Simplicity is a virtue.

From Washington, DC

• STAT News reports,
  • “The Department of Justice has a warning for health care executives: Don’t be another Theranos. 
  • “As the Trump administration continues its fight against Medicare and Medicaid fraud, it is also expanding its investigations into corporate wrongdoing, DOJ officials announced this month.”
  • “A key part of that plan is making it easier for companies themselves to report potential criminal activity, and encouraging whistleblowing, Jacob Foster, deputy assistant attorney general in the National Fraud Enforcement division, said Thursday at the STAT Summit in Boston. Foster oversees the unit that investigates health care fraud.” * * *
  • “Going forward, companies in the health care sector looking to file voluntary self-disclosures will find a one-stop shop at the DOJ, Foster said. They previously would’ve had to navigate a separate process at the Department of Health and Human Services, but that is now being consolidated under the health care fraud section at the DOJ. 
  • “Under the new policy, companies that report potential criminal misconduct can reap the benefits — such as a limited cap on financial damages — from both agencies at once. 
  • :The health care fraud section at the DOJ brings a range of expertise under one roof to handle issues like the emerging field of digital health technology, Foster said. DOJ will make use of data analytics and artificial intelligence algorithms to try and suss out instances of corporate wrongdoing, like providers billing for unneeded services, companies fabricating patient records, or health tech companies adding redundant diagnoses. 
  • “The department will also design new programs that “appropriately incentivize” whistleblowers to report fraud, according to an Oct. 1 memo from Assistant Attorney General Colin M. McDonald. Health care investigators also look at social media, news reports, and other sources of information to learn about companies possibly breaking the law, Foster said.” 
     
• This new Justice Department policy “making it easier for companies themselves to report potential criminal activity, and encouraging whistleblowing” is available here.

• The American Hospital Association News tells us,
  • “The Centers for Disease Control and Prevention issued a reminder Oct. 14 that the declaration supporting the emergency use of COVID-19 in vitro diagnostics tests will end Dec. 26. The December end date marks the end of a 180-day transition period from the end of the COVID-19 emergency use authorization declarations announced June 30. The EUA declarations were issued in 2020 to accelerate access to medical products during the COVID-19 pandemic.”

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

• Federal News Network reports,
  • “The Office of Personnel Management and the White House Task Force to Eliminate Fraud are partnering to hire the next cohort of the US Tech Force. The two-year program will place applicants across agencies, including the General Services Administration, the Social Security Administration, the Office of Personnel Management, the Department of Health and Human Services, the State and Treasury departments. Vice President JD Vance says the partnership will help the government identify fraud, waste and abuse and reduce reliance on foreign technological advancements. Tech Force positions are open to the public and federal employees through career transition and reinstatement programs. The job announcement closes October 23.”
    
• FedSmith offers an approach that allows federal and postal employees and annuitants to compare health coverage without getting overwhelmed.

• Tammy Flanagan, writing in Govexec, explains that “Federal retirees face more than a COLA change in 2027.”
  • “From Medicare premiums and Social Security earnings limits to a federal pay freeze, several changes could affect retirees’ finances and the benefits available to them next year.”

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

• The AP reports,
  • “For the first time in more than a quarter-century, Americans have a new option when shopping for sunscreen: a skin-protecting chemical that’s long been a go-to option in Europe and other parts of the world.
  • “The U.S. Food and Drug Administration approved bemotrizinol — sometimes called BEMT — in June. The first sunscreens containing it are now hitting U.S. store shelves, including formulas from Neutrogena and other manufacturers.
  • “Dermatologists say the chemical fills an important market gap by offering broad protection, like the most well-established sunscreen ingredients, but without their cosmetic downsides, including white streaking.”

• Fierce Pharma tells us,
  • “U.S.-based generic drugmaker Par Health has issued a voluntary recall of 22 lots of the direct thrombin inhibitor argatroban for IV injection that could be contaminated with cellulose, polystyrene, polyethylene terephthalate, stopper material, and potentially even stainless steel.
  • “The recall, which was published to the FDA’s website on Oct. 14th, is Par’s third in a matter of weeks.”

