From Washington, DC

• Roll Call tells us,
  • “As Congress spent months arguing over COVID-19-era enhanced premium tax credits that many people on the Affordable Care Act used to subsidize their health insurance, a relatively narrow debate over a single policy grew into a much broader and more complicated discussion about how to lower health care costs. 
  • “Concerns about those costs are a top issue for voters ahead of this year’s midterms. But whether Congress can meaningfully address the issue and how candidates communicate that idea to voters depends on the type of cost increases and what is driving them. 
  • “A main reason is that health-related costs mean different things to different people, such as higher insurance premiums, more expensive drugs, co-pay increases, surprise charges or unexpected gaps in coverage.
  • “Health care is probably the most complicated sector of the economy,” said Jonathan Burks, executive vice president of health and economic policy at the Bipartisan Policy Center. “I think when policymakers are talking about affordability, the reason that they can say ‘affordability’ and yet be nowhere near agreement on what they specifically want to do is because of that complexity.”

• Federal News Network reports,
  • “The Trump administration is telling most agencies to proceed with terminating their collective bargaining agreements and derecognizing their federal unions in response to a pair of 2025 executive orders, despite ongoing litigation.
  • I”n a memo issued Thursday, Office of Personnel Management Director Scott Kupor advised all agencies covered by President Donald Trump’s orders to move forward with either amending or fully canceling their collective bargaining agreements. The president’s orders last year directed a majority of agencies to cancel their union contracts, citing “national security” concerns.
  • “For various reasons, including litigation, implementation of these executive orders at certain agencies and agency subdivisions has been delayed,” Kupor wrote in the Feb. 12 memo. “[OPM] now advises agencies and agency subdivisions covered by [the orders] that they should proceed to terminate or modify collective bargaining agreements.”
  • “The OPM memo tells agencies to notify their federal unions that the agreements are being terminated. It adds, though, that federal employees and agencies not covered by the two executive orders [here and here] can continue collective bargaining procedures as normal.”

• NCQA announced the draft measurement year 2027 changes to its HEDIS quality measures. The public comment period ends on March 13, 2026 at 5 pm ET. HEDIS measures form a major part of OPM’s FEHB/PSHB plan performance assessment.

• The American Hospital Association News relates,
  • “The Department of Health and Human Services Feb. 13 issued a request for information on a new 340B rebate model program. The RFI said HHS’ Health Resources and Services Administration’s Office of Pharmacy Affairs, which currently oversees the 340B Drug Pricing Program, will accept comments through March 19.
  • “The RFI asks 340B stakeholders to provide answers to a long list of questions so that HRSA can evaluate whether it should implement a 340B rebate model pilot program and how such a program might be designed. HRSA expressly encourages commenters to “include supporting facts, research, and evidence.”
  • “In a statement, Aimee Kuhlman, AHA vice president of advocacy and grassroots, said, “The AHA welcomes HRSA’s attempt to gather detailed information about the impact of a rebate model. We look forward to working with the agency to answer the many specific questions it has posed to 340B hospitals and other stakeholders. We hope that after careful consideration of comments from 340B hospitals and other stakeholders, HRSA will recognize that imposing hundreds of millions of dollars in costs on hospitals serving rural and underserved communities is not a sound policy.”

From the Food and Drug Administration front,

• STAT News reports,
  • “The Food and Drug Administration on Friday rejected bitopertin, a therapy developed by Disc Medicine to treat the rare blood disorder porphyria, which makes patients extremely sensitive to sunlight. 
  • “It’s the first experimental drug to go through FDA Commissioner Marty Makary’s new program to fast-track drug reviews. The agency previously approved a generic antibiotic through the new drug review program in December.
  • “The FDA, in its letter rejecting bitopertin, cited “uncertainties” about the correlation between the blood-based biomarker used as the efficacy goal in Disc’s clinical trials and clinical benefit for patients.” 

• Fierce Pharma informs us,
  • “With the writing apparently on the wall, PTC Therapeutics has called off its latest bid for FDA approval of its Duchenne muscular dystrophy (DMD) drug Translarna. 
  • “Late Thursday, PTC revealed that it withdrew its FDA application for Translarna in nonsense mutation DMD after receiving feedback on its filing from the regulator. 
  • “FDA shared that based on its review to date, the data in the [New Drug Application] submission are unlikely to meet the Agency’s threshold of substantial evidence of effectiveness to support approval of Translarna,” Matthew Klein, M.D., PTC’s chief executive, explained in a statement. 
  • “PTC is “disappointed that FDA approval cannot be achieved,” Klein said, citing the decades of development work that have gone into the company’s protein restoration therapy. 
  • “In a letter to the U.S. DMD community, PTC cited unresolvable “differences in data interpretation” with the FDA, Pharmaphorum reports.” 
• and
  • “It’s déjà vu all over again. Just as the kidney disease space becomes increasingly competitive, Novartis has found itself intending to turn a statistical miss into a regulatory win.
  • “Despite the phase 3 Align trial narrowly failing to hit its kidney function endpoint, Novartis announced Friday that it will pursue traditional FDA approval for Vanrafia (atrasentan) in IgA nephropathy (IgAN).” * * *
  • “For its part, Novartis is leaning on a “positive difference” with Vanrafia versus placebo in eGFR change from baseline at Week 136, as well as a “clinically meaningful” improvement for the drug at Week 132, when study treatment ended.” 

