From Washington, DC
- Federal News Network reports,
- “Federal employees’ retirement applications are continuing to flood the Office of Personnel Management. In February, another 31,000 retirement claims entered the agency’s systems. That puts OPM’s Retirement Services center at yet another record high of pending applications — now reaching above 65,000 cases with pensions that are yet-to-be finalized. That’s an 88% increase since OPM’s inventory last October, when retirements from the deferred resignation program first began trickling in.”
- The Government Accountability Office posted a report titled “Private Dental and Vision Insurance: Market Concentration Varied Among States.”
- “As in health insurance markets, people looking for dental or vision insurance may face a concentrated market—i.e., only a few companies to choose from. Consumer choice may also be affected by “vertical integration”—e.g., when a vision insurance company owns the ophthalmologist’s practice and the company that makes glasses frames and lenses.
- “Dental and vision insurance market concentration varied across states. Little research is available that shows the effects of concentration and vertical integration in these markets. Groups representing dental and vision care insurers, providers, and consumers shared varying opinions on potential effects.”
- The American Hospital Association New tells us,
- “March 8-14 marks Patient Safety Awareness Week. The AHA has several resources including podcasts, videos and reports that show how AHA members are advancing patient safety through innovative programs and technologies. LEARN MORE”
- Beckers Clinical Leadership adds,
- “The use of artificial intelligence in diagnosis, rural healthcare access and federal funding cuts are among the most pressing patient safety concerns facing healthcare organizations in 2026, according to a new report from the Emergency Care Research Institute and the Institute for Safe Medication Practices.” * * *
- “Here are the 10 most pressing patient safety challenges in 2026, per the report:
- “Navigating the AI diagnostic dilemma
- “Reduced access to rural healthcare increases health risks and disparities
- “Increasing rates of preventable acute diseases in communities and healthcare settings
- “Effects of federal funding cuts on healthcare operations and patient safety
- “Lack of recognition and reporting of harm events
- “Structural and systemic barriers inhibit equitable pain management for women
- “Persistent workforce shortages continue to burden staff and restrict access to care
- “The impact on system improvement when a culture of blame hinders learning
- “Emergency department boarding contributes to worse patient outcomes
- “Persistent gaps in manufacturer packaging and labeling design continue to undermine medication safety efforts.
From the Food and Drug Administration front,
- Fierce Pharma reports,
- “The FDA is doubling down on its goal to increase biosimilar drug availability in the U.S. with a fresh draft guidance proposing more changes to streamline development of the cheaper biologic copies.
- “The newly proposed guidance (PDF) focuses on clinical pharmacokinetic (PK) testing, a core aspect of biosimilar drug testing that serves as a key comparative test to weigh a proposed biosimilar against the approved product it references.
- “In its draft guidance, the FDA offers recommendations for streamlining unnecessary PK testing when “scientifically justified,” a change that could save biosimilar drugmakers up to 50% of their PK study costs, which equates to about $20 million, the agency said in a press release.
- and
- “In a dizzying span of seven months in 2022, Bristol Myers Squibb gained FDA approval for three new products, touting each with the potential to achieve $4 billion in peak sales.
- “While multiple myeloma drug Opdualag and cardiomyopathy treatment Camzyos became blockbusters last year, psoriasis med Sotyktu wasn’t close.
- “With a new FDA nod in hand for Sotyktu, however, BMS can reach more patients with the oral med, which was acquired in the drugmaker’s 2019 buyout of Celgene for $74 billion.
- “The U.S. regulator has endorsed Sotyktu as a treatment for adults with active psoriatic arthritis. It becomes the first drug in its class as a selective allosteric tyrosine kinase 2 (TYK2) inhibitor to be approved in the indication. The thumbs up comes on top of Sotyktu’s original FDA approval for moderate-to-severe plaque psoriasis.”
From the judicial front,
- The AHA News reports,
- “The U.S. District Court for the Southern District of Florida March 6 ruled in favor of five Florida hospitals in a case challenging the methodology used by the Leapfrog Group regarding hospital safety ratings. In particular, the court determined that Leapfrog’s methodology violated Florida’s unfair and deceptive business practices law. “Leapfrog’s change in methodology has no scientific basis, unfairly penalizes non-participating hospitals, and misrepresents hospital safety,” Judge Donald M. Middlebrooks wrote. The court’s injunction requires Leapfrog to cease assigning safety grades to hospitals, remove grades assigned to the plaintiff hospitals in 2024 and 2025, and issue corrective disclosures, along with other actions.”
