Simplicity is a virtue.

From Washington, DC

• Beckers Payer Issues reports,
  • “The Trump administration is overhauling federal price transparency rules for payers and self-insured employers, including cutting so-called “ghost rates,” expanding out-of-network price disclosures and requiring executives to vouch for the accuracy of the data.
  • “The final rule, released Oct. 5 by CMS and the Labor and Treasury departments, revises the price transparency regulations first finalized in 2020 during President Trump’s first term, which have required payers to post their negotiated rates since 2022. Hospitals have been required to post their prices under separate federal rules since 2021. The new rule takes effect Dec. 5, though most of the data requirements will be phased in across 2027. 
  • The change follows a CMS proposal and an executive order from the president last year that directed federal agencies to step up price transparency enforcement.”
• The rule is applicable to the FEHB and PSHBP programs pursuant to the Public Health Act, which CMS regulates.
• Here is a CMS link to the agency’s fact sheet on the new TiC rule.

• Also today, CMS released an update to its Group Health Plan user guide for Section 111 reporting.

• Per a Department of Health and Human Services news release,
  • “The U.S. Department of Health and Human Services (HHS) today announced the appointment of Michael R. Caputo to the President’s Cancer Panel. The panel is an independent federal advisory body charged with monitoring the development and execution of the activities of the National Cancer Program and reporting to the President on progress, efficacy, and opportunities for improvement in the national effort against cancer. The Panel was established by law through the National Cancer Act of 1971.
  • “Caputo brings 35 years of global public affairs experience spanning government, public policy, political campaigns, and the private sector. He previously served as Assistant Secretary for Public Affairs at HHS in 2020, where he led the Department’s communications during the COVID-19 response and helped establish and guide Operation Warp Speed.”

• Beckers Hospital Review lets us know,
  • “Healthcare accounted for about 3 of every 4 U.S. jobs added from September 2025 to September 2026, according to an Oct. 5 analysis from the Peterson-KFF Health System Tracker.
  • “The sector added 372,000 jobs during that period, a 2% increase, while the rest of the economy added 124,000, a 0.1% increase. Healthcare job growth outpaced every other sector, and the industry now makes up a record 11.7% of all U.S. jobs.
  • “In September, healthcare added 17,000 jobs, below its average monthly gain of 33,000 over the prior 12 months, according to Bureau of Labor Statistics data.”
• and
  • “The Federal Trade Commission has warned 24 of the nation’s largest health systems that incomplete, inaccurate or untimely price disclosures could violate federal consumer protection law, even if the organizations comply with CMS’ hospital price transparency requirements.
  • “FTC Chair Andrew Ferguson on Oct. 5 sent letters to the organizations urging them to review their pricing practices and take corrective action where needed, particularly for routine, nonemergency services scheduled in advance.
  • “The letters mark another layer of federal scrutiny for hospitals’ pricing practices. The FTC said CMS’ price transparency rules establish a baseline for disclosures but do not provide hospitals with a “safe harbor” from liability under Section 5 of the FTC Act, which prohibits unfair or deceptive business practices.”

• MedTech Dive adds,
  • “The Advanced Research Projects Agency for Health has awarded more than $100 million to four organizations working on biosensors.
  • “The Massachusetts Institute of Technology received the largest award, securing up to $37.9 million to develop a wearable patch for continuous sensing of heart failure biomarkers.
  • “The other recipients include Novelna, New York University and University of Washington, which are working on devices focused on heart attacks, inflammation and perimenopause. ARPA-H said it plans to commit a total of $117.4 million to the program over 4.5 years.”

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

• Kevin Moss, writing in Federal News Network, explains “how the 2027 FEHB premium increase will impact federal employees and annuitants.”

• FedSmith offers a potpourri of Open Season news.
  • “2027 FEHB Changes: Weight Loss Drug Rules, a New FSA Card, and Plans Leaving
  • “From weight loss drug rules to a new FSA card and plans leaving the program, here are the biggest 2027 FEHB changes to know before Open Season.” * * *
  • “Full FEHB, PSHB, and FEDVIP plan brochures and OPM’s Plan Comparison Tool will be available on OPM.gov in early November.
  • “Open Season changes for non-postal employees take effect January 10, 2027. Changes for PSHB enrollees and annuitants take effect January 1, 2027.”

