Monday report

Simplicity is a virtue.

From Washington, DC,

  • Per a Centers for Medicare and Medicaid news release,
    • “The Centers for Medicare & Medicaid Services (CMS) today announced significant premium savings for millions of Medicare beneficiaries in 2027, with weighted average MA premiums projected to fall more than 16% from 2026 to 2027, and average prescription drug premiums in Medicare Advantage projected to plummet 38%. 
    • “Additionally, average premium for stand-alone Part D prescription drug plans is projected to rise by less than $1 per month in 2027. Despite speculation and misleading reports related to the appropriate sunsetting of the Part D Stabilization Demonstration Project, there is broad pricing stability across the Part D market.
    • “The strong 2027 outlook means Medicare beneficiaries will continue to have access to affordable coverage and broad plan choice without relying on billions of dollars in temporary subsidies to insurance companies. More than 99% of Medicare beneficiaries will have access to at least one Medicare Advantage Plan, while 97% will have access to 10 or more options. 
    • “CMS is releasing this key information ahead of the upcoming Medicare Open Enrollment, which runs from October 15, 2026, through December 7, 2026.” * * *
    • “To view premiums and costs for 2027 MA and Part D plans, visit: www.cms.gov/medicare/coverage/prescription-drug-coverage, and select the 2027 landscape source file under “Downloads.”
    • “For state-by-state information, important dates, and enrollment resources for MA and Part D in 2027, visit: https://www.cms.gov/files/document/2027-medicare-advantage-part-d-landscape-state-state-fact-sheets.pdf.” 
  • Beckers Hospital Review reports,
    • “The Comprehensive Care for Joint Replacement (CJR) model saved Medicare $180 million in its final three performance years without changing care quality, according to the program’s final evaluationreleased Sept. 24.
    • “CMS launched CJR in 2016 as its first mandatory bundled payment program, requiring hospitals in randomly selected cities to take financial responsibility for hip and knee replacements and the 90 days after discharge. Hospitals could earn a payment from CMS or owe money back depending on whether episode spending came in under or over a target price. The model ended in December 2024. 
    • “The final report covered the three years after CMS extended and reworked the model (October 2021 through December 2024). During that stretch, 321 hospitals across 34 metro areas performed about 143,000 joint replacements that counted toward the model, which was about 9% of all hospital-based joint replacements in the U.S. CMS had narrowed the model to higher-spending markets, so CJR patients tended to be somewhat older and sicker than joint replacement patients nationwide.”
  • and
    • “The Trump administration is developing an initiative aimed at moving production of 86 essential medicines to the U.S. within 18 months, according to a Sept. 25 Bloomberg report.
    • “Under the initiative, the Office of Management and Budget would solicit proposals from the healthcare industry on opportunities to move production of drugs on the list to the U.S., according to the report. A committee would identify and act on industry proposals.
    • “The effort cites “national security” and aims to reduce or eliminate dependence on medicines produced by foreign entities of concern, including China, Russia, Iran and North Korea, according to an OMB document cited by Bloomberg.
    • “The initiative builds on broader federal efforts to strengthen domestic supplies of critical drugs. The Economic Development Administration put $15.97 million toward a Civica-led project to build a fully domestic supply chain for four sterile injectables. Nine drugmakers that signed most-favored-nation pricing agreements with the administration this month also committed to invest at least $19.6 billion collectively in U.S. manufacturing.”
  • Beckers Payer Issues relates,
    • “House Democrats have drafted an 84-page health policy agenda outlining what the party would pursue if it wins a House majority in November, according to a Sept. 25 report from Politico, which first obtained the document.
    • “The new agenda follows reports earlier this month that the caucus was privately discussing a broader expansion of the Medicare program, along with policies aimed at breaking up vertically integrated healthcare companies such as UnitedHealth Group and CVS Health.”
  • and
    • “Medicare Advantage plan choice will fall in more than half of states in 2027, even as CMS projects lower average premiums and a nearly unchanged number of available plans nationwide.
    • “The decline follows widespread disruption in 2026, when as many as 2.9 million MA enrollees had to find new coverage after their plans were discontinued or the insurer exited the market. Individual insurers have signaled a similar pullback for next year, with Humana saying in July that its 2027 plan exits are expected to affect about 600,000 members.”
  • Beckers Hospital Review adds,
    • “Researchers at Yale University have outlined 10 new policy proposals they say could save billions in healthcare spending, targeting Medicare Advantage payments, site-neutral payments, drug costs, nursing home care and other areas.
    • “Nine of the proposals carry annual savings estimates that together range from about $70 billion to $84 billion, while the remaining proposal is estimated to save households $44 to $58 a month. 
    • “The proposals are the latest additions to the Yale Health Care Affordability Lab’s 1% Steps project, which now includes 23 policies with estimated annual savings of about $450 billion, or roughly 8% of the $5.5 trillion the U.S. spends on healthcare annually, according to a Sept. 28 news release. The lab cautioned that the total is not a Congressional Budget Office-style estimate and does not account for potential interactions among the proposals.
    • “None of these ideas alone will fix the American health care system, but stacked together, these targeted reforms add up to substantial savings,” Zack Cooper, PhD, director of the lab, said in the release.”
  • HR Dive lets us know,
    • “The U.S. Department of Labor is trying to help workplaces prepare for opioid-related overdoses in the workplace, according to a news release issued Thursday. 
    • “DOL’s Occupational Safety and Health Administration released a fact sheet Thursday that “provides practical information that focuses on empowering workplaces to recognize the signs of an overdose and act immediately.” 
    • “The guidance comes as employers grapple with drug use among employees, with some reports showing nearly 20% of workers use some kind of substance.”

