculated and how to verify your creditable service.”
  • Federal News Network adds,
    • “More than 55,000 federal retirement applications are still pending finalization at the Office of Personnel Management. That’s after OPM managed to shave off about 10,000 applications from its total case inventory last month. During March, OPM received close to 15,000 incoming retirement applications, but processed over 22,000. Roughly half of those claims were completed digitally through OPM’s new processing system, which OPM said can finalize retirements at about double the speed as the traditional system.”

From the census front,

  • Per a U.S. Census Bureau news release,
    • “The nation turns 250 this year and Americans’ median age — the age at which half of the population is younger and half is older — continues to rise, climbing from 39.2 in 2024 to 39.4 in 2025.
    • “We use population estimates released today to examine changes in the U.S. age structure by sex from 2001, when the median age was 35.6, to 2025.
    • “One striking shift is that while women continued to outnumber men at older ages, the gap between the sexes narrowed in the past 25 years.
    • “In 2001, there were 70.6 males for every 100 females age 65 and older. By 2025, the ratio had increased substantially to 81.6.
    • “The gap among those age 80 and older narrowed even more dramatically — from 50.9 males per 100 females in 2001 to 68.3 in 2025.
    • “Mortality rates for older men have been decreasing faster than for women and, as a result, men’s share of the older population has increased,” said Marc Perry, senior demographer in the U.S. Census Bureau’s Population Division. “But the mortality gap between men and women is still there. In fact, the current mortality rate for men age 65 and older is roughly where the equivalent rate for women was 50 years ago.”
  • The Wall Street Journal reports,
    • “The nation’s fertility rates hit record lows in 2025 as childbearing continued to shift toward older women, according to new federal data released Thursday. For the sixth straight year, the number of children born in the U.S. remained at roughly 3.6 million.
    • “The number of births per 1,000 women ages 15 to 44—the general fertility rate—reached a record low of 53.1 in 2025, according to provisional data from the Centers for Disease Control and Prevention. The rate has mostly headed down since 2007, a prerecession peak when millennial women started to enter their prime childbearing years.
    • “One long-term trend driving the slide: a sharp decrease in birthrates for teens and women in their 20s. In 2025, birthrates for women in their late 30s exceeded those for women in their early 20s for the first time.”

From the Food and Drug Administration front,

  • STAT News reports,
    • “Despite a mandate from the Trump administration to remove barriers for health artificial intelligence companies, the Food and Drug Administration has denied a proposal that would have made it easier for large developers of AI-enabled medical devices to put their products on the market.”
  • Modern Healthcare reports,
    • “The Food and Drug Administration has sent a warning letter to Medline Industries over reported issues with syringes used in cardiac procedures and the company could face regulatory action if the issues are not corrected.
    • “The company received the letter March 25 following a December inspection of its facility in Glen Falls, New York. The agency said the Namic angiographic control syringes, which are packaged into Medline’s cardiovascular procedure kits, were disconnecting from the hub that controls the flow of fluids. The letter was made public Tuesday.”
    • “In the warning letter, the agency said there were 221 complaints about the syringes and 177 medical device reports, including one involving air being injected into a patient and another exposing a clinician to a biohazard.”
  • MedTech Dive relates,
    • The Food and Drug Administration’s device center launched an innovation challenge Tuesday to give patients access to home medical devices to reduce hospital readmissions.
    • The Center for Devices and Radiological Health plans to select nine devices from different manufacturers by Dec. 4 for the challenge. Selected companies will have opportunities for early engagement with the FDA, including feedback to help refine device design and testing, and the chance to demonstrate their technology at FDA research facilities. 
    • The program, called the Reducing Readmissions through Device Innovation for the Home Innovation Challenge, is part of the device center’s Home as a Healthcare Hub initiative, which started in 2024. The initiative is intended to support innovation for medical devices used in the home, while considering diverse perspectives and people’s living environments.
  • and
    • “Philips sent an urgent field safety notice to customers in March instructing them to no longer use non-pneumatic nebulizers, including vibrating mesh nebulizers, with its Trilogy Evo ventilators.
    • “The Food and Drug Administration posted the action in its database last week as a Class I recall. It applies to Philips’ Trilogy Evo, Trilogy Evo O2, Trilogy Evo Universal and Trilogy EV300 ventilators.
    • “A Philips spokesperson wrote in an email to MedTech Dive that the ventilators may be used safely by following the revised instructions.”
  • Radiology Business tells us,
    • “Experts are sounding the alarm on a newly approved use of dermal filler in the décolleté area, citing concerns over its potential effect on breast cancer screening exams. 
    • “Radiesse, manufactured by Merz Aesthetics, is a subdermal filler used to smooth wrinkles and decrease the visibility of fine lines. The U.S. Food and Drug Administration on April 8 approved its use for the décolleté area—the upper chest above the breasts—in adults 22 and older. 
    • “The filler contains hydroxylapatite microspheres, which may be visible on medical imaging. Given the location of the implant and its close proximity to imaged area, experts are concerned it could affect the visibility of breast tissue on mammograms, masking small lesions. Experts voiced these concerns to the FDA during an advisory meeting about the product last August. 
    • “As a breast imager, my focus is to find a cancer as small as possible,” Sandra Shuffett, MD, of Baptist Health Medical Group in Lexington, Kentucky, explained during the panel. “That is my concern, with the fillers potentially obscuring a cancer on a mammogram until it grows larger and then requires more serious treatment.” 
    • “Merz Aesthetics has refuted these claims, maintaining the safety and efficacy of the product. As a precautionary measure, however, the FDA is requesting that the company conduct a postmarket assessment of 30 individuals to determine whether the filler affects breast imaging. The study will require participants receiving the injections to undergo baseline breast imaging before completing three filler treatments six weeks apart; they will complete additional breast imaging one month after all the treatments have been administered.” 

From the public health, medical and Rx research front,

  • Per an Epic news release,
    • “Epic Research now monitors health conditions across the U.S. at the county level and publishes Health Alerts when elevated rates are detected. The alerts use statistical models applied to real-world medical records to detect when the rate of a health condition in a county is higher than expected. Each alert is reviewed by the Epic Research team before it is published.
    • “You can view active Health Alerts here. You can also subscribe to receive Health Alerts by email. Subscribers receive new alert notifications when an elevated rate is first detected in a state and weekly summaries of all active, new, and resolved alerts.”
  • NBC News reports,
    • “Regular exercise and about seven hours of sleep a night could protect brain health in the long term, a study published Wednesday in the journal PLOS One found. Long bouts of sedentary behavior may increase dementia risk.
    • “It’s the latest data to show that people don’t need elaborate and expensive longevity hacks to stay mentally sharp as they age. Simple lifestyle changes could reduce a person’s risk of late-onset dementia by as much as 25%, according to the study. 
    • “About 1 in 9 people in the United States will develop Alzheimer’s disease, according to the Alzheimer’s Association, meaning a person’s overall risk is about 11%. With the suggested changes in lifestyle, the average person’s risk decreases to about 8%.
    • “The reduction is “fairly comparable to the effect sizes sometimes seen with medications for chronic diseases,” said Akinkunle Oye-Somefun, a researcher at York University in Toronto, who led the study. 
    • “Breaking up longer periods of sitting had the greatest effect, the study found.” 
  • MedPage Today adds,
    • “People who followed a high-quality plant-based diet had a lower risk of Alzheimer’s disease and other dementia, while those with a low-quality plant-based diet had a higher risk, prospective data showed.
    • “At baseline, people who ate the most plant foods overall had a 12% lower risk of dementia over nearly 11 years of follow-up compared with those who ate the least (HR 0.88, 95% CI 0.85-0.92), reported Song-Yi Park, PhD, of the University of Hawaii at Manoa in Honolulu, and co-authors.
    • “However, not all plant-based diets performed equally well. People with a high-quality plant-based diet at baseline had a lower dementia risk (HR 0.93, 95% CI 0.89-0.97), while those with a low-quality plant-based diet had a higher dementia risk (HR 1.06, 95% CI 1.01-1.10), Park and colleagues wrote in Neurology.”
  • BioPharma Dive relates,
    • “Invivyd said Thursday it has discovered and is preparing for human testing an antibody drug for measles, infections of which have spiked as of late in the U.S. due in part to rising vaccine hesitancy.  
    • “The Connecticut-based biotechnology company also provided an update for its lead program, an antibody for COVID-19 prevention, alongside its plans for the new drug’s development. Invivyd sees the antibody, known as VMS063, as a possible treatment for the disease or a preventive option for those who can’t, or won’t, get vaccinated. 
    • “VMS063 uses a similar strategy as approved antibody drugs for respiratory syncytial virus, which work by latching onto a surface “fusion” protein and blocking entry into cells. Invivyd said VMS063 could be the “first precision therapy” for measles and address the “immunity gap” emerging due to lower vaccination rates.” 
  • Health Day notes,
    • “In pediatric patients, influenza vaccine effectiveness (VE) varied across 2021 to 2024 seasons, but did help prevent influenza-associated hospitalizations and outpatient visits, according to a study published online April 6 in Pediatrics.” * * *
    • “Our study shows influenza VE ranged, but overall, was effective at preventing influenza-associated hospitalizations and outpatient visits in children aged 6 months to 17 years,” the authors write. “Higher pediatric influenza vaccine coverage could amplify the benefits of vaccination among children.”
  • Genetic Engineering and Biotechnology News tells us,
    • “The biological connection between a pregnant woman and her developing baby—the human maternal–fetal interface—is a specialized, transient organ composed of uterine cells from the mother and fetal cells that acts as a barrier, supports fetal growth, and maintains the mother’s health. The cellular complexity of the maternal-fetal interface has limited scientists’ ability to study how healthy pregnancies develop and why complications arise. The underlying cellular, molecular, and spatial programs of the interface—which forms about a week after fertilization and lasts until birth—has remain incompletely defined.
    • “Now, the human maternal–fetal interface has been mapped in unprecedented detail by scientists at the University of California, San Francisco (UCSF), revealing new cell types and providing insights into conditions such as preeclampsia, preterm birth, and miscarriage.
    • “By examining this tissue cell by cell across pregnancy, we can begin to understand both normal development and what may go wrong,” said Susan J. Fisher, PhD, professor of obstetrics, gynecology, and reproductive sciences at UCSF.”
  • Endocrinology Advisor notes,
    • “Elevated BMI in infancy and early childhood has a nearly null effect on pubertal timing. In contrast, high BMI in mid-childhood (starting around 6 years of age) and late childhood shows a strong, direct association with earlier onset.”

