Monday Report

CMS

Monday Report

David Ermer–CMS, Congress, COVID-19 vaccine, FDA, Medical / Rx research, Mental health care, NIH, Obesity, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC,

  • Roll Call reports,
    • “Five months after announcing his esophageal cancer diagnosis, Virginia Rep. Gerald E. Connolly said Monday that he won’t seek a 10th term and also plans to step down as the top Democrat on the House Oversight and Government Reform Committee.
    • “The sun is setting on my time in public service,’’ Connolly, 75, said in a message to his constituents in Virginia’s 11th District. “With no rancor and a full heart, I move into this final chapter full of pride in what we’ve accomplished together over 30 years.” * * *
    • “Until his permanent successor on the committee is chosen, Connolly has asked Massachusetts Rep. Stephen F. Lynch to cover for him as the panel’s top Democrat, Politico reported Monday.”
    • Best wishes, Congressman.
  • STAT News tells us,
    • “In keeping with the Trump administration’s quest to slash spending at the federal health department, it’s hired a famously thrifty technology entrepreneur to lead Medicare. 
    • “As the CEO of health IT company Collective Medical, Chris Klomp flew bargain-priced Frontier Airlines and once boasted about sleeping in rental cars and crummy motels on business trips. The office snacks were from Costco. The penny-pinching didn’t stop after the bootstrapped company raised nearly $50 million from blue chip investors like Kleiner Perkins. One morning, Klomp arrived at the company’s headquarters just outside Salt Lake City, his 1960’s teal Ford pickup loaded full of printer paper that was on sale at Staples.” * * *
    • “Under Klomp’s watch, crucial decisions will be made about the direction of Medicare. They include whether to rein in abusive coding and denials practices by private Medicare Advantage plans that cover a majority of enrollees, whether to reform how Medicare pays doctors and hospitals, and whether it will pay for a new breed of obesity medications. Because of Medicare’s reach, other insurers often follow its lead on payments and other policies, putting Klomp in a position to significantly influence the entire American health care system.”
  • Healio adds,
    • “Medicare Part D coverage of obesity medications could lead to a large increase in health care costs due to the prices of the drugs, according to data from a microsimulation model published in JAMA Health Forum.
    • “As Healio previously reported, CMS decided to not move forward with a previously proposed rule to have Medicare begin covering obesity medications in the 2026 calendar year, though the agency said it could reconsider the proposal in future rulemaking.
    • “If Medicare were to cover obesity medications, however, there could be huge financial implications, according to David D. Kim, PhD, assistant professor of medicine and public health sciences at University of Chicago. 
    • “Our finding is that obesity drugs [would be] a pretty substantial cost, [about] $47 billion over the next 10 years,” Kim told Healio. “These are important numbers, because a lot of people say that GLP-1s will save a lot of money in health care because obesity is a risk factor for many other conditions. … Our paper highlighted that in some sense, GLP-1s do save money, but not enough to offset the high prices of the medication.”
  • BioPharma Dive lets us know,
    • “Novavax claims it can surmount the latest regulatory hurdle hindering its quest to win full U.S. clearance of its COVID-19 vaccine, saying Monday it believes its application is still approvable pending an agreement with the Food and Drug Administration on a postmarketing clinical trial.
    • “Last week, Novavax revealed the agency had requested what’s known as a postmarketing commitment to further study the shot in clinical tests. On Friday, The Wall Street Journal reported the FDA had asked Novavax to conduct an additional randomized clinical trial, which would be a costly and time-consuming additional step for the company.
    • “A spokesperson for Novavax, contacted by BioPharma Dive Friday, said the company “cannot comment on the details of the request” while engaging with the FDA. It’s unclear when exactly the agency wants Novavax to complete the study.”

From the judicial front,

  • Modern Healthcare reports,
    • “Elevance Health is facing a second lawsuit accusing it of maintaining inaccurate provider directories, also known as “ghost networks.”
    • The plaintiffs are three people covered under New York state employee health benefits who allege that Elevance Health division Carelon Behavioral Health misrepresented providers as in-network, causing them financial harm. The attorneys are seeking class-action status.” * * *
    • Pollock Cohen and Walden Macht Haran & Williams filed the lawsuit against Elevance Health subsidiary Anthem Blue and Cross Blue Shield of New York in the U.S. District Court for the Southern District of New York.
    • “The Elevance Health plaintiffs allege Carelon Behavioral Health, which administers mental health benefits to state and municipal employees enrolled in the New York State Health Insurance Program’s Empire Plan, misled policyholders seeking mental healthcare.”

From the public health and medical research front,

  • STAT News reports,
    • “A clinical trial run by the National Cancer Institute seems to confirm that a single dose of the vaccine used to prevent infection with the human papilloma virus is just as effective as two — and, therefore, also helps to prevent cancer.
    • “The result could transform efforts to reach the three-quarters of children globally who should receive the vaccines but don’t. The shots prevent cervical cancer and also anal, penile, and some head-and-neck cancers. Worldwide, 350,000 women die from cervical cancer, the most common HPV cancer.
    • “I think we can all agree that one dose and two doses of … these fantastic vaccines work really well,” said Aimée R. Kreimer, the NCI investigator who presented the new data here Monday at the annual meeting of the American Association for Cancer Research. “We’re really excited about these results.”
    • “In developed countries, including the U.S., two doses of the vaccines are currently recommended. But in the clinical trial, whether one dose or two doses were used, the results were equivalent, according to the study of 20,000 girls between ages 12 and 16 in Costa Rica who were followed for 4 1/2 years. In all cases, the estimated efficacy of the vaccines was upwards of 97%.”
  • Per MedPage Today,
    • “Another benefit of GLP-1 receptor agonist (RA) use may be protection from persistent atrial fibrillation (Afib or AF) after ablation, according to a large Veterans Affairs database.
    • “New initiators of these drugs in 2015-2022 — specifically people with type 2 diabetes (T2D), obesity, and active Afib — showed significant improvement in their time to first hospitalization for Afib, Afib-related procedures (cardioversion/ablation), or all-cause mortality over a median 3 years of follow-up (HR 0.87, 95% CI 0.68-0.96) when compared against controls getting a DPP-4 inhibitor (DPP4i) or sulfonylurea.
    • “Accounting for mortality as competing risk, the Afib burden trended numerically in favor of the GLP-1 RA group (HR 0.85, 95% CI 0.61-1.03), noted Varun Sundaram, MD, PhD, MSc, of Case Western Reserve University in Cleveland, in his presentation of the TRANSFORM-AF study at the Heart Rhythm Society annual meeting.
    • “This is an exciting study for people with AF, T2D, and obesity along with the clinicians treating them. This retrospective study suggests there is a cardioprotective effect of GLP-1RA compared to DPP4i in hard AF endpoints,” commented James Lo, MD, PhD, of Weill Cornell Medicine/New York-Presbyterian Hospital in New York City.
  • Medical News Today warns us,
    • “A multi-decade study finds that the damage done by smoking, heavy drinking, and being physically inactive begins at a far younger age than previously understood.
    • “Although the unwanted health consequences of these habits over the long term are well-known, the research offers evidence that their negative impact, though not as severe, actually occurs over the short term.
    • “Participants in the study were assessed for depression, sense of well-being, metabolic risk, and sense of healthfulness, all of which suffered as a result of smoking, drinking, and being inactive.
    • “While it is no surprise that a lifetime of smoking, heavy drinking, and physical inactivity is a recipe for ill health later in life. 
    • “Now, a new study finds that these habits can result in health issues as young as the age of 36, including their influence on mental health.
    • “The findings of the study were recently published in the Annals of Medicine.”
  • Health Day adds,
    • “Risk factors for dementia could start taking their toll as early as a person’s 20s and 30s, a new study says.
    • “Younger adults who carry known risks for dementia performed worse on memory and thinking tests between ages 24 and 44, researchers report in the May issue of the journal The Lancet: Regional Health Americas.
    • “The findings lay the groundwork for early detection of Alzheimer’s disease and dementia, researchers say.
    • “This is the first study to look at risk factors of dementia and Alzheimer’s disease in a large group of generally healthy younger adults, researchers say.
    • “Previously, research on Alzheimer’s disease risk factors has focused on individuals aged 50 and older,” lead researcher Allison Aiello, a professor of epidemiology at the Columbia University Aging Center, said in a news release.
    • “These new results show that well-established risk factors and blood biomarkers for dementia appear to start affecting cognitive function even before middle age, Aiello said.
    • “These risk factors include education level, gender, blood pressure, cholesterol, exercise and body mass index, a measure of body fat based on height and weight, results show. All these are measured using a Cardiovascular Risk Factors, Aging, and Incidence of Dementia (CAIDE) score.”
  • The American Medical Association tells us what doctors wish their patients knew about insomnia.
  • Benefits Pro relates,
    • “According to researchers, the survey reveals a possible cognitive dissonance: Americans know they should schedule a preventive care screening or wellness visit, but their behavior often suggests otherwise. For 65% of Americans, experiencing a health scare is what made them realize they need to be more proactive about their health. Attitudes about preventive care are often counterintuitive, however, as many of those who believe they will be diagnosed with cancer are more likely to delay screenings (62% vs. 42%).
    • “Many avoid going to the doctor instead of doing what they can to avoid a health scare or detect a problem early,” Tom Morey, Aflac’s senior vice president and chief actuary, said in a statement while also noting his own health crisis that kept him away from work for nearly two years and in and out hospitals for 18 months. “It starts with making preventive care a priority and taking steps toward establishing a trusted relationship with a primary care doctor. Personally, this helped me to feel more confident, more in control of my health, and more empowered to deal with an illness that, otherwise, may have gone undetected.”
  • Health Day also informs us,
    • “Breast cancer patients fare better if they continue to exercise during their treatment, and a new program can help women get the activity they need to boost their odds, researchers say.
    • “The Comprehensive Oncology Rehabilitation and Exercise (CORE) program assesses women’s physical activity needs based on the stage to which their cancer has progressed, researchers reported today in the journal Cancer.
    • “More than 3 in 5 patients (62%) completed their referral to an exercise program designed to meet their specific needs, researchers said.
    • “CORE may serve as a model workflow algorithm aimed to integrate both exercise and rehabilitation services from time of diagnosis and beyond,” senior researcher Adriana Coletta, an investigator at the University of Utah’s Huntsman Cancer Institute, said in a news release.”
  • Consumer Reports, writing in the Washington Post, points out,
    • “You often hear that fish is brain food. True, but so are eggs, pork loin and Brussels sprouts. That’s because they’re rich in choline, a nutrient related to B vitamins.
    • “Choline is critically important for a variety of body and brain functions,” says Ramon Velazquez, an assistant professor at the Arizona State University-Banner Neurodegenerative Disease Research Center in Tempe. It’s part of all cell membranes, and in recent years there’s been increasing evidence linking it to better cognitive function and even a lower risk of Alzheimer’s disease. But about 90 percent of people don’t get enough of it.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Most Blue Cross and Blue Shield companies lost money last year as rising Medicaid and Medicare costs squeezed their bottom lines.
    • “The vast majority of 31 Blues companies reported weaker operating margins as membership declined and medical and pharmaceutical costs rose, according to an analysis of state financial filings that Mark Farrah Associates performed for Modern Healthcare.
    • “Across the Blues, operating margin fell 3.2 percentage points from a 0.3% gain in 2023 to a 2.9% loss in 2024. Just eight Blues companies reported positive operating margins last year.
    • “That contrasts with the annual margin growth enjoyed by national, publicly traded insurers. For-profit insurers average operating margin rose 1.6 percentage points to 2.4% in 2024, according to the health data analytics firm.”
  • Beckers Payer Issues tells us fifty things to know about UnitedHealth Group.
  • Fierce Healthcare relates,
    • “While health plans are not likely to feel the most acute effects from the Trump administration’s tariffs, they face downhill impacts from market volatility and rising costs, according to a new analysis from Fitch Ratings.
    • “The report examines the way tariffs could affect multiple types of insurance and estimates that health insurers in particular face moderate exposure to the slower economic growth and financial performance that are more indirect results of the tariffs.
    • “Health plans benefit in this particular case from the vast majority of their operations being domestic. However, while that suggests the impacts will be fairly limited in the short term, the effects would ramp up should the tariffs remain in place for an extended period, or if they evolve to be more restrictive.
    • “As an example, tariffs on pharmaceutical products would also likely lead to short-term cost pressures on insurers, according to Fitch.”
  • FiercePharma notes,
    • “Ending a 20-year-plus drought, Merck & Co.’s Keytruda demonstrated that its use around surgery can reduce the risk of certain head and neck cancers from returning.
    • “Continuous use of Keytruda—both before and after surgery—reduced the risk of recurrence or death by 27% in patients with stage 3 or 4a, resected, locally advanced head and neck squamous cell carcinoma (HNSCC), according to results from the phase 3 Keynote-689 trial presented at the American Association for Cancer Research Annual Meeting 2025.
    • “In the study, Keytruda was added to postoperative radiotherapy with or without chemo. Investigators compared the perioperative Keytruda regimen with the sans-Keytruda standard treatment.
    • “Keynote-689 marks the first positive trial in more than two decades in resected locally advanced HNSCC, making Keytruda the first PD-1 inhibitor to mount such a benefit.”
  • Per BioPharma Dive,
    • “Merck KGaA has agreed to buy biotechnology company SpringWorks Therapeutics, announcing Monday a $3.9 billion deal after months of negotiations over an acquisition.
    • “The German pharmaceutical firm will pay $47 per SpringWorks share, a small premium to the stock’s closing price Friday but 17% higher than the $40.28 it closed at on Feb. 7, the last trading day before reports emerged of the companies’ discussions.
    • “SpringWorks has developed two drugs that are approved in the U.S. to treat rare tumors. Ogsiveo is cleared for adults with desmoid tumors, while Gomekli won the Food and Drug Administration’s OK in February for adults and children with neurofibromatosis type 1 who experience symptoms from a type of benign tumor.”
  • Per MedTech Dive,
    • “Medtronic has filed for Food and Drug Administration approval of its Hugo soft tissue robotic surgery system with a urologic indication, marking a major step in its bid to compete with Intuitive Surgical. The company said Saturday that it made the submission in the first quarter of 2025. 
    • “Medtronic also completed enrollment in hernia and benign gynecology studies and received approval to start a trial in oncologic gynecology procedures. The studies will support submissions for additional U.S. indications for the robot.
    • “Data from the company’s investigational device exemption study for the Hugo robot in urologic surgery, presented at the American Urological Association annual meeting, met the primary goals for safety and effectiveness, according to Medtronic.”

