Simplicity is a virtue.

From Washington, D.C.

• STAT News reports,
  • “Congress is considering the first major overhaul of how Medicare pays doctors in more than a decade, and both Democrats and Republicans appear to agree on the outlines of an approach.
  • “The main policy under consideration would link Medicare’s doctor pay rates to a medical inflation measure, giving doctors guaranteed pay boosts, as hospitals and other parts of the health care system have long received.  
  • “In doing so, Congress would be retreating from the notion that Medicare can control how many services physicians provide on a national basis, an idea that has undergirded Medicare’s doctor payments for decades. And it would reduce the government’s push to get clinicians to engage in value-based care, where they get paid more to keep patients healthy.” * * *
  • “The measure under consideration is called the Patients First Act, and would establish a permanent, annual payment hike linked to the Medicare Economic Index (MEI), minus 1%. 
  • “During a recent House committee hearing, Republicans and Democrats praised the Patients First Act. No one in either party spoke against it. Congressional Medicare advisers also recommended the MEI minus 1% formula.
  • “Following the hearing, Energy and Commerce health subcommittee Chair Morgan Griffith (R-Va.) predicted that Congress would pass some of the doctor pay measures, but he cautioned about the need for “tweaks” due to their cost.
  • “Some of them may need a few tweaks, but I don’t think we would’ve done this today if we weren’t at least going to try to get some of them across the finish line during lame duck,” Griffith said.”

• Fierce Healthcare relates,
  • “The Senate Finance Committee has advanced the nominees for two key Department of Health and Human Services posts.
  • “The committee members voted 15 to 12 to advance the nomination of Chris Klomp to serve as Deputy HHS Secretary and 14 to 13 to advance the nomination of Ge Bai, Ph.D., as Assistant Secretary for Planning & Evaluation (ASPE) at the agency. The nominees had addressed the committee on Sept. 15 alongside nominees for positions at the Internal Revenue Service and U.S. Tax Court.
  • “Klomp is a rising star at HHS and currently leads the Department of Medicare at the agency. If his nomination is approved, he would become second-in-command at the department, a position that has been vacant since Jim O’Neill departed in February.”
• and
  • “The Senate Committee on Health, Education, Labor and Pensions (HELP) today questioned Heidi Overton, M.D., Ph.D., the president’s pick for FDA commissioner, in a hearing marked by tightrope-walking on issues like vaccines, abortions, flavored vapes and whether or not Donald Trump is capable of being wrong. 
  • “Overton conceded multiple times during the hearing that vaccines approved by the FDA, as well as the so-called “abortion pill” mifepristone, are safe and effective. But she stopped short of admitting that Trump has been wrong when dispensing medical information out of line with what the scientific evidence shows. 
  • “The committee will next vote on whether to send Overton’s nomination to the full senate for approval.” 

• Healthcare Dive tells us,
  • “CMS Administrator Dr. Mehmet Oz delivered a candid assessment of artificial intelligence’s impact on healthcare costs Wednesday: It’s going to get worse before it gets better.
  • “Short term, AI is going to be inflationary because it’s going to turbocharge the ability of the current billing systems to work more effectively,” Oz said at Oracle’s annual health and life sciences summit in Orlando. 
  • “It’s the latest signal from the industry that AI could be inflating healthcare costs — even as its proponents argue the technology will lower them over time.” * * *
  • “For providers, AI-powered coding is enabling them to bill insurers for more conditions when they treat patients. They say the technology helps them more accurately bill for care, while insurers say doctors are using AI to charge more money without any actual increase in medical care.
  • “A study released by the insurer group Blue Cross Blue Shield Association on Thursday found that the increase of billing has added nearly $1 billion in healthcare costs between 2023 and 2025. The group said the study “raises concerns” that AI tools are contributing to higher spending.” * * *
  • “Although Oz noted the increase in healthcare costs, he said AI was still essential in the industry.
  • “I guarantee you we will lose lives if we don’t use AI in the day-to-day trench warfare of fighting disease in America,” he said.
  • “Oz said he hoped AI would lower healthcare costs in the long run, and that the government was relying on one particular area to make that happen: accountable care organizations.”

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

• Following up on yesterday’s post about FedSmith’s helpful breakdown of the FEHB / PSHB questions for which OPM has requested public comment, it turns out that the public already has submitted 113 comments to the agency. You can access those comments here. In contrast to OPM’s limited posting of comments on its modified system of records notice, OPM has posted all 113 comments received to data on this new topic.