• Targeted Oncology relates,
  • “The FDA will review FYB206, an investigational biosimilar candidate referencing pembrolizumab (Keytruda), after accepting its biologics license application (BLA), marking the first publicly announced acceptance of a filing for a pembrolizumab biosimilar, according to a news release from Zydus Lifesciences and Formycon.¹
  • “The application was sent to the FDA in the third quarter of 2026. The Biosimilar User Fee Amendments (BsUFA) set a 12-month goal from submission to completed review, made up of a filing review lasting as long as 60 days followed by a 10-month substantive review. On that schedule, a regulatory decision could come in the third quarter of 2027, and a regulatory dossier has also been filed with Health Canada, according to the companies.”

From the Medicare Advantage front,

• Beckers Hospital Review reports,
  • “Kaiser Permanente led the 2027 U.S. News & World Report ratings for the “best overall” Medicare Advantage companies.
  • “The ratings, published Oct. 14, are based on a five-point scale, assigning weights to more than 30 CMS quality measures. After calculating contract ratings, U.S. News determined enrollment-adjusted average ratings for carriers. U.S. News considered MA companies among the “best” if they had an overall rating of at least 3.8 once rounded and served at least 1,000 beneficiaries in December 2025 in each of 10 or more states or territories where they still offer 2027 coverage.
  • “These ratings looked at standalone MA contracts, as well as ones that also cover Part D. For the publication’s Medicare Part D ratings, the same two companies secured the “best overall” recognition in 2026 and 2027. In 2027, Humana scored 3.8, and Centene scored 3.5. To qualify as a top Part D company, insurers needed to have served at least 1,000 Part D beneficiaries in each of at least 10 jurisdictions where they still offer coverage for 2027. The threshold was an enrollment-weighted average rating of at least 3.5 after rounding.”

From the Affordable Care Act marketplace front,

• Beckers Payer Issues relates,
  • “CMS has reinstated a small number of enrollees who lost coverage after the agency canceled ACA policies for more than 760,000 people, according to a KFF Health News report published Oct. 15 in NPR.
  • “KFF Health News learned of the reinstatements through insurance industry sources, finding that not all of those who lost coverage were fraudulently enrolled. 
  • “On Aug. 31, CMS canceled 315,000 policies for 2026 that covered more than 760,000 individuals. These enrollees signed up with agent or broker assistance but lacked citizenship or immigration documentation, and issuers were unable to find claims or did not have records of contact, according to a September rulemaking document. CMS told Becker’s on Oct. 15 that another criterion was whether premiums were fully covered by advance payments of the premium tax credit. CMS expected that these cuts would lead to a return of roughly $2.2 billion in subsidies.”

No Surprises Act News

• Beckers Payer Issues relates,
  • “Arbitration awards under the No Surprises Act can reach nearly 6% of total commercial medical spend in some regions, UnitedHealthcare CEO Tim Noel said during an Oct. 13 earnings call. 
  • “The medical cost trend for UnitedHealthcare’s commercial business is “exceeding” an initial expectation of 11%, Mr. Noel said. While Mr. Noel pointed to clinician cost intensity and expensive specialty drugs as part of that, he also said there has been “an acceleration of costs related to the No Surprises Act.” He cited “ongoing abuse” driven by “a relatively small number of clinician groups and third-party organizations.”
  • “Mr. Noel said this translates to billions of dollars in additional costs that hit consumers and employers.” 

From the judicial front,

• Per a Justice Department news release,
  • “A Kansas CEO and owner of an internet platform was sentenced yesterday to 19 years in prison for his role in operating a platform that generated false doctors’ orders and prescriptions to defraud Medicare and other federal health care benefit programs out of more than $1 billion.
  • “The Department of Justice and our agency partners dismantled one of the largest telemedicine fraud schemes ever, and yesterday’s lengthy prison sentence holds the orchestrator of that scheme accountable,” said Assistant Attorney General Colin M. McDonald of the Justice Department’s National Fraud Enforcement Division. “The defendant’s fraud scheme lured hundreds of thousands of elderly and disabled Americans into a sophisticated international telemarketing system with one goal: stealing as much as possible from the Medicare trust fund. The Fraud Division will continue to leverage its resources to take down complex fraud operations like Blackman’s DMERx.”

