Tuesday Report

COVID-19

Tuesday Report

David Ermer–CDC, CMS, Congress, COVID-19, Electronic health records, Generative AI, Medical / Rx research, Medicare, Mental health care, Obesity, Patient safety, Rx coverage, Telehealth, U.S. Healthcare–

From Washington, DC

  • Federal News Network interviews Bloomberg Government deputy news director Loren Duggan about what’s next for the Big Beautiful Bill Act.
  • Per a Senate press release,
    • Senate Judiciary Committee Chairman Chuck Grassley (R-Iowa) joined Sens. John Cornyn (R-Texas) and Amy Klobuchar (D-Minn.) to introduce the Don’t Sell My DNA Act to safeguard consumers’ sensitive genetic data during corporate bankruptcy proceedings.
    • The Don’t Sell My DNA Act strengthens consumer privacy protections by:
      • Modernizing the Bankruptcy Code to include genetic information in the definition of “personally identifiable information”;
      • Requiring written notice and affirmative consumer consent prior to the use, sale or lease of genetic information during bankruptcy proceedings; and
      • Requiring the trustee or debtor in possession of genetic information to permanently delete any data not subject to a sale or lease.
    • “Consumers should feel confident that any personal information shared with a public company isn’t up for grabs when that company files for bankruptcy,” Grassley said. “This bill would fill gaps in current law to help safeguard consumers’ genetic information and ensure Americans’ DNA isn’t treated like any other financial asset.”
  • The American Hospital Association lets us know,
    • Department of Health and Human Services Secretary Robert F. Kennedy Jr. May 27 announced in a post on X that the Centers for Disease Control and Prevention would no longer recommend the COVID-19 vaccine for healthy children and pregnant women. 
  • Per Fierce Healthcare,
    • “The Centers for Medicare & Medicaid Services (CMS) Innovation Center announced Monday it is extending three tracks within the Kidney Care Choices (KCC) Model through 2027.
    • “Starting in performance year 2026, the model’s financial methodology and participation options will be modified to “improve model sustainability,” the agency said. However, one KCC Model track will be shuttered a year early at the end of December.
    • “The KCC Model has 93 participants, and implementation first began in January 2022. The most recent participants were announced Jan. 15.”
  • The Equal Employment Opportunity Commission announced last week
    • The EEOC collects workforce data from employers with more than 100 employees (lower thresholds apply to federal contractors). Employers meeting the reporting thresholds have a legal obligation to provide the data; it is not voluntary.  * * *
    • The 2024 EEO-1 Component 1 data collection opened on Tuesday, May 20, 2025. The deadline to file the 2024 EEO-1 Component 1 report is Tuesday, June 24, 2025.
    • “As part of EEOC Acting Chair Lucas’ efforts to identify continued cost savings for the American public, there will be a shorter collection period during which filers may submit their 2024 reports. The collection period will not extend beyond the Tuesday, June 24, 2025 “Published Due Date” deadline. Additionally, beginning with the 2024 EEO-1 Component 1 data collection, all communications sent to filers will be electronic.” * * *
    • “Filers should visit the dedicated EEO-1 Component 1 website at www.eeocdata.org/eeo1
      to access the EEO-1 Component 1 Online Filing System (OFS), to find supplementary resource materials such as the 2024 EEO-1 Component 1 Instruction Booklet and 2024 EEO-1 Component 1 Data File Upload Specifications, and to get the latest updates. Filers needing additional assistance can access the Filer Support Team Message Center upon logging into the OFS.”

In Food and Drug Administration News,

  • The American Hospital Association News tells us,
    • “The Food and Drug Administration has identified a Class I recall of certain lots of BD esophagogastric balloon tamponade tubes due to the potential for serious injury or death. BD said it became aware of some users encountering challenges removing the plastic plugs from the rubber lumen to inflate the balloons. BD and their subsidiary C.R. Bard Urology and Critical Care sent all affected customers a letter with updated use instructions. There have been two serious injuries, and one death associated with the issue.”
  • Per Fierce Pharma,
    • Despite facing ongoing legal pressure from its rival United Therapeutics, Liquidia has successfully landed a pair of long-awaited FDA approvals for its dry powder formulation of treprostinil.
    • The FDA has cleared treprostinil—also known by the trade name Yutrepia—to improve exercise ability in adults with pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD).
  • and
    • The FDA has also approved Sanofi’s meningococcal vaccine MenQuadfi for use in infants as young as 6 weeks, multiple news outlets reported Tuesday. The shot was already cleared to protect against four prolific strains of meningococcal bacteria in individuals as young as 2 years and older.
    • The FDA based its decision on data from three phase 3 trials that found MenQuadfi worked as well as GSK’s rival meningococcal vaccine Menveo when given with other routine vaccines in children between the ages of 6 weeks to 19 months, Reuters pointed out. Sanofi’s trials enrolled more than 6,000 participants.
  • BioPharma Dive reports,
    • “A patient who received an experimental gene therapy developed by Rocket Pharmaceuticals has died following treatment, the company disclosed Tuesday.
    • “According to Rocket, the patient experienced what’s known as capillary leak syndrome, where plasma and proteins seep from blood vessels into surrounding tissue, and later died from an acute systemic infection.
    • “The Food and Drug Administration ordered the study’s halt Friday, while Rocket works with clinical trial monitors and other experts to investigate the cause. The company said it is focusing on a “novel immune suppression agent” it recently added to a pre-treatment preparatory regimen.”

From the judicial front,

  • The American Medical Association informs us,
    • “In a win for the nation’s youth—and all Americans’ health—the U.S. Supreme Court has ruled (PDF) that the Food and Drug Administration (FDA) did not act in an arbitrary and capricious manner when it told applicants that they could not put certain flavored e-cigarette liquids on the shelf.
    • “The unanimous decision overturned a 5th U.S. Circuit Court of Appeals ruling. Had that appellate-court ruling been allowed to stand, companies could have marketed products that clearly were designed to appeal to children, with names such as “Jimmy the Juice Man Peachy Strawberry,” “Suicide Bunny Mother’s Milk and Cookies,” “Pink Lemonade,” “Iced Pineapple Express” and “Killer Kustard Blueberry.”
    • “Justice Samuel A. Alito Jr., who wrote the opinion for the court, said the FDA did not act arbitrarily and capriciously when it denied the companies’ applications for premarket approval of the tobacco products. The companies challenged the agency’s decision arguing that, among other things, that the FDA didn’t give them fair notice about the evidentiary and comparative requirements used during the application stage and that the agency had changed its position on scientific evidence. 
    • “The high court remanded the case to the 5th Circuit to review other legal arguments, so this is not the end of the litigation, but it is a favorable step forward. The 5th Circuit’s decision was an outlier among the federal circuits that have considered similar cases.”
  • Per Govexec,
    • “At least one agency’s staff impacted by the mass dismissals of probationary workers can pursue their reinstatements as a class, the panel that hears federal employees’ challenges to firings has for the first time ruled, creating a new path for sweeping reversals of those terminations. 
    • “Hundreds of recently hired and subsequently fired employees at the Homeland Security Department will be part of a class action alleging their dismissals were unlawful after a Merit Systems Protection Board administrative judge granted the request. The DHS ruling was the first to come down after a consortium of lawyers filed similar challenges on behalf of fired probationary employees at 20 federal agencies. 
    • “I find that a class appeal is the fairest and most efficient way to adjudicate the appeal and that the putative class counsel and named appellants will adequately represent the interests of the parties,” said Sara Snyder, the chief administrative judge for MSPB’s western regional office.” 

