Midweek update

David Ermer–ACA, CDC, CMS, FDA, Federal employment benefits, Medical / Rx research, Mental health care, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC,

  • The American Hospital Association News reports,
    • “The Centers for Medicare & Medicaid Services Oct. 21 announced that Amazon, Axon Enterprise, Inc., Google, Meta and Oracle Corp. are in support of its prior authorization pledge announced last year. The pledge involves streamlining prior authorization processes and increasing transparency for patients and providers by 2027. The AHA recently launched a new website on prior authorization, containing prior authorization news and resources. The website will be updated with additional resources and guidance as they become available.”
  • and 
    • “The AHA submitted comments to the Centers for Medicare & Medicaid Services Oct. 21 on its preliminary calendar year 2027 Medicare clinical laboratory fee schedule rates. The AHA said the preliminary rates highlight the need for substantial reforms to CMS’ methodology, saying they are based on incomplete data. The AHA discussed the requirement under the Protecting Access to Medicare Act that called for hospital outreach laboratories and other clinical laboratories to report their private payer data to CMS between May 1 and July 31, 2026. Only 2% of laboratories paid under Medicare Part B reported any information at all to CMS. The AHA noted there was widespread confusion among laboratories that did report their data regarding whether they were suitably qualified as “applicable laboratories” and what data they needed to report. The AHA expressed concerns that the underreporting means CMS’ preliminary 2027 rates do not reflect the “market-based payments” that Congress mandated under PAMA, resulting in substantial proposed cuts to Medicare CLFS reimbursement for hundreds of codes. The AHA said these cuts threaten seniors’ access to essential clinical laboratory testing and continued investment in diagnostic innovation.
    • “The AHA also said it was concerned that CMS’ approach to collecting applicable private payer information directly from clinical laboratories is inadequate for setting fully “market-based” rates. To help address these concerns, the AHA urged CMS to provide support and technical assistance to Congress as it considers the Reforming and Enhancing Sustainable Updates for Laboratory Testing Services (RESULTS) Act of 2025, which consists of efforts designed to improve private payer data collection by CMS to set Medicare Part B CLFS rates.” 
  • Healthcare Dive relates
    • “Some major insurers in the Affordable Care Act exchanges are expanding into new counties for 2027, even as many of their peers run for the exit amid ongoing cost and policy turbulence.
    • Centene, the largest ACA insurer in the U.S., is expanding into 55 additional counties in Alabama, Iowa, Illinois, Louisiana, Michigan, New Jersey and Texas next year; while Oscar Health, one of the fastest-growing carriers in the exchanges, is adding 140 new counties, including by entering South Carolina for the first time.
    • “The changes, announced in press releases Tuesday, show a continued bet on the ACA among some major participants in the exchanges, which may see a growth opportunity as their competitors downsize and leave their members looking for new carriers.”

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

  • FedSmith explains “Prescription Drug Coverage: What Every Federal Employee Should Check.”
    • Learn how to save on FEHB prescription costs by reviewing your medications, checking formularies, and comparing mail-order and retail pharmacy options.
  • FedWeek reports,
    • “More than a year after creating the deferred resignation program—and enticing some 140,000 persons to leave federal employment under those offers last year—the Trump administration has formally put it into regulation.
    • “A notice in the October 19 Federal Register finalizes rules proposed in June giving agencies broad authority to use extended periods of administrative leave, formerly typically limited to only a few days or even hours, for that purpose. The rules also authorize putting employees on that form of paid leave—also called excused absence—between receiving a RIF notice and the RIF separation date, and “to facilitate the voluntary resignation of employees with documented poor performance or misconduct” under a settlement agreement.
    • “They also clarify certain technical aspects of deferred resignation offers, including specifying that agencies have sole authority over whether to grant an employee’s request to withdraw acceptance of such an offer.”

