Simplicity is a virtue.
From Washington, DC,
- Beckers Payer Issues reports,
- “The House Committee on Oversight and Government Reform announced an investigation into pharmacy benefit managers Optum Rx, CVS Caremark and Express Scripts Oct. 23, reviewing their auditing practices of independent pharmacies.
- “The investigation stems from concerns “that independent pharmacies have potentially been targeted for punitive audits in retaliation for their public support of legislation recently passed by the committee,” the committee’s chairman, James Comer, R-Ky., said.
- “Under HR 6610, PBMs for Federal Employees Health Benefits Program plans would pay in-network pharmacies a benchmark price with a capped margin. The PBMs would also pay a dispensing fee that aligns with what the state Medicaid program pays. The Pharmaceutical Care Management Association, which represents PBMs, pushed back against the bill amid the committee’s July markup.
- “Let’s understand this bill for what it is: a huge cash transfer from taxpayers to pharmacists and nothing more,” PCMA President and CEO David Marin said in a July 22 statement. “It makes providing health benefits to federal workers far more expensive, simply as a gift to one industry.”
- “Mr. Comer said that since the July markup, several independent pharmacies that backed the bill received more audit notices than usual.”
- The FEHBlog heartily agrees with PCMA. The FEHB and PSHB programs should not be treated like test subjects.
- Beckers Hospital Review explains the “6 ways the federal government is going after drug prices.”and lists “Medicare’s proposed 2027 pay cuts, by specialty.”
- The American Hospital Association News relates,
- “The Centers for Medicare & Medicaid Services has launched a new initiative to help recruit and retain nurses in nursing homes, the agency announced Oct. 23. Under the Nurses for Nursing Homes initiative, nursing students and licensed nurses interested in working in a nursing home could be eligible to qualify for up to $40,000 in student loan repayment and/or a $10,000 stipend in exchange for a three-year commitment to work in a qualifying nursing home in a rural or higher labor-shortage area. CMS said the $275 million program is expected to support more than 4,000 nurses nationwide and will be funded through civil monetary penalties collected by CMS and states from nursing homes. CMS has committed $100 million, while states are committing to at least $175 million. A website for the program includes details on eligibility requirements, open positions, details on how to apply and other information.”
- and
- “The Centers for Medicare & Medicaid Services Oct. 23 released a proposed rule implementing new Health Insurance Marketplace eligibility verification requirements enacted under public law 1, which was signed into law in July 2025. Beginning in plan year 2028, this proposal would require the Marketplaces to verify certain eligibility information before providing advance premium tax credits and cost-sharing reductions, particularly related to citizenship and lawful presence status; residency; non-employer-sponsored minimum essential coverage; and annual household income, family size and eligible noncitizen status. The rule also would require enrollees to provide or confirm key eligibility information annually to continue receiving financial assistance, essentially ending automatic reenrollment for enrollees receiving premium tax credits. Comments are due 30 days after publication in the Federal Register.”
- Over the past week, CMS has issued news releases about contributions to the following State rural health programs:
- STAT News tells us,
- “The Trump administration late on Thursday proposed a rule that would severely restrict future U.S. investment in the Chinese biotech sector but still allow American drugmakers to buy the rights to medicines invented in the country.
- “The Treasury Department proposed the rule to implement a law, called the Comprehensive Outbound Investment National Security Act, that restricts U.S. investment in industries of concern to national security. The department added biotechnology to the list of industries subject to COINS restrictions, joining the likes of semiconductors, artificial intelligence, and quantum technology.
- “The proposal would prohibit U.S. companies from entering financial transactions with Chinese biotech companies or Chinese manufacturers of biotechnology-related equipment and tools, according to the research firm Veda.
- “We are surprised by the aggressiveness of the proposed rule,” Veda stated in a research note to clients. “Both in terms of its prohibition of all biotechnology-related transactions and the broadness of the definition of biotechnology.”
From the U.S. Office of Personnel Management front,
- Kevin Moss, writing in Federal News Network, points out “What’s changing in FEHB for 2027 (and ways to save)” during the Federal Benefits Open Season which begins on November 9, 2026.
- Fedsmith calls attention to benefit matters that federal and postal employees and annuitants may need to address before yearend.
From the U.S. Food and Drug Administration front,
- Beckers Health IT reports,
- “The FDA has issued its most serious recall classification for certain hospital glucose meters after a software issue that could cause test results to be assigned to the wrong patient was linked to one serious injury.
