Tuesday Report

Federal employment benefits

Tuesday Report

David Ermer–AHRQ, CDC, CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, NIH, OPM, Rx coverage, SDOH, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • Last week, the President issued another Executive Order on deregulation. The EO begins
    • “Deregulation is a critical priority for my Administration.  We will foster prosperity by freeing Americans from the heavy burden of Federal regulations accumulated over decades.”
  • The American Hospital Association (AHA) News tells us,
    • “The Department of Health and Human Services May 13 announced a 60-day public comment period opened for stakeholders regarding its request for information to remove outdated or unnecessary regulations. The request stems from an executive order issued in January requiring HHS to implement a “10-to-1” rule, eliminating at least 10 existing regulations for every new regulation introduced. Comments on the RFI can be submitted at regulations.gov/deregulation.”
  • When will OPM make a similar deregulation announcement?
  • The Congressional Research Service released a report on the House Oversight and Government Reform Committee’s budget reconciliation measures. The Congressional Budget Office posted its own report on those recommendations.
    • “In CBO’s estimation, the reconciliation recommendations of the House Committee on Oversight and Government Reform would, on net, decrease deficits by $51.0 billion over the 2025‑2034 period. The estimated budgetary effects of the legislation are shown in Table 1. The costs of the legislation mainly fall within budget functions 550 (health), 600 (income security), 800 (general government), and 950 (undistributed offsetting receipts).”
  • Modern Healthcare reports,
    • “Doctors that treat Medicare beneficiaries would receive a pay boost under the sweeping tax-and-spending cuts legislation House Republicans unveiled Monday.
    • “Medicare reimbursements to physicians declined 2.9% this year, provoking outcries from medical societies that complain doctor pay has failed to keep up with cost increases. The GOP measure would raise rates next year and remake the Medicare Physician Fee Schedule to link future updates to the Medicare Economic Index, which generally rises faster than overall inflation.
    • “In 2026, the legislation would hike Medicare physician payments by an estimated 2.25%. That projection is based on how the bill would modify the “conversion factor” that determines Medicare fees for physician services. Next year, that formula would be boosted by 75% of growth in the Medicare Economic Index. In later years, it would fall to 10% of medical inflation.
    • “The physician pay increase comes with a downside for some providers, however. While the measure would raise rates, it would curtail financial incentives under alternative payment models.”
  • Bloomberg Law reports,
    • “House Republicans revived a set of policies that would change how prescription drug middlemen do business, as President Donald Trump again denounced the industry, sending shares of some of the companies down Monday.
    • “The budget proposal from the House Committee on Energy and Commerce includes a set of reforms that Congress considered last year but ultimately didn’t pass. It would remove one method that the companies, which negotiate with drugmakers and pharmacies on behalf of employers, health insurers and government programs, use to boost profits.
    • “The revival of the modest reforms in the House budget plan adds to pressure on the companies, which are already facing intense scrutiny in Washington. Trump complained about the companies known as pharmacy benefit managers during a press conference Monday touting his executive order intended to help lower the prices Americans pay for drugs.”
  • The Senate Judiciary Committee held a hearing today on the allegedly adverse impact of prescription benefit manager practices on rural pharmacies.
  • Beckers Hospital Review looks into a Republican budget reconciliation proposal in Congress to “place a 10-year moratorium on state and local governments regulating AI. The provision would prevent any laws targeting AI models, systems or automated decision tools during that time.”
  • The AHA News informs us,
    • “The Centers for Medicare & Medicaid Services May 13 launched a new strategy focused on three pillars: promoting evidence-based prevention, empowering people to achieve their health goals, and driving choice and competition. To support the new strategic plan, CMS Administrator Mehmet Oz, M.D., and Innovation Center Director Abe Sutton hosted a public webinar highlighting the Innovation Center’s commitment to take learnings from historical investments in value-based care to the “Make America Healthy Again” initiative. They also highlighted the need for models to demonstrate cost savings and improved outcomes in accordance with statutory requirements. The agency posted FAQs regarding the new strategic direction on a new homepage.”
  • and
    • “The Centers for Medicare & Medicaid Services May 12 issued a proposed regulation that would change how states may structure provider taxes for purposes of generating revenue for their Medicaid programs. CMS states that these changes are intended to prevent states from adopting provider taxes that are not “generally redistributive” and therefore may be in violation of the statute. While CMS notes that they have particular concerns about certain Medicaid managed care organization taxes, these policies, if adopted, would apply to all provider taxes. The public has 60 days to comment.”
  • Beckers Hospital Review offers eight things to know about this proposed regulation.
  • The U.S. Preventive Services Task Force confirmed today the continuing validity of its Grade A recommendation of “early, universal screening for syphilis infection during pregnancy [for asymptomatic women]; if an individual is not screened early in pregnancy, the USPSTF recommends screening at the first available opportunity.” * * * “To achieve the benefit of screening, it is important that screening occur as early in pregnancy as possible and that everyone with abnormal syphilis test results receive timely, evidence-based evaluation and treatment.”

From the judicial front,

  • STAT News reports,
    • “The now 13-year-long legal saga over who invented CRISPR took yet another unexpected turn on Monday, in a ruling that could not only change U.S. ownership of patent rights to the groundbreaking gene-editing technology but more broadly redefine how the law determines when an invention has been made. 
    • “The U.S. Court of Appeals for the Federal Circuit sided with the University of California and the University of Vienna in their bid to revive a fight over foundational CRISPR-Cas9 patents that the schools say should go to their Nobel Prize-winning scientists Jennifer Doudna and Emmanuelle Charpentier. In 2022, the U.S. Patent and Trademark Office determined that a group of scientists led by Feng Zhang of the Broad Institute of Harvard and the Massachusetts Institute of Technology had conceived of uses of the technology in humans before Doudna and Charpentier.” 

From the public health and medical research front,

  • From HHS news releases,
    • “The U.S. Food and Drug Administration (FDA) today announced that it is initiating action to remove concentrated ingestible fluoride prescription drug products for children from the market. Unlike toothpaste with fluoride or fluoride rinses, these products are swallowed and ingested by infants and toddlers. They have also never been approved by the FDA. Ingested fluoride has been shown to alter the gut microbiome, which is of magnified concern given the early development of the gut microbiome in childhood. Other studies have suggested an association between fluoride and thyroid disorders, weight gain and possibly decreased IQ.
    • “The best way to prevent cavities in children is by avoiding excessive sugar intake and good dental hygiene, not by altering a child’s microbiome. For the same reason that fluoride may kill bacteria on teeth, it may also kill intestinal bacteria important for a child’s health,” said FDA Commissioner Marty Makary, M.D., M.P.H. “I am instructing our Center for Drug Evaluation and Research to evaluate the evidence regarding the risks of systemic fluoride exposure from FDA-regulated pediatric ingestible fluoride prescription drug products to better inform parents and the medical community on this emerging area. When it comes to children, we should err on the side of safety.”
  • and
    • “The U.S. Department of Health and Human Services (HHS) and U.S. Food and Drug Administration (FDA) today announced the next steps in Operation Stork Speed–a groundbreaking initiative to ensure the safety, reliability, and nutritional adequacy of infant formula for American families. The FDA issued a Request for Information (RFI) to begin the nutrient review process required by law for infant formula. Currently, infant formula must meet minimum and maximum levels of certain nutrients. While the FDA regularly reviews individual nutrient requirements for infant formula, this will be the first comprehensive review since 1998.
    • “Operation Stork Speed brings radical transparency to ingredients in infant formula and puts science front and center,” said HHS Secretary Robert F. Kennedy, Jr. “Every child has a fundamental right to a healthy start. We’re giving parents the truth and the tools to make that happen. You can’t Make America Healthy Again if we don’t fix what nourishes our youngest and most vulnerable Americans.”
    • “Through the RFI, the FDA is seeking public input to help determine whether existing nutrient requirements should be revised based on the latest scientific data, including international. The agency also welcomes data on potential adjustments to existing minimum or maximum levels, recommendations for additional nutrients to consider, and how such changes may improve health outcomes.
    • “Commenters will have 120 days to submit responses. Further information on how to submit a comment can be found here.”
  • This week’s issue of NIH Research Matters covers the following topics — “Measuring tinnitus | Fat metabolism & pancreatic cancer | Senescent cell subtypes.”
  • The Washington Post reports,
    • “More U.S. high-schoolers used nicotine pouches — smokeless nicotine powder products — last year than the year before, according to new research published in JAMA Network Open.
    • “The researchers, who used data from a nationally representative survey of 10,146 youths in 2023 and 2024, said 5.4 percent of 10th- and 12th-graders reported having used nicotine pouches, up from 3 percent the year before. The 10th- and 12th-graders’ use of pouches in the 12 months and 30 days before the surveys also increased year to year. Males were also more likely to use pouches than females.
    • “Looking at race and ethnicity data, use was highest among White, non-Hispanic 10th- and 12th-grade teens — 9 percent had used a nicotine pouch at some point. Teens in rural areas were also more likely to use the products than urban or suburban youths: In 2024, 11.2 percent of rural youths vs. 5.9 percent of suburban and 3 percent of urban youths said they’d used a pouch.”
  • Per Healio,
    • “Social determinants of health at the community level, such as median income and walkability, have a larger influence on hip replacement outcomes than an individual patient’s race, according to data.
    • “The study was inspired by “persistent disparities observed in total hip arthroplasty outcomes, often attributed to individual factors such as race,” study author Bella Mehta, MD, MBBS, MS, a rheumatologist at Hospital for Special Surgery, told Healio.”
  • Per MedPage Today,
    • “Treating early Alzheimer’s disease patients with lecanemab (Leqembi) was feasible and most patients tolerated the drug well, a retrospective study at one specialty memory clinic showed.
    • “Infusion-related reactions occurred in 37% of 234 Alzheimer’s patients treated with lecanemab and typically were mild, according to Suzanne Schindler, MD, PhD, of Washington University School of Medicine in St. Louis, and co-authors.
    • “Amyloid-related imaging abnormalities (ARIA) emerged in 42 of 194 people (22%) who received at least four lecanemab infusions and had at least one MRI, the researchers reported in JAMA Neurology.
    • “Overall, 29 people (15%) had ARIA with brain edema or effusion (ARIA-E) — with or without ARIA with brain hemorrhage or hemosiderin deposition (ARIA-H), including microhemorrhages and superficial siderosis — and 13 people had isolated ARIA-H (6.7%).
    • “Most ARIA cases were asymptomatic (74%) and radiographically mild (62%). Eleven patients (5.7%) developed symptomatic ARIA; two (1.0%) were patients with clinically severe ARIA symptoms. No patients developed a macrohemorrhage or died.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Andrew Witty is stepping down as chief executive officer of UnitedHealth, citing personal reasons, the healthcare giant announced Tuesday.
    • “Witty, who has run UnitedHealth since 2021, is departing following a sharp downturn in the company’s financial performance from higher medical spending and unfavorable policy changes. He will be replaced effective immediately by Stephen Hemsley, the chairman of UnitedHealth’s board and its CEO from 2006 to 2017.
    • “UnitedHealth also suspended its 2025 guidance on Tuesday, pointing to the ongoing increase in medical care activity.”
  • The Wall Street Journal adds,
    • “In a call with analysts Tuesday, the company said it was seeing medical costs continue to accelerate beyond the trends it flagged last month and signs that the issue was spreading beyond enrollees in its Medicare plans. 
    • “To all stakeholders, including employees and shareholders, I’m deeply disappointed in and apologize for the performance setbacks we have encountered from both external and internal challenges,” Hemsley said. “This company has both the opportunities and capabilities to deliver exceptional services and outcomes for customers, consumers and care providers, and to continue to reliably generate the earnings growth that align with our 13% to 16% long term growth range.”
    • “The company said it expects to return to growth in 2026.”
  • Beckers Payer Issues offers us five things to know about Mr. Hemsley.
  • Beckers Payer Issues also discusses recent developments in the GLP-1 drug market.

Thursday Report

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

From Washington, DC,

  • The Senate Press Gallery indicates that the Majority Leader John Thune (R SD) plans to file cloture motions on six Presidential nominees (not including Scott Kupor) on Monday. Nevertheless, this action gives the FEHBlog hope that Scott Kupor’s nomination to be OPM Director will be brought to Senate floor this month.
  • The American Hospital Association News tells us,
    • “Reps. Jennifer McClellan, D-Va., and Don Bacon, R-Neb., and Sens. Jeff Merkley, D-Ore., and Cindy Hyde-Smith, R-Miss., today reintroduced AHA-supported legislation addressing mental health and substance use disorder facility shortages. The Mental Health Infrastructure Improvement Act (H.R. 3266) would establish a new federal loan and loan guarantee program within the Department of Health and Human Services to build or renovate mental health or substance use disorder treatment facilities. At least a quarter of the funding would be reserved for pediatric- and adolescent-serving facilities. The bill would also prioritize facilities located in high-need, underserved or rural areas, and those capable of providing integrated care for patients with complex needs.”
       
  • Federal News Network informs us,
    • “The Office of Personnel Management is hoping the sole-source, one-year contract it just awarded to Workday, a cloud-based HR services company, will help the agency manage what’s turned into a massive influx of HR work.” * * *
    • “The contract with Workday will cover services for HR and personnel processing, payroll and benefits systems, time and attendance tracking, talent acquisition and performance management, all while ensuring compliance with federal requirements, according to the contract award notice.” * * *
    • “The Workday contract, worth $342,200, will last for one year, at the end of which OPM said it plans to conduct an open competition for the next iteration of the HR IT contract.”
  • Per an FDA news release,
    • “In a historic first for the agency, FDA Commissioner Martin A. Makary, M.D., M.P.H., today announced an aggressive timeline to scale use of artificial intelligence (AI) internally across all FDA centers by June 30, 2025, following the completion of a new generative AI pilot for scientific reviewers.
    • “I was blown away by the success of our first AI-assisted scientific review pilot. We need to value our scientists’ time and reduce the amount of non-productive busywork that has historically consumed much of the review process. The agency-wide deployment of these capabilities holds tremendous promise in accelerating the review time for new therapies,” said Dr. Makary.
    • “The generative AI tools allow FDA scientists and subject-matter experts to spend less time on tedious, repetitive tasks that often slow down the review process.
    • “This is a game-changer technology that has enabled me to perform scientific review tasks in minutes that used to take three days,” said Jinzhong (Jin) Liu, Deputy Director, Office of Drug Evaluation Sciences, Office of New Drugs in FDA’s Center for Drug Evaluation and Research (CDER).”
  • Tammy Flanagan, writing in Govexec, lets us know how Social Security benefits fit into the federal retirement picture.

