Thursday Report

Federal employment benefits

Thursday Report

David Ermer–Congress, COVID-19 testing, Federal employment benefits, Medical / Rx research, Mental health care, Obesity, OPM, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC

  • Modern Healthcare reports,
    • “Senate Republicans are considering cuts to Medicare spending to help pay for Donald Trump’s signature legislative package.
    • “The GOP lawmakers are proceeding cautiously as they expand their search for savings to a popular health insurance program nearly all Americans rely upon in retirement, presenting the move as an effort to root out waste, fraud and abuse. That includes cutting payments to health insurance companies that run private Medicare plans.”
  • The Wall Street Journal adds,
    • “Humana, the second-biggest Medicare insurer, has told congressional staffers that it will support moves that would curtail billing practices worth billions in extra payments to the industry, according to staffers and a document viewed by The Wall Street Journal.
    • “The stance by a leader in the Medicare Advantage business—in which insurers offer privately run Medicare plans—represents an important development in a growing debate over how the companies are paid in the $460 billion program.
    • “Insurers get paid more for covering sicker patients in Medicare Advantage, giving companies an incentive to record more diagnoses. Humana has told congressional staffers that it is willing to back new limits on lucrative payments insurers can gain from diagnoses recorded by nurse practitioners who visit millions of enrollees in their homes, according to a one-page policy overview shared with congressional staffers.
    • “After the Journal published this article Thursday morning, the biggest Medicare insurer, UnitedHealth Group, posted a statement saying that it too would support a new limit on the use of diagnoses from home visits.”
  • Healio points out,
    • HHS has ended a government-funded program that distributed free COVID-19 tests to community organizations, a department spokesperson confirmed to Healio.
    • “With COVID-19 behaving more like the seasonal flu — rising and falling through the year — and tests widely available at retail stores nationwide, continued federal distribution is a significant waste of taxpayers’ dollars,” the spokesperson said. “The COVID-19 pandemic is over.” * * *
    • “The program differed from the mail-based program that was started and stopped several times throughout the pandemic and provided U.S. residents the opportunity to get free COVID-19 tests delivered directly to their homes.”
    • “HHS is in the process of purchasing a supply of tests that can distinguish between COVID-19 and influenza to have on hand for emergencies.”
  • Tammy Flanagan, writing in Govexec, discusses “Should you stay, or should you go? 10 tips for navigating your federal retirement decision. What to consider—financially and emotionally—before leaving government service.”

From the public health and medical research front,

  • Chief Healthcare Executive tells us,
    • Two years ago, the American Diabetes Association and The Leapfrog Group announced that they were joining forces to recognize hospitals for providing excellent care to patients with diabetes.
    • Now, the groups are announcing honors for a second batch of recipients, and they’re recognizing more than twice as many hospitals.
    • The American Diabetes Association and the Leapfrog Group have announced 36 hospitals as 2025 Recognized Leaders in Caring for People Living with Diabetes. A year ago, the groups recognized 17 hospitals [which are listed in the article].
    • The organizations say they want to give public recognition to hospitals, but they are also highlighting the importance of providing proper care for patients with diabetes.
    • Nearly one-third of patients admitted to hospitals (30%) are diagnosed with diabetes. Some of those are patients that are being treated in the hospital for another illness or injury.
  • The New York Times reports,
    • “The technology that powered Covid vaccines may also lead scientists to a cure for H.I.V. Using mRNA, Australian researchers said they were able to trick the virus to come out of hiding, a crucial step in ridding the body of it entirely.
    • “The research, published last week in Nature Communications, is still preliminary, and so far, has been shown to be successful only in a lab. But it suggests that mRNA has potential far beyond its use in vaccines as a means to deliver therapies against stubborn adversaries.
    • “Short for messenger RNA, mRNA is a set of instructions for a gene. In the case of Covid vaccines, the instructions were for a piece of the coronavirus. In the new study, they are for molecules key to targeting H.I.V.
    • “Dr. Sharon Lewin, director of the Cumming Global Center for Pandemic Therapeutics in Melbourne, who led the study, called mRNA a “miraculous” tool “to deliver things that you want into places that were not possible before.”
  • STAT News adds,
    • “People with diabetes who were taking GLP-1 drugs had a low but elevated risk of an age-related eye disease that can sometimes lead to blindness, a new observational study concludes, adding to a short list of concerns about eye health in people taking the powerful medications.
    • “The research, published Thursday in JAMA Ophthalmology, found that after one year, more than twice as many people on GLP-1 drugs developed neovascular age-related macular degeneration compared to similar people who were not taking the drugs. The risk was 0.2% in people taking GLP-1s and 0.1% in those who didn’t. Participants, drawn from health records of nearly 140,000 patients in Canada, were matched for socioeconomic status and a long list of conditions in addition to diabetes.” * * *
    • “Seeing such a clear signal in our study was striking,” co-author Reut Shor of the University of Toronto told STAT. “The absolute risk remains low, but the advanced form of AMD is a condition with serious implications for vision and quality of life. So a doubling of risk is clinically meaningful, particularly for vulnerable populations like older adults who may already be at elevated baseline risk.”
  • Per Health Day,
    • “A quality improvement strategy can improve electronic health record-based screening for depression and anxiety in people with epilepsy, according to a study published online April 16 in the Journal of Clinical and Translational Science.
    • “Heidi M. Munger Clary, M.D., M.P.H., from the Wake Forest University School of Medicine in Winston-Salem, North Carolina, and colleagues developed an implementation strategy for anxiety and depression screening among people treated at an epilepsy center. Implementation outcomes were evaluated five months postimplementation compared to two three-month preimplementation time frames.”
  • and
    • Dietary patterns seem to be associated with depressive symptoms, according to a study published online June 3 in BMJ Nutrition, Prevention & Health.
    • Gabriella Menniti, M.D., from Unity Health Toronto, and colleagues conducted a cross-sectional study using National Health and Nutrition Examination Survey 2007 to 2018 data to examine the association between restrictive dietary patterns and depressive symptoms stratified by sex and body mass index.
  • Per MedPage Today,
    • High blood pressure (BP) awareness increasingly slipped under the radar since the COVID-19 pandemic, according to nationally representative health data.
    • Results from National Health and Nutrition Examination Survey (NHANES) cycles, spanning the years 2013 to 2023, showed no improvement in the proportion of adults having hypertension, diabetes, and high cholesterol who self-reported being unaware and never diagnosed. In fact, hypertension awareness stood out for trending significantly in the wrong direction:
      • Adults with hypertension not realizing it: 14.6% in 2013-2014 to 17.8% in 2021-2023
      • Adults with diabetes not realizing it: 27.5% to 28.9%
      • Adults with high total cholesterol not realizing it: 11.5% to 11.9%
    • “Given declining cardiometabolic health in young adults, it is concerning that approximately one in three with hypertension, two in five with diabetes, and one in four with a high cholesterol level are unaware of having these conditions. Policy efforts to address these gaps in awareness are needed to prevent future cardiovascular events,” wrote Rishi Wadhera, MD, MPP, MPhil, of Beth Israel Deaconess Medical Center and Harvard T.H. Chan School of Public Health in Boston, and colleagues in JAMA Cardiology“

From the U.S. healthcare business front,

  • Beckers Hospital Review informs us,
    • “Nonprofit hospitals are seeing margins improve as patient demand for care soars, according to Kaufman Hall’s “National Hospital Flash Report” released June 5.
    • “Kaufman Hall, a Vizient company, analyzed data from 1,300 hospitals collected by Strata Decision Technology for its monthly report.
    • “Hospital performance from January to April outpaced the first four months of 2024, largely driven by patient volume and hospital efficiency,” said Erik Swanson, managing director and group leader, data and analytics, at Kaufman Hall. “Operating room minutes, ED visits and inpatient revenue are trending upward, demonstrating a strong demand for services. A decline in average length of stay indicates that hospitals are triaging, treating, and discharging patients effectively and appropriately.”
  • Modern Healthcare reports,
    • “Nineteen critical access hospitals in Nebraska have formed a clinically integrated network, the third coalition of its kind created over the past three months.
    • “The Nebraska High Value Network aims to give rural hospitals the scale to lower costs, invest in new technology, improve treatment and expand value-based contracts while remaining independent. The network, announced Thursday, follows similar alliances in Montana, Ohio, Minnesota and North Dakota.” * * *
    • “Cibolo Health, the rural health advisory firm that helped launch these hospital collaborations, will manage daily operations of the Nebraska High Value Network. The network will include clinical and business integration committees led by member hospital executives who will oversee quality and administrative initiatives.”
  • Beckers Clinical Leadership lets us know,
    • “The District of Columbia has the most physicians per 100,000 population, while Idaho has the fewest specialist physicians and Nevada has the fewest primary care physicians per 100,000, KFF data found.
    • “KFF used data from Redi-Data to find the number of MD and DO active state-licensed physicians as of April 2025. Becker’s used Census data from 2025 to find the population of each state.
    • “There are 535,542 primary care physicians and 570,655 specialist physicians in the U.S. this year.
    • “[The article includes a chart with] the number of primary care and specialist physicians per 100,000 people in each state and the District of Columbia.”
  • Per MedTech Dive,
    • “Johnson & Johnson CFO Joseph Wolk, at the Bernstein investor conference last week, tempered the company’s expectation that it would suffer a $400 million tariff impact this year.
    • “Wolk gave the update after the U.S. and China reached a temporary agreement to pause escalating tariff rates between the two countries for 90 days.
    • “Weeks before the pause, J&J had predicted on an April’s earnings call that it would incur tariff-related costs of about $400 million this year, primarily affecting its medtech business.
    • “But Wolk, at the Bernstein conference, suggested the forecasted tariff hit could change in the future.
    • “Just based on the retaliatory China tariffs that we had in our $400 million assessment, that probably cuts the $400 million down to $200 million,” Wolk said, responding to a question about the shifting tariffs landscape. That does not include any impact that could result from the Trump administration’s Section 232 investigations, he said. The Trump administration has launched special investigations into the pharmaceutical and semiconductor industries that could lead to tariffs.
    • “In addition, Wolk noted, tariffs between the U.S. and Europe remain in flux.” 

Monday Report

David Ermer–CDC, CMS, FDA, Federal employment benefits, Medical / Rx research, Obesity, OPM, Telehealth, U.S. Healthcare, Uncategorized–
Photo by Sven Read on Unsplash

From Washington, DC,

  • Federal News Network tells us,
    • “The White House is not requesting an increase in pay for federal employees in fiscal 2026. President Donald Trump released more details of his budget request for next year late Friday afternoon. The appendix section of the budget proposals also includes provisions to continue the pay freeze for certain non-career Senior Executive Service members and political appointees. In all, the new budget document details more specific discretionary spending requests for each agency. Unlike the “skinny” budget released in early May, the administration did include funding requests for the Office of Personnel Management, the Education Department and independent agencies like the Consumer Financial Protection Bureau.”
  • Healthcare Dive adds,
    • “The White House released a more detailed budget proposal on Friday that yields more information on how the Trump administration is aiming to reshape the HHS next year, including drastic cuts to the National Institutes of Health.
    • “The updated proposal doubles down on plans to slash the NIH’s budget nearly in half, consolidate the HHS’ 28 operating divisions into 15, eliminate dozens of federal healthcare and social welfare programs and terminate more than 5,000 contracts.
    • “The Trump administration argues the changes are necessary to streamline HHS functions and eliminate priorities around diversity, equity and inclusion panned by conservatives.
    • ‘The administration can’t fully implement the budget without the support of Congress. Lawmakers usually make changes to the executive branch’s spending wish list in appropriations legislation.
  • Beckers Hospital Review points out,
    • “HHS has proposed oversight of the 340B drug pricing program to the Centers for Medicare & Medicaid Services as part of a broader reorganization. 
    • “The move, initially referenced in a preliminary memo from White House officials in April, would place the 340B program under CMS’s Program Management authority, allowing the agency to use its in-house drug pricing expertise and streamline oversight, according to HHS’s Budget in Brief. 
    • “Funding for 340B oversight would be maintained at $12 million to “provide oversight and auditing of covered entities and drug manufacturers, support operational improvements, and increase operational efficiencies,” the document said. 
    • “The 340B drug pricing program requires drug manufacturers to offer discounts on outpatient prescription drugs to eligible safety-net hospitals. CMS Program Management is a key part of the federal health infrastructure, overseeing the administration of Medicare, Medicaid, the Children’s Health Insurance Program and the Federal Exchange.” 
  • Per Federal News Network,
    • “The Trump administration is proposing changes that would make it easier to fire federal employees accused of misconduct in a matter of days, because they no longer meet “suitability and fitness” standards required to join the federal workforce.
    • “The Office of Personnel Management, in a proposed rule it will publish Tuesday in the Federal Register, plans to expand suitability adjudications normally reserved for federal job applicants to include current employees.
    • “The proposed rule, once finalized, would allow the Trump administration to fast-track the firing of federal employees, on the grounds that they no longer meet suitability standards for federal employment.
    • “OPM’s proposed rule states agencies must remove federal employees within five workdays, if it decides they no longer meet the suitability standard.”

From the Food and Drug Administration front,

  • Cardiovascular Business reports,
    • “BiVacor has received the FDA’s breakthrough device designation for its titanium Total Artificial Heart (TAH), which serves as a bridge to transplant for patients with end-stage heart failure.
    • “BiVacor’s TAH is based on rotary blood pump technology and approximately the size of an adult’s fist. It has no valves or flexing ventricle chambers, and its only moving part is a magnetically suspended double-sided centrifugal pump impeller.
    • “The FDA’s decision signals just how much potential the agency sees in this technology. The breakthrough devices program is designed to help medical devices make it through the approval process faster than they would otherwise. Its representatives work directly with the manufacturer, for example, and submissions are prioritized.
    • “This is more than a regulatory milestone,” Daniel Timms, PhD, founder and chief technology officer of BiVacor, said in a statement. “It’s a validation of a concept we’ve spent decades proving that a fully implantable, TAH isn’t just possible, it’s necessary. Patients with biventricular failure have been overlooked for too long. The early results from our clinical trial show that we can give them a second chance, without the compromises of older technologies. The breakthrough device designation puts us on a faster track to deliver exactly that.”
  • MedPage Today notes,
    • “The FDA granted de novo authorization to the first artificial intelligence (AI) program to support breast cancer risk prediction from screening mammograms.
    • “The program, called Clairity Breast, analyzes mammograms for subtle features that correlate with future breast cancer risk, according to a news release from Clairity. The analysis results in a 5-year risk score validated from analysis of more than 77,000 mammograms from multiple hospital-based and free-standing mammography facilities.
    • “The system can be applied immediately to clinical practice, Larry Norton, MD, a breast cancer specialist at Memorial Sloan Kettering Cancer Center in New York City, told MedPage Today.
    • “We’re very excited about it,” said Norton, who also is founding scientific director of the Breast Cancer Research Foundation, which supported development of Clairity Breast. “We were confident that it’s going to turn out to be something that’s going to help people, something that we think really has great science behind it.”

From the judicial front,

  • Bloomberg Law reports,
    • “The US Court of Appeals for the Fifth Circuit granted a Texas doctor group’s request Friday to rehear its challenge to a Biden administration rule governing the arbitration process for surprise medical bill disputes.
    • “The No Surprises Act protects patients from most unexpected out-of-network bills by requiring insurers and medical providers to undergo an arbitration process for payment disputes. But the process is the subject of countless legal battles, and the Texas Medical Association has successfully challenged multiple provisions of the implementation regulations.
    • “A three-judge panel previously upheld several portions of the rule (RIN: 1210-AC17) in a mixed decision regarding the qualifying payment amount—a key factor arbitrators use to settle disagreements. The Texas Medical Association had asked the full panel to reconsider the decision upholding the exclusion of bonuses as well as the inclusion of “ghost rates,” or contracted rates for services that a doctor hasn’t actually provided.”

