FEHBlog

Friday Report

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

From Washington, DC,

  • Federal News Network tells us,
    • “Agencies will not be able to fill or create any federal jobs for another three months, after President Donald Trump extended the current federal hiring freeze until July 15.
    • “But even after the hiring freeze lifts later this summer, agencies will still be limited in how many new employees they can hire, and how many new positions they can create. The White House said it will cap agencies to one new hire for every four federal employees who leave the civil service.”
    • Here’s a fact sheet on the hiring freeze extension.
  • Fierce Healthcare adds,
    • “President Donald Trump and the Office of Personnel Management (OPM) are moving forward with “Schedule F,” a policy to make it easier to remove workers from federal agencies like the Department of Health and Human Services (HHS), Fierce Healthcare has confirmed.
    • “Implementing Schedule F will deprive 50,000 federal employees of civil service protections by classifying them as “at-will” workers. Once a final rule is issued, another executive order will be released to directly move positions under the final rule’s authority.
    • “The OPM’s proposed rule will give authority to the government to cut workers over performance that does not align with the administration’s priorities without procedural delays.”
    • The proposed rule appeared in the Federal Register’s public inspection list today. The proposed rule will be published in the Federal Register on April 23, 2025.

In Food and Drug Administration news,

  • BioPharma Dive informs us,
    • “The Food and Drug Administration will aim to limit the participation of industry experts in the advisory committees that the agency consults for some regulatory decisions, Martin Makary, the FDA’s new commissioner, announced Thursday.
    • “Advisory committees, which the FDA typically convenes for additional input on high-profile reviews or thorny clinical and regulatory issues, regularly include an industry representative alongside a dozen or so independent experts.
    • “These representatives don’t vote on questions put to the committee. They are meant to share the perspective of their industry broadly, rather than of the specific company that employs them. There are also usually patient or consumer representatives on the panels.
    • “Now, when not explicitly required by statute, the FDA will restrict industry representatives from taking part as a committee member.”
  • Per Fierce Pharma,
    • “On its way to generating sales of $14 billion in just its seventh full year on the market, Sanofi and Regeneron’s Dupixent has experienced few setbacks. One came in 2023, however, when the FDA rejected the immunosuppressant as a treatment for chronic spontaneous urticaria (CSU), asking for more data.
    • “Eighteen months later—and backed by more conclusive results—the companies have convinced the U.S. regulator to sign off on Dupixent for the difficult-to-treat skin condition. With the nod, Dupixent becomes the first new medicine for CSU in more than a decade. 
    • “The approval clears Dupixent to be used by those age 12 and older who remain symptomatic despite using histamine-1 (H1) antihistamines. It’s a population of more than 300,000 among the roughly 3 million in the U.S. who have CSU, the companies said in a release.”
  • Per Medscape,
    • “The US Food and Drug Administration (FDA) has granted marketing authorization to CT-132 (Click Therapeutics), an adjunctive, first-in-class prescription digital therapeutic for the preventive treatment of episodic migraine in adults, its development company announced in a statement.
    • “The mobile smartphone app uses biological, psychologic, and behavioral approaches to target pain processing and includes such tools as an eDiary tracker and short daily lessons. It is intended for use alongside other acute and preventive treatments for migraine. 
    • “The marketing authorization, which was reviewed through the FDA’s de novo pathway for medical devices, is based on results from two recent clinical trials: the phase 3 ReMMi-D trial and the ReMMiD-C bridging study. As reported by Medscape Medical News, the findings were presented at the recent American Academy of Neurology (AAN) 2025 Annual Meeting.”

From the public health and medical research front,

  • The Center for Disease Control and Prevention announced today,
    • “Seasonal influenza activity continues to decline. COVID-19 and RSV activity are declining nationally to low levels.
    • “COVID-19
      • “COVID-19 activity continues to decline nationally. Wastewater levels are at low levels, emergency department visits are at very low levels, and laboratory percent positivity is stable.
      • “Additional information about current COVID-19 activity can be found at: CDC COVID Data Tracker: Home
    • “Influenza
    • RSV
      • “RSV activity continues to decline in most areas of the country.
    • Vaccination
      • “Vaccination coverage with influenza and COVID-19 vaccines is low among U.S. adults and children. Vaccination coverage with RSV vaccines remains low among U.S. adults.”
  • The University of Minnesota CIDRAP adds,
    • “The CDC confirmed 10 new pediatric flu deaths, bringing the season’s total to 198. This compares with 207 deaths last flu season. Nine of the new deaths were from influenza A and 1 from influenza B. Of the 8 influenza A cases for which scientists performed subtyping, 5 were caused by the H1N1 strain, and 3 were H3N2.”
  • The American Hospital Association (AHA) News tells us,
    • “The Centers for Disease Control and Prevention April 18 announced there have been 800 reported cases of measles across the country this year. Twenty-four states have reported cases and there have been 10 outbreaks. Most cases (94%) have been outbreak-associated. 
    • “Texas, which has the largest outbreak of any state, April reported a total of 597 cases. Michigan also reported an outbreak yesterday — the state’s first since 2019 — with three cases. CDC data shows that 11% of all cases have been hospitalized. The vaccination status of 96% of all cases is classified as “unvaccinated or unknown.”
  • The New York Times adds,
    • “As the United States struggles to contain a resurgence of measles that has swept through swaths of the Southwest, neighboring countries are responding to their own outbreaks.
    • “Canada has reported more than 730 cases this year, making this one of the worst measles outbreaks in the country since it declared the virus “eliminated” in 1998. Mexico has seen at least 360 measles cases and one death, most of them in the northern state of Chihuahua, according to Mexican health authorities.
    • “Many of the communities grappling with measles have large Mennonite populations that public health officials have linked to outbreaks. The multinational resurgence has concerned epidemiologists, who fear that simultaneous outbreaks near the U.S. border will make it more difficult to contain the virus.
    • “It’s just a line on the map that separates them — we share air, we share space,” said Lisa Lee, an epidemiologist at Virginia Tech.”
  • Medscape lets us know,
    • “Five classic risk factors for cardiovascular disease — high blood pressure, high cholesterol, obesity, diabetes, and smoking — at age 50 can reduce life expectancy by more than 10 years. This is the conclusion of an international study led by German researchers and presented at the 2025 American College of Cardiology Scientific Session.
    • “These five factors account for approximately 50% of the global burden of cardiovascular diseases. Our central question was how many additional years of life are possible if these factors are absent or modified in middle age,” said Christina Magnussen, MD, PhD, deputy director of the Department of Cardiology at the University Medical Center Hamburg-Eppendorf, Hamburg, Germany, during her presentation in Chicago.
    • “The findings, also published in The New England Journal of Medicine, show that lifestyle changes and risk management in middle age can make a significant difference. Lowering blood pressure and quitting smoking had the most significant impacts.”
  • Diagnostic Imaging points out,
    • “Emerging research suggests that prior mammography screening within five years of breast cancer diagnosis for seniors significantly reduces the risks of later-stage diagnosis and breast cancer-specific mortality.
    • “For the study, recently published in JAMA Network Open, researchers reviewed data from the Surveillance, Epidemiology, and End Results (SEER)-Medicare database for 13,028 women who had screening mammography-detected breast cancer. Over 77 percent of the cohort had at least one mammography screening in a five-year period prior to diagnosis and over 69 percent were in their 70s, according to the study. The researchers also noted that over 29 percent were diagnosed with later-stage (T2+ or N1+) disease.
    • “Multivariable analysis revealed that women having at least one mammography screening in the five years prior to diagnosis had a 54 percent lower risk of a later-stage presentation at diagnosis. The study authors found that these women also had a 36 percent lower risk of breast cancer-specific death.”
  • Per HealthDay,
    • “People might think they can reduce their risk of cancer by occasionally swapping their cigarettes for a vape pen — but they would be wrong, a new study says.
    • “So-called “dual users” — folks who both smoke and vape – are exposed to the same levels of nicotine and cancer-causing toxins as those who only smoke cigarettes, researchers reported in the journal Nicotine and Tobacco Research.”
  • Per the AHA News,
    • “A study published April 17 by JAMA Otolaryngology Head and Neck Surgery found that up to 32% of dementia cases from 2011-2019 could be attributed to hearing loss confirmed through testing. Self-reported hearing loss was not associated with higher dementia risk.”

From the U.S. healthcare business front,

  • CBS News reports,
    • “Blue Cross Blue Shield of Massachusetts says it will soon stop covering popular drugs for weight loss, like Ozempic and Wegovy.
    • “The medications have skyrocketed in price and popularity, but they’re now being blamed for crippling budgets in the public and private sector. As one of the fastest growing classes of medications, GLP-1 weight-loss drugs were originally brought on the market to treat diabetes. But their secondary use as a way for users to suppress diets and slim down sent sales through the roof. 
    • “Blue Cross announced Thursday that starting on January 1, 2026, standard coverage plans will not cover GLP-1s for weight loss. The company will continue to cover patients who are using the drugs for diabetes treatment. 
    • “Studies suggest nearly 1 in 8 people have used GLP-1s as the drugs become more common. That’s given drug companies the reason to increase prices.” 
  • FEHB premiums continue to reverberate from OPM’s sudden decision in January 2023 to require all FEHB plans to cover GLP-1 drugs for obesity. Traditionally, OPM announces a mandate in the call letter for benefit proposals and allows the carrier to raise its premiums in advance of the mandate. OPM should stick with tradition and in any event curb its mandate habit. The FEHBlog wonders whether Lilly’s GLP-1 pill will reduce overall costs on obesity drugs.
  • Modern Healthcare relates,
    • Hospitals are zeroing in on alternative care models to improve the nursing work experience and patient outcomes while lowering costs.
    • Eight in 10 nurse leaders are piloting new care models in their organizations, ranging from virtual nursing to home health, according to a recent study by healthcare solutions company Wolters Kluwer.
  • Per an ICER news release,
    • “This week, ICER released a Draft Evidence Report assessing the comparative clinical effectiveness and value of tolebrutinib (Sanofi) for the treatment of secondary progressive multiple sclerosis (SPMS).
    • “This preliminary draft marks the midpoint of ICER’s eight-month process of assessing this treatment, and the findings within this document should not be interpreted to be ICER’s final conclusions. The report will be open to public comment until May 13th. Click here for information on submitting a public comment.“
  • Per Beckers Hospital Review,
    • “Several large health systems reported operating losses in 2024, underscoring ongoing financial strain despite rising patient volumes and revenue growth. While inpatient revenue is climbing, expense pressures, cybersecurity disruptions and shifting care dynamics continue to weigh on margins — leaving even some of the nation’s largest systems in the red.
    • “In February, average hospital operating margins fell to 2.5%, down from 3.4% in January, according to Kaufman Hall’s latest “National Hospital Flash Report.” Despite the dip, margins remained above 2024’s year-to-date average, suggesting that while performance has improved compared to recent years, financial stability remains fragile.
    • “In the early months of 2025, volumes remain strong across the board,” Erik Swanson, managing director and data and analytics group leader at Kaufman Hall, said in an April 8 report.  “Emergency visits are rising, which is leading to challenges with ED boarding for many organizations. Data also show that inpatient revenue is growing while outpatient revenue has slowed, which points to the rapid growth in outpatient care in the last few years reaching its peak.”
    • The article describes the results for 11 health systems.

Thursday Report

David Ermer–Electronic health records, FDA, Government Contracting, NCQA, Obesity, Rx coverage, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC

  • Yesterday, the President signed an executive order titled “Ensuring Commercial, Cost-Effective Solutions in Federal Contracts.” Here are links to a fact sheet and a Govexec commentary titled “The President’s procurement order offers a real opportunity. Let’s not squander it.” Amen to that sentiment.
  • STAT News notes regarding the President’s April 15 executive order on lowering drug costs,
    • There also is no specific mention of the rebate rule from Trump’s first term that attempted to eliminate the safe harbor for rebates in anti-kickback law for Medicare Part D and Medicare Advantage. The goal was to force insurers to pass rebates to patients directly, instead of using them to lower premiums or provide other benefits. However, the order calls for re-evaluating the role of drug middlemen known as pharmacy benefits managers.
    • [Former Sen. Wyden stafer Anna] Kaltenboech said there is less need to eliminate rebates when Medicare negotiation lowers the list price from which rebates are negotiated. 
  • Healthcare Dive relates,
    • “Surescripts’ data exchange has been designated a Qualified Health Information Network under the federal government’s health information sharing framework, the e-prescribing giant said Tuesday. 
    • “As a QHIN, Surescripts will be able to transfer health data through the Trusted Exchange Framework and Common Agreement, or TEFCA, a framework created by the HHS’ Assistant Secretary for Technology Policy to facilitate the exchange of health records among providers, patients, payers and public health agencies. 
    • “Surescripts’ addition brings the total number of QHINs to nine, according to the Sequoia Project, the recognized coordinating entity that oversees TEFCA.”
  • NCQA released its policy recommendations to the Trump Administration on April 15, 2025.
    • The fragmented U.S. health care system makes it challenging for people to navigate treatment and receive high-quality care. Advancements in quality measurement, care integration and interoperability are essential for creating a more efficient and accountable health care system.
    • NCQA developed recommendations for the Trump administration in three core areas.
      • Implementation of value-based care models that prioritize care integration.
      • A strong digital health infrastructure that facilitates seamless data exchange, promotes adoption of digital quality measures and maximizes the full potential of interoperable health care data.
      • Integration of behavioral and physical care and removal of barriers to behavioral health and substance-use disorder treatment.