Thursday Report

David Ermer–CDC, CMS, Congress, COVID-19, FDA, Medical / Rx research, Mental health care, NIH, OPM, SCOTUS, Telehealth, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC

  • The American Hospital Association (AHA) News lets us know,
    • “Senate Health, Education, Labor, and Pensions Committee Chairman Bill Cassidy, M.D., R-La., today released a report detailing findings from an investigation into how covered entities use and generate revenue from the 340B Drug Pricing Program. As part of his investigation, Cassidy requested information from hospitals, Federally Qualified Health Centers, contract pharmacies and drug manufacturers.  
    • “Cassidy said the “investigation underscores that there are transparency and oversight concerns that prevent 340B discounts from translating to better access or lower costs for patients,” and the report outlines potential reforms needed to improve the program to better serve patients.   
    • “In a statement shared with media, AHA President and CEO Rick Pollack said, “The AHA appreciates Senator Cassidy’s leadership on 340B issues. As his report correctly observes, the 340B program was created to help hospitals reach more eligible patients and provide more comprehensive services. Even this investigation — which the report recognizes was ‘limited in scope’ given the variety of 340B hospitals across the country — demonstrates that hospitals use 340B savings to provide financial assistance to low-income patients and to maintain programs that enhance patient services and access to care. In short, 340B is vital in advancing health in communities across the country.”  
  • The President signed an executive order strengthening probationary periods in the federal civil service. Here’s a link to a fact sheet.
  • Govexec tells us, “Ex-feds launch websites to help unemployed civil servants find new jobs. Many federal employees are looking for positions outside of government following reductions in force and the Trump administration’s push for workers to take separation incentives.”
  • Per a Drug Enforcement Administration news release,
    • DEA’s National Prescription Drug Take Back Day is your chance to rid your medicine cabinet of unneeded and unwanted medications. Start your spring cleaning this year on April 26 by visiting a collection site near you.
    • Mark your calendar for this upcoming event! Participating drop-off sites will be open from 10 a.m. to 2 p.m. (local time) on Saturday, April 26. Collection sites are located around the country and will be collecting:
      • Tablets
      • Capsules
      • Patches
      • Other solid forms of prescription drugs.
  • The U.S. Preventive Services Task Force posted for public comment a draft research plan for evaluating a measure regarding “Vision in Children Ages 6 Months to 5 Years: Screening.” The public comment deadline is May 21, 2025.
  • Per the AHA News,
    • “The Food and Drug Administration has identified a Class I recall of Q’Apel Medical 072 Aspiration System after the company submitted three device event reports that included a tip detachment, a vessel rupture and a vasospasm.”

From the judicial front,

  • Professor Katie Keith wrote an article in Health Affairs Forefront about the Kennedy v. Braidwood Management oral argument presented to the Supreme Court last Monday.
  • Fierce Pharma informs us,
    • “Halozyme is not holding back against Merck & Co. in the companies’ injectable Keytruda patent dispute, having now escalated a verbal warning into a lawsuit.
    • “In a lawsuit filed Thursday in a New Jersey federal court, Halozyme alleges that a proposed subcutaneous formulation of Merck’s popular cancer drug Keytruda infringes 15 of its patents.
    • “Those intellectual properties belong to a Halozyme patent family called Mdase, which covers a large group of modified human hyaluronidases. A hyaluronidase protein may allow for under-the-skin administration of otherwise intravenously infused drugs.
    • “Halozyme is seeking an injunction to block Merck’s planned commercialization of subcutaneous (SC) Keytruda, which is under FDA review with a decision expected by Sept. 23. The San Diego drug delivery expert is also asking for monetary relief and “an enhancement of damages,” because the alleged infringement is said to be willful, according to its complaint.
    • “Even though SC Keytruda has not reached the market, Merck opened itself to patent litigation after publicly laying out its intention to launch the product this year pending FDA approval.”

In State government news,

  • Mercer offers a roundup of selected state healthcare developments in the first quarter of 2025.

From the public health and medical research front,

  • CNN reports,
    • “The United States has seen progress in reducing certain cancer risks, as overall smoking rates remain on a decline. But for other risk factors, such as those tied to cervical cancer, there is room for improvement, according to a new American Cancer Society report.
    • “The prevalence of people smoking fell from about 14% in 2019 to 11% in 2023, according to the report published Wednesday in the journal Cancer Epidemiology, Biomarkers & Prevention. Cigarette smoking is known to significantly increase the risk of developing cancer. It’s estimated to cause about 1 out of every 3 cancer deaths in the US. * * *
    • “The prevalence of people being up-to-date on recommended cervical cancer screenings has dropped from 74.8% in 2019 to 73.4% in 2021 among ages 21 to 65, the report found, leaving more women at risk of not detecting disease early. The reported noted that the decrease is alarming as HPV vaccination rates have remained “statistically unchanged” in recent years. In 2023, 61.4% of adolescents ages 13 to 17 were up-to-date for the HPV vaccination series, similar to 61.7% in 2021 and up from 54.2% in 2019.
    • “HPV or human papillomavirus is a group of more than 150 viruses that can cause certain types of cancer. Spread primarily through sexual contact, most cases of HPV clear on their own within two years, but when the infection does not go away, health problems like cancer may occur – which is why preventing these infections with vaccination has been key.”
  • The National Cancer Institute announced,
    • “Researchers have discovered what appears to be a critical biological driver of the most common form of ovarian cancer. The discovery, they believe, could spearhead the development of approaches for finding ovarian cancer at its earliest stages or preventing the disease from taking hold in the first place.
    • “Multiple studies have shown that high-grade serous ovarian cancer arises from precancerous growths called serous tubal intraepithelial carcinoma (STIC) lesions in the fallopian tubes. These lesions can eventually travel into the ovaries and transform into full-blown tumors.
    • “In this new study, Lan Coffman, M.D., Ph.D., of the University of Pittsburgh School of Medicine, and her colleagues showed that STIC lesions appear to arise and turn into tumors in the ovaries with the assistance of a type of stem cell that they called high-risk mesenchymal stem cells (MSCs).
    • “These high-risk MSCs—which have specific characteristics that appear to help their cancer-fueling capabilities—were abundant in the tissue, or stroma, immediately underneath STIC lesionsExit Disclaimer in fallopian tube tissue samples from women without cancer. They were also sometimes present in normal tissue. 
    • “When the researchers implanted high-risk MSCs along with healthy fallopian tube cells into mice, some developed ovarian cancer, including, in some cases, metastatic cancer, the researchers reported March 14 in Cancer Discovery.
    • “It’s not yet clear if high-risk MSCs are the primary instigator that causes healthy fallopian cells to transform into high-grade serous ovarian cancer, Dr. Coffman said, but the group’s findings support the idea that these cells are intimately involved. 
    • “What we believe we’re seeing is that [high-risk MSCs] are a supportive ‘soil’ for cancer initiation,” she said.”
  • Beckers Hospital Review adds,
    • “Some early-onset colorectal cancers may be caused by exposure to a bacterial toxin within the first 10 years of life, according to a study published April 23 in Nature.
    • “An international research team, led by Ludmil Alexandrov, PhD, from the University of California San Diego, analyzed 981 colorectal cancer genomes from patients across 11 countries for the study.” 
  • STAT News points out “Studies zoom in on clues to why Lyme disease persists and which antibiotic to prescribe. Cellular debris lingering in the liver and and a penicillin relative are identified.”
  • The AHA News tells us,
    • “A study published April 8 by the Public Library of Science’s Journal of Global Public Health found that driving while infected with COVID-19 raises the risk of an accident by 25%. The study analyzed public health and transportation data from seven states from 2020-2023. The results showed a significant association between acute COVID-19 infections and an increase in vehicle crashes.”
  • The Wall Street Journal reports,
    • A new study by French researchers found that some combinations of food additives were associated with a higher risk of Type 2 diabetes.
    • Researchers found that combinations of emulsifiers, colors and sweeteners increased the diabetes risk beyond what could be explained by individual substances alone.
    • Food-industry representatives defended combinations of what they said were safe ingredients, which they said are important for food safety and quality.
  • WTW notes, “Therapeutic alliance, the bond between client and therapist, is a game-changer in mental health programs. Employers must focus on measuring to predict better results and reduce dropout rates.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • Merck’s first-quarter net income increased, driven by Keytruda sales, reaching $5.08 billion, or $2.01 a share, up from $4.76 billion year-over-year.
    • Despite sales of Keytruda rising 4% to $7.2 billion, Merck cut its 2025 adjusted earnings projection, citing tariffs and a license agreement.
    • Sales of HPV vaccine Gardasil fell 41% due to lower Chinese demand, while animal-health product sales rose 5% to $1.6 billion.
  • and
    • “Roche’s Q1 sales beat estimates due to demand for drugs like Ocrevus and Hemlibra.
    • “Roche is boosting its U.S. manufacturing to avoid potential tariffs, investing $50 billion over five years.
    • “Roche maintains its full-year guidance, anticipating mid-single-digit sales growth.”
  • Healthcare Dive adds,
    • “Molina beat analyst expectations for earnings and revenue in the first quarter, with a topline of $11.1 billion, up 12% year over year, and net income of $298 million, down 1% year over year, according to results released Wednesday.
    • “The California-based insurer said its medical costs increased moderately in the quarter, mostly due to utilization of long-term supports and services, expensive drugs and behavioral health, along with more spending on seasonal illnesses like the flu. However, costs were generally in line with what Molina had predicted, a bright spot after UnitedHealth, the largest private insurer in the U.S., reported an unexpected spike in spending earlier this month.
    • “Molina’s results can be viewed as “good enough,” TD Cowen analyst Ryan Langston wrote in a note on the insurer’s first quarter performance.”
  • Per BioPharma Dive,
    • Sanofi’s first-quarter sales and profit exceeded analyst expectations, but the company held tight on its full-year guidance amid looming threats of new tariffs from the Trump administration and regulatory uncertainty.
    • Sales climbed 9.7% to 9.9 billion euros, or $11.3 billion, in the period, beating the consensus analyst estimate of 9.6 billion euros. Earnings for the core business rose almost 16% to 1.79 euros a share, topping the consensus expectation of 1.70 euros a share.
    • The French drugmaker benefited from the launch of new drugs and the continuing growth of Dupixent, a blockbuster medicine used to treat conditions including asthma, eczema and chronic obstructive pulmonary disease. The drug’s sales jumped 20% to 3.5 billion euros in the quarter, Sanofi said Thursday.
  • Per MedTech Dive,
    • Medtronic is seeking Food and Drug Administration clearance for an interoperable version of its latest insulin pump, an important step in the manufacturer’s collaboration with diabetes technology rival Abbott. 
    • Medtronic said on Thursday that it made two 510(k) submissions to the FDA: one for its MiniMed 780G insulin pump as an alternate controller enabled device, and another for its SmartGuard insulin dosing algorithm as an interoperable automated glycemic controller.
    • The clearances would allow Medtronic’s technology to be part of an automated insulin delivery system, which can adjust insulin dosing to patients based on real-time readings from glucose monitors, using components made by other companies.
  • and
    • Edwards Lifesciences maintained full-year financial forecasts on Wednesday, projecting sales of its heart valves would offset hits from tariff and acquisition costs.
    • First-quarter sales of transcatheter aortic valve replacements, Edwards’ largest business, were better than the company expected, executives said on an earnings call.
    • Edwards’ TAVR sales were stifled last year by capacity constraints as heart teams performed more mitral and tricuspid valve procedures with the company’s newest devices. Hospitals are now addressing capacity issues by expanding capabilities for handling increased volumes, said Larry Wood, group president of TAVR and surgical structural heart. 
  • Modern Healthcare reports,
    • “Health systems have been shouldering the cost of mobile integrated healthcare programs for at-risk patients, but some insurers may be ready to start picking up the tab as providers prove they can save money.
    • “UMass Memorial Health, Geisinger, Prisma Health and others that operate these at-home care programs say the service saves millions of dollars by preventing emergency room visits and rehospitalizations of chronically ill patients. Government and private insurers have been covering little to none of the cost, but that could be changing as systems get information to prove the programs are effective.”
  • Mobihealth News informs us,
    • San Francisco-based Hinge Health, a digital musculoskeletal care platform, announced it is partnering with Cigna Healthcare to offer the health insurance company’s self-insured clients access to Hinge’s digital musculoskeletal (MSK) care platform. 
    • Hinge offers individuals with MSK conditions access to a multidisciplinary care team, including health coaches, orthopedic surgeons and physical therapists, as well as to digital tools like surgery decision support.
    • The company also provides a pelvic health program tailored for women and Enso, its FDA-cleared wearable that delivers electrical pulses to help alleviate everyday pain.
    • Cigna’s members who choose to enroll will have access to Hinge Health through Cigna’s condition-specific care program Pathwell Bone & Joint Solution.
    • Hinge touts that it is now an MSK provider for the five largest national health plans in the U.S. by self-insured lives. 
  • Per Fierce Healthcare,
    • “Health insurers can’t lose sight of improvements to the consumer experience as they find ways to reduce and manage rising costs, according to a new report from Forrester.
    • “The analysts offered one broad takeaway for payers: “Cut costs, not corners.” They noted that the industry is at a key crossroads where it’s critical to improve consumer experience and boost trust and consider those challenges as they build strategies around cost.
    • “Health insurers must improve CX, build consumer trust, and find innovative ways to create more sustainable cost structures and better economics for customers,” they wrote. “But the thirst for cost efficiency can’t cloud insurers’ strategic visions to create better health outcomes.”
  • Per Fierce Pharma,
    • “With the threat of Trump administration’s tariffs swirling and biopharma companies bracing for impact, many are announcing their intention to strengthen their presence in the U.S.
    • “The latest to hop on the invest-in-USA bandwagon is Thermo Fisher Scientific. The Massachusetts-based producer of medical instruments, diagnostics and pharmaceuticals will spend an additional $2 billion in the U.S. over the next four years “strengthening American innovation, manufacturing and economic competitiveness,” the company said in a release.
    • “Three-quarters of the pledge will bolster Thermo Fisher’s manufacturing operations, while the remaining $500 million will expand its R&D efforts.”

