Thursday Report

CDC

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.”

Midweek Report

David Ermer–CDC, CMS, Congress, FDA, Generative AI, HSA, Medical / Rx research, Mental health care, Obesity, Rx coverage, U.S. Healthcare–
Photo by Joshua Hoehne on Unsplash

From Washington, DC,

  • Govexec tells us,
    • Rep. Gerry Connolly, D-Va., died Wednesday morning after a battle with esophageal cancer. He was 75 years old.
    • Connolly is leaving behind a legacy as a legislator who fought for the federal workforce, government contractors and the economic development of his home region of Northern Virginia.
    • In April, Connolly announced he would not seek re-election in 2026 and would step down from his post as the ranking member of the House Oversight Committee. He first announced his diagnosis in November, shortly after easily winning a ninth term to the House.
  • RIP, Congressman.
  • The Wall Street Journal reports,
    • “House Republicans made a series of last-minute changes to their sprawling tax-and-spending bill, searching for a path that could unite the party’s warring wings headed into a nail-biter floor vote expected early Thursday.
    • “New language to assuage conservatives would accelerate new Medicaid work requirements to December 2026 from 2029 and end certain tax credits for wind energy and solar energy by 2028 instead of a slower phaseout through 2031. The updates would also formally lock in a $40,000 cap on the state and local tax deduction starting this year, up from a $30,000 cap in the prior plan; that change was designed to satisfy Republicans from high-tax states such as New York and New Jersey. 
    • “Lawmakers from states such as Florida and Texas that haven’t expanded Medicaid under Obamacare would get a favorable change to a funding formula, and border states would get $12 billion for security costs incurred during the Biden administration. An indoor-tanning excise tax that was eliminated in the original bill text would be maintained and a nuclear-energy tax break would be expanded. Federal land swaps in Nevada and Utah would be eliminated. Gun-rights supporters won changes to the tax treatment of suppressors. 
    • “The revised legislation advanced in an initial vote in the early hours of Thursday morning, with all Republicans except one in favor, and all Democrats opposed.” * * *
    • “I believe we are going to land this airplane,” Johnson said during a hectic day of legislating that saw the House Rules Committee start a hearing at 1 a.m. and continue past sunset. He is trying to finish the bill in the House before Memorial Day; it would then go to the Senate, and Republicans are aiming to get it to Trump’s desk by July 4.” 
  • Per the New York Times,
    • “The House early Thursday narrowly passed a wide-ranging bill to deliver President Trump’s domestic agenda, after Speaker Mike Johnson put down several mini-rebellions in Republican ranks to muscle the legislation to its first major victory over unified Democratic opposition.
    • “The early morning vote was 215 to 214, mostly along party lines.”
  • Fierce Healthcare adds,
    • “We have a tiny sliver that really matters to employers and working families,” said James Gelfand, president and CEO of The ERISA Industry Committee, a group representing large employers. “But I can say those provisions are monumental to us.”
    • “There’s a laundry list of items Gelfand and others are happy the bill, in its current form, includes.
    • “Employer-offered worksite clinics with free or discounted primary care services would now be available to employees on high-deductible health plans (HDHPs), even if they already have an HSA.” * * *
    • “Other changes allow HSA funds to be spent on gym memberships, increases the HSA contribution limit for some individuals, classifies bronze and catastrophic plans as a HDHP that can pair with an HSA and permits one spouse to contribute to an HSA even if the other spouse has a flexible spending account.” * * *
    • “The bill [further codifies a rule from 2019 creating the [ICHRA] program and lets employees use pretax dollars through a cafeteria plan to pay for on-exchange marketplace premiums, explains the KFF.
  • and
    • “A bipartisan bill aiming to reform prior authorization has been reintroduced in the Senate.
    • “The Improving Seniors’ Timely Access to Care Act seeks to streamline the prior auth process in Medicare Advantage (MA), which would ease administrative burdens on providers and reduce delays in accessing care for patients.
    • “The bill is co-sponsored by Sens. Roger Marshall, R-Kan., and Mark Warner, D-Va., and is supported by dozens of senators on both sides of the aisle. A version of the legislation in the House is also backed by a bipartisan group.”
  • Per an CMS news release,
    • “Today, the Centers for Medicare & Medicaid Services (CMS) announced a significant expansion of its auditing efforts for Medicare Advantage (MA) plans. Beginning immediately, CMS will audit all eligible MA contracts for each payment year in all newly initiated audits and invest additional resources to expedite the completion of audits for payment years 2018 through 2024.”
  • The American Hospital Association News informs us,
    • “The Administration for Strategic Preparedness and Response today released a bulletin on workplace violence in health care that includes recommendations for strengthening security protocols, enhancing emergency preparedness, supporting workforce mental health and promoting information sharing.”