From the judicial front,

• The AHA News reports,
  • “The U.S. District Court for the Eastern District of Texas Feb. 12 vacated a final rule by the Federal Trade Commission that changed premerger notification rules, form and instructions under the Hart-Scott-Rodino Antitrust Improvements Act. The rule had increased reporting requirements on the HSR form. The final rule was challenged by the U.S. Chamber of Commerce in 2024.
  • “First, the Final Rule exceeds the FTC’s statutory authority because the agency has not shown that the Rule’s claimed benefits will ‘reasonably outweigh’ its significant and widespread costs,” Judge Jeremy D. Kernodle wrote in his opinion. “Though the FTC asserts that the Rule will detect illegal mergers and save agency resources, the FTC fails to substantiate these assertions. The Final Rule is therefore not ‘necessary and appropriate,’ and the statute ‘does not authorize [the FTC] to promulgate [the Final Rule].’”
  • “The AHA filed an amicus brief in the case last year, explaining that the changes made by the FTC under the HSR Act were “unnecessary and unlawful.” Key aspects of yesterday’s decision, including the court’s rejection of the FTC’s reliance on a study regarding hospital mergers, were based on arguments made in the AHA’s amicus brief.”

From the public health and medical / Rx research front,

• The Centers for Disease Control and Prevention announced today,
  • “Seasonal influenza activity remains elevated nationally. RSV activity is elevated in many areas of the country. Emergency department visits for RSV are highest among infants under 1 year and children 1-4 years old. RSV hospitalizations are highest among infants less than 1 year old. COVID-19 activity is elevated in some areas of the country.
  • “COVID-19
    • “COVID-19 activity is elevated in some areas of the country.
  • “Influenza
    • “Seasonal influenza activity remains elevated nationally. Influenza A activity is decreasing while influenza B activity is increasing nationally and in most areas of the country; however, trends vary by region.
    • “Additional information about current influenza activity can be found at: Weekly U.S. Influenza Surveillance Report | CDC
  • “RSV
    • “RSV activity is elevated in many areas of the country, including emergency department visits among infants under 1 year and children 1-4 years old. Hospitalizations are highest among infants less than 1 year old.
  • “Vaccination
    • “National vaccination coverage for COVID-19, influenza, and RSV vaccines remains low for children and adults. COVID-19, influenza, and RSV vaccines can provide protection against severe disease this season. It is not too late to get vaccinated this season. Talk to your doctor or trusted healthcare provider about what vaccines are recommended for you and your family.”

• The University of Minnesota’s CIDRAP adds,
  • “Six more US children died of influenza last week, for a total of 66 pediatric deaths this respiratory illness season, as flu rates remained moderate to very high in different regions of the country, per the weekly FluView update from the Centers for Disease Control and Prevention (CDC).
  • “Of all pediatric deaths this season, 90% who were eligible for vaccination were unvaccinated. This age-group has been particularly vulnerable, with high-severity illness, while both adults and older adults are currently categorized as having moderate-severity illness. 
  • “The 2024-25 influenza season saw 289 pediatric deaths—the most reported in a non-pandemic flu season since the CDC began tracking child flu deaths in 2004.
  • “COVID-19 rates are still elevated and are growing in some states, but ED visits for the virus are decreasing.”

• The AHA News tells us,
  • “The South Carolina measles outbreak has grown to 950 cases, the state’s Department of Public Health reported Feb. 13. Of those, 246 cases are under age 5, 611 cases are from age 6-17, 82 cases are age 18 or older, and the ages of 11 cases are unknown. Since Jan. 1, 910 confirmed measles cases nationwide have been reported to the Centers for Disease Control and Prevention. The vaccination status of 94% of cases is classified as unvaccinated or unknown.”
    
• The UMN CIDRAP again adds,
  • Vermont and New York health officials are reporting their first measles cases of the year. * * *
  • The New York measles case was diagnosed in an unvaccinated infant, according to The New York Times.
  • “The Vermont measles case occurred in an adult in Washington County who became sick after recent international travel, according to the Vermont Department of Health.” 
    
