Friday Report

OPM

Friday Report

David Ermer–CDC, CMS, COVID-19, FDA, Medical / Rx research, NCQA, Obesity, OPM, Rx coverage, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC

  • Federal News Network tells us,
    • “The Office of Personnel Management is taking a second bite at the apple to modernize its human resources platform.
    • “OPM released a new request for proposals on Thursday through the General Services Administration schedules program for a secure, cloud-based software-as-a-service (SaaS) human capital management (HCM) platform.
    • “The objective of this acquisition is to deploy an integrated, enterprise-wide core HR platform—powered by a secure, FedRAMP-authorized SaaS solution—that consolidates key human capital functions, including personnel management, time and attendance, leave, benefits administration, learning and performance management and workforce analytics,” the RFP states. “The platform must enable seamless interoperability with critical external systems (e.g., USA Staffing, GSA Payroll, eOPF, eHRI, LMS, and benefits systems) and eliminate the data and process gaps currently affecting onboarding, pay accuracy, personnel action sequencing, leave eligibility and audit reporting.”
    • “The solicitation says the platform will be used for OPM’s workforce of 2,000 to 3,000 people.”
  • Fierce Healthcare informs us,
    • “The Centers for Medicare & Medicaid Services (CMS) revealed several updates to the ACO REACH program in 2026, though the model’s long-term future remains unclear.
    • “The CMS said it is making changes to the model based on preliminary data on 2023 performance (PDF), which found that standard accountable care organizations saved $197.5 million in aggregate that year. New entrant ACOs, meanwhile, generated $36.8 million in aggregate savings, reducing gross spending at higher rates that standard organizations.
    • “In addition, high-needs ACOs reduced spending by $2.3 million in the aggregate, according to the preliminary report. The CMS is set to release full data on ACO REACH later this year.
    • “The proposed changes come in a confusing environment for ACOs, which have pushed the agency to outline plans for the ACO REACH program, currently set to expire in 2026.”
  • The American Hospital Association News let us know,
    • “AHA May 23 submitted recommendations to the Department of Justice and Federal Trade Commission in response to the agencies’ requests for information on unnecessary or burdensome anticompetitive regulations. “[T]he U.S. health care system imposes a bewildering array of regulations on hospitals and health systems, adding significant administrative costs, disincentivizing pro-competitive arrangements, and promoting vertical consolidation of large commercial insurers to the detriment of patients and providers across the country,” AHA Deputy General Counsel Julie Rapoport Schenker wrote in the letters to the agencies. The AHA’s recommendations included addressing regulations that foster anticompetitive conduct by insurers and limit the ability of hospitals and health systems to thrive in a competitive free market, among others.” 

From the public health and medical research front,

  • The University of Minnesota’s CIDRAP points out,
    • “Excess deaths in the United States kept rising even after the peak of the COVID-19 pandemic, with more than 1.5 million in 2022 and 2023 that would have been prevented had US death rates matched those of peer countries, estimates a Boston University (BU)-led study today in JAMA Health Forum.
    • “The data show a continuation of a decades-old trend toward increasing US excess deaths, mainly among working-age adults, largely driven by drug overdoses, gun violence, auto accidents, and preventable cardiometabolic causes, the researchers say.
    • “The US has been in a protracted health crisis for decades, with health outcomes far worse than other high-income countries,” says lead and corresponding author Jacob Bor, ScD, said in a BU news release. “This longer-run tragedy continued to unfold in the shadows of the COVID-19 pandemic.”
  • The Centers for Disease Control and Prevention announced today,
    • “Seasonal influenza, COVID-19, and RSV activity is low.
    • “COVID-19
      • “COVID-19 activity has declined to low levels nationally. Wastewater levels are at low levels, emergency department visits are at very low levels, and laboratory percent positivity is stable.
      • “Additional information about current COVID-19 activity can be found at: CDC COVID Data Tracker: Home.
    • “Influenza
    • “RSV
      • “RSV activity has declined to low levels in most areas of the country.”
  • The New York Times reports,
    • “Cancer screening poses a quandary for women with dense breast tissue. They’re at elevated risk for breast cancer, but mammograms often miss tumors buried in dense breasts — and insurers often resist paying for additional scans that may help find the masses.
    • “Now a large study comparing various types of scans has found that mammography enhanced with iodine-based dye can detect three times as many invasive cancers in dense breast tissue as ultrasound.
    • “And so-called contrast-enhanced mammography can find tumors that are much smaller than those found by regular mammography. M.R.I.s are better at detecting more tumors than standard mammograms, the study found but are considerably more expensive.
    • “The scans were given to women with dense breast tissue who had already undergone mammograms that hadn’t turned up any abnormalities.”
    • “Contrast-enhanced mammography needs to become standard of care for women with dense breasts,” if they are at high risk of developing breast cancer, said Dr. Fiona J. Gilbert, a professor of radiology at the University of Cambridge’s School of Clinical Medicine. She is lead author of the study, which was published Wednesday in The Lancet.”
  • NCQA offers via LinkedIn a White Paper, Webinar and a New HEDIS Measure for Asthma Awareness Month, which is May.
    • “The HEDIS MY 2026 measure set will include a new measure focused on asthma, Follow-Up After Acute Care Visits for Asthma (AAF-E). Patients with uncontrolled asthma are more likely to seek care for acute exacerbations, rather than focusing on preventive care. The new measure focuses on the patient-clinician relationship as encouraging treatment adherence and efficacy. Guiding patients toward non-acute care—and clinicians with whom they have a trusted relationship—may help improve asthma outcomes.”
  • The Wall Street Journal delves into “new tests [that] promise to reveal the secrets in your blood. A wave of diagnostic tests—some here, some coming—can identify cancer and Alzheimer’s at earlier stages and predict flare-ups of other conditions.”
  • Per HCPLive,
    • “Semaglutide demonstrated notable protective effects on osteoporosis and gout in people with obesity and type 2 diabetes (T2D) in a new cohort study.
    • “The impact of newer anti-obesity medications on skeletal health remains incompletely understood, particularly in populations with varying metabolic profiles,” lead investigator Jo-Ching Chen, Chung Shan Medical University Hospital, Taichung, Taiwan, and colleagues wrote.
    • “Chen and colleagues conducted a 5-year cohort study examining skeletal health outcomes in people with obesity and T2D receiving semaglutide vs conventional glucose-lowering medications (sitagliptin, empagliflozin, glipizide), and obese individuals without T2D receiving semaglutide vs traditional anti-obesity medications (Contrave, phentermine, Qsymia).”
  • Per Fierce Pharma,
    • “After meeting the mark alongside Keytruda in PD-L1-positive breast cancer earlier this year, Gilead Sciences’ antibody-drug conjugate Trodelvy has impressed in a solo showing in a similar indication.
    • “In the late-stage Ascent-03 trial, Trodelvy bested standard-of-care chemotherapy at extending the time before disease worsening or death in certain patients with previously untreated metastatic triple-negative breast cancer (TNBC).
    • “The study specifically assessed the TROP2-targeted ADC in patients who aren’t candidates for PD-1 or PD-L1 inhibitors, either because their tumors don’t express the PD-L1 protein or because the patients are ineligible.
    • “The “highly statistically significant and clinically meaningful” improvement on the progression-free survival metric allowed the study to meet its primary endpoint, Gilead said. The company will discuss the Ascent-03 results with regulators and plans to present detailed results from the trial at an upcoming medical meeting.”

From the U.S. healthcare business front,

  • Healthcare Dive reports
    • “The nation’s leading nonprofit healthcare providers struggled financially during the quarter ended March 31.
    • “Most of the major systems, including Kaiser Permanente, Mass General Brigham, Cleveland Clinic, Mayo Clinic, Ascension and Providence, recorded operating margins that were flat or lower than this time last year, despite growing patient volumes.
    • “The results come as analysts have been sounding the alarm with escalating urgency about how headwinds, including market volatility and policy changes in Washington, could harm provider finances.” 
  • Beckers Health IT explains “two ways Amazon is changing healthcare, per CEO Andy Jassy.”
  • Per Health Leaders,
    • “A recent Experian Health survey shows steady improvement in access to care but suggests a disconnect between patients and providers on digital tools.
    • “Providers continue to face challenges with capacity constraints and staffing shortages.
    • “Patients call for better pricing estimates and self-scheduling tools.”
  • Healthcare Innovation lets us know,
    • Aligning itself with new strategies coming out of the Center for Medicare and Medicaid Innovation, the Health Care Payment Learning & Action Network (HCPLAN) announced it will launch four new initiatives focused on healthcare choice and competition, patient empowerment, preventative care, and technology-enabled healthcare, while discontinuing its alternative payment model measurement effort, which had been funded by CMMI.
    • The HCPLAN is a group of public and private healthcare leaders that was formed to provide thought leadership, strategic direction, and ongoing support to accelerate the adoption of alternative payment models (APMs) and accountable care.
    • Since its launch in 2015, the HCPLAN APM Measurement Effort has monitored the shift of U.S. healthcare from fee-for-service to APMs. The 2024 APM Measurement Effort results demonstrated the continued growth in APM adoption and initiatives to enhance patient access, affordability, and quality of care. As part of its efforts to advance the availability and reduce the cost of key data needed to improve care, the HCPLAN will explore alternative pathways for the continuation of this effort.
  • MedTech Dive explores “Why Medtronic plans to spin out its diabetes business. While some analysts questioned why Medtronic would leave a fast-growing market, others backed the company’s plan to focus on segments with higher margins.”
  • Per Fierce Healthcare,
    • “Pharmacy benefit manager WellDyne is partnering with Waltz Health to bring greater transparency to its specialty pharmacy clients.
    • “WellDyne is teaming up with Waltz as well as Mark Cuban Cost Plus Drugs as part of its broader member routing strategy, which surfaces real-time alerts and smart prompts that can help its members find the most affordable medication option for them.
    • “The PBM’s tech stack also uses automated algorithms to adjudicate claims in the background and let members know when they may be able to achieve savings. The technology optimizes claims across different touch points including retail, home delivery, discount cards and other avenues.
    • “Rich Wipperfurth, chief commercial officer for WellDyne, said traditional models are also built on simplicity but in a way that steers the member toward preferred distribution channels, pharmacies and other sources.
    • “WellDyne wants to inject more choice back into the equation, Wipperfurth said.”

Thursday Report

David Ermer–CDC, CMS, Congress, COVID-19 vaccine, FDA, Federal employment benefits, Medical / Rx research, NIH, Obesity, OPM, Rx coverage, SCOTUS, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC

  • The Wall Street Journal reports,
    • President Trump’s “big, beautiful bill” squeezed through the House after a late scramble to get rival factions on board. Next it goes to the Senate, where GOP lawmakers are already making demands and party leaders will once again need to bridge sharp disagreements.
    • The more than 1,000-page bill passed the House early Thursday morning after Speaker Mike Johnson (R., La.) found a recipe that satisfied just enough lawmakers, who approved the measure by just one vote after an all-night session. Now Senate Republican leader John Thune (R., S.D.) needs to line up enough support within his own narrow majority—without making changes that fracture the fragile House agreement and derail the party’s hopes to finish the bill by its July 4 target.
  • Federal News Network explains,
    • “Four of the six provisions on federal benefits cuts that originated from Republicans on the House Oversight and Government Reform Committee remain in the House-passed version of the bill, which now heads to the Senate for consideration. But notably, the proposed change to a “high-5” annuity calculation is no longer on the table. The provision was struck from the reconciliation legislation prior to the House’s passage of the bill.
    • “Oversight committee Democrats, as well as Rep. Mike Turner (R-Ohio), led efforts to remove the “high-5” proposal from the reconciliation bill. Rep. Stephen Lynch (D-Mass.) proposed an amendment to strike the “high-5” provision, which was ultimately adopted.
  • Tammy Flanagan, writing in Govexec, answers frequently asked questions about federal retirement.
  • The American Hospital Association (AHA) News tells us,
    • “Food and Drug Administration Commissioner Marty Makary testified May 22 before the Senate Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies on the discretionary budget proposal for fiscal year 2026. The proposal includes $93.8 billion for the Department of Health and Human Services, which oversees the FDA. The allocation is a 26.2% reduction from the FY 2025 enacted level.”  
  • The House of Representatives and the Senate left Washington DC today for a weeklong District/State work break following Memorial Day next Monday. The Senate Majority Leader announced his plans to file additional cloture motions for Presidential nominees when the Senate returns to Capitol Hill on June 2. That list does not include the President nominee for OPM Director Scott Kupor.
  • The AHA News informs us,
    • “The White House May 22 released its Make America Healthy Again report that focuses on childhood chronic disease. The report highlights findings from the MAHA Commission related to poor diet, exposure to environmental chemicals, lack of physical activity, stress and overmedicalization. The report lists a series of recommendations and next steps for research, including studies on nutrition, lifestyle interventions and precision toxicology. In parallel, the commission will develop a strategy to be released in August.”
  • The Washington Post assesses the report here.
  • The AHA News adds,
    • “The Departments of Labor, Health and Human Services, and the Treasury May 22 released several new guidance documents and requests for information on price transparency, following the February executive orderon the same subject. As part of this package, CMS released new guidance on calculating the estimated allowed amount values in the hospital machine-readable files. Whenever possible, hospitals should use the average dollar amount received over the last 12-month period (or less, if the payment methodology was only used for part of the year), which should be derived from the electronic remittance data. If there is no historic data, hospitals should use the expected payment amount, encoded as a dollar figure. This replaces previous guidance which allowed hospitals to use a code of nine number nines to signify that there was not sufficient historic data for that item or service over the last year. CMS also released an RFI on hospital price transparency accuracy and completeness. Comments are due July 21. The AHA plans to submit comments.  
    • “The departments also released a FAQ document, announcing that a new standard format for the insurer machine-readable files will be released Oct. 1, 2025. The new format aims to reduce the file size of the insurer files by decreasing duplicative data. In addition, the departments issued an RFI on improving prescription drug price transparency as part of the Transparency in Coverage, or insurer transparency rule.”

