Friday report

David Ermer–CDC, CMS, FDA, Government Contracting, Mental health care, OPM, Rx coverage, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC,

  • Avalere Health offers insights concerning HHS Secretary’s decision to fill out the membership of the U.S. Preventive Services Task Force announced yesterday.
    • “For life sciences companies and health plans, the USPSTF’s ability to resume its work—and potential new approaches to evidence review with its new members—will be consequential. The Task Force’s recommendations influence preventive care practice, clinical quality strategies, and, most notably, health plan preventive service coverage requirements.” * * *
    • “Health plans should prepare for the potential release of delayed recommendations and for a more active USPSTF agenda. This includes maintaining processes to assess coverage requirements, benefit configuration, coding, provider-network capacity, member communications, and implementation timelines once final A or B recommendations are issued. USPSTF last shared a recommendation update in August 2025, with four topics pending final recommendation statements.
    • “As the Task Force resumes activity under new leadership and a substantially different membership profile, transparency, methodological consistency, and implementation relevance will be central to maintaining trust in its recommendations.”
  • Per a Centers for Medicare and Medicaid Services (CMS) news release.
    • “The Centers for Medicare & Medicaid Services (CMS) is working to end skyrocketing drug costs as the agency announces today that all 50 states, plus the District of Columbia and Puerto Rico, have applied to participate in an initiative which provides most-favored-nation pricing for certain prescription drugs to people with Medicaid. Forty states and Puerto Rico have already signed agreements to participate in this historic program that will lower Medicaid drug costs to what other countries pay, saving an estimated $64.3 billion in taxpayer dollars over the next ten years, while preserving or enhancing beneficiaries’ quality of care.” * * *
    • “The GENErating cost Reductions fOr U.S. Medicaid (GENEROUS) Model is a landmark CMS Innovation Center initiative designed to not only lower drug spending in Medicaid but also improve quality of care and health outcomes by increasing access to critical medications and strengthening the Medicaid program overall. Under the GENEROUS Model: 
      • “Participating manufacturers will make covered outpatient drugs available at most-favored nation pricing to participating state Medicaid programs.
      • “Under agreements with states, participating manufacturers will be invoiced by states for supplemental rebates to effectuate international prices. CMS will monitor pricing accuracy. CMS will share in rebates with states via a reduction in the federal share of Medicaid payments.” * * *
    • “Remaining states have until Sept. 30, 2026, to sign agreements with CMS to participate in the model. The GENEROUS Model launched in January 2026 and runs for five years.
    • “For information on states participating the GENEROUS Model, visit: https://www.cms.gov/priorities/innovation/innovation-models/generous.” 
  • In today’s Federal Register, the Federal Acquisition Council promulgated proposed rules implementing the Revolutionary FAR Overhaul’s (RFO) FAR provision deviations.
  • The FAR Council explains on the acquisition,gov website,
    • “The RFO Phase 2 rule-making process has been organized in 12 FAR Cases, as outlined in the chart. The FAR Council has published Proposed Rules (PR) for the first 4 of 12 RFO-related FAR cases.
    • “With this publication, it’s the perfect time to show how public feedback informed key changes from the model deviations to the proposed rules. Your voice made a difference. The FAR Council received almost 1,600 valuable comments, primarily from industry (80%), but also from industry associations (7%) and federal government employees (13%). The public feedback received informed the FAR Council’s work in preparing the proposed rules. 
    • ‘While all public comments received may not be reflected, the tables below highlight examples of key policy updates that resulted from some of the public feedback submitted via acquisition.gov. The tables are organized by the RFO-related FAR rules, and will be continuously updated as the remaining RFO-related rules are published over the coming months.” 
  • Per Department of Health and Human Services news releases,
    • “The U.S. Department of Health and Human Services (HHS), through the Office of the Assistant Secretary for Financial Resources (ASFR), today announced a new Department-wide policy establishing the HHS Personal Protective Equipment (PPE) Forecast. This is the first official, recurring process to identify, consolidate, and publish anticipated HHS purchases of personal protective equipment covered by the Make PPE in America Act.
    • “The new forecast will give U.S. PPE manufacturers a clearer and more predictable signal of future HHS demand. By turning the Department’s acquisition plans into actionable market visibility, the initiative will help domestic companies make better-informed decisions about hiring, production, capital investment, and manufacturing capacity while strengthening the supply chains HHS relies on during routine operations and public health emergencies.” * * *
    • American manufacturers and small businesses can review HHS procurement forecast opportunities through the HHS Small Business Customer Experience platform.
  • and