From the public health and medical research front,

  • Medpage Today points out,
    • “Detections of H5N1 avian influenza have slowed in both animals and humans, but continued surveillance is warranted, CDC researchers said.
    • “In dairy cattle, cases surged over the fall and early winter but eased in January, while cases in poultry flocks fell after February, and came down last month in backyard flocks, according to data on CDC’s website that was shared during a clinician outreach and communication activity (COCA) call on Tuesday.
    • “Most of our human cases are known to be associated with animal exposures, so fewer infections in the animals leads to fewer infections in people,” Alicia Budd, MPH, team lead of the national surveillance and outbreak response team at the National Center for Immunization and Respiratory Diseases (NCIRD), said during the call.
    • “It’s certainly great to see these declines in both animal and human cases, but it’s also critical that we maintain targeted monitoring and our general surveillance, so that if this situation changes, we’d be able to identify that quickly,” Budd added.”
  • and
    • “The nation’s infant mortality rate dropped last year after 2 years of hovering at a late-pandemic plateau.
    • “Some experts think one reason for the drop could be a vaccination campaign against respiratory syncytial virus (RSV)opens in a new tab or window, which is a common cause of cold-like symptoms that can be dangerous for infants.
    • “The infant mortality national rate dropped to about 5.5 infant deaths per 1,000 live births in 2024, according to provisional data from the CDC posted Thursday. That’s down from about 5.6 per 1,000 live births, where it had been the previous 2 years.
    • “CDC officials believe the findings will not change much when the final numbers come out later this year.”
  • Per Healio,
    • “Tobacco-related ischemic heart disease mortality has increased in the U.S. since 1999.
    • “The aging of the population and the introduction of novel nicotine products may be among the drivers.”
  • and
    • “A risk prediction model assesses seven variables to determine the best intervention for lowering type 2 diabetes risk.
    • “Intensive lifestyle intervention was the optimal treatment strategy for most adults.”
  • Per Cardiovascular Business,
    • “Cardiovascular risk factors such as obesity and high blood pressure are much more prevalent in some parts of the United States than others—and some of those gaps are only widening as time goes on. 
    • “That was the biggest takeaway from a new analysis published in The American Journal of Cardiology. The study’s authors reviewed answers to the Behavioral Risk Factor Surveillance System (BRFSS) survey from 2011 to 2021 to track changes in various health inequities over time.
    • “Delays in preventive care and screening as well as economic loss, disruptions in insurance coverage and worsening social determinants of health (food insecurity, housing instability) have fallen more heavily on low-income, minority and rural communities since the pandemic,” wrote first author Rachel K. Gardner, MD, a researcher with Beth Israel Deaconess Medical Center and Brigham and Women’s Hospital, and colleagues. “In addition, the spillover effects of the pandemic have disproportionately impacted some U.S. states more than others. Together, these changes could have profound implications for cardiovascular health across the country. However, little is known about how inequities in the burden of cardiometabolic and lifestyle risk factors across U.S. states have changed, especially since the pandemic. Understanding these epidemiological changes in place-based inequities is critically important and could inform targeted public health and policy interventions at the state- and national-level to advance cardiovascular health.”
    • “The BRFSS survey is the world’s largest continuous health survey of its kind, collecting data from more than 400,000 adult participants each year. Gardner et al. based their comparison on data from 506,467 adults who participated in the survey in 2011 as well as 438,693 who participated in 2021.” * * *
    • Click here for the full study.
  • Beckers Hospital Review reports,
    • “Moderna’s new combination vaccine for seasonal influenza and COVID-19 has outperformed current standard vaccines in a large phase 3 clinical trial, showing stronger immune responses to both viruses in adults 50 years or older. 
    • “The findings, published May 7 in JAMA Network, come from a randomized study of more than 8,000 participants conducted across 146 U.S. sites. Participants either received the investigational combo vaccine mRNA-1083 or the standard influenza and COVID-19 vaccines recommended for their age group. 
    • “Among adults ages 50 to 64, mRNA-1083 generated a stronger immune response against all four influenza strains. In adults 65 and older, it outperformed the high-dose flu vaccine in three of the four strains. In both age groups, the vaccine also produced higher immune responses to SARS-CoV-2 compared to standard COVID-19 vaccine.”
  • The National Institutes of Health announced,
    • “Researchers at the National Institutes of Health (NIH) have completed a comprehensive analysis of cancer statistics for different age groups in the United States and found that from 2010 through 2019, the incidence of 14 cancer types increased among people under age 50. Of these cancer types, nine—including several common cancers, such as breast cancer and colorectal cancer—also increased in some groups of people aged 50 and older. However, the incidence of 19 other cancer types—including lung cancer and prostate cancer—decreased among people under age 50, so the total rate of all cancers diagnosed in both younger and older age groups did not increase, nor did the rate of cancer death.
    • “This study provides a starting point for understanding which cancers are increasing among individuals under age 50,” said lead investigator Meredith Shiels, Ph.D., of NIH’s National Cancer Institute. “The causes of these increases are likely to be cancer specific, including cancer risk factors becoming more common at younger ages, changes in cancer screening or detection, and updates to clinical diagnosis or coding of cancers.”
    • “The study appeared May 8, 2025, in Cancer Discovery“.
  • The National Cancer Institute adds,
    • “Scientists have developed a method of rapidly measuring the levels of certain genetic mutations in brain tissue samples collected from patients during surgery. 
    • “In a new study, researchers showed that the droplet digital polymerase chain reaction (ddPCR) method they developed could produce results in 15 minutes—the first time ddPCR has generated results so quickly. 
    • “Their tool accurately measured the levels of tumor cells in dozens of brain tissue samples, they reported. And it detected minute numbers of cancer cells, as few as five cells per square millimeter, according to findings published February 25 in Med.
    • “The researchers developed the tool, which they call Ultra-Rapid ddPCR, to provide surgeons with information that could potentially help guide their decision-making during surgery.
    • “This new technology could be an additional source of information for a surgeon who is deciding whether to keep removing tissue during an operation,” said study co-leader Daniel Orringer, M.D., a neurosurgeon at NYU Grossman School of Medicine. “If the test detects tumor cells at a surgical margin, then surgeons could decide to keep cutting.”

In Food and Drug Administration News,

  • Cardiovascular Business reports,
    • “The U.S. Food and Drug Administration (FDA) has approved the balloon-expandable Sapien 3 transcatheter aortic valve replacement (TAVR) platform from Edwards Lifesciences for treating asymptomatic severe aortic stenosis (AS). 
    • “This is the first time the FDA has approved any TAVR technology in asymptomatic patients. The decision covers the Sapien 3, Sapien 3 Ultra and Sapien 3 Ultra Resilia TAVR valves.
    • “This approval is a powerful opportunity to streamline patient care and improve the efficiency of the healthcare system,” Larry Wood, Edwards’ corporate vice president and group president of TAVR and surgical technologies, said in a statement announcing the news. “We are proud to partner with leading physicians to advance our knowledge of this deadly disease with high quality science and optimize the treatment pathway for patients.”
  • Per Medical Economics,
    • “BrightHeart, a Paris-based artificial intelligence company for obstetrics and pediatric cardiology, announced it has received FDA 510(k) clearance for an updated version of its BrightHeart platform. The new approval allows clinicians to access the company’s AI-driven analysis in real time using a cart-side tablet during fetal ultrasound exams.
    • “The technology aims to address a persistent clinical challenge: detecting congenital heart defects (CHDs) in utero. CHDs are the most common type of birth defect, but up to 70% go undiagnosed during standard prenatal ultrasounds, according to the company.
    • “BrightHeart’s AI platform flags potential structural abnormalities in the fetal heart, helping to alert clinicians to possible CHDs during routine exams. The company says the real-time tablet integration streamlines workflows and improves the accuracy of screenings.
    • “Our product expansion builds upon the success of our initial pilot experience, bringing real-time feedback directly to the clinicians to streamline the workflow and enhance accuracy,” said Cécile Dupont, CEO of BrightHeart and partner at Sofinnova Partners. “We were thrilled to achieve clearance through our first Special 510(k) submission within just a few months.”

From the U.S. healthcare business front,

  • Medical Economics reports,
    • “Nonphysician providers now make up more than two out of every five health care professionals in the United States, as hospitals and medical groups increasingly rely on advanced practice providers to meet growing patient demand and improve efficiency, according to a new report from Kaufman Hall.
    • “The Physician Flash Report, released by the health care consulting firm and its parent company Vizient, found that 40.6% of the nation’s provider workforce is composed of APPs such as nurse practitioners and physician assistants. The report points to continued growth in this segment and predicts that APPs and physicians may soon comprise equal halves of the clinician workforce.
    • “Advanced practice providers like physician assistants and nurse practitioners play a vital and increasingly visible role in health care,” said Matthew Bates, managing director and Physician Enterprise Service Line leader with Kaufman Hall. “When deployed correctly, advanced practice providers let physicians practice at the top of their license. They give doctors more time to focus on diagnosis and treatment, which can make physician practices more efficient and address other challenges, including physician burnout.”
  • Reuters tells us,
    • “Another Big Pharma is opening up its wallet to pour billions into its U.S. operations amid political pressure from the Trump administration.
    • “This time it’s Gilead coming to the table with a fresh $11 billion in hand to spend across its manufacturing and research centers in the U.S.
    • “Gilead broke down the new spending routes in a Wednesday release. The majority, $5 billion, will be funneled into technology, operations, and R&D site activities, while $4 billion will go into capital projects, including labs and equipment. The final $2 billion will be “invested in digital and advanced engineering initiatives,” the pharma said.”
  • The White House summarized all of these drug manufacturing investments here.
  • Fierce Healthcare relates,
    • “Ayble Health, a virtual GI clinic, has teamed up with Priority Health, a nonprofit health plan in Michigan, to offer commercial members access to the digestive health solution. 
    • “Ayble relies on a multidisciplinary care team, AI-powered nutrition and psychology programs and wellness tools to manage symptoms. Starting June 1, Ayble will be available as a standard benefit for Priority members who have a MyPriority HMO or employer health plan. More than 500,000 adult members will have access. 
    • “When it comes to sourcing solutions like Ayble Health, Priority Health looks for approaches that can improve care quality, engage patients effectively and provide cost-efficient services,” Alicia Coronas, vice president of employer solutions product and marketing at Priority, told Fierce Healthcare. “We evaluate solutions to find the best-in-class partner that is aligned to our vision and mission.”

Wednesday Report

David Ermer–COVID-19 vaccine, FDA, Federal employment benefits, Medical / Rx research, Mental health care, U.S. Healthcare, Uncategorized–

From Washington, DC,

  • Federal News Network helpfully answers “common questions: about House Oversight Committee’s budget reconciliation cuts to federal and postal employee retirement benefits.
  • The Wall Street Journal reports,
    • “President Trump said he would nominate Casey Means, a California doctor and wellness influencer, to be the next surgeon general.
    • “Means has become more prominent with the rise of Health Secretary Robert F. Kennedy Jr.’s “Make America Healthy Again” movement. She and her brother, Kennedy adviser Calley Means, wrote a book, “Good Energy,” that became popular with Trump campaign staffers and later with Kennedy.
    • “Trump’s previous pick for the role, Dr. Janette Nesheiwat, was scheduled to face a Senate confirmation hearing later this week. Trump said she would work with Kennedy at HHS in a different role.”
  • Beckers Health IT adds,
    • “The FDA has appointed Jeremy Walsh as its first chief artificial intelligence officer, marking a step in tech modernization at the agency. 
    • “Mr. Walsh, who announced the career move in a May 2 LinkedIn post, will also oversee information technology in the role. 
    • “He joins the FDA after 14 years at government contractor Booz Allen Hamilton as a chief technologist, according to a May 6 report from Politico. In that role, Mr. Walsh developed cloud infrastructure and data analytics systems for agencies like the FDA, CDC, NIH, the Department of Veterans Affairs and military health services. 
    • “The appointment follows an April 3 directive from the Office of Management and Budget that stated each federal agency must appoint a chief AI officer within 60 days.”
  • Per BioPharma Dive,
    • “A panel of Food and Drug Administration advisers will meet May 22 to discuss updating the formula of COVID-19 vaccines ahead of the fall and winter season, according to a draft notice posted Wednesday.
    • “The Vaccines and Related Biological Products Advisory Committee will provide recommendations on selecting the specific coronavirus variant COVID vaccine manufacturers should target with booster shots. Their advice isn’t binding, but the FDA tends to follow it.”

