Midweek Update

CMS

Midweek Update

David Ermer–CDC, CMS, FDA, Medicare, OPM, Patient safety, SCOTUS, Telehealth, U.S. Healthcare–
Photo by Kelly Sikkema on Unsplash

From Washington, DC,

  • Roll Call tells us,
    • “Higher health care costs and a law Congress passed last year to boost retirement benefits for public sector workers worsened the long-term outlook of Social Security and Medicare trust funds, according to annual reports released Wednesday by the programs’ trustees. 
    • “The trust funds for Medicare and Social Security benefits would be depleted faster than expected compared to last year’s estimates, losing the ability to provide full benefits to retirees in some cases years earlier than previously projected.
    • “The Hospital Trust Fund will only be able to pay 100 percent of scheduled benefits until 2033, three years earlier than the trustees reported last year, according to the trustee report. After that point, the program will only be able to pay 89 percent of total scheduled benefits, a summary says.” * * *
    • “The long-term combined outlook of the Social Security Old-Age and Survivors Insurance Trust Fund and Disability Insurance Trust Fund worsened slightly, speeding up by about three calendar quarters compared to last year’s projection, thanks largely to the passage of a law last year that boosts benefits for public sector retirees.
    • “Absent congressional action to shore up the program, the Social Security Old-Age and Survivors Insurance Trust Fund would lose the ability to pay full benefits to retirees starting in the first quarter of 2033, at which point benefits would face a 23 percent cut. That’s the same calendar year projected last year, but the estimated depletion date moved up three calendar quarters, the trustees said in the report. 
    • “If combined with the Disability Trust Fund, which would require congressional action, the Social Security Trust Fund could pay out full benefits until the third quarter of 2034, three quarters earlier than last year’s 2035 projection. At that point, retirees would see their benefits cut by 19 percent.” 
  • Federal News Network informs us,
    • “The Trump administration is attempting to address what it says are inflated numbers of high-performing federal employees, while also telling agencies to swiftly discipline or remove any feds deemed poor performers.
    • “In a memo published Tuesday, the Office of Personnel Management told agencies to begin adopting a new performance management system designed by the Trump administration. The new system attempts to more strictly delineate between different levels of employee performance and encourage agencies to rate fewer employees as high performers.
    • “For many decades now, performance management across the federal workforce has fallen short of what the American people should expect,” OPM Acting Director Charles Ezell wrote in Tuesday’s memo to agencies. “Too often, this has resulted in a lack of accountability and inflated performance ratings.”
    • “OPM began its reform efforts earlier this year by updating the performance standards and expectations for career members of the Senior Executive Service, as well as those in Senior Level, Scientific and Professional positions. Those performance expectations are now being broadened to cover nearly all career federal employees.”
  • Healthcare Dive notes,
    • “A nascent form of health coverage that creates an alternative gateway for employers to offer Affordable Care Act coverage to their workers is seeing rising uptake, especially among midsize to large employers.
    • “Adoption of individual coverage health reimbursement arrangements, or ICHRA plans, rose 34% from 2024 to 2025 among employers with 50 or more full-time employees, according to a new report from trade association the HRA Council.
    • “Still, the vast majority of ICHRA users remain companies with fewer than 20 employees, most of which are providing health coverage for the first time through the arrangements, the HRA Council said.”
  • Beckers Hospital Review ranks States by percentage of Medicaid births using a new KFF analysis.

From the judicial front,

  • The Wall Street Journal reports,
    • “The Supreme Court cleared the way for states to restrict gender-transition treatments for minors, rejecting arguments that Tennessee’s ban on puberty blockers and other medical therapies amounted to unconstitutional discrimination. 
    • “Wednesday’s decision, which broke 6-3 along ideological lines, was the latest setback for transgender rights, after several months in which the Trump administration has adopted policies that range from expelling transgender personnel from the military to halting educational funding for states or institutions that permit transgender athletes on women’s sports teams. 
    • “This case carries with it the weight of fierce scientific and policy debates about the safety, efficacy, and propriety of medical treatments in an evolving field,” Chief Justice John Roberts wrote for the court. “The voices in these debates raise sincere concerns; the implications for all are profound,” he continued, but the Constitution “does not resolve these disagreements. Nor does it afford us license to decide them as we see best.”
    • “That task, he wrote, was best left to the legislature.”
  • KFF adds,
    • “As a result of the decision, minors across the US will continue to see their access to gender affirming care determined at least in part based on where they live. However, access to these services is being debated in venues beyond the judiciary, including in Congress and by the Trump Administration. The Trump Administration has taken a range of actions aimed at limiting access to gender affirming care, especially for minors and Congress too has taken up the issue. The reconciliation bill still being finalized includes a prohibition on Medicaid covering gender affirming care in Senate and House-passed versions. These efforts will likely face, and some cases already have faced, litigation. While the ruling on this case is quite limited (narrowly focused on equal protection claims and Tennessee’s ban), it could have some bearing on the outcome of future challenges.”
  • Bloomberg Law reports,
    • “A Biden administration rule prohibiting health care providers from sharing reproductive healthcare information with law enforcement was invalidated by a federal judge Wednesday.
    • “Judge Matthew J. Kacsmaryk ruled that the US Department of Health and Human Services’ rule was contrary to law since it illegally limits state public health laws, impermissibly re-defines “person” and “public health,” and oversteps the authority delegated by US Congress, he said in an opinion.” * * *
    • “The case is Purl v. Dep’t of Health and Human Services, N.D. Tex., No. 2:24-cv-00228, 6/18/25.”
  • Per Beckers Payer Issues,
    • “A former Medicare Advantage executive has been found not guilty of healthcare fraud. 
    • “A jury found Kenia Valle Boza, the former director of Medicare risk adjustment analytics for HealthSun Health Plans, not guilty of one count of conspiracy to commit healthcare fraud and wire fraud, and three counts of major fraud against the U.S., according to court documents. 
    • “The Department of Justice alleged Ms. Boza orchestrated a scheme to submit fraudulent and false information to CMS to increase the reimbursement HealthSun received from the federal government. 
    • “The department declined to prosecute HealthSun, which was acquired by Elevance Health in 2017, because of the organization’s “prompt voluntary self-disclosure, cooperation, and remediation,” according to a 2023 news release. The company also agreed to pay $53 million in repayments to the government.” 

From the Food and Drug Administration front,

  • STAT News points out,
    • “Vinay Prasad will now hold three separate jobs at the Food and Drug Administration, solidifying his position as a top adviser to Commissioner Marty Makary.
    • “Prasad will serve as the agency’s chief medical and scientific officer, in addition to leading the center that regulates vaccines, gene therapies, and the blood supply, according to an internal memo obtained by STAT. Traditionally, the agency’s chief scientist and chief medical officer have been two distinct roles. 
    • “In this capacity, he will serve as a trusted advisor to the FDA Commissioner and other senior officials on cross-cutting and emerging medical and scientific issues impacting regulatory science and public health,” Makary wrote in the memo announcing the news to staff. The agency didn’t immediately respond to a request for comment.
    • “The role greatly expands Prasad’s purview, giving him explicit authority to oversee and weigh in on regulatory issues in any center. He will advise Makary on medical policy and regulatory decisions and represent the FDA at advisory committee meetings and external forums.”
  • The Wall Street Journal reports,
    • “FDA approved Gilead’s Yeztugo, a twice-yearly injectable PrEP drug, showing 99.9% effectiveness in trials.
    • “Analysts project Yeztugo sales to reach $1.6 billion in 2028, posing competition to GSK’s Apretude.
    • “Yeztugo, priced at $28,218 annually, offers improved HIV prevention uptake.”
  • Per MedTech Dive,
    • “A problem with Dexcom’s receivers for its glucose sensors may cause people to not get an audible alert for low or high blood sugar levels, the Food and Drug Administration said in an enforcement report posted Monday. More than 2 million devices are affected by the Class I recall, the highest risk category.
    • “The receiver, a handheld device that gives glucose readings, may not provide an audible alert due to a manufacturing problem. Dexcom said in a letter to customers that, as of May, it had received 56 reports of severe adverse events, such as seizure, loss of consciousness, and other hypoglycemic or hyperglycemic symptoms. All of the people recovered, the company said.
    • ‘The recall applies to receivers associated with Dexcom’s G7, G6, One and One+ CGMs. Dexcom is asking users to return the affected devices and is offering replacements.”
  • and
    • “Q’Apel Medical has recalled a device for removing blood clots in the brain over an issue linked to two injuries, the Food and Drug Administration said Tuesday.
    • “The company asked customers to return Hippo 072 Aspiration Systems and Cheetah Delivery Tools after receiving a warning letter in which the FDA raised concerns about the device’s tip.
    • “Using the recalled devices may have serious adverse health consequences including contractions or tears in the blood vessels and death, the FDA said.”
  • and
    • Centerline Biomedical has recalled guidewires used in vascular procedures over a fault that could cause serious injury or death, the Food and Drug Administration said Friday.
    • The company has asked customers to return devices from the affected lots because the coating can come off during the procedure and be left inside the patient.
    • No customers have reported serious injuries or deaths associated with the fault. The potential for serious harm led the FDA to publish a Class I recall notice.

From the public health and medical research front,

  • The Washington Post reports,
    • “A simple test of your balance, strength and flexibility, known as the sitting-rising test, could be an early indicator of how long you’ll live, according to a large-scale new study of mobility and mortality.
    • “The study, published Wednesday in the European Journal of Preventive Cardiology, looked at how well 4,282 men and women aged between 46 and 75 could lower themselves from a standing position to the floor and then stand back up again with as little assistance as possible from their hands, knees, furniture or human helpers.
    • “The test assesses “all the aspects of fitness that are not aerobic,” said Claudio Gil Araújo, the study’s lead author and research director at an exercise-medicine clinic in Rio de Janeiro, where the data were collected. Those aspects include muscular health, balance, flexibility and body composition, he said, each of which is important for longevity and health.”
  • The New York Times relates,
    • As Americans scramble to respond to rising rates of suicidal behavior among youth, many policymakers have locked in on an alarming metric: the number of hours a day that American children spend glued to a glowing screen.
    • But a study published on Wednesday in the medical journal JAMA, which followed more than 4,000 children across the country, arrived at a surprising conclusion: Longer screen time at age 10 was not associated with higher rates of suicidal behavior four years later.
    • Instead, the authors found, the children at higher risk for suicidal behaviors were those who told researchers their use of technology had become “addictive” — that they had trouble putting it down or felt the need to use it more and more. Some children exhibited addictive behavior even if their screen time was relatively low, they said.
  • Health Day lets us know,
    • “People with severe depression who receive electroshock therapy are significantly less likely to commit suicide, a new evidence review says.
    • “Electroconvulsive therapy (ECT) lowered the risk of death by suicide 34% among patients with severe depression, according to findings published June 13 in the journal Neuroscience Applied.
    • “Depression patients receiving ECT also had a 30% lower risk of death from any cause, researchers said.
    • “They said these benefits might be even greater than reflected, given that ECT has improved as a psychiatric treatment.
    • “Modern ECT appears to be more effective than it was in the past,” said lead researcher Dr. Timur Liwinski, a clinician scientist at the University of Basel in Switzerland.
    • “Since our analysis spans many decades, it’s likely that today’s ECT offers even stronger protection against suicide than the 34% reduction we identified overall,” Liwinski said in a news release.”
  • Per MedPage Today,
    • “A meta-analysis of 24 observational studies confirms excess risks of heart attack, stroke, and cardiovascular death among cannabis users.
    • “The report joins a growing body of evidence linking cannabis use to significant health harms.
    • “Nevertheless, the meta-analysis was unable to account for cannabis mode of administration, product potency, or intensity of use.”
  • Per STAT News,
    • “Scholar Rock said Wednesday that its investigational therapy helped preserve lean mass among patients taking a powerful weight loss drug, as concerns grow that patients taking new obesity treatments may be losing too much muscle.”
  • CBS News reports,
    • “At least 3% of measles cases confirmed so far this year have been in people who received two doses of the measles vaccine, meaning they were fully vaccinated, the Centers for Disease Control and Prevention says. 
    • “About three dozen of the nearly 1,200 measles infections in 2025 have been in people with two vaccine doses, the agency said Friday in its weekly update on cases. An additional 2% of cases were in people who received at least one dose of the measles vaccine.
    • “Many of the cases were in Texas, which on Tuesday counted a 21st confirmed measles case in someone with at least two doses of the vaccine.”