From the public health and medical research front,

  • CBS News reports,
    • Cases of the new COVID-19 variant NB.1.8.1, linked to a large surge in China, have been detected in multiple locations across the United States, according to the Centers for Disease Control and Prevention. The earliest cases in the U.S. date back to late March and early April, and were detected through a screening program at airports for arriving international travelers.
    • “CDC is aware of reported cases of COVID-19 NB.1.8.1 in China and is in regular contact with international partners,” a CDC spokesperson said in a statement last week.
    • The spokesperson said that, so far, too few U.S. sequences have been reported of NB.1.8.1 to be included in the agency’s variant estimates dashboard.
    • But hospitalizations abroad have raised questions about the new variant, its symptoms and more.
    • Answers to those questions may be found in the CBS News article.
  • ABC News adds,
    • “More than five years after the first cases of COVID-19 were detected in the United States, hundreds of people are still dying every week.
    • “Last month, an average of about 350 people died each week from COVID, according to data from the Centers for Disease Control and Prevention (CDC).” * * *
    • “The experts said there are a few reasons why people might still be dying from the virus, including low vaccination uptake, waning immunity and not enough people accessing treatments.” * * *
    • “CDC data shows that those aged 75 and older currently have the highest rate of COVID-19 deaths at 4.66 per 100,000.”
  • The American Medical Association let us know what doctors wish their patients knew about lung cancer screening.
  • The Washington Post relates,
    • “Engagement with digital technology was associated with a 58 percent reduced risk of cognitive impairment in people middle-aged and older, according to a study in the journal Nature Human Behavior.
    • “Researchers conducted a systematic review of 57 studies to see whether exposure to technology has helped or harmed cognition among the first generation of adults with prolonged exposure to digital devices such as smartphones, tablets and computers. The studies involved more than 411,000 adults with an average age of 69.
    • “The analysis revealed that technology could play a role in preserving brain function, not worsening it, said co-authors Jared Benge, a clinical neuropsychologist at the University of Texas at Austin’s Dell Medical School, and Michael Scullin, an associate professor of psychology and neuroscience at Baylor University.”
  • Per Medscape,
    • “Herpes simplex virus 1 (HSV-1) infection is associated with an increased risk of developing Alzheimer’s disease (AD), but treating the viral infection may offer protection, a new study found.
    • “In a matched case-control study of nearly 700,000 older adults, HSV-1 was more common in those with AD, and antiviral therapy for HSV-1 was associated with a lower risk of developing AD.
    • “However, the authors and outside experts cautioned that no firm conclusions can be drawn from this observational study and called for more research.
    • “The study was published online on May 20 in BMJ Open. It was funded by Gilead Sciences, which is actively involved in the research and development of treatments for HSV.”
  • The Wall Street Journal points out,
    • Good posture improves circulation, respiration, digestion and bladder function. It also enhances cognitive ability and mood.
    • To improve posture, become aware of your body position, stand against a wall to align yourself, and perform dynamic stretching exercises.
    • Upright posture is associated with confidence, self-esteem, and reduced anxiety. Physical therapists can help develop personalized plans to improve posture.

From the U.S. healthcare business front,

  • Fair Health released today a claims-based analysis of GLP-1 drugs and obesity. Beckers Hospital Review summarizes this analysis here.
  • The Wall Street Journal considers the price outlook for GLP-1 drugs used to treat obesity.
  • Fierce Pharma tells us,
    • “After a fourth quarter in which revenue boomed throughout the biopharma industry, there were reversals for several drugmakers in the first three months of 2025. 
    • “The companies that took the biggest hits were in the United States, where there is already considerable angst in the industry over the tariff threats and drug price-slashing aspirations of President Donald Trump, along with the unsettling prospects of having a pharma adversary, Robert F. Kennedy Jr., heading up the Department of Health and Human Services.
    • “Among the top 25 revenue companies in the industry in Q1, there were seven that saw year-over-year sales declines, all from the U.S. Viatris took the biggest hit at 11%, followed by Pfizer (-8%), Organon (-7%), Bristol Myers Squibb (-6%), Regeneron (-4%), Merck (-2%) and Gilead (-0.3%).”
  • Per BioPharma Dive,
    • “Eli Lilly is wagering up to $1 billion on a private biotechnology company developing new, non-opioid pain drugs that have already caught the attention of other large pharmaceutical firms.
    • “Per an announcement Tuesday, Lilly plans to acquire SiteOne Therapeutics in an all-cash deal. The companies aren’t disclosing how much money is being exchanged upfront or when they expect the transaction to close. But, if SiteOne’s research programs hit certain regulatory and commercial goals, the amount paid to its shareholders could reach that 10-figure mark.”
  • and
    • “Biogen is partnering with RNA drug developer City Therapeutics to develop a better way of reaching an unspecified target that “mediates key central nervous system diseases.” Biogen will pay City, a startup that launched publicly late last year, $16 million in upfront fees and invest another $30 million in convertible notes that could later become a minority stake. “With this effort, we are further expanding the modalities in our R&D toolbox to potentially reach our targets of interest more precisely by adding an RNAi-based approach,” Biogen research head Jane Grogan said in a statement.”
  • Per an Institute for Clinical and Economic Review news release,
    • “ICER today released a Draft Evidence Report assessing the comparative clinical effectiveness and value of apitegromab(Scholar Rock Holdings), nusinersen (Spinraza®, Biogen), onasemnogene abeparvovec-xioi (Zolgensma®, Novartis), and risdiplam (Evrysdi®, Genentech) for spinal muscular atrophy (SMA).
    • “This preliminary draft marks the midpoint of ICER’s eight-month process of assessing this treatment, and the findings within this document should not be interpreted to be ICER’s final conclusions.”
  • Beckers Health IT discusses why Texas Health is taking a loss on its hospital at home program and summarizes Medscape’s list of telehealth friendly states which Utah leads.
  • Beckers Clinical Leadership identifies the 24 U.S. hospitals that have received the American Nurses Credentialling Center’s Magnet with Distinction award. “The Magnet with Distinction program was created as a special designation to celebrate hospitals and healthcare organizations that exceed scoring thresholds required to earn Magnet recognition.”
  • The Wall Street Journal reports,
    • “AI-powered ambient-listening technology is expanding in healthcare, documenting doctor-patient encounters.
    • “AI scribes save doctors time on documentation, reducing burnout and improving focus on patients, according to pilot programs.
    • “Concerns exist around patient privacy, data security and costs, but patient feedback has been largely positive.”
  • Fierce Healthcare offers insights into how Anthem Blue Cross is growing its behavioral health network in California.
    • “The insurer’s network is built on partnerships with multiple organizations, with recent additions including Headway, Rula and Octave. Through its relationship with these firms, the insurer is seeking to make it simpler for members to find providers that meet their unique needs.
    • “Through Headway, the insurer connects employers and plan members with personalized services. Rula, meanwhile, makes it easier for members to schedule an appointment with one of the more than 10,000 providers in its network.
    • “Octave, similarly, is built to make it simple for members to find a provider across multiple specialties, backgrounds and evidence-based approaches, according to the announcement.”
  • NIST explains for those interested how an MRI machine works.

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.”

Tuesday Report

David Ermer–CDC, Congress, COVID treatment, COVID-19 vaccine, FDA, Federal employment benefits, Generative AI, Medical / Rx research, Mental health care, Obesity, Rx coverage, U.S. Healthcare–
Photo by Michele Orallo on Unsplash

From Washington, DC,

  • Following up on yesterday’s post about the House budget reconciliation bill, Govexec informs us,
    • “According to the latest draft of the bill, published early Monday morning, Republicans have ditched the plan to effectively un-grandfather employees hired prior to 2014 into paying more of their paychecks toward their retirement benefits.
    • “On the FERS supplement, which can amount to one-third of a federal retiree’s income until they turn 62, lawmakers expanded an exemption for federal workers who are required to retire early, such as air traffic controllers and federal law enforcement personnel, to cover all such employees, regardless of whether they actually are forced out because they hit the mandatory retirement age. The implementation date, previously set on the date of the bill’s enactment, has been shifted to Jan. 1, 2028, and language now exists clarifying that federal employees may maintain eligibility for the supplement provided they are “entitled” to it prior to 2028.
    • “The latest draft also delays the change in federal retirees’ annuity calculations from the high-3 to high-5 average salary model by one year, to Jan. 1, 2028.”
  • KFF posted a summary of Medicaid provisions in the House budget reconciliation bill.
  • Roll Call reports,
    • “President Donald Trump urged the House GOP to stop negotiating and pass his “big, beautiful” filibuster-proof reconciliation bill Tuesday, with sharp words for blue-state Republicans pushing for more tax relief and conservatives seeking additional spending cuts.
    • “In an appearance during the weekly GOP conference meeting, Trump told conservatives to lay off Medicaid, scolded blue-state Republicans for rejecting a $30,000 cap on state and local tax deductions and urged the party to increase the country’s borrowing limit through the rest of his term, members leaving the meeting said. * * *
    • “Trump’s visit did little to move the needle in support of the bill, leaving leadership where they started the week: trying to strike a balance between steeper cuts needed to satisfy conservatives without alienating centrists, and finding space for more SALT relief.
    • “Republicans can afford to lose no more than three GOP votes and pass the partisan legislation.
    • “After the meeting, Speaker Mike Johnson said he was ready to convene the holdouts in smaller groups to try to reach a deal.”
  • Per a Congressional press release,
    • “Congressman Gerald E. Connolly (D-VA) and Congressman James Comer (R-KY), the Ranking Member and Chairman of the House Committee on Oversight and Government Reform respectively, introduced the Esophageal Cancer Awareness Act, bipartisan legislation to commission a Government Accountability Office (GAO) study on gaps in screening and prevention of esophageal cancer. 
    • “Esophageal Cancer is quickly on the rise, touching the lives of tens of thousands of Americans – including mine,” said Ranking Member Connolly. “It is vital that we all do our part to raise awareness and push for more research and more effective prevention efforts. I am immensely grateful to my colleague, Chairman Comer, for joining me in introducing this important legislation today. Together, we will fight to end esophageal cancer, bringing hope to thousands of American families.” * * *
    • “Text of the legislation is available here.”
  • The American Hospital Association News tells us,
    • Secretary of Health and Human Services Robert F. Kennedy Jr. May 20 appeared before the Senate Appropriations Committee for a hearing to testify on the discretionary budget proposal for fiscal year 2026.
      • Roll Call offers more details on the hearing.
  • and
    • “The Department of Health and Human Services May 20 announced it has identified specific pricing targets for pharmaceutical manufacturers to meet to satisfy requirements of the Trump administration’s executive order allowing consumers to make direct purchases from drug manufacturers at “most favored nation” pricing, the lowest cost paid for the same medications in an Organization for Economic Co-operation and Development country with a gross domestic product per capita that is at least 60% of the U.S. GDP per capita.”
      • Beckers Hospital Review calls attention to six things to know about this announcement.