From the public health and medical research front,

  • The Wall Street Journal reports,
    • The first GLP-1 weight-loss pill is a step closer to hitting the market.
    • Eli Lilly said its experimental pill met its goals in a pivotal study, helping diabetes patients lower blood sugar—and even reduce weight, bringing an oral version of the booming class of drugs closer to patients seeking to lose weight.
    • Physicians and patients have been hoping for pill versions of popular GLP-1s for weight loss. Approved versions are all given by injection, and a pill would be a more convenient option. 
    • “It really gives us an opportunity to reach many more patients than you can reach with an injectable,” said Jeffrey Emmick, senior vice president of product development at Lilly Cardiometabolic Health. * * *
    • “Thursday’s results are the first from several studies of the daily pill, called orforglipron, expected this year from Lilly in patients with Type 2 diabetes and obesity.” * * * 
    • “The orforglipron results showed the drug worked safely in adults with Type 2 diabetes compared with subjects who received a placebo after 40 weeks, according to Lilly. Orforglipron showed promising safety and efficacy results consistent with current injectable GLP-1 drugs on the market, Lilly said. 
    • “The study measured weight loss as a secondary goal. The drug reduced weight by an average of 16 pounds, or 7.9%, at the highest dose, without reaching a weight plateau at the time the study ended, Lilly said. The most common side effects were gastrointestinal-related and were generally mild to moderate in severity, Lilly said. 
    • “Late-stage study results evaluating orforglipron in obese patients are expected later this year. 
    • “Lilly expects to submit the drug for approval from global regulatory agencies for weight loss by the end of this year, and for Type 2 diabetes treatment next year.”
  • The American Journal of Managed Care tells us,
    • “Healthy dietary patterns reduce GI cancer risk and mortality, while unhealthy patterns increase risk, particularly for colorectal and liver cancers.
    • “PCA-derived dietary patterns show stronger associations with GI cancer risk than RRR-derived patterns, despite some methodological limitations.
    • “High intake of fruits, vegetables, whole grains, and legumes may improve survival post-GI cancer diagnosis due to their protective properties.
    • “Further research is needed on specific cancer biomarkers and dietary changes post-diagnosis to better understand diet’s role in cancer prevention.”
  • Per Health Day,
    • “Long brisk walks might lower a person’s risk for heart rhythm problems, a new study says.
    • “Folks who stride faster than 4 miles per hour have a 43% lower risk of developing an abnormal heart rhythm, compared with those who amble at a pace of less than 3 miles an hour, researchers reported April 15 in the journal Heart.
    • “The time spent walking also influenced risk, with people who spent more time at an average or brisk pace enjoying a 27% lower risk of heart rhythm problems, researchers said.”
  • and
    • “An experimental blood test might be able to help doctors predict whether someone will recover their mobility following a spinal cord injury.
    • “The test looks for fragments of spinal cord DNA floating freely in a person’s blood, researchers recently reported in the Journal of Clinical Investigation.
    • “Higher levels of this DNA is associated with more severe spinal cord injuries that cause paralysis, researchers found.
    • “If you have a spinal cord injury, your main question is simple: Am I going to walk again?” lead researcher Dr. Tej Azad, neurosurgery chief resident at Johns Hopkins University School of Medicine, said in a news release.
    • “With the new blood test, we are trying to bring a precision medicine framework to spinal cord injury with something that tells you about injury severity and can hopefully predict neurological recovery,” he continued.”
  • The Wall Street Journal offers an essay on eating disorder which is worth a gander.

From the U.S. healthcare business front,

  • Healthcare Dive informs us,
    • “UnitedHealth underperformed earnings and revenue expectations in the first quarter and lowered its earnings guidance for the full year, two signs of waning performance that analysts said were uncharacteristic of the healthcare behemoth.
    • “The company’s first quarter problems were centered in two segments: its insurance division UnitedHealthcare, which has struggled to control heightened costs in Medicare Advantage and saw utilization spike even higher in the quarter; and its care delivery unit Optum Health, which saw patient profitability fall and was hit hard by policy changes enacted by the Biden administration.
    • “UnitedHealth executives said both trends were addressable over the course of the year. Still, the Minnetonka, Minnesota-based healthcare giant slashed its 2025 outlook for adjusted earnings per share to between $26 and $26.50, almost 12% below the company’s original guide.”
  • Modern Healthcare adds,
    • “Elevance Health will beat its earnings guidance for the first quarter despite high Medicare Advantage costs, the company announced Thursday.
    • “The health insurer reported that while Medicare Advantage spending was elevated during the period, it fell within the range the company anticipated. Elevance Health affirmed its guidance in a filing to the Securities and Exchange Commission after leading Medicare Advantage carrier UnitedHealth Group disclosed it underperformed in the first quarter, triggering a sell-off of health insurance stocks.”
  • Healthcare Dive notes,
    • “Cone Health has purchased the remaining ownership of HealthTeam Advantage from Novant Health, leaving Cone the sole owner of the Medicare Advantage payer.
    • “HealthTeam Advantage has 22,000 members across six MA plans in North Carolina. The ownership change shouldn’t affect their coverage or provider networks, Brendan Hodges, HealthTeam Advantage’s CEO, said in a statement.
    • “Financial terms of the deal were not disclosed.”
  • Fierce Healthcare lets us know,
    • “The tortoise (Eli Lilly) has caught the hare (Novo Nordisk), according to a report from BMO Capital Markets, which cites the superior commercial and clinical portfolios of the Indianapolis company compared to those of its Danish rival.
    • “In pronouncing the change of the guard, BMO has downgraded Novo’s shares from “outperform” to “market perform.” Translation: The analysts are advising investors to hold Novo shares rather than buying more of them.
    • “The report comes as Lilly and Novo remain the two fastest-growing large pharmaceutical companies, based largely on booming sales of their diabetes and obesity products. With their surges over the last few years, Lilly and Novo have become the drugmakers with the largest market caps in the U.S. and Europe, respectively, with Lilly’s value nearly twice that of second-place Johnson & Johnson.”
  • and
    • “Twenty-six rural hospitals have banded together to form the Ohio High Value Network (OHVN), a clinically integrated network that will serve more than 2.5 million patients.
    • “The network announced Thursday morning is an effort to coordinate care, share operational best practices, reduce contracting costs and lighten member hospitals’ administrative burdens.
    • “The member hospitals are spread across 37 of Ohio’s counties, with an additional hospital in bordering West Virginia. The group said in a release it “is in discussions” with other rural Ohio hospitals that are interested in joining.” 
  • KFF shares “10 Things to Know About Rural Hospitals.”

Midweek Report

David Ermer–CDC, CMS, Medical / Rx research, Medicare, Mental health care, Rx coverage, U.S. Healthcare–
Photo by Thought Catalog on Unsplash

From Atlanta, Georgia

  • MedPage Today brings us news from the April 15-16 ACIP meeting,
    • “Last June, CDC’s Advisory Committee on Immunization Practices (ACIP) unanimously recommended that all adults ages ≥75 years and adults ages 60 to 74 years who are at increased risk of severe RSV disease receive a single dose of RSV vaccine; the committee did not endorse one vaccine over another. That vote supplanted the committee’s earlier recommendation that adults ages 60 and older may receive RSV vaccination “after engaging in shared clinical decision making with their healthcare provider.”
    • Today, “[t]he ACIP voted 14-0, with one abstention, on Wednesday to recommend that high-risk patients ages 50 to 59 be vaccinated for respiratory syncytial virus (RSV) and also added a new option for meningococcal vaccination.
    • “I don’t think I can say it enough, but [we need] more studies in moderate-to-severe immunocompromised patients who are at highest risk for RSV disease,” ACIP member Mini Kamboj, MD, of Weill Cornell Medical College, in New York City, said after she voted for the recommendation. This is “a call to action,” she said.”
  • and
    • “The CDC’s vaccine advisors [also] are considering options that would narrow the recommendations for the fall COVID vaccine to only include groups at higher risk for severe illness.
    • Seasonal COVID shots are currently recommended for everyone 6 months and older, but CDC’s Lakshmi Panagiotakopoulos, MD, MPH, presented findings from a recent poll of the ACIP COVID-19 Work Group showing that 76% of its members supported a non-universal (risk-based) recommendation for the 2025-2026 respiratory virus season.
  • and
    • At its meeting on Tuesday, the [ACIP] considered whether the U.S. should move to single-dose human papillomavirus (HPV) vaccination instead of the currently recommended schedule.
    • At present, the U.S. recommends two doses of HPV vaccine if they are started before age 15, and three doses if they are started at age 15 or older, and for people who are immunocompromised. Routine vaccination starts at age 11 or 12 — though it can be started at age 9 — while catch-up vaccination is recommended through age 26. Shared clinical decision making is advised for those 27 to 45.
    • “However, global HPV vaccination schedules have shifted in recent years, with the World Health Organization recommending in 2022 a two-dose schedule for those 9 and older, with an option for a one-dose schedule for those between 9 and 20. The U.K. and Australia have adopted this schedule, too.”
  • and
    • “The number of cases reported in the ongoing measles outbreak in the southwestern U.S. is likely an undercount, according to the CDC scientist leading the response to the outbreak.
    • “We do believe there’s quite a large amount of cases that are not reported,” David Sugerman, MD, CDC’s senior scientist for the 2025 measles response, said during the Advisory Committee on Immunization Practices meeting on Tuesday.”

From the judicial front,

  • Federal News Network tells us,
    • “A federal judge on Tuesday issued a preliminary injunction that prevents the U.S. Department of Labor from requiring government contractors and grant recipients to certify they do not operate any diversity, equity and inclusion programs that run afoul of anti-discrimination laws until further order from the court.
    • “Judge Matthew Kennelly of the U.S. District Court for the Northern District of Illinois issued the ruling in response to a lawsuit filed by Chicago Women in Trades, a nonprofit dedicated to training and retaining women in skilled construction trades that receives several grants from the Department of Labor.
    • “The certification provision is a key part of President Donald Trump’s executive orders aimed at curbing DEI programs because contractors and grant recipients could be subjected to crippling financial penalties under the False Claims Act if they are found in violation of it.” * * *
    • “Kennelly had already issued a temporary restraining order against the Labor Department last month that was shorter in duration. His order is limited in scope because he declined to extend the injunction to other federal agencies beyond DOL.”
  • The American Hospital News informs us,
    • “A Minnesota state court April 15 dismissed a lawsuit filed by PhRMA challenging the state’s law protecting 340B pricing for contract pharmacy arrangements. The court ruled that the state law is not preempted by federal law, does not engage in unconstitutional extraterritorial regulation and that the law does not violate Minnesota’s Single Subject and Title Clause.
    • “The AHA filed an amicus brief in the case last year and filed others in similar cases for multiple states, in defense of those states’ 340B contract pharmacy laws.”
  • Beckers Payer Issues reports,
    • “CMS has denied an appeal from Humana to raise its 2025-star ratings, the company disclosed in an April 15 court filing. 
    • “Humana saw its Medicare Advantage star ratings drop significantly from 2024 to 2025, which will hurt the company’s 2026 revenues. Star ratings determine the bonuses CMS pays to MA plans. 
    • “Humana filed its lawsuit in October 2024 challenging the ratings in federal district court in Texas.”
  • In September 2019, WHYY, a Philadelphia PBS news outlet, reported
    • “Seventeen local defendants, including five medical professionals, are among those ensnared in a coordinated health care fraud enforcement action across Pennsylvania, New Jersey, New York, Connecticut and Washington, D.C., involving more than $800 million in loss and the distribution of over 3.25 million opioid pills in so-called pill mill clinics, the U.S. Justice Department said Thursday.”
    • A Justice Department press release states that on April 15, 2025, “a federal jury convicted a medical doctor [who was one of the medical professionals ensnared in September 2019], for his participation in conspiracies to commit health care fraud and wire fraud and to unlawfully distribute controlled substances.” Those crimes impacted FEHB plans, among other health plans.
  • Govexec points out,
    • As federal employees continue to face widespread layoffs, unions and advocacy groups on Wednesday launched a network to provide legal advice to government workers. 
    • The goal of the Rise Up: Federal Workers Legal Defense Network is to recruit attorneys to provide individual guidance to federal employees who fear losing their jobs or have already lost them. 
    • “Our network is already fighting back against illegal firings and other abuse of federal workers, but thousands of federal workers still need legal advice and representation,” according to the coalition’s website. “That means we need thousands of lawyers to help.” * * *
    • Federal employees can request legal assistance here.