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

  • Federal News Network reports,
    • “As agencies walk back the Trump administration’s controversial essay question from federal job postings, the Office of Personnel Management is directing them to replace it with a new prompt.
    • ‘Agencies must now include a question stating, “In this role, you will be expected to professionally and efficiently implement executive direction. Provide an example where you implemented leadership direction on a strategy or policy decision that differed from your own recommendation.”
    • “A Sept. 18 memo from OPM told agencies to begin including the new question on all upcoming federal job announcements. It replaces a prompt from the Trump administration that previously asked applicants to name a few executive orders or policy initiatives “significant” to them and explain how they would help implement those orders if hired.
    • “Agencies are expected to include OPM’s replacement question on job announcements that close on or after Sept. 26. So far, about 2,400 job announcements contain the revised question, OPM said Friday in a court filing.”

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

  • STAT News reports,
    • “The FDA has approved AbbVie’s once-daily Parkinson’s pill, tavapadon, to be sold as Juvmo. The drug is part of its $8.7 billion acquisition of Cerevel Therapeutics. The dopamine receptor agonist was approved for adults with Parkinson’s based on a late-stage study that showed the drug helped improve symptoms, Reuters writes. 
    • “AbbVie has said it sees more than $5 billion in combined sales from its Parkinson’s portfolio, though Citi analysts have cautioned that Juvmo’s uptake could be gradual as Medicare coverage negotiations play out.”
  • Fierce Pharma relates,
    • “Roche’s Gazyva just increased its foothold in the autoimmune market with a fresh FDA approval, becoming the first new treatment option in 70 years for patients with idiopathic nephrotic syndrome (INS).
    • “The regulator cleared the anti-CD20 monoclonal antibody to reduce the risk of relapse in adults and children 2 and older with frequently relapsing or steroid-dependent, childhood-onset INS who are in complete remission.
    • “The FDA green light, Gazyva’s second autoimmune indication in less than 12 months, cementing the 2013 cancer drug’s second act in immune-mediated diseases.”
  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today approved Emcitate (tiratricol) tablets for oral suspension to treat peripheral thyrotoxicosis (excess thyroid hormone levels in the blood that causes symptoms, such as rapid heart rate, increased blood pressure and adverse effects on metabolism) in patients with MCT8 deficiency, also known as Allan-Herndon-Dudley syndrome. Emcitate is the first therapy approved by the FDA to treat symptoms of this very rare, devastating genetic disease. This approval reflects the FDA’s dedication to patients with rare genetic diseases, many of whom have serious unmet medical needs.
    • “Until now, patients living with MCT8 deficiency and their families had no FDA-approved treatment option,” said Marina Zemskova, M.D., Deputy Director of the Division of General Endocrinology in the FDA’s Center for Drug Evaluation and Research. “Emcitate’s approval reflects the FDA’s deep commitment to patients with rare conditions who are in need of meaningful treatment options.”
  • MedTech Dive tells us,
    • “The Food and Drug Administration last week released a draft guidancedocument spelling out what the agency wants to see in premarket submissions for robotically assisted surgical devices.
    • “The 50-page document details criteria for system stability and latency, instrument motion and position control, visualization, software, wireless technology, cybersecurity, sterilization, clinical data, labeling, training and more.
    • “The agency also said it will hold a two-day public workshop on Dec. 2-3 focused on evaluating the benefits and risks of robotic medical devices with autonomous or remote teleoperation capabilities.”

