Tuesday report

Rx coverage

Tuesday report

David Ermer–CMS, Congress, FDA, Medical / Rx research, Medicare, Rx coverage, U.S. Healthcare, Uncategorized–
  • The Wall Street Journal reports,
    • “The Medicare agency will extend a short-term program that will pay for weight-loss drugs such as Eli Lilly’s Zepbound and Novo Nordisk’s NOVO.B -4.19%decrease; red down pointing triangle Wegovy, guaranteeing access to the popular medications will continue for seniors next year. 
    • “The decision by the Centers for Medicare and Medicaid Services comes after big Medicare insurers signaled that they didn’t initially plan to join a separate, longer-term payment model for the drugs that was supposed to launch at the start of 2027, throwing its future into question.
    • “Instead, the interim Medicare program, which starts in July and was expected to run only until the end of 2026, will continue until the end of 2027. Under this program, the government effectively pays for the medications, rather than adding them to Medicare insurers’ drug plans, which forces the insurers to account for the cost. 
    • “A CMS spokeswoman said the agency was extending the short-term program “after listening to stakeholder feedback.” The change will “allow data collection that will support a more effective potential implementation” of the longer-term model.
    • “The decision is good news for manufacturers such as Lilly and Novo Nordisk, which are counting on Medicare coverage to boost sales of their weight-loss drugs. Previously, Medicare Part D plans have been barred from covering weight-loss drugs, which means seniors who want to take them have had to pay several hundred dollars a month out of pocket.”
  • The House Appropriations Committee did not complete voting on the Financial Services and General Government (FSGG) bill today, having taken up and passed a Military Construction and Veterans Affair bill as the first order of business. The Committee will resume considering the FSGG bill tomorrow morning at 10 am ET.
  • The American Hospital Association News lets us know,
    • “Secretary of Health and Human Services Robert F. Kennedy Jr. April 21 testified in two hearings on the proposed fiscal year 2027 HHS budget, which requests $111.1 billion. In the morning, Kennedy testified before the Energy and Commerce Committee Health Subcommittee, and in the afternoon, he appeared before the Senate Appropriations Committee’s Subcommittee on Labor, Health and Human Services, Education, and Related Agencies. He testified last week in a pair of meetings, one at the House Ways and Means Committee and another at the House Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies.
    • ‘While the budget request is not binding, it serves as a preliminary framework for Congress and the administration as they determine federal funding levels and the scope of health care policy this year.”
  • STAT News relates
    • “The Trump administration will ask states to create new plans to verify medical providers paid by federally funded health care programs as part of a broad effort to combat fraud in government programs, Mehmet Oz, the administrator of the Centers for Medicare and Medicaid Services, said Tuesday.
    • “The administration will ask states to develop plans in the next month to revalidate providers in “high-risk” areas to determine whether they exist and have the right to provide services, Oz said at Politico’s health care summit.
    • “The announcement is another step from the administration in its aggressive — and highly publicized — attacks on alleged waste, fraud, and abuse in federal health care programs. The administration has targeted certain programs and providers primarily in Democrat-led states such as Minnesota and California, though the administration’s claims have been disputed at times by state leaders. 
    • “We’re asking the states to own that problem,” Oz said.
    • “States that don’t take the effort seriously, he said, could become targets of closer federal scrutiny.”
  • The Government Accountability Office (GAO) adds,
    • “GAO has designated Medicare a high-risk program due, in part, to its complexity and potential for fraud. Fraud schemes in traditional Medicare often focus on certain services, such as durable medical equipment. Fraudsters may use stolen or inappropriately obtained Medicare beneficiary identifiers to submit fraudulent claims for unneeded or never provided services.
    • The Centers for Medicare & Medicaid Services (CMS), which oversees Medicare, uses data analytics on claims in traditional Medicare to identify anomalous patterns indicative of emerging fraud schemes and potentially fraudulent behaviors, such as billing spikes. CMS uses these analytics to develop leads for investigations and to inform administrative actions that can prevent potentially fraudulent payments, such as suspending provider payments. For example, in 2023 and 2024, CMS suspended payments to, and later revoked the enrollment of, 15 providers involved in a scheme that allegedly billed Medicare for more than $4 billion in urinary catheters that were never supplied. Selected private payers GAO spoke with reported using data analytics in ways similar to CMS—namely, to identify anomalous provider billing patterns to generate leads for investigations and to inform actions like payment suspensions.
    • CMS estimates that from fiscal years 2022 through 2024, it prevented a total of $11.9 billion in potentially fraudulent Medicare payments by taking administrative actions on providers engaged in potential fraud.
    • Here is a link to the GAO report.
  • The American Journal of Managed Care tells us
    • “Cancers with the highest lethality receive disproportionately lower levels of federal research support, according to a research letter published today in JAMA Network Open.
    • “Outcome-weighted metrics (mortality, 5-year survival, MIR) better capture unmet need than incidence alone when assessing cancer burden and urgency. 
    • “Lung cancers accounted for 151,401 deaths, exceeding pancreatic (49,211), breast (22,606), and prostate (5,219) among the cancers evaluated. 
    • “Mortality-to-incidence ratios highlighted extreme lethality in SCLC and pancreatic cancer (>0.85), while breast and prostate cancers showed low ratios (<0.10) consistent with higher survivorship. 
    • “Funding per estimated death was markedly higher for breast ($69,800) and prostate ($126,992) than pancreatic ($8,945) and SCLC ($2,818), supporting a composite allocation framework.”

From the Food and Drug Administration front,

  • Radiology Business informs us,
    • “Conavi Medical, a Toronto based medtech company, received U.S. Food and Drug Administration (FDA) clearance for a next-generation hybrid imaging system capable of performing intravascular ultrasound (IVUS) and optical coherence tomography (OCT) at the same time. 
    • “Conavi has carved out its own space in the field of intravascular imaging by developing hybrid systems that save cath labs valuable space by performing two different exams of a patient’s coronary anatomy at once. The company’s original Novasight Hybrid System gained FDA clearance in 2018.” * * *
    • “Conavi hopes to start commercializing this next-generation technology and initiate a limited market release in the second half of 2026.”

From the judicial front,

  • STAT News reports,
    • “A judge is expected to sentence OxyContin maker Purdue Pharma to forfeit $225 million to the Justice Department on Tuesday, clearing the way for the company to finalize a settlement of thousands of lawsuits it faces over its role in the opioid crisis.
    • “The penalty was agreed to in a 2020 pact to resolve federal civil and criminal probes it was facing. If the judge signs off, other penalties will not be collected in return for Purdue settling the other lawsuits.
    • “After years of legal twists and turns, the settlement was approved by another judge last year and could take effect May 1. It requires members of the Sackler family who own the company to pay up to $7 billion to state, local and Native American tribal governments, some individual victims and others.”

From the public health and medical research front,

  • MedPage Today reports,
    • “A mobile health intervention helped pregnant patients with overweight or obesity reduce gestational weight gain (GWG), a cluster-randomized trial showed.
    • “The weekly rate of GWG was significantly lower in the intervention group versus the standard care group (mean 0.25 vs 0.28 kg/week; mean between-group difference -0.03, 95% CI -0.05 to -0.01), reported Monique M. Hedderson, PhD, of Kaiser Permanente Northern California in Pleasanton, and colleagues.
    • “Total GWG was also significantly lower in the intervention group, at a mean of 9.7 kg compared with 10.6 kg in the standard care group (mean between-group difference -0.87, 95% CI -1.40 to -0.34), they wrote in JAMA Network Open.” * * *
    • “The Lifestyle, Eating, and Activity in Pregnancy (LEAP) intervention utilizes a smartphone app, wireless scale, and activity tracker to promote healthy eating and increased activity. As a stepped intervention, more intensity is reserved for those on track to gain more weight. All participants are given a personalized calorie target and weekly education topics, and are encouraged to track weight, activity, and diet. Step two adds two weekly personalized chat messages with a lifestyle coach/registered dietitian and step three adds biweekly telephone sessions.
    • “LEAP shows “that combining clinician engagement with patient‑facing digital tools can improve gestational weight outcomes in real‑world care settings,” Hedderson said.”
  • Medscape points out,
    • “The American College of Physicians (ACP) has updated its guidance on screening for breast cancer in asymptomatic average-risk women using recent high-quality clinical recommendations from guideline developers from expert societies around the world.
    • “Publishing in the Annals of Internal Medicine, panelists led by Amir Qaseem, MD, PhD, MHA, the ACP’s chief scientific officer and senior vice president of clinical policy, made five recommendations, taking into account age group and breast density category.
    • “This updated guidance statement is based on new data and new or updated guidelines evaluated by the ACP since the publication of our 2019 guidance statement, which is over 7 years old,” Qaseem told Medscape Medical News.”
  • The American Medical Association lets us know what doctors wish their patient knew about appendicitis.
    • “There’s a pain in your abdomen. Is it something as simple as gas or is it appendicitis? Four physicians share what to keep in mind about appendicitis.”
  • Health Day informs us,
    • “The overdose-reversing drug naloxonehas been rightly hailed as a lifesaving breakthrough, saving countless lives from opioid ODs.
    • “But a new study warns that the wonder drug has its limits, especially when confronted with overdoses involving the powerful new wave of synthetic opioids like fentanyl.
    • “Naloxone may not fully reverse ODs caused by synthetic opioids, researchers report in the May issue of the journal Anesthesiology.
    • “As a result, bystanders should be ready to give additional doses of naloxone if the first doesn’t restore an overdose victim’s breathing, researchers said.”
  • Genetic Engineering and Biotechnology News relates,
    • “Researchers from Kindai University in Japan have developed a machine learning model that accurately predicts the origin of diverse cancer types in patients with cancers of unknown primary (CUP) by analyzing CpG-based DNA methylation. Results showed that the model correctly identified the cancer type in about 95% of cases in the test cohort and achieved 87% accuracy when applied to an independent validation cohort from 31 cases representing 17 different cancer types. The work was presented at the American Association for Cancer Research (AACR) Annual Meeting.  
    • “Our findings suggest that DNA-based approaches can help identify where a cancer may have started, even when the original tumor is not visible,” said Marco A. De Velasco, PhD, a faculty member in the department of genome biology at Kindai University in Japan.”  
  • STAT News notes,
    • “BioAge Labs said Tuesday that its investigational pill for cardiovascular risk prevention significantly reduced inflammation in an early study, as more drug companies target inflammation as a way to treat a range of chronic conditions.
    • “In a Phase 1 study of people with obesity and elevated inflammation levels, patients taking a 60-milligram dose of the drug, called BGE-102, experienced an 85% reduction in a measure of inflammation called high-sensitivity C-reactive protein (hs-CRP) after one week, and the reduction was maintained three weeks out. That’s a similar effect seen in patients who took a higher 120-mg dose in the study, which the company previously reported.”
    • “Additionally, 87% of patients taking the 60-mg dose achieved hs-CRP levels of less than 2 mg/liter, the threshold thought to be associated with a lower risk of cardiovascular complications.
    • “High cholesterol and blood pressure have long been known contributors to heart disease, but researchers more recently identified inflammation as a risk factor as well. Companies like BioAge are betting that drugs that can effectively reduce inflammation could one day be as widely used as statins.” 