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

  • Fox 10 News in Mobile, Alabama, reports,
    • “The FDA issued its highest-risk warning for a California-based company amid concerns over a multistate cheese E. coli outbreak.
    • “The Class I classification applied to all affected Graziers raw milk cheese products manufactured by California-based Sierra Nevada Cheese Company, including Monterey Jack, jalapeño jack, medium cheddar and sharp cheddar varieties, according to a press release. 
    • “The affected products were distributed in Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Maryland, New Jersey, Oregon, Texas, Washington and Wisconsin.
    • “Investigators said 13 people in nine states became sick. More than half of those infected were children age 5 and younger.”
  • Health lets us know,
    • “Check your medicine cabinet: More than 4 million tubes of toothpaste have been recalled nationwide. According to the Food and Drug Administration (FDA), the toothpaste was initially recalled on Sept. 10 over deviations from Current Good Manufacturing Practice (CGMP), which ensures the identity, strength, quality, and purity of drugs. On Monday, the FDA gave the recall the second-highest risk level, Class II, for the possibility of temporary or reversible health effects.”
  • Per a company news release,
    •  BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced the U.S. Food and Drug Administration (FDA) has approved its supplemental New Drug Application (sNDA) for use of the oral pellet formulation of once-daily ORLADEYO® (berotralstat) for prophylactic therapy in adults and adolescents aged 12 years and older. The new 150 mg ORLADEYO pellet formulation provides an alternative administration option for adults and adolescents who may have difficulty swallowing, prefer not to take a capsule or choose to remain on a pellet formulation beyond age 12. 
    • With this approval, prescribers can now provide their adult and adolescent patients with the option to take once-daily, orally administered ORLADEYO for prophylaxis to prevent attacks of HAE [hereditary angioedema] in either capsule or pellet formulation. The ORLADEYO pellet formulation is sprinkle-like in appearance and size and can be poured directly into the mouth and swallowed immediately with water or milk, or sprinkled over a spoonful of soft, non-acidic food.
  • Cardiovascular Business reports,
    • “The U.S. Food and Drug Administration (FDA) has cleared Elucid’s FFR-IQ software for the noninvasive estimation of fractional flow reserve from coronary CT angiography (FFR-CT). The artificial intelligence (AI)-based technology incorporates coronary anatomy and plaque composition into its estimation of coronary physiology to provide more accuracy.
    • “Plaque composition, coronary anatomy and physiology are closely connected,” Amir Ahmadi, MD, clinical associate professor of medicine (cardiology) at the Icahn School of Medicine at Mount Sinai and Elucid’s lead scientific advisor, said in a statement. “BioIntegrated FFR-CT incorporates anatomy and plaque characteristics into the physiological estimate itself. Together with plaque assessment, this approach can help physicians evaluate the significance of an individual lesion while also addressing the patient’s broader atherosclerotic disease and need for preventive treatment.”
    • “Elucid said physicians told the company they want a more accurate FFR-CT algorithm that considered other factors that could impact hemodynamics; this newly approved algorithm does just that.
    • “Elucid is now the third vendor to offer FFR-CT commercially in the U.S., following prior approvals by Heartflow in 2016 and KeyaMed in 2022. Other vendors are also developing their own versions of FFR-CT. Interest in the technology has also increased rapidly recently as coronary CT angiography (CCTA) continues to rapidly gain momentum among care teams.”

From the judicial front,

  • The American Hospital News reports,
    • “The U.S. District Court for the District of Maine should deny motions by several drug companies and Pharmaceutical Research and Manufacturers of America to intervene in the lawsuit challenging the administration’s revised 340B rebate model, the AHA and its co-plaintiffs argued in a filing submitted Oct. 21.
    • “The AHA and plaintiffs noted that the court previously rejected similar intervention requests in litigation over an earlier version of the 340B rebate model, finding that the federal government could adequately defend its own policy.
    • “The AHA, Maine Hospital Association and four safety-net hospitals filed suit Oct. 9 to stop the revised rebate program, arguing that it would impose more than $1 billion in annual administrative costs on hospitals and divert resources away from patient care. The lawsuit seeks to prevent implementation of the program, which is scheduled to take effect Jan. 1, 2027.” 

From the fraud, waste, and abuse front,

  • The AP reports,
    • “President Donald Trump and Vice President JD Vance on Tuesday announced a $25 million program to encourage the public to blow the whistle on suspected fraud in the U.S. government as they ramp up efforts to end the abuse of federal programs and dollars.
    • “The White House said that under the Fraud Whistleblower Incentive Program, anyone who submits a tip that leads to a fraud conviction or a significant federal enforcement action is eligible to receive up to $30,000, and that the Justice Department will administer the program.”