• Tammy Flanagan, writing in Govexec, tells us,
  • “What changed in your federal benefits in 2026 — and what could change next? Agencies updated federal retirement, insurance, Social Security and Thrift Savings Plan programs, while Congress considered proposals affecting future pay and benefits. This article summarizes the changes that took place in 2026 along with the links to official sources.
  • “Review the 2026 changes now and watch for 2027 updates this fall. During Federal Benefits Open Season, OPM will soon begin to publish 2027 plans, premiums and coverage information. The September CPI release on Oct. 14, 2026, will provide the final CPI-W data used to determine 2027 Social Security and federal retirement COLAs.”

From the Food and Drug Administration front,

• MedPage Today reports,
  • “With some trepidation, a majority of an FDA advisory committee Thursday endorsed the Galleri multicancer early detection blood test.
  • “By 6-4 and 7-2 (with one abstention) margins, the molecular and clinical genetics panel of the Medical Services Advisory Committee voted that the test was effective and that its benefits outweigh the risks. However, many panel members who voted yes had reservations about their votes.
  • “The panel was more decisive on the question of safety, voting unanimously (10-0) in favor of Galleri.
  • “While most panel members agreed that as a diagnostic test Galleri was safe, effective, and demonstrated a positive benefit/risk profile, particularly for cancers for which screening tests are unavailable, they were concerned about the lack of outcome data supporting the test’s premarket approval (PMA) application, as well as the use of the term “early” in describing the purpose of the test.
  • “I really struggled with this one … I did change my vote twice,” said Jason Dominitz, MD, MHS, of the VA Puget Sound Health Care System in Seattle, explaining his yes vote on Galleri’s effectiveness. “Clearly, there are clinically impactful results of the test. People get a diagnosis work-up, cancers are found, but does that lead to clinically clinical benefit? I don’t see that we have evidence of clinical benefit at this time.”
  • “The question comes down to what do you call clinical effectiveness,” said Stanley Lipkowitz, MD, PhD, of the National Cancer Institute, who voted no. “As an oncologist, I generally look at that as outcome, and we don’t have that data.” * * *
  • “While not bound by its advisors’ recommendations, the FDA usually follows their advice.”

• USA Today relates,
  • “Officials have classified the risk level of a thyroid medicine recall initiated last month to its most serious category.
  • “On Sept. 22, the U.S. Food and Drug Administration categorized the recall – which applies to one lot of thyroid tablets sold by Vitruvias Therapeutics Inc. – as a Class I recall, its highest risk level.
  • “Last month, Vitruvias Therapeutics Inc. recalled one lot of its 30 mg thyroid tablets because they could be superpotent, or stronger than intended, according to a FDA recall notice published on Aug. 24.
  • “The affected products include thousands of units distributed nationwide from January to September 2025 with an expiration date in September 2026, according to the notice.
  • “A Class I recall – the most serious FDA category – indicates that using the product is likely to cause serious health effects or death, according to the agency.”

• CBS News considers “whether an FDA crackdown [noted in yesterday’s FEHBlog will] curb access to cheaper GLP-1 weight-loss drugs?
  • Scott Brunner, CEO of Alliance for Pharmacy Compounding, said that the FDA’s warning wasn’t about the volume alone, but the lack of documentation to prove that Empower was appropriately making the drug for individual patient needs.
  • “The FDA is possibly marking a line in the sand,” said Darshan Kulkarni, founding partner of the Kulkarni Law Firm and an expert in healthcare and pharmacy law. For now, though, the FDA’s warning shot is more likely to prompt compounding pharmacies to reframe how they differentiate their weight-loss products than to immediately stop making them, he said.
  • “But with the FDA taking a stance on the limits of compounded weight-loss drugs, he said, “That avenue is definitely getting narrower.”