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • :UnitedHealth Group UNH reported first-quarter results that substantially overshot Wall Street expectations and raised its annual guidance, signaling progress in its financial turnaround.
    • The announcement is likely to build investor confidence in the healthcare company’s current direction, a year after UnitedHealth announced an earnings shortfall that touched off an unprecedented share meltdown for the company.
    • “Former Chief Executive Stephen Hemsley returned to the top job last May, saying the company needed a reset. He has focused on retrenching and bolstering margins.” * * * 
    • “UnitedHealth highlighted changes made under Hemsley’s tenure, including replacing almost half the company’s top 100 executives and making substantial artificial-intelligence investments. UnitedHealth said it had struck a deal to take over Alegeus Technologies, a benefits-administration company, without disclosing the financial terms.”  
  • BioPharma Dive relates,
    • “Flagship Pioneering has launched a new biotechnology firm that believes it’s found a way to solve the problems that have long held back genetic medicine. 
    • “Called Serif Biomedicines, the startup officially debuted on Tuesday armed with $50 million in funding and the ability to make what it refers to as “modified DNA” medicines.
    • “According to CEO and co-founder Jacob Rubens, Serif’s drugs are designed to combine the strengths of multiple types of genetic medicines, from gene therapy to the messenger RNA and small-interfering RNA approaches popularized by companies like Moderna and Alnylam Pharmaceuticals. Its treatments consist of two components: finely tuned instructions for a therapeutic protein as well as an mRNA sequence for “co-factors” that can help the treatment get into a cell’s nucleus. They’re sent to cells with the help of fatty shells called lipid nanoparticles, which are commonly used to deliver complex medicines.”
  • Adam Fein writes in his Drug Channels blog,
    • “Drug Channels Institute’s (DCI’s) latest analysis reveals that PBM-affiliated specialty pharmacies continue to dominate the dispensing of specialty drugs. 
    • “For 2025, DCI has identified more than 1,900 dispensing locations with specialty pharmacy accreditation from one or both of the two major independent accreditation organizations. The overall number of accredited locations grew by only 3% in 2025, but is more than five times larger than the 2015 figure.
    • “However, market share for the dispensing of specialty drugs remains highly concentrated. For 2025, the three largest specialty pharmacies accounted for two-thirds of total prescription revenues from pharmacy-dispensed specialty drugs. These businesses are all owned by vertically integrated organizations that also own a PBM.”
  • Beckers Hospital Review informs us,
    • “More Wegovy prescriptions are being written as GLP-1 weight loss drugs gain traction across retail, telehealth and direct-to-consumer channels, according to an April 20 report from Truveta Research.
    • “The growth follows the FDA’s December approval of oral Wegovy (semaglutide) and other GLP-1 pills. Diverging commercialization strategies from manufacturers are also reshaping how patients access these therapies and how health systems approach formularies and metabolic care programs.”

Monday report

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

From Washington, DC,

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

From the public health and medical / Rx research front,

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

From the U.S. healthcare business front,

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

Weekend update

David Ermer–Congress, Medical / Rx research, Mental health care, Rx coverage–

From Washington, DC,

  • Roll Call previews this weeks activities on Capitol Hill.
    • “The House Appropriations Committee begins its markup of both the Military Construction-VA and Financial Services spending bills on Tuesday, with subcommittee consideration of the National-Security State and Agriculture bills scheduled for Thursday.
    • “Senate appropriators have a full slate of hearings on Tuesday and Wednesday, with Health and Human Services Secretary Robert F. Kennedy Jr. slated to appear before the Labor-HHS-Education Appropriations Subcommittee on Tuesday.
    • “A bunch of other Cabinet members will follow at their respective subcommittees on Wednesday, including Treasury Secretary Scott Bessent.”
  • The New York Times reports,
    • “President Trump on Saturday signed an executive order seeking to hasten research into the therapeutic benefits of LSD, Ecstasy, psilocybin and other mind-altering drugs by ordering federal agencies to ease restrictions that have long limited the ability of scientists to study them.
    • “The measure also provides $50 million for state-level research into ibogaine, a powerful psychedelic made from the root of a Central African shrub that has been drawing interest from researchers for its potential to treat opioid use disorder and other forms of substance abuse.
    • “The funding will most immediately benefit Texas, which has already committed $50 million to studying ibogaine but recently failed to secure matching funds from a private drug developer.
    • “I’m pleased to announce historic reforms to dramatically accelerate access to new medical research and treatments based on psychedelic drugs,” Mr. Trump said from the Oval Office, where he was joined by a number of top cabinet officials and the podcaster Joe Rogan.”
  • Here is a link to the White House fact sheet on this executive order.

From the census front,

  • The New York Times informs us,
    • “Fertility in the United States has been declining since the Great Recession, and reached a new low last year, according to federal data released Thursday {april 9], causing some to fear a baby bust.
    • “But it’s not clear that will happen. Instead, there could be a lull, demographers say — a period of very low fertility that could eventually rebound.
    • “That’s because of a drastic shift among American women who are now of childbearing age: They are waiting longer to have babies. They’ve become much less likely to have them in their teens or 20s — and much more likely to in their 30s or 40s.
    • “Demographers have a name for this kind of lull in fertility: a “postponement transition.” It happened in the 1990s in Europe, then rebounded somewhat as the younger women who delayed pregnancy eventually had children. It also happened in the United States in the 1970s, as more women pursued college and careers after the women’s movement. These women didn’t end up having fewer children; they just had them later.”

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “Doctors may be getting closer to having a potent weapon against a genetic driver of lung cancer that has long lacked any targeted treatment options.
    • “Researchers on Sunday presented early results of clinical trials of two experimental drugs targeting a gene called KRAS, one of the most common and challenging drivers of human cancers. Each drug takes aim at a different KRAS mutation that drives lung cancer, which kills more people worldwide each year than any other form of the disease.
    • “KRAS mutations act as an accelerator in cancer cells. Both drugs shrank tumors and slowed disease progression in patients with advanced cancer that had progressed despite standard chemotherapy and immunotherapy, raising hopes that doctors may be homing in on a new option for a form of cancer that has long resisted treatment. 
    • “I’ve never been this hopeful about KRAS mutations,” said Dr. Lei Deng, an oncologist at Fred Hutch Cancer Center in Seattle who wasn’t involved in either study. The research was presented at the American Association for Cancer Research annual meeting.”
  • Healio points out,
    • “Odds for developing Parkinson’s disease increased with newer groundwater and with carbonate aquifers, according to a poster presented at the American Academy of Neurology Annual Meeting. 
    • “Our previous studies have focused a lot on air pollution, but we know from prior research that contaminated drinking water can also impact health,” Brittany Krzyzanowski, PhD, who conducted the study at Barrow Neurological Institute, told Healio.
    • “There’s a wealth of underused data on drinking water sources, like aquifer type and groundwater characteristics, so we took the opportunity to explore how these factors might be linked to Parkinson’s disease,” said Kryzyzanowski, who is now with the Atria Research Institute.”

Froom the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Eli Lilly LLY is in advanced talks to acquire Kelonia Therapeutics for more than $2 billion, according to people familiar with the matter.
    • “A deal could come as soon as Monday, assuming the talks don’t fall apart, the people said. The deal price could also include additional consideration if Kelonia reaches certain milestones, they said.
    • “Privately held Kelonia is developing a next-generation treatment for the blood cancer multiple myeloma. Buying it would position Eli Lilly to boost its position in the lucrative blood-cancer segment of the $240 billion global cancer-drug market.
    • Kelonia has raised just under $60 million to date, with its last public valuation being a little over $100 million as of April 2022, according to data from PitchBook.
    • “Kelonia is developing a next-generation so-called CAR-T therapy. CAR-T therapies deliver genes—or genetically altered cells—to help a patient’s immune system fight the cancer. 
    • “We have something that is truly transformative to the space,” Kelonia Chief Executive Kevin Friedman said in an interview in January at an industry conference.”
  • Fierce Healthcare tells us,
    • “More than 80% of primary care physicians are concerned about financial stability over the next several years, new research from Elation Health found.
    • “The health tech company surveyed 280 PCPs from Jan. 31 to Feb. 23 for its 2026 Primary Care Pulse Survey Report. Fifty-two percent of respondents were fully independent and 48% have some affiliation. 
    • “As financial pressures mount for PCP practices, 64% cite government and commercial payer reimbursement as their top concern. Staffing costs, workforce challenges, technology and IT costs and rising operational costs are also challenges for responding physicians. 
    • “Simultaneously, the report found 68% of respondents are actively developing plans to address concerns—ranging from increasing marketing to adopting new payment models. Sixty-seven percent of respondents plan to implement changes within the next two years while 27% report already implementing membership or cash-pay models and 18% report adopting value-based payment structures.” 

