Friday Report

Congress

Friday Report

David Ermer–CDC, CMS, Congress, COVID-19, FDA, Generative AI, Medical / Rx research, OPM, SCOTUS, U.S. Healthcare–

FEHBlog note: Since the FEHBlog launched in 2006, the FEHBlog has featured a photograph at the top of the post. The FEHBlog learned today that email subscribers to the FEHBlog see a blank spot at the top of the page as the email system blocks photographs. For that reason, the FEHBlog has stopped using photographs in the blog except when necessary.

From Washington, DC,

  • Roll Call informs us,
    • “Senate Republicans say they are looking for ways to safeguard rural hospitals from proposed cuts to a key Medicaid funding method, amid concerns from the powerful hospital lobby and others that the budget reconciliation bill could force many facilities to close.
    • “The draft text that the Senate Finance Committee released this week reduces the ability of states who expanded Medicaid under the 2010 health care law to levy taxes on providers to fund their programs. 
    • “Senate Majority Leader John Thune, R-S.D., told reporters Wednesday he is working on the issue, though he did not offer details. Leadership is attempting to balance directives to cut government spending with demands from senators like Josh Hawley, R-Mo., who said that the bill should protect rural hospitals from the effects of shrinking provider taxes.
    • “The right thing to do is not defund rural hospitals to pay for your pet projects,” Hawley said. “So, if you want your pet project in the bill, go find your own money. Don’t defund rural hospitals.” 
    • “Medicaid is often one of the top payers for rural facilities.”
  • STAT News adds,
    • “Hospitals are now lobbying senators to return to the House’s version of the bill, which also is expected to substantially cut hospitals’ revenues and the number of patients covered — but less so than the Senate’s version of the bill. 
    • “But that lobbying effort is butting up against senators who want to further reduce government spending. The Congressional Budget Office has not yet projected the budget impact of the Senate bill.”
  • The American Hospital Association News tells us,
    • The Centers for Medicare & Medicaid Services June 20 announced it is finalizing its 2025 Marketplace Integrity and Affordability final rule. The rule shortens the open enrollment period for the federal marketplace to Nov. 1-Dec. 15 starting in 2027, and limits open enrollment periods for state-based marketplaces to Nov. 1-Dec. 31. The rule also includes a change to the premium adjustment percentage that would increase the maximum annual cost sharing limitation. Additionally, the rule makes updates to the income verification process and pre-enrollment verification process for SEPs, changes to the essential health benefits, modifications to the redetermination and re-enrollment processes, and ends a special enrollment period for low-income individuals, among other policies. Many of the provisions reinstate policies finalized during the prior Trump administration.
  • Here is a link to CMS’s fact sheet on this final rule.
  • Govexec lets us know,
    • “The White House and its Department of Government Efficiency are spearheading efforts to shake up the Postal Service, according to details of the meetings obtained by Government Executive, with topics including pricing for mail and general reform proposals. 
    • “The meetings were not clearly within the scope of a memorandum of understanding former Postmaster General Louis DeJoy signed with DOGE, which focused on specific cost-cutting measures and real estate planning. Some of the meetings also involved top officials from the Treasury Department, White House attorneys and policy advisors and additional USPS executives. A source familiar with the meetings confirmed DOGE has been active at the Postal Service’s Washington headquarters in recent months.” 
  • Per an OPM news release,
    • This week, the U.S. Office of Personnel Management (OPM) Inspector General (IG) released a report that uncovered widespread compliance failures and weak internal oversight in the agencyʼs telework and remote work programs during the Biden Administration.
    • The report revealed more than half of OPM employees reviewed failed to meet basic in-office requirements and nearly a third of sampled teleworkers had expired or missing agreements. Additionally, 15 percent of remote workers had no approved agreement on file, and many discrepancies flagged by HR remained unresolved for months.
    • Since President Trump took office, OPM has reinstated in-office requirements to restore a culture of accountability and public service.
    • “Under the previous administration, OPMʼs telework and remote work policies were mismanaged and oversight was virtually nonexistent,” Acting Director Chuck Ezell said. “That era of telework abuse is over. At President Trumpʼs direction, OPM has restored in-person operations to ensure federal employees are working for the taxpayers.”
    • OPM has already implemented new internal controls and compliance reviews, and effective March 3, 2025, all employees are required to report to their official duty station full-time.
    • Read the OIG report here.

From the Food and Drug Administration front,

  • The Wall Street Journal reports,
    • “Sanofi and Regeneron Pharmaceuticals said they got Food and Drug Administration approval for anti-inflammatory drug Dupixent as a treatment for a rare skin disease, adding an eighth indication in the U.S. for their blockbuster medicine.
    • “France’s Sanofi and Tarrytown, N.Y.-based Regeneron said Friday that the FDA gave the green light for Dupixent as a treatment of adult patients with bullous pemphigoid, a skin disease that mainly affects elderly people and is characterized by itch, blisters and lesions, as well as a reddening of the skin.”

From the judicial front,

  • SCOTUSblog reports,
    • In a splintered decision, the Supreme Court did not allow a retired firefighter to sue her prior employer under the ADA. The majority opinion, written by Justice Gorsuch, determined the retiree was not a “qualified individual” under the law. In dissent, Justice Jackson called the majority opinion “counterintuitive.”
  • and
    • “On Friday, the Supreme Court opined on a challenge by retailers of e-cigarettes to an FDA decision. The majority opinion, written by Justice Amy Coney Barrett, held that the challengers were “adversely affected” by the FDA’s decision and could thus seek judicial review in the 5th Circuit.”
  • The AHA News relates,
    • “The U.S. District Court for the Northern District of Iowa June 18 vacated components of the Centers for Medicare & Medicaid Services’ minimum nurse staffing rule requiring nursing homes to have a registered nurse onsite 24/7 and prescribing a minimum total nurse staffing hours per resident day. The court kept in place the rule’s enhanced facility assessment and Medicaid reporting requirements.
    • “CMS’s general rulemaking power to promulgate ‘such other requirements as the Secretary deems necessary’ does not constitute clear authorization to mandate rigid staffing requirements for [long-term care] facilities,” wrote District Court Judge Leonard T. Strand in the ruling. “Therefore, I find that CMS did not have authority to promulgate the 24/7 RN requirement and the HPRD requirements pursuant to its health and safety rulemaking authority.”
    • “A district court in Texas also vacated the minimum staffing mandate in April.”
  • Beckers Payer Issues points out,
    • “New York City can implement an Aetna Medicare Advantage plan for its retirees, the state’s highest court ruled June 18. 
    • “The city has pushed to switch its health benefits for retired city employees to a Medicare Advantage plan since 2021. A group of retired employees sued to block the plan, arguing that the city had promised to provide supplemental Medicare benefits, and that their healthcare benefits would be diminished under an MA plan. 
    • “The New York Court of Appeals ruled against the retirees, reversing lower courts’ decisions. The judges ruled the city was not obligated to offer Medigap plans to its retirees. The court also ruled the retirees did not prove their care would be harmed under an MA plan.” 

From the public health and medical research front,

  • The Centers for Disease Control and Prevention announced today,
    • “Seasonal influenza activity is low. COVID-19 and RSV activity is very low.
    • “COVID-19
      • “COVID-19 wastewater activity is low and emergency department visits and laboratory percent positivity are at very low levels.
    • “Influenza
    • “RSV
      • “RSV activity is very low.
  • The University of Minnesota’s CIDRAP adds,
    • “New findings presented at the annual meeting of the American Society for Microbiology suggest increased levels of fungal spores in the air are strongly linked to surges in cases of influenza and COVID-19.
    • “The study was based on daily spore samples taken in 2022 and 2024 in San Juan and Caguas, Puerto Rico, where fungal spores and pollen are endemic and present year-round. The data on spores was matched to data on the daily incidence of people diagnosed with COVID-19 and flu.
    • “The researchers found increases in fungal spore counts matched surges in flu and COVID activity. There was no relationship between pollen levels and respiratory illness activity.
    • “The findings from our study suggest that monitoring airborne fungal spore levels could help predict short-term outbreaks (spikes) of flu and COVID-19, giving public health systems an early warning signal,” study author Felix Rivera-Mariani, PhD said in a press release from the American Society of Microbiology. “Our findings also highlight the potential role of environmental factors—not just person-to-person spread—in contributing to the incidence of respiratory viral infections. That could open new doors for targeted public health alerts, especially in areas with high outdoor airborne fungi.” 
  • and
    • “The US Centers for Disease Control and Prevention (CDC) reported 17 more measles cases today in its weekly update, bringing its total for the year to 1,214 confirmed cases from 36 jurisdictions.
    • “Although measles cases have slowed since peaking in late March, the uptick in cases brings the country closer to surpassing the 1,274 cases reported in 2019, which to date is the highest number reported in a single year since the disease was eliminated from the United States in 2020. There were 285 confirmed measles cases in 2024. 
    • “The CDC reported two additional outbreaks (three or more related cases), bringing the 2025 total to 23 outbreaks. Of the 1,214 confirmed US cases, 89% are outbreak associated. Only 16 outbreaks were reported in 2024, with 69% of confirmed cases associated with those outbreaks. The biggest outbreak in 2025 has been in West Texas, which has seen 750 confirmed cases since late January.”
  • and
    • “Since late April, an infectious diseases specialist at Stanford University and his colleagues have been volunteering their time on a project they hope will help educate the public, and combat misinformation, about the safety and efficacy vaccines.
    • “The project, led by Jake Scott, MD, is a spreadsheet of all the randomized controlled trials (RCTs) that have ever been conducted for licensed vaccines. The idea, hatched on the social media site X, was prompted by responses to an old video of current Department of Health and Human Services Secretary Robert F. Kennedy Jr., in which he claims that none of vaccines mandated for US children has ever been tested in preclinical studies against a placebo. In one of the responses, infectious disease physician Brad Spellberg, MD, suggested a crowd-sourced effort to identify and post all of the RCTs in which vaccines have been tested against a placebo.
    • “That night Scott, a self-proclaimed “spreadsheet geek” who has previously collaborated with Spellberg, began building a spreadsheet using Google Sheets, creating criteria for inclusion, and seeding it with seven vaccine RCTs. Each entry has columns for the name of the vaccine, the date the RCT was published, which populations were studied, how many people were involved in the study and, importantly, the types of placebo or active comparator that were used for the control group.
    • “By the next morning, there were 20 vaccine RCTs on the spreadsheet. By May 5, the list had grown to 100. The spreadsheet now stands at more than 270 RCTs and continues to grow. Scott and his colleagues, who aim to eventually publish a peer-reviewed paper on the project in a medical journal, thoroughly review each entry before inclusion and provide links to the RCTs on PubMed.
    • “I think we’re kind of looking at the tip of the iceberg,” Scott told CIDRAP News. “There’s going to be, I would say, easily 400-plus, maybe 500-plus trials with millions and millions of participants.”
  • The AP reports,
    • “Older U.S. adults are increasingly dying from unintentional falls, according to a new federal report published Wednesday, with white people accounting for the vast majority of the deaths. 
    • “From 2003 to 2023, death rates from falls rose more than 70% for adults ages 65 to 74, the report from the U.S. Centers for Disease Control and Prevention said. The rate increased more than 75% for people 75 to 84, and more than doubled for seniors 85 and older.
    • “Falls continue to be a public health problem worth paying attention to,” said Geoffrey Hoffman, a University of Michigan researcher who was not involved in the new report. “It’s curious that these rates keep rising.”
  • MedTech Dive notes five things to watch at the American Diabetes Association’s upcoming scientific session.
    • “At the American Diabetes Association’s Scientific Sessions, companies like Abbott, Dexcom and Beta Bionics will share the latest data on diabetes technology and new partnerships.
    • “The annual conference takes place June 20-23 in Chicago, with industry leaders gathering to discuss new developments in diabetes treatments. This year’s event follows new ADA standards of care that would expand access to continuous glucose monitors, recommending that the devices be used in adults with Type 2 diabetes who are taking glucose-lowering medications other than insulin.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Health insurers will pledge to smooth the preapproval process following backlash after the killing of an executive last year.
    • “Insurers will create a standard for electronic requests by 2027, with 80% answered in real time if documentation is included.
    • “The industry plan includes reducing procedures subject to authorization, improving explanations, and helping patients changing insurers.”
  • and
    • “Planes have been jetting from Ireland to the U.S. this year carrying something more valuable than gold: $36 billion worth of hormones for popular obesity and diabetes drugs.
    • “The frantic airlift of those ingredients—more than double what was imported from Ireland for all of last year—reflects the collision of two powerful forces: tariff-driven stockpiling and weight-loss drug demand.
    • “The peptide- and protein-based hormones feed into a category of drugs that include wildly popular GLP-1 treatments and newer types of insulin known as analogues. Taken together the shipments weighed just 23,400 pounds, according to U.S. trade data, equivalent to the weight of less than four Tesla Cybertrucks.
    • “Fit into temperature-controlled air-cargo containers, the pharmaceutical ingredients have had a huge impact on the U.S. trade imbalance. The shipments have propelled Ireland, a country of only 5.4 million people, to the second-largest goods-trade imbalance with the U.S., trailing only China. They accounted for roughly half of the $71 billion in goods the U.S. imported from the country in the first four months of the year.
    • “Nearly 100% of the imports had a final destination of Indiana, according to U.S. customs records. Eli Lilly, the drug giant behind weight loss and diabetes drugs Zepbound and Mounjaro, is headquartered in Indianapolis.”
  • Mercer Consulting notes,
    • “It’s been over three years since group health plan sponsors and issuers, in order to comply with the Transparency in Coverage final rule, began posting Machine-Readable Files that contain in-network negotiated charges for every medical item and service with providers in their networks, as well as out-of-network allowed amounts and billed charges. This data had previously been considered by insurers as proprietary and confidential, but the government recognized the need to make healthcare costs more transparent. The rule also requires group health plan sponsors and issuers to post files for negotiated rates and historical net prices for covered prescription drugs, but regulators have delayed that particular requirement .
    • “But even though the data has been available to the public since July 2022, almost 70% of very large employers (5,000+ employees) responding to our 2025 Health Policy Survey report that they have yet to meaningfully use the data.
    • “Impeding use is the sheer amount of data that was dropped on the internet all at once, but not all in one place. According to a recent report from the Congressional Review Service, users have faced significant challenge * * *.
  • Per Fierce Healthcare,
    • “Hinge Health, which just went public last month, launched a referral network of in-person providers to complement its virtual physical therapy platform.
    • “The curated provider network for musculoskeletal (MSK) care, called HingeSelect, includes imaging centers and brick-and-mortar physical therapy providers to help bridge the gap between in-person and digital care. The aim is to offer a more comprehensive end-to-end MSK care model, executives said.
    • “Hinge Health’s technology and in-house orthopedic physicians triage and direct downstream care. When in-person care, such as imaging or injections, is required, members are connected to pre-vetted providers at up to 50% below PPO rates.” 
  • Per Beckers Payer Issues,
    • “Philadelphia-based Independence Blue Cross has launched a new GenAI customer service tool to support customer service representatives in improving accuracy and speed of customer interactions, according to a news release shared with Becker’s. 
    • “The pilot, initiated in February 2025, tasked more than 40 customer service representatives with using the tool to assist with member-specific questions, summarize complex medical policies and search benefits. 
    • “The AI tool was found to have reduced the number of steps customer representatives must take to access critical information and improved efficiency by increasing the percentage of customers who receive solutions on their first inquiry. It also documents responses and validates the information with Independence Blue Cross’ existing customer relationship system.”