- “The recall affects Nova Biomedical’s StatStrip Glucose Hospital Meter System Gen 2.0, a handheld device used by hospitals to measure patients’ blood glucose levels.”
- Beckers Hospital Review adds,
- “The FDA has warned Baxter International over significant manufacturing violations at its Baxter Healthcare drug manufacturing facility in Round Lake, Ill., including deficiencies involving contamination controls and sterile injectable production.
- “The agency identified the violations during a March 23-April 2 inspection, according to a Sept. 29 warning letter. The FDA said environmental monitoring had detected cephalosporin in multiple areas outside the intended production area since January 2025 and cited deficiencies in Baxter’s monitoring program.
- “The FDA also identified deficiencies involving aseptic processing, visual inspection of sterile injectable drugs and investigations into leaking products and sterility failures. The agency said Baxter’s current equipment, process and airflow design posed “excessive contamination risk.”
- MedTech Dive relates,
- “Edwards Lifesciences has won Food and Drug Administration approval for its Pascal Precision system for tricuspid valve repair, the company said Wednesday.
- “Pascal’s expanded label covers use in patients with symptomatic severe tricuspid regurgitation. Edwards previously received FDA approval for the device in degenerative mitral regurgitation.
- “The approval should expand the group of tricuspid repair patients that Edwards can treat, Leerink Partners said in a note to investors.”
- PharmExec informs us,
- “The FDA today approved a subcutaneous induction regimen for AbbVie’s Skyrizi (risankizumab-rzaa) in adults with moderately to severely active Crohn’s disease. The decision lets patients start treatment at home with an on-body injector (OBI) induction pack instead of an intravenous infusion and continue with the same device during maintenance.1
- “AbbVie filed for the new regimen April 27 and had said it anticipated approval later in 2026. The decision changes how therapy begins, not who is eligible, because intravenous induction remains an option.1
- “People living with Crohn’s disease need treatments that can deliver meaningful disease control from the start,” said Roopal Thakkar, M.D., executive vice president, research and development, chief scientific officer, AbbVie. “With the approval of subcutaneous induction, we are building on the strong efficacy of Skyrizi while giving patients and physicians greater flexibility in how treatment is initiated. This is one more example of how AbbVie continues to advance treatment to better meet the needs of people living with Crohn’s disease.”
- Cardiovascular Business lets us know,
- “Eko Health has received U.S. Food and Drug Administration (FDA) clearance for Core 300, a new artificial intelligence (AI)-enabled stethoscope that offers both traditional analog and advanced digital listening capabilities.
- “The Core 300 stethoscopes give clinicians the ability to instantly switch from traditional listening to digital listening when evaluating both pediatric and adult patients. The technology behind Eko Health’s digital listening capabilities includes up to 35x amplification, noise cancellation and real-time heart data that is then displayed on the device.
- “These stethoscopes can also be connected to the Eko App or Eko’s FDA-cleared AI models for additional benefits. In addition, the battery life was designed to last for weeks at a time.”
No Surprises Act News
- The American Hospital Association News reports,
- “The Centers for Medicare & Medicaid Services Oct. 23 announced that the submission period opened for petitions to deny the recertification of three independent dispute resolution entities. Members of the public, providers, facilities and others can submit a petition, which must identify the IDR entity seeking recertification and detail the reasons for the petition. The three organizations seeking recertification are National Medical Reviews Inc.; Keystone Peer Review Organization, Inc., which also does business as Acentra; and MCMC Services LLC. The petition period is open through Oct. 29. The departments of Health and Human Services, Labor, and the Treasury will make a final decision on recertification after reviewing any petitions submitted.”
From the judicial front,
- Fierce Healthcare reports,
- “Centene has become the latest insurer to sue the federal government over its 2027 Medicare Advantage star ratings.
- “In a lawsuit filed Thursday in Georgia’s Southern District Court, the company argues that the Centers for Medicare & Medicaid Services violated the Administrative Procedure Act in determining its latest scores. Centene says that CMS ran afoul of “core statutory safeguards” in deploying 17 measures.
- “The use of those measures ultimately caused “significant injury” to the company, according to the complaint. For 2027, 9% of Centene’s members are enrolled in plans with at least four stars, which declined from 18% in the prior year.