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

  • STAT News reports,
    • “At first blush, it might seem like Charleston, W.Va., New York, N.Y., and Janesville, Wis., have little in common. 
    • “But those three metros were flagged in a new report as having some of the country’s highest per-person health care spending. And there are other surprises, too. Three metros in California — a state known for its high prices — are among the lowest spenders, and two in West Virginia are among the highest. 
    • “The Health Care Cost Institute, a nonprofit, independent research group, released the report today along with a new data tool called Health Cost Landscape, which allows users to search for specific U.S. metro areas and examine the factors behind health spending there.  
    • “The tool and accompanying report rely on 1.3 billion medical claims from 2018 to 2022 from employer-sponsored health plans, representing more than 38 million people with employer sponsored insurance each year. 
    • “The fact that there’s not a consistent theme among the 10 highest and lowest spending metros speaks to the “irrationality” of health care spending in the U.S., said Katie Martin, HCCI’s CEO. Spending will always be a combination of price and utilization, but figuring out why each region landed on the list requires drilling down into its specific characteristics.” 
  • KKaufman Hall released its National Hospital Flash Report for February 2026.
    • “Key Takeaways
      • “Cost pressures are driving a tenuous financial outlook. Hospital expenses are elevated in early 2026 compared to 2025, while revenues are pressured by an eroding payer mix and remain below sustainable levels.
      • “Hospital performance is bifurcating. There is significant variation in hospital performance by size, geography, and market position.
      • “Softer, uneven volumes reflect shifting care patterns. Patient days have softened in early 2026 while the average length of stay remains relatively steady, reflecting both demographic shifts and changes in where care is delivered.
      • “Outpatient revenue is rising in early 2026. Outpatient care offers significant benefits to both patients and health systems, though hospitals must manage both revenue dilution and a greater concentration of high-acuity patients as a result.”
  • Kaufman Hall also posted its “M&A quarterly activity report: Q1 2026.”
    • “The Q1 2026 trends reflect an industry undergoing transformation. Health systems are repositioning by withdrawing from underperforming or non-core markets, building capital to invest in new capabilities, proactively seeking partners to increase resilience or enhance access to care and services, and placing big bets on new combinations of resources and capabilities. A return to more robust levels of deal-making is a sign that organizations remain well aware of the need to seek combinations and partnerships to face the challenges and opportunities that lie ahead.”
  • Fierce Healthcare tells us,
    • “Advocate Health notched a strong 2025 with more revenue, patients, operating income and bottom line gains than the year prior. 
    • “The nation’s third-largest nonprofit health system reported Wednesday over $38.9 billion in total revenue during the year ended Dec. 31, 2025, a nearly 12% increase over the year before. 
    • “Total expenses rose a hair slower, by about 11%, to $37.4 billion, leaving the organization with more than $1.5 billion in operating income (4.0% operating margin). It had reported a $1.2 billion operating income (3.5% operating margin) in 2024.” 
  • Beckers Hospital Review points out four hospitals that closed in the first quarter of 2026.
  • The Wall Street Journal reports,
    • “Eli Lilly’s Foundayo weight-loss pill is now available in the U.S. following the Food and Drug Administration’s approval.
    • “The drug is available through Eli Lilly’s direct sales platform, telehealth providers, and is shipping to retail pharmacies.
    • “Foundayo’s starting dose costs $149 a month, matching the price of Novo Nordisk’s competing GLP-1 pill.”
  • Beckers Hospital Review adds,
    • “Novo Nordisk’s recently approved high-dose Wegovy formulation has entered the U.S. market and is available for $399 per month for self-paying patients, the drugmaker said April 7. 
    • “In March, the FDA approved Wegovy HD, a 7.2-mg injection of semaglutide, as a weight loss medication. Prior to the approval, the highest dose of injectable Wegovy was 2.4 milligrams. 
    • “Wegovy HD’s launch comes days after the FDA approved Eli Lilly’s GLP-1 pill, Foundayo, which is the second FDA-approved GLP-1 pill for weight loss — the first is Novo Nordisk’s Wegovy pill. 
    • “Novo Nordisk’s direct-to-consumer platform offers self-paying patients to fill injectable Wegovy prescriptions for $199 per month’s supply of the 0.25-, 0.5-, 1-, 1.7- or 2.4-mg dosages. Wegovy HD is offered for $399 per month’s supply.” 
  • Per Fierce Healthcare,
    • “Humana is teaming up with digital health company b.well Connected Health to make it easier for members to access their health data across multiple providers, health plans, pharmacies and digital health apps. 
    • “The partnership aligns with a broader push by the Trump administration to give patients easier access to their health information.
    • “As part of the partnership with b.well, Humana will also be able to access its members’ data in real-time at the point of claims processing and securely respond to data requests from providers and other health plans, supporting care coordination and quality improvement, the insurer said in an April 9 press release.”
  • and
    • “Amazon is expanding its health conditions program with two recently announced partnerships focusing on nutrition therapy and sleep care. 
    • “The retail giant launched its Health Benefits Connector program in January 2024, which aims to help connect customers with virtual care benefits. Teladoc, Rula Health, Talkspace, Omada Health and Hinge Health are several of the organizations involved with the program.
    • “The most recent to join is virtual sleep clinic Dreem Health.
    • “Eligible customers can enroll in the care provider’s sleep services, which include sleep diagnostics using Sunrise Group’s FDA-approved home sleep test. Dreem Health will be the first sleep health provider on the platform, according to the April 9 announcement. 
    • “Artificial intelligence-driven nutrition therapy platform Berry Street also announced March 31 it would be joining Amazon’s program. The platform has a network of more than 1,500 registered dietitians providing nutrition therapy for weight loss, diabetes, cardiovascular disease and maternal health.”
  • MedTech Dive informs us,
    • “One year after President Donald Trump’s “Liberation Day” declaration in a White House Rose Garden ceremony unleashed a tariff policy targeting top U.S. trading partners, medtech companies are still absorbing the shocks.
    • “Tariffs on imports from China, Mexico, Canada, the European Union and other key trade partners were meant to boost domestic manufacturing, but in the medtech sector, where integrated global supply chainsdesigned for efficiency can take years to establish, reshoring has not been the primary response. That’s in contrast to the pharmaceutical industry and certain other sectors, where companies are pouring billions of dollars into building new production facilities in the U.S.
    • “To manage the extra expenses brought by tariffs, medtech companies have tried to avoid raising prices for hospitals and health systems or cutting R&D budgets, according to industry advisers and analysts. Instead, they are accelerating efforts to drive down costs across their organizations.
    • “They have to find levers elsewhere,” said Glenn Hunzinger, PwC’s U.S. health industries leader. “They’re not passing the prices on to customers. They’re just bearing the brunt of it and trying to find efficiency, which was always the focus.”

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.”

Weekend update

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

Happy Easter!

From Washington, DC,

  • Congress remains on a State/District work break this week. Both Houses of Congress return to Capitol Hill on April 13.
  • Govexec reports,
    • “President Trump’s fiscal 2027 budget proposal, released Friday morning, would freeze federal civilian employees’ pay in 2027, all while granting a sizeable raise for members of the armed services.
    • “An Office of Management and Budget spokesperson told Government Executive that under Trump’s budget, civilian workers would receive no pay increase next January. But under the plan, members of the military would receive between a 5% and 7% pay increase, with the highest raises going to the lowest ranked personnel.”
  • The U.S. Office of Personnel Management has released its Fiscal Year 2027 Congressional Budget Justification.
    • Worth noting on page 84
      • The FEHB Protection Act of 2025 (FPA) requires OPM to strengthen eligibility verification and oversight of the FEHB Program. OPM is directed to issue regulations and implement verification processes by July 4, 2026, conduct a comprehensive family member eligibility audit between July 4, 2026 – July 4, 2029, and establish a process for removal of ineligible individuals (completed in December, 2025 per statutory deadline).
    • FEHBlog observation — Any improvement in eligibility verification should begin with adding the HIPAA 820 electronic enrollment roster transaction to OPM’s enrollment system. That transaction would allow carriers to reconcile premium payments to individual enrollments. What is the sense of performing this family member audit if carriers don’t know if the individual with self and family or self and family coverage (or half of the enrollment with self only coverage) is paying the correct premium?
  • Healthcare Dive reports,
    • “Antitrust regulators are warning Tennessee not to terminate an agreement giving its health department oversight of Ballad Health, a hospital monopoly in the state.
    • “The Tennessee legislature is considering bills that would allow Ballad’s certificate of public advantage, or COPA, to expire in 2028. Balled was formed in 2018 under the COPA, a controversial mechanism that allows potentially anticompetitive hospital mergers to go through in exchange for increased state oversight for a period of time.
    • “Without the COPA, all state supervision of Ballad’s care quality, availability and access, along with population health initiatives, would end.
    • “That could have steep consequences for Tennessee patients, including higher healthcare costs and poorer quality of care, the Federal Trade Commission said in the letter sent Wednesday.”
  • MedTech Dive relates,
    • “The Trump administration is adjusting how Section 232 tariffs on steel, aluminum and copper imports and derivative products are calculated, according to a proclamation President Donald Trump signed Thursday. 
    • “Under the new rules, which go into effect April 6, goods made almost entirely of aluminum, steel or copper, including steel coils and aluminum sheets, will face a 50% tariff for the value of the item. 
    • “However, derivative articles “substantially made” of steel, aluminum or copper will incur a 25% levy, per a White House fact sheet. Such goods include steel cooking appliances, silverware, diesel-engine trains and semi-trailer hauling trucks, according to a list provided by the White House.” 

