Simplicity is a virtue.

From Washington, DC,

• CBS News reports,
  • “The Senate confirmed Keith Sonderling to lead the Department of Labor on Wednesday, officially installing the nominee who has been leading in an acting capacity since Lori Chavez-DeRemer’s exit in April.
  • “In a party-line 47 to 41 vote, the Senate confirmed Sonderling.
  • “Sonderling served in several roles at the Department of Labor and the Equal Employment Opportunity Commission during President Trump’s first administration. He previously practiced employment and labor law at a Florida law firm.”

• The American Hospital Association News relates,
  • “The Centers for Medicare & Medicaid Services’ 340B Part D claims data repository became available Oct. 1 for voluntary data submissions. While data submissions will remain voluntary for now, the agency has proposed making data submissions mandatory starting Jan. 1, 2027. CMS has multiple resources available to support 340B entities and their third-party administrators with data submissions, including a user guide, companion guide, fact sheet and an FAQ.” 
• and
  • “The Department of Health and Human Services’ Health Resources and Services Administration Oct. 1 announced approval of 10 drug companies to participate in the 340B Rebate Model Pilot Program. The approved companies are AbbVie, Amgen, Astellas Pharma US, AstraZeneca, Bristol Meyers Squibb, Boehringer Ingelheim Pharmaceuticals, GlaxoSmithKline, Merck Sharp & Dohme, Pfizer and Teva Pharmaceuticals. See the HRSA webpage for more details about the drug companies approved to participate in the Rebate Model Pilot Program, as well as FAQs.
  • “The AHA Aug. 7 issued a Regulatory Advisory that includes a detailed summary of the HRSA announcement on the rebate model pilot program. The program would begin Jan. 1, 2027.
  • “The AHA remains deeply concerned that HHS has chosen to move forward with a 340B Rebate Model Pilot Program despite the overwhelming evidence that it will impose massive new administrative and financial burdens on hospitals that serve America’s most vulnerable patients,” an AHA spokesperson said. “We are reviewing today’s materials and are considering all available options to prevent this flawed program from going into effect.”
    
• Beckers Hospital Review adds,
  • “An October report from Berkeley Research Group estimates how much patients and payers spend on 340B drugs, beyond what covered entities pay to acquire them.” * * *
    • “BRG calculates the gap between acquisition cost and reimbursement, which it calls “340B drug margin,” at $142.2 billion in 2025, more than double the $63.6 billion margin in 2021.
    • “Private and commercial insurers covered the largest share of that margin (63%), followed by Medicare (25%) and Medicaid managed care plans (7%). Medicaid fee-for-service generates no margin because it reimburses covered entities at acquisition cost.
    • “As a share of the overall U.S. pharmaceutical market, 340B prescriptions now account for 27% of net spending, up from about 18% in 2021. BRG attributed the program’s growth mainly to hospitals acquiring off-site clinics, expanded hospital participation following the Affordable Care Act and growing use of contract pharmacies, which now number roughly 35,000 nationally, up from about 1,300 in 2010.”

• CMS has posted a table showing the “Top 10 Section 111 Group Health Plan (GHP) Reporting Error Codes from January 1- June 30, 2026”

From the Medicare Advantage front,

• Healthcare Dive and Fierce Healthcare discuss the Medicare Advantage landscape as we approch the beginning of Medicare’s Open Enrollment period on October 15.

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

• Govexec reports
  • “Nearly all of the portfolios in the federal government’s 401(k)-style retirement savings program lost value last month, as the broader investment market encountered broad volatility.
  • “The small- and mid-size businesses in the Thrift Savings Plan’s S Fund saw the worst decline, falling 3.86% in September. Since January, the S Fund is up 11.62%. The C Fund’s common stocks nearly broke even, finishing the month just 0.35% in the red. So far this year, the C Fund has grown 12.73%.” * * *
  • “The only TSP fund to post gains was the government securities of the G Fund, which grew at a statutorily mandated rate of 0.40%. So far this year, the G Fund has grown 3.41%.”

• Tammy Flanagan, writing in Govexec, considers “Retiring in 2027? Picking the right date could pay off.”
  • “The date you leave federal service can affect when your annuity begins and how much you receive for unused annual leave.”

