Simplicity is a virtue.

From Washington, DC,

• Modern Healthcare reports.
  • “Congress extended most annually funded healthcare programs through December, setting a likely end-of-year deadline for action.
  • “Lawmakers will have to decide which stalled health initiatives, from prior-authorization rules to transparency measures, would advance alongside must-pass extensions.
  • “Anti-fraud proposals could provide budgetary offsets to fund more expensive measures like a new Medicare physician payment system.”

• Beckers Hospital Review relates,
  • “The Trump administration says it will mail $500 checks to nearly one million Americans in 30 states to refund what it called “overcharges” from ACA exchange fees collected under the Biden administration.
  • “On Sept. 10, the White House said insurers that sell plans on the federal exchange pay user fees to fund the platform’s operations, and that those fees generated a surplus that was never returned to consumers. The refunds, which are set to go out starting in October, will be provided to enrollees who did not receive premium tax credit assistance and paid the full cost of their premiums.” 

• Per a Department of Health and Human Services news release,
  • “The U.S. Department of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA), today announced awards to 132 hospitals totaling nearly $25 million through the Rural Hospital Provider Assistance Program to help eligible small rural hospitals maintain their medical workforce, sustain essential healthcare services, and strengthen access to care for the communities they serve across 13 states.” * * *
  • “Awarded hospitals may use this funding to retain physicians, nurses, and other healthcare providers, allowing hospitals to preserve essential services, including emergency, inpatient, and other critical healthcare services. This support helps ensure rural communities can continue to access affordable care when and where they need it.
  • “A complete list of award recipients and more information about the program is available at Rural Hospital Provider Support Program FY 2026 Grant Awards.”

• Per a Centers for Medicare and Medicaid Services news release,
  • “The Trump Administration announced today that an $11.7 million investment is being delivered to support rural nursing care facilities and strengthen the healthcare workforce across rural communities in Vermont through the federal Rural Health Transformation Program (RHTP). Of this, Vermont is committing $9 million of those funds to provide tuition benefits to healthcare professionals in underserved or hard-to-fill positions who commit to serving rural communities within the state for at least five years after graduation. The remaining $2.7 million provides funding for three rural nursing homes to increase their capacity to serve residents with complex medical issues and four community partners to increase training of Licensed Nursing Assistants (LNA) to serve in rural healthcare and long-term care settings across the state.”
    
• Cardiovascular Business relates,
  • “On Thursday, Sept. 10, CMS officially finalized a new national coverage determination (NCD) for TAVR. Arguably the biggest change is that TAVR will now be covered in Medicare beneficiaries who present with asymptomatic severe aortic stenosis (AS). The treatment of asymptomatic patients has been a hot topic in recent years. Some specialists see it as a way to treat patients early and avoid long-term damage. Others disagree, preferring to save TAVR for patients who present with symptoms. 
  • “Another key update is that Medicare beneficiaries with symptomatic severe AS is now covered without any sort of coverage with evidence development (CED) requirements. The TAVR NCD has always required facilities performing TAVR to follow certain CED rules that require patient data to be collected through clinical trials or registries. This is no longer the case when it comes to performing TAVR on symptomatic patients. 
  • “Five leading U.S. medical societies—the American Association for Thoracic Surgery, American College of Cardiology, Heart Failure Society of America, Society for Cardiovascular Angiography and Interventions and Society of Thoracic Surgeons—did work together to argue that CED requirements should still be in place, but CMS still moved forward with that particular proposal. 
  • “It is worth noting, however, that CED requirements are still in place when it comes to performing TAVR on asymptomatic patients.”