- “In implementing each of the individual Star measures that Centene challenges, CMS violated applicable law and thereby caused Centene to lose out on hundreds of millions of dollars in revenue that Centene could use to strengthen benefits, reduce premiums, and improve health outcomes,” the company said in the lawsuit.”
From the public health and medical / Rx research front,
- The Centers for Disease Control and Prevention announced today,
- “COVID-19, flu, and RSV are key indicators of overall respiratory illness activity
- “The amount of acute respiratory illness causing people to seek health care is very low.
- RSV activity is very low in most areas of the country.
- “COVID-19 activity remains elevated in some regions but is declining nationally.
- “Seasonal flu activity is increasing in many parts of the country but remains low nationally.
- “Rhinovirus/Enterovirus (RV/EV) is elevated nationally, and parainfluenza viruses (PIV) are increasing.”
- Beckers Clinical Leadership adds,
- “Hawaii, Florida and Louisiana are reporting the highest percent of influenza-like illnesses.
- “The CDC defines influenza-like illness, or ILI, as a fever of 100 degrees or greater, along with a cough and/or sore throat. The agency collects data on outpatient visits to healthcare providers for respiratory illness through ILINet. ILI percentages are weighted for state population and compared to baseline levels to assess flu activity. For more information on how the metric is calculated, click here.
- “Hospitals reported 4,811 new flu admissions in the week ending Oct. 17, up from 4,024 the week prior, according to the CDC’s latest FluView report. About 2.2% of outpatient visits involved patients with respiratory illness. This metric sits below the national baseline of 2.9% and is up from 2.1% the week prior.”
- The article ranks the State by their ILI percentages.
- and
- “The CDC has now activated six emergency responses for pathogens in 2026 — the latest a level 3 response to a record dengue outbreak in Florida — a pace that underscores how many infectious disease threats are landing on hospitals and public health agencies at once.
- “From a fatal new spillover in France to a bird flu outbreak left uncontained on a U.S. mink farm, the past several weeks have handed infection prevention and clinical leaders a dense cluster of public health concerns.”
- The American Hospital Association News tells us,
- “There are now 1,338 confirmed measles cases in Pennsylvania this year as the state’s ongoing outbreak continues, according to the latest data from the Pennsylvania Department of Health. Of those, 255 individuals have been hospitalized. The agency said that more than 56,000 doses of the measles, mumps and rubella vaccine were administered by healthcare providers across the state in September, and more than 39,000 have been administered so far this month. Providers typically administer 25,000 doses per month, the department said. Nationally, there have been 4,588 confirmed measles cases this year, according to the latest update from the Centers from Disease Control and Prevention. The vaccination status of 96% of cases is unvaccinated or unknown.”
- The University of Minnesota’s CIDRAP reports,
- “Two new studies underscore the importance of the hepatitis B virus (HBV) vaccine birth dose, with a US study predicting that dropping or delaying initial vaccination would drive up chronic infections and an Ethiopian study finding lower mother-to-child transmission (MTCT) with birth-dose receipt.
- ‘After US Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. panned the first study, as well as the New York Times’coverage of it, on X, experts quickly pointed out deficiencies in his objections.”
- The Washington Post relates,
- “While cigarette smoking is still the primary risk factor for lung cancer, a growing proportion of patients with the disease are nonsmokers like [Bryant] Lin [M.D.]. Last week, Pope Leo had part of his right lung removed because of adenocarcinoma, the most common type of lung cancer. He is not known to have ever lit up.
- “The drop in smoking rates in the United States and other countries has unexpectedly shed light on this as an emerging health issue. Never-smoker lung cancer is now the eighth leading cause of cancer-related death in the U.S. and the fifth most common cause of cancer-related deaths worldwide.
- “Because I’m a physician, most people make the assumption I’ve never smoked, and they ask, ‘Why did you get lung cancer?’” Lin said. “Then I explain to them that roughly one out of five people with lung cancer in the United States have never smoked.”
- “A growing body of research is identifying the disease’s unique clinical characteristics. In September, a study described a rare mutation concentrated in the southeastern U.S. that puts never-smokers at 60 times higher risk of developing lung cancer. The demographics of patients are also distinct — for instance, women who have never smoked are more than twice as likely to get lung cancer as men who have never smoked.”