From the U.S. Food and Drug Administration front,

• Cardiovascular Business reports,
  • “The U.S. Food and Drug Administration (FDA) has approved the Edwards Lifesciences Autus surgical pulmonary valvethat is the first size-adjustable valve designed for pediatric patients with congenital heart disease. The valve previously received FDA Breakthrough Device designation for its potential to address an important unmet need.
  • “Typically, children with congenital heart disease outgrow their valves and require repeat open-heart surgeries to explant the old valves and implant larger valves. Instead of repeat surgeries, the Autus is designed to be expanded as a child grows through a minimally invasive transcatheter procedure, offering a new, less invasive way to care for these children over the long term.
  • “This valve is a game changer,” explained Jennifer Romano, MD, MS, a heart surgeon at C.S. Mott Children’s Hospital, and past-president of the Society of Thoracic Surgeons (STS), in a statement from September when her team performed the first Autus procedure in the U.S. “Typically, we give these children a temporary fix, knowing they will need more surgeries down the road. “Now, we may be giving a child a valve that could potentially last them a lifetime. This could be transformative.”

• MedTech Dive relates,
  • “The Food and Drug Administration has selected the first participants for an innovation challenge for home devices that could be used to reduce hospital readmissions.
  • “The first five participants include large medtech firm BD, wearable EEG startup Epitel, infant care company Prapela, Current Health, a company making software for cancer care, and Skribe Medical, which makes a device to assess cardiac function.
  • “The FDA’s device center plans to choose a total of nine participants by Dec. 4 for the challenge, called Reducing Readmissions through Device Innovation for the Home, or READI-Home. The selected manufacturers will have opportunities for early engagement with the FDA, including feedback on device design and testing, and demonstrations at the agency’s research facilities.”
• and
  • “Medtronic said Wednesday it received a breakthrough device designation from the Food and Drug Administration for a drug-coated balloon catheter to treat peripheral artery disease below the knee.
  • “While drug-coated balloons are commonly used to treat PAD above the knee, none are indicated in the U.S. for use below the knee, where improved treatment options are needed, Medtronic said. PAD causes reduced blood flow to the limbs due to plaque buildup in the arteries. Patients with advanced PAD can be at risk for amputation.
  • “Medtronic said it is planning a randomized pivotal trial to study the paclitaxel-coated device, called IN.PACT BTK, in about 400 patients with below-the-knee lesions.”

• BioPharma Dive identifies “5 FDA decisions to watch in the fourth quarter of 2026.”
  • “The next three months will feature anticipated decisions on a new kind of cancer immunotherapy, as well as medicines important to the futures of Roche, GSK and Gilead.”

No Surprises Act News,

• Federal Hearings and Appeals Services, a certified independent dispute resolution entity, informs us,
  • “Our Account Services team members spend their days immersed in the Independent Dispute Resolution (IDR) process and fielding questions from parties. FHAS recently launched a new “Common Questions” series on our blog to share the questions we receive most often, and the answers we’re providing.
  • “Lately, we’ve seen some confusion around the new IDR Registry and the new IDR Gateway, so we’ll address those common questions, here. As a starting place, let’s clarify some basics.
  • “The Gateway is the platform. The Registry is a database inside it.
  • “The IDR Gateway is CMS’s new secure, account-based platform for managing Federal IDR disputes. It replaces the single-use web forms that parties have used since 2022.
  • “Both providers and payers need to register or sign up for a Gateway account. See our earlier post, The IDR Gateway Is Here, for more details on the Gateway roll-out.
  • “The IDR Registry is different. It is a searchable database of payer information that will live inside the Gateway.
  • “Only payers register in the IDR Registry – health insurance issuers, self-insured group health plans and their sponsors, and FEHB carriers. Each payer will carry an IDR registration number, and initiating parties will be able to access this number by referring to a given health plan’s notice of payment or denial.” * * *
  • “When might the Registry be available?
  • “Not right away, and the timeline has several steps. The Final Rule does not set a calendar date for the Registry. Instead, the Registry provisions become applicable 90 business days after the Departments issue guidance announcing that the Gateway functionality supporting the Registry is available, and payers have until the later of that date, or the date they begin offering coverage, to register. The Departments extended that window from the 30 business days originally proposed and noted that the extra time is meant to let payers set up lines of communication across their TPAs and service providers. CMS’s published implementation timeline lists the Registry first among the Gateway-dependent provisions it plans to roll out beginning in spring 2027, ahead of the new open negotiation, initiation, and IDRE selection workflows. Counting forward from a spring 2027 announcement, 90 business days runs roughly four to four and a half months. A reasonable expectation is that payers will be fully registered, and registration numbers will begin appearing on remittances, in the second half of 2027. The Departments have said they will publish updates as each provision is operationalized, and we will share those as they arrive.
  • “In the meantime, one related change lands sooner. Beginning with items and services furnished on or after Jan. 1, 2027, payers must use specified claim adjustment reason codes (CARCs) and remittance advice remark codes (RARCs) to indicate whether a claim is subject to the No Surprises Act and the Federal IDR process. That is a separate requirement from the Registry, but it addresses a neighboring question and arrives first.”
• FEHBlog observation: I created a Gateway account for my client and upon doing so, all of the IDR cases showed up in a list. I compared the Gateway list against my list and I found two cases on my list that weren’t on the Government’s list. I am assuming that those cases were dropped without letting me know which is OK with me.