In State government news,

  • STAT News reports,
    • “Arkansas Gov. Sarah Sanders has signed a first-in-the-nation law (HB 1150) that prohibits pharmacy benefit managers from operating both retail and mail-order pharmacies, a move designed to eliminate a conflict of interest that has been blamed for boosting the price of medicines and forcing independent pharmacies to close.
    • “At issue is an ongoing concern that the largest pharmacy benefit managers — which are controlled by CVS Health, Cigna, and UnitedHealth Group — favor their own pharmacy operations. Critics say that by doing so, these companies not only dominate the design of health plans for tens of millions of Americans but also distort the distribution and pricing for prescription medicines.” * * *
    • “The Arkansas bill has gone further than other states. The legislation would force the owners of the pharmacy benefit managers to make a choice — continue operating these industry middlemen or relinquish the right to run retail or mail-order pharmacies that operate in the state. By doing so, state lawmakers have argued they will reduce costs for state residents.”
  • KARK, a Little Rock television station, adds,
    • “CVS Health welcomes a good faith discussion with policy makers in Arkansas and across the country on ways to make medicine more affordable and accessible,” CVS shared in a statement. “Unfortunately, HB1150 is bad policy that accomplishes just the opposite: it will take away access to pharmacy care in local communities, hike prescription drug spending across the state by millions of dollars each year, and cost hundreds of Arkansans their jobs.”
    • “According to CVS, they have 23 pharmacies across the state. They also noted that this law will close more than 100 mail-order pharmacies in Arkansas.”

From the public health and medical research front,

  • Per BioPharma Dive, “New research kindles excitement around stem cell therapies for Parkinson’s Disease. Two studies published in Nature found stem cell-derived products can not only be safely transplanted into the brain but also show promising — albeit unproven — signs of efficacy.”
  • The National Academy of Sciences announced,
    • Oral health is an essential part of overall health, but issues around insurance coverage, workforce, and more, are leaving millions of Americans without sufficient oral health care. The @NASEM Health and Medicine Division hosted a workshop in November 2024 to address some of the barriers to care. Read a recap of the event here: https://tinyurl.com/5epd9rcs
  • Per MedCity News,
    • “Drugs have been the standard migraine treatment for decades. The severe headaches, nausea, and other problems associated with this common disorder now have a digital treatment option, a mobile app developed by prescription digital medicines startup Click Therapeutics.
    • “The FDA marketing authorization announced Tuesday permits use of the Click digital therapeutic for the prevention of episodic migraine in patients age 18 and older. Episodic migraine is defined as having fewer than 15 headache days per month. The Click migraine app, known in development as CT-132, does not replace migraine drugs. The FDA authorization covers use of the app as an adjunct to standard migraine treatments, which is how it was evaluated in clinical trials.
    • “Click’s research is based on mapping of the entire brain. The company has found faulty brain circuits implicated in many diseases, Chief Medical Officer Shaheen Lakan said in a 2023 interview. For various indications, the New York-based startup develops software that takes users through a series of tasks that have the effect of retraining and rewiring the brain over the course of weeks.”
  • Per Cancer Network
    • The incidence of pancreatic and colorectal adenocarcinoma has increased among young adults, highlighting a need for heightened awareness of this trend when evaluating younger patients with possible symptoms, according to findings from a retrospective cohort study published in JAMA Network Open.1
    • Findings from the trial revealed that a total of 275,273 patients with pancreatic adenocarcinoma were reported between 2000 and 2021, 51.8% of whom were male and 87.1% of whom were 55 years or older. An overall increasing incidence trend was noted, with the highest annual percentage change (APC) observed in those aged 15 to 34 years (4.35%; 95% CI, 2.03%-6.73%). The APC for the aforementioned age group was significantly higher than in those 55 years or older (1.74%; 95% CI, 1.59%-1.89%; P = .007) and those aged 35 to 54 years (1.54%; 95% CI, 1.18%-1.90%; P = .004).
  • Medscape lets us know,
    • “Can long-term physical activity influence mortality and biological aging? Researchers at the University of Jyväskylä in Jyväskylä, Finland, set out to answer this question and uncovered a surprising finding: Moderate physical activity had the most significant positive effect on longevity, reducing mortality by 7% over a 30-year period.
    • “Interestingly, higher levels of physical activity did not confer additional mortality benefits. The study was published in the European Journal of Epidemiology.”

From the U.S. healthcare business front,

  • Beckers Payer Issues tells us why “patient expectations will push healthcare to evolve by 2030, according to 21 payer executives.” 
  • Fierce Healthcare informs us,
    • “The Peterson Center on Healthcare released a new report that recommends policymakers narrow payment guidelines for a service they think could rocket spending in the public sector. 
    • “The costs of remote monitoring on Medicare have grown significantly in the years since the codes became available to providers, from $6.8 million in 2019 to $194.5 million in 2023. The services can be used for a host of chronic conditions that many Americans suffer from, including diabetes, hypertension and heart disease. 
    • “The Peterson Center takes issue with the increasing number of Medicare, Medicaid and Medicare Advantage patients who have been prescribed remote monitoring and the increasing amount of time their providers keep them using the technology. 
    • The report finds that chronic conditions only benefit from intense monitoring by providers for a short period of time, which varies by condition. Without additional guardrails, the report says public spending on remote monitoring could increase dramatically.
    • Under the current requirements for remote monitoring, CMS does not dictate which conditions should be monitored or for how long. Because CMS currently does not limit the amount of time that a provider can charge Medicare, Peterson calls them “forever codes.” 
    • The codes have only been in existence since 2019, but Peterson recommends policymakers steer providers towards high-value services and away from ongoing monitoring with no discernible clinical benefit.
  • Healthcare Dive notes,
    • “Ascension Health has inked a definitive agreement to acquire full ownership of a Texas hospital and its ancillary businesses from Community Health Systems for $460 million, the health system said Tuesday.
    • “Ascension Seton, a subsidiary of Ascension Texas, will purchase the remaining 80% stake in 126-bed Cedar Park Regional Medical Center. Although the system already owned a minority interest in Cedar Park, Ascension said acquiring full ownership would represent a “significant step” toward expanding medical services and care access in the Central Texas community.
    • “The deal is expected to close this summer, subject to regulatory approvals.
  • Per Modern Healthcare,
    • “The Permanente Medical Group and Northwest Permanente said Wednesday they have formed an affiliation.
    • “The medical groups will remain separate but will collaborate clinically and share innovations as part of the agreement. The groups will work together on telehealth, population health and workforce wellness, in addition to pursuing more subspecialty partnerships and scaling IT initiatives, a spokesperson said.” * * *
    • “The Permanente Medical Group and Northwest Permanente are independent, physician-led groups that partner with the Kaiser Foundation Health Plan to serve patients in Oregon, Washington and California. The Permanente Medical Group has nearly 10,000 physicians across 116 specialties, while Northwest Permanente has more than 1,300 physicians across 54 specialties. The groups collectively care for 5.2 million members.”
  • and
    • “Abbott Laboratories will make new investments in U.S. manufacturing, with the impact of tariffs on medical devices and diagnostics looming over the industry.
    • “It expects to spend $500 million on two facilities, located in Illinois and Texas, Abbott said in a statement Wednesday. The investments are to expand existing plants and boost U.S. research and development, a spokesperson said. The company will hire as many as 200 people in Illinois and as many as 100 people in Texas to support the work.”
  • Beckers Clinical Leadership relates,
    • “Mark Cuban’s latest move to disrupt the pharmaceutical supply chain is expanding — this time, tackling the injectable drug market through a new partnership with distributor Morris & Dickson.
    • “His company, Mark Cuban Cost Plus Drug Co., is partnering with Morris & Dickson, a full-line and specialty pharmaceutical distributor, to improve access to injectables nationwide. 
    • “The collaboration, announced April 14, aims to mitigate drug shortages, streamline procurement and provide equitable access to providers of all sizes. It also promotes sourcing flexibility by removing volume commitments, according to a news release.”

Tuesday Report

David Ermer–AHRQ, CDC, Congress, FDA, Generative AI, Medical / Rx research, Mental health care, NIH, Obesity, Telehealth, U.S. Healthcare–

From Washington, DC,

  • Bloomberg Law reports,
    • “President Donald Trump wants Congress to change a policy that gives certain drugs longer protection from drug price negotiations in Medicare, a fix that could address one of the drug industry’s top complaints with the Biden-era law.
    • “Trump directed his health secretary to work with lawmakers to end the differential treatment for small molecule drugs, typically pills, that face Medicare price negotiations sooner that more complex biologic medications.
    • “The directive came in an executive order Trump signed at the White House Tuesday. The order was light on specifics and included a grab-bag of other health policy goals.”
  • Modern Healthcare adds
    • “A bipartisan group of state attorneys general wants Congress to pass legislation that would break up healthcare conglomerates such as UnitedHealth Group, CVS Health and Cigna.
    • “Under the auspices of the National Association of Attorneys General, more than three dozen officials wrote congressional leaders on Monday asking them to ban companies from owning both pharmacy benefit managers and pharmacies, citing anticompetitive effects of consolidation in the healthcare system.”
    • Here is a link to that letter.
  • Fierce Pharma tells us,
    • “A two-day meeting of the Advisory Committee on Immunization Practices (ACIP), which was originally scheduled for February but was postponed by new HHS Secretary Robert F. Kennedy Jr., is underway today [April 15] in Atlanta and will conclude with panel votes on several vaccines on Wednesday afternoon.
    • “The independent advisers, who meet three times a year to inform vaccine policies in the U.S., today will discuss (PDF) the effectiveness of vaccines that defend against COVID-19, Mpox, chikungunya, HPV, cytomegalovirus (CMV) and the flu.
    • “The last item on Tuesday’s agenda will be an update on the U.S. measles outbreak. On Friday, the Centers for Disease Control and Prevention (CDC) reported 712 cases in more than 20 states, with the most concentrated spread underway in West Texas.”
  • Per a Senate news release,
    • “Sen. Chuck Grassley (R-Iowa), a member of the Senate Agriculture Committee and a lifelong family farmer, joined Sens. Pete Ricketts (R-Neb.) and Deb Fischer (R-Neb.), along with Reps. Randy Feenstra (R-Iowa) and Mark Alford (R-Mo.), in a letter urging the Make America Healthy Again (MAHA) Commission to use sound science and risk-based analysis in its policy decisions, particularly on crop protection tools and food-grade ingredients.
    • The letter was sent to Health and Human Services (HHS) Secretary Robert F. Kennedy Jr, Department of Agriculture (USDA) Secretary Brooke Rollins and Environmental Protection Agency (EPA) Administrator Lee Zeldin.
      • “We write to express our strong appreciation for your leadership and interest in working with each of you to ensure America has the healthiest people in the world. In recent decades, chronic illness rates have risen. This warrants our careful scrutiny to support better health outcomes. It is essential that policies supported by sound science and risk-based analyses are used to accomplish this goal,” the lawmakers wrote.
      • “We have concerns that environmentalists are advancing harmful health, economic, or food security policies under the guise of human health. Despite insinuations to the contrary, regular testing by FDA and USDA finds that more than 99% of all pesticide residues meet extremely conservative limits established by EPA according to the best available science,” they continued.”
    • Here’s a link to the letter.

From the judicial front,

  • Bloomberg Law tells us,
    • “The Central States, Southeast and Southwest Areas Health and Welfare Fund and participant Charles A. Whobrey sued Arkansas Insurance Commissioner Alan McClain April 11, arguing a law requiring health plans to report pharmacy cost data and pay pharmacies a minimum amount violates the Employee Retirement Income Security Act. 
    • “The multiemployer benefit plan serves 500,000 people via local chapters of the International Brotherhood of Teamsters.
    • “It’s the latest in a broader legal fight over states’ attempts to regulate pharmacy benefit managers, which oversee the prescription drug benefit for health plans. The US Supreme Court is weighing whether to accept a case challenging an Oklahoma law regulating pharmacy benefit managers after determining that ERISA did not preempt a separate Arkansas PBM law in 2020.” * * *
    • “The case is Central States, Southeast and Southwest Areas Health and Welfare Fund et al v. McClain, in his official capacity as Insurance Commissioner of Arkansas et al., N.D. Ill., No. 1:25-cv-03938, complaint filed 4/11/25.”