From the Foord and Drug Administration front,

  • The Wall Street Journal points out,
    • “The Trump administration released a more stringent set of guidelines for approving Covid-19 vaccines, requiring more evidence for new shots for healthy adults and children.
    • “Any new Covid vaccines for many children and adults will be required to undergo randomized, controlled trials before receiving Food and Drug Administration approval, FDA Commissioner Dr. Marty Makary and the agency’s new vaccines chief, Dr. Vinay Prasad, wrote Tuesday in the New England Journal of Medicine. The agency expects that it will be able to approve the shots for adults older than 64 and high-risk groups based on antibody testing but will encourage drugmakers to conduct more randomized trials for those shots too.”
  • MedPage Today notes,
    • The FDA warned that some people develop severe itching, or pruritus, after stopping long-term use of the antihistamines cetirizine (Zyrtec) or levocetirizine (Xyzal).
    • Prescribing information for the oral allergy drugs — which are taken daily and sold both in prescription and over-the-counter (OTC) forms — will be updated to warn about the post-discontinuation risk. The itching typically occurs within a few days of stopping the products.
    • “Restarting the medicine resolved pruritus in most individuals, and tapering off the medicine after restarting it resolved symptoms in some who tried this approach,” the FDA said in its safety communication.”
  • Fierce Pharma adds,
    • “Roche looks unlikely to be able to move its DLBCL drug Columvi earlier in the treatment sequence after experts in an FDA advisory committee joined the agency in questioning the regional imbalance of clinical trial data. What’s more, both FDA Commissioner Martin Makary, M.D., and longtime FDA oncology chief Richard Pazdur, M.D., have a new message for drug developers.
    • “A panel of experts on the FDA’s Oncologic Drugs Advisory Committee voted 8 to 1 Tuesday that results from Roche’s phase 3 Starglo trial are not applicable to a U.S. patient population. The trial evaluated the combination of Columvi and the chemotherapy regimen GemOx in second- or later-line transplant-ineligible DLBCL. 
    • “A patient representative cast the only yes vote.”
  • MedTech Dive announced the creation of an online database that tracks FDA approval of medical devices that incorporate artificial intelligence.

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “The Covid-19 virus in the U.S. has largely faded from view. But it hasn’t faded away. 
    • “National wastewater data shows low Covid-19 activity, according to the Centers for Disease Control and Prevention. The weekly reported Covid-19 deaths in April were slightly down compared with the same time a year earlier, federal data shows. Still, more than 300 Covid-19-related deaths were reported weekly as recently as mid-April. 
    • “Some infectious-disease specialists said they expect more cases this summer, as there have been somewhat regular summertime increases in the past. Others cautioned that Covid-19 can still surprise us, more than five years after it spurred a global pandemic that killed more than 1.2 million Americans. 
    • “It is at our lowest levels it has been since the beginning of the pandemic,” said Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota. “Our challenge is we don’t know what that means for tomorrow.” 
  • Per MedPage Today,
    • “The use of antibiotics in patients hospitalized with non-severe COVID-19 was not associated with better outcomes, a large retrospective cohort study found.
    • “Among more than half a million U.S. patients with COVID, those given antibiotics on their first day of hospitalization had a slightly higher rate of deterioration or death compared with those who didn’t receive antibiotics (20.8% vs 18.4%), reported researchers led by Michael Pulia, MD, PhD, of the University of Wisconsin-Madison.
    • “The difference didn’t meet criteria for being of clinical significance. However, a propensity-matched analysis did show a significantly higher odds of poor clinical outcomes for those who received antibiotics (OR 1.03, 95% CI 1.01-1.05, P=0.003), according to findings published in JAMA Network Open.
    • “Hopefully, studies like this raise the bar for antibiotic initiation in patients with confirmed COVID-19, even if they are sick enough to require hospital admission,” Pulia told MedPage Today.
    • “Pulia noted that there’s often a lot of uncertainty as to whether a patient hospitalized with COVID also has a bacterial infection, so physicians may prescribe antibiotics to be safe. “Hopefully, studies like this will reduce this uncertainty and improve judicious antibiotic use, thus helping in the fight against antibiotic resistance,” he said.”
  • The New York Times discusses “A New System Aims to Save Injured Brains and Lives. Nearly 100 neurology experts collaborated on the creation of a new method of evaluating patients with traumatic brain injuries.”
  • The latest National Institutes of Health’s (NIH) Research Matters covers “Cancer trends in younger people | Measuring biological age | Brain rewiring in motor learning.”
  • Per a NIH news release,
    • For the first time, researchers at the National Institutes of Health (NIH) identified patterns of metabolites in blood and urine that can be used as an objective measure of an individual’s consumption of energy from ultra-processed foods. Metabolites are left after the body converts food into energy, a process known as metabolism. Scientists used these data to develop a score based on multiple metabolites, known as a poly-metabolite score, that has the potential to reduce the reliance on, or complement the use of, self-reported dietary data in large population studies. The findings appeared May 20, 2025, in PLOS Medicine.   
    • “Limitations of self-reported diet are well known. Metabolomics provides an exciting opportunity to not only improve our methods for objectively measuring complex exposures like diet and intake of ultra-processed foods, but also to understand the mechanisms by which diet might be impacting health,” said lead investigator Erikka Loftfield, Ph.D., M.P.H., of NIH’s National Cancer Institute.”
  • MedPage points out,
    • “Dementia incidence fell among Medicare beneficiaries from 2015 to 2021, but prevalence rose.
    • “Incidence was higher for Black beneficiaries than any other racial or ethnic group.
    • “Those living in socioeconomically deprived neighborhoods had the highest incidence and prevalence.”
  • FYI, “Prevalence differs from incidence in that prevalence includes all cases, both new and preexisting, in the population at the specified time, whereas incidence is limited to new cases only.”

From the U.S. healthcare business front,

  • BioPharma Dive reports,
  • STAT News lets us know,
    • “Developers of digital mental health treatments now have fresh economic data to help make the case for broader coverage of their apps.
    • “Companies selling Food and Drug Administration-cleared apps for the treatment of psychiatric and other conditions have long struggled with adoption by patients, providers, and payers for many reasons. Clinical evidence supporting these prescription digital therapeutics has gradually improved, but policymakers and insurers have been hesitant to open the path to reimbursement too quickly.” * * *
    • “In a new report, the Peterson Health Technology Institute (PHTI) finds that Rejoyn, an app for depression from Otsuka Precision Health, and DaylightRx, an app for anxiety from Big Health, warrant further adoption because their clinical trials show strong evidence of benefits. Both apps are intended to be used alongside ongoing mental health treatment, and in most cases, the institute found the apps will save money.” * * *
    • “Elsewhere, advocates from the American Telemedicine Association’s advocacy arm, ATA Action, are preparing to brief lawmakers about data showing that Germany’s broad expansion of coverage for digital apps resulted in 234 million euros in spending from 2020 to 2024. The report, produced by Germany’s National Association of Statutory Health Insurance Funds, also found 861,000 total app activations. That’s a cost of about 271 euros per use.”
  • Fierce Healthcare adds,
    • “Employers are continuing to invest in their well-being programs, but they will be raising the bar for what’s expected from their vendors.
    • “The Business Group on Health released a survey looking at employer strategies around well-being initiatives, polling 131 firms that employ 11.2 million people collectively. The employers represent multiple sizes and geographies, with 60% being multinational.
    • “The survey found that 93% of employers intend to either maintain or expand their well-being programs for 2025. Most (73%) said they will keep their existing offerings, while 20% said they will grow.
    • “In tandem, 94% of those surveyed said they will be increasing the expectations they have for well-being program vendors to show improvements to outcomes. Jim Winkler, chief strategy officer for the Business Group, said during a media briefing that this isn’t a new trend but that employers are simply turning up the heat on these vendors.”
  • Per Institutes for Clinical and Economic Review news releases,
    • The Institute for Clinical and Economic Review (ICER) posted a Protocol today [May 19] outlining how it will conduct a new annual analysis titled the “Launch Price and Access Report,” which will examine launch prices and patient access for new FDA-approved treatments. This protocol was developed with input from a multi-stakeholder working group consisting of patient and consumer advocates, clinicians, policy experts, payers, and life science companies.”
  • and
    • The Institute for Clinical and Economic Review (ICER) announced today [May 20] that it will assess the comparative clinical effectiveness and value of cytisinicline (Achieve Life Sciences) for smoking cessation [which is the first new smoking cessation drug for many years].
    • The assessment will be publicly discussed during a meeting of the Midwest CEPAC in January 2026, where the independent evidence review panel will deliberate and vote on evidence presented in ICER’s report.
    • ICER’s website provides timelines of key posting dates and public comment periods for this assessment. 
  • Reuters reports,
    • “Online weight-loss company Noom has begun offering smaller doses of compounded versions of Novo Nordisk’s (NOVOb.CO) Wegovy as the U.S. drugs regulator clamps down on mass production of copies of the in-demand medicine.
    • “Noom will offer its version of compounded semaglutide – the active ingredient in Wegovy and diabetes drug Ozempic – as part of a program personalized for patients, which it says will comply with changing U.S. Food and Drug Administration regulations.”
  • Beckers Payer Issues informs us,
    • “CVS Health has named Creagh Milford, DO, as president of Oak Street Health.
    • “Dr. Milford has been with CVS since 2021, most recently serving as president of retail health. 
    • “I’m excited to start a new chapter at CVS Health as President of Oak Street Health, where I have the honor of developing and executing business strategy to further grow the organization,” he wrote on Linkedin on May 19. “As a practicing physician, I am passionate about providing consumer-centric primary care to patients — and Oak Street Health shares that passion, resulting in better experiences and outcomes for the older adults we serve.”