Midweek Report

David Ermer–CDC, CMS, Medical / Rx research, Medicare, Mental health care, Rx coverage, U.S. Healthcare–
Photo by Thought Catalog on Unsplash

From Atlanta, Georgia

  • MedPage Today brings us news from the April 15-16 ACIP meeting,
    • “Last June, CDC’s Advisory Committee on Immunization Practices (ACIP) unanimously recommended that all adults ages ≥75 years and adults ages 60 to 74 years who are at increased risk of severe RSV disease receive a single dose of RSV vaccine; the committee did not endorse one vaccine over another. That vote supplanted the committee’s earlier recommendation that adults ages 60 and older may receive RSV vaccination “after engaging in shared clinical decision making with their healthcare provider.”
    • Today, “[t]he ACIP voted 14-0, with one abstention, on Wednesday to recommend that high-risk patients ages 50 to 59 be vaccinated for respiratory syncytial virus (RSV) and also added a new option for meningococcal vaccination.
    • “I don’t think I can say it enough, but [we need] more studies in moderate-to-severe immunocompromised patients who are at highest risk for RSV disease,” ACIP member Mini Kamboj, MD, of Weill Cornell Medical College, in New York City, said after she voted for the recommendation. This is “a call to action,” she said.”
  • and
    • “The CDC’s vaccine advisors [also] are considering options that would narrow the recommendations for the fall COVID vaccine to only include groups at higher risk for severe illness.
    • Seasonal COVID shots are currently recommended for everyone 6 months and older, but CDC’s Lakshmi Panagiotakopoulos, MD, MPH, presented findings from a recent poll of the ACIP COVID-19 Work Group showing that 76% of its members supported a non-universal (risk-based) recommendation for the 2025-2026 respiratory virus season.
  • and
    • At its meeting on Tuesday, the [ACIP] considered whether the U.S. should move to single-dose human papillomavirus (HPV) vaccination instead of the currently recommended schedule.
    • At present, the U.S. recommends two doses of HPV vaccine if they are started before age 15, and three doses if they are started at age 15 or older, and for people who are immunocompromised. Routine vaccination starts at age 11 or 12 — though it can be started at age 9 — while catch-up vaccination is recommended through age 26. Shared clinical decision making is advised for those 27 to 45.
    • “However, global HPV vaccination schedules have shifted in recent years, with the World Health Organization recommending in 2022 a two-dose schedule for those 9 and older, with an option for a one-dose schedule for those between 9 and 20. The U.K. and Australia have adopted this schedule, too.”
  • and
    • “The number of cases reported in the ongoing measles outbreak in the southwestern U.S. is likely an undercount, according to the CDC scientist leading the response to the outbreak.
    • “We do believe there’s quite a large amount of cases that are not reported,” David Sugerman, MD, CDC’s senior scientist for the 2025 measles response, said during the Advisory Committee on Immunization Practices meeting on Tuesday.”

From the judicial front,

  • Federal News Network tells us,
    • “A federal judge on Tuesday issued a preliminary injunction that prevents the U.S. Department of Labor from requiring government contractors and grant recipients to certify they do not operate any diversity, equity and inclusion programs that run afoul of anti-discrimination laws until further order from the court.
    • “Judge Matthew Kennelly of the U.S. District Court for the Northern District of Illinois issued the ruling in response to a lawsuit filed by Chicago Women in Trades, a nonprofit dedicated to training and retaining women in skilled construction trades that receives several grants from the Department of Labor.
    • “The certification provision is a key part of President Donald Trump’s executive orders aimed at curbing DEI programs because contractors and grant recipients could be subjected to crippling financial penalties under the False Claims Act if they are found in violation of it.” * * *
    • “Kennelly had already issued a temporary restraining order against the Labor Department last month that was shorter in duration. His order is limited in scope because he declined to extend the injunction to other federal agencies beyond DOL.”
  • The American Hospital News informs us,
    • “A Minnesota state court April 15 dismissed a lawsuit filed by PhRMA challenging the state’s law protecting 340B pricing for contract pharmacy arrangements. The court ruled that the state law is not preempted by federal law, does not engage in unconstitutional extraterritorial regulation and that the law does not violate Minnesota’s Single Subject and Title Clause.
    • “The AHA filed an amicus brief in the case last year and filed others in similar cases for multiple states, in defense of those states’ 340B contract pharmacy laws.”
  • Beckers Payer Issues reports,
    • “CMS has denied an appeal from Humana to raise its 2025-star ratings, the company disclosed in an April 15 court filing. 
    • “Humana saw its Medicare Advantage star ratings drop significantly from 2024 to 2025, which will hurt the company’s 2026 revenues. Star ratings determine the bonuses CMS pays to MA plans. 
    • “Humana filed its lawsuit in October 2024 challenging the ratings in federal district court in Texas.”
  • In September 2019, WHYY, a Philadelphia PBS news outlet, reported
    • “Seventeen local defendants, including five medical professionals, are among those ensnared in a coordinated health care fraud enforcement action across Pennsylvania, New Jersey, New York, Connecticut and Washington, D.C., involving more than $800 million in loss and the distribution of over 3.25 million opioid pills in so-called pill mill clinics, the U.S. Justice Department said Thursday.”
    • A Justice Department press release states that on April 15, 2025, “a federal jury convicted a medical doctor [who was one of the medical professionals ensnared in September 2019], for his participation in conspiracies to commit health care fraud and wire fraud and to unlawfully distribute controlled substances.” Those crimes impacted FEHB plans, among other health plans.
  • Govexec points out,
    • As federal employees continue to face widespread layoffs, unions and advocacy groups on Wednesday launched a network to provide legal advice to government workers. 
    • The goal of the Rise Up: Federal Workers Legal Defense Network is to recruit attorneys to provide individual guidance to federal employees who fear losing their jobs or have already lost them. 
    • “Our network is already fighting back against illegal firings and other abuse of federal workers, but thousands of federal workers still need legal advice and representation,” according to the coalition’s website. “That means we need thousands of lawyers to help.” * * *
    • Federal employees can request legal assistance here.

In State government news,

  • STAT News reports,
    • “Arkansas Gov. Sarah Sanders has signed a first-in-the-nation law (HB 1150) that prohibits pharmacy benefit managers from operating both retail and mail-order pharmacies, a move designed to eliminate a conflict of interest that has been blamed for boosting the price of medicines and forcing independent pharmacies to close.
    • “At issue is an ongoing concern that the largest pharmacy benefit managers — which are controlled by CVS Health, Cigna, and UnitedHealth Group — favor their own pharmacy operations. Critics say that by doing so, these companies not only dominate the design of health plans for tens of millions of Americans but also distort the distribution and pricing for prescription medicines.” * * *
    • “The Arkansas bill has gone further than other states. The legislation would force the owners of the pharmacy benefit managers to make a choice — continue operating these industry middlemen or relinquish the right to run retail or mail-order pharmacies that operate in the state. By doing so, state lawmakers have argued they will reduce costs for state residents.”
  • KARK, a Little Rock television station, adds,
    • “CVS Health welcomes a good faith discussion with policy makers in Arkansas and across the country on ways to make medicine more affordable and accessible,” CVS shared in a statement. “Unfortunately, HB1150 is bad policy that accomplishes just the opposite: it will take away access to pharmacy care in local communities, hike prescription drug spending across the state by millions of dollars each year, and cost hundreds of Arkansans their jobs.”
    • “According to CVS, they have 23 pharmacies across the state. They also noted that this law will close more than 100 mail-order pharmacies in Arkansas.”

From the public health and medical research front,

  • Per BioPharma Dive, “New research kindles excitement around stem cell therapies for Parkinson’s Disease. Two studies published in Nature found stem cell-derived products can not only be safely transplanted into the brain but also show promising — albeit unproven — signs of efficacy.”
  • The National Academy of Sciences announced,
    • Oral health is an essential part of overall health, but issues around insurance coverage, workforce, and more, are leaving millions of Americans without sufficient oral health care. The @NASEM Health and Medicine Division hosted a workshop in November 2024 to address some of the barriers to care. Read a recap of the event here: https://tinyurl.com/5epd9rcs
  • Per MedCity News,
    • “Drugs have been the standard migraine treatment for decades. The severe headaches, nausea, and other problems associated with this common disorder now have a digital treatment option, a mobile app developed by prescription digital medicines startup Click Therapeutics.
    • “The FDA marketing authorization announced Tuesday permits use of the Click digital therapeutic for the prevention of episodic migraine in patients age 18 and older. Episodic migraine is defined as having fewer than 15 headache days per month. The Click migraine app, known in development as CT-132, does not replace migraine drugs. The FDA authorization covers use of the app as an adjunct to standard migraine treatments, which is how it was evaluated in clinical trials.
    • “Click’s research is based on mapping of the entire brain. The company has found faulty brain circuits implicated in many diseases, Chief Medical Officer Shaheen Lakan said in a 2023 interview. For various indications, the New York-based startup develops software that takes users through a series of tasks that have the effect of retraining and rewiring the brain over the course of weeks.”
  • Per Cancer Network
    • The incidence of pancreatic and colorectal adenocarcinoma has increased among young adults, highlighting a need for heightened awareness of this trend when evaluating younger patients with possible symptoms, according to findings from a retrospective cohort study published in JAMA Network Open.1
    • Findings from the trial revealed that a total of 275,273 patients with pancreatic adenocarcinoma were reported between 2000 and 2021, 51.8% of whom were male and 87.1% of whom were 55 years or older. An overall increasing incidence trend was noted, with the highest annual percentage change (APC) observed in those aged 15 to 34 years (4.35%; 95% CI, 2.03%-6.73%). The APC for the aforementioned age group was significantly higher than in those 55 years or older (1.74%; 95% CI, 1.59%-1.89%; P = .007) and those aged 35 to 54 years (1.54%; 95% CI, 1.18%-1.90%; P = .004).
  • Medscape lets us know,
    • “Can long-term physical activity influence mortality and biological aging? Researchers at the University of Jyväskylä in Jyväskylä, Finland, set out to answer this question and uncovered a surprising finding: Moderate physical activity had the most significant positive effect on longevity, reducing mortality by 7% over a 30-year period.
    • “Interestingly, higher levels of physical activity did not confer additional mortality benefits. The study was published in the European Journal of Epidemiology.”