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

• ABC News reports,
  • “More than 122,000 cases of Gatorade are being voluntarily recalled due to undeclared food dyes, according to the U.S. Food and Drug Administration.
  • “The recalled cases of Gatorade Lemon Lime, Gatorade Lemon Lime Zero, Gatorade Orange and Gatorade Orange Zero were distributed in more than two dozen states, the FDA said.
  • “The recall impacts 28-ounce bottles of Gatorade Lemon Lime, Lemon Lime Zero, Orange, and Orange Zero that did not declare the presence of Yellow No. 6 and/or Yellow No. 5 colors and bear lot dates between April 2027, May 2027 and June 2027. A full list of lot dates and states where the recalled drinks were distributed can be viewed on the FDA website.”

• Per an FDA news release,
  • “The U.S. Food and Drug Administration today announced a request for information (RFI) describing approaches the agency is considering for the design of early-phase clinical trials of ibogaine drug products and seeking public input on those approaches. The RFI seeks comments, data, and information on specific protocol elements relevant to ibogaine drug development, including dose selection and escalation, care setting, safety monitoring, eligibility criteria, stopping rules and safety oversight.
  • “This RFI marks the latest FDA action to advance President Trump’s April 2026 executive order on Accelerating Medical Treatments for Serious Mental Illness, which directed agencies to accelerate research into psychedelic medicine.” * * *
  • “The public will have 45 days following publication in the Federal Register to submit comments, data or information to the docket. Stakeholders are encouraged to submit comments electronically at regulations.gov by searching for Docket No. FDA-2026-N-10429. Written/paper submissions may also be sent to: Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
  • “The comment period closes Friday, November 20, 2026. Late comments will not be considered.”

• Becker’s Hospital Review relates,
  • “The FDA has approved pirtobrutinib (Jaypirca, Eli Lilly) for adults with previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma with no known 17p deletion.
  • T”he Oct. 2 approval was based on BRUIN CLL-313, a trial involving 282 patients randomized 1:1 to receive pirtobrutinib or bendamustine plus a rituximab product for six cycles.
  • With an estimated median follow-up of 28 months, median progression-free survival was not estimable in the pirtobrutinib arm and was 33.5 months in the bendamustine and rituximab arm.
  • Serious adverse reactions occurred in 28% of patients taking pirtobrutinib. The most common nonlaboratory adverse reactions were upper respiratory tract infections (27%), rash (22%) and COVID-19 (21%). The recommended pirtobrutinib dose is 200 milligrams orally once daily until disease progression or unacceptable toxicity. The drug received orphan drug designation.

• Radiology Business tells us,
  • “The U.S. Food and Drug Administration has cleared AI software designed to improve pediatric bone age assessments. 
  • “The 510(k) clearance covers Visiana’s BoneXpert, a machine learning software that determines bone age in patients ages 2 to 21 using the Greulich-Pyle method. The software is intended to support pediatric radiologists in evaluating children with growth and pubertal disorders. 
  • “Bone age assessments are commonly used to evaluate whether a child’s skeletal development is consistent with their chronological age. Manual assessment is a known challenge and can vary between readers, potentially making longitudinal evaluation more difficult.  
  • “BoneXpert addresses this by analyzing radiographs of either hand and providing an annotated image showing the contours of the bones it evaluated and the individual bone ages assigned to them. The software also checks each radiograph and withholds a result when an image falls outside its validated scope, while the radiologist remains responsible for the final assessment and diagnostic decision.” 

• Benzinga adds,
  • “The U.S. Food and Drug Administration has extended its review of Novo Nordisk A/S’ (NYSE:NVO) Biologics License Application for denecimig, an investigational hemophilia A treatment, following a manufacturing plant inspection.
  • “Mike Doustdar, president and CEO of Novo Nordisk, said the company is addressing agency requests as efficiently as possible while working closely with regulators to make better care something patients can count on.”

From the Medicare Advantage front,

• Beckers Payer Issues reports,
  • “Health Care Service Corp. has cut its Medicare Advantage footprint in half less than two years after buying Cigna’s Medicare business for $3.3 billion, but the Chicago-based insurer says the narrowed focus will allow it to achieve sustainable growth over time.
  • “The company is coming off a costly year, posting a net loss of more than $1.9 billion in 2025, after net income of $659 million the year prior. HCSC attributed the loss to elevated utilization and higher acuity across all of its lines of business.
  • “We’re actually at or ahead of most of the targets we set before the deal closed, from an integration and financial performance perspective,” Stephen Harris, president of government markets at HCSC, told Becker’s. “We feel really good about where we are and the momentum we have going into 2027.”