From the Food and Drug Administration front,

  • Per BioPharma Dive,
    • “Advisers to the Food and Drug Administration have recommended COVID-19 vaccine makers continue to target their shots to the so-called JN.1 coronavirus strain for the upcoming fall and winter seasons, maintaining guidance they gave last year.
    • The advisory committee convened Thursday for the first time under the Trump administration, meeting two days after FDA leadership unveiled new guidelines for COVID vaccine approvals. All nine members of the panel voted in favor of targeting shots to the JN.1 family of variants.
    • The FDA doesn’t have to follow the panel’s advice but usually does.”
  • STAT News adds,
    • “In another sign of growing scrutiny over Covid-19 vaccines, the Food and Drug Administration has asked the two makers of mRNA vaccines to widen the age range of boys and young men that their labels say are at risk for a rare side effect causing heart inflammation.
    • “The letters, first reported by CBS News, asked Moderna and partners Pfizer and BioNTech to make updates to safety information based on new studies of myocarditis or pericarditis or both after vaccination. Both reactions are rare and known to occur most often in young men within a week after the second shot in the two-dose Covid-19 vaccine regimen, according to the Centers for Disease Control and Prevention. Most cases were mild, causing no more than brief chest pain.”
  • Per MedTech Dive,
    • “Stryker has received 510(k) clearance for a minimally invasive back pain treatment, positioning it to challenge Boston Scientific for the market. 
    • “The Food and Drug Administration clearance, which Stryker disclosed Monday, covers the use of the OptaBlate basivertebral nerve ablation system to provide relief for low back pain.
    • “Stryker is entering a growing market. Boston Scientific’s rival device, which it acquired for $850 million upfront in 2023, “grew strong double digits” in the first quarter, CEO Mike Mahoney told investors in an April earnings call.”
  • Per Fierce Pharma,
    • “While GSK’s Nucala may not have earned the distinction of becoming the first FDA approved biologic for chronic obstructive pulmonary disease (COPD), the British drugmaker is confident its IL-5 antibody still has a major role to play in tackling the traditionally tough-to-treat respiratory condition.
    • “Now, following an unexpected delay earlier this month, the company has a fresh FDA green light to put its thesis to the test.
    • “The FDA on Thursday approved Nucala as an add-on maintenance treatment for adults with inadequately controlled COPD and an eosinophilic phenotype.” 
  • and
    • “In a somber end to an FDA advisory committee’s two-day scouring of multiple drugmakers’ oncology data, Pfizer’s pitch to expand Talzenna into a broader prostate cancer population has failed to impress.
    • “Late Wednesday, eight outside experts on the FDA’s Oncologic Drugs Advisory Committee delivered a unanimous 8-to-0 ‘No’ vote on the question of whether Pfizer’s PARP inhibitor Talzenna has a favorable benefit-risk profile in metastatic castration-resistant prostate cancer (mCRPC) patients without homologous recombination repair (HRR) gene mutations.
    • “Patients without HRR mutations make up the majority of the mCRPC patient population at about 70%, according to briefing docs released ahead of the meeting.”

From the judicial front,

  • Healthcare Dive tells us,
    • “A bankruptcy judge on Wednesday approved Rite Aid’s pharmacy asset sales to a variety of buyers, including some of the bankrupt drugstore chain’s rivals.
    • “Financial details were not disclosed, and sale documents redacted purchase prices for Rite Aid’s assets, which went to retail pharmacy chains like CVS and Walgreens, along with grocers Albertsons, Kroger and Giant Eagle and other buyers.” * * *
    • “The liquidation is a growth opportunity for CVS, already the nation’s largest drugstore chain with more than 9,000 pharmacies. The Woonsocket, Rhode Island-based company purchased prescription files from 625 Rite Aid stores in 15 states and fully acquired 64 brick-and-mortar Rite Aid locations in Idaho, Oregon and Washington.”
  • The Associated Press reports,
    • “The Supreme Court’s conservative majority on Thursday declined to reinstate independent agency board members fired by President Donald Trump, endorsing a robust view of presidential power.” * * *
    • “The court’s action essentially extended an order Chief Justice John Roberts issued in April that had the effect of removing two board members who Trump fired from agencies that deal with labor issues, including one with a key role for federal workers as Trump aims to drastically downsize the workforce.
    • “Neither agency has enough appointed members to take final actions on issues before them, as Trump has not sought to appoint replacements.”
    • “The decision Thursday keeps on hold an appellate ruling that had temporarily reinstated Gwynne Wilcox to the National Labor Relations Board and Cathy Harris to the Merit Systems Protection Board.”
  • Bloomberg Law points out,
    • “A federal district court judge in California said she will likely extend a freeze on President Donald Trump’s plan to lay off thousands of federal workers, dealing another blow to his unprecedented overhaul of the federal workforce. 
    • “Judge Susan Illston of the US District Court for the Northern District of California at a Thursday hearing said she is inclined to grant a preliminary injunction halting the layoffs while the case proceeds, temporarily protecting the jobs of thousands of federal workers.” 

From the public health and medical research front,

  • NBC News reports,
    • “New data from Truveta, a health care and analytics company, shows that the percentage of 6-month-old babies in Texas getting their measles vaccination in April increased by more than 30 times the prior year’s average.
    • “That means parents aren’t just getting the vaccine early, they’re getting it as early as they can,” Nina Masters, a senior scientist at Truveta and part of the research team, said in an interview with NBC News.
    • “Typically, the MMR is given in two doses, around a child’s first birthday, and again around the time a child enters kindergarten, at age 4 or 5. One dose is 93% effective at preventing measles, according to the Centers for Disease Control and Prevention. A second dose increases protection to 97%.”
  • Per Fierce Pharma,
    • “Roche, hoping to carve out a standard-of-care spot for its PI3K inhibitor Itovebi, now has another leg to stand on with new evidence that shows the drug can extend the lives of certain patients with breast cancer.
    • “Adding Itovebi to Ibrance and Faslodex slashed the risk of death by 33% in patients with PIK3CA-mutated, HR-positive, HER2-negative locally advanced or metastatic breast cancer that has grown during or after hormone therapy treatment. The data, to be presented at the American Society of Clinical Oncology’s (ASCO’s) annual meeting, come from Roche’s pivotal phase 3 INAVO120 trial. 
    • “In the 325-patient study, Roche’s Itovebi triplet combination kept patients alive for a median of 34 months compared to 27 months for those who took a placebo along with Ibrance and Faslodex.”
  • and
    • “Roche’s plan to bolster Tecentriq’s position in small cell lung cancer with Jazz Pharmaceuticals’ Zepzelca has paid off. But the pair’s success leaves room for improvement for future contenders.
    • “Adding Zepzelca on top of Tecentriq as maintenance treatment of first-line extensive-stage small cell lung cancer (ES-SCLC) significantly reduced patients’ risk of death by 27% compared with Tecentriq alone, according to data from the phase 3 IMforte trial.
    • “Patients who received the combo lived a median 13.2 months, versus 10.6 for those who got Tecentriq alone. The results will be presented at the 2025 American Society of Clinical Oncology annual meeting.”
  • STAT News relates,
    • “Merus said Thursday that a combination of its experimental drug petosemtamab with the checkpoint inhibitor Keytruda has kept 79% of patients with newly diagnosed metastatic head and cancer alive for at least one year, according to a new analysis of a mid-stage clinical trial. 
    • “The survival data are only a snapshot. Merus, a Dutch biotech, will need to complete a larger, randomized study to prove more definitively that its drug can extend the lives of patients with head and neck cancer beyond the ability of current treatments. But for now, the preliminary survival results are encouraging and matched the expectations of investors.
    • “Merus released the new petosemtamab data ahead of a presentation next week at the annual meeting of the American Society of Clinical Oncology.”
  • Per BioPharma Dive, “AI tool could help doctors ID breast cancers vulnerable to Enhertu. Tumors with low- and ultra-low levels of a protein called HER2 are treatable with Enhertu, but harder to identify. New research shows AI can improve diagnosis.”
  • Per a National Institutes of Health news release,
    • “National Institutes of Health (NIH) scientists have developed a new surgical technique for implanting multiple tissue grafts in the eye’s retina. The findings in animals may help advance treatment options for dry age-related macular degeneration (AMD), which is a leading cause of vision loss among older Americans. A report about the technique published today in JCI Insight.
    • “In diseases such as AMD, the light-sensitive retina tissue at the back of the eye degenerates. Scientists are testing therapies for restoring damaged retinas with grafts of tissue grown in the lab from patient-derived stem cells. Until now, surgeons have only been able to place one graft in the retina, limiting the area that can be treated in patients, and as well as the ability to conduct side-by-side comparisons in animal models. Such comparisons are crucial for confirming that the tissue grafts are integrating with the retina and the underlying blood supply from a network of tiny blood vessels known as the choriocapillaris.
    • “For the technique, investigators designed a new surgical clamp that maintains eye pressure during the insertion of two tissue patches in immediate succession while minimizing damage to the surrounding tissue.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Health insurance companies initially declined to pay more than one dollar for every $10 providers submitted in claims last year, an increase from 2023.
    • “Payers in 2024 initially denied 11.8% of dollars associated with hospital-based claims, according to a report from consultant Kodiak Solutions. That compares with 11.53% of dollars denied in 2023.
    • “The company examined data from its revenue cycle analytics platform used by more than 2,100 hospitals and 300,000 physicians. It categorized any initial bill that commercial, Medicaid and Medicare insurers initially rejected, or requested more information for, as a denial.
    • “Insurers often overturned their initial denials and ended up paying nearly 97% of dollars requested, according to the report.”
  • Reuters informs us,
    • “Median annual list price for new drugs over $370,000 in 2024
    • “72% of new drugs in 2024 for orphan diseases
    • “Drugmakers emphasize value, offer savings programs amid rising list prices.”
  • The International Foundation for Employee Benefit Plans shares its survey of GLP-1 drug coverage and expenses among employer sponsored plans.
  • Fierce Pharma notes,
    • “It’s plainly apparent that Novo Nordisk has had May 22 circled its calendar since February, when the FDA began the countdown for compounders to stop selling their versions of semaglutide.
    • “Now that the day has come, the Danish drugmaker is capitalizing on the chance to steer more patients toward its branded offerings.
    • “Self-paying patients new to Wegovy can access a one-month supply of the obesity blockbuster for $199 through June 30, Novo announced on Thursday. After that, the drug will go for its standing price of $499 a month for cash-paying customers, which was discounted in March from a previous price tag of $650 per month.”
  • Fierce Healthcare relates,
    • “Shares of Hinge Health jumped 22% above the initial public offering price in the company’s New York Stock Exchange debut on Thursday, bringing its market capitalization to more than $3 billion.
    • “The physical therapy company’s stock opened at $39.25 on Thursday and closed at $37.56, up 17% from its $32 per share IPO price. Hinge Health’s IPO has been closely watched given the recent stagnation in the exit markets and signals a potential upswing in the public investor market.”
  • Becker Hospital Review announced,
    • “Northern Light Inland Hospital and its associated clinical services in Waterville, Maine, will officially close May 27, marking the end of operations for the facility that has been gradually winding down since the closure was announced earlier this year.
    • “The hospital’s emergency department will stop accepting new patients at 12 p.m. on May 27. All remaining clinical services will cease at 5 p.m. the same day, the health system said in a May 22 news release.”

Friday Report

David Ermer–CDC, Congress, COVID-19, FDA, Federal employment benefits, Generative AI, Medical / Rx research, OPM, Rx coverage, U.S. Healthcare, Uncategorized–
Photo by Sincerely Media on Unsplash

From Washington, DC,

  • The Wall Street Journal reports,
    • “House Republican spending hawks blocked the party’s giant tax-and-spending bill on Friday, delivering President Trump a setback over disagreements on Medicaid, clean-energy tax breaks and budget deficits.
    • “The holdouts—Reps. Chip Roy of Texas, Ralph Norman of South Carolina, Josh Brecheen of Oklahoma and Andrew Clyde of Georgia—stopped the Budget Committee from advancing the legislation, which leaders hope to pass by the full House next week. The panel failed to move the bill on a 16-21 vote, with those four Republicans and Rep. Lloyd Smucker (R., Pa.) joining all Democrats in opposition. Smucker, who backs the measure, said he voted no for procedural reasons, so he can call for a revote later.
    • “Budget Committee Chairman Jodey Arrington (R., Texas) said lawmakers were close to agreements on making changes to win the necessary votes. The committee scheduled its session to resume at 10 p.m. Sunday.”
  • and
    • “The U.S. lost its last triple-A credit rating.
    • “Moody’s Ratings downgraded the U.S. government on Friday, citing large fiscal deficits and rising interest costs.
    • “Runaway budget deficits mean U.S. government borrowing will balloon at an accelerating rate, pushing interest rates up over the long term, Moody’s said. The firm said in a March report that fiscal weakness looked set to continue even under analysts’ best-case scenarios.”
  • Modern Healthcare adds,
    • “Long-sought legislation to monitor and restrict how pharmacy benefit mangers operate could finally pass — if Republicans can move their sweeping budget bill that includes a string of those provisions.
    • ‘New PBM measures are tucked into the bill advanced Wednesday by the House Energy and Commerce Committee, which aims to cut more than $880 billion in spending, including $625 billion from Medicaid. The restrictions have long been championed by Health Subcommittee Chair Buddy Carter (R-Ga.), who was a pharmacist before becoming a congressman.”
  • Per Govexec
    • “The Trump administration is abiding by a court order to pause layoffs across most federal agencies, but it is still finding ways to shrink the federal workforce through involuntary means. 
    • “The Housing and Urban Development Department has begun once again firing its probationary employees—those recently hired or promoted—through a process distinct and separate from a reduction in force. Other agencies, including the Labor Department and National Science Foundation, meanwhile, are walking back recent RIFs due to a court-issued temporary restraining order. 
    • “That order specifically prevented agencies from issuing layoffs or taking any action to implement their Agency RIF and Reorganization Plans, which were mandated by the Office of Management and Budget and the Office of Personnel Management earlier this year. Agencies that were on the cusp of implementing RIFs, such as the Interior Department, have put those plans on ice at least until the restraining order is set to expire after May 23.”
  • FedWeek called our attention to this OPM benefits administration letter about “Family Member Eligibility Verification Updates and Enrollment Processing.”
  • Fierce Pharma informs us,
    • “On the heels of a production-tinged executive order earlier this month, the Trump administration is doubling down on efforts to boost medicine manufacturing in the U.S.
    • “In a new public-private partnership spearheaded by the administration, the Department of Health and Human Services’ (HHS’) Administration for Strategic Preparedness and Response (ASPR) and the Defense Advanced Research Projects Agency (DARPA) are linking up with several universities and companies in a bid to improve manufacturing for essential medicines using technologies such as artificial intelligence, machine learning and informatics.
    • “The project, dubbed Equip-A-Pharma, will allow the federal agencies to work directly with Battelle Memorial Institute and Aprecia, Bright Path Laboratories, Rutgers University and Mark Cuban’s Cost Plus Drugs as the partners strive to boost domestic manufacturing of eight drugs and their active pharmaceutical ingredients, the ASPR said in a Thursday press release.”
  • STAT News reports,
    • “Optum, the health data and care provider division of UnitedHealth Group, is developing a way to calculate how sick Medicare patients are through artificial intelligence, instead of relying solely on diagnosis codes submitted by physicians.
    • “Ken Cohen, a physician and Optum’s executive director of translational research, said Thursday at a conference organized by America’s Physician Groups that he was working with the Duke-Margolis Institute for Health Policy on this “next generation” of Medicare risk coding using AI.”

