Simplicity is a virtue

From Washington, DC

• Per a Department of Labor news release,
  • “The U.S. Department of Labor’s Employee Benefits Security Administration today finalized a landmark rule that will require pharmacy benefit managers and their affiliated brokers and consultants to disclose their fees and compensation to large employers’ self-insured group health plans. 
  • “In finalizing this rule, the Department has ensured that employers can see how much drug manufacturers, pharmacies, and others pay pharmacy benefit managers for the first time. Employers can use that information to negotiate contracts and seek lower prescription drug costs for workers and their families.” * * *
  • Issued under ERISA’s statutory service provider prohibited transaction exemption, the final rule requires PBMs to disclose the following information for the first time:
    • Rebates and other payments from drug manufacturers.
    • Compensation received when the price paid by the plan for a prescription drug exceeds the amount reimbursed to the pharmacy. 
    • Payments recouped from pharmacies in connection with prescription drugs dispensed to plan participants.   
  • “The final rule also allows plan fiduciaries to audit the accuracy of PBM disclosures and provides additional relief for plan fiduciaries if a PBM fails to meet its obligations.
  • This final rule is applicable to plan years beginning on or after July 1, 2027.
  • “Read the notice of the final rule on pharmacy benefit manager disclosures.”

• The American Hospital Association News relates,
  • “A coalition of healthcare organizations, including the AHA, sent a letter Oct. 27 to the Center for Medicare and Medicaid Innovation recommending changes to its Ambulatory Specialty Model. The mandatory payment model, set to begin Jan. 1, 2027, focuses on specialty care for beneficiaries with heart failure or low back pain. The organizations recommended delaying the launch of the model and holding participants harmless from downside risk in the first year if the launch is not delayed. They also requested CMMI to maintain ongoing communications and support, including timely data, operational guidance, technical support and a single, consolidated help desk. Additionally, the organizations urged CMMI to share prospective performance thresholds for cost and quality performance categories prior to the model’s start date. CMMI was also asked to allow practice-level reporting of quality measures to align with other Centers for Medicare & Medicaid Services models and programs and minimize participant burden.”
•  and
  • “Extending Medicaid coverage by 12 months following childbirth increased use of postpartum care among mothers with pregnancy complications such as diabetes and hypertension, according to a study published Oct. 14 by the Columbia University Mailman School of Public Health. The study analyzed Medicaid claims data on births from 2019-2023 in New York and Texas. Researchers found postpartum outpatient visits rose 28% for those with diabetes and 19% for those with hypertension in New York, and 58% and 51% in Texas, where baseline postpartum care rates were lower. Diabetes screening increased 5 percentage points in New York and 12 in Texas. Diabetes screening then declined in Texas after coverage ended during the unwinding of the continuous enrollment provision of the COVID-19 public health emergency.”

• Modern Healthcare tells us,
  • “The Centers for Medicare and Medicaid Services is offering states mitigation strategies as they hustle to implement Medicaid work requirements by the Jan. 1 deadline. 
  • “CMS has created checklists of mitigation strategies states can choose to implement as they race to complete their work requirement verification systems. Starting next year, most working-age adults without disabilities must prove they work, volunteer or go to school for at least 80 hours a month to qualify for Medicaid.
  • “States seeking flexibility from CMS will need to identify actions that may not be complete before the deadline, explain how they intend to resolve those problems and offer alternative implementation timeframes, according to the memo CMS sent to states. CMS will conduct its own analyses and approve flexibilities or offer enforcement discretion.” 

• Healthcare Dive discusses “Prior authorization in the real world: Takeaways from Epic ahead of looming API deadline.”
  • “As a Jan. 1 deadline looms for payers to adopt new prior authorization tech, Epic’s Vice President of Value-Based Care Ryan Bohochik breaks down the industry’s progress so far.”
  • “CMS-regulated payers, such as Medicare Advantage, Medicaid and marketplace insurers, are now confronting a Jan. 1 deadline to implement the three prior authorization application programming interfaces — sets of rules that enable computer programs to communicate directly with one another —  under a federal interoperability rule that was finalized in 2024.”