From the Food and Drug Administration front,

  • BioPharma Dive points out,
    • “After discussions with the Food and Drug Administration, Moderna on Wednesday said it has voluntarily withdrawn its application for a combination COVID-19 and influenza shot in adults aged 50 years and older.
    • “The biotechnology company said it plans to resubmit its candidate later this year after it gathers data from an ongoing Phase 3 trial of a standalone seasonal influenza vaccine it’s developing. Earlier this month, Moderna had told investors the FDA would require efficacy data from this trial before considering approval of the combo vaccine.
    • “Moderna’s confirmation comes one day after the FDA announced new rules for COVID vaccine approvals, for which it will now require placebo-controlled studies for any clearance in healthy adults under 65 years old.”
  • and
    • “Expert advisers to the Food and Drug Administration on Tuesday backed Johnson & Johnson’s Darzalex for people with an asymptomatic form of multiple myeloma that often progresses into more severe blood cancer.
    • “Members of the Oncologic Drugs Advisory Committee voted 6-2 that the benefits of Darzalex’s use in high-risk smoldering multiple myeloma outweighed its risks. However, panelists wrestled with some controversial aspects of the Phase 3 trial J&J is using to ask for an expanded approval. Namely, FDA staff had flagged the trial’s inclusion of patients that could be classified as having a lower risk of progression, as well as an unclear survival benefit following disease progression.
    • “The FDA isn’t required to follow the advice of its outside expert panels but usually does.”
  • MedTech Dive adds,
    • “Teal Health published data Monday from a trial of its cervical cancer screening sample self-collection device in JAMA Network Open.
    • “The paper describes a trial of 599 people who both self-collected samples and underwent standard clinician collection. Self-collection correctly identified 95.2% of the positive samples.
    • “Teal won Food and Drug Administration approval for the self-collection device in early May, setting the company up to start shipping the product to customers in June.”
  • The New York Times provides helpful background information about the Alzheimer’s Disease blood test that the FDA approved for marketing last week.
    • “The test, manufactured by Fujirebio Diagnostics, is intended to be used only by specialists in Alzheimer’s, the F.D.A. said. Its mouthful of a name — Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio — describes what the test measures: levels of two proteins, amyloid and tau, that are hallmarks of Alzheimer’s disease.
    • “In people who develop Alzheimer’s, amyloid begins to accumulate and form plaques in the brain more than 20 years before any symptoms of cognitive impairment. Tau accumulates later, forming tangles in the brain, and is much more closely correlated with cognitive decline.” * * *
    • “The F.D.A., and Alzheimer’s experts, emphasized that the blood test should be given only to people who are already experiencing cognitive decline and are ages 55 and older. Moreover, it should not be used on its own to diagnose or to rule out Alzheimer’s.”

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “Biden’s cancer diagnosis has sparked a debate over prostate-cancer screening guidelines.
    • “Increased diagnoses of later-stage cancers are suspected to be linked to changing screening guidance.
    • “Some prostate-cancer specialists said that there has also been a shift in how they manage lower-risk prostate cancer.”
  • Per STAT News,
    • “In what researchers hope could be a case of 1 + 1 = 3, new research suggests that combining a model to predict 10-year cardiovascular risk with an imaging test of coronary arteries could be better than either method alone at identifying people in danger of their first heart attack.
    • “The model is PREVENT, which computes a risk score based on measures familiar from the primary care office: blood pressure, cholesterol levels, kidney function, age, and BMI, as well as questions about type 2 diabetes, smoking, and social determinants of health. The imaging test is a CT scan that detects calcium buildup in arteries leading to the heart. High amounts of calcium, alone and inside fatty plaques, can lead to blockages and heart attacks.” * * *
    • “It’s not always clear who should be screened for coronary calcium; thus, we decided to see if the PREVENT score could be used in this novel manner,” Morgan Grams of New York University’s Grossman School of Medicine told STAT. She is an author of the study published Wednesday in the Journal of the American Heart Association. “Once we determined that it could, we assessed whether the coronary calcium score could add information to PREVENT in the prediction of incident cardiovascular disease. It did.”
       