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

  • OPM Director Scott Kupor resorted to his Secrets of OPM blog [found on Substack) to ably debunk recent challenges to the cost savings created by last year’s massive reduction in federal employment.
    • “GAO estimates that agencies spent about $9.5 billion on all paid administrative leave in 2025 and attributes about $6.7 billion of that to the Deferred Resignation Program. For the sake of argument, let’s charge the entire $9.5 billion to DRP anyway. It was a one-time expense.
    • “What did the taxpayer get for it? Using rough averages, the fully loaded cost of a federal employee is about $150,000 per year. For 270,000 employees, that is more than $40 billion in annual costs. These are not one-time costs, but costs incurred every year in perpetuity.
    • “So, for a one-time expense of at most $9.5 billion, taxpayers save more than $40 billion each year. That’s a 400+% annual return, and the outlay paid for itself in under six months.”
  • Here is a link to Senator Adam Schiff’s (D CA) news release about the letter that he and fifteen other Democrat Senators sent to OPM on October 16 questioning the OPM’s use of FEHB and PSHB protected health information to help OPM’s effort to combat fraud, waste, and abuse in hose programs.
    • “We support responsible efforts to protect the integrity of federal health-benefit programs. However, OPM’s proposals create an unnecessarily broad, decades-long, re-identifiable medical history of millions of workers, retirees, spouses, children, and other family members. We strongly urge OPM to suspend further implementation while these concerns are addressed and to work with Congress, federal employees and retirees, health plans, privacy and civil-rights experts, reproductive-health advocates, and other affected stakeholders to establish safeguards commensurate with the sensitivity of the information at issue. 
    • “We request a written response and briefing by OPM on the office’s efforts related to the above requested actions no later than September 25, 2026.”

From the Food and Drug Administration front,

  • Cure reports,
    • “The Food and Drug Administration (FDA) has approved Inluriyo (imlunestrant) in combination with Verzenio (abemaciclib) for adults with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, ESR1-mutated advanced or metastatic breast cancer whose disease has progressed following at least one line of endocrine therapy.
    • “The approval, announced Sept. 18, 2026, applies to patients whose ESR1 mutation is identified using an FDA-authorized test. The FDA also approved the Guardant360 CDx assay as a companion diagnostic to identify patients with ESR1-mutated breast cancer who may be eligible for the treatment combination.
    • “Inluriyo and Verzenio are both manufactured by Eli Lilly and Company.”
  • MedTech Dive relates,
    • “Cognita Imaging recently received a $1.29 million research contract from the Food and Drug Administration to test a new method of evaluating artificial intelligence-generated radiology reports. The goal is to assess whether a “jury” of large language models can evaluate another AI model’s report, and which cases need radiologist oversight.
    • “The contract, which started on June 22 and will run for 18 months, is intended to address a core problem with generative AI. Currently, most tools are evaluated against a panel of radiologist experts, but for models that can evaluate a wide variety of cases and generate different outputs, this becomes more challenging and time-consuming.”
  • STAT News tells us,
    • “In January, a paper published in Science analyzed government mortality figures, data on drugs seized by the DEA, and Reddit posts to determine that decreasing fentanyl potency due to Chinese government crackdowns could explain the recent decline in U.S. opioid overdose deaths. But when another research team tried to replicate that study, they didn’t come to the same conclusion.
    • “A simplistic supply shock is not supported by the evidence,” the authors wrote yesterday in Science Advances.
    • “The researchers noted that as fentanyl purity increased across the country, there was no associated national drop in overdose rates. While there did seem to be a broad association between declining purity and overdoses, it was shared with other, unrelated trends. And importantly, the DEA acknowledged at the time that increasing purity in its drug seizures was likely due to a change in its sampling plan.
    • “It’s also critical not to overlook geographic variability in the drug supply, the replication study authors wrote. As one of them told Lev Facher when the first study was published, many regions had declining overdose rates before potency apparently began to drop. — Theresa Gaffney