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

• Fedweek reports,
  • “OPM has stressed to agencies the legal protections for federal supervisors and managers who take disciplinary actions against their subordinates and for federal employees who report issues with performance or conduct that can lead to such actions.
  • “OPM has received reports from some agencies that employees are reluctant to report a colleague’s misconduct or to serve as a witness — and supervisors and managers are reluctant to recommend or propose discipline — because they fear the subject of the report will respond with an equal employment opportunity (EEO) complaint, a grievance, an Inspector General (IG) complaint, or some other proceeding naming them personally,” says a memo.
  • “Some of the reluctance reported to OPM rests on an understandable but mistaken premise: that an EEO complaint, grievance, or appeal filed by the subject of a report is a proceeding against the official who made it. It is not,” it adds.”

• FedSmith discusses “When an HDHP and HSA Make Sense—and When They Don’t.”
  • “Learn how FEHB High-Deductible Health Plans with HSAs can lower premiums, offer tax advantages, and build long-term healthcare savings.”
• and points out
  • “Before federal managers call employees resistant to AI, they should find out what employees are resisting. The same hesitation may reflect fear of job loss, uncertainty about approved tools or a legitimate concern that AI-generated information could be wrong. The overhaul of federal employee surveys gives agencies an opportunity to ask.”

• Tammy Flanagan, writing in Govexec, answers “more Medicare questions? Here’s what federal retirees need to know.”
  • “Got questions about HSA contributions, TRICARE For Life or keeping FEHB or PSHB when you enroll in Medicare? Here are answers to help you navigate the details of your federal health benefits.”

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

• Bloomberg Law reports,
  • “Infant formula manufacturers face new requirements to change the amount of four nutrients they must include in products designed to replace or supplement breast milk under a proposed rule the FDA released Thursday. 
  • “A baby formula product’s level of iodine, Vitamin A, Vitamin D, and manganese would have to change under the Food and Drug Administration’s proposal, which estimates implementing the changes by reformulating and relabeling products will cost manufacturers between $8.4 million to $31.7 million annually. 
  • “The agency’s proposal comes after the Trump administration in 2025 launched the first comprehensive review in decades of nutrients FDA regulations require in baby formula products.” 

• A Department of Health and Human Services news release adds, “While that process moves forward, the FDA is taking action now — releasing new chemical contaminant testing data showing that most infant formula samples had low or non-detectable levels of contaminants.”

• The Pharmaletter relates,
  • “German drugmaker Stada said Thursday that the US regulator has approved Lucamzi (ranibizumab-blrz), a biosimilar to Lucentis (ranibizumab), providing another treatment option for wet age-related macular degeneration (wAMD) and other serious eye conditions.
  • “The company and its partners are finalizing preparations for a US commercial launch. Stada did not disclose a launch date or price in its announcement, although it said the product would offer a lower-cost option and help improve patient access.”

• Reuters tells us,
  • “The US Food and Drug Administration on Thursday warned of safety ​risks associated with Medline (MDLN.O), opens new tab beds and accessories after ‌the company reported two deaths and 16 serious injuries linked to fire, entrapment and asphyxiation hazards.
  • “According to the regulator, Medline has ​told customers it is discontinuing and exiting the ​market for all Medline-branded beds and associated products, ⁠including homecare, bariatric and long-term care beds, as ​well as pendants, accessories and replacement parts.”

• Cardiovascular Business tells us,
  • The U.S. Food and Drug Administration (FDA) has shared an update about an alert the agency first published in September about certain Automated Impella Controllers (AICs) from Johnson & Johnson MedTech. 
  • At the time, the FDA said these devices should be removed from where they are used or sold, but it was still investigating the issue to learn more. Now, with its investigation complete, the agency has officially ruled that this is a Class I recall, which means using the devices could cause “serious adverse health consequences or death.”
• and
  • “Medtronic is recalling its CareLink SmartSync device manager due to a risk of inaccurate longevity estimates being displayed for the Micra AV2 leadless pacemaker or Micra VR2 leadless pacemaker. Unlike many recalls, no devices need to be returned to the manufacturer. Instead, customers can download a software update to resolve the issue going forward.
  • “The U.S. Food and Drug Administration (FDA) has ruled this a Class II recall, which means using the technology without a software update could cause “temporary or medically reversible adverse health consequences.” No adverse events have been reported at this time.
  • “Click here for additional details from the FDA.”