From the FDA front,

  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today cleared for marketing the first in vitro diagnostic device that tests blood to aid in diagnosing Alzheimer’s disease. The Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio is for the early detection of amyloid plaques associated with Alzheimer’s disease in adult patients, aged 55 years and older, exhibiting signs and symptoms of the disease.
    • “Alzheimer’s disease impacts too many people, more than breast cancer and prostate cancer combined,” said FDA Commissioner Martin A. Makary, M.D., M.P.H. “Knowing that 10% of people aged 65 and older have Alzheimer’s, and that by 2050 that number is expected to double, I am hopeful that new medical products such as this one will help patients.”
  • STAT News adds,
    • “Jason Karlawish, a professor of medicine at the University of Pennsylvania who specializes in Alzheimer’s research, said that “used right, this is a test that could really help to improve the diagnostic experience.”
    • “But with the availability of easier-to-use tests, there’s always the risk of “some frisky prescribing habits,” Karlawish said. Particularly in the field of Alzheimer’s, where just a small number of doctors are trained to treat the increasingly common condition, “the outcome can be inappropriate prescribing of the tests because a lot of people have a desire to get it, but not a lot of clinicians know how to properly use it.”
    • “The test should only be used to help diagnose people who have confirmed cognitive impairment, and there’s a risk some doctors may skip the step of confirming, as it’s “much easier to order a test than it is to talk to a patient,” Karlawish said. 
    • “Still, “in the history of Alzheimer’s disease, this is a big day,” he said. “The notion 10 years ago that there’d be a blood test that detects the pathologies of Alzheimer’s was a bit of a science fiction fantasy kind of story, and now here it is FDA-approved and ready for clinical practice.”
  • Reuters points out,
    • “The U.S. Food and Drug Administration has approved Amneal Pharmaceuticals’ (AMRX.O), opens new tab self-administered migraine drug, giving way to a quick and more convenient treatment option for patients.
    • “The treatment, branded as Brekiya, delivers a single dose of the drug called dihydroergotamine mesylate via an autoinjector. It is approved for the treatment of acute cases of migraine and severe, one-sided pain in the head called cluster headaches in adults, the drugmaker said on Thursday.”

From the judicial front,

  • The American Hospital Association News informs us,
    • “A U.S. district court judge for the District of Columbia May 15 ruled the Department of Health and Human Services must preapprove the use of 340B “rebate models” before they can be implemented, which the department has not yet done for any of the models pursued by the plaintiff drug companies. 
    • “Judge Dabney Friedrich issued the ruling in a case brought by a number of drug companies, finding that when the statute says that in implementing price reductions, “any rebate or discount” taken into account shall be “as provided by the Secretary,” it means that HHS has the authority to approve or reject the proposed rebate models. “Put another way, the statute contemplates that the Secretary may ‘have as a condition’ or ‘stipulate’ how any rebate or discount is accounted for in the price ultimately paid by covered entities.” * * *
    • “HHS recently announced that it will be “in a position to provide guidance” about the drug industry’s proposed use of “rebate models” by the end of May.”

From the public health and medical research front.

  • The Centers for Disease Control and Prevention announced today,
    • “Seasonal influenza, COVID-19, and RSV activity is low and declining.
    • “COVID-19
      • “COVID-19 activity has declined to low levels nationally. Wastewater levels are at low levels, emergency department visits are at very low levels, and laboratory percent positivity is stable.
      • “Additional information about current COVID-19 activity can be found at: CDC COVID Data Tracker: Home.
    • “Influenza
    • “RSV
      • “RSV activity has declined to low levels in most areas of the country.”
  • The University of Minnesota CIDRAP notes,
    • “The US measles picture grew by 23 cases this week, according to today’s update from the Centers for Disease Control and Prevention (CDC).
    • “A total of 1,024 confirmed measle cases have been reported from 31 jurisdictions, with 14 outbreaks (defined as 3 or more related cases). Ninety-two percent of confirmed cases are outbreak-associated.
    • “Of the cases, 96% have occurred in people who are either unvaccinated or have unknown vaccination status, and 128 (13%) of case-patients have been hospitalized, including 69 children under the age of 5. Three deaths have been confirmed to date, including two in unvaccinated school-aged children.” * * *
    • “The CDC notes on its measles outbreak page that one the reasons for more measles activity is because MMR coverage among kindergartners is now below 95%—the level needed to maintain elimination status. Two doses of the MMR vaccine are 97% effective at preventing measles, and one dose is about 93% effective.”
  • The American Journal of Managed Care lets us know,
    • “Higher dietary inflammatory index (DII) scores are significantly associated with an increased risk of Alzheimer disease–related death among American adults, according to a study published in Experimental Gerontology.
    • “Although the exact mechanisms of Alzheimer disease remain unknown, accumulating evidence suggests that chronic inflammation plays a key role in its pathogenesis and progression. In particular, past research shows that neuroinflammation accelerates neuronal damage, synaptic loss, and cognitive decline observed in patients with Alzheimer disease.
    • “Anti-inflammatory diets can alleviate neuroinflammation in patients with Alzheimer disease by reducing systemic inflammation through several immune pathways in the brain and indirectly through the gut microbiome and body circulation pathways. Therefore, the researchers emphasized that an anti-inflammatory diet may constitute a beneficial nutritional approach in Alzheimer disease management.”
  • The Wall Street Journal reports
    • “Electricity is gaining traction as a potential treatment for diseases like cancer and rheumatoid arthritis.
    • “Companies like Novocure and SetPoint Medical are developing devices that use electricity to treat diseases.
    • “Clinical trials show promise, with devices extending survival for some cancer patients and improving arthritis symptoms.”
  • STAT News adds,
    • “Leading oncologists said this week that artificial intelligence will one day be as integrated into cancer care as it is in smartphones and self-driving cars — and that this is a change we should welcome.
    • “Their comments, made at STAT’s Breakthrough Summit West on Wednesday, reflected an optimistic view for how the health care system can use AI across nearly all aspects of cancer care, from matching patients with clinical trials to predicting how they might fare on a given treatment. Some of this work is already happening. The panelists noted that AI has the potential to offer deep expertise across a growing number of precisely defined cancer indications, and that the technology can generate insights research focused on individual hypotheses might miss.”

From the U.S. healthcare business front,

  • Beckers Hospital Review relates,
    • “Cleveland Clinic reported an operating income of $52.8 million (1.3% margin) in the first quarter, up slightly from $50.2 million (1.3% margin) in the same period last year, according to financial documents published May 16.”
  • and
    • “Phoenix-based Banner Health reported an operating income of $142.4 million (3.6% margin) in the first quarter, up from an $89.3 million operating gain (2.4% margin) in the first quarter of 2024, according to financial documents published May 15.”
  • Healthcare Dive reports,
    • “Rite Aid is selling more than 1,000 pharmacies to rival drugstore operators as the beleaguered “pharmacy chain limps through bankruptcy processes for a second time.
    • Rite Aid said it was formally pursuing sales of “substantially all of its assets” earlier this month. Now, healthcare companies CVS Health and Walgreens, along with grocery stores Albertsons, Kroger and Giant Eagle, are among the buyers snapping up Rite Aid stores, the company said on Thursday.
    • “CVS is one of the biggest buyers, agreeing to acquire prescription files from 625 Rite Aid locations in 15 states in areas where it already has a presence, along with fully buying and operating 64 stores in Idaho, Oregon and Washington. The sales are subject to approval by a New Jersey bankruptcy court, which is scheduled to hold a hearing on May 21 regarding the transactions.”
  • Fierce Healthcare tells us,
    • “More than 6 in 10 survey respondents say they expect their healthcare organizations to see higher revenue from value-based care arrangements this year than in 2024, according to a joint report from the National Association of Accountable ACOs and health tech company Innovaccer.
    • “The report surveyed 168 executive and clinical leaders at health systems, accountable care organizations, specialty providers, federally qualified health centers and other delivery organizations.
    • “The findings indicate a growing reliance on VBC programs for some organizations. A significant segment, 30%, of organizations said a quarter of their revenue is tied to VBC contracts. More than 20% indicated at least half of their revenue is derived from fully capitated or downside risk contracts.
    • “Three-fourths of respondents believe further financial support would propel VBC adoption more.”
  • The Wall Street Journal reports,
    • “Novo Nordisk CEO Lars Fruergaard Jorgensen is stepping down after eight years in the role.
    • “The move follows market challenges, a share-price decline, and pressure from its controlling foundation.
    • “Former CEO Lars Rebien Sorensen will join the board amid concerns about losing ground to Eli Lilly.”

Wednesday Report

David Ermer–CDC, CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, NIH, OPM, U.S. Healthcare–
Thanks to Alexandr Hovhannisyan for sharing their work on Unsplash.

From Washington, DC,

  • NBC News reports
    • “Two Key House committees advanced their portions of a sweeping package for President Donald Trump’s agenda on party-line votes Wednesday following marathon meetings. 
    • “The tax-writing Ways and Means Committee advanced its bill, which would permanently extend Trump’s 2017 cuts, Wednesday morning after a session that clocked in at more than 17 hours.
    • “Later Wednesday, the Energy and Commerce Committee passed its legislation, which includes steep Medicaid cuts, after meeting for more than 26 hours.”
    • “The House Agriculture Committee was still debating its part of the broader package which includes a $290 billion cut to Supplemental Nutrition Assistance Program (SNAP), late Wednesday afternoon. The panel began its markup around 7:30 p.m. Tuesday before breaking around midnight and reconvening Wednesday morning. 
    • “The Ways and Means and Energy and Commerce committees did not make substantive changes to the original plans offered by their chairs.” 
  • Following the creation of committee recommendations, the House Budget Committee will take responsibility for the budget reconciliation bill. Per a Budget Committee news release today,
    • “On Friday, May 16th, 2025, at 9:00 AM in 210 Cannon House Office Building, the House Committee on the Budget will hold a markup to provide for reconciliation pursuant to title II of the Concurrent Resolution on the Budget for Fiscal Year 2025, H. Con. Res. 14. 
    • “Committee hearings and markups are available LIVE from our website or YouTube.”
  • The American Hospital Association News tells us,
    • “Department of Health and Human Services Secretary Robert F. Kennedy Jr. May 14 testified on President Trump’s discretionary budget proposal for fiscal year 2026 in hearings before the House Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies and the Senate Committee on Health, Education, Labor and Pensions. The proposal includes $93.8 billion for HHS, which is a 26.2% reduction from the FY 2025 enacted level.”
  • The Wall Street Journal offers its insights on these hearings here.
  • Federal News Network lets us know that OPM is proceeding with its retirement application processing improvements, notwithstanding the cancellation of the Workday contract.
  • Govexec takes on “Age gap retirement planning for federal employees: Avoiding the ‘Widow’s Penalty,’ Medicare planning and more. How to think about the best ways to utilize your retirement and health care benefits when you may be older, or younger, than your spouse.”
  • Per a CMS news release,
    • “The Centers for Medicare & Medicaid Services (CMS) is taking bold steps to modernize the nation’s digital health ecosystem with a focus on empowering Medicare beneficiaries through greater access to innovative health technologies. The agency, in partnership with the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (ASTP/ONC), is seeking public input on how best to advance a seamless, secure, and patient-centered digital health infrastructure. The goal is to unlock the power of modern technology to help seniors and their families take control of their health and well-being, manage chronic conditions, and access care more efficiently.” * * *
    • “The request for information (RFI) invites input from patients, caregivers, providers, payers, technology developers, and other stakeholders on how CMS and ASTP/ONC can: 
      • “Drive the development and adoption of digital health management and care navigation applications; 
      • “Strengthen interoperability and secure access to health data through open, standards-based technologies; 
      • “Identify barriers preventing the seamless exchange of health information across systems; and
      • Reduce administrative burden while accelerating progress toward value-based, patient-centered care.”
    • “The public comment period will be open through June 16. The RFI is available at https://public-inspection.federalregister.gov/2025-08701.pdf, and the public should submit all comments through the provided weblink.”

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “The number of people who died of drug overdoses in the U.S. dropped dramatically in 2024, a promising sign amid a national fentanyl crisis that has fueled a surge in drug-related deaths in recent years.  
    • “Drug-overdose deaths dropped by 27% to around 80,000 deaths in 2024 from about 110,000 in 2023, according to preliminary data released by the Centers for Disease Control and Prevention on Wednesday. The deaths reported last year fell closer to levels not seen since before the Covid-19 pandemic, which exacerbated the country’s drug-overdose crisis and led to a surge in deaths.
    • “Yearly declines in new overdose deaths are rare and tend to be small, making 2024’s drop unprecedented in its scope. This is also only the fourth year in more than three decades in which the U.S. reported fewer drug fatalities, but also the second in a row after a modest reduction in 2023.” * * *
    • “Despite the drop in drug-overdose related deaths in 2024, the yearly tally is still much higher than those recorded less than a decade ago and before the opioid crisis took off in the 1990s. The U.S. recorded well over 100,000 deaths a year from 2021 to 2023, according to federal data.”
  • Reuters informs us,
    • “The Texas health department reported 717 cases of measles in the state on Tuesday, an increase of eight since its last update on Friday, as the U.S. battles one of the worst outbreaks of the childhood disease in the country.
    • “Cases in Gaines County, the epicenter of the outbreak, rose to 405 from 403 since the last update, according to the Texas Department of State Health Services.
    • “Texas had reported seven additional cases in the last update on Friday, which was the lowest increase since the outbreak began in February.
    • “New Mexico’s health department reported 71 cases, unchanged from its last update. Most of the state’s cases are from Lea County, adjacent to Gaines County in Texas.”
  • Per Becker’s Hospital Review,
    • “Seventy-six percent of oncologists reported seeing an increasing number of patients presenting with advanced-stage cancer. Of those, 75% attributed the increase to screening barriers, according to a survey published May 13 by the Harris Poll on behalf of Quest Diagnostics. 
    • “The Harris Poll surveyed 174 medical oncologists and 76 surgical oncologists on their experiences with advanced-stage cancer diagnoses and recurrence between Aug. 6 and Sept. 4.” * * *
    • “Read the full survey results here.” 
  • The National Cancer Institute (NCI) posted its latest edition of Cancer Currents, which is a research blog.
  • Per HCPLive,
    • “Findings from a recent study suggest iron deficiency anemia (IDA)independently and significantly increases the odds of ischemic stroke in young adults.
    • “IDA is the most common form of anemia globally. It results from iron deficiency, when there are insufficient iron stores to support the production of red blood cells. IDA disproportionately affects women due to regular iron losses through menstruation and increased iron demands during pregnancy. Maternal anemia can lead to the child exhibiting intellectual disability, autism spectrum disorder, and attention-deficit/hyperactivity disorder.
    • “Additionally, it is currently estimated that 10-15% of all strokes occur in adults aged 18-50, a group that also exhibits an increased prevalence of IDA. However, little data has been collected regarding the association between IDA and stroke in young adults.
    • “Although multiple studies have explored the association of IDA and thrombotic events in children, our study was the first to explore its role in ischemic stroke in a young adult population, that is, most susceptible to IDA,” wrote Jahnavi Gollamudi, MD, University of Cincinnati, and colleagues.
    • “Investigators classified patients into 2 groups: those with a first-time ischemic stroke diagnosis were defined as Group A, and those without a history of ischemic stroke were defined as Group B.”
  • Per a National Institutes of Health news release,
    • “Researchers at the National Institutes of Health (NIH) have identified a series of changes in the architecture and cell composition of connective tissues of the breast, known as stromal tissue, that is associated with an increased risk of developing aggressive breast cancer among women with benign breast disease, and poorer rates of survival among women with invasive breast cancer. This process, which they call stromal disruption, could potentially be used as a biomarker to identify women with benign breast disease who are at high risk of developing aggressive breast cancers, as well as those with breast cancer who may be at increased risk of recurrence or death.
    • “Such insights could help inform the development of cancer prevention and treatment strategies that target the stromal microenvironment. In addition, stromal disruption is inexpensive to assess and could be widely adopted, particularly in low-resource settings where molecular analysis is impractical or very expensive.”
  • Per Fierce Pharma,
    • “After flexing its antibody-drug conjugate bona fides at last year’s American Society of Clinical Oncology (ASCO) conference, AbbVie is advancing its solid tumor ambitions with a new FDA green light.
    • “The FDA on Wednesday granted an accelerated approval to AbbVie’s c-Met-directed ADC Emrelis, also known as telisotuzumab vedotin, as a new treatment option for adults with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) who’ve previously received systemic therapy. The drug is cleared in patients whose tumors exhibit high overexpression of the c-Met protein.
    • “The c-Met protein is overexpressed in around 25% of patients with advanced epidermal growth factor receptor wild-type, non-squamous NSCLC, and roughly half of those patients have high c-Met overexpression, AbbVie explained in a press release.”
  • Per BioPharma Dive,
    • “A two-drug regimen involving an experimental cancer immunotherapy from iTeos Therapeutics and GSK didn’t significantly delay tumor progression in a Phase 2 trial, leading the companies to end development and terminate the collaboration they formed around the drug four years ago.
    • “When added to GSK’s drug Jemperli, the immunotherapy, known as belrestotug and aimed at a cellular target called TIGIT, didn’t meet preset criteria for progression-free survival compared to Jemperli alone in people with non-small cell lung cancer. The study showed a “trend below the meaningful threshold” for drug responses in study arms including people with head and neck cancer, the companies said Tuesday.
    • “Based on the results, iTeos and GSK are stopping all ongoing trials of belrestotug, including an ongoing Phase 3 study in lung cancer. iTeos is “taking immediate steps to preserve capital” as well as starting a strategic review.”