From the public health and medical / Rx research front,

• Beckers Clinical Leadership reports,
  • “Pediatric infectious disease specialists in Pennsylvania, home to the nation’s largest measles outbreak in more than three decades, are treating an influx of children with severe complications from a virus many physicians have little experience with, NBC News reported Oct. 14.
  • “Patrick Gavigan, MD, a pediatric infectious disease physician at Penn State Health Golisano Children’s Hospital in Hershey, said he expected measles to behave like COVID-19 in children, mainly manifesting as respiratory illness and hitting those with underlying conditions hardest. Instead, the virus is causing serious complications beyond the lungs in many previously healthy children, including in the gut, liver and brain, according to the report.
  • For example, some children are developing encephalitis, or brain inflammation, in response to the virus, according to Dr. Gavigan.
  • “They go from walking and talking one day to the next having significant neurologic dysfunction,” he told NBC News. Dr. Gavigan added that these patients recover slowly and often aren’t back to normal by the time they leave the hospital.”
• and
  • “New dementia cases worldwide are projected to more than double by 2050, from an estimated 11.4 million in 2023 to 24.7 million, according to a meta-analysis published Oct. 12 in JAMA Neurology.
  • “Researchers led by the University of New South Wales in Sydney analyzed participant-level data from 22 population-based cohorts. The cohorts included 38,418 adults aged 60 and older without dementia at baseline, across 18 countries and territories on six continents. Approximately 3,001 participants developed dementia as of 2021. 
  • “The projection assumes age- and sex-specific dementia rates stay constant. That means the growth reflects an aging global population, not an increase in individual risk.”

• MedScape relates,
  • “The combination of a low-calorie diet with a supervised exercise regimen induced nonpharmacologic remission of early-onset type 2 diabetes (T2D) in more than half of participants in a new study, with low drop-out rates and preservation of lean mass.
  • “The take-home message is that in early-onset type 2 diabetes, people should ideally have a potent nondrug option to tackle [the disease],” first author Kaberi Dasgupta, MD, a professor of medicine and director of the Division of General Internal Medicine at McGill University in Montréal, Quebec, Canada, told Medscape Medical News.
  • “In addition to inducing diabetes remission, the diet/supervised exercise intervention “shifts weight loss where we want it to be — from the fat compartment — and also increased muscle health, strength, and fitness, improving mood, lowering distress related to diabetes, and enhancing quality of life,” she said.”

• MedPage Today tells us,
  • “Continuous glucose monitors (CGMs) are recommended for patients with type 1 diabetes and insulin-treated type 2 diabetes, but evidence has been limited in those with non-insulin-treated type 2 diabetes.
  • “Compared with routine care, adults with non-insulin-treated type 2 diabetes using CGMs had a significantly lower HbA1c level and more time spent in the target glucose range in a 26-week trial.
  • “Adherence to the device was high, and no cases of severe hypoglycemia or hyperglycemia-related serious adverse events were observed.”

• The Washington Post informs us,
  • “About 12 percent of new cancer cases worldwide in 2024 were caused by infectious agents such as viruses and bacteria, according to a recent study by the International Agency for Research on Cancer.
  • “That means a sizable share of the cancer burden around the world is preventable with tools we already have, including vaccines and other preventative measures, researchers said.
  • “We have very actionable targets,” said Gary Clifford, a cancer epidemiologist and one of the authors of the study that published in the Lancet Oncology. “We have very many tools against these viruses already.” * * *
  • “Existing measures like condoms, vaccines for HPV and cervical cancer screening can prevent infection and cancers associated with infectious diseases, experts said.”
• and
  • “A woman’s ovaries bring center-stage energy for decades of her life: governing fertility and interacting with organs from the brain to the heart, from the skeleton to the immune system. Because of that, they have attracted scads of scientific research.
  • “But after menopause, around age 50, the spotlight on the ovary has historically gone dark. A study published Wednesday in the journal Aging Cell shows that an ovary continues to play an important role even in its retirement years, with functions that do not diminish and may still affect the rest of the body.
  • “Above all, the study underscores why the postmenopausal ovary is worthy of attention.
  • “Women are living three [more] decades with this organ in their body, and we have no idea what it’s doing,” Francesca Duncan, an associate professor of obstetrics and gynecology at Northwestern University said. “We really owe it to half our population to understand what’s happening.”

