Simplicity is a virtue.

From Washington, DC,

• Beckers Hospital Review reports,
  • “In July, committees in the House and Senate advanced price transparency legislation that aims to expand disclosure requirements for hospitals, insurers and other healthcare providers.
  • “The Senate Committee on Health, Education, Labor and Pensions advanced the Patients Deserve Price Tags Act, which would implement new price transparency requirements for hospitals, insurers, laboratories, imaging providers and ASCs, while also expanding group health plans’ access to claims and reimbursement data held by insurers and PBMs.
  • “Starting in 2027, the bill would require hospitals to extend consumer-friendly price disclosures to every shoppable service they offer, eliminating the current cap that lets hospitals limit that disclosure to 300 services. A hospital CEO, CFO or similarly senior official would have to personally attest that pricing data is accurate — an attestation the bill treats as material to federal payment, which could raise False Claims Act exposure for errors. The bill would also eliminate online price-estimator tools as a standalone compliance option, add escalating daily penalties tied to bed count, and extend similar disclosure requirements to labs, imaging providers and hospital-affiliated ASCs by mid-2027. Providers would also be barred from pursuing collections when charges exceed a prior good-faith estimate, absent documented exceptions.
  • “The American Hospital Association opposed the bill, citing added administrative burden and objecting specifically to the removal of price-estimator tools as a compliance method and to a new ownership-disclosure requirement.
  • “Meanwhile, the House Energy and Commerce Committee advanced its own package, the Lower Costs, More Transparency Act. Starting in 2028, the bill would codify existing hospital shoppable-service and cash-price posting rules into law, require hospitals to publish facility identifiers and any ownership stake of 5% or more, and extend transparency mandates to freestanding ASCs, labs and imaging centers for the first time. It would also require insurers and group plans to publicly report prior authorization data — including denial rates, appeal-overturn rates and average decision times — and to disclose how premium dollars are split between claims, taxes and fees, and retained earnings, including at the Medicare Advantage plan level.
  • “The AHA said it supports giving patients clearer price information but warned that writing current requirements into law could limit CMS’ flexibility to refine them going forward.”

• Beckers Payer Issues relates,
  • “Enacting site-neutral payments under Medicare for imaging services would generate an estimated $9.7 billion in combined savings over 10 years, according to a new analysis commissioned by the Blue Cross Blue Shield Association.
  • “The report, prepared by external consulting groups and published Aug. 24, quantifies both the Medicare impact and the spillover effects on commercial insurance markets. In July, CMS proposedin its 2027 hospital outpatient prospective payment system rule to extend site-neutral payment policies to imaging services without contrast (X-rays and MRIs for example) to off-campus hospital outpatient departments. Under the proposal, payments would be reduced from the full OPPS rate to the physician fee schedule equivalent rate, or an estimated 60% reduction.
  • “If finalized, the BCBSA analysis estimates $7.2 billion in total Medicare savings from 2027 to 2036, with $5.3 billion going to the federal government and $1.9 billion in reduced beneficiary out-of-pocket costs. CMS itself estimated $260 million in combined savings in 2027 alone, split between $190 million in government savings and $70 million in beneficiary savings.
  • “In the commercial market, the analysis estimates $2.5 billion in total commercial savings over the 10-year period, broken down as $1.6 billion in employer premium contributions, $530 million in enrollee premium contributions and $300 million in member out-of-pocket savings.”

• Fierce Pharma informs us,
  • “RNA-based vaccines and therapeutics may have faced a bumpy road in the U.S. recently, but a major new federal investment proves the government is still betting big on its future.
  • “The Advanced Research Projects Agency for Health (ARPA-H) has narrowed down to five teams—a mix of biotechs and academic institutions—that will now receive up to $125 million in aggregate to help automate the production process for potential on-demand, personalized RNA-based medicines. 
  • “The new project falls under ARPA-H’s Genetic Medicines and Individualized Manufacturing for Everyone (GIVE) program, which it says aims to build out automated production and real-time quality control through a distributed network. The idea, according to the agency, is to enable manufacturing of treatments near the patients they serve, rather than keeping genetic medicines sequestered around “major biomanufacturing hubs.
  • “Manufacturing expenses and the logistical headaches associated with the actual administration of genetic medicines—such as gene therapies—have proven to be a limiting factor for the field’s uptake in the real world.”  