Tuesday report

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

From Washington, DC,

  • KFF compares the healthcare provisions in the House of Representatives big, beautiful bill against the developing Senate version. Of note the Senate version does not include the House bill’s provisions expanding the utility of health savings accounts.
  • STAT News adds,
    • “The Medicare pay bump for doctors that was part of the House version of Republicans’ tax bill was dropped in the Senate’s version, released Monday evening. 
    • “The provision, which would boost doctors’ payment for treating Medicare patients by tying it to inflation, has long been a top priority for physician groups.” 
  • Federal News Network tells 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.”
  • Radiology Business reports,
    • “Radiology Partners has “significantly outmatched other provider groups” via the No Surprises Act, scoring wins at more than 600% of the initial “qualifying payment amount” offer, according to new research. 
    • “The Centers for Medicare & Medicaid Services recently released NSA data from the first half of 2024. As Radiology Business reported previously, industry giant Rad Partners was the No. 1 initiator of these disputes tied to out-of-network healthcare services, with 136,784 between January and July. Georgetown University researchers recently took a closer look at the data, publishing their findings June 11 in Health Affairs. 
    • “They highlighted RP’s significant payment wins via the “independent dispute resolution” (IDR) process in 2024. In Q1, the practice earned a median prevailing offer at 631% of the qualifying payment amount—essentially, the median contracted rate for a service in the same geographic region. These wins continued in Q2, with a median at 610% of QPA.  
    • “These high numbers highlight the disconnect between the two sides as they debate what constitutes a reasonable payment for [out-of-network] services,” Jack Hoadley, PhD, research professor emeritus with Georgetown’s Center on Health Insurance Reforms, and co-authors explained. “Providers believe the high volume of IDR disputes reflects inadequate payment by plans, exacerbated by possible manipulation of the [qualifying payment amount]. Plans respond that their QPAs are accurate and that providers should be willing to accept payments that align closely with in-network rates.”P

From the Food and Drug Administration front,

  • The Wall Street Journal reports,
    • “Embracing artificial intelligence. Taking on companies that make ultra-processed foods. And offering a fast-track to approve drugs the Trump administration views as a priority.
    • “Welcome to the new Food and Drug Administration as envisioned by Dr. Marty Makary, who is leading the agency under Health Secretary Robert F. Kennedy Jr. Both men have said they want to overhaul the agency, citing what they see as the FDA’s reputation for coziness with pharmaceutical companies.
    • “Makary’s goal is “to deliver more transparency, unleash innovation, eliminate conflicts and lower drug pricing,” said Calley Means, a White House adviser and ally of Makary’s.
    • “The changes are coming so swiftly, and often without input from career scientists, that Makary faces declining staff morale threatening to stymie his efforts. He must also contend with the administration’s staff cuts at the FDA, which have been partly undone but shrank the workforce nonetheless. And critics say Makary is playing fast and loose with the FDA’s commitment to world-class science.”
  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today announced its Commissioner’s National Priority Voucher (CNPV) program to enhance the health interests of Americans. The new voucher may be redeemed by drug developers to participate in a novel priority program by the FDA that shortens its review time from approximately 10-12 months to 1-2 months following a sponsor’s final drug application submission.
    • “The new CNPV process convenes experts from FDA offices for a team-based review rather than using the standard review system of a drug application being sent to numerous FDA offices. Clinical information will be reviewed by a multidisciplinary team of physicians and scientists who will pre-review the submitted information and convene for a 1-day “tumor board style” meeting.
    • “Using a common-sense approach, the national priority review program will allow companies to submit the lion’s share of the drug application before a clinical trial is complete so that we can reduce inefficiencies. The ultimate goal is to bring more cures and meaningful treatments to the American public,” said FDA Commissioner Marty Makary M.D., M.P.H. “As a surgical oncologist, we often made multidisciplinary decisions with a team of doctors on major life-and-death questions for patients, incorporating the latest medical studies in a 1-day tumor board-style discussion. This voucher harnesses that model to deliver timely decisions for drug developers.”  
  • Per Modern Healthcare,
    • “Taiwanese surgical robotics company Brain Navi Biotechnology said Tuesday the Food and Drug Administration approved its NaoTrac neurosurgical robot.
    • “It’s designed to assist with brain tumor biopsies, deep brain stimulation and other complex brain surgeries.”
  • Per Cardiovascular Business,
    • “Inquis Medical, a California-based medtech company focused on peripheral vascular treatments, has received U.S. Food and Drug Administration (FDA) clearance for its Aventus Thrombectomy System to be used to treat pulmonary embolism (PE).
    • “The Aventus Thrombectomy System, a next-generation mechanical thrombectomy device, was previously cleared to target blood clots in a patient’s peripheral arteries. This new expanded clearance paves the way for PE patients to be treated using the same technology.”
  • Per MedTech Dive,
    • “Zyno Medical has recalled infusion pumps that shipped with software that had not undergone verification and validation testing, the Food and Drug Administration said Monday.
    • “The company released the Z-800 pumps with incorrect software versions. The software created a risk of incorrect air-in-line detection and audio alarms that could cause serious harm.
    • “Zyno has not reported any serious injuries or deaths. The recall, which the FDA assigned to Class I, started eight months after Zyno removed Z-800 pumps from use over another software issue.”

From the State law front,

  • Healthcare Dive reports,
    • “Iowa passed a law last week that places limits on pharmacy benefit managers, joining a growing number of states cracking down on the drug middlemen in an effort to constrain rising prescription drug costs and protect rural pharmacies. 
    • “The legislation includes numerous provisions aimed at tamping down on PBMs’ “outsized control” over the pharmaceutical supply chain, Gov. Kim Reynolds said in a statement. That includes preventing PBMs from steering patients to particular pharmacies, equalizing reimbursement between pharmacies and reforming how PBMs are paid.
    • “However, some experts have raised concerns that the law could lead to higher costs for health plans and patients.”

From the judicial front,

  • Bloomberg Law reports,
    • “The FDA lawfully determined that Novo Nordisk A/S’s Ozempic drug shortage ended and that drug compounders can’t keep making copies of the weight loss medicine, a federal judge ruled. 
    • “Judge Mark T. Pittman for the US District Court for the Northern District of Texas agreed with the Food and Drug Administration that it lawfully removed semaglutide from the drug shortage list last year, granting on June 13 the agency’s motion for summary judgment against compounders. 
    • “The opinion is currently sealed but will eventually be redacted, according to the court’s docket.”
    • The case number is 4:25-cv-00174.