• Contemporary OB/GYN adds,
  • “The American College of Obstetricians and Gynecologists (ACOG) has issued its most comprehensive guidance to date on managing menopause, with a new clinical practice guideline covering menopausal hormone therapy (MHT), nonhormonal medications, and nonpharmacologic treatment of vasomotor symptoms (VMS), sleep disturbance, and mood symptoms. Clinical Practice Guideline No. 13, published online October 15, 2026, in Obstetrics & Gynecology, replaces Practice Bulletin No. 141 from January 2014.
  • “According to the guidance, 50% to 92% of women in menopause report VMS, 16% to 66% of women in the United States report menopause-related sleep disruption, and more than one-third of perimenopausal and postmenopausal women worldwide report depressive symptoms. ACOG is also developing companion guidance on genitourinary syndrome of menopause, expected in 2027.” * * *
  • “View the complete and full guidance via Obstetrics & Gynecology, here.”
    .
• Beckers Hospital Review notes,
  • “An Oct. 13 analysis from the Health Transformation Alliance examined linked claims and EHR data for 12.7 million patients from 2018 through 2025 to identify who is most and least likely to respond to GLP-1 therapy.”

• Beckers Behavioral Health points out,
  • “Adults with schizophrenia and Type 2 diabetes who started a glucagon-like peptide-1 receptor agonist were less likely to be hospitalized or seen in the emergency department for psychiatric reasons than peers who started a dipeptidyl peptidase-4 inhibitor, a sodium-glucose cotransporter-2 inhibitor or none of the three drug classes, according to a study published in The Lancet Psychiatry.
  • “The results point to a possible psychiatric upside to GLP-1 therapy beyond blood sugar and weight control, though the study’s observational design means it cannot show the drugs caused the lower risk.”
• and
  • “The rate of opioid use disorder diagnoses among commercially insured patients rose 32.7% nationwide between 2022 and 2025, FAIR Health found in its latest analysis of commercial health claims.
  • “The national rate reached 596 patients with an opioid use disorder diagnosis per 100,000 commercially insured patients receiving medical services in 2025, up from 449 in 2022. The findings were published as part of FAIR Health’s annual Opioid Tracker update, according to an Oct. 14 news release from the organization.”

• Per an Institute of Clinical and Economic Review news release,
  • “The Institute for Clinical and Economic Review (ICER) today released a Draft Evidence Report assessing the comparative clinical effectiveness and value of two new treatments: nomlabofusp (Larimar Therapeutics, Inc.) and omaveloxolone (Skyclarys®, Biogen Inc.) for Friedreich’s Ataxia, a rare, genetic disorder. 
  • “Downloads: Draft Evidence Report | Draft Voting Questions
  • “This preliminary draft marks the midpoint of ICER’s eight-month process of assessing this treatment, and the findings within this document should not be interpreted to be ICER’s final conclusions.“

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

• The Wall Street Journal reports,
  • “Pharmaceutical companies are investing billions of dollars into protein degraders, a new class of drugs designed to target disease-driving proteins.
  • “These drugs work by using a cell’s recycling system to destroy smooth proteins that traditional medicines can’t easily latch on to.
  • “While the FDA has approved a handful of these drugs, scientists are still working to ensure they don’t accidentally destroy healthy proteins.”
• and
  • “AstraZeneca is partnering with Insitro to use artificial intelligence to find new treatments for cardiometabolic diseases.
  • “AstraZeneca will pay Insitro $40 million upfront and up to $1.46 billion if development and commercial targets are met.
  • “Insitro will use its AI platform to identify disease causes, while AstraZeneca will lead clinical development and commercialization.”

• Beckers Health IT relates,
  • “Epic is working with Amazon Pharmacy, Mark Cuban Cost Plus Drugs and other pharmacy companies to develop a tool that will allow clinicians and patients to compare prescription drug prices directly within its EHR system.
  • “The new feature, called Prescription Marketplace, will allow clinicians and patients at health systems using Epic to compare medication prices across pharmacies before a prescription is sent, according to an Oct. 15 news release from the EHR vendor.
  • “The tool will display pharmacies’ cash prices alongside what patients would pay through their insurance plans, allowing them to determine whether paying cash could be less expensive.
  • “Amazon Pharmacy has worked with Epic since early 2025 to help develop the feature. Mark Cuban Cost Plus Drugs is also working with the company on its development, and executives from Costco and Eli Lilly’s LillyDirect voiced support for the tool in the release.”