From the public health and medical research front,

  • Beckers Hospital Review tells us that “U.S. News & World Report released its annual Best States rankings May 6, and Hawaii took the top spot for healthcare.”
  • The Los Angeles County, California, Department of Public Health “has declared a community-wide outbreak of hepatitis A following a sustained increase in clinical cases and elevated virus levels detected in local wastewater. Public Health confirmed 165 hepatitis A cases in LA County since 2024, which is three times the number of cases reported in 2023. Although unhoused individuals are at higher risk for contracting hepatitis A infection because they often have limited access to handwashing and toileting facilities, of the 29 hepatitis A cases confirmed to date in 2025, most have been among people without travel or housing risk factors. This increase in hepatitis A infections among people without risk factors has corresponded with recent increases in hepatitis A wastewater concentrations. While the risk to the general public remains low, community-wide protection actions are needed to ensure that transmission of hepatitis A is reduced.”
    • The County recommended vaccination against the disease for
      • “Any LA County resident who did not previously receive a hepatitis A vaccination and is seeking protection
      • “People experiencing homelessness
      • “People who use drugs (including non-injection).”
  • The National Cancer Institute lets us know that “A device that measures the “stickiness” of cancer cells in tumor samples may help predict the likelihood of a patient’s cancer metastasizing. Researchers believe the device could eventually help doctors make more informed treatment choices.”
  • Per Fierce Pharma,
    • Johnson & Johnson has generated evidence that the pace of oncology innovation is overwhelming physicians. A recent survey commissioned by the company found oncologists are struggling to keep up with new treatments and guidelines, pointing to a need for additional support to ensure patients get the most appropriate therapy.
    • Working with the Harris Poll, J&J surveyed 500 oncologists, urologists and advanced practice providers (APPs) across academic and community settings in the U.S. Three out of four oncologists said they find the pace of new drug development overwhelming. Around 70% of oncologists admitted they struggle to navigate the complexities of cancer treatment guidelines.
    • The survey suggests that continuing medical education helps, with 92% of oncologists agreeing it is crucial for providing cutting-edge treatments, but that more support is often needed. Extra support could help close the gap between the availability of new drugs and their successful implementation in clinical practice.
  • MedPage Today informs us,
    • “Fremanezumab (Ajovy) reduced depression symptoms and monthly migraine attacks in people with episodic or chronic migraine and major depressive disorder, the phase IV UNITE trial showed.
    • “The mean change from baseline in monthly migraine days during a 12-week double-blind period was -5.1 days (95% CI -6.09 to -4.13) with fremanezumab and -2.9 days (95% CI -3.89 to -1.96) with placebo (P<0.001), reported Richard Lipton, MD, of the Albert Einstein College of Medicine in New York City, and co-authors.”
  • Per Health Day,
    • “Patients with diverticulitis often try to control the digestive condition by cutting nuts, seeds and popcorn out of their daily diet.
    • “But that’s not necessary, a new study has found.
    • “Nuts and seeds do not increase the risk of diverticulitis, according to findings published May 5 in the Annals of Internal Medicine.
    • “Our findings refute the widely held belief that dietary intake of particulate matter [like nuts or seeds] should be avoided to prevent diverticulitis,” wrote the team led by senior researcher Dr. Anne Peery, a gastroenterologist with the University of North Carolina at Chapel Hill.
    • “However, people can lower their risk of diverticulitis by adopting one of four common health-focused diets, researchers found.
    • “We assessed diet quality and found that multiple healthy diet patterns were associated with a reduced risk for incident diverticulitis in women,” researchers wrote.”
  • Per Medscape,
    • “Lingering fatigue and depression are more common among women than men cancer survivors and often lead to a decrease in recreational physical activities in all patients, new data showed.
    • “However, moderate physical activity was linked to an almost 50% lower risk for cancer-related fatigue, and both moderate and vigorous physical activity were associated with a two- to fivefold reduced risk for depression among cancer survivors, according to the analysis presented at the American Association for Cancer Research (AACR) Annual Meeting 2025.
    • “The findings “highlight the importance of providing special attention and tailored interventions such as exercise programs, support groups, and mind-body behavioral techniques for vulnerable groups to help effectively manage fatigue and improve participation in recreational activities as they are an essential aspect of quality of life,” Simo Du, MD, a resident at NYC Health + Hospitals and Jacobi Medical Center/Albert Einstein College of Medicine, New York City, said in a news release.”

From the U.S. healthcare business front,

  • Healthcare Finance reports,
    • “Hospitals across the U.S. are seeing both higher revenues and higher expenses, and operating margins have begun to contract slightly, according to March data published by Strata. 
    • “After holding steady at 1% in both January and February, operating margins for U.S. health systems narrowed slightly to 0.9% in March. Non-labor expenses rose faster than other expenses, due in part to double-digit increases in both drug and supply expenses versus the same month last year.
    • “Nationally, patient demand was up, with outpatient visits outpacing inpatient admissions. This compares with decreases in patient demand in February.
    • “Gross outpatient revenues led overall hospital revenue increases, jumping 10% year-over-year as hospitals and health systems continued to see care shift from inpatient to outpatient settings. 
    • “Per-physician expenses rose to $1.2 million in the first quarter, representing an increase of 3% from Q4 2024 and 10.3% from Q1 2024, data showed.”
  • Beckers Hospital Review adds, “Hospital margins had a slight increase in March despite significant patient volume declines, according to Kaufman Hall’s “National Hospital Flash Report” released May 7.”
  • Modern Healthcare relates,
    • “Cleveland Clinic and Regent Surgical are working together to build ambulatory surgery centers.
    • “The nonprofit health system and the ASC developer announced a joint venture Wednesday. Cleveland Clinic is the majority owner of the venture, which will feature the Cleveland, Ohio-based system’s brand, according to a news release. The system did not say how many facilities will be built or when they will open.”
  • Healthcare Dive points out,
    • “Northwell Health has completed its merger with Danbury, Connecticut-based Nuvance Health, the system said in a Wednesday press release.
    • “The deal officially closed May 1, after the systems received the final greenlight from Connecticut regulators last month.
    • “The merger creates a nearly $23 billion system, with 28 hospitals, 1,050 ambulatory care sites, 73 urgent care centers and more than 104,000 employees, according to the news release.
    • “Northwell President and CEO Michael Dowling will remain at the helm of Northwell and lead the combined system, according to a company spokesperson. Meanwhile, Nuvance President and CEO John Murphy will oversee Nuvance operations, reporting to Dowling.”
  • and
    • “One year has passed since Steward Health Care filed for bankruptcy, launching the largest healthcare provider restructuring in decades, including a monthslong effort to sell its 31 hospitals.
    • “Five Steward hospitals have permanently closed since its bankruptcy, while two more temporarily paused services. Many of the remaining facilities have landed back in the hands of private equity and investor owners, according to a new report from the Private Equity Stakeholder Project.
    • “The outlook for the hospitals is grim, after those that were “lucky enough not to close” were “simply punted from one investor-owned company to another, with little oversight or conditions from regulators to protect patients and community access to critical healthcare services,” the report says.”
  • Per MedCity News,
    • “Amyotrophic lateral sclerosis has been a tough area for drug research, but Eli Lilly has been spreading its bets in this neurodegenerative disease by striking deals with other companies. The pharmaceutical giant is adding to its stable of ALS drug candidates with a licensing agreement that brings a novel antibody on track to begin testing in humans.
    • “According to deal terms announced Tuesday, Lilly is licensing Alchemab’s ATLX-1282, an antibody that the companies say brings a first-in-class approach to ALS and other neurodegenerative diseases. Specific financial details were not disclosed, but Lilly is committing up to $415 million to its partner, which includes an upfront payment and milestone payments.”

Weekend update

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

From Washington, DC

  • Congress returns to Capitol Hill tomorrow following a two week long District / State work break.
  • Here is a link to this week’s calendar of Senate and House of Representatives committee business.
  • Roll Call offers an overview of this week’s activities.
    • “President Donald Trump is scheduled to meet at the White House Monday afternoon with Speaker Mike Johnson, beginning the first of several key legislative weeks for the president’s immigration, economic and tax policy agenda.”
  • Per a House Oversight Committee press release issued last Friday,
    • “House Committee on Oversight and Government Reform Chairman James Comer (R-Ky.) announced a markup will take place on Wednesday, April 30th at 10:00 a.m. ET to consider budget legislation to advance President Trump’s agenda to provide tax relief for American families and small businesses, rein in wasteful spending, and reduce the federal budget deficit for the American taxpayers. The House Oversight Committee’s budget reconciliation instructions require a net reduction in the federal deficit of no less than $50 billion and reforms to help balance the federal budget. Following the markup, the Committee will finalize its section of the budget legislation and transmit it directly to the House Committee on the Budget, which will compile and present the final package for consideration by the U.S. House of Representatives.”
  • The list of measures to be included in the markup includes
    • “SEC. 90006. FEHB PROTECTION –– Requires a comprehensive audit of employee dependents currently enrolled in FEHB plans—such as verifying marriage certificates and birth certificates—and requires any ineligible individual found to be receiving FEHB coverage be disenrolled. ($1.5 billion in net savings).”
  • This measure unfortunately overlooks the fact that OPM can but chooses not to use the HIPAA 820 electronic enrollment roster which would allow carriers to reconcile each enrollee with his / her premium payments. What is the sense of confirming family member eligibility if you don’t know whether the enrollee is paying the correct premium?
  • Federal News Network interviews Kevin Moss about what to expect from the FEHB / PSHB in 2026. What’s missing from OPM’s call letter and technical guidance? New cost containment measures.

From the public health and medical research front,

  • The New York Times reports,
    • “When a person develops solid tumors in the stomach or esophagus or rectum, oncologists know how to treat them. But the cures often come with severe effects on quality of life. That can include removal of the stomach or bladder, a permanent colostomy bag, radiation that makes patients infertile and lasting damage from chemotherapy.
    • “So a research group at Memorial Sloan Kettering Cancer Center, using a drug from the pharmaceutical company GSK, tried something different.
    • “The researchers started with a group of 103 people. The trial participants were among the 2 to 3 percent of cancer patients with tumors that should respond to immunotherapy, a drug that overcomes barriers that prevent the immune system from attacking cancers.
    • “But in clinical trials, immunotherapy is not supposed to replace the standard treatments. The researchers, led by Dr. Luis A. Diaz Jr. and Dr. Andrea Cercek, decided to give dostarlimab, an immunotherapy drug, on its own.” * * *
    • “In 49 of the patients, who had rectal cancer, the tumors disappeared and, after five years, have not recurred. Cancers also vanished for 35 of 54 patients who had other cancers, including in the stomach, esophagus, liver, endometrium, urinary tract and prostate.
    • “Out of all 103 patients, cancers recurred in only five. Three got additional doses of immunotherapy and one, whose tumor recurred in a lymph node, had the lymph node removed. Those four patients so far have no evidence of disease. The fifth patient had additional immunotherapy that made the tumor shrink.
    • “The investigators reported their results Sunday at the annual meeting of the American Association for Cancer Research and in a paper published in The New England Journal of Medicine.
    • “The results, said Dr. Bert Vogelstein, an oncologist at Johns Hopkins in Baltimore, are “groundbreaking.”
  • Medscape tells us,
    • “Malnutrition-related diabetes, distinct from both type 1 and type 2, has now been officially recognized and named “type 5 diabetes.”
    • “The vote to endorse the category took place on April 8, during the International Diabetes Federation’s (IDF’s) World Diabetes Congress, held in Bangkok, Thailand. In January 2025, a panel met in India to draft a consensus statement about the condition, due to be published soon, Meredith Hawkins, MD, professor of medicine at Albert Einstein College of Medicine, Bronx, New York, told Medscape Medical News.
    • “Malnutrition-related diabetes has historically been vastly underdiagnosed and poorly understood…The IDF’s recognition of it as ‘type 5 diabetes’ is an important step toward raising awareness of a health problem that is so devastating to so many people,” Hawkins said.”
  • The New York Times Well site provides a personalized protein target and protein counter. Check it out.

Monday Report

David Ermer–CMS, Congress, COVID-19, FDA, Federal employment benefits, Medical / Rx research, Medicare, Obesity, U.S. Healthcare–
Photo by Sven Read on Unsplash
  • Paul Wolfowitz, writing in the Wall Street Journal, shares “Reflections on Lincoln 160 Years After His Murder. America’s greatest president had moral vision, strategic genius, and astounding eloquence.” RIP.
    • “Tuesday is the 160th anniversary of Abraham Lincoln’s assassination. That grim milestone invites speculation about what might have been had he lived to serve out his second term. It is also an occasion to reflect on what made Lincoln great—why his example still matters.
    • “Lincoln is the greatest American president not because he was perfect, but because he had so many leadership qualities crucial for confronting the challenges facing him. He combined moral vision with strategic genius, a rare mix for any political leader.” * * *
    • “So, I am grateful to Providence that we had a leader of Lincoln’s stature at a time of our greatest need. And so should we all be.”

From Washington, DC,

  • From an FTC news release,
    • “Today, the Federal Trade Commission launched a public inquiry into the impact of federal regulations on competition, with the goal of identifying and reducing anticompetitive regulatory barriers. The FTC launched this inquiry in response to President Trump’s Executive Order on Reducing Anticompetitive Regulatory Barriers. * * *
    • “In a Request for Information, the FTC invites members of the public to comment on how federal regulations can harm competition in the American economy. The RFI seeks to understand what federal regulations have an anticompetitive effect. Members of the public—including consumers, workers, businesses, start-ups, potential market entrants, investors, and academics—are encouraged to comment.
    • “The public will have 40 days to submit comments at Regulations.gov, no later than May 27, 2025. Once submitted, comments will be posted to Regulations.gov.
    • “Comments submitted to the U.S. Department of Justice Anticompetitive Regulations Task Force at Regulations.gov that contain information falling within the scope of the FTC’s RFI do not need to be resubmitted in response to the FTC’s RFI.” 
  • When will OPM invite deregulatory ideas from the public? Speaking of OPM,
  • Federal News Network tells us,
    • “The Office of Personnel Management faces a steep bill for employee relocation expenses, as it plans to bring staff working remotely back to the office.
    • “As part of its return-to-office plans, OPM is planning to spend nearly $42 million to relocate approximately 250 employees — spending about $166,000 per employee.
    • “The relocation cost per employee is higher than the annual salary of most federal employees, according to recent data analysis from the Pew Research Center. It also exceeds the maximum salary a career federal employee can receive under the General Schedule pay scale (not including locality pay). An OPM spokesperson declined a request for comment.
    • “OPM will pay certain mandatory relocation expenses. But the agency told employees in an April 4 email, first reported by Federal News Network, that “it is unlikely we will have the financial resources to relocate a significant number of employees who are greater than 50 miles from an OPM site.”
  • Govexec informs us,
    • “The Office of Personnel Management last week issued new guidance encouraging agencies to pay political appointees the maximum federal salary and removing career HR workers from the appointment process.
    • “The April 10 memo from acting OPM Director Charles Ezell to agency heads reminds them of the “great flexibility” they have when setting the pay of employees hired under Schedule C of the federal government’s excepted service, the portion of the federal workforce made up of low-level political appointees.
    • “Such flexibility is important to attract highly-qualified Schedule C employees to serve in important confidential, policy-determining, policy-making and policy-advocating roles,” Ezell wrote. “Well-qualified Schedule C employees are needed ‘to drive the unusually expansive and transformative agenda the American people elected President Trump to accomplish.’”
    • “The memo notes that Schedule C salaries cap out at $195,200. And it instructs agencies to “revoke delegations and sub-delegations” provided to agency HR employees as part of their work onboarding and vetting political appointees on behalf of the White House.”
  • Per an OPM news release,
    • “For the first time, U.S. Office of Personnel Management (OPM) personalized Retirement Booklets are now accessible online as digital downloads [at] servicesonline.opm.gov.”
  • MedTech Dive also points out,
    • “The Trump administration is investigating the effects of pharmaceutical imports on national security, disclosing Monday a probe that is likely to lay the foundation for sector-wide tariffs in the near future.
    • “The investigation, which was announced in a federal notice posted online, appears to be wide-ranging, covering branded and generic medicines, as well the active drug ingredients they contain. It will be conducted by the Department of Commerce under a legal authority known as Section 232, which President Donald Trump used earlier this year to expand duties on steel and aluminum.”
  • Per Beckers Clinical Leadership,
    • “CMS is proposing to modify several hospital quality measures and remove four others, including those focused on health equity and social drivers of health.
    • “The agency outlined the changes April 11 as part of its 2026 proposed rule for the Medicare payment systems that cover inpatient and long-term care hospitals.” 