From the public health and medical research front,

  • CBS News reports,
    • “The Centers for Disease Control and Prevention has updated its warning about the risk of contracting measles while traveling, after the agency tallied dozens of cases so far this year in travelers who were infectious while flying on airplanes within the U.S.
    • “Travelers can catch measles in many travel settings including travel hubs like airports and train stations, on public transportation like airplanes and trains, at tourist attractions, and at large, crowded events,” the agency now says, in an update published Wednesday.”
  • Per HCPLive,
    • “Cardiac deaths have risen since 2020, with more occurring at home, indicating a potential gap in care for heart disease patients during the pandemic.
    • “Hospital data showed a 20–34% reduction in acute myocardial infarction hospitalizations, while at-home cardiac deaths increased, suggesting changes in care-seeking behavior.”
  • MedPage Today informs us,
    • “Measles, mumps, and rubella (MMR) vaccination rates in children declined in some counties across the U.S. during the COVID-19 pandemic, researchers found.
    • “Across 2,066 counties in 33 states with both pre- and post-pandemic vaccination data, the county-level mean MMR vaccination rate decreased from 93.92% to 91.26%, according to Lauren Gardner, PhD, of Johns Hopkins University in Baltimore, and colleagues.
    • “A decline in coverage was reported in 78% of counties during this time, and only four states — California, Connecticut, Maine, and New York — had an increase in median county-level vaccination rates, they reported in a JAMA research letter.”
  • The American Medical Association tells us what doctors wish their patients knew about e-cigarettes.
  • Consumer Reports, writing in the Washington Post, discusses “What to know about nerve pain and tingling hands and feet. Tingling or painful sensations in your hands and/or feet are the main symptoms of neuropathy.”
  • The Wall Street Journal reports,
    • “Novartis said Pluvicto demonstrated positive results in patients with PSMA-positive metastatic hormone-sensitive prostate cancer.
    • “The Swiss pharmaceutical company on Monday said Pluvicto showed statistically significant and clinically meaningful benefits—including combined with hormone therapy versus hormone therapy alone—with positive trend in overall survival.
    • “The results are from a prespecified interim analysis of a Phase 3 trial, it said.
    • “Pluvicto is already approved for metastatic castration-resistant prostate cancer and now shows potential in patients in an earlier disease setting, it said.
    • “The company will present results at an upcoming medical meeting and based on FDA feedback, will submit for regulatory review in the second half of the year, it said.
    • “Pluvicto is a radioactive medication used to treat some types of prostate cancer.”
  • Per BioPharma Dive,
    • “An experimental medicine from Vera Therapeutics succeeded in a late-stage trial in a rare kidney disease, positioning the company to discuss an approval application with U.S. regulators in the near future. 
    • “According to Vera, the drug, called atacicept, met its main goal in a Phase 3 trial in IgA nephropathy, a chronic condition that can lead to kidney failure. After 36 weeks of treatment, atacicept was associated with a 42% reduction versus a placebo — and a 46% decline from the study’s start — in the amount of protein in participants’ urine, an important marker of kidney health. 
    • “Without providing specifics, Vera said atacicept’s other efficacy results were “consistent with or better than” what was observed in mid-stage testing and had a safety profile “comparable to placebo.” The company will share the data with the Food and Drug Administration in the coming weeks and intends to file an accelerated approval request in the fourth quarter.”
  • Per Fierce Pharma,
    • “Amgen has detailed a positive phase 3 readout for its T-cell engager Imdelltra in previously treated small cell lung cancer (SCLC).
    • “The DLL3xCD3 bispecific has shown that it can help patients live longer, has a more tolerable safety profile and improves certain cancer-related symptoms compared with chemotherapy in second-line SCLC, according to results from the phase 3 DeLLphi-304 trial. The data will be presented June 2 at the 2025 American Society of Clinical Oncology annual meeting and simultaneously published in The New England Journal of Medicine.
    • “The drug significantly reduced the risk of death by 40% versus chemo in SCLC patients who had tried one line of platinum-based chemotherapy. Patients in the Imdelltra arm lived a median 13.6 months, compared with 8.3 months for chemo.
    • “All patient subgroups appeared to have benefited, regardless of their prior PD-1/L1 exposure, presence of brain metastases or liver metastases, and the type of prior chemotherapy. Among those who had tried a PD-1/L1 inhibitor, Imdelltra’s death risk reduction was 39%. In PD-1/L1-naïve patients, the number was 35%.
    • “These data underscore Imdelltra’s potential to transform patient outcomes and the small cell lung cancer treatment paradigm,” Amgen’s R&D chief, Jay Bradner, M.D., said in a statement.
    • “Findings from the DeLLphi-304 trial could help convert Imdelltra’s accelerated approval earned last year into a full approval.”

From the U.S. healthcare business front,

  • Fierce Healthcare relates,
    • “UnitedHealth Group shareholders signed off on the planned compensation package for newly-reinstated CEO Stephen Hemsley.
    • “Hemsley, who returned to the CEO role last month, will earn a $1 million base salary each year. He will also receive a one-time $60 million equity award in nonqualified stock options.”
  • The Wall Street Journal reports,
    • “BioNTech & Bristol Myers will jointly develop BioNTech’s BNT327 cancer-drug candidate.
    • “Bristol Myers will make a $1.5B upfront payment to BioNTech, with $2B in payments through 2028.
    • “BNT327 is being evaluated in Phase 3 trials as a first-line treatment in lung cancer.”
  • Per Fierce Pharma,
    • “In late April, when Sanofi revealed that it was selling a controlling stake in its consumer health business Opella for 10 billion euros ($11.4 billion), chief financial officer Francois Roger said that the French drugmaker would “explore external growth opportunities for bolt-on acquisitions.”
    • “Just five weeks later, Sanofi has made a deal few would describe as “bolt-on,” as it has bought out Massachusetts-based Blueprint Medicines for up to $9.5 billion.
    • “With the deal, Sanofi gains Blueprint’s portfolio of rare immunological disease treatments, including systemic mastocytosis (SM) pill Ayvakit, which generated sales of $479 million last year and has peak sales potential of $2 billion, the 14-year-old company projected last year.
    • “Blueprint also brings a next-generation SM candidate in elenestinib, a KIT D816V inhibitor which is the subject of a phase 2/3 study, and an early-stage KIT inhibitor BLU-808. KIT plays a central role in mast cell activation, Sanofi said, which is implicated in a broad range of inflammatory diseases.”
  • STAT News lets us know,
    • “Atai Life Sciences, among the most prominent biotechs focused on psychedelic medicines, said Monday it will merge with private psychedelic startup Beckley Psytech, pending results of a trial for a drug based on the practice of “smoking toad.”
    • “The new company will be known as Atai Beckley, with Beckley Psytech shareholders receiving 31% of shares in the entity.  The deal, which values Beckley at $370 million, comes as the Trump administration has expressed support for the field.” 
  • Beckers Hospital Review informs us,
    • “St. Louis-based Ascension is reportedly in talks to acquire ambulatory surgery center company AmSurg for about $3.9 billion, according to Bloomberg.
    • “AmSurg split from Envision Healthcare when the company emerged from bankruptcy in 2023. It is now backed by Pacific Investment Management Co., King Street Capital Management and Partners Group.
    • “A potential acquisition would significantly expand Ascension’s footprint in the ASC space, aligning with the broader trend toward lower-cost, outpatient care settings. AmSurg has a network of more than 250 surgery centers across 34 states and supports nearly 2,000 physicians, according to its website.”
  • and
    • “Blythe, Calif.-based Palo Verde Hospital is at risk of shutting down due to financial challenges over resignations and months of litigation, The Desert Sun reported May 30. Becker’s reached out to the hospital, which remains open as of June 2. 
    • “Congressman Raul Ruiz, MD, raised concern for the 51-bed hospital in a May 28 letter, obtained by the Sun, to California Gov. Gavin Newsom, asking the state for $4 million in emergency funding, otherwise the hospital could shutter “as soon as tomorrow.”
  • Beckers Hospital Review also collected eight GLP-1 updates for your information.
  • Per Healthcare IT News,
    • “The Clinic by Cleveland Clinic, an initiative with telemedicine technology and services company Amwell, has been getting life-changing results from leading-edge virtual care. 
    • “The Clinic has been providing virtual second opinions by the many top specialists at the renowned healthcare organization. The platform connects patients to more than 3,500 specialists across Cleveland Clinic without the need for the patients to travel to a major medical center.
    • “Misdiagnoses contribute to more than 800,000 deaths or disabilities each year in the U.S., Johns Hopkins has found, costing the healthcare system hundreds of billions, beyond the human cost. 
    • “Data from the Clinic by Cleveland Clinic shows that in 67% of cases patients receive a new diagnosis or treatment recommendation after seeking a second opinion.”
  • Per Fierce Healthcare,
    • “Electronic health records giant Epic announced Monday that more than 1,000 hospital customers and 22,000 clinics using its EHR are now live on a government-backed data exchange, as the company doubles down on a commitment it made last year.
    • “Epic said in an announcement that it marks a significant milestone in “making health information seamlessly and securely available wherever care happens.”
    • “In March, Epic reported that more than 2,000 hospital customers and more than 50,000 Epic clinics were either live or preparing to go live on the federal Trusted Exchange Framework and Common Agreement (TEFCA) framework for nationwide health data exchange, according to Becker’s Health IT.
    • “The company’s goal is to have all its customers live on TEFCA by the end of the year, Epic said in August. The health IT company now commands 42.3% of the hospital EHR market, up from 39.1% a year prior, so shifting all its hospital customers to TEFCA would represent a significant share of U.S. hospitals.”
  • and
    • “Digital health company Scripta Insights is joining forces with RxSaveCard with the goal of making it easier for employers to manage drug costs and meet their fiduciary duties.
    • “RxSaveCard offers a proprietary cost management and payment solution for pharmacy benefits, and those tools will be integrated into Scripta’s AI-powered Rx Navigation platform.
    • “For members, the integration is designed so they can better find savings for a variety of drugs, including high-cost specialty products.
    • “The platform is designed to identify lower-cost options both in the member’s prescription drug coverage or through cash-pay, according to an announcement from the companies.”

Thursday Report

David Ermer–CDC, CMS, Congress, Electronic health records, FDA, Federal employment benefits, Medical / Rx research, Mental health care, Obesity, OPM, Rx coverage, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC

  • Modern Healthcare relates,
    • “A coalition of healthcare trade associations and companies representing 550 providers and accountable care organizations is pleading with Congress to restore incentive bonuses for Medicare alternative payment models.
    • “The American Medical Association, Boston-based Mass General Brigham and others wrote congressional leaders Thursday expressing concern that failure to renew bonus payments will worsen providers’ financial instability, particularly in underserved regions.
    • “While we have seen steady growth for advanced [alternative payment models] in recent years, 2025 is a pivotal year for Medicare’s value transformation,” the letter says. “The expiration of Medicare’s advanced [alternative payment model] incentive payments and sharp increase in qualifying thresholds is creating significant challenges for physician practices and hospitals as they plan for the years ahead.”
  • BioPharma Dive reports,
    • “The U.S. The Department of Health and Human Services has canceled a contract with Moderna to develop messenger RNA vaccines against influenza strains seen as potential pandemic risks, leaving the future of the underlying research uncertain.
    • “Moderna revealed in a statement Wednesday that the HHS had terminated the contract, which could have handed the company more than $700 million in total funding. Moderna also reported that an experimental H5 avian influenza vaccine it’s developed showed promising results in an early-stage clinical trial. But without the government’s help, it will now be forced to “explore alternatives for late-stage development and manufacturing.”
    • “While the termination of funding from HHS adds uncertainty, we are pleased by the robust immune response and safety profile observed in this interim analysis,” said CEO Stéphane Bancel, in a statement. “These clinical data in pandemic influenza underscore the critical role mRNA technology has played as a countermeasure to emerging health threats.”
  • Govexec tells us,
    • “Federal job applicants will soon be quizzed on their favorite Trump administration policy as part of the hiring process, according to the Office of Personnel Management’s new “merit hiring plan.”
    • “How would you help advance the president’s executive orders and policy priorities in this role?” asks one of four essay questions that job seekers must answer if they are seeking any federal position GS-5 or above. “Identify one or two relevant executive orders or policy initiatives that are significant to you, and explain how you would help implement them if hired.”
    • “The federal government’s dedicated HR agency published the plan via a joint memo from Vince Haley, director of President Trump’s Domestic Policy Council and acting OPM Director Charles Ezell. The document is a hodgepodge of bipartisan reforms developed under both Trump and former President Biden to accelerate and improve the hiring process, alongside plans to eradicate longstanding efforts to make the federal workforce more reflective of the American populace.”
  • Tammy Flanagan, writing in Govexec, discusses what the latest FERS changes found in the budget reconciliation bill mean for federal and postal employee retirement benefits.
  • The Congressional Budget Office announced its 2025 panel of health advisors.
  • STAT News informs us,
    • “The White House will fix errors in a much-anticipated federal government report spearheaded by U.S. Health and Human Services Secretary Robert F. Kennedy Jr., which decried America’s food supply, pesticides and prescription drugs.
    • “Kennedy’s wide-ranging “Make America Healthy Again” report, released last week, cited hundreds of studies, but a closer look by the news organization NOTUS found that some of those studies did not actually exist.
    • “Asked about the report’s problems, White House press secretary Karoline Leavitt said the report will be updated.
    • “I understand there was some formatting issues with the MAHA report that are being addressed, and the report will be updated,” Leavitt told reporters during her briefing. “But it does not negate the substance of the report, which, as you know, is one of the most transformative health reports that has ever been released by the federal government.”
  • The International Foundation of Employee Benefits Plans discusses what the President’s April 15 executive order on PBM transparency means for employers and other purchasers of PBM services.
  • Per Fierce Pharma,
    • “Six years after being spun out from Novartis and becoming a public company, eye care specialist Alcon has gained its first FDA approval for a prescription drug, scoring a nod for dry eye disease (DED) treatment Tryptyr (acoltremon ophthalmic solution).
    • “Tryptyr, which is administered as a single drop twice daily, is a first-in-class TRPM8 receptor agonist intended to activate tear production. 
    • “Tryptyr is the first eye drop that stimulates corneal nerves to directly address tear deficiency, a known cause of (DED),” Marjan Farid, M.D., professor of ophthalmology at the University of California, Irvine, said in a release.
    • “There are roughly 38 million in the U.S. who have DED. Fewer than 10% of those who have been diagnosed are being treated with a prescription product, according to Alcon.”

From the judicial front,

  • Chain Drug Review reports,
    • “Express Scripts, a Cigna-owned pharmacy benefit manager, and CVS Health have filed separate lawsuits against the state of Arkansas, seeking to halt the implementation of a new law that would bar PBMs from owning, managing, or controlling pharmacies within the state. 
    • “In a statement, CVS Health said the “unconstitutional law puts local politics ahead of patients, restricting their access to life-saving medications and undermining fair competition.“
    • “The lawsuits, filed Thursday in the U.S. District Court for the Eastern District of Arkansas, argue that the law, scheduled to take effect in 2026, is unconstitutional under multiple provisions, according to Modern Healthcare. Both companies claim the legislation would lead to significant disruptions in pharmacy access, workforce displacement, and increased medication costs.”
    • FEHBlog note — Good luck, CVS and ESI.
  • The Groom Law Group, which represents ERIC in its federal court lawsuit challenging the problematic to say the least 2024 mental health parity amendments, brings us up to date on the litigation, which so far has been successful.