From the U.S. Office of Personnel Management front,

• Govexec reports,
  • “The Office of Personnel Management’s healthcare and insurance division, following recent staffing reductions, is getting new leadership ahead of its busy Open Season. 
  • “Matthew Kiley, a former Department of Health and Human Services official under the first Trump administration, will serve as the associate director of OPM’s healthcare and insurance division, starting Sept. 8, according to an internal memo obtained by Government Executive.
  • “A copy of Kiley’s resume shared with OPM employees and partially viewed by GovExec shows Kiley is the founder and former president of the Weyhill Group, a boutique management consulting firm in the greater Philadelphia area that serves clients in financial services, insurance and healthcare. 
  • “According to Kiley’s LinkedIn page, he also led the Office of Health Policy within HHS’ Office of the Assistant Secretary for Planning and Evaluation (ASPE) between November 2019 and and January 2021.”
•  Good luck, Mr. Kiley.

• Federal News Network tells us,
  • “Agencies have a few months left to survey their employees before the required end-of-year deadline — and for most, it will be their first time distributing the Federal Employee Viewpoint Survey on their own.
  • “The change comes in the wake of the Office of Personnel Management’s proposal to decentralize the governmentwide employee engagement survey, which OPM has run for more than 20 years. Starting this year, however, OPM intends to leave the survey creation and distribution to individual agencies.
  • “Agencies have flexibility in determining the approach, timing and methodology that best meets their needs, provided their survey addresses all required elements,” OPM wrote in a July guidance document.
  • “For some federal workforce experts, moving FEVS to an agency-specific survey has been a welcome change. The opportunity for agencies to now add in questions tailored specifically to their own workforces is “exactly how it should be,” said Sydney Heimbrock, public sector chief industry advisor at Qualtrics.”

From the Food and Drug Administration front,

• Pharmaceutical Technology reports,
  • “The US Food and Drug Administration (FDA) has continued its clampdown on the illegal trade of black-market peptides by issuing a string of warnings to online sellers, as non-approved drugs within this class generate a significant interest amongst the public on social media. 
  • “The five warning letters, which were issued to US-headquartered Peak Performance Peptides, Royal Peptides, NuScience Peptides, Peptide Partners and TXP Innovations LLC dba Tex Peptides, all detail violations in FDA regulations related to the sale of new peptide-based drugs, which remain unapproved and unregulated.  
  • “The FDA’s issues primarily centre around each company’s attempts to sell illicit weight loss products, with all five websites flagged in this crackdown advertising their own versions of Eli Lilly’s obesity candidate, retatrutide – a drug that is yet to secure approval within any global market. This comes a little after Lilly itself sounded the alarm on the drug’s burgeoning black market, which has begun to take off as some patients look to secure cheaper alternatives to branded weight loss medications.” 

• BioPharma Dive relates,
  • “After a year of ups and downs, UniQure on Wednesday said it’s submitted applications for what could become the first medication approved to treat the underlying cause of Huntington’s disease.
  • “The Dutch company is asking the Food and Drug Administration to give its AMT-130 gene therapy a priority review, which could result in a decision in about eight months. UniQure said it’s also completed a submission with U.K. regulators.
  • “UniQure based its applications on previously announced three-year data that showed AMT-130 could significantly slow signs of disease progression. It’s asking the FDA for an “accelerated approval,” which means it would have to later supply research confirming the product’s clinical benefits.”

From the fraud, waste and abuse front,

• Bloomberg Tax reports,
  • “The next phase of federal fraud enforcement is going to be data-driven. After using data mining and matching to uncover pandemic-relief fraud, the Justice Department and other agencies are expanding those tools to healthcare, foreign bribery, securities, consumer fraud, and public safety cases.
  • “This shift is significant and changes how investigations begin. The DOJ recently announced it is building the most sophisticated, innovative, and data-driven white-collar law enforcement component in the world, uniquely positioned to fight fraud at every level. This will include a cross-disciplinary team of experts in data science, and cutting-edge technology and resources.
  • “Rather than waiting for tips, audits, or referrals, the government will be using analytics, AI, cloud computing, and shared agency data to spot outliers and build cases earlier. For companies and individuals operating in data-rich regulatory environments, fraud risk may surface long before a subpoena arrives.”