• The American Hospital Association News tells us,
  • “The National Institutes of Health has launched its Connecting the Community for Maternal Health Challenge: Research Capacity Building in Maternity Care Deserts 2.0. The competition will award more than $3 million to encourage and reward biomedical research in maternal health with an emphasis on maternal morbidity and mortality and maternal health deserts. The challenge consists of four phases: recruitment, training, proposal and research. The recruitment phase closes Sept. 23 and is required to be eligible for later phases. If selected, participants in each phase will be considered for awards ranging from $10,000 to $300,000.”
• and
  • “The Federal Trade Commission announced Sept. 9 that it rescinded its 2021 policy statement that extended applicability of its health breach notification rule to health apps and connected devices that collect consumer health information. The commission said the 2021 statement was superseded by its 2024 update to the health breach notification rule. The FTC said the recission is part of the administration’s deregulation efforts and follows the commission’s policy of avoiding unnecessary use of subregulatory guidance.”

• Fierce Healthcare relates,
  • “Federal healthcare agencies are accelerating efforts to expand artificial intelligence’s role in healthcare, with clinical AI emerging as a top strategic priority for the Centers for Medicare & Medicaid Services.
  • “At a healthcare AI event hosted by the Consumer Technology Association (CTA) in Washington, D.C., on Wednesday, Stephanie Carlton, deputy administrator at CMS, outlined the agency’s evolving AI strategy as it aims to establish clearer pathways for AI market access and regulation while also exploring reimbursement frameworks for AI-enabled technologies.
  • “Carlton also serves as chief clinical AI officer at CMS, a newly created position that signals the Trump administration’s push to advance AI in clinical care.
  • “A centerpiece of CMS’ AI strategy is the ACCESS model—Advancing Chronic Care with Effective, Scalable Solutions. Carlton hinted that the agency would soon expand that model. Announced in December and launched in July, ACCESS is a new 10-year program for value-based chronic condition management that leans heavily on technology and AI to scale to large populations of patients.”

• Healthcare Dive tells us,
  • “The Department of Veterans Affairs has selected Amwell to facilitate telehealth delivery across the agency.  
  • “Amwell’s platform, which mainly offers virtual health visits, will help veterans connect with VA providers or other specialists in clinic. It will also support other telehealth services, such as virtual care delivery and care coordination within VA hospitals. 
  • “The VA signed a letter of intent to implement Amwell’s platform. A binding contract will depend on Amwell satisfying federal requirements, including a review by the VA’s chief information officer.”

• Per an Institute for Clincical and Economic Review news release,
  • “The Institute for Clinical and Economic Review (ICER) announced today that it will develop a special report for the Centers for Medicare & Medicaid Services (CMS) on darolutamide (Nubeqa®, Bayer) for treatment of prostate cancer. This report will be submitted to CMS as part of the 2027 public comment process defined in CMS guidance on Medicare Drug Price Negotiations for price applicability year 2029. 
  • “While the final list of drugs subject to negotiation will not be released until February 2027, ICER is developing this report with the expectation that darolutamide will be subject to negotiation next year. The report will reflect legislative specifications in the Inflation Reduction Act and the most recent CMS guidance regarding price negotiations.
  • “ICER’s expertise in comparative clinical effectiveness and value will continue to help inform the important conversations around Medicare drug price negotiation,” said ICER’s President and CEO Sarah K. Emond, MPP. “While we know CMS may consider many different factors and inputs during negotiations, we believe ICER’s approach to applying the guidance in a consistent framework offers important information to all stakeholders engaged in this process.”
  • “The research protocol is now available.
  • “ICER’s website provides timelines of key posting dates and public comment periods for this assessment.“

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

• Federal News Network reports,
  • “It may not come as a surprise that Americans’ trust in government has declined over the last several decades. When the first systematic measurement was taken by the National Election Study in 1958, about 75 percent of Americans said they trusted their government.
  • “Today that number has basically inverted, sitting at a discouraging 27 percent, according to the annual survey by the Partnership for Public Service.
  • “The unexpected news may not be Americans’ low confidence in government as much as how they report feeling about the federal employees who work for it. The same survey found that 65 percent of Americans view federal workers as competent, even while giving low marks to government as a single entity. Even more favorable, public perception of the federal workforce is the highest it’s been since the Partnership first asked the question in 2021.”
• and
  • interviews a financial expert about the F Fund available in the Thrift Savings Plan.
    • “The TSP’s F Fund has trailed the G Fund over the last several years. Before deciding what that means for your own investments, it helps to understand what’s happening in the bond market.”