From the public health and medical /Rx research front,

  • The Centers for Disease Control and Prevention announced today
    • “As of September 18, 2026, the amount of acute respiratory illness causing people to seek health care is very low.
    • “COVID-19 activity is elevated and increasing nationally, but hospitalizations remain low overall.
    • “Rhinovirus/Enterovirus (RV/EV) and group A strep are increasing nationally.
    • “RSV activity and seasonal flu activity are low.”
  • The University of Minnesota’s CIDRAP reports,
    • “With 177 new cases added today, the US measles count has climbed to 3,471. * * *
    • “Today’s increase marks the sixth straight week of triple-digit increases in cases.
    • “The CDC today noted 39 outbreaks, one more than last week. Last year saw 48 measles outbreaks, defined as three or more related cases. Total cases for all of 2025 reached 2,289, which was the most since 1991 until the country surpassed that level in July. 
    • “The 2026 total is already 52% higher than the 2025 total, with more than three months left in the year.
    • “All but 17 of this year’s cases have been locally acquired, with the rest tied to international travel. Cases have been confirmed in 45 states plus New York City and Washington, DC.
  • The Washington Post tells us,
    • “Paul Nestadt is about as steeped in suicide prevention as a person can be.” * * *
    • “Nestadt has sought to intervene in ways that don’t require pinpointing people at risk.
    • “Chief among them: making it harder for people to carry out the act of killing themselves.
    • “Instead of asking every doctor to figure out which patient will die by suicide and locking that patient up, it might be that we need to make sure there aren’t loaded guns available,” Nestadt said.
    • “Although medication and therapy are lifesaving measures, many clinicians, researchers and people who have lost loved ones to suicide agree that more is needed. When it comes to firearms, however, broad policy approaches face major constitutional and political challenges.
    • “Research shows that limiting access to lethal means is one of the most promising approaches to save lives. It can involve erecting barriers on buildings and bridges to prevent people from jumping, as well as decreasing the number of pills someone can buy or be prescribed at once.
    • “And reducing access to guns, which are the most common and lethal method used for suicide in the United States.”
  • Beckers Behavioral Health shares summaries of “34 new behavioral health study findings to know.”
  • MedPage Today lets us know,
    • “A quarter of patients with cirrhosis caused by metabolic dysfunction-associated steatotic liver disease (MASLD) presented before the age of 50 with distinct risk profiles, data from a prospective study showed.
    • “In models adjusting for demographic and metabolic factors, a high genetic risk score and type 2 diabetes were independently associated with early-onset MASLD cirrhosis.
    • “Reliance on age-dependent first-line liver fibrosis tools can miss cases, the researchers suggested.”
  • Per Health Day,
    • “Wearable sensors might be the key to better tracking and treating a person’s knee arthritis, a new study says.
    • “Strapped to the foot, these sensors work as well as motion capture cameras in tracking a person’s natural stride, researchers reported recently in the journal JMIR Formative Research.
    • “This stride data could be used to track how a person with knee arthritis walks, allowing doctors to track arthritis progression and potentially offer individualized therapy, researchers said.”
  • and
    • “More people are seeking emergency help for gambling problems in the face of expanded online betting markets, a new study says.
    • “ER visits for gambling disorders nearly doubled following the legalization of single-event sports betting and expansion of online gambling markets in Ontario, researchers reported Sept. 15 in the American Journal of Preventive Medicine.
    • “Most people experiencing gambling problems will never seek care, so the concern is that the increases in ED visits for gambling disorders we observed may be revealing much larger increases in gambling-related harm,” senior researcher Dr. Daniel Myran said in a news release. He’s research chair at North York General Hospital in Toronto.”
  • Per Genetic Engineering and Biotechnology News,
    • “Diabetic kidney disease is one of the most common and serious complications of diabetes, yet the chain of events linking high blood sugar to kidney damage remains incompletely understood. Now, a stem cell-based model suggests that glucose itself may help trigger an inflammatory response inside kidney tissue—one that can damage key epithelial cells.
    • “Researchers led by Benjamin S. Freedman, PhD, at the University of Washington and University of Miami, report that human kidney organoids exposed to elevated glucose developed tissue-intrinsic inflammation and epithelial cell detachment, including detachment of podocytes, specialized cells essential for the kidney’s filtration barrier. The study, “Elevated glucose in kidney organoids induces tissue-intrinsic inflammation driving epithelial detachment,” was published recently in Stem Cell Reports.
    • “High sugar causes inflammation in these organoids even though they lack an immune system,” Freedman said. “This was unexpected and gives us a new way to think about how diabetes can affect kidneys and other organs.”
  • Per Beckers Hospital Review,
    • “An investigational immunotherapy was found to almost double median overall survival in patients with previously treated squamous non-small cell lung cancer, according to new trial data.
    • “Gotistobart, developed by BioNTech and OncoC4, showed a median overall survival of 18.5 months, nearly double the 10-month median among patients who received standard of care chemotherapy, according to a Sept. 14 news release from the companies.
    • “The trial results were presented Sept. 14 at the International Association for the Study of Lung Cancer’s World Conference on Lung Cancer in Seoul.”

