Simplicity is a virtue.
From Washington, DC,
- The American Hospital Association News reports,
- “The departments of Health and Human Services, Labor and the Treasury [and the Office of Personnel Management] issued a final rule May 28 intended to improve the functioning of the No Surprises Act (NSA) independent dispute resolution process. The rule streamlines communication between payers, providers and certified IDR entities and clarifies timelines and processes. It improves the functionality of the IDR process by finalizing various changes, including allowing up to 50 items and services to be batched in the same payment dispute. The final rule also increases access to the IDR process by reducing the administrative fees associated with it. The AHA supported many of these changes in comments on the proposed rule.”
- Here are links to the CMS fact sheet and a Beckers Payer Issues article on the final rule
- The rule decreases the federal government fee for handling an NSA arbitration from $115 per party to $15 per party. The FEHBlog expects the arbitrators’ fees to increase accordingly over time. No good deed, etc.
- The FEHBlog also expected the final rule to include an administrative remedy that would allow providers and payers to enforce or challenge arbitration awards.
- The FEHBlog agrees with AHIP’s comments on the final rule.
- “While the focus on addressing flawed incentives in the IDR process is a significant first step, more action is needed to protect Americans from unconscionable price gouging by some PE-backed providers and IDR middlemen.” – Chris Bond, AHIP spokesman”
- Tammy Flanagan, writing in Govexec, discusses “[w]hat retiring feds should do before asking for help.
- “Clear timelines, complete records and focused questions can make retirement problems easier to resolve, especially as agencies face mounting workloads.”
- Federal News Network tells us,
- “The Postal Service is putting immediate restrictions on nonessential spending to avoid running out of cash sooner than expected.
- “Postmaster General David Steiner wrote in a memo Tuesday that the restrictions will impact hiring, travel and training as well as other areas of spending. Departments within USPS may be asked to provide a summary of “cost-containment actions taken and expected savings.”
- “Steiner told members of the House Oversight Committee in March that USPS will run out of cash in early 2027, as long as it continues to pay its bills on time. But USPS is relying on some emergency measures to conserve cash.
- “As you are aware, we are currently experiencing a temporary cash-flow shortage that requires us to take decisive steps to manage our available resources responsibly,” Steiner wrote in the memo. “To protect core operations and ensure that we can continue meeting all essential obligations, we are implementing immediate restrictions on non-essential spending across all departments.”
From the Food and Drug Administration front,
- MedPage Today reports,
- “The FDA’s vaccine advisors voted 8 to 0, with one abstention, in favor of a monovalent XFG vaccine for COVID-19 shots for the 2026-2027 season.
- “The Vaccines and Related Biological Products Advisory Committee (VRBPAC) also discussed the need to target the long-simmering BA.3.2 variant, also known as “cicada,” though most expressed confidence that targeting XFG was the right way to go.
- “The XFG variant is the most common variant in the U.S. right now, and looking at the other JN.1 variants that may be coming up, I still think that the BA.3.2 variant is not as common. I think we have to keep surveillance very vigilant though,” said Anna Durbin, MD, of Johns Hopkins Bloomberg School of Public Health in Baltimore, adding that the “immunogenicity of the vaccines looks good, so I was very comfortable voting yes.”
- Fierce Pharma relates,
- “AstraZeneca has fired another volley in its bladder cancer competition with Merck’s Keytruda, with the FDA on Thursday clearing its PD-L1 inhibitor Imfinzi as part of the first immunotherapy combo regimen in patients with high-risk non-muscle-invasive bladder cancer (NMIBC) who haven’t previously received standard of care Bacillus Calmette-Guérin (BCG) treatment.
- “The green light clears Imfinzi in the indication alongside BCG induction and maintenance therapy, AZ said in a May 28 release.
- “This marks the second recent bladder cancer nod for Imfinzi, which was approved in March of last year in muscle invasive bladder cancer (MIBC), in that instance in combination with the chemotherapies gemcitabine and cisplatin ahead of bladder-removing surgery and then on its own following the procedure.”