  • Per a National Institute of Health news release,
    • Research teams funded by the National Institutes of Health (NIH) have created a versatile set of gene delivery systems that can reach different neural cell types in the human brain and spinal cord with exceptional accuracy. These delivery systems are a significant step toward future precise gene therapy to the brain that could safely control errant brain activity with high precision. In contrast, current therapies for brain disorders mostly treat only symptoms.
    • The new delivery systems carry genetic material into the brain and spinal cord for targeted use by specific cell types. This platform has the potential to transform how scientists can study neural circuits. It provides researchers with gene delivery systems for various species used in research, without the need for genetically modified, or transgenic, animals. Examples include illuminating fine structures of brain cells with fluorescent proteins and activating or silencing circuits that control behavior and cognition.
    • “Imagine this new platform as a delivery truck dropping off specialized genetic packages in specific cell neighborhoods in the brain and spinal cord,” said John Ngai, Director of the NIH’s Brain Research Through Advancing Innovative Neurotechnologies® Initiative, or The BRAIN Initiative®. “With these delivery systems, we can now access and manipulate specific cells in the brain and spinal cord – access that was not possible before at this scale.”
  • Healio notes,
    • “Increased dietary fiber was associated with reduced likelihood of stroke, especially small-vessel stroke, in addition to reduced all-cause mortality and improved poststroke survival, researchers reported.
    • “Data on the link between daily dietary fiber intake and odds of stroke and adverse stroke outcomes were published in Stroke.”

From the U.S. healthcare business front,

  • The Wall Street Journal lets us know,
    • “Sanofi will acquire Vigil Neuroscience for $470M, potentially reaching $600M with milestone payments.
    • “The deal centers on neurology, adding VG-3927, an Alzheimer’s treatment, to Sanofi’s pipeline.
    • “Vigil’s VGL101 molecule will return to Amgen before the Sanofi acquisition closes in Q3.”
  • Fierce Healthcare reports,
    • “Digital physical therapy company Hinge Health priced its IPO at $32 per share on Wednesday, at the top of the company’s expected price range.
    • “The company said it raised $437 million by selling 13,666,000 million shares of its Class A common stock, according to a press release issued Wednesday. Hinge Health said it sold 8.5 million shares and 5.1 million shares are being sold by existing shareholders.
    • “Hinge Health will begin trading tomorrow morning on the New York Stock Exchange under the ticker symbol “HNGE.” The offering is expected to close May 23.”
  • Fierce Pharma relates,
    • “Cigna’s Evernorth is rolling out a new pharmacy benefit management program that caps members’ monthly cost for key GLP-1 drugs.
    • “Evernorth said in an announcement that through its Express Scripts arm it negotiated directly with the manufacturers for Wegovy and Zepbound—Novo Nordisk and Eli Lilly, respectively—to cap patients’ monthly costs at $200. The company said this could save as much as $3,600 per year compared to savings patients receive through direct-to-consumer discount programs.
    • “Evernorth added that the costs will contribute toward a patient’s deductible as well.
  • CNBC adds, “Evernorth’s new weight loss pricing program will begin in the second half of the year, as employers begin to make decisions about coverage for next year’s plans.”
  • Per STAT News,
    • “Five years after launching, a unique nonprofit drug company has published data showing that consumers and health plans saved considerable money on a generic cancer medicine thanks to its “transparent” pricing model. And it maintains that the findings validate plans to distribute and — eventually — manufacture still more copycat medicines for the U.S. market.
    • “The company — CivicaScript — was created as a vehicle to combat stubbornly high drug prices even after dominant brand-name medicines lost patent protection and generic competitors entered the market. Backed mostly by 18 Blue Cross Blue Shield plans, the nonprofit made its first drug available — a generic version of the Zytiga prostate cancer treatment — in August 2022.
    • “The initial wholesale price was $160, plus an $11 dispensing fee paid to pharmacies, but uptake was slow until it was accepted by pharmacy benefit managers and other health plans. But eventually, the gambit worked: Between September 2023 and December 2023, patients saved 64% and payers saved 92% by purchasing the generic distributed by CivicaScript, according to a new analysis.”
  • Beckers Payer Issues offers the view of eleven payer “leaders to learn what’s overhyped in healthcare.” 

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.”