From the public health and medical / Rx research front,

  • STAT News reports,
    • “[S]ome experts in health communication believe the time has come to reconsider the way government agencies communicate to the public about the [measles] virus. Yes, measles can be deadly, they say, but counterintuitively, health officials would have more success if their messaging clearly confirmed what many parents already know: Most children will survive.
    • “Public health agencies and experts should say forthrightly that for most healthy children measles is an unpleasant, self-limited illness from which they recover completely,” Peter Sandman, a retired risk communication expert formerly at Rutgers University, said in an email. “It has to be said repeatedly and emphatically.” 
    • “Public health experts STAT spoke to emphasized that there are many downstream health issues that could befall children who are infected with measles, and that vaccines are crucial and safer than trying to build immunity through exposure to the disease. But saying most children recover could ultimately build trust.”
  • NBC News adds,
    • “The Pennsylvania Department of Health issued an alert Monday to doctors about an increase in measles infections in pregnant women, as well as a concerning rise in congenital measles — a disease that’s rarely, if ever, seen in the U.S. 
    • “The department said that 66 pregnant women in Pennsylvania had been diagnosed with measles since the state’s outbreak began in April. “Getting measles while pregnant increases the risk of miscarriage, early labor, and low birth weight,” a department spokesperson said in an email.” 
  • Per MedPage Today,
    • “Children who started the two-dose human papillomavirus (HPV) vaccine series at age 9 or 10 years were more than twice as likely to get both shots versus those who began later, a cluster randomized trial showed.
    • “Across 31 U.S. pediatric practices, kids who were recommended to receive HPV vaccination starting at age 9 or 10 had better initiation and completion rates by age 13 versus those who received vaccination starting at age 11 or 12:
      • Initiation rates: 77.1% vs 67% (adjusted HR 2.52, 95% CI 1.93-3.27)
      • Completion rates: 61.6% vs 45.1% (aHR 2.85, 95% CI 2.12-3.83)
    • “What our data show is that the age at which families first hear about the HPV vaccine recommendation changes how many children are protected, and how soon,” said Sean O’Leary, MD, MPH, of the Children’s Hospital Colorado Anschutz Medical Campus in Aurora, during a press briefing ahead of the IDWeek annual meeting. “For clinicians who now start at 11 or older, we would suggest at least considering earlier introduction in their offices.”
  • The New York Times relates,
    • “In the United States, rabies can seem like a disease of the past, a remote risk caused by a mostly vanquished virus. But in recent months, this ancient foe has returned to the spotlight.
    • “A handful of unusual outbreaks have made headlines: rabid beavers at a Maryland state park, a cluster of goat cases at a North Carolina petting zoo. Officials in several states, including Idaho and Alabama, flagged surges in animal cases; California set an annual record for rabid bats.
    • “And last month, the Centers for Disease Control and Prevention issued a national health advisory, citing reports of “local increases in human rabies exposures.” The agency reported an uptick in the use of medical interventions — antibody treatments and vaccines — designed to protect people exposed to potentially rabid animals.
    • “So far, no human rabies cases have been reported in 2026. And it’s unclear whether the reported surges reflect a real increase in rabies risk. But they are worth keeping a close eye on, experts said, and highlight the persistence of rabies as a complex, ever-evolving threat.”
  • Beckers Clinical Leadership points out how this season’s flu cases compare to past seasons.
    • “As of early October, the rate of outpatient visits for flu-like illness was tracking as the third-highest since 2010. In the week ending Oct. 10, about 2.1% of outpatient visits were for respiratory illness — up from 1.6% during the same week last season, CDC data shows. This marks the third highest weekly rate behind the 2022-23 season (2.5%) and the 2023-24 season (2.4%). The CDC classified both of these seasons as moderately severe.”
  • Beckers Behavioral Health notes,
    • “States that legalized online sports betting saw increases in antidepressant and anti-anxiety medication use, along with outpatient diagnoses of depression and anxiety, a study published Oct. 14 in JAMA Psychiatry found.
    • “Researchers at the Baltimore-based Johns Hopkins Bloomberg School of Public Health analyzed employer-sponsored health insurance claims from January 2016 to December 2023. The study compared 22 states that legalized online sports betting between 2018 and 2022 with 13 states that had not legalized it by the end of 2023.
  • Health Day tells us,