From the public health and medical research front,

  • Cardiovascular Business reports,
    • “Mayo Clinic in Rochester, Minnesota, is the No. 1 heart hospital in the United States, according to a data-based ranking published by Newsweek. Cleveland Clinic and its Miller Family Heart, Vascular & Thoracic Institute came in at No. 2, followed by Massachusetts General Hospital/the Corrigan Minehan Heart Center at No. 3, NYU Langone Hospitals – Tisch Hospital at No. 4 and Stanford Health Care/Stanford Hospital at No. 5.
    • “The ranking is part of a new America’s Best Hospitals for Specialize Care 2025 report.
    • “Newsweek and Statista partnered on the list, naming their Top 200 Hospitals for Cardiac Care. While 45% of each facility’s overall score was determined by a variety of hospital quality metrics, another 35% was determined by survey responses from U.S. healthcare professionals collected in early 2025. In addition, 15% of the overall scores was determined by patient satisfaction surveys, and the final 5% was based on Statista’s PROMs Implementation Survey.“
  • Per Health Day,
    •  “Rheumatoid arthritis (RA) has steadily increased around the world during the past three decades, a new AI-powered study reports.
    • “The autoimmune disease affected 17.9 million people worldwide in 2021, a 13% increase from 1990, researchers reported today in the Annals of the Rheumatic Diseases.
    • “Results indicate that the global burden of RA has been vastly underestimated, researchers concluded.
    • “Further, the research team projects that rheumatoid arthritis will continue to increase unless steps are taken to prevent it or treat existing cases.”
  • and
    • “A new breakthrough can help people with schizophrenia keep up with their psychiatric meds, researchers said.
    • “A pill taken just once a week, gradually releasing medicine from within the stomach, can greatly simplify the drug schedule faced by schizophrenia patients, researchers reported June 10 in the journal The Lancet.
    • “The newly developed pill maintains consistent levels of the psychiatric drug risperidone in patient’s bodies, and controlled their symptoms just as well as daily doses, results showed.
    • “We’ve converted something that has to be taken once a day to once a week, orally, using a technology that can be adapted for a variety of medications,” researcher Giovanni Traverso, an associate professor of mechanical engineering at MIT, said in a news release.”
  • Per Beckers Hospital Review,
    • “A study found that a once-daily pill called obicetrapib significantly lowered LDL cholesterol in patients at high risk for heart disease. 
    • ‘The clinical trial, published May 7 in The New England Journal of Medicine, enrolled 2,500 participants with either a history of atherosclerotic cardiovascular disease or familial hypercholesterolemia, all of which were already taking the maximum tolerated doses of other cholesterol-lowering drugs. 
    • “After 84 days, those taking NewAmsterdam Pharma’s obicetrapib saw their LDL levels drop nearly 30% while the placebo group experienced a slight increase. The cholesterol-lowering effect was consistent across the treatment group and the rate of side effects was similar among the two groups.”
  • MedPage Today discusses “What the MAHA Report Gets Right, and Wrong, on Nutrition. Time will tell the impact of ensuing policies on health.”
  • and lets us know
    • “A rheumatology trainee who went on TikTok to find information on her own condition may have uncovered a novel and possibly tectonic approach to treating fibromyalgia, her presentation here suggested.
    • “That experience led to an analysis of the massive TriNetX medical records database, which indicated that fibromyalgia patients who used glucagon-like peptide-1 (GLP-1) receptor agonist drugs were less likely to use opioids and to report pain, fatigue, and malaise compared with propensity-matched non-users, according to Nouran Eshak, MBChB, of the Mayo Clinic in Scottsdale, Arizona.
    • “The findings were strong enough, Eshak told attendees at the European Alliance of Associations for Rheumatology annual meeting, that clinicians should “consider using GLP-1 agonists in fibromyalgia patients when comorbidities such as obesity, diabetes, or sleep apnea are present.” Those are approved indications for such agents, and therefore patients would face fewer barriers to access.
    • “Still, these findings are no substitute for prospective data, such as from randomized trials, Eshak stressed.”
  • The NIH’s Reseach Matters covers the following topics this week — “Y chromosome loss and cancer | Cysteine and weight loss | Treating malaria in mosquitoes.”
  • Per Medscape,
    • “When canagliflozin (Invokana) was approved in 2013, the SGLT2 inhibitor was touted as a first in a new medication class that was, at the time, the only oral, once-daily medication to reduce blood glucose as well as body weight and systolic blood pressure.
    • “Since then, additional SGLT2 inhibitors have been approved (dapagliflozin, empagliflozin, bexagliflozin, and ertugliflozin), and the indications for prescribing the medications have expanded.
    • “The medications have gone from targeting glucose-lowering to also providing cardiac protection, including for diabetes-free patients with heart failure.
    • “Next, experts said, discussions will focus on other decisions, such as when and whether to prescribe the SGLT2 inhibitors with GLP-1 receptor agonists for the best outcomes.”

From the U.S. healthcare business front,

  • BioPharma Dive reports,
    • “Eli Lilly agreed to buy Verve Therapeutics for $1 billion, betting on the promise of one-and-done gene therapies to treat cardiovascular disease. 
    • “The deal announced Tuesday offers Verve stockholders $10.50 a share, plus a contingent value right worth another $3 a share. The non-tradeable CVR would pay out if the company’s experimental VERVE-102 treatment advances enough to dose a patient in a Phase 3 trial within 10 years of the transaction’s closing.
    • “Verve CEO Sekar Kathiresan and other top stockholders have already agreed to tender shares that represent about 17.8% of Verve’s outstanding stock and the gene editing company’s board recommends that all investors agree to the tender offer, Lilly said. A second-step merger will follow if needed. The companies expect to complete the transaction in the third quarter.”
  • The Wall Street Journal reports,
    • “Dozens of companies have pledged to build more manufacturing in the U.S. since President Trump took office. Generic drugmakers aren’t among them. 
    • “And they have no plans to change that anytime soon.
    • “Makers of generics—cheaper copies that make up 90% of Americans’ prescription medications—say further domestic investment is too risky in such a low-margin and unpredictable business, unless the government helps to steady the sector. 
    • “Drugmakers want more clarity from the Trump administration on the potential pharmaceutical tariffs, which some companies warn could lead them to close U.S. plants altogether. 
    • “Where’s the incentive?” said Richard Saynor, chief executive officer of Sandoz, whose U.S. slate of roughly 150 generic drugs range from blood thinners to antipsychotics. “You sell a packet of antibiotics more cheaply than a packet of M&M’s. That’s offensive, and we lose money doing that.”
  • and
    • “Fresenius Medical Care could end up benefiting from blockbuster obesity drugs, according to its chief executive, contrary to concerns that such treatments could be negative for the dialysis specialist.
    • “I believe [the effect] is neutral to positive, not negative,” Fresenius Medical Care’s Chief Executive Helen Giza said in an interview.
    • “Ozempic and others in the class of drugs known as GLP-1 have shown promise in clinical trials beyond their most common uses for diabetes and weight loss to treat heart, kidney and liver diseases, among a growing list of conditions. As signs of their potential emerged, investors raced to look for winners and losers.”
  • Per STAT News,
    • “A central theme in Humana’s plan for boosting Medicare Advantage profitability in the future is a strategy its peers have relied on for over a decade: coaxing members in for their annual wellness visits.”
  • Per Fierce Healthcare,
    • “Lark Health is rolling out a new, artificial-intelligence-enabled platform to manage the costs related to GLP-1s, and it has tapped a former insurance industry executive to lead the charge.
    • “Matthew Gibbs, who previously served as chief pharmacy officer at Blue Shield of California, will join Lark as president. In that role, he will spearhead the launch of LarkVantage, a platform designed to mitigate the challenges associated with utilization reviews for GLP-1s.”
  • Reuters informs us,
    • “Eli Lilly (LLY.N) will ship the two highest doses of its popular weight-loss drug Zepbound to cash-paying customers on its website starting early August, the U.S. drugmaker said on Monday.
    • “With the addition of the 12.5 milligrams and 15 mg doses, all approved doses of Zepbound will be available on the website in single-dose vials for $499 per month or less, regardless of insurance status, the company said.
    • “Lilly and rival Novo Nordisk (NOVOb.CO), opens new tab started offering vials at discounted prices on their respective websites to expand access and stave off competition from compounded versions or cheaper copies of their weight-loss drugs.
    • “The LillyDirect website was launched last year to help patients directly order some drugs.”

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.

Friday report

David Ermer–ACA, CDC, Congress, COVID-19, FDA, Federal employment benefits, Medical / Rx research, Obesity, Telehealth–
Photo by Sincerely Media on Unsplash

From Washington, DC,

  • Govexec tells us,
    • “On Thursday night, the Senate Homeland Security and Governmental Affairs Committee published its portion of the budget reconciliation bill, which aims to cut federal spending to partially pay for tax cuts for the wealthy and increased immigration enforcement.
    • “Gone from the bill are House-passed provisions that would require all federal workers to contribute 4.4% of their basic pay toward the Federal Employees Retirement System, reduce their FERS benefit calculation from the average highest three years of salary to the highest five years, and eliminate the FERS supplement for employees who retire before Social Security kicks in at age 62.
    • “But in their place is a more draconian iteration of the controversial plan to force future federal workers to choose between a more expensive defined benefit annuity and at-will employment, meaning they can be fired “for good cause, bad cause, or no cause at all.” Under the Senate plan, all new federal hires would pay more than double toward FERS compared to feds hired after 2014—9.4% of their basic pay—and those who elect to accrue civil service protections would pay an additional 5 percentage points on top of that, or 14.4% of basic pay.”
  • Federal News Network adds,
    • “The Trump administration would proceed with plans to downsize the federal workforce and reorganize agencies with minimal interference from Congress, under a Senate committee’s proposal.
    • “The Senate Homeland Security and Governmental Affairs Committee, in its contribution to the budget reconciliation package, would allow the Trump administration to proceed with sweeping changes to the federal workforce — including those currently stalled by federal judges — without approval from Congress.
    • “The committee’s section of the “One Big, Beautiful Bill,” which passed the House last month, also sets aside $100 million for the Office of Management and Budget to oversee and implement the Trump administration’s reorganization plans over the next decade.”
  • Fierce Pharma lets us know,
    • “Independent Sens. Bernie Sanders of Vermont and Angus King of Maine have introduced a bill that would ban pharmaceutical companies from advertising directly to consumers.
    • “The End Prescription Drug Ads Now Act would prevent drugmakers from promoting prescription drugs through television, radio, print, digital platforms and social media.” * * *
    • “The proposal is likely to receive support from the Trump administration.” 
  • KFF released a report about “ACIP, CDC, and Insurance Coverage of Vaccines in the United States.”
  • The Sequoia Blog notes,
    • Recent guidance from the Department of Health and Human Services (HHS), Health Resources and Services Administration (HRSA), and the United State Preventive Services Task Force (USPSTF) will impact coverage for women that must be provided by group health plans at no-cost, explained further [in the blog post].
  • Radiology Business adds,
    • “Radiology Partners was the No. 1 initiator of No Surprises Act payment disputes in the second half of 2024 with 136,784, according to new data released Wednesday. 
    • “The El Segundo, California-based industry giant accounted for about 15% of all disputes in Q4 of 2024 and 18% in Q3. HaloMD, a San Antonio, Texas, firm specializing in NSA dispute resolutions, was No. 2, initiating 134,318, followed by Knoxville, Tennessee, multispecialty group TeamHealth with 94,598. 
    • “In a summary document, the Centers for Medicare & Medicaid Services highlighted the “high volume of disputes” handled between July 1 and Dec. 31, 2024. Provider groups such as Rad Partners initiated a total of 853,374 disputes through the federal independent dispute resolution (IDR) portal, up 40% from the first half of 2024. Across all of last year, a small number of organizations were responsible for the majority of disputes, CMS noted.
    • “Many of the top initiating parties are (or are represented by) large practice management companies, medical practices or revenue cycle management companies representing hundreds of individual practices, providers or facilities,” the agency said May 28. “The top three initiating parties (Radiology Partners, HaloMD, and TeamHealth) represent thousands of clinicians across multiple states and accounted for approximately 43% of all disputes initiated in the last six months of 2024.”
  • STAT News points out,
    • “The links between ultra-processed food and higher risk of diabetes will be the focus of the first wave of health secretary Robert F. Kennedy Jr.’s national “Take Back Your Health” campaign, according to a notice posted on a government site for contractors.
    • “The notice invites public relations agencies to pitch strategies for the launch of the ad campaign, “a wake-up call to Americans that eating processed foods dramatically increases the risk of diabetes and chronic disease.”

From the Food and Drug Administration front,

  • Per Fierce Pharma,
    • “The FDA has approved Moderna’s mRESVIA for the prevention of lower respiratory tract disease caused by respiratory syncytial virus (RSV) in adults ages 18 to 59 who are at an increased risk for severe disease.
    • “Back in May, mRESVIA scored an FDA approval in adults 60 and older, becoming Moderna’s second commercial product behind the company’s first-generation COVID-19 shot, Spikevax.”
  • and
    • “Despite a recent rebuff from an FDA advisory committee, the first treatment for a specific and underserved cohort of U.S. bladder cancer patients has crossed the FDA finish line as UroGen Pharma’s Zusduri.
    • “The New Jersey-based pharma paired chemotherapy mitomycin with a sterile hydrogel using its sustained-release RTGel technology to create a localized therapy for potent tumor ablation of recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). It’s a drug delivery combo familiar to UroGen from its 2020 approved Jelmyto, another hydrogel and mitomycin pairing formulated as a liquid solution made for delivery in the kidney’s pyelocalyceal system that is indicated for low-grade upper tract urothelial cancer.”
    • “In its phase 3 ENVISION trial, UroGen found that Zusduri could deliver a 78% complete response for patients with LG-IR-NMIBC at three months, with 79% of those patients still event-free 12 months later.”