Weekend Update

David Ermer–Congress, COVID-19 vaccine, Medical / Rx research, Obesity, U.S. Healthcare–

From Washington, DC

  • The House Budget Committee will resume consideration of the budget reconciliation bill tonight at 10 pm ET.
  • The New York Times reports that “The Food and Drug Administration on Friday approved the Novavax Covid-19 vaccine, but only for older adults and for others over age 12 who have at least one medical condition that puts them at high risk from Covid.”

From the public health and medical research front,

  • The New York Times further reports,
    • “Surgeons in Southern California have performed the first human bladder transplant, introducing a new, potentially life-changing procedure for people with debilitating bladder conditions.
    • “The operation was performed earlier this month by a pair of surgeons from the University of California, Los Angeles, and the University of Southern California on a 41-year-old man who had lost much of his bladder capacity from treatments for a rare form of bladder cancer.
    • “I was a ticking time bomb,” the patient, Oscar Larrainzar, said on Thursday during a follow-up appointment with his doctors. “But now I have hope.”
    • “The doctors plan to perform bladder transplants in four more patients as part of a clinical trial to get a sense of outcomes like bladder capacity and graft complications before pursuing a larger trial to expand its use.”
  • and
    • “Kristin Kramer woke up early on a Tuesday morning 10 years ago because one of her dogs needed to go out. Then, a couple of odd things happened.
    • “When she tried to call her other dog, “I couldn’t speak,” she said. As she walked downstairs to let them into the yard, “I noticed that my right hand wasn’t working.”
    • “But she went back to bed, “which was totally stupid,” said Ms. Kramer, now 54, an office manager in Muncie, Ind. “It didn’t register that something major was happening,” especially because, reawakening an hour later, “I was perfectly fine.”
    • “So she “just kind of blew it off” and went to work.
    • “It’s a common response to the neurological symptoms that signal a T.I.A., a transient ischemic attack or ministroke. At least 240,000 Americans experience one each year, with the incidence increasing sharply with age.” * * *
    • “Now, a large epidemiological study by researchers at the University of Alabama at Birmingham, published in JAMA Neurology, points to another reason to take T.I.A.s seriously: Over five years, study participants’ performance on cognitive tests after a T.I.A. drops as steeply as it does among victims of a full-on stroke.” * * *
    • “An accompanying editorial by Dr. Eric Smith, a neurologist at the University of Calgary, was pointedly headlined “Transient Ischemic Attack — Not So Transient After All!”
  • Medscape adds,
    • Is it time for universal screening for atrial fibrillation (AF), the most commonly treated type of arrhythmia that sets people up for strokes?
    • The question is important. While estimates of prevalence vary, a recent study found AF affects about 4% of the adult population or about 10 million in the United States. More than 795,000 people in the United States have a strokeeach year, and AF is blamed for 1 in 7.
    • For now, however, US organizations that issue guidelines and many leading cardiologists agree: It’s not yet warranted and may result in anticoagulation overtreatment, along with what they call the “nontrivial” risk for bleeding from that treatment.
    • However, it’s definitely a stay tuned situation, as researchers continue to investigate whether widespread screening can reduce the number of strokes in the broad population, others look at the role of “smart” technology, and still others focus on subsets of the population that might benefit most from routine screening.
  • The Washington Post points out,
    • “Eating an unhealthy diet is tied to an earlier first period, a new analysis suggests.
    • “The study linked a girl’s first menstrual period — a milestone known as menarche — to what she ate, showing ties between potentially inflammatory diets rich in processed and refined foods, red meat and beverages such as soda and an earlier onset of menstruation.
    • “Published in Human Reproduction, the study looked at 7,530 participants in the Growing Up Today Study, an ongoing study that evaluates factors thought to influence health across a lifetime. Participants enrolled in 1996 and 2004 and answered questionnaires about diet and activity, general health, family history, demographic factors and when they got their first period.
    • “Researchers assessed participants’ diets using two rubrics: the Alternative Healthy Eating Index, a score based on participants’ adherence to a healthy diet, and the Empirical Dietary Inflammatory Pattern, which identifies diets linked to inflammation. These potentially inflammatory diets are higher in processed foods, beverages like soda and juice, and red meat.
    • “Ninety-three percent of participants started their period during the study, at a median age of 13.1 years. But the age of menarche varied among participants with different diets. Overall, having a healthier diet predicted later menarche, and those who ate the healthiest diet were 8 percent less likely to get their first period in the next month. The association remained after researchers adjusted for body mass index, height and neighborhood socioeconomic status.”

From the U.S. healthcare business front,

  • The Wall Street Journal let us know,
    • “A government crackdown on cheaper copies of Ozempic and similar diabetes and weight-loss drugs was intended to shut the door on that booming market.
    • “It hasn’t exactly worked out that way. 
    • “Instead, some compounding pharmacies and telehealth companies that make the copies have found new ways in. They are making and selling dosages slightly different from the standard, FDA-approved amounts or including additives such as vitamins B3 and B12. Others have changed how the drug is taken, switching from injectables to under the tongue drops or pills.
    • “These providers are relying on a law that allows bespoke versions of drugs that are unavailable commercially. Though some patients report delays in receiving the compounded medications, many are still getting them—at least for now—said patients and industry professionals. 
  • MedTech Dive tells us,
    • “Siemens Healthineers said Wednesday it is investing $150 million to expand production in the U.S.
    • “Siemens is relocating manufacturing operations for its radiation oncology business Varian from Mexico to the U.S. The company said the change will add around 50 jobs in California.
    • “The company is also building a 60,000 square foot “Experience Center” in North Carolina, investing $141 million in a research and innovation district that it has been involved with since 2023.”

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.”

Thursday Report

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

From Washington, DC,

  • Healthcare Dive summarizes the healthcare-related provisions of the various House committee budget reconciliation recommendations that the House Budget Committee will take up tomorrow.
  • As promised, the Departments of Health and Human Services, Labor, and the Treasury released today a non-enforcement policy concerning the 2024 mental health parity amendments.
    • “The Departments have requested that the ERIC litigation be held in abeyance while the Departments reconsider the 2024 [Mental Health Parity] Final Rule, including whether to issue a notice of proposed rulemaking rescinding or modifying the regulation through notice and comment rulemaking.
    • The Departments will not enforce the 2024 Final Rule or otherwise pursue enforcement actions, based on a failure to comply that occurs prior to a final decision in the litigation, plus an additional 18 months. This enforcement relief applies only with respect to those portions of the 2024 Final Rule that are new in relation to the 2013 final rule. The Departments note that MHPAEA’s statutory obligations, as amended by the CAA, 2021, continue to have effect. 
  • The Wall Street Journal reports,
    • “The Trump administration is planning to drop recommendations that pregnant women, teenagers and children get Covid-19 vaccines as a matter of routine, according to people familiar with the matter.
    • “The Department of Health and Human Services, led by Secretary Robert F. Kennedy Jr., is expected to remove the Centers for Disease Control and Prevention’s recommendations for those groups around the same time it launches a new framework for approving vaccines, the people said.
    • “The exact timing of the announcement wasn’t clear, the people said, though it was expected in the coming days.”
  • Tammy Flanagan, writing in Govexec, discusses “Getting ready to retire. What you should do and how you should approach your retirement and health benefits planning before leaving federal service.”