- and
- “As AbbVie continues to capitalize on its ImmunoGen deal, the growth of commercial antibody-drug conjugate (ADC) Elahere, another of the acquired company’s clinical assets has crossed the FDA finish line.
- “The FDA on Wednesday announced the approval of AbbVie’s CD123-direct ADC pivekimab sunirine-pvzy, which will hit the market under the Decnupaz moniker, as a treatment for adults with the rare blood cancer blastic plasmacytoid dendritic cell neoplasm (BPDCN).
- “The condition is a rare and aggressive cancer of the bone marrow and blood that can also affect organs like the lymph nodes, spleen and skin. Most patients with BPDCN present with purple-colored skin lesions and the malignancy is often diagnosed in more men than women, with most patients aged 60 years and older.”
- Health Exec tells us,
- “The U.S. Food and Drug Administration (FDA) said it’s aware of an issue with IV tubes, where black matter has been found within the walls of the plastic walls, signaling a contamination issue.
- “ICU Medical said samples containing the particulates are being returned for analysis to help identify the problem. Until then, the devices are being removed from use and distribution.
- “Typically sterile, these tubes are used to connect medication and fluid bags to patients, as administered through an IV line.
- “ICU Medical and the FDA said in an announcement this could be a potentially high-risk issue, though there was no mention of patient injuries. The FDA described the notice as an early alert regarding a potential safety issue.”
From the judicial front,
- Modern Healthcare reports,
- “Clover Health won a lawsuit [in the U.S. District Court for the Southern District of Georgia] challenging its 2026 Medicare Advantage star ratings.
- “A federal court ruled that 20 quality measures the Centers for Medicare and Medicaid Services used are improper.
- “The decision could have industrywide implications because CMS rated all Medicare Advantage insurers on those metrics.
- “CMS filed a motion to reconsider the ruling.
From the public health and medical / Rx research front,
- The American Hospital Association News reports,
- “The Centers for Disease Control and Prevention today released a report highlighting data on patients hospitalized during a 2025 measles outbreak centered in West Texas. There were 762 confirmed cases during the outbreak, which lasted from late January through mid-August 2025. The report found that of the 60 hospitalized patients, nearly 91% were children and adolescents under age 18 and nearly 56% were age 4 or younger. Additionally, 4 out of 5 hospitalized adults age 18-44 were pregnant women in their third trimester. Available medical records of 54 patients were reviewed. All 54 were found to be unvaccinated or had an unknown vaccination status.”
- Healio relates,
- “Measures of ideal heart health including healthy levels of physical activity, BMI, BP and sleep were associated with lower risk for severe COVID-19 among people with no history of heart disease during the pandemic, researchers reported.
- “For every 1 standard deviation increase in total American Heart Association’s Life’s Essential 8 score, individuals without prior CVD experienced an approximately 20% reduced risk for severe COVID-19 infection, according to data published in the Journal of the American Heart Association.”
- Health Day adds,
- “Being incredibly fit shouldn’t increase a young adult’s risk of dangerous irregular heart rhythm, a new study says.
- “Young male athletes and fitness buffs aren’t more likely to develop atrial fibrillation, despite earlier studies that showed an apparent link, researchers reported May 21 in the journal Circulation.
- “Our study shows that there are good reasons to nuance and tone down the message, which has been widespread at times, that high levels of fitness or participating in races would pose a big risk to a person’s cardiovascular health,” said lead investigator Marcel Ballin, an associated researcher at Uppsala University in Sweden.
- “The risk of atrial fibrillation is certainly not zero, but that said, the benefits are significantly greater,” he said in a news release.”
- and
- “Adopting low-insulinemic and planetary health diets during menopause is associated with optimized weight management, according to a study published online May 20 in JAMA Network Open.