- “Two-thirds of nonsmoking-related lung cancer happens in women, so there’s certainly an association with female sex,” said Jaclyn LoPiccolo, a medical oncologist at the Dana-Farber Cancer Institute and author of the mutation study. “Nonsmoking-related lung cancer is also more common in people of East Asian descent, but whether that’s a genetic or environmental association, we don’t yet know.”
- “Regardless of gender or ethnicity, risk factors include exposure to secondhand smoke, radon, air pollution and asbestos. A family historyof any cancer diagnosed before age 50 in a first-degree relative is associated with increased lung cancer risk in nonsmokers.”
- Health Day points out,
- “For patients with atrial fibrillation (AF) and acute ischemic stroke, early initiation of rhythm control is associated with a lower risk for recurrent stroke or systemic embolism (SE), according to a study published online Oct. 21 in Neurology.”
- and
- “Women who enter menopause prematurely may have a higher risk of heart problems, due in part to higher blood sugar levels, a new study says.
- “Women with menopause that occurred before age 40 had higher rates of heart disease and insulin resistance, researchers reported Tuesday at the annual meeting of The Menopause Society.
- “Our findings suggest that insulin resistance may be one important pathway linking premature menopause with increased cardiovascular disease risk, highlighting the importance of cardiometabolic health in women who experience menopause before age 40,” lead researcher Zailing Xing said in a news release. She is assistant professor of epidemiology at Florida A&M University.”
- MedPage Today adds,
- “Neurokinin (NK)-receptor antagonists improved sleep disturbances in menopausal women, a meta-analysis of randomized controlled trials showed.
- “Among women with moderate-to-severe vasomotor symptoms, the agents were associated with improvements in sleep disturbance as early as 4 weeks (standardized mean difference [SMD] -3.94, 95% CI -5.71 to -2.16) compared with placebo, reported Maria Julia Lemos, MD, of Kurah Women’s Health Institute in Macaé, Brazil, and colleagues.
- “This trend continued at 12 weeks (SMD -3.11, 95% CI -4.60 to -1.61) and 24 weeks (SMD -2.04, 95% CI -3.93 to -0.15), Lemos reported during a presentation at the Menopause Society annual meeting that was co-published in Menopause.
- “For women with hot flashes who can’t or don’t want to use hormone therapy, especially when poor sleep is one of their main complaints, these drugs are a good option to consider,” Lemos told MedPage Today. “They may help women sleep better, not just have fewer hot flashes.”
- Harvard Health notes,
- “A new pill that dramatically lowers harmful LDL cholesterol may be a good option for people who can’t tolerate statins or who haven’t lowered their LDL enough despite their current treatment with cholesterol-lowering drugs.
- “Approved by the FDA in July 2026, enlicitide (Lipfendra) is the first oral version of a class of drugs known as PCSK9 inhibitors. These drugs work by mimicking the effect of a naturally occurring variant in the PCSK9 gene that leads to very low LDL levels. But the original drugs — which are given by injection once or twice a month — aren’t widely used. Some people aren’t comfortable giving themselves an injection. Also, most insurance companies won’t cover the cost (which range from $200 to $500 or more per month) until a person has tried other therapies without success.
- “Enlicitide is a daily pill that must be taken on an empty stomach with a sip of water, black coffee, or plain tea. It lowers LDL by nearly 60%, which is similar to the injectable PCSK9 drugs. Less than 10% of users experienced either dizziness or diarrhea, the two most common side effects. A month’s supply will cost about $300; for now, insurance coverage remains unclear.”
- Per STAT News,
- “A multiple sclerosis treatment from Novartis cut by a third the rates of relapses that people with the condition have compared to a standard treatment, data presented Friday show. While that efficacy doesn’t match the performance of a rival drug from Roche, Novartis’ treatment has a cleaner safety profile that could give it a shot at being competitive in the market.”
- and
- “A chemotherapy-free combination of Tango Therapeutics’ experimental drug vopimetostat and Revolution Medicines’ recently approved Rasonque shrank tumors in 82% of patients with advanced pancreatic cancer, early-stage data presented at ESMO show. The Phase 1/2 trial enrolled 22 heavily pretreated patients whose tumors harbor MTAP deletions, a genetic alteration found in roughly 40% of pancreatic cancers.”
- Beckers Hospital Review adds,
- “Bristol Myers Squibb said Oct. 23 a study participant died from septic pneumonia about six weeks after receiving a dose of a CAR-T cell therapy being tested for multiple sclerosis.