• Cardiovascular Business informs us,
  • “U.S. healthcare payment policies are accelerating physician consolidation and driving up the cost of care, according to Rick Snyder, MD, president of HeartPlace and chief physician executive at U.S. Heart and Vascular. He is also the vice president of the American Independent Medical Practice Association (AIMPA) and a former president of the Texas Medical Association. In addition, Snyder has held policy-focused positions with the American College of Cardiology and the Society for Cardiovascular Angiography and Interventions.
  • “In his role with AIMPA, he testified before Congress during this year’s House Energy and Commerce Committee hearings focused on healthcare affordability. He argued that the nation’s healthcare system spends more than any other country of healthcare, but has lower life expectance and poorer outcomes than other Western nations. According to Snyder, this is not due to a lack of spending, but a lack of cost efficiency.” 

• MedTech Dive points out,
  • “Labcorp has agreed to buy certain laboratory testing businesses from Opko Health subsidiary BioReference Health for $722 million, plus an additional sum of up to $150 million tied to revenue from a prostate cancer blood test. The final purchase price could be adjusted based on closing revenues, the companies said Thursday.
  • “Labcorp is acquiring businesses focused on clinical and women’s health testing services, urology and diagnostic services provided to correctional institutions. The deal also adds more than 80 patient service centers to Labcorp’s network.
  • “In addition, the lab services provider is gaining BioReference Health’s 4Kscore test, which has Food and Drug Administration approval to help predict the likelihood of finding aggressive prostate cancer before a biopsy decision.”
• and
  • “Zimmer Biomet said Tuesday it has inked a multi-year extension to its exclusive distribution agreement with Think Surgical.
  • “The deal, which extends an agreement signed in 2024, positions Zimmer to continue distributing an exclusive version of Think’s TMINI wireless handheld miniature robotic system. 
  • “Zimmer’s exclusive version of TMINI is compatible with its Persona knee system, a personalized product used in total knee replacements.”

• Per Fierce Healthcare,
  • “The Elevance Health Foundation has launched a new prize program aimed at supporting solutions aimed at improving patient safety, with the first crop of winners targeting challenges like health literacy, fall prevention and medication errors.
  • “Elevance will dispense $4 million in prizes to four organizations through the first round of the program. The goal is to identify scalable, community-based solutions to tackle critical patient safety risks. The Patient Safety Prize falls under the foundation’s Community Action Leadership umbrella, and the team saw an opportunity to move beyond its core focus areas with these programs.
  • “The winners include: Care Synergy’s CAPABLE, or Community Aging in Place—Advancing Better Living for Elders, program; NYU Grossman School of Medicine; the Public Health Institute’s Population Health Innovation Lab; and the Parkland Center for Clinical Evaluation.”

• Per Beckers Health IT,
  • “OpenEvidence drew 271 million queries from 952,008 U.S. clinicians between January 2024 and June 2026, according to a study published Oct. 15 in JAMA.
  • “Researchers from Somerville, Mass.-based Mass General Brigham and Boston-based Harvard Medical School analyzed query logs from OpenEvidence users with verified National Provider Identifiers. Vishal Patel, MD, and Samuel Finlayson, MD, PhD, contributed equally as lead authors, and Anupam Jena, MD, PhD, oversaw the study.
  • “Dr. Finlayson and two other co-authors, including OpenEvidence’s chief medical officer, were OpenEvidence employees during the study. The company provided the data and contributed to the analysis.
  • “Monthly active users grew from 355 in January 2024 to 703,265 in June 2026. Average monthly queries per active user rose from 18 to 39.5, and month-over-month retention climbed from about 70% to 90%.
  • “Physicians accounted for 556,200 users. Nurse practitioners and physician assistants used the platform most intensively, at 44.5 queries per active user-month, compared with 37.1 for physicians. Physicians within a decade of medical school graduation made up 24.3% of the physician workforce but submitted 61.8% of physician queries.”