- “Tong Xia, M.D., Ph.D., from Brigham and Women’s Hospital in Boston, and colleagues compared dietary patterns and their associations with weight gain and obesity risk in the years surrounding menopause. The analysis included 38,283 women participating in the Nurses’ Health Study II, with 12-year observations surrounding menopause.
- “The researchers found that after adjusting for age, race and ethnicity, marital status, income, postmenopausal hormone therapy use, parity, smoking, alcohol, energy intake, physical activity, and baseline body mass index, the reverse empirical dietary index for hyperinsulinemia (EDIH; quintile 5 versus 1) was associated with the largest reduction in weight gain (mean, −0.28 kg/year). The lowest risk for incident obesity was seen with the Planetary Health Diet Index (PHDI; hazard ratio, 0.46) and reverse EDIH (hazard ratio, 0.51). The largest positive correlations in the EDIH were seen with red or processed meats, sodium, and French fries, while for the PHDI, the largest positive correlations were seen with nuts, unsaturated fats, whole-grain carbohydrates, and vegetable protein.”
- The Washington Post informs us,
- Ozempic was supposed to be a gut story. Then Allison Shapiro looked at the brain scans.
- An assistant professor at the University of Colorado Anschutz, she was part of a team studying 13 teens and young women with a hormonal disorder affecting the ovaries who were put on GLP-1 drugs. As part of testing to catalogue the effect of the medication on their bodies, Shapiro took snapshots of their brains before and after.
- She was astonished to find extensive changes.
- Within only a few months, the brain connections in the salience network, which helps target attention, had multiplied.
- “We didn’t expect to see this effect, and we really don’t know what it means,” Shapiro said.”
- BioPharma Dive tells us,
- “An RNA-based shot developed by GSK and Ionis Pharmaceuticals helped wipe out hepatitis B in about a fifth of the patients who received it in a pair of clinical trials, according to study results published Thursday in the New England Journal of Medicine.
- “Called bepirovirsen, the shot could represent an important advance for people with chronic hepatitis B infections, less than 1% of whom can achieve such a “functional cure” with the help of oral antivirals. None of the participants who received a placebo hit that mark in the two trials presented Thursday.
- ‘The Food and Drug Administration is already reviewing an approval application for bepirovirsen, and has granted the drug “fast track” and “breakthrough therapy” designations that could speed up its evaluation. An approval decision is expected no later than Oct. 26.”
- Genetic Engineering and BioTechnology News points out,
- “Biohub, the non-profit research organization co-founded by Priscilla Chan, MD, and Mark Zuckerberg, has now unveiled the latest update to the ESM protein language model family, with expanded capabilities in binder design and protein function mapping for therapeutic discovery. The release comes just seven months after Biohub recruited the team behind EvolutionaryScale.
- “The system includes ESMC (Evolutionary Scale Modeling Cambrian), a language model trained on approximately 2.8 billion sequences drawn from a breadth of life, including organisms adapted to extreme environments, and more than 20,000 types of proteins found in the human body. Evolutionary information encoded in ESMC is translated into atomic-resolution protein structures and interactions using the design engine and prediction model, ESMFold2.
- “Alex Rives, PhD, head of science at Biohub and former chief scientist at EvolutionaryScale, presented the work at this week’s “AI in Biology” symposium at Cold Spring Harbor Laboratory.
- “These models aim to transform the earliest stages of drug discovery by making biology more programmable. While traditional discovery workflows rely on slow and resource intensive experimental screens to identify promising drug candidates, rational protein design guided by in silico predictions has the potential to dramatically accelerate development timelines.
- “We’re at an exciting point in protein biology where accurate digital representations allow asking experimental questions at a scale that wouldn’t be possible in the laboratory,” Rives told GEN Edge.”
From the U.S. healthcare business front,
- Modern Healthcare reports,
- “Highmark Health recovered in the first quarter after reporting losses last year, the health system and insurer announced Thursday.
- “The Pittsburgh-based nonprofit company reported a 1,308% jump in first-quarter net income to $183 million and a 1,340% improvement in operating income to $216 million. Revenues grew 3.8% to $8.3 billion. Highmark Health lost $175 million in 2025.