From the public health, medical / Rx research front,

  • The Washington Post reports,
    • “Uri Alon was long puzzled by a textbook statistic: longevity, the thinking went, was about 20 percent in our genes.>” * * *
    • “The original studies that were used to estimate how much of lifespan was inherited were studies of Scandinavian twins from the tail-end of the 19th century.
    • “During that era, “extrinsic” mortality was high — deaths that aren’t related to the deterioration of aging, such as accidents, violence or deaths from infections that are now uncommon because of better nutrition, therapies and hygiene.
    • “His team examined a database of Swedish twins born later, between 1900 and 1935, and found that these extrinsic deaths were masking the inherited component of lifespan. When they applied their model, designed to remove extrinsic deaths, to databases of Scandinavian twins and the siblings of centenarians who lived to at least 100, the heritability of lifespan markedly increased — to about half.” * * *
    • “Thomas Perls, a longevity researcher at Boston University and the founding director of the New England Centenarian Study, agrees that genetics play a major role in lifespan, but that it depends on what age you are talking about.
    • “At the very extremes of old age — people who live to 105 or even 110 — genetics play a major role in lifespan. But Perls points to a 2018 study in the journal Circulation that suggests that even without winning the genetic lottery, an average person can probably get to about 88 years old as a man, and 93 years old as a woman. That depends on embracing good health-related behaviors. He also notes that socioeconomic advantages contribute — access to health care, education, healthy food.”
  • and
    • “Joseph Buxbaum was initially unconvinced. When early hints of a connection between autism and Alzheimer’s began to appear in the medical literature a few years ago, they struck him as implausible — one a condition of early brain development, the other driving decline in old age.
    • “But the signals kept accumulating, and over time, his skepticism gave way to a new line of inquiry that could transform scientists’ understanding of the two diseases.
    • “I came to this kicking and screaming. I didn’t want to believe it,” Buxbaum, a professor of psychiatry, neuroscience, and genetics/genomic sciences at the Icahn School of Medicine at Mount Sinai, said.” * * *
    • “The idea that two conditions at opposite ends of life might be biologically linked is beginning to upend long-standing assumptions in brain science, blurring a divide that has shaped the field for decades. Now, some researchers have begun to see the two as intertwined: that understanding Alzheimer’s may require looking back to how the brain develops, and that insights into autism might, in turn, reshape how we understand Alzheimer’s itself.”
  • Medscape tells us,
    • “For decades, clinical dietetics has been based on standardized nutritional recommendations for the general population: food pyramids, and Italy’s nutrient reference values, and dietary indications applied uniformly for conditions such as hypercholesterolemia or hypertension.
    • “In routine practice, however, physicians have increasingly observed that patients with the same caloric intake and physical activity can show different outcomes in terms of weight change, glycemic control, or lipid profile.
    • “This interindividual variability, once considered a clinical anomaly, is now supported by scientific literature. Response to diet does not depend exclusively on energy balance but also on a series of individual biological characteristics that influence nutrient metabolism and the interaction between diet and the body’s physiology.”
    • “Precision nutrition frames diet from a simple quantitative tool of nutrients to a personalized metabolic intervention.
    • “Applications of precision nutrition extend beyond body weight management. It has potential relevance in numerous clinical conditions, including gastrointestinal disorders such as irritable bowel syndrome, food intolerances, kidney stones, and various cardiometabolic conditions.”
  • and
    • “Analysis of real-world pharmacovigilance data shows that GLP-1s demonstrate distinct adverse event patterns across indications, primarily related to metabolic, nutritional, gastrointestinal, and psychiatric disorders, with different profiles observed across treatments.” * * *
    • “As millions of patients are taking GLP-1s for weight control and obesity treatment worldwide, clinicians should be vigilant in monitoring for unanticipated long-term adverse effects,” the authors of the study wrote.”
    • “The study was led by David Stone, Departments of Oncological Sciences and Biomedical Informatics, University of Utah, Salt Lake City. It was published online in Obesity.”

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

  • Beckers Payer Issues reports,
    • “The Blue Cross Blue Shield Association submitted a wide-ranging letter to CMS on March 30 in response to the agency’s information request on its Comprehensive Regulations to Uncover Suspicious Healthcare, or CRUSH, initiative. 
    • [Three of] Seven BCBSA Recommendations
      • “1. CMS should notify Medicare Advantage plans in real time when it suspends payments to a provider over suspected fraud because bad actors are exploiting the current information gap by shifting billing from original Medicare to MA after CMS acted on suspected fraud in fee-for-service.
      • “2. CMS should remove any contractual or policy language that requires MA plans to continue paying claims when fraud is suspected, regardless of whether CMS has paid its portion. The association also recommends that suspect claims be tagged with a unique code or priced at zero member liability at the time of a CMS payment suspension, so MA plans can identify those claims before payment.” * * *
      • “6. Overall, the association says the independent dispute resolution process under the No Surprises Act is broken and needs structural fixes. BCBSA recommends CMS launch the IDR Gateway as soon as possible, implement baseline eligibility screening before payment or review, establish an upfront eligibility fee to deter bad-faith submissions, and create performance metrics.”
  • The Health Care Cost Institute relates,
    • “The prevalence of depression and anxiety has increased steadily since 2019. Previous research, including a report from HCCI,  has identified a concurrent steady increase in the use of antidepressant and anxiolytic medications. Previous studies have found that most people receive prescriptions for psychotropic medications from their primary care providers. This finding describes national prescribing patterns, but few analyses have examined sub-national patterns and whether there is variation at a state level.” * * *
    • “Nationally, approximately three quarters of antidepressant and anxiolytic prescription fills are prescribed by a primary care provider. The remaining quarter of fills are prescribed by psychiatrists and psychiatric NPs, and a small fraction (<1%) are prescribed by other mental health professionals.” * * *
    • “At the state level, there is variation in the proportion of antidepressant and anxiolytic fills prescribed by each provider type. The proportion of fills prescribed by a PCP range from 55% in Washington, D.C. to nearly 86% in West Virginia.  Likewise, Washington D.C. has the highest proportion of fills prescribed by a psychiatrist or psychiatric NP (44%) while West Virginia has the lowest (14%).  The proportion of prescriptions from other mental health providers is highest in Rhode Island (5%) and lowest in Mississippi (0.2%).”
    • “At a national level, the proportion of antidepressant and anxiolytics prescribed by a psychiatrist or psychiatric NP increased by about 2 percentage points from 2018-2022.”
    • “More research is needed to understand the implications of high levels of PCP prescribing. One study found that patients who are treated by PCPs were less likely to be adherent to antidepressant treatment than patients who are treated by psychiatrists, and that patients treated by multiple providers had lower odds of nonadherence than patients treated by a single provider. Future studies should investigate why patients are receiving antidepressant and anxiolytic prescriptions from PCPs. This phenomenon could be related to mental health provider shortages or could indicate integration of mental health care into primary care, which is an objective of collaborative care models. Additional areas of research should include the role of other mental health providers, including allied health professionals, in prescribing medication, and outcomes associated with these prescribing provider types. Understanding how and why people are prescribed medications to treat mental health conditions is foundational for making informed decisions and effective policy to promote mental health care access.”
  • “The Wall Street Journal explains how a consumer can obtain healthcare advice from a AI tool.  The journalist does so in consultation with a human doctor.”

Friday report

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

From Washington, DC,

  • Per an OPM news release,
    • “The US Office of Personnel Management (OPM) released its Plan Year 2027 Carrier Call Letter for the Federal Employees Health Benefits (FEHB) and Postal Service Health Benefits (PSHB) Programs, outlining a clear shift toward prevention, wellness, and long-term health outcomes.
    • “The guidance calls on FEHB and PSHB carriers to help advance a healthcare approach that prioritizes prevention, improves health outcomes, and supports long-term affordability.
    • “The Plan Year 2027 priorities emphasize empowering individuals to take a more active role in their health while encouraging carriers to expand access to non-pharmaceutical interventions and digital therapeutics, promote cost-effective sites of care, and reduce unnecessary or low-value services. Over time, these changes are expected to prevent chronic conditions and drive meaningful cost savings.
    • “This year’s carrier letter reflects this administration’s commitment to WellCare and prioritizing the health and longevity of federal workers,” OPM Associate Director for Healthcare and Insurance Shane Stevens said. “Today’s health decisions shape outcomes for years to come.  By focusing on prevention and giving individuals the tools to take ownership of their health our participants have enhanced opportunities to improve their health while ensuring a more sustainable program for federal employees, retirees, and taxpayers.”
    • “OPM will continue working with carriers to implement these changes and strengthen a healthcare system centered on wellness and prevention. Read the letter to carriers here.”
  • FEHBlog Observation — While the call letter does include a boatload of new mandates, those mandates sit on topic of ideas from the Obama and Biden administrations because OPM rarely looks back. It’s high time to offset new spending by cleaning house on earlier mandates.
  • The American Hospital Association reports,
    • “President Trump April 3 submitted to Congress his budget request for fiscal year 2027. The top-line request proposes a 10% decrease ($73 billion) in non-defense discretionary spending. The budget requests $111.1 billion in discretionary funding for the Department of Health and Human Services, a 12.5% ($15.8 billion) reduction from FY 2026 enacted. The HHS proposal does not include any new mandatory spending proposals. While this proposal is not binding, it serves as a preliminary framework for both Congress and the administration as they determine federal funding levels and shape health care policy this year.”  
  • STAT News relates,
    • “The Trump administration is slashing the number of quality and care measures that Medicare Advantage plans will be graded on, a move that will funnel an extra $18.6 billion toward health insurers over the next decade.
    • “The final regulation, released Thursday by President Trump’s Centers for Medicare and Medicaid Services, is significantly more beneficial for the insurance industry than originally expected. CMS previously estimated these changes to star ratings would cost $13.2 billion between 2028 and 2036 when the rule was proposed in November.
    • “The extra funding from star ratings provides a sizable buffer for Medicare Advantage insurers, which are awaiting final payment rates for 2027 and experiencing higher medical claims. Insurers have lobbied Trump officials for more money in their baseline payments, and to scale back changes in how they record the sicknesses of their members. The government is supposed to release that regulation no later than April 6.”
  • Bloomberg Law adds,
    • “President Donald Trump’s plan to cover weight-loss medications for some people in the Medicare program for the elderly would cost the health insurers billions in its first year, a new analysis found. 
    • “The Trump administration has argued that the lower prices it negotiated with drugmakers last year would offset the cost of adding coverage for millions of new patients. The plan will “expand access and lower prices for obesity GLP-1 medication without passing the bill to taxpayers,” Mehmet Oz, director of the Centers for Medicare and Medicaid Services, said in a video promoting the plan. 
    • “But a new analysis undercuts that claim. Savings of more than $900 million during the program’s first year would only cover the costs for an estimated 4.4% of the patients who would become newly eligible for the drugs, according to researchers led by Vanderbilt University Professor of Health Policy Stacie Dusetzina.
    • “The findings published in the Journal of the American Medical Association come ahead of a crucial April 20 deadline for health insurers to decide whether they will join the optional program next year. The Trump administration has said it won’t proceed with the plan unless insurers covering 80% of the Medicare population join.
    • “All of the major insurers participating in Medicare’s drug benefit program would need to opt-in to hit that threshold. Dusetzina said she doesn’t see any clear path for the plans to increase access without a significant financial hit.”
  • FEHBlog Observation: This Medicare program would benefit the FEHB and PSHBP which currently covers these GLP-1 drug expenses for federal and Postal annuitants over age 65.
  • Fierce Pharma notes,
    • “The U.K. can officially declare itself free of tariffs on drug exports to the U.S. after its government signed off on the landmark U.S.- U.K. pharmaceutical partnership that first came to be in December. 
    • “In exchange for the tariff reprieve, the U.K. will boost the net price its National Health Service (NHS) pays for novel treatments by 25%. The arrangement lasts at least three years and makes the U.K. the first in the world to secure 0% tariffs on U.S. pharma exports, U.K. officials said in a Thursday press release. 
    • “First announced in December, the partnership protects a UK pharmaceutical industry that added £28.5 billion to the UK economy in 2025, employs over 50,000 people in highly skilled, well-paid jobs, and exported almost £21 billion in pharmaceutical products worldwide last year,” the government explained.” 