• Radiology Business informs us,
  • “A novel artificial intelligence model could improve the identification of a potentially deadly pregnancy complication that often goes undetected. 
  • “Placenta accreta spectrum happens when the placenta improperly attaches, typically too deeply, to the uterine wall. Due to its potential to trigger life-threatening hemorrhage during or after delivery, it is considered a high-risk complication of pregnancy and is a leading cause of maternal mortality and morbidity. 
  • “Despite the dangers associated with the condition, its presence often (up to half the time) evades detection during pregnancy. With instances of PAS on the rise, there is a critical need for methods of identifying the condition prior to delivery. 
  • “This week, during the Society for Maternal-Fetal Medicine (SMFM) 2026 Pregnancy Meeting, researchers shared new data on a novel AI tool they believe could help improve the diagnosis of PAS. 
  • “Our team is very excited about the potential clinical implications of this model for accurate and timely diagnosis of PAS,” researcher Alexandra L. Hammerquist, MD, a maternal-fetal medicine fellow at Baylor College of Medicine in Houston, said during the presentation. “We are hopeful that its use as a screening tool will help decrease PAS-related maternal morbidity and mortality.”   

• Fierce Healthcare informs us,
  • “While Generation Z and millennial workers still account for fewer claims than their baby boomer counterparts, claims in these populations are rising fast, according to a new report.
  • “UnitedHealthcare and the Health Action Council (HAC) earlier this month released their annual white paper digging into key trends impacting the employer market and found that the number of claims for lower-aged workers are increasing more quickly than they did for baby boomers.
  • “Between 2023 and 2025, the year-over-year growth rate in claims was nearly double that of baby boomers. The study also found that younger individuals were developing conditions like diabetes or obesity earlier in life and were less likely to be engaged with a primary care provider (PCP), instead frequenting the emergency room.
  • “All of these factors can drive up medical costs for employers in the long term, according to the report.” * * *
  • “For employers or plan sponsors that identify this trend, the challenge is how to best engage this population around their health. One approach, Kurtzweil said, is to try and incentivize them to develop a primary care relationship through education and communication programs that make clear the value of a PCP.
  • “Or, plan sponsors can consider alternative options like on-site clinics or virtual care that can connect people to the healthcare system without necessarily leaning on primary care, he said.”

• The Health Care Cost Institute lets us know,
  • “Nearly half of adults in the US have high blood pressure or high cholesterol, which are key risk factors of heart disease – the leading cause of death in the US.  HHS estimates about 30 million adults in the US have blood pressure at levels where medication use is recommended but are untreated. The American Heart Association estimates the direct and indirect costs of cardiovascular disease in the US is more than $414B. Commonly used, low-cost medications can effectively treat high blood pressure and high cholesterol and prevent more serious and costly heart-related conditions like heart attack or stroke.” 
    
• Medscape adds,
  • “Patients worried about potential side effects of statins can rest easy, according to a new large-scale study: The vast majority of adverse effects listed on statin medications simply never occur.
  • “The study, published in The Lancet, analyzed individual patient data from 154,000 patients in 23 large, randomized controlled trials conducted by the Cholesterol Treatment Trialists’ Collaboration.”

• Healio points out,
  • “Night shift workers and individuals who regularly achieve fewer than 6 hours of sleep demonstrate an increased risk for osteoarthritis, according to findings published in Arthritis Care & Research. 
  • “We chose to study the associations of shift work and sleep with osteoarthritis because accumulating laboratory evidence had indicated that maintenance of daily circadian rhythms are critical for homeostasis of articular cartilage and other joint tissues,” Elizabeth Yanik, PhD, ScM, assistant professor in the department of orthopedic surgery at Washington University, St. Louis, told Healio. “However, few studies had investigated the relationships between circadian clock disruption, sleep and osteoarthritis risk in humans.”

• The Wall Street Journal adds,
  • “Attention lapses from sleep deprivation result from the brain’s efforts to clean itself, a process usually occurring during sleep, research suggests.
  • “A study in Nature Neuroscience found sleep-deprived brains experience fluid pulses during wakefulness, causing brief attention reductions.
  • “During these attention lapses, cerebrospinal fluid surges through the brain, and study participants experienced slower reactions and missed cues.”

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

• The Wall Street Journal reports,
  • “Annual inflation slowed in January, falling more than economists expected, helped by declining prices for gasoline and used vehicles.
  • “Cooler price increases overall are positive news for the economy, easing concerns that the Trump administration’s steep tariffs will lead to broader ongoing inflation. Yet price increases in January for items like computers and washing machines suggest inflation is continuing to weigh on Americans exhausted by price hikes.
  • “Consumer prices rose 2.4% in January from a year earlier, cooler than 2.7% in December and below the 2.5% economists surveyed by The Wall Street Journal had expected. Core prices, which exclude volatile food and energy items, rose 2.5% from a year earlier, in line with expectations.” * * *
  • “Analysts and economists have focused on the rising price of goods as a way to measure tariff impact, but the report also showed higher costs for an array of services, including airline tickets and hospital care. Overall, costs for services rose at their fastest monthly clip in a year, a frustrating data point for economists who have warned that lingering services inflation will be hard to slow.” 