From the Food and Drug Administration front,

• Per a FDA news release,
  • “The FDA and CDC, in collaboration with state and local partners, are investigating illnesses in a multistate outbreak of Salmonella Bovismorbificans infections linked to recalled broccoli sprouts grown by Evergreen Fresh Sprouts, LLC of Moyie Springs, ID. This outbreak is currently being investigated separately from the shiga toxin-producing E. coli and Salmonella outbreak linked to alfalfa sprouts also being investigated by FDA, CDC, and state partners.
  • “Based on epidemiological information collected by CDC and state partners, a total of 22 people infected with the outbreak strain of Salmonella have been reported from four states. Illnesses started on dates ranging from July 7, 2026, to August 26, 2026. Of the 19 people interviewed, all 19 (100%) reported eating sprouts and 17 (89%) reported specifically eating broccoli sprouts. There have been two hospitalizations and no deaths.
  • “FDA’s and state partners’ traceback investigations have identified Evergreen Fresh Sprouts, LLC as the common grower of broccoli sprouts that were eaten by patients before becoming ill. On September 4, 2026, Evergreen Fresh Sprouts, LLC initiated a recall of broccoli sprouts based on a positive Salmonella result from a broccoli sprouts sample collected and analyzed by Montana state officials. According to whole genome sequencing analysis conducted by state partners and reviewed by FDA, the positive sample is the same strain of Salmonella that is causing illnesses in this outbreak. Consumers, restaurants, and retailers should not eat, sell, or serve recalled broccoli sprouts grown by Evergreen Fresh Sprouts, LLC with expiration dates of 9/7, 9/9, 9/11, 9/14, and 9/16.”

• The Washington Post reports,
  • “Federal officials are poised to declare the end of the nation’s largest known cyclosporiasis outbreak after thousands of people became sick after eating shredded iceberg lettuce, according to two people familiar with the matter.
  • “The update may come as soon as later Thursday, according to the people, who spoke on the condition of anonymity to discuss an ongoing investigation. However, the timing is not guaranteed. In mid-July, Taylor Farms voluntarily recalled products from the market as federal officials began linking its lettuce from central Mexico to a cyclosporiasis outbreak. Food and Drug Administration enforcement records show recalled products were packaged for nine food service and retail operations, such as Subway and Yum Brands, which owns Taco Bell, KFC and Pizza Hut.”

• BioPharma Dive relates.
  • Biohaven shares fell by more than 10% Thursday after the company revealed that the Food and Drug Administration has placed a partial hold on an experimental epilepsy medicine it recently sold off rights to in a licensing deal.
  • In a regulatory filing, Biohaven disclosed that the FDA has requested additional data related to a “metabolite,” or drug-related substance, that was identified in rodent studies of its treatment opakalim. The agency instructed Biohaven to pause recruitment in an ongoing late-stage trial until it can provide more information. Dosing will continue for those already involved in that study, “RISE-2.”
  • Importantly, the hold doesn’t affect a separate late-stage trial, “RISE-3,” that’s fully enrolled. That study is still expected to produce results later this year in what is a “key event” for Biohaven, wrote William Blair analyst Myles Minter. Should opakalim succeed in testing and win approval, Biohaven will be eligible for milestone payments and sales royalties from licensing partner SK Pharmaceuticals.