Friday report

David Ermer–CDC, CMS, Congress, COVID-19, FDA, Medical / Rx research, Mental health care, No Surprises Act, Rx coverage, U.S. Healthcare–

From Washington, DC,

  • Roll Call reports,
    • “Health and Human Services Secretary Robert F. Kennedy Jr. sought to distance himself from U.S. measles outbreaks on Friday at a House Education and Workforce Committee hearing on the administration’s fiscal 2027 budget request.
    • “The hearing, part of Kennedy’s weeklong tour of Congress on the budget, was relatively light on spending discussions, as Democrats who have repeatedly requested such a hearing with Kennedy looked to pin him down on a range of issues. The hearing was often combative, with Democrats drawing attention to issues such as vaccines and Kennedy’s focus on school nutrition.”
  • Per an HHS news release,
    • “The U.S. Department of Health and Human Services today announced the appointment of Casey B. Mulligan, PhD, as Chief Economist and Chief Regulatory Officer. Mulligan is a renowned University of Chicago economist who served as Chief Economist on the Council of Economic Advisers during the first Trump Administration. He most recently served as the U.S. Small Business Administration’s Chief Counsel for Advocacy.
    • “Mulligan will advise Health and Human Services Secretary Kennedy Robert F. Kennedy, Jr., and other agency leaders on policy development to continue to make health care more affordable for the American people. His portfolio will include cost-benefit analysis of regulation, econometric modeling, and program evaluation of major expenditures.”
  • Fierce Healthcare relates,
    • “Insurers hoping for a reprieve from an out-of-network billing system largely favoring healthcare providers will likely be left wanting as federal policymakers sit on their hands and one large payer’s bid to limit the claims faces an uphill battle, strategy firm Capstone concluded in a new report.” * * *
    • “Capstone expects any meaningful reversal of the IDR trend to most likely stem from direct action by payers. Chief among these is an administrative penalty Elevance Health implemented in 11 states for its Anthem BCBS commercial business. The policy levies a fee equal to 10% of the allowed amount on facility claims involving OON providers.
    • “The policy has faced substantial pushback from provider groups, though it still went into effect Jan. 1 in the 11 states with plans to expand similar fees in two more. Capstone noted that one of the initial states, Indiana, has already enacted legislation against the practice and that the broader policy is primed for legal challenges.
    • “However, if Elevance’s model is adopted more broadly, the OON ecosystem could shrink as facilities internalize the direct financial cost of hosting OON providers,” Capstone wrote. “In that scenario, provider groups would face pressure to either absorb the loss of facility relationships or accept often-lower in-network rates.” 
  • Bloomberg Law points out,
    • “The head of the Department of Labor’s employee benefits regulator defended how he’s changed the agency before lawmakers, saying he’s cut down on excessive litigation and enforcement.
    • “Daniel Aronowitz, leader of the Employee Benefit Security Administration, told members of a House Education and the Workforce subcommittee that the agency had reoriented its approach to follow the Employee Retirement Income Security Act, boasting that it was “the most pro-ERISA EBSA administration ever.” * * *
    • “The agency is revisiting a Biden-era [mental health] parity rule creating a comparative test to ensure employers are covering mental health equally with medical and surgical benefits. EBSA halted enforcement of the rule after The ERISA Industry Committee sued.
    • “Aronowitz noted that he didn’t believe the rule’s comparative analyses “got us anywhere. It just created cost and burden.”
    • “But he said EBSA is conducting investigations on medical necessity denials, exclusions for autism and opioid treatment, so-called “ghost networks” of unavailable doctors, and conflicts of interest.”
  • Thompson Reuters discusses this year’s obligation to provide notices of creditable coverage to Medicare Part D eligible individuals and to CMS.
    • “Sponsors of HRAs and other account-based plans, which are typically offered alongside major medical plans, will welcome the relief from providing burdensome and potentially confusing Part D creditable coverage notices. Sponsors of plans that remain subject to the disclosure requirements should use the 2027 parameters when determining whether their plans’ prescription drug coverage is creditable for that year.”
  • Healthcare Dive tells us,
    • “Employers, lawmakers, patient advocates, price transparency groups and more urged the Department of Labor to quickly finalize a rule that would force pharmacy benefit managers, shadowy middlemen in the drug supply chain, to share more pricing and compensation information.
    • “PBMs did not feel the same, according to industry comments on the proposed regulation.
    • “The rule has been caught up between two powerful industries — healthcare purchasers like employers and the PBMs they contract with to manage their drug benefits — since it was proposed in January, amid growing criticism of PBMs and a broader bet from the Trump administration that better price transparency will lower healthcare costs.”
  • and
    • “The CMS has proposed repealing the alternative pathway for new technology add-on payments, or NTAP, beginning in fiscal year 2028. The change is included as part of the 2027 Inpatient Prospective Payment Systems proposed rule. 
    • “Under the proposal, medical devices with breakthrough device designation would be required to meet the same eligibility criteria as other available technologies to receive the additional payments under the NTAP pathway.
    • “Industry trade group AdvaMed said the alternative pathway policy, implemented by the first Trump administration, has worked well. AdvaMed, in an emailed statement to MedTech Dive, said “it would be disappointing if this progress were rolled back.”

From the Food and Drug Administration front,

  • Healio reports,
    • “The FDA has cleared an HPV self-collection kit and approved a related HPV assay for at-home use, enabling patients to obtain their own sample for cervical cancer screening.
    • “The Onclarity HPV Self-Collection Kit (Waters Corp.) is tested with the BD Onclarity HPV Assay (Waters Corp.), which now supports specimens collected both in clinic and at home. The assay detects all high-risk, carcinogenic genotypes and is the only FDA-approved HPV assay to identify “six individually and three groups of pooled results,” according to a manufacturer press release.
    • “The at-home, self-collection kit could help reduce barriers for unscreened or underscreened individuals, who comprise nearly 60% of cervical cancer cases.”
  • MedTech Dive relates
    • “Philips has received Food and Drug Administration clearance for an artificial intelligence-enabled CT system.
    • “The 510(k) clearance, which Philips disclosed Thursday, covers a Verida device that the company claims reduces image noise by 80% and reconstructs scans twice as fast as its predecessor.
    • “Jie Xue, chief business leader for precision diagnosis at Philips, recently said Verida’s throughput sets it apart from photon-counting CT technology. GE HealthCare and Siemens Healthineers sell photon-counting devices.”
  • CVS Health informs us,
    • “New treatments take years of research, clinical trials, and regulatory review before reaching patients. Several therapies approaching FDA decisions this spring could expand treatment options for people managing a range of conditions.
    • “CVS Caremark’s Clinical Pipeline Services team — made up of licensed clinical pharmacists and analysts — monitors new therapies moving through the drug pipeline and evaluates what those approvals could mean for members. The team’s latest Drugs to Watch report identifies several notable therapies with decisions expected between April and June 2026, including:
      • “A new oral option for patients with treatment-resistant hypertension
      • ​​​”A more convenient, at-home format for early Alzheimer’s disease treatment that avoids lengthy IV infusions​​​​​​​​​​
      • “The first FDA-approved treatment for a chronic ​​​​liver infection
      • “An additional non-nicotine option for adults looking to quit smoking.”

From the judicial front,

  • Bloomberg Law reports,
    • “A wave of hospital bankruptcies has brought in its wake high-stakes lawsuits aiming to boost creditor payouts by targeting health insurers over allegedly systemic claim denials.
    • “At least nine different health insurers in the past six months have been sued by bankruptcy estates or trustees appointed under bankruptcy plans for three major health-care businesses, according to court documents reviewed by Bloomberg Law. 
    • “Lawsuits against insurers for Steward Health Care System LLC, CarePoint Health Systems Inc., and Jackson Hospital & Clinic Inc. seek a combined $427.9 million and represent 32,000 patient claims across 32 hospitals and providers and six states.
    • “The litigation is ramping up as hospital bankruptcies accelerate amid disputes over private equity ownership, real estate investment trust structures, and federal cuts.” * * *
    • “A trustee for CarePoint, which operated three New Jersey safety-net hospitals before it filed for Chapter 11 in November 2024, sued Cigna Health & Life Insurance Co. in February. It argued Cigna underpaid its hospitals for various services by more than $114 million.
    • “Steward’s trustee filed at least seven lawsuits against insurers, including Blue Cross of Florida, CareSource Ohio, and Aetna Health, seeking to recover more than $63 million and alleging they withheld valid reimbursements.
    • “Jackson Hospital took a different approach, bringing a more than $250 million antitrust suit against Blue Cross and Blue Shield of Alabama in December. The insurer used market domination to allow for a pattern of baseless claim denials for emergency care, the suit said.”