From the U.S. healthcare business front,

  • Beckers Payer Issues tells us why “patient expectations will push healthcare to evolve by 2030, according to 21 payer executives.” 
  • Fierce Healthcare informs us,
    • “The Peterson Center on Healthcare released a new report that recommends policymakers narrow payment guidelines for a service they think could rocket spending in the public sector. 
    • “The costs of remote monitoring on Medicare have grown significantly in the years since the codes became available to providers, from $6.8 million in 2019 to $194.5 million in 2023. The services can be used for a host of chronic conditions that many Americans suffer from, including diabetes, hypertension and heart disease. 
    • “The Peterson Center takes issue with the increasing number of Medicare, Medicaid and Medicare Advantage patients who have been prescribed remote monitoring and the increasing amount of time their providers keep them using the technology. 
    • The report finds that chronic conditions only benefit from intense monitoring by providers for a short period of time, which varies by condition. Without additional guardrails, the report says public spending on remote monitoring could increase dramatically.
    • Under the current requirements for remote monitoring, CMS does not dictate which conditions should be monitored or for how long. Because CMS currently does not limit the amount of time that a provider can charge Medicare, Peterson calls them “forever codes.” 
    • The codes have only been in existence since 2019, but Peterson recommends policymakers steer providers towards high-value services and away from ongoing monitoring with no discernible clinical benefit.
  • Healthcare Dive notes,
    • “Ascension Health has inked a definitive agreement to acquire full ownership of a Texas hospital and its ancillary businesses from Community Health Systems for $460 million, the health system said Tuesday.
    • “Ascension Seton, a subsidiary of Ascension Texas, will purchase the remaining 80% stake in 126-bed Cedar Park Regional Medical Center. Although the system already owned a minority interest in Cedar Park, Ascension said acquiring full ownership would represent a “significant step” toward expanding medical services and care access in the Central Texas community.
    • “The deal is expected to close this summer, subject to regulatory approvals.
  • Per Modern Healthcare,
    • “The Permanente Medical Group and Northwest Permanente said Wednesday they have formed an affiliation.
    • “The medical groups will remain separate but will collaborate clinically and share innovations as part of the agreement. The groups will work together on telehealth, population health and workforce wellness, in addition to pursuing more subspecialty partnerships and scaling IT initiatives, a spokesperson said.” * * *
    • “The Permanente Medical Group and Northwest Permanente are independent, physician-led groups that partner with the Kaiser Foundation Health Plan to serve patients in Oregon, Washington and California. The Permanente Medical Group has nearly 10,000 physicians across 116 specialties, while Northwest Permanente has more than 1,300 physicians across 54 specialties. The groups collectively care for 5.2 million members.”
  • and
    • “Abbott Laboratories will make new investments in U.S. manufacturing, with the impact of tariffs on medical devices and diagnostics looming over the industry.
    • “It expects to spend $500 million on two facilities, located in Illinois and Texas, Abbott said in a statement Wednesday. The investments are to expand existing plants and boost U.S. research and development, a spokesperson said. The company will hire as many as 200 people in Illinois and as many as 100 people in Texas to support the work.”
  • Beckers Clinical Leadership relates,
    • “Mark Cuban’s latest move to disrupt the pharmaceutical supply chain is expanding — this time, tackling the injectable drug market through a new partnership with distributor Morris & Dickson.
    • “His company, Mark Cuban Cost Plus Drug Co., is partnering with Morris & Dickson, a full-line and specialty pharmaceutical distributor, to improve access to injectables nationwide. 
    • “The collaboration, announced April 14, aims to mitigate drug shortages, streamline procurement and provide equitable access to providers of all sizes. It also promotes sourcing flexibility by removing volume commitments, according to a news release.”

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.”

Weekend Update

David Ermer–CMS, Congress, FDA, Medical / Rx research, Medicare, Obesity, OPM, Rx coverage, U.S. Healthcare–
Texas Blue bonnets

From Washington, DC,

  • The Wall Street Journal reports,
    • “President Trump’s “one big, beautiful bill” is headed for one big, ugly negotiation. 
    • “Congressional Republicans last week approved the fiscal blueprint that lets them pack disparate items from Trump’s wish list into a single bill that won’t need Democratic votes. GOP lawmakers expect the giant legislation to extend expiring tax cuts, implement Trump’s new tax-cut promises, increase the debt limit, cut spending and boost border security and national defense. 
    • “The one-bill strategy bets that Republicans lock arms with Trump and plunge ahead, unwilling to defy the president on an up-or-down vote on his agenda. Packaging everything together could give each party faction victories to highlight, even if they must accept pieces they detest. 
    • “The next few months will bring a blur of policies, numbers and congressional procedures that will make Republicans confront internal fractures over tax rates, incentives, Medicaid and budget deficits. The unity they have displayed so far will be tested, particularly in the House, where Speaker Mike Johnson (R., La.) has guided a fractious majority through tight votes by reassuring lawmakers they can fight over details later.”
  • Federal News Network lets us know,
    • “Although the details of House Republicans’ narrowly approved budget framework are still up in the air, some initial proposals show the possibility of changes to federal benefits, mainly in retirement and health care.
    • “As part of the GOP budget resolution, the House Oversight and Government Reform Committee is looking at cuts of at least $50 billion from its mandatory spending, according to the framework that lawmakers approved in a vote of 216-214 on Thursday. That level of spending cuts would almost certainly dig into federal benefits, the National Active and Retired Federal Employees Association (NARFE) said.
    • “Given the only major mandatory spending under the committee’s jurisdiction is federal retirement and health benefits, cuts of such a magnitude would necessarily come from cuts to federal retirement and health benefits,” NARFE wrote in a letter to Congress last week.” * * *
    • “A spokesperson for Oversight Committee Republicans declined to comment on where the proposed spending cuts would most likely move forward. But many proposals are already circulating, including several possibilities that could bring changes to federal employees’ retirement benefits, health insurance and more.”
  • Govexec adds,
    • “President Trump appears set to propose freeze civilian federal employees’ pay next year, according to draft budget documents.
    • “The news came in the form of a passback, which is effectively the Office of Management and Budget’s response to agencies’ individual budget submissions. A report by the Congressional Research Service says agencies can appeal certain programmatic decisions to OMB, the documents are, for all intents and purposes, the office’s final decision.
    • “A copy of one agency’s passback, obtained by Government Executive, said the document’s funding levels “reflect a pay freeze for civilian employees in calendar year 2026.”
    • “If enacted, it would mark the first year that federal workers have not received a pay increase since 2013, the last of three years of pay freezes amid sequestration. President Trump previously proposed pay freezes in the first three of his annual budget submissions, but Congress ultimately overruled him each time, with raises in the range of 1.4% to 2.6%.
    • “In 2020, he proposed a 1% across-the-board pay increase for feds as part of his budgetary request but reneged on that pledge and supported efforts to freeze their pay later in funding negotiations. Congress ultimately adopted the 1% increase that year.”
  • The American Hospital Association points out a bevy of proposed Medicare regulations.
    • “The Centers for Medicare & Medicaid Services April 11 issued a  proposed rule that would increase Medicare inpatient prospective payment system rates by a net 2.4% in fiscal year 2026, compared with FY 2025, for hospitals that are meaningful users of electronic health records and submit quality measure data. 
    • “This 2.4% payment update reflects a hospital market basket increase of 3.2% as well as a productivity cut of 0.8%. This update also reflects CMS’ proposal to rebase and revise the market basket to a 2023 base year. In addition, the rule includes a proposed $1.5 billion increase in disproportionate share hospital payments and a proposed $234 million increase in new medical technology payments. Overall, it would increase hospital payments by $4 billion in FY 2026 as compared to FY 2025.  
    • “In addition, CMS has included in the rule its previously published request for information seeking input on opportunities to streamline regulations and reduce burdens on providers.”
  • and
    • “The Centers for Medicare & Medicaid Services April 11 proposed increasing the long-term care hospital standard rate payments by 2.2% in fiscal year 2026 relative to FY 2025. This includes a 3.4% market basket update reduced by a 0.8 percentage point productivity adjustment. In addition, it includes a reduction of 0.3 percentage points due to CMS’ proposal to raise the fixed-loss amount for high-cost outlier payments to $91,247. The agency also has included in the rule its previously published request for information seeking input on opportunities to streamline regulations and reduce burdens on providers.”
  • and
    • “The Centers for Medicare & Medicaid Services April 11 issued a proposed rule for the inpatient psychiatric facility prospective payment system for fiscal year 2026.  
    • “CMS proposes to increase IPF payments by a net 2.4%, equivalent to $70 million, in FY 2026. The payment update reflects a proposed market-basket update of 3.2% minus a productivity adjustment of 0.8 percentage points. CMS also proposes to update the outlier threshold so that estimated outlier payments remain at 2.0% of total payments. In addition, the agency would increase the adjustment factors for IPFs with teaching status and rural location and recognize increases to IPF teaching caps as required by law.”
  • and
    • The Centers for Medicare & Medicaid Services April 11 issued a proposed rule for the skilled nursing facility prospective payment system for fiscal year 2026. The proposal would increase aggregate payments by 2.8%, which reflects a 3.0% market basket update, a 0.8 percentage point cut for productivity, and an increase of 0.6 percentage points for the market basket forecast error for FY 2024. CMS also is proposing changes to some ICD-10 code mappings for payment classifications. In addition, it has included in the rule its previously published request for information seeking input on opportunities to streamline regulations and reduce burdens on providers.  
  • CMS adds
    • On April 11, 2025, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule that proposes updates to Medicare payment policies and rates for hospices under the Fiscal Year (FY) 2026 Hospice Wage Index and Payment Rate Updated Proposed Rule (CMS-1835-P). CMS is publishing this proposed rule consistent with the legal requirements to update Medicare payment policies for hospices annually. 
  • The public comment deadline for all five proposed rules is June 10, 2025. FEHB carriers certainly would appreciate receiving

From the public health and medical research front,

  • The New York Times offers “Five Science-Backed Longevity ‘Hacks’ That Don’t Cost a Fortune.” Check it out.
  • Per Kaufmann Hall,
    • This week’s graphic highlights data from a recent study published by The Lancet on cancer incidence trends in the United States between 2000 and 2019 among those born between 1920 and 1990. Of the 34 types of cancer studied, 17 were found to have an increased incidence among those from the Generation X and Millennial cohorts. Compared to individuals in the 1955 cohort, incidence of small intestinal, thyroid, kidney and renal pelvic, and pancreatic cancers among those in the 1990 cohort was about three times higher. The incidence of those in the Generation X cohorts was also higher among these four cancers compared to the 1955 cohort’s rate. More adults are also getting diagnosed with cancer at younger ages
  • The Wall Street Journal considers “The Latest in Hernia Repair: New Techniques, New Research. As the population ages, the incidence of hernias is increasing. How do you know when surgery is needed?”
  • The Guardian reports,
    • “People who use the drug Mounjaro are able to sustain weight loss for three years, data from a trial suggests.
    • “Mounjaro, nicknamed the “King Kong” of weight loss drugs, contains tirzepatide and is self-administered in once-a-week injections.
    • “It works by mimicking two hormones called GLP-1 and GIP, resulting in appetite suppression, increased production of insulin, greater insulin sensitivity and a reduction in the rate at which food is emptied from the stomach. The medication is available for weight loss to some people on the NHS and it can also be bought privately with a prescription.”
  • Per Medscape,
    • Now that the US Food and Drug Administration has removed both tirzepatide and semaglutide from its Drug Shortages List, the widespread compounding of these drugs is ending. Tirzepatide’s deadline has already passed, while physicians and pharmacies have until April 22 for semaglutide. An estimated 2 million Americans have been using these more affordable copycats every month.
    • Even with direct-to-consumer discounts, monthly doses of brand-name versions cost hundreds more than compounded ones, putting them beyond the reach of many people. This means a significant number of compounded glucagon-like peptide 1 (GLP-1) users will be forced to go cold turkey — but studies consistently show weight regain when patients stop taking them abruptly. [The article suggests] how can you help your patients?
  • Per NPR Shots,
    • “Scientists have re-created a pain pathway in the brain by growing four key clusters of human nerve cells in a dish.
    • “This laboratory model could be used to help explain certain pain syndromes and offer a new way to test potential analgesic drugs, a Stanford team reports in the journal Nature.
    • “It’s exciting,” says Dr. Stephen Waxman, a professor at Yale School of Medicine who was not involved in the research.”

From the U.S. healthcare business front,

  • The KFF Peterson Health System Tracker assesses how cost affects access to healthcare and examines challenges with effective price transparency analyses.
  • Beckers Hospital Review tells us,
    • Physicians are seeing slower pay growth in the last year amid economic uncertainty, according to Medscape’s “Physician Compensation Report 2025.”
    • The company surveyed 7,322 physicians across 29 specialties from Oct. 3, 2024 to Jan. 15, 2025, and found compensation increased around 3.6% on average for physicians, which was the lowest growth rate since 2011 when Medscape first began reporting compensation.
    • Pay gains were around 1.4% for primary care physicians, hitting $281,000 last year, and 1% for specialists, hitting $398,000. Pay growth was the lowest since 2021 at the height of the pandemic. The pay figures cover base salary, incentive bonus and other income including profit-sharing.
    • “Specialists’ compensation was squeezed by payer reimbursement cuts, and we saw fewer specialties reporting pay increases than in several years,” the report states. “Nor was it a banner year for primary care physicians. With a lot of uncertainty in the political and regulatory arenas, and the post-COVID salary spending seemingly done, it seems like a good time for physicians to be careful with their expenses.”
  • and
    • “U.S. Bankruptcy Court Judge Kate Stickles has approved N.J.-based Hudson Regional Hospital to take over operational control of three Jersey City, N.J.-based CarePoint Health hospitals, allowing the system to exit bankruptcy.
    • “Hudson Regional now owns and operates Bayonne (N.J.) Medical Center and operates both Jersey City-based Christ Hospital and Hoboken (N.J.) University Medical Center, under the approved management agreement. Each hospital is now operated by an affiliated property owner, according to an April 11 news release shared with Becker’s.” 