From the U.S. healthcare business front,

  • Fierce Healthcare reports from the AHIP 2025 conference which concluded today in Las Vegas.
    • “Medicare Advantage has historically enjoyed bipartisan popularity, but, as the program has grown, so too has scrutiny of insurers’ practices.
    • “Mike Hoak, vice president of public policy at Humana, said this is a natural cycle for public programs like MA, where policymakers don’t want to see it fail or kill it outright but want to continue evolving it to ensure it works effectively. 
    • “There was a similar reappraisal of Medicare Part D, he said.
    • “There is a really bipartisan feeling amongst policymakers: ‘I love the program,’ and—for some of them, at least—’I’d like to see it grow, but it is time for some nips and tucks,'” Hoak said. “I think Medicare Advantage is at that inflection point right now.”
  • and
    • Cigna Healthcare’s chief medical officer, Amy Flaster, M.D., joined the insurer at a difficult time for the industry.
    • Flaster stepped into the CMO role in December as health plans grappled with a wave of public outcry and frustration following the murder of UnitedHealthcare CEO Brian Thompson. 
    • She said in the wake of the shooting and public conversation that followed, the insurer “took time to reflect” on what its customers and society as a whole were saying and used that as fuel to make several “commitments to better” that are powering the company’s work moving forward.
    • “I think it was also an interesting turning point at Cigna, where we heard a lot of feedback and loud voices coming from society, from our customers, wanting to see a better system that serves their needs more efficiently, more effectively,” Flaster said in an interview with Fierce Healthcare at AHIP 2025.
  • Per Healthcare Dive,
    • “Ascension has entered a definitive agreement to acquire ambulatory surgery provider Amsurg, the nonprofit health system said Tuesday.
    • “The deal, which Ascension expects to close later this year pending regulatory approval, will add more than 250 ambulatory surgery centers across 34 states to Ascension’s outpatient portfolio.
    • “A spokesperson for the health system declined to comment on the size of the deal. However, sources told Bloomberg that Ascension was paying $3.9 billion for the provider.” 
  • Per Beckers Hospital Review,
    • “Mark Cuban’s Cost Plus Drug Co. and virtual care provider 9amHealth have partnered to offer obesity medications through a new program targeting self-insured employers. 
    • “Under the partnership, 9amHealth will use low-cost oral obesity medications sourced from Cost Plus Drugs alongside branded GLP-1 drugs acquired through direct manufacturer deals, according to a June 17 news release from the company. 
    • “The medications are a part of a broader obesity treatment program that includes telehealth-based support from clinicians specializing in conditions such as diabetes, high blood pressure and high cholesterol. 
    • “The program is aimed at employers who are looking to expand weight management coverage for workers without relying on traditional pharmacy benefit managers, the release said.” 
  • and
    • “Hospital labor costs related to drug shortage management have significantly increased, from $359 million in 2019 to $894 million in 2024 — a nearly 150% increase, according to a Vizient report published June 17. 
    • “Vizient surveyed 132 of its clients to measure the financial toll of medication shortages. Respondents included pharmacy and procurement leaders at health systems, medical centers, children’s hospitals, critical access hospitals, specialty hospitals, clinics and ambulatory care facilities. 
    • “Pediatric facilities were particularly strained, as they monitored 25% more shortages and exceeded pharmacy budgets more often than general facilities. 
    • “Overall, hospitals and other healthcare facilities spent 20.2 million hours in 2024 managing these shortages. In 2019, that figure was 8.6 million hours. 
    • “To cope, most facilities shifted workloads onto already stretched staff, while only a fraction opted to hire additional pharmacy personnel,” the report said. “These findings underscore an urgent issue: Drug shortages aren’t just about supply — they’re draining time, money and an already fragile healthcare system.”

Monday report

David Ermer–CDC, CMS, Congress, FDA, Medical / Rx research, U.S. Healthcare, Uncategorized–
Photo by Sven Read on Unsplash

From Washington, DC

  • Per a Senate news release,
    • “U.S. Senate Finance Committee Chairman Mike Crapo (R-Idaho) today released legislative text within the Finance Committee’s jurisdiction for inclusion in Senate Republicans’ budget reconciliation bill.” * * *
    • “Click HERE to view bill text.
    • “Click HERE for a section-by-section.
    • “Click HERE for a bill overview.”
  • STAT News adds,
    • “To help pay for President Trump’s tax cuts, the Senate is clamping down on tactics that states use to boost federal Medicaid funding, according to legislation released by the Senate Finance Committee on Monday.
    • “The text includes harsher restrictions on Medicaid provider taxes than a version of the bill recently passed by the House. It also places stricter limits on programs that states use to boost Medicaid funding to health care providers, known as State directed payments.
    • “The Finance Committee, led by Sen. Mike Crapo (R-Idaho), is responsible for the largest portion of the budget reconciliation bill that Republicans are using to make good on Trump’s promise to extend expiring tax cuts and create new ones. The House passed its version of the One Big Beautiful Bill last month, and Senate Republicans are now negotiating it.”
  • The American Hospital Association News tells us,
    • “The Centers for Medicare & Medicaid Services June 13 announced it approved state plan amendments to expand Medicaid access to care for tribal communities in six states: Minnesota, New Mexico, Oregon, South Dakota, Washington and Wyoming. The approvals allow the Indian Health Service and tribal clinics to provide Medicaid clinic services in homes, schools and other community locations.” 

From the judicial front,

  • Bloomberg Law informs us,
    • “Eli Lilly & Co. and health tech company Kalderos Inc. are seeking to revive lawsuits in the DC Circuit after a federal judge ruled a US health agency acted lawfully when it didn’t approve drugmaker proposals to discount medicines through a rebate model.
    • “The notices to appeal the order were filed Thursday in the US Court of Appeals for the District of Columbia Circuit after a lower court ruled May 15 found the Health Resources and Services Administration didn’t act illegally when it denied drugmaker bids to discount medicines through a rebate model rather than up front to covered entities under the federal 340B Drug Pricing Program.”
  • MedTech Dive lets us know,
    • “When the deadline to appeal the court decision that blocked the Food and Drug Administration’s final rule regulating laboratory developed tests as medical devices slipped by in May without a word from the agency, industry groups were relieved that the plan they sued to stop was dead.
    • “The U.S. District Court for the Eastern District of Texas found the FDA’s attempt to expand jurisdiction over LDTs exceeded its statutory authority. Yet regulatory experts think the agency may still see room to assert authority over LDTs in other ways. A recent warning letter to a diagnostics company points to one avenue the agency could take, attorneys said.”
  • The Wall Street Journal reports,
    • “All 55 attorneys general signed onto a $7.4 billion settlement with Purdue Pharma and the Sackler family for their role in the opioid crisis.
    • “The attorneys general, who represent all eligible U.S. states and territories, finished signing the settlement on Monday after it was reached in principle in January.
    • “The deal ends the Sacklers’ control of Purdue, bars them from selling opioids in the U.S. and delivers funding across the country to support opioid-addiction treatment and prevention.
    • “The settlement requires resolution of legal claims by state and local governments. The local government sign-on process will be contingent on bankruptcy-court approval, according to several attorneys general.
    • “The Sackler family has told the attorneys general it plans to proceed with the settlement.”