From the judicial front,

  • Beckers Behavioral Health reports,
    • “A federal jury in Fort Worth, Texas, convicted Kevin Curry, 64, of nearby Frisco on Sept. 24 in a $26 million healthcare fraud, kickbacks and money laundering scheme.
    • “Mr. Curry billed TRICARE, the military’s health program, for transcranial magnetic stimulation therapy that was medically unnecessary or not provided, according to a Sept. 25 news release from the Department of Justice.”

From the public health and medical / Rx research front,

  • Beckers Behavioral Health reports,
    • “Breast and prostate cancer incidence is rising among people of every race and ethnicity in the U.S., while lung cancer incidence and death rates are dropping sharply, according to the CDC’s “Annual Report to the Nation on the Status of Cancer,” published Sept. 22 in Cancer.
    • “Researchers analyzed data from population-based cancer registries and the National Center for Health Statistics’ National Vital Statistics System to track cancer incidence through 2022 and death rates through 2023 by cancer type, sex, race and ethnicity and age.
    • “The CDC report follows the American Association for Cancer Research’s 16th annual “Cancer Progress Report,” which found the U.S. cancer death rate declined 35% between 2015 and 2024.
    • “The decline in cancer deaths was driven largely by “accelerated progress against lung cancer,” the CDC said in a Sept. 22 news release.”
  • The New York Times relates,
    • “More than 50 new cases of measles have been reported in Pennsylvania since Wednesday, state health officials said, as efforts continue to combat an outbreak that has spread across the state.
    • “The 55 new cases, reported by the Pennsylvania Department of Health in a statement on Friday, bring the total number of cases to 890 across 39 counties so far this year.
    • “The outbreak has led to 173 hospitalizations and four measles-associated deaths, according to the department.
    • “While daily numbers fluctuate,” the department said, “tracking these trends provides Pennsylvanians and health care providers with visibility into community transmission across the Commonwealth and helps inform the department’s ongoing response.”
  • STAT News tells us,
    • “Metal mixtures found in the leftover smoke, ash and debris from the deadly 2023 Maui wildfires were harmful to the lung health of people living nearby long after the burning ended, a new study says.
    • “The work shows that major wildfires, which are worsening with the planet’s warming, could have lasting effects beyond immediate exposure.
    • “New research published in the journal Proceedings of the National Academy of Sciences on Monday found higher metal levels, associated with respiratory harm, in nearby residents up to a year and a half after the fires.”
    • “As part of the Maui Wildfire Exposure Study, one of the largest postfire investigations in the country, University of Hawai‘i researchers studied the urine of 1,400 adults. They found substantially elevated concentrations of metals such as arsenic, cadmium, copper and antimony.”
  • MedPage Today asks “One Shot or Two? What to Know About HPV Vaccination Recommendations.”
    • — Guidance is evolving
  • Per Health Day,
    • “Cutting back on ultra-processed food could provide a boost to your mental health, a new pilot study says.
    • “People had less depression and anxiety after cutting their ultra-processed food intake by more than 85%, researchers reported Sept. 23 in JAMA Psychiatry.
    • “The results indicate that junk food “may harm your gut in ways that ripple up to your brain,” lead researcher Dr. Nyasha Chagwedera, an assistant professor of psychiatry and behavioral sciences at the University of California, San Francisco, said in a news release.”
  • Per Healio,
    • “Approximately one in four adults with hepatitis C virus infection who initiated treatment with direct-acting antivirals did not undergo follow-up RNA testing, according to a research letter published in JAMA Network Open.
    • “However, 90% of that unmonitored population had been prescribed at least 56 days of DAA therapy, potentially leaving cured individuals unaccounted for and highlighting a notable gap in HCV surveillance efforts.
    • “Measuring care outcomes is essential to monitoring progress toward hepatitis C elimination,” Hasan Symum, PhD, of the CDC’s division of viral hepatitis, and colleagues wrote.”
  • BioPharma Dive informs us,
    • “Shares in eye-drug developer Kodiak Sciences more than doubled Monday after the company said its two drugs for macular degenerationsucceeded in a Phase 3 clinical trial that compared them with Regeneron Pharmaceuticals’ Eylea.
    • “Kodiak’s Zenkuda was able to match Eylea’s eyesight improvement using an individualized dosing strategy that allowed more than half of trial participants to receive injections only once every six months compared with once every eight weeks for Eylea, Kodiak said. The biotech’s second drug, called tabirafusp alfa tedromer, also matched Eylea using an individualized dosing strategy.
    • :The company expects to ask the Food and Drug Administration for approval of Zenkuda in wet age-related macular degeneration, the condition treated in the trial reported Monday, along with two other eye disorders in the fourth quarter of 2026. The news marks a turnaround for Kodiak and Zenkuda, which failed to match Eylea in a trial that read out more than four years ago. Kodiak’s market value climbed by more than $3 billion
  • The Wall Street Journal notes,
    • Roche Holding ROP  said it stopped work on one of its obesity-drug candidates, after clinical-trial data suggested the medicine wouldn’t hit internal targets.
    • The Swiss drugmaker said it returned rights to the medicine, emugrobart, to its majority-owned business Chugai Pharmaceutical, which originally discovered the drug and licensed it to Roche.
    • “We have made the decision to discontinue development,” Roche’s pharmaceuticals chief executive, Teresa Graham, said at an event with investors in London on Monday. “We are returning that molecule to Chugai, and Chugai is looking to further development in [spinal muscular atrophy] as well as considering potential outlicensing opportunities.
    • “Roche had previously estimated the drug had potential to reach annual peak sales of between 1 billion and 2 billion Swiss francs ($1.21 billion-$2.41 billion). The company is also developing two obesity injections and a pill, and sees potential for each of them to exceed 3 billion francs in peak sales.”