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.”

Thursday Report

David Ermer–CDC, CMS, Congress, FDA, Medical / Rx research, Medicare, Rx coverage, U.S. Healthcare–
Photo by Michele Orallo on Unsplash

From Washington, DC,

  • Yesterday, the Senate Homeland Security and Governmental Affairs Committee favorably reported the President’s nominee for OPM Director, Scott Kupor, by a 7-4 vote. Mr. Kupor’s nomination will be headed for the Senate floor following the upcoming two week break from Capitol Hill.
  • Today, the American Hospital Association News let us know,
    • The House, by a vote of 216-214, passed the revised budget resolution for fiscal year 2025. This follows the Senate’s passage of the bill last week. Reps. Victoria Spartz, R-Ind., and Thomas Massie, R-Ky., joined all Democrats today in voting “no.”  
    • Notably, the resolution instructs the House Energy and Commerce Committee, which has primary jurisdiction over Medicaid and other health care programs, to cut a minimum of $880 billion in spending. * * *
    • With the House and Senate’s passage of the resolution, Congress can move forward with the reconciliation process. The next step calls for specific committees to begin drafting legislation consistent with their instructions in the budget resolution. This is where the hard work begins, as House and Senate committees must decide on the specific policies to be included within the reconciliation bill.  
    • The budget resolution gives Senate and House committees until May 9 to report legislation, but this is not a binding deadline. 
  • The approved budget resolution (page 47) calls for the House Oversight and Government Reform Committee to “submit changes in law within its jurisdiction to reduce the deficit by not less than $50,000,000,000 for the period of fiscal years 2025 through 2034.”
  • The AHA News further informs us,
    • The Trump administration yesterday [April 9] released executive orders on reducing anti-competitive regulatory barriers and repealing certain regulations deemed unlawful.  
    • The order on reducing anti-competitive barriers directs federal agencies to review all regulations subject to their rulemaking authority and identify those that create de facto or de jure monopolies, create barriers to entry for new market participants, create or facilitate licensure or accreditation requirements that unduly limit competition, or otherwise impose anti-competitive restraints or distortions in the market.   
    • The order on repealing unlawful regulations is linked to a Feb. 25 executive order that directed agencies within 60 days to identify unlawful and potentially unlawful regulations to be repealed. The new order instructs agencies to take steps to immediately repeal regulations and provide justification within 30 days for any identified as unlawful but have not been targeted for repeal, explaining the basis for the decision not to repeal.
  • Govexec adds,
    • “On Feb. 19, Trump signed an executive order requiring agencies, within 60 days and in coordination with the Office of Management and Budget and Elon Musk-backed Department of Government Efficiency, to identify for elimination or modification regulations that are unconstitutional or unlawful. 
    • “With roughly a week-and-a-half before that deadline, the president on Wednesday [April 9] declared that such regulations can be repealed without going through the notice and comment period. When an agency promulgates a new rule, or revokes one, it must seek, respond to and potentially incorporate public comment on the proposal. The process usually takes at least a year. 
    • “The Trump administration, however, is arguing that it does not have to take this step because of the “good cause” exception in the Administrative Procedure Act, which is the law that sets rulemaking requirements. The exception provides that agencies do not have to perform notice and comment if doing so would be “impracticable, unnecessary or contrary to the public interest.”
    • “Retaining and enforcing facially unlawful regulations is clearly contrary to the public interest,” the memo said. “Furthermore, notice-and-comment proceedings are ‘unnecessary’ where repeal is required as a matter of law to ensure consistency with a ruling of the United States Supreme Court. Agencies thus have ample cause and the legal authority to immediately repeal unlawful regulations.”
  • Fierce Healthcare notes, “The American people, more than any Federal official, know which regulations stifle entrepreneurship and economic growth,” the White House wrote in its fact sheet. “You are invited to tell us which regulations impede competition and should be changed or repealed.” The FEHBlog is a big fan of deregulation.
  • The AHA News was full of Washington, DC, news today.
    • “The Government Accountability Office yesterday [April 9] released a report calling for the Department of Health and Human Services to improve its efforts responding to drug shortages. The report found that although drug shortages have decreased since 2020, shortages are lasting longer. HHS responded to the GAO report, informing the GAO that its coordinator position overseeing medical product supply chains would be eliminated in May, leaving HHS without leadership to coordinate its drug shortage activities. The GAO recommended HHS implement a method to formally conduct any drug shortage activity and collaborate with other federal agencies.”
  • and
    • “The National Counterintelligence and Security Center, the FBI, and the Defense Counterintelligence and Security Center yesterday released guidance on mitigating deceptive online recruitment activities by foreign intelligence entities, particularly groups in China, that target current and former federal government employees. The agencies said the entities are posing as legitimate consulting firms, corporate recruiters, public policy institutions and other organizations on social and professional networking websites. The actors are said to be using deceptive online job offers and other virtual approaches to target individuals with federal backgrounds who may be seeking new employment.”
  • Beckers Hospital Review adds,
    • “More than one-third (41%) of active drug shortages began in 2022 or earlier, according to a new report from the American Society of Health-System Pharmacists. 
    • “The report tracks national drug shortage trends from January 2001 through March 2025. So far this year, the ASHP has reported 26 new drug shortages. Since an all-time high of 323 active drug shortages in early 2024, the number of active shortages is now 270. 
    • “The “[w]orkload required to manage shortages, including work to change pharmacy automation and electronic health records, adds to the challenges of pharmacy staff shortages,” the report said. 
    • “In 2024, 17% of shortages were related to manufacturing issues, 9% to Hurricane Helene, 9% to business decisions, 8% to supply and demand, and 2% to a raw material problem. Manufacturers did not or refused to provide a reason for 55% of shortages.” 
  • In an HHS press release, the new CMS Administrator, Dr. Mehmet Oz, shares his vision for CMS.
    • “I want to thank President Trump and Secretary Kennedy for their confidence in my ability to lead CMS in achieving their vision to Make America Healthy Again,” said Dr. Oz. “Great societies protect their most vulnerable. As stewards of the health of so many Americans – especially disadvantaged youth, those with disabilities, and our seniors, the CMS team is dedicated to delivering superior health outcomes across each program we administer. America is too great for small dreams, and I’m ready to get work on the President’s agenda.”
  • Per an FDA press release,
    • “Today, the U.S. Food and Drug Administration is taking a groundbreaking step to advance public health by replacing animal testing in the development of monoclonal antibody therapies and other drugs with more effective, human-relevant methods. The new approach is designed to improve drug safety and accelerate the evaluation process, while reducing animal experimentation, lowering research and development (R&D) costs, and ultimately, drug prices.
    • “The FDA’s animal testing requirement will be reduced, refined, or potentially replaced using a range of approaches, including AI-based computational models of toxicity and cell lines and organoid toxicity testing in a laboratory setting (so-called New Approach Methodologies or NAMs data). Implementation of the regimen will begin immediately for investigational new drug (IND) applications, where inclusion of NAMs data is encouraged, and is outlined in a roadmap also being released today. To make determinations of efficacy, the agency will also begin use pre-existing, real-world safety data from other countries, with comparable regulatory standards, where the drug has already been studied in humans.”

In State government news,

  • STAT News reports,
    • An Arkansas bill that would prohibit pharmacy benefit managers from operating retail and mail-order pharmacies was passed by the state senate and is now headed to Gov. Sarah Sanders, the first time such a bill has gotten this far down the legislative path in the United States.
    • “The bill is designed to eliminate what state — and some federal — lawmakers have called a conflict of interest that has forced residents to pay more for medicines and hastened the demise of independent pharmacies. And it arrives as scrutiny of pharmacy benefit managers and their role in the opaque pricing of prescription drugs has increased dramatically. A spokesman for Sanders declined to say whether she would sign the bill and, if so, when.” * * *
    • “As for CVS, the company sent us a statement saying “This bill rips medicine away from sick patients and makes it harder for people to achieve better health. A veto will protect communities, improve care, and help hundreds of thousands of Arkansans get the medicines they need. Governor Sanders should choose people over misguided policy that will lead to serious consequences.”
    • “A spokeswoman for Express Scripts directed us to a web site where the company argues state residents will lose the convenience of home delivery as well as focused care for certain diseases that are treated by medicines distributed through a specialty pharmacy operation called Accredo.”

From the public health and medical research front,

  • Tech Target tells us,
    • “Only half of Americans are getting regular cancer screenings and routine medical care, signaling a need for more public awareness of the importance of primary and preventive care, according to the Prevent Cancer Foundation’s 2025 Early Detection Survey.
    • “The survey of 7,000 U.S. adults aged 21 or older showed that only 51% of people are accessing routine medical care and cancer screening, a significant 10 percentage-point downswing from a similar 2024 survey.
    • “There are numerous reasons patients miss their cancer screenings, but most generally center on public awareness and information, the survey continued. For example, 43% of respondents said they weren’t aware that they needed to be screened for a certain type of cancer. Likewise, 40% said they didn’t have any symptoms of disease and another 40% said they had no family history of the illness.”
  • Per Health Day,
    • “Stroke, dementia and depression share 17 common risk factors
    • “Improving any of the risk factors can improve odds against any of the three brain health problems
    • “High blood pressure and kidney disease had the biggest impact on risk.”
  • Per the American Journal of Managed Care,
    • “Newer glucose-lowering medications glucagon-like peptide-1 receptor agonists (GLP-1 RAs) and sodium-glucose cotransporter-2 (SGLT2) inhibitors significantly reduced the risk of major cardiovascular events and heart failure in older adults with type 2 diabetes (T2D), according to one study.1 The findings suggest these treatments outperform dipeptidyl-peptidase-4 (DPP-4) inhibitors, regardless of age, and support their use in clinical guidelines for elderly populations.”
  • Per MedCity News,
    • “Solu Therapeutics, a company developing a new type of antibody drug, unveiled $41 million in financing on Wednesday for clinical testing of a therapy with the potential to bring a safer and more effective approach to blood cancers.
    • “Boston-based Solu has already begun dosing patients in a Phase 1 test of lead program STX-0712 in resistant or refractory chronic myelomonocytic leukemia (CMML) and other hematologic malignancies. The target of the drug is CCR2, a receptor that plays a role in cancer development and progression. The Solu drug is intended to eliminate CCR2-positive cells. It does so in a novel way.”

From the U.S. healthcare business front,

  • The New York Times reports,
    • “Seniors across the country are wearing very expensive bandages.
    • “Made of dried bits of placenta, the paper-thin patches cover stubborn wounds and can cost thousands of dollars per square inch.
    • “Some research has found that such “skin substitutes” help certain wounds heal. But in the past few years, dozens of unstudied and costly products have flooded the market.
    • “Bandage companies set ever-rising prices for new brands of the products, taking advantage of a loophole in Medicare rules, The New York Times found. Some doctors then buy the coverings at large discounts but charge Medicare the full sticker price, pocketing the difference.
    • ‘Partly because of these financial incentives, many patients receive the bandages who do not need them. The result, experts said, is one of the largest examples of Medicare waste in history.
    • “Private insurers rarely pay for skin substitutes, arguing that they are unproven and unnecessary. But Medicare, the government insurance program for seniors, routinely covers them. Spending on skin substitutes exceeded $10 billion in 2024, more than double the figure in 2023, according to an analysis of Medicare data done for The Times by Early Read, a firm that evaluates costs for large health companies.
    • “Medicare now spends more on the bandages than on ambulance rides, anesthesia or CT scans, the analysis found.”
  • The KFF Peterson Health System Tracker identifies health spending issues to watch this year.
  • Fierce Pharma reports
    • “On the heels of similar investment pledges from Eli Lilly and Johnson & Johnson, Switzerland’s Novartis is stepping up to the plate with a major plan to grow its U.S. footprint.
    • “Novartis will spend $23 billion to build and expand 10 U.S. facilities over the next five years, the company said in a Thursday press release. Reuters first reported the news following an interview with Novartis’ CEO Vas Narasimhan.
    • “The outlay is the latest in a series of moves seemingly spurred on by the threat of import tariffs on pharmaceuticals under the second Trump administration.
    • “On the production front, Novartis will build four new manufacturing facilities in “soon-to-be-determined states,” plus establish new radioligand therapy plants in Florida and Texas. The company will also expand existing radioligand manufacturing facilities in Indiana, New Jersey and California.”
  • Per MedCity News,
    • “Teladoc Health, a virtual care company, unveiled its new Cardiometabolic Health Program on Tuesday to prevent the advancement of diabetes, hypertension and obesity.
    • “Purchase, New York-based Teladoc Health serves both employers and health plans. In addition to support for weight management and diabetes, it offers mental health care, primary care and specialty services.
    • “The new program provides a premium subscription to BetterSleep, an app that’s focused on improving sleep quality. Patients also gain access to one-on-one support with a registered dietitian, outreach from health coaches, at-home testing for cardiometabolic measures and health insights from connected devices (like blood glucose meters). The program is available to those with a body mass index of 25 or above.”
  • Healthcare Dive relates,
    • “Kandu Health and Neurolutions have merged and raised $30 million to support stroke recovery and rehabilitation, the companies said Tuesday.
    • “The merger brings together Neurolutions’ brain computer interface technology and Kandu Health’s telehealth services to try to improve stroke patients’ outcomes after they leave the hospital. 
    • “Patients will have access to Neurolutions’ IpsiHand, a device that is cleared for use in the U.S. The system translates brain signals to enable stroke patients to open and close their hands.”
  • Per Beckers Hospital Review,
    • “West Orange, N.J.-based RWJBarnabas Health and the Rutgers Cancer Institute of New Jersey plan to open the state’s first freestanding cancer facility in May.
    • “Three things to know:
      • “The $750 million, 520,000-square-foot project broke ground in 2021. It is a 12-story facility that will house inpatient and outpatient cancer services, along with research laboratories. 
      • “The freestanding cancer facility is adjacent to the Robert Wood Johnson University Hospital and Rutgers Cancer Institute of New Jersey campus in New Brunswick, N.J.
      • “The cancer pavilion is designed to serve as a leading model for cancer care on the East Coast, uniting research, education and patient care under one roof.”