From the judicial front,

  • Fierce Healthcare notes,
    • “Originally approved by the FDA in 1998, Amgen’s Enbrel is still sailing along without facing biosimilar competition in the United States. And unless a court rules otherwise, the Southern California company will retain its patent protection on the inflammatory disease medicine until 2029.
    • “Hoping to alter the timetable is Swiss generics and biosimilars specialist Sandoz, which has filed an antitrust lawsuit in federal court in Virginia claiming that Amgen has blocked competition to “unlawfully extend its monopoly,” according to the complaint.
    • “Amgen, according to the lawsuit, allegedly did this by purchasing patent rights from one of its competitors, Swiss pharma giant Roche, which was developing a product from the same drug class to compete with Enbrel. Without these patents, Enbrel would have been subject to competition from biosimilars—as was the case in Europe—by as early as 2016.
    • “Sandoz is seeking an injunction preventing Amgen from using the patent rights to block biosimilar competition. Sandoz wants to launch its Enbrel biosimilar Erelzi as soon as possible. The company also is pursuing treble damages, which could be tripled, according to antitrust law.”
  • and
    • “The Department of Justice will head to mediation with UnitedHealth Group and Amedisys April 18 as part of an ongoing antitrust lawsuit.
    • “Both companies are attempting to finalize a $3.3 billion merger, which was challenged under the Biden administration Nov. 12 for allegedly threatening competition in the home health and hospice industry. Now, mediation will occur Aug. 18, as signed by Magistrate Judge Susan Gauvey on April 10.” 

From the public health and medical research front,

  • The American Medical Association lets us know what doctors wish their patients knew about asthma. “Asthma can be life-threatening if you don’t get treatment. Two physicians, from Bayhealth and Rush University System for Health, share more.”
  • Cardiovascular Business relates,
    • “Following a Mediterranean-style diet that still leaves room for lean beef is associated with significant improvements in blood pressure (BP) and vascular health, according to new data published in Current Developments in Nutrition.
    • “The Mediterranean diet, named after the traditional eating habits of Greece and Italy, is based on whole grains, fruits, vegetables, legumes, nuts, seeds and olive oil. It primarily focuses on plant-based options, but does permits fish, seafood, poultry and dairy products to be eaten occasionally. 
    • “The Mediterranean diet is often viewed as one of the healthiest ways a person can eat. The team behind this latest analysis aimed to learn just how flexible these diets can be. If someone follows a Mediterranean-style diet, but wants to enjoy a little more meat, what does that mean for their cardiovascular health?
    • “Increasingly, the importance of customizing dietary choices to reflect personal preferences is recognized to promote sustained adherence to a healthy dietary pattern,” wrote first author Jennifer Fleming, PhD, an assistant teaching professor in the department of nutritional sciences at Penn State, and colleagues. “Therefore, although current dietary guidance consistently recommends limiting red meat, more clarity is needed about the amount of lean unprocessed red meat that can be incorporated into healthy dietary patterns that promote cardiovascular health.”
  • STAT News reports,
    • “Verve Therapeutics said initial data show that its investigational gene-editing therapy lowered cholesterol without inducing serious side effects, a positive step for the company after it paused development of an earlier treatment due to safety concerns.
    • “The early data from an ongoing Phase 1 study show that a single infusion of the therapy, called Verve-102, led to greater decreases in “bad” LDL cholesterol with higher doses, according to an announcement Monday. Among the four participants who received the highest dose of 0.6 mg/kg, they experienced an average 53% reduction in cholesterol.” * * *
    • “While the Verve-102 data are early, they move the company closer to its goal of using a one-time therapy to target a common condition that continues to be one of the leading killers in the developed world. The current chronic drugs that inhibit PCSK9 are not enough for patients with higher cholesterol, Verve argues, since patients often don’t take them consistently.”
  • The New York Times calls attention to a new study.
    • Middle-aged and older adults who sought hospital or emergency room care because of cannabis use were almost twice as likely to develop dementia over the next five years, compared with similar people in the general population, a large Canadian study reported on Monday.
    • When compared with adults who sought care for other reasons, the risk of developing dementia was still 23 percent higher among users of cannabis, the study also found.
    • The study included the medical records of six million people in Ontario from 2008 to 2021. The authors accounted for health and sociodemographic differences between comparison groups, some of which play a role in cognitive decline.
    • The data do not reveal how much cannabis the subjects had been using, and the study does not prove that regular or heavy cannabis use plays a causal role in dementia.
  • The Wall Street Journal considers whether long-Covid is rewriting the rules of aging. Brain decline alarms doctors. Millions of long-Covid patients continue to struggle with cognitive difficulties.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Pfizer is halting development of its experimental weight-loss pill, as the booming obesity drug market remains out of reach for the drug giant.
    • “The company said Monday the stoppage comes after it reviewed clinical data and a study subject developed a liver injury that might have been caused by the drug, called danuglipron.” 
  • The benefits consulting firm WTW offers a report titled “GLP-1 Drugs in 2025: Cost, access and the future of obesity treatment. “Employer health plans brace for another year of soaring costs as GLP-1 utilization continues to rise — per member per month spending on these medications nearly doubled each year since 2021.”
  • Per Beckers Payer Issues,
    • “Medicare Advantage plans spent $38 billion on non-Medicare benefits in 2024, according to a Medicare Payment Advisory Commission report. 
    • “The group, which advises Congress on Medicare issues, held a meeting April 10. According to a presentation, MA plans received $83 billion in rebates from the federal government. Plans used these rebates to cover non-Medicare, or supplemental, benefits. These benefits include hearing, vision and dental care alongside fitness reimbursements, over-the-counter allowances and other benefits. These rebates are also used to reduce cost sharing and provide prescription drug benefits. 
    • “According to MedPAC, current data on supplemental benefit use in MA is inadequate to determine the value the funding is providing.” 
  • Per Fierce Healthcare,
    • “Average physician pay rose 3.6% between 2023 and 2024, from $363,000 to $376,000—about in line with recent years but well behind increases from before the pandemic.
    • “That’s according to Medscape’s latest physician compensation report, which also highlighted particularly narrow increases in year-over-year compensation for primary care docs (1.4%, from $277,000 to $281,000) and specialists (1%, from $394,000 to $398,000).
    • “The annual survey also counted more specialties reporting pay drops than pay increases, as well as a shrinking percentage of doctors who feel fairly compensated and a widening of pay gaps across gender and racial and ethnic lines.”
  • Beckers Hospital Review adds,
    • “Annual average compensation for U.S. physicians in four medical specialties surpassed $500,000 in 2024, according to Medscape’s “Comparing Your Pay Against Your Peers’: Medscape Physician Compensation Report 2025.“
    • “Orthopedic specialists topped the list as the highest-paid physicians last year, while those practicing public health and preventive medicine reported the lowest earnings.
    • “With the exception of anesthesiology, all seven of the top-earning specialties in 2024 have consistently ranked among the 10 highest-paid specialties in each of the last five editions of the annual report.”

Friday Report

David Ermer–AHRQ, CDC, CMS, COVID-19, FDA, Federal employment benefits, Medical / Rx research, Medicare, NIH, Obesity, Rx coverage, SCOTUS, U.S. Healthcare–

From Washington, DC.

  • Medical Economics reports,
    • Health care is in crisis, but tying physician reimbursement to inflation is one way to stabilize the American health care system, according to the American Medical Association (AMA).
    • On April 10, the Medicare Payment Advisory Commission voted unanimously to recommend Congress replace current law updates to the physician fee schedule with an annual change based on the Medicare Economic Index, such as MEI minus 1%.
    • That is “a timely recommendation as lawmakers wrestle with how to handle yet another cut in physician pay,” according to AMA. Association President Bruce A. Scott, MD, issued a statement of support similar to previous ones because the issue has been under discussion for months. In fact, Scott noted MedPAC has suggested the same to Congress at least three consecutive years.
      The current baseline increase to physician reimbursement is 0.25%, or 0.75% for doctors participating in an alternative payment model. MedPAC said Congress should consider setting reimbursement at the rate of the Medicare Economic Index minus 1%, every year for the foreseeable future.
  • Fierce Healthcare lets us know,
    • “A new assessment of 18 Center for Medicare and Medicaid Innovation models reaffirms recent criticism of the agency’s aggregate cost savings—or more accurately, losses—while highlighting several individual payment models that appear effective in cutting down federal spending and improving care quality.
    • “The white paper published Wednesday by healthcare consulting and advisory firm Avalere Health looked at newer quality metrics for outcomes than prior CMMI model analyses and also dug into whether the agency had been transparent and provided opportunities for feedback when designing the models.
    • “The findings come in the wake of a damning late 2023 Congressional Budget Office assessment of the agency’s work, which found CMMI increased indirect spending by $5.4 billion between 2011 and 2020 (0.1% of net Medicare spending during that time) and spurred sharp scrutiny from cost-conscious lawmakers.”
  • and
    • “Disability protections against gender dysphoria implemented via rulemaking during the Biden administration will not be supported going forward, the Department of Health and Human Services (HHS) announced April 10.
    • “In a two-page clarification, HHS Secretary Robert F. Kennedy Jr. signed off on a rule update that declares language characterizing gender dysphoria as a disability to not be enforceable because its inclusion was in the preamble—not the regulatory text—to a final rule from May 2024.
    • “The Department is nonetheless concerned there has been significant confusion about the preamble language referencing gender dysphoria in the [final rule],” the update (PDF) in the Federal Register reads. “It is well-established that where, as here, the language included in the regulatory text itself is clear, statements made in the preamble to a final rule published in the Federal Register, lack the force and effect of law and are not enforceable.”
  • Federal News Network tells us, “OPM lacks funds to relocate ‘significant’ number of remote employees in return-to-office plans. OPM is joining many agencies in giving employees another chance to take a “deferred resignation” offer before it proceeds with nonvoluntary layoffs.”
  • Tammy Flanagan, writing in Govexec, informs us about “What to know about early retirement offers to federal employees.

From the Food and Drug Administration front,

  • Fierce Pharma relates
    • “Bristol Myers Squibb has received the FDA’s green light to introduce another immunotherapy-based treatment in first-line liver cancer.
    • “The company’s combination of Opdivo and Yervoy is now approved for patients with newly diagnosed unresectable or metastatic hepatocellular carcinoma, the FDA said Friday.
    • “The immunotherapy regimen combines two well-established agents and may offer the potential for a longer life compared with traditional targeted therapy, Wendy Short Bartie, Bristol Myers’ senior VP of U.S. oncology commercialization, said in an interview with Fierce Pharma.
    • “The first-line approval also converted a previous accelerated approval for Opdivo-Yervoy as a second-line liver cancer treatment. Further, it puts BMS toe to toe with two other immuno-oncology regimens—Roche’s Tecentriq and Avastin, and AstraZeneca’s Imfinzi and Imjudo.”
  • Per MedTech Dive,
    • “Intuitive said Thursday the Food and Drug Administration has cleared a stapler for use with its single-port robotic surgery system.
    • “The device, which Intuitive said is the first stapler designed for single-port robotic surgery, shares features found in the company’s multi-port products to reduce the risk of tissue damage.
    • “CFO Jamie Samath said in January that the stapler nod would trigger the start of “broad commercial efforts” for the single-port system in two indications recently authorized by the FDA.”
  • and
    • “Dexcom received Food and Drug Administration clearance for a 15-day version of its G7 glucose sensor, the company announced Thursday.
    • “Dexcom claims its continuous glucose monitor is the most accurate and has the longest wear time. The company also expects the shift from a 10-day to a 15-day sensor to improve its margins, executives said in a February earnings call.
    • “The announcement alleviated investor concerns that a recent FDA warning letter might delay the decision. Dexcom expects a full launch in the second half of 2025, giving the company time to integrate the updated device with insulin pumps.”

From the judicial front,

  • The Congressional Research Service offers a legal sidebar about the impending April 21 oral argument in the Kennedy v Braidwood Management case which concerns the Affordable Care Act’s preventive care services coverage mandate.
  • Bloomberg Law reports,
    • “A Maine woman can’t proceed with a suit claiming that her health insurance plan’s coverage exclusion for weight loss drugs unlawfully discriminates against obese people, a federal court said.
    • “Rebecca Holland didn’t allege any facts showing that Elevance Health Inc. ever regarded her or other obese plan members as disabled, the US District Court for the District of Maine said Wednesday. Her “bare conclusory allegations to the contrary” didn’t support a ruling that the exclusion was discriminatory, Chief Judge Lance E. Walker said.
    • “Medicare and private insurers generally cover the cost of drugs like Ozempic when used to treat Type 2 diabetes but have been reluctant to pay for it when used for weight loss purposes. Several state and federal plaintiffs are trying to change that by claiming that obesity qualifies as a disability, and the exclusions violate discrimination laws.”