From the judicial front,

  • The Wall Street Journal reports,
    • “Anne Wojcicki, the co-founder and former CEO of 23andMe, is poised to regain control of the DNA-testing company after a nonprofit she controls topped a prior bid.
    • “23andMe said Friday that a nonprofit backed by Wojcicki was the new buyer for the company’s assets, offering $305 million.
    • “Last month, 23andMe said Regeneron, a biotech based in Tarrytown, N.Y., had won the bidding during a bankruptcy auction to buy the company for $256 million. 
    • “The bidding reopened early this month, after Wojcicki, through her nonprofit, TTAM Research Institute, made the unsolicited offer. TTAM is an acronym that aligns with the first letters of 23andMe.
    • “Regeneron declined to make a bid that topped TTAM’s offer, which is being financed by Wojcicki and her affiliated entities, according to a court filing. The TTAM bid still needs to be approved by the court.”

From the public health and medical research front,

  • The Centers for Disease Control and Prevention announced today,
    • Reported on Friday, June 13, 2025
    • Seasonal influenza activity is low. COVID-19 and RSV activity is very low.
    • COVID-19
      • COVID-19 wastewater activity, emergency department visits, and laboratory percent positivity are at very low levels.
    • Influenza
    • RSV
      • RSV activity is very low.
  • The University of Minnesota’s CIDRAP adds,
    • Dozens of medical and public health organizations have signed a letter urging insurers to continue covering COVID-19 vaccination in pregnant patients.
    • The letter from the American College of Obstetricians and Gynecologists is in response to the recent move by the Department of Health and Human Services (HHS) and the Centers for Disease Control and Prevention (CDC) to no longer recommend COVID-19 shots for healthy pregnant women.
  • and
    • “In its latest update on variant proportion estimates, the US Centers for Disease Control and Prevention (CDC) said the level of NB.1.8.1 viruses, recently added as a variant under monitoring (VUM) by the World Health Organization (WHO), has grown from 15% to 37% since late May, bringing it nearly even with LP.8.1, which has been dominant over the last few months.” * * *
    • “The CDC also reported a rise in XFG variant proportions, which rose from 6% to 8% over the same period. Both viruses are descendants of the JN.1 Omicron SARS-CoV-2 variant.”
  • and
    • “The US Centers for Disease Control and Prevention (CDC) today in its weekly measles update reported 29 more cases, bringing the national total to 1,197 cases and coming within 77 cases of matching the total from 2019, which was the most since the disease was eliminated from the country in 2000.
    • “So far, 35 states have reported cases, one more than a week ago, which likely reflects Arizona’s first cases of the year.
    • “Four more outbreaks were reported, bringing the national total to 21. For comparison, the CDC recorded 16 outbreaks for all of 2024. Of measles cases reported this year, 90% have been part of outbreaks. Last year, 69% of the illnesses were related to outbreaks.
    • “School-aged children are the most affected group (37%), followed closely by adults ages 20 and older (33%), and children younger than 5 years old (29%).”
  • The AHA New relates,
    • “The Centers for Disease Control and Prevention has added new resources for health care providers to its Be Ready for Measles Toolkit. They include a decision tree to help providers determine when to give measles, mumps and rubella vaccinations to adults; checklists for summer camps; and immunity records templates.” 
  • CBS News reports,
    • “The average age of moms giving birth in the U.S. continues to rise, hitting nearly 30 years old in 2023, according to a new report from the Centers for Disease Control and Prevention.
    • “In the report, published Friday by the CDC’s National Center for Health Statistics, researchers found the average age of all mothers giving birth in the United States increased from 28.7 years old in 2016 to 29.6 in 2023. For new first-time moms, average age also increased, from 26.6 in 2016 to 27.5 in 2023. The data was taken from the National Vital Statistics System, which includes all birth records in the country.” 
  • The New York Times reports, “In Some Ozempic Households, the Weight Loss Is Contagious. Patients taking the drugs are finding their families are benefiting, too.”
  • Managed Healthcare Executive adds,
    • “Glucagon-like peptide-1 receptor agonists (GLP-1RAs) — a class of drugs typically prescribed for type 2 diabetes and weight loss — may significantly reduce the risk of developing several common age-related eye diseases, including age-related macular degeneration (AMD) and glaucoma, according to a study published online earlier this year in Ophthalmology.
    • “The study, based on an analysis of electronic health records (EHRs) from older patients in the United States, revealed that GLP-1RAs were associated with lower rates of age-related macular degeneration, as well as primary open-angle glaucoma (POAG), when compared with other common medications such as metformin, insulin, statins and aspirin.”
  • Per MedPage Today,
    • Starting fecal immunochemical testing (FIT) at ages 40 to 49 was associated with reduced colorectal cancer (CRC) incidence and mortality compared with starting screening at age 50, a Taiwanese cohort study suggested.
    • Among over 263,000 participants, the incidence of CRC was 26.1 per 100,000 person-years for those who participated in early screening (at ages 40 to 49) versus 42.6 per 100,000 person-years for those who participated in regular screening (at age 50 and older), reported Tony Hsiu-Hsi Chen, PhD, of National Taiwan University in Taipei, and colleagues.
    • The mortality rate was 3.2 per 100,000 person-years for the early screening group compared with 7.4 per 100,000 person-years for the regular screening group, they noted in JAMA Oncology.
  • Per Health Day,
    • “A good number of people don’t know that high blood pressure is a silent killer, increasing a person’s heart risk with no obvious symptoms, a new poll has found.
    • “More than a third of Americans (37%) erroneously think high blood pressure always has noticeable symptoms like dizziness or shortness of breath, according to a survey by the University of Pennsylvania’s Annenberg Public Policy Center.
    • “In truth, high blood pressure usually has no signs or symptoms to indicate its presence, according to the U.S. Centers for Disease Control and Prevention (CDC).
    • “Likewise, nearly 4 in 10 people (39%) mistakenly believe that “feeling calm and relaxed” is an indication that blood pressure is normal, the poll shows.
    • “And very few people — only 13% — know the correct reading that reflects high blood pressure, 130/80, poll results show.
    • “Because controlling blood pressure reduces one’s risk of serious health problems, including heart attacks and strokes, correcting misperceptions about ways to identify it should be a public health priority,” Patrick Jamieson, director of the policy center’s Annenberg Health and Risk Communication Institute, said in a news release.”

From the healthcare business front,

  • The Wall Street Journal reports,
    • “AstraZeneca said it entered into a strategic research collaboration with China’s CSPC Pharmaceuticals, focused on artificial intelligence-driven research, valued at up to $5.33 billion.
    • “The partnership aims to advance the discovery and development of novel oral candidates, with the potential to treat diseases across multiple indications, the British pharmaceutical giant said Friday.
    • “Under the terms of the deal, CSPC will receive an upfront payment of $110 million. It is also eligible to receive up to $1.62 billion in potential development milestone payments and up to $3.6 billion in sales milestone payments, as well as potential single digit royalties based on annual net sales of the products.
    • “The British group will have rights to exercise options for exclusive licenses to develop and commercialize worldwide candidates identified under the agreement.
    • “The research will be carried out by CSPC and will utilize its AI-driven technology.
    • “The collaboration boosts AstraZeneca’s presence in China following the $2.5 billion investment in the country announced earlier this year, while it also strengthens its collaboration with the Chinese group.”
  • Modern Healthcare reports,
    • “Amazon is restructuring its healthcare division and another high-profile executive is departing the company.
    • “As part of the restructuring, Amazon’s Vice President of Health Partnerships and Marketing Aaron Martin is planning to leave the company later this summer after assisting with the transition, according to a person familiar with the situation.
    • “The moves were made to simplify the company’s structure, reduce layers and elevate tenured leaders across six teams, said Neil Lindsay, senior vice president at Amazon Health Services, in a statement on Friday. 
    • “Two of Amazon’s healthcare teams will focus on Amazon’s One Medical virtual and in-person care product, with one focused on clinical care delivery while the other is centered on operations and performance. The four other teams will focus on pharmacy, growth and network development, compliance as well as a segment focused on marketing and technology.”
  • Medscape tells us,
    • “Hospitals are struggling with long emergency room (ER) wait times, capacity issues, and staffing shortages. A growing number of patients with cellulitis, chronic obstructive pulmonary disorder, pneumonia, and other chronic conditions are being asked to skip hospital stays and return home.
    • “Hospital at Home models may be the answer. The explosion of Hospital at Home programs now makes it possible to provide acute level care at home. Today, 378 hospitals in 140 health systems and 39 states have been approved to provide healthcare at home. And a recent report found that 71% of health systems planned to launch Hospital at Home models.
    • “Digital care is the way of the future,” said Melissa Meier, MSN, RN, manager of Digital Care for OSF OnCall, the Digital Health Division for OSF HealthCare in Peoria, Illinois. “We’re always looking at ways to help reach more patients [and] always being on the cutting edge to reach our patients wherever they are is super important…[Hospital at Home] is certainly an answer for that.”
  • Per Beckers Hospital Review,
    • Becker’s has compiled a list of the hospitals with a CMS five-star rating for care transitions.
    • CMS’ “Patient survey (HCAHPS)-Hospital” database listed hospital ratings based on the Hospital Consumer Assessment of Healthcare Providers and Systems survey. This is a national, standardized survey of hospital patients about their experience during a recent inpatient hospital stay. The survey was completed between July 2023 and June 2024. The data was last updated April 30. 
    • [The article lists] the 195 hospitals by state with five-star care transition ratings.
  • Per BioPharma Dive,
    • “Quest Diagnostics has partnered with The University of Texas MD Anderson Cancer Center to develop a cancer risk blood test.
    • “The collaboration, which Quest disclosed Tuesday, builds on MD Anderson’s research into protein biomarkers that may indicate a patient is at high risk of cancer diagnosis in the coming years.
    • “MD Anderson’s approach is potentially a cheaper way than liquid biopsies to find patients who would benefit from conventional screening, according to the announcement. Quest is aiming to launch the test next year.”
  • and
    • “Novo Nordisk is planning Phase 3 clinical trials for a obesity drug combination called amycretin, adding another emerging weight-loss medicine to the list of prospects it has in advanced testing.
    • “The Danish drugmaker said Thursday the trials could begin in early 2026 and will test both an injectable and an oral formulation. In a Phase 2 trial, amycretin helped people with obesity lose up to 22% of their body weight over 36 weeks, topping Novo’s marketed medication Wegovy as well as Eli Lilly’s rival Zepbound.
    • “Amycretin targets GLP-1, as Wegovy does, but also a separate metabolic hormone called amylin that has drawn increasing interest from drugmakers. Earlier this week, shares of Metsera climbed by double digits after the biotechnology company reported promising Phase 1 data for an amylin-targeting agent.”