Monday Report

David Ermer–CMS, Congress, FDA, Medical / Rx research, Medicare, Mental health care, NIH, Rx coverage, SCOTUS, U.S. Healthcare–
Photo by Sven Read on Unsplash
  • The Wall Street Journal reports,
    • “House Republicans’ moves to advance President Trump’s “one big, beautiful bill” this week have been cast into doubt by defections from GOP lawmakers worried that spending cuts are being pushed aside in a rush to enact tax reductions.
    • “Republican leaders want to vote on a fiscal framework that would unlock a fast track to legislation carrying many Trump priorities, including tax cuts and new spending on border security and the military. Trump and House Speaker Mike Johnson (R., La.) are hoping to show progress on extending expiring tax cuts to counteract the market chaos sparked in recent sessions by Trump’s tariff rollout.” 
  • and
    • The Trump administration will substantially increase payment rates for Medicare insurers next year, generating more than $25 billion in additional revenue for the industry and doubling the boost proposed in January.
    • The rate increase of 5.06%, compared with 2.23% in the earlier proposal from the Biden administration, overshoots even optimistic expectations from many Wall Street analysts, and will likely lead to a rally in the shares of big Medicare insurers such as UnitedHealth Group, Humana and CVS Health, parent of Aetna.
    • The Centers for Medicare and Medicaid Services announced the increase for 2026 payment rates on Monday. Investors are expected to view the bump as a sign of the Trump administration’s support for Medicare Advantage, the program under which private insurers administer the benefits of the federal program for older and disabled Americans. 
      The Medicare agency said the increase in the planned payment rate reflected rising medical costs, and that more recent data had led to the steeper final rise compared with the January proposal. 
  • Here are links to the CMS Medicare Advantage and Medicare D 2026 rate announcement, the related CMS fact sheet, and a CMS fact sheet about final 2026 Part D program redesign instructions:
    • “In CY 2026, the structure of the Part D benefit will be updated to reflect provisions of the IRA that become effective on January 1, 2026. The CY 2026 updates include the following:
    • “The CY 2026 annual out-of-pocket (OOP) threshold of $2,100, which is the original 2025 out-of-pocket cap of $2,000, adjusted based on the annual percentage increase in average expenditures for covered Part D drugs in the U.S. for Part D eligible individuals in the previous year (API).
    • “Changes to the liability of enrollees, sponsors, manufacturers, and CMS in the new standard Part D benefit design, specifically to account for the start of negotiated prices taking effect with respect to selected drugs for initial price applicability year 2026 under the Negotiation Program; and
    • “The establishment of the selected drug subsidy program.” * * *
    • “With the enhancements to the Part D benefit under the IRA, the current simplified determination methodology no longer reflects actuarial equivalence with defined standard Part D coverage. Accordingly, CMS has developed a revised simplified determination methodology that better reflects actuarial equivalence with the richer Part D defined standard benefit under the IRA. For CY 2026 only, non-RDS group health plans are permitted to use either the existing simplified determination methodology or the revised simplified determination methodology to determine whether their prescription drug coverage is creditable. Under the revised simplified determination methodology, the group health plan coverage must be designed to pay at least 72% of participants’ prescription drug expenses, versus 60% under the existing methodology.” 
  • In another surprising Medicare development, STAT News informs us,
    • “Medicare’s financial future unexpectedly got a lot rosier, at least according to some federal budget wonks. 
    • “The Congressional Budget Office recently published its long-term predictions of the federal budget and buried a big surprise for people who follow the Medicare program. The government’s primary piggy bank that pays for Medicare [Part A hospital and other facility] benefits won’t be depleted until 2052 — 17 years later than what CBO analysts predicted last year. 
    • “Quite a few responded they don’t believe it,” he said. “But they [CBO] do have their justification there. And of course this is a long-term projection, and a lot can change.”
  • The New York Times reports,
    • “Health Secretary Robert F. Kennedy Jr. kicked off a tour through southwestern states on Monday by calling on states to ban fluoride in drinking water supplies, a move that would reverse what some medical experts consider one of the most important public health practices in the country’s history.
    • “The announcement came at a news conference in Utah, the first state to enact such a ban into law. The state’s new law is set to take effect in early May, despite concerns from public health experts who consider fluoridation of water core to preventing tooth decay.
    • “It makes no sense to have it in our water supply,” Mr. Kennedy said, echoing a position he took during the 2024 presidential campaign. “I’m very, very proud of this state for being the first state to ban it, and I hope many more will come.”
    • “The Centers for Disease Control and Prevention, which Mr. Kennedy oversees as health secretary, has listed fluoridation as one of the 10 great public health achievements of the 20th century. After the news conference, Stefanie Spear, Mr. Kennedy’s principal deputy chief of staff, said Mr. Kennedy would direct the C.D.C.’s community preventative services task force to study fluoride and make a new recommendation.”
  • Per FedSmith,
    • “Retirement planning is a complex process for federal employees, requiring careful attention to eligibility rules and regulations. Among the many requirements that determine post-retirement benefits, the 5-year rule plays a crucial role in three key programs: Federal Employees Health Benefits (FEHB), Federal Employees’ Group Life Insurance (FEGLI), and Roth Thrift Savings Plan (Roth TSP). Understanding these rules can ensure a smooth transition into retirement while maintaining access to critical benefits.”
    • The article provides an understanding of these important rules.

From the judicial front,

  • Govexec relates,
    • “There’s a quorum again on the board that hears appeals of firings and suspensions of federal employees after a majority of judges on the U.S. Court of Appeals for the D.C. Circuit vacated an earlier decision that temporarily enabled President Donald Trump to remove a Democratic appointee to the Merit Systems Protection Board. 
    • “Trump in February attempted to fire Cathy Harris, a Biden appointee, from the MSPB. A district judge blocked the removal, but that order was paused on March 28 in a 2-1 decision by a three-judge panel of the D.C. Circuit while it heard the Trump administration’s appeal. 
    • “On Monday, however, a majority of D.C. circuit court judges overruled that decision through en banc reconsideration, which is a rare process that can be utilized if a litigant feels a circuit panel didn’t adhere to Supreme Court precedent. Such reconsideration involves all circuit judges who are in regular active service rather than the usual three-judge panel. 
    • “The circuit court judges were split 7-4 in granting the motion for en banc reconsideration. 
    • “At issue in this case is Humphrey’s Executor, a 1935 Supreme Court decision that found the president doesn’t have unfettered authority to remove officials on multimember, quasi-judicial bodies.” * * *
    • “Monday’s decision, as well as the overturned March 28 order, also apply to Gwynne Wilcox, a Biden appointee to the National Labor Relations Board who Trump similarly fired but who was later reinstated by a district court. 
    • “In a brief, lawyers for the Trump administration said they would seek emergency relief from the Supreme Court if Wilcox and Harris were allowed to return to their positions.”  
  • Bloomberg Law reports,
    • “A federal judge in Texas on Monday vacated a Biden administration rule that would have required about 75% of US nursing homes to add direct-care workers or face administrative penalties and fines.
    • “In his order granting a motion for summary judgment for the plaintiffs, the American Health Care Association, Judge Matthew J. Kacsmaryk of the U.S. District Court for the Northern District of Texas, said the nation’s nursing homes suffer from “failures,” including “inadequate staffing levels, poor infection control, failures in oversight and regulation, and deficiencies that result in actual patient harm.” All of which “deserve an effectual response,” he wrote.
    • “But any regulatory response must be consistent with Congress’s legislation governing nursing homes. The Final Rule’s challenged provisions are not,” Kacsmaryk declared of the varied requirements of the mandate, which included that facilities have a registered nurse on site around the clock. “Though the Final Rule attempts to remedy chronic nursing home deficiencies, it does so deficiently.” 
    • “Although “rooted in laudable goals, the Final Rule still must be consistent with Congress’s statutes,” Kacsmaryk added. “To allow otherwise permits agencies to amend statutes though they lack legislative power. Separation of powers demands more than praiseworthy intent.”

From the public health and medical research front,

  • The American Hospital Association News clarifies,
    • “A second Texas child died from measles April 3 amid an ongoing outbreak in the state, the Texas Department of State Health Services announced April 6. The child was not vaccinated and had no reported underlying conditions, the agency said. The latest death follows a child that died Feb. 26. An unvaccinated adult in New Mexico that died in March also tested positive for measles after their death, but measles was not confirmed as the official cause of death.”
  • The American Medical Association News lets us know what doctors wish their patients knew about improving their mental health.
  • Per MedPage Today,
    • “Biomarker and cognitive data supported treatment with the anti-amyloid agent lecanemab (Leqembi) for up to 36 months in early Alzheimer’s disease, initial findings from the CLARITY AD open-label extension study suggested.
    • “Continuous treatment led to greater changes in plasma amyloid-beta 42/40 levels, reported Christopher van Dyck, MD, of Yale University in New Haven, Connecticut, in a poster presented at the American Academy of Neurologyopens (AAN) annual meeting.” * * *
    • “Serious adverse events occurred in 20.5% of the total sample of 1,616 people in the core CLARITY AD trial and the open-label extension study who received lecanemab. Amyloid-related imaging abnormalities with edema (ARIA-E) occurred in 14.7%, ARIA with hemosiderin deposits (ARIA-H) occurred in 23.8%, and intracerebral hemorrhage (ICH) occurred in 0.7%. Three deaths concurrent with ARIA or ICH occurred.
    • “These findings provide the first evidence for a continued benefit of lecanemab and disease modification over the long term, out to 36 months,” van Dyck told MedPage Today.
    • “They also suggest that individuals with lower pathology — no or low tau, or low amyloid — experience a particularly robust stabilization of symptoms,” he continued. “These results collectively underscore the importance of early initiation and continued long-term treatment.”
  • and
    • “In a study of people without a history of cancer, comorbidities in midlife were associated with an overall risk of cancer.
    • “There was a stronger association between comorbidities and risk of multiple individual cancer types.
    • “The findings support the incorporation of formal comorbidity screening and/or risk assessment as a routine aspect of cancer screening visits.”
  • AHA News tells us,
    • “The National Institutes of Health April 7 released a study that found twins — smaller at birth on average than singletons — develop slower in early pregnancy than what was previously known. The ultrasound study found that twins have less fat tissue and muscle mass than singletons beginning at 15 weeks. Scientists believe the smaller size could be a way of adapting to accommodate more resources for two fetuses later in pregnancy. The NIH said confirmation of the findings in additional research could help guide physicians in monitoring and managing twin pregnancies.”
  • Per BioPharma Dive,
    • “Rhythm Pharmaceuticals on Monday said its drug for rare obesity conditions met the main goal of a Phase 3 clinical trial, helping people with weight gain triggered by brain injury lose about one-sixth of their body weight over one year of treatment.
    • The company plans to ask U.S. and European regulators to expand approval of the drug, called setmelanotide. The once-daily shot is marketed as Imcivree after being authorized in the U.S. in 2020 to treat people with genetically driven forms of obesity.
    • Imcivree earned $130 million in 2024 sales across its currently approved uses. Stifel analyst Paul Matteis wrote in a note to clients that the new indication is “a blockbuster opportunity with the potential for a fast ramp” in sales, adding that the weight loss data look “very strong.”