From the public health and medical / Rx research front,

  • The Centers for DIsease Control and Prevention announced today,
    • “COVID-19
      • “COVID-19 activity is low in most areas of the country.
    • “Influenza
      • “Seasonal influenza activity continues to decrease. Influenza A activity is low across all HHS regions and influenza B activity continues to trend downward.
      • “Additional information about current influenza activity can be found at: Weekly U.S. Influenza Surveillance Report | CDC
    • “RSV
      • “RSV activity started later than expected in most regions of the United States, though illness is not more severe compared with recent seasons. This unusual timing means higher levels of RSV activity may continue through April in many regions. Emergency department visits and hospitalizations for RSV are highest among infants and children less than 4 years old.
    • “Vaccination
      • “National vaccination coverage for COVID‑19, influenza, and RSV remained low among both adults and children. COVID-19, influenza, and RSV vaccines can provide protection against severe disease. Talk to your doctor or trusted healthcare provider about what vaccines are recommended for you and your family.”
  • The American Hospital Association News reports,
    • “There are now 602 cases in the Utah measles outbreak, the state’s Department of Health and Human Services reported April 14. Of those, 405 cases have been diagnosed this year. The confirmed total of measles cases reported nationwide in 2026 has increased to 1,748, according to the latest data from the Centers for Disease Control and Prevention. There have been 19 reported outbreaks across 33 jurisdictions. The vaccination status of 92% of cases is unvaccinated or unknown.”
  • Medscape adds,
    • Use of preexposure prophylaxis (PrEP) for HIV prevention in adolescents and young adults is “strikingly low,” though youth aged 13-24 years have nearly 1 in 5 new HIV infections in the US, according to a new study in JAMA Pediatrics. Use is particularly low in women and young people who live in the South and Midwest.
    • “Efforts to expand PrEP use among youths should address geographic disparities, legal and policy barriers, and clinician engagement to improve equitable access to HIV prevention,” the authors wrote, led by Nicholas Venturelli, MD, MPH, with Boston Children’s Hospital in Boston.
  • The University of Minnesota’s CIDAP relates,
    • “Historically, shigellosis cases in the United States have primarily been seen in young children in daycare settings and in people who’ve traveled to countries with poor sanitation. Infections with Shigella, a gut pathogen that causes diarrhea and vomiting, have also been fairly easy to treat.
    • “But the profile of who’s most at risk of shigellosis is changing, and the infections is becoming much harder to treat, according to a report published last week in Morbidity and Mortality Weekly Report, the flagship publication of the Centers for Disease Control and Prevention (CDC).
    • “In the report, researchers from the CDC and health departments across the country revealed that the vast majority of US Shigella infections from 2011 through 2023 were in adult men, a high proportion of whom (47%) had HIV. Analysis of nearly 17,000 Shigella isolates found that the proportion of isolates considered extensively drug-resistant (XDR) rose from 0% during 2011-2015 to 8.5% in 2023. 
    • “Approximately one-third of patients were hospitalized. And among patients with travel history, more than 80% reported no recent international travel.
    • “The report’s corresponding author said the findings reflect changes in epidemiology and resistance that are transforming Shigella from a primarily self-limiting infection that rarely required antibiotics into an emerging public health threat with limited treatment options. 
    • “Together, it’s a very concerning pattern of XDR Shigella strains that are being seen among vulnerable populations,” Naeemah Logan, MD, an epidemiologist with the CDC’s National Center for Emerging and Zoonotic Infectious Diseases, told CIDRAP News.”
  • The AP informs us,
    • “The worrisome rise in colorectal cancer deaths in younger adults is concentrated in people with less education, suggesting socioeconomic factors could be driving the escalation, according to a new study.
    • “Celebrity deaths — including Chadwick Boseman in 2020 and James Van Der Beekearlier this year — have highlighted the increase in colorectal cancer deaths among younger adults, but the new paper was called the first to parse which people are most affected by the alarming rise. 
    • “The researchers found that over the last 30 years, the rise in colorectal cancer deaths in young adults occurred almost entirely among people without a four-year college degree.
    • “Of course, getting a college degree doesn’t protect you from getting colon cancer. Rather, experts say it’s a marker for other issues: People without degrees tend to earn less money, have poorer diets, exercise less and get less medical care.
    • “It’s not totally unexpected that the death risk is concentrated in the less advantaged, but the paper published Thursday in JAMA Oncology is the first national study to actually show the connection, said Dr. Paolo Boffetta, a researcher at Stony Brook Cancer Center in New York who wasn’t involved in the work.” 
  • The New York Times points out,
    • “Researchers at the University of Pittsburgh reported on Friday that they had trained the immune systems of a few patients to accept liver transplants without the drugs needed to avoid organ rejection.
    • “Three of eight patients have now been off the drugs for at least three years, perhaps an early step toward a new approach to transplantation that experts in the field have long hoped for. The study was published in Nature Communications.
    • “They’ve gone a long way toward proving a principle,” said Dr. William Jarnagan, chief of liver and transplant surgery at Memorial Sloan Kettering Cancer Center, who was not involved in the study.
    • “With further development, it could really be a game changer,” he added.
    • “Dr. Joohyun Kim, a liver transplant surgeon at Yale who was not involved with the study, said, “Even 10 years ago, people thought ‘tolerance induction’ was a dream.”
  • The Genetic Engineering and Biotechnology News adds,
    • “The American Association for Cancer Research (AACR) Annual Meeting kicks off this weekend in San Diego. A whirlwind of sessions, keynotes, fireside chats, posters, and exhibitors, the meeting is THE annual event for the cancer community.
    • “Before the conference, GEN spoke with AACR program chairs Paul S. Mischel, MD, Professor and Vice Chair for Research for the Department of Pathology at Stanford Medicine of Stanford University and Alice T. Shaw, MD, PhD, Chair of the Department of Medical Oncology and the Chief of Strategic Partnerships at Dana-Farber. In this interview, they share their perspectives on the event, what attendees should be looking out for, and what they, personally, are most looking forward to.”
  • and
    • “For pathogens like HIV, malaria, and rapidly evolving influenza strains, coaxing the immune system to produce the rare, highly potent antibodies needed for protection has long been a scientific bottleneck. Vaccines can train B cells to evolve such broadly neutralizing antibodies, but only under ideal conditions—and only in a small fraction of people. Even attempts to genetically edit mature B cells produced responses that faded as the cells died out.
    • “A team at The Rockefeller University has now taken a more upstream approach: programming hematopoietic stem and progenitor cells (HSPCs)—the source of all B lymphocytes—to carry permanent genetic instructions for therapeutic antibodies or other proteins. Because the immune system naturally amplifies rare, useful cells after vaccination, even a tiny number of edited stem cells can seed a durable, boostable immune response.
    • “The immune system is inefficient in that it produces a vast quantity of cells to protect itself,” said Harald Hartweger, a research assistant professor in Michel Nussenzweig’s Laboratory of Molecular Immunology. “We wanted to take advantage of the immune system’s ability to amplify useful, rare cells.”
    • “The study, published in Science and titled “B lymphocyte protein factories produced by hematopoietic stem cell gene editing,” demonstrates that CRISPR‑edited HSPCs can mature into B cells that express engineered antibodies upon vaccination. A standard vaccination then acts as the trigger: antigen exposure drives those edited B cells to expand, differentiate into plasma cells, and secrete high titers of the inserted antibody that last long-term.”

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

  • Fierce Healthcare reports,
    • “The Purchaser Business Group on Health has released new data that highlights some of the key healthcare priorities of its jumbo employer members, with—perhaps unsurprisingly—the escalating affordability crisis as the biggest challenge.
    • “Rounding out the top three priorities are data analytics and transparency, as well as an interest in advanced primary care. PBGH based the findings of a survey of more than two dozens of its members, which represent some of the largest employers in the United States.
    • “Elizabeth Mitchell, president and CEO of PBGH, said in an interview that the escalating cost pressures have driven “a much more proactive approach from our members to address these concerns, which are simply not being addressed by the industry.”
    • “The urgency of that concern is absolutely growing,” Mitchell said. There is “also a heightened focus on transparency and understanding prices, and we are enabling that because they cannot just keep writing blank checks to the healthcare system when they have poor outcomes and just no demonstrable improvement in quality or value.”
  • Beckers Hospital Review informs us,
    • “Little Rock, Ark.-based Baptist Health reached a definitive agreement to acquire Magnolia (Ark.) Regional Medical Center.
    • “The deal, subject to customary regulatory approvals, is expected to be completed by July 12, according to an April 16 Baptist news release. On that date, the hospital will be rebranded as Baptist Health Medical Center-Magnolia.
    • “While it is an extremely challenging time to operate community hospitals, we have a proven track record of operating rural hospitals successfully in Arkansas,” Baptist President and CEO Troy Wells said in the release.”
  • and
    • “Mark Cuban has a pitch for hospitals: Manufacture drugs in their own parking lot.
    • “Mr. Cuban’s Cost Plus Drugs previously launched a Dallas-based manufacturing facility to address supply issues, starting with epinephrine and norepinephrine production. More recently, Mr. Cuban said his facility can also produce Pitocin, pediatric cancer drugs and sterile water — and that generic tablets can be cheaper when made in Dallas versus purchased from India.
    • “During Becker’s Spring 2026 Chief Pharmacy Officer Summit, Mr. Cuban explained how Cost Plus — which includes pharmacy, contracting, procurement and manufacturing businesses — is “modularizing” its manufacturing facilities.
    • “We’ve been able to take the manufacturing facility we have in Dallas and not only make it much smaller than what everybody else has done to that point, but we’ve been able to modularize them and put them in a pod that is effectively a tractor trailer,” Mr. Cuban said. “The trailers that go on the back that you see going down the road — we can manufacture sterile injectables in that tractor trailer.”
    • “Cost Plus is selling these manufacturing pods, which can be deployed anywhere from hospital sites to disaster zones to research facilities. He said rare disease therapies that historically cost upward of $500,000 and took six months to produce can now cost roughly $50,000 and possibly take less time.
    • “That, literally, over the long term, is going to be our biggest business and will save the most lives and money,” he said. “The more efficient we become at using robotics and AI, the less expensive we can manufacture drugs.” 
  • BioPharma Dive relates,
    • “Through an acquisition announced Friday, Belgian drug company UCB is wagering more than $1 billion on a cutting-edge medicine that’s being tested as a potential therapy for a few seizure disorders as well as Alzheimer’s disease.
    • “UCB offered to buy privately held Neurona Therapeutics for $650 million up front while dangling another $500 million in future, milestone-based payments. If completed, the deal would hand UCB an experimental therapy that uses pluripotent stem cells engineered to calm the brain and repair neural networks.
    • “The therapy, codenamed NRTX‑1001, is currently being evaluated in clinical trials as a treatment for patients with hard-to-treat forms of a common epilepsy rooted in the “mesial temporal lobe” part of the brain.”
  • and
    • “Kailera Therapeutics, a high-profile drug startup aiming to compete with Novo Nordisk and Eli Lilly in obesity, said Thursday it banked $625 million in one of the sector’s largest-ever initial public offerings.
    • “The IPO haul far surpasses the $500 million it set out to raise in terms set earlier this week. Kailera sold more than 39 million shares at $16 apiece. It’ll begin trading on the Nasdaq stock exchange on Friday under the ticker symbol “KLRA.”
    • “Kailera’s offering is among the biggest, by total proceeds, raised by a venture-backed biopharmaceutical company, according to BioPharma Dive data. Its IPO eclipses Acelyrin’s $540 million stock sale in 2023, Sana Biotechnology’s $588 million issuance in 2021, and Moderna’s then-record $604 million pricing in 2018.”
  • MedTech Dive lets us know,
    • “GE HealthCare is expanding a mammography collaboration with RadNet subsidiary DeepHealth.
    • “The partnership brings more of DeepHealth’s artificial intelligence tools to GE HealthCare’s mammography machines, including a workflow for complex cases that may benefit from a secondary review.
    • “The companies announced the expanded initiative at the Society of Breast Imaging Annual Symposium on Thursday.”