From the U.S. healthcare business front,

  • We start with global news from the Wall Street Journal,
    • “GSK will acquire a liver-disease treatment from Boston Pharmaceuticals for up to $2 billion as it seeks to boost its pipeline of new drugs.
    • “The British pharma giant said Wednesday that it will pay the U.S. biotech company $1.2 billion upfront, with a further $800 million in potential success-based milestone payments.
    • “The drug is currently in late-stage trials, with a potential market launch in 2029. It aims to treat a form of liver disease characterized by inflammation and damage caused by a build-up of fat. GSK said the drug is also being explored for use in alcohol-related liver disease, and that mid-stage data has shown potential to reverse liver fibrosis and halt disease progression.
    • “Unlike current daily tablet treatments, efimosfermin is designed to be administered as a monthly shot. GSK plans to develop it both as a monotherapy–which uses one type of treatment–and in combination with its own experimental liver-disease therapies.”
  • and
    • “Danish pharmaceutical company Novo Nordisk has signed a collaboration deal with U.S. biotech Septerna that will see the two companies develop pills to treat obesity, type 2 diabetes and other cardiometabolic diseases.
    • “Under the terms of the agreement, Septerna is eligible to receive around $2.2 billion from Novo Nordisk, including over $200 million in upfront and near-term milestone payments.
    • “The U.S. company will also receive research, development and commercial milestone payments, on top of tiered royalties on global net sales of marketed products. Novo Nordisk will cover all research-and-development costs.”
  • STAT News lets us know,
    • “The mood at the annual meeting of the American Society of Cell and Gene Therapy isn’t amazing. The biotech market has been bad for years. The FDA and NIH are shrouded in uncertainty. But many researchers tried to project confidence. Over the last four years, 16 gene and cell therapies have been approved, as one presenter noted Tuesday. Also, there was a purple-clad Mardi Gras-style stilt walker directing attendees into the main hall — so there’s that.”
  • Beckers Hospital Review points out that “A total of 66 hospitals [named in the article] received both Healthgrades’ Outstanding Patient Experience and Patient Safety Excellence awards.”
  • Per Beckers Payer Issues,
    • “Contract disputes between insurers and health systems are down in 2025 compared to the second half of 2024.
    • “According to data from FTI Consulting, there were 133 total disputes in 2024, compared to 86 in 2023 and 51 in 2022. In the first quarter of 2025, 26 total disputes have been recorded, compared to 50 in Q4 2024 and 37 in Q3 2024. Network breaks between Medicare Advantage plans and health systems tripled from 2022 to 2024.
    • “FTI has tracked media reports regarding negotiations over reimbursement rates between provider organizations and insurance companies during each quarter since early 2022.”
  • HR Dive notes,
    • “While 86% of employers think their benefits are modern, only 59% of workers agree,  according to the results of Prudential’s 2025 Benefits and Beyond study, released Monday. 
    • “Workers say their top challenges are saving for retirement (45%), cost of everyday goods (44%), cost of housing (29%) and making it paycheck to paycheck (26%); and 1 in 10 workers identified being able to survive paycheck to paycheck as their No. 1 worry, the study found. 
    • “The study’s findings are clear: When it comes to workplace benefits, there is a disconnect on what companies offer and what employees actually need — now and in the future,” the press release said.”

Tuesday Report

David Ermer–AHRQ, CDC, CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, NIH, OPM, Rx coverage, SDOH, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • Last week, the President issued another Executive Order on deregulation. The EO begins
    • “Deregulation is a critical priority for my Administration.  We will foster prosperity by freeing Americans from the heavy burden of Federal regulations accumulated over decades.”
  • The American Hospital Association (AHA) News tells us,
    • “The Department of Health and Human Services May 13 announced a 60-day public comment period opened for stakeholders regarding its request for information to remove outdated or unnecessary regulations. The request stems from an executive order issued in January requiring HHS to implement a “10-to-1” rule, eliminating at least 10 existing regulations for every new regulation introduced. Comments on the RFI can be submitted at regulations.gov/deregulation.”
  • When will OPM make a similar deregulation announcement?
  • The Congressional Research Service released a report on the House Oversight and Government Reform Committee’s budget reconciliation measures. The Congressional Budget Office posted its own report on those recommendations.
    • “In CBO’s estimation, the reconciliation recommendations of the House Committee on Oversight and Government Reform would, on net, decrease deficits by $51.0 billion over the 2025‑2034 period. The estimated budgetary effects of the legislation are shown in Table 1. The costs of the legislation mainly fall within budget functions 550 (health), 600 (income security), 800 (general government), and 950 (undistributed offsetting receipts).”
  • Modern Healthcare reports,
    • “Doctors that treat Medicare beneficiaries would receive a pay boost under the sweeping tax-and-spending cuts legislation House Republicans unveiled Monday.
    • “Medicare reimbursements to physicians declined 2.9% this year, provoking outcries from medical societies that complain doctor pay has failed to keep up with cost increases. The GOP measure would raise rates next year and remake the Medicare Physician Fee Schedule to link future updates to the Medicare Economic Index, which generally rises faster than overall inflation.
    • “In 2026, the legislation would hike Medicare physician payments by an estimated 2.25%. That projection is based on how the bill would modify the “conversion factor” that determines Medicare fees for physician services. Next year, that formula would be boosted by 75% of growth in the Medicare Economic Index. In later years, it would fall to 10% of medical inflation.
    • “The physician pay increase comes with a downside for some providers, however. While the measure would raise rates, it would curtail financial incentives under alternative payment models.”
  • Bloomberg Law reports,
    • “House Republicans revived a set of policies that would change how prescription drug middlemen do business, as President Donald Trump again denounced the industry, sending shares of some of the companies down Monday.
    • “The budget proposal from the House Committee on Energy and Commerce includes a set of reforms that Congress considered last year but ultimately didn’t pass. It would remove one method that the companies, which negotiate with drugmakers and pharmacies on behalf of employers, health insurers and government programs, use to boost profits.
    • “The revival of the modest reforms in the House budget plan adds to pressure on the companies, which are already facing intense scrutiny in Washington. Trump complained about the companies known as pharmacy benefit managers during a press conference Monday touting his executive order intended to help lower the prices Americans pay for drugs.”
  • The Senate Judiciary Committee held a hearing today on the allegedly adverse impact of prescription benefit manager practices on rural pharmacies.
  • Beckers Hospital Review looks into a Republican budget reconciliation proposal in Congress to “place a 10-year moratorium on state and local governments regulating AI. The provision would prevent any laws targeting AI models, systems or automated decision tools during that time.”
  • The AHA News informs us,
    • “The Centers for Medicare & Medicaid Services May 13 launched a new strategy focused on three pillars: promoting evidence-based prevention, empowering people to achieve their health goals, and driving choice and competition. To support the new strategic plan, CMS Administrator Mehmet Oz, M.D., and Innovation Center Director Abe Sutton hosted a public webinar highlighting the Innovation Center’s commitment to take learnings from historical investments in value-based care to the “Make America Healthy Again” initiative. They also highlighted the need for models to demonstrate cost savings and improved outcomes in accordance with statutory requirements. The agency posted FAQs regarding the new strategic direction on a new homepage.”
  • and
    • “The Centers for Medicare & Medicaid Services May 12 issued a proposed regulation that would change how states may structure provider taxes for purposes of generating revenue for their Medicaid programs. CMS states that these changes are intended to prevent states from adopting provider taxes that are not “generally redistributive” and therefore may be in violation of the statute. While CMS notes that they have particular concerns about certain Medicaid managed care organization taxes, these policies, if adopted, would apply to all provider taxes. The public has 60 days to comment.”
  • Beckers Hospital Review offers eight things to know about this proposed regulation.
  • The U.S. Preventive Services Task Force confirmed today the continuing validity of its Grade A recommendation of “early, universal screening for syphilis infection during pregnancy [for asymptomatic women]; if an individual is not screened early in pregnancy, the USPSTF recommends screening at the first available opportunity.” * * * “To achieve the benefit of screening, it is important that screening occur as early in pregnancy as possible and that everyone with abnormal syphilis test results receive timely, evidence-based evaluation and treatment.”

From the judicial front,

  • STAT News reports,
    • “The now 13-year-long legal saga over who invented CRISPR took yet another unexpected turn on Monday, in a ruling that could not only change U.S. ownership of patent rights to the groundbreaking gene-editing technology but more broadly redefine how the law determines when an invention has been made. 
    • “The U.S. Court of Appeals for the Federal Circuit sided with the University of California and the University of Vienna in their bid to revive a fight over foundational CRISPR-Cas9 patents that the schools say should go to their Nobel Prize-winning scientists Jennifer Doudna and Emmanuelle Charpentier. In 2022, the U.S. Patent and Trademark Office determined that a group of scientists led by Feng Zhang of the Broad Institute of Harvard and the Massachusetts Institute of Technology had conceived of uses of the technology in humans before Doudna and Charpentier.” 

From the public health and medical research front,

  • From HHS news releases,
    • “The U.S. Food and Drug Administration (FDA) today announced that it is initiating action to remove concentrated ingestible fluoride prescription drug products for children from the market. Unlike toothpaste with fluoride or fluoride rinses, these products are swallowed and ingested by infants and toddlers. They have also never been approved by the FDA. Ingested fluoride has been shown to alter the gut microbiome, which is of magnified concern given the early development of the gut microbiome in childhood. Other studies have suggested an association between fluoride and thyroid disorders, weight gain and possibly decreased IQ.
    • “The best way to prevent cavities in children is by avoiding excessive sugar intake and good dental hygiene, not by altering a child’s microbiome. For the same reason that fluoride may kill bacteria on teeth, it may also kill intestinal bacteria important for a child’s health,” said FDA Commissioner Marty Makary, M.D., M.P.H. “I am instructing our Center for Drug Evaluation and Research to evaluate the evidence regarding the risks of systemic fluoride exposure from FDA-regulated pediatric ingestible fluoride prescription drug products to better inform parents and the medical community on this emerging area. When it comes to children, we should err on the side of safety.”
  • and
    • “The U.S. Department of Health and Human Services (HHS) and U.S. Food and Drug Administration (FDA) today announced the next steps in Operation Stork Speed–a groundbreaking initiative to ensure the safety, reliability, and nutritional adequacy of infant formula for American families. The FDA issued a Request for Information (RFI) to begin the nutrient review process required by law for infant formula. Currently, infant formula must meet minimum and maximum levels of certain nutrients. While the FDA regularly reviews individual nutrient requirements for infant formula, this will be the first comprehensive review since 1998.
    • “Operation Stork Speed brings radical transparency to ingredients in infant formula and puts science front and center,” said HHS Secretary Robert F. Kennedy, Jr. “Every child has a fundamental right to a healthy start. We’re giving parents the truth and the tools to make that happen. You can’t Make America Healthy Again if we don’t fix what nourishes our youngest and most vulnerable Americans.”
    • “Through the RFI, the FDA is seeking public input to help determine whether existing nutrient requirements should be revised based on the latest scientific data, including international. The agency also welcomes data on potential adjustments to existing minimum or maximum levels, recommendations for additional nutrients to consider, and how such changes may improve health outcomes.
    • “Commenters will have 120 days to submit responses. Further information on how to submit a comment can be found here.”
  • This week’s issue of NIH Research Matters covers the following topics — “Measuring tinnitus | Fat metabolism & pancreatic cancer | Senescent cell subtypes.”
  • The Washington Post reports,
    • “More U.S. high-schoolers used nicotine pouches — smokeless nicotine powder products — last year than the year before, according to new research published in JAMA Network Open.
    • “The researchers, who used data from a nationally representative survey of 10,146 youths in 2023 and 2024, said 5.4 percent of 10th- and 12th-graders reported having used nicotine pouches, up from 3 percent the year before. The 10th- and 12th-graders’ use of pouches in the 12 months and 30 days before the surveys also increased year to year. Males were also more likely to use pouches than females.
    • “Looking at race and ethnicity data, use was highest among White, non-Hispanic 10th- and 12th-grade teens — 9 percent had used a nicotine pouch at some point. Teens in rural areas were also more likely to use the products than urban or suburban youths: In 2024, 11.2 percent of rural youths vs. 5.9 percent of suburban and 3 percent of urban youths said they’d used a pouch.”
  • Per Healio,
    • “Social determinants of health at the community level, such as median income and walkability, have a larger influence on hip replacement outcomes than an individual patient’s race, according to data.
    • “The study was inspired by “persistent disparities observed in total hip arthroplasty outcomes, often attributed to individual factors such as race,” study author Bella Mehta, MD, MBBS, MS, a rheumatologist at Hospital for Special Surgery, told Healio.”
  • Per MedPage Today,
    • “Treating early Alzheimer’s disease patients with lecanemab (Leqembi) was feasible and most patients tolerated the drug well, a retrospective study at one specialty memory clinic showed.
    • “Infusion-related reactions occurred in 37% of 234 Alzheimer’s patients treated with lecanemab and typically were mild, according to Suzanne Schindler, MD, PhD, of Washington University School of Medicine in St. Louis, and co-authors.
    • “Amyloid-related imaging abnormalities (ARIA) emerged in 42 of 194 people (22%) who received at least four lecanemab infusions and had at least one MRI, the researchers reported in JAMA Neurology.
    • “Overall, 29 people (15%) had ARIA with brain edema or effusion (ARIA-E) — with or without ARIA with brain hemorrhage or hemosiderin deposition (ARIA-H), including microhemorrhages and superficial siderosis — and 13 people had isolated ARIA-H (6.7%).
    • “Most ARIA cases were asymptomatic (74%) and radiographically mild (62%). Eleven patients (5.7%) developed symptomatic ARIA; two (1.0%) were patients with clinically severe ARIA symptoms. No patients developed a macrohemorrhage or died.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Andrew Witty is stepping down as chief executive officer of UnitedHealth, citing personal reasons, the healthcare giant announced Tuesday.
    • “Witty, who has run UnitedHealth since 2021, is departing following a sharp downturn in the company’s financial performance from higher medical spending and unfavorable policy changes. He will be replaced effective immediately by Stephen Hemsley, the chairman of UnitedHealth’s board and its CEO from 2006 to 2017.
    • “UnitedHealth also suspended its 2025 guidance on Tuesday, pointing to the ongoing increase in medical care activity.”
  • The Wall Street Journal adds,
    • “In a call with analysts Tuesday, the company said it was seeing medical costs continue to accelerate beyond the trends it flagged last month and signs that the issue was spreading beyond enrollees in its Medicare plans. 
    • “To all stakeholders, including employees and shareholders, I’m deeply disappointed in and apologize for the performance setbacks we have encountered from both external and internal challenges,” Hemsley said. “This company has both the opportunities and capabilities to deliver exceptional services and outcomes for customers, consumers and care providers, and to continue to reliably generate the earnings growth that align with our 13% to 16% long term growth range.”
    • “The company said it expects to return to growth in 2026.”
  • Beckers Payer Issues offers us five things to know about Mr. Hemsley.
  • Beckers Payer Issues also discusses recent developments in the GLP-1 drug market.