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

  • Modern Healthcare reports,
    • “UConn Health’s proposed acquisitions of Bristol and Day Kimball hospitals have been delayed. “Farmington, Connecticut-based UConn said Friday it is committed to the deal but needs more time for due diligence and planning to ensure the facilities’ long-term financial sustainability.
  • STAT News relates,
    • “Blockbuster GLP-1 drugs have transformed the lives of millions of people. Lately, they’re undergoing a makeover of their own.
    • “Once promoted as tools to address obesity as a medical issue, GLP-1 drugs are increasingly being seen — and marketed — as a way to look and feel better generally. And, as the pioneer in the field, Novo Nordisk, in particular, has leaned into the shift.
    • “In advertisements around the world, the company has trotted out slogans like “Live lighter” and “Summer Glow Up.” On its website, Novo no longer labels its treatment, Wegovy, as a “weight management” drug or “anti-obesity” medicine, but instead as a “weight loss” drug. And the company now often refers to the people who take its drugs less as “patients” and more as “customers.”
    • “It’s a long way from the pitch Novo and its rival GLP-1 maker, Eli Lilly, once made — that obesity is a chronic biological disease, just like diabetes and heart disease, and the drugs don’t merely help people lose weight, but also improve health outcomes.
    • “The shift, observers note, is no accident.” 
  • Physicians Practice tells us,
    • “About a third of medical groups have used AI to build their own software, and many of those homegrown tools sit in the parts of the practice that handle patient data: scheduling, prior authorization, denials and patient-facing workflows.
    • “A Sept. 22 MGMA Stat poll of 228 medical group leaders found 34 percent have built an app or workflow tool in-house using AI, according to MGMA’s write-up of the results. Another 8 percent tried but never launched a project, 54 percent haven’t tried and 10 percent weren’t sure.
    • “The approach, often called “vibe coding,” lets someone describe what they want in plain language and have a generative AI tool write the code. It puts working software within reach of physicians and administrators who have never written a line of it.
    • “Respondents described building tools for scheduling, prior authorization and denial work, internal dashboards, inventory management, call handling, recalls and staff tracking. Some projects moved closer to protected health information, including charting support, biologic-ordering workflows, coding and audit guidance, and patient-facing tools.”
  • Healthcare IT News adds,
    • “Artificial intelligence capabilities are creating a new operational reality in healthcare right now and are needed to alleviate immense systemic pressures, said Seema Verma, general manager of Oracle Health and Life Sciences, on Wednesday as she opened the 2026 Oracle Health and Life Sciences Summit in Orlando, Florida.
    • “Verma announced a series of specifically engineered AI agents for clinical workflows, revenue cycle management and life sciences in her opening keynote address.
    • “These are not isolated product announcements,” she explained. “They are pieces of a much larger transformation across payers, providers, pharma and for all patients.”

Leave a Reply

Your email address will not be published. Required fields are marked *