From the public health and medical / Rx research front,

• Reuters reports,
  • “With wildfires becoming larger and more prevalent, ​today we report on a study that suggests a link between exposure during pregnancy to harmful particles in smoke from the ‌infernos and autism in the women’s children. Speaking of harmful particles, we also feature a study that may have discovered one way in which microplastics in our systems are causing health problems.”

• Beckers Clinical Leadership adds,
  • “A PNAS analysis led by Stanford researchers suggests earlier estimates of long COVID’s effects may have been inflated by how studies selected their comparison groups, though the authors said the findings do not mean long-term symptoms are not real.”

• Health Day relates,
  • “More people in the United States are vaping and at a higher frequency since 2013, according to a study published online Oct. 20 in Tobacco Control.
  • “Makenna N. Gomes, from the University of Waterloo in Ontario, Canada, and colleagues examined population-level patterns of e-cigarette use between 2013-2014 and 2022-2023 in both youth (aged 12 to 17 years) and adults. The total number of vaping days was determined using data from the Population Assessment of Tobacco and Health study.
  • “The researchers observed increases in total vaping days (+183 percent), past 30-day vaping (+45 percent), and daily vaping (+230 percent) over time. Among those under the minimum legal age of 21 years and those who vaped in the past 30 days, vaping days more than quadrupled (+337 percent) and accounted for 16 percent of all vaping days in the 2022-2023 wave. Since the pandemic, adult vaping days continued to increase due to increases in vaping frequency and population growth.”
• and
  • “Suicidal thoughts and actions spiked among middle-aged and senior Americans in the years following the COVID-19 pandemic, a new study says.
  • “Suicidal thoughts increased by nearly 43% among Americans 50 and older, according to findings recently published in the Journal of Affective Disorders.
  • “Meanwhile, suicide planning and suicide attempts more than tripled, researchers found.
  • “These increases were concentrated among people without traditional risk factors for suicide, such as major depression or alcohol use disorder, researchers said.
  • “These findings suggest that many older adults who are struggling are not the ones our current screening approaches are designed to catch,” noted lead researcher Dr. Kevin Yang, a research fellow in psychiatry at the UCLA National Clinician Scholars Program.
  • “If a growing share of suicidal thoughts and plans is showing up in people without a depression diagnosis or recent substance use, we need to rethink how we identify risk and reach older adults before a crisis occurs,” Yang said in a university news release.”

• STAT News tells us,
  • “For years, scientists have struggled to elucidate key biological differences between early onset colorectal cancer, typically in patients under the age of 50, and older patients. They’ve long believed that these cancers must be biologically distinct, since younger patients tend to be far more difficult to treat. They’re often diagnosed at later stages with tumors with more aggressive features.” * * *
  • On Thursday, Kimmie Ng, a colorectal cancer researcher and director of the Dana-Farber Cancer Institute Young-Onset Colorectal Cancer Center published a new study in Nature Medicine that may help illuminate critical differences between older and younger colorectal cancer patients. With 189 tumors, it’s the largest biological database — what researchers call a single cell atlas — of colorectal cancer tumors in patients ranging from their 20s to their 90s. The atlas, along with the technology Ng and her colleagues used, should help researchers control for variables that confounded studies in the past.
  • “It has the largest number of young onset tumors, 54 of them,” Ng said. “We intentionally designed our study to try to overcome these prior limitations in the published literature.”
  • “The atlas has enabled Ng and her team to see some characteristics  that may set early onset colorectal cancers apart. In particular, their analysis suggested that tumors in younger patients seem to be surrounded by a different cell environment that may make it more difficult for chemotherapies and immunotherapies to attack them. They also seem to have genetic differences that are associated with more aggressive and metastatic behavior.”
  • The article includes an interview with Dr. Ng.