From the public health and medical / Rx research front,

• MedPage Today reports,
  • “Over 2 million new cancer cases were attributable to infections globally in 2024, according to an analysis of worldwide cancer incidence, highlighting the importance of effective prevention measures.
  • “Infections led to an estimated 2.3 million new cancer cases in 2024, including gastric cancer, cervical cancer, hepatocellular carcinoma, leukemias and lymphomas, and nasopharyngeal cancer, which accounted for 12% of all cancer cases worldwide.
  • “Among 12 carcinogenic infectious agents, the largest numbers of cancer cases were attributable to:
    • “Helicobacter pylori: 760,000 cases, population-attributable fraction (PAF) 4%
    • “Human papillomavirus (HPV): 750,000 cases, PAF 4%
    • “Hepatitis B virus (HBV): 360,000 cases, PAF 2%
    • “Epstein-Barr virus (EBV): 260,000 cases, PAF 1%
    • “Hepatitis C virus (HCV): 160,000 cases, PAF <1%
    • “Kaposi’s sarcoma-associated herpesvirus (KSHV): 35,000 cases, PAF <1%
  • Most cancers attributable to H. pylori were non-cardia gastric cancers (700,000 cases), while cervical cancer accounted for most HPV-attributable cases (600,000). HBV and HCV were responsible for 330,000 and 130,000 cases of hepatocellular carcinoma, respectively, while EBV led to 110,000 nasopharyngeal cancers, reported Harriet Rumgay, PhD, of the International Agency for Research on Cancer in Lyon, France, and colleagues in Lancet Oncology.”
• and
  • “Maternal infection or sepsis is the third-leading cause of pregnancy-related death in the U.S., and Mississippi is the state with the third highest maternal mortality rate.
  • “In this study of Mississippi births, maternal sepsis disproportionately affected mothers with preterm births or c-sections, those with chronic comorbidities, Black women, and Medicaid enrollees.
  • “Overall, sepsis was recorded in 0.06% of the births from 2016 to 2025, but was involved in 32.4% of the delivery-associated hospital deaths.”

• The American Medical Association lets us know “5 things patients should know about GLP-1 medications.”
  • “Sean Hashmi, MD, talks about the benefits of GLP-1 medications—as well as some misunderstandings—on the latest “Health vs. Hype” podcast episode.”

• The latest issue of the National Institutes of Health’s Research Matters covers the following topics:
  • “Antiviral drug did not improve Long COVID symptoms” 
    • “A clinical trial for Long COVID found that treating patients with a common antiviral drug for up to 25 days did not improve symptoms.
    • “The findings suggest that other approaches to manage symptoms and treat Long COVID are needed.”
  • “tRNA treatment may help restore cystic fibrosis proteins” 
    • “Lipid nanoparticles that deliver engineered transfer RNA restored functional proteins in cell and animal models of cystic fibrosis.
    • “This strategy may represent a potential therapeutic approach for cystic fibrosis and other genetic diseases caused by nonsense mutations.”
  • “Bacterial infection may alter developing gut” 
    • “C. difficile bacteria caused lasting changes to cells in the intestines of newborn mice.
    • “The findings suggest that early-life C. difficile infections may alter gut stem cells and immunity into adulthood.”