From the public health and medical research front,

  • The Wall Street Journal lets us know,
    • “Adults diagnosed with autism spectrum disorder experience a range of benefits, including improved self-understanding, reduced self-blame and enhanced communication with others.
    • “The diagnosis can lead to positive changes in relationships, as individuals can now better explain their needs and behaviors to loved ones.
    • “Adults with autism may make adjustments to their routines and social interactions to accommodate their sensory sensitivities and communication challenges.”
  • Cardiovascular Business points out,
    • “Smoking marijuana and eating THC-based gummies have a negative impact on a person’s vascular health, according to new research published in JAMA Cardiology. In fact, the impact appears to be comparable to the damage seen in some tobacco users.
    • “There is a popular belief that marijuana smoke is harmless,” wrote first author Leila Mohammadi, MD, PhD, a vascular specialist with the University of California San Francisco, and colleagues. “However, marijuana smoke contains many of the thousands of chemicals contained in tobacco smoke, along with fine particles that contribute to cardiovascular morbidity and mortality. As cannabis legalization increases, it is crucial to understand the public health and clinical implications of marijuana use.” * * *
    • “Click here to review the full analysis.”
  • Per MedPage Today,
    • “Use of the investigational non-opioid analgesic resiniferatoxin appeared to improve pain control in patients with advanced cancer who had intractable pain, though all patients experienced adverse events (AEs), according to an interim analysis of a first-in-human phase I trial.
    • “Among 19 patients with refractory cancer pain localized to the abdomen and/or lower extremities, a total of 213 treatment-emergent AEs were reported with a single intrathecal injection of resiniferatoxin, including 37 serious AEs in 14 patients, and at least one AE in all patients, reported Andrew J. Mannes, MD, of the NIH, and colleagues.” * * *
    • “In an accompanying editorial, Krishna B. Shah, MD, and Bilal Dar, MD, both of the Baylor College of Medicine in Houston, noted that the improvements in efficacy “exceeded thresholds typically considered clinically meaningful,” and that the drug has the potential to provide “durable, opioid-sparing analgesia while preserving functional and cognitive abilities.”
    • “These interim results “represent an important step toward expanding the therapeutic interventional opioid-sparing options for patients with refractory cancer pain,” they wrote.”
  • Medscape notes,
    • “Extreme fatigue, bone loss, and abdominal pain are real-world adverse events noted with the use of glucagon-like peptide 1 receptor agonists (GLP-1s) that may not have been apparent from the clinical trials.
    • “In a wide-ranging “meet the professor” lecture at the American Association of Clinical Endocrinology (AACE) Annual Meeting 2025, obesity expert W. Timothy Garvey, MD, the Charles E. Butterworth, Jr. professor and university professor at the University of Alabama (UAB) and director of the UAB Diabetes Research Center at Birmingham, Alabama, said these phenomena all point to the importance of close clinical management of people taking GLP-1s and to the dangers of online prescribing of these medications.
    • “You can’t engage in complications-centric obesity care unless you evaluate the patient for complications, which doesn’t happen with online availability of prescriptions,” said Garvey.”
  • Per BioPharma Dive,
    • “Intellia Therapeutics shares dropped 25% early Thursday after the gene-editing company disclosed that one patient in an ongoing Phase 3 trial had signs of liver stress.
    • “Lab tests showed the patient had grade 4 liver transaminase elevations that “appear to be resolving” without hospitalization or medical treatment and have since fallen to less dangerous levels, Intellia said in a filing with the Securities and Exchange Commission late Wednesday. “We continue to monitor these events as the Magnitude study progresses,” the company said.
    • “The Magnitude trial is testing Intellia’s experimental therapy in a type of deadly heart condition known as transthyretin amyloidosis with cardiomyopathy, or ATTR-CM. Intellia has already recruited 365 patients and plans to enroll a total of 765 by early 2027. Though the study is blinded, it’s likely that the patient with the potentially serious liver signals received treatment with Intellia’s therapy, analysts said.”

From the U.S. healthcare business front,

  • Fierce Healthcare tells us,
    • “Healthcare C-suite leaders are trying to keep pace with rapid changes in U.S. economic and regulatory policies in the first four months of the second Trump administration.
    • “Among 700 business executives across six industries, nearly half (48%) of business executives rank economic policy among the top three factors driving strategic change over the next one to two years, according to a new PwC May pulse survey. 
    • “For healthcare executives, persistent policy and market volatility is a bigger concern, with six out of 10 (61%) rethinking short-term business strategies due to economic policies.
    • “Leaders at healthcare organizations also cited a number of other factors affecting short-term strategic changes — AI and data regulations (56%), U.S. trade policy (44%) and U.S. federal government spending and budget policy (37%). Healthcare C-suite leaders seem less concerned about corporate tax policy, cited by 34% as a factor driving short-term strategic changes, as well as the U.S. antitrust and competition environment (24%), climate policy (22%) and U.S. immigration policy (22%).
    • “About half (48%) of the business executives surveyed expect the current uncertainty to last less than a year, but many anticipate it could extend through the next presidential election.” 
  • Modern Healthcare reports,
    • “Private practice is slowly fading as a way to do business, going the way of landline phones, bank deposit slips and fax machines.
    • “An analysis by the American Medical Association found the percentage of physicians in a practice wholly owned by physicians last year to be at the lowest level since the survey began in 2012. The AMA examined data from its biennial Physician Practice Benchmark Survey, most recently conducted in 2024.
    • “The percentage of physicians working in private practice has dropped below 45%.
    • “Of the remaining physicians surveyed, the highest percentage are employed by hospitals.
    • “Along with that shift, only 35% of physicians described their employment status as owners in 2024.”
  • The Wall Street Journal explains how Novo Nordisk lost its mojo in the GLP-1 drugs market.
    • “Novo Nordisk, once Europe’s most valuable company, is losing its grip on the anti-obesity market due to production issues and slow marketing.
    • “Eli Lilly’s weight-loss drug Zepbound has surpassed Novo Nordisk’s Wegovy in weekly U.S. prescriptions, and Lilly has a more promising pipeline.
    • “Novo Nordisk’s CEO was ousted, shares have tumbled, and the company faces challenges in R&D and direct-to-consumer marketing.”
  • Per an Institute for Clinical and Economic Review (ICER) news release,
    • ICER publishes Evidence Report on Treatment for Secondary Progressive Multiple Sclerosis
    • There are significant uncertainties regarding long term efficacy of tolebrutinib;
    • ICER estimates that treatment would achieve common thresholds of cost-effectiveness if priced between $3,250 and $5,900 per year.
  • Health Affairs concludes in a recent article,
    • “Because many value-based care programs in the US are fragmented, heterogeneous and complex, none are driving large-scale, systemic change. Clinical care redesign driven by value-based healthcare programs has been halting and has achieved far less than promised.
    • “A rising mood of despair over the ability to achieve a sustainable, high-value healthcare system is causing some to support interventions such as price controls and heavier regulation to drive down spending. However, a key missing ingredient in value-based reforms has been sufficiently nuanced information about the clinical context in which patients are treated. A primary challenge in finally achieving high value healthcare in the US is discovering how to harness the comprehensive and nuanced data generated in the provision of care, which is available in each patient’s EHR, to support systemic care redesign to achieve better outcomes at lower cost. Adding that key ingredient could be transformative.
    • “The system currently used to extract data from EHRs in the US, ICD-10-CM, does not adequately capture clinical detail and nuance. Gaps, limitations, and errors in describing healthcare today lead directly to our inability to accurately measure both the outcomes resulting from the care provided and the cost of that care. The WHO created and released ICD-11 to address these issues, and with an appropriate comprehensive extension such as ICD-11-CCL the ability to measure and attain value in healthcare would be achievable. However, even if the US loses access to ICD-11, there is another viable option. SNOMED CT is a comprehensive clinical terminology, optimized for the capture of clinical nuance, that uses architecture designed for computerized data analytics. It is already used to capture and store clinical content in EHRs and could be leveraged through the creation of a comprehensive code set to also extract and transmit data with all clinical nuance preserved. Such a system would overcome most, if not all, of the current limitations in ICD-10-CM and could empower existing value-based programs to improve the cost-effectiveness of healthcare.”
  • Per Fierce Healthcare,
    • “Retail giant Walmart is rolling out a new platform for insurers and benefit managers that’s designed to make it easier to encourage healthy eating.
    • “The tool, called Everyday Health Signals, is powered by artificial intelligence, analyzing a consumers’ retail history on Walmart.com to surface personalized feedback such as shopping lists and nutrition analyses. Given that the retailer sees 145 million customers each week in stores and online, it has a bevy of data to pull from, according to an announcement.
    • “Eligible customers can opt in to allowing Everyday Health Signals to dig into their shopping history, Walmart said.
    • “The program is initially launching in partnership with NationsBenefits, connecting its members to data they can use to meet key health goals. Walmart intends to expand to other insurers and benefits organizations in the future.”
  • and
    • “Humana is the latest major insurer to partner with digital sleep clinic Dreem Health to improve members’ sleep care.
    • “California-based Dreem Health was acquired by sleep diagnostics company Sunrise in December. The company already has partnerships with the country’s largest payers including Aetna, Blue Cross Blue Shield, Cigna, HealthNet, UnitedHealthcare and Medicare.
    • “Sunrise was built on the back of research conducted by Jean-Benoit Martinot, M.D., the father of Sunrise CEO and founder Laurent Martinot. The company developed a small device that patients are able to use to diagnose sleep disorders from anywhere—without the inconvenience of spending the night hooked up to wires in a lab—while still providing a near-similar level of information.
    • “Our dream today is to become the largest sleep clinic in the country,” said Laurent Martinot in an interview with Fierce Healthcare. “We already have the largest virtual care sleep clinic. We would like to become the No. 1 one place you go if you feel you are not sleeping well and you need some care.”
    • “The Sunrise device is a diagnostic tool that is able to measure jaw movements, muscle contractions and snoring noises (through a built-in mic) from the comfort of a patient’s own bed. It’s disposable and is able to record data for up to three nights. A report is generated after just one night of sleep, allowing a care team to engage and start next steps immediately.”
  • Modern Healthcare reports,
    • “Highmark Health is off to a challenging start to the year as its insurance business dinged the company’s bottom line during the first quarter.
    • “On Thursday, the privately held for-profit Blue Cross and Blue Shield licensee reported net income of $13 million, a steep decline from $194 million the prior year, as revenue rose 11% to $8 billion
    • “As we’ve seen with the nationals on the health plan side, elevated trends are here to stay,” said Carl Daley, chief financial officer and treasurer of Highmark Health.”
  • Per BioPharma Dive,
    • “Cancer drugmaker iTeos Therapeutics said Wednesday it plans to wind down operations and seek to sell the company’s assets and intellectual property rights.
    • “ITeos has for years struggled to develop a cancer treatment that sufficiently impressed investors and its pharmaceutical partners. Two weeks ago, it said it was shelving its most advanced drug prospect, a TIGIT-targeting treatment developed with GSK.
    • “The immuno-oncology developer is the latest biotechnology company considering merger prospects or liquidatation of its assets this year. Others such as Cargo Therapeutics and Third Harmonic Bio have made their own plans to dissolve.”

Memorial Day Weekend Update

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

Happy Memorial Day!

From Washington, DC

  • Congress is on a District / State work break this week.
  • Federal News Network points out five workforce bills for federal employees to watch this summer.
  • Federal News Network also looks back at the history of the Federal Employees Dental and Vision Insurnace Program which was launch in late 2006.

From the public health and medical research front,

  • The Washington Post sheds light on an e Coli outbreak “which a Feb. 11 internal Food and Drug Administration memo linked to a single lettuce processor and ranch as the source of the contamination. In what many experts said was a break with common practice, officials never issued public communications after the investigation or identified the grower who produced the lettuce.”
  • The Post also lets us know,
    • The National Cancer Institute says 85 percent of children diagnosed with cancer are alive at least five years later and that there were nearly 496,000 pediatric cancer survivors in the United States in 2020. While the good news is encouraging, long-term survivor care brings its own challenges — something pediatric oncologists are working to improve.
    • “Kids with cancer are beating a disease we never beat 30, 40 years ago,” says Greg Armstrong, who chairs the department of epidemiology and cancer control at St. Jude’s Children’s Research Hospital and is also the principal investigator of its Childhood Cancer Survivor Study. “There’s an entire population of kids who didn’t exist before. Now we need to figure out how to best support them.”
  • Consumer Reports, writing in the Washington Post, explains how to cope with heartburn.
  • The New York Times considers whether or not there is a “least bad” alcohol for human consumption. “We all know about the health risks of drinking. But if you’re going to partake, it’s natural to want to minimize the damage.”
  • The Wall Street Journal considers
    • “A lack of fiber causes changes in the microbiome that can trigger immune dysfunction and chronic inflammation.
    • “Low fiber intake may contribute to rising cancer rates among young people, especially with the popularity of ultra-processed foods.
    • “Increase fiber intake through diverse fruits, vegetables and whole grains, rather than relying on supplements.”
  • Medscape discusses the overlooked link between Vitamin D and GI health.
  • RAND delves into suicide among veterans.
  • In GLP-1 drug news, the Wall Street Journal notes
    • GLP-1 drugs like Ozempic show promise beyond diabetes/weight loss, potentially treating heart, kidney, liver issues, sleep apnea, and Alzheimer’s.
    • Millions more could benefit from GLP-1s, but doctors caution against use in people who don’t medically fit the bill because it could cause malnourishment.
    • The use of GLP-1 drugs will grow, but high costs, tolerability, and manufacturing capacity could limit uptake despite new versions being developed.
  • and
    • Some consumers are microdosing GLP-1 drugs like Ozempic to save money, lessen side effects, or for perceived health benefits.
    • Doctors note some patients are ‘super responders’ and can maintain weight loss at low doses, but most will need to escalate their dose.
    • A survey found 36% of GLP-1 users microdose, often learning about it from TikTok, despite safety concerns from doctors and manufacturers.

From the U.S. healthcare business front,

  • Blue Cross Blue Shield of Michigan’s CEO Tricia Smith, writing in Crain’s Detroit Business, explains how her company is tackling the healthcare affordability issue.
  • Per Beckers Payer Issues,
    • Blue Cross Blue Shield of Minnesota will offer access to specialty behavioral care through partnerships with Equip and Pelago. 
    • Equip provides fully virtual care for eating disorders, according to a May 22 news release. 
    • Pelago offers virtual treatment for opioid and alcohol dependency. It provides three levels of care based on acuity. Both Equip and Pelago will be available to BCBS Minnesota members with commercial or individual coverage. 
  • Beckers Hospital Review offers ten things to know about HCA and Tenet Health, two large U.S. healthcare systems.
  • Fierce Healthcare explains how rural hospitals are powering innovation in healthcare.
    • “One of the best examples of rural innovation scaling to broader impact is Project ECHO, launched in my native New Mexico to address the hepatitis C crisis in underserved areas. Faced with long waitlists and limited specialist access, Sanjeev Arora, M.D., developed a model that used simple videoconferencing technology to mentor rural clinicians in treating complex conditions. 
    • “Instead of centralizing care, it democratized it—turning primary care providers into specialists through case-based learning and ongoing support. What started as a rural solution became a global model, now used in over 40 countries to manage everything from cancer to addiction to COVID-19. Project ECHO redefined how knowledge moves through healthcare. And it all began by listening deeply to the needs of rural providers and designing something that worked in their reality first.”