From the public health and medical research front,

  • The National Academy of Sciences announced,
    • “Bird flu has infected livestock, wildlife, pets, and humans. Most people have general questions about the looming threat of this highly pathogenic virus, and we have answers. Join @NASEM Health and Medicine Division and @NASEM Earth & Life Sciences on April 29, 2025, for the first public webinar of a special series addressing H5N1 avian influenza. Learn how we got here, who’s at risk, and what’s at stake. Can’t make the date/time? All registrants will receive a link to the recording. Register here: https://tinyurl.com/bdhrywv2
  • The New York Times reports,
    • “The number of children living with autism in the U.S. is growing.
    • “About 1 in 31 children aged eight years old in 2022 had autism—an increase from previous years, according to a report from the Centers for Disease Control and Prevention published Tuesday. 
    • “Increased awareness and screening of the disorder partly explains its rise over time. Health and Human Services Secretary Robert F. Kennedy Jr. has said he is assembling a team of researchers to focus on the root causes of the increase and expects to begin to have answers by September. 
    • “The autism epidemic has now reached a scale unprecedented in human history because it affects the young,” he said Tuesday. “Autism is preventable and it is unforgivable that we have not yet identified the underlying causes. We should have had these answers 20 years ago.”
    • “The idea that vaccines cause autism, which Kennedy has pushed, has long been debunked by scientists, after multiple studies have failed to find a link.”
  • The Rand Organization informs us,
    • “Specialized hospital services that aid people with opioid use disorder regardless of why they are admitted can boost the number of patients who begin treatment with FDA-approved medication for opioid use disorder and increase the likelihood they remain engaged in that care once discharged, according to a new study.
    • “Reporting results from the first parallel assignment randomized clinical trial of a hospital-based addiction consultation service for people with opioid use disorder, researchers found that people who received treatment from a specialized addiction consultation service were about twice as likely to begin medication treatment for opioid use disorder as patients who received the normal course of care.
    • “In addition, those who received care from the special program were significantly more likely to link to care for opioid use disorder once they were discharged.
    • “Researchers say the study contributes to growing evidence that an inpatient addiction consultation service can have a positive effect on treatment initiation and linkage to post-discharge care. The findings are published in the journal JAMA Internal Medicine.”
  • AHRQ offers advice on “Implementing [US Preventive Services Task Force] Recommended Mental Health and Substance Use Screening and Counseling Interventions in Primary Care Settings for Children and Adolescents.”
  • Per Medscape,
    • “New data confirmed the safety and efficacy of AXS-05, a combination of dextromethorphan and bupropion, for the treatment of agitation associated with Alzheimer’s disease (AD).
    • “In the phase 3 ACCORD-2 study, AXS-05 (Axsome Therapeutics) met the primary and key secondary endpoints by statistically significantly delaying and preventing AD agitation relapse compared with placebo and was generally well tolerated.
    • “Overall, the data “build on the previous positive phase 2/3 studies and support the use of AXS-05 as a safe and effective treatment for Alzheimer’s disease agitation,” George Grossberg, MD, Saint Louis University School of Medicine, St. Louis, said at a press briefing announcing the results.
    • “Grossberg presented the late-breaking findings from ACCORD-2 on April 7 at the American Academy of Neurology (AAN) 2025 Annual Meeting.”
  • Per a National Cancer Institute news release,
    • “Many adolescents and young adults (AYAs) with advanced cancer don’t have discussions with their clinicians about how they want to approach palliative care until the final weeks of life, a study of medical records of nearly 2,000 young patients showed.
    • “The researchers also found that, as of more than 2 months before their deaths, few AYAs in the study had documented goals for care of any kind in their medical records, including things such as how aggressive they would like to be with their cancer treatments.
    • “The findings come from an NCI-funded study that analyzed how documented discussions between AYA patients with advanced cancer and their providers about the goals of care change over the patients’ last few months of life.  The study results were published December 19 in JAMA Network Open.”
  • Per an NIH news release,
    • “New studies in rats suggest the drug reserpine, approved in 1955 for high blood pressure, might treat the blinding disease retinitis pigmentosa. No therapy exists for this rare inherited disease, which starts affecting vision from childhood. A report on the studies, conducted at the National Institutes of Health (NIH), published today in eLife.
    • “The discovery of reserpine’s effectiveness may greatly speed therapeutics for retinitis pigmentosa and many other inherited retinal dystrophies, which can be caused by one of more than a thousand possible mutations affecting more than 100 genes. Reserpine’s neuroprotective effect is independent of any specific underlying gene mutation,” said the study’s lead investigator, Anand Swaroop, Ph.D., senior investigator at NIH’s National Eye Institute.”
  • STAT News reports,
    • “U.S. researchers will soon test whether livers from a gene-edited pig could treat people with sudden liver failure — by temporarily filtering their blood so their own organ can rest and maybe heal.
    • “The first-of-its-kind clinical trial has been cleared by the Food and Drug Administration, according to pig producer eGenesis, which announced the step Tuesday with its partner OrganOx.” * * *
    • “The new study, which is expected to get underway later this spring, is a twist on the quest for animal-to-human organ transplants. Researchers won’t transplant the pig liver but instead will attach it externally to study participants.
    • “The liver is the only organ that can regenerate, but the question is whether having the pig’s liver filter the patient’s blood for several days could give it that chance.”

From the U.S. healthcare business front,

  • Beckers Payer Issues notes,
    • “CMS’ payment increase of 5.03% in 2026 “will likely significantly support the recovery” of Medicare Advantage plans as they continue to face rising medical costs, according to Fitch Ratings.
    • “Increased government scrutiny, reduced base payments and rising utilization in the last couple of years has put pressure on the program, leading plans to reduce benefits or pull back from unprofitable markets. CMS’ rate hike will increase payments to MA plans by more than $25 billion in 2026.
    • “While the higher 2026 payment rates do not resolve all the challenges facing MA insurers, they help relieve some pressures from increased healthcare utilization in the program,” Fitch analysts wrote April 14. “Depending on the insurer, the higher rates could enable a mix of enhancement of benefits in certain geographies, mitigation of Star Ratings pressure, or partial margin recovery.”
    • “Fitch expects MA to remain a key focus for insurers, and a clearer picture on the success of course correction measures will become available in the next few weeks as Q1 earnings reports are released.”
  • Per Fierce Pharma,
    • “Even as tariffs start to take a toll on Johnson & Johnson’s medtech business—with the threat of pharmaceutical duties not far behind—the New Jersey drug giant is confident it can weather any upcoming trade war turbulence. In fact, the company is boosting its sales guidance for the year following the close of a new neuroscience acquisition.
    • “J&J now expects to generate total operational sales of $91.6 billion to $92.4 billion in 2025, representing a $700 million increase over the forecast it initially unveiled in January, the company said in a Tuesday earnings release (PDF).
    • “J&J’s finance chief, Joseph Wolk, attributed the bump to J&J’s recent acquisition of neuroscience player Intra-Cellular Therapies for $14.6 billion. The deal, which closed earlier this month, allowed J&J to get its hands on the approved schizophrenia and bipolar disorder med Caplyta.”
  • Per Beckers Hospital Review,
    • “At the end of 2023, more than one-third of new prescriptions to treat Type 2 diabetes were GLP-1s, such as Mounjaro and Ozempic, among others, according to a study published April 15 in Annals of Internal Medicine. 
    • “Researchers at Mass General Brigham, based in Somerville, Mass., reviewed claims data from January 2021 to December 2023 to evaluate utilization trends among diabetes medications. 
    • “The drugs included glucagon-like peptide-1 receptor agonists (Ozempic), glucose-dependent insulinotropic polypeptide receptors (Mounjaro), glucose-lowering medications (metformin and insulin) and weight-lowering medications (phentermine). 
    • “Over those three years, use of Mounjaro, Ozempic and sodium-glucose cotransporter-2 inhibitors increased among adults with Type 2 diabetes. Use of other glucose-lowering drugs, including metformin, rapidly declined.
  • and
    • “Houston-based Texas Children’s has experienced “astounding” results from AI projects in recent months, its IT leader told Becker’s.
    • “Myra Davis, executive vice president and chief information and innovation officer of Texas Children’s, was recently recognized for her work when she was nominated for an ORBIE award for the nation’s top healthcare CIO.
    • “Becker’s caught up with Ms. Davis to discuss her most innovative IT projects — and what comes next.”
  • The New York Times reports,
    • “The quest to create an A.I. therapist has not been without setbacks or, as researchers at Dartmouth thoughtfully describe them, “dramatic failures.”
    • “Their first chatbot therapist wallowed in despair and expressed its own suicidal thoughts. A second model seemed to amplify all the worst tropes of psychotherapy, invariably blaming the user’s problems on her parents.
    • “Finally, the researchers came up with Therabot, an A.I. chatbot they believe could help address an intractable problem: There are too many people who need therapy for anxiety, depression and other mental health problems, and not nearly enough providers.
    • “Fewer than a third of Americans live in communities where there are enough mental health providers to meet the local demand. According to one study, most people with mental health disorders go untreated or receive inadequate treatment.
    • “So the team at Dartmouth College embarked on the first clinical trial of a generative A.I. therapist. The results, published in the New England Journal of Medicine-AI, were encouraging.
    • “Chatting with Therabot, the team’s A.I. therapist, for eight weeks meaningfully reduced psychological symptoms among users with depression, anxiety or an eating disorder.”
  • Per BioPharma Dive,
    • “Bristol Myers Squibb on Monday said its drug Camzyos failed a Phase 3 trial in people with a progressive heart condition, closing off an opportunity to expand use of a medicine it sees as a future blockbuster.
    • “According to Bristol Myers, Camzyos missed the dual main goals of a study focused on the non-obstructive form of “HCM,” or hypertrophic cardiomyopathy. It failed to meaningfully improve peak oxygen consumption as well as scores on an assessment of heart health. The company didn’t provide study details, but said more information will be shared “with the scientific community in the future.”
    • “Camzyos was acquired through the $13 billion buyout of MyoKardia in 2020 and two years later became the first drug cleared for use in the “obstructive” and more common form of the disease. Biotechnology companies Cytokinetics and Edgewise Therapeutics are developing similar medicines that are both in the advanced stages of clinical testing. Cytokinetics’ drug, aficamten, could be approved in the U.S. later this year.”

Monday Report

David Ermer–CMS, Congress, COVID-19, FDA, Federal employment benefits, Medical / Rx research, Medicare, Obesity, U.S. Healthcare–
Photo by Sven Read on Unsplash
  • Paul Wolfowitz, writing in the Wall Street Journal, shares “Reflections on Lincoln 160 Years After His Murder. America’s greatest president had moral vision, strategic genius, and astounding eloquence.” RIP.
    • “Tuesday is the 160th anniversary of Abraham Lincoln’s assassination. That grim milestone invites speculation about what might have been had he lived to serve out his second term. It is also an occasion to reflect on what made Lincoln great—why his example still matters.
    • “Lincoln is the greatest American president not because he was perfect, but because he had so many leadership qualities crucial for confronting the challenges facing him. He combined moral vision with strategic genius, a rare mix for any political leader.” * * *
    • “So, I am grateful to Providence that we had a leader of Lincoln’s stature at a time of our greatest need. And so should we all be.”

From Washington, DC,

  • From an FTC news release,
    • “Today, the Federal Trade Commission launched a public inquiry into the impact of federal regulations on competition, with the goal of identifying and reducing anticompetitive regulatory barriers. The FTC launched this inquiry in response to President Trump’s Executive Order on Reducing Anticompetitive Regulatory Barriers. * * *
    • “In a Request for Information, the FTC invites members of the public to comment on how federal regulations can harm competition in the American economy. The RFI seeks to understand what federal regulations have an anticompetitive effect. Members of the public—including consumers, workers, businesses, start-ups, potential market entrants, investors, and academics—are encouraged to comment.
    • “The public will have 40 days to submit comments at Regulations.gov, no later than May 27, 2025. Once submitted, comments will be posted to Regulations.gov.
    • “Comments submitted to the U.S. Department of Justice Anticompetitive Regulations Task Force at Regulations.gov that contain information falling within the scope of the FTC’s RFI do not need to be resubmitted in response to the FTC’s RFI.” 
  • When will OPM invite deregulatory ideas from the public? Speaking of OPM,
  • Federal News Network tells us,
    • “The Office of Personnel Management faces a steep bill for employee relocation expenses, as it plans to bring staff working remotely back to the office.
    • “As part of its return-to-office plans, OPM is planning to spend nearly $42 million to relocate approximately 250 employees — spending about $166,000 per employee.
    • “The relocation cost per employee is higher than the annual salary of most federal employees, according to recent data analysis from the Pew Research Center. It also exceeds the maximum salary a career federal employee can receive under the General Schedule pay scale (not including locality pay). An OPM spokesperson declined a request for comment.
    • “OPM will pay certain mandatory relocation expenses. But the agency told employees in an April 4 email, first reported by Federal News Network, that “it is unlikely we will have the financial resources to relocate a significant number of employees who are greater than 50 miles from an OPM site.”
  • Govexec informs us,
    • “The Office of Personnel Management last week issued new guidance encouraging agencies to pay political appointees the maximum federal salary and removing career HR workers from the appointment process.
    • “The April 10 memo from acting OPM Director Charles Ezell to agency heads reminds them of the “great flexibility” they have when setting the pay of employees hired under Schedule C of the federal government’s excepted service, the portion of the federal workforce made up of low-level political appointees.
    • “Such flexibility is important to attract highly-qualified Schedule C employees to serve in important confidential, policy-determining, policy-making and policy-advocating roles,” Ezell wrote. “Well-qualified Schedule C employees are needed ‘to drive the unusually expansive and transformative agenda the American people elected President Trump to accomplish.’”
    • “The memo notes that Schedule C salaries cap out at $195,200. And it instructs agencies to “revoke delegations and sub-delegations” provided to agency HR employees as part of their work onboarding and vetting political appointees on behalf of the White House.”
  • Per an OPM news release,
    • “For the first time, U.S. Office of Personnel Management (OPM) personalized Retirement Booklets are now accessible online as digital downloads [at] servicesonline.opm.gov.”
  • MedTech Dive also points out,
    • “The Trump administration is investigating the effects of pharmaceutical imports on national security, disclosing Monday a probe that is likely to lay the foundation for sector-wide tariffs in the near future.
    • “The investigation, which was announced in a federal notice posted online, appears to be wide-ranging, covering branded and generic medicines, as well the active drug ingredients they contain. It will be conducted by the Department of Commerce under a legal authority known as Section 232, which President Donald Trump used earlier this year to expand duties on steel and aluminum.”
  • Per Beckers Clinical Leadership,
    • “CMS is proposing to modify several hospital quality measures and remove four others, including those focused on health equity and social drivers of health.
    • “The agency outlined the changes April 11 as part of its 2026 proposed rule for the Medicare payment systems that cover inpatient and long-term care hospitals.” 