From the public health and medical research front,

  • The Center for Disease Control and Prevention announced today,
    • “Seasonal influenza activity continues to decline. COVID-19 and RSV activity are declining nationally to low levels.
    • “COVID-19
      • “COVID-19 activity is declining nationally. Wastewater levels are at low levels, emergency department visits are at very low levels, and laboratory percent positivity is stable. Emergency department visits and hospitalizations are highest in older adults and emergency department visits are also elevated in young children.
      • “There is still time to benefit from getting your recommended immunizations to reduce your risk of illness this season, especially severe illness and hospitalization.
      • “CDC expects the 2024-2025 COVID-19 vaccine to work well for currently circulating variants. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.
    • “Influenza
    • “RSV
      • “RSV activity is declining in most areas of the country. Emergency department visits and hospitalizations are highest in children and hospitalizations are elevated among older adults in some areas.
    • “Vaccination
      • “Vaccination coverage with influenza and COVID-19 vaccines is low among U.S. adults and children. Vaccination coverage with RSV vaccines remains low among U.S. adults. Many children and adults lack protection from respiratory virus infections provided by vaccines.”
  • The American Hospital News points out,
    • “There have been 712 confirmed cases of measles reported by 25 states so far this year, according to the latest figures released April 11 by the Centers for Disease Control and Prevention. The agency said 93% of those cases (660 of 712) are outbreak-associated and 11% of cases have been hospitalized. The vaccination status of 97% of cases is classified as “unvaccinated or unknown.”
  • ProPublic adds,
    • “In the past six months, two babies in Louisiana have died of pertussis, the disease commonly known as whooping cough.
    • “Washington state recently announced its first confirmed death from pertussis in more than a decade.
    • “Idaho and South Dakota each reported a death this year, and Oregon last year reported two as well as its highest number of cases since 1950.
    • “While much of the country is focused on the spiraling measles outbreak concentrated in the small, dusty towns of West Texas, cases of pertussis have skyrocketed by more than 1,500% nationwide since hitting a recent low in 2021 amid the COVID-19 pandemic. Deaths tied to the disease are also up, hitting 10 last year, compared with about two to four in previous years. Cases are on track to exceed that total this year.”
  • The New York Times reports,
    • “Surgeons removed a genetically engineered pig’s kidney from an Alabama woman after she experienced acute organ rejection, NYU Langone Health officials said on Friday.
    • “Towana Looney, 53, lived with the kidney for 130 days, which is longer than anyone else has tolerated an organ from a genetically modified animal. She has resumed dialysis, hospital officials said.
    • “Dr. Robert Montgomery, Ms. Looney’s surgeon and the director of the NYU Langone Transplant Institute, said that the so-called explant was not a setback for the field of xenotransplantation — the effort to use organs from animals to replace those that have failed in humans.
    • “This is the longest one of these organs has lasted,” he said in an interview, adding that Ms. Looney had other medical conditions that might have complicated her prognosis.
    • “All this takes time,” he said. “This game is going to be won by incremental improvements, singles and doubles, not trying to swing for the fences and get a home run.”
  • Health Day notes,
    • “About one in 10 U.S. adults with substance use disorder (SUD) report past-year hospitalizations, according to a research letter published online April 1 in the Annals of Internal Medicine.
    • “Eden Y. Bernstein, M.D., M.P.H., from the University of Colorado School of Medicine in Aurora, and colleagues described the prevalence of hospitalizations among U.S. adults with SUD. Adults were classified into non-mutually exclusive groups by presence of any SUD, individual SUD, and two or more SUDs. The proportion and number of U.S. adults who reported hospitalizations was estimated for each group.
    • “The researchers identified 60 million U.S. adults with SUD, of whom 5.8 million (9.7 percent) reported past-year hospitalizations. The proportion of hospitalized adults ranged from 7.3 to 23.6 percent among those with alcohol use disorder (AUD) and opioid use disorder (OUD), respectively. Among adults with SUD, those with versus without past-year hospitalizations were more likely to be older and more likely to have two or more medical comorbid conditions. Hospitalized adults with AUD, cannabis use disorder, and tobacco use disorder were also more likely to have serious mental illness. Across all groups apart from AUD, hospitalized adults were less likely to be uninsured. Hospitalized adults with OUD were less likely to be non-Hispanic Black.”
  • Per a National Cancer Institute news release,
    • “Why do some cancers come back many years after treatments had eliminated all signs of the disease? The answer may involve rogue cancer cells that spread to other parts of the body early in the disease and then enter a sleeping, or dormant, state, according to a growing body of research. 
    • “These dormant cancer cells can survive in the body undetected for months, years, or even decades, the research suggests. At some point, however, the cells may awaken and begin the process of forming metastatic tumors.  
    • “What causes disseminated cancer cells to enter, and then to leave, a dormant state is not known. 
    • “But recent studies of tumor dormancy have yielded clues that scientists believe could one day help them find ways to prevent metastases, which account for most cancer deaths.”
  • Genetic Engineering and Biotechnology News adds,
    • “Cancer vaccines have been a tantalizing idea for decades, but the vast complexity of the human immune system has posed significant challenges. Now, technological advances like rapid DNA sequencing, lymph node targeting, and AI-informed antigen selection are enabling the creation of precision vaccines that target cancers effectively while minimizing harmful side effects.”
  • AHRQ’s Effective Health Care Program shares a paper about “Management of Suicidal Thoughts and Behaviors in Youth: A Systematic Review.”
  • The University of Minnesota’s CIDRAP relates,
    • “A new smartphone-sized device can deliver tuberculosis (TB) test results at the point of care in less than an hour, an innovation that could improve diagnosis of the deadly disease in settings in which access to healthcare facilities and lab equipment is limited, its Tulane University developers reported yesterday in Science Translational Medicine.
    • “Over 90% of new TB cases occur in low- and middle-income countries.” 

From the U.S. healthcare business front,

  • Beckers Hospital Review calls attention to the fact that CMS has approved seven new health systems to offer hospital at home programs.
  • Beckers Payer Issues informs us,
    • “CVS Health has named Benjamin Kornitzer, MD, as Aetna’s chief medical officer. 
    • “Most recently, Dr. Kornitzer was chief medical officer at agilon health, a primary care physician services company primarily serving Medicare Advantage patients.
    • “He also previously served as CMO of Mount Sinai Health System in New York.”
  • Fierce Healthcare reports,
    • “A better consumer experience has implications for clinical improvements, according to a new report from CVS Health.
    • “The healthcare giant is putting a focus on innovation in this area, and to identify opportunities conducted an analysis that compared Net Promoter System (NPS) scores with clinical outcomes. It found that, for example, patients who were highly satisfied with the experience at their pharmacies were more likely to be adherent to their medications.
    • “The white paper notes that nonadherence to prescribed medications drives 16% of U.S. health spending each year, or about $500 billion.” 
  • Modern Healthcare tells us,
    • “Eli Lilly is partnering with digital health companies to boost sales of its weight loss medications.
    • “The drugmaker added hybrid weight loss startup Knownwell to its third-party marketplace of telehealth offerings earlier this month. Eli Lilly has also signed deals with Ro, Form Health and 9am Health.” 
  • BioPharma Dive recently updated its prescription drug patent tracker.
  • Bloomberg Law adds,
    • “Novo Nordisk A/S and Eli Lilly & Co. are using dense clusters of patents to extend monopolies on blockbuster diabetes and weight-loss drugs including Ozempic, Wegovy, and Mounjaro, fueling high prices and health inequities, according to an advocacy group report.
    • “The pharmaceutical companies’ adoption of a “financialized business model” prioritizes profits and shareholder returns through an aggressive strategy for securing additional patents for minor changes to extend their drugs’ market exclusivity well beyond the expiration of its original patents, according to a report released Thursday by the Initiative for Medicines, Access and Knowledge on “the heavy price” of those glucagon-like peptide 1 therapies.” * * *
    • In a statement Friday, Lilly said the “report is grossly inaccurate and includes patents that have nothing to do with tirzepatide.”
    • “To date, Lilly has only listed three patents in the Orange Book for” its two tirzepatide products, it added.
    • “Our business model is built on the fact that patents are limited in scope and duration, and when they expire, we welcome generic and biosimilar manufacturers to develop lower-cost alternatives,” the statement continued. “Lilly is already focused on developing the next innovation for patients that will eventually become generic.”
    • “The Orange Book is a US Food and Drug Administration registry listing patents that cover approved drugs that allows branded-drug makers to trigger a 30-month delay of FDA approval by filing a suit alleging infringement of a listed patent.
    • “Novo in a Friday statement said it has no more than four patents listed in the Orange Book for Ozempic , no more than eight for Wegovy, and 11 for Rybelsus.
    • “While the US healthcare system is complex and there are many factors that play a role in determining what people will pay for medicines,” Novo said, “the net price of Ozempic has declined by 40% since launch in the US and Wegovy is following a similar trajectory.”

Weekend Update

David Ermer–Congress, FDA, Federal employment benefits, Generative AI, Medicare, Mental health care, Obesity, U.S. Healthcare–
Texas bluebonnets

From Washington, DC,

  • Roll Call reports,
    • “The Senate adopted a fiscal 2025 budget blueprint early Saturday mostly along party lines after a debate that began the night before, teeing up the House for a climactic final vote next week.
    • “Republicans beat back numerous amendments en route to adopting the measure on a 51-48 vote. 
    • “Rand Paul, R-Ky., voted “no” as he’s long promised due to the resolution’s allowance for raising the statutory debt limit by up to $5 trillion.
    • “Maine’s Susan Collins was the other GOP “no” vote, having earlier expressed concerns about potential Medicaid cuts later in the reconciliation process but not saying how she’ll vote. Collins is up for reelection in 2026 in a Democratic-leaning state.
    • “No Democrats voted for it.:
  • and
    • ​”Speaker Mike Johnson and his GOP leadership team on Saturday sought to tamp down a brewing revolt on the budget resolution that emerged even before the Senate adopted the plan in the wee hours and gained steam later in the morning.
    • “Johnson and the rest of the top four House Republican leaders sent a letter to the rank and file ahead of next week’s House vote on the Senate-revised budget blueprint assuring them that they will not accept watered-down spending cuts in the eventual filibuster-proof reconciliation bill the process is intended to unlock.
    • “We have and will continue to make it clear in all discussions with the Senate and the White House that —in order to secure House passage — the final reconciliation bill must include historic spending reductions while protecting essential programs,” the letter says.
    • “The leadership comments come after key figures in the conference, including House Budget Chairman Jodey C. Arrington, R-Texas; Freedom Caucus Chairman Andy Harris, R-Md., and Rep. Chip Roy, R-Texas, the Freedom Caucus policy chair, all expressed opposition to the Senate budget plan.” * * *
    • “The House GOP leadership letter Saturday * * * [laid] out a process they say will lead to a pre-negotiated settlement between the two chambers. 
    • “The reconciliation bill “must be drafted using a collaborative process that results in a single product that both chambers can pass, and President [Donald] Trump can sign into law,” the leadership wrote. “We have made it clear the House will NOT accept nor participate in an ‘us versus them’ process resulting in a take it or leave it proposition from the Senate.”
    • “The letter goes on to say that immediately after adopting the budget, House and Senate committees “will begin preparing together their respective titles of the reconciliation bill to be marked up in the next work period.”
    • ‘The process House GOP leaders laid out appears to follow what Democrats and then-President Joe Biden employed during the 117th Congress when they enacted two reconciliation bills. Both of those packages went through committee markups in the House, but not in the Senate; but senators were able to make their voices heard through amendment “vote-a-ramas” in that chamber.”
  • On April 9, 2025, at 10 am, the Senate Homeland Security and Governmental Affairs Committee will hold a “business meeting to consider the nominations of Scott Kupor, of California, to be Director of the Office of Personnel Management for a term of four years, and Eric Matthew Ueland, of Virginia, to be Deputy Director for Management, Office of Management and Budget.”
  • Federal News Network offers an interview with Kevin Moss about “the benefits and caveats to having both Medicare and FEHB. While enrolling in Medicare with FEHB coverage may seem like duplicating benefits, it can provide cost savings.”

From the public health and medical research front,

  • The Wall Street Journal reports,
    • A second child who was diagnosed with measles has died in Texas, marking another death in a growing measles outbreak that has so far sickened hundreds of people, hospitalized dozens and spread to nearby states. 
    • The school-age child was being treated for measles-related complications at UMC Health System in Lubbock, Texas, said the health system’s spokesman, Aaron Davis. The child, who died Thursday, wasn’t vaccinated, didn’t have any known underlying health conditions and died of “measles pulmonary failure,” according to the Texas Department of State Health Services.
    • “This unfortunate event underscores the importance of vaccination,” Davis said. * * *
    • “Health and Human Services Secretary Robert F. Kennedy Jr. traveled to Gaines County, Texas, the center of the measles outbreak, to console the two families who have lost children, he said in a post on X.” 
  • STAT News adds,
    • “Health secretary Robert F. Kennedy Jr. said Sunday that “the most effective way to prevent the spread of measles is the MMR vaccine,” his most direct statement yet on the issue, following the death of a second child of the condition in the outbreak in West Texas.” 
  • The Washington Post informs us,
    • Brandy Ellis [, a 49-year-old insurance compliance consultant] calls herself a cyborg.
    • Two small electrodes — thin metal wires — implanted deep inside her brain lead under her skin to a battery pack in her chest. Pulsing about 130 times a second, the deep brain stimulation (DBS) device, a kind of pacemaker, energizes an area that scientists say is key in regulating moods. * * *
    • “DBS is one of several emerging, high-tech therapeutic approaches — a.k.a. electroceuticals — that proponents say are extending psychiatry’s ability to help millions of patients. Increasingly over the past 20 years, testimonials to the potential of treatments that modulate brain functioning, such as DBS, transcranial magnetic stimulation, vagus nerve stimulation and, most recently, focused ultrasound, have been fueling new hope, despite considerable expense and hardship for patients, and mixed evidence of their effectiveness.
    • “Emory University neurologist and psychiatrist Patricio Riva Posse, one of Ellis’s therapists, describes the new trends — combined with ever more sophisticated brain-scanning technologies and new optimism about psychedelic drugs such as ketamine and psilocybin — as explosive progress.”
  • Per Medscape,
    • This patient case [discussed in the article] is a prime example of how, in some instances, losing weight with glucagon-like peptide 1 (GLP-1) agonists can impact muscle mass. To combat this health risk, more clinicians are now emphasizing on fat loss vs weight loss in patients taking GLP-1s. Weight loss refers to the overall decrease in weight from the body, which can include fat, muscle, and water, whereas fat loss refers only to the reduction of fat from the body.