Thursday Report

David Ermer–CDC, CMS, Congress, COVID-19 vaccine, FDA, Federal employment benefits, Medical / Rx research, NIH, Obesity, OPM, Rx coverage, SCOTUS, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC

  • The Wall Street Journal reports,
    • President Trump’s “big, beautiful bill” squeezed through the House after a late scramble to get rival factions on board. Next it goes to the Senate, where GOP lawmakers are already making demands and party leaders will once again need to bridge sharp disagreements.
    • The more than 1,000-page bill passed the House early Thursday morning after Speaker Mike Johnson (R., La.) found a recipe that satisfied just enough lawmakers, who approved the measure by just one vote after an all-night session. Now Senate Republican leader John Thune (R., S.D.) needs to line up enough support within his own narrow majority—without making changes that fracture the fragile House agreement and derail the party’s hopes to finish the bill by its July 4 target.
  • Federal News Network explains,
    • “Four of the six provisions on federal benefits cuts that originated from Republicans on the House Oversight and Government Reform Committee remain in the House-passed version of the bill, which now heads to the Senate for consideration. But notably, the proposed change to a “high-5” annuity calculation is no longer on the table. The provision was struck from the reconciliation legislation prior to the House’s passage of the bill.
    • “Oversight committee Democrats, as well as Rep. Mike Turner (R-Ohio), led efforts to remove the “high-5” proposal from the reconciliation bill. Rep. Stephen Lynch (D-Mass.) proposed an amendment to strike the “high-5” provision, which was ultimately adopted.
  • Tammy Flanagan, writing in Govexec, answers frequently asked questions about federal retirement.
  • The American Hospital Association (AHA) News tells us,
    • “Food and Drug Administration Commissioner Marty Makary testified May 22 before the Senate Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies on the discretionary budget proposal for fiscal year 2026. The proposal includes $93.8 billion for the Department of Health and Human Services, which oversees the FDA. The allocation is a 26.2% reduction from the FY 2025 enacted level.”  
  • The House of Representatives and the Senate left Washington DC today for a weeklong District/State work break following Memorial Day next Monday. The Senate Majority Leader announced his plans to file additional cloture motions for Presidential nominees when the Senate returns to Capitol Hill on June 2. That list does not include the President nominee for OPM Director Scott Kupor.
  • The AHA News informs us,
    • “The White House May 22 released its Make America Healthy Again report that focuses on childhood chronic disease. The report highlights findings from the MAHA Commission related to poor diet, exposure to environmental chemicals, lack of physical activity, stress and overmedicalization. The report lists a series of recommendations and next steps for research, including studies on nutrition, lifestyle interventions and precision toxicology. In parallel, the commission will develop a strategy to be released in August.”
  • The Washington Post assesses the report here.
  • The AHA News adds,
    • “The Departments of Labor, Health and Human Services, and the Treasury May 22 released several new guidance documents and requests for information on price transparency, following the February executive orderon the same subject. As part of this package, CMS released new guidance on calculating the estimated allowed amount values in the hospital machine-readable files. Whenever possible, hospitals should use the average dollar amount received over the last 12-month period (or less, if the payment methodology was only used for part of the year), which should be derived from the electronic remittance data. If there is no historic data, hospitals should use the expected payment amount, encoded as a dollar figure. This replaces previous guidance which allowed hospitals to use a code of nine number nines to signify that there was not sufficient historic data for that item or service over the last year. CMS also released an RFI on hospital price transparency accuracy and completeness. Comments are due July 21. The AHA plans to submit comments.  
    • “The departments also released a FAQ document, announcing that a new standard format for the insurer machine-readable files will be released Oct. 1, 2025. The new format aims to reduce the file size of the insurer files by decreasing duplicative data. In addition, the departments issued an RFI on improving prescription drug price transparency as part of the Transparency in Coverage, or insurer transparency rule.”

From the Food and Drug Administration front,

  • Per BioPharma Dive,
    • “Advisers to the Food and Drug Administration have recommended COVID-19 vaccine makers continue to target their shots to the so-called JN.1 coronavirus strain for the upcoming fall and winter seasons, maintaining guidance they gave last year.
    • The advisory committee convened Thursday for the first time under the Trump administration, meeting two days after FDA leadership unveiled new guidelines for COVID vaccine approvals. All nine members of the panel voted in favor of targeting shots to the JN.1 family of variants.
    • The FDA doesn’t have to follow the panel’s advice but usually does.”
  • STAT News adds,
    • “In another sign of growing scrutiny over Covid-19 vaccines, the Food and Drug Administration has asked the two makers of mRNA vaccines to widen the age range of boys and young men that their labels say are at risk for a rare side effect causing heart inflammation.
    • “The letters, first reported by CBS News, asked Moderna and partners Pfizer and BioNTech to make updates to safety information based on new studies of myocarditis or pericarditis or both after vaccination. Both reactions are rare and known to occur most often in young men within a week after the second shot in the two-dose Covid-19 vaccine regimen, according to the Centers for Disease Control and Prevention. Most cases were mild, causing no more than brief chest pain.”
  • Per MedTech Dive,
    • “Stryker has received 510(k) clearance for a minimally invasive back pain treatment, positioning it to challenge Boston Scientific for the market. 
    • “The Food and Drug Administration clearance, which Stryker disclosed Monday, covers the use of the OptaBlate basivertebral nerve ablation system to provide relief for low back pain.
    • “Stryker is entering a growing market. Boston Scientific’s rival device, which it acquired for $850 million upfront in 2023, “grew strong double digits” in the first quarter, CEO Mike Mahoney told investors in an April earnings call.”
  • Per Fierce Pharma,
    • “While GSK’s Nucala may not have earned the distinction of becoming the first FDA approved biologic for chronic obstructive pulmonary disease (COPD), the British drugmaker is confident its IL-5 antibody still has a major role to play in tackling the traditionally tough-to-treat respiratory condition.
    • “Now, following an unexpected delay earlier this month, the company has a fresh FDA green light to put its thesis to the test.
    • “The FDA on Thursday approved Nucala as an add-on maintenance treatment for adults with inadequately controlled COPD and an eosinophilic phenotype.” 
  • and
    • “In a somber end to an FDA advisory committee’s two-day scouring of multiple drugmakers’ oncology data, Pfizer’s pitch to expand Talzenna into a broader prostate cancer population has failed to impress.
    • “Late Wednesday, eight outside experts on the FDA’s Oncologic Drugs Advisory Committee delivered a unanimous 8-to-0 ‘No’ vote on the question of whether Pfizer’s PARP inhibitor Talzenna has a favorable benefit-risk profile in metastatic castration-resistant prostate cancer (mCRPC) patients without homologous recombination repair (HRR) gene mutations.
    • “Patients without HRR mutations make up the majority of the mCRPC patient population at about 70%, according to briefing docs released ahead of the meeting.”

From the judicial front,

  • Healthcare Dive tells us,
    • “A bankruptcy judge on Wednesday approved Rite Aid’s pharmacy asset sales to a variety of buyers, including some of the bankrupt drugstore chain’s rivals.
    • “Financial details were not disclosed, and sale documents redacted purchase prices for Rite Aid’s assets, which went to retail pharmacy chains like CVS and Walgreens, along with grocers Albertsons, Kroger and Giant Eagle and other buyers.” * * *
    • “The liquidation is a growth opportunity for CVS, already the nation’s largest drugstore chain with more than 9,000 pharmacies. The Woonsocket, Rhode Island-based company purchased prescription files from 625 Rite Aid stores in 15 states and fully acquired 64 brick-and-mortar Rite Aid locations in Idaho, Oregon and Washington.”
  • The Associated Press reports,
    • “The Supreme Court’s conservative majority on Thursday declined to reinstate independent agency board members fired by President Donald Trump, endorsing a robust view of presidential power.” * * *
    • “The court’s action essentially extended an order Chief Justice John Roberts issued in April that had the effect of removing two board members who Trump fired from agencies that deal with labor issues, including one with a key role for federal workers as Trump aims to drastically downsize the workforce.
    • “Neither agency has enough appointed members to take final actions on issues before them, as Trump has not sought to appoint replacements.”
    • “The decision Thursday keeps on hold an appellate ruling that had temporarily reinstated Gwynne Wilcox to the National Labor Relations Board and Cathy Harris to the Merit Systems Protection Board.”
  • Bloomberg Law points out,
    • “A federal district court judge in California said she will likely extend a freeze on President Donald Trump’s plan to lay off thousands of federal workers, dealing another blow to his unprecedented overhaul of the federal workforce. 
    • “Judge Susan Illston of the US District Court for the Northern District of California at a Thursday hearing said she is inclined to grant a preliminary injunction halting the layoffs while the case proceeds, temporarily protecting the jobs of thousands of federal workers.” 

From the public health and medical research front,

  • NBC News reports,
    • “New data from Truveta, a health care and analytics company, shows that the percentage of 6-month-old babies in Texas getting their measles vaccination in April increased by more than 30 times the prior year’s average.
    • “That means parents aren’t just getting the vaccine early, they’re getting it as early as they can,” Nina Masters, a senior scientist at Truveta and part of the research team, said in an interview with NBC News.
    • “Typically, the MMR is given in two doses, around a child’s first birthday, and again around the time a child enters kindergarten, at age 4 or 5. One dose is 93% effective at preventing measles, according to the Centers for Disease Control and Prevention. A second dose increases protection to 97%.”
  • Per Fierce Pharma,
    • “Roche, hoping to carve out a standard-of-care spot for its PI3K inhibitor Itovebi, now has another leg to stand on with new evidence that shows the drug can extend the lives of certain patients with breast cancer.
    • “Adding Itovebi to Ibrance and Faslodex slashed the risk of death by 33% in patients with PIK3CA-mutated, HR-positive, HER2-negative locally advanced or metastatic breast cancer that has grown during or after hormone therapy treatment. The data, to be presented at the American Society of Clinical Oncology’s (ASCO’s) annual meeting, come from Roche’s pivotal phase 3 INAVO120 trial. 
    • “In the 325-patient study, Roche’s Itovebi triplet combination kept patients alive for a median of 34 months compared to 27 months for those who took a placebo along with Ibrance and Faslodex.”
  • and
    • “Roche’s plan to bolster Tecentriq’s position in small cell lung cancer with Jazz Pharmaceuticals’ Zepzelca has paid off. But the pair’s success leaves room for improvement for future contenders.
    • “Adding Zepzelca on top of Tecentriq as maintenance treatment of first-line extensive-stage small cell lung cancer (ES-SCLC) significantly reduced patients’ risk of death by 27% compared with Tecentriq alone, according to data from the phase 3 IMforte trial.
    • “Patients who received the combo lived a median 13.2 months, versus 10.6 for those who got Tecentriq alone. The results will be presented at the 2025 American Society of Clinical Oncology annual meeting.”
  • STAT News relates,
    • “Merus said Thursday that a combination of its experimental drug petosemtamab with the checkpoint inhibitor Keytruda has kept 79% of patients with newly diagnosed metastatic head and cancer alive for at least one year, according to a new analysis of a mid-stage clinical trial. 
    • “The survival data are only a snapshot. Merus, a Dutch biotech, will need to complete a larger, randomized study to prove more definitively that its drug can extend the lives of patients with head and neck cancer beyond the ability of current treatments. But for now, the preliminary survival results are encouraging and matched the expectations of investors.
    • “Merus released the new petosemtamab data ahead of a presentation next week at the annual meeting of the American Society of Clinical Oncology.”
  • Per BioPharma Dive, “AI tool could help doctors ID breast cancers vulnerable to Enhertu. Tumors with low- and ultra-low levels of a protein called HER2 are treatable with Enhertu, but harder to identify. New research shows AI can improve diagnosis.”
  • Per a National Institutes of Health news release,
    • “National Institutes of Health (NIH) scientists have developed a new surgical technique for implanting multiple tissue grafts in the eye’s retina. The findings in animals may help advance treatment options for dry age-related macular degeneration (AMD), which is a leading cause of vision loss among older Americans. A report about the technique published today in JCI Insight.
    • “In diseases such as AMD, the light-sensitive retina tissue at the back of the eye degenerates. Scientists are testing therapies for restoring damaged retinas with grafts of tissue grown in the lab from patient-derived stem cells. Until now, surgeons have only been able to place one graft in the retina, limiting the area that can be treated in patients, and as well as the ability to conduct side-by-side comparisons in animal models. Such comparisons are crucial for confirming that the tissue grafts are integrating with the retina and the underlying blood supply from a network of tiny blood vessels known as the choriocapillaris.
    • “For the technique, investigators designed a new surgical clamp that maintains eye pressure during the insertion of two tissue patches in immediate succession while minimizing damage to the surrounding tissue.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Health insurance companies initially declined to pay more than one dollar for every $10 providers submitted in claims last year, an increase from 2023.
    • “Payers in 2024 initially denied 11.8% of dollars associated with hospital-based claims, according to a report from consultant Kodiak Solutions. That compares with 11.53% of dollars denied in 2023.
    • “The company examined data from its revenue cycle analytics platform used by more than 2,100 hospitals and 300,000 physicians. It categorized any initial bill that commercial, Medicaid and Medicare insurers initially rejected, or requested more information for, as a denial.
    • “Insurers often overturned their initial denials and ended up paying nearly 97% of dollars requested, according to the report.”
  • Reuters informs us,
    • “Median annual list price for new drugs over $370,000 in 2024
    • “72% of new drugs in 2024 for orphan diseases
    • “Drugmakers emphasize value, offer savings programs amid rising list prices.”
  • The International Foundation for Employee Benefit Plans shares its survey of GLP-1 drug coverage and expenses among employer sponsored plans.
  • Fierce Pharma notes,
    • “It’s plainly apparent that Novo Nordisk has had May 22 circled its calendar since February, when the FDA began the countdown for compounders to stop selling their versions of semaglutide.
    • “Now that the day has come, the Danish drugmaker is capitalizing on the chance to steer more patients toward its branded offerings.
    • “Self-paying patients new to Wegovy can access a one-month supply of the obesity blockbuster for $199 through June 30, Novo announced on Thursday. After that, the drug will go for its standing price of $499 a month for cash-paying customers, which was discounted in March from a previous price tag of $650 per month.”
  • Fierce Healthcare relates,
    • “Shares of Hinge Health jumped 22% above the initial public offering price in the company’s New York Stock Exchange debut on Thursday, bringing its market capitalization to more than $3 billion.
    • “The physical therapy company’s stock opened at $39.25 on Thursday and closed at $37.56, up 17% from its $32 per share IPO price. Hinge Health’s IPO has been closely watched given the recent stagnation in the exit markets and signals a potential upswing in the public investor market.”
  • Becker Hospital Review announced,
    • “Northern Light Inland Hospital and its associated clinical services in Waterville, Maine, will officially close May 27, marking the end of operations for the facility that has been gradually winding down since the closure was announced earlier this year.
    • “The hospital’s emergency department will stop accepting new patients at 12 p.m. on May 27. All remaining clinical services will cease at 5 p.m. the same day, the health system said in a May 22 news release.”