From the FDA front,

  • Per an HHS press release,
    • “The U.S. Food and Drug Administration today is taking a major step to increase transparency and ensure the safety of chemicals in our food. The agency is launching a stronger, more systematic review process for food chemicals already on the market—especially those that concern consumers most.
    • “No parent should ever worry about what’s in their child’s food,” said HHS Secretary Robert F. Kennedy, Jr. “We’re taking decisive action and using every authority we have to clean up the food supply and protect American families.”
    • “Under the leadership of Secretary Kennedy and FDA Commissioner Martin A. Makary, M.D., M.P.H., the FDA will roll out several key actions over the coming months:
      • “A modernized, evidence-based prioritization scheme for reviewing existing chemicals. A draft will be released for public comment soon.
      • “A final, systematic post-market review process shaped by stakeholder input.
      • “An updated list of chemicals under review, including BHT, BHA, and ADA. The FDA will also take steps to expedite its review of chemicals currently under review like phthalates, propylparaben, and titanium dioxide. FDA will continue to share information about the status of this work on its public website as part the agency’s push for greater transparency.”
  • Fierce Pharma adds,
    • “Six years after Merck bought out Peloton Therapeutics, the New Jersey drugmaker is not remaining stationary with the crown jewel of the deal.
    • “On Wednesday, the FDA approved a third indication for Welireg (belzutifan), signing off on the hypoxia-inducible factor-2 alpha (HIF-2a) inhibitor to treat patients with rare pheochromocytoma or paraganglioma (PPGL) tumors in the endocrine system.
    • “The approval covers patients 12 and older with locally advanced, unresectable or metastatic PPGL and makes Welireg the first oral treatment for advanced PPGL, per Merck.”
  • Per MedPage Today,
    • The FDA granted a first-ever approval for a first-line therapy for anal cancer to the PD-1 inhibitor retifanlimab (Zynyz), the agency announced Thursday.
    • The approval stipulates use in combination with carboplatin and paclitaxel in newly diagnosed locally advanced/metastatic squamous cell carcinoma of the anal canal (SCAC) or as monotherapy for patients whose disease progressed on platinum-based chemotherapy.
    • “Patients with inoperable, locally recurrent, or metastatic anal cancer have historically faced poor 5-year survival rates and limited treatment options,” said Marwan Fakih, MD, of City of Hope in Duarte, California, in a statement from drugmaker Incyte. “This approval marks an important advancement as it makes a new treatment approach available for this challenging disease.”

From the public health and medical research front,

  • The Wall Street Journal tells us,
    • “Health and Human Services Secretary Robert F. Kennedy Jr. has made combating chronic diseasea rallying cry as he looks to overhaul the health department and “Make America Healthy Again.”
    • “So how healthy is America, historically? It isn’t that we used to be healthier, data show, but the biggest threats have changed.
    • “The deadliest scourges in the U.S. were once infectious, with influenza and tuberculosis topping the list at the start of the 20th century. Better sanitation and advances in antibiotics and vaccines muzzled them, transforming Americans’ well-being. Medical innovations and antismoking campaigns then spurred decades of progress against heart disease and cancer.
    • “But chronic diseases, persistent or long-lasting health conditions, are undermining that momentum, contributing to our stalled life expectancy over the past decade that trails behind that of other wealthy nations.
    • “Much of the gap in life expectancy is due to deaths among working-age adults, says Dr. Steven Woolf, a life-expectancy researcher at the Virginia Commonwealth University.
    • “Americans die earlier and are sicker than people in other high-income countries,” he said. “This has been true for a long time, and the trend is getting worse.”
  • Health Day informs us,
    • “More U.S. teenagers are getting weight-loss surgery, despite the discovery of new drugs like Ozempic/Wegovy that help people drop pounds surgery-free, a new study says.
    • “Weight loss surgeries for teens increased 15% between 2021 and 2023, researchers reported earlier this month in The Journal of Pediatrics.
    • “Further, much of the increase in weight-loss surgery is due to its increased popularity among Hispanic and Black teenagers, groups disproportionately affected by severe obesity compared to white teens, researchers said.
    • “The number of U.S. adolescents having access to this treatment that we know is safe and effective is the highest it’s ever been, and hopefully it’s the start of a positive weight loss journey that will get them to better health,” lead researcher Sarah Messiah, director of the Child and Adolescent Population Health Program at UT Southwestern Medical Center, said in a news release.”
  • Per Beckers Hospital Review,
    • “Adult patients taking Wegovy saw a reduced risk of experiencing a major adverse cardiovascular event within the first three months of treatment, according to a secondary analysis of the drug’s clinical trial data, presented May 12 at the European Congress on Obesity.”
  • Very good news from an NIH news release,
    • “A research team supported by the National Institutes of Health (NIH) has developed and safely delivered a personalized gene editing therapy to treat an infant with a life-threatening, incurable genetic disease. The infant, who was diagnosed with the rare condition carbamoyl phosphate synthetase 1 (CPS1) deficiency shortly after birth, has responded positively to the treatment. The process, from diagnosis to treatment, took only six months and marks the first time the technology has been successfully deployed to treat a human patient. The technology used in this study was developed using a platform that could be tweaked to treat a wide range of genetic disorders and opens the possibility of creating personalized treatments in other parts of the body.
    • “A team of researchers at the Children’s Hospital of Philadelphia (CHOP) and the Perelman School of Medicine at the University of Pennsylvania (Penn) developed the customized therapy using the gene-editing platform CRISPR. They corrected a specific gene mutation in the baby’s liver cells that led to the disorder. CRISPR is an advanced gene editing technology that enables precise changes to DNA inside living cells. This is the first known case of a personalized CRISPR-based medicine administered to a single patient and was carefully designed to target non-reproductive cells so changes would only affect the patient.
    • “As a platform, gene editing — built on reusable components and rapid customization — promises a new era of precision medicine for hundreds of rare diseases, bringing life-changing therapies to patients when timing matters most: Early, fast, and tailored to the individual,” said Joni L. Rutter, Ph.D., director of NIH’s National Center for Advancing Translational Sciences (NCATS).”
  • BioPharma Dive adds,
    • “We are still in very early days,” said Rebecca Ahrens-Nicklas, an assistant professor of pediatrics at the University of Pennsylvania and study author. Doctors will monitor KJ’s progress and are considering other ways to evaluate the therapy’s effects without a biopsy.
    • “Yet the findings could carry important implications for drug research. There are more than 7,000 rare diseases, many of which are so uncommon they’re unlikely to be profitable for any companies that develop treatments for them. Gene editing could be a powerful solution, but an expensive development path and slim sales prospects make such medicines tough investment propositions. A large number of biotechnology firms pursuing gene editing are struggling to survive.” 
  • Here is a link to the All of Us Research Project’s Medical Minutes.
  • Per MedPage Today,
    • “First-line treatment with nivolumab (Opdivo) and ipilimumab (Yervoy) significantly improved survival compared with lenvatinib (Lenvima) or sorafenib (Nexavar) for patients with unresectable hepatocellular carcinoma (HCC), the randomized phase III CheckMate 9DW trial showed.
    • “Of more than 600 patients, median overall survival (OS) was 23.7 months with the PD-1 inhibitor and CTLA-4 inhibitor combination versus 20.6 months with single-agent tyrosine kinase inhibitors (HR 0.79, 95% CI 0.65-0.96, P=0.018), reported Peter R. Galle, MD, of the University Medical Center in Mainz, Germany, and colleagues.
    • “Respective OS rates were 49% versus 39% at 24 months and 38% versus 24% at 36 months, they wrote in The Lancet.
    • “The overall survival rates “are the longest and highest reported for the approved systemic treatments in this setting,” wrote Galle and colleagues, adding that the results “support nivolumab plus ipilimumab as a first-line treatment” in unresectable HCC.
    • “Results of this trial led to the recent FDA approval of the combination as first-line treatment for adults with unresectable or metastatic HCC.”
  • Per Fierce Pharma,
    • “Merck’s Keytruda, with more than 40 approved indications, hasn’t yet been able to crack specifically into ovarian cancer. But with promising early results from a phase 3 study in certain patients, the checkpoint inhibitor may have found its place.
    • “At a pre-specified interim analysis of Merck’s phase 3 Keynote-B96 trial, which is testing Keytruda plus chemotherapy with or without Roche’s Avastin in patients with platinum-resistant recurrent ovarian cancer, the drug showed “statistically significant and clinically meaningful” improvements in progression-free survival regardless of patients’ PD-L1 status, Merck reported on Thursday.
    • “The trial compared the Keytruda regimen against placebo and chemotherapy, again with or without Avastin.”
  • HHS’s AHRQ released a systematic review finding
    • “No completed studies show if blood-based, multicancer screening tests help people compared with no screening or standard single-cancer screenings. We do not know if these tests save lives, reduce advanced cancers, or improve quality of life.
    • “We found 20 studies covering 109,177 people that tested how accurate 19 different multicancer screening tests were. Thirteen of these studies had serious flaws in how they were conducted.
    • “Accuracy varied widely based on:
      • “What the tests measured and how researchers analyzed it,
      • “How many and which types of cancers researchers tried to find,
      • “Which types of people were tested, and
      • “How the studies were designed.
    • “We graded the strength of evidence for accuracy as insufficient, meaning we cannot draw firm conclusions.
    • “We only found one study reporting on potential harms from multicancer screening tests. We graded the strength of evidence as insufficient for harms based on this single study.
    • “Studies that will be completed in the next 2 to 4 years may give more information about whether multicancer screening tests work and whether they have harms.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Higher patient volumes were not enough to keep CommonSpirit Health in the black during its latest quarter.
    • “Patient volumes soared across the country over the past couple of years due to a rebound in demand after the COVID-19 pandemic and overall population growth in fast-growing markets.
    • “The trend largely boosted net patient revenue and helped pad bottom lines for many health systems. Volume growth is one part of CommonSpirit’s strategy to improve operating performance.
    • “However, this year may bring a more complicated dynamic, given continued inflation, tariffs and federal funding uncertainty weighing on hospital finances.
    • “Chicago-based CommonSpirit recorded a $42 million net loss in its third quarter, compared with $282 million in net income a year ago, according to financial documents published Thursday. Results are not adjusted for the California provider fee program, which would add supplemental payments if approved by the Centers for Medicare and Medicaid Services.
    • “CommonSpirit said its financial results were impacted by expenses increasing at a faster rate than revenue, despite strong volumes, lower lengths of stay and higher productivity levels.”
  • Beckers Hospital Review lets us know,
    • “Texas Rural Hospital in Cleveland is set to reopen within the next week after it abruptly closed its doors the week of May 12 due to funding shortages, KIAH reported May 15. 
    • “The hospital’s lease agreement with Cleveland-based Emergency Hospital Systems, a community emergency hospital system, ended in March 2025. It then gained new ownership under HealCrest Network, a spokesperson for EHS said in a May 14 statement shared with Becker’s.
    • “Hospital employees told KIAH that they did not receive pay on May 9; however, the hospital said it plans to repay them in the coming days.”
  • and
    • [Another article shows] “the adjusted expenses per inpatient day in 2023 for nonprofit, for-profit, and government hospitals in every U.S. state, based on the latest estimates provided by Kaiser State Health Facts. 
    • “The figures are based on information from the 2023 American Hospital Association Annual Survey. They are an estimate of the expenses incurred in a day of inpatient care and have been adjusted upward to reflect an estimate of outpatient service volumes, according to the KFF. 
    • “The foundation notes the figures are “only an estimate of expenses incurred by the hospital” for one day of inpatient care and do not substitute actual charges or reimbursement for care provided.
    • “To see how expenses compare to one year prior, find 2022’s adjusted expenses per inpatient day here. 
      • National average
      • Nonprofit hospitals: $3,288
      • For-profit hospitals: $2,529
      • State/local government hospitals: $2,857
  • Per a press release,
    •  “Blue Cross and Blue Shield of Massachusetts, Inc. and Blue Cross and Blue Shield of Massachusetts HMO Blue, Inc. (together, Blue cross) today reported a combined after-tax first quarter net income of $37 million on revenue of $2.6 billion (1.4% net margin). These results reflect an operating and other loss of $9.8 million (-0.4% operating margin) and investment income of $46.8 million.
    • “The big story is that spending on medical and pharmacy services for our members remains elevated, at near historic highs,” said Chief Financial Officer Ruby Kam. “Two notable callouts in the first quarter involve higher spending due to the difficult flu season as well as the continued impact of high-cost GLP-1 medications.” Kam said the company projects operating and net losses for full-year 2025 and has implemented a comprehensive plan to improve its financial results. Last year, the company posted the worst operating loss in its 87-year history.
    • “Blue Cross is the leading private health plan in Massachusetts with 3 million members.”
  • Fierce Healthcare points out,
    • “Earlier this month, pharmacy chain Rite Aid filed bankruptcy for the second time in less than two years, revealing that it would seek buyers for its retail locations.
    • “In the Pacific Northwest, it’s garnering interest from pharmacy rival CVS Health, according to a report in Bloomberg. Rite Aid CEO Matthew Schroeder told employees on Thursday that CVS had made a bid on a large number of stores in Washington, Oregon and Idaho along with patient prescription data, according to a recording reviewed by the outlet.
    • “If a deal were to go through, it would give CVS greater reach in a region where its presence is currently smaller, per the article.
    • “Schroeder said that Rite Aid has also received bids on some of its assets from multiple other pharmacy groups, including Walgreens, Albertsons, Kroger and Giant Eagle, Bloomberg reported.”
  • Per an Institute for Clinical and Economic Research news release,
    • “Institute for Clinical and Economic Review Publishes Final Evidence Report on Treatment for Retinitis Pigmentosa. Independent appraisal committee voted that current evidence is adequate to demonstrate a net health benefit of sonpiretigene isteparvovec compared to usual care.”