Monday report

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

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the census front,

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

From the public health and medical / Rx research front,

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

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

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

Weekend Update

David Ermer–Congress, Medical / Rx research, Rx coverage, U.S. Healthcare, Uncategorized–

From Washington, DC

  • Per a Senate news release,
    • “The U.S. Senate Health, Education, Labor, and Pensions (HELP) Committee will hold a hearing Thursday [April 16 at 10 AM] on how Congress can lower the cost of prescription drugs for American families by increasing competition among generic and biosimilar manufacturers. U.S. Senator Bill Cassidy, M.D. (R-LA), Chairman of the HELP Committee, is spearheading President Trump’s mission to make health care affordable.”
  • Hopefully, Congress will resolve the Department of Homeland Security shutdown this week. Federal News Network adds,
    • “Homeland Security Secretary Markwayne Mullin is recalling all furloughed Department of Homeland Security staff to report to their next scheduled shift, despite the ongoing partial government shutdown.
    • “In an official message sent to DHS employees late Friday afternoon, staff were told that “all DHS employees, excepted and non-excepted/non-exempt” are to be returned “to a work and paid status, effective on your next regularly scheduled duty day.”
  • Here’s a link to Roll Call’s projected activities on Capitol Hill this week.

From the public health and medical / Rx research front,

  • MedPage Today reports,
    • About one in five males older than 15 years is infected with a high-risk HPV type.
    • Among males ages 9 to 26 years, those who received the 9-valent HPV vaccine had a lower risk of a composite of HPV-related cancers compared with those who were unvaccinated.
    • These results indicate that HPV vaccination should be sex-neutral, researchers said.
  • The New York Times asks whether you are confused about the new cholesterol guidelines? If so, here’s what to hnow.
    • “New recommendations suggest that some people should start trying to lower their cholesterol as early as age 30.”
  • and
    • lets us know about “D.W.I.s, relationship problems, accusations of secret drinking: Auto-brewery syndrome can wreak havoc on people’s lives and reputations.”
      • “The Mystifying Syndrome That Makes People Spontaneously Drunk.”
  • NPR Shots informs us
    • “Forty percent of Americans have their daily lives interrupted by uncomfortable bowel symptoms, according to the American Gastroenterological Association. That’s a lot of troubled guts.
    • “But Dr. Trisha Pasricha says at the other end of the spectrum, there are people who experience “poophoria.” That’s Pasricha’s term for a state of being where doing your business is painless and worry-free. “ I just want you to poop quickly, effortlessly, and then go live your best life,” she says.”
    • The article provides the Doctor’s advice.

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “The Affordable Care Act of 2010’s medical loss ratio provision, which requires insurers to spend 80-85% of premium dollars on medical care, likely accelerated revenue diversification through venture capital arms, said Rachel Sachs, a law professor and co-director at The Cordell Institute at Washington University School of Law. Insurers are incentivized to find other profit generators that are not capped by federal legislation.
    • “Acquiring a stake in a company can lead to long-term financial gain if they exit their position or acquire the business. Cigna, for example, purchased telehealth provider MDLive in 2021 after Cigna Ventures invested in its Series E round in 2018.
    • “An insurer also may see value in the emerging company’s product and encourage the parent company to deploy it.” * * *
  • Fierce Pharma relates,
    • “Novartis is launching a three-front push to close healthcare gaps in heart disease and cancer, expanding initiatives to roughly triple its footprint by 2030. 
    • “The three initiatives include the new Inclusive Health Accelerators (IHA) program. Launched in five U.S. cities this week, IHAs are designed to support early detection of prostate and breast cancer and address care gaps in underserved populations. Novartis will use the community-driven IHA model to support access to education, free screenings, diagnosis and follow‑up care.
    • ‘Basel-based Novartis will collaborate with local groups in New York, Los Angeles, Detroit, Houston and Baltimore to deliver the services. The initiative builds on existing U.S. partnerships, such as the Health Assessments and Rapid Transformation program that Novartis launched last year.”
  • and
    • “As geopolitics bring reshoring interest to a fever pitch, the United States Pharmacopeia (USP) is adding to the impetus for local drug production with a warning that homes in on the pharmaceutical building blocks known as key starting materials. 
    • “In its new supply chain vulnerabilities update (PDF), USP, a nonprofit that helps set quality standards for medicines, highlighted 100 acute and chronic medications that, while not necessarily all in current shortage, are at risk of supply gaps and other disruptions. This is due to bottlenecks in their production chains, especially in the upstream phase focused on activities like sourcing raw materials, according to USP. 
    • “Looking at the broad trends, some 30% of the drugs on USP’s updated list are currently in shortage, per the U.S. FDA. Many of the therapeutics that have made it into the lineup are deemed essential by the World Health Organization or FDA, including multiple hospital drugs, chemotherapies, steroids and anesthetics, as well as drugs for chronic conditions like ADHD, diabetes and cardiac diseases, among many others.
    • “Notably, 63% of the medicines identified for their supply chain vulnerabilities are injectables, which USP chalked up to the “inherent manufacturing complexity” of that dosage form. Oral solid meds like tablets and capsules represented the second-biggest group of vulnerable drugs, making up 22% of the list, according to USP. 
    • “In perhaps the biggest flag from the updated list, USP noted that nearly half (48%) of the drugs included have at least one of their key starting materials (KSMs) solely manufactured in one country, which the organization deemed a “potential point of failure.” 
  • BioPharma Dive informs us,
    • “Chinese biotechnology company Oricell Therapeutics said Friday it banked more than $110 million in a “pre-IPO” venture funding that will help it advance a portfolio of cell therapies for tough-to-treat solid tumors. 
    • “Oricell’s lead program is being tested against advanced hepatocellular carcinoma, an aggressive liver cancer that most frequently occurs in people with chronic organ damage. That therapy, Ori-C101, has already completed early testing in humans and demonstrated what the company claims to be a “best-in-class efficacy and safety profile.” 
  • The Wall Street Journal adds,
    • “Finding innovative ways to treat cancer is Pfizer’s biggest priority so to boost cutting-edge technologies, Pfizer executives went to Shenyang, China. There, last summer, Pfizer paid $1.25 billion to China’s 3SBio for rights to a cancer drug candidate.
    • “Not long ago, China was a backwater for drug research. Its companies made pharmaceutical ingredients or lower-cost generic drugs. Its patients offered an opportunity for big drugmakers to sell medicines developed in the West. 
    • “Now it’s a major player in biotechnology. Researchers and startups in China are racing to develop hot new medicines for cancer, weight-loss and other diseases. Many are on the cutting edge of molecular biology. 
    • “China is rallying their innovation to degrees that we haven’t seen before,” Pfizer Chief Executive Albert Bourla said. 
    • “Looking to tap in to the innovation, big drugmakers and investors are spending billions to lock up rights to promising Chinese-originated drug candidates like 3SBio’s.”

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.”

Tuesday report

David Ermer–CDC, CMS, FDA, Medical / Rx research, Medicare, Rx coverage, Telehealth, U.S. Healthcare, Uncategorized–

From Washington, DC

  • Avalere Health breaks down yesterday’s CMS Medicare Advantage premium announcement.
  • Per an HHS news release,
    • “The Health Resources and Services Administration (HRSA) today announced more than $135 million in new funding opportunities to expand nutrition services and strengthen the rural health workforce. Secretary of Health and Human Services Robert F. Kennedy, Jr., alongside HRSA Administrator Tom Engels and Representative Juan Ciscomani (AZ-06), announced this important investment during a Preventative Care Roundtable with key stakeholders.
    • “Preventative care cuts costs, improves outcomes, and drives our mission to Make America Healthy Again,” said Secretary Kennedy. “These investments expand access to high-quality, affordable care—especially in rural communities that need it most.”
    • “HRSA is committed to strengthening the health workforce, advancing preventative care, and expanding access to essential nutrition services,” said HRSA Administrator Engels. “By supporting new rural residency programs to deliver evidence-based nutrition services, we are creating a stronger, more sustainable system of care that helps prevent chronic disease, improves health outcomes, and advances HHS and Make America Healthy Again priorities for communities across the country.”
  • Beckers Hospital Review tells us,
    • AbbVie and Genentech are the latest drugmakers to sell prescription medications on TrumpRx, CBS News reported April 6.
    • “They are the 10th and 11th drugmakers to offer discounted medications on the website. 
    • TrumpRx now lists AbbVie’s best-selling anti-inflammatory drug Humira — in syringe or pen form — for $950, representing an 86% discount off the list price. Genentech’s antiviral medication Xofluza is also available for $50, down from a list price of $168.” * * *
    • “Since launching in February, TrumpRx’s list has expanded from 43 medications to 69. Amgen also recently added its arthritis treatment Enbrel and plaque psoriasis drug Otezla to the platform.”
  • Bloomberg Law reports,
    • “President Donald Trump is in no hurry to tap a permanent attorney general to replace Pam Bondi following her ouster, according to people familiar with the matter, allowing Todd Blanche time to settle into his role as the US Justice Department’s acting chief.”
  • NewsNation relates,
    •  “Acting Attorney General Todd Blanche revealed key details Tuesday about the Department of Justice’s newly created National Fraud Enforcement Division.
    • “Our vision is to build a robust fraud-fighting squad capable of investigating and prosecuting the full spectrum of fraud against taxpayer dollars,” Blanche explained. 
    • “Blanche said the division will be staffed with some of the DOJ’s “best prosecutors,” including experts in health care, tax, benefits and corporate fraud.
    • “There will be an additional 93 prosecutors in every district across the country devoted to the mission of combating fraud,” Blanche added.”