Tuesday Report

David Ermer–CDC, Congress, COVID treatment, COVID-19 vaccine, FDA, Federal employment benefits, Generative AI, Medical / Rx research, Mental health care, Obesity, Rx coverage, U.S. Healthcare–
Photo by Michele Orallo on Unsplash

From Washington, DC,

  • Following up on yesterday’s post about the House budget reconciliation bill, Govexec informs us,
    • “According to the latest draft of the bill, published early Monday morning, Republicans have ditched the plan to effectively un-grandfather employees hired prior to 2014 into paying more of their paychecks toward their retirement benefits.
    • “On the FERS supplement, which can amount to one-third of a federal retiree’s income until they turn 62, lawmakers expanded an exemption for federal workers who are required to retire early, such as air traffic controllers and federal law enforcement personnel, to cover all such employees, regardless of whether they actually are forced out because they hit the mandatory retirement age. The implementation date, previously set on the date of the bill’s enactment, has been shifted to Jan. 1, 2028, and language now exists clarifying that federal employees may maintain eligibility for the supplement provided they are “entitled” to it prior to 2028.
    • “The latest draft also delays the change in federal retirees’ annuity calculations from the high-3 to high-5 average salary model by one year, to Jan. 1, 2028.”
  • KFF posted a summary of Medicaid provisions in the House budget reconciliation bill.
  • Roll Call reports,
    • “President Donald Trump urged the House GOP to stop negotiating and pass his “big, beautiful” filibuster-proof reconciliation bill Tuesday, with sharp words for blue-state Republicans pushing for more tax relief and conservatives seeking additional spending cuts.
    • “In an appearance during the weekly GOP conference meeting, Trump told conservatives to lay off Medicaid, scolded blue-state Republicans for rejecting a $30,000 cap on state and local tax deductions and urged the party to increase the country’s borrowing limit through the rest of his term, members leaving the meeting said. * * *
    • “Trump’s visit did little to move the needle in support of the bill, leaving leadership where they started the week: trying to strike a balance between steeper cuts needed to satisfy conservatives without alienating centrists, and finding space for more SALT relief.
    • “Republicans can afford to lose no more than three GOP votes and pass the partisan legislation.
    • “After the meeting, Speaker Mike Johnson said he was ready to convene the holdouts in smaller groups to try to reach a deal.”
  • Per a Congressional press release,
    • “Congressman Gerald E. Connolly (D-VA) and Congressman James Comer (R-KY), the Ranking Member and Chairman of the House Committee on Oversight and Government Reform respectively, introduced the Esophageal Cancer Awareness Act, bipartisan legislation to commission a Government Accountability Office (GAO) study on gaps in screening and prevention of esophageal cancer. 
    • “Esophageal Cancer is quickly on the rise, touching the lives of tens of thousands of Americans – including mine,” said Ranking Member Connolly. “It is vital that we all do our part to raise awareness and push for more research and more effective prevention efforts. I am immensely grateful to my colleague, Chairman Comer, for joining me in introducing this important legislation today. Together, we will fight to end esophageal cancer, bringing hope to thousands of American families.” * * *
    • “Text of the legislation is available here.”
  • The American Hospital Association News tells us,
    • Secretary of Health and Human Services Robert F. Kennedy Jr. May 20 appeared before the Senate Appropriations Committee for a hearing to testify on the discretionary budget proposal for fiscal year 2026.
      • Roll Call offers more details on the hearing.
  • and
    • “The Department of Health and Human Services May 20 announced it has identified specific pricing targets for pharmaceutical manufacturers to meet to satisfy requirements of the Trump administration’s executive order allowing consumers to make direct purchases from drug manufacturers at “most favored nation” pricing, the lowest cost paid for the same medications in an Organization for Economic Co-operation and Development country with a gross domestic product per capita that is at least 60% of the U.S. GDP per capita.”
      • Beckers Hospital Review calls attention to six things to know about this announcement.

From the Foord and Drug Administration front,

  • The Wall Street Journal points out,
    • “The Trump administration released a more stringent set of guidelines for approving Covid-19 vaccines, requiring more evidence for new shots for healthy adults and children.
    • “Any new Covid vaccines for many children and adults will be required to undergo randomized, controlled trials before receiving Food and Drug Administration approval, FDA Commissioner Dr. Marty Makary and the agency’s new vaccines chief, Dr. Vinay Prasad, wrote Tuesday in the New England Journal of Medicine. The agency expects that it will be able to approve the shots for adults older than 64 and high-risk groups based on antibody testing but will encourage drugmakers to conduct more randomized trials for those shots too.”
  • MedPage Today notes,
    • The FDA warned that some people develop severe itching, or pruritus, after stopping long-term use of the antihistamines cetirizine (Zyrtec) or levocetirizine (Xyzal).
    • Prescribing information for the oral allergy drugs — which are taken daily and sold both in prescription and over-the-counter (OTC) forms — will be updated to warn about the post-discontinuation risk. The itching typically occurs within a few days of stopping the products.
    • “Restarting the medicine resolved pruritus in most individuals, and tapering off the medicine after restarting it resolved symptoms in some who tried this approach,” the FDA said in its safety communication.”
  • Fierce Pharma adds,
    • “Roche looks unlikely to be able to move its DLBCL drug Columvi earlier in the treatment sequence after experts in an FDA advisory committee joined the agency in questioning the regional imbalance of clinical trial data. What’s more, both FDA Commissioner Martin Makary, M.D., and longtime FDA oncology chief Richard Pazdur, M.D., have a new message for drug developers.
    • “A panel of experts on the FDA’s Oncologic Drugs Advisory Committee voted 8 to 1 Tuesday that results from Roche’s phase 3 Starglo trial are not applicable to a U.S. patient population. The trial evaluated the combination of Columvi and the chemotherapy regimen GemOx in second- or later-line transplant-ineligible DLBCL. 
    • “A patient representative cast the only yes vote.”
  • MedTech Dive announced the creation of an online database that tracks FDA approval of medical devices that incorporate artificial intelligence.

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “The Covid-19 virus in the U.S. has largely faded from view. But it hasn’t faded away. 
    • “National wastewater data shows low Covid-19 activity, according to the Centers for Disease Control and Prevention. The weekly reported Covid-19 deaths in April were slightly down compared with the same time a year earlier, federal data shows. Still, more than 300 Covid-19-related deaths were reported weekly as recently as mid-April. 
    • “Some infectious-disease specialists said they expect more cases this summer, as there have been somewhat regular summertime increases in the past. Others cautioned that Covid-19 can still surprise us, more than five years after it spurred a global pandemic that killed more than 1.2 million Americans. 
    • “It is at our lowest levels it has been since the beginning of the pandemic,” said Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota. “Our challenge is we don’t know what that means for tomorrow.” 
  • Per MedPage Today,
    • “The use of antibiotics in patients hospitalized with non-severe COVID-19 was not associated with better outcomes, a large retrospective cohort study found.
    • “Among more than half a million U.S. patients with COVID, those given antibiotics on their first day of hospitalization had a slightly higher rate of deterioration or death compared with those who didn’t receive antibiotics (20.8% vs 18.4%), reported researchers led by Michael Pulia, MD, PhD, of the University of Wisconsin-Madison.
    • “The difference didn’t meet criteria for being of clinical significance. However, a propensity-matched analysis did show a significantly higher odds of poor clinical outcomes for those who received antibiotics (OR 1.03, 95% CI 1.01-1.05, P=0.003), according to findings published in JAMA Network Open.
    • “Hopefully, studies like this raise the bar for antibiotic initiation in patients with confirmed COVID-19, even if they are sick enough to require hospital admission,” Pulia told MedPage Today.
    • “Pulia noted that there’s often a lot of uncertainty as to whether a patient hospitalized with COVID also has a bacterial infection, so physicians may prescribe antibiotics to be safe. “Hopefully, studies like this will reduce this uncertainty and improve judicious antibiotic use, thus helping in the fight against antibiotic resistance,” he said.”
  • The New York Times discusses “A New System Aims to Save Injured Brains and Lives. Nearly 100 neurology experts collaborated on the creation of a new method of evaluating patients with traumatic brain injuries.”
  • The latest National Institutes of Health’s (NIH) Research Matters covers “Cancer trends in younger people | Measuring biological age | Brain rewiring in motor learning.”
  • Per a NIH news release,
    • For the first time, researchers at the National Institutes of Health (NIH) identified patterns of metabolites in blood and urine that can be used as an objective measure of an individual’s consumption of energy from ultra-processed foods. Metabolites are left after the body converts food into energy, a process known as metabolism. Scientists used these data to develop a score based on multiple metabolites, known as a poly-metabolite score, that has the potential to reduce the reliance on, or complement the use of, self-reported dietary data in large population studies. The findings appeared May 20, 2025, in PLOS Medicine.   
    • “Limitations of self-reported diet are well known. Metabolomics provides an exciting opportunity to not only improve our methods for objectively measuring complex exposures like diet and intake of ultra-processed foods, but also to understand the mechanisms by which diet might be impacting health,” said lead investigator Erikka Loftfield, Ph.D., M.P.H., of NIH’s National Cancer Institute.”
  • MedPage points out,
    • “Dementia incidence fell among Medicare beneficiaries from 2015 to 2021, but prevalence rose.
    • “Incidence was higher for Black beneficiaries than any other racial or ethnic group.
    • “Those living in socioeconomically deprived neighborhoods had the highest incidence and prevalence.”
  • FYI, “Prevalence differs from incidence in that prevalence includes all cases, both new and preexisting, in the population at the specified time, whereas incidence is limited to new cases only.”

From the U.S. healthcare business front,

  • BioPharma Dive reports,
  • STAT News lets us know,
    • “Developers of digital mental health treatments now have fresh economic data to help make the case for broader coverage of their apps.
    • “Companies selling Food and Drug Administration-cleared apps for the treatment of psychiatric and other conditions have long struggled with adoption by patients, providers, and payers for many reasons. Clinical evidence supporting these prescription digital therapeutics has gradually improved, but policymakers and insurers have been hesitant to open the path to reimbursement too quickly.” * * *
    • “In a new report, the Peterson Health Technology Institute (PHTI) finds that Rejoyn, an app for depression from Otsuka Precision Health, and DaylightRx, an app for anxiety from Big Health, warrant further adoption because their clinical trials show strong evidence of benefits. Both apps are intended to be used alongside ongoing mental health treatment, and in most cases, the institute found the apps will save money.” * * *
    • “Elsewhere, advocates from the American Telemedicine Association’s advocacy arm, ATA Action, are preparing to brief lawmakers about data showing that Germany’s broad expansion of coverage for digital apps resulted in 234 million euros in spending from 2020 to 2024. The report, produced by Germany’s National Association of Statutory Health Insurance Funds, also found 861,000 total app activations. That’s a cost of about 271 euros per use.”
  • Fierce Healthcare adds,
    • “Employers are continuing to invest in their well-being programs, but they will be raising the bar for what’s expected from their vendors.
    • “The Business Group on Health released a survey looking at employer strategies around well-being initiatives, polling 131 firms that employ 11.2 million people collectively. The employers represent multiple sizes and geographies, with 60% being multinational.
    • “The survey found that 93% of employers intend to either maintain or expand their well-being programs for 2025. Most (73%) said they will keep their existing offerings, while 20% said they will grow.
    • “In tandem, 94% of those surveyed said they will be increasing the expectations they have for well-being program vendors to show improvements to outcomes. Jim Winkler, chief strategy officer for the Business Group, said during a media briefing that this isn’t a new trend but that employers are simply turning up the heat on these vendors.”
  • Per Institutes for Clinical and Economic Review news releases,
    • The Institute for Clinical and Economic Review (ICER) posted a Protocol today [May 19] outlining how it will conduct a new annual analysis titled the “Launch Price and Access Report,” which will examine launch prices and patient access for new FDA-approved treatments. This protocol was developed with input from a multi-stakeholder working group consisting of patient and consumer advocates, clinicians, policy experts, payers, and life science companies.”
  • and
    • The Institute for Clinical and Economic Review (ICER) announced today [May 20] that it will assess the comparative clinical effectiveness and value of cytisinicline (Achieve Life Sciences) for smoking cessation [which is the first new smoking cessation drug for many years].
    • The assessment will be publicly discussed during a meeting of the Midwest CEPAC in January 2026, where the independent evidence review panel will deliberate and vote on evidence presented in ICER’s report.
    • ICER’s website provides timelines of key posting dates and public comment periods for this assessment. 
  • Reuters reports,
    • “Online weight-loss company Noom has begun offering smaller doses of compounded versions of Novo Nordisk’s (NOVOb.CO) Wegovy as the U.S. drugs regulator clamps down on mass production of copies of the in-demand medicine.
    • “Noom will offer its version of compounded semaglutide – the active ingredient in Wegovy and diabetes drug Ozempic – as part of a program personalized for patients, which it says will comply with changing U.S. Food and Drug Administration regulations.”
  • Beckers Payer Issues informs us,
    • “CVS Health has named Creagh Milford, DO, as president of Oak Street Health.
    • “Dr. Milford has been with CVS since 2021, most recently serving as president of retail health. 
    • “I’m excited to start a new chapter at CVS Health as President of Oak Street Health, where I have the honor of developing and executing business strategy to further grow the organization,” he wrote on Linkedin on May 19. “As a practicing physician, I am passionate about providing consumer-centric primary care to patients — and Oak Street Health shares that passion, resulting in better experiences and outcomes for the older adults we serve.”

Monday Report

David Ermer–CDC, Congress, Federal employment benefits, Medical / Rx research, Obesity, Rx coverage, U.S. Healthcare, Uncategorized–
Photo by Sven Read on Unsplash

From Washington, DC

  • Roll Call reports,
    • “House Budget Committee Republicans advanced a sweeping reconciliation bill Sunday night, but for the GOP, the internal debate is far from over. * * *
    • “Rep. Chip Roy, R-Texas, one of four conservative Budget Committee members who agreed to vote “present” Sunday to allow the House to move forward with the bill designed to implement Trump’s policy agenda, said in a statement, “the bill does not yet meet the moment.”
    • “The Rules Committee is scheduled to convene at 1 a.m. Wednesday to set the ground rules for floor debate on the measure after releasing an updated committee print version of the legislative text overnight.
    • “Among the newest changes is the removal of a provision opposed by Rep. Michael R. Turner, R-Ohio, that would force federal agency employees, lawmakers and congressional staff to contribute more of their salaries to their pension plans. The effective dates of two other pension-related provisions would be delayed to 2028.”
    • “Roy said provisions related to curbing spending enacted under President Joe Biden, especially for environmental and energy programs, needed to see further cuts. He also criticized the bill’s Medicaid language.
    • “Roy said in a statement that the bill “fails to end the Medicaid money laundering scam and perverse funding structure that provides seven times more federal dollars for each dollar of state spending for the able-bodied relative to the vulnerable. This all ultimately increases the likelihood of continuing deficits and non-Obamacare-expansion states like Texas expanding in the future,” Roy said in a statement.”
  • STAT News adds,
    • “Although moderate and conservative Republicans disagree over some Medicaid policies that have been considered, both groups support imposing work requirements on adults without kids or disabilities. For that reason, the bill leaned hard on that policy by applying work requirements on beneficiaries up to the age of 64, instead of 55. Those people would keep Medicaid if, twice a year, they document that they’re working at least 80 hours a month. They could also maintain coverage if they perform community service or are enrolled in educational programs.
    • “Those work requirements would take effect in 2029, and conservatives are demanding they start next year.” 
  • Here is a link to a House Budget Committee document that identifies the changes that the Committee approved last night.