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

  • Modern Healthcare reports.
    • “Molina Healthcare is pulling its all of its Medicare plans from three states for the 2027 plan year, the company notified third-party marketers Friday.
    • “The health insurer announced in February that it would completely exit the national market for individual Medicare Advantage plans to focus on Dual Eligible Special Needs Plans, or D-SNPs, for people who qualify for both Medicare and Medicaid. The company tried to sell the individual Medicare Advantage business but failed to find a buyer.
    • “In Connecticut, Mississippi and Nevada, Molina Healthcare is going a step further by ending individual, D-SNP and other Medicare plan sales, according to the notice.”
  • Beckers Clinical Leadership relates,
    • “Two UC Health emergency departments avoided more than 3,500 unnecessary head and cervical spine CT scans over 23 months with no missed injuries identified, according to a study published in the Western Journal of Emergency Medicine.
    • “The quality improvement campaign ran at University of Cincinnati Medical Center and West Chester Hospital in West Chester Township, Ohio. The campaign paired continuing education on clinical decision rules for head and cervical spine imaging with decision-support software embedded in the EHR, plus quarterly feedback showing physicians how their own ordering compared with peers’. Teams also created patient handouts to reassure those who expected a scan they did not need.
    • “Physician-researchers estimated the effort eliminated 3,542 scans in low-risk trauma patients, avoiding $6.2 million in patient charges at roughly $1,750 per scan and saving 14,168 hours of patient waiting time. The campaign also avoided 6,021.4 millisieverts of radiation exposure — the equivalent of roughly 2,000 years of background radiation for one person.
    • “A safety review identified no patient harm and no missed injuries.” * * *
    • “View the full study here.”
  • Beckers Hospital Review tells us,
    • “Paul Krakovitz, MD, became CEO of Greensboro, N.C.-based Cone Health on March 16, roughly 15 months after the five-hospital system joined Risant Health, the nonprofit created by Oakland, Calif.-based Kaiser Permanente. Dr. Krakovitz previously held leadership roles at Cressey & Company, Intermountain Health and Cleveland Clinic.
    • “Now, Risant is involved in Cone Health’s value-based care work, bringing tools developed through Kaiser Permanente’s experience with the model to the community health system. Risant is also helping fund Cone Health’s $40 million effort to rebuild its Epic platform after years of technical debt limited the system’s ability to adopt newer capabilities.
    • “Dr. Krakovitz discussed with Becker’s the system’s work with Risant, its Epic investment and Cone Health’s efforts to move away from volume and toward more proactive care.
    • “He said Risant has brought additional resources and focus to Cone Health’s value-based care strategy while the health system remains focused on its local community.
    • “The value-based care tools that Risant brings from a national scale is just something that is incredibly unusual to be able to deploy in a community health system, and it’s a huge benefit, both for our clinicians and for our community,” Dr. Krakovitz said.”
  • Beckers Health IT adds,
    • “Techstars and the Mid-Atlantic Permanente Medical Group selected nine startups for a healthcare accelerator focused on emerging technologies and care delivery.
    • “More than 1,200 startups applied for the 2026 Techstars Healthcare Accelerator powered by Permanente Medicine Mid-Atlantic States, according to a Sept. 18 news release.
    • “The three-month program began Sept. 14 and will connect participating companies with Techstars investors and mentors as well as physicians and healthcare leaders from the Mid-Atlantic Permanente Medical Group.”
  • Beckers Hospital Review points out,