From the judicial front,

  • Fierce Healthcare notes,
    • “Originally approved by the FDA in 1998, Amgen’s Enbrel is still sailing along without facing biosimilar competition in the United States. And unless a court rules otherwise, the Southern California company will retain its patent protection on the inflammatory disease medicine until 2029.
    • “Hoping to alter the timetable is Swiss generics and biosimilars specialist Sandoz, which has filed an antitrust lawsuit in federal court in Virginia claiming that Amgen has blocked competition to “unlawfully extend its monopoly,” according to the complaint.
    • “Amgen, according to the lawsuit, allegedly did this by purchasing patent rights from one of its competitors, Swiss pharma giant Roche, which was developing a product from the same drug class to compete with Enbrel. Without these patents, Enbrel would have been subject to competition from biosimilars—as was the case in Europe—by as early as 2016.
    • “Sandoz is seeking an injunction preventing Amgen from using the patent rights to block biosimilar competition. Sandoz wants to launch its Enbrel biosimilar Erelzi as soon as possible. The company also is pursuing treble damages, which could be tripled, according to antitrust law.”
  • and
    • “The Department of Justice will head to mediation with UnitedHealth Group and Amedisys April 18 as part of an ongoing antitrust lawsuit.
    • “Both companies are attempting to finalize a $3.3 billion merger, which was challenged under the Biden administration Nov. 12 for allegedly threatening competition in the home health and hospice industry. Now, mediation will occur Aug. 18, as signed by Magistrate Judge Susan Gauvey on April 10.” 

From the public health and medical research front,

  • The American Medical Association lets us know what doctors wish their patients knew about asthma. “Asthma can be life-threatening if you don’t get treatment. Two physicians, from Bayhealth and Rush University System for Health, share more.”
  • Cardiovascular Business relates,
    • “Following a Mediterranean-style diet that still leaves room for lean beef is associated with significant improvements in blood pressure (BP) and vascular health, according to new data published in Current Developments in Nutrition.
    • “The Mediterranean diet, named after the traditional eating habits of Greece and Italy, is based on whole grains, fruits, vegetables, legumes, nuts, seeds and olive oil. It primarily focuses on plant-based options, but does permits fish, seafood, poultry and dairy products to be eaten occasionally. 
    • “The Mediterranean diet is often viewed as one of the healthiest ways a person can eat. The team behind this latest analysis aimed to learn just how flexible these diets can be. If someone follows a Mediterranean-style diet, but wants to enjoy a little more meat, what does that mean for their cardiovascular health?
    • “Increasingly, the importance of customizing dietary choices to reflect personal preferences is recognized to promote sustained adherence to a healthy dietary pattern,” wrote first author Jennifer Fleming, PhD, an assistant teaching professor in the department of nutritional sciences at Penn State, and colleagues. “Therefore, although current dietary guidance consistently recommends limiting red meat, more clarity is needed about the amount of lean unprocessed red meat that can be incorporated into healthy dietary patterns that promote cardiovascular health.”
  • STAT News reports,
    • “Verve Therapeutics said initial data show that its investigational gene-editing therapy lowered cholesterol without inducing serious side effects, a positive step for the company after it paused development of an earlier treatment due to safety concerns.
    • “The early data from an ongoing Phase 1 study show that a single infusion of the therapy, called Verve-102, led to greater decreases in “bad” LDL cholesterol with higher doses, according to an announcement Monday. Among the four participants who received the highest dose of 0.6 mg/kg, they experienced an average 53% reduction in cholesterol.” * * *
    • “While the Verve-102 data are early, they move the company closer to its goal of using a one-time therapy to target a common condition that continues to be one of the leading killers in the developed world. The current chronic drugs that inhibit PCSK9 are not enough for patients with higher cholesterol, Verve argues, since patients often don’t take them consistently.”
  • The New York Times calls attention to a new study.
    • Middle-aged and older adults who sought hospital or emergency room care because of cannabis use were almost twice as likely to develop dementia over the next five years, compared with similar people in the general population, a large Canadian study reported on Monday.
    • When compared with adults who sought care for other reasons, the risk of developing dementia was still 23 percent higher among users of cannabis, the study also found.
    • The study included the medical records of six million people in Ontario from 2008 to 2021. The authors accounted for health and sociodemographic differences between comparison groups, some of which play a role in cognitive decline.
    • The data do not reveal how much cannabis the subjects had been using, and the study does not prove that regular or heavy cannabis use plays a causal role in dementia.
  • The Wall Street Journal considers whether long-Covid is rewriting the rules of aging. Brain decline alarms doctors. Millions of long-Covid patients continue to struggle with cognitive difficulties.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Pfizer is halting development of its experimental weight-loss pill, as the booming obesity drug market remains out of reach for the drug giant.
    • “The company said Monday the stoppage comes after it reviewed clinical data and a study subject developed a liver injury that might have been caused by the drug, called danuglipron.” 
  • The benefits consulting firm WTW offers a report titled “GLP-1 Drugs in 2025: Cost, access and the future of obesity treatment. “Employer health plans brace for another year of soaring costs as GLP-1 utilization continues to rise — per member per month spending on these medications nearly doubled each year since 2021.”
  • Per Beckers Payer Issues,
    • “Medicare Advantage plans spent $38 billion on non-Medicare benefits in 2024, according to a Medicare Payment Advisory Commission report. 
    • “The group, which advises Congress on Medicare issues, held a meeting April 10. According to a presentation, MA plans received $83 billion in rebates from the federal government. Plans used these rebates to cover non-Medicare, or supplemental, benefits. These benefits include hearing, vision and dental care alongside fitness reimbursements, over-the-counter allowances and other benefits. These rebates are also used to reduce cost sharing and provide prescription drug benefits. 
    • “According to MedPAC, current data on supplemental benefit use in MA is inadequate to determine the value the funding is providing.” 
  • Per Fierce Healthcare,
    • “Average physician pay rose 3.6% between 2023 and 2024, from $363,000 to $376,000—about in line with recent years but well behind increases from before the pandemic.
    • “That’s according to Medscape’s latest physician compensation report, which also highlighted particularly narrow increases in year-over-year compensation for primary care docs (1.4%, from $277,000 to $281,000) and specialists (1%, from $394,000 to $398,000).
    • “The annual survey also counted more specialties reporting pay drops than pay increases, as well as a shrinking percentage of doctors who feel fairly compensated and a widening of pay gaps across gender and racial and ethnic lines.”
  • Beckers Hospital Review adds,
    • “Annual average compensation for U.S. physicians in four medical specialties surpassed $500,000 in 2024, according to Medscape’s “Comparing Your Pay Against Your Peers’: Medscape Physician Compensation Report 2025.“
    • “Orthopedic specialists topped the list as the highest-paid physicians last year, while those practicing public health and preventive medicine reported the lowest earnings.
    • “With the exception of anesthesiology, all seven of the top-earning specialties in 2024 have consistently ranked among the 10 highest-paid specialties in each of the last five editions of the annual report.”

Weekend Update

David Ermer–CMS, Congress, FDA, Medical / Rx research, Medicare, Obesity, OPM, Rx coverage, U.S. Healthcare–
Texas Blue bonnets

From Washington, DC,

  • The Wall Street Journal reports,
    • “President Trump’s “one big, beautiful bill” is headed for one big, ugly negotiation. 
    • “Congressional Republicans last week approved the fiscal blueprint that lets them pack disparate items from Trump’s wish list into a single bill that won’t need Democratic votes. GOP lawmakers expect the giant legislation to extend expiring tax cuts, implement Trump’s new tax-cut promises, increase the debt limit, cut spending and boost border security and national defense. 
    • “The one-bill strategy bets that Republicans lock arms with Trump and plunge ahead, unwilling to defy the president on an up-or-down vote on his agenda. Packaging everything together could give each party faction victories to highlight, even if they must accept pieces they detest. 
    • “The next few months will bring a blur of policies, numbers and congressional procedures that will make Republicans confront internal fractures over tax rates, incentives, Medicaid and budget deficits. The unity they have displayed so far will be tested, particularly in the House, where Speaker Mike Johnson (R., La.) has guided a fractious majority through tight votes by reassuring lawmakers they can fight over details later.”
  • Federal News Network lets us know,
    • “Although the details of House Republicans’ narrowly approved budget framework are still up in the air, some initial proposals show the possibility of changes to federal benefits, mainly in retirement and health care.
    • “As part of the GOP budget resolution, the House Oversight and Government Reform Committee is looking at cuts of at least $50 billion from its mandatory spending, according to the framework that lawmakers approved in a vote of 216-214 on Thursday. That level of spending cuts would almost certainly dig into federal benefits, the National Active and Retired Federal Employees Association (NARFE) said.
    • “Given the only major mandatory spending under the committee’s jurisdiction is federal retirement and health benefits, cuts of such a magnitude would necessarily come from cuts to federal retirement and health benefits,” NARFE wrote in a letter to Congress last week.” * * *
    • “A spokesperson for Oversight Committee Republicans declined to comment on where the proposed spending cuts would most likely move forward. But many proposals are already circulating, including several possibilities that could bring changes to federal employees’ retirement benefits, health insurance and more.”
  • Govexec adds,
    • “President Trump appears set to propose freeze civilian federal employees’ pay next year, according to draft budget documents.
    • “The news came in the form of a passback, which is effectively the Office of Management and Budget’s response to agencies’ individual budget submissions. A report by the Congressional Research Service says agencies can appeal certain programmatic decisions to OMB, the documents are, for all intents and purposes, the office’s final decision.
    • “A copy of one agency’s passback, obtained by Government Executive, said the document’s funding levels “reflect a pay freeze for civilian employees in calendar year 2026.”
    • “If enacted, it would mark the first year that federal workers have not received a pay increase since 2013, the last of three years of pay freezes amid sequestration. President Trump previously proposed pay freezes in the first three of his annual budget submissions, but Congress ultimately overruled him each time, with raises in the range of 1.4% to 2.6%.
    • “In 2020, he proposed a 1% across-the-board pay increase for feds as part of his budgetary request but reneged on that pledge and supported efforts to freeze their pay later in funding negotiations. Congress ultimately adopted the 1% increase that year.”
  • The American Hospital Association points out a bevy of proposed Medicare regulations.
    • “The Centers for Medicare & Medicaid Services April 11 issued a  proposed rule that would increase Medicare inpatient prospective payment system rates by a net 2.4% in fiscal year 2026, compared with FY 2025, for hospitals that are meaningful users of electronic health records and submit quality measure data. 
    • “This 2.4% payment update reflects a hospital market basket increase of 3.2% as well as a productivity cut of 0.8%. This update also reflects CMS’ proposal to rebase and revise the market basket to a 2023 base year. In addition, the rule includes a proposed $1.5 billion increase in disproportionate share hospital payments and a proposed $234 million increase in new medical technology payments. Overall, it would increase hospital payments by $4 billion in FY 2026 as compared to FY 2025.  
    • “In addition, CMS has included in the rule its previously published request for information seeking input on opportunities to streamline regulations and reduce burdens on providers.”
  • and
    • “The Centers for Medicare & Medicaid Services April 11 proposed increasing the long-term care hospital standard rate payments by 2.2% in fiscal year 2026 relative to FY 2025. This includes a 3.4% market basket update reduced by a 0.8 percentage point productivity adjustment. In addition, it includes a reduction of 0.3 percentage points due to CMS’ proposal to raise the fixed-loss amount for high-cost outlier payments to $91,247. The agency also has included in the rule its previously published request for information seeking input on opportunities to streamline regulations and reduce burdens on providers.”
  • and
    • “The Centers for Medicare & Medicaid Services April 11 issued a proposed rule for the inpatient psychiatric facility prospective payment system for fiscal year 2026.  
    • “CMS proposes to increase IPF payments by a net 2.4%, equivalent to $70 million, in FY 2026. The payment update reflects a proposed market-basket update of 3.2% minus a productivity adjustment of 0.8 percentage points. CMS also proposes to update the outlier threshold so that estimated outlier payments remain at 2.0% of total payments. In addition, the agency would increase the adjustment factors for IPFs with teaching status and rural location and recognize increases to IPF teaching caps as required by law.”
  • and
    • The Centers for Medicare & Medicaid Services April 11 issued a proposed rule for the skilled nursing facility prospective payment system for fiscal year 2026. The proposal would increase aggregate payments by 2.8%, which reflects a 3.0% market basket update, a 0.8 percentage point cut for productivity, and an increase of 0.6 percentage points for the market basket forecast error for FY 2024. CMS also is proposing changes to some ICD-10 code mappings for payment classifications. In addition, it has included in the rule its previously published request for information seeking input on opportunities to streamline regulations and reduce burdens on providers.  
  • CMS adds
    • On April 11, 2025, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule that proposes updates to Medicare payment policies and rates for hospices under the Fiscal Year (FY) 2026 Hospice Wage Index and Payment Rate Updated Proposed Rule (CMS-1835-P). CMS is publishing this proposed rule consistent with the legal requirements to update Medicare payment policies for hospices annually. 
  • The public comment deadline for all five proposed rules is June 10, 2025. FEHB carriers certainly would appreciate receiving