From the public health and medical research front,

  • The Washington Post reports,
    • “Around 1 in 7 U.S. adults who smoke might have some degree of disability, according to a study published in the journal Tobacco Control.
    • “The researchers used data from the 2019-2023 National Health Interview Survey (NHIS) for about 150,000 people. During that period, 14.1 percent of adults who currently smoked had a disability, and estimates for any kind of disability were significantly higher for current or former adult smokers.
    • “The study looked at different kinds of disabilities and found that the prevalence of vision, hearing, mobility and cognitive disability was two to 2.4 times higher among those who currently smoked. About 16.5 percent of women who smoke and 12.1 percent of men who smoke have a disability, the study says. The study also looked at race and ethnicity, finding that 19 percent of non-Hispanic smokers had a disability vs. 11 percent of Hispanic smokers.”
  • The American Medical Association lets us know what doctors wish their patients knew about tendinitis.
  • STAT News relates,
    • To Rebecca Stone, the single most important fact about ovarian cancer is that it’s usually a misnomer. The most common kind — responsible for 70% of cases and 90% of deaths — often has its silent beginnings not in the ovary, but in the fallopian tube. This isn’t just an interesting factoid; as a gynecologic oncologist at Johns Hopkins, Stone sees it as a reason to evangelize. There’s no way to screen for so-called ovarian cancer, no colonoscopy, mammogram, or Pap smear equivalent. It’s typically found late, once it’s already spread. The treatments are middling at best. Among the best tools is surgical prevention: If someone doesn’t want more kids, and is considering another abdominal surgery, a surgeon can offer to take the tubes out.
    • Opportunistic salpingectomy, it’s called. “Somebody says, ‘Can I get my tubes tied?’ And I will say, ‘Well, actually, we don’t tie tubes anymore, we remove them,’” said Greg Marchand, an OB-GYN in Mesa, Ariz. There are exceptions, but generally, since the American College of Obstetricians and Gynecologists recommended offering it in 2015, he’s gone with salpingectomy.
  • It is odd that the article does not mention FDA Administrator Dr. Marty Makary who discusses this issue in his recent book Blind Spots.
  • Health Day tells us,
    • “Brain changes in sleepless teens could make them more likely to be impulsive and aggressive, a new study says.
    • “Teenagers with less sleep had lower connectivity between the parts of the brain that play a critical role in decision making, self-reflection and information processing, researchers reported June 13 in the journal Brain and Behavior.
    • “Problems in these parts of the brain are also linked to mental illnesses like depression, ADHD and schizophrenia, researchers said.
    • “Sleep isn’t just good for children. It helps keep their mental health intact and helps them regulate their emotions,” senior researcher Assaf Oshri, director of the University of Georgia Center for Developmental Science, said in a news release.”
  • and
    • “Struggling to get a good night’s sleep? A new study suggests that a natural solution might be found right in your fridge: fruits and veggies.
    • “Researchers from the University of Chicago and Columbia University found that eating more fruits, vegetables and whole grains during the day may lead to better sleep that same night.
    • “Dietary modifications could be a new, natural and cost-effective approach to achieve better sleep,” study co-author Dr. Esra Tasali, director of the UChicago Sleep Center, said in a news release.
    • “The study — published June 11 in the journal Sleep Health — is one of the first to show that what you eat during the day may affect your sleep that very night, researchers said.”
  • Per HR Executive,
    • “While it may seem surprising—given the ongoing push by many American workers to stay remote or hybrid post-pandemic—many workers are craving support and connection, as the nation’s loneliness crisis rises. Recent research identified loneliness as a significant and emerging threat to workers’ mental and physical health. And, experts say, it can have widespread effects on the workplace.
    • “In its survey, Loneliness in America 2025, Cigna found that 52% of U.S. workers report feeling lonely. The resulting impact on business is both profound and measurable, according to the Evernorth Research Institute, the research arm of Evernorth, Cigna’s health services business.
    • “Among other concerning results, the research found that lonely employees are more likely to miss work, disengage while at work and/or leave their jobs altogether. This is creating ripple effects that cost employers in productivity, morale and talent retention, researchers wrote.’
  • Per BioPharma Dive,
    • “Roche will advance an experimental Parkinson’s disease drug with a mixed track record into late-stage development, announcing Mondaythat it is “encouraged by the efficacy signals” the medicine displayed in earlier testing despite missing its main objectives in two clinical trials.
    • “The Swiss drugmaker and partner Prothena said continued study of trial enrollees suggested that the antibody drug, known as prasinezumab, delayed progression of symptoms like tremors or joint stiffness in people with early-stage disease.
    • “Roche and Prothena have been developing prasinezumab for more than a decade, having first initiated trials shortly after signing a partnership deal in 2013. The drug targets alpha-synuclein, a protein that can misfold and build up in the brains of Parkinson’s patients, and that’s been the focus of an array of drug programs. Study results have largely disappointed, however.”
  • Per Fierce Pharma,
    • “Roche and AbbVie have once again come up short in their attempt to gain an additional indication for their blockbuster blood cancer treatment Venclexta.
    • “A phase 3 trial of the therapy in previously untreated patients with higher-risk myelodysplastic syndromes (MDS) did not achieve its primary endpoint of overall survival, the companies said Monday. In the global study of approximately 500 patients, the combination of Venclexta plus the chemotherapy azacitidine was pitted against placebo plus azacitidine.
    • “The companies said they will present full data from the trial at an upcoming medical meeting.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Health systems are expanding their ambulatory surgery center networks in a bid to lower costs and manage overcrowded operating rooms.
    • “ASCs can provide a more convenient, lower-cost alternative for lucrative procedures like knee replacements and cataract surgeries. Health system executives say the transition of many services from hospitals to surgery centers is inevitable. Advancing technology, shifting regulations, patient preference and pressure from insurers and lawmakers to reduce hospital costs will make sure of that, they said.”
  • and
    • “Welsh, Carson, Anderson & Stowe made an unspecified investment in Constitution Surgery Alliance, an ambulatory surgery center operator with growth plans.
    • “The private equity firm will help fund a national expansion of the company, which manages 16 facilities in five states, according to a Monday news release.”
  • EXL offers payers a white paper titled “Embrace the new era of Utilization Management: Modernizing ineffective approaches with advanced technology.” Check it out.
  • On a related note, Beckers Hospital Review points out,
    • “As hospitals and health systems face increasing pressure to maintain margins and secure sustainable reimbursement, a growing number of leaders are turning to an old business truth: What gets measured, gets managed.
    • “Payer “scorecards” are gaining traction as hospitals seek to hold insurers accountable, reduce administrative friction and strengthen their negotiating position. By systematically tracking performance metrics such as denial rates, response times and contract compliance, providers aim to shift the balance at the negotiating table.
    • “I often emphasize to my clients that data is their greatest leverage,” Brad Gingerich, vice president of payer strategy at Ensemble Health Partners, said during an episode of the Becker’s Healthcare Podcast. “One of the most important steps is proactively holding payers accountable. The moment a payer fails to meet its contractual KPIs, we flag it immediately — whether through formal demand letters or direct discussions.” 
  • Beckers Hospital Review also informs us,
    • “Total prescription dispensing revenue at U.S. retail pharmacies hit $683 billion in 2024, marking a 9% increase from the previous year, according to a June 16 post from the Drug Channels Institute.
    • “The institute calculated estimated total prescription revenue for the 15 largest pharmacy companies in the U.S. based on 2024 calendar year data. COVID-19 vaccine revenue was excluded from the analysis.
    • “Collectively, the top 15 pharmacy companies accounted for about three-fourths of overall dispensing revenue from retail, mail-order, long-term care and specialty pharmacies. Nearly half of that revenue came from CVS Health, Walgreens Boots Alliance, Cigna and UnitedHealth Group. Elevance Health made the list for the first time after acquiring several pharmacy firms in 2024, including Kroger Specialty Pharmacy. 
    • “GLP-1s were the main driver of revenue increases last year, accounting for more than 80% of the overall growth.”
  • Per Fierce Pharma,
    • “Neurology specialist Supernus Pharmaceuticals will snap up Sage Therapeutics, which was once valued at more than $9 billion, for $561 million up front, with the hope that it can help transform a newly launched treatment for postpartum depression (PPD) into the indication’s standard of care.
    • “The buyout of Massachusetts-based Sage comes after a takeover bid, earlier this year by Biogen, which offered $7.22 per share for the struggling, 15-year-old biotech. 
    • “Six months later, Supernus got the job done with an offer of $8.50 per share, plus a contingent value right (CVR) worth $3.50 per share if a set of milestones are achieved, which would bump up the value of the deal to $795 million.”

Weekend Update

David Ermer–CDC, CMS, Congress, Medical / Rx research, Obesity, SCOTUS, U.S. Healthcare–

Happy belated Flay Day!

From Washington, DC

  • The Daily Caller explains,
    • The Senate’s confirmation of Trump nominees as of June 5 outpaced the Biden administration by 16 nominees and the first Trump administration by 33 nominees, according to information compiled by the Senate GOP leadership-aligned Senate Republicans Communications Center (SRCC).
    • Still, nearly 100 nominees are awaiting floor consideration, according to the Senate executive calendar.
    • The backlog is due in part to Senate Democrats placing blanket holds on hundreds of Trump nominees, requiring the Senate to use finite floor time to confirm each civilian nominee individually through multiple roll call votes. As a result, nearly 60% of the votes taken in the Senate during the 119th Congress have been related to nominations, according to the SRCC.
  • Roll Call summarizes other Senate work during this short workweek here.
  • The Supreme Court will be issuing opinions on Wednesday June 18 this week.
  • Tammy Flanagan, writing in Govexec, asks “Think you’re ready to tap your TSP? Here’s what you might be missing. Before touching your Thrift Savings Plan funds, make sure you understand the rules—and the risks—you might not have planned for.”

From the public health and medical research front.

  • STAT News reports,
    • “Sarepta Therapeutics said Sunday that it was halting shipments of its Duchenne muscular dystrophy gene therapy for patients who can no longer walk, following the death of a second [male] person who received the treatment.
    • “Sarepta disclosed the first patient death — a 16-year-old boy — in March. Both occurred from acute liver failure, a side effect that has been seen with other gene therapies. The company said both patients were non-ambulatory, meaning their disease had progressed to the point they relied on a wheelchair. Most children with Duchenne lose the ability to walk by adolescence.
    • “The company said early Sunday it was working with experts to come up with an enhanced immunosuppressive regimen that could make the therapy, called Elevidys, safer for non-ambulatory patients. It said it would talk with the Food and Drug Administration about the the proposed regimen. 
    • “Sarepta also said it was pausing dosing in an ongoing clinical trial of Elevidys, called ENVISION, that’s focused on older ambulatory and non-ambulatory patients.” 
  • Per Fortune Well,
    • “Researchers at the University of California San Francisco have identified the U.S. regions, as defined by the Centers for Disease Control and Prevention, where dementia occurs most often.
    • “The large and comprehensive study, published in JAMA Neurology, examined data on more than 12.6 million veterans 65 and older enrolled in the Veterans Health Administration system; only 2% were women. 
    • “Researchers found the highest incidence in the Southeast (North Carolina, South Carolina, Georgia, Florida) and the lowest in the Mid-Atlantic states (Delaware, Maryland, Pennsylvania, Virginia, West Virginia, New Jersey, Washington D.C.).” 
  • The Washington Post informs us,
    • A common genetic variant is linked to a doubled dementia risk for older men, a recent analysis in Neurology suggests.
    • The study used data from Aspirin in Reducing Events in the Elderly (ASPREE), which followed elderly patients in the United States and Australia with no history of cardiovascular disease, dementia or cognitive decline between 2010 and 2017.
    • Researchers focused on 12,174 Australians of European ancestry over age 70, and looked for variants in the HFE gene. The gene is critical to regulating the body’s iron levels, and variants are common among people of European descent.
    • Those who carry two copies of the p.C282Y variant in the HFE gene can develop hemochromatosis, a condition that causes iron overload in the body, and resulting conditions such as liver cirrhosis, liver cancer, frailty, arthritis and dementia.
    • One in 3 people carry a gene variant called H63D, and 1 in 36 carry two copies, John Olynyk, a professor at the Curtin Medical Research Institute in Perth, Australia, says in a news release about the new study.
    • “Having just one copy of this gene variant does not impact someone’s health or increase their risk of dementia. However, we found having two copies of the variant more than doubled the risk of dementia in [previously healthy] men, but not women,” Olynyk says.
  • NPR offers “Advice for trying GLP-1 drugs for weight loss from a doctor who’s been there.”
  • The New York Times reports,
    • “Many older people embrace vaccines. Research is proving them right.
    • “Newer formulations are even more effective at preventing illnesses that commonly afflict seniors — perhaps even dementia.”
  • and
    • “Many Falls Are Preventable. These Tips Can Help. Small changes and good habits make a difference.”
  • The Wall Street Journal reports,
    • When Officer Chelsea Johnston came across a wanted felon one evening in May, Johnston jerked her cruiser in front of him, sprinted after him and tackled him to the ground. Still catching her breath, Johnston motioned for someone to step out of the cruiser: Joy Bogese.
    • “Thank God,” the man said. “It’s you.” 
    • Bogese, who served time for financial crimes that fed a heroin addiction, now spends many of her evenings in a police cruiser as a recovery specialist helping people with addiction get into treatment. The man asked Bogese to help him get into a drug-treatment program at the local jail, where Bogese occasionally facilitates groups. 
    • She is part of a growing effort in Chesterfield County’s [Virginia] fight against addiction. In this county of nearly 400,000, overdose deaths have dropped by half in a single year—about double the decline of the rest of the country—to levels seen before the crisis began in 2015.
    • The precipitous drops have astounded public officials and health-policy experts, who have traveled across the country in an attempt to learn the formula and replicate it. Governors, members of Congress and sheriffs from as far away as Alaska have all come through, along with an acting U.S. drug czar.
  • Per Medscape,
    • “A prospective study found that increased consumption of olive oil was associated with a reduced risk for breast cancer, particularly oestrogen receptor–negative (ER−) and human epidermal growth factor receptor 2–negative (HER2−) breast cancers. A systematic review revealed that case-control studies more frequently reported this protective association, whereas prospective studies did not report any association.”