Weekend Update

David Ermer–Congress, FDA, Medical / Rx research, OPM, Rx coverage, U.S. Healthcare–

From Washington, DC,

  • The Senate Executive Calendar informs us that Majority Leader Thune is bringing to the Senate floor nominations that received Committee approval in the same week as OPM Director nominee Scott Kupor (Calendar No. 81).
  • The Wall Street Journal reports,
    • “House Republicans are releasing their plan to cut Medicaid spending, with the program’s defenders in the GOP appearing to win the intraparty clash over how aggressively to change the system that provides health insurance to more than 70 million low-income and disabled people. 
    • “A section-by-section summary of the bill text, which was viewed by The Wall Street Journal, includes some of the changes Republicans have weighed for Medicaid, including work requirements and more frequent eligibility checks. But it doesn’t lower the minimum share the federal government contributes to Medicaid in each state, cap per-person federal spending in the program or other steps some spending hawks sought.” * * *
    • “The bill would require Medicaid recipients to work, volunteer or attend school for 80 hours a month. The requirement would apply to most able-bodied adults through age 64 without dependents and includes exceptions for pregnant women, people with substance-use disorders and others.”
  • Fierce Healthcare tells us,
    • “Senators Shelley Moore Capito, R-W.Va., and Jeanne Shaheen, D-N.H., reintroduced the Access to Prescription Digital Therapeutics (PDT) Act on Thursday to expand access to software-based treatments.
    • “Advocates will bring new economic data from Germany to make the case to Congress, Centers for Medicare & Medicaid Services (CMS) Director Mehmet Oz, M.D., and Department of Health and Human Services Secretary Robert F. Kennedy Jr. to create pathways for coverage of the technologies. 
    • “By leaning into the Make America Healthy Again (MAHA) crowd in Washington, advocates at the American Telemedicine Association’s (ATA’s) lobbying arm think they have an unprecedented chance to pass the bill. 
    • “The Access to PDT Act would create a reimbursement pathway for software that treats medical conditions, like Cognoa’s early autism diagnosis product and Freespira’s panic attack disorder treatment. The category has broadly struggled with uptake because the Medicare program does not have the authority to cover the technologies under its existing benefit categories.”
  • Bloomberg Law reports,
    • “President Donald Trump said he plans to sign an executive order to cut prescription drug prices by mandating that the US pays the same price for drugs as whichever country pays the lowest price in the world.
    • “He said in a social media post that that he would sign the order at 9 am Monday, Washington time. He predicted pharmaceutical prices could drop 30% to 80%. 
    • “Trump’s Truth Social post didn’t detail how the order would work. He also didn’t specify potential limits on the policy, such as if it would apply only to government programs like Medicare or Medicaid, or if the White House sees a way to apply this more broadly.”
    • If true, this would be a policy mistake in the FEHBlog’s opinion. Government price controls usually backfire.
  • Federal News Network reports,
    • “The Office of Personnel Management appears to be walking back the surprise sole-source contract award it made just a week ago for HR information technology services.
    • “On Friday, OPM posted a one-sentence notice on SAM.gov saying that the justification and approval it issued a week earlier, explaining its no-bid award to Workday, was being “canceled in its entirety.”
    • “Spokespeople for OPM and Workday did not immediately respond to inquiries from Federal News Network, and the reasons for canceling the justification document were not immediately clear. Also unclear was whether the government was canceling the $342,200 award entirely, or merely the approval document that allowed the contract to go forward without a competitive bidding process. However, federal contracting experts said the agency would not be able to proceed with the award without a documented justification and approval.”
  • Medical Economic informs us,
    • “Osteoboost Health Inc. announced Wednesday the nationwide release of Osteoboost, the first and only FDA-cleared prescription medical device for low bone density, offering new hope for the more than 50 million Americans affected by osteopenia and osteoporosis.
    • “The wearable device delivers targeted vibration therapy to the spine and hips—areas most vulnerable to osteoporotic fractures. Cleared through the FDA’s De Novo pathway and designated a Breakthrough Device, Osteoboost represents a major innovation in preventative care for bone health.
    • “The longevity conversation is everywhere, but people rarely mention bone health even though it is fundamental to aging with confidence,” said Laura Yecies, CEO of Osteoboost Health. “Osteoboost empowers people to lead longer, stronger, and more active lives.”
    • “Designed for at-home use, the belt-like device requires 30 minutes a day of therapy and can be worn while performing everyday tasks such as walking or cooking.”

From the judicial front,

  • Govexec relates,
    • “Federal agencies cannot take any action to implement its widespread layoff plans across government after a federal judge ruled the Trump administration has likely acted unlawfully in ordering the staffing reductions. 
    • “The pause came in the form of a temporary restraining order and will last at least 14 days, Judge Susan Illston for the U.S. Court for the Northern District of California ruled Friday evening, meaning agencies cannot issue any reduction-in-force notices through May 23. The order came as several agencies, such as the Interior Department, Agriculture and others, were expected to begin implementing large-scale layoffs in the coming days. 
    • “The order prevents agencies from implementing their Agency RIF and Reorganization Plans, previously mandated by the Office of Personnel Management and Office of Management and Budget, and President Trump’s executive order that precipitated them. It applies to OMB and OPM, as well as the departments of Agriculture Commerce, Energy, Health and Human Services, Housing and Urban Development, Interior, Labor, State, Treasury, Transportation and Veterans Affairs. It also applies to AmeriCorps, the Environmental Protection Agency, the General Services Administration, the National Labor Relations Board, the National Science Foundation, the Small Business Administration and the Social Security Administration.”
  • Here is a Dropbox link to the Judge’s opinion, which the Justice Department has appealed to the U.S. Court of Appeals for the Ninth Circuit.

From the public health and medical research front,

  • The New York Times fills us in on the hepatitis A outbreak in Los Angele County, California.
    • “The first signs of the infection can look a lot like a classic stomach bug: fever, fatigue, nausea and a loss of appetite, followed by vomiting and diarrhea. Over time, people who become infected can also experience yellowed skin and eyes, dark urine and pale stools.
    • “One of the challenges to halting a hepatitis A outbreak is that contact tracing can be nearly impossible. The infection can incubate for up to seven weeks before symptoms appear, and a person carrying the virus can spread it for up to two weeks before they feel ill.
    • “In addition, a significant proportion of people who become infected don’t experience major symptoms, said Dr. Edward Jones-Lopez, an infectious disease specialist with Keck Medicine of the University of Southern California, so they do not visit their doctor, who in turn does not run a blood test and report the case.”
  • Per Medscape,
    • “Many of the US children not vaccinated with the measles-mumps-rubella (MMR) vaccine in the past decade were also missing other routine vaccinations after 12 months of age, according to data presented at Pediatric Academic Societies (PAS) 2025 Meeting.
    • “Efforts to increase MMR vaccination should include outreach to families whose children fall behind on vaccines or may have lost contact with primary care,” Sophia R. Newcomer, PhD, MPH, of the University of Montana in Missoula, Montana, and colleagues reported in a poster.
    • “The findings have particular significance in the midst of the current measles outbreaks, which have resulted in three deaths, including two children, in 2025. The Centers for Disease Control and Prevention (CDC) reported 884 total cases in 2025 as of April 25, most of which (93%) are associated with the 11 outbreaks in the country. The cases have spread to 29 states excluding Washington, DC, with 11% of cases involving hospitalization. Most of the cases were in children younger than 5 years (30%) or aged 5-19 years (38%), and 97% of the children were unvaccinated or their vaccination status was unknown.”
  • The Washington Post discusses new alternatives to knee replacement surgery. “Physicians caution that the treatments aren’t permanent fixes, but they may work well for some.”
  • Cardiovascular Business points out,
    • “Tirzepatide is associated with a much lower all-cause mortality rate than semaglutide when patients present with type 2 diabetes, chronic kidney disease (CKD) and heart failure, according to new data presented at SCAI 2025 Scientific Sessions, the annual meeting of the Society for Cardiovascular Angiography and Interventions (SCAI).
    • “Tirzepatide and semaglutide are both popular diabetes drugs being used more and more for weight loss and other benefits.
    • “Tirzepatide is a popular dual GIP/GLP-receptor agonist sold by Eli Lilly and Company under the brand names Zepbound and Mounjaro. It has previously been linked to improved outcomes in patients with sleep apnea and heart failure with preserved ejection fraction. 
    • “Semaglutide, meanwhile, is a GLP-1 receptor agonist sold by Novo Nordisk under the brand names Wegovy and Ozempic. It has been associated with a long list of health benefits, including several associated with improvements in cardiovascular symptoms in patients with and without diabetes.” * * *
    • Tirzepatide is associated with a much lower all-cause mortality rate than semaglutide when patients present with type 2 diabetes, chronic kidney disease (CKD) and heart failure, according to new data presented at SCAI 2025 Scientific Sessions, the annual meeting of the Society for Cardiovascular Angiography and Interventions (SCAI).” * * *
    • “Lead author Adbul Wali Khan, MD, a resident at the University of Missouri Kansas City, presented the group’s findings. Overall, semaglutide was linked to a higher one-year risk of all-cause mortality, acute myocardial infarction, ischemic stroke and hospital readmission than tirzepatide. The rates of hemorrhagic stroke, atrial fibrillation, atrial flutter and cardiac arrest were comparable between the two drugs.
    • “Semaglutide did appear to perform better than tirzepatide in one important way; HbA1c levels were less likely to be under 7% for patients treated with tirzepatide than those treated with semaglutide.” 
  • Medscape considers whether new approaches can turn the tide against U.S. pain problems.

From the U.S. healthcare business front,

  • Per Fierce Healthcare,
    • “Omada Health, a virtual chronic care provider, filed to go public Friday, marking the second digital health company making plans for an initial public offering in 2025.
    • “The company has not specified the number of shares to be offered or the price range for the proposed offering.
    • “It intends to list on the Nasdaq Global Market under the ticker symbol “OMDA.”
  • Per Healthcare Dive,
    • “New Insulet CEO Ashley McEvoy set out her priorities for the diabetes technology company on Thursday. 
    • “Insulet is already a standout success story,” McEvoy told investors during her first call after taking on the role, adding that the firm is one of the fastest-growing businesses in medtech. “Now is the time to envision what it will take to expand from a medtech platform with emerging global strength to a durable world leader in diabetes management.” 
    • “McEvoy was named chief executive in late April, with the goal of helping the insulin pump maker prepare for its next phase of growth. Previously, she led Johnson & Johnson’s medtech business unit and has more than 15 years of leadership experience in the medical device sector. 
    • “McEvoy said Insulet sits at the intersection of consumer health and medtech.
    • “I have a deep appreciation for the consumer’s increasing role in healthcare decisions and understanding that is especially relevant to a wearable technology like Omnipod,” McEvoy said.”

Thursday Report

David Ermer–CDC, Congress, COVID-19 vaccine, FDA, Federal employment benefits, Medical / Rx research, NIH, OPM, SDOH, U.S. Healthcare, Uncategorized–
Photo by Josh Mills on Unsplash

From Washington, DC,

  • The Senate Press Gallery indicates that the Majority Leader John Thune (R SD) plans to file cloture motions on six Presidential nominees (not including Scott Kupor) on Monday. Nevertheless, this action gives the FEHBlog hope that Scott Kupor’s nomination to be OPM Director will be brought to Senate floor this month.
  • The American Hospital Association News tells us,
    • “Reps. Jennifer McClellan, D-Va., and Don Bacon, R-Neb., and Sens. Jeff Merkley, D-Ore., and Cindy Hyde-Smith, R-Miss., today reintroduced AHA-supported legislation addressing mental health and substance use disorder facility shortages. The Mental Health Infrastructure Improvement Act (H.R. 3266) would establish a new federal loan and loan guarantee program within the Department of Health and Human Services to build or renovate mental health or substance use disorder treatment facilities. At least a quarter of the funding would be reserved for pediatric- and adolescent-serving facilities. The bill would also prioritize facilities located in high-need, underserved or rural areas, and those capable of providing integrated care for patients with complex needs.”
       