From the public health and medical research front,

  • The New York Times offers “Five Science-Backed Longevity ‘Hacks’ That Don’t Cost a Fortune.” Check it out.
  • Per Kaufmann Hall,
    • This week’s graphic highlights data from a recent study published by The Lancet on cancer incidence trends in the United States between 2000 and 2019 among those born between 1920 and 1990. Of the 34 types of cancer studied, 17 were found to have an increased incidence among those from the Generation X and Millennial cohorts. Compared to individuals in the 1955 cohort, incidence of small intestinal, thyroid, kidney and renal pelvic, and pancreatic cancers among those in the 1990 cohort was about three times higher. The incidence of those in the Generation X cohorts was also higher among these four cancers compared to the 1955 cohort’s rate. More adults are also getting diagnosed with cancer at younger ages
  • The Wall Street Journal considers “The Latest in Hernia Repair: New Techniques, New Research. As the population ages, the incidence of hernias is increasing. How do you know when surgery is needed?”
  • The Guardian reports,
    • “People who use the drug Mounjaro are able to sustain weight loss for three years, data from a trial suggests.
    • “Mounjaro, nicknamed the “King Kong” of weight loss drugs, contains tirzepatide and is self-administered in once-a-week injections.
    • “It works by mimicking two hormones called GLP-1 and GIP, resulting in appetite suppression, increased production of insulin, greater insulin sensitivity and a reduction in the rate at which food is emptied from the stomach. The medication is available for weight loss to some people on the NHS and it can also be bought privately with a prescription.”
  • Per Medscape,
    • Now that the US Food and Drug Administration has removed both tirzepatide and semaglutide from its Drug Shortages List, the widespread compounding of these drugs is ending. Tirzepatide’s deadline has already passed, while physicians and pharmacies have until April 22 for semaglutide. An estimated 2 million Americans have been using these more affordable copycats every month.
    • Even with direct-to-consumer discounts, monthly doses of brand-name versions cost hundreds more than compounded ones, putting them beyond the reach of many people. This means a significant number of compounded glucagon-like peptide 1 (GLP-1) users will be forced to go cold turkey — but studies consistently show weight regain when patients stop taking them abruptly. [The article suggests] how can you help your patients?
  • Per NPR Shots,
    • “Scientists have re-created a pain pathway in the brain by growing four key clusters of human nerve cells in a dish.
    • “This laboratory model could be used to help explain certain pain syndromes and offer a new way to test potential analgesic drugs, a Stanford team reports in the journal Nature.
    • “It’s exciting,” says Dr. Stephen Waxman, a professor at Yale School of Medicine who was not involved in the research.”

From the U.S. healthcare business front,

  • The KFF Peterson Health System Tracker assesses how cost affects access to healthcare and examines challenges with effective price transparency analyses.
  • Beckers Hospital Review tells us,
    • Physicians are seeing slower pay growth in the last year amid economic uncertainty, according to Medscape’s “Physician Compensation Report 2025.”
    • The company surveyed 7,322 physicians across 29 specialties from Oct. 3, 2024 to Jan. 15, 2025, and found compensation increased around 3.6% on average for physicians, which was the lowest growth rate since 2011 when Medscape first began reporting compensation.
    • Pay gains were around 1.4% for primary care physicians, hitting $281,000 last year, and 1% for specialists, hitting $398,000. Pay growth was the lowest since 2021 at the height of the pandemic. The pay figures cover base salary, incentive bonus and other income including profit-sharing.
    • “Specialists’ compensation was squeezed by payer reimbursement cuts, and we saw fewer specialties reporting pay increases than in several years,” the report states. “Nor was it a banner year for primary care physicians. With a lot of uncertainty in the political and regulatory arenas, and the post-COVID salary spending seemingly done, it seems like a good time for physicians to be careful with their expenses.”
  • and
    • “U.S. Bankruptcy Court Judge Kate Stickles has approved N.J.-based Hudson Regional Hospital to take over operational control of three Jersey City, N.J.-based CarePoint Health hospitals, allowing the system to exit bankruptcy.
    • “Hudson Regional now owns and operates Bayonne (N.J.) Medical Center and operates both Jersey City-based Christ Hospital and Hoboken (N.J.) University Medical Center, under the approved management agreement. Each hospital is now operated by an affiliated property owner, according to an April 11 news release shared with Becker’s.” 

Cybersecurity Dive

David Ermer–Cybersecurity–

From the cybersecurity policy and law enforcement front,

  • Federal News Network tells us,
    • “The second Trump administration’s cybersecurity policy is still coming into view, but GOP lawmakers are calling for the White House to kick off a review of existing and future cyber regulations.
    • “Lawmakers and policy experts are particularly focused on three key rules: the Cybersecurity and Infrastructure Security Agency’s incident reporting requirements; the Department of Health and Human Services’ proposed update to health care security requirements; and the Securities and Exchange Commission’s 2023 cybersecurity risk management requirements.”
  • FEHBlog note — As early as April 21, federal agencies will be announcing the withdrawal of certain proposed rules, such as the HIPAA Security Rule amendments, which stripped the rule of its most important feature — flexibility, and the repeal of certain final rules under a February 19, 2025, executive order which a Presidential memorandum supplemented last Wednesday.
  • The American Hospital Association News explained on April 10,
    • The Trump administration yesterday released executive orders on reducing anti-competitive regulatory barriers and repealing certain regulations deemed unlawful.  
    • The order on reducing anti-competitive barriers directs federal agencies to review all regulations subject to their rulemaking authority and identify those that create de facto or de jure monopolies, create barriers to entry for new market participants, create or facilitate licensure or accreditation requirements that unduly limit competition, or otherwise impose anti-competitive restraints or distortions in the market.   
    • The order on repealing unlawful regulations is linked to a Feb. [19] executive order [published in the Federal Register on Feb. 25] that directed agencies within 60 days to identify unlawful and potentially unlawful regulations to be repealed. The new order instructs agencies to take steps to immediately repeal regulations and provide justification within 30 days for any identified as unlawful but have not been targeted for repeal, explaining the basis for the decision not to repeal.
  • The Mintz law firm points out that on April 7, 2025, OMB issued new guidance for the Federal Government’s use of artificial intelligence (AI), and President Trump signed an EO for AI Data Centers.
  • Security Week reports,
    • The National Institute of Standards and Technology (NIST) has announced that all CVEs published before January 1, 2018, will be marked as ‘Deferred’ in the National Vulnerability Database (NVD).
    • This means that, because the CVEs are old, NIST will no longer prioritize updating NVD enrichment or initial NVD enrichment data for them, unless they are or have been included in CISA’s Known Exploited Vulnerabilities (KEV) catalog.
    • “CVEs marked as Deferred will display a banner on their CVE Detail Pages indicating this status. This change will take place over the span of several nights. We are doing this to provide additional clarity regarding which CVE records are prioritized,” NIST announced.
    • “We will continue to accept and review requests to update the metadata provided for these CVE records. Should any new information clearly indicate that an update to the enrichment data for the CVE is appropriate, we will continue to prioritize those requests as time and resources allow,” NIST said.
  • Per an April 10, 2025, HHS press release,
    • “Today, the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) announced a settlement with Northeast Radiology, P.C. (NERAD), a professional corporation that provides clinical services at medical imaging centers in New York and Connecticut, concerning potential violations of the Health Insurance Portability and Accountability Act (HIPAA) Security Rule.” * * *
    • “OCR initiated its investigation of NERAD after receiving a breach report from NERAD in March 2020 about a breach of unsecured ePHI. NERAD reported that between April 2019 and January 2020, unauthorized individuals had accessed radiology images stored on NERAD’s PACS server. NERAD notified the 298,532 patients whose information was potentially accessible on the PACS server of this breach. OCR’s investigation found that NERAD had failed to conduct an accurate and thorough risk analysis to determine the potential risks and vulnerabilities to the ePHI in NERAD’s information systems.
    • “Under the terms of the resolution agreement, NERAD agreed to implement a corrective action plan that will be monitored by OCR for two years and paid $350,000 to OCR.” * * *
    • “The resolution agreement and corrective action plan may be found at: https://www.hhs.gov/sites/default/files/ocr-hipaa-settlement-nerad.pdf, opens in a new tab [PDF, 369 KB]“

From the cybersecurity breaches and vulnerabilities front,

  • The Wall Street Journal reports,
    • “Chinese officials acknowledged in a secret December [2024] meeting that Beijing was behind a widespread series of alarming cyberattacks on U.S. infrastructure, according to people familiar with the matter, underscoring how hostilities between the two superpowers are continuing to escalate.
    • “The Chinese delegation linked years of intrusions into computer networks at U.S. ports, water utilities, airports and other targets, to increasing U.S. policy support for Taiwan, the people, who declined to be named, said.  
    • “The first-of-its-kind signal at a Geneva summit with the outgoing Biden administration startled American officials used to hearing their Chinese counterparts blame the campaign, which security researchers have dubbed Volt Typhoon, on a criminal outfit, or accuse the U.S. of having an overactive imagination.” * * *
    • “A Chinese official would likely only acknowledge the intrusions even in a private setting if instructed to do so by the top levels of Xi’s government, said Dakota Cary, a China expert at the cybersecurity firm SentinelOne. The tacit admission is significant, he said, because it may reflect a view in Beijing that the likeliest military conflict with the U.S. would be over Taiwan and that a more direct signal about the stakes of involvement needed to be sent to the Trump administration.
    • “China wants U.S. officials to know that, yes, they do have this capability, and they are willing to use it,” Cary said.”
  • Per Bleeping Computer,
    • “Laboratory Services Cooperative (LSC) has released a statement informing it suffered a data breach where hackers stole sensitive information of roughly 1.6 million people from its systems.
    • “LSC is a Seattle-based nonprofit organization that provides centralized laboratory services to its member affiliates, including select Planned Parenthood centers.
    • “It plays a crucial role within its niche, supporting organizations in the reproductive health services across more than 35 U.S. states, handling sensitive lab testing, billing, and personal data.”
  • and
    • “Oracle finally confirmed in email notifications sent to customers that a hacker stole and leaked credentials that were stolen from what it described as “two obsolete servers.”
    • “However, the company added that its Oracle Cloud servers were not compromised, and this incident did not impact customer data and cloud services.
    • “Oracle would like to state unequivocally that the Oracle Cloud—also known as Oracle Cloud Infrastructure or OCI—has NOT experienced a security breach,” Oracle says in a customer notification shared with Bleeping Computer.”
  • and
    • “Phishing-as-a-service (PhaaS) platform Tycoon2FA, known for bypassing multi-factor authentication on Microsoft 365 and Gmail accounts, has received updates that improve its stealth and evasion capabilities.
    • “Tycoon2FA was discovered in October 2023 by Sekoia researchers, who later reported significant updates on the phishing kit that increased its sophistication and effectiveness.
    • “Trustwave now reports that the Tycoon 2FA threat actors have added several improvements that bolster the kit’s ability to bypass detection and endpoint security protections.”
  • The Cybersecurity and Infrastructure Security Agency added five known exploited vulnerablities to its catalog this week.
  • CISA announced yesterday,
    • Fortinet is aware of a threat actor creating a malicious file from previously exploited Fortinet vulnerabilities (CVE-2024-21762, CVE-2023-27997, and CVE-2022-42475) within FortiGate products. This malicious file could enable read-only access to files on the device’s file system, which may include configurations. Fortinet has communicated directly with the account holders of customers identified as impacted by this issue based on the available telemetry with mitigation guidance.
    • See the following resource for more information: Analysis of Threat Actor Activity | Fortinet Blog