From the public health and medical research front,

  • Blue Cross FEP offers a healthcare checklist for women of all ages on LinkedIn.
  • The American Medical Association tells us “what doctors wish patients knew about getting a cesarean section.”
  • The New York Times reports
    • “Men are taller than women, by an average of about five inches. But why? It’s not a genetic inevitability — there are many species in the tree of life where females outclass males.
    • “A new study, published on Monday in the Proceedings of the National Academy of Sciences that involved genetic data from a million people, has found a partial explanation.
    • “It involves a gene called SHOX, which is known to be associated with height. SHOX is present on both the X chromosome — females have two X chromosomes — and the Y chromosome; males have one X and one Y.”
  • Per Medscape,
    • “An oral obesity treatment (SYNT-101) that mimics the metabolic effects of gastric bypass established preliminary safety, tolerability, and efficacy in a first-in-human study.”
  • and
    • “An online obesity clinic named Embla was associated with weight loss like that seen in randomized controlled trials (RCTs) of semaglutide, but with less than half of the semaglutide dose, according to new real-world data.
    • “Average weight loss reached 16.7% after 64 weeks’ use of the digital health platform, which combines tailored semaglutide dosing with intensive behavioral therapy delivered via an app. In clinical trials of semaglutide, the dose was 2.4 mg/wk, but patients in the present study used an average of 1 mg/wk. Similar mean weight loss was observed across baseline body mass index (BMI) classes and with all medication doses.
    • “This [study] showed us that combining an intensive behavioral intervention within an e-health weight management clinic can reproduce some of the results we see in confirmatory trials but in the context of a real-world cohort and with far less medication used,” said lead researcher Henrik Gudbergsen, MD, chief medical officer at Embla and general practitioner.
    • “The intensive behavioral therapy is key, and it goes a long way when you want to lose weight,” Gudbergsen added. He presented the findings at European Congress on Obesity (ECO) 2025. Publication of the study in The Lancet Digital Health is pending, but a preprint version is available.”
  • MedPage Today informs us, “Health officials are making a renewed call for vigilance against bird flu, but some experts are puzzling over why reports of new human cases have stopped.” * * *
    • During a call with U.S. doctors this month one CDC official noted that there is a seasonality to bird flu: Cases peak in the fall and early winter, possibly due to the migration patterns of wild birds that are primary spreaders of the virus.
    • That could mean the U.S. is experiencing a natural — maybe temporary — decline in cases.” * * *
    • “The CDC characterizes the risk to the general public as low, although it is higher for people who work with cattle and poultry or who are in contact with wild birds.
    • “Earlier this month, an agency assessment said there is a “moderate risk” that currently circulating strains of bird flu could cause a future pandemic, but the CDC stressed that other emerging forms of bird flu have been similarly labeled in the past.
    • “Still, research is continuing.”
  • Advice from GoodRx
    • Over the last few years, many artificial tear products have been recalled over safety concerns. These recalls have included products from Global Pharma Healthcare, Kilitch Healthcare India, and Brassica Pharma. Most recently, eye drops made by BRS Analytical Service, LLC have been recalled.
    • Recalled artificial tear eye drops, gels, and ointments had previously been sold in retail stores, such as CVS and Walmart, and online. Before using or buying artificial tears, check the most recent recall list to see if your product is affected.
    • Contact your healthcare team right away if you’ve used artificial tears and notice vision changes or eye infection symptoms.

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Regeneron Pharmaceuticals, a biotechnology company with a long history of large-scale genetics research, plans to buy DNA testing firm 23andMe out of bankruptcy, announcing Monday it was named the successful bidder in a court-run auction.
    • “Regeneron’s offer, which is still subject to court and regulatory approvals, is a bet it can do what 23andMe couldn’t and mine the troves of genetics data the testing firm collects to discover new drug targets. Regeneron plans to continue 23andMe’s consumer genome services without interruption — a task made easier by its decade of experience sequencing the DNA of millions of people through its genetics center. * * *
    • “Under the proposed deal, Regeneron will pay $256 million to acquire “substantially all” of 23andMe’s assets, including its personal genome service, health and research service and biobank. It will also offer jobs to all of the employees at those business units.
    • “The purchase would not include the telehealth business Lemonaid Health, which 23andMe will wind down.
    • “Regeneron expects the deal will close in the third quarter, assuming it obtains all the necessary approvals. An ombudsman appointed by the bankruptcy court will review the transaction to assess how it might affect the privacy of individuals who previously used 23andMe to sequence their genome. A report from that review is due to the court by June 10, and a hearing is set for June 17.”
  • Fierce Pharma informs us,
    • “With $27 billion earmarked to expand its U.S. production footprint starting this year, Eli Lilly is busy scouting out potential sites for new drug ingredients plants.
    • “Eli Lilly is jockeying for a tax break in Texas as it weighs whether to build a $5.9 billion active pharmaceutical ingredient (API) manufacturing facility in Houston, according to a recent filing (PDF) with the state.
    • “Should the proposal move forward, Lilly plans to purchase roughly 236 acres at Houston’s Generation Park from the commercial development’s owner, McCord Development. The final project would comprise multiple buildings and outdoor facilities, plus infrastructure buildout and equipment installation, according to the filing.
    • “Assuming Lilly settles in Houston, the drugmaker expects the new plant will employ 604 full-time staffers upon ramp-up completion. The company would look to hire operations technicians and production specialists, as well as a mix of roles across maintenance, quality control, engineering, administration and management functions.”
  • Per Fierce Healthcare,
    • “Vertical consolidation in healthcare has been a hot-button topic of late as regulators eye strategies to bring down healthcare costs.
    • “But do these massive “payvider” firms do more harm than good? The jury is still out, according to a panel of experts hosted by the Brookings Institution. The panelists highlighted both the risks of vertical integration between payers and providers as well as the potential positives of these relationships.”
  • and
    • “A new study suggests “upcoding” practices are growing across outpatient service lines.
    • “The report, compiled by researchers at Trilliant Health, found that the share of visits that were coded at higher intensities grew in emergency care, urgent care and physician office visits between 2018 and 2023. For example, the number of emergency department visits coded as 99284, or level four of five total, grew from 32.5% to 39.6% in the study window.
    • “Providers use standard CPT codes for outpatient visits, ranging from level one to level five, to indicate the intensity of services offered and the amount of time clinicians spent with a patient.
    • “The study similarly found an increase in urgent care visits coded at level four, with the share growing from 34% to 40.6% between 2018 and 2023. For physician office visits, the share of those coded at level four increased from 38.5% to 45%.
    • “In tandem, the study found a decline in the number of patient visits coded at lower intensity. For urgent care, the share of visits coded at level one decreased from 9.5% to 2.9% by 2023.”
  • Beckers Hospital Review lets us know,
    • “U.S. hospitals and health systems in many regions are seeing a sharp rise in uncompensated care, with new data showing big increases in bad debt and charity care deductions during the first quarter of 2025.
    • “Disruptions in health insurance coverage can drive increases in bad debt and charity care deductions for U.S. hospitals and health systems. According to the latest data from Q1 2025, health systems across the country already experienced significant increases in bad debt and charity deductions in recent years,” noted Strata in its “Healthcare Performance Trends: Q1 2025” report.”

Friday Report

David Ermer–CDC, Congress, COVID-19, FDA, Federal employment benefits, Generative AI, Medical / Rx research, OPM, Rx coverage, U.S. Healthcare, Uncategorized–
Photo by Sincerely Media on Unsplash

From Washington, DC,

  • The Wall Street Journal reports,
    • “House Republican spending hawks blocked the party’s giant tax-and-spending bill on Friday, delivering President Trump a setback over disagreements on Medicaid, clean-energy tax breaks and budget deficits.
    • “The holdouts—Reps. Chip Roy of Texas, Ralph Norman of South Carolina, Josh Brecheen of Oklahoma and Andrew Clyde of Georgia—stopped the Budget Committee from advancing the legislation, which leaders hope to pass by the full House next week. The panel failed to move the bill on a 16-21 vote, with those four Republicans and Rep. Lloyd Smucker (R., Pa.) joining all Democrats in opposition. Smucker, who backs the measure, said he voted no for procedural reasons, so he can call for a revote later.
    • “Budget Committee Chairman Jodey Arrington (R., Texas) said lawmakers were close to agreements on making changes to win the necessary votes. The committee scheduled its session to resume at 10 p.m. Sunday.”
  • and
    • “The U.S. lost its last triple-A credit rating.
    • “Moody’s Ratings downgraded the U.S. government on Friday, citing large fiscal deficits and rising interest costs.
    • “Runaway budget deficits mean U.S. government borrowing will balloon at an accelerating rate, pushing interest rates up over the long term, Moody’s said. The firm said in a March report that fiscal weakness looked set to continue even under analysts’ best-case scenarios.”
  • Modern Healthcare adds,
    • “Long-sought legislation to monitor and restrict how pharmacy benefit mangers operate could finally pass — if Republicans can move their sweeping budget bill that includes a string of those provisions.
    • ‘New PBM measures are tucked into the bill advanced Wednesday by the House Energy and Commerce Committee, which aims to cut more than $880 billion in spending, including $625 billion from Medicaid. The restrictions have long been championed by Health Subcommittee Chair Buddy Carter (R-Ga.), who was a pharmacist before becoming a congressman.”
  • Per Govexec
    • “The Trump administration is abiding by a court order to pause layoffs across most federal agencies, but it is still finding ways to shrink the federal workforce through involuntary means. 
    • “The Housing and Urban Development Department has begun once again firing its probationary employees—those recently hired or promoted—through a process distinct and separate from a reduction in force. Other agencies, including the Labor Department and National Science Foundation, meanwhile, are walking back recent RIFs due to a court-issued temporary restraining order. 
    • “That order specifically prevented agencies from issuing layoffs or taking any action to implement their Agency RIF and Reorganization Plans, which were mandated by the Office of Management and Budget and the Office of Personnel Management earlier this year. Agencies that were on the cusp of implementing RIFs, such as the Interior Department, have put those plans on ice at least until the restraining order is set to expire after May 23.”
  • FedWeek called our attention to this OPM benefits administration letter about “Family Member Eligibility Verification Updates and Enrollment Processing.”
  • Fierce Pharma informs us,
    • “On the heels of a production-tinged executive order earlier this month, the Trump administration is doubling down on efforts to boost medicine manufacturing in the U.S.
    • “In a new public-private partnership spearheaded by the administration, the Department of Health and Human Services’ (HHS’) Administration for Strategic Preparedness and Response (ASPR) and the Defense Advanced Research Projects Agency (DARPA) are linking up with several universities and companies in a bid to improve manufacturing for essential medicines using technologies such as artificial intelligence, machine learning and informatics.
    • “The project, dubbed Equip-A-Pharma, will allow the federal agencies to work directly with Battelle Memorial Institute and Aprecia, Bright Path Laboratories, Rutgers University and Mark Cuban’s Cost Plus Drugs as the partners strive to boost domestic manufacturing of eight drugs and their active pharmaceutical ingredients, the ASPR said in a Thursday press release.”
  • STAT News reports,
    • “Optum, the health data and care provider division of UnitedHealth Group, is developing a way to calculate how sick Medicare patients are through artificial intelligence, instead of relying solely on diagnosis codes submitted by physicians.
    • “Ken Cohen, a physician and Optum’s executive director of translational research, said Thursday at a conference organized by America’s Physician Groups that he was working with the Duke-Margolis Institute for Health Policy on this “next generation” of Medicare risk coding using AI.”

From the FDA front,

  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today cleared for marketing the first in vitro diagnostic device that tests blood to aid in diagnosing Alzheimer’s disease. The Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio is for the early detection of amyloid plaques associated with Alzheimer’s disease in adult patients, aged 55 years and older, exhibiting signs and symptoms of the disease.
    • “Alzheimer’s disease impacts too many people, more than breast cancer and prostate cancer combined,” said FDA Commissioner Martin A. Makary, M.D., M.P.H. “Knowing that 10% of people aged 65 and older have Alzheimer’s, and that by 2050 that number is expected to double, I am hopeful that new medical products such as this one will help patients.”
  • STAT News adds,
    • “Jason Karlawish, a professor of medicine at the University of Pennsylvania who specializes in Alzheimer’s research, said that “used right, this is a test that could really help to improve the diagnostic experience.”
    • “But with the availability of easier-to-use tests, there’s always the risk of “some frisky prescribing habits,” Karlawish said. Particularly in the field of Alzheimer’s, where just a small number of doctors are trained to treat the increasingly common condition, “the outcome can be inappropriate prescribing of the tests because a lot of people have a desire to get it, but not a lot of clinicians know how to properly use it.”
    • “The test should only be used to help diagnose people who have confirmed cognitive impairment, and there’s a risk some doctors may skip the step of confirming, as it’s “much easier to order a test than it is to talk to a patient,” Karlawish said. 
    • “Still, “in the history of Alzheimer’s disease, this is a big day,” he said. “The notion 10 years ago that there’d be a blood test that detects the pathologies of Alzheimer’s was a bit of a science fiction fantasy kind of story, and now here it is FDA-approved and ready for clinical practice.”
  • Reuters points out,
    • “The U.S. Food and Drug Administration has approved Amneal Pharmaceuticals’ (AMRX.O), opens new tab self-administered migraine drug, giving way to a quick and more convenient treatment option for patients.
    • “The treatment, branded as Brekiya, delivers a single dose of the drug called dihydroergotamine mesylate via an autoinjector. It is approved for the treatment of acute cases of migraine and severe, one-sided pain in the head called cluster headaches in adults, the drugmaker said on Thursday.”

From the judicial front,

  • The American Hospital Association News informs us,
    • “A U.S. district court judge for the District of Columbia May 15 ruled the Department of Health and Human Services must preapprove the use of 340B “rebate models” before they can be implemented, which the department has not yet done for any of the models pursued by the plaintiff drug companies. 
    • “Judge Dabney Friedrich issued the ruling in a case brought by a number of drug companies, finding that when the statute says that in implementing price reductions, “any rebate or discount” taken into account shall be “as provided by the Secretary,” it means that HHS has the authority to approve or reject the proposed rebate models. “Put another way, the statute contemplates that the Secretary may ‘have as a condition’ or ‘stipulate’ how any rebate or discount is accounted for in the price ultimately paid by covered entities.” * * *
    • “HHS recently announced that it will be “in a position to provide guidance” about the drug industry’s proposed use of “rebate models” by the end of May.”

From the public health and medical research front.

  • The Centers for Disease Control and Prevention announced today,
    • “Seasonal influenza, COVID-19, and RSV activity is low and declining.
    • “COVID-19
      • “COVID-19 activity has declined to low levels nationally. Wastewater levels are at low levels, emergency department visits are at very low levels, and laboratory percent positivity is stable.
      • “Additional information about current COVID-19 activity can be found at: CDC COVID Data Tracker: Home.
    • “Influenza
    • “RSV
      • “RSV activity has declined to low levels in most areas of the country.”
  • The University of Minnesota CIDRAP notes,
    • “The US measles picture grew by 23 cases this week, according to today’s update from the Centers for Disease Control and Prevention (CDC).
    • “A total of 1,024 confirmed measle cases have been reported from 31 jurisdictions, with 14 outbreaks (defined as 3 or more related cases). Ninety-two percent of confirmed cases are outbreak-associated.
    • “Of the cases, 96% have occurred in people who are either unvaccinated or have unknown vaccination status, and 128 (13%) of case-patients have been hospitalized, including 69 children under the age of 5. Three deaths have been confirmed to date, including two in unvaccinated school-aged children.” * * *
    • “The CDC notes on its measles outbreak page that one the reasons for more measles activity is because MMR coverage among kindergartners is now below 95%—the level needed to maintain elimination status. Two doses of the MMR vaccine are 97% effective at preventing measles, and one dose is about 93% effective.”
  • The American Journal of Managed Care lets us know,
    • “Higher dietary inflammatory index (DII) scores are significantly associated with an increased risk of Alzheimer disease–related death among American adults, according to a study published in Experimental Gerontology.
    • “Although the exact mechanisms of Alzheimer disease remain unknown, accumulating evidence suggests that chronic inflammation plays a key role in its pathogenesis and progression. In particular, past research shows that neuroinflammation accelerates neuronal damage, synaptic loss, and cognitive decline observed in patients with Alzheimer disease.
    • “Anti-inflammatory diets can alleviate neuroinflammation in patients with Alzheimer disease by reducing systemic inflammation through several immune pathways in the brain and indirectly through the gut microbiome and body circulation pathways. Therefore, the researchers emphasized that an anti-inflammatory diet may constitute a beneficial nutritional approach in Alzheimer disease management.”
  • The Wall Street Journal reports
    • “Electricity is gaining traction as a potential treatment for diseases like cancer and rheumatoid arthritis.
    • “Companies like Novocure and SetPoint Medical are developing devices that use electricity to treat diseases.
    • “Clinical trials show promise, with devices extending survival for some cancer patients and improving arthritis symptoms.”
  • STAT News adds,
    • “Leading oncologists said this week that artificial intelligence will one day be as integrated into cancer care as it is in smartphones and self-driving cars — and that this is a change we should welcome.
    • “Their comments, made at STAT’s Breakthrough Summit West on Wednesday, reflected an optimistic view for how the health care system can use AI across nearly all aspects of cancer care, from matching patients with clinical trials to predicting how they might fare on a given treatment. Some of this work is already happening. The panelists noted that AI has the potential to offer deep expertise across a growing number of precisely defined cancer indications, and that the technology can generate insights research focused on individual hypotheses might miss.”