Monday Report

David Ermer–CDC, Congress, Federal employment benefits, Medical / Rx research, Obesity, Rx coverage, U.S. Healthcare, Uncategorized–
Photo by Sven Read on Unsplash

From Washington, DC

  • Roll Call reports,
    • “House Budget Committee Republicans advanced a sweeping reconciliation bill Sunday night, but for the GOP, the internal debate is far from over. * * *
    • “Rep. Chip Roy, R-Texas, one of four conservative Budget Committee members who agreed to vote “present” Sunday to allow the House to move forward with the bill designed to implement Trump’s policy agenda, said in a statement, “the bill does not yet meet the moment.”
    • “The Rules Committee is scheduled to convene at 1 a.m. Wednesday to set the ground rules for floor debate on the measure after releasing an updated committee print version of the legislative text overnight.
    • “Among the newest changes is the removal of a provision opposed by Rep. Michael R. Turner, R-Ohio, that would force federal agency employees, lawmakers and congressional staff to contribute more of their salaries to their pension plans. The effective dates of two other pension-related provisions would be delayed to 2028.”
    • “Roy said provisions related to curbing spending enacted under President Joe Biden, especially for environmental and energy programs, needed to see further cuts. He also criticized the bill’s Medicaid language.
    • “Roy said in a statement that the bill “fails to end the Medicaid money laundering scam and perverse funding structure that provides seven times more federal dollars for each dollar of state spending for the able-bodied relative to the vulnerable. This all ultimately increases the likelihood of continuing deficits and non-Obamacare-expansion states like Texas expanding in the future,” Roy said in a statement.”
  • STAT News adds,
    • “Although moderate and conservative Republicans disagree over some Medicaid policies that have been considered, both groups support imposing work requirements on adults without kids or disabilities. For that reason, the bill leaned hard on that policy by applying work requirements on beneficiaries up to the age of 64, instead of 55. Those people would keep Medicaid if, twice a year, they document that they’re working at least 80 hours a month. They could also maintain coverage if they perform community service or are enrolled in educational programs.
    • “Those work requirements would take effect in 2029, and conservatives are demanding they start next year.” 
  • Here is a link to a House Budget Committee document that identifies the changes that the Committee approved last night.

From the public health and medical research front,

  • Blue Cross FEP offers a healthcare checklist for women of all ages on LinkedIn.
  • The American Medical Association tells us “what doctors wish patients knew about getting a cesarean section.”
  • The New York Times reports
    • “Men are taller than women, by an average of about five inches. But why? It’s not a genetic inevitability — there are many species in the tree of life where females outclass males.
    • “A new study, published on Monday in the Proceedings of the National Academy of Sciences that involved genetic data from a million people, has found a partial explanation.
    • “It involves a gene called SHOX, which is known to be associated with height. SHOX is present on both the X chromosome — females have two X chromosomes — and the Y chromosome; males have one X and one Y.”
  • Per Medscape,
    • “An oral obesity treatment (SYNT-101) that mimics the metabolic effects of gastric bypass established preliminary safety, tolerability, and efficacy in a first-in-human study.”
  • and
    • “An online obesity clinic named Embla was associated with weight loss like that seen in randomized controlled trials (RCTs) of semaglutide, but with less than half of the semaglutide dose, according to new real-world data.
    • “Average weight loss reached 16.7% after 64 weeks’ use of the digital health platform, which combines tailored semaglutide dosing with intensive behavioral therapy delivered via an app. In clinical trials of semaglutide, the dose was 2.4 mg/wk, but patients in the present study used an average of 1 mg/wk. Similar mean weight loss was observed across baseline body mass index (BMI) classes and with all medication doses.
    • “This [study] showed us that combining an intensive behavioral intervention within an e-health weight management clinic can reproduce some of the results we see in confirmatory trials but in the context of a real-world cohort and with far less medication used,” said lead researcher Henrik Gudbergsen, MD, chief medical officer at Embla and general practitioner.
    • “The intensive behavioral therapy is key, and it goes a long way when you want to lose weight,” Gudbergsen added. He presented the findings at European Congress on Obesity (ECO) 2025. Publication of the study in The Lancet Digital Health is pending, but a preprint version is available.”
  • MedPage Today informs us, “Health officials are making a renewed call for vigilance against bird flu, but some experts are puzzling over why reports of new human cases have stopped.” * * *
    • During a call with U.S. doctors this month one CDC official noted that there is a seasonality to bird flu: Cases peak in the fall and early winter, possibly due to the migration patterns of wild birds that are primary spreaders of the virus.
    • That could mean the U.S. is experiencing a natural — maybe temporary — decline in cases.” * * *
    • “The CDC characterizes the risk to the general public as low, although it is higher for people who work with cattle and poultry or who are in contact with wild birds.
    • “Earlier this month, an agency assessment said there is a “moderate risk” that currently circulating strains of bird flu could cause a future pandemic, but the CDC stressed that other emerging forms of bird flu have been similarly labeled in the past.
    • “Still, research is continuing.”
  • Advice from GoodRx
    • Over the last few years, many artificial tear products have been recalled over safety concerns. These recalls have included products from Global Pharma Healthcare, Kilitch Healthcare India, and Brassica Pharma. Most recently, eye drops made by BRS Analytical Service, LLC have been recalled.
    • Recalled artificial tear eye drops, gels, and ointments had previously been sold in retail stores, such as CVS and Walmart, and online. Before using or buying artificial tears, check the most recent recall list to see if your product is affected.
    • Contact your healthcare team right away if you’ve used artificial tears and notice vision changes or eye infection symptoms.