  • Federal News Network informs us,
    • “The Office of Personnel Management is hoping the sole-source, one-year contract it just awarded to Workday, a cloud-based HR services company, will help the agency manage what’s turned into a massive influx of HR work.” * * *
    • “The contract with Workday will cover services for HR and personnel processing, payroll and benefits systems, time and attendance tracking, talent acquisition and performance management, all while ensuring compliance with federal requirements, according to the contract award notice.” * * *
    • “The Workday contract, worth $342,200, will last for one year, at the end of which OPM said it plans to conduct an open competition for the next iteration of the HR IT contract.”
  • Per an FDA news release,
    • “In a historic first for the agency, FDA Commissioner Martin A. Makary, M.D., M.P.H., today announced an aggressive timeline to scale use of artificial intelligence (AI) internally across all FDA centers by June 30, 2025, following the completion of a new generative AI pilot for scientific reviewers.
    • “I was blown away by the success of our first AI-assisted scientific review pilot. We need to value our scientists’ time and reduce the amount of non-productive busywork that has historically consumed much of the review process. The agency-wide deployment of these capabilities holds tremendous promise in accelerating the review time for new therapies,” said Dr. Makary.
    • “The generative AI tools allow FDA scientists and subject-matter experts to spend less time on tedious, repetitive tasks that often slow down the review process.
    • “This is a game-changer technology that has enabled me to perform scientific review tasks in minutes that used to take three days,” said Jinzhong (Jin) Liu, Deputy Director, Office of Drug Evaluation Sciences, Office of New Drugs in FDA’s Center for Drug Evaluation and Research (CDER).”
  • Tammy Flanagan, writing in Govexec, lets us know how Social Security benefits fit into the federal retirement picture.

From the public health and medical research front,

  • Medpage Today points out,
    • “Detections of H5N1 avian influenza have slowed in both animals and humans, but continued surveillance is warranted, CDC researchers said.
    • “In dairy cattle, cases surged over the fall and early winter but eased in January, while cases in poultry flocks fell after February, and came down last month in backyard flocks, according to data on CDC’s website that was shared during a clinician outreach and communication activity (COCA) call on Tuesday.
    • “Most of our human cases are known to be associated with animal exposures, so fewer infections in the animals leads to fewer infections in people,” Alicia Budd, MPH, team lead of the national surveillance and outbreak response team at the National Center for Immunization and Respiratory Diseases (NCIRD), said during the call.
    • “It’s certainly great to see these declines in both animal and human cases, but it’s also critical that we maintain targeted monitoring and our general surveillance, so that if this situation changes, we’d be able to identify that quickly,” Budd added.”
  • and
    • “The nation’s infant mortality rate dropped last year after 2 years of hovering at a late-pandemic plateau.
    • “Some experts think one reason for the drop could be a vaccination campaign against respiratory syncytial virus (RSV)opens in a new tab or window, which is a common cause of cold-like symptoms that can be dangerous for infants.
    • “The infant mortality national rate dropped to about 5.5 infant deaths per 1,000 live births in 2024, according to provisional data from the CDC posted Thursday. That’s down from about 5.6 per 1,000 live births, where it had been the previous 2 years.
    • “CDC officials believe the findings will not change much when the final numbers come out later this year.”
  • Per Healio,
    • “Tobacco-related ischemic heart disease mortality has increased in the U.S. since 1999.
    • “The aging of the population and the introduction of novel nicotine products may be among the drivers.”
  • and
    • “A risk prediction model assesses seven variables to determine the best intervention for lowering type 2 diabetes risk.
    • “Intensive lifestyle intervention was the optimal treatment strategy for most adults.”
  • Per Cardiovascular Business,
    • “Cardiovascular risk factors such as obesity and high blood pressure are much more prevalent in some parts of the United States than others—and some of those gaps are only widening as time goes on. 
    • “That was the biggest takeaway from a new analysis published in The American Journal of Cardiology. The study’s authors reviewed answers to the Behavioral Risk Factor Surveillance System (BRFSS) survey from 2011 to 2021 to track changes in various health inequities over time.
    • “Delays in preventive care and screening as well as economic loss, disruptions in insurance coverage and worsening social determinants of health (food insecurity, housing instability) have fallen more heavily on low-income, minority and rural communities since the pandemic,” wrote first author Rachel K. Gardner, MD, a researcher with Beth Israel Deaconess Medical Center and Brigham and Women’s Hospital, and colleagues. “In addition, the spillover effects of the pandemic have disproportionately impacted some U.S. states more than others. Together, these changes could have profound implications for cardiovascular health across the country. However, little is known about how inequities in the burden of cardiometabolic and lifestyle risk factors across U.S. states have changed, especially since the pandemic. Understanding these epidemiological changes in place-based inequities is critically important and could inform targeted public health and policy interventions at the state- and national-level to advance cardiovascular health.”
    • “The BRFSS survey is the world’s largest continuous health survey of its kind, collecting data from more than 400,000 adult participants each year. Gardner et al. based their comparison on data from 506,467 adults who participated in the survey in 2011 as well as 438,693 who participated in 2021.” * * *
    • Click here for the full study.
  • Beckers Hospital Review reports,
    • “Moderna’s new combination vaccine for seasonal influenza and COVID-19 has outperformed current standard vaccines in a large phase 3 clinical trial, showing stronger immune responses to both viruses in adults 50 years or older. 
    • “The findings, published May 7 in JAMA Network, come from a randomized study of more than 8,000 participants conducted across 146 U.S. sites. Participants either received the investigational combo vaccine mRNA-1083 or the standard influenza and COVID-19 vaccines recommended for their age group. 
    • “Among adults ages 50 to 64, mRNA-1083 generated a stronger immune response against all four influenza strains. In adults 65 and older, it outperformed the high-dose flu vaccine in three of the four strains. In both age groups, the vaccine also produced higher immune responses to SARS-CoV-2 compared to standard COVID-19 vaccine.”
  • The National Institutes of Health announced,
    • “Researchers at the National Institutes of Health (NIH) have completed a comprehensive analysis of cancer statistics for different age groups in the United States and found that from 2010 through 2019, the incidence of 14 cancer types increased among people under age 50. Of these cancer types, nine—including several common cancers, such as breast cancer and colorectal cancer—also increased in some groups of people aged 50 and older. However, the incidence of 19 other cancer types—including lung cancer and prostate cancer—decreased among people under age 50, so the total rate of all cancers diagnosed in both younger and older age groups did not increase, nor did the rate of cancer death.
    • “This study provides a starting point for understanding which cancers are increasing among individuals under age 50,” said lead investigator Meredith Shiels, Ph.D., of NIH’s National Cancer Institute. “The causes of these increases are likely to be cancer specific, including cancer risk factors becoming more common at younger ages, changes in cancer screening or detection, and updates to clinical diagnosis or coding of cancers.”
    • “The study appeared May 8, 2025, in Cancer Discovery“.
  • The National Cancer Institute adds,
    • “Scientists have developed a method of rapidly measuring the levels of certain genetic mutations in brain tissue samples collected from patients during surgery. 
    • “In a new study, researchers showed that the droplet digital polymerase chain reaction (ddPCR) method they developed could produce results in 15 minutes—the first time ddPCR has generated results so quickly. 
    • “Their tool accurately measured the levels of tumor cells in dozens of brain tissue samples, they reported. And it detected minute numbers of cancer cells, as few as five cells per square millimeter, according to findings published February 25 in Med.
    • “The researchers developed the tool, which they call Ultra-Rapid ddPCR, to provide surgeons with information that could potentially help guide their decision-making during surgery.
    • “This new technology could be an additional source of information for a surgeon who is deciding whether to keep removing tissue during an operation,” said study co-leader Daniel Orringer, M.D., a neurosurgeon at NYU Grossman School of Medicine. “If the test detects tumor cells at a surgical margin, then surgeons could decide to keep cutting.”

In Food and Drug Administration News,

  • Cardiovascular Business reports,
    • “The U.S. Food and Drug Administration (FDA) has approved the balloon-expandable Sapien 3 transcatheter aortic valve replacement (TAVR) platform from Edwards Lifesciences for treating asymptomatic severe aortic stenosis (AS). 
    • “This is the first time the FDA has approved any TAVR technology in asymptomatic patients. The decision covers the Sapien 3, Sapien 3 Ultra and Sapien 3 Ultra Resilia TAVR valves.
    • “This approval is a powerful opportunity to streamline patient care and improve the efficiency of the healthcare system,” Larry Wood, Edwards’ corporate vice president and group president of TAVR and surgical technologies, said in a statement announcing the news. “We are proud to partner with leading physicians to advance our knowledge of this deadly disease with high quality science and optimize the treatment pathway for patients.”
  • Per Medical Economics,
    • “BrightHeart, a Paris-based artificial intelligence company for obstetrics and pediatric cardiology, announced it has received FDA 510(k) clearance for an updated version of its BrightHeart platform. The new approval allows clinicians to access the company’s AI-driven analysis in real time using a cart-side tablet during fetal ultrasound exams.
    • “The technology aims to address a persistent clinical challenge: detecting congenital heart defects (CHDs) in utero. CHDs are the most common type of birth defect, but up to 70% go undiagnosed during standard prenatal ultrasounds, according to the company.
    • “BrightHeart’s AI platform flags potential structural abnormalities in the fetal heart, helping to alert clinicians to possible CHDs during routine exams. The company says the real-time tablet integration streamlines workflows and improves the accuracy of screenings.
    • “Our product expansion builds upon the success of our initial pilot experience, bringing real-time feedback directly to the clinicians to streamline the workflow and enhance accuracy,” said Cécile Dupont, CEO of BrightHeart and partner at Sofinnova Partners. “We were thrilled to achieve clearance through our first Special 510(k) submission within just a few months.”

From the U.S. healthcare business front,

  • Medical Economics reports,
    • “Nonphysician providers now make up more than two out of every five health care professionals in the United States, as hospitals and medical groups increasingly rely on advanced practice providers to meet growing patient demand and improve efficiency, according to a new report from Kaufman Hall.
    • “The Physician Flash Report, released by the health care consulting firm and its parent company Vizient, found that 40.6% of the nation’s provider workforce is composed of APPs such as nurse practitioners and physician assistants. The report points to continued growth in this segment and predicts that APPs and physicians may soon comprise equal halves of the clinician workforce.
    • “Advanced practice providers like physician assistants and nurse practitioners play a vital and increasingly visible role in health care,” said Matthew Bates, managing director and Physician Enterprise Service Line leader with Kaufman Hall. “When deployed correctly, advanced practice providers let physicians practice at the top of their license. They give doctors more time to focus on diagnosis and treatment, which can make physician practices more efficient and address other challenges, including physician burnout.”
  • Reuters tells us,
    • “Another Big Pharma is opening up its wallet to pour billions into its U.S. operations amid political pressure from the Trump administration.
    • “This time it’s Gilead coming to the table with a fresh $11 billion in hand to spend across its manufacturing and research centers in the U.S.
    • “Gilead broke down the new spending routes in a Wednesday release. The majority, $5 billion, will be funneled into technology, operations, and R&D site activities, while $4 billion will go into capital projects, including labs and equipment. The final $2 billion will be “invested in digital and advanced engineering initiatives,” the pharma said.”
  • The White House summarized all of these drug manufacturing investments here.
  • Fierce Healthcare relates,
    • “Ayble Health, a virtual GI clinic, has teamed up with Priority Health, a nonprofit health plan in Michigan, to offer commercial members access to the digestive health solution. 
    • “Ayble relies on a multidisciplinary care team, AI-powered nutrition and psychology programs and wellness tools to manage symptoms. Starting June 1, Ayble will be available as a standard benefit for Priority members who have a MyPriority HMO or employer health plan. More than 500,000 adult members will have access. 
    • “When it comes to sourcing solutions like Ayble Health, Priority Health looks for approaches that can improve care quality, engage patients effectively and provide cost-efficient services,” Alicia Coronas, vice president of employer solutions product and marketing at Priority, told Fierce Healthcare. “We evaluate solutions to find the best-in-class partner that is aligned to our vision and mission.”

Weekend update

David Ermer–Congress, Obesity, OPM, U.S. Healthcare–

From Washington, DC,

  • Roll Call offers a summary of this week’s activities on Capitol Hill.
  • Bloomberg Law explains that House Oversight Committee “Benefits reductions [approved last Wednesday] will next go before the House Budget Committee, which is tasked with assembling bills into a reconciliation package that will have to be approved by the House and Senate.”
  • In a Federal News Network commentary, an OPM executive from the Obama and Biden administrations criticizes the Trump Administration for allowing carrier more flexibility in managing GLP-1 drug coverage for obesity. The FEHBlog agrees with OPM’s decision because carriers hold the financial risk for their respective FEHB plans. That is quite an incentive to sensibly manage benefits.
  • In any case, this criticism is surprising because the Biden administration caused FEHB premiums to explode, in the FEHBlog’s opinion, by mandating coverage of GLP-1 drugs for obesity in January 2023 without allowing carriers to adjust premiums until the following January. While federal government procurement law permits OPM to make unilateral contract amendments, OPM is obligated to provide the contractor with a concurrent equitable price adjustment. All price adjustments in the FEHB are made through the benefit and rate negotiation process. Consequently, all benefit mandates must be run through that process.
  • HR Dive tells us,
    • “Field staff for the U.S. Department of Labor’s Wage and Hour Division will not apply the agency’s 2024 independent contractor rule in their enforcement of the Fair Labor Standards Act, a DOL bulletin announced Thursday.
    • “Instead, the department directed staff to apply a 2008 fact sheet as well as a 2019 opinion letter to any matters in which no payments for back pay or civil monetary penalties have been made to either individuals or DOL.
    • “The agency said it is still considering rescinding the Biden administration’s rule, which faces ongoing litigation. “Until further action is taken, the 2024 Rule remains in effect for purposes of private litigation and nothing in this Field Assistance Bulletin changes the rights of employees or responsibilities of employers under the FLSA,” DOL noted.”
  • and
    • “U.S. Department of Justice attorneys asked the 5th U.S. Circuit Court of Appeals to temporarily suspend the Labor Department’s appeals in two cases challenging its 2024 Fair Labor Standards Act overtime rule, according to an April 24 court filing.
    • “Texas district court judges twice blocked DOL’s final rule, which increased the minimum salary threshold for overtime pay eligibility in two steps. First, a November 2024 decision sided with plaintiffs including the state of Texas and enjoined the rule nationwide. A second judgment set aside and vacated the rule in response to a lawsuit by marketing agency Flint Avenue.
    • “The government asked that the 5th Circuit place its appeals in abeyance “pending the agency’s reconsideration of the rule.” It said counsel for the appellees in both cases did not oppose its request.”

From the public health and medical research front,

  • NPR Shots lets us know,
    • “Older Americans want to know if they are in the early stages of Alzheimer’s disease and would happily take a blood test to find out, according to a national survey.
    • “The survey of 1,700 people 45 and older, part of a report from the Alzheimer’s Association, found growing interest in testing, diagnosis and treatment for the deadly disease.” * * *
    • “The responses show that people are becoming less afraid and more proactive about an Alzheimer’s diagnosis, says Elizabeth Edgerly, a clinical psychologist who directs community programs for the Alzheimer’s Association.”