• Beckers Hospital Review informs us,
  • “A case report from researchers at the University of Colorado Anschutz Medical Campus in Aurora links tirzepatide, sold as Zepbound, to lithium toxicity in a 50-year-old woman with bipolar disorder. It is the fourth reported case of tirzepatide-associated lithium toxicity, MedPage Todayreported Oct. 26.
  • “Jay Davis, MD, and colleagues published the case in the Journal of Clinical Psychopharmacology. The patient’s serum lithium level was 0.7 mmol/L before she started weekly 2.5-milligram tirzepatide injections for weight management.
  • “Three weeks later, she arrived at a psychiatry appointment with a tremor in both hands, slurred speech and blurred vision. Her lithium level had climbed to 1.2 mmol/L. She had not changed her lithium dose or started other drugs, but said she was eating smaller meals and feeling full sooner.
  • “Her physicians cut her nightly lithium dose from 900 milligrams to 450 milligrams, and her symptoms resolved. Her lithium level measured 0.4 mmol/L 17 days later. She and her physician decided not to restart tirzepatide.
  • ‘Dr. Davis told MedPage that the leading explanation is that eating and drinking less causes the kidneys to reabsorb more lithium. He said incretin drugs will likely be prescribed more often to patients on lithium, and awareness of the interaction still needs to grow.”

From the U.S. healthcare business front,

• The Wall Street Journal reports on several quarterly financial reports from pharmaceutical manufacturers.
  • “Gilead Sciences raised its full-year product sales guidance to between $31 billion and $31.3 billion.
  • “The company’s third-quarter revenue grew to $8.3 billion, driven by strong sales in its HIV portfolio.
  • “The company’s third-quarter profit came in at $2.43 billion, down from $3.05 billion a year earlier.”
• and
  • Merck’s third-quarter sales rose 5% to $18.09 billion, beating Wall Street expectations.
  • The cancer drug Keytruda generated $8.6 billion in sales, representing nearly half of Merck’s total worldwide sales in the quarter.
  • Merck raised its full-year adjusted earnings forecast to a range of $2.77 to $2.82 per share.
• and
  • “Eli Lilly’s third-quarter revenue rose 39% to $24.4 billion, driven by high demand for its diabetes and obesity drugs Mounjaro and Zepbound.
  • “The pharmaceutical company raised its full-year revenue guidance to a range of $91 billion to $92 billion.
  • “Eli Lilly executives said a majority of new patients in Medicare’s Bridge coverage expansion program started on one of the company’s medicines.”
• and
  • “Bristol Myers Squibb raised its full-year revenue outlook after third-quarter revenue increased 7% to $13.1 billion.
  • “The company’s third-quarter net income was $2.2 billion, or $1.05 a share, compared with $2.2 billion, or $1.08 a share, a year earlier.
  • “Bristol Myers Squibb cut its full-year adjusted earnings view to $6.35 to $6.55 a share due to charges and licensing impacts.”

• Fierce Healthcare relates,
  • “Strong performance across its hospital and ambulatory businesses during the third quarter led Tenet Healthcare to raise its 2026 earnings guidance by 4%, with executives asserting that the core strength of operations will yield continued earnings growth in 2027 despite policy headwinds. 
  • “The for-profit this week reported $5.63 billion in net operating revenues for the quarter, not counting $646 million in contract termination revenue tied to its divorce with CommonSpirit Health that was recognized during the quarter. The tally was 6.5% above the same period last year and above the $5.47 billion consensus estimate, per Zacks Investment Research. 
  • The bigger standouts were its $6.64 adjusted earnings per share, well above the prior year’s $3.70 earnings per share and more than 40% above the consensus estimate of $4.60 per share. “Further, executives highlighted third-quarter adjusted EBITDA of $1.36 billion (about 16% above the street, per Stephens), about 10% year-over-year growth when excluding $147 million in one-time items stemming from the shifting timing of its CommonSpirit contract winddown.”