From the U.S. healthcare business front,

  • Beckers Hospital Review relates,
    • “Cleveland Clinic reported an operating income of $52.8 million (1.3% margin) in the first quarter, up slightly from $50.2 million (1.3% margin) in the same period last year, according to financial documents published May 16.”
  • and
    • “Phoenix-based Banner Health reported an operating income of $142.4 million (3.6% margin) in the first quarter, up from an $89.3 million operating gain (2.4% margin) in the first quarter of 2024, according to financial documents published May 15.”
  • Healthcare Dive reports,
    • “Rite Aid is selling more than 1,000 pharmacies to rival drugstore operators as the beleaguered “pharmacy chain limps through bankruptcy processes for a second time.
    • Rite Aid said it was formally pursuing sales of “substantially all of its assets” earlier this month. Now, healthcare companies CVS Health and Walgreens, along with grocery stores Albertsons, Kroger and Giant Eagle, are among the buyers snapping up Rite Aid stores, the company said on Thursday.
    • “CVS is one of the biggest buyers, agreeing to acquire prescription files from 625 Rite Aid locations in 15 states in areas where it already has a presence, along with fully buying and operating 64 stores in Idaho, Oregon and Washington. The sales are subject to approval by a New Jersey bankruptcy court, which is scheduled to hold a hearing on May 21 regarding the transactions.”
  • Fierce Healthcare tells us,
    • “More than 6 in 10 survey respondents say they expect their healthcare organizations to see higher revenue from value-based care arrangements this year than in 2024, according to a joint report from the National Association of Accountable ACOs and health tech company Innovaccer.
    • “The report surveyed 168 executive and clinical leaders at health systems, accountable care organizations, specialty providers, federally qualified health centers and other delivery organizations.
    • “The findings indicate a growing reliance on VBC programs for some organizations. A significant segment, 30%, of organizations said a quarter of their revenue is tied to VBC contracts. More than 20% indicated at least half of their revenue is derived from fully capitated or downside risk contracts.
    • “Three-fourths of respondents believe further financial support would propel VBC adoption more.”
  • The Wall Street Journal reports,
    • “Novo Nordisk CEO Lars Fruergaard Jorgensen is stepping down after eight years in the role.
    • “The move follows market challenges, a share-price decline, and pressure from its controlling foundation.
    • “Former CEO Lars Rebien Sorensen will join the board amid concerns about losing ground to Eli Lilly.”

Thursday Report

David Ermer–AHRQ, Congress, COVID-19 vaccine, FDA, Federal employment benefits, Medical / Rx research, Rx coverage, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC,

  • Healthcare Dive summarizes the healthcare-related provisions of the various House committee budget reconciliation recommendations that the House Budget Committee will take up tomorrow.
  • As promised, the Departments of Health and Human Services, Labor, and the Treasury released today a non-enforcement policy concerning the 2024 mental health parity amendments.
    • “The Departments have requested that the ERIC litigation be held in abeyance while the Departments reconsider the 2024 [Mental Health Parity] Final Rule, including whether to issue a notice of proposed rulemaking rescinding or modifying the regulation through notice and comment rulemaking.
    • The Departments will not enforce the 2024 Final Rule or otherwise pursue enforcement actions, based on a failure to comply that occurs prior to a final decision in the litigation, plus an additional 18 months. This enforcement relief applies only with respect to those portions of the 2024 Final Rule that are new in relation to the 2013 final rule. The Departments note that MHPAEA’s statutory obligations, as amended by the CAA, 2021, continue to have effect. 
  • The Wall Street Journal reports,
    • “The Trump administration is planning to drop recommendations that pregnant women, teenagers and children get Covid-19 vaccines as a matter of routine, according to people familiar with the matter.
    • “The Department of Health and Human Services, led by Secretary Robert F. Kennedy Jr., is expected to remove the Centers for Disease Control and Prevention’s recommendations for those groups around the same time it launches a new framework for approving vaccines, the people said.
    • “The exact timing of the announcement wasn’t clear, the people said, though it was expected in the coming days.”
  • Tammy Flanagan, writing in Govexec, discusses “Getting ready to retire. What you should do and how you should approach your retirement and health benefits planning before leaving federal service.”

From the FDA front,

  • Per an HHS press release,
    • “The U.S. Food and Drug Administration today is taking a major step to increase transparency and ensure the safety of chemicals in our food. The agency is launching a stronger, more systematic review process for food chemicals already on the market—especially those that concern consumers most.
    • “No parent should ever worry about what’s in their child’s food,” said HHS Secretary Robert F. Kennedy, Jr. “We’re taking decisive action and using every authority we have to clean up the food supply and protect American families.”
    • “Under the leadership of Secretary Kennedy and FDA Commissioner Martin A. Makary, M.D., M.P.H., the FDA will roll out several key actions over the coming months:
      • “A modernized, evidence-based prioritization scheme for reviewing existing chemicals. A draft will be released for public comment soon.
      • “A final, systematic post-market review process shaped by stakeholder input.
      • “An updated list of chemicals under review, including BHT, BHA, and ADA. The FDA will also take steps to expedite its review of chemicals currently under review like phthalates, propylparaben, and titanium dioxide. FDA will continue to share information about the status of this work on its public website as part the agency’s push for greater transparency.”
  • Fierce Pharma adds,
    • “Six years after Merck bought out Peloton Therapeutics, the New Jersey drugmaker is not remaining stationary with the crown jewel of the deal.
    • “On Wednesday, the FDA approved a third indication for Welireg (belzutifan), signing off on the hypoxia-inducible factor-2 alpha (HIF-2a) inhibitor to treat patients with rare pheochromocytoma or paraganglioma (PPGL) tumors in the endocrine system.
    • “The approval covers patients 12 and older with locally advanced, unresectable or metastatic PPGL and makes Welireg the first oral treatment for advanced PPGL, per Merck.”
  • Per MedPage Today,
    • The FDA granted a first-ever approval for a first-line therapy for anal cancer to the PD-1 inhibitor retifanlimab (Zynyz), the agency announced Thursday.
    • The approval stipulates use in combination with carboplatin and paclitaxel in newly diagnosed locally advanced/metastatic squamous cell carcinoma of the anal canal (SCAC) or as monotherapy for patients whose disease progressed on platinum-based chemotherapy.
    • “Patients with inoperable, locally recurrent, or metastatic anal cancer have historically faced poor 5-year survival rates and limited treatment options,” said Marwan Fakih, MD, of City of Hope in Duarte, California, in a statement from drugmaker Incyte. “This approval marks an important advancement as it makes a new treatment approach available for this challenging disease.”

From the public health and medical research front,

  • The Wall Street Journal tells us,
    • “Health and Human Services Secretary Robert F. Kennedy Jr. has made combating chronic diseasea rallying cry as he looks to overhaul the health department and “Make America Healthy Again.”
    • “So how healthy is America, historically? It isn’t that we used to be healthier, data show, but the biggest threats have changed.
    • “The deadliest scourges in the U.S. were once infectious, with influenza and tuberculosis topping the list at the start of the 20th century. Better sanitation and advances in antibiotics and vaccines muzzled them, transforming Americans’ well-being. Medical innovations and antismoking campaigns then spurred decades of progress against heart disease and cancer.
    • “But chronic diseases, persistent or long-lasting health conditions, are undermining that momentum, contributing to our stalled life expectancy over the past decade that trails behind that of other wealthy nations.
    • “Much of the gap in life expectancy is due to deaths among working-age adults, says Dr. Steven Woolf, a life-expectancy researcher at the Virginia Commonwealth University.
    • “Americans die earlier and are sicker than people in other high-income countries,” he said. “This has been true for a long time, and the trend is getting worse.”
  • Health Day informs us,
    • “More U.S. teenagers are getting weight-loss surgery, despite the discovery of new drugs like Ozempic/Wegovy that help people drop pounds surgery-free, a new study says.
    • “Weight loss surgeries for teens increased 15% between 2021 and 2023, researchers reported earlier this month in The Journal of Pediatrics.
    • “Further, much of the increase in weight-loss surgery is due to its increased popularity among Hispanic and Black teenagers, groups disproportionately affected by severe obesity compared to white teens, researchers said.
    • “The number of U.S. adolescents having access to this treatment that we know is safe and effective is the highest it’s ever been, and hopefully it’s the start of a positive weight loss journey that will get them to better health,” lead researcher Sarah Messiah, director of the Child and Adolescent Population Health Program at UT Southwestern Medical Center, said in a news release.”
  • Per Beckers Hospital Review,
    • “Adult patients taking Wegovy saw a reduced risk of experiencing a major adverse cardiovascular event within the first three months of treatment, according to a secondary analysis of the drug’s clinical trial data, presented May 12 at the European Congress on Obesity.”
  • Very good news from an NIH news release,
    • “A research team supported by the National Institutes of Health (NIH) has developed and safely delivered a personalized gene editing therapy to treat an infant with a life-threatening, incurable genetic disease. The infant, who was diagnosed with the rare condition carbamoyl phosphate synthetase 1 (CPS1) deficiency shortly after birth, has responded positively to the treatment. The process, from diagnosis to treatment, took only six months and marks the first time the technology has been successfully deployed to treat a human patient. The technology used in this study was developed using a platform that could be tweaked to treat a wide range of genetic disorders and opens the possibility of creating personalized treatments in other parts of the body.
    • “A team of researchers at the Children’s Hospital of Philadelphia (CHOP) and the Perelman School of Medicine at the University of Pennsylvania (Penn) developed the customized therapy using the gene-editing platform CRISPR. They corrected a specific gene mutation in the baby’s liver cells that led to the disorder. CRISPR is an advanced gene editing technology that enables precise changes to DNA inside living cells. This is the first known case of a personalized CRISPR-based medicine administered to a single patient and was carefully designed to target non-reproductive cells so changes would only affect the patient.
    • “As a platform, gene editing — built on reusable components and rapid customization — promises a new era of precision medicine for hundreds of rare diseases, bringing life-changing therapies to patients when timing matters most: Early, fast, and tailored to the individual,” said Joni L. Rutter, Ph.D., director of NIH’s National Center for Advancing Translational Sciences (NCATS).”
  • BioPharma Dive adds,
    • “We are still in very early days,” said Rebecca Ahrens-Nicklas, an assistant professor of pediatrics at the University of Pennsylvania and study author. Doctors will monitor KJ’s progress and are considering other ways to evaluate the therapy’s effects without a biopsy.
    • “Yet the findings could carry important implications for drug research. There are more than 7,000 rare diseases, many of which are so uncommon they’re unlikely to be profitable for any companies that develop treatments for them. Gene editing could be a powerful solution, but an expensive development path and slim sales prospects make such medicines tough investment propositions. A large number of biotechnology firms pursuing gene editing are struggling to survive.” 
  • Here is a link to the All of Us Research Project’s Medical Minutes.
  • Per MedPage Today,
    • “First-line treatment with nivolumab (Opdivo) and ipilimumab (Yervoy) significantly improved survival compared with lenvatinib (Lenvima) or sorafenib (Nexavar) for patients with unresectable hepatocellular carcinoma (HCC), the randomized phase III CheckMate 9DW trial showed.
    • “Of more than 600 patients, median overall survival (OS) was 23.7 months with the PD-1 inhibitor and CTLA-4 inhibitor combination versus 20.6 months with single-agent tyrosine kinase inhibitors (HR 0.79, 95% CI 0.65-0.96, P=0.018), reported Peter R. Galle, MD, of the University Medical Center in Mainz, Germany, and colleagues.
    • “Respective OS rates were 49% versus 39% at 24 months and 38% versus 24% at 36 months, they wrote in The Lancet.
    • “The overall survival rates “are the longest and highest reported for the approved systemic treatments in this setting,” wrote Galle and colleagues, adding that the results “support nivolumab plus ipilimumab as a first-line treatment” in unresectable HCC.
    • “Results of this trial led to the recent FDA approval of the combination as first-line treatment for adults with unresectable or metastatic HCC.”
  • Per Fierce Pharma,
    • “Merck’s Keytruda, with more than 40 approved indications, hasn’t yet been able to crack specifically into ovarian cancer. But with promising early results from a phase 3 study in certain patients, the checkpoint inhibitor may have found its place.
    • “At a pre-specified interim analysis of Merck’s phase 3 Keynote-B96 trial, which is testing Keytruda plus chemotherapy with or without Roche’s Avastin in patients with platinum-resistant recurrent ovarian cancer, the drug showed “statistically significant and clinically meaningful” improvements in progression-free survival regardless of patients’ PD-L1 status, Merck reported on Thursday.
    • “The trial compared the Keytruda regimen against placebo and chemotherapy, again with or without Avastin.”
  • HHS’s AHRQ released a systematic review finding
    • “No completed studies show if blood-based, multicancer screening tests help people compared with no screening or standard single-cancer screenings. We do not know if these tests save lives, reduce advanced cancers, or improve quality of life.
    • “We found 20 studies covering 109,177 people that tested how accurate 19 different multicancer screening tests were. Thirteen of these studies had serious flaws in how they were conducted.
    • “Accuracy varied widely based on:
      • “What the tests measured and how researchers analyzed it,
      • “How many and which types of cancers researchers tried to find,
      • “Which types of people were tested, and
      • “How the studies were designed.
    • “We graded the strength of evidence for accuracy as insufficient, meaning we cannot draw firm conclusions.
    • “We only found one study reporting on potential harms from multicancer screening tests. We graded the strength of evidence as insufficient for harms based on this single study.
    • “Studies that will be completed in the next 2 to 4 years may give more information about whether multicancer screening tests work and whether they have harms.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Higher patient volumes were not enough to keep CommonSpirit Health in the black during its latest quarter.
    • “Patient volumes soared across the country over the past couple of years due to a rebound in demand after the COVID-19 pandemic and overall population growth in fast-growing markets.
    • “The trend largely boosted net patient revenue and helped pad bottom lines for many health systems. Volume growth is one part of CommonSpirit’s strategy to improve operating performance.
    • “However, this year may bring a more complicated dynamic, given continued inflation, tariffs and federal funding uncertainty weighing on hospital finances.
    • “Chicago-based CommonSpirit recorded a $42 million net loss in its third quarter, compared with $282 million in net income a year ago, according to financial documents published Thursday. Results are not adjusted for the California provider fee program, which would add supplemental payments if approved by the Centers for Medicare and Medicaid Services.
    • “CommonSpirit said its financial results were impacted by expenses increasing at a faster rate than revenue, despite strong volumes, lower lengths of stay and higher productivity levels.”
  • Beckers Hospital Review lets us know,
    • “Texas Rural Hospital in Cleveland is set to reopen within the next week after it abruptly closed its doors the week of May 12 due to funding shortages, KIAH reported May 15. 
    • “The hospital’s lease agreement with Cleveland-based Emergency Hospital Systems, a community emergency hospital system, ended in March 2025. It then gained new ownership under HealCrest Network, a spokesperson for EHS said in a May 14 statement shared with Becker’s.
    • “Hospital employees told KIAH that they did not receive pay on May 9; however, the hospital said it plans to repay them in the coming days.”
  • and
    • [Another article shows] “the adjusted expenses per inpatient day in 2023 for nonprofit, for-profit, and government hospitals in every U.S. state, based on the latest estimates provided by Kaiser State Health Facts. 
    • “The figures are based on information from the 2023 American Hospital Association Annual Survey. They are an estimate of the expenses incurred in a day of inpatient care and have been adjusted upward to reflect an estimate of outpatient service volumes, according to the KFF. 
    • “The foundation notes the figures are “only an estimate of expenses incurred by the hospital” for one day of inpatient care and do not substitute actual charges or reimbursement for care provided.
    • “To see how expenses compare to one year prior, find 2022’s adjusted expenses per inpatient day here. 
      • National average
      • Nonprofit hospitals: $3,288
      • For-profit hospitals: $2,529
      • State/local government hospitals: $2,857
  • Per a press release,
    •  “Blue Cross and Blue Shield of Massachusetts, Inc. and Blue Cross and Blue Shield of Massachusetts HMO Blue, Inc. (together, Blue cross) today reported a combined after-tax first quarter net income of $37 million on revenue of $2.6 billion (1.4% net margin). These results reflect an operating and other loss of $9.8 million (-0.4% operating margin) and investment income of $46.8 million.
    • “The big story is that spending on medical and pharmacy services for our members remains elevated, at near historic highs,” said Chief Financial Officer Ruby Kam. “Two notable callouts in the first quarter involve higher spending due to the difficult flu season as well as the continued impact of high-cost GLP-1 medications.” Kam said the company projects operating and net losses for full-year 2025 and has implemented a comprehensive plan to improve its financial results. Last year, the company posted the worst operating loss in its 87-year history.
    • “Blue Cross is the leading private health plan in Massachusetts with 3 million members.”
  • Fierce Healthcare points out,
    • “Earlier this month, pharmacy chain Rite Aid filed bankruptcy for the second time in less than two years, revealing that it would seek buyers for its retail locations.
    • “In the Pacific Northwest, it’s garnering interest from pharmacy rival CVS Health, according to a report in Bloomberg. Rite Aid CEO Matthew Schroeder told employees on Thursday that CVS had made a bid on a large number of stores in Washington, Oregon and Idaho along with patient prescription data, according to a recording reviewed by the outlet.
    • “If a deal were to go through, it would give CVS greater reach in a region where its presence is currently smaller, per the article.
    • “Schroeder said that Rite Aid has also received bids on some of its assets from multiple other pharmacy groups, including Walgreens, Albertsons, Kroger and Giant Eagle, Bloomberg reported.”
  • Per an Institute for Clinical and Economic Research news release,
    • “Institute for Clinical and Economic Review Publishes Final Evidence Report on Treatment for Retinitis Pigmentosa. Independent appraisal committee voted that current evidence is adequate to demonstrate a net health benefit of sonpiretigene isteparvovec compared to usual care.”