From the U.S. healthcare business front,

  • BioPharma Dive provides us with an “M&A recap: Big pharma starts the year mostly avoiding billion-dollar deals. Big-ticket biotech buyouts have become scarce in recent months. U.S. policy upheaval threatens to keep it that way.”
  • Here is a link to Optum Rx’s Winter 2025 report on notable new drugs.
  • Per MedTech Dive,
    • “Eargo and Hearx have merged to create the over-the-counter hearing aid company LXE Hearing, the companies said Monday.
    • “Hearx, the maker of Lexie hearing aids, and Eargo competed for the OTC hearing aid market that the Food and Drug Administration created through the publication of a final rule in 2022. 
    • “Patient Square Capital, which took Eargo private in 2024, has invested $100 million in the combined company. LXE said the investment reflects confidence in the direct-to-patient hearing market.”
  • HR Dive relates,
    • “The U.S. Equal Employment Opportunity Commission has reached a settlement in two pregnancy discrimination cases and filed a new lawsuit on a third, the agency announced Thursday in a series of media releases.
    • “In the first settlement, an assisted living facility paid $20,000 to resolve allegations that it refused to schedule and then fired a temporary worker upon learning she was pregnant. In the second, a plant nursery paid $40,000 to resolve allegations it did not allow a worker to return after maternity leave. EEOC’s newly filed lawsuit alleged an employer refused to allow a worker with a high-risk pregnancy to work remotely to limit her exposure to COVID-19.  
    • “The actions highlight the agency’s continued interest in enforcing the relatively new Pregnant Workers Fairness Act. However, Acting Chair Andrea Lucas has expressed her opposition to aspects of the agency’s final rule, which was passed in April 2024.”

From the artificial intelligence front,

  • The Washington Post reports,
    • “In 2017, Ezekiel Emanuel, a well-known oncologist and health policy commentator, said radiologists would soon be out of work thanks to machine learning.
    • “That hasn’t happened, but although artificial intelligence isn’t replacing radiologists, it has significantly changed their field.
    • “More than three-quarters of the AI software cleared by the Food and Drug Administration for medical use is designed to support radiology practice, says Curtis Langlotz, a radiology professor at Stanford University and president of the Radiological Society of North America’s board of directors.
    • “Radiology is leading the way in the development and implementation of AI in clinical practice,” he adds. But AI isn’t reducing the need for human input.
    • “AI is not a better kind of intelligence, it’s just a different kind of intelligence,” Langlotz says. “A human plus a machine is better than either one alone. I would say that has been true since I began studying AI in the 1980s, and it continues to be true today.”

Tuesday Report

David Ermer–Congress, COVID-19 testing, FDA, Federal employment benefits, Medical / Rx research, NIH, Obesity, OPM, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Michele Orallo on Unsplash

From Washington, DC

Capitol Hill News

  • The Wall Street Journal reports,
    • The House [of Representatives] narrowly approved a Republican proposal to fund the government into the fall, as GOP lawmakers remained largely united following a last-minute push from the White House, overcoming Democratic opposition and setting up a fight in the Senate. 
    • Funding for the federal government expires this weekend. The GOP proposal would extend funding through Sept. 30 at fiscal 2024 spending levels, but it includes $13 billion in cuts in nondefense spending and $6 billion in increased military spending. It allocates additional money for border enforcement and forces Washington, D.C., to cut $1 billion from its budget. 
    • The measure passed 217-213, with Rep. Thomas Massie of Kentucky being the only Republican to vote against it. Democrats were largely united in opposition, with one Democrat, Rep. Jared Golden of Maine, voting yes. * * *
    • “The matter now heads to the Senate, where Republicans will need Democratic support to advance the bill. Senate Democrats were wrestling over the matter Tuesday. Some saw the funding deadline as their only leverage to push back against GOP efforts to dismantle federal programs, while others were wary of playing hardball and triggering a government shutdown. 
    • The House left town after Tuesday’s vote, effectively giving the Senate the option of approving or blocking the House measure—but not revising it.” 
  • Fierce Healthcare adds,
    • “Rep. Greg Murphy, M.D., R-N.C., posted on X Monday night that Johnson and Senate Majority Leader John Thune have agreed to include a doc pay fix in Congress’ budget reconciliation, which is expected to be finished in May to align with President Donald Trump’s first 100 days.
    • “A doc pay fix, which would counteract a 2.83% cut to Medicare physicians’ payment rates that went into effect Jan. 1, has been a central focus for provider lobbying groups as well as for physician members of the legislature. It was seen as the driving force behind passing an expanded healthcare package.
    • “The Energy and Commerce committee has an $880 billion deficit reduction target. E&C will identify those cuts from programs within its jurisdiction like Medicaid and other healthcare programs. It could identify some of those savings from items in the December healthcare package that did not make it into last year’s funding bill, such as PBM reform.”
  • Per Govexec,
    • “Also on Tuesday, Sen. Jerry Moran, R-Kan., who chairs the Senate Veterans Affairs Committee, announced during a hearing he will put forward legislation that will also seek to put some constraints on the Trump administration’s efforts to remake the Veterans Affairs Department’s workforce. He said VA must work closely with Congress and stakeholders such as veterans service organizations when seeking to make staffing cuts. The Republican chairman added he has voiced his reservations to VA Secretary Doug Collins.”

HHS News

  • The Washington Post reports,
    • Robert F. Kennedy Jr. is making one of his first official moves aimed at increasing oversight of the chemicals found in the nation’s food supply — a key component of his “Make America Healthy Again” agenda to root out chronic disease and childhood illness.
    • On Monday, Kennedy, who serves as the nation’s top health official, announced he was directing the Food and Drug Administration to “explore potential rulemaking” to tighten a decades-old loophole allowing food companies to put chemicals in their products without notifying the nation’s food regulators.
    • The practice Kennedy is targeting, known as “generally recognized as safe” (GRAS), can occur when companies self-certify the safety of a food additive. Companies aren’t required to tell the FDA when they include some chemicals and substances in their products, meaning there are probably hundreds of such ingredients added to the food supply without government oversight.
  • Per a March 10, 2025, CMS news release,
    • “Today, the Centers for Medicare & Medicaid Services (CMS) released a proposed rule to address the troubling amount of improper enrollments impacting Affordable Care Act (ACA) Health Insurance Marketplaces across the country. CMS’ 2025 Marketplace Integrity and Affordability Proposed Rule includes proposals that take critical and necessary steps to protect people from being enrolled in Marketplace coverage without their knowledge or consent, promote stable and affordable health insurance markets, and ensure taxpayer dollars fund financial assistance only for the people the ACA set out to support.” * * *
    • “View the 2025 Marketplace Integrity and Affordability Proposed Rule (CMS-9884-P) here: https://www.cms.gov/files/document/MarketplacePIRule2025.pdf
    • “For additional information on the rule and its proposals, view the CMS fact sheet:  https://www.cms.gov/newsroom/fact-sheets/2025-marketplace-integrity-and-affordability-proposed-rule” 
  • Per Modern Healthcare,
    • “The U.S. Department of Health and Human Services increased its voluntary buyout offer for some employees for further layoffs this week as the agency faces pressure to reduce headcount, according to an email viewed by Bloomberg. 
    • “In addition to a $25,000 lump-sum buyout offer, some HHS workers would also receive around two months of paid administrative leave if they chose to accept the buyout. * * *
    • “The buyout offer was available to employees this week and expires Friday. The original buyout offer was extended to a “broad population of HHS employees,” according to an email. However, the Food and Drug Administration told staff Monday that employees responsible for reviewing drugs, medical devices and tobacco products aren’t eligible for the buyout program. 
    • “The HHS buyout offers are in addition to an early retirement program that relaxed service requirements for retirement.”
  • The U.S. Preventive Services Task Force issued a final recommendation on screening for food insecurity which received an inconclusive “I” grade.
    • “For children, adolescents, and adults:
      “The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for food insecurity on health outcomes in the primary care setting.”
  • Per Axios,
    • “The federal government’s free at-home COVID test distribution program has been suspended and is no longer accepting orders” as of March 9, 2025.
    • “For some previously distributed tests, expiration dates were extended to account for data that revealed a longer-than-expected shelf life.
    • “A full list of approved tests and their revised expiration dates is posted on the FDA website.”

FDA News

  • Per Cardiovascular Business,
    • “Google has received U.S. Food and Drug Administration (FDA) for Loss of Pulse Detection, a new smartwatch feature that detects when a person’s heart stops beating and then automatically alerts emergency services. 
    • “Loss of Pulse Detection asks the user if they are OK when it first detects the loss of pulse. If no response is provided, it triggers an audio alarm and countdown to when emergency services will be notified. If the countdown reaches zero, the alert is officially sent out.
    • “This feature is already available in 14 different countries. It will be made available in the United States for Google’s Pixel Watch 3 in the weeks ahead.”
  • Per Modern Healthcare,
    • “Siemens Healthineers has received clearance from the Food and Drug Administration for its Naeotom Alpha class of photon-counting computed tomography scanners.
    • “The company unveiled the two scanners in December, touting the Naeotom Alpha.Pro and Naeotom Alpha.Prime as more affordable options to its original Naeotom Alpha photon-counting CT, which received FDA clearance in September 2021.
    • “Photon-counting CT is a new technology that uses lower radiation doses than conventional CT and produces clearer images with fewer distortions.
    • “Siemens Healthineers’ photon-counting CTs are the only commercially available scanners of their kind available for clinical use but competitors are working to bring their versions to market.”

From the judicial front,

  • Govexec reports,
    • “A federal judge has ordered the acting head of the Office of Personnel Management to testify at a court hearing examining the legality of the Trump administration’s mass firings of federal employees, but the key workforce official has informed the court he will ignore the order. 
    • “Acting OPM Director Charles Ezell was slated to appear in a U.S. District Court in San Francisco on Thursday after Judge William Alsup ruled Monday on Monday that he must do so, but he will now face a to-be-determined sanction. The Trump administration had sought to block his testimony, saying it would raise constitutional concerns, but the judge rejected the argument. Ezell has already submitted written testimony, Alsup said, and now must be subject to cross examination. 
    • “After initial publication of this story, the Trump administration Tuesday evening informed the court Ezell would not testify and withdrew his written declaration suggesting he did not order the probationary firings across government. It called live testimony “not necessary” for Ezell or any other official. The plaintiffs in the case are seeking testimony from human resources personnel throughout government.” 