• Beckers Hospital Review tells us,
  • “Seattle-based Fred Hutchinson Cancer Center recorded operating income of $25.7 million (1% margin) for fiscal year 2026, down from operating income of $82.8 million (3.3% margin) in fiscal 2025, according to its audited financial statements for the 12 months ended June 30. 
  • “Fred Hutch reported total revenue of $2.7 billion in fiscal 2026, a 6.4% increase year over year. Patient service revenue rose 17% to $1.9 billion, while research grants and contracts revenue decreased 1.4% to $493 million. Contributions decreased 27.1% to $141.8 million, and investment income and realized gains fell 44.3% to $76.9 million.
  • “Total expenses were $2.6 billion for fiscal 2026, a 9% increase year over year. Supplies and pharmaceuticals rose 21.7% to $891.1 million. Salaries, wages and benefits increased 5.4% to $902.7 million, and purchased services were flat at $349.2 million.”
• and
  • “Salisbury, Md.-based TidalHealth reported a $49.1 million operating loss (-3.8% margin) in the fiscal year ending June 30, 2026, compared to a $33.9 million operating loss (-3.4% margin) in 2025, according to financial documents posted Oct. 28.”
    
• Beckers Behavioral Health informs us
  • “Houston-based PsychPlus has acquired Precision Psychiatric Services, a California psychiatric group, adding more than 100 psychiatrists to its clinical network. PsychPlus announced the deal Oct. 23. Financial terms were not disclosed.
  • Precision, founded in 2018, is a physician-led organization with hospital partnerships across California. It provides psychiatric care in emergency departments, inpatient behavioral health facilities, medical-surgical units, outpatient clinics and addiction treatment settings. Its hybrid model pairs in-person psychiatry with telepsychiatry.
  • “PsychPlus plans to use the combined network to help hospitals and health systems manage psychiatric workforce shortages, expand clinical coverage and improve patient throughput.
  • “Precision has built an exceptional psychiatric organization with deep clinical expertise and strong hospital relationships throughout California,” said Faisal Tai, MD, founder and CEO of PsychPlus.”

• Fierce Healthcare points out.
  • “Optum Rx is launching a new program that aims to integrate specialized care for women navigating menopause into the pharmacy benefit.
  • “The program is a virtual-first offering that connects eligible women with clinicians that have been certified with the Menopause Society. Through the program, they can access both hormonal and nonhormonal therapies, symptom tracking, education and one-on-one patient coaching.
  • “Tracy Spencer, senior vice president for product and strategy at Optum Rx, told Fierce Healthcare that 50 million women are currently experiencing symptoms related to either perimenopause, menopause and post-menopause. And 40% of those women say those symptoms impact their work performance.
  • “This is an area that remains one of the most underserved in healthcare, which is why we’re here today, because closing that gap for women’s health is really important,” Spencer said.”
• and
  • “Blue Cross Blue Shield of Massachusetts is teaming up with precision medicine company Medzown to make it easier for members with complex conditions to participate in clinical trials.
  • “In the partnership, Medzown’s tech stack will identify the members that are most likely to benefit from a novel therapy for their condition and then match them with potential clinical trials. The company will then deploy a team of scientists, clinical trial experts and care navigators to work alongside the patient and their care team through the process.
  • “Jennifer Levin Carter, M.D., the CEO of Medzown, told Fierce Healthcare that there’s no shortage of new drugs and therapies coming through the pipeline for complex diseases like cancer, but access is a significant challenge.
  • “The next frontier for precision medicine is making sure that the right patient can actually get access,” Carter said.”
    
• Healthcare Dive notes,
  • “When nine widely used AI models were prompted with questions about medication dosing, about 19.5 per 1,000 answers contained an error that was serious or potentially lethal, according to new research from health tech company Doximity.
  • “Doximity’s research, which was launched in tandem with the company’s new dose verification tool, claims other popular AI models got doses wrong in at least 2.3% of answers.
  • “It’s the company’s latest attempt to differentiate itself from major AI companies like OpenAI and Anthropic that are expanding their presence in healthcare.”