• The HHS Office of Inspector General tells us,
  • “CMS oversight of Medicare Part D sponsors did not prevent payments to pharmacies for some OTC drugs sold under obsolete Rx-only labeling.
  • “Part D sponsors made payments for five drugs associated with obsolete Rx-only labeling more than 1 year after the brand-name drugs were switched to OTC use. For calendar years (CYs) 2021 through 2023, Part D sponsors made $587.7 million in ineligible payments associated with the five drugs.
  • “The ineligible payments occurred because CMS: (1) updated its Part D Formulary Reference File using obsolete FDA data on Rx-only drugs and (2) did not set a timeframe for Part D sponsors to reject payments for OTC drugs sold under obsolete Rx-only labeling.
  • “Before we issued our draft report, FDA issued a policy in December 2025 requiring generic drug manufacturers to update their labeling “at the earliest time possible and within 6 months” after FDA approves an associated brand-name drug’s switch from Rx-only to OTC use.
  • “We recommend that CMS issue guidance on timeframes for Part D sponsors to reject payments for OTC drugs sold under obsolete Rx-only labeling after an Rx-to-OTC switch. This step could have helped to prevent $587.7 million in ineligible payments for CYs 2021 through 2023.
  • “CMS concurred with our recommendation.”

No Surprises Act News

• Beckers Hospital Review reports,
  • “The House Ways and Means Committee is working on an overhaul of the No Surprises Act and a markup could happen in September, Punchbowl News reported Aug. 19. 
  • “Congress passed legislation creating the No Surprises Act in 2020, but critics say the law’s independent dispute resolution process has produced inflated reimbursement awards, raising concerns about rising healthcare costs. 
  • “The emerging proposal would combine Rep. Greg Murphy’s bill penalizing insurers that miss payment deadlines with new provisions aimed at curbing ineligible provider claims, according to the report. For revenue cycle teams, that’s a potential two-way street: faster insurer payment on IDR-eligible claims, but stricter eligibility standards before a claim can enter the process in the first place.
  • “The Senate HELP Committee is also planning a roundtable on the No Surprises Act this fall, according to the report.” 

• Beckers ACS Review informs us,
  • “New federal data shows the independent dispute resolution process created under the No Surprises Act is being used more than ever. Total federal IDR disputes rose from 653,445 in Q3 of 2025 to 719,118 in Q4 of 2025 — a roughly 10% jump. 
  • “One state is driving an outsize share. According to CMS’ IDR Supplemental Tables for Q3 and Q4 2025, Texas generated more arbitration disputes than the next nine states combined.”

• Modern Healthcare shares information about the federal IDR dispute arbitrators.
  • “Arbitrators rule for providers at varying rates. Some back providers as much as 98% of the time, while others approach an even split in the fourth quarter of 2025, according to Georgetown University research published in the journal Health Affairs Forefront last month.
  • “Island Peer Review Organization, Provider Resources, EdiPhy Advisors, MCMC Services and Maximus Federal Services side with providers more than 90% of the time, while Medical Evaluators of Texas and ProPeer Resources pick providers’ bids less than 60% of the time, according to an analysis of Centers for Medicare and Medicaid Services data from the second half of 2025 by Elevance Health Vice President of Health Economics Ariel Bayewitz. * * *
  • “The sway arbitrators hold underscores their significance and why the industry needs greater transparency, said Erin Duffy, managing director of the University of Southern California Schaeffer Institute for Public Policy and Government Service. “There’s so much opacity right now,” she said.” * * *
  • “Each time an arbitrator determines a dispute is eligible and then makes a ruling, it collects a fee. If providers and insurers cannot mutually agree on an arbitrator, one is randomly assigned. 
  • “Fee amounts are decided at an arbitrator’s discretion. Island Peer Review Organization, EdiPhy Advisors and Livanta charge the most, according to a Modern Healthcare analysis of CMS data.
  • “Since the federal system has seen millions of more disputes than expected, arbitrators have received exponentially larger payouts than anticipated.”