No Surprises Act News

• Modern Healthcare reports,
  • “A group of nearly 70 employers, unions, patient advocates and other organizations is calling on Congress to rework the No Surprises Act of 2020. 
  • “The letter, led by left-leaning advocacy group Families USA and cosigned by 67 organizations, asked congressional leaders to address concerns about the law’s Independent Dispute Resolution process.
  • “Under the No Surprises Act, IDR arbitrators determine appropriate out-of-network reimbursement rates, with claims predominantly filed by providers or their aligned companies.” * * *
  • “Letter signers are calling on Congress to replace what they call the “baseball-style” arbitration process with a benchmark payment methodology that promotes market-based prices and discourages excessive reimbursement. 
  • “In an accompanying report, Families USA is also advocating for subjecting ground ambulance services to the law’s requirements; strengthening the federal process for certifying mediators; and requiring arbitrators to disclose their ownership structures, payment agreements and dispute outcomes information.” 

From the fraud, waste, and abuse front,

• Per a Justice Department news release,
  • “Dompé U.S. Inc. (Dompé), based in California, has agreed to pay $32 million to resolve allegations that, between 2018 and 2021, it paid Medicare beneficiary co-pays through two patient assistance foundations to induce the purchase of its drug, Oxervate, in violation of the Anti-Kickback Statute and the False Claims Act.”
  • The claims resolved by the settlement are allegations only and there has been no determination of liability.

From the public health and medical / Rx research front

• MedCity News reports,
  • “Heart disease is the leading cause of death among women in the United States, yet it remains chronically underrecognized, underdiagnosed and undertreated in this population. According to research from the American Heart Association (AHA), by the year 2050, the rate of total cardiovascular disease (CVD) in women will rise to 14.4%, a 3.7% increase from 2020 data.
  • “Data for reproductive age women (ages 20 to 44) shows a similarly troubling increase, from 1 in 4 in 2020 to nearly 1 in 3 in 2050 having clinical CVD. Diabetes in this same young age group is also projected to more than double, from 6% to nearly 16%.
  • “A critical opportunity exists at the intersection of prevention and rapid diagnostics in women’s health. Early intervention based on accurate diagnosis of both metabolic risk factors and acute cardiac events could help make the difference between life and death for women.”

• Cardiovascular Business adds,
  • “Too much light exposure at night, both when asleep and awake, may be bad for the heart. That was the eye-opening takeaway from a new study published in European Heart Journal.
  • “Previous observational studies have linked nighttime light exposure with a higher risk of cardiovascular disease, but little is known about the related cardiac structure and functional changes,” senior author Lu Qi, MD, PhD, a researcher with Tulane University, said in a statement. “We carried out this research to find out what happens to the heart over time when people are exposed to too much light at nighttime.”
  • “Qi et al. tracked data from more than 11,000 UK Biobank participants. They wore a light sensor on their wrists for seven days. Three years later, they all underwent a cardiac MRI scan.
  • “Overall, study participants exposed to the most light—three lux or more—were associated with thickening of the wall of the left ventricle not seen in participants exposed to lower amounts of light. MRI results also showed that participants exposed to high amounts of light were experiencing issues with their heart muscle’s ability to flex during heartbeats, an early sign of heart damage.  

• The New York Times relates,
  • “In the last few years, there’s been a cultural push for women in midlife to build strong bones.
  • “Menopause influencers and medical organizations alike have focused on the message that women’s risk for fractures increases dramatically after menopause, and that they should think about their bone density much earlier than their mothers might have.
  • “The American Medical Association recommends that women get their first DEXA scan — a low-dose X-ray that is the gold standard test for determining bone density — at 65 or older, unless they have a risk factor for osteoporosis.
  • “But a growing number of doctors and bone health experts now recommend earlier scans. They argue that if women wait until 65, they may miss a critical window to prevent osteoporosis.” The article delves into the details of this issue.

• MedPage Today lets us know,
  • “People who consumed their hot beverages at a “very hot” temperature had a threefold higher risk for squamous cell carcinoma of the esophagus compared with those who drank them at a “warm” temperature, an analysis of two large U.K. cohorts suggested.”
• and
  • “Borderline anemia — hemoglobin levels 0 to 1 g/dL above the WHO threshold — was associated with a higher risk of mortality, a prospective cohort study suggested.
  • “When stratifying results by age and sex, borderline anemia was associated with higher risks for all-cause, cardiovascular, and cancer mortality in men of all ages and in women 60 and older.
  • “These findings suggest that the relationship between hemoglobin concentration and long-term health cannot be captured by a single diagnostic cutoff, researchers said.”