From the judicial front,

• Fierce Healthcare offers a overview of “healthcare’s high-stakes courtroom battles.”

From the public health and medical / Rx research front,

• The Washington Post reports,
  • “Pennsylvania’s measles outbreak has hit a sobering milestone, surpassing 1,000 cases — the first U.S. outbreak to do so in 35 years.
  • “In Pennsylvania, the virus has moved through communities where many children and adults have gone years without the two doses of measles vaccine needed for reliable protection. The widening outbreak has infected 1,004 people spread across 39 counties and hospitalized nearly 200 people, authorities reported Monday.”

• The New York Times adds,
  • “Gov. Kathy Hochul declared a statewide health emergency in New York State on Monday as measles cases increased dangerously across rural counties where vaccination rates have lagged.
  • “As of Saturday, 108 measles cases had been reported across the state this year, the most since 2019, when New York was the epicenter of a national outbreak. Most of the cases are in rural areas, concentrated in the Finger Lakes region.
  • “Ms. Hochul’s declaration will relax rules about who can administer vaccines to make it easier for midwives, pharmacists and other health care workers to give shots to prevent measles.”

• NBC News relates,
  • “The chickenpox vaccine appears to protect against shingles, according to a large new analysis. 
  • “Anyone who got infected with chickenpox as a child is at risk of later developing shingles, a painful, blistering rash that usually appears on one side of the body. For unknown reasons, cases of shingles have been gradually rising, even among younger adults, research has shown.
  • “However, new data suggests that a steep decline in chickenpox cases over the last three decades, thanks to the chickenpox vaccine, may contribute to a decline in shingles in the coming years.
  • “New data suggests that people ages 34 and younger may be less likely to develop shingles than previous generations. That’s because they are more likely to have been vaccinated against the varicella zoster virus, or chickenpox, which can reactivate years later as shingles.
  • “Our data suggest that trend is now reversing in the very youngest adults, the first generation eligible to be vaccinated against chickenpox as children,” said registered nurse Kersten Bartelt, lead author of the report from Epic Research, which conducts research on health trends.”

• MedPage Today tells us,
  • “Hormone therapy should be the first-line treatment for women with menopausal vasomotor symptoms, according to new guidance from the American College of Physicians (ACP).
  • “Women with a uterus should receive estrogen in combination with progestogen, while those without a uterus can receive estrogen monotherapy as first-line therapy, according to ACP’s new clinical guidelineopens in a new tab or windowon pharmacologic treatments for vasomotor symptoms.
  • “Both are listed as strong recommendations based on high-certainty evidence, Amir Qaseem, MD, PhD, MHA, and guideline authors wrote in the Annals of Internal Medicine.”

• Beckers Behavioral Health calls attention to “the drug trends mot worrying to behavioral health leaders.”
  • “Fentanyl is no longer the only substance keeping addiction clinicians up at night. Some of the newest threats are being sold not by dealers, but at gas stations, smoke shops and online.
  • “From potent animal sedatives contaminating the opioid supply in the Northeast and Midwest to concentrated kratom derivatives marketed as botanical supplements, the substances patients are using are changing faster than the systems built to respond to them. At the same time, technology is making behavioral addictions such as online sports betting more accessible than ever. 
  • “Becker’s asked three psychiatry and addiction medicine leaders what trends they are seeing among their patients, which drugs they expect to take off and what worries them most.”

• Cardiovascular Business informs us,
  • “Orforglipron, a GLP-1 pill being sold by Eli Lilly and Company under the brand name Foundayo, is both safe and effective in obese or overweight patients with type 2 diabetes. That was the primary takeaway from new data presented at the European Association for the Study of Diabetes annual meeting in Milan, Italy, and simultaneously published in The Lancet.[1]
  • “In April, the U.S. Food and Drug Administration (FDA) approved orforglipron as a once-daily treatment for weight-related medical problems in obese and overweight adults. When the FDA requested additional data on the drug’s effect on cardiovascular outcomes, Lilly shared early positive results from ACHIEVE-4, a randomized trial of more than 2,700 patients who received either orforglipron or insulin glargine. Now, the full results of that analysis have been shared with the public for the first time.
  • “Overall, the researchers behind ACHIEVE-4 found that orforglipron was associated was a 16% lower risk of major adverse cardiovascular events (MACEs) than insulin glargine. A MACE was defined as either cardiovascular death, a heart attack, a stroke or a hospitalization for unstable chest pain. This finding met the prespecified criteria to be seen as noninferior to insulin glargine.”