From the Food and Drug Administration front,

  • Fierce Pharma reports,
    • “One year into his tumultuous tenure as the FDA’s commissioner, Marty Makary, M.D., has laid out ambitious internal goals and perhaps a more ambitious legislative wish list in his fiscal year 2027 budget proposal (PDF) to Congress.
    • “Alongside the justification of a $7.2 billion budget request, including $3.3 billion from congressional appropriations and $3.9 billion in industry-paid user fees, Makary is asking for a broad set of legislative actions. 
    • “The proposed changes would, among other things, create a new clinical trial initiation pathway as an alternative to the existing Investigational New Drug (IND) pathway, allow the FDA to disclose more information to the public in complete response letters, remove the interchangeability determination for biosimilars, give domestic generic manufacturers an upper hand and permanently authorize the rare pediatric disease priority review voucher program.”
  • The Wall Street Journal relates,
    • “Novo Nordisk NOVO.B launched its higher-dose Wegovy weight-loss shot in the U.S. after the new treatment gained regulatory approval there last month.
    • ‘The Danish drugmaker said Tuesday that Wegovy HD is now available nationwide through more than 70,000 pharmacies, its online pharmacy, certain telehealth providers and other outlets.
    • “Wegovy HD is a once-weekly injection that contains 7.2 milligrams of active ingredient semaglutide, offering the highest weight-loss of any Wegovy injection so far, the company said.” * * *
    • “In a trial of adults with obesity but without diabetes, patients taking a 7.2 milligram dose of Wegovy over about a year and a half lost 21% of their body weight on average, while around one in three people lost 25% or more of their body weight.
    • “Prior to the launch of Wegovy HD, the highest available injectable dose was 2.4 milligrams of semaglutide, which has shown to help patients lose around 18% of their body weight on average.
    • “The higher dose of Wegovy was approved by the Food and Drug Administration nearly three weeks ago under an accelerated approval process based on the results of the trial.”
  • Beckers Hospital Review tells us,
    • “Pfizer and BioNTech have halted a U.S. study of their updated COVID-19 vaccine in adults ages 50-64 due to slow enrollment, a Pfizer spokesperson confirmed to Becker’s.
    • “We can confirm our communication to the FDA about the status of the Pfizer-BioNTech COVID-19 vaccine postmarketing activities, including our intent to stop study C4591081,” the spokesperson said. “Notably, this study is not ending as a result of any safety or benefit-risk concerns.”
    • “The spokesperson added that the companies “intend to stop the study due to slow enrollment and therefore the inability to generate relevant postmarketing data.”

From the public health and medical / Rx research front,

  • The American Hospital Association News reports,
    • “A Centers for Disease Control and Prevention report published April 7 found that 47.2% of all U.S. adults met federal guidelines for aerobic physical activity in 2024. The report found that 52.3% of men and 42.4% of women met the standards. The CDC found that the prevalence of meeting the guidelines increased with education level. Aerobic physical activity was higher among adults without disabilities (49.8%), those with a healthy weight (54.8%), and those with excellent or very good health (57.8%). The analysis was based on data from the 2024 National Health Interview Survey.” 
  • Healio adds,
    • “Modest real-world weight loss may significantly reduce a person’s risk for cancer, according to results of a retrospective observational study.
    • “The risk reduction conferred by nonsurgical weight loss appeared consistent over multiple time intervals.
    • “The benefits became apparent quickly, with each 1% reduction in BMI equating to an approximately 1% reduction in cancer risk after as little as 3 years of follow-up.
    • “I definitely was surprised by the results, especially that we saw them as early as we did,” Daniel M. Rotroff, PhD, chairman of the department of quantitative health sciences and Eddie J. Brandon Endowed Chair for Diabetes Research at Cleveland Clinic, told Healio. “A 1% BMI reduction for a 1% reduction in risk may not sound like a lot but, when you think about some interventions achieving 5% weight loss pretty rapidly — and [some GLP-1 or dual GLP-1/GIP receptor agonists] achieving 10% or greater — that is a really meaningful reduction in cancer risk.”
  • Infectious Disease Advisor points out,
    • “The significant burden of respiratory syncytial virus-associated hospitalization in older adults, particularly those with underlying conditions, underscores the need for targeted vaccination strategies.”
  • MedPage Today adds,
    • “Influenza vaccines were effective in preventing related hospitalizations and outpatient visits among U.S. kids in recent years, but vaccine uptake remained low.
    • “Vaccine effectiveness against hospitalization ranged from 28% during the 2021-2022 flu season to 67% in the 2023-2024 season, and against outpatient visits ranged from 28% during the 2021-2022 season to 56% in the 2023-2024 season.
    • “Experts pointed to a need to properly communicate the benefits of influenza vaccines, especially as “distrust in vaccines grows.”
  • Health Day tells us,
    • “Cancer risk is higher for people battling autoimmune diseases, but the danger declines after they start taking anti-inflammatory medications, a new report finds.
    • “Italian researchers reporting in the journal Cancers found a 32% increase in the odds for cancer in the first year after a diagnosis for an autoimmune disease such as lupus, rheumatoid arthritis or psoriasis.
    • “However, after patients start taking drugs to ease the runaway inflammation that characterizes these illnesses, their cancer risk declines.
    • “The peak risk observed in the early stages suggests that chronic inflammation, rather than treatments, is a key factor in cancer development,” said Daniela Marotto, co-senior author of the study. She is head of rheumatology at the Local Health Authority of Gallura, in Italy.”
  • Health Day adds,
    • “Catching tumors early is crucial to lung cancer survival
    • “New robotic technologies, along with other innovations, is making early detection safer and easier on patients
    • “Often, detection, staging and treatment are done during the same procedure.”
  • Per STAT News,
    • “For some advanced cancers, sequencing the tumor genome should be one of the first steps patients and physicians take. But a new study finds that many patients never receive genomic testing and so never get the chance to know if they might have benefitted from newer, more targeted therapies.
    • “The study, published on Tuesday in JAMA Network Open, examined how many patients diagnosed with one of five different metastatic cancers received genetic sequencing for the cancers. For most cancers in the study, roughly half of patients in the cohort received genetic sequencing. Patients with low income, Medicare or Medicaid coverage, and Black or Hispanic race or ethnicity were also less likely to receive sequencing.”
  • MedPage informs us,
    • “Under physician supervision, 26% of older adults successfully stopped levothyroxine while maintaining stable thyrotropin and free thyroxine levels for a year.
    • “Discontinuation was more common in patients taking lower levothyroxine doses at baseline.
    • “Researchers urged clinicians to reassess thyroid therapy in older adults to avoid overtreatment and its associated risks.”

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

  • Fierce Healthcare reports,
    • “Last summer, the insurance industry broadly agreed to reform a major healthcare pain point: prior authorization.
    • “Now, two of the industry’s leading organizations are offering a look at progress toward those goals. AHIP and the Blue Cross Blue Shield Association released a report on Tuesday that found leading health plans reduced prior authorizations for an array of services by 11% since the pledge was made.
    • “This equates to 6.5 million fewer prior auth requests for patients, according to the report. Reductions in Medicare Advantage specifically were 15%, it reads.
    • “Health plans have taken important initial steps to support patients and are working toward the shared goal of delivering answers at the point of care whenever possible—a goal that will require both plans and providers to eliminate manual processes and adopt real-time electronic data sharing,” said Mike Tuffin, AHIP President and CEO, in the announcement.”
  • Physicians’ Practice adds,
    • “Access to affordable health care has displaced administrative burden as the single biggest policy concern among U.S. physicians, according to athenahealth’s fifth annual Physician Sentiment Survey. The shift signals the industry’s growing concern over systemic cost and coverage pressures, stretching well beyond the exam room.
    • “The survey, conducted online by The Harris Poll in October 2025 among 1,045 primary care physicians and specialists nationwide, found that 52% of physicians now consider access to affordable health care to be the most pressing issue they want policymakers to address. That figure was 44% in the 2025 survey and 38% in 2024, a 14-point climb in just two years. For the first time in the survey’s five-year history, the issue overtook minimizing excessive documentation requirements, which fell to 46% from 49% in 2024.”
  • The Wall Street Journal charts the weight loss drug frenzy ongoing in our country.
    • “The market for weight loss drugs is exploding and patients may have several new options in coming years.”
  • The Journal also relates,
    • “Gilead Sciences GILD agreed to buy German biotechnology company Tubulis for $3.15 billion to expand its portfolio of a cancer technology that aims to better guide chemotherapies to tumors.
    • “Tubulis’s lead drug is a targeted cancer therapy known as an antibody-drug conjugate. It is in mid-stage trials for ovarian and lung cancers. The German company has another antibody-drug conjugate in earlier stages of development that is being tested across several tumor types.”
    • “The deal, announced Tuesday, is expected to close by the end of June and includes up to $1.85 billion in potential milestone payments. Gilead already had a two-year research partnership, signed in 2024, with Tubulis.”
  • Per an Institute for Clinical and Economic Review news release,
    • “The Institute for Clinical and Economic Review (ICER) today released a Draft Evidence Report assessing the comparative clinical effectiveness and value of Comirnaty® (Pfizer, BioNTech), Spikevax® (Moderna), mNexspike® (Moderna), and Nuvaxovid® (Sanofi) for the protection against Covid-19, including both the short- and long-term effects of the infection. 
    • “This preliminary draft marks the midpoint of ICER’s eight-month process of assessing these treatments, and the findings within this document should not be interpreted to be ICER’s final conclusions.“
  • Per Fierce Healthcare,
    • “Alloy Health, a virtual platform serving women in midlife, is expanding its weight care program with two new offerings: micro-dosing and the Wegovy pill.
    • “Micro-dosing will allow for more personalized dosing for women who, for whatever reason, do not tolerate the manufacturer-made doses. The Wegovy pill introduces a daily oral GLP-1 option for women who prefer an alternative to injections. The company hopes to keep adding more brand-name products, including the Zepbound KwikPen, as they become available. 
    • “The products build on Alloy’s existing weight care program, launched last year, which aims to offer menopause-specialized weight care. The program offers physician-led hormonal expertise with personalized care plans designed for midlife women. Alloy is an entirely asynchronous, text-based provider.” 
  • and
    • “Artificial intelligence-enabled virtual care company Counsel Health is building out its clinical offerings to include lifestyle and chronic condition services. 
    • “The expansion will first focus on lifestyle conditions, including hair loss and sexual health, with plans to broaden its scope to chronic conditions later in 2026, including services to address high cholesterol and obesity. 
    • “If its chatbot recommends consultation with a physician, users can pay $29 to schedule follow-up care. Counsel Signature members, the company’s annual membership plan, will be able to use the expanded capabilities at no extra cost, according to a company announcement.”
  • Beckers Payer Issues lets us know,
    • “Cigna Healthcare offers the best digital experience to commercial members, while UPMC Health Plan provides the best experience to Medicare Advantage enrollees, according to J.D. Power’s 2026 U.S. Healthcare Digital Experience Study. Both plans topped their respective segments in last year’s ranking as well.
    • “Overall, the segment average for commercial plan digital experience is 658 on a 1,000-point scale. For MA, the segment average is 645. Both figures represent an improvement over the 2025 study, which recorded averages of 653 for commercial plans and 597 for Medicare Advantage.
    • “The study measured satisfaction across visual appeal; navigation; information/content; speed; and telehealth. The 2026 study included evaluations from 7,687 members of the 17 largest MA plans and 16 largest commercial plans, fielded from August through December 2025.”
    • More results are available in the article.
  • Modern Healthcare reports,
    • “Health systems and health plans are embracing performance-based contracts with digital health vendors. 
    • “In 2025, 75% of health plans and 61% of health systems implemented performance-based contracts with digital health vendors, according to a 2025 survey conducted by Peterson Health Technology Institute. In addition, the majority of the organizations that didn’t use performance-based contracts last year expressed interest in doing them.
    • “The contracts can ensure that payment is tied to return on investment and measurable outcomes. That makes formulating them tricky.”