From the ransomware front,

  • Morphisec discusses the most notable ransomware attacks from the last six months.
  • Cybersecurity Dive informs us,
    • “Remote access tools were the initial entry point in eight of every 10 ransomware attacks in 2024, according to a report released Thursday by At-Bay. VPNs accounted for about two-thirds of ransomware attack entry points. 
    • “Indirect ransomware claims continue to rise, showing a 43% increase in 2024, according to At-Bay. Indirect ransomware is when an attack begins on a third-party vendor or business partner, often leading to a data breach or business interruption of a downstream client or partner. The report cites the 2023 MOVEit breaches and the 2024 CDK attacks. 
    • “Overall, the frequency of ransomware claims returned to record levels seen in 2021 after a decreased rate of attacks in 2022 and 2023, according to At-Bay.” 
  • and
    • “Sensata Technologies was struck by a ransomware attack earlier this week that disrupted several of the company’s operations, according to a regulatory filing.
    • “Sensata disclosed that a ransomware attack on Sunday encrypted certain devices on the network. The Attleboro, Mass.-based company specializes in sensors, controls and other industrial technology for the automotive, aerospace and manufacturing sectors.
    • “The incident has temporarily impacted Sensata’s operations, including shipping, receiving, manufacturing production, and various other support functions. While the company has implemented interim measures to allow for the restoration of certain functions, the timeline for a full restoration is not yet known,” Sensata said in the SEC filing.”
  • Dark Reading lets us know,
    • “While ransomware represented the costliest cyber-insurance claims in 2024, incidents of financial fraud continue to be far more numerous, with both often triggered by security failures at a third-party firm.
    • “That insight comes from the latest tranche of cyber-insurance data released this year, this time by cyber-insurance firm At-Bay. Financial fraud — most often following a phishing attack — remained the most common type of cyberattack leading to an insurance claim, according to At-Bay’s “2025 InsurSec Report,” released this week. While the cyber insurer saw 16% more claims in 2024 than the year before, the overall cost of each incident declined to $166,000, down from $213,000 in 2021.”
  • Microsoft Security explains how cyber attackers exploit domain controllers using ransomware.
  • CSO in a commentary article notes,
    • “If you didn’t pay much attention to news of the recent Codefinger ransomware attack, it’s probably because ransomware has become so prevalent that major incidents no longer feel notable.
    • “But Codefinger is not just another ransomware breach to add to the list of incidents where businesses lost sensitive data to attackers. In key respects, Codefinger represents a substantially new type of ransomware attack.
    • “By extension, the incident is a reminder of why conventional cybersecurity techniques won’t always protect businesses and their data — and why organizations need to think beyond the basics regarding defending against ransomware.”
  • Tech Target discusses best practices on reporting ransomware attacks.

From the cybersecurity defenses front,

  • Security Week notes,
    • “As the threat landscape grows more sophisticated, Chief Information Security Officers (CISOs) are continuously searching for innovative ways to safeguard their organizations. Yet one of the most potent tools in their arsenal remains underutilized – DNS (domain name systems).”
  • An ISACA blog entry discusses how to build AI governance by design.
  • Per Bleeping Computer,
    • “Microsoft is testing a new Defender for Endpoint capability that will block traffic to and from undiscovered endpoints to thwart attackers’ lateral network movement attempts.
    • “As the company revealed earlier this week, this is achieved by containing the IP addresses of devices that have yet to be discovered or onboarded to Defender for Endpoint.
    • “Redmond says the new feature will prevent threat actors from spreading to other non-compromised devices by blocking incoming and outgoing communication with devices using contained IP addresses.”
  • Here is a link to Dark Reading’s CISO Corner.

Friday Report

David Ermer–AHRQ, CDC, CMS, COVID-19, FDA, Federal employment benefits, Medical / Rx research, Medicare, NIH, Obesity, Rx coverage, SCOTUS, U.S. Healthcare–

From Washington, DC.

  • Medical Economics reports,
    • Health care is in crisis, but tying physician reimbursement to inflation is one way to stabilize the American health care system, according to the American Medical Association (AMA).
    • On April 10, the Medicare Payment Advisory Commission voted unanimously to recommend Congress replace current law updates to the physician fee schedule with an annual change based on the Medicare Economic Index, such as MEI minus 1%.
    • That is “a timely recommendation as lawmakers wrestle with how to handle yet another cut in physician pay,” according to AMA. Association President Bruce A. Scott, MD, issued a statement of support similar to previous ones because the issue has been under discussion for months. In fact, Scott noted MedPAC has suggested the same to Congress at least three consecutive years.
      The current baseline increase to physician reimbursement is 0.25%, or 0.75% for doctors participating in an alternative payment model. MedPAC said Congress should consider setting reimbursement at the rate of the Medicare Economic Index minus 1%, every year for the foreseeable future.
  • Fierce Healthcare lets us know,
    • “A new assessment of 18 Center for Medicare and Medicaid Innovation models reaffirms recent criticism of the agency’s aggregate cost savings—or more accurately, losses—while highlighting several individual payment models that appear effective in cutting down federal spending and improving care quality.
    • “The white paper published Wednesday by healthcare consulting and advisory firm Avalere Health looked at newer quality metrics for outcomes than prior CMMI model analyses and also dug into whether the agency had been transparent and provided opportunities for feedback when designing the models.
    • “The findings come in the wake of a damning late 2023 Congressional Budget Office assessment of the agency’s work, which found CMMI increased indirect spending by $5.4 billion between 2011 and 2020 (0.1% of net Medicare spending during that time) and spurred sharp scrutiny from cost-conscious lawmakers.”
  • and
    • “Disability protections against gender dysphoria implemented via rulemaking during the Biden administration will not be supported going forward, the Department of Health and Human Services (HHS) announced April 10.
    • “In a two-page clarification, HHS Secretary Robert F. Kennedy Jr. signed off on a rule update that declares language characterizing gender dysphoria as a disability to not be enforceable because its inclusion was in the preamble—not the regulatory text—to a final rule from May 2024.
    • “The Department is nonetheless concerned there has been significant confusion about the preamble language referencing gender dysphoria in the [final rule],” the update (PDF) in the Federal Register reads. “It is well-established that where, as here, the language included in the regulatory text itself is clear, statements made in the preamble to a final rule published in the Federal Register, lack the force and effect of law and are not enforceable.”
  • Federal News Network tells us, “OPM lacks funds to relocate ‘significant’ number of remote employees in return-to-office plans. OPM is joining many agencies in giving employees another chance to take a “deferred resignation” offer before it proceeds with nonvoluntary layoffs.”
  • Tammy Flanagan, writing in Govexec, informs us about “What to know about early retirement offers to federal employees.

From the Food and Drug Administration front,

  • Fierce Pharma relates
    • “Bristol Myers Squibb has received the FDA’s green light to introduce another immunotherapy-based treatment in first-line liver cancer.
    • “The company’s combination of Opdivo and Yervoy is now approved for patients with newly diagnosed unresectable or metastatic hepatocellular carcinoma, the FDA said Friday.
    • “The immunotherapy regimen combines two well-established agents and may offer the potential for a longer life compared with traditional targeted therapy, Wendy Short Bartie, Bristol Myers’ senior VP of U.S. oncology commercialization, said in an interview with Fierce Pharma.
    • “The first-line approval also converted a previous accelerated approval for Opdivo-Yervoy as a second-line liver cancer treatment. Further, it puts BMS toe to toe with two other immuno-oncology regimens—Roche’s Tecentriq and Avastin, and AstraZeneca’s Imfinzi and Imjudo.”
  • Per MedTech Dive,
    • “Intuitive said Thursday the Food and Drug Administration has cleared a stapler for use with its single-port robotic surgery system.
    • “The device, which Intuitive said is the first stapler designed for single-port robotic surgery, shares features found in the company’s multi-port products to reduce the risk of tissue damage.
    • “CFO Jamie Samath said in January that the stapler nod would trigger the start of “broad commercial efforts” for the single-port system in two indications recently authorized by the FDA.”
  • and
    • “Dexcom received Food and Drug Administration clearance for a 15-day version of its G7 glucose sensor, the company announced Thursday.
    • “Dexcom claims its continuous glucose monitor is the most accurate and has the longest wear time. The company also expects the shift from a 10-day to a 15-day sensor to improve its margins, executives said in a February earnings call.
    • “The announcement alleviated investor concerns that a recent FDA warning letter might delay the decision. Dexcom expects a full launch in the second half of 2025, giving the company time to integrate the updated device with insulin pumps.”

From the judicial front,

  • The Congressional Research Service offers a legal sidebar about the impending April 21 oral argument in the Kennedy v Braidwood Management case which concerns the Affordable Care Act’s preventive care services coverage mandate.
  • Bloomberg Law reports,
    • “A Maine woman can’t proceed with a suit claiming that her health insurance plan’s coverage exclusion for weight loss drugs unlawfully discriminates against obese people, a federal court said.
    • “Rebecca Holland didn’t allege any facts showing that Elevance Health Inc. ever regarded her or other obese plan members as disabled, the US District Court for the District of Maine said Wednesday. Her “bare conclusory allegations to the contrary” didn’t support a ruling that the exclusion was discriminatory, Chief Judge Lance E. Walker said.
    • “Medicare and private insurers generally cover the cost of drugs like Ozempic when used to treat Type 2 diabetes but have been reluctant to pay for it when used for weight loss purposes. Several state and federal plaintiffs are trying to change that by claiming that obesity qualifies as a disability, and the exclusions violate discrimination laws.”

From the public health and medical research front,

  • The Center for Disease Control and Prevention announced today,
    • “Seasonal influenza activity continues to decline. COVID-19 and RSV activity are declining nationally to low levels.
    • “COVID-19
      • “COVID-19 activity is declining nationally. Wastewater levels are at low levels, emergency department visits are at very low levels, and laboratory percent positivity is stable. Emergency department visits and hospitalizations are highest in older adults and emergency department visits are also elevated in young children.
      • “There is still time to benefit from getting your recommended immunizations to reduce your risk of illness this season, especially severe illness and hospitalization.
      • “CDC expects the 2024-2025 COVID-19 vaccine to work well for currently circulating variants. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.
    • “Influenza
    • “RSV
      • “RSV activity is declining in most areas of the country. Emergency department visits and hospitalizations are highest in children and hospitalizations are elevated among older adults in some areas.
    • “Vaccination
      • “Vaccination coverage with influenza and COVID-19 vaccines is low among U.S. adults and children. Vaccination coverage with RSV vaccines remains low among U.S. adults. Many children and adults lack protection from respiratory virus infections provided by vaccines.”
  • The American Hospital News points out,
    • “There have been 712 confirmed cases of measles reported by 25 states so far this year, according to the latest figures released April 11 by the Centers for Disease Control and Prevention. The agency said 93% of those cases (660 of 712) are outbreak-associated and 11% of cases have been hospitalized. The vaccination status of 97% of cases is classified as “unvaccinated or unknown.”
  • ProPublic adds,
    • “In the past six months, two babies in Louisiana have died of pertussis, the disease commonly known as whooping cough.
    • “Washington state recently announced its first confirmed death from pertussis in more than a decade.
    • “Idaho and South Dakota each reported a death this year, and Oregon last year reported two as well as its highest number of cases since 1950.
    • “While much of the country is focused on the spiraling measles outbreak concentrated in the small, dusty towns of West Texas, cases of pertussis have skyrocketed by more than 1,500% nationwide since hitting a recent low in 2021 amid the COVID-19 pandemic. Deaths tied to the disease are also up, hitting 10 last year, compared with about two to four in previous years. Cases are on track to exceed that total this year.”
  • The New York Times reports,
    • “Surgeons removed a genetically engineered pig’s kidney from an Alabama woman after she experienced acute organ rejection, NYU Langone Health officials said on Friday.
    • “Towana Looney, 53, lived with the kidney for 130 days, which is longer than anyone else has tolerated an organ from a genetically modified animal. She has resumed dialysis, hospital officials said.
    • “Dr. Robert Montgomery, Ms. Looney’s surgeon and the director of the NYU Langone Transplant Institute, said that the so-called explant was not a setback for the field of xenotransplantation — the effort to use organs from animals to replace those that have failed in humans.
    • “This is the longest one of these organs has lasted,” he said in an interview, adding that Ms. Looney had other medical conditions that might have complicated her prognosis.
    • “All this takes time,” he said. “This game is going to be won by incremental improvements, singles and doubles, not trying to swing for the fences and get a home run.”
  • Health Day notes,
    • “About one in 10 U.S. adults with substance use disorder (SUD) report past-year hospitalizations, according to a research letter published online April 1 in the Annals of Internal Medicine.
    • “Eden Y. Bernstein, M.D., M.P.H., from the University of Colorado School of Medicine in Aurora, and colleagues described the prevalence of hospitalizations among U.S. adults with SUD. Adults were classified into non-mutually exclusive groups by presence of any SUD, individual SUD, and two or more SUDs. The proportion and number of U.S. adults who reported hospitalizations was estimated for each group.
    • “The researchers identified 60 million U.S. adults with SUD, of whom 5.8 million (9.7 percent) reported past-year hospitalizations. The proportion of hospitalized adults ranged from 7.3 to 23.6 percent among those with alcohol use disorder (AUD) and opioid use disorder (OUD), respectively. Among adults with SUD, those with versus without past-year hospitalizations were more likely to be older and more likely to have two or more medical comorbid conditions. Hospitalized adults with AUD, cannabis use disorder, and tobacco use disorder were also more likely to have serious mental illness. Across all groups apart from AUD, hospitalized adults were less likely to be uninsured. Hospitalized adults with OUD were less likely to be non-Hispanic Black.”
  • Per a National Cancer Institute news release,
    • “Why do some cancers come back many years after treatments had eliminated all signs of the disease? The answer may involve rogue cancer cells that spread to other parts of the body early in the disease and then enter a sleeping, or dormant, state, according to a growing body of research. 
    • “These dormant cancer cells can survive in the body undetected for months, years, or even decades, the research suggests. At some point, however, the cells may awaken and begin the process of forming metastatic tumors.  
    • “What causes disseminated cancer cells to enter, and then to leave, a dormant state is not known. 
    • “But recent studies of tumor dormancy have yielded clues that scientists believe could one day help them find ways to prevent metastases, which account for most cancer deaths.”
  • Genetic Engineering and Biotechnology News adds,
    • “Cancer vaccines have been a tantalizing idea for decades, but the vast complexity of the human immune system has posed significant challenges. Now, technological advances like rapid DNA sequencing, lymph node targeting, and AI-informed antigen selection are enabling the creation of precision vaccines that target cancers effectively while minimizing harmful side effects.”
  • AHRQ’s Effective Health Care Program shares a paper about “Management of Suicidal Thoughts and Behaviors in Youth: A Systematic Review.”
  • The University of Minnesota’s CIDRAP relates,
    • “A new smartphone-sized device can deliver tuberculosis (TB) test results at the point of care in less than an hour, an innovation that could improve diagnosis of the deadly disease in settings in which access to healthcare facilities and lab equipment is limited, its Tulane University developers reported yesterday in Science Translational Medicine.
    • “Over 90% of new TB cases occur in low- and middle-income countries.” 