Thursday report

David Ermer–ACA, Congress, FDA, Generative AI, Medical / Rx research, Patient safety, Telehealth, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC

  • The Wall Street Journal reports
    • “House Republicans narrowly passed a $9.4 billion rescissions package that includes cuts to foreign aid as well as the entity that funds National Public Radio and the Public Broadcasting Service.
    • “The vote was 214-212, after some last-minute arm-twisting by GOP leaders convinced two Republicans to switch their votes to yes from no. All Democrats were opposed. The package now heads to the Senate, where it could face more scrutiny from Republicans.”
  • Beckers Payer Issues tells us,
    • “Proposed changes to Medicare Advantage are unlikely to be included in a final budget deal, The Hill reported June 11. 
    • “Senators had floated adding provisions of the No UPCODE Act, which targets overpayments in the program, to the massive federal budget bill. 
    • “Sen. Kevin Cramer, R-N.D., who first raised the idea of targeting MA savings in the bill, told The Hill the final legislation is unlikely to touch Medicare.”
  • STAT News informs us,
    • The Trump administration is pushing pharmaceutical companies to begin negotiations to bring their drug prices in line with what other countries pay — usually far less than Americans.
    • “Under President Trump’s direction, HHS is demanding that pharmaceutical companies end their obstruction and come to the table—just as they already do with nearly every other economically comparable nation—to negotiate fair, transparent pricing for Americans,” an agency spokesperson said in a statement to STAT, adding that the companies were “prevent[ing] progress of lowering prices for the American people.”
    • “The spokesperson did not immediately clarify how companies were preventing that progress. The administration’s statement comes after pharmaceutical executives said they were expecting more details about the kinds of drugs that would be up for negotiations and the price targets for them. 
    • ‘It also comes after a number of drug companies have met with the administration. At least three firms said this week that talks have not yet gotten into the details of pricing, instead mostly consisting of exchanging high-level ideas about the pharmaceutical market.”
  • The International Foundation of Employee Benefit Plans points out
    • The Internal Revenue Service (IRS) issued 2025 draft 1094-B, 1095-B, 1094-C, and 1095-C forms for use by employers, plan sponsors and group health insurers to report health coverage to plan members and the IRS.
  • Per MedTech Dive,
    • “Medtronic has recalled ventilators and asked customers to stop using the devices because of a fault linked to two serious injuries and one death, the company said Wednesday.
    • “Affected Newport HT70 and HT70 Plus ventilators can shut down during use or fail to effectively sound the shutdown alert alarm. The company also recalled certain related Newport service parts. There have been 63 medical device reports about the problem.
    • ‘The Food and Drug Administration said in a Class 1 recall database entry about the fault this week that 4,842 affected ventilators are in commerce worldwide.”

From the judicial front,

  • Bloomberg Law reports,
    • A trio of air ambulance providers lost [Dropbox link] an appeals court bid to overturn a decision in two surprise medical bill disputes, narrowing the legal path for physicians to challenge alleged malfeasance from health insurers in court.
    • The consolidated case revolves around two conflicting provisions of the No Surprises Act, which requires doctors and insurers to settle unexpected out-of-network bills via arbitration rather than balance billing the patient. 
    • The US Court of Appeals for the Fifth Circuit’s decision accompanies a separate ruling also issued [Dropbox link] Thursday in which the same panel of judges upheld a lower court’s decision, similarly, asserting that surprise billing arbitration disputes may not be addressed through litigation.
    • The Fifth Circuit sided against air ambulance companies Guardian Flight LLC, Reach Air Medical Services LLC, and Calstar Air Medical Services LLC in the consolidated case challenging Aetna Health Inc., Kaiser Foundation Health Plan Inc., and arbitrator Medical Evaluators of Texas ASO LLC over what the providers said were misrepresentations during the arbitration process. 
    • Judges Stuart Kyle Duncan, a Donald Trump appointee, Jerry E. Smith, a Ronald Reagan appointee, and Edith Brown Clement, a George H. W. Bush appointee, also reversed the lower court’s ruling in determining that MET was protected from litigation under the No Surprises Act.

From the public health and medical research front,

  • CBS News reports,
    • “Check your medicine cabinet — Zicam nasal swabs and Orajel baby teething swabs are being recalled due to potential microbial contamination, according to federal health officials.
    • “In an alert from the U.S. Food and Drug Administration, Church & Dwight Co., Inc., the brands’ manufacturer, voluntarily issued the recall after the potential contamination was discovered, which was identified as fungi in the cotton swab components of the products. 
    • “The recalled products include all lots of Zicam Cold Remedy Nasal Swabs (with UPC 732216301205), all lots of Zicam Nasal AllClear Swabs (UPC 732216301656) and all lots of Orajel Baby Teething Swabs (UPC 310310400002). All other Zicam and Orajel products are not affected by this recall, the FDA said.
    • “Consumers with any recalled products should stop using them immediately, the FDA advised.”
  • Health Imaging notes,
    • “New MRI data suggest that patients who weathered severe cases of COVID-19 may sustain long-lasting heart damage. 
    • “Specifically, researchers have uncovered evidence indicating patients who have been hospitalized with the virus may develop long-term left ventricular systolic dysfunction and coronary microvascular dysfunction. These findings were detailed this week in JAMA Network Open, where experts revealed the damage was evident on imaging nearly one year after patients had recovered from their initial infection. 
    • “In long COVID, or postacute sequelae of SARS-CoV-2 infection (PASC), patients commonly experience cardiopulmonary symptoms, including dyspnea, palpitations, chest pain, and fatigue, which impair quality of life and functional capacity,” Jannike Nickander, MD, PhD, with the department of clinical physiology at Karolinska University Hospital, in Sweden, and colleagues noted. “The underlying pathophysiological mechanisms are not fully understood but may stem from myocardial injury sustained during acute COVID-19 due to hypoxia, systemic hyperinflammation, hypercoagulability, and direct viral invasion of endothelial cells and cardiomyocytes.” 
  • Fierce Healthcare relates,
    • “Urine drug test (UDT) data can generate timely estimates of overdose deaths, a new study suggests. 
    • “The study, published in JAMA Network Open by specialty lab Millennium Health and The Ohio State University, aimed to determine whether UDT data could provide near real-time indications of overdose trends. Effective responses to the overdose crisis must be prompt, the study noted, which requires a timely evaluation of current trends. However, current publicly available data on fatal overdoses in the U.S. can lag by at least six months. 
    • “We were determined to close that gap,” Eric Dawson, vice president of clinical affairs at Millennium Health, told Fierce Healthcare. “We wanted to be able to tell people, here’s what’s happening today with overdoses—compared to here’s what you’re being told today happened six months ago.” 
  • The International Foundation of Employee Benefit Plans offers a new look at virtual care.
    • “What’s next for virtual care? One area of focus is the further development of hybrid solutions that offer virtual-first care coupled with in-person clinics. Many vendors are also introducing their own health plan and/or TPA for a virtual-first solution. These can be offered alongside traditional health plans (e.g., not necessarily as a full replacement offering). Supplemental and/or coordinating carrier care management is also an avenue explored by new digital health startups offering virtual care. Another trend influencing virtual care is the development of artificial intelligence (AI) as a tool and the related ability to become more predictive and proactive around population health management and outreach. It will be important, however, for employers to track how these virtual offerings impact quality outcomes, engagement and positive user experience.
    • “Overall, the opportunity is clear—Virtual care as a component of a broader health care system can provide convenient and efficient care while increasing access and lowering costs for employer populations. Integration with in-person care will always be important, but technological developments will pave the way to create a more seamless patient experience.”

From the U.S. healthcare business front,

  • BioPharma Dive reports,
    • “COVID vaccine maker BioNTech is buying rival CureVac, announcing Thursday an all-stock deal weeks before the two companies were due to face off in a German court over potentially billions of dollars worth of royalties related to intellectual property on messenger RNA drugs.
    • “Per deal terms, each CureVac share will be exchanged for about $5.46 worth of BioNTech’s U.S.-listed shares, valuing the company at $1.25 billion. Upon the deal’s close, CureVac shareholders will own between 4% and 6% of BioNTech.
    • “In the early days of the COVID-19 pandemic, BioNTech and CureVac were among the companies racing to develop the first coronavirus vaccines. BioNTech, however, partnered with Pfizer and won approval of the first COVID-19 shot, while CureVac’s program never made it to market. The two companies have since been embroiled in patent litigation.”
  • Per Healthcare Dive,
    • “Cigna unveiled a number of new digital tools on Thursday meant to improve customer experience with its health benefits portal, including a virtual assistant based on generative artificial intelligence.
    • “The rollout — part of the insurer’s larger push to make it easier for members to access and afford the benefits they’re due — also includes a new tool to match patients to in-network providers.
    • “Experts have raised concerns about rising adoption of AI in the healthcare sector due to the technology’s tendency to make mistakes. Cigna said its new features were developed with “rigorous” research and testing within an AI governance framework.”
  • and
    • “Mergers and acquisitions should play an “important role” in Teladoc’s future business strategy, the virtual care firm’s CEO said Wednesday. 
    • “We’re going to make investments not just for the short term, but things that we think are going to start to increase that [total addressable market], start to increase the scope and range of what we can do. And we think that’s the right place to deploy our capital,” CEO Chuck Divita said at the Goldman Sachs Global Healthcare Conference.
    • “The telehealth company has already completed two acquisitions this year, scooping up preventive care firm Catapult Health in February and virtual mental health provider UpLift last month.”
  • Beckers Hospital Review calls attention to “six hospital partnerships and proposed deals that were called off or unwound so far this year”

Midweek report

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

From Washington, DC

  • Roll Call tells us,
    • “House Republicans rescued their “big, beautiful” reconciliation bill from an early death in the Senate Wednesday by passing a measure deleting various provisions that would have violated Senate budget rules.
    • “To avoid a stand-alone vote on the fixes, automatic adoption of the resolution correcting the engrossment of the House reconciliation bill was embedded in a rule needed for floor debate of an unrelated bill that would cancel $9.4 billion in foreign aid and public broadcasting funds. The House adopted the rule on a nearly party-line vote of 213-207.
    • “Rules Chairwoman Virginia Foxx, R-N.C., said during floor debate that no new provisions were added to the reconciliation bill. She said the corrections measure only deleted some provisions for technical reasons “to make sure this big, beautiful bill has its day in the Senate.”
  • The American Hospital Association News informs us,
    • “The Senate Health, Education, Labor, and Pensions Committee today released its text for the budget reconciliation bill. The text includes one health care provision, which would fund cost-sharing reduction payments to insurers in Affordable Care Act marketplaces. It also includes several policies related to student loan and repayment programs, including the termination of the Grad PLUS loan program effective July 1, 2026, and a change to the Public Service Loan Forgiveness Program for new borrowers that would not allow medical or dental residents to count their time in residency as qualifying payments for loan repayment.” 
  • STAT News reports,
    • “Senate health committee Chair Bill Cassidy (La.) is the latest Republican to take an interest in legislation that would tie U.S. brand drug prices to lower prices in other wealthy countries, according to seven people following the issue.” * * *
    • “Trump last month announced plans for pushing U.S. drug prices down to foreign levels, and more details are supposed to be forthcoming. However, it’s not clear that the administration could pressure drugmakers into matching the prices they charge abroad, which are typically much lower, without Congress passing a law that requires them to do so.” * * *
    • “After Trump’s announcement, Sen. Josh Hawley (R-Mo.) also introduced a bill with Sen. Peter Welch (D-Vt.) that would base U.S. prices on what other countries pay. 
    • “Cassidy’s bill would apply to Medicare prices, while the Hawley/Welch bill would apply to all retail drugs, not just those for which Medicare pays. 
    • “The Cassidy bill would instruct Medicare to claw back what it is owed when drugmakers charge prices that are higher than the foreign reference prices. It sets criteria for the countries that would be used to set prices, and Medicare would maintain that list. 
    • ‘The Hawley/Welch bill enforces its requirement for lower prices with civil monetary penalties that are 10 times the difference between the U.S. list price and the average price of the drug sold in Canada, France, Germany, Japan, Italy, and the United Kingdom.”    
  • The Washington Post reports,
    • Health and Human Services Secretary Robert F. Kennedy Jr. named eight people to the influential federal panel that recommends vaccines to Americans Wednesday, elevating several vaccine critics days after he purged the group’s entire membership.
    • His picks for the Advisory Committee on Immunization Practices include a well-known pediatric infectious diseases expert and at least two people who have criticized the use of mRNA coronavirus vaccines. Some of the more notable selections include Martin Kulldorff, the co-author of the Great Barrington Declaration * * * and Vicky Pebsworth, who has been listed on the board of the nation’s oldest anti-vaccine group.
    • “All of these individuals are committed to evidence-based medicine, gold-standard science, and common sense,” Kennedy said in a Wednesday X post announcing the picks. “They have each committed to demanding definitive safety and efficacy data before making any new vaccine recommendations.”
    • “The other new members are Joseph R. Hibbeln, a psychiatrist; Retsef Levi, a professor of operations management; Robert W. Malone, a biochemist; Cody Meissner, a pediatrician; James Pagano, an emergency medicine physician; Michael Ross, a professor of obstetrics and gynecology.”
  • Federal News Network relates,
    • “More than 460 laid-off employees at the nation’s top public health agency received notices Wednesday that they are being reinstated, according to a union representing the workers.
    • “The U.S. Department of Health and Human Services confirmed reinstatement notices went out to the former Centers for Disease Control and Prevention employees but provided few details.
    • “About 2,400 CDC employees lost their jobs in a wave of cuts across federal health agencies in early April, according to a tally at the time.” * * *
    • “An estimated 200 of the reinstated workers are based in the CDC’s National Center for HIV, Viral Hepatitis, STD, and Tuberculosis Prevention, HHS officials confirmed. Staffers at a CDC lab that does testing for sexually transmitted diseases are being brought back, said one CDC employee who wasn’t authorized to discuss what happened and spoke to The Associated Press on condition of anonymity.
    • “Also reinstated are an estimated 150 employees at the CDC’s National Center for Environmental Health, including people staffing a lab that works on lead poisoning, according to the union and employees.”
  • Per Fierce Pharma,
    • “Nine years after selling Medivation to Pfizer for $14 billion, David Hung, M.D., is going toe to toe with the New York drugmaker and two other pharma giants in a lung cancer field.
    • “Hung’s Nuvation Bio has won FDA approval for Ibtrozi, or taletrectinib, to treat patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). With the nod, Ibtrozi will go up against existing medicines from Pfizer, Bristol Myers Squibb and Roche.
    • “ROS1 is a well-established subset of NSCLC. As it stands, Roche’s Rozlytrek is largely duking it out with BMS’ Augtyro, while Pfizer’s first-generation tyrosine kinase inhibitor (TKI) Xalkori gradually falls out of favor.
    • “However, ROS1 NSCLC has not been viewed as a major market opportunity, with combined Rozlytrek and Augtyro sales reaching roughly $200 million in 2024 despite their additional uses in NTRK gene fusion-positive solid tumors.
    • “But Hung believes Ibtrozi boasts a unique profile that could allow the next-generation TKI to reach new heights. For their part, analysts at Jefferies see potential for the Nuvation drug to become a blockbuster.”