From the U.S. healthcare business front,

  • Kauffman Hall points out,
    • Mehmet Oz, MD, the new CMS Administrator, in a Senate confirmation hearing, expressed support for exploring multi-year products for Medicare Advantage. While his remarks were made in the context of avoiding unnecessary member churn and associated elevated broker commissions, there are much broader ramifications of transitioning from single-year to multi-year health plan products. His remarks have sparked interest in the industry to explore this idea further.” * * *
    • “Multi-year health plan products have the potential to change a lot about how healthcare business models work today. Given the inherent complexity, it is likely to be a slow journey towards the destination. Even so, incumbent health insurers and risk-bearing providers would be well-advised to start strategizing and building / experimenting with prototypes to manage their risk of being disrupted by multi-year-native health plan innovators. The new administration has already shown that it can move with alacrity and is not afraid to be disruptive in the process. The shift to multi-year plans could come sooner than expected. Or it may not. But in any case, it is better to be prepared.”
  • The FEHB Program was offered on a multi-year basis for two years in the 1980’s although an Open Season was held between the two years in which there were no benefit changes.
  • The Washington Post reports, “Nurse practitioners step in as geriatrician ranks shrink. Nurse practitioners are not trying to replace doctors — they’re trying to meet patients’ needs, wherever those patients are, an expert said.”
  • Per MedTech Dive,
    • “Chris Scoggins is taking the helm of Abbott’s diabetes business at a busy time for the company and the diabetes tech industry. Scoggins was promoted to Abbott’s executive vice president of diabetes care in December. Since then, Abbbott has collaborated with insulin pump firms Tandem Diabetes Care and Sequel Med Tech to integrate its planned glucose-ketone sensor with their devices. 
    • “Scoggins spoke with MedTech Dive about the company’s strategic approach ahead of the American Diabetes Association’s Scientific Sessions in June.”
    • The article includes the interview.

Tuesday report

David Ermer–CMS, Congress, FDA, Medical / Rx research, Medicare, U.S. Healthcare–

From Washington, DC,

  • Politico reports,
    • “House Republicans have finalized changes to the party-line tax and spending package the chamber passed last month, to keep the bill in compliance with Senate rules. 
    • “An early copy of the amendment House Republicans plan to adopt this week, first obtained by POLITICO, would remove $2 billion for Pentagon military intelligence programs and strike policy that would have allowed mining in a protected wilderness in the Midwest, among other changes. By nixing items the Senate parliamentarian has flagged, the bill will retain its “privilege” and has a chance at passing the Senate without having to overcome the filibuster.
    • “House GOP leaders plan to adopt the tweaks on the floor Wednesday, according to House Majority Leader Steve Scalise. 
    • “So, the House doesn’t have to vote again on passage of the bill that was difficult to whip the first time, the changes will be adopted through a fast-track tactic. By approving a resolution this week to tee up floor debate on a separate bill, the House will be voting to amend the megabill before it is officially transmitted to the Senate.”
  • Fierce Pharma tells us,
    • “As President Donald Trump vows to bridge the drug pricing gap between the U.S. and other developed countries with his “most favored nation” (MFN) policy, Pfizer CEO Albert Bourla is calling for a U.S. government-led push to increase overall drug spending outside the U.S.
    • “While the exact mechanism of implementing MFN to reduce drug prices in the U.S. remains unclear, Bourla proposed (PDF) that other countries should spend a certain percentage of their GDP per capita on innovative medicines.
    • “Bourla laid out the concept Monday at the Goldman Sachs annual global healthcare conference, drawing a comparison to how members of the North Atlantic Treaty Organization (NATO) have agreed to commit 2% of their national GDP to defense spending.
    • “The U.S. is spending about 0.8% of GDP per capita on innovative drugs within 10 years of their launch, Bourla said. That’s higher than the 0.5% by Italy and Spain, or 0.4% in Germany, while the U.K. is spending about 0.3%, he said.” * * *
    • “To Bourla, reining in U.S. drug costs and increasing foreign countries’ expenditures are two sides of the same coin. In the U.S., it remains to be seen how the health department will enforce MFN, and Bourla said he doesn’t expect the industry will gain much clarity anytime soon.”
  • MedCity News opines,
    • “[P]olicy leaders overlook the fact that IVF is priced at around $20,000 per cycle because the system can’t expand to meet demand. Adding more insurance money will only inflate the queue, unless general insurers follow the lead of specialized fertility insurers that focus on actual outcomes; they have every incentive to keep costs controlled and success rates high. We risk repeating what happened in higher education, when the federal government expanded funding for college without restraining the total price. College prices continue to rise far faster than inflation. This is not a mistake we can afford with IVF.
    • “President Trump’s plan to fix IVF might look bold in a headline. In reality, it doesn’t create a single new embryology lab. It doesn’t hire one more specialist. It won’t change the fact that right now, only people with plenty of money can afford IVF, and throwing subsidies at a market that’s already bottlenecked only shifts who pays. If we keep ignoring capacity, we prolong the same heartbreak and keep IVF out of reach for many hopeful parents.
    • “We need more clinics, cutting-edge automation, and better oversight so clinics aren’t pressured to cut corners or limit embryo transfers just to stretch funding. We need a fundamental restructuring that rewards a successful pregnancy rather than a never-ending list of procedures.”
  • Per Beckers Payer Issues,
    • “Groups representing insurers are pushing back on proposed tighter regulations on Medicare Advantage coding. 
    • “Senate Republicans are considering targeted changes to Medicare Advantage as part of the sweeping “One Big Beautiful Bill.” Lawmakers are considering adding provisions of the No UPCODE Act to the package. 
    • “The bipartisan proposal was first floated by Sens. Bill Cassidy, MD, and Jeff Merkley in 2023, and would make changes to the risk-adjustment model MA plans use to bill the federal government and limit the ability to include old or unrelated medical conditions in the cost of care.”
  • Per a CMS news release,
    • “As he turns 65 on Wednesday, June 11, CMS Administrator Dr. Mehmet Oz is using his own Medicare enrollment experience to help Americans better understand how to sign up for Medicare and select the coverage that best fits their needs. Through a new video and social media series, Dr. Oz is walking future enrollees through simple steps they can take to get started—beginning with Medicare.gov.
    • Dr. Oz’s public service messages highlight key reminders for those approaching Medicare eligibility:
      • Start early to learn about options.
      • Enrollment paths may vary depending on whether someone is already receiving Social Security benefits or whether you are still working and have employer coverage.
        Use Medicare.gov to get clear, personalized guidance on enrollment and coverage.
      • To watch Dr. Oz’s messages, visit: 
        Dr. Mehmet Oz displays his Medicare card
  • JAMA Open informs us,
    • “The findings of a cross-sectional study suggest that although 988 has been contacted more than 16 million times since its launch [in July 2022], there remains opportunity to increase 988 use. For example, the past-year 988 contact rate of 23.7 per 1000 is less than half that of the rate of adult emergency department visits that include a mental health diagnosis (53.0 per 1000 population).4 Furthermore, there was regional and state-level variation in 988 use. This is consistent with state variation in funding for and legislative attention toward 988, both of which may affect awareness and use. Lower rates of 988 use in the South, which is more politically conservative than other regions, is also consistent with prior research showing less favorable attitudes toward 988 among Republicans than Democrats.
    • “Study limitations relate to 988 contacts being assigned to states according to area code, uncertainty about the 988 repeat contact rates, and state-level variation in the existence of other crisis lines that are not part of the 988 network. Despite these inherent data limitations, our findings suggest that there are opportunities to increase 988 use, especially in southern states.”

From the public health and medical research front,

  • Healio lets us know,
    • “Data show men were less likely to seek care for diabetes, HIV/AIDS and hypertension.
    • “More research is needed to track gender-related health risks and how they change over time, a researcher told Healio.”
  • MedPage Today points out,
    • “Active transportation modes in midlife — notably, cycling — were tied to a lower dementia risk over 13 years.
    • “Cycling was also associated with higher hippocampal volume.”
  • Cardiovascular Business reports,
    • “A nationwide data analysis found that nearly one-third of U.S. adults with hypertension may be eligible for therapy by two catheter renal denervation (RDN) devices cleared by U.S. Food and Drug Administration (FDA). However, the study’s authors noted that eligibility alone does not indicate which of the 35 million patients are most likely to benefit from the treatment. The study was published June 4 online in JACC: Interventions.[1]
    • “Co-author of the study Eric Secemsky, MD—a cardiologist and researcher from Beth Israel Deaconess Medical Center and Harvard Medical—and his team used data from the National Health and Nutrition Examination Survey (NHANES) to estimate the proportion of hypertension patients who meet the FDA’s criteria for consideration of RDN.
    • “The researchers then broke down how many patients would qualify for RDN using the same criteria of each study for the two approved devices. They also looked at how many patients would qualify under the Society for Cardiovascular Angiography and Interventions (SCAI) 2023 RDN position statement on patient selection and best practices.
    • “The authors found that on-medication, sham-controlled randomized trials had the most selective enrollment criteria, matching only about 2% of U.S. adults with hypertension. In contrast, U.S. single-arm registries and the SCAI 2023 position statement estimated a much larger potential eligibility, approaching 25 million Americans. This discrepancy underscores the challenge of generalizing highly selective trial results to a broader patient population in real-world settings.”
  • MedCity News lets us know,
    • “An experimental Metsera obesity drug led to an average 8.4% weight loss(Opens in a new window) in a small clinical trial, preliminary results that keep the biotech competitive in the crowded mix of companies pursuing a promising new metabolic target, but with the potential to offer less frequent dosing than its rivals.
    • “The drug, MET-233i, is a peptide engineered to activate amylin, a hormone that, like GLP-1, plays a role in regulating blood sugar and appetite. New York-based Metsera designed MET-233i with technology enabling the medication to last longer in the body.
    • “The 8.4% weight loss mark reported Monday was achieved by the 1.2 mg dose, the highest of four doses of the drug administered weekly for five weeks in a two-part Phase 1 study. Each part enrolled 40 participants. In the single-ascending dose portion of the study, in which a group of participants received just a single dose, the 1.2 mg dose led to an average 3.8% loss in body weight that was maintained for five weeks.”
    • “Metsera said its drug’s half-life of 19 days supports once-monthly dosing. That would be an advantage over the once-weekly dosing of the GLP-1 drugs currently available and the clinical-stage amylin drugs in development by other companies, such as Novo Nordisk, Roche, and AbbVie.”