- “The U.S. District Court for the Southern District of Florida March 6 ruled in favor of five Florida hospitals in a case challenging the methodology used by the Leapfrog Group regarding hospital safety ratings. In particular, the court determined that Leapfrog’s methodology violated Florida’s unfair and deceptive business practices law. “Leapfrog’s change in methodology has no scientific basis, unfairly penalizes non-participating hospitals, and misrepresents hospital safety,” Judge Donald M. Middlebrooks wrote. The court’s injunction requires Leapfrog to cease assigning safety grades to hospitals, remove grades assigned to the plaintiff hospitals in 2024 and 2025, and issue corrective disclosures, along with other actions.”
- Per a Justice Department news release,
- “A Texas man was sentenced Friday to 90 months in prison for his role in a $59.9 million conspiracy to pay kickbacks and submit claims for medically unnecessary durable medical equipment (DME) to Medicare.
- “According to court documents, Patrick Cassells, 65, of Fulshear, Texas, owned and operated three DME companies and concealed his role in one of those companies by falsely identifying another individual as the sole owner and manager in a Medicare enrollment application. Cassells paid illegal kickbacks to co-conspirators who sent him signed doctors’ orders and other paperwork necessary to bill Medicare for orthotic braces such as knee, back, shoulder and wrist braces. The kickbacks were disguised by referring to the doctors’ orders as “leads” and the services provided as “marketing.” Based on these orders, which were issued without doctors examining or treating the patients, Cassells submitted claims to Medicare that falsely represented that the braces were medically necessary. In total, through the three companies, Cassells caused over $59.9 million in false and fraudulent claims to Medicare, for which Medicare paid over $27 million. Cassells used proceeds of the fraud to purchase personal vehicles and vehicles that he intended to export to Nigeria.
- “In June 2024, Cassells pleaded guilty in the Southern District of Texas to one count of conspiracy to commit health care fraud.
- “In addition to the prison sentence, Cassells was ordered to pay $25,402,614.97 in restitution and forfeiture, and to forfeit four vehicles and three properties in the Houston area.”
From the public health and medical / Rx research front,
- The Hill reports
- “New data showed childhood obesity has hit a record high in recent years, while federal changes such as cuts to food assistance programs and a revamped food pyramid reignite debates over how to handle the issue.
- “A Centers for Disease Control and Prevention (CDC) report late last month showed more than 1 in 5 U.S. children and teenagers were obese between 2021 to 2023, compared to only 5.2 percent between 1971-1974. The number of children with severe obesity in recent years has hit 7 percent.
- “School meals, physical activity and weight loss drugs have all become talking points in the problem, which is a major issue in the “Make America Healthy Again” movement associated with Health and Human Services Secretary Robert F. Kennedy Jr.
- “Experts point to school meals and increased activity as key ways to address childhood obesity, with research showing school meals are the healthiest eating options some students have all day.
- “They’re noting that this increase in obesity occurred during COVID-19 and that jump in childhood obesity happened during the years when millions of kids lost access to reliable school meals. So, when schools closed for virtual learning, children lost a critical source of daily nutrition,” said Erin Hysom, senior child nutrition policy analyst on the Child Nutrition Programs and Policy team for the Food Research & Action Center.”
- The American Medical Association lets us know what doctors wish their patients knew about multiple sclerosis.
- Brown & Brown released a guide for employers on how to support women’s heart health.
- MedPage Today tells us,
- “Infection with Kaposi sarcoma-associated herpesvirus (KSHV) is the cause of Kaposi sarcoma, a type of cancer where lesions grow on the skin and other parts of the body.
- “This CDC report detailed 46 cases of suspected donor-derived KSHV-related complications among 153 transplant recipients from 2021-2025, roughly five times the number of cases reported from 2016-2020.
- “Of the 74 transplant recipients identified as having a KSHV infection, 61% developed Kaposi sarcoma.” * * *
- “A key challenge is the lack of an FDA-approved serology assay to screen for KSHV in donors and recipients. The existing assay for clinical testing is operator-dependent and not easy to scale, Durand noted. A molecular PCR-based assay could theoretically monitor transplant recipients for infection, she added, “but we don’t know who to monitor, how often to monitor, nor what to do with a positive test.”
- “Despite the challenges, Durand recommended that clinicians keep the KSHV diagnosis in mind, particularly in lung and liver recipients who present with signs and symptoms that might be explained by the virus.”
- and in better news,
- “Along with the use of AI, routine screening mammograms could identify women at higher risk of cardiovascular disease, a retrospective cohort study suggested.
- “A greater amount of AI-calculated breast arterial calcification on imaging was associated with an increased risk of major adverse cardiovascular events.
- “These findings indicate an opportunity to use routine mammograms for early cardiovascular risk stratification without additional radiation exposure.”