From the public health and medical / Rx research front,

• STAT News reports,
  • “Professional organizations representing pediatricians, family physicians, obstetricians, and other medical professionals jointly released guidelines Wednesday for who should get vaccines aimed at staving off influenza, Covid-19, and respiratory syncytial virus, or RSV, this coming winter.
  • “The combined effort, undertaken in conjunction with the University of Minnesota’s Vaccine Integrity Project, has two goals: to help medical professionals guide their patients, and to help individuals plan to get the vaccinations that should help them either evade these ailments, or minimize their risks of severe illness if they do become infected.” * * *
  • “A spokesperson for the CDC confirmed Wednesday that this respiratory season, flu and Covid vaccines, as well as monoclonal antibodies given to babies to protect them against RSV, will continue to be provided under the federal government’s Vaccines for Children program, which supplies free vaccines for roughly half of the nation’s children.” * * *
  • “Papers outlining the rationale for the various vaccination recommendations were published Wednesday in the Journal of the American Medical Association, JAMA, and an interactive tool to help doctors and the public review the science behind the decisions will be posted on the Vaccine Integrity Project’s website.”
     
• Beckers Clinical Leadership adds,
  • “The American Academy of Pediatrics reaffirmed its recommendation that young and high-risk children receive COVID-19 vaccines and expanded the list of high-risk children it advises to receive respiratory syncytial virus immunization for a second season.
  • “The recommendations, published Sept. 2, come amid upheaval among federal health officials. About three weeks ago, President Donald Trump directed HHS to assess a reduced immunization schedule for children.
  • “COVID-19 vaccines and the respiratory syncytial virus (RSV) products are expected to remain covered under private insurance and the Vaccines for Children program.”
• and
  • “More parents are declining hepatitis B vaccination and vitamin K prophylaxis for infants, and female infants are less likely than males to receive either, according to a research letter published Aug. 31 in JAMA. 
  • “Researchers at Children’s Hospital of Philadelphia and University of Pennsylvania, also in Philadelphia, set out to determine whether a infant’s sex was associated with a parent’s acceptance of vitamin K prophylaxis and hepatitis B vaccines. 
  • “The retrospective study analyzed live births from January 2018 to December 2025 at three University of Pennsylvania hospitals. Across 93,163 infants, 777 — or 8.3 infants per 1,000 births — did not receive vitamin K prophylaxis. For all infants, the rate of vitamin K prophylaxis declines doubled between 2018 and 2025. 
  • “A larger number, 9,400, did not receive the hepatitis B vaccine, according to the study. The rate equals 100.9 infants per 1,000 births. Parental declines increased between 2018 and 2025. 
  • “Compared to infant males, infant females were less likely to receive either the vitamin K or hepatitis B vaccine, the researchers found.”

• Yesterday, the CDC offered recommendations for seasonal flu vaccinations.
  • Because of legal uncertainties and inquiries, the CDC states the recommendations for seasonal influenza vaccination from the July 2025 immunization schedule remain in effect for the 2026-2027 influenza season.

• Health Day tells us,
  • “Low T” is a trendy health topic, with aging men sold testosterone as a veritable Fountain of Youth.
  • “But too much testosterone can also pose a risk to heart health, a new evidence review says.
  • “Men with low testosterone or high testosterone levels both have a higher risk of atrial fibrillation, a heart health disorder that increases risk of stroke, researchers report in the Journal of the Endocrine Society.
  • “Both too little and too much testosterone appear to raise the risk of atrial fibrillation, through separate biological mechanisms, which means the dose and the target level matter,” said senior researcher Dr. Rajat Barua in a news release. He is a cardiologist at the Kansas City Veterans Affairs Medical Center in Kansas City, Missouri.”
• and
  • “There’s been a shocking increase in the number of kids who’ve accidentally eaten recreational drugs left around by adults, a new study says.
  • “The rate of accidental ingestions of recreational drugs among children younger than age 6 increased by more than 3,300% between 2000 and 2024, researchers report in the journal BMC Public Health. 
  • “Weed accounted for 85% of these reported ingestions, with edibles representing about half of all ingestions, researchers found.
  • “The recreational drug ingestion rate among children younger than 6 years reported to United States poison centers increased substantially over the study period, with increases especially pronounced for edible marijuana and psilocybin products,” said senior researcher Dr. Gary Smith in a news release. He is director of the Center for Injury Research and Policy at Nationwide Children’s Hospital in Columbus, Ohio.”
• and
  • “Lower predicted prevalences of birth defects are seen in association with periconception parental vitamin B₁₂ and postconception maternal red blood cell (RBC) folate, according to a study published online Sept. 1 in the Annals of Internal Medicine.”