    • “More teen girls are vaping than boys.
    • “About 7.8% of teen girls vape compared to 4.6% of boys.
    • “Less than half of 1% of all teens smoke cigarettes.”
  • and
    • “Black children’s race may put them at greater risk for a more severe form of asthma.
    • “Black kids are nearly three times as likely to suffer from T2-high asthma as white kids.
    • “This increased risk comes regardless of environmental or social factors like neighborhood air quality or family income, researchers say.”
  • Per BioPharma Dive,
    • “A Roivant subsidiary will ask regulators to approve a new indication for its anti-inflammatory medicine brepocitinib after posting successful results in two Phase 3 studies in an eye condition called non-infectious uveitis that can lead to blindness.
    • “In the trials, known as Clarity-1 and Clarity-2, patients were able to last for a median of more than 48 weeks before “treatment failure,” a measure of eye inflammation and other markers, compared with 12 weeks for those on a placebo. The brepocitinib patients also went 40 weeks without needing immunosuppressive steroids, setting a new bar in treating the disease. And the drug succeeded on every secondary endpoint, including resolving macular edema, the company said Wednesday.
    • “The Roivant unit, Priovant Therapeutics, already has Food and Drug Administration approval to sell brepocitinib under the brand name Lisraya to treat adults with the skin disease dermatomyositis. Priovant now plans to submit a supplemental application to expand the medicine’s use in the first half of next year.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • Elevance Health ELV lifted its guidance for the year again after higher premium yields and pharmacy growth drove profit and revenue higher, offsetting a drop in membership.
    • “The health-insurance company on Wednesday said it now expects earnings per share of at least $22 for 2026, up from the prior $20.10. Adjusted earnings per share is now seen at $29 or higher, up from previous guidance of at least $27 a share.
    • “Analysts expect adjusted earnings of $27.26 a share for the year, according to FactSet.” * * *
    • “The company said it benefited from higher premium yields, increased product revenue from its pharmacy benefit manager CarelonRx, and growth in service fees.
    • “The benefit-expense ratio, a closely watched metric that compares health costs with premium revenue, improved by 70 basis points to 90.6%, driven by better performance in Medicare Advantage and individual Affordable Care Act plans.”
  • Beckers Payer Issues adds,
    • “Newly enabled competition between Blue Cross Blue Shield plans is continuing to contribute to Elevance Health’s commercial insurance business, leadership said on the company’s quarterly earnings call Oct. 21.
    • “Dubbed the “second blue bid,” the provision stems from a $2.67 billion settlement that resolved class action allegations dating back to 2012 that BCBS plans conspired to divide up markets to avoid competing with one another. The settlement eliminated a rule that required large employers to work with the BCBS plan covering their headquarters’ geography, thereby allowing certain national accounts to solicit bids from a competing Blues plan.
    • “Elevance, which owns 14 BCBS companies, said in January that it won nine of 11 second blue bid accounts in its first year competing under the provision. Morgan Kendrick, the company’s president of commercial and specialty health benefits, said on the third quarter earnings call that second blue bid opportunities have also been a component of its 1.7 million-member national accounts pipeline for 2027. 
  • and
    • “Elevance named Jeff Park as president of healthcare services subsidiary Carelon, effective Dec. 1. Mr. Park was most recently president of health technology company Waltz Health. Along with other healthcare leadership roles, he previously served as COO of pharmacy benefit manager Optum Rx, according to his LinkedIn profile.” * * *
    • “Carelon revenue grew 5.4% year over year, reaching $19.3 billion for the third quarter. This was spurred by CarelonRx product revenue and further expansion of Carelon Services risk-based solutions. Carelon’s operating margin was 4.7%, up from 4.2% in third-quarter 2025.
    • “CarelonRx’s operating gain was $616 million for the quarter, up 10.8% year over year. Its operating margin grew to 5.3%, up 20 basis points from the same period last year.”
  • and
    • “Horizon Blue Cross Blue Shield of New Jersey has agreed to acquire multispecialty physician group Summit Health’s New Jersey operations, including CityMD urgent care sites in the state, the insurer confirmed to Becker’s.
    • “We are excited by the opportunity to preserve access to high quality care for all of Summit Health’s patients, improve healthcare quality and affordability for our members, and to support the continued independence of Summit Health’s physicians and clinicians for the benefit of New Jerseyans,” a Horizon spokesperson said Oct. 21.