- Health Day tells us,
- “Telemedicine has not led to a significant rise in new mental health patients from rural or underserved communities
- ‘High use of virtual visits led to a 3.6% decrease in the total number of new patients seen by therapists
- “State licensing laws are likely the barrier to reaching patients across state lines.”
- Genetic Engineering and BioTechnology News informs us,
- “Researchers at Washington University School of Medicine in St. Louis have developed genetically altered astrocytes that express chimeric antigen receptors (CARs) as a promising immunotherapy system capable of clearing accumulations of amyloid-β (Aβ)—a hallmark pathological feature of Alzheimer’s disease (AD)—in the brains of mice.
- “Recently approved anti-Aβ antibody therapies have shown moderate success in slowing AD progression. However, these treatments require large doses, repeated administration, and are associated with potentially serious side effects.
- “To reduce the frequency of treatment and potentially improve the efficacy of anti-amyloid therapy, scientists headed by Marco Colonna, MD, the Robert Rock Belliveau, MD, professor of pathology at WashU Medicine engineered CAR-expressing astrocytes—CAR-As, as a new type of cellular immunotherapy. Their tests in mice showed that a single injection of the CAR-A treatment prevented amyloid plaques from developing when given before plaques start to form. A single treatment in animals that had already developed plaques also cut the amount of amyloid plaques in half.
- “This study marks the first successful attempt at engineering astrocytes to specifically target and remove amyloid beta plaques in the brains of mice with Alzheimer’s disease,” said Colonna. “Although more work needs to be done to optimize the approach and address potential side effects, these results open up an exciting new opportunity to develop CAR-astrocytes into an immunotherapy for neurodegenerative diseases and even brain tumors.”
- STAT News points out,
- “Xenon Pharmaceuticals said Monday that its treatment for a common type of seizure disorder significantly reduced the frequency of those seizures compared to a placebo — achieving the main goal of a Phase 3 clinical trial.
- “The new study results also exceeded the treatment effect reported in the company’s previous mid-stage study.
- Xenon said it expects to seek the approval of its drug, called azetukalner, with the Food and Drug Administration in the third quarter.
- “In the Phase 3 study, a 25 mg dose of azetukalner reduced the frequency of seizures over a month by 53% compared to 10% in the placebo arm. The difference, just under 43 percentage points, was statistically significant. Participants were treated for 12 weeks.
- “A 15 mg dose of azetukalner also reduced seizure frequency more than placebo with statistical significance.”
- Per BioPharma Dive,
- “Bristol Myers Squibb said Monday that a regimen including its experimental protein-degrading drug mezigdomide produced positive results in a late-stage trial of patients with relapsed or refractory multiple myeloma.
- “Investigators found that a combination of mezigdomide and two other standard myeloma therapies was associated with a “statistically significant and clinically meaningful improvement” in progression-free survival when compared to treatment with those two other drugs. Bristol didn’t provide specifics, but said that safety findings were “consistent” with the known profile of mezigdomide and the other components of the regimen.
- “Mezigdomide is one of several protein-degrading therapies that Bristol Myers acquired in 2019 buyout of Celgene and sees as successors to blood cancer drugs Revlimid and Pomalyst. Another, iberdomide, hit one of its primary goals in a Phase 3 study late last year and is now under review by the Food and Drug Administration.”
- and
- “Roche’s experimental drug giredestrant missed the main goal of a Phase 3 trial testing it as an initial treatment for breast cancer, the company said Monday. A combination of the therapy and Pfizer’s Ibrance failed to delay progression or death compared to Ibrance and hormone treatment.
- “The data is a blow to the Swiss drugmaker’s ambitions for giredestrant, which is already under Food and Drug Administration review in people whose breast cancer has progressed and succeeded in staving off relapses after surgery.
- “The trial’s failure will also likely reinforce doubts about the commercial potential of drugs in giredestrant’s class, called oral SERDs. The two approved drugs in the class, Menarini’s Orserdu and Eli Lilly’s Inluriyo, have so far only been approved for people whose breast cancer carries a certain mutation.”
From the U.S. healthcare business and artificial intelligence front,
- Modern Healthcare announced its Leading Women 2026. Congrats to them.
- Fierce Healthcare announced its Fierce 15 healthcare companies.
- BioPharma Dive reports,
- “Novo Nordisk will begin offering its popular obesity drugs on Hims & Hers’ telehealth platform, ending a messy dispute that resulted in a lawsuit and a crackdown by U.S. drug regulators.
- “Under a deal announced Monday, Hims will provide access to Novo’s GLP-1 medicines — the diabetes drug Ozempic and the injectable and pill forms of the weight loss therapy Wegovy — to U.S. consumers at the same prices as other telehealth firms. Hims will no longer promote “compounded” versions of GLP-1 drugs on its website or in advertisements, and will give existing patients the chance to switch to “FDA-approved alternatives,” according to a statement from Novo.