From the public health, medical and Rx research front,

  • The University of Minnesota’s CIDRAP reports,
    • “US flu activity keeps trending downward, according to the latest FluView report from the Centers for Disease Control and Prevention (CDC).
    • “Flu cases are declining across most of the country, the CDC said, with influenza A viruses waning and influenza B viruses showing varying levels of activity. That trend follows the typical seasonal flu virus patterns. The proportion of tests that were positive for flu fell to 9.8%, down from 11.5% the previous week, and the proportion of outpatient visits for flu remained below the national baseline for the second straight week, falling from 2.8% to 2.6%.
    • “For the season overall, influenza A viruses have been the most frequently reported. Of the influenza A viruses collected so far, 92.7% have belonged subclade K, which contains mutations that developed after this season’s flu vaccine strains were selected.
    • “Weekly hospital admissions for flu also declined, dropping from 5,640 the previous week to 3,050 this week. But an additional four pediatric deaths were reported this week, bringing the total for the season to 127. Although the CDC has classified the current flu season as moderate for adults, for children it’s been a high severity season.
    • “The CDC estimates there have been 30 million illnesses, 370,000 hospitalizations, and 23,000 deaths from flu so far this season.”
    • “Overall, the amount of acute respiratory illness causing Americans to seek health care is low, the CDC said in its respiratory illness update. But respiratory syncytial virus (RSV) activity picked up later than normal this year and is currently at elevated levels, though it appears to have peaked in most regions, and the virus isn’t making people sicker than in previous seasons. Emergency department visits and hospitalizations for RSV are highest among children aged 4 and under.
    • “COVID-19 levels are low across most of the country.
    • “The CDC also noted that human metapneumovirus (HMPV) activity is rising across the country, which is typical for this time of year. Symptoms of HMPV include cough, fever, nasal congestion, and shortness of breath.“
  • Beckers Clinicial Leadership adds,
    • “The new “Cicada” variant identified in more than half of U.S. states may be more likely to infect children than adults, CNN reported April 2.
    • “The variant, BA.3.2, earned its nickname because it has largely remained undetected or “underground” — like its insect namesake — since first discovered in a five-year-old boy in South Africa in November 2024.” 
  • The American Hospital Association relates,
    • “Cases in the Utah measles outbreak have increased to 559, the state’s Department of Health and Human Services reported March 31. The agency said 362 cases have been diagnosed so far this year during the outbreak, which began in June 2025. The Centers for Disease Control and Prevention reported today that there are 1,671 measles cases nationwide across 33 jurisdictions. There have been 17 outbreaks reported this year, with 94% of confirmed cases being outbreak-associated. The vaccination status of 92% of cases is unvaccinated or unknown.” 
  • KFF Health News points out,
    • “This week, the Centers for Disease Control and Prevention posted online its first large tranche of advanced genetic data from measles viruses spreading last year. Scientists with knowledge of the operation expect the agency to post heaps more in weeks to come, revealing whether the U.S. has lost its hard-won measles elimination status.” * * *
    • “The CDC did not answer queries from KFF Health News on its timeline for publishing measles data or analyses. However, once all the data is public, researchers can run quick initial analyses that will signal whether outbreaks across the U.S. last year resulted from the continuous spread of the disease between states, rather than separate introductions from abroad.
    • “If there was continuous transmission for a year, that means the U.S. has lost its status as a country that has eliminated measles. That status, which the U.S. has held since 2000, reflects a country’s vaccination rates: Two doses of the measles-mumps-rubella vaccine prevent most infections and so stop outbreaks from growing.
    • “More careful analyses take weeks.”
  • Reuters tells us,
    • “Medetomidine, which is also known as ‘rhino tranq,’ or ‘dex’, is ​not approved for human use but is approved for sedation ​and analgesia in dogs.
    • “The agencies said it has increasingly been detected in law enforcement drug seizures, drug product and paraphernalia samples and wastewater samples, ​with the highest concentrations in the Northeast region.
    • “The CDC said ​stopping medetomidine after regular use can trigger severe withdrawal, with symptoms including hypertension, ‌anxiety, ⁠nausea, vomiting and fluctuating alertness, which may require emergency or intensive care. It can also cause profound sedation, slow heart rate and hypotension.
    • “Because fentanyl is involved in most overdoses involving medetomidine, opioid ​overdose reversal medications ​like naloxone ⁠should be administered to restore normal breathing, the agencies said.”
  • Health Day tells us,
    • “A new rapid urine test could lead to more targeted and effective treatment of urinary tract infections (UTI), researchers say.
    • “It currently takes labs two to three days to determine which antibiotic would work best against an individual’s UTI.
    • “But the new test can turn around results in just under six hours, creating the potential for same-day antibiotic prescriptions for a UTI, researchers reported in this month’s issue of the Journal of Antimicrobial Chemotherapy.”
  • Medscape informs us,
    • “A group of diabetes professionals is proposing a change from the term prediabetes to the use of a three-stage classification of type 2 diabetes (T2D), with the aim of promoting earlier treatment and risk reduction.
    • “When is it too early to start to intervene in the process of diabetes?” said Moshe Phillip, MD, director of the Institute for Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children’s Medical Center, Petah Tikva, Israel, co-author of a comment paper on the topic published earlier this year in the Lancet Diabetes & Endocrinology.
    • “One of the mistakes that “we as a community have done in the past” is to label people as having prediabetes “because ‘prediabetes’ means that you are healthy,” he told Medscape Medical News.
    • “Actually, many of those that are defined as having prediabetes have a higher risk for all complications, mainly cardiovascular, he explained.” * * *
    • “Yet there is no drug approval process for prediabetes, despite the evidence that agents such as metformin, pioglitazone, and GLP-1 drugs can prevent progression to T2D and reduce cardiovascular risk.”

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

  • Modern Healthcare reports
    • “Elevance Health will apply its policy deducting pay from hospitals that refer some members to out-of-network providers to facilities in New York.
    • “Starting July 1, Elevance Health’s Anthem Blue Cross Blue Shield subsidiary may reduce New York hospitals’ pay by 7.5% or terminate facilities from its network if hospitals refer commercial members to inpatient or outpatient providers without a contract.
    • “Hospitals cannot pass the monetary penalty onto patients, according to an April 1 notice sent to providers.
    • “Rural, critical access and safety-net hospitals are exempt. Hospitals will also not be penalized for referring patients to emergency services or an out-of-network pre-approved provider. Additionally, the penalty will not apply when no in-network providers are available to provide the same care within the same geographic area.”
  • Healthcare Dive offers a commentary from Dr. Catherine Gaffigan is the president of health solutions at Elevance Health in which Dr. Gaffigan explains how this practice holds down health care costs.
  • Medical Economics relates,
    • “Medical Economics spoke with Shannon Sims, M.D., Ph.D., FAMIA, chief product officer at Vizient, and Matthew Bates, M.P.H., managing director at Kaufman Hall, about Vizient’s 2026 State of the Industry Report and what it describes as a reset moment for U.S. health care. When asked what changes physicians will feel first, both pointed to the same two shifts: artificial intelligence (AI) moving into everyday workflow and advanced practice providers (APPs) taking on a larger share of clinical care.
    • “Bates framed the AI transition as a move out of the hype cycle and into practical use. Ambient listening — tools that generate clinical notes from recorded patient encounters — is the clearest example. “It is moving from a niche to really changing the way we practice, particularly in clinic and office settings,” Bates said.
    • “Sims explained that, “what most physicians will see day to day is the use of AI tools to automate or reduce the burdens they feel,” pointing specifically to documentation, billing, medication refills and patient access as areas where meaningful improvement is already within reach. Now, he says the window for sitting it out is closing. “If [physicians] do not [embrace these tools], they risk falling behind and losing some of the relevance and ability to practice in the way they would like to.”
    • “On APPs, Bates was equally blunt. The physician shortage is real, it isn’t resolving quickly, and APPs are filling the gap. How health systems build effective, high-quality teams around that reality, rather than just plugging holes, is one of the central operational questions of the moment.”
  • Radiology Business adds,
    • “A Harvard University economist claims that imaging volumes are falling in the U.S., blunting the need for more radiologists. 
    • “David M. Cutler, PhD, a noted researcher and professor, shared the thought in an editorial published Thursday by JAMA Health Forum. He cited research including 2019 study published by the Radiological Society of North America showing that imaging use stabilized or declined between 2010 and 2016.
    • “Dipping utilization combined with lower reimbursement per procedure has led to a “sustained slowdown in imaging spending growth,” Cutler wrote. 
    • “In addition to helping with cost concerns, the reduction in imaging use has helped to minimize a potential shortage of radiologists,” he wrote April 2. “For some time, economists were worried about a looming radiologist shortage. The decrease in imaging has allowed the U.S. to meet the need for imaging without an increase in radiologists.”
    • “The claims appear to contradict both anecdotal and numerous published academic reports stating the contrary. Another RSNA-published study last year found that emergency departments’ use of CT imaging has increased substantially since 2013. Another JACR study published in January estimated that radiology exam caseloads climbed 31% since 2018. A third shared by Health Affairs in 2024 said overall spending on radiology services leapt almost 36% between 2010 and 2021.”  