From the public health and medical research front,

  • STAT News points out,
    • “Deaths from alcohol-related liver diseases have been rising for years — and at an accelerated rate for groups including women, young adults, and Indigenous people. New data suggest a surge in deaths in the early months of the pandemic has continued in subsequent years. 
    • “The study presents a discouraging picture of the nation’s liver health. Between 2018 and 2022, the most recent year for which mortality data are available, the annual percentage change in alcohol-associated liver disease deaths was nearly 9%, compared to 3.5% between 2006 and 2018. 
    • “Men still made up the bulk of these deaths, with 17 deaths per 100,000 people. But women’s death rates sped up, jumping up to 8 deaths from 3 per 100,000 people in the time period studied. On average, the annual percent change in women’s mortality was 4.3% — nearly twice that of men. Researchers also highlight a worsening trend of sudden and dangerous liver inflammation appearing in young people.
    • “While alcohol-associated liver disease (ALD) mortality was relatively stable from 1999 to 2006, it’s been on the rise since then, and has worsened especially since 2018, according to findings published Wednesday in JAMA Network Open. Experts know the pandemic had something to do with that change, since studies suggest people drank more during the Covid era. But new data, and the continuing influx of younger patients with severe illness, further troubles liver doctors and public health researchers. 
    • “It puts numbers to what we’re seeing in the hospital, in the clinic,” said Brian Lee, a hepatologist and liver transplant specialist at Keck Medicine of USC who was not involved with the study.”
  • The American Journal of Managed Care lets us know,
    • “In the process of recovering from COVID-like symptoms, mental health and well-being took close to 3 times as long to recover compared with physical health, according to new research published online today. These new data from December 2020 through the end of August 2022 show that although physical health tends to bounce back by 3 months after symptoms became apparent, mental well-being can take up to 9 months to reach a comparable level of recovery.
    • “In Open Forum Infectious Diseases, these findings and additional data from the CDC’s INSPIRE project (Innovative Support for Patients with SARS-CoV-2 Infections Registry; NCT04610515) shed new light on recovery after COVID-like symptoms.1 The study authors also highlight that up to 1 year after infection, close to 20% of patients continued to report a reduced health-related quality of life (HRQOL) vs before their self-reported COVID-like symptoms, and that there is potential for underestimation of other illnesses because of this; among their study population, health recovery recovered to a higher level for those who reported COVID-like symptoms vs those who tested negative.
    • “For patient prognostics, we found somewhat more pronounced recovery (i.e., return to the optimal HRQOL) for those in the COVID+ group compared to the COVID− groups, after adjustment,” the study authors wrote. Their results speak to the need for ongoing vigilance on the part of health care providers toward their patients’ mental health throughout recovery and to tailor care strategies accordingly.”
  • Per MedPage Today,
    • “CT colonography, also known as virtual colonoscopy, reduced the incidence of colorectal cancer by up to 75% versus no screening, while stool DNA testing reduced the incidence by 59%.
    • “Stool testing was cost-effective relative to no screening, while CT colonography was actually cost saving.
    • “CT colonography should be considered a legitimate first-line screening option along with stool testing and optical colonoscopy.”
  • Per Medical News Today,
    • As people are living longer, there is a greater emphasis on healthy aging. 
    • Diet is one aspect that can contribute to healthier aging.
    • A new study found that consuming more foods and beverages rich in flavonoids may help lower a person’s risk of certain aspects of unhealthy aging, such as frailty and poor mental health.
    • Flavonoids are found in a variety of fruits, vegetables, and plant-based foods, such as: 
      • Berries like blueberries and raspberries; Citrus fruits like oranges and grapefruit; Dark chocolate; Fruits such as peaches and bananas; Green and black tea; Leafy greens such as kale and spinach; Red wine; Vegetables such as peas, onions, and tomatoes
  • The Washington Post relates,
    • “With a silly smile and frilly gills, the axolotl has wriggled its way into the hearts of millions, becoming a popular aquarium pet and pop culture icon in video games, children’s books and toy stores.
    • “But this adorable species of salamander is also helping researchers investigate a serious medical mystery: Could the human body be coaxed to regrow a severed arm or leg?
    • “Scientists are turning to the axolotl because it is an expert at regeneration. After losing a limb, an adult axolotl can grow it back fresh and new.
    • “In a study published in the journal Nature Communications on Tuesday, scientists used axolotls genetically engineered to glow in the dark to understand the molecular underpinnings of this amazing trait.
    • “This species is special,” said James Monaghan, a Northeastern University biologist who led the research. They’ve “really become the champion of some extreme abilities that animals have.”
  • GenEdge reports,
    • “Scientists at the Max Planck Institute for Metabolism Research have identified a network of nerve cells that may be responsible for a reduction in feelings of hunger that may be felt as a result of smelling food, in mice. The team discovered a direct connection from the nose to a group of nerve cells in the brain that are activated by the smell of food and, when activated, trigger a feeling of fullness in lean mice, but not in obese mice. The discovery may suggest that treating obesity might require different advice about smelling food before a meal based on a person’s weight.
    • “Our findings highlight how crucial it is to consider the sense of smell in appetite regulation and in the development of obesity,” said study lead Sophie Steculorum, PhD, research group leader at the Max Planck Institute for Metabolism Research. “Our study shows how much our daily-lives’ eating habits are influenced by the smell of food. Since we discovered that the pathway only reduces appetite in lean mice, but not in obese mice, our study opens up a new way to help prevent overeating in obesity.”
  • The Wall Street Journal reports,
    • “Some health-obsessed Americans believe the next antiaging therapeutic already exists—in the medicine cabinets of millions of diabetes patients.
    • “The widely used class of drugs, called SGLT2 inhibitors and sold under brand names such as Jardiance and Farxiga, have been on the market for over a decade as Type 2 diabetes medications. They have also gained regulatory approval to treat conditions like heart failure and kidney disease. 
    • ‘Recently, though, the drugs have emerged as a hot topic on popular health podcasts and Reddit forums for longevity enthusiasts, many of whom don’t suffer from any of those conditions. Instead, they are adding SGLT2 inhibitors to a roster of hacks they hope will help them live healthier for longer—or in other words, increase their healthspan.” * * *
    • “This is probably the drug class of our era,” says Dr. Timothy Gong, section physician leader for heart failure and transplant cardiology at Baylor University Medical Center, who has researched SGLT2 inhibitors. “You see cardiologists, nephrologists, endocrinologists, even general internists as well, just getting so excited.”
    • “Gong says he wouldn’t be surprised to take an SGLT2 inhibitor one day, once they are studied more, though he’s free from heart issues and diabetes. Yet it’s too early to prescribe it for longevity benefits in otherwise healthy patients. 
    • “I don’t think that the evidence is strong enough yet for us to be able to say that,” he says.” 

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Risant Health CEO Dr. Jaewon Ryu said the new nonprofit system is making progress rolling out the first wave of its value-based care platform.
    • “The system is growing quickly, having completed two acquisitions in the past year-and-a-half. Oakland, California-based Kaiser Permanente launched Risant in early 2024 with the acquisition of Geisinger Health, followed by another deal in December to buy Cone Health. Kaiser formed Risant as a separate entity to acquire health systems and create a national value-based care network.
    • “As Risant expands, it is implementing a gameplan for value-based care throughout its footprint, ranging from primary care guidelines to technological tools that can help improve patient care.”
  • The Pharmacy Times discusses “The Role of Pharmacists in Cardiovascular Health: A Collaborative Approach to Treatment, Counseling, and Nutrition.”
  • Per Fierce Healthcare,
    • NeuroFlow, a behavioral health tech company, has launched a suite of analytics tools to help payers and providers understand population risk.
    • BHIQ is a standalone product built on the analytics work NeuroFlow has already routinely been doing for years. It leverages existing data, like historical EHR, claims and pharma data, to predict the behavioral health needs of a population or a patient. It also helps organizations understand the efficacy of their interventions. NeuroFlow piloted BHIQ with a number of partners including commercial payers, Medicaid and Medicare Advantage plans and ACOs. 
    • “This certainly is not meant to be a replacement to a diagnostic tool, and it’s not meant to diagnose issues,” NeuroFlow CEO Chris Molaro told Fierce Healthcare. “It’s more of a compass to help point them in the right direction and give them insight into where there may be risk—and then stratify that risk.” 
    • “BHIQ is meant to complement NeuroFlow’s other offerings, though it can be purchased separately. Compared to the company’s product for measurement-based care, which draws on patient-reported outcomes questionnaires, BHIQ does not require patients to download an app or respond to surveys. This means organizations have another pathway for data analysis.”
  • and
    • “Alternative pharmacy benefit manager and administrator Capital Rx is acquiring Amino Health, a care navigation company.
    • “The acquisition, the company said, will allow Capital Rx to offer a better member-facing experience to complement its unified claims platform on the back end.” * * *
    • “Amino Health CEO John Asalone positions the company as helping large, self-insured employers (often Fortune 100 companies) lower their costs through a sleek interface helping members search for top-rated providers, view integrated cost estimates, uncover prescription drug savings and book appointments easily. This allows members to not only search by medical provider or procedure but also search for drugs like GLP-1s.”
  • and
    • “Blue Shield of California has teamed up with Zocdoc for members to more easily schedule in-person appointments with providers in their health plan network, the companies announced on Wednesday. 
    • “Zocdoc connects consumers with primary care providers and specialists and to see their schedules and book appointments digitally. Blue Shield of California is bringing that seamless digital experience to its members to facilitate access to covered providers. 
    • “The new feature is available through Blue Shield of California’s searchable provider directory on its website. With the last-mile infrastructure provided by Zocdoc, members can immediately see the participating providers’ availability and book an appointment.”

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.