From the U.S. healthcare business front,

  • Fierce Healthcare notes,
    • “Employers are aiming to be more strategic in how they administer benefits as costs continue to rise, according to a new survey from the consulting firm WTW.
    • “WTW released its latest Benefits Trends Survey on Tuesday and found that rising benefit costs were the largest factor driving the strategy around coverage for employers. In addition, employers ranked the financial pressures on budgets as the fourth-highest factor.
    • “Close to half (44%) of those surveyed said that they faced challenges in delivering on their health benefit strategies given rising costs, with 44% saying the same about wellness programs and 36% saying they faced challenges around leave offerings.
  • and
    • “The American Medical Association underwent its annual leadership change on Tuesday, inaugurating otolaryngologist Bobby Mukkamala, M.D. as the 180th president of the nation’s largest physician association. 
    • “The organization’s House of Delegates, composed of its member physicians and residents, also chose urologic surgeon William Underwood III, M.D., as its president-elect. Underwood will assume the presidency in June 2026. 
    • “Mukkamala is a Flint, Michigan-based physician who attended the University of Michigan Medical School and completed his residency at Loyola University Medical Center in Chicago. Mukkamala said in an interview with Fierce Healthcare in June 2024 that he hopes to work on prevention of chronic diseases rather than the “sick care” model that costs the health system millions.
    • “He will also continue the heavy-hitting physician group’s advocacy on increasing physician pay and easing the burden of prior authorization, two top concerns for physicians.” * * *
    • “Underwood, the new president-elect, has spent his 25-year career in Buffalo, New York as a urologic surgeon and doing robotic urologic surgery. He holds patents for discovering a biomarker in prostate cancer and has co-authored nearly 120 peer-reviewed publications, book chapters and published abstracts.” * * *
    • “It is an incredible honor to be chosen by my peers to represent physicians and the patients we serve at this critical moment for health care and medicine,” Underwood said in a statement. “The AMA is leading the way in fighting for a rational Medicare payment system, to rein in prior authorization, and reduce physician burnout. I will stand up to advocate for our profession in a way that will inspire, motivate, and activate physicians to join the AMA in our efforts to improve the health of our nation.”
  • Modern Healthcare reports,
    • “Mayo Clinic is investing in an ambient clinical artificial intelligence startup, the health system said Tuesday.
    • “The Rochester, Minnesota-based health system made an undisclosed investment and entered into a collaboration focused on ambient clinical intelligence with Hellocare.ai, a healthcare artificial intelligence and virtual care company.
    • “Mayo becomes the fourth major health system to invest in Hellocare.ai since April. The investment is an extension of Hellocare.ai’s $47 million Series A funding round that included support from a group of health systems including Cincinnati-based Bon Secours Mercy Health, Aurora, Colorado-based UCHealth, OSF Ventures, the corporate investment arm of OSF HealthCare.
    • “Hellocare has developed an AI-enabled software and hardware platform for hospitals and health systems featuring cameras and microphones mounted on patient room televisions to assist clinical staff with tasks such as ambient documentation and patient monitoring. The company also offers a virtual care solution that supports clinicians with rounds, medication checks and patient discharge.”
  • and
    • “Abbott and Tandem Diabetes Care announced Tuesday an agreement to combine Abbott’s upcoming dual glucose-ketone sensor with Tandem’s insulin delivery systems to create integrated diabetes solutions.
    • “The sensor is in development, but once it’s commercially available, it will be able to detect an early rise in ketone levels to help patients avoid diabetic ketoacidosis. The company expects the sensor to be available next year, according to a spokesperson.”
  • Per Beckers Hospital Review,
    • “Cleveland-based University Hospitals recorded a $49.7 million operating loss (-3% operating margin) in the first quarter of 2025, an improvement from a $74.6 million operating loss (-4.9% margin), according to its June 10 financial report.  
    • “The system reported total operating revenue of $1.7 billion for the three months ended March  31, a 9.7% increase year over year. University Hospitals said that revenue growth was driven by a $106 million increase in net patient service revenue. 
    • “Total operating expenses increased 7.6% year over year to $1.7 billion. The growth was primarily driven by increased labor costs and patient care supplies of $39 million and $51 million, respectively.

Tuesday Report

David Ermer–CDC, CMS, Congress, FDA, Medical / Rx research, Medicare, NIH, Rx coverage, U.S. Healthcare–
Thanks to Alexandr Hovhannisyan for sharing their work on Unsplash.
  • This afternoon, the House of Representatives passed by voice vote the Esophageal Cancer Awareness Act, HR 3490.
    • “This bill requires the Government Accountability Office to report to Congress on (1) the impact of esophageal cancer-related health care spending under the Federal Employees Health Benefits Program (FEHBP) for federal employees and retirees diagnosed with esophageal cancer, and (2) how often FEHBP participants with a high risk of esophageal cancer undergo screenings according to established guidelines.” 
    • The bill honors the late Rep. Gerald Connelly (D VA) who died from the disease. The bill now heads to Senate.
  • The New York Times reports,
    • “President Trump on Tuesday ratcheted up pressure on Senate Republicans to quickly embrace and pass legislation carrying his domestic agenda, intensifying a battle inside the G.O.P. about what should be in the measure and how much it should cost.”
  • Govexec adds,
    • “The Trump administration plans to send its first spending cuts request to Congress on Tuesday, asking lawmakers to swiftly eliminate $9.4 billion in funding for the Corporation for Public Broadcasting and various foreign aid programs.
    • “The request for what are called rescissions allows the White House budget office to legally freeze spending on those accounts for 45 days while the Republican-controlled Congress debates whether to approve the recommendation in full or in part, or to ignore it.
    • “The proposal calls on lawmakers to eliminate $1.1 billion from the Corporation for Public Broadcasting, which provides funding for National Public Radio and the Public Broadcasting Service. That means NPR and PBS would lose their already approved federal allocations, if the request is approved by Congress.”
  • Fierce Healthcare points out,
    • “The Centers for Medicare and Medicaid Services plans to undertake several new health tech initiatives, senior leaders announced today at a closed meeting with stakeholders. 
    • “The Department of Health and Human Services held a meeting today to discuss health tech policy and its recent request for information on health tech initiatives. CMS seems to be moving ahead with some of the initiatives it asked stakeholders to provide feedback on in its RFI — among them a national provider directory and modern identity verification for Medicare beneficiaries.
    • “This comes as the HHS’ health IT office announced a new leader this morning, Thomas Keane, M.D. Keane spoke at the meeting of stakeholders today at the Hubert H. Humphrey building in Washington, D.C.” 
  • Healthcare Dive adds,
    • Thomas Keane, a software engineer and interventional radiologist, began his role as national coordinator [for health information technology] Monday, the spokesperson said. He previously worked at the ASTP and served as a senior advisor to the deputy secretary of the HHS, according to his biography on the agency’s website. 
  • Healthcare Dive also relates,
    • “The Trump administration rescinded guidance on Tuesday directing hospitals to perform abortions during medical emergencies, even in states with restrictive abortion bans. 
    • “The Biden administration published the guidance in 2022, shortly after Roe v. Wade was overturned, asserting doctors were required to perform emergency care, even if that included abortions, under the Emergency Medical Treatment and Labor Act. * * *
    • “The CMS now says that guidance “does not reflect the policy of this Administration.” The new guidance is effective May 29, and furthers an executive order from President Donald Trump seeking to remove regulatory red tape, the CMS said.” * * *
    • “Texas and Idaho, which have some of the nation’s most restrictive abortion bans, have repeatedly argued that there is no conflict between EMTALA and their policies, because both states allow abortion when the mother’s life is at risk.”

From the judicial front,

  • Modern Healthcare reports,
    • “A federal district court judge on Tuesday denied motions to dismiss complaints in two lawsuits against data analytics firm MultiPlan — now operating as Claritev — and a number of insurers.
    • “Judge Matthew Kennelly of the U.S. District Court for the Northern District of Illinois denied Claritev’s motion to dismiss complaints in two lawsuits involving federal and state antitrust and consumer protection claims.” * * *
    • “Both lawsuits allege Claritev colluded with insurers to reduce pay for out-of-network providers, violating state and federal antitrust laws under the Sherman Act.
    • “We remain confident in the strength of our legal position and look forward to presenting the facts as the case moves forward,” Claritev said in a statement Tuesday. “These lawsuits will only serve to increase healthcare cost for employers and patients. We will vigorously defend ourselves through the legal process while remaining focused on delivering value to our customers and the broader healthcare ecosystem.”
  • Per Healthcare Dive,
    • “Centene is being sued for wrongful death after one of its members died after failing to get the mental healthcare he needed because of the insurer’s inadequate provider networks, according to the lawsuit filed by the member’s mother.
    • “The suit, filed late May in the Superior Court of Maricopa County in Arizona, accuses Centene’s subsidiary in the state, Health Net, of maintaining “ghost networks” — wherein insurers say providers are in network that aren’t, inflating the care options available under their plans to the detriment of actual access.
    • “As a result, Centene violated state and federal laws requiring network accuracy and adequacy, according to the suit, which also accuses the St. Louis-based payer of negligence and fraud. Centene did not respond to a request for comment.”
  • Per MedTech Dive,
    • “The Food and Drug Administration did not appeal a recent U.S. District Court decision that set aside the agency’s final rule aimed at increasing its authority over laboratory developed tests, according to two lab industry groups.
    • “The 60-day window for the FDA to appeal the ruling by the U.S. District Court for the Eastern District of Texas expired over the weekend. The Association for Molecular Pathology supported the FDA’s move not to appeal.
    • “This decision should finally conclude the FDA’s unwarranted and overreaching attempts to assert regulatory authority over LDTs,” AMP President Jane Gibson said in an emailed statement.”