- “Highmark Health Plans’ strategic adjustments in Medicare and Medicaid drove the rebound, Highmark Health Chief Financial Officer and Treasurer Carl Daley said.”
- Fierce Pharma relates
- “The top pharmacy benefit manager (PBM) in the U.S., CVS Caremark, will restore coverage to obesity products from Eli Lilly, allowing a significant number of patients to gain access to the drugs through their existing insurance.
- “CVS will begin covering Lilly’s GLP-1 pill Foundayo on Monday of next week, June 1, while coverage of Lilly’s injected treatment Zepbound begins on October 1. CVS Caremark, which is the pharmacy chain’s drug benefits unit, is the largest PBM in the country.”
- and
- “CVS Health is growing its partnership with Salesforce, leveraging its agentic AI-driven Agentforce Health to boost personalization in its call centers.
- “The companies announced on Thursday morning that the platform will connect data across CVS, including Aetna and Caremark, to make it easier for call center teams to address a member’s unique needs in a single interaction when possible.
- “The Agentforce tool will surface critical insights to call center teams in advance, preparing them more effectively for conversations. The goal, the partners said, is to improve the experience for both the member and the workers through a more streamlined interaction.”
- OptumRx, writing in Linked In, discusses the four drug classes that drive spending.
- Inflamatory conditions drugs,
- Oncology drugs,
- Diabetes drugs, and
- Obestty Drugs.
- Beckers Payer Issues points out,
- “CVS Health’s insurance branch will roll out “Aetna Mental Health On Demand” in 2027, the company said in a May 28 news release.
- “Aetna members who are at least 13 years old will be able to access licensed clinicians via chat, phone or video. These professionals are trained on a “single-session intervention model” to drive immediate impact, such as through crisis management. Clinicians can provide a personalized plan, advocate for members, connect them with more resources and help with follow-ups and further care coordination.
- “The platform also contains integrated AI tools for note-taking and administrative tasks. Clinicians participated in hundreds of chats and were able to respond to members within 13 seconds, the news release said about an initial rollout.”
- Healthcare Dive tells us,
- “Teladoc Health said Thursday it is partnering with Walmart to add its virtual care services to the retail giant’s digital healthcare platform.
- “With the partnership, Teladoc’s virtual care offerings — including urgent care, dermatology and nutrition support — are now available through Walmart’s Better Care Services platform, which connects customers to third-party digital health providers.
- “The deal should put Teladoc’s services in front of more potential patients, Kelly Bliss, president of the company’s U.S. group health business, told Healthcare Dive. “We have the largest nationwide network of virtual care providers in the country, and so we want to activate that network and our clinical services wherever people are making health decisions,” she said.”
- and
- “Amazon’s healthcare leader is stepping down from this summer, and the co-founder of telehealth company Amwell will replace him, the retail and technology giant said Wednesday.
- “Neil Lindsay, who became senior vice president of Amazon Health Services in 2021, is leaving to pursue personal projects, he said in a message to Amazon employees.
- “Dr. Roy Schoenberg, the former co-CEO of Amwell who helped found the telehealth provider two decades ago, will start as new head of Amazon’s health business on July 1. Lindsay will stay on as an advisor to Schoenberg through the end of the year.”
- Per MedTech Dive.
- “Ōura plans to roll out a swath of health and wellness features in June, following the launch of its latest smart ring.
- “Among the new additions will be a tool to track nighttime blood pressure patterns and the ability to view nighttime breathing data over a 30-day period. Ōura announced the features, along with its Ōura Ring 5, on Thursday.
- “Jason Russell, vice president of consumer software product at Ōura, told MedTech Dive that the blood pressure feature is intended to show trends in overnight changes and the relationship to daily habits, such as sleep, stress and exercise.
- “Ōura plans to offer blood pressure signals as a wellness feature, meaning it would not be regulated as a medical device, but there are some limitations on what it can tell users.”