Monday report

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

From Washington, DC,

Photo by Sven Read on Unsplash
  • The Wall Street Journal reports,
    • “Senate Majority Leader John Thune (R., S.D.) is trying to release this week a revised version of President Trump’s “big, beautiful bill.”
    • “But as he races to pass the legislation ahead of Republicans’ self-imposed July 4 deadline, he has got about as many problems as there are GOP senators, with lawmakers battling over the additional borrowing and spending cuts that will be used to finance tax relief, plus spending on the border and military.
    • “The House in May passed its own version by a one-vote margin, and Trump has urged the Senate to move the multitrillion-dollar bill quickly. But GOP senators want changes, and lawmakers disagree over the depth of cuts to Medicaid, clean-energy tax credits and nutrition assistance, with some seeking to protect their own states’ interests and others accusing colleagues of not taking federal deficits seriously.”
  • The American Hospital Association News tells us,
    • “The White House June 6 issued a memorandum directing the Secretary of the Department of Health and Human Services “to take appropriate action to eliminate waste, fraud, and abuse in Medicaid, including by ensuring Medicaid payments rates are not higher than Medicare, to the extent permitted by applicable law.” In the memo, the administration expresses its view that rapid growth in state directed payment programs [“SPDs”] is a threat to the nation’s long-term stability, and that the “imbalance between Medicaid and Medicare payment rates under these programs jeopardizes access to care for seniors.”  
    • “The memo is in addition to the ongoing congressional reconciliation deliberations, which also include provisions impacting SDPs.”
  • Per HHS news releases,
    • “Jim O’Neill was sworn in today [June 9, 2025] as the Deputy Secretary of Health and Human Services by Secretary Robert F. Kennedy, Jr. With decades of experience at the intersection of health care, technology, and public service, O’Neill will help Kennedy oversee an agency that includes the National Institutes of Health, the U.S. Food and Drug Administration, the Centers for Disease Control and Prevention, the Centers for Medicare and Medicaid Services, the Administration for Children and Families, and many others.
    •  “Jim O’Neill’s extensive experience in Silicon Valley and government makes him ideally suited to transition HHS into a technological innovation powerhouse. He will help us harness cutting-edge AI, telemedicine, and other breakthrough technologies to deliver the highest quality medical care for Americans,” said Secretary Kennedy. “As my deputy, he will lead innovation and help us reimagine how we serve the public. Together, we will promote outcome-centric medical care, champion radical transparency, uphold gold-standard science, and empower Americans to take charge of their own health.”
  • and
    • “The U.S. Department of Health and Human Services (HHS) today took a bold step in restoring public trust, links to an external website, opens in a new tab by totally reconstituting the Advisory Committee for Immunization Practices (ACIP), an advisory committee that makes recommendations on the safety, efficacy, and clinical need of vaccines to the Centers for Disease Control and Prevention (CDC). Under the leadership of HHS Secretary Robert F. Kennedy, Jr., the agency removed the 17 sitting members of the ACIP committee and will replace them with new members currently under consideration.” * * *
    • “ACIP will convene its next meeting, links to an external website June 25 through June 27 at CDC headquarters in Atlanta.”

From the Food and Drug Administration front,

  • Per Fierce Pharma,
    • “As several pharma juggernauts prepare for the upcoming respiratory syncytial virus (RSV) season, the FDA has blessed Merck’s entrant. 
    • “The monoclonal antibody, clesrovimab, will be known commercially as Enflonsia and will challenge Sanofi and AstraZeneca’s blockbuster Beyfortus.
    • “Enflonsia has been approved to prevent lower respiratory tract disease from RSV in children who are born during or entering their first RSV season, the U.S. regulator said in a social media post. The nod arrived one day ahead of the agency’s target decision date.” * * *
    • “Meanwhile, Sanofi and AZ have been unchallenged with Beyfortus as the lone prophylactic RSV antibody for children. The drug generated sales of 1.7 billion euros ($1.8 billion) last year. In 2023, reports emerged that demand for the antibody outstripped early supply.
    • “Also Monday, Sanofi said that it and partner AZ have already manufactured as many doses of Beyfortus as they supplied last year and that production remains ongoing. The companies added that they will begin shipping early in the third quarter.
    • “Enflonsia has delivered trial results that suggest it can compete with Beyfortus.” 
  • and
    • “A new era of hypertension treatment is on the horizon for U.S. patients with the FDA approval of George Medicines’ Widaplik, a three-in-one pill that can serve as an initial treatment to help lower blood pressure.
    • “The drug combines established high blood pressure meds telmisartan, amlodipine and indapamide and is the first triple-combination therapy to boast a label from the FDA that allows its use as an early treatment, helping patients who may need multiple drugs to achieve blood pressure goals with one fell swoop. 
    • “Its three dosing options—one low dose and two standard doses—can deliver the benefits of a triple-combo approach “early in the treatment pathway with an established safety profile and good tolerability,” according to a June 9 press release from George Medicines.”
    • “The drug is specifically approved for patients who are likely to need more than one medicine to achieve blood pressure goals.”
  • and
    • “When it comes to the use of PD-1 inhibitors in stomach cancer, the FDA has put its money where its mouth is.
    • “After questioning the benefits of checkpoint inhibitors in stomach cancer cases without PD-L1 expression, the FDA has moved to restrict the use of Merck & Co.’s and Bristol Myers Squibb’s immunotherapies in those patients.
    • “BMS’ Opdivo, used in combination with chemotherapy, is now allowed in advanced or metastatic gastric, gastroesophageal junction (GEJ) and esophageal cancers only among patients whose tumors express PD-L1. Simultaneously, the approval for a combination of Opdivo and BMS’ Yervoy in first-line esophageal squamous cell carcinoma has also been limited to PD-L1-positive disease.
    • “Similarly, the label for Merck’s Keytruda in gastric, GEJ and esophageal cancers has been narrowed to PD-L1-positive tumors as well. The amendment to Keytruda’s gastric or GEJ adenocarcinoma uses only touches HER2-negative disease in this situation because the drug’s HER2-positive approvals in those settings had already been narrowed to PD-L1-positive cases in March.
    • “The revised indications reflect the patient populations for whom the drugs have favorable risk-benefit assessments, the FDA said in two separate letters (PDFs) sent to the drugmakers late May.”
  • Per MedTech Dive,
    • “Baxter has recalled its Novum IQ large volume pump in response to an under-infusion risk linked to one serious injury report, the Food and Drug Administration said Friday.
    • “Baxter is keeping the pumps on the market and updating the instructions to advise users on how to prevent the devices from infusing up to 50% less than the set amount. More than 34,500 units are affected across the U.S. and Canada, according to a recall database entry. 
    • “Variability of 10% or more can put infants at risk of dehydration, inadequate drug therapy and nutrition and insufficient blood infusion, the FDA said, leading to serious harm and death.”

From the judicial front,

  • Fierce Healthcare tells us,
    • “The leading organization representing pharmacy benefit manager companies is now also suing Arkansas officials over its new law banning PBMs from owning pharmacies. 
    • “Joining the Pharmaceutical Care Management Association (PCMA) in the lawsuit as a plaintiff is alternative PBM and founding member of TransparencyRx, Navitus Health Solutions. The lawsuit was filed in the Eastern District of Arkansas against the Arkansas State Board of Pharmacy.”
    • “Express Scripts and CVS Health had sued state officials at the end of May.”

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “Health officials are investigating a salmonella outbreak linked to eggs from August Egg Co. and sold under several brands.
    • “As of June 5, 79 people had been reported infected with the outbreak strain, with at least 21 hospitalizations, the Centers for Disease Control and Prevention said.
    • “The CDC, the Food and Drug Administration and state officials are investigating.
    • “August Egg, of Hilmar, Calif., recalled 1.7 million dozen brown cage-free and brown certified organic eggs.
    • “The eggs were distributed at stores including Walmart, Ralphs, Safeway, Save Mart, FoodMaxx, Lucky, Smart & Final, Raleys and Food 4 Less. Brands include Clover, First Street, Nulaid, O Organics, Marketside, Raleys, Simple Truth, Sun Harvest and Sunnyside.
    • “The eggs were available from various retailers in California and Nevada. Additionally, they were sold at Walmart locations in Washington, Arizona, Wyoming, New Mexico, Nebraska, Indiana and Illinois.”
  • The American Medical Association lets us know what doctors wish their patients knew about myocarditis.
  • Beckers Hospital Review shares information from an “American Cancer Society [study that] used data from the North American Association of Central Cancer Registries to calculate incidence rates per 100,000 people for each state and each cancer type” over the period 2017 through 2021. Kentucky had the highest incidence rate.
  • MedPage Today points out,
    • “Participation in a cervical cancer screening program in a safety-net health system more than doubled when patients received at-home test kits by mail rather than just a telephone reminder to get screened, a randomized trial showed.
    • “Six months after initial contact, 17.4% of patients invited by telephone to attend a clinic-based screening had participated in the program as compared with 41.1% of those who had an at-home test for human papillomavirus (HPV) mailed to them. The participation rate increased to almost 50% among patients who received the home test kit and a follow-up phone call from a patient navigator. More than 80% of screening participants in the two self-collection groups, returned the home test kit as opposed to being tested in a clinic.
    • “The results suggest that use of self-collection test kits could be considered in safety-net settings with low participation in cervical cancer screening programs, reported Jane R. Montealegre, PhD, of the University of Texas MD Anderson Cancer Center in Houston, and co-authors in JAMA Internal Medicineopens in a new tab or window.
    • “Too many women, especially those who are uninsured, live in rural areas, or come from marginalized and underserved communities, aren’t getting screened for cervical cancer,” Montealegre said in a statement. “These results show that self-collection testing could be a solution to increasing access to screening and, in turn, reducing the burden of cervical cancer in the U.S.”
  • and
    • “More widespread and consistent use of pre-exposure prophylaxis (PrEP) has the potential to dramatically reduce the incidence of HIV in the U.S., but substantial barriers to PrEP remain, particularly access, stigma, and non-HIV specialist physicians’ knowledge of the growing slate of options.
    • “New PrEP options on the horizon may help alleviate some of these barriers as physician awareness also increases. 
    • “There’s data from contraception [studies] that if you have more choice, the uptake is higher overall,” Matthew Spinelli, MD, of the University of California San Francisco, told MedPage Today. “PrEP is highly effective, and if the populations that need it had access to it, we would see the end of the HIV epidemic.” 
  • The Wall Street Journal relates,
    • “For patients with a rare type of blood cancer, treatment might finally be coming out of the Dark Ages.
    • “People with the chronic condition polycythemia vera make too many red blood cells, thickening their blood and increasing the risk for clots, heart attacks or strokes. The main treatment consists of regular blood draws—essentially bloodletting—to keep the disease in check.
    • “But a new drug from Protagonist Therapeutics and Takeda can slow down a patient’s production of red blood cells and nearly eliminates the need for phlebotomies, new data show, potentially reducing patients’ fatigue and other consequences of routine blood draws.
    • “I think that this drug would really be groundbreaking for patients,” said Dr. Bart Scott, a professor at Fred Hutchinson Cancer Center in Seattle, who treats patients with polycythemia vera and had some who enrolled in the drugmakers’ trial. “The time for leeches is over.” * * *
    • “The 52-week [trial] data is expected around the spring of 2026, and Takeda plans to file for Food and Drug Administration approval after that, said Dr. Phuong Khanh Morrow, head of the oncology therapeutic area at Takeda.”
  • Per BioPharma Dive,
    • “An experimental cholesterol-lowering pill from Merck & Co. succeeded in a pair of late-stage studies, the company said Monday [June 9, 2025].
    • “In one study, Merck’s drug, enlicitide, was tested against a placebo in people already taking statins and who have either an inherited condition that causes high cholesterol or are at risk of atherosclerosis. The second trial evaluated enlicitide against other oral therapies, such as ezetimibe, in people on statins and with abnormally high levels of fats in the blood.
    • “Merck didn’t provide specifics but said in both cases enlicitide met all of its study objectives and demonstrated “statistically significant and clinically meaningful reductions” in LDL-C, or “bad” cholesterol, without any important differences in the number of adverse events. Details will be presented at a future medical meeting. Company shares climbed 2% in early trading Monday.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “The healthcare industry added 62,000 jobs in May, exceeding the sector’s average monthly gain of 44,000 workers over the past year, according to a new report from the U.S. Bureau of Labor Statistics released Friday [June 6, 2025]. 
    • “Employers added 30,000 hospital jobs, 29,000 ambulatory healthcare services roles and 6,000 skilled nursing positions last month, according to the report. 
    • “The monthly jobs data demonstrates continued strong demand for healthcare workers, despite broader economic uncertainty and reports of some health systems freezing hiring or implementing layoffs.”
  • Beckers Payer Issues notes, “Many insurers are asking for double-digit rate increases in 2026 for the individual and small group exchange markets as they face a potential expiration of enhanced premium tax credits and rising costs.”
  • Modern Healthcare reports,
    • “Dr. Bobby Mukkamala’s is tapping into decades of medical experience, as well as his recent time as a patient with a brain tumor, as he begins his one-year term as American Medical Association president.
    • “Healthcare runs in the family. His father is a retired radiologist, his mother a retired pediatrician and his wife is a obstetrician-gynecologist.
    • “In an interview, the Flint, Michigan-based otolaryngologist said he plans to focus on physician shortages related to burnout and the uptick in non-physician caregivers. He also plans to address the hoops most patients have to jump through to receive adequate care, an experience made clear to him late last year when he was diagnosed with a brain tumor. Most of the tumor was removed in surgery and he is receiving treatment for the residual 10%.”
  • Beckers Hospital Review informs us,
    • Detroit-based Henry Ford Health recorded an operating income of $77.5 million (2.4% operating margin) in the first quarter of 2025, down from an operating income of $98.5 million (4.5% margin) during the same quarter in 2024, according to its May 28 financial report.  
  • and
    • Pittsburgh-based Allegheny Health Network recorded an operating income of $7.7 million (0.6% operating margin) in the first quarter of 2025, up from an operating loss of $31.3 million (-2.5% margin) during the same period last year, according to its May 29 financial report. 
  • and also
    • lists “seven drug new shortages and discontinuations, according to drug supply databases from the FDA and the American Society of Health-System Pharmacists.” 