• Modern Healthcare relates,
  • “Health systems are investing billions of dollars into inpatient facilities, driven by an aging population and increasing demand for specialized care. 
  • “In recent years, providers have largely focused their investing on extensive outpatient projects. They also face ongoing cost pressures and regulatory uncertainty.
  • “Still, several are looking to add to their inpatient footprint. 
  • “Mark Pascaris, senior director at credit ratings agency Fitch Ratings, said demand for inpatient projects is particularly strong in competitive markets with growing populations.
  • “I think we have and will continue to see plenty of big-ticket hospital constructions,” Pascaris said. “We can’t ignore the inpatient footprint. The [COVID-19] pandemic taught all of us that we still need ICUs. We still need inpatient surgery suites.” 

• Per Beckers Payer Issues,
  • “Humana is in talks with Sarasota, Fla.-based MaxHealth — a primary care network and platform focused on adults and seniors — regarding an acquisition, Bloomberg reported Feb. 12.
  • “According to Bloomberg sources, MaxHealth, owned by private equity firm Arsenal Capital Partners’ Best Value Healthcare, could have been valued at about $1 billion.
  • “Humana President and CEO Jim Rechtin previously said the company is looking to expand its primary care footprint.
  • “We also hope to soon announce a strategic acquisition in the primary care space,” Mr. Rechtin saidon a Feb. 11 earnings call.” 

• The Employee Benefits Research Institute prepared a report titled “Cell and Gene Therapies in Employment-Based Health Insurance: Financing the High-Cost, High-Impact Future.” Check it out.

• MedCity News considers “From Claims Payer to Care Partner: What AI Really Changes in Health Insurance, and What It Doesn’t.”
  • “AI can help health plans reduce friction, speed revenue-cycle throughput, and improve member experience, but only when it is deployed with strong data discipline, modern integration patterns, and a governance model that treats AI as “augmented intelligence,” meaning powerful, assistive, and accountable.”

• The Wall Street Journal notes,
  • “In one experiment, offering human contact to loan applicants during the approval process made them much more likely to eventually accept a loan if offered.
  • “A study found that providing access to a human, even if unused, boosts customer satisfaction and confidence in sensitive online transactions.
  • “Only about 10% of customers offered human assistance actually use it, suggesting the cost of providing the option is lower than perceived.”

• Fierce Pharma points out,
  • “Determined to avoid a repeat of the supply shortfalls that plagued early GLP-1 rollouts for obesity, Eli Lilly has amassed a sizable store of its oral weight loss candidate orforglipron. 
  • “Specifically, Lilly had secured “pre-launch inventories” worth $1.5 billion as of Dec. 31, with most of that supply tied to orforglipron, the company said in a securities filing this week. 
  • “The update on Lilly’s pending launch inventory comes after the Indianapolis drugmaker said last February that it had built up nearly $550 million in early inventory that was again primarily related to orforglipron.” 

• BioPharma Dive informs us,
  • “Moderna reported better-than-expected fourth quarter sales and affirmed revenue growth estimates for 2026 despite soft demand for its COVID-19 vaccine and recent, high-profile pushback from the Food and Drug Administration.
  • “The biotechnology company said Friday it recorded revenue of $678 million over the final three months of last year and $1.9 billion for all of 2025, figures that came at the higher end of a projected forecast from November. U.S. sales more than halved between the third and fourth quarters, but still made up more than 60% of Moderna’s full-year revenue, in part because of the successful launch of the COVID shot mNEXSPIKE and a strong U.S. retail COVID vaccine market.”

• Per MedTech Dive,
  • “Dexcom is watching for expanded Medicare coverage of its continuous glucose monitors to people with Type 2 diabetes who don’t take insulin. 
  • “New CEO Jake Leach told investors on Thursday that the company has been “sitting here waiting for a coverage decision” from the Centers for Medicare and Medicaid Services. Dexcom expects CMS to propose a coverage expansion in the first half of 2026, BTIG analyst Marie Thibault wrote in a note to clients Thursday. 
  • “Dexcom started to see commercial coverage unlock for Type 2, non-insulin users toward the end of last year, Leach said. He expects broader Medicare coverage for that group would allow nearly 12 million people to access CGMs. 
  • “In the meantime, the American Diabetes Association updated its guidelines last year to recommend clinicians consider using CGMs for Type 2 diabetes when patients are taking glucose-lowering medications other than insulin. Leach said that real world data the company has been generating supports that decision, and that Dexcom has launched a registry for non-insulin users.”