Monday Report

David Ermer–ACA, CDC, Congress, COVID-19 vaccine, FDA, Medical / Rx research, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash
  • Roll Calls offers a summary of this week’s activities on Capitol Hill.
  • The Senate Majority Leader filed cloture today on Eric Ueland who is the President’s nominee for OMB Deputy Director. Mr. Ueland shared the stage with Mr. Kupor, the President’s nominee for OPM Director, at their Senate Homeland Security Committee confirmation hearing on April 3.
  • The American Hospital Association News tells us,
    • “The White House May 12 released an executive order to reduce prescription drug costs by allowing consumers to make direct purchases from drug manufacturers at “most favored nation” pricing, the lowest cost paid for the same medications in other countries. The order directs the Secretary of Health and Human Services to propose rules that impose most favored nation pricing and take other measures to reduce prescription drug costs.’ 
  • BioPharma Dive adds,
    • “In a press briefing on Monday, White House officials revealed key details in the order. HHS will communicate the most-favored-nation prices to drugmakers and establish a mechanism for selling them directly to consumers at that price. If companies don’t use those prices, a new figure would be set through negotiation or federal regulation.
    • “The White House will also ask the Food and Drug Administration to expand reimportation from countries with lower drug costs, officials said, though those requests would occur at a time of heightened tensions regarding global trade.
    • “The Department of Commerce and U.S. Trade Representative will additionally be instructed to take action against countries that keep their drug prices low, the officials added.”
  • The Wall Street Journal reports, “The pharmaceutical industry’s reaction to President Trump’s executive order on drug prices? It could have been worse.”
  • Per Fierce Healthcare,
    • “The Trump administration has issued new draft guidance for the third cycle of Medicare drug price negotiations.
    • “The proposals seek to boost transparency in the program and put a focus on negotiating for the drugs that come at the highest cost to Medicare. The agency is also aiming to avoid negative impacts from the negotiated prices on U.S.-based pharmaceutical innovation, according to an announcement.
    • “Under the guidance, drugs administered under Medicare Part B would be potentially included for the first time. The agency is looking for feedback in comments on how to manage access to the maximum fair price negotiated for Part B drugs.
    • “The guidance also outlines that CMS may choose to renegotiate the price for certain drugs already set for 2026 or 2027.”
  • Modern Healthcare tells us,
    • “A record 24.3 million people signed up for health insurance on federal and state-based marketplaces during the exchange open enrollment period for 2025.
    • “Fueled by enhanced subsidies enacted in 2021 and extended in 2022, the number blew past the record set a year ago by nearly 2.9 million — a 13% increase, the Centers for Medicare and Medicaid Services reported Monday. The more sizable tax credits will expire at the end of this year, barring a congressional renewal.”
  • The AHA New informs us,
    • “The AHA May 12 responded to the Office of Management and Budget’s April 11 request for information on regulatory relief, making 100 suggestions to the Trump administration to help reduce burden on hospitals and health systems. “The Trump administration has rightly pointed out that the health status of too many Americans does not reflect the greatness or wealth of our nation,” said AHA President and CEO Rick Pollack. “Excessive regulatory and administrative burdens are a key contributor, as they add unnecessary cost to the health care system, reduce patient access to care and stifle innovation.”  
    • “The AHA’s recommendations fall under four categories: billing, payment and other administrative requirements; quality and patient safety; telehealth; and workforce.”

From the judicial front,

  • On May 9 (although the FEHBlog did not find it until today), the Justice Department asked the U.S. District Court of the District of Columbia to hold the ERISA Industry Committee’s lawsuit challenging the legality of the 2024 federal mental health parity amendments in abeyance while the governing agencies decide whether to modify or rescind the amendments. Here is a Dropbox link to the motion. The government’s motion states in short:
    • “The Departments have informed undersigned counsel that they intend to reconsider the 2024 Rule at issue in this litigation, including whether to issue a notice of proposed rulemaking rescinding or modifying the regulation.” * * *
    • “The 2024 Rule has two applicability dates: plan years beginning on or after January 1, 2025, and plan years (in the individual market, policy years) beginning on or after January 1, 2026. On April 25, 2025, the Departments informed undersigned counsel that they intend to (1) issue a non-enforcement policy in the near future covering the portions of the 2024 Rule that are applicable for plan years beginning on or after January 1, 2025, and January 1, 2026, and (2) reexamine the Departments’ current MHPAEA enforcement program more broadly. To confer with Plaintiff about the requested stay, Defendants provided Plaintiff with a copy of the non-enforcement policy that they expect to publicly release memorializing their intention not to enforce the portions of the 2024 Rule that are applicable for plan years beginning on or after January 1, 2025, and January 1, 2026.” 
  • Today, the presiding Judge Timothy J. Kelly granted the motion and ordered the parties to file status reports every 90 days beginning August 7, 2025.