• BioPharma Dive points out,
  • “An experimental pneumococcal vaccine from Vaxcyte succeeded in the first of three late-stage studies, sending the biotechnology company’s shares soaring and inching it closer to a potential regulatory submission.
  • “Called VAX-31, the shot met all of its main efficacy objectives in the study. Among adults 50 years or older, VAX-31 matched the effectiveness of Pfizer’s Prevnar 20 and Merck & Co.’s Capvaxive in protecting against 28 strains of the bacteria that causes pneumococcal disease and proved superior against three “unique” strains. VAX-31 was inferior compared to Capvaxive on two strains when using a more rigorous statistical threshold. But that finding surpassed analyst and investor expectations heading into the readout.
  • “Vaxcyte said its vaccine was “well tolerated” and demonstrated a safety profile similar to Prevnar 20 and Capvaxive across all ages studied. The most common adverse events were “generally mild-to-moderate,” and the majority resolved within two days of vaccination. Vaxcyte will report results from two additional late-stage trials next year and seek approval if the data are positive.”

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

• STAT News reports,
  • “Workers and employers are drowning in their health insurance premiums. The reason for that deluge: the health care industry’s high and inscrutable prices.
  • “Health insurers don’t set their premiums in a vacuum. The biggest factor is the care people receive. And the biggest factor driving the cost of that care, STAT has found, is not how often people are going to the hospital or doctor’s office, but the out-of-control prices charged by every part of the health care industry, which workers and businesses are often powerless to stop.
  • “For Gerard Anderson, America’s high prices are as obvious, yet unnoticeable, as the oxygen we breathe. He has studied health care spending and policy for the past four decades, even helping design Medicare’s hospital payment system in the 1980s. He co-wrote a seminal paper in 2003, and again in 2019, that blared the culprit of America’s outlier health spending figures: “It’s the prices, stupid.” 
  • “Some things don’t change,” Anderson, a professor at Johns Hopkins, told STAT. 
  • “One thing is changing, however, Anderson said. He and others are working with state policymakers and employers, who are signaling an openness to government intervention to curb health care costs — an idea normally anathema in the private sector.”

• BioPharma Dive relates,
  • “Shionogi is expanding in rare diseases, announcing Monday a deal to acquire Texas-based IntraBio for a drug called Aqneursa that has gained approvals in two inherited disorders.
  • “Per deal terms, Shionogi will pay IntraBio’s shareholders $2 billion in cash and turn the company into a wholly owned subsidiary of its New Jersey-headquartered U.S. division. Shionogi said it will review the transaction’s effects on its financial outlook for the current fiscal year, which ends next March.
  • “The transaction will help expand a rare disease business Shionogi launched with the acquisition last year of the ALS drug Radicava from Tanabe Pharma. Aside from Radicava, Shionogi’s U.S. portfolio includes the COVID-19 medicine Xocova and a treatment for complicated urinary tract and hospital acquired respiratory infections.”

• The Wall Street Journal adds,
  • “GE HealthCare Technologies GEHC said Monday it planned to purchase a manufacturer of radioactive substances used in medical imaging procedures for $945 million in cash.
  • “The deal marks a continued push by medical-equipment maker GE HealthCare into the growing market for radiopharmaceuticals, which have uses for both diagnosing and treating diseases including cancer, heart disease and Alzheimer’s. 
  • “Drugmakers such as Novartis and other devicemakers have been investing in the segment. In August, Curium struck a deal to acquire Lantheus Holdings for an initial $6.7 billion in a consolidation of two radiopharma companies.”