• The Washington Post tells us,
  • “People tend to think about supplements the way they think about food: Things that are inherently good or bad for you. Green beans are good. Potato chips are bad. Vitamin D and fish oil belong, presumably, on the green-bean side of the ledger.
  • “But the aging brain may change the calculation, putting some of America’s most popular supplements under new scrutiny.
  • “Recent research is raising a largely overlooked question: Can something that benefits (or is at least neutral to) a young, healthy brain become less helpful — or even harmful — as the brain ages?”
  • “In January, researchers reported an association between vitamin D supplement use and faster cognitive decline among older adults who already had normal vitamin D blood levels. In April, another study found that adults 55 and older taking omega-3 supplements showed greater cognitive deterioration over time than nonusers. Then, in June, researchers reported that people taking glucosamine, used for joint pain, appeared to have a much higher likelihood of progressing from mild cognitive impairment to dementia over five years than their peers who were not taking it.
  • “I was stunned,” said Ramon Sun, a professor of biochemistry and molecular biology at the University of Florida and the lead author of the glucosamine paper.” * * *
  • “The studies are mostly observational, meaning they don’t prove causation, and those links with mental deterioration may be because of the supplements or something else entirely.
  • “But together they point toward a possibility that researchers are beginning to take seriously: Aging changes how the brain handles fats, calcium and glucose, and how it responds to inflammation, which could alter how nutrients and drugs reach brain tissue in the first place.”

• Beckers Health IT informs us,
  • “The American Heart Association’s PREVENT cardiovascular risk equations is now integrated into Epic’s EHR platform.
  • “The integration brings the cardiovascular risk assessment tool into clinicians’ existing workflows, where it can be used to estimate patients’ risk for heart attack, stroke and heart failure and inform prevention and treatment discussions.
  • “The PREVENT equations incorporate measures of cardiovascular, kidney and metabolic health and provide estimates of cardiovascular disease risk over 10- and 30-year periods. The tool is intended for adults ages 30 to 79 without a history of cardiovascular disease, according to a Sept. 10 news release.
  • “The equations were developed using health information from more than 6.5 million adults from a range of racial, ethnic, geographic and socioeconomic backgrounds, according to the association.”
  • “Recent American Heart Association and American College of Cardiology guidelines for managing high blood pressure, abnormal cholesterol and cardiovascular-kidney-metabolic syndrome recommend use of the PREVENT equations for cardiovascular risk assessment and treatment decisions.
  • “Embedding the equations within Epic is intended to make the risk estimates available at the point of care without requiring clinicians to use a separate tool, according to the association.”

• Beckers Hospital Review points out,
  • “Among 31 cancer centers, 100% said they were experiencing a shortage of at least one anti-cancer drug, according to data published Sept. 10 by the National Comprehensive Cancer Network.
  • “The data summarizes August survey responses from pharmacy directors and other clinical and administrative leaders at 31 NCCN members, a Sept. 10 news release said.”

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

• Healthcare Dive reports,
  • “Medicare Advantage insurers could see their star ratings fall next year — and lose out on the lucrative bonuses the ratings represent — after regulators boosted many of the thresholds for achieving the quality scores.
  • “Earlier this week, the CMS released draft cutpoints, the thresholds the agency uses to convert MA plans’ quality and performance scores into a 1 to 5 star rating, as part of the preview process before regulators announce official results in early October.
  • “About 50% of cutpoints got harder, 33% were unchanged and 17% actually got easier, according to analysis by the Newton Smith Group, an MA consultancy.”
    