    • “A number of healthcare organizations have recently closed medical departments or ended services at facilities to shore up finances, focus on more in-demand services or address staffing shortages.
    • “Here [in the article] are 60 department closures or services that are ending or have been announced, advanced or finalized that Becker’s reported since Jan. 1, 2026.
  • Fierce Healthcare informs us,
    • “Angle Health raised $600 million in equity financing, reaching a total valuation of $2.7 billion, to continue expanding its artificial intelligence-native healthcare benefits platform for small businesses.
    • “According to the company, the financing includes a $200 million series C funding round and a $400 million tender offer. The startup’s valuation has more than doubled since its December series B round when it raised $134 million, the Wall Street Journal reported. The company raised a $58 million series A round in January 2023.
    • “Vitruvian Partners led the round, with participation from new investor Town Hall Ventures and existing investors Blumberg Capital, Portage Ventures, PruVen Capital and Y Combinator. They expect to close the round later in September.”
  • and
    • “Oura and Counsel Health are teaming up to participate in CMS’ 10-year chronic condition management program, betting that continuous health data from Oura’s smart ring paired with medical AI can help move the needle on conditions like hypertension.
    • “Counsel Health, an AI-native primary care company, plans to participate in CMS’ Advancing Chronic Care with Effective Scalable Solutions (ACCESS) Model under the early cardio-kidney-metabolic (eCKM) track, with smart ring maker Oura serving as the preferred wearable partner.
    • “It is an early example of how the CMS chronic care initiative could become a proving ground for AI-powered, wearable-enabled care delivery.”
  • and
    • “Humana researchers found that cancer patients who received specialty pharmacy care coordination services had fewer hospitalizations and emergency department visits, along with lower medical costs.
    • “The study, conducted by Humana Pharmacy Analytics and Consulting, analyzed health outcomes for people with cancer who are Humana Medicare Advantage members with Part D prescription plan coverage and who received medication adherence care coordination guidance, as compared to those who opted out of coordination. 
    • “Humana’s CenterWell Specialty Pharmacy Oncology Center of Excellence (COE) provided the care coordination services over the course of one year. That COE program provides specialized, personalized clinical care and mail-order delivery for patients managing complex cancer diagnoses and therapies. Within CenterWell, Humana’s health care services organization, CenterWell Pharmacy serves many Humana members as a mail-order pharmacy and also serves patients who are not enrolled in a Humana plan.
    • “The research was published in the Expert Review of Pharmacoeconomics & Outcomes Research.”
  • Fierce Pharma notes,
    • “As expected, the past U.S. Labor Day holiday took a toll on obesity drugs’ prescription numbers. According to IQVIA data cited by Citi, weekly scripts for Novo’s Wegovy pill dropped roughly 12% sequentially to about 161K for the last week. The decline for Foundayo was modest, at just 1%, as the Lilly drug still managed to rake in more than 47K scripts. 
    • “Lilly this week said Foundayo captured more than 30% of new patients in the U.S. market for oral obesity ​treatments, Reuters reported. 
    • “Citing Bloomberg Symphony data, Jefferies analysts suggested in a Friday note that Foundayo’s recent acceleration “has been driven primarily by retail/commercial channels.”
    • “Elsewhere, Lilly’s total Zepbound scripts were down 8.5% week over week, but the GIP/GLP-1 drug expanded its market share by 0.4% versus Novo’s Wegovy franchise, whose scripts decreased 10% during the period.”

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