From the public health and medical research front,

  • Healio lets us know,
    • “The diabetes mortality rate in the U.S. dropped from 28.1 deaths per 100,000 people in 2000 to 19.1 deaths per 100,000 in 2019.
    • “Reductions in diabetes mortality were observed for all racial and ethnic groups.”
  • The Wall Street Journal reports,
    • “GLP-1s, including Ozempic, show promise in preventing age-related conditions like Alzheimer’s, osteoarthritis and certain cancers.
    • “GLP-1s work by suppressing appetite and reducing inflammation, potentially contributing to their preventive health benefits.
    • “While promising, more robust studies are needed to confirm the causal effects of GLP-1s on longevity and healthspan.”
  • The National Institutes of Health offers a research bulletin on the following topics: “Predicting preeclampsia | Liver gene editing | Mapping MS-like brain lesions.”
  • MedPage Today tells us five things that patients with low back pain need from their doctors and
    • “BMI was lower in kids whose mothers received a responsive parenting intervention in the INSIGHT randomized clinical trial.
    • “Across ages 3 to 9 years, children in a responsive parenting group had a lower mean BMI than those in a control group.
    • “The impact appeared significant only for girls.”
  • Per a news release,
    • “The Institute for Clinical and Economic Review (ICER) announced today that it will assess the comparative clinical effectiveness and value of brensocatib (Insmed Incorporated) for the treatment of non-cystic fibrosis bronchiectasis (NCFB).
    • “The assessment will be publicly discussed during a meeting of the CTAF in September 2025, 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.”
  • The National Cancer Institute informs us,
    • “For men with metastatic castration-resistant prostate cancer, an initial treatment that combines enzalutamide (Xtandi) and talazoparib (Talzenna)may help them live longer than just getting enzalutamide alone, according to updated results from a large clinical trial. Enzalutamide is a type of drug known as an androgen receptor antagonist and talazoparib is part of a group of drugs called PARP inhibitors.” * * *
    • “More information about the trial, which was funded by Pfizer, the maker of talazoparib, is available in this Cancer Currents story.”
  • Fierce Pharma adds,
    • “After Gilead Sciences’ lenacapavir made waves with stellar clinical results as a twice-yearly HIV prevention candidate, the drug has shown promise being dosed even further apart at only once a year.
    • “Two different once-yearly formulations of lenacapavir achieved blood concentrations that exceeded those associated with the strong HIV prevention efficacy that twice-yearly lenacapavir showed in phase 3 preexposure prophylaxis (PrEP) studies.
    • “The pharmacokinetic results came from a small phase 1 trial presented at the Conference on Retroviruses and Opportunistic Infections and simultaneously published in The Lancet.
    • “Based on the early-stage data, Gilead plans to start a phase 3 program for once-yearly lenacapavir in the second half of this year, with the potential for regulatory filings in 2027, Jared Baeten, M.D., Ph.D., Gilead’s vice president of HIV clinical development, told Fierce Pharma.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Hinge Health filed Monday for a proposed initial public offering.
    • “The virtual musculoskeletal health company, which contracts with employers, pharmacy benefit managers and large insurance companies to provide physical therapy and pain relief services, has been considered a potential IPO candidate since last year.”
  • and
    • “Tampa General Hospital and Mass General Brigham are teaming up to open a radiation oncology center in Florida.
    • “The 10,000-square-foot facility in Palm Beach Gardens will be co-branded and jointly owned. Tampa General will handle daily operations, while Mass General Brigham will provide oversight on quality and safety, according to a Tuesday news release.
    • “The center is scheduled to open in early 2026, the release said.”
  • Per Fierce Pharma,
    • “At its sprawling complex in Durham, N.C., Merck has opened a new $1 billion, 225,000-square-foot manufacturing plant slated to produce bulk substance for its megablockbuster HPV vaccine Gardasil.
    • “Merck built the new plant on the 262-acre campus it has occupied since 2004, where the pharma giant produces a variety of vaccines including shots to prevent chickenpox, measles and rubella.
    • “The complex manufactured more than 70 million doses last year, with the figure expected to increase this year, a Merck spokesperson said in an email. The campus now employs more than 1,000 people.”
  • Per STAT News,
    • “In the last two years, hundreds of businesses have cropped up to meet the surge in demand for the obesity and diabetes medications known as GLP-1s. The majority prescribe compounded copies of the drugs — a tenuous business strategy as shortages of the branded versions of the medications have come to an end. 
    • “Now, some businesses are setting their sights on another opportunity in compounding: hormones.
    • “Dozens of wellness and direct-to-consumer telehealth companies offering GLP-1s have begun marketing cash-pay hormone replacement therapy to women in perimenopause and menopause, and testosterone replacement therapy to men. Noom, best-known for its weight loss app and more recent GLP-1 offering, launched an HRT program for menopause in late February, and telehealth company Hims & Hers plans to roll out at-home testing over the next year to enable care for low testosterone, perimenopause, and menopause.
    • “Patients and physicians have long advocated for better access to hormone-based care. Men with low testosterone levels due to hypogonadism can face stigma as they seek care, and many women struggle to receive medically appropriate estrogen and progesterone to address serious hot flashes and help prevent osteoporosis. But clinicians and health policy researchers expressed concern that the emerging commodification of hormone replacement therapies — often marketed as a personalized fix for low energy, libido, and other age-related concerns — could lead to inappropriate prescriptions and put patients at risk.” 
  • Beckers Hospital Review points out,
    • “In August, Kaiser Permanente embarked on the largest rollout of generative AI in healthcare to date.
    • “The Oakland, Calif.-based health system offered Abridge, an ambient AI listening tool that drafts clinical notes for the EHR, to tens of thousands of providers.
    • “Becker’s caught up with Brian Hoberman, MD, executive vice president of IT and CIO at the Permanente Federation, at the HIMSS conference in Las Vegas to find out how the implementation is going.”
    • Here’s a link to that interview.
  • The Wall Street Journal adds,
    • “Last year, some cancer patients in Tennessee and Mississippi got a startling offer: Instead of videoconferencing with oncology specialists located hours away, they could see a hologram doctor, courtesy of the same special effects that have projected the Jonas Brothers and other celebrities at concerts and live events.
    • “The offer came from West Cancer Center & Research Institute, a health system that employs about 61 doctors and serves about 19,240 new patients a year across 12 locations in Tennessee, Mississippi and Arkansas. The system’s main clinic is in Germantown, Tenn., a suburb of Memphis.
    • “Its doctors typically spend hours on the road each week getting to the satellite clinics to see patients in more rural locations, while also relying heavily on videoconferencing for check-ins. Now, however, two of those clinics are replacing the video calls with life-size hologram-like displays, part of a cross-industry push to take videoconferencing to the next level.”

Thursday Report

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

From Washington, DC

  • Fierce Healthcare reports,
    • “New legislation advanced by a voice vote March 4 would codify 14 pre-deductible healthcare services through high-deductible health plans (HDHPs).
    • “It codifies guidance from President Donald Trump’s first term increasing flexible coverage options for HDHPs. The bill would allow medical products and services like beta-blockers, blood pressure monitors, glucometers, inhalers and cholesterol drugs to be more easily covered by insurance by letting insurers pay for low-cost services before a deductible is reached.
    • “This legislation provides employers and their employees with greater flexibility to design healthcare coverage options that expand access to treatments for chronic diseases,” said Ways and Means Committee Chairman Jason Smith, R-Missouri, in a statement on the House floor. “By providing flexible coverage options for more people living with chronic health conditions, we can help lower their costs and improve their health and well-being.” * * *
    • “The bill must still be passed by the full Senate.”
  • Roll Call tells us,
    • “Senate Republicans called on the Trump administration Wednesday to use the formal rescissions process to claw back money already appropriated by Congress that the “Department of Government Efficiency” has identified as wasteful.
    • “It’s also a way to avoid legal setbacks that have befallen the White House in its push to freeze agency budgets and programs, including foreign aid accounts.
    • “One day after President Donald Trump singled out small-dollar examples of waste in his joint address to Congress, the de facto leader of the DOGE effort, Elon Musk, came to the Capitol to soothe concerns over how some of the cuts have been implemented. Many lawmakers have expressed alarm at the wholesale gutting of agencies and the firing of thousands of federal employees.
    • “Hoping to regain some of their power of the purse, senators asked Musk at a private lunch to have the White House submit a rescissions package for congressional approval for any funding it deems fraudulent or wasteful. Congress would then have 45 days to approve the request, or else the money must be spent as appropriated once the clock runs out.
    • “What we got to do as Republicans is capture their work product, put it in a bill and vote on it,” Senate Budget Chairman Lindsey Graham, R-S.C., told reporters. “So the White House, I’m urging them to come up with a rescission package.”
    • “Graham said Musk was receptive to the idea and hadn’t known about the rescissions process as an available tool to cut spending.”
  • BioPharma Dive lets us know,
    • “Marty Makary, the Johns Hopkins surgeon who President Donald Trump chose to lead the Food and Drug Administration, fended off pressure from Republican and Democratic senators Thursday over a canceled agency meeting on influenza vaccines. 
    • “Questioned by several lawmakers at a hearing held to evaluate his nomination, Makary would not commit to reconvening the meeting, at which agency advisers were set to discuss the composition of this year’s flu shots. Members of the panel were notified last week that they would not meet as scheduled. 
    • “Instead, Makary seemed to indicate he would take a broader look at the role the advisory committee plays in the FDA’s vaccine decision-making and whether it is providing useful advice. 
    • “You have my commitment to review what the committees are doing [and] how they are being used,” Makary told Senator Bill Cassidy, R-La., who serves as chair of the Senate Health, Education, Labor, and Pensions Committee reviewing Markary’s nomination.” 
  • Per an HHS press release,
    • “Today, the Centers for Medicare & Medicaid Services (CMS) alerted providers of their obligation to protect American children from often irreversible chemical and surgical mutilation, including interventions that cause sterilization. Hospital providers were alerted of serious quality and safety concerns associated with harmful, medical interventions for gender dysphoria. CMS also announced it may begin taking steps to align its policies and regulations with medical evidence and to safeguard children from often irreversible experiments. CMS will continue to follow any applicable substantive and procedural requirements in taking any future action.” * * *
    • “Similar alerts are also being sent by other HHS agencies to grantees. View the CMS alert here: https://www.cms.gov/files/document/QSSAM-25-02-Hospitals.pdf”  
  • Govexec informs us,
    • “Special Counsel Hampton Dellinger said in a statement to Government Executive that he is dropping his lawsuit to reverse his removal by Donald Trump, enabling the president to name his own person to lead the office that protects federal employees and whistleblowers from prohibited personnel practices.
    • “A district judge on March 1 blocked Dellinger’s firing, but the U.S. Court of Appeals for the D.C. Circuit on Wednesday allowed for him to be removed while it considers the Trump administration’s appeal.”
  • Federal News Network interviewed Tammy Flanagan about RIFs and early retirement for federal employees.

From the judicial front,

  • Thompson Reuters relates,
    • A federal trial court [in Maine} has dismissed a proposed class action lawsuit against an insurer/health plan administrator alleging discrimination under Affordable Care Act (ACA) Section 1557 for failure to cover weight-loss drugs. The participant alleged that the insurer’s plan violated Section 1557 (which prohibits discrimination in certain health programs and activities based on race, color, national origin, sex, age, or disability) because it excluded prescription drug coverage for commonly prescribed weight-loss medications if they were prescribed solely to treat obesity. She argued that she did not have access to the prescription medications required to treat her obesity (which she alleged was a disability and diagnosed health condition), while other participants had access to prescription medications medically necessary to treat their diagnosed health conditions, including the same or similar medications.
    • Concluding that the participant’s allegations did not support a finding of disability under Section 1557, the court dismissed the case. It determined that the participant had not plausibly shown that she was disabled merely as a function of her body mass index, nor that the insurer had ever regarded her as disabled. Pointing out that disability is an essential element of a Section 1557 disability discrimination claim, the court held that the participant had failed to state a claim for relief.
  • Fierce Health notes,
    • “Dozens of providers have filed new lawsuits against Blues insurers, arguing that the plans colluded to block competition and reimburse them at lower rates.
    • “The payers reached a tentative $2.8 billion settlement agreement in Alabama court in October, but the new lawsuits opt out of it and instead press for a jury trial. The Blue Cross Blue Shield Association and 33 of its affiliates are named in the new suits.
    • “Providers who have signed on to the filings include the University of Pennsylvania Health System, Geisinger, MedStar, CommonSpirit and physician staffing firm TeamHealth. They argue that the alleged collusion between Blues plans violated antitrust laws.”

From the Food and Drug Administration,

  • Cardiovascular Business reports,
    • “Genentech, part of the Roche Group, has received U.S. Food and Drug Administration (FDA) approval for tenecteplase, the company’s new intravenous treatment for acute ischemic stroke (AIS) in adult patients. Genentech will be marketing and selling tenecteplase under the brand name TNKase. 
    • “Tenecteplase is only the second clot-busting medication for stroke to gain approval from the FDA—and the first in decades. The only other one, alteplase, is also sold by Genentech under the brand name Activase.
    • ‘Tenecteplase is a tissue plasminogen activator given to patients through a single five-second intravenous bolus. This is much faster than alteplase, which was administered by giving patients an IV bolus that is then followed by a 60-minute infusion.”
  • The American Hospital Association (AHA) News adds,
    • “The Food and Drug Administration March 5 announced that Baxter Healthcare Corporation recalled its Spectrum infusion pumps due to the potential for missing motor mounting screws. The FDA said missing motor mounting screws could lead to insufficient or excessive therapy, interruption in therapy or delay in therapy, which can result in serious adverse health consequences. Baxter has reported one serious injury related to the issue.”
  • Per MedTech Dive,
    • “Philips stopped selling an implant used to repair damaged arteries after reports of 20 injuries and some devices needing to be removed.
    • “The Food and Drug Administration said in a Monday recall notice that all customers should stop using Philips’ Tack Endovascular System immediately. The agency classified the recall as Class I, the highest risk category.
    • “Philips is not aware of serious harm or death accompanying the use of the device, a company spokesperson wrote in an email. The FDA said no deaths were reported.”

From the public health and medical research front,

  • The AHA News points out,
    • “The Centers for Disease Control and Prevention March 4 announced it sent agency experts to Texas to assist local officials in responding to the state’s measles outbreak. The CDC said the partnership, known as an Epi-Aid, is a rapid response effort by the agency’s Epidemic Intelligence Service to respond to urgent public health issues such as disease outbreaks. EIS officers will provide onsite support for one to three weeks. 
    • “As of March 4, there were 159 measles cases identified, according to the Texas Department of State Health Services. Twenty-two patients have been hospitalized and a school-aged child died Feb. 26. Texas DSHS officials said additional cases are likely to occur.” 
  • The New York Times reports
    • “Women’s brains are superior to men’s in at least in one respect — they age more slowly. And now, a group of researchers reports that they have found a gene in mice that rejuvenates female brains.
    • “Humans have the same gene. The discovery suggests a possible way to help both women and men avoid cognitive declines in advanced age.
    • “The study was published Wednesday in the journal Science Advances. The journal also published two other studies on women’s brains, one on the effect of hormone therapy on the brain and another on how age at the onset of menopause shapes the risk of getting Alzheimer’s disease.”
  • and
    • “Postpartum depression affects about one in every seven women who give birth, but little is known about what happens in the brains of pregnant women who experience it. A new study begins to shed some light.
    • “Researchers scanned the brains of dozens of women in the weeks before and after childbirth and found that two brain areas involved in the processing and control of emotions increased in size in women who developed symptoms of postpartum depression.
    • “The results, published Wednesday in the journal Science Advances, constitute some of the first evidence that postpartum depression is associated with changes in the brain during pregnancy.”
  • The Washington Post adds,
    • “Bacterial vaginosis, a common vaginal infection also known as BV, has long been treated as a women’s condition; but a new study adds to evidence that it is a sexually transmitted infection and suggests that treating a male partner can help reduce recurrence.
    • “BV affects nearly 1 in 3 women of reproductive age globally. It has been associated with increased risk of adverse birth outcomes, HIV and other sexually transmitted infections, according to the World Health Organization. It has a high recurrence rate, with more than half of those who are treated experiencing the condition again within three months.
    • “The study, led by a team of Australian researchers, was published in the New England Journal of Medicine on Wednesday.”
  • The U.S. Preventive Services Task Force released for public comment a Draft Research Plan regarding Cognitive Impairment in Older Adults: Screening. The public comment deadline is April 2, 2025.
  • Per MedPage Today,
    • “In a retrospective study, semaglutide use leading up to bariatric surgery was not linked with greater weight loss a year after surgery.
    • “Rates of diabetes remission and complications were also comparable between semaglutide users and controls.
    • “Previous studies have found that taking semaglutide after surgery can help patients shed more pounds.”
  • Per Healio,
    • “Using visualized coronary calcium scoring independently reduced plaque progression among patients at intermediate risk vs. usual care.
    • “Improvements in lipid profiles were also reported.”
  • Per Medscape,
    • “Reports of children in the United States with influenza-associated encephalopathy or encephalitis (IAE) increased from none during the 2020-2021 flu season to a preliminary 14% for the 2024-2025 season, based on a new analysis from the Centers for Disease Control and Prevention (CDC).
    • “IAE involves a range of neurologic syndromes triggered by flu infection of the respiratory tract, with diagnosis based on brain lesions detectable on imaging, wrote Amara Fazal, MD, and colleagues at the CDC’s National Center for Immunization and Respiratory Diseases.
    • “A series of anecdotal reports of pediatric cases with IAE in January 2025 prompted the CDC’s investigation; the findings were published in the Morbidity and Mortality Weekly Report (MMWR).”