Notable Death

  • The Wall Street Journal reports,
    • “By the time patients seek therapy for post-traumatic stress disorder, many have spent years suppressing their worst memories and avoiding the places and situations they associate with the most difficult moments of their lives. 
    • “Edna Foa asked them to get closer to those moments.
    • “She asked women who had survived rape to recount what happened, and encouraged soldiers to explain what they had seen in war. It wasn’t an easy ask, but patients had been avoiding so many things for so long that their worlds had gotten smaller and many were willing to try something, even if it felt drastic. 
    • “At first, revisiting memories and places that they feared could be distressing. Over time—typically eight to 15 sessions—the prolonged exposure therapy could make the memories of the traumatic events approachable and turn them into something they could emotionally process and ultimately take power over.
    • “Foa, a clinical psychologist who died March 24 at the age of 88, didn’t just pioneer prolonged exposure therapy, one of the most effective, evidence-based therapies used for treating PTSD in the U.S.; she also created an ecosystem to get it into practice. She trained thousands of healthcare professionals on how to treat patients, and trained others how to do the training. She also wrote books, manuals and patient workbooks to make sure that the training was implemented correctly.”
  • RIP

Tuesday report

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

From Washington, DC

  • OPM Director Scott Kupor created another post in his Secrets of OPM blog today. This post is titled “Trust but verify,” which has always been the FEHBlog’s favorites Reaganism. Director Kupor concludes,
    • “We have a lot of work to do to ensure the federal government can continue to attract all of the skills needed to deliver on our promises to the American people. While “In America we trust,” in federal hiring we will “trust, but verify.”
  • Modern Healthcare informs us,
    • “A bipartisan House bill that lawmakers plan to introduce this week would cap annual Medicare physician reimbursement cuts at 2.5% while giving regulators more leeway to set annual payment updates.
    • “The Provider Reimbursement Stability Act of 2025 is far from the Medicare payment system overhaul doctors have failed to win for years and it does not include a raise for 2027. But the measure would address underlying aspects of the rate-setting process that medical societies say contributed to pay cuts and modest increases in recent years. 
    • “Under the legislation, CMS would gain financial flexibility, could consider medical inflation in narrow circumstances when calculating fees, and would make changes to the base values it uses to set rates and correct errors that the American Medical Association estimates have cost doctors billions.”
  • STAT News tells us,
    • “Sellers of health savings accounts see an opening for expanding their market, and they’re ramping up lobbying efforts to seize the opportunity.
    • “A group of companies and organizations tied to the HSA industry this year formed a nonprofit called the Great American Health Alliance, or GAHA, a riff on Make America Healthy Again, or MAHA. * * *
    • “Members of GAHA include HealthEquity, one of the largest administrators of HSAs, and the American Bankers Association, which represents institutions holding about 90% of HSAs. GAHA is run by brothers Keith Nahigian, who is the group’s president and has worked for multiple GOP presidential campaigns, and Ken Nahigian, who led the Trump transition in 2017 and was health secretary Robert F. Kennedy Jr.’s liaison to senators during his confirmation process.”
  • American Hospital Association News reports,
    • “The Department of Health and Human Services March 31 announced that it is reverting a 2024 reorganization of health IT leadership and services. The dually titled Office of the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health IT will now restore ONC as a singularly titled office. The HHS Chief Technology Officer, HHS Chief Artificial Intelligence Officer and HHS Chief Data Officer roles and responsibilities will move back under the HHS Office of the Chief Information Officer. HHS said the changes reinforce OCIO’s responsibility for enterprise IT, cybersecurity and data operations, while ONC will focus on health IT policy, standards and certification.”
  • and
    • “The Centers for Medicare & Medicaid Services March 20 released a memorandum reinforcing hospital nutrition service obligations for hospitals. The memo reminds hospitals of the Medicare conditions of participation that require hospitals to ensure menus and diets meet individual patient nutritional needs in accordance with recognized dietary practices. It also asks hospitals to review and revise their food and nutrition service policies, standard menus, therapeutic protocols and other practices to align with the recently released 2025-2030 Dietary Guidelines for Americans. CMS makes several recommendations for hospital inpatient menus, including limiting ultra-processed foods; eliminating sugar-sweetened beverages unless clinically appropriate in limited scenarios; eliminating refined grains and replacing them with 100% whole grains; prioritizing minimally processed protein sources, including plant-based options; and emphasizing vegetables, fruits, legumes, nuts, seeds, seafood and healthy fats.” 
  • The Wall Street Journal adds,
    • “New nutrition guidance from the American Heart Association advises getting protein from plants rather than meat, choosing low-fat or fat-free dairy and using olive, soybean and canola oils instead of beef tallow and butter. 
    • “The recommendations, released Tuesday by the association, contrast with dietary guidelines that the Trump administration introduced earlier this year.
    • “The differences add to disagreements between the federal government and mainstream medical groups on medicine and nutrition advice, after the Health and Human Services Department under Health Secretary Robert F. Kennedy Jr., for instance, sought to dial back vaccine recommendations and President Trump told pregnant women to minimize Tylenol use.
    • * * * “The association’s latest recommendations are mostly unchanged from the guidelines that it released in 2021 and that the federal government had issued before this year.
    • “Like the federal government, the AHA defines a healthy diet as rich in vegetables and fruits and low in added sugars and ultraprocessed foods. 
    • “Dr. Stacey Rosen, AHA’s president, who is a cardiologist and a senior vice president of women’s health at Northwell Health in New York, said the government’s encouragement to eat red meat and full-fat dairy products could hurt people’s health. “It has been shown repeatedly to be a not healthy way to eat,” she said.”

From the Food and Drug Administration front,

  • Fierce Pharma reports,
    • “Amgen’s rare disease drug Tavneos is under mounting regulatory scrutiny, with the FDA warning of serious liver injuries, including some fatalities, among patients who received the drug. 
    • “From the drug’s approval in 2021 through October 2024, 76 cases of drug-induced liver injury with “reasonable evidence” of a causal association to Tavneos were reported to the FDA Adverse Event Reporting System (FAERS), according to a Tuesday safety communication.
    • “The medicine is available as an adjunct treatment for severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis. But the FDA is looking to change that with a request for Amgen to withdraw the product, which the company has so far resisted.”
  • Reuters relates,
    • “The U.S. Food and Drug Administration has approved a higher dose of Biogen’s (BIIB.O), opens new tab spinal muscular atrophy drug Spinraza, the company said on Monday, after rejecting it last year.
    • “The approval for a potentially ​more effective treatment marks a boost for the U.S. drugmaker battling intensifying competition ​from therapies such as Roche’s (ROPC.S), opens new tab oral drug Evrysdi and Novartis’ (NOVN.S), opens new tab gene therapies ⁠Zolgensma and Itvisma.”
  • Cardiovascular Business tells us,
    • “Anumana, a Massachusetts-based artificial intelligence (AI) company co-founded by nference and Mayo Clinic, has secured U.S. Food and Drug Administration (FDA) clearance for its advanced pulmonary hypertension (PH) algorithm. The algorithm, which previously received the FDA’s breakthrough device designation, was designed to detect signs of PH in standard 12-lead electrocardiograms (ECGs).
    • “PH is a life-threatening condition that can be difficult for care teams to diagnose. It directly impacts the arteries in a patient’s lungs as well as the right side of their heart. While there is no cure, treatments are available once a diagnosis is confirmed. 
    • ‘Anumana’s newly cleared AI model was built with data from more than 250,000 de-identified Mayo Clinic patients. It runs entirely within the care team’s own hospital or health system environment.
    • “According to Anumana, the algorithm was linked to a sensitivity of 73% and specificity of 74.4% in adult patients presenting with dyspnea. A separate study found that it was able to identify more than 85% of patients presenting with pulmonary arterial hypertension as well as 78% of patients presenting with chronic thromboembolic pulmonary hypertension.”
  • and
    • “A new-look embolic protection device for reducing the risk of stroke after transcatheter aortic valve replacement (TAVR) is associated with clinical outcomes comparable to Boston Scientific’s Sentinel Cerebral Protection System, according to new data presented at ACC.26 in New Orleans.
    • “The device in question is the Emboliner Embolic Protection System from California-based Emboline. Features include a double-wall, cylindrical mesh filter made of Nitinol and a self-sealing port that allows devices such as TAVR delivery systems to pass through when necessary. 
    • “The ProtectH2H clinical trial was a head-to-head comparison of the Emboliner and Sentinel devices. It is believed to be the first head-to-head analysis of any two embolic protection devices for TAVR. More than 500 TAVR patients with a mean age of 79 years old were enrolled out of the United States, Germany and Brazil. Patients were excluded if they had experienced a stroke in the previous six months.”