• Beckers Hospital Review tells us,
  • “Chicago-based CommonSpirit Health will consolidate its five regions into three service areas, West, Central and East, effective in January, CFO Michael Browning said during the system’s fiscal 2026 earnings call Oct. 2.
  • “The change replaces the California, Central, South, Mountain and Northwest regions established after a 2024 portfolio review that consolidated eight operating divisions into five. Each service area president will sit on the system’s enterprise leadership cabinet.
  • “CommonSpirit confirmed in a September statement to Becker’s that it was evolving its operating model “to better leverage our system scale and more effectively support our markets.”
• and
  • “Salt Lake City-based Intermountain Health is exiting Trinsic, a Colorado clinically integrated network it operates as a joint venture with Aurora, Colo.-based UCHealth, with UCHealth taking over the network after Dec. 7, according to a WARN notice Intermountain filed Oct. 2 with the Colorado Department of Labor and Employment.
  • “The notice says Trinsic’s Broomfield, Colo., operating unit will close Dec. 4 and 117 employees will be affected, with first separations expected Dec. 9. Affected roles include 29 nurse care managers, 24 clinical care coordinators and 14 nonclinical care coordinators.
  • “Intermountain said in the notice that it expects most, if not all, Trinsic employees who live and work in Colorado will have the opportunity to keep working for Trinsic, subject to UCHealth’s hiring decisions. Employees who live and work outside Colorado may not have the same opportunity.”

• Fierce Healthcare informs us,
  • ‘Trinity Health grew its operating income from a narrow loss to a $281.1 million gain (1.1% operating margin) in the fiscal year ended June 30, 2026, a performance improvement the large nonprofit attributed to stronger volumes, expense management and payment rates. 
  • “Operating revenue across the organization rose 5.2% year over year to $26.8 billion, outpacing a 4.4% rise in operating expenses, according to recently shared financial documents. 
  • “When disregarding “other items” including asset impairment charges ($42.7 million in FY2026) and restructuring costs ($103.9 million in FY2026), the 91-hospital system more than doubled its operating income to $427.8 million (1.6% operating margin) in the fiscal year ended June 30, 2026, its management touted in a financial summary.”
• and
  • “iRhythm completed on Monday its acquisition of cardiac remote patient monitoring company VitalConnect for $237.5 million.
  • “iRhythm provides end-to-end cardiac monitoring services, while VitalConnect’s monitoring platform supports multiple modalities—and has the capability to monitor up to 11 physiological parameters, according to an Oct. 5 press release.
  • “In addition to the $237.5 million deal, iRhythm provided VitalConnect with $10 million in working capital between signing and closing, executives say. The acquisition is expected to increase iRhythm’s revenue growth rate and maintain its 15% adjusted EBITDA margin target for 2027.”
• and
  • “Grindr is ramping up its focus on healthcare with plans to acquire PurposeMed Inc., the parent company of telehealth provider Freddie.
  • “Freddie provides access to HIV prevention and PrEP care through telehealth visits. Grindr plans to pick up PurposeMed for $250 million in cash and stock, consisting of $190 million in cash and $60 million in Grindr common stock. 
  • “The agreement also includes the potential for up to $70 million in additional cash consideration tied to 2027 performance targets, payable in 2028. The companies expect the deal to close in the fourth quarter, subject to applicable closing conditions.”

• Beckers Clinical Leadership points out the ten most in-demand physician specialties.
  • “Hematology/oncology
  • “Gastroenterology
  • “Cardiology (interventional)
  • “Endocrinology
  • “Cardiology (noninvasive)
  • “Radiology
  • “Urology
  • “Anesthesiology
  • “Neurology
  • “Obstetrics/gynecology
    • View the full report here.

From the Nobel Prize front,

• The Wall Street Journal reports,
  • “A trio of neuroscientists were awarded the 2026 Nobel Prize in Physiology or Medicine for their pioneering work on optogenetics, a method of controlling nerve cells with light, which makes it possible to study how the brain shapes memories, feelings and behaviors.
  • “Announcing the prize recipients Monday at the Karolinska Institute in Stockholm, the Nobel committee said the work of Drs. Karl Deisseroth, Peter Hegemann and Georg Nagel had laid the foundation of a new era in neuroscience.
  • “The work “unlocked new understanding of how the brain works, new possibilities for treating neurological and psychiatric disorders,” said Jonathan Levin, president of Stanford University, where Deisseroth is a neuroscientist and psychiatrist. 
  • “Hegemann is based at Humboldt University in Berlin and Nagel at the University of Würzburg in Germany.”