Midweek update

David Ermer–CDC, CMS, Congress, FDA, Medical / Rx research, NIH, No Surprises Act, OPM, Patient safety, Rx coverage, U.S. Healthcare–

From Washington, DC,

  • The Wall Street Journal reports,
    • “President Trump on Wednesday endorsed a two-part plan to quickly fund most of the Department of Homeland Security and then use a special procedure to pay for immigration enforcement with only GOP votes, stepping in to resolve a standoff between Republican congressional leaders.” * * *
    • “Congress could now pass a bill funding most of DHS that the Senate approved last week, and Trump set a goal of June 1 for funding the rest of the department using a process called budget reconciliation. The maneuver requires a simple majority for budget-focused bills, rather than the 60 votes typically required in the Senate, which Republicans control 53-47.
    • [Senate Majority Leader John] Thune [(R., SD)] and House Speaker Mike Johnson (R., La.), who had publicly disagreed over the best way to end the DHS shutdown, issued a joint statement backing Trump’s directive and saying they agreed on the two-step path to fully fund the department in “coming days.”
  • Healthcare Dive reports,
    • “Elevance avoided steep sanctions against its Medicare Advantage plans that were set to kick in on Wednesday, after the CMS granted the insurer an extension to make up for incorrect risk adjustment data reporting stretching back years.
    • “Earlier this year, the CMS notified Elevance that it planned to prevent the insurer’s MA plans from enrolling new members, along with other sanctions, starting on March 31 after finding that Elevance failed to comply with federal data submission requirements. Elevance asked regulators for more time to comply, and the CMS granted the company’s request in mid-March, according to a disclosure from Elevance.
    • “Elevance now has until May 30 to correct its data reporting before sanctions kick in. The CMS also exempted several of Elevance’s MA plans that weren’t impacted by the noncompliance from the potential penalties.”
  • The Labor Department issued a “Frequently Asked Question (FAQ) regarding implementation of certain provisions of Title I (the No Surprises Act)(1) of division BB of the Consolidated Appropriations Act, 2021. This FAQ has been prepared jointly by the Departments of Labor, Health and Human Services (HHS), and the Treasury (collectively, the Departments), along with the Office of Personnel Management (OPM).”
    • The FAQ 73 concerns an ongoing Qualifying Payment Amount dispute long pending before the U.S. Court of Appeals for the Fifth Circuit.
    • “Q1: Are the Departments and OPM extending the enforcement relief regarding the use of QPAs announced in FAQs Part 71?
      • “Yes. The Departments and OPM extend the exercise of enforcement discretion, originally provided in FAQs Part 62 and extended in FAQs Parts 67, 69, and 71, under the relevant No Surprises Act provisions for any plan or issuer, or party to a payment dispute in the Federal IDR process, that uses a QPA calculated in accordance with the 2021 methodology, for items and services furnished on or after February 1, 2026, and before October 1, 2026, the first day of the calendar month that begins after 6 months from the issuance of these FAQs. This exercise of enforcement discretion applies to QPAs for purposes of calculating patient cost sharing, providing required disclosures with an initial payment or notice of denial of payment,(14) and providing required disclosures and submissions under the Federal IDR process.
      • “HHS similarly extends its exercise of enforcement discretion under the relevant No Surprises Act provisions for a provider, facility, or provider of air ambulance services that bills, or holds liable, a participant, beneficiary, or enrollee for a cost-sharing amount based on a QPA calculated in accordance with the 2021 methodology, for items and services furnished on or after February 1, 2026, and before October 1, 2026.”
  • Per an OPM March 31, 2026, news release,
    • “Today, the Office of Personnel Management (OPM) announced the President’s Commission on White House Fellowships is now accepting applications for the 2026-27 class of White House Fellows.”
  • Per a CMS news release,
    • “The Centers for Medicare & Medicaid Services (CMS), through the CMS Innovation Center, announced that organizations participating in certain Innovation Center models may begin offering a new Substance Access Beneficiary Engagement Incentive (BEI) starting April 1, 2026. Through this optional incentive, eligible hemp-derived products can be incorporated into patient care plans under clinician guidance, consistent with model requirements and applicable law.
    • “This milestone reflects the Administration’s broader efforts to expand access to innovative, patient-centered care. It also aligns with President Trump’s Executive Order supporting research and innovation related to hemp-derived products. It marks a meaningful step as CMS begins testing how emerging care tools can be integrated into coordinated care to improve outcomes and quality of life. 
    • “CMS is committed to innovation that meets patients where they are while maintaining strong safeguards and clinical oversight,” said CMS Administrator Dr. Mehmet Oz. “Under the President’s leadership, we’re expanding the tools available to improve patients’ health while generating important insights into how providers can use these tools safely and effectively in real-world care settings.” * * *
    • “More information about the Substance Access Beneficiary Engagement Incentive, including eligibility criteria and program requirements, is available at: https://www.cms.gov/priorities/innovation/substance-access-beneficiary-engagement-incentive.”
  • The American Hospital Association News relates,
    • “The Centers for Medicare & Medicaid Services March 30 announced that C2C Innovative Solutions will replace Maximus in reviewing and processing appeals of adverse organization determinations and reconsiderations made by Medicare Advantage plans as of May 1. Maximum will continue to process appeals requests received on or before April 30. CMS said there will be a short period when both Maximus and C2C are issuing decisions. Updates on procedures for submitting appeal case files and other communications will become available on C2C’s website beginning April 1.” 
  • The Wall Street Journal informs us,
    • “The latest Census Bureau data show the broad effects of a big immigration slowdown in the U.S., and a lot more.
    • “The numbers for the year through June 2025 also show fewer people bailing on America’s tech epicenter, a modest Midwest rebound and rising appeal for small southern metros.” 

From the Food and Drug Administration front,

  • In the biggest healthcare news of the day, the Wall Street Journal reports,
    • “The weight-loss pill wars start now. 
    • “Eli Lilly’s once-daily pill for weight loss got approval from U.S. drug regulators Wednesday. The all-clear sets up a battle with rival Novo Nordisk, which has been selling a pill version of its Wegovy since the start of this year.
    • “The Wegovy pill has had one of the best drug launches in history. Now that the Food and Drug Administration has approved its pill, Lilly will seek to overtake the rival, and further its dominance of the booming $70 billion-plus market for weight-loss and diabetes drugs known as GLP-1s.
    • “It will be a battle royal for GLP-1 pill leadership between Novo and Lilly,” Leerink Partners analyst David Risinger said.
    • “Lilly has won a weight-loss fight before: While Novo Nordisk pioneered the use of GLP-1 drugs for weight loss with its Wegovy and Ozempic weekly injections, Lilly’s Zepbound and Mounjaro injections now outsell them.
    • “Yet Novo Nordisk plans to avoid the mistakes that hurt it during the last round, and will seek to hold on to its early lead by emphasizing the effectiveness of its pill.
    • “Analysts are betting on Lilly, expecting its pill, named Foundayo, to generate about $21 billion in global sales by 2030, compared with $4 billion for the Wegovy pill, according to pharmaceutical commercial intelligence firm Evaluate.”
  • Fierce Pharma relates,
    • “The FDA has delayed its target decision date for Orca Bio’s blood cancer cell therapy candidate Orca-T by three months to July 6.
    • “The review extension comes after the company submitted additional data related to chemistry, manufacturing and controls (CMC) a couple of weeks ago upon request by the agency, Orca Bio’s CEO Nate Fernhoff, Ph.D., told Fierce.
    • “Fernhoff wouldn’t specify the exact nature of the FDA’s questions but said the company doesn’t believe “any of these to be fundamental or unaddressable.”
  • MedTech Dive tells us,
    • “Distalmotion has submitted a 510(k) application to expand the label of its Dexter robotic surgery system in the U.S., the company said Wednesday.
    • “The company aims to expand use of Dexter in gynecological indications, strengthening its push to support ambulatory surgical centers that want to perform more outpatient procedures.  
    • “Distalmotion has identified ASCs, which may have less space, resources and infrastructure than hospitals, as sites of care where Dexter could have an advantage over existing surgical robots.”
  • Cardiovascular News informs us,
    • “The U.S. Food and Drug Administration (FDA) has confirmed a new recall of the purge cassettes sold with certain Johnson & Johnson MedTech Impella heart pumps. The alert covers individually packaged Generation 1 Purge Cassettes as well as the ones sold with certain Impella RP, Impella 2.5, Impella CP, Impella CP with Smart Assist, Impella 5.0 and Impella 5.5 with Smart Assist heart pumps. 
    • “The FDA issued this recall due to a risk of the purge cassettes leaking. Purge cassettes play a critical role in patient care, delivering a rinsing fluid to the catheter that prevents blood from flowing back into the motor.
    • “A purge leak may lead to low purge pressure if it goes unaddressed,” according to Johnson & Johnson MedTech. “This can lead to biomaterial ingress, which may lead to an unexpected pump stop. A pump stop may result in a loss of hemodynamic support and lead to patient death.”
    • “The leaks have been linked to four serious injuries and no deaths.”