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention reminds us,
    • “Chronic kidney disease (CKD) affects more than 37 million U.S. adults. That’s more than 1 in 10 people. The risk is even higher for people with diabetes or high blood pressure. Nearly 4 in 10 adults with diabetes and 2 in 10 adults with high blood pressure have CKD. 
    • “Most people with CKD—about 9 in 10—do not know they have it. CKD often has no early symptoms, but simple blood and urine tests can help find it early. Knowing your risk and getting tested could help protect your kidneys.”
  • Avalere Health marks “National Kidney Month with An Outlook in the 2026 Kidney Care Policy, Payment, and Treatment Landscape.”
    • “Evolving kidney transplant regulations, payment reforms, and accelerated innovation in treatments are opening new opportunities across the kidney care landscape.”
  • This week’s issue of NIH Reseach Matters covers the following topics:
    • SuperAgers show unique cell signatures in the brain
      • “Researchers linked neuron creation to exceptional recall and memory in older adults.
      • “Understanding how new neurons are created in adulthood could help lead to interventions that promote healthy aging.”
    • Scientists identify proteins tied to food tolerance
      • “Scientists identified parts of proteins that interact with immune cells and allow mice to tolerate certain foods rather than have an allergic reaction.
      • “The findings enhance our current understanding of food tolerance and may lead to new therapies for people with food allergies.”
    • Using RNA to treat heart attacks
      • “An RNA-based lipid nanoparticle therapy helped the heart recover from a heart attack in animal studies.
      • “The results suggest a new strategy for treating heart attacks and repairing damage to the heart.”
  • MedPage tells us,
    • “Significant incidental findings detected on low-dose CT lung cancer screening were associated with an increased risk of an extrapulmonary cancer diagnosis over the following year.
    • “Risk differences were significantly higher for urinary cancers, as well as lymphoma and leukemia.
    • “Certain significant incidental findings should be assessed as potential indicators of undiagnosed cancers, researchers said.”
  • Healio adds,
    • “MRIs may be a reasonable option for high-risk patients with extremely dense breasts.
    • “A simulation study found MRIs moderately reduced breast cancer mortality in this group but increased rates of false positives.”
  • and
    • “In stable patients without heart failure, discontinuing beta-blockers 1 year after a heart attack was noninferior to continued use for all-cause death, recurrent MI or HF hospitalization, researchers reported. 
    • “The SMART-DECISION trial is the first randomized study to demonstrate the noninferiority of beta-blocker discontinuation in post-MI patients without left ventricular systolic dysfunction or heart failure,” Joo-Yong Hahn, MD, a cardiologist at Samsung Medical Center in Seoul, South Korea, said during a press conference at the American College of Cardiology Scientific Session. The results were simultaneously published in The New England Journal of Medicine.”
  • The Wall Street Journal reports,
    • “AstraZeneca AZN reported mixed results from three late-stage clinical trials of an experimental treatment for a rare metabolic disease, but remains confident the drug can generate annual peak sales of $3 billion to $5 billion.
    • “The U.K. drugmaker expects to be able to launch the medicine, efzimfotase alfa, in more markets than its predecessor treatment, Strensiq, the chief executive of AstraZeneca’s rare-disease unit Alexion, Marc Dunoyer, said in an interview Tuesday. It plans to submit data to regulators as soon as possible, Dunoyer added.
    • “AstraZeneca said the results of the studies support the drug’s potential to transform the treatment of hypophosphatasia, a rare, chronic disease caused by deficient activity of an enzyme that is important for building healthy bones and supporting proper muscle function.”

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

  • Modern Healthcare reports,
    • “Kurt Small has been named as president and CEO of CareFirst BlueCross BlueShield, effective May 4. 
    • “Small is the president of Medicaid for Elevance Health. 
    • He will succeed Ja’Ron Bridges, who has been serving as interim president and CEO since Brian Pieninck left the company in September to become president and CEO of GuideWell and its insurer subsidiary Florida Blue, a CareFirst spokesperson said Tuesday. * * *
    • “Bridges will return to his former role as CareFirst’s executive vice president and chief financial officer. 
    • “Small held several leadership roles at Blue Cross and Blue Shield of Minnesota, Highmark and Aetna prior to joining CareFirst, an independent licensee of the Blue Cross Blue Shield Association.”
  • Healthcare Dive adds,
    • “Elevance announced a slate of mid-level executive appointments on Tuesday as the company continues to shuffle its leadership roster to try to combat waning profits.
    • “The insurer named two new executives to its health benefits division, including a new president of government business after the previous president was promoted to lead Elevance’s broader insurance arm.
    • “Carelon, Elevance’s health services division, added four new executives, including its first chief growth and strategy officer as the company seeks to accelerate Carelon’s expansion.”
    • “The appointments are effective immediately.”
  • The Wall Street Journal informs us,
    • “Eli Lilly LLY has agreed to buy clinical-stage company Centessa Pharmaceuticals CNTA for an initial payment of about $6.3 billion in a deal that expands the drugmaker’s neuroscience portfolio and capabilities into sleep medicine.
    • “Eli Lilly on Tuesday said it will pay an initial $38 a share in cash for Centessa, a 38% premium to Monday’s closing price of $27.58 for the U.K.-based company.
    • “Centessa investors will also receive nontransferrable contingent value rights worth up to an additional $9 a share, bringing the total potential deal consideration to about $7.8 billion, or $47 a share.
    • “The deal is slated to close in the third quarter.’
  • Fierce Pharma adds,
    • “Despite a healthy roster of late-stage assets and a revenue turnaround in 2025, it’s no secret that Biogen has been seeking near-term sales drivers ahead of its planned product rollouts later in the decade. 
    • “Now, the company is responding by bulking up in immunology—and paving the way for its future ambitions in kidney diseases—with an M&A play that adds two ongoing launches to its marketed drugs portfolio.
    • “On Tuesday, Biogen unveiled a deal to acquire Apellis Pharmaceuticals for $41 per share in cash, representing a total transaction value of roughly $5.6 billion. For Biogen, the deal grants access to the approved Apellis meds Syfovre for the eye condition geographic atrophy (GA) and Empaveli, approved by the FDA last year in the rare kidney diseases complement 3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN).” 
  • The Wall Street Journal notes,
    • “Big drugmakers are pursuing smaller acquisitions, typically under $10 billion, reflecting a more cautious approach to dealmaking.
    • “Deals between $1 billion and $10 billion represent 76% of pharmaceutical transactions by value this year to date.
    • “Companies like Eli Lilly and Biogen are making smaller deals to bolster pipelines and avoid risks associated with large acquisitions.”
  • Per an Institute for Clinical and Economic Review news release,
    • “The Institute for Clinical and Economic Review (ICER) today releaseda Final Evidence Report assessing the comparative clinical effectiveness and value of sibeprenlimab (Voyxact®, Otsuka Holdings Co., Ltd.), atacicept (Vera Therapeutics, Inc.), and delayed-release budesonide (“Nefecon”, Tarpeyo®, Calliditas Therapeutics AB) for IgA nephropathy.
    • “ICER’s report on this therapy was the subject of the February 2026 public meeting of the California Technology Assessment Forum (CTAF), one of ICER’s three independent evidence appraisal committees. 
    • “Downloads: Final Evidence Report | Report-at-a-Glance | Policy Recommendations“
  • Beckers Hospital Review informs us,
    • “Retail and e-commerce giants are rapidly expanding their presence in pharmacy services, prompting new concerns among hospital and health system leaders about losing ground in patient access and workforce recruitment.
    • “Amazon, for example, is significantly scaling its pharmacy footprint. The company plans to expand its same-day prescription delivery service to 4,500 U.S. cities and towns by the end of 2026 — adding nearly 2,000 new communities as it targets patients affected by pharmacy closures, staffing shortages and transportation barriers.
    • “Walmart is taking a different approach, focusing heavily on its workforce. The retailer recently promoted 3,000 pharmacy technicians into pharmacy operations team lead roles while also increasing pay. Technician wages now average $22 per hour, with some earning as much as $40.50 depending on certification and location. The newly created team lead roles average $28 per hour, with potential earnings up to $42.”
  • and
    • “Novo Nordisk has launched a multimonth subscription program for Wegovy, which claims to offer more predictable, lower pricing for eligible self-pay patients who enroll through select telehealth providers.
    • “The program is currently available through Ro, WeightWatchers and LifeMD. Additional platforms, including Hims & Hers and Sesame, are expected to join, according to a March 31 news release from Novo. Patients can choose three-, six- or 12-month subscriptions, with longer terms offering lower monthly costs.
    • “Under the program, Wegovy injections are priced at $329 per month for a three-month subscription, $299 per month for six months and $249 per month for 12 months — representing savings of up to $1,200 annually. Oral formulations are priced at $289, $269 and $249 per month across the same timeframes, respectively, with savings of up to $600 annually.
    • “The subscription model aims to reduce cost uncertainty and support adherence for patients managing obesity, a chronic condition that requires ongoing care, according to the release.”
  • Healthcare Innovation considers the “Link Between Ambient Scribes and Increased Coding Intensity.”
    • “Allison Oakes, Ph.D., Trilliant’s chief research officer, discusses how AI-enabled documentation may intersect with coding activity.”
    • “According to Trilliant, AI scribing tools have been associated with an increase in high-intensity outpatient billing codes across six health systems.
    • “The increase in higher-intensity billing codes may reflect improved documentation accuracy rather than intentional overbilling.
    • “Enhanced transparency and auditability of AI-driven billing are crucial for detecting potential issues and ensuring fair reimbursement practices.”
  • Radiology Business has a different outlook.
    • “Imaging interpretation times have more than doubled over the course of a decade, according to new Neiman Health Policy Institute research published Tuesday. 
    • “Current workforce shortages in the specialty are being spurred by increasing per-patient demand for imaging, an aging population and the limited supply of radiologists. As hiring challenges persist, there are growing concerns about the impact on patient care, experts write in JACR. 
    • “Researchers recently aimed to assess how turnaround times—or the period between when a scan is performed and a radiologist reads the images—have changed in recent years. They found that the length of this window leapt by 113% between 2014 and 2023, with worsening wait times beginning two years after the COVID-19 pandemic. 
    • “The potential negative clinical impact of growing turnaround time for the interpretation of imaging must be closely monitored, especially if the trend worsens,” study co-author Cindy Yuan, MD, with the Indiana University School of Medicine, said in a statement March 13. “We think these results are an early indicator of a worsening problem. If the sudden change in 2022 reflects that there is no remaining capacity for the radiology workforce to absorb new workload, then continued imaging growth will eventually impact patients.”
  • MedTech Dive points out,
    • “Whoop, the wearable company that sparked a debate on wellness regulations, has raised $575 million.
    • “The series G round values Whoop at $10.1 billion, the company said on Tuesday. Abbott joined as a strategic investor.
    • “Whoop plans to put the funds toward its U.S. and international growth, as well as personalized health features.”
  • Fierce Healthcare relates,
    • “eMed pocketed $200 million in funding to build out its AI agentic platform and offer new models for employers, including programs for GLP-1 medications.
    • “The funding round boosts the company’s valuation to $2 billion. AON Consulting led the round along with prominent investors former NFL player Tom Brady, founding chief wellness officer, Jeff Aronin, founder, chairman and CEO of Paragon Biosciences; Ara Cohen, co-founder and co-managing Member of Knighthead Capital Management; Antonio Gracias, founder and CEO of Valor Equity Partners; Joe Lonsdale, founder and managing partner at 8VC and co-founder of Palantir; R.J. Melman, CEO, Lettuce Entertain You Restaurants; Tom Ricketts, chairman of the Chicago Cubs; and former X CEO and current eMed CEO Linda Yaccarino. 
    • “The company plans to use the fresh capital to support and fund a new capitated model designed to help employers bend the healthcare cost curve. GLP-1 medications are the most requested workplace benefit, yet only one in five companies provide the benefit, according to the company.”