Per the U.S. healthcare business front,

  • BioPharma Dive reports,
    • “The threat of tariffs on pharmaceuticals imported to the U.S. hasn’t yet pushed drugmakers off course, with many of the largest companies indicating they expect to be able to absorb any impact in the short term.
    • “Speaking on earnings calls in recent weeks, pharma executives have, for the most part, told investors their supply chains are flexible enough to mitigate the effects of new levies — for this year, at least. With a few exceptions, the large drugmakers that have reported financials for the first quarter are maintaining their sales and profit guidance for 2025.”

Friday Report

David Ermer–CDC, CMS, COVID-19, FDA, Medical / Rx research, NIH, OPM, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC,

  • The American Hospital Association News tells us,
    • “President Trump today released his discretionary spending budget blueprint for fiscal year 2026. The “skinny budget” request, which includes top line discretionary funding priorities, is not binding but can act as a starting point for Congress and the administration as they begin the appropriations process to fund the government. The administration later this month is expected to issue its full budget request, which will include its proposed changes to mandatory spending and tax policy.”  
  • Bloomberg Law adds,
    • “The president’s [skinny] budget calls for $557 billion in non-defense spending next year, which represents a cut of $163 billion from current levels. National security funding would increase to $1.01 trillion, a 13% increase from the previous year. Any final spending plan for regular agency budgets will need some Democratic support to pass the Senate, one of the few opportunities the minority party has to exert some leverage while Republicans have unified control over the federal government.”
  • Federal News Network informs us,
    • “Amid the Trump administration’s sweeping overhaul of the federal workforce, the Office of Personnel Management has shuttered an office that was central to developing leadership skills governmentwide.
    • “The Center for Leadership Development (CLD), an arm within OPM’s Human Resources Solutions (HRS) office, was bulldozed as part of an OPM reduction in force (RIF) in April. Federal News Network confirmed the elimination of the office with OPM, as well as two sources who provided further information on the condition of anonymity for fear of professional retribution.
    • “About 140 employees were working in the CLD office back in January, but those numbers had dwindled to about 80 employees over the last few months, according to an OPM employee familiar with the situation. Many CLD employees opted into the deferred resignation program (DRP) or voluntarily left their jobs. OPM notified the remaining employees on April 18 that their positions were being eliminated as part of the agency’s RIF.”

From the Food and Drug Administration front,

  • The Wall Street Journal reports,
    • “Novo Nordisk NOVO.B said the Food and Drug Administration accepted its submission of a new drug application for a Wegovy pill to treat obesity amid a tense race to get an oral weight-loss medication on the market.
    • “The Bagsvaerd, Denmark, company said Friday that if the application is approved, Wegovy would become the first oral formulation of a GLP-1 drug for chronic weight management.
    • “The FDA’s deadline to decide on the application will be in the fourth quarter, the company said.
    • “The application is based on results from a phase 3 randomized, controlled trial evaluating the efficacy and safety of the drug over 64 weeks, the company said.”
  • Per a National Cancer Institute news release,
    • “The Food and Drug Administration (FDA) has approved the combination of two immunotherapy drugs for the initial treatment of some people with advanced colorectal cancer. The approval is for the use of nivolumab (Opdivo) and ipilimumab (Yervoy) for people whose tumors are classified as MSI-H or dMMR.
    • “About 5% of people with advanced colorectal cancer have MSI-H or dMMR tumors, which means the tumors are unable to properly repair certain types of DNA damage that can occur during cell division. Several colorectal cancer experts said the approval should immediately make the combination the preferred initial, or first-line, treatment for people with advanced MSI-H or dMMR colorectal cancer. 
    • “The approval was based on updated findings from a large clinical trial, called CheckMate-8HW in which all participants had advanced colorectal cancer with MSI-H or dMMR tumors. Patients in the trial who were treated with the combination of nivolumab and ipilimumab lived substantially longer without their cancer getting worse, a measure known as progression-free survival, than patients treated with nivolumab alone.”
  • Modern Healthcare reports,
    • GE HealthCare said Friday it received Food and Drug Administration clearance for its artificial intelligence tool that uses deep learning to outline organs at risk in MRI images and help improve radiation therapy planning.
    • MR Contour DL can outline 37 organs and structures in the head-neck and pelvic areas. The process previously had to be done manually.
    • The AI model will be integrated into the company’s Intelligent RT radiation therapy workflow management solution, which provides clinicians with a real-time view of a patient’s radiation therapy treatment journey.
  • Cardiovascular Business relates,
    • “The U.S. Food and Drug Administration (FDA) has approved the balloon-expandable Sapien 3 transcatheter aortic valve replacement (TAVR) platform from Edwards Lifesciences for treating asymptomatic severe aortic stenosis (AS). 
    • “This is the first time the FDA has approved any TAVR technology in asymptomatic patients. The decision covers the Sapien 3, Sapien 3 Ultra and Sapien 3 Ultra Resilia TAVR valves.
    • “This approval is a powerful opportunity to streamline patient care and improve the efficiency of the healthcare system,” Larry Wood, Edwards’ corporate vice president and group president of TAVR and surgical technologies, said in a statement announcing the news. “We are proud to partner with leading physicians to advance our knowledge of this deadly disease with high quality science and optimize the treatment pathway for patients.”
  • MedTech Dive adds,
    • “Intuitive Surgical received Food and Drug Administration clearance for its da Vinci Single Port surgical system for procedures performed through the anus.
    • “The clearance covers the use of the system for transanal local excision/resection, enabling physicians to reach lesions in the upper rectum without cutting the abdomen, according to the Thursday announcement. Conventional transabdominal rectal resection can require multiple incisions and the removal of the rectum. 
    • “Intuitive designed the single port device to navigate narrow body cavities. Physicians can control up to three multi-jointed instruments and a camera through a single entry point.”

From the public health and medical research front,

  • The Centers for Disease Control and Prevention announced today,
    • “Seasonal influenza activity continues to decline. COVID-19 and RSV activity are declining nationally to low levels.
    • “COVID-19
      • “COVID-19 activity continues to decline nationally. Wastewater levels are at low levels, emergency department visits are at very low levels, and laboratory percent positivity is stable.
      • “Additional information about current COVID-19 activity can be found at: CDC COVID Data Tracker: Home
    • “Influenza
    • “RSV
      • “RSV activity continues to decline in most areas of the country.
    • “Vaccination
      • “Vaccination coverage with influenza, COVID-19, and RSV vaccines remained low among U.S. adults and children during the 2024─25 respiratory virus illness season.”
  • Per the AHA News,
    • “The U.S. has had 935 confirmed cases of measles so far this year, according to the latest data from the Centers for Disease Control and Prevention. Cases have been reported by 29 states, with Texas reporting the most at 683 — a 20% increase from last week. There have been 12 outbreaks, and 93% of confirmed cases (869 of 935) are outbreak-associated. The vaccination status of 96% of all cases is classified as “unvaccinated or unknown.”
  • The University of Minnesota’s CIDRAP adds,
    • “The nation is now experiencing 12 [measles] outbreaks, one more than the previous week, and 93% of illnesses reported are connected to outbreaks.
    • “In related developments, CBS News reported yesterday that Health and Human Services Secretary Robert F. Kennedy Jr. would ask the CDC to develop new guidance for treating measles with drugs and vitamins. Today, the CDC posted new resources for public health departments and parents, along with a fact sheet for clinicians that covers two alternative treatments that Kennedy has pushed, including vitamin A, antibiotics, and inhaled steroids.”
  • and
    • “Twelve more US children have died of influenza, surpassing theprevious high for a flu season outside of a pandemic year, the Centers for Disease Control and Prevention (CDC) said in its weekly update today.
    • “The pediatric deaths push the season total to 216, surpassing last season’s total of 207. Ten of the children died of influenza A, and two died from influenza B. Subtyping showed that eight of the influenza A deaths were caused by the H1N1 strain, and four were H3N2.”
  • CNN offers an interview with its wellness editor, who is an emergency medicine doctor, about whooping cough.
  • Per the University of Minnesota CIDRAP,
    • “A study published earlier this week in Nature Communications using claims data from the US Veterans Affairs (VA) Healthcare System finds protection from the 2024-25 Pfizer COVID-19 vaccine was 68%, 57%, and 56% against COVID-19–associated hospitalizations, emergency department and urgent care (ED/UC) visits, and outpatient visits, respectively.
    • “However, the authors caution that uptake of the vaccine was extremely low—only 3.7% through November 2024—and the study did not assess waning effectiveness.”
  • The New York Times reports,
    • The video is just under two and a half minutes long. A slim man with close-cropped hair walks into a room, pulls a long black mamba — whose venom can kill within an hour — from a crate and allows it to bite his left arm. Immediately after, he lets a taipan from Papua New Guinea bite his right arm. “Thanks for watching,” he calmly tells the camera, his left arm bleeding, and then exits.
    • Over nearly 18 years, the man, Tim Friede, 57, injected himself with more than 650 carefully calibrated, escalating doses of venom to build his immunity to 16 deadly snake species. He also allowed the snakes — mostly one at a time, but sometimes two, as in the video — to sink their sharp fangs into him about 200 times.
    • This bit of daredevilry (one name for it) may now help to solve a dire global health problem. More than 600 species of venomous snakes roam the earth, biting as many as 2.7 million people, killing about 120,000 people and maiming 400,000 others — numbers thought to be vast underestimates.
    • In Mr. Friede’s blood, scientists say they have identified antibodies that are capable of neutralizing the venom of multiple snake species, a step toward creating a universal antivenom, they reported on Friday in the journal Cell.
  • The AHA News notes, “Older adults may be in circumstances that exacerbate challenges to accessing behavioral health care and have complex needs that can complicate behavioral health treatment. This new infographic gives statistics about how behavioral health care needs change in an aging population.” 
  • Healio tells us,
    • “Once-weekly semaglutide 2.4 mg significantly reduced steatohepatitis and liver fibrosis symptoms among adults with metabolic dysfunction-associated steatohepatitis and moderate or advanced liver fibrosis, researchers reported.
    • “In findings from part one of the ESSENCE phase 3 trialpublished in The New England Journal of Medicine,semaglutide 2.4 mg (Wegovy, Novo Nordisk) conferred greater improvements in multiple liver endpoints compared with placebo. In addition to greater improvements in steatohepatitis and liver fibrosis, researchers also observed greater weight loss, reduced insulin resistance and improvement in noninvasive liver markers with the GLP-1 medication.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Cigna is building on client demand for tools to support patients on GLP-1 weight loss drugs, announcing two new programs on Friday meant to improve clinical care around the dispensing of GLP-1s and provide home delivery of the medications.
    • “The programs come as payers that contract with Cigna’s massive pharmacy benefit manager Express Scripts for their drug benefits want to offer GLP-1s but are put off by the medications’ steep list prices and unpredictable long-term outcomes, according to Cigna.
    • “The programs were announced in tandem with Cigna’s first quarter results, which came in well above analysts’ expectations. Revenue of $65.5 billion was up more than 14% year over year, while net income of $1.3 billion compares to a loss of $277 million same time last year. Cigna raised its 2025 profit outlook following the results.”
  • and
    • “Amwell narrowed its losses on growing revenue in the first quarter as the telehealth vendor continued to roll out products as part of a contract with the Department of Defense.
    • “The company posted a net loss of $18.4 million, down from $73.4 million in the prior-year period. Amwell reported revenue of $66.8 million, compared with $59.5 million in the first quarter last year. 
    • “The telehealth firm has deployed scheduled virtual visits across the Military Health System, executives said in an earnings call Thursday. However, rollouts for its automated and digital behavioral health programs will take place in the third quarter instead of the second due to leadership changes at the Defense Health Agency, leaders said.”
  • Fierce Healthcare points out,
    • “UnitedHealth Group and Amedisys have found buyers for key divestitures aimed at getting their $3.3 billion merger over the finish line, according to new filings.
    • “In documents submitted to the Securities and Exchange Commission (SEC), Amedisys said April 30 the companies entered an agreement to sell off certain Amedisys home health and hospice centers, as well as some of UnitedHealth’s care centers, to BrightSpring Health Services and the Pennant Group.
    • “Completion of these sales is contingent on several factors, according to the filing, including the final closure of the UnitedHealth-Amedisys deal.
    • “Financial terms were not disclosed in Amedisys’ filing, but the Pennant Group noted in a separate SEC document that it would pay about $102.5 million for the assets it’s buying from Amedisys and UnitedHealth.”
  • Per Biopharma Dive,
    • “Amgen on Thursday said its just-launched biosimilar of Johnson & Johnson’s autoimmune drug Stelara recorded $150 million in sales in the first quarter, spotlighting rising revenue from the biotech’s portfolio of copycat biologics.
    • “During the company’s first quarter earnings call, commercial chief Murdo Gordon said Amgen’s biosimilar products recorded $735 million in sales, roughly 9% of the company’s revenues. Those sales climbed 35% compared to the same period last year, showing the business “continues to contribute meaningfully to our long-term growth,” CEO Robert Bradway said.
    • “Still, Amgen’s overall performance is uneven. While some products are thriving, like an Avastin lookalike that booked $179 million in sales, others, such as its Humira biosimilar are struggling. Amgen recently launched a biosimilar version of Regeneron’s eye drug Eylea and could begin marketing a copycat form of AstraZeneca’s rare disease treatment Soliris sometime before the middle of the summer.”
  • and
    • “Madrigal Pharmaceuticals said its pioneering medicine for a common liver disease brought in $137.3 million in the first quarter, surpassing analyst estimates by more than $20 million. 
    • “More than 17,000 patients have now taken the drug, known as Rezdiffra, Madrigal said Thursday. It won Food and Drug Administration approval in March 2024, becoming the first medication cleared to treat metabolic dysfunction-associated steatohepatitis, or MASH.
    • “The company said it’s now looking toward a potential mid-year approval that would position Rezdiffra as the first available MASH treatment in Europe. CEO Bill Sibold said he’s looking to build on what he described as an “exceptional launch” in the U.S.”
  • Fierce Pharma adds
    • “AstraZeneca has taken a key step in advancing Breztri Aerosphere toward a potential label expansion and achieving its goal of annual sales of $3 billion to $5 billion for the 3-in-1 inhaler.
    • “Two phase 3 trials evaluating the effectiveness and safety of Breztri in a total of 4,434 patients with uncontrolled asthma have met their primary endpoints. The studies showed that Breztri delivered statistically significant and clinically meaningful improvements in lung function compared to dual-drug combinations of inhaled corticosteroid (ICS) and long-acting beta2-agonist (LABA) maintenance treatments, AZ said.
    • “Data from the KALOS and LOGOS studies will be shared with regulatory authorities and presented at an upcoming medical meeting, the company added.”