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Regeneron Pharmaceuticals, a biotechnology company with a long history of large-scale genetics research, plans to buy DNA testing firm 23andMe out of bankruptcy, announcing Monday it was named the successful bidder in a court-run auction.
    • “Regeneron’s offer, which is still subject to court and regulatory approvals, is a bet it can do what 23andMe couldn’t and mine the troves of genetics data the testing firm collects to discover new drug targets. Regeneron plans to continue 23andMe’s consumer genome services without interruption — a task made easier by its decade of experience sequencing the DNA of millions of people through its genetics center. * * *
    • “Under the proposed deal, Regeneron will pay $256 million to acquire “substantially all” of 23andMe’s assets, including its personal genome service, health and research service and biobank. It will also offer jobs to all of the employees at those business units.
    • “The purchase would not include the telehealth business Lemonaid Health, which 23andMe will wind down.
    • “Regeneron expects the deal will close in the third quarter, assuming it obtains all the necessary approvals. An ombudsman appointed by the bankruptcy court will review the transaction to assess how it might affect the privacy of individuals who previously used 23andMe to sequence their genome. A report from that review is due to the court by June 10, and a hearing is set for June 17.”
  • Fierce Pharma informs us,
    • “With $27 billion earmarked to expand its U.S. production footprint starting this year, Eli Lilly is busy scouting out potential sites for new drug ingredients plants.
    • “Eli Lilly is jockeying for a tax break in Texas as it weighs whether to build a $5.9 billion active pharmaceutical ingredient (API) manufacturing facility in Houston, according to a recent filing (PDF) with the state.
    • “Should the proposal move forward, Lilly plans to purchase roughly 236 acres at Houston’s Generation Park from the commercial development’s owner, McCord Development. The final project would comprise multiple buildings and outdoor facilities, plus infrastructure buildout and equipment installation, according to the filing.
    • “Assuming Lilly settles in Houston, the drugmaker expects the new plant will employ 604 full-time staffers upon ramp-up completion. The company would look to hire operations technicians and production specialists, as well as a mix of roles across maintenance, quality control, engineering, administration and management functions.”
  • Per Fierce Healthcare,
    • “Vertical consolidation in healthcare has been a hot-button topic of late as regulators eye strategies to bring down healthcare costs.
    • “But do these massive “payvider” firms do more harm than good? The jury is still out, according to a panel of experts hosted by the Brookings Institution. The panelists highlighted both the risks of vertical integration between payers and providers as well as the potential positives of these relationships.”
  • and
    • “A new study suggests “upcoding” practices are growing across outpatient service lines.
    • “The report, compiled by researchers at Trilliant Health, found that the share of visits that were coded at higher intensities grew in emergency care, urgent care and physician office visits between 2018 and 2023. For example, the number of emergency department visits coded as 99284, or level four of five total, grew from 32.5% to 39.6% in the study window.
    • “Providers use standard CPT codes for outpatient visits, ranging from level one to level five, to indicate the intensity of services offered and the amount of time clinicians spent with a patient.
    • “The study similarly found an increase in urgent care visits coded at level four, with the share growing from 34% to 40.6% between 2018 and 2023. For physician office visits, the share of those coded at level four increased from 38.5% to 45%.
    • “In tandem, the study found a decline in the number of patient visits coded at lower intensity. For urgent care, the share of visits coded at level one decreased from 9.5% to 2.9% by 2023.”
  • Beckers Hospital Review lets us know,
    • “U.S. hospitals and health systems in many regions are seeing a sharp rise in uncompensated care, with new data showing big increases in bad debt and charity care deductions during the first quarter of 2025.
    • “Disruptions in health insurance coverage can drive increases in bad debt and charity care deductions for U.S. hospitals and health systems. According to the latest data from Q1 2025, health systems across the country already experienced significant increases in bad debt and charity deductions in recent years,” noted Strata in its “Healthcare Performance Trends: Q1 2025” report.”

Friday Report

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

From Washington, DC,

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

From the FDA front,

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

From the judicial front,

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

From the public health and medical research front.

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

From the U.S. healthcare business front,

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

Wednesday Report

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

From Washington, DC,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Tuesday Report

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

From Washington, DC,

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

From the judicial front,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

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.”