• Per a National Institutes of Health news release,
  • “A National Institutes of Health (NIH)-funded study has shown that the GLP-1 drug semaglutide extended lifespan in older, healthy mice by tempering the detrimental effects of aging. Researchers at the University of California, Berkeley directly compared the effects of the treatment to those of reduced food intake. They found that the drug mimicked the anti-aging benefits of calorie restriction, conferring even greater benefits in some areas.
  • “While GLP-1s have been found to delay the onset of many age-related diseases in animals, this new study in healthy older mice offers evidence that these drugs may slow physiological aging itself, a notion that could potentially tie the widespread benefits of GLP-1s to a common source.
  • “Most chronic diseases are deeply rooted in the aging process. If GLP-1 agonists do indeed slow it down, then a wide range of clinical benefits is exactly what you’d expect to see,” said Rafael de Cabo, Ph.D., a senior investigator at the NIH’s National Institute on Aging (NIA), and author of a commentary on the new study.”

• Beckers Hospital Review points out,
  • “More than a dozen experimental obesity drugs are working their way through clinical trials, and the last year has reshuffled the leaderboard: some candidates have advanced into pivotal phase 3 studies, others have won approval overseas and at least one program has been abandoned. 
  • “[The article includes] a status check on 13 of the most closely watched drugs.

• MedPage Today notes,
  • “In a cohort study of men with nonmetastatic prostate cancer, the highest level of post-diagnosis saturated fat consumption was associated with greater all-cause mortality compared with the lowest level.
  • “This increased risk of all-cause mortality was likely due to deaths from cardiovascular disease.
  • “There was no association between consumption of dietary fats and prostate cancer mortality.”

• Per STAT News
  • “The biotech company Ultragenyx said Wednesday that its experimental therapy for Angelman syndrome, a rare disease that causes severe intellectual disabilities and developmental delays, showed no benefit compared to a sham treatment in a large Phase 3 trial. 
  • “The drug, GTX-102, had shown powerful results in early trials, raising the hopes of families affected by the devastating condition. Many advocates for patients with other neurological conditions also hoped it could be the first of many medicines that improve cognition, communication, and other aspects of the lives of patients with intellectual disabilities.
  • “The news is a significant blow for Ultragenyx’s business as well. Although the company has multiple approved medicines, they are for mostly ultra-rare diseases, and investors had been banking on the Angelman drug as the company’s path to profitability.”

From the U.S. healthcare business and artificial intelligence front,

• The New York Times reports,
  • Large and small employers are bracing for what looks to be the sharpest increase in health care costs in more than two decades. The cost per worker is projected to go up an average of 11 percent next year, or somewhat lower if workers’ insurance benefits are reduced, according to a U.S. survey released Wednesday.
  • “The employers’ final costs, after they make changes to health plans, are still expected to increase about 8 percent next year, the steepest since 2003, according to Marsh, the benefits consultant formerly known as Mercer.
  • “More than a third of the 1,800 employers surveyed said they anticipated that costs would rise at least 10 percent after making cuts.” * * *
  • “The Marsh survey is the latest report by an employer group or benefit consultant predicting a sharp rise in health care costs next year. Many Americans, even those with insurance, are already struggling to afford care, according to various surveys, and health care has become a top issue for voters.
  • “This seems to be a new normal,” said Ellen Kelsay, the chief executive of Business Group on Health, which represents large employers that offer health benefits.”

• Beckers Hospital Review adds,
  • “Hospitals are seeing more self-pay patients as coverage losses mount across both the ACA and Medicaid markets.
  • “In a study published Aug. 31, Epic Research found self-pay visits are increasing across hospital settings as Medicaid enrollment has fallen across the country following the expiration of continuous enrollment protections in place during the pandemic. 
  • “Epic’s research looked at more than 550 million U.S. healthcare encounters between the first quarter of 2022 and the second quarter of 2026 and found that self-pay visits are increasing the most in emergency departments, climbing from 5.5% to 7.6% during the period. Across the same timeframe, self-pay inpatient admissions rose from 1.9% to 2.6%, births from 0.8% to 1.3% and primary care from 1.8% to 1.9%.”
• and
  • “New Hyde Park, N.Y.-based Northwell Health recorded operating income of $76.1 million (1.4% margin) in the second quarter of 2026, down from $100.3 million (2% margin) in the same quarter last year, according to its Aug. 31 financial report.” 