From the public health and medical / Rx research front

• Beckers Hospital Review reports,
  • “A recent study found 11.3% of healthcare personnel surveyed reported persistent long COVID symptoms.
  • “The study, published in the American Journal of Industrial Medicine, used electronic surveys to collect symptom data at three and six months post-infection from 1,496 healthcare personnel. Long COVID was defined as the same moderate or severe symptom reported at both time points. 
  • “Here are the findings.
    • “1. Older age was associated with higher odds of persistent symptoms, and female healthcare personnel had greater odds of persistent symptoms than male personnel. 
    • “2. Prior COVID infection or more than two underlying health conditions were also associated with higher odds of long COVID.
    • “3. Physicians, licensed practical and registered nurses, and therapists or therapy assistants had lower odds of long COVID than nonclinical healthcare personnel.”

• MedPage Today tells us,
  • Lyme disease is the nation’s most frequently reported vector-borne disease.
  • In a U.S. cohort study, 29.5% of people positive for the bacteria that causes Lyme disease also tested positive for at least one of three other tick-borne pathogens.
  • The study suggests that even with typical Lyme disease symptoms, clinicians should consider the presence of other tick-borne pathogens, which may have implications for treatment.
• and
  • “Residual lifetime ovarian cancer risk warrants consideration of risk-reducing bilateral salpingo-oophorectomy for healthy older BRCA carriers.
  • “Individualized decision-making about surgery should weigh risk reduction against impact on fertility and quality of life.
  • “Substantial residual risk remains for women who delay surgery to age 50, particularly for BRCA1 carriers.”

• Health Day adds,
  • “Glucose patterns captured by continuous glucose monitors (CGMs) are linked to cardiometabolic risk in adults without diabetes, according to a study published online Sept. 17 in Diabetes Care.”

• The American Medical Association lets us know “what doctors want patients to know about high cholesterol.” 
  • “Sorting through the good, the bad and the ugly about high cholesterol can be confusing. Understanding your overall risk, and not just one number, can help.”

• Cardiovascular Business considers “Semaglutide is improving the heart health of millions—but how? Experts are stumped.”
  • “Professor Helen Colhoun, MBBChBAO, MD, a healthcare researcher and diabetes specialist with the University of Edinburgh, et al. tracked differences related to body weight, waist circumference, lipids, blood pressure and more in patients given semaglutide and those given a placebo. The overall conclusion was improvements in weight loss and waist circumference only partially explain the cardiovascular benefits being seen among patients given semaglutide. There is something more going on there—but what that happens to be is not yet totally clear.
  • “Our analyses could not fully ascribe the effects of semaglutide on cardiovascular disease to known risk factors with any certainty,” Calhoun said. “Whether we combine all risk factors together or look at some subsets of the risk factors, no more than half of the reduction in heart disease could be explained by the changes in these risk factors. These results suggest that semaglutide should be considered as a cardiovascular disease reduction drug and not just as a weight loss drug.” 
  • “She added that more research is still needed to help clinicians learn more about this significant trend. 
  • “Click here to read the full analysis.”

• Reuters points out,
  • “Scientists have created a detailed map of gene activity within a crucial part of the brain called the prefrontal cortex, gaining insight into normal development and major brain disorders such as Alzheimer’s disease, Parkinson’s disease and ​schizophrenia.
  • “In nine separate studies, the researchers examined changes in individual types of brain cells that occur over time and made progress toward deciphering molecular processes ‌that underlie some of the most devastating brain disorders, a step toward possible new treatments.
  • “The prefrontal cortex is the front part of the brain’s outer layer, located behind the forehead. It helps a person plan, make decisions, regulate emotions and adapt behavior. It also is sensitive to age-related decline, and its functions are affected in many psychiatric and neurodegenerative disorders.” * * *
  • “The research identified patterns shared across some of the diseases as well as some ​specific to individual disorders.
  • “Together, these studies help explain where disease-related changes occur and which biological processes deserve closer investigation,” said Dr. Panos Roussos, director of the Center for Disease Neurogenomics at ​the Icahn School of Medicine at Mount Sinai in New York City and a leader of the research published on Wednesday in Nature, opens new tab and other journals.
  • “A useful treatment needs to influence the right biological process in the right cells. This map helps narrow that search. It can identify vulnerable cell populations, reveal processes associated with preserved brain function and help researchers decide which potential treatment targets to test,” Roussos ​said.”