From the U.S. healthcare business front,

  • Fierce Healthcare points out,
    • “Emergency department use has nearly recovered to prepandemic levels, but rising acuity, insufficient capacity and a laundry list of financial roadblocks are straining their viability and threatening patients’ access to care, according to a new report from RAND’s healthcare research arm.
    • “The nonprofit, nonpartisan organization’s nearly 200-page report (PDF)—sponsored by the Emergency Medicine Policy Institute (EMPI)—paints a distressing picture of the current state of EDs, which are among the few settings where patients receive 24/7 unscheduled acute care regardless of payment thanks to the federal Emergency Medical Treatment and Labor Act (EMTALA).
    • “EDs, the report notes, have lately faced more complex and sicker patients. Steady increases in demand and limited capacity have led to an increase in ED crowding (referred to as boarding), longer waits and potentially violence toward healthcare workers, which compromise care quality and emergency care worker attrition due to burnout. At the same time, EDs are providing more uncompensated care and expanding the scope of their work into specialties like geriatric care and care coordination.”
  • Per BioPharma Dive,
    • “Labcorp is now offering a blood-based biomarker test in the U.S. to support the diagnosis of Alzheimer’s disease.
    • “The immunoassay measures the ratio of ptau-217 and beta amyloid 42, two distinct biomarkers of Alzheimer’s, according to the Wednesday announcement. The Global CEO Initiative on Alzheimer’s Disease has called ptau-217 one the most promising blood-based biomarkers for amyloid status.
    • “Manufacturers of Alzheimer’s drugs have identified blood tests as a way to reduce the reliance on imaging and cerebrospinal fluid assays and to accelerate diagnosis and treatment.”
  • and
    • “GSK is betting potentially billions of dollars that a smaller drug company’s technology can help create new treatments for brain-corroding diseases.
    • “Through a licensing deal announced Sunday, GSK has gained access to drug delivery technology from South Korea’s ABL Bio. This “Grabody-B” platform is designed to shuttle medicines across arguably the trickiest obstacle in neuroscience — the blood-brain barrier or “BBB” — by using a protein that normally shepherds an important growth hormone across the divide.
    • “The platform had already caught the attention of another pharmaceutical giant, Sanofi, which in 2022 entered a collaboration with ABL to develop new therapies for diseases like Parkinson’s.”
  • KFF Health News tells us,
    • “Underscoring the massive scale of America’s medical debt problem, a New York-based nonprofit has struck a deal to pay off old medical bills for an estimated 20 million people.
    • “Undue Medical Debt, which buys patient debt, is retiring $30 billion worth of unpaid bills in a single transaction with Pendrick Capital Partners, a Virginia-based debt trading company. The average patient debt being retired is $1,100, according to the nonprofit, with some reaching the hundreds of thousands of dollars.
    • “The deal will prevent the debt being sold and protect millions of people from being targeted by collectors. But even proponents of retiring patient debt acknowledge that these deals cannot solve a crisis that now touches around 100 million people in the U.S.
    • “We don’t think that the way we finance health care is sustainable,” Undue Medical Debt chief executive Allison Sesso said in an interview with KFF Health News. “Medical debt has unreasonable expectations,” she said. “The people who owe the debts can’t pay.”
    • “In the past year alone, Americans borrowed an estimated $74 billion to pay for health care, a nationwide West Health-Gallup survey found. And even those who benefit from Undue’s debt relief may have other medical debt that won’t be relieved.
    • “This large purchase also highlights the challenges that debt collectors, hospitals, and other health care providers face as patients rack up big bills that aren’t covered by their health insurance.”

From the artificial intelligence front,

  • Modern Healthcare interviewed Pat Geraghty, Guidewell’s CEO, who discusses the use of AI in prior authorization approvals
    • “How do you educate consumers about the value of prior authorization? 
    • “There’s been a lot of noise around this topic recently. 
    • “We don’t want to come out and say, “let me just explain prior auth to you.” What we’re trying to do is say, “We know we can be better. We can use technology to help us be better. We can make the process quicker and smoother, and we’re going to do that and we’re committing to that.”
    • “We also want to be clear about the rest of the issues around prior auth. There is some clarification and explaining that is appropriate, but it’s not the lead thing. The lead thing is making sure we’re taking the hassle out of the process.
    • “How are you using technology to improve the process? 
    • “We use AI to say yes, not deny, and that allows us to get a very quick answer to the provider. We had 2.4 million authorizations last year that were done in just seconds. About 80% of our prior authorizations are on an automated basis.
    • “But the more complex the issue is, the more it really does involve the oversight of a clinician who understands the area that is being reviewed. You wouldn’t want to give up those kinds of dialogues. Oftentimes the discussions may end up with a modified treatment plan that’s best for all involved. It also is one of the ways we have a check on fraud, waste and abuse.
    • “The thing we find that drives the highest volume for denials is when a service is not covered by the health plan.”
  • The Washington Post reports, “AI is coming to skin cancer detection. Technology is already assisting with diagnoses, but experts predict better tools for non-experts will become available in the not-too-distant future.”

Friday Report

David Ermer–CDC, CMS, Congress, COVID-19, FDA, Generative AI, Medical / Rx research, Medicare, Rx coverage, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC,

  • The American Hospital Association News reports,
    • “The Senate over the weekend is expected to cast a final vote on its revised budget resolution for fiscal year 2025. Senate Republicans April 3 voted to proceed on the resolution which kicked off debate. Today the Senate was slated to debate and process a number of amendments before holding a final vote on the resolution. The budget resolution is expected to pass and move to the House for consideration next week.” 
  • Per a CMS fact sheet,
    • The Centers for Medicare & Medicaid Services (CMS) issued a final rule on April 4, 2025, that modernizes and improves Medicare Advantage (MA), Medicare Prescription Drug Benefit (Part D), Medicare cost plan, and Programs of All-Inclusive Care for the Elderly (PACE) programs. The Contract Year (CY) 2026 MA and Part D final rule implements changes related to prescription drug coverage, the Medicare Prescription Payment Plan, dual eligible special needs plans (D-SNPs), Star Ratings, and other programmatic areas, including the Medicare Drug Price Negotiation Program. This final rule also codifies existing sub-regulatory guidance in the MA and Part D programs. 
    • CMS is not finalizing certain provisions from the proposed rule at this time. CMS may address these proposals in future rulemaking, as appropriate. CMS is also announcing that it is not finalizing three provisions from the proposed rule (Enhancing Health Equity Analyses: Annual Health Equity Analysis of Utilization Management Policies, Procedures and Ensuring Equitable Access to Medicare Advantage Services—Guardrails for Artificial Intelligence, and Part D Coverage of Anti-Obesity Medications (AOMs) and Application to the Medicaid Program). 
    • This fact sheet discusses the major provisions of the CY 2026 MA and the Part D final rule. The final rule can be downloaded here: https://www.federalregister.gov/public-inspection/2025-06008/medicare-and-medicaid-programs-contract-year-2026-policy-and-technical-changes-to-the-medicare. 
  • The Wall Street Journal emphasizes,
    • “The Trump administration said Friday that Medicare and Medicaid won’t expand coverage of popular anti-obesity drugs, rejecting a proposal issued late last year by the Biden administration.
    • “The decision deals a blow, at least for now, to Americans who are covered by the government health-insurance programs and wanted their help paying for the popular but pricey drugs. 
    • “Yet the administration left open the possibility of revisiting the decision later.
    • “Expanding coverage of the obesity medications “is not appropriate at this time,” a Centers for Medicare and Medicaid Services spokeswoman said.
    • “She said CMS may reconsider the policy after more review of the drugs’ “potential benefits” and “relevant costs,” including costs to state Medicaid agencies.”
  • For perspective, STAT News pointed out last September
    • A new report from congressional budget experts this week estimated that it would cost Medicare an additional $35 billion over nine years if the program began covering GLP-1 drugs for obesity. But the report also noted that half of seniors who would qualify for obesity coverage already have access to the drugs for other conditions.
  • Per a House Budget Committee news release,
    • “House Budget Committee Chairman Jodey Arrington (R-Texas) today appointed Budget Committee Member Rep. Blake Moore (R-Utah) to chair the Committee’s Health Care Task Force. 
    • “The Task Force will build on its work from the 118th Congress by examining opportunities to modernize and personalize the health care system and support policies to fuel innovation and increase patient access to quality and affordable care. One of the initial areas of focus for the Budget Health Care Task Force will be examining the budgetary effects of chronic disease and opportunities to Make America Healthy Again.” 
  • Per an HHS news release,
    • “HHS Secretary Robert F. Kennedy, Jr. will embark [next Monday through Wednesday] on a multi-state tour to celebrate MAHA initiatives in the Southwest. He will meet with elected officials, tribal leaders, nutrition experts, and charter school visionaries as he works to fulfill President Trump’s promise to Make America Healthy Again.

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 to low levels. Wastewater levels and emergency department visits are at 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 AHA News tells us,
    • “There are 607 confirmed cases of measles across the U.S., according to the latest data released April 4 by the Centers for Disease Control and Prevention. The majority of cases are in Texas, as an outbreak in the state has grown to 481 cases, according to the Texas Department of State Health Services.  
    • “Cases have been reported by 21 states, with 93% being outbreak-associated, according to the CDC. The vaccination status of 97% of cases is classified as “unvaccinated or unknown.” 
  • Per Health Day,
    • “Strokes caused by an artery tear are landing five times as many Americans in the hospital these days, a new study says.
    • “Cervical artery dissection involves a small tear in the inner lining of an artery in the neck that supplies blood to the brain.
    • “Blood can clot at the site of the tear. If the clot breaks loose, it can travel to the brain and cause a stroke.
    • “Hospitalizations for this sort of stroke have increased nearly fivefold during the past 15 years, according to findings published April 2 in the journal Neurology.
    • “Cervical artery dissection is an important cause of stroke, especially in people under 50, so it is crucial to detect it right away,” senior researcher Dr. Shadi Yaghi, a vascular neurologist at Brown University in Providence, R.I., said in a news release.
    • “Strokes that are not fatal can lead to long-term disability, poor mental health and reduced quality of life,” he said. “Our research found a dramatic increase in the number of hospitalizations for cervical artery dissection, with rates rising steadily year over year.” 
    • “These sort of tears in the cervical artery are most often caused by a motor vehicle crash or other accident that causes neck strain, researchers said. However, activities as simple as heavy lifting has been known to cause a cervical artery tear in some people.”
  • The New York Times shares “10 Small Things Neurologists Wish You’d Do for Your Brain. Easy everyday habits can help keep you sharp. And it’s never too late to start them.”
  • Per MedTech Dive,
    • “Boston Scientific’s pulsed field ablation catheter, Farapulse, was noninferior to Medtronic’s Arctic Front cryoballoon in a randomized trial, researchers found in a study published in The New England Journal of Medicine.
    • “The study, which was published Monday and funded by a Swiss hospital, randomized 210 patients with symptomatic paroxysmal atrial fibrillation to undergo PFA or cryoablation. Atrial tachyarrhythmia, a heart rhythm disorder where the atria beat too fast, recurred in 39 patients in the PFA cohort and 53 people in the cryoablation group.
    • “Medtronic reported declines in its cryoablation business last year but said the losses were offset by growth of its PulseSelect single-shot catheter, which competes with Farapulse for the growing PFA market.”

From the U.S. healthcare business front,

  • Fierce Healthcare informs us,
    • “Rural areas are quickly losing independent physicians and medical practices amid the corporatization of healthcare, a new report finds.
    • “The report was commissioned by the Physicians Advocacy Institute (PAI), a nonprofit advocacy organization focused on fair and transparent payment policies. The research, conducted by Avalere Health, used the IQVIA OneKey database, which contains physician and practice location information on health system ownership.
    • “The number of independent doctors in rural areas fell 43% from January 2019 to January 2024, with rural areas losing 5% of all practicing physicians. Meanwhile, people in rural areas had access to 11% fewer medical practices as of January 2024.
    • “Nearly 9,500 doctors left independent practice in rural areas, predominantly in the Midwest and Northeast. States like Indiana, Massachusetts, New Jersey and Ohio lost more than 50% of independent docs.
    • “This decline in rural healthcare providers has been primarily driven by a drop in independent docs and practices as well as the acquisition of these practices by hospitals and corporate entities, the report said.” 
  • Beckers Hospital Review lets us know,
    • “South Bend, Ind.-based Beacon Health System has signed a definitive agreement to acquire Ascension Michigan’s southwest region, which includes four hospitals, 35 outpatient clinics and an ambulatory surgery center.
    • “The hospitals include:
      • “Ascension Borgess Hospital (Kalamazoo)
      • “Ascension Borgess Allegan Hospital
      • “Ascension Borgess-Lee Hospital (Dowagiac)
      • “Ascension Borgess-Pipp Hospital (Plainwell)
    • “Expanding our reach deeper into southwest Michigan broadens access to high-quality, affordable care for communities served by Ascension, extends our service area and provides growth opportunity to further strengthen the health system,” Beacon Health CEO Kreg Gruber said in an April 3 news release. “This acquisition will create a bright future for these communities by ensuring access to quality healthcare services for generations.”
  • Per Fierce Pharma,
    • “With a label expansion for Uplizna pushing the drug into an untouched rare disease market, Amgen is getting its money’s worth out of another drug from its $27.8 billion Horizon Therapeutics buy. 
    • “Uplizna is the first drug to win an FDA approval for immunoglobulin G4-related disease (IgG4-RD), a chronic inflammatory condition that can present in multiple organs and cause fibrosis and permanent organ damage, with or without symptoms.
    • “The CD19-targeted therapy made strides in treating the disease in its phase 3 MITIGATE trial. In the study, Uplizna demonstrated an 87% reduction in the risk of IgG4-RD flares over placebo during the 52-week placebo-controlled period, with 10.3% of those on Uplizna experiencing a flare-up compared to 59.7% of those taking placebo.
    • “With the approval, patients and physicians now have a “proven treatment that targets a key driver of the disease, reducing the risk of flares and reliance on harmful long-term steroid use,” Amgen’s executive vice president of R&D Jay Bradner, M.D., said in a company release. “This approval underscores Amgen’s ongoing commitment and leadership in developing innovative treatments targeting CD19+ B-cells across multiple therapeutic areas.”
    • “Now, the road ahead for Amgen’s success in IgG4-RD lays in raising awareness of the rare disease, which was only recently established with an International Classification of Diseases code in 2023. About 20,000 people are estimated to have the disease in the U.S., but the exact number is hard to pinpoint due to limited data, according to Amgen.”
  • and
    • “As the respiratory syncytial virus (RSV) vaccine field grapples with a significantly reduced market size thanks to regulatory uncertainties, GSK and Pfizer have decided to lay to rest their patent feud.
    • “GSK and Pfizer have moved to scrap a patent lawsuit around their respective RSV vaccines, according to a filing in the U.S. District Court in Delaware.
    • “The settlement comes after a U.K. high court in November sided with Pfizer, ruling that two GSK RSV vaccine patents were invalid.”