News from the American Society of Clinical Oncology’s conference

  • The New York Times reports,
    • “A group of 97 patients had longstanding multiple myeloma, a common blood cancer that doctors consider incurable, and faced a certain, and extremely painful, death within about a year.
    • “They had gone through a series of treatments, each of which controlled their disease for a while. But then it came back, as it always does. They reached the stage where they had no more options and were facing hospice.
    • “They all got immunotherapy, in a study that was a last-ditch effort.
    • “A third responded so well that they got what seems to be an astonishing reprieve. The immunotherapy developed by Legend Biotech, a company founded in China, seems to have made their cancer disappear. And after five years, it still has not returned in those patients — a result never before seen in this disease.
    • “These results, in patients whose situation had seemed hopeless, has led some battle-worn American oncologists to dare to say the words “potential cure.”
    • “The new study, reported Tuesday at the annual conference of the American Society of Clinical Oncology and published in The Journal of Clinical Oncology, was funded by Johnson & Johnson, which has an exclusive licensing agreement with Legend Biotech.”
  • Per Fierce Pharma,
    • “Though they are both multiple myeloma drugs with the same mechanism of action, Sanofi’s Sarclisa has had difficulty competing with Johnson & Johnson’s powerhouse Darzalex, largely because it reached the market five years later.
    • “But one advancement that could help Sanofi close some of the gap is its on-body delivery system for its CD38 antibody.
    • “Tuesday, at the American Society of Clinical Oncology annual meeting in Chicago, Sanofi presented data from two trials that showed Sarclisa administered subcutaneously (SC) from an investigational on-body injector (OBI) reduced treatment time and produced similar efficacy and safety compared to intravenous (IV) infusion.”
  • Per BioPharma Dive,
    • “An experimental, non-hormonal drug from Bayer can reduce the hot flashes and other menopausal side effects many women taking a common breast cancer therapy experience, according to results from a late-stage clinical trial run by the pharmaceutical company.
    • “The study, known as Oasis-4, is the fourth successful trial test of Bayer’s drug, called elinzanetant. Detailed data presented at the American Society of Clinical Oncology’s annual meeting Monday showed treatment reduced vasomotor symptoms in women receiving endocrine therapy to treat or prevent hormone receptor-positive breast cancer.”
  • and
    • “A Johnson & Johnson drug currently used for advanced prostate cancer can help keep the disease from progressing in men who are at earlier stages and have certain genetic mutations, according to newly unveiled data from a Phase 3 clinical trial.
    • “Results from this trial, named Amplitude, were released Tuesday at the American Society of Clinical Oncology’s meeting in Chicago. They could potentially expand the number of people able to receive J&J’s Akeega, a pill that combines the active ingredients from the medicines Zejula and Zytiga.”
  • The Wall Street Journal reports,
    • “Roche said Tecentriq combined with lurbinectedin shows significant survival benefits for patients with extensive-stage small cell lung cancer.
    • “The Swiss pharmaceutical company said Tuesday that late-stage trials showed the combination led to a 46% reduction in the risk of the disease progressing or death, and 27% reduction in the risk of death.
    • “The combination can be used a as a first-line maintenance treatment for people with the cancer following induction therapy with carboplatin, etoposide and Tecentriq, it said.
    • “The safety profile of the combination was consistent with the known safety profiles of Tecentriq and lurbinectedin, Roche said.”

In other medical research and public health news,

  • Cigna, writing in LinkedIn, explains why early detection is so important to fighting breast cancer.
  • The latest issue of the National Institutes of Health’s Research Matter covers “Customized gene therapy | Parents with substance use disorders | Ultra-processed food consumption.”
  • The New York Times discusses “Anorexia in Middle Age and Beyond. A growing number of older women are seeking treatment for eating disorders. Many have struggled without help for decades.”
  • MedCity News informs us,
    • “The World Health Organization estimates that about 10% of women and girls of reproductive age around the world — roughly 190 million people — suffer from chronic pain as a result of endometriosis. 
    • “Take this estimate with a grain of salt, though — it’s likely too low. The average diagnostic delay for endometriosis patients is eight years, driven in large part by the fact that the standard method used to diagnose the disease is an invasive surgical procedure.”
    • Boston-based biotech startup Heranova Lifesciences is working to address this problem by developing a non-invasive blood-based test. Just this spring, the company announced the LDT validation and U.S. launch of this product, which is called HerResolve. * * *
    • “The gold standard that doctors use to diagnose endometriosis is laparoscopy followed by histological confirmation. With this method, doctors put patients under anesthesia and perform a laparoscopy to look at the tissue and lesions growing outside the uterus — then, the doctor takes a tissue sample to confirm the diagnosis under a microscope.
    • “This method of testing is invasive — and not very quick. Heranova’s test seeks to address these issues by using machine learning to analyze a panel of biomarkers in a patient’s blood sample to determine whether or not they have endometriosis. 
    • “The test’s accuracy is on par with laparoscopy followed by histopathology, said Farideh Bischoff, Heranova’s chief medical officer.”
  • Per Health Day,
    • “Clinicians consider administration of human papillomavirus (HPV) vaccine as feasible at age 9 to 10 years, and parents appear to be receptive to discussing vaccination at this age, according to a study published online June 2 in Pediatrics.
    • “Caroline K. Tietbohl, Ph.D., from the University of Colorado and Children’s Hospital Colorado in Aurora, and colleagues conducted an explanatory sequential mixed-methods study as part of an ongoing randomized trial that compared initiation at ages 9 to 10 years (intervention) versus 11 to 12 years (control) across 17 practices in Colorado (nine intervention) and 16 practices in California (eight intervention). At one month after study initiation, practice clinicians were surveyed, and semi structured interviews were conducted at three months after study initiation.” * * *
    • “The results of our prospective trial will determine if initiating vaccination earlier increases vaccination completion rates, especially by age 13 years,” the authors write.
  • The Wall Street Journal reports,
    • People are more likely to get cancer as they age. Dr. Miriam Merad has an unconventional idea of how that might be reversed: using allergy drugs and other seemingly unlikely medications to damp a condition known as “inflammaging.”
    • The immunologist and oncologist has spent years examining malignant tumors to learn why people over age 50 account for nine in 10 cancer diagnoses in the U.S. She and her research team at the Icahn School of Medicine at Mount Sinai in New York City have homed in on an answer: the aging immune system. Their studies of individual immune cells in human lung tumors, as well as in old mice, have revealed how chronic, or pathogenic, inflammation in older people—dubbed inflammaging—interferes with the immune system and fuels cancer growth.
    • Merad and other researchers are testing whether existing anti-inflammatory medications usually used to fight rheumatoid arthritis or allergy conditions like asthma or eczema can slow cancer in older patients. They are also searching for new drugs. “Aging is something that we think we can transform,” says Merad, director of the Marc and Jennifer Lipschultz Precision Immunology Institute at Mount Sinai.”

From the U.S. healthcare business front,

  • Becker Payer Issues lets us know,
    • “Following a tumultuous period for UnitedHealth Group, new CEO and board chair Stephen Hemsley addressed investors on June 2, acknowledging the company’s recent shortcomings and detailing his plan to restore the high performance that investors and customers expect moving forward.
    • “Mr. Hemsley expressed a deep commitment to regaining trust through increased transparency, improved pricing strategies, and a renewed focus on internal operations, particularly at Optum Health and UnitedHealthcare. 
    • “We are well aware we have not fulfilled your expectations or our own,” he said. “We apologize for that performance and we are humbly determined to earn back your trust and your confidence.”
    • The article also provides eight notes on Mr. Hemsley’s talk.
  • STAT News adds,
    • UnitedHealth Group’s new CEO told investors that the company is reevaluating how it tallies Medicare Advantage patients’ diagnoses for reimbursement purposes, an issue currently under investigation by the Justice Department. 
    • Stephen Hemsley’s remarks during the company’s annual shareholder meeting on Monday signal a noteworthy shift: UnitedHealth is now publicly acknowledging potential issues with how it assesses the health of its Medicare Advantage members.” * * *
    • “Our management team has been working with urgency through a comprehensive and methodical review of our operations from end to end,” Hemsley said. “Digging into every part of the organization to evaluate how we have been performing and to improve that performance.”
  • Fierce Pharma notes,
    • “Medicare Part D beneficiaries can now tap into Amazon Pharmacy’s PillPack for pre-sorted medication packets, the retail giant announced on Tuesday.
    • “PillPack sorts a patient’s medications into personalized, tear-away packets that are labeled by date and time, which can make it easier to follow prescribed regimens. The expansion brings this service to more than 50 million Part D enrollees who take daily medications, Amazon said.
    • “Once eligible customers sign up for packets through PillPack, Amazon Pharmacy will coordinate needed refills to ensure prescriptions arrive on time.
    • “In addition to growing its reach in the Part D market, Amazon announced that it will roll out new services to support caregivers in managing medications for a family member or loved one.”
  • Modern Healthcare reports,
    • “Pyx Health, a digital mental health platform, on Tuesday announced its acquisition of FarmboxRx, a company that provides fresh produce food boxes to Medicare and Medicaid members.”
  • Beckers Hospital Review informs us that “Hospitals [are] push[ing] back on low Leapfrog grades.”
  • Per Fierce Healthcare,
    • “In January, H1 picked up provider data management software company Ribbon Health to broaden its reach into the health plan, provider system and digital health sectors.
    • “Five months later, the healthcare tech company has acquired Veda Data Solutions to build out its provider data and automation solutions for payers.
    • “Financial terms of the deal were not disclosed.
    • “Founded 10 years ago, Veda fixes bad provider data for healthcare organizations. Inaccurate and out-of-date health plan provider directories continue to be a thorny problem in healthcare and can make it difficult for patients to find a clinician when they need care.”

Monday Report

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

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the judicial front,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Thursday Report

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

From Washington, DC

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

From the judicial front,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Tuesday Report

David Ermer–CDC, CMS, Congress, COVID-19, Electronic health records, Generative AI, Medical / Rx research, Medicare, Mental health care, Obesity, Patient safety, Rx coverage, Telehealth, U.S. Healthcare–

From Washington, DC

  • Federal News Network interviews Bloomberg Government deputy news director Loren Duggan about what’s next for the Big Beautiful Bill Act.
  • Per a Senate press release,
    • Senate Judiciary Committee Chairman Chuck Grassley (R-Iowa) joined Sens. John Cornyn (R-Texas) and Amy Klobuchar (D-Minn.) to introduce the Don’t Sell My DNA Act to safeguard consumers’ sensitive genetic data during corporate bankruptcy proceedings.
    • The Don’t Sell My DNA Act strengthens consumer privacy protections by:
      • Modernizing the Bankruptcy Code to include genetic information in the definition of “personally identifiable information”;
      • Requiring written notice and affirmative consumer consent prior to the use, sale or lease of genetic information during bankruptcy proceedings; and
      • Requiring the trustee or debtor in possession of genetic information to permanently delete any data not subject to a sale or lease.
    • “Consumers should feel confident that any personal information shared with a public company isn’t up for grabs when that company files for bankruptcy,” Grassley said. “This bill would fill gaps in current law to help safeguard consumers’ genetic information and ensure Americans’ DNA isn’t treated like any other financial asset.”
  • The American Hospital Association lets us know,
    • Department of Health and Human Services Secretary Robert F. Kennedy Jr. May 27 announced in a post on X that the Centers for Disease Control and Prevention would no longer recommend the COVID-19 vaccine for healthy children and pregnant women. 
  • Per Fierce Healthcare,
    • “The Centers for Medicare & Medicaid Services (CMS) Innovation Center announced Monday it is extending three tracks within the Kidney Care Choices (KCC) Model through 2027.
    • “Starting in performance year 2026, the model’s financial methodology and participation options will be modified to “improve model sustainability,” the agency said. However, one KCC Model track will be shuttered a year early at the end of December.
    • “The KCC Model has 93 participants, and implementation first began in January 2022. The most recent participants were announced Jan. 15.”
  • The Equal Employment Opportunity Commission announced last week
    • The EEOC collects workforce data from employers with more than 100 employees (lower thresholds apply to federal contractors). Employers meeting the reporting thresholds have a legal obligation to provide the data; it is not voluntary.  * * *
    • The 2024 EEO-1 Component 1 data collection opened on Tuesday, May 20, 2025. The deadline to file the 2024 EEO-1 Component 1 report is Tuesday, June 24, 2025.
    • “As part of EEOC Acting Chair Lucas’ efforts to identify continued cost savings for the American public, there will be a shorter collection period during which filers may submit their 2024 reports. The collection period will not extend beyond the Tuesday, June 24, 2025 “Published Due Date” deadline. Additionally, beginning with the 2024 EEO-1 Component 1 data collection, all communications sent to filers will be electronic.” * * *
    • “Filers should visit the dedicated EEO-1 Component 1 website at www.eeocdata.org/eeo1
      to access the EEO-1 Component 1 Online Filing System (OFS), to find supplementary resource materials such as the 2024 EEO-1 Component 1 Instruction Booklet and 2024 EEO-1 Component 1 Data File Upload Specifications, and to get the latest updates. Filers needing additional assistance can access the Filer Support Team Message Center upon logging into the OFS.”