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

• Beckers Payer Issues reports,
  • “The Cigna Group is partnering with OpenAI to integrate AI into clinical workflows, with a first focus on cancer care.
  • “Under the collaboration announced Sept. 23, OpenAI’s tools will be built into workflows across Accredo Specialty Pharmacy and the insurance business, Cigna Healthcare. The first new capability will give oncology nurses and case managers an AI-enabled view that pulls together clinical, pharmacy, behavioral and benefits information for each member.
  • ‘The companies said the goal is to identify member needs earlier and personalize support between physician visits, when patients are often dealing with side effects, new symptoms and unanswered questions. The system is designed to feed insights from member responses back into future guidance and workflows over time.”

• Cotiviti adds,
  • “Cotiviti and MedCity News just published the 2026 Healthcare AI Readiness Index revealing fascinating insights, including a striking contradiction.
  • “AI adoption is essentially universal in healthcare. Investment in AI is accelerating, and executives clearly see operational value. Yet only a minority feel prepared for AI-enabled cyberthreats. Less than 40% have detailed governance policies, more than 60% of respondents report shadow AI usage, and most still require human oversight for the highest-consequence decisions.
  • “Healthcare doesn’t have an AI adoption challenge. It has an AI readiness challenge. Governance, cybersecurity, and human oversight are all evidence of the broader gap between AI adoption and readiness. This gap may be the most important risk that healthcare executives aren’t measuring.”

• Healthcare Dive points out,
  • “Investment in health IT is a top priority for a majority of providers and payers, though executives are seeking solutions for specific use cases that provide measurable results, a new survey from Bain & Company and KLAS Research shows.
  • “Tools that target revenue cycle management, patient engagement and clinical workflows are attracting attention — and investment dollars — from providers. Payers are focused on utilization management, care navigation and claims processing.
  • ‘Executives are especially emphasizing measurable return on investment when it comes to AI, with some seeking returns of 3x to 3.9x their original investment, according to the survey.”

• Fierce Healthcare relates,
  • “UnitedHealth Group has named Jodee Kozlak to the newly created role of chief administrative officer, the healthcare giant announced Thursday morning.
  • “Kozlak will take the position on Sept. 28, per the announcement. In this role, she will be tasked with leading the company’s enterprise modernization efforts, including a portfolio that will initially include people, real estate, procurement and corporate security.
  • “Kozlak is currently chair of the board at C.H. Robinson Worldwide, a transportation and third-party logistics company, and is lead independent director for KB Home, a homebuilding company. She served as the global senior vice president for the Alibaba Group from 2016 to 2017, supporting the company’s expansion outside of China.
  • “She also held multiple leadership roles at Target Corporation between 2004 and 2015, including in human resources and legal, UnitedHealth said in the announcement.”

• Beckers ASC Review informs us,
  • “Private equity ownership has become increasingly common across physician practices over the last decade, with investors backing groups in specialties like anesthesiology, orthopedics, gastroenterology and pain management. 
  • “Now, a new federal bill aims to ban it outright.
  • “Democratic lawmakers introduced the Stop Corporate Takeovers of Physicians Act on Sept. 16. The federal bill would ban private equity firms, insurers and other for-profit corporations from owning or controlling physician practices.
  • “Becker’s connected with 14 physicians, healthcare executives and attorneys to get their take on the bill. Most agreed the legislation is unlikely to pass or to fully undo private equity’s footprint in healthcare, but several said it targets the right problem and could shape future deals. Many also warned that the bill’s exemptions for hospitals and nonprofits could speed up hospital consolidation, and that it does little to address the reimbursement pressures pushing independent practices toward outside investors in the first place.”

• Cardiovascular Business notes,
  • “The Heart Failure Society of America (HFSA) has released a new comprehensive look at heart failure (HF) clinics in the United States. The report includes more than 300 HF programs located in 47 states that serve approximately 626,000 patients.
  • “HFSA wanted to shine a spotlight on the country’s specialty clinics, often found in academic medical centers, while highlighting care gaps where many patients remain underserved. For instance, many Southern and Appalachian states—areas known for especially high risks of HF and other cardiovascular conditions—still have fewer clinics than are needed to ensure patients can easily access high-quality care.
  • “This report shows where specialty heart failure care exists in the United States and, just as importantly, where it doesn’t,” HFSA President Kenneth B. Margulies, MD, said in a statement. “The clinics in this database represent professional, multidisciplinary care. But the mismatch between where that care is concentrated and where the disease burden is heaviest is the central challenge our country needs to address.” * * *
  • “Click here for the full report. Its release comes just days before ASM 2026, HFSA’s annual scientific meeting.”