• Health Day relates,
  • “Stable employment in midlife is associated with better cognitive health in later life, according to a study published online Sept. 23 in Alzheimer’s & Dementia.
  • “Erika T. Beidelman, from the Columbia University Mailman School of Public Health in New York City, and colleagues used data from 2,418 participants in the Health and Retirement Study (1998 to 2014) to examine associations of workforce participation and job insecurity with later cognition.
  • “The researchers found that among women, compared with secure employment, self-employment, early retirement, not being in the labor force, and secure-to-retirement trajectories were significantly associated with lower memory and executive function scores (β range = −0.13 to −0.32 standard deviation units). For men, inconsistent employment was associated with poorer performance across most cognitive domains versus secure employment. In women, employment instability and early retirement were associated with higher odds of cognitive impairment.”

• The New York Times offers “Clues to Why a Breakthrough Pancreatic Cancer Drug Eventually Stops Working”
  • “Researchers are asking why patients, like former Senator Ben Sasse, inevitably develop resistance to the drug daraxonrasib.”

• Genetic Engineering and Biotechnology News tells us,
  • Methicillin-­resistant Staphylococcus aureus (MRSA) has rapidly risen to become one of the gravest threats to global health, with deaths from Staphylococcus aureus (S. aureus) having doubled worldwide since 1990. In severe cases, the bacteria invade the bloodstream in life-threatening systemic infections, which have a high risk of kidney injury and failure.
  • S. aureus is one of the most concerning bacterial pathogens, given that MRSA accounts for the largest increase in the global antimicrobial resistance burden. In addition, deaths attributable to S. aureus infections have doubled since 1990, making it a leading cause of bacterial mortality worldwide. Despite the continued focus on research, tissue reservoirs that permit bacterial persistence remain poorly defined.
  • “Now, a new study reveals how MRSA exploits the osmotic environment of the inner kidneys to establish a bacterial reservoir and hide from the immune system. This work suggests that MRSA can establish niches in the kidneys and the findings provide a mechanistic explanation for a longstanding question in the field of MRSA biology, and could inform future strategies aimed at limiting kidney damage from infections.
  • “This work is published in Science Translational Medicine in the paper, “Hyperosmotic niche adaptation and tissue polyamines underlie MRSA persistence in the kidney.”

• STAT News informs us,
  • “Invivyd’s pursuit of a Covid vaccine alternative gets a lift, but an FDA hurdle may await
    • “The small biotech company is developing an injectable, low-dose monoclonal antibody.”

• Per Fierce Healthcare,
  • “Taiho Pharmaceutical, together with U.S.-based subsidiary Taiho Oncology, has inched closer to approval of another oral combination treatment for patients with blood cancers.  
  • “In new phase 3 topline results, Taiho reported that its investigational, all-oral drug combination of azacitidine and cedazuridine successfully treated patients with myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemia (CMML), two blood disorders that can lead to acute myeloid leukemia (AML).
  • “Azacitidine is an established chemotherapy already used to treat MDS and AML. But Taiho’s formulation uniquely pairs the chemo with the cytidine deaminase inhibitor cedazuridine, which blocks the chemo-disintegrating enzyme cytidine deaminase in the digestive tract, allowing the cancer treatment to survive oral delivery.”
• and
  • “While Foundayo’s insulin-matching potential in type 2 diabetes had been established in a topline readout earlier this year, Eli Lilly on Wednesday unveiled the fullest picture yet of its oral GLP-1’s ability to keep blood sugar in check, cut weight and, crucially, demonstrate cardiovascular safety in patients with compounding metabolic conditions.
  • “In a deep dive into the Indianapolis drugmaker’s late-stage Achieve-4 trial, which compared Foundayo (orforglipron) with titrated insulin glargine in adults with type 2 diabetes and obesity or overweight who were at increased cardiovascular risk, Lilly’s drug proved noninferior to insulin on the risk of major adverse cardiovascular events (MACE) while delivering greater reductions in A1C and weight.
  • “The comprehensive results were presented as part of Lilly’s showing at the European Association for the Study of Diabetes (EASD) annual meeting in Milan this week and simultaneously published in The Lancet.”