Wednesday Report

David Ermer–CDC, CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, NIH, OPM, U.S. Healthcare–
Thanks to Alexandr Hovhannisyan for sharing their work on Unsplash.

From Washington, DC,

  • NBC News reports
    • “Two Key House committees advanced their portions of a sweeping package for President Donald Trump’s agenda on party-line votes Wednesday following marathon meetings. 
    • “The tax-writing Ways and Means Committee advanced its bill, which would permanently extend Trump’s 2017 cuts, Wednesday morning after a session that clocked in at more than 17 hours.
    • “Later Wednesday, the Energy and Commerce Committee passed its legislation, which includes steep Medicaid cuts, after meeting for more than 26 hours.”
    • “The House Agriculture Committee was still debating its part of the broader package which includes a $290 billion cut to Supplemental Nutrition Assistance Program (SNAP), late Wednesday afternoon. The panel began its markup around 7:30 p.m. Tuesday before breaking around midnight and reconvening Wednesday morning. 
    • “The Ways and Means and Energy and Commerce committees did not make substantive changes to the original plans offered by their chairs.” 
  • Following the creation of committee recommendations, the House Budget Committee will take responsibility for the budget reconciliation bill. Per a Budget Committee news release today,
    • “On Friday, May 16th, 2025, at 9:00 AM in 210 Cannon House Office Building, the House Committee on the Budget will hold a markup to provide for reconciliation pursuant to title II of the Concurrent Resolution on the Budget for Fiscal Year 2025, H. Con. Res. 14. 
    • “Committee hearings and markups are available LIVE from our website or YouTube.”
  • The American Hospital Association News tells us,
    • “Department of Health and Human Services Secretary Robert F. Kennedy Jr. May 14 testified on President Trump’s discretionary budget proposal for fiscal year 2026 in hearings before the House Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies and the Senate Committee on Health, Education, Labor and Pensions. The proposal includes $93.8 billion for HHS, which is a 26.2% reduction from the FY 2025 enacted level.”
  • The Wall Street Journal offers its insights on these hearings here.
  • Federal News Network lets us know that OPM is proceeding with its retirement application processing improvements, notwithstanding the cancellation of the Workday contract.
  • Govexec takes on “Age gap retirement planning for federal employees: Avoiding the ‘Widow’s Penalty,’ Medicare planning and more. How to think about the best ways to utilize your retirement and health care benefits when you may be older, or younger, than your spouse.”
  • Per a CMS news release,
    • “The Centers for Medicare & Medicaid Services (CMS) is taking bold steps to modernize the nation’s digital health ecosystem with a focus on empowering Medicare beneficiaries through greater access to innovative health technologies. The agency, in partnership with the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (ASTP/ONC), is seeking public input on how best to advance a seamless, secure, and patient-centered digital health infrastructure. The goal is to unlock the power of modern technology to help seniors and their families take control of their health and well-being, manage chronic conditions, and access care more efficiently.” * * *
    • “The request for information (RFI) invites input from patients, caregivers, providers, payers, technology developers, and other stakeholders on how CMS and ASTP/ONC can: 
      • “Drive the development and adoption of digital health management and care navigation applications; 
      • “Strengthen interoperability and secure access to health data through open, standards-based technologies; 
      • “Identify barriers preventing the seamless exchange of health information across systems; and
      • Reduce administrative burden while accelerating progress toward value-based, patient-centered care.”
    • “The public comment period will be open through June 16. The RFI is available at https://public-inspection.federalregister.gov/2025-08701.pdf, and the public should submit all comments through the provided weblink.”

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “The number of people who died of drug overdoses in the U.S. dropped dramatically in 2024, a promising sign amid a national fentanyl crisis that has fueled a surge in drug-related deaths in recent years.  
    • “Drug-overdose deaths dropped by 27% to around 80,000 deaths in 2024 from about 110,000 in 2023, according to preliminary data released by the Centers for Disease Control and Prevention on Wednesday. The deaths reported last year fell closer to levels not seen since before the Covid-19 pandemic, which exacerbated the country’s drug-overdose crisis and led to a surge in deaths.
    • “Yearly declines in new overdose deaths are rare and tend to be small, making 2024’s drop unprecedented in its scope. This is also only the fourth year in more than three decades in which the U.S. reported fewer drug fatalities, but also the second in a row after a modest reduction in 2023.” * * *
    • “Despite the drop in drug-overdose related deaths in 2024, the yearly tally is still much higher than those recorded less than a decade ago and before the opioid crisis took off in the 1990s. The U.S. recorded well over 100,000 deaths a year from 2021 to 2023, according to federal data.”
  • Reuters informs us,
    • “The Texas health department reported 717 cases of measles in the state on Tuesday, an increase of eight since its last update on Friday, as the U.S. battles one of the worst outbreaks of the childhood disease in the country.
    • “Cases in Gaines County, the epicenter of the outbreak, rose to 405 from 403 since the last update, according to the Texas Department of State Health Services.
    • “Texas had reported seven additional cases in the last update on Friday, which was the lowest increase since the outbreak began in February.
    • “New Mexico’s health department reported 71 cases, unchanged from its last update. Most of the state’s cases are from Lea County, adjacent to Gaines County in Texas.”
  • Per Becker’s Hospital Review,
    • “Seventy-six percent of oncologists reported seeing an increasing number of patients presenting with advanced-stage cancer. Of those, 75% attributed the increase to screening barriers, according to a survey published May 13 by the Harris Poll on behalf of Quest Diagnostics. 
    • “The Harris Poll surveyed 174 medical oncologists and 76 surgical oncologists on their experiences with advanced-stage cancer diagnoses and recurrence between Aug. 6 and Sept. 4.” * * *
    • “Read the full survey results here.” 
  • The National Cancer Institute (NCI) posted its latest edition of Cancer Currents, which is a research blog.
  • Per HCPLive,
    • “Findings from a recent study suggest iron deficiency anemia (IDA)independently and significantly increases the odds of ischemic stroke in young adults.
    • “IDA is the most common form of anemia globally. It results from iron deficiency, when there are insufficient iron stores to support the production of red blood cells. IDA disproportionately affects women due to regular iron losses through menstruation and increased iron demands during pregnancy. Maternal anemia can lead to the child exhibiting intellectual disability, autism spectrum disorder, and attention-deficit/hyperactivity disorder.
    • “Additionally, it is currently estimated that 10-15% of all strokes occur in adults aged 18-50, a group that also exhibits an increased prevalence of IDA. However, little data has been collected regarding the association between IDA and stroke in young adults.
    • “Although multiple studies have explored the association of IDA and thrombotic events in children, our study was the first to explore its role in ischemic stroke in a young adult population, that is, most susceptible to IDA,” wrote Jahnavi Gollamudi, MD, University of Cincinnati, and colleagues.
    • “Investigators classified patients into 2 groups: those with a first-time ischemic stroke diagnosis were defined as Group A, and those without a history of ischemic stroke were defined as Group B.”
  • Per a National Institutes of Health news release,
    • “Researchers at the National Institutes of Health (NIH) have identified a series of changes in the architecture and cell composition of connective tissues of the breast, known as stromal tissue, that is associated with an increased risk of developing aggressive breast cancer among women with benign breast disease, and poorer rates of survival among women with invasive breast cancer. This process, which they call stromal disruption, could potentially be used as a biomarker to identify women with benign breast disease who are at high risk of developing aggressive breast cancers, as well as those with breast cancer who may be at increased risk of recurrence or death.
    • “Such insights could help inform the development of cancer prevention and treatment strategies that target the stromal microenvironment. In addition, stromal disruption is inexpensive to assess and could be widely adopted, particularly in low-resource settings where molecular analysis is impractical or very expensive.”
  • Per Fierce Pharma,
    • “After flexing its antibody-drug conjugate bona fides at last year’s American Society of Clinical Oncology (ASCO) conference, AbbVie is advancing its solid tumor ambitions with a new FDA green light.
    • “The FDA on Wednesday granted an accelerated approval to AbbVie’s c-Met-directed ADC Emrelis, also known as telisotuzumab vedotin, as a new treatment option for adults with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) who’ve previously received systemic therapy. The drug is cleared in patients whose tumors exhibit high overexpression of the c-Met protein.
    • “The c-Met protein is overexpressed in around 25% of patients with advanced epidermal growth factor receptor wild-type, non-squamous NSCLC, and roughly half of those patients have high c-Met overexpression, AbbVie explained in a press release.”
  • Per BioPharma Dive,
    • “A two-drug regimen involving an experimental cancer immunotherapy from iTeos Therapeutics and GSK didn’t significantly delay tumor progression in a Phase 2 trial, leading the companies to end development and terminate the collaboration they formed around the drug four years ago.
    • “When added to GSK’s drug Jemperli, the immunotherapy, known as belrestotug and aimed at a cellular target called TIGIT, didn’t meet preset criteria for progression-free survival compared to Jemperli alone in people with non-small cell lung cancer. The study showed a “trend below the meaningful threshold” for drug responses in study arms including people with head and neck cancer, the companies said Tuesday.
    • “Based on the results, iTeos and GSK are stopping all ongoing trials of belrestotug, including an ongoing Phase 3 study in lung cancer. iTeos is “taking immediate steps to preserve capital” as well as starting a strategic review.”

From the U.S. healthcare business front,

  • We start with global news from the Wall Street Journal,
    • “GSK will acquire a liver-disease treatment from Boston Pharmaceuticals for up to $2 billion as it seeks to boost its pipeline of new drugs.
    • “The British pharma giant said Wednesday that it will pay the U.S. biotech company $1.2 billion upfront, with a further $800 million in potential success-based milestone payments.
    • “The drug is currently in late-stage trials, with a potential market launch in 2029. It aims to treat a form of liver disease characterized by inflammation and damage caused by a build-up of fat. GSK said the drug is also being explored for use in alcohol-related liver disease, and that mid-stage data has shown potential to reverse liver fibrosis and halt disease progression.
    • “Unlike current daily tablet treatments, efimosfermin is designed to be administered as a monthly shot. GSK plans to develop it both as a monotherapy–which uses one type of treatment–and in combination with its own experimental liver-disease therapies.”
  • and
    • “Danish pharmaceutical company Novo Nordisk has signed a collaboration deal with U.S. biotech Septerna that will see the two companies develop pills to treat obesity, type 2 diabetes and other cardiometabolic diseases.
    • “Under the terms of the agreement, Septerna is eligible to receive around $2.2 billion from Novo Nordisk, including over $200 million in upfront and near-term milestone payments.
    • “The U.S. company will also receive research, development and commercial milestone payments, on top of tiered royalties on global net sales of marketed products. Novo Nordisk will cover all research-and-development costs.”
  • STAT News lets us know,
    • “The mood at the annual meeting of the American Society of Cell and Gene Therapy isn’t amazing. The biotech market has been bad for years. The FDA and NIH are shrouded in uncertainty. But many researchers tried to project confidence. Over the last four years, 16 gene and cell therapies have been approved, as one presenter noted Tuesday. Also, there was a purple-clad Mardi Gras-style stilt walker directing attendees into the main hall — so there’s that.”
  • Beckers Hospital Review points out that “A total of 66 hospitals [named in the article] received both Healthgrades’ Outstanding Patient Experience and Patient Safety Excellence awards.”
  • Per Beckers Payer Issues,
    • “Contract disputes between insurers and health systems are down in 2025 compared to the second half of 2024.
    • “According to data from FTI Consulting, there were 133 total disputes in 2024, compared to 86 in 2023 and 51 in 2022. In the first quarter of 2025, 26 total disputes have been recorded, compared to 50 in Q4 2024 and 37 in Q3 2024. Network breaks between Medicare Advantage plans and health systems tripled from 2022 to 2024.
    • “FTI has tracked media reports regarding negotiations over reimbursement rates between provider organizations and insurance companies during each quarter since early 2022.”
  • HR Dive notes,
    • “While 86% of employers think their benefits are modern, only 59% of workers agree,  according to the results of Prudential’s 2025 Benefits and Beyond study, released Monday. 
    • “Workers say their top challenges are saving for retirement (45%), cost of everyday goods (44%), cost of housing (29%) and making it paycheck to paycheck (26%); and 1 in 10 workers identified being able to survive paycheck to paycheck as their No. 1 worry, the study found. 
    • “The study’s findings are clear: When it comes to workplace benefits, there is a disconnect on what companies offer and what employees actually need — now and in the future,” the press release said.”