- “The phase 1 trial included 66 patients with highly active relapsing multiple sclerosis or progressive forms of multiple sclerosis. In the study, most adverse events were “brief and reversible,” according to BMS.
- “After receiving the CAR-T therapy, zolacabtagene autoleucel, 28 of the 66 participants experienced cytokine release syndrome events, or hyperinflammation. Six patients had immune effector cell-associated neurotoxicity syndrome, including one life-threatening case, which resolved within two to four days.”
From the U.S. healthcare business and artificial intelligence front,
- Beckers Payer Issues reports,
- “Blue Cross Blue Shield of Massachusetts and Burlington, Mass.-based Tufts Medicine are partneringon a new health plan for BCBS employees, as well as AI implementation to streamline prior authorization.
- “The HMO, Tufts Medicine Alliance Network, includes access to Tufts Medicine, Boston Children’s Hospital and Dana-Farber Cancer Institute. The HMO also provides next-day primary care access and specialist access within 21 days, according to an Oct. 22 news release.
- “BCBS told Becker’s that about 35% of its workforce lives within the plan’s region, and that the plan will be available during their open enrollment. BCBS and Tufts Medicine said they are considering expanding the HMO’s availability to other employers in the future and are collaborating on similar offerings.”
- Fierce Pharma relates,
- “Last week’s federal holiday, Columbus Day, led to an unsurprising dip for prescriptions of both Novo Nordisk’s Wegovy pill and Eli Lilly’s oral GLP-1 rival Foundayo in the U.S.
- “In the prior-week reporting period, Novo’s Wegovy pill saw prescriptions fall slightly to around 173K versus the 173.5K tallied the week ending Oct. 9, according to Citi and Jefferies analysts, both of whom leverage prescribing data from IQVIA.”
- “For that same period, prescriptions of Eli Lilly’s GLP-1 pill Foundayo slipped around 4% week over week to 58K.
- “The minor reversal for both drugs shouldn’t come as a surprise, given that national holidays are liable to impact weekly prescribing trends.
- “Looking at the broader oral GLP-1 market, Lilly’s share presently sits a little higher than 25%, according to the Jefferies team, while Novo holds a nearly 75% piece of the pie.
- “Meanwhile, as Novo and Lilly vie over the ever-important U.S. obesity market, the GLP-1 opportunity taking shape across other massive countries like China, India and Brazil could grow from $6.6 billion now to a whopping $22 billion by the middle of the next decade, according to a new J.P. Morgan estimate reported by Reuters Friday.”
- MedTech Dive tells us,
- “Qiagen said Wednesday it has agreed to a takeover offer from EQT Private Equity valued at 10.8 billion euros (about $12.1 billion), including approximately $1.1 billion of debt.
- “The agreement comes less than two months after the testing company, long a rumored takeover target, installed Jonathan Pratt as its new CEO. Six years ago, Thermo Fisher Scientific was set to buy Qiagen, but the deal fell apart after shareholders objected to the price.
- “William Blair analysts, in a Thursday note, said EQT’s all-cash offer of 46.50 euros per share (about $52.20) was reasonable, given Qiagen’s relatively lower growth profile.”
- Beckers Health IT informs us,
- “Philadelphia-based Jefferson Health’s ambient AI rollout was associated with up to 16.6% less after-hours documentation and up to 39.3% faster chart closure among its most active users, according to a study published Oct. 23 in NEJM Catalyst Innovations in Care Delivery.
- “The analysis covered 5,234 clinicians with access to Abridge’s ambient documentation tool, which runs inside Jefferson’s Epic EHR. It also covered 283,028 ambulatory encounters with matched patient experience surveys from July 1 to Dec. 31, 2025. Use was voluntary, and about 34% of clinicians with access actively recorded visits.
- “Results were reported in two cohorts that reflect the separate EHR instances of Jefferson and Allentown, Pa.-based Lehigh Valley Health Network, which merged in August 2024. Among 637 clinicians who met the usage thresholds, Epic Signal data comparing 12 weeks before and after adoption showed several declines. Time in notes per appointment fell 10.5% and 17.3%. “Pajama time” fell 8.9% and 16.6%. Time to chart closure fell 25.3% and 39.3%. Weekly progress note volume held steady or rose.”