• Per an Institute for Clinical and Economic Review (ICER) news release,
  • “The Institute for Clinical and Economic Review (ICER) today posted its revised Evidence Report assessing the comparative clinical effectiveness and value of baxdrostat (Baxfendy™, AstraZeneca) and lorundrostat (Mineralys Therapeutics, Inc.) for hypertension.
  • “Downloads: Evidence Report | Voting Questions | Public Comments | Response to Public Comments
  • “High blood pressure is common, leads to serious complications like heart disease, strokes, and kidney failure, and is frequently undertreated,” said ICER’s Chief Medical Officer David Rind, MD, MSc. “Baxdrostat and lorundrostat are from a new class of medications intended for patients that may need more than standard first-line therapies. The hope is that they may have fewer side effects and reduce clinical events, but evidence for such benefits is currently limited.”
  • “Register here to watch the live webcast of the October 29th ICER public meeting.”

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

• Beckers ASC Review reports,
  • “Philadelphia-based Penn Medicine, Independence Blue Cross and Franklin, Tenn.-based Regent Surgical are building an ASC company with a structure Regent CEO Travis Messina said the industry has not seen before: a health system, a health plan and a management company, all as owners.
  • “All the research that I’ve done suggests that there has never been a partnership in the ASC space that included a health system, a health plan and a management company,” Mr. Messina told Becker’s. “We believe it’s the first of its kind in that regard.”
  • “The three organizations announced Sept. 24 they will develop at least 18 ASCs across Pennsylvania, New Jersey and Delaware.” 

• Beckers Hospital Review relates,
  • “Vizient named its 2026 top performers for quality, recognizing hospitals across seven cohorts and five medical groups for ambulatory care.
  • “The Bernard A. Birnbaum, MD, Quality Leadership Award is based on the Vizient Quality and Accountability Study. The study scores hospitals in six domains: safety, mortality, effectiveness, efficiency, patient centeredness and variation in care, according to a Sept. 24 news release from the company.
  • “The data comes from the Vizient Clinical Data Base, the Hospital Consumer Assessment of Healthcare Providers and Systems survey and the CDC’s National Healthcare Safety Network. The clinical database covers more than 1,600 hospitals across more than 250 health systems in 49 states.”
• and
  • “Chicago-based CommonSpirit recorded an operating loss of $430 million (-1.0% operating margin) in fiscal 2026 — excluding special charges — compared to an operating loss of $687 million (-1.8% margin) the year prior, according to its Sept. 30 financial report.”
• and
  • “Nashville, Tenn.-based Vanderbilt Health recorded operating income of $452 million (4.7% operating margin) in fiscal 2026, compared to operating income of $255 million (3.0% margin) the year prior, according to its Sept. 30 financial report.” 
• and
  • “Morgantown, W.Va.-based WVU Health System has acquired Greensburg, Pa.-based Independence Health System’s five hospitals and their affiliated physician practices and outpatient facilities. 
  • “The hospitals are Butler (Pa.) Memorial Hospital, Clarion (Pa.) Hospital, Frick Hospital in Mount Pleasant, Latrobe (Pa.) Hospital and Westmoreland Hospital in Greensburg. They will begin operating under WVU Medicine’s brand immediately, according to an Oct. 1 news release.
  • “WVU Health System signed a definitive agreement June 2 to acquire the hospitals. The parties shared plans for the acquisition in mid-November 2025.”
• and
  • “Tallahassee-based Florida State University and Tallahassee Memorial HealthCare have finalized core agreements that set the long-term framework for FSU Health, the university’s integrated academic health system for North Florida.
  • “The agreements include lease and operating agreements and other definitive legal documents, including an academic and clinical framework covering Tallahassee Memorial Hospital and a planned FSU Health hospital in Panama City Beach, Fla., according to a Sept. 30 news release.
  • “TMH will keep running day-to-day operations under the FSU Health brand. That includes Tallahassee Memorial Hospital, the future Panama City Beach hospital, TMH’s other clinical sites and its employed physician network, TMH Physician Partners. The deal keeps TMH’s existing charity care policy at both hospitals. It also creates a new governance structure that lets FSU nominate board candidates in Tallahassee and Panama City Beach.”
    