From the judicial front,

  • ABHW reports,
    • “The Association for Behavioral Health and Wellness (ABHW), the national voice for payers that manage behavioral health insurance benefits for 200 million people, issued the following statement in response to the Trump Administration’s announcement that they will issue a new proposed rule on the Mental Health Parity and Addiction Equity Act (MHPAEA), including anticipated significant revisions to the provisions of the Rule, as ABHW had requested. The Administration has indicated through court documents that it intends to include this rulemaking on the 2026 Spring Regulatory Agenda, and to issue a notice of proposed rulemaking no later than December 31, 2026.”

From the public health and medical / Rx research front,

  • Per a National Institutes of Health news release,
    • “Researchers at the National Institutes of Health (NIH) have identified a novel, highly potent opioid that shows potential as a therapy for both pain and opioid use disorder. In a study published in Nature, the team observed the new drug’s effect in laboratory animals. They showed that it has high pain-relieving effects without causing respiratory depression, tolerance or other indicators of potential for addiction in humans.
    • “Opioid pain medications are essential for medical purposes, but can lead to addiction and overdose,” said Nora D. Volkow, M.D., director of NIH’s National Institute on Drug Abuse (NIDA). “Developing a highly effective pain medication without these drawbacks would have enormous public health benefits.”
    • “The team investigated formulations of an understudied class of synthetic opioid compounds, known as nitazenes. Nitazenes selectively engage mu-opioid receptors, primary targets for opioid drugs in the brain and peripheral nervous system. However, nitazenes had been shelved in the 1950s due to their excessive potency. The scientific team revisited this class of compounds with a focus on harnessing their selectivity for the mu opioid receptor and engineering new nitazenes with a safer pharmacological profile.
    • “Our goal was to study the profile, or pharmacology, of these drugs,” said Michael Michaelides, Ph.D., senior author and NIDA investigator. “We wanted to decrease the potency and create a potential therapeutic. What we discovered exceeded our expectations.”
  • STAT News reports,
    • “Few things will give a man as much of an insight into the female body as growing up with sisters. Painful, irregular periods, body hair, skin trouble: Al Barrus, a 43-year-old veteran and communications specialist from New Mexico, heard all about it growing up, the only male of three siblings. He’s also known for a while that one of his sisters had been diagnosed with polycystic ovary syndrome, an endocrinological disorder and leading cause of infertility associated with a range of issues including high androgen levels, insulin resistance, and enlarged ovaries. His other sister, too, had some PCOS symptoms. 
    • “Recently, he’s begun to wonder: Could he have it, too? 
    • “Not exactly PCOS but a “male form.” Where women with PCOS’ levels of androgen are too high, his are too low; rather than hirsutism (excess body hair), he has sparse body and facial hair and began going bald as a teenager. He has other issues similar to the ones that can appear in women with PCOS: high levels of the hormone prolactin, suspected insulin resistance, obesity, mental health struggles.” * * *
    • “It took more than a decade, but at last, there is a name, though it is still tightly under wraps “pending submission to a journal for publication,” said Robert Norman, a professor emeritus of reproductive and periconceptual medicine at Adelaide University and one of the experts who worked on selecting a new name. He declined an interview request: “I think you would find it frustrating talking with us when we are not going to reveal the new name yet!” 
  • The American Hospital Association News relates,
    • “The Centers for Disease Control and Prevention has temporarily paused rabies and pox virus testing, according to an update on its website March 30. The pox virus family consists of several viruses, including smallpox and mpox. The CDC typically confirms infections for rabies and pox viruses, among several other infectious diseases.”
  • MedPage Today 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 informs us,
    • “Incidence of fractures among women begins to rise at age 35 years and increases dramatically starting at age 45 years, whereas men have their highest rates of fracture at age 35 to 45 years, according to data from the UK Biobank.
    • “Our findings reveal a previously underrecognized trajectory of increasing fracture risk in women beginning as early as age 35 years old, with a marked acceleration from the mid-40s,” Catherine Rolls, MSc, research associate in the musculoskeletal research unit and translational and applied research group at University of Bristol in the U.K., and colleagues wrote in a study published in Journal of Bone and Mineral Research. “This female-specific pattern resembles the postmenopausal risk profiles traditionally seen in older populations and suggests that skeletal vulnerability begins earlier than often assumed.”
  • Health Day points out,
    • “Teenagers might be known for being night owls, but they’ll be healthier if they can get to bed earlier, a new study says.
    • “Teens who stay up late and sleep the morning away are more likely to eat more and be less physically active, especially when school is in session, researchers report in the April issue of the journal Sleep Health.
    • “Sleep timing — when teens go to bed and wake up — had the biggest influence on sedentary and eating behavior in teens,” senior researcher Julio Fernandez-Mendoza, a professor of psychiatry and behavioral health at Penn State College of Medicine, said in a news release.
    • “It’s something parents need to pay attention to — and protect — during critical developmental years like adolescence,” he said.”
  • Per MedTech Dive,
    • “Medtronic said it will support a new study of its Symplicity Spyral procedure in patients with uncontrolled high blood pressure and multivessel artery disease who are undergoing percutaneous coronary intervention. Global guidelines indicate patients with both conditions need more aggressive hypertension management, the device maker said this weekend at the American College of Cardiology’s annual meeting.
    • “Medtronic’s Symplicity Spyral renal denervation device won Food and Drug Administration approval in late 2023 to treat patients whose high blood pressure cannot be controlled by drugs. The new study, called EMBRACE, will evaluate renal denervation performed in the same procedure as PCI, a treatment to remove plaque buildup and open blocked coronary arteries.
    • “Separately, Medtronic released results from a pooled analysis of the SPYRAL HTN ON and OFF MED trials showing that patients who underwent a renal denervation procedure to improve their blood pressure had a significantly lower rate of hypertensive emergencies (40%) at three years than those who received a sham treatment.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “The combination of technology and alternative care options is slowing the growth rate of healthcare spending.
    • “In January, the Centers for Medicare and Medicaid Services said healthcare expenditures rose 7.2%, to $5.3 trillion, in 2024. Healthcare spending accounted for 18% of gross domestic product in 2024, less than the 21.2% the agency projected.
    • “Advances in care delivery, reduced pricing on some treatments and payer restrictions on care utilization drove down spending, according to a recent study by public policy organization Brookings Institute. 
    • “The healthcare spending growth rate relative to GDP from 2010 to 2024 is the lowest in a 14-year period since 1960, the study said. 
    • “While we’re documenting that the healthcare cost curve has bent and we think that there are reasons that it will continue to be bent, it could still bend more,” said Lev Klarnet, one of the study’s authors and a doctoral student in business economics at Harvard University.
    • “Here are three takeaways from the research.
      • Cost sharing, prior authorizations reduce demand
      • Outpatient procedures are saving money, and
      • “Technology is lowering costs by improving health.”
  • and
    • “The Leapfrog Group will expand its rating system for ambulatory surgery centers.
    • “Starting in July, Leapfrog plans to use publicly reported Centers for Medicare and Medicaid Services data to compare safety and quality measures across nearly 4,000 ASCs, similar to how the independent watchdog group rates hospitals, according to a Tuesday news release. 
  • Beckers Payer Issues reminds us,
    • “For the first time, payers must publicly post data on how often they deny prior authorization requests, how quickly they process them and how often denials are overturned on appeal. The first reports are due March 31 under a rule CMS finalized in 2024.” 
  • Fierce Healthcare tells us,
    • “It’s been seven years since the American Medical Association (AMA) launched its Joy in Medicine program to address physician burnout. 
    • “The issue is far from resolved, with burnout peaking during the COVID-19 pandemic. Recent estimates have found that more than half of surgeons are still burned out. Amid pressing financial challenges and as organizations struggle to recruit clinicians, the need for joy in medicine has never been more pressing.
    • “The AMA’s voluntary program is meant to serve as a guide to health systems looking to assess and address their institutions’ levels of burnout. Organizations must apply and it is free to participate. About 1,800 organizations have participated to date.”
  • BioPharma Dive informs us,
    • “Merck and Co. has signed an agreement with California-based Infinimmune to develop multiple antibodies for various disease targets, the companies announced Tuesday.
    • “Per deal terms, Merck could load Infinimmune with up to $838 million in upfront and milestone payments if any of the drug candidates make it into clinical testing and onto the market. Neither company disclosed how much was offered as an upfront payment. Merck will hold exclusive rights to develop and commercialize drugs that are discovered through the collaboration.”
  • Beckers Hospital Review shares “the big bets 20 pharmacy leaders are making right now.”
  • The Wall Street Journal points out,
    • “The nation’s costliest autism therapy provider will shut down by mid-May, the company’s human resources chief said in an email to employees one week after the state of Indiana said it would bar the firm from billing Medicaid.
    • “The autism-therapy provider, Piece by Piece Autism Centers, received $340,000 in Medicaid payments per patient in 2023, the highest level in the country, The Wall Street Journal reported last month in an article examining how some providers had outpaced regulators in their fast-growing businesses.
    • “Once Piece by Piece—which state officials have said abused the taxpayer-funded program for low-income people—closes, its centers will be operated by a rival autism-therapy provider, Applied Behavior Center for Autism, emails show. Applied Behavior Center settled federal civil fraud allegations over billing issues just three years ago without admitting wrongdoing, the Justice Department announced at the time.”

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.”