• Healthcare Dive relates,
  • “Johns Hopkins Health Plans is elevating its finance leader to interim CEO while the Baltimore-area managed care company looks for a permanent successor for its previous chief executive, who left to join a rival insurer last month.
  • “Placing Daniel Chojnowski in the interim position will provide stability as JHHP recruits for its next CEO, the insurer said in a Tuesday post on LinkedIn. James Holland, JHHP’s former chief executive, served in the role for seven years before leaving to lead Humana’s Medicaid division in August.
  • “Chojnowski “embodies the modern CFO, which has evolved from the number-crunching budget guard to a strategic partner, helping to steer organizational decisions,” JHHP said.”

• Tech Target tells us,
  • “Since 1936, Nemours Children’s Health has provided pediatric healthcare, research and education to children and families. Today, Nemours has more than 70 specialty, primary and urgent care facilities in Delaware, Florida, Pennsylvania and New Jersey. It is reimagining how to deliver pediatric healthcare for better health outcomes, with the belief that nearly 80% of what affects a child’s health occurs in their home, school and community.
  • “As hospitals and healthcare organizations across the U.S. face rising costs, staffing pressures and demand for capacity, hospital-at-home programs are evolving into enterprise-scale distributed care models. That shift requires healthcare providers to coordinate remote monitoring, clinical workflows, escalation processes, scheduling and patient engagement across integrated technology platforms. Nemours Children’s approached Advanced Care at Home (ACaH) not as a standalone telehealth initiative, but as a coordinated care delivery model integrated into enterprise workflows, operational oversight and its existing Epic electronic health record (EHR) infrastructure.
  • “For Nemours, hospital-at-home became less of a telehealth service and more of a distributed operating model requiring centralized workflow coordination, operational accountability and enterprise-wide visibility.
  • “Through its ACaH program, Nemours Children’s extends certain pediatric care, monitoring and recovery services into patients’ homes through remote monitoring, virtual visits, care coordination and integrated clinical workflows.”
    
• Fierce Healthcare informs us,
  • “Thyme Care landed a series E financing round of more than $125 million backed by strategic payers and providers as it aims to expand beyond cancer care navigation.
  • “The fresh financing will fuel the company’s continued growth and establish a new parent organization, Thyme Companies, that aims to build a broader portfolio of businesses to address broader cancer care challenges.
  • “JPMorgan’s Morgan Health led the series E round, with participation from strategic investors including Humana and CVS Health Ventures, valuing the oncology-focused company at more than $2 billion. Institutional investors AlleyCorp, HealthQuest Capital, Foresite Capital, Concord Health Partners, Frist Cressey Ventures, Town Hall Ventures and a16z Bio + Health also backed the round.”

• Per MedTech Dive,
  • “Medtronic said it will invest about $700 million in a partnership with Cornerstone Robotics that includes rights to distribute the Hong Kong-based company’s soft tissue surgical robot in China, Singapore and Europe.
  • “Cornerstone developed its Sentire robotic system in-house and won Europe’s CE mark in May for its use in general surgery and gynecologic, thoracic and urologic procedures. The robot is also approved in China and Singapore.
  • “Distributing Cornerstone’s Sentire robot alongside Medtronic’s Hugo system will expand access to robotic surgery and give surgeons and health systems more choice, Medtronic said. “It’s a global play for us. It’s one of a number of investments we’re making in soft tissue,” Medtronic CEO Geoff Martha told investors on the company’s earnings call Tuesday.”
• and
  • “Stryker said Monday it has agreed to acquire ZuriMED, a company making a device to treat rotator cuff tears. The companies did not share the terms of the deal.
  • “Zurich, Switzerland-based ZuriMED makes a system for rotator cuff augmentation, a procedure where a patch is applied to a torn rotator cuff to support healing and prevent the tissue from re-tearing. 
  • “Stryker expects the acquisition to strengthen its rotator cuff portfolio and support shoulder specialists in sports medicine and arthroplasty.”