From the public health and medical research front,

  • STAT News lets us know,
    • “Health secretary Robert F. Kennedy Jr. and his lieutenants have sent multiple signals in recent weeks that they envisage a world in which far fewer people are urged to get Covid-19 shots each fall. They aren’t the first ones to suggest it.
    • “The Advisory Committee on Immunization Practices — the expert panel that has, until now, guided the nation’s vaccine policies — is already talking about changing policy in ways that would have this exact effect. A presentation from the group’s meeting last month suggests that, if they’re allowed to meet this summer, they’ll recommend annual shots for adults 65 and older, some younger adults with medical conditions that increase their risk of severe illness from Covid infection, including pregnant people, possibly health care workers, and some very young children. Read more from STAT’s Helen Branswell.”
  • MedPage Today points out,
    • [T]he mumps vaccine’s less-than-stellar performance is no secret. Infectious disease experts readily acknowledge that the mumps portion of the vaccine isn’t as good as the measles or rubella portions.
    • “We eliminated measles by 2000 and rubella by 2005, but we’ve never eliminated mumps,” Paul Offit, MD, of the Children’s Hospital of Philadelphia, told MedPage Today. “So it’s true that it’s not as good of a vaccine as those two.”
    • “Indeed, mumps cases occur every year, and there have been several “outbreak” years in the last two decades — but the CDC isn’t hiding that. It reports mumps cases on its website.
    • “And it doesn’t mean the baby should be thrown out with the bath water. In fact, the mumps vaccine “has dramatically reduced the incidence of mumps by about 99%,” since it was introduced in 1967, Offit said, highlighting the accompanying drop in incidence of acquired deafness.
    • “Mumps was the most common cause of acquired deafness in the U.S.,” Offit said. “Now, homes for the deaf have closed.”
    • “Mumps cases fell from more than 150,000 in 1968 to 357 in 2024, according to CDC data.”
  • and
  • Per BioPharma Dive,
    • “Safety concerns have spurred the Food and Drug Administration and Centers for Disease Control and Prevention to recommend suspending use of Valneva’s chikungunya vaccine in people at least 60 years of age.
    • “The recommendation announced Monday comes days after the European Medicines Agency temporarily suspended use of the vaccine, known as Ixchiq, in those over 65 pending an investigation. A committee advising the CDC previously suggested a precaution for use in a similar age group.
    • “The FDA and CDC have upheld recommendations for use in adults between 18 and 60 years of age, while the EMA still endorses the shot for individuals between 12 and 64.”
  • The American Medical Association lets us know what doctors wish their patient knew about cancer screenings and prevention.
  • Consumer Reports, writing in the Washington Post, discusses, “how to ease IBS symptoms. Irritable bowel syndrome affects 10 to 15 percent of U.S. adults. Dietary and other changes can help.”
  • Per Fierce Pharma,
    • “The HER2-targeted antibody-drug conjugate that Pfizer gained from its Seagen buyout has delivered positive results in a pivotal study among Chinese patients with newly diagnosed bladder cancer, a readout that bodes well for the New York pharma’s own global phase 3 trial.
    • “A combination of the HER2 agent, called disitamab vedotin, and Junshi Biosciences’ PD-1 inhibitor toripalimab outperformed chemotherapy at both delaying tumor progression and extending patients’ lives as a first-line treatment for HER2-expressing locally advanced or metastatic urothelial carcinoma, RemeGen said Monday.
    • “The results came from an interim analysis of a Chinese phase 3 trial coded RC48-C016, which has now met its two primary endpoints of progression-free survival and overall survival, according to RemeGen. The company said the improvements were statistically significant and clinically meaningful.”

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “Kaiser Permanente logged a 2.9% operating margin and 16.1% year-over-year jump in first-quarter operating revenues on the back of recent health system acquisitions through its Risant Health subsidiary, the Oakland, California-based integrated health system announced Friday.
    • “Year-over-year overall performance reflected a continued focus on affordability for members and customers and the addition of Risant Health revenues,” the system said.
    • “The topline results shared ahead of Kaiser’s required filings outline more than $31. 8 billion of operating revenues and $30.9 billion of operating expenses, both well above the $27.4 billion and $26.5 billion of Q1 2024.
    • “These translated to an operating income of $932 million for the quarter ended March 31, 2025, a slight decline from the prior year’s $935 million and 3.4% operating margin.”
  • Per Beckers Payer Issues,
    • On average, insurers pay 4.7% higher commercial prices to hospitals that are a part of their Medicare Advantage networks compared to those not in network, according to a study published May 8 in Health Services Research.
    • The study analyzed 5,654 insurer-hospital contracts across seven large insurers that offer both commercial (employer-sponsored and ACA) and MA health plans. The researchers used data from Turquoise Health, the American Hospital Association, and Clarivate, focusing on five commonly used services. 
    • “We compared inpatient negotiated commercial prices between insurers at the same hospital that do not include the hospital in their MA network and those that do,” the researchers wrote. “We used Poisson regression with hospital fixed effects, adjusting for insurer fixed effects and insurer-market covariates.” * * *
    • “We find suggestive evidence consistent with this ‘price-shifting’ hypothesis, where prices in the commercial market may be adjusted to secure agreement over MA networks. We find that insurers pay higher commercial prices to hospitals that are in their MA networks,” the researchers concluded.”
  • MedTech Dive notes,
    • “Roche Diagnostics will build a $550 million expansion to produce continuous glucose monitors at an Indianapolis facility. Roche will use the site to make its Accu-Chek Smartguide devices, which launched last year in Europe as the company’s first CGM.
    • “Our goal is to initiate production within three years, followed by preparing for future generations of that CGM solution,” Richeal Cline, head of global operations for Roche Diagnostics, said in a Monday press conference. 
    • “The Indianapolis site is Roche Diagnostics’ North American headquarters. It houses research and development, laboratories, manufacturing and other functions, and produces Roche’s Accu-Chek diabetes test strips. The facility is one of two global distribution hubs for the company.
    • “Roche will refurbish an existing building for the manufacturing space and may construct new buildings to meet future demand, Cline said.”
  • Beckers Hospital Review tells us,
    • “Walgreens is expanding its use of robotic micro fulfillment centers to handle prescription volume as part of a renewed push to streamline pharmacy operations and address staffing challenges, CNBC reported May 11.
    • “The company told the news outlet it plans to have its 11 automated facilities serve more than 5,000 stores by the end of 2025, up from 4,800 in February. 
    • ‘The centers, first introduced in 2021, use robots and conveyor systems to fill maintenance prescriptions for chronic conditions such as diabetes and high blood pressure. However, Walgreens had paused the expansion in 2023 to address performance issues and gather feedback from its stores. 
    • “The new expansion is aimed at reducing routine tasks for in-store pharmacy staff to free them up for more clinical work like vaccinations and health screenings, the report said.” 

Friday Report

David Ermer–CDC, Congress, COVID-19, FDA, Medical / Rx research, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC,

  • Govexec reports,
    • “The U.S. Postal Service confirmed on Friday it will name David Steiner, a long-time CEO of Waste Management and FedEx board member, to become the nation’s 76th postmaster general, handing the reins to the executive while the mailing agency continues to reel financially and is in the midst of major political and operational disruption. 
    • “Steiner will succeed former Postmaster General Louis DeJoy, who resigned amid pressure in March, and Doug Tulino, who is currently the acting USPS chief. The Postal Service’s board of governors hired an outside firm to conduct a search to replace DeJoy and made the selection as required by law, though The Washington Post, which first reported Steiner’s selection, said President Trump and his administration pushed for the hire. 
    • “Still, the postal board threw its full weight behind Steiner. 
    • “Dave is the right person to lead the Postal Service at this time to ensure this magnificent and historic organization thrives into the future,” said Amber McReynolds, the board’s chair and a President Biden appointee. “Dave is a highly regarded leader and executive with tremendous vision, experience and skill that can be applied to the long-term mission and business needs of the Postal Service. 
    • “Steiner, who is expected to take over his new role in July, called it an “incredible honor” to be named as postmaster general. While Trump has floated the possibility of removing the Postal Service’s independent status, Steiner committed to it. He also vowed to work closely with postal unions, industry associations, customers and policymakers.”
       