    • “The deal is subject to regulatory review and financial terms were not disclosed. Summit operates more than 120 locations across New Jersey, New York and Connecticut, while CityMD operates more than 180 urgent care centers across the three states.” 
  • Fierce Healthcare relates,
    • “Kaiser Permanente’s Risant Health has tapped Oklahoma’s largest nonprofit provider as the next to join its growing cadre of regional health systems.
    • “Integris Health and the nonprofit value-based care platform announced Wednesday their signed definitive agreement, which is subject to regulatory review but could close in early 2027. Financial terms were not disclosed. 
    • “The deal would make Integris the third regional health system to join Risant, following Pennsylvania’s Geisinger Health and North Carolina’s Cone Health, both deals that closed in 2024.”
  • and
    • “Alcon—the eye-focused pharma spun out of Novartis—is handing over $550 million to buy outNeurotech Pharmaceuticals, its encapsulated cell therapy platform and commercial medicine Encelto.
    • “Encelto, greenlit in March of 2025, is the first and only FDA approved therapy for macular telangiectasia type 2, a rare and progressive type of central vision loss. So far, the drug is only available in the U.S., where Neurotech estimates there are 25,000 MacTel patients and 2,000 to 3,000 new diagnoses each year. Through the merger, Alcon will now endeavor give the drug-device combo a more global reach, the pharma said in a statement. 
    • “Neurotech will also bring the tech behind Encelto to Alcon. The biotech’s encapsulated cell therapy approach pairs a surgically placed implant with cells that have been genetically engineered to produce therapeutic proteins. In the case of Encelto, the implant continuously releases recombinant human ciliary neurotrophic factor (rhCNTF), a protein that can travel to the retina and protect the photoreceptors—cells that are implicated in MacTel vision loss.” 
  • The Wall Street Journal informs us,
    • “Abbott ABT Laboratories plans to separate its nutrition business into an independent company by the end of next year, distancing itself from an embattled unit that has dragged down earnings and been the subject of years of litigation.
    • “The newly created company, set to house brands including Pedialyte electrolyte beverages and Similac infant formula, is expected to generate about $8.5 billion in annual sales.
    • “Chief Executive Robert Ford said the separation will allow both companies to sharpen focus and direct resources more effectively. Abbott will dial in on its core portfolio, which includes higher-growth categories such as medical devices and diagnostics, while the nutrition company will aim to capitalize on growing demand in the global nutrition market.
    • “We believe both businesses will be better positioned for the future as independent organizations,” Ford said on a call with analysts.”
  • Beckers Hospital Review lets us know,
    • “There are more than 400 birth centers in the U.S., and the number varies widely by state, from 92 in Texas to none in 10 states, according to Oct. 15 data the American Association of Birth Centers shared with Becker’s. Six states and the District of Columbia have one birth center.
    • “The count includes all birth centers known to the association, said Kate Bauer, executive director of AABC. She said state differences stem from factors such as state regulations, the midwifery workforce, insurance reimbursement and other elements that affect sustainability.
    • “An Oct. 20 Commonwealth Fund report on freestanding birth centers found that birth center births accounted for 0.62% of U.S. births in 2024, up from 0.23% in 2004, though access varies widely by state.”
  • Per Radiology Business,
    • “Capitol Imaging Services is expanding in South Florida with the acquisition of four outpatient centers. 
    • “The private equity-backed, Houston-based radiology group is buying Impression Imaging for an undisclosed sum, the two announced Tuesday. Capitol said the move establishes a strong presence in the Sunshine State and “marks an important step” as the group expands into molecular imaging and theranostics. 
    • “Founded in 2012 by physicians, Impression Imaging operates Florida locations in the communities of Tamarac, Pembroke Pines, Boca Raton and Coral Springs. 
    • “The addition of Impression Imaging to the Capitol Imaging Services network aligns perfectly with our mission to provide patients and physicians with the highest quality screening and advanced diagnostic imaging services,” John Stagg, CEO of Capitol Imaging, said in an announcement Oct. 20. “This acquisition expands our presence in Florida while strengthening our commitment to bringing cutting-edge imaging technology, precision diagnostics and greater patient access to every medical community we serve.”

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