Weekend update

David Ermer–Congress, Generative AI, Medical / Rx research, Mental health care, Obesity, OPM, SCOTUS, U.S. Healthcare–

From Washington, DC,

  • The Senate maintains a daily Executive Calendar. There are now eight nominees whose names were reported to the Senate floor before Scott Kupor. According to the unanimous consent resolution page in the front of the calendar, the Senate will consider tomorrow the nominations of the earliest reported nominee David Fotouhi (March 13) and two nominees reported in May after Mr. Kupor (April 9). The FEHBlog think that this is the pattern that the Senate leadership is following, which means that the Senate is likely to take up Mr. Kupor’s nomination later this month. 
  • Roll Call summarizes expected Congressional activities for this week here.
    • As Senate committees continue to release their proposals for the House-passed reconciliation package this week, the House plans to vote on President Donald Trump’s proposals to rescind foreign aid and other spending, including for public broadcasting.
    • “The rescissions request sent to Congress by the Trump Administration takes the federal government in a new direction where we actually cut waste, fraud, and abuse and hold agencies accountable to the American people,” House Majority Leader Steve Scalise, R-La., said in a statement.
  • The Supreme Court will be issuing another batch of opinions this coming Thursday.
  • Last Thursday, HR Dive tells us,
    • “A federal appeals court’s “background circumstances” requirement for majority-group plaintiffs who seek to prove job discrimination cuts against both Title VII of the 1964 Civil Rights Act and U.S. Supreme Court precedent, Justice Ketanji Brown Jackson wrote for a unanimous SCOTUS on Thursday.
    • “The court reversed the 6th U.S. Circuit Court of Appeals’ decision in Ames v. Ohio Department of Youth Services, which had dismissed a heterosexual woman’s claim that she was unlawfully passed over for a promotion in favor of a lesbian woman and subsequently demoted, after which a gay man was hired to fill her original role. The plaintiff alleged that those decisions constituted illegal discrimination on the basis of her sexual orientation, which the Supreme Court has said is a form of sex-based discrimination under Title VII.
    • “The 6th Circuit held that the plaintiff could not show background circumstances to support her suspicion that her employer discriminated against her on the basis of her status as a member of a majority group.
    • “Justice Jackson, however, wrote that such requirements flout the Supreme Court’s case law, which “makes clear that the standard for proving disparate treatment under Title VII does not vary based on whether or not the plaintiff is a member of a majority group.”
    • “The court vacated and remanded the case to the 6th Circuit for further proceedings.”
  • Federal News Network interviews Tammy Flanagan about “what retiring feds need to know about their benefits in transition.”
    • “Timing is everything when thinking about when to drop your retirement paperwork. Understanding what happens to your leave balances, health insurance, and survivor benefits can inform that decision. Hear with more on those key considerations is the Founder and Principal Retirement specialist at Retire Federal, Tammy Flanagan.”

From the public health and medical research front,

  • The University of Minnesota’s CIDRAP informs us,
    • “A new gene-tracking study in Nature shows that mpox spread among people in Nigeria for 8 years before it sparked a global outbreak in 2022.
    • “Using genomic tracing, researchers from Nigeria, the United States, Cameroon, Ethiopia, and Belgium estimate that the ancestor of the clade 2 mpox virus (mpxv) that ignited an international outbreak beginning in May 2022 first emerged in southern Nigeria in August 2014 and spread to 11 Nigerian states before human infections were detected in 2017. 
    • “In light of the findings, the authors write, “We need improved surveillance in the wildlife population in the forest systems to better understand the transmission and maintenance of MPXV in animal hosts,” as well as better human surveillance.
    • “We could have very easily prevented the 2022 multi-country outbreak if countries in Africa were given better access to therapeutics, vaccines, and surveillance technologies,” says first author Edyth Parker, PhD, MPhil, a researcher with the Institute of Genomics and Global Health and with the International Biosecurity and Biosafety Initiative for Science, in a Scripps Research news release. “In a vulnerably connected world, we cannot neglect epidemics until they get exported to the Global North.”
  • Medscape offers these reports from the recent American College of Obstetricians and Gynecologists (ACOG) 2025 Annual Meeting.
    • Changing the prescribing protocol for low-dose aspirin (LDA) for preeclampsia prevention from risk-based to universal significantly increased aspirin use in pregnant patients, based on new data presented at the American College of Obstetricians and Gynecologists (ACOG) 2025 Annual Meeting.
    • The use of LDA to reduce the risk for preeclampsia has been well established as an inexpensive and simple intervention, but it has remained underutilized nationwide, said lead author Meryl Y. Grimaldi, MD, of SBH Health System, New York City, in an interview.
    • “Many of the patients we care for at SBH Health are at high risk for preeclampsia, but we wanted to ensure that our eligible patients received the benefits of this intervention,” said Grimaldi, who presented the study at the meeting.
  • and
    • “Clinicians need to discuss and offer all patients a variety of pain management options for in-office gynecologic procedures ranging from intrauterine device (IUD) insertion to biopsies, according to new guidance published by the American College of Obstetricians and Gynecologists (ACOG). The guidelines, published on May 15, are the first formal ones from ACOG to not only acknowledge the range of pain experiences that can be associated with different procedures but also to explicitly lay out recommendations for the conversations providers should have with their patients about what pain management options are available.
    • “This guidance speaks to more than just Ob/Gyns,” Co-Author Genevieve Hofmann, DNP, women’s health nurse practitioner and assistant professor of Ob/Gyn at the University of Colorado School of Medicine in Aurora, Colorado, said during a discussion with the press on May 17 at American College of Obstetricians and Gynecologists (ACOG) Annual Meeting in Minneapolis. “It speaks to any physician who’s providing these types of services and certainly to advanced practice registered nurses who work in women’s health and provide these services.”
  • Medscape adds,
    • Regeneron said on Monday [June 2, 2025,] its experimental drug helped patients preserve up to 51% of lean mass and lose more fat when used in combination with Novo Nordisk’s popular obesity drug Wegovy in a mid-stage trial. 
    • In the 599-patient study, those on Wegovy alone lost about 7.9 pounds of muscle, while those on a combination of Regeneron’s trevogrumab and Wegovy lost up to 4.2 pounds. 
    • The combination helped patients shed up to 11.3% of their body weight compared with 10.4% for those on only Wegovy. 
    • The results mark an early win for Regeneron in the race against nearly a dozen companies to develop obesity treatments that preserve muscle, as they vie for a share of the potential $150 billion weight-loss drug market. 

From the U.S. healthcare business front,

  • Medical Economics “spoke with Mark McClellan, M.D., Ph.D., director, Duke-Margolis Institute for Health Policy, and a former administrator at CMS, about why value-based care hasn’t been adopted more quickly.” and let us know that “New Marit Health data from May, 2025, reveal that physicians feel most satisfied where compensation aligns with cost of living, practice expectations and quality of life. These 10 states show that perceived fairness matters just as much as raw earnings.”
  • The Wall Street Journal reports,
    • Unexpected healthcare costs can arise in retirement, such as uncovered drugs, isolation and concierge care.
    • Medicare Part D may not cover all drugs, potentially leading to high out-of-pocket expenses for uncovered medications.
    • Retirees may face unexpected travel costs for medical care based on retirement location or feel compelled to pay for concierge medical care.
  • All PSHB plans and Most FEHB plans offer Medicare Part D plans which are integrated with the regular plan formulary, thereby reducing one of the Journal’s identified risks.
  • Per BioPharma Dive,
    • “Hiroyuki Okuzawa holds an enviable position. The veteran Daiichi Sankyo executive took over as the Japanese drugmaker’s new CEO two months ago and inherited a company whose cancer medicines have, over the past half-decade, won it three of the pharmaceutical industry’s largest licensing deals.
    • “One of those medicines, the antibody-drug conjugate Enhertu, again took the spotlight at the American Society of Clinical Oncology’s annual meeting here, showing potential to become part of standard therapy for the frontline treatment of advanced breast cancer. It did the same in 2022 and 2024.
    • “Okuzawa can point to Enhertu and four other antibody-drug conjugates Daiichi Sankyo’s developing with AstraZeneca and Merck & Co. as proof of the strength of its research laboratories. By 2030, the company plansto have these five “ADCs” approved across more than 30 tumor types, which would allow it to treat nearly 400,000 cancer patients each year.
    • “We’d like to become one of the most important players in oncology,” said Okuzawa, noting aspirations to crack the top 10 companies by cancer drug sales. “Our senior leaders are now talking about not only top 10, but maybe top 5. We’re very much confident in our ADCs.”
  • Per Fierce Healthcare,
    • Neuroscience technology company Brooklyn Health is using artificial intelligence to target a fundamental problem in neurology and psychiatry: the flawed approach to mental health outcomes measurement.
    • The startup aims to modernize mental health measurement and scoring in central nervous system (CNS) drug development, an area of CNS research that faces limitations in objectivity and standardization. 
    • “Clinical interviews, the standard for symptom assessment, are fundamentally unreliable and imprecise,” said Anzar Abbas, Ph.D., a neuroscientist and founder of Brooklyn Health, in an interview.
    • “Brooklyn’s platform uses AI and digital phenotyping methods it developed to evaluate the quality and scoring of clinical interviews in real time.” * * *
    • “Brooklyn’s current focus in on drug development and central nervous system clinical trials to improve outcome measurement, essentially, how well a drug is working. But the company has ambitions beyond clinical trials to support outcome measurement across all forms of behavioral health delivery, including in-clinic psychiatric care and virtual mental health platforms.” 
  • The Washington Post reports on a smartphone app Death Clock AI that predicts how many years a user has left before beginning to push daisies as they day.