Midweek Update

David Ermer–CMS, Congress, FDA, Medical / Rx research, Mental health care, Obesity, OPM, Rx coverage, SCOTUS, Telehealth, U.S. Healthcare–

From Washington, DC

  • Per a House Oversight Committee press release,
    • “As part of the budget reconciliation process, the House Committee on Oversight and Government Reform held a markup today and passed budget legislation that advances President Trump’s agenda and saves American taxpayers over $50 billion. The Committee will now finalize its section of the budget legislation and transmit it directly to the House Committee on the Budget, which will compile and present the final package for consideration by the U.S. House of Representatives.”
  • Govexec provides details on the markup here.
  • Federal News Network tells us,
    • “Agencies are facing a roughly two-week deadline to show the Trump administration how they plan to implement coming changes for probationary employees.
    • “By May 16, agencies are expected to report their plans for adding a new “affirmative” certification requirement for probationary employees. Agencies are also expected to detail how they intend to train supervisors and HR practitioners on the coming changes, according to new guidance the Office of Personnel Management published Tuesday.
    • “The guidance outlines more detailed expectations for agencies to update how they manage probationary periods following President Donald Trump’s executive order last Thursday. That order called for the creation of “Civil Service Rule XI” and added a hurdle for probationary employees to clear before they become tenured employees. Agencies will now be required to review and actively sign off on probationary workers’ continued employment before they can reach a tenured employment status.”
  • Per Healthcare Dive,
    • “House Republicans are calling on the Center for Medicare and Medicaid Innovation to rethink its priorities under the Trump administration, including by improving transparency with providers and focusing on payment models that save the government money.
    • “In a letter sent this week by Republicans on the House Ways and Means Committee to CMS Administrator Dr. Mehmet Oz and CMMI Director Abe Sutton, lawmakers said they were “concerned” with the innovation center’s track record of creating models that often don’t improve care quality or reduce costs. 
    • “The legislators added that CMMI has also “promoted a political agenda ahead of its Congressionally mandated purpose,” like focusing on health equity instead of cost savings.” 

From the Food and Drug Administration front,

  • STAT News points out,
    • “Nearly 12% of Americans still smoke cigarettes, the leading cause of preventable death nationwide. Yet there are only two medications authorized by the Food and Drug Administration to help them quit — the more effective of which, varenicline, can come with unsavory side effects like nausea that make people less likely to stick with treatment.
    • “A new pill with fewer side effects could soon be available from the Washington state-based biotech Achieve Life Sciences. The company plans to file for FDA approval of its drug, called cytisinicline, in June. 
    • “Rick Stewart, Achieve’s co-founder and CEO, told STAT that he expects the drug to be approved in mid-2026 and to launch in the U.S. by the end of that year. “This will be the first new drug for nicotine dependence in nearly 20 years,” he said.” 
  • Fierce Healthcare informs us,
    • “While Johnson & Johnson isn’t the first to secure FDA approval for an FcRn-blocking antibody in myasthenia gravis, the New Jersey drugmaker is confident that a broad label will land its product an enviable market position in the long run.
    • “The FDA on Wednesday approved J&J’s nipocalimab under the brand name Imaavy as a new treatment option for generalized myasthenia gravis (gMG). The green light, which J&J says covers the “broadest population of people living with gMG,” includes patients ages 12 and older who are anti-acetylcholine receptor (AChR) or anti-muscle-specific kinase (MuSK) antibody positive.
    • “Anti-AChR and anti-MuSK antibody-positive people make up more than 90% of the total antibody-positive gMG population, J&J estimates. All told, the company figures gMG—which causes the communication between the body’s nerves and muscles to break down—affects around 700,000 people worldwide.”
  • Per MedTech Dive,
    • “Medtronic has won Food and Drug Administration approval for the Omniasecure defibrillation lead, the company said Friday.
    • “The lead connects to an implantable defibrillator and treats potentially life-threatening types of irregular heart rhythm. Medtronic said Omniasecure is the world’s smallest defibrillation lead.
    • “The approval limits the use of the lead to the right ventricle. Medtronic shared data on placing the lead in the left bundle branch last week but has yet to win FDA approval in that setting.
  • MedCity News lets us know,
    • “Patients with the most severe form of a certain inherited disease have skin that is susceptible to wounds, some that never fully heal. For years, the only treatment was supportive care, including laborious and frequent changes of wound dressings covering much of the body. Biotechnology research in this disease, epidermolysis bullosa (EB), has pursued therapeutic options. A personalized treatment that Abeona Therapeutics makes from a patient’s own skin cells is now approved by the FDA, marking the agency’s third approval in this rare disorder in the past two years.
    • “The regulatory decision announced Tuesday covers the treatment of wounds in adults and children who have recessive dystrophic epidermolysis bullosa (RDEB). The therapy, known in development as prademagene zamikeracel, or pz-cel for short, will be marketed under the brand name Zevaskyn. Cleveland-based Abeona expects Zevaskyn will become available in the third quarter of this year.
    • “We have heard from the RDEB community that there is a persistent, unmet need to meaningfully heal RDEB wounds, especially those that are chronic and prone to infection,” CEO Vishwas Seshdari said during a Tuesday morning conference call. “Through a single application, Zevaskyn can provide people with RDEB the opportunity for significant wound closure and pain reduction in even the most severe wounds.”

From the judicial front,

  • Federal News Network relates,
    • “The U.S. Supreme Court said Wednesday that federal employees who also are in the military reserve must be paid the equivalent of their civilian salaries when called to active duty during national emergencies.
    • “The 5-4 decision could affect hundreds of thousands of people, ensuring that they don’t suffer financially when they temporarily leave one form of government service for another.
    • “The justices ruled in an appeal filed by an air traffic controller who spent about five years on active duty in the Coast Guard at a pay rate lower than what he earns as a Federal Aviation Administration employee.”
  • Reuters reports,
    • “Genetic testing company 23andMe agreed on Tuesday to allow a court-appointed overseer to take charge of ensuring customers’ genetic data remains protected during the company’s bankruptcy, settling a dispute with several U.S. states.
    • “Those states had argued the company was not taking data security seriously enough.
    • “U.S. Bankruptcy Judge Brian Walsh approved the agreement at a court hearing in St. Louis, Missouri, ordering the appointment of a consumer protection ombudsman who will be empowered to review 23andMe’s handling of customers’ genetic information and its security policies.”

From the public health and medical research front,

  • CNBC reports,
    • “Aon researchers found that within two years, improved health outcomes for patients who were taking GLP-1 drugs lowers the growth rate of medical care costs. 
    • “Aon looked at medical claims data for 139,000 U.S.-based workers with employer health coverage who took GLP-1 medications between 2022 and 2024.
    • “Since 2023, GLP-1s have driven up employer spending on drugs at a faster pace than high-priced specialty drugs used to treat cancer and autoimmune conditions, according to an Evernorth study.”
  • Beckers Hospital Review considers what is driving increased use of GLP-1 drugs among children.
  • Per Cardiovascular Business,
    • “Drinking champagne may be associated with significant cardiovascular benefits, according to a new study published in the Canadian Journal of Cardiology.
    • “The study identified dozens of lifestyle changes that may help lower a person’s risk of sudden cardiac arrest (SCA). Some of the changes—eating more fruit, losing weight—were straightforward, but a few of the research team’s findings were unexpected. Drinking champagne and/or white wine, for example, was linked to a reduced SCA risk. The same was also true for spending more time at a computer—though that may tell us more about education levels than screen time.
    • “These findings all come from a new exposome-wide association study (EWAS) out of China. The study’s authors explored the UK Biobank study, focusing on data from more than 500,000 patients. They then looked for associations between SCA and 125 different modifiable lifestyle factors.
    • “To our knowledge, all previous studies on the risk factors of SCA were hypothesis-driven and focused on a limited number of candidate exposure factors grounded in previous knowledge or theoretical frameworks,” wrote first author Huihuan Luo, PhD, a researcher with Fudan University in Shanghai, China, and colleagues. “This might lead to publication bias distorting summary conclusions and might increase the likelihood of false positive findings resulting from inter-related exposures. More importantly, the hypothesis-driven approach might miss important exposures or relationships beyond the predefined hypothesis. To tackle these limitations, a hypothesis-free, data-driven EWAS has emerged as a robust analytical framework for simultaneously exploring hundreds of exposures. This data-driven approach does not rely on previous knowledge and facilitates the identification of novel or underexplored associations.” * * *
    • Click here for the full study.
  • Per Medscape,
    • “People with osteoarthritis are more likely to be diagnosed with other pain-related comorbidities such as fibromyalgia, chronic fatigue syndrome (CFS), gout, and irritable bowel syndrome and psychological comorbidities such as depression, according to observational data presented at the World Congress on Osteoarthritis (OARSI) 2025 Annual Meeting.
    • “The study also found that all these five conditions were themselves associated with an increased risk for incident osteoarthritis, and in the case of fibromyalgia, there may be a causal association.
    • “Physiotherapist and epidemiologist Subhashisa Swain, MPH, PhD, of the Nuffield Department of Primary Care Health Sciences at the University of Oxford, Oxford, England, presented an analysis of data from the multicenter European Comorbidities in Osteoarthritis (ComOA) study, which is examining electronic health records to identify associations between 61 different comorbidities with osteoarthritis and the clusters and trajectories of those comorbidities and osteoarthritis.”
  • The New York Times offers guidance on hip exercises.

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Humana beat earnings expectations for the first quarter and reaffirmed its 2025 guidance on Wednesday, after medical costs came in as predicted. It’s a positive development for the insurer, which has been rocked by higher spending in privatized Medicare plans and the safety-net Medicaid program.
    • “Humana attributed the results to higher Medicare and Medicaid premiums and membership growth in Medicare prescription drug plans and state contracts. Earnings were offset somewhat by an ongoing decline in Medicare Advantage membership after Humana culled underperforming plans to resuscitate margins this year.
    • “However, it’s still early in 2025, so Humana is remaining cautious when it comes to medical utilization, executives said. The payer’s outlook is also complicated by uncertainty stemming from its ongoing legal bid to improve MA quality ratings.”
  • The American Hospital Association News notes,
    • “The AHA April 30 released a report highlighting how hospitals and health systems continue to experience significant financial headwinds that can challenge their ability to provide care to their patients and communities. The report outlines the financial burden of heightened expenses hospitals have faced in recent years in caring for patients, as well as the increasing strain on the field.  
    • “It explains how hospitals have raised wages to recruit and retain staff amid workforce shortages and how Medicare and Medicaid continue to underpay hospitals for patient care as shortfalls worsen. Other findings include how practices of certain Medicare Advantage plans exacerbate hospitals’ financial burden, and that tariffs on medical imports could significantly raise costs for hospitals as nearly 70% of medical devices marketed in the U.S. are manufactured exclusively overseas. 
    • “This report should serve as an alarm bell that a perfect storm of rising costs, inadequate reimbursement, and certain corporate insurer practices are jeopardizing the ability of hospitals to deliver high-quality, timely care to their communities,” said AHA President and CEO Rick Pollack. “With so much at stake, policymakers must recommit to making preserving access to hospital care a national priority.” 
  • The Wall Street Journal reports,
    • “Trump’s executive order on drug prices is seen as a win for the pharmaceutical industry.
    • “Drugmakers spent millions lobbying against pharmacy-benefit managers (PBMs), blaming them for high drug prices.
    • “PhRMA funded various groups, including minority healthcare nonprofits, to criticize PBMs.”
  • Per Fierce Healthcare,
    • “UnitedHealth Group announced Tuesday that Patrick Conway, M.D., would take the helm of its Optum division.
    • “Conway, an insurance industry and health policy veteran, was previously the CEO of Optum’s pharmacy benefit management unit, Optum Rx. He also held leadership roles at the company’s healthcare delivery arm, Optum Health.
    • “Conway will step in as CEO of Optum on May 6. His prior work includes serving as the director of the Center for Medicare and Medicaid Innovation at the Centers for Medicare & Medicaid Services, which is responsible for developing critical payment models for government insurance programs.”
  • and
    • “Despite the poor financial performance of BetterHelp, whose revenue fell by 11% in Q1, Teladoc has grown its investment in virtual mental healthcare by acquiring UpLift in a $30 million all-cash transaction.
    • “The deal closed on April 30, the same day as Teladoc’s first quarter 2025 earnings call. The company fared worse than Wall Street expected in Q1, posting a net loss of $93 million, or $0.53 lost per share. Wall Street Analysts expected the company share price to decrease by $0.33.
    • “A significant upside to the acquisition is the new-found ability for BetterHelp customers to use insurance coverage for mental health services, a barrier that has kept some customers from signing up with the cash-pay mental health provider. UpLift will be included in the company’s BetterHelp reporting segment going forward, executives said.
    • “UpLift provides virtual mental health therapy, psychiatry and medication management services. It serves the health plan market and covers 100 million lives. It has a network of over 1,500 mental health providers.”
  • Per BioPharma Dive,
    • “Novartis will pay $800 million upfront to acquire Regulus Therapeutics, a San Diego biotechnology company that launched nearly two decades ago with plans to make drugs capable of targeting small strips of nucleic acid known as microRNA.
    • “Announced Wednesday, the acquisition will hand the Swiss pharmaceutical firm a drug prospect called farabursen, which recently completed a Phase 1b study in people with autosomal dominant polycystic kidney disease, or ADPKD.
    • “Per deal terms, Regulus shareholders will receive $7 in cash per share, a premium of more than 100% to the stock’s closing price Tuesday. Additionally, Novartis has committed to pay an additional $7 per share via a so-called contingent value right that’s linked to the achievement of an unspecified regulatory milestone.”
  • and
    • “Sales of BridgeBio’s new heart medicine Attruby blew past analyst expectations in the first quarter, as the company built by “science nerds” took on market behemoth Pfizer.
    • “Net product revenue reached $36.7 million in the period, surpassing the consensus analyst estimate of $12.6 million. The drug won Food and Drug Administration approval in November to treat a genetic condition known as transthyretin amyloidosis with cardiomyopathy.
    • “As of April 25, Attruby had 2,072 prescriptions written by 756 prescribers, BridgeBio said Tuesday after the market closed. That momentum built on encouraging numbers released in February and helped push the company’s shares up in early trading Wednesday.”
  • Per Beckers Hospital Review,
    • “Mark Cuban Cost Plus Drug Co. has secured another partnership targeting the specialty pharmaceutical market, according to an April 28 news release shared with Becker’s. 
    • “EverPharm, a specialty unit-dose medication company, is joining its portfolio with Cost Plus Drugs’ pricing model, which is the drug’s manufacturing cost plus a 15% markup and a $10 shipping and labor fee. On April 16, Cost Plus Drugs launched a similar partnership with Morris & Dickson, a full-line and specialty pharmaceutical distributor. 
    • “The partnership with EverPharm will roll out in phases, the release said, with an initial focus on offering key unit-dose medicines to pharmacies and healthcare providers through the Cost Plus Marketplace.”