
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.”