• Health Exec relates,
  • “For certain aspects of healthcare, Arizona is the freest state in the nation. The least free? New Jersey.
  • “The findings have nothing to do with no-cost services and everything to do with the legal, regulatory and policy environments governing healthcare across the United States. 
  • “They’re from the Center for Modern Health, a libertarian think tank focused on advancing free-market ideas in health policy.
  • “In the Center’s own words, the 2026 Health Freedom Index reflects state-level data on the degree of choice and freedom available to patients, healthcare professionals, insurers and entrepreneurs. 
  • “For each state, the project’s researchers measured performance across 54 variables and five kinds of “freedom”—professional, institutional, patient, payment and delivery—and used the sums to index the states from best to worst. 
  • “In addition, the project “aims to promote transparency and informed discussion about the role of freedom, voluntary exchange and institutional design in American healthcare.”

• Beckers Hospital Review points out the top rehabilitation hospital in each State based on U.S. News & World Report compilation of a list of the top rehabilitation hospitals in every state. 

• The Wall Street Journal informs us,
  • “An Association for Accessible Medicines report says 90% of biologic drugs losing patent protection by 2034 have no biosimilars in development.
  • “The lack of low-cost alternatives could cost Americans nearly $200 billion in healthcare savings over the next decade.
  • “The dispensing rate of available biosimilars over brand-name drugs fell to 23% in 2025, down from about 40% in 2024.”

• STAT News notes,
  • “When Kura Oncology decided to take aim at a protein involved in cell division and signaling, researchers reported a bonus finding: Targeting the protein, menin, didn’t just control the growth of leukemia cells, it also helped control blood sugar levels in animal studies. The biotech on Wednesday announced that it is turning that insight into a new company.
  • “The new firm, Caspian Therapeutics, is launching with $50 million in financing to develop menin inhibitors for diabetes and other cardiometabolic diseases. The initial funding, led by BVF Partners and joined by Eli Lilly and members of Kura’s leadership team, among others, is meant to advance Caspian’s lead small molecule drug through an early-phase clinical trial in diabetes and support the development of a second candidate.”

• Per Beckers Physician Leadership,
  • “Physician assistants averaged a salary of $155,000 in 2026, continuing a run of steady raises since 2022, according to a report from Medscape.
  • “The topline number hides a more complicated picture: pay growth varies widely by specialty setting, state and gender, and base salary itself grew more slowly than the bonus and incentive pay layered on top of it.”

• Per Fierce Healthcare,
  • “Electronic prescribing platform Interra Health announced Tuesday that it now supports the U.S. Centers for Medicare and Medicaid Services’ (CMS) GLP-1 Bridge program for Medicare Part D beneficiaries.
  • “Eligible Part D enrollees can access GLP-1 medications at $50 per month through the program, which launched July 1. For Interra patients, the platform alerts providers when patients may be eligible to enroll in the program. Moreover, it instructs providers to submit proper codes and complete required prior authorizations.
  • “Interra Health Chief Business Development Officer J.B. Powell told Fierce Healthcare the program has delivered “more than 170,000 point-of-prescribing alerts to more than 30,000 unique prescribers” since its launch, adding that its requirements could “be confusing” for providers and patients to understand eligibility.”
• and
  • “Plans to build a new, $2 billion-plus patient care tower and other accompanying upgrades at the University of Iowa Health Care’s main campus are off the table in favor of smaller-scale upgrades to existing facilities, the academic system said Wednesday. 
  • “Iowa Health Care had previously described the new patient tower as “critical to our ability to meet the healthcare needs of Iowans for years to come.” Primary construction wasn’t scheduled to begin in earnest until 2028 and targeted a 2032 completion.
  • “The organization is still facing a capacity crunch, noting in Wednesday’s announcement that it turns away 3,000 to 5,000 patient transfers a year “due to space constraints” even as it recorded over 41,000 inpatient admissions, almost 1.7 million clinical visits and over 43,000 major surgeries last fiscal year. 
  • “However, “significant financial challenges” facing the healthcare industry at large have limited Iowa Health Care’s ability to “responsibly” deploy capital toward the project. The organization stressed that its finances are stable, but now plans to submit a revised $380 million capital plan to its board later this month.”