From the U.S. healthcare business front,

  • Beckers Hospital Review offers five takeaways from this week’s HIMSS conference and lets us know the amount of cash on hand for 35 U.S. healthcare systems as of December 31, 2024.
  • Beckers Payer Issues lets us know,
    • Blue Cross and Blue Shield of North Carolina has restructured to become a subsidiary of a new parent holding company, CuraCor Solutions.
    • CuraCor will include Blue Cross NC and other fully owned companies, allowing the new organization “to quickly partner and invest in new health programs and technologies to benefit customers,” according to a March 6 news release shared with Becker’s.
    • Blue Cross NC members will experience no changes to coverage, services or the open enrollment process. Insurance cards, provider networks and Medicaid and Medicare offerings will also remain the same.
  • Per Fierce Healthcare,
    • “Datavant is beefing up its data retrieval network with a new layer of artificial intelligence that will allow health plans and risk-bearing providers to improve operations and patient care by accessing and analyzing a trove of clinical data.
    • “Value-based care arrangements require health plans and risk-bearing providers to navigate complicated requirements for managing patient data and monitoring population health. While providers and health plans face increasing cost pressure and administrative burden, Datavant touts that the enhanced platform will ease the administrative burden of locating and analyzing patient and member data.
    • “Datavant’s new Clinical Insights Platform is the result of Datavant’s integration with Apixio. It acquired the company’s connected care platform and value-based care solutions in September 2024. With the release of the Clinical Insights Platform, the Apixio brand will sunset and the combined Datavant-Apixio product will be sold.”

Tuesday Report

David Ermer–CDC, Congress, COVID-19, COVID-19 vaccine, FDA, Federal employment benefits, Medicare, NIH, OPM, Rx coverage, U.S. Healthcare–

From Washington, DC

  • The Wall Street Journal offers a summary of seven takeaways from the President’s speech on Tuesday night.
  • Bloomberg Law tells us,
    • “A battle over legislation that would make it easier for Medicare cancer patients to get their drugs may reignite this week when a key Republican lawmaker is expected to reintroduce the proposal.
    • “The measure (H.R. 5526) was passed in the House in September 2024 but stalled in the Senate amid opposition from the pharmacy industry. Rep. Diana Harshbarger (R-Tenn.), a pharmacist, said in a statement to Bloomberg Law the legislation “is one of my top healthcare priorities, and I expect to reintroduce it this week.”
    • “This legislation had strong bipartisan support in Congress last year because it would greatly benefit the lives of countless seniors who need life-saving medications but might not be able to access them easily,” Harshbarger said. “I’m looking at all legislative opportunities to advance this bill and get it enacted into law.”
    • “The legislation, and S. 3458 introduced last Congress by former Sen. Kyrsten Sinema (I-Ariz.), would have amended the physician self-referral law and restored a Covid-19 pandemic-era waiver that allowed Medicare patients to receive their oral cancer medications through the mail, by courier, or via pick-up by family members.”
  • Wolters Kluwer lets us know,
    • “On March 2, 2025 the United States Department of the Treasury announced that with respect to the Corporate Transparency Act (CTA), it will not enforce any penalties or fines associated with the beneficial ownership information reporting (BOIR) rule under the current deadlines, and it will further not enforce any penalties or fines against United States citizens or domestic reporting companies or their beneficial owners after a forthcoming rule change takes effect. 
    • “The Treasury Department also announced that it will be issuing a proposed rulemaking that will narrow the scope of the BOI reporting rule to foreign reporting companies only. Treasury stated that it was taking this step “in the interest of supporting hard-working American taxpayers and small businesses and ensuring that the rule is appropriately tailored to advance the public interest.”
    • The Treasury Department’s press release can be read in full here: https://home.treasury.gov/news/press-releases/sb0038“
  • Federal News Network tells us,
    • “The Trump administration’s Office of Personnel Management has revised its guidance on probationary employees, now stating that OPM was not directing agencies to fire federal workers.
    • “An update to OPM’s Jan. 20 memo on Tuesday adds a paragraph clarifying that any decision to fire employees should be left to individual agencies.
    • “Please note that, by this memorandum, OPM is not directing agencies to take any specific performance-based actions regarding probationary employees,” the updated memo states. “Agencies have ultimate decision-making authority over, and responsibility for, such personnel actions.”
  • Kevin Moss, writing in Federal News Network, discusses how federal annuitants can control their FEHB premiums.
  • Per an FDA news release,
    • On Monday, the FDA approved the first generics of Xarelto (rivaroxaban), 2.5 mg, tablets to reduce the risk of major cardiovascular events in adult patients with coronary artery disease (CAD) and to reduce the risk of major thrombotic vascular events in adult patients with peripheral artery disease (PAD), including patients who have recently undergone a lower extremity revascularization procedure due to symptomatic PAD. Anticoagulants (blood thinners) are among the most commonly prescribed medications in the U.S., and Monday’s approval of the first generics of rivaroxaban, 2.5 mg, tablets will make a direct impact on American patients who rely on anticoagulant medications. Approving safe and effective generics to help provide patients more treatment options continues to be a priority for the FDA.

From the judicial front,

  • Per Fierce Healthcare,
    • “UnitedHealth Group notched a major court win in a legal challenge over its Medicare Advantage (MA) billing practices that is stretching into its second decade.
    • “The suit was first filed by a whistleblower in 2011, and the Department of Justice (DOJ) joined the case in 2017. The court-appointed special master released its report this week, in which, after reviewing the evidence, it determined “that the government is lacking any evidence in support of two essential elements of its False Claim Act and related common law claims.”
    • “The suit alleges that UnitedHealth conducted reviews of patients’ medical records that allowed it to identify underpayments while ignoring instances of overbilling. This would enable the company to juice its risk scores and thus its MA payouts.” * * *
    • “In the lawsuit, the feds argue that the billing practices allowed UHG to pocket $2.1 billion. The special master rebuffed an analysis from a government expert who identified 1.97 million codes among 28 million that were allegedly unsupported by the patients’ diagnoses.
    • “The special master noted in its report that the expert did not review medical charts before making this determination.” * * *
    • “The special master’s report recommends that the courts grant UHG a summary judgement and reject the DOJ’s request for partial summary adjudication.”

From the public health and medical research front,

  • Katelyn Jetelina, a/k/a Your Local Epidemiologist, remarks
    • “If you’re 65+ or moderately/severely immunocompromised, a spring Covid-19 vaccine is available. Last October, CDC recommended a second dose of the 2024-2025 Covid-19 vaccine for this spring. It’s a 6-month recommended interval, so the first people will be eligible this week.
    • “Are they still working? Yes. Data published last week showed Covid-19 vaccines provided 45% additional protection against hospitalizations this winter.”
  • The Wall Street Journal points out that the Health and Human Services Department under its new leadership is heightening its scrutiny of vaccines.
  • In this week’s online Research Matter, NIH discusses “Tracking diet from stool samples | Diabetes & antibiotic resistance | Cancer cell cooperation.”
  • Per an NIH news release,
    • An observational study supported by the National Institutes of Health (NIH) found that infants who had more diverse bacteria in their gut had lower childhood blood pressure, and this protective association was stronger if they were breastfed for at least six months. The findings published in the Journal of the American Heart Association.
    • For the research, investigators reviewed data from 526 children enrolled in a prospective study in Denmark. They looked for connections between infant gut bacteria, which can be influenced by nutrition and supports a variety of health functions, and childhood blood pressure. To assess this, they collected fecal samples to analyze bacteria in the infants’ intestines during their first week, month, and year of life. Three and six years later, they measured the children’s blood pressure.
    • The researchers found children with more diverse gut bacteria at one month had lower blood pressure six years later. They then assessed the influence of breastfeeding, which was measured in this study for durations of at least six months. They discovered that among children breastfed for at least six months, the blood-pressure lowering effect of having more diverse bacteria in their gut was even stronger. Specifically, those with a greater diversity of gut bacteria throughout the first month of life had systolic blood pressure that was about 2 mm Hg lower six years later if they were breastfed for at least six months.
  • The National Cancer Institute points out,
    • “A new study has identified a group of genetic changes that are likely involved in the development of cancer in children. According to the findings, genomic changes affecting large pieces of DNA, called structural variants, contribute to an estimated 1% to 6% of pediatric solid tumors.” * * *
    • “Overall, the researchers estimated that structural variants are involved in the development of 1% to 6% of neuroblastomas, Ewing sarcomas, and osteosarcomas. That is a rough estimate limited by the relatively small number of children in the study and the exclusion of certain types of structural variants due to technical limitations, the team noted.”
  • STAT News reports,
    • “It’s easy to think cervical cancer could be 100% preventable. Along with lung, breast, and colorectal cancer, it has screening tests to find precancerous changes that can be treated before full-blown cancer develops. Even more, there is a highly effective vaccine against HPV, the virus that causes most cervical cancer diagnoses.
    • “Still, those two forms of prevention are not enough if people aren’t getting them, a research letter published Monday in JAMA Network Open reports. The cross-sectional study found incidence and mortality rates have been climbing in rural counties in the United States since 2012, going in the wrong direction after declining since 2001. Cases were 25% higher and deaths were 42% higher in rural counties compared to urban counties through 2019. 
    • “Researchers said those jumps in incidence and mortality showing up in rural areas may be a result of lower screening, diagnosis, and treatment rates, all an offshoot of reduced options for care outside cities.
    • “There was also a trend toward higher incidence among Black women starting in 2017, but that rise was not statistically significant. Other research, from the American Cancer Society, has concluded the mortality rate for Black women is roughly 65% higher than the rate for white women.”
  • BioPharma Dive relates,
    • “Merck & Co.’s cancer immunotherapy Keytruda is one of the pharmaceutical industry’s biggest successes. The drug’s arrival in 2014 introduced a new way of treating cancer and, over time, it became standard therapy for a panoply of different tumors. Clinical achievements brought about commercial performance, making Keytruda the world’s best-selling medicine.
    • “After the repeated failure of past attempts to improve on Keytruda, a new class of drugs might finally offer a better backbone for immunotherapy’s next decade.
    • “Last September, biotechnology companies Summit Therapeutics and Akeso revealed clinical trial results showing one of these drugs significantly outperformed Keytruda. Called ivonescimab, it cut the risk of lung cancer progression in half compared to Keytruda in a Phase 3 study — a result so striking it sparked a wave of investment in oncology research practically overnight.
    • “This really was a ‘black swan’ event,” said Allen Yang, Summit’s chief medical officer. “It’s clearly what everybody’s been looking for.”

From the U.S. healthcare business front,

  • Fierce Healthcare shares news from this week’s HIMSS conference being held in Las Vegas.
  • Healthcare Dive adds,
    • “Lightning-fast evolution in artificial intelligence and growing adoption of the models is giving rise to concerns that AI could exacerbate existing divides between technological haves and have-nots in the healthcare industry.
    • “But all types of providers — regardless of location or finances — can adopt AI, experts said Monday at the HIMSS conference in Las Vegas.
    • “It’s just a question of knowing how.
    • “Rural hospitals, smaller systems and health clinics without a massive IT infrastructure should reach out to AI companies to discuss potential partnerships, said Graham Walker, co-director of advanced development at Kaiser Permanente’s medical group, during a panel.”
  • The Wall Street Journal reports,
    • “Walgreens Boots Alliance is closing in on a deal with private-equity firm Sycamore Partners that would take the struggling drugstore chain off the public market for around $10 billion, according to people familiar with the matter. 
    • “The sides are aiming to complete a deal as soon as Thursday, assuming a last-minute snag doesn’t delay the talks or end them entirely, the people said. 
    • “They have been discussing Sycamore paying between $11.30 a share and $11.40 a share in cash, the people said. The deal could also include contingent value rights that would increase the value if certain targets are later reached, they added. 
    • “Should Sycamore complete the deal for the whole company, it is expected to maintain the core U.S. retail business and sell off or take public the other parts of the company, the people said.”
  • Modern Healthcare informs us,
    • “CVS Health has dealt its Medicare Shared Savings Program accountable care organization business to Wellvana, the companies announced Tuesday.
    • “As part of the all-stock transaction, CVS Health took a minority stake in Wellvana, a privately held physician-enablement vendor. The companies did not disclose the terms of the deal and did not immediately respond to interview requests.”
  • Beckers Payer Issues lets us know,
    • “Blue Cross Blue Shield of Michigan reported a loss of $1.02 billion on enterprise revenue of $40.6 billion in 2024, driven by rising utilization of expensive medical services and costs for prescription and specialty drugs.
    • “The company reported an underwriting loss of $1.7 billion in 2024, resulting in a negative operating margin of -4.2%. These losses were partly offset by strong performance from the company’s investment portfolio. 
    • “In 2024, Blue Cross saw an increase of $3 billion for medical and pharmacy claims costs compared to 2023. There was an increase of $900 million in pharmacy claims costs, including $544 million for specialty drugs, of which $215 million was for new indications on autoimmune drugs. GLP-1 drugs alone produced $1.1 billion in claims in 2024, a 29% increase from 2023.
    • “Total membership stands at 5.1 million. There are 663,000 Medicare Advantage members, 286,000 Medicaid members, and 160,000 ACA members.”
  • Healthcare Dive tells us,
    • “Winston-Salem, North Carolina-based Novant Health and Durham, North Carolina-based Duke University Health System will partner to build an unspecified number of new campuses across North Carolina, according to a Monday press release.
    • “The partnership aims to increase patient access to primary care and advanced specialty treatment, as well as shorten wait times for care.
    • “Construction on the first sites will begin this summer, and facilities will open approximately 18 months after work begins, according to the news release.”