• The Wall Street Journal lets us know,
  • “Walgreens’ private-equity owner is nearing a deal to sell U.K. pharmacy chain Boots for close to $9 billion including debt, according to people familiar with the matter.
  • “It has been discussing a deal to sell Boots to the Canadian arm of the Weston family, which owns a food-business empire, the people said. A deal could be completed in the coming weeks, assuming talks don’t fall apart.
  • “Sycamore Partners took Walgreens private in 2025 in a deal valued at $24 billion including debt (and roughly $10 billion without). It separated the company into five units to facilitate potential sales of noncore units, including Boots.
  • “Boots houses the former international businesses of Walgreens, which includes Boots operations in the U.K. and businesses in Thailand, Mexico, Germany and China.”
• and
  • “France’s Sanofi SAN and Regeneron REGN Pharmaceuticals said they would expand their longstanding alliance to jointly develop and market new immunology medicines, in a deal that could net the U.S. drugmaker up to $8 billion.
  • “The two companies have collaborated for more than two decades in a partnership that spawned one of the top-selling medicines worldwide, Dupixent, approved for a range of conditions that include asthma and eczema.
  • “With Dupixent due to begin losing patent protection in the early 2030s, both sides had signaled they were discussing an updated framework for their relationship.” 

• Fierce Healthcare tells us,
  • “Specialty pharmacy is a key cost driver for employers and insurers, with developments in this space showing no signs of slowing down.
  • “For example, a recent study from the Pharmaceutical Strategies Group found that 43% of employers and benefit leaders view managing specialty pharmacy spend as a top goal. And, per that report, while specialty drugs generally make up about half of the development pipeline, 76% of novel new drugs approved by the Food and Drug Administration in 2025 were specialty products.
  • “It’s with that backdrop that Blues-backed pharmacy benefit manager Prime Therapeutics convened stakeholders from across the pharmaceutical supply chain for its annual Specialty Summit last month. One of the prevailing themes of the conference—a need to break down silos between the pharmacy benefit and medical benefit to more effectively manage the full patient care journey.”
• and
  • “Since 2022, federal price transparency rules have required health insurers to publish their negotiated hospital rates, aiming to give providers, employers and patients greater visibility into healthcare costs. However, the resulting machine-readable files are often so large and inconsistent that most organizations struggle to use them effectively.
  • A single payer’s pricing file can contain billions of rows, often published in varying formats and riddled with errors. According to a recent provider survey, nearly 40% of organizations report limited or no meaningful use of Transparency in Coverage data when preparing for payer negotiations. 
  • Startup Payerset launched four years ago to tackle this challenge, building the infrastructure required to normalize the data and render it usable across the formats healthcare organizations rely on. 
  • The company launched an artificial intelligence-powered, self-service research assistant that unifies negotiated rate data, claims, policy and market benchmarking into one platform. Payerset’s platform draws on 20 trillion rate records retained since 2024, with more than 10 trillion more processed every quarter, according to the company.
  • Using the research assistant tool, health systems can ask plain-English questions about their market position and get instant, data-backed answers, executives say.
  • “It’s like having extra researchers on your team,” Jerry DiMaso, Payerset co-founder and CEO, told Fierce Healthcare.

• Healthcare Dive adds,
  • “Patients are less willing to use artificial intelligence for healthcare if it requires access to personal data or protected health information, according to a new survey.
  • “Healthcare consumers are primarily concerned about data privacy and the accuracy of AI-generated information, with around 89% saying AI responses in healthcare need human oversight, the survey by Wolters Kluwer shows.
  • “This trust gap means that less than a third of U.S. adults are using AI to find a healthcare provider, navigate their health insurance or create a diet plan, even though these applications are frequently marketed as key uses for AI in healthcare.”