In Food and Drug Administration News,

  • The American Hospital Association News tells us,
    • “The Food and Drug Administration has identified a Class I recall of certain lots of BD esophagogastric balloon tamponade tubes due to the potential for serious injury or death. BD said it became aware of some users encountering challenges removing the plastic plugs from the rubber lumen to inflate the balloons. BD and their subsidiary C.R. Bard Urology and Critical Care sent all affected customers a letter with updated use instructions. There have been two serious injuries, and one death associated with the issue.”
  • Per Fierce Pharma,
    • Despite facing ongoing legal pressure from its rival United Therapeutics, Liquidia has successfully landed a pair of long-awaited FDA approvals for its dry powder formulation of treprostinil.
    • The FDA has cleared treprostinil—also known by the trade name Yutrepia—to improve exercise ability in adults with pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD).
  • and
    • The FDA has also approved Sanofi’s meningococcal vaccine MenQuadfi for use in infants as young as 6 weeks, multiple news outlets reported Tuesday. The shot was already cleared to protect against four prolific strains of meningococcal bacteria in individuals as young as 2 years and older.
    • The FDA based its decision on data from three phase 3 trials that found MenQuadfi worked as well as GSK’s rival meningococcal vaccine Menveo when given with other routine vaccines in children between the ages of 6 weeks to 19 months, Reuters pointed out. Sanofi’s trials enrolled more than 6,000 participants.
  • BioPharma Dive reports,
    • “A patient who received an experimental gene therapy developed by Rocket Pharmaceuticals has died following treatment, the company disclosed Tuesday.
    • “According to Rocket, the patient experienced what’s known as capillary leak syndrome, where plasma and proteins seep from blood vessels into surrounding tissue, and later died from an acute systemic infection.
    • “The Food and Drug Administration ordered the study’s halt Friday, while Rocket works with clinical trial monitors and other experts to investigate the cause. The company said it is focusing on a “novel immune suppression agent” it recently added to a pre-treatment preparatory regimen.”

From the judicial front,

  • The American Medical Association informs us,
    • “In a win for the nation’s youth—and all Americans’ health—the U.S. Supreme Court has ruled (PDF) that the Food and Drug Administration (FDA) did not act in an arbitrary and capricious manner when it told applicants that they could not put certain flavored e-cigarette liquids on the shelf.
    • “The unanimous decision overturned a 5th U.S. Circuit Court of Appeals ruling. Had that appellate-court ruling been allowed to stand, companies could have marketed products that clearly were designed to appeal to children, with names such as “Jimmy the Juice Man Peachy Strawberry,” “Suicide Bunny Mother’s Milk and Cookies,” “Pink Lemonade,” “Iced Pineapple Express” and “Killer Kustard Blueberry.”
    • “Justice Samuel A. Alito Jr., who wrote the opinion for the court, said the FDA did not act arbitrarily and capriciously when it denied the companies’ applications for premarket approval of the tobacco products. The companies challenged the agency’s decision arguing that, among other things, that the FDA didn’t give them fair notice about the evidentiary and comparative requirements used during the application stage and that the agency had changed its position on scientific evidence. 
    • “The high court remanded the case to the 5th Circuit to review other legal arguments, so this is not the end of the litigation, but it is a favorable step forward. The 5th Circuit’s decision was an outlier among the federal circuits that have considered similar cases.”
  • Per Govexec,
    • “At least one agency’s staff impacted by the mass dismissals of probationary workers can pursue their reinstatements as a class, the panel that hears federal employees’ challenges to firings has for the first time ruled, creating a new path for sweeping reversals of those terminations. 
    • “Hundreds of recently hired and subsequently fired employees at the Homeland Security Department will be part of a class action alleging their dismissals were unlawful after a Merit Systems Protection Board administrative judge granted the request. The DHS ruling was the first to come down after a consortium of lawyers filed similar challenges on behalf of fired probationary employees at 20 federal agencies. 
    • “I find that a class appeal is the fairest and most efficient way to adjudicate the appeal and that the putative class counsel and named appellants will adequately represent the interests of the parties,” said Sara Snyder, the chief administrative judge for MSPB’s western regional office.” 

From the public health and medical research front,

  • CBS News reports,
    • Cases of the new COVID-19 variant NB.1.8.1, linked to a large surge in China, have been detected in multiple locations across the United States, according to the Centers for Disease Control and Prevention. The earliest cases in the U.S. date back to late March and early April, and were detected through a screening program at airports for arriving international travelers.
    • “CDC is aware of reported cases of COVID-19 NB.1.8.1 in China and is in regular contact with international partners,” a CDC spokesperson said in a statement last week.
    • The spokesperson said that, so far, too few U.S. sequences have been reported of NB.1.8.1 to be included in the agency’s variant estimates dashboard.
    • But hospitalizations abroad have raised questions about the new variant, its symptoms and more.
    • Answers to those questions may be found in the CBS News article.
  • ABC News adds,
    • “More than five years after the first cases of COVID-19 were detected in the United States, hundreds of people are still dying every week.
    • “Last month, an average of about 350 people died each week from COVID, according to data from the Centers for Disease Control and Prevention (CDC).” * * *
    • “The experts said there are a few reasons why people might still be dying from the virus, including low vaccination uptake, waning immunity and not enough people accessing treatments.” * * *
    • “CDC data shows that those aged 75 and older currently have the highest rate of COVID-19 deaths at 4.66 per 100,000.”
  • The American Medical Association let us know what doctors wish their patients knew about lung cancer screening.
  • The Washington Post relates,
    • “Engagement with digital technology was associated with a 58 percent reduced risk of cognitive impairment in people middle-aged and older, according to a study in the journal Nature Human Behavior.
    • “Researchers conducted a systematic review of 57 studies to see whether exposure to technology has helped or harmed cognition among the first generation of adults with prolonged exposure to digital devices such as smartphones, tablets and computers. The studies involved more than 411,000 adults with an average age of 69.
    • “The analysis revealed that technology could play a role in preserving brain function, not worsening it, said co-authors Jared Benge, a clinical neuropsychologist at the University of Texas at Austin’s Dell Medical School, and Michael Scullin, an associate professor of psychology and neuroscience at Baylor University.”
  • Per Medscape,
    • “Herpes simplex virus 1 (HSV-1) infection is associated with an increased risk of developing Alzheimer’s disease (AD), but treating the viral infection may offer protection, a new study found.
    • “In a matched case-control study of nearly 700,000 older adults, HSV-1 was more common in those with AD, and antiviral therapy for HSV-1 was associated with a lower risk of developing AD.
    • “However, the authors and outside experts cautioned that no firm conclusions can be drawn from this observational study and called for more research.
    • “The study was published online on May 20 in BMJ Open. It was funded by Gilead Sciences, which is actively involved in the research and development of treatments for HSV.”
  • The Wall Street Journal points out,
    • Good posture improves circulation, respiration, digestion and bladder function. It also enhances cognitive ability and mood.
    • To improve posture, become aware of your body position, stand against a wall to align yourself, and perform dynamic stretching exercises.
    • Upright posture is associated with confidence, self-esteem, and reduced anxiety. Physical therapists can help develop personalized plans to improve posture.

From the U.S. healthcare business front,

  • Fair Health released today a claims-based analysis of GLP-1 drugs and obesity. Beckers Hospital Review summarizes this analysis here.
  • The Wall Street Journal considers the price outlook for GLP-1 drugs used to treat obesity.
  • Fierce Pharma tells us,
    • “After a fourth quarter in which revenue boomed throughout the biopharma industry, there were reversals for several drugmakers in the first three months of 2025. 
    • “The companies that took the biggest hits were in the United States, where there is already considerable angst in the industry over the tariff threats and drug price-slashing aspirations of President Donald Trump, along with the unsettling prospects of having a pharma adversary, Robert F. Kennedy Jr., heading up the Department of Health and Human Services.
    • “Among the top 25 revenue companies in the industry in Q1, there were seven that saw year-over-year sales declines, all from the U.S. Viatris took the biggest hit at 11%, followed by Pfizer (-8%), Organon (-7%), Bristol Myers Squibb (-6%), Regeneron (-4%), Merck (-2%) and Gilead (-0.3%).”
  • Per BioPharma Dive,
    • “Eli Lilly is wagering up to $1 billion on a private biotechnology company developing new, non-opioid pain drugs that have already caught the attention of other large pharmaceutical firms.
    • “Per an announcement Tuesday, Lilly plans to acquire SiteOne Therapeutics in an all-cash deal. The companies aren’t disclosing how much money is being exchanged upfront or when they expect the transaction to close. But, if SiteOne’s research programs hit certain regulatory and commercial goals, the amount paid to its shareholders could reach that 10-figure mark.”
  • and
    • “Biogen is partnering with RNA drug developer City Therapeutics to develop a better way of reaching an unspecified target that “mediates key central nervous system diseases.” Biogen will pay City, a startup that launched publicly late last year, $16 million in upfront fees and invest another $30 million in convertible notes that could later become a minority stake. “With this effort, we are further expanding the modalities in our R&D toolbox to potentially reach our targets of interest more precisely by adding an RNAi-based approach,” Biogen research head Jane Grogan said in a statement.”
  • Per an Institute for Clinical and Economic Review news release,
    • “ICER today released a Draft Evidence Report assessing the comparative clinical effectiveness and value of apitegromab(Scholar Rock Holdings), nusinersen (Spinraza®, Biogen), onasemnogene abeparvovec-xioi (Zolgensma®, Novartis), and risdiplam (Evrysdi®, Genentech) for spinal muscular atrophy (SMA).
    • “This preliminary draft marks the midpoint of ICER’s eight-month process of assessing this treatment, and the findings within this document should not be interpreted to be ICER’s final conclusions.”
  • Beckers Health IT discusses why Texas Health is taking a loss on its hospital at home program and summarizes Medscape’s list of telehealth friendly states which Utah leads.
  • Beckers Clinical Leadership identifies the 24 U.S. hospitals that have received the American Nurses Credentialling Center’s Magnet with Distinction award. “The Magnet with Distinction program was created as a special designation to celebrate hospitals and healthcare organizations that exceed scoring thresholds required to earn Magnet recognition.”
  • The Wall Street Journal reports,
    • “AI-powered ambient-listening technology is expanding in healthcare, documenting doctor-patient encounters.
    • “AI scribes save doctors time on documentation, reducing burnout and improving focus on patients, according to pilot programs.
    • “Concerns exist around patient privacy, data security and costs, but patient feedback has been largely positive.”
  • Fierce Healthcare offers insights into how Anthem Blue Cross is growing its behavioral health network in California.
    • “The insurer’s network is built on partnerships with multiple organizations, with recent additions including Headway, Rula and Octave. Through its relationship with these firms, the insurer is seeking to make it simpler for members to find providers that meet their unique needs.
    • “Through Headway, the insurer connects employers and plan members with personalized services. Rula, meanwhile, makes it easier for members to schedule an appointment with one of the more than 10,000 providers in its network.
    • “Octave, similarly, is built to make it simple for members to find a provider across multiple specialties, backgrounds and evidence-based approaches, according to the announcement.”
  • NIST explains for those interested how an MRI machine works.