Weekend update

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

From Washington, DC,

  • Congress left town late last week on two weeklong recess which wraps around the upcoming Passover and Easter holidays.
  • Beckers Payer Issues reports,
    • “Healthcare took center stage in governors’ 2026 “State of the State” addresses.
    • “The National Governors Association compiled excerpts from across the country that focused on healthcare, ranging from technology use to the Rural Health Transformation Program to insurance reforms.”
  • The FEHBlog expects that OPM’s call letter for 2026 FEHB and PSHB benefit and rate proposals will be released this week, and the sooner the better.

From the public health and medical / Rx research front,

  • ABC News reports on how online gambling has become a public health crisis for our Nation’s youth.
    • “[T]he link between gambling early and gambling addiction has become increasingly clear. While only 1% of adults who gamble report addictions, the Journal of Behavioral Addictions reports that between 2% and 7% of young people who place bets report gambling addictions. 
    • “Young people’s brains are particularly susceptible to this because … the parts of their brains that respond to these rewards develop more quickly,” said Dr. Nasir Naqvi, the director of Columbia University’s gambling disorders clinic. “So they become sensitive to these awards and to that dopamine release before the part of their brain that helps them to control these behaviors.” 
    • “Naqvi says he now routinely hears about children as young as 13 seeking support for possible addictions to gambling. 
    • “I don’t want to overstate the problem. But yes … it’s a looming public health crisis,” Naqvi told ABC News. “In fact, it’s already here.” 
  • Medscape reports,
    • “Going into 2026, widespread shortages of most major diabetes medications had largely stabilized: The shortages of Humulin and lispro insulin vials, and therefore medications, that dogged Indianapolis-based Eli Lilly in spring and summer 2024 have resolved, and it, like other manufacturers, has largely caught up with much of the demand for its GLP-1 products as well. 
    • “However, experts from the advocacy group T1D Strong say that shortages of GLP-1 receptor agonists, basal and rapid-acting insulin analogues, and several frontline oral agents are expected to persist into 2026 as the supply chain remains unstable, and especially in certain geographic pockets. 
    • “When shortages occur, it often falls to primary care clinicians to improvise substitutions and bridge strategies, while hospitalists see the downstream effects of shortages in real time in patients who show up with conditions like dehydration, medication errors, and avoidable admissions. The challenge has shifted from simply locating medication to building structured, risk-based strategies that prevent treatment gaps and protect the most vulnerable patients.” “
  • and
    • “Repeating the same meals and keeping calorie intake steady produced more weight loss than eating a more varied diet among individuals living with overweight or obesity, a short-term trial showed.
    • “Conventional wisdom around dieting says you should incorporate a lot of different foods to avoid getting bored and that you should splurge on the weekends or special occasions so you don’t feel as deprived,” lead author Charlotte Hagerman, PhD, of the Oregon Research Institute, Springfield, Oregon, told Medscape Medical News. “This contradicts research showing that consistency makes your behavior more habitual, that is, more automatic or effortless.
    • “We wanted to formally test these competing ideas in a group of people trying to lose weight,” she explained. “Maintaining a healthy diet in today’s food environment requires constant effort and self-control. Creating routines around eating may reduce that burden and make healthy choices feel more automatic.”

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

  • Modern Healthcare reports,
    • “Insurers and providers are locked in more messy contract disputes than in previous years
    • “A convergence of economic pressures across nearly all business lines has raised the stakes.
    • “Reimbursement disagreements are just one factor as providers object to insurance company practices.
    • “Both sides are equipped with unprecedented access to price transparency data.”
  • STAT News reports,
    • “Alex Zhavoronkov, CEO of Insilico Medicine, can’t stop complimenting Eli Lilly. “Lilly is better in AI than Insilico, and no other company is better in AI than us … except for these guys,” he said. 
    • “He insisted he wasn’t saying nice things about Lilly just because the pharma giant has signed a new deal with Insilico that’s worth $115 million up front and approximately $2.75 billion in biobucks, which are contingent on achieving regulatory and commercial milestones. After calling Lilly’s tirzepatide, which he is on, “the best drug ever invented by humans,” he said he’s been consistently singing Lilly’s praises for a year. “Mounjaro makes me so happy every day. I want to develop the next one.
    • “It looks like Zhavoronkov might have the opportunity to do just that — his AI drug development company’s new deal with Lilly, announced on Sunday, includes rights for the Mounjaro and Zepbound manufacturer to develop, manufacture, and commercialize some of Insilico’s preclinical AI-discovered candidates for oral therapeutics. Though he declined to say which assets Lilly licensed, he said that the company is the “absolutely best partner” for the candidates and that “nobody is better than them” in these disease areas. Insilico’s pipeline webpage recently was updated to note that a candidate targeting GLP-1 has been out-licensed to an undisclosed partner.” 
  • Beckers Hospital Review relates,
    • “Hospitals and health systems have continued to close maternity units, citing ongoing financial challenges, workforce shortages and declining birth rates. However, in rural Kansas, AdventHealth Ottawa — part of Altamonte Springs, Fla.-based AdventHealth — recently restored labor and delivery services to Franklin County.
    • “The AdventHealth Ottawa Family Birth Place temporarily closed in 2023 and reopened in September 2025 with a fully staffed labor and delivery team. As of August 2025, the hospital had hired 11 full-time staff for the unit, with additional providers joining in 2026.
    • “Maternity care challenges remain significant. A report reflecting data stretching into 2026 from the Center for Healthcare Quality and Payment Reform found that fewer than half of U.S. rural hospitals still offer labor and delivery services. In a dozen states, fewer than one-third do.
    • “Becker’s has reported similar trends, including 29 maternity service closures in 2025 and seven in 2026. Against that backdrop, AdventHealth Ottawa’s reopening stands out.
    • “What’s unique about Ottawa is that we’re an OB desert that does not sit in a population desert, so there’s a lot of population around us that doesn’t have OB services,” AdventHealth Ottawa President and CEO Brendan Johnson said in a hospital video. “But within a large circumference, there’s about 400 to 500 births a year that didn’t have a place to go.”
  • and
    • “Defining return on investment for healthcare technology has never been more consequential — or more contested. As health systems face mounting financial pressure, workforce strain and the rapid proliferation of AI-driven tools, the question of what truly constitutes a return on a technology investment has grown more complex than a simple cost-benefit calculation. The old metrics — uptime, deployment speed, license cost — no longer tell the full story. 
    • ‘”Across the industry, a new framework is emerging, one that measures ROI not just in dollars saved or revenue gained but in time restored to clinicians, cognitive burden lifted, outcomes improved, and trust strengthened between technology and the people who use it. From community hospitals to academic medical centers, health system leaders are redefining what it means for technology to deliver value. Becker’s asked 50 healthcare leaders how they define ROI for a technology they invest in.” [The answers are found in the article.]

Thursday report

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

From Washington, DC,

  • Roll Call reports,
    • “President Donald Trump announced Thursday night he would immediately begin paying Transportation Security Administration workers through an emergency executive order.
    • “The order promised to end long delays at the nation’s airports and allow TSA workers to get paychecks they have been denied during a partial shutdown of the Department of Homeland Security that has persisted for more than 40 days. 
    • “It also offered a partial reprieve for Congress, which has been locked in a bitter partisan standoff over immigration enforcement policies that has kept the department unfunded for weeks. Long lines at airport checkpoints and complaints from TSA workers had become critical pressure points in a search for an end to the shutdown.”
  • Per a White House fact sheet,
    • Today, President Donald J. Trump signed an Executive Order eliminating racially discriminatory “diversity, equity, and inclusion” (DEI) practices by Federal contractors and their subcontractors, ensuring merit-based and efficient contracting and employment.
      • The Order requires that all Federal contracts that are subject to the Federal Property and Administrative Services Act include a clause prohibiting contractors and their subcontractors from engaging in racially discriminatory DEI activities.
      • The Order directs the Office of Management and Budget to issue guidance to contracting agencies to ensure compliance and identify economic sectors that pose a particular risk of engaging in racially discriminatory DEI activities.
      • The Order authorizes contracting agencies to cancel, terminate, or suspend contracts — and to suspend or debar contractors — for failure to comply.
      • The Order directs the Attorney General to prioritize potential claims under the False Claims Act against contractors or subcontractors that are in violation of the contractual terms prohibiting racially discriminatory DEI activities, and ensure the prompt review of related civil actions brought by private persons.
      • The Order directs the Federal Acquisition Regulatory Council to amend Federal Acquisition Regulations to include this clause and remove any conflicting provisions.  
  • Per a CMS news release,
    • “The U.S. Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS) announced the members of the Healthcare Advisory Committee, a new federal advisory body comprised of leaders from across the healthcare system to provide expert advice on improving, strengthening and modernizing U.S. healthcare.
    • “The Committee will advise HHS Secretary Robert F. Kennedy Jr. and CMS Administrator Dr. Mehmet Oz on ways to improve how care is financed and delivered across Medicare, Medicaid, the Children’s Health Insurance Program, and the Health Insurance Marketplace.
    • “This Administration is bringing leaders together to tackle the challenges facing American patients and the health care system, putting prevention front and center,” said HHS Secretary Robert F. Kennedy, Jr. “This committee will help us shift from a sick care system to a true health care system by delivering practical solutions that drive real change.”
    • “We received an overwhelming response from highly qualified candidates across the country,” said CMS Administrator Dr. Mehmet Oz. “These members bring deep expertise across care delivery, financing, innovation, and patient engagement. Their insights will help us advance higher-quality care, reduce administrative burden, and strengthen the sustainability of our programs, while supporting efforts to transform our healthcare system and restore a stronger focus on patients.” * * *
    • “The Committee will convene its first meeting later this year. Additional information, including meeting notices and opportunities for public engagement, will be published in the Federal Register and on the CMS website.
    • “For more information, visit: www.cms.gov/priorities/healthcare-advisory-committee/overview“
  • Federal News Network tells us,
    • “Thrift Savings Plan participation is at an all-time high — and nearly 90% of Federal Employee Retirement System (FERS) participants are contributing enough to receive a full match from the government. The TSP board is also reporting that participant satisfaction with the agency’s customer service center is at nearly 94%. Satisfaction scores have remained at that level, now for more than a year. (Federal Retirement Thrift Investment Board – TSP monthly report, March 2026)”