From the artificial intelligence front,

  • Beckers Payer Issues discusses how health plans can use “AI to Drive Patient Outcomes & Health Plan ROI.”
  • Modern Healthcare adds,
    • “Artificial intelligence and other cutting-edge innovations could radically reshape how care is delivered, but tapping technology’s full potential and getting a return on investments is far off, according to industry executives.
    • “We need enduring, ambitious vision,” said Dr. Vivek Garg, chief medical officer at Humana’s CenterWell healthcare services division, during Modern Healthcare’s 2030 Playbook conference in Nashville Wednesday. “You’re going to need the leadership and the board to make trade-offs and to make investments. …They’ve got to do it because they know what they stand for, and they want to see what they can become and how much further they can go in their vision.” * * *
    • “More collaboration between payers and providers is imperative, said Mike Bennett, chief strategy and transformation officer at Highmark Health.
    • “If we both don’t start working together and using the tools we both have, we’re going to end up leaving [our populations] behind,” Bennett said. “AI doesn’t care whether you’re a payer or provider.”

Thursday Report

David Ermer–CMS, Congress, Medical / Rx research, OPM, Telehealth–
Photo by Josh Mills on Unsplash

From Washington, DC

  • The FEHBlog watched today’s confirmation hearing for the President’s nominee for OPM Director, Scott Kupor. Clearly, Mr. Kupor is on a glide path to Senate confirmation. The next step toward that goal will occur at a business meeting of the Senate Homeland Security and Government Affairs Committee on Wednesday April 9 at 10 am.
  • The American Hospital Association News tells us,
    • “The Senate April 3 by a vote of 53-45 confirmed Mehmet Oz as the new administrator for the Centers for Medicare & Medicaid Services.” 
  • The Wall Street Journal reports,
    • “Health and Human Services Secretary Robert F. Kennedy Jr. said he would reinstate some programs and federal workers cut earlier this week as part of his sweeping reorganization of the department.
    • “Some programs that were cut, they’re being reinstated,” Kennedy said Thursday. “Personnel that should not have been cut were cut. We’re reinstating them.”
  • Per Senate news releases,
  • and
    • “Senate Judiciary Committee Chairman Chuck Grassley (R-Iowa) led a markup on six bipartisan Grassley-backed bills to boost competition in the pharmaceutical industry and improve access to more affordable prescription drugs. All six bills advanced in committee by voice vote.” Five of the six bills target pharma, while the sixth bill requests an FTC study of consolidation in the PBM industry.
  • Healthcare Dive reports,
    • “AdvaMed, one of the medical device industry’s largest trade groups, reiterated its opposition to broad-based tariffs Wednesday, saying the actions would hurt innovation, cost jobs and increase healthcare costs, after the Trump administration announced new duties on most U.S. trading partners.
    • “The medtech industry should be exempted from these tariffs,” CEO Scott Whitaker said in a statement.” * * *
    • “Meanwhile, providers have been bracing for the impact of tariffs after the American Hospital Association, alongside the Healthcare Distribution Alliance, also failed to secure carve-outs for critical medical supplies, despite months of lobbying.”
  • Stars and Stripes informs us,
    • “The Department of Defense has scheduled “listening sessions” at three U.S. military bases in Japan next week to collect feedback on a pilot program designed to connect DOD civilians with Japanese health care providers.  Anyone who has used the program — the Health Insurance Enhancement for DOD Civilian Employees in Japan — is encouraged to participate at sessions at Misawa Air Base, Camp Foster and Yokosuka Naval Base, according to a March 28 email distributed by the Defense Health Agency’s National Capital Region.”
  • The Government Accountability Office released a report about DOD’s Actions to Address Challenges with Accessing Health Care in Japan and Guam.
    • The Department of Defense relies on its civilian employees and contractors in Japan and Guam to provide services such as engineering, food service, and teaching. They may receive health care at military facilities but only on a space-available basis—after active-duty service members and their families.
    • Accessing health care through local providers can be difficult. For example, in Japan, they face language barriers and must pay for care up front. DOD started a program intended to help them find providers and pay bills. In Guam, DOD has a working group to address issues that may arise from planned growth of the civilian population on Guam.

From the judicial front,

  • Modern Healthcare reports,
    • “Federal Trade Commission Chair Andrew Ferguson said he will get involved in the agency’s [internal] legal action against the leading pharmacy benefit managers.
    • “In a post shared Thursday on the social media platform X, Ferguson said he no longer is recusing himself from the matter.” * * *
    • “Ferguson, a critic of PBMs, recused himself due to his prior role in advising Virginia’s attorney general on the decision to file an amicus brief in a class-action lawsuit against PBMs, he wrote Thursday in a statement shared on the social media platform. He said his stance had changed to “ensure that the case can continue.”
    • “He said he consulted with the agency’s ethics attorneys when making the decision to involve himself.
    • “The FTC did not immediately respond to questions about next steps. In the Tuesday order pausing the case, FTC General Counsel Lucas Croslow said the pause would remain in effect for at least 105 days, and an evidentiary hearing date would be scheduled 225 days after the stay is lifted.”
  • Fierce Healthcare relates,
    • “The Department of Justice is urging the courts to reject a legal expert’s report that puts its longstanding challenge to UnitedHealthcare’s Medicare Advantage billing practices in jeopardy.
    • “In a memorandum issued this week, DOJ argues that the court-appointed special master’s report, which was released in March, erred in determining that the agency had not presented enough evidence to support the main claims in the case. 
    • “In addition, DOJ alleges that the special master is also pushing to make California’s Central District Court “the first and only court in the nation to read a new requirement into the reverse False Claims Act.” In the report, it interprets a key phrase in the FCA as requiring “proof of an affirmative act of deception,” which DOJ says is “inconsistent with the text, structure and purpose of the FCA.” * * *
    • “In a statement, UnitedHealth emphasized that its “business practices have always been transparent, lawful and approved by our regulator, CMS.”
    • “After more than a decade of DOJ’s wasteful and expensive challenge to our Medicare Advantage business, the Special Master concluded there was no evidence to support the DOJ’s claims we were overpaid or that we did anything wrong,” the company said.
    • “A judge will now be tasked with ruling on whether the case will move forward.”

From the public health and medical research front,

  • Cardiovascular Business offers key takeaways from the 2025 conference of the American Association of Cardiologists.
  • Per an NIH news release,
    • “An artificial intelligence (AI)-driven screening tool, developed by a National Institutes of Health (NIH)-funded research team, successfully identified hospitalized adults at risk for opioid use disorder and recommended referral to inpatient addiction specialists. The AI-based method was just as effective as a health provider-only approach in initiating addiction specialist consultations and recommending monitoring of opioid withdrawal. Compared to patients who received provider-initiated consultations, patients with AI screening had 47% lower odds of being readmitted to the hospital within 30 days after their initial discharge. This reduction in readmissions translated to a total of nearly $109,000 in estimated healthcare savings during the study period.
    • “The study, published in Nature Medicine, reports the results of a completed clinical trial, demonstrating AI’s potential to affect patient outcomes in real-world healthcare settings. The study suggests investment in AI may be a promising strategy specifically for healthcare systems seeking to increase access to addiction treatment while improving efficiencies and saving costs.
    • “Addiction care remains heavily underprioritized and can be easily overlooked, especially in overwhelmed hospital settings where it can be challenging to incorporate resource-intensive procedures such as screening,” said Nora D. Volkow, M.D., director of NIH’s National Institute on Drug Abuse (NIDA). “AI has the potential to strengthen implementation of addiction treatment while optimizing hospital workflow and reducing healthcare costs.”
  • Per Cardiovascular Business,
    • “New research shows early-pregnancy blood pressure trajectories are strongly associated with new-onset hypertension years after pregnancy. This may help better stratify risk for targeted surveillance and early interventions, and improve the prediction of cardiovascular disease risk in women later in life. The study was published in the American Heart Association Journal Hypertension this week.[1]
    • “Blood pressure patterns observed in the first half of pregnancy, even among women without hypertensive disorders of pregnancy (HDP), can identify women at greater risk of developing hypertension up to 14 years after giving birth. The new findings are from a large observational study supported by the National Institutes of Health (NIH). Among groups of women who did not develop HDP, those with higher-risk blood pressure patterns, including elevated-stable patterns during early pregnancy, were still 11 times more likely to develop hypertension years later than those women with less risky blood pressure patterns.”  
  • Per HCP Live,
    • “Bariatric surgery improves survival and is cost-effective for patients with obesity and cirrhosis, compared to lifestyle modifications alone.
    • “Sleeve gastrectomy and Roux-en-Y gastric bypass show increased expected survival and quality of life benefits, despite higher initial costs.
    • “The study emphasizes the need for greater awareness and uptake of bariatric surgery, given its long-term health improvements and potential reductions in obesity-related comorbidities.”
  • Fierce Pharma tells us,
    • “The interim results of a phase 3 trial of Merck’s pulmonary arterial hypertension (PAH) treatment Winrevair were so conclusive that the company not only halted the study for efficacy but did the same two months later in another trial of the first-in-class activin signaling inhibitor.
    • “Merck has revealed data from the study, providing further evidence of the value of Winrevair, which has been approved in more than 40 countries, including in the U.S. a year ago. 
    • “The Zenith trial included 172 patients at the highest risk of mortality—those in the World Health Organization Functional Class (FC) III or IV—and achieved its primary endpoint of time to clinical worsening to first morbidity or mortality event.”
  • Medscape reports,
    • “A low-density lipoprotein cholesterol (LDL-C) level below 70 mg/dL was associated with a 26% reduced risk of all-cause dementia and a 28% lower risk of Alzheimer’s disease-related dementia (ADRD), with statin use further decreasing that risk, a new study suggests.
    • “While earlier research had suggested lower LDL levels may offer a protective advantage against dementia, these findings provide a specific target number, which investigators said could prove helpful in clinical practice. 
    • “These findings emphasize the importance of targeted LDL-C management as part of dementia prevention strategies, with potential integration into clinical guidelines,” lead investigator Yerim Kim, MD, PhD, Department of Neurology, Kangdong Sacred Heart Hospital, Hallym University College of Medicine, Seoul, South Korea, and colleagues wrote.”

From the U.S. healthcare business front,

  • Fierce Healthcare takes a five year look back at the COVID 19 pandemic and how it impacted healthcare.
  • Beckers Payer Issues offer thoughts about “From volume to value: The shift in healthcare that’s helping put patients first.”
  • Plan Adviser lets us know,
    • “Research and investment provider Devenir LLC reported that health savings account balances rose 19% in 2024 from 2023 levels, reaching almost $147 billion. The number of accounts grew 5% last year, according to the firm’s year-end survey.
    • “The sustained growth in both assets and participation demonstrates a growing awareness among consumers and employers of HSAs’ long-term value in managing healthcare costs,” said Jon Robb, a Devenir senior vice president of research and technology, in a statement.”
  • Per Beckers Hospital Review
    • “California has the highest hourly mean wage for registered nurses in the U.S., and Oregon has the highest hourly mean wage for RNs after adjusted for cost of living, according to data published April 2 by the Bureau of Labor Statistics.
    • “[In the article you will find] the mean hourly and annual wages for nurses in 49 states and Washington, D.C., adjusted for cost of living. Becker’s calculated these figures using May 2024 salary data from BLS and 2024 cost of living index data from the World Population Review.” 
  • and
    • “Heritage Valley Kennedy Hospital in Kennedy Township, Pa., will close on June 30 due to declining patient volume and reduced insurance reimbursements, according to an April 2 news release shared with Becker’s.
    • “Following the closure, emergency care, outpatient surgery, and diagnostic services will shift to Heritage Valley’s Sewickley and Beaver locations, according to the report. Some services, including a walk-in clinic, X-rays and physical rehabilitation, will remain available at the adjacent medical office building.
    • “Heritage Valley said it is in talks with Encompass Rehabilitation about its leased 12-bed unit at Kennedy Hospital and is exploring partnerships to sustain behavioral health services in the area.”