Friday Report

David Ermer–CDC, CMS, COVID-19, FDA, Medical / Rx research, NCQA, Obesity, OPM, Rx coverage, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC

  • Federal News Network tells us,
    • “The Office of Personnel Management is taking a second bite at the apple to modernize its human resources platform.
    • “OPM released a new request for proposals on Thursday through the General Services Administration schedules program for a secure, cloud-based software-as-a-service (SaaS) human capital management (HCM) platform.
    • “The objective of this acquisition is to deploy an integrated, enterprise-wide core HR platform—powered by a secure, FedRAMP-authorized SaaS solution—that consolidates key human capital functions, including personnel management, time and attendance, leave, benefits administration, learning and performance management and workforce analytics,” the RFP states. “The platform must enable seamless interoperability with critical external systems (e.g., USA Staffing, GSA Payroll, eOPF, eHRI, LMS, and benefits systems) and eliminate the data and process gaps currently affecting onboarding, pay accuracy, personnel action sequencing, leave eligibility and audit reporting.”
    • “The solicitation says the platform will be used for OPM’s workforce of 2,000 to 3,000 people.”
  • Fierce Healthcare informs us,
    • “The Centers for Medicare & Medicaid Services (CMS) revealed several updates to the ACO REACH program in 2026, though the model’s long-term future remains unclear.
    • “The CMS said it is making changes to the model based on preliminary data on 2023 performance (PDF), which found that standard accountable care organizations saved $197.5 million in aggregate that year. New entrant ACOs, meanwhile, generated $36.8 million in aggregate savings, reducing gross spending at higher rates that standard organizations.
    • “In addition, high-needs ACOs reduced spending by $2.3 million in the aggregate, according to the preliminary report. The CMS is set to release full data on ACO REACH later this year.
    • “The proposed changes come in a confusing environment for ACOs, which have pushed the agency to outline plans for the ACO REACH program, currently set to expire in 2026.”
  • The American Hospital Association News let us know,
    • “AHA May 23 submitted recommendations to the Department of Justice and Federal Trade Commission in response to the agencies’ requests for information on unnecessary or burdensome anticompetitive regulations. “[T]he U.S. health care system imposes a bewildering array of regulations on hospitals and health systems, adding significant administrative costs, disincentivizing pro-competitive arrangements, and promoting vertical consolidation of large commercial insurers to the detriment of patients and providers across the country,” AHA Deputy General Counsel Julie Rapoport Schenker wrote in the letters to the agencies. The AHA’s recommendations included addressing regulations that foster anticompetitive conduct by insurers and limit the ability of hospitals and health systems to thrive in a competitive free market, among others.” 

From the public health and medical research front,

  • The University of Minnesota’s CIDRAP points out,
    • “Excess deaths in the United States kept rising even after the peak of the COVID-19 pandemic, with more than 1.5 million in 2022 and 2023 that would have been prevented had US death rates matched those of peer countries, estimates a Boston University (BU)-led study today in JAMA Health Forum.
    • “The data show a continuation of a decades-old trend toward increasing US excess deaths, mainly among working-age adults, largely driven by drug overdoses, gun violence, auto accidents, and preventable cardiometabolic causes, the researchers say.
    • “The US has been in a protracted health crisis for decades, with health outcomes far worse than other high-income countries,” says lead and corresponding author Jacob Bor, ScD, said in a BU news release. “This longer-run tragedy continued to unfold in the shadows of the COVID-19 pandemic.”
  • The Centers for Disease Control and Prevention announced today,
    • “Seasonal influenza, COVID-19, and RSV activity is low.
    • “COVID-19
      • “COVID-19 activity has declined to low levels nationally. Wastewater levels are at low levels, emergency department visits are at very low levels, and laboratory percent positivity is stable.
      • “Additional information about current COVID-19 activity can be found at: CDC COVID Data Tracker: Home.
    • “Influenza
    • “RSV
      • “RSV activity has declined to low levels in most areas of the country.”
  • The New York Times reports,
    • “Cancer screening poses a quandary for women with dense breast tissue. They’re at elevated risk for breast cancer, but mammograms often miss tumors buried in dense breasts — and insurers often resist paying for additional scans that may help find the masses.
    • “Now a large study comparing various types of scans has found that mammography enhanced with iodine-based dye can detect three times as many invasive cancers in dense breast tissue as ultrasound.
    • “And so-called contrast-enhanced mammography can find tumors that are much smaller than those found by regular mammography. M.R.I.s are better at detecting more tumors than standard mammograms, the study found but are considerably more expensive.
    • “The scans were given to women with dense breast tissue who had already undergone mammograms that hadn’t turned up any abnormalities.”
    • “Contrast-enhanced mammography needs to become standard of care for women with dense breasts,” if they are at high risk of developing breast cancer, said Dr. Fiona J. Gilbert, a professor of radiology at the University of Cambridge’s School of Clinical Medicine. She is lead author of the study, which was published Wednesday in The Lancet.”
  • NCQA offers via LinkedIn a White Paper, Webinar and a New HEDIS Measure for Asthma Awareness Month, which is May.
    • “The HEDIS MY 2026 measure set will include a new measure focused on asthma, Follow-Up After Acute Care Visits for Asthma (AAF-E). Patients with uncontrolled asthma are more likely to seek care for acute exacerbations, rather than focusing on preventive care. The new measure focuses on the patient-clinician relationship as encouraging treatment adherence and efficacy. Guiding patients toward non-acute care—and clinicians with whom they have a trusted relationship—may help improve asthma outcomes.”
  • The Wall Street Journal delves into “new tests [that] promise to reveal the secrets in your blood. A wave of diagnostic tests—some here, some coming—can identify cancer and Alzheimer’s at earlier stages and predict flare-ups of other conditions.”
  • Per HCPLive,
    • “Semaglutide demonstrated notable protective effects on osteoporosis and gout in people with obesity and type 2 diabetes (T2D) in a new cohort study.
    • “The impact of newer anti-obesity medications on skeletal health remains incompletely understood, particularly in populations with varying metabolic profiles,” lead investigator Jo-Ching Chen, Chung Shan Medical University Hospital, Taichung, Taiwan, and colleagues wrote.
    • “Chen and colleagues conducted a 5-year cohort study examining skeletal health outcomes in people with obesity and T2D receiving semaglutide vs conventional glucose-lowering medications (sitagliptin, empagliflozin, glipizide), and obese individuals without T2D receiving semaglutide vs traditional anti-obesity medications (Contrave, phentermine, Qsymia).”
  • Per Fierce Pharma,
    • “After meeting the mark alongside Keytruda in PD-L1-positive breast cancer earlier this year, Gilead Sciences’ antibody-drug conjugate Trodelvy has impressed in a solo showing in a similar indication.
    • “In the late-stage Ascent-03 trial, Trodelvy bested standard-of-care chemotherapy at extending the time before disease worsening or death in certain patients with previously untreated metastatic triple-negative breast cancer (TNBC).
    • “The study specifically assessed the TROP2-targeted ADC in patients who aren’t candidates for PD-1 or PD-L1 inhibitors, either because their tumors don’t express the PD-L1 protein or because the patients are ineligible.
    • “The “highly statistically significant and clinically meaningful” improvement on the progression-free survival metric allowed the study to meet its primary endpoint, Gilead said. The company will discuss the Ascent-03 results with regulators and plans to present detailed results from the trial at an upcoming medical meeting.”

From the U.S. healthcare business front,

  • Healthcare Dive reports
    • “The nation’s leading nonprofit healthcare providers struggled financially during the quarter ended March 31.
    • “Most of the major systems, including Kaiser Permanente, Mass General Brigham, Cleveland Clinic, Mayo Clinic, Ascension and Providence, recorded operating margins that were flat or lower than this time last year, despite growing patient volumes.
    • “The results come as analysts have been sounding the alarm with escalating urgency about how headwinds, including market volatility and policy changes in Washington, could harm provider finances.” 
  • Beckers Health IT explains “two ways Amazon is changing healthcare, per CEO Andy Jassy.”
  • Per Health Leaders,
    • “A recent Experian Health survey shows steady improvement in access to care but suggests a disconnect between patients and providers on digital tools.
    • “Providers continue to face challenges with capacity constraints and staffing shortages.
    • “Patients call for better pricing estimates and self-scheduling tools.”
  • Healthcare Innovation lets us know,
    • Aligning itself with new strategies coming out of the Center for Medicare and Medicaid Innovation, the Health Care Payment Learning & Action Network (HCPLAN) announced it will launch four new initiatives focused on healthcare choice and competition, patient empowerment, preventative care, and technology-enabled healthcare, while discontinuing its alternative payment model measurement effort, which had been funded by CMMI.
    • The HCPLAN is a group of public and private healthcare leaders that was formed to provide thought leadership, strategic direction, and ongoing support to accelerate the adoption of alternative payment models (APMs) and accountable care.
    • Since its launch in 2015, the HCPLAN APM Measurement Effort has monitored the shift of U.S. healthcare from fee-for-service to APMs. The 2024 APM Measurement Effort results demonstrated the continued growth in APM adoption and initiatives to enhance patient access, affordability, and quality of care. As part of its efforts to advance the availability and reduce the cost of key data needed to improve care, the HCPLAN will explore alternative pathways for the continuation of this effort.
  • MedTech Dive explores “Why Medtronic plans to spin out its diabetes business. While some analysts questioned why Medtronic would leave a fast-growing market, others backed the company’s plan to focus on segments with higher margins.”
  • Per Fierce Healthcare,
    • “Pharmacy benefit manager WellDyne is partnering with Waltz Health to bring greater transparency to its specialty pharmacy clients.
    • “WellDyne is teaming up with Waltz as well as Mark Cuban Cost Plus Drugs as part of its broader member routing strategy, which surfaces real-time alerts and smart prompts that can help its members find the most affordable medication option for them.
    • “The PBM’s tech stack also uses automated algorithms to adjudicate claims in the background and let members know when they may be able to achieve savings. The technology optimizes claims across different touch points including retail, home delivery, discount cards and other avenues.
    • “Rich Wipperfurth, chief commercial officer for WellDyne, said traditional models are also built on simplicity but in a way that steers the member toward preferred distribution channels, pharmacies and other sources.
    • “WellDyne wants to inject more choice back into the equation, Wipperfurth said.”

Thursday Report

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

From Washington, DC

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

From the Food and Drug Administration front,

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

From the judicial front,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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