  • The FEHBlog took a peek at reginfo.gov this morning, and he noticed the following:
    • “Department of Labor
      “AGENCY: DOL-EBSA RIN: 1210-AC30 Status: Pending Review
      “TITLE:Transparency in Coverage
      “STAGE: Prerule Economically Significant: No
      “RECEIVED DATE: 05/02/2025 LEGAL DEADLINE: None”
    • The FEHBlog expects that this prerule ties in with paragraph 12 of the President’s April 15, 2025, executive order on drug costs:
      • “Sec. 12. Improving Transparency into Pharmacy Benefit Manager Fee Disclosure. Within 180 days of the date of this order, the Secretary of Labor shall propose regulations pursuant to section 408(b)(2)(B) of the Employee Retirement Income Security Act of 1974 to improve employer health plan fiduciary transparency into the direct and indirect compensation received by pharmacy benefit managers.”
    • Evidently, you can request an EO 12886 meeting at this pre-rule stage. https://www.reginfo.gov/public/do/eoDetails?rrid=937013
  • On Monday, May 12, the Trump Administration must answer ERIC’s challenge to the legality of the 2024 mental health parity rule changes.  The FEHBlog reviewed the PACER docket sheet this morning, and the government has not asked for more time to answer beyond May 12. The Administration could resolve the case by withdrawing the rule making.
  • Per Radiology Business,
    • “Sen. Roger Marshall, MD, R-Kan., introduced legislation on Wednesday to boost Medicare payments for radiologists and other physicians. 
    • “The lawmaker is proposing the ‘‘Medicare Patient Access and Practice Stabilization Act of 2025.’’ This comes after Rep. Greg Murphy, MD, R-N.C., in January introduced the same bill in the U.S. House, which has now gathered 167 co-sponsors. 
    • “Marshall—who practiced as an OB-GYN specialist for 25 years before joining Congress—had not issued a statement about the proposal as of late Thursday. His office did not immediately respond to a Radiology Business request for comment.
    • “Anders Gilberg, senior VP of government affairs for the Medical Group Management Association, touted the bill on social media May 7. He said the initial proposal is to increase Medicare physician reimbursement by 8.51% starting on June 1.”

In Food and Drug Administration news,

  • MedCity News reports,
    • “On Friday, a San Francisco-based startup received FDA approval for the first-ever at-home cervical cancer test.
    • “The company, named Teal Health, was founded in 2020 and has raised $23 million. The startup has developed an at-home cervical cancer screening kit, which seeks to give patients an alternative to the in-office pap smear. 
    • “Many women don’t get a pap smear, which is the standard screening method for cervical cancer — CDC guidelines say that women should be tested regularly from ages 21-65, yet only 1 in 4 women of screening age get screened. Not only do many women struggle to find access to this exam, but many patients find the pap test to be uncomfortable and invasive.”
    • The article explains the at-home testing process.
    • “The startup is preparing to launch in California first, and it is already in network with Aetna, Cigna, UnitedHealthcare and Anthem Blue Cross Blue Shield, [CEO and founder Kara] Egan stated.
    • “We’re also in conversations with several large national payers to get this covered nationally. For us, the goal is to make sure it’s affordable for women,” she declared.
    • “She said Teal plans to start shipping tests to patients’ homes sometime next month.”
  • Per a National Institutes of Health news release,
    • “Today, the U.S. Food and Drug Administration (FDA) and the National Institutes of Health (NIH) announced a new, joint innovative research initiative that will serve as a key element in fulfilling U.S. Department of Health and Human Services Secretary Robert F. Kennedy, Jr.’s commitment to Make America Healthy Again. With diet-related chronic diseases continually rising, it is imperative that the FDA and NIH work in lockstep to invest in gold standard science, prioritize a better understanding of the root causes to end the diet-related chronic disease crisis and safeguard the health of America’s children.
    • “Under the new Nutrition Regulatory Science Program, the FDA and NIH will implement and accelerate a comprehensive nutrition research agenda that will provide critical information to inform effective food and nutrition policy actions to help make Americans’ food and diets healthier. The initiative will aim to answer questions such as:
      • “How and why can ultra-processed foods harm people’s health?
      • “How might certain food additives affect metabolic health and possibly contribute to chronic disease?
      • “What is the role of maternal and infant dietary exposures on health outcomes across the lifespan, including autoimmune diseases?
    • “Answering these questions and many others will enable effective policy development and help promote the radical transparency Americans deserve about the foods they are eating and how those foods can impact their health.”
  • To that end, an HHS news release announced that the FDA “granted three new color additive petitions that will expand the palette of available colors from natural sources for manufacturers to safely use in food.”
  • STAT News tells us,
    • “The FDA has granted accelerated approval to Verastem’s combination treatment for ovarian cancer. It licensed and has paired two drugs — avutometinib, an MEK inhibitor first developed by Roche subsidiary Chugai Pharmaceutical, with defactinib, an adhesion kinase blocker developed by Pfizer. The approval is for adults with a recurrent KRAS-mutated form of the disease who have already received systemic therapy.
    • “The approval of the treatment, called Avmapki Fakzynja, is based on a study of 57 pre-treated patients who showed a 44% overall response rate, with responses lasting up to 31 months. The company is also testing this combination in Phase 1/2 trial in patients with front-line metastatic pancreatic cancer.”

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.
    • “Vaccination
      • “New research finding: In the first RSV season with widespread availability of RSV prevention products (maternal vaccine and nirsevimab), RSV-associated hospitalization rates among infants were lower than in prepandemic seasons. A report released in the May 8, 2025, MMWR demonstrated that in 2024–25, RSV hospitalization rates were 45-52% lower in infants younger than 3 months old and 28-43% lower in infants younger than 8 months old compared to 2018-2020 seasons before product introduction.”
  • The University of Minnesota’s CIDRAP adds,
    • “A 2024-25 flu season that has been classified as high severity has now reached low transmission levels, but 10 new flu-related deaths in children bring the season’s total to 226, the most since 2009-10, when 288 pediatric deaths were recorded, according to the latest FluView update today from the Centers for Disease Control and Prevention (CDC).”
  • and
    • “In a weekly update today, the US Centers for Disease Control and Prevention (CDC) reported 66 more measles cases, pushing the national total to 1,001 and in just over 4 months keeps the nation on track to pass the 2019 total, which marked the nation’s worst year since the disease was declared to be eliminated in 2000.
    • “The steady rise in cases is fueled by multiple outbreaks, with two more reported this week. The CDC is tracking 14 outbreaks that are responsible for 93% of cases.
    • “The Texas Department of State Health Services (TDSHS) today reported 7 more cases since its last update on May 6, lifting the state’s total to 709 confirmed patients, of whom 679 (96%) were unvaccinated or had an unknown vaccination status. The number of affected counties remained at 29, and most cases are in Gaines County, the outbreak’s epicenter.
    • “Five more hospitalizations were reported, putting that total at 92. The number of deaths remained at two.”
  • BioPharma Dive informs us,
    • “Pittsburgh-based pharmaceutical firm Viatris on Thursday said a pain drug it’s been developing succeeded in two large clinical trials, setting the stage for an approval filing later this year.
    • “The drug is a reformulated version of an old medication, meloxicam, designed to more quickly treat the sharp, “acute” pain felt after an injury or operation.”

From the U.S. business healthcare front,

  • Fierce Healthcare reports,
    • “The American Medical Association (AMA) has announced John Whyte, M.D., as its new CEO and executive vice president, effective July 1.
    • “Whyte, a practitioner and author with experience at government agencies and private sector medical media outlets, will be taking over for James Madara, M.D. The outbound executive had shared plans to end his 14-year run last June.
    • “Unlike the physician association’s president and president-elect titles, which are voted on by membership for single-year terms, the CEO position is appointed by the AMA’s board of trustees for an open-ended tenure. They are tasked with overseeing the organization’s day-to-day operations.”
  • and
    • “Artificial intelligence assistants could ease the transition to value-based care for primary care practices, a new report by Phyx Primary Care found. 
    • “VBC can be administratively burdensome due to its enhanced reporting requirements. Primary care practices report that the transition to VBC is often long and results in a mix of VBC and fee-for-service billing practices. 
    • “In a study of 120 physicians who had used an AI scribe for 30 days or more, providers reported a 40% reduction in clinical review time for complex patients and a 32% decrease in physician burnout. The study was conducted by Phyx Primary Care, a nonprofit innovation lab that evaluates emerging technologies and evolving payment models.” 
  • Healthcare Dive relates,
    • “HCA Healthcare, Tenet Healthcare, Universal Health Services and Community Health Systems all posted financial results that beat Wall Street expectations for the first quarter of 2025. 
    • “Still, the health systems are maintaining their full-year outlooks as they exit the first quarter, despite most systems growing their revenue.” 
  • Per a press release,
    • Blue Cross Blue Shield of Massachusetts (“Blue Cross”) today announced a new virtual-first primary care option designed to support members’ health when and where they need it. CloseKnit, which provides virtual and in-person access to primary care, is now available to most Blue Cross members. This comes at a critical time as Massachusetts continues to face a primary care physician shortage.
    • As part of their agreement, CloseKnit is participating in Blue Cross’ value-based payment program and provides members with convenient and timely access to primary care.
    • Here is a link to CloseKnit’s website.

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.”