From the judicial front,

  • Bloomberg Law reports,
    • “The government can lawfully limit federal health carriers from covering certain gender transition procedures, the EEOC said in a new ruling.
    • “The Republican-controlled commission on Thursday rejected claims from a group of transgender current and former federal employees that the Office of Personnel Management’s health coverage policy violated anti-discrimination laws. 
    • “The ruling in Sam T. v. Kupor adds to the Equal Employment Opportunity Commission’s efforts under the Trump administration to chip away at transgender rights in the private and federal sectors.”
  • An OPM news release adds,
    • “The EEOC’s landmark ruling reinforces OPM’s duty to manage the FEHB Program responsibly and protect taxpayer-funded benefits for federal employees and retirees,” Associate Director for Healthcare and Insurance Shane Stevens said. “Federal health benefits must be administered in a way that is fiscally responsible, legally sound, delivers high-quality care, and works toward improved health outcomes.”
  • The next step for this lawsuit is federal district court.
  • The Wall Street Journal relates,
    • “The Justice Department filed an antitrust lawsuit against the prominent hospital system NewYork-Presbyterian, alleging that it used restrictions in its contracts with insurers to limit price competition and block lower-cost healthcare options.
    • “The suit, first reported by The Wall Street Journal, was filed Thursday in the U.S. District Court for the Southern District of New York. It is the latest development in a broader Justice Department effort focused on whether hospital systems use hidden contracts to protect their market position and maintain high prices.”

From the public health and medical / Rx research front.

  • The American Hospital Association News reports,
    • “An American Heart Association study published March 25 found that children born to mothers with premature placental separation could be at higher risk of heart disease by age 28. They also are nearly three times more likely to be hospitalized for heart-related complications, such as heart failure, ischemic heart disease, heart attack, blocked arteries or general cardiovascular disease. The study examined nearly three million pregnancies and found that approximately 1% were impacted by placental abruption. Although limited in scope and not focused on interventions, the study highlights the importance of postpartum and postnatal monitoring for maternal and infant complications.” 
  • The Washington Post points out “five things you need to know about meningitis.”
    • “Two people died in an outbreak of bacterial meningitis in England. The infection, which is rare, requires prompt medical treatment to avoid severe complications.”
  • MedPage Today tells us,
    • “After peaking at over 185,000 courses in 2015, prescriptions for direct-acting antivirals (DAAs) for hepatitis C virus infections dropped 63% by 2025.
    • “While those older than 61 years accounted for over 40% of DAA-treated patients in 2015, that percentage shrank to roughly 25% by 2025.
    • “Specialists wrote two-thirds of DAA prescriptions in 2015, but their share fell to 28% by 2025.” * * *
    • “These are “sobering numbers” that reflect the need for a national HCV elimination plan such as the Cure Hepatitis C Act of 2025, Debika Bhattacharya, MD, of the University of California Los Angeles, told MedPage Today. “We must expand access to DAAs.”
  • and
    • “Patients with a history of depression or anxiety were less likely to see their mental health decline while on GLP-1 medications.
    • “The link between GLP-1 drug use and lower risk of psychiatric decline was more pronounced for semaglutide than for other agents.
    • “The data may allay prior concerns about suicidality, which prompted an FDA investigation in 2023.”
  • and
    • “Alzheimer’s can be detected early with p-tau blood biomarkers, but some tests can lead to overdiagnosis.
    • “Combining p-tau217 and eMTBR-tau243 may refine diagnostic accuracy and reduce false-positives.
    • “Plasma eMTBR-tau243 also could help identify people with high tau burden.”
  • NPR adds,
    • “Babies under 6 months old still have one of the highest rates of hospitalization from COVID-19 infections compared to other age groups, but no COVID vaccine is available for these infants.
    • “That’s one reason the American College of Obstetricians and Gynecologists, or ACOG, recommends COVID vaccination during pregnancy.
    • “There are a number of studies that show one of the benefits of COVID vaccination during pregnancy is the passage of antibodies to the newborn, and then that protects the newborn against COVID,” says Dr. Kevin Ault, a professor of obstetrics and gynecology at Western Michigan University Homer Stryker M.D. School of Medicine in Kalamazoo, Mich.”

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

  • MedCity News reports,
    • “Affordability is top of mind for executives at AHIP as Americans battle skyrocketing healthcare costs.
    • “We are laser-focused on affordability at AHIP,” said Mike Tuffin, president and CEO of AHIP. “That’s, of course, the issue at every kitchen table. … We see the cost of hospital care, certainly the cost of brand prescription drugs, specialty care, imaging, down the line, just continuing to rise faster than wages, faster than inflation. That’s driving up premiums across all markets. Premiums directly reflect the underlying cost of medical care.”
    • “Tuffin made these comments during a press briefing on Tuesday at the AHIP Medicare, Medicaid, Duals & Commercial Markets Forum in Washington, D.C. AHIP is an advocacy organization for health insurers.
    • “As for what’s leading to the rising cost of care, Tuffin pointed the finger at hospital consolidation, as well as actions by drug manufacturers like patent thickets (in which there is a dense web of multiple patents around one medication). 
    • “Tuffin added that AHIP is focused on improving affordability across four zones:
      • “More competition, especially for prescription drugs, and addressing hospital consolidation
      • “Site of service reforms, and increasingly using the home as a site of service. According to Tuffin, too much care is delivered at the costliest sites of care, like the emergency room
      • “Tackling administrative burden, as the healthcare system is still “far too dependent on fax machines”
      • “Aligning incentives around patient care outcomes and driving value across the system.”
  • The Wall Street Journal assesses the “Weight Loss Drug Frenzy: What’s Here and What’s Likely Coming Next.”
    • “The market for weight loss drugs is exploding and patients may have several new options in coming years.”
  • Beckers Payer Issues relates,
    • “Centene has named Kate Casso senior vice president of finance operations and innovation and Theodore Pienkos corporate controller and chief accounting officer.
    • “Ms. Casso has been with Centene for more than two decades and has served as the company’s corporate controller and chief accounting officer since April 2021, according to a March 24 regulatory filing. 
    • “Ms. Casso will focus in part on enterprise and finance innovation while continuing to lead data analytics, medical economics, payment integrity, finance shared services and financial planning and analysis. 
    • “Mr. Pienkos has been with Centene since 2011 and has served as the company’s deputy corporate controller since August 2024. He previously served as vice president of finance and accounting.
    • “Both appointments were effective March 18.”
  • BioPharma Dive informs us,
    • “Merck’s deal for Terns [mentioned in yesterday’s FEHBlog post] sparks debate over a possible biotech bidding war
    • “Some analysts argue the $6.7 billion offer undervalues biotech’s lead cancer drug, although investors may be happy with one-year returns.”
  • and
    • “Shares of Maze Therapeutics, a San Francisco-area biotechnology company, fell over 30% Wednesday despite positive clinical trial results for a progressive kidney disease drug that could potentially compete with a rival therapy from Vertex Pharmaceuticals.
    • “Maze said that, in a mid-stage trial, treatment with its experimental drug, “MZE829,” led to a “clinically meaningful” reduction of protein levels in urine by an average of almost 36% in people with a kidney disease caused by mutations in a gene called APOL1. Maze said it will continue enrollment for its Phase 2 trial and plans to meet with regulators to advance MZE829 into pivotal testing for AMKD, or APOL1-mediated kidney disease.
    • “Full results from the Phase 2 trial will be presented at a future medical conference, Maze added.”
  • Beckers Payer Issues informs us that “UnitedHealthcare has launched Avery, a generative AI companion that helps members navigate healthcare services.”
  • Health Exec adds,
    • “U.S. patients wait an average 31 days to see a doctor, so it’s no wonder 65% of surveyed consumers have consulted AI specifically because it’s faster and easier.
    • “Meanwhile 77% of clinicians appreciate the technology’s contributions to healthcare—yet 1 in 5 patients have tried to hide their use of AI from their doctors. 
    • “Most who admit to the secrecy chalk it up to a fear of being judged. 
    • “The findings are from a survey report released March 24 by Zocdoc, a digital appointment-booking service that has markedly increased its use of AI.”
  • Fierce Healthcare notes,
    • “OpenEvidence released an artificial intelligence-powered medical coding feature embedded in its clinical AI assistant.
    • “The new feature, called Coding Intelligence, provides automatic Current Procedural Terminology (CPT) code suggestions, evaluation and management (E/M) level recommendations with supporting medical decision-making rationale written directly into the note and ICD-10 diagnoses, according to the company.
    • “The tool, available in OpenEvidence Visits, provides coding derived from the clinical documentation and it automatically applies at the end of every doctor-patient visit, executives said.
    • “Without any extra work, OpenEvidence is able to generate concise rationale for their CPT + E/M suggestions. It truly captures the complexity of the encounter and saves me hours when I’m at the ER,” said Ania Bilski, M.D., vice president of clinical AI at OpenEvidence.”