- “Novo will, as a result, dismiss its patent infringement lawsuit against Hims while “reserving the right to refile in the future.” News of the deal was first reported by Bloomberg.”
- Beckers Hospital Review adds,
- “Amazon Pharmacy has added Eli Lilly’s Zepbound KwikPen in the 2.5-mg starter dose for $299 per month through its cash-pay model.
- “Zepbound is a multidose injectable medication approved for chronic weight management and, more recently, moderate-to-severe obstructive sleep apnea. With a valid prescription, Amazon customers can order the KwikPen online for home delivery, including same-day delivery in nearly 3,000 cities and towns, according to a March 9 news release. That reach is expected to grow to 4,500 locations by the end of 2026.
- “Amazon Pharmacy has supplied GLP-1 medications since 2021 and works with partners including LillyDirect, WeightWatchers, UpScriptHealth and Noom. To date, the company said, its platform has saved customers “more than $200 million,” with GLP-1s representing the largest share of savings, according to the release.”
- and
- “New York City-based NewYork-Presbyterian is beginning to see early signals from its hospital-at-home program, which launched in November 2025 as health systems across the country continue testing whether acute-level hospital care can be delivered safely in patients’ homes.
- “The model allows certain patients who would otherwise require inpatient admission to receive hospital-level treatment at home through a combination of in-person nursing visits, remote patient monitoring and virtual physician oversight. Programs like these expanded rapidly during the COVID-19 pandemic under a federal waiver that allowed hospitals to bill Medicare for hospital-at-home services.
- “Although the waiver was extended until 2030, many health systems are still evaluating whether the care model can deliver consistent outcomes and operational reliability outside traditional hospital walls.
- “At NewYork-Presbyterian, early data has been encouraging.”
- Per an Institute of Clinical and Economic Review news release,
- “The Institute for Clinical and Economic Review (ICER) announced today that it will assess the comparative clinical effectiveness and value of tavapadon (AbbVie Inc.) for Parkinson’s disease.
- “The assessment will be publicly discussed during a meeting of the California Technology Assessment Forum (CTAF) in October 2026, where the independent evidence review panel will deliberate and vote on evidence presented in ICER’s report.
- “ICER’s website provides timelines of key posting dates and public comment periods for this assessment.”
- Per a Blue Cross news release,
- “New research from the Blue Cross Blue Shield Association (BCBSA) and its data analytics partner Blue Health Intelligence® (BHI®) suggests that the growing use of AI in hospital billing is driving higher health care costs by increasing the number and severity of diagnoses billed without any record of the expected treatment.
- “Analyzing de-identified claims data from tens of thousands of maternity admissions nationwide, researchers found a sharp increase in cases coded for acute posthemorrhagic anemia, a serious condition that typically requires interventions such as blood transfusions. However, many patients coded with the diagnosis never received those treatments.
- “Something is disconnected,” said Dr. Razia Hashmi, BCBSA’s vice president of Clinical Affairs. “Among hospitals showing the fastest rise in diagnoses of post-partum anemia, the rise in patients coded with this condition wasn’t paired with the level of care we would have expected, and the patterns we’re seeing point to AI‑enabled coding.”
- “The cost impact is significant, reaching approximately $2.3 billion in spending:
- “Researchers estimate that roughly $663 million in inpatient spending and at least $1.67 billion in outpatient spending may be tied to more aggressive, AI-enabled coding practices nationwide.”
- Healthexec shares “four points about healthcare AI that notable experts are emphasizing in the public square.”
- Per MedTech Dive,
- “Agilent Technologies said Monday it agreed to acquire Biocare Medical for $950 million in cash to expand its pathology portfolio.
- “Biocare’s antibody, reagent and instrument business complements Agilent’s offerings in clinical and research pathology and includes immunohistochemistry and in situ hybridization, Agilent said.
- “Since 2021, Biocare has generated annual double-digit revenue and profit growth. Revenue exceeded $90 million in 2025. The laboratory instruments and services provider is buying Biocare from an investor group led by Excellere Partners and GHO Capital Partners.”
- and
- “Zimmer Biomet shared data on its smart knee implant at the American Academy of Orthopaedic Surgeons conference on Wednesday.
- “The company found that patients who used its Persona IQ implant with a care management platform had better outcomes a year after surgery than people with a traditional knee implant.
- “Mike Anderson, Zimmer’s clinical strategy associate director, said the results of the analysis showed that the company’s technology was associated with lower rates of revision surgery and periprosthetic joint infection, less use of opioids, and fewer visits to urgent care and physical therapy.”