From the U.S. healthcare business front,

  • Beckers Hospital Review calls attention to the fact that CMS has approved seven new health systems to offer hospital at home programs.
  • Beckers Payer Issues informs us,
    • “CVS Health has named Benjamin Kornitzer, MD, as Aetna’s chief medical officer. 
    • “Most recently, Dr. Kornitzer was chief medical officer at agilon health, a primary care physician services company primarily serving Medicare Advantage patients.
    • “He also previously served as CMO of Mount Sinai Health System in New York.”
  • Fierce Healthcare reports,
    • “A better consumer experience has implications for clinical improvements, according to a new report from CVS Health.
    • “The healthcare giant is putting a focus on innovation in this area, and to identify opportunities conducted an analysis that compared Net Promoter System (NPS) scores with clinical outcomes. It found that, for example, patients who were highly satisfied with the experience at their pharmacies were more likely to be adherent to their medications.
    • “The white paper notes that nonadherence to prescribed medications drives 16% of U.S. health spending each year, or about $500 billion.” 
  • Modern Healthcare tells us,
    • “Eli Lilly is partnering with digital health companies to boost sales of its weight loss medications.
    • “The drugmaker added hybrid weight loss startup Knownwell to its third-party marketplace of telehealth offerings earlier this month. Eli Lilly has also signed deals with Ro, Form Health and 9am Health.” 
  • BioPharma Dive recently updated its prescription drug patent tracker.
  • Bloomberg Law adds,
    • “Novo Nordisk A/S and Eli Lilly & Co. are using dense clusters of patents to extend monopolies on blockbuster diabetes and weight-loss drugs including Ozempic, Wegovy, and Mounjaro, fueling high prices and health inequities, according to an advocacy group report.
    • “The pharmaceutical companies’ adoption of a “financialized business model” prioritizes profits and shareholder returns through an aggressive strategy for securing additional patents for minor changes to extend their drugs’ market exclusivity well beyond the expiration of its original patents, according to a report released Thursday by the Initiative for Medicines, Access and Knowledge on “the heavy price” of those glucagon-like peptide 1 therapies.” * * *
    • In a statement Friday, Lilly said the “report is grossly inaccurate and includes patents that have nothing to do with tirzepatide.”
    • “To date, Lilly has only listed three patents in the Orange Book for” its two tirzepatide products, it added.
    • “Our business model is built on the fact that patents are limited in scope and duration, and when they expire, we welcome generic and biosimilar manufacturers to develop lower-cost alternatives,” the statement continued. “Lilly is already focused on developing the next innovation for patients that will eventually become generic.”
    • “The Orange Book is a US Food and Drug Administration registry listing patents that cover approved drugs that allows branded-drug makers to trigger a 30-month delay of FDA approval by filing a suit alleging infringement of a listed patent.
    • “Novo in a Friday statement said it has no more than four patents listed in the Orange Book for Ozempic , no more than eight for Wegovy, and 11 for Rybelsus.
    • “While the US healthcare system is complex and there are many factors that play a role in determining what people will pay for medicines,” Novo said, “the net price of Ozempic has declined by 40% since launch in the US and Wegovy is following a similar trajectory.”

Thursday Report

David Ermer–CDC, CMS, Congress, FDA, Medical / Rx research, Medicare, Rx coverage, U.S. Healthcare–
Photo by Michele Orallo on Unsplash

From Washington, DC,

  • Yesterday, the Senate Homeland Security and Governmental Affairs Committee favorably reported the President’s nominee for OPM Director, Scott Kupor, by a 7-4 vote. Mr. Kupor’s nomination will be headed for the Senate floor following the upcoming two week break from Capitol Hill.
  • Today, the American Hospital Association News let us know,
    • The House, by a vote of 216-214, passed the revised budget resolution for fiscal year 2025. This follows the Senate’s passage of the bill last week. Reps. Victoria Spartz, R-Ind., and Thomas Massie, R-Ky., joined all Democrats today in voting “no.”  
    • Notably, the resolution instructs the House Energy and Commerce Committee, which has primary jurisdiction over Medicaid and other health care programs, to cut a minimum of $880 billion in spending. * * *
    • With the House and Senate’s passage of the resolution, Congress can move forward with the reconciliation process. The next step calls for specific committees to begin drafting legislation consistent with their instructions in the budget resolution. This is where the hard work begins, as House and Senate committees must decide on the specific policies to be included within the reconciliation bill.  
    • The budget resolution gives Senate and House committees until May 9 to report legislation, but this is not a binding deadline. 
  • The approved budget resolution (page 47) calls for the House Oversight and Government Reform Committee to “submit changes in law within its jurisdiction to reduce the deficit by not less than $50,000,000,000 for the period of fiscal years 2025 through 2034.”
  • The AHA News further informs us,
    • The Trump administration yesterday [April 9] released executive orders on reducing anti-competitive regulatory barriers and repealing certain regulations deemed unlawful.  
    • The order on reducing anti-competitive barriers directs federal agencies to review all regulations subject to their rulemaking authority and identify those that create de facto or de jure monopolies, create barriers to entry for new market participants, create or facilitate licensure or accreditation requirements that unduly limit competition, or otherwise impose anti-competitive restraints or distortions in the market.   
    • The order on repealing unlawful regulations is linked to a Feb. 25 executive order that directed agencies within 60 days to identify unlawful and potentially unlawful regulations to be repealed. The new order instructs agencies to take steps to immediately repeal regulations and provide justification within 30 days for any identified as unlawful but have not been targeted for repeal, explaining the basis for the decision not to repeal.
  • Govexec adds,
    • “On Feb. 19, Trump signed an executive order requiring agencies, within 60 days and in coordination with the Office of Management and Budget and Elon Musk-backed Department of Government Efficiency, to identify for elimination or modification regulations that are unconstitutional or unlawful. 
    • “With roughly a week-and-a-half before that deadline, the president on Wednesday [April 9] declared that such regulations can be repealed without going through the notice and comment period. When an agency promulgates a new rule, or revokes one, it must seek, respond to and potentially incorporate public comment on the proposal. The process usually takes at least a year. 
    • “The Trump administration, however, is arguing that it does not have to take this step because of the “good cause” exception in the Administrative Procedure Act, which is the law that sets rulemaking requirements. The exception provides that agencies do not have to perform notice and comment if doing so would be “impracticable, unnecessary or contrary to the public interest.”
    • “Retaining and enforcing facially unlawful regulations is clearly contrary to the public interest,” the memo said. “Furthermore, notice-and-comment proceedings are ‘unnecessary’ where repeal is required as a matter of law to ensure consistency with a ruling of the United States Supreme Court. Agencies thus have ample cause and the legal authority to immediately repeal unlawful regulations.”
  • Fierce Healthcare notes, “The American people, more than any Federal official, know which regulations stifle entrepreneurship and economic growth,” the White House wrote in its fact sheet. “You are invited to tell us which regulations impede competition and should be changed or repealed.” The FEHBlog is a big fan of deregulation.
  • The AHA News was full of Washington, DC, news today.
    • “The Government Accountability Office yesterday [April 9] released a report calling for the Department of Health and Human Services to improve its efforts responding to drug shortages. The report found that although drug shortages have decreased since 2020, shortages are lasting longer. HHS responded to the GAO report, informing the GAO that its coordinator position overseeing medical product supply chains would be eliminated in May, leaving HHS without leadership to coordinate its drug shortage activities. The GAO recommended HHS implement a method to formally conduct any drug shortage activity and collaborate with other federal agencies.”
  • and
    • “The National Counterintelligence and Security Center, the FBI, and the Defense Counterintelligence and Security Center yesterday released guidance on mitigating deceptive online recruitment activities by foreign intelligence entities, particularly groups in China, that target current and former federal government employees. The agencies said the entities are posing as legitimate consulting firms, corporate recruiters, public policy institutions and other organizations on social and professional networking websites. The actors are said to be using deceptive online job offers and other virtual approaches to target individuals with federal backgrounds who may be seeking new employment.”
  • Beckers Hospital Review adds,
    • “More than one-third (41%) of active drug shortages began in 2022 or earlier, according to a new report from the American Society of Health-System Pharmacists. 
    • “The report tracks national drug shortage trends from January 2001 through March 2025. So far this year, the ASHP has reported 26 new drug shortages. Since an all-time high of 323 active drug shortages in early 2024, the number of active shortages is now 270. 
    • “The “[w]orkload required to manage shortages, including work to change pharmacy automation and electronic health records, adds to the challenges of pharmacy staff shortages,” the report said. 
    • “In 2024, 17% of shortages were related to manufacturing issues, 9% to Hurricane Helene, 9% to business decisions, 8% to supply and demand, and 2% to a raw material problem. Manufacturers did not or refused to provide a reason for 55% of shortages.” 
  • In an HHS press release, the new CMS Administrator, Dr. Mehmet Oz, shares his vision for CMS.
    • “I want to thank President Trump and Secretary Kennedy for their confidence in my ability to lead CMS in achieving their vision to Make America Healthy Again,” said Dr. Oz. “Great societies protect their most vulnerable. As stewards of the health of so many Americans – especially disadvantaged youth, those with disabilities, and our seniors, the CMS team is dedicated to delivering superior health outcomes across each program we administer. America is too great for small dreams, and I’m ready to get work on the President’s agenda.”
  • Per an FDA press release,
    • “Today, the U.S. Food and Drug Administration is taking a groundbreaking step to advance public health by replacing animal testing in the development of monoclonal antibody therapies and other drugs with more effective, human-relevant methods. The new approach is designed to improve drug safety and accelerate the evaluation process, while reducing animal experimentation, lowering research and development (R&D) costs, and ultimately, drug prices.
    • “The FDA’s animal testing requirement will be reduced, refined, or potentially replaced using a range of approaches, including AI-based computational models of toxicity and cell lines and organoid toxicity testing in a laboratory setting (so-called New Approach Methodologies or NAMs data). Implementation of the regimen will begin immediately for investigational new drug (IND) applications, where inclusion of NAMs data is encouraged, and is outlined in a roadmap also being released today. To make determinations of efficacy, the agency will also begin use pre-existing, real-world safety data from other countries, with comparable regulatory standards, where the drug has already been studied in humans.”

In State government news,

  • STAT News reports,
    • An Arkansas bill that would prohibit pharmacy benefit managers from operating retail and mail-order pharmacies was passed by the state senate and is now headed to Gov. Sarah Sanders, the first time such a bill has gotten this far down the legislative path in the United States.
    • “The bill is designed to eliminate what state — and some federal — lawmakers have called a conflict of interest that has forced residents to pay more for medicines and hastened the demise of independent pharmacies. And it arrives as scrutiny of pharmacy benefit managers and their role in the opaque pricing of prescription drugs has increased dramatically. A spokesman for Sanders declined to say whether she would sign the bill and, if so, when.” * * *
    • “As for CVS, the company sent us a statement saying “This bill rips medicine away from sick patients and makes it harder for people to achieve better health. A veto will protect communities, improve care, and help hundreds of thousands of Arkansans get the medicines they need. Governor Sanders should choose people over misguided policy that will lead to serious consequences.”
    • “A spokeswoman for Express Scripts directed us to a web site where the company argues state residents will lose the convenience of home delivery as well as focused care for certain diseases that are treated by medicines distributed through a specialty pharmacy operation called Accredo.”

From the public health and medical research front,

  • Tech Target tells us,
    • “Only half of Americans are getting regular cancer screenings and routine medical care, signaling a need for more public awareness of the importance of primary and preventive care, according to the Prevent Cancer Foundation’s 2025 Early Detection Survey.
    • “The survey of 7,000 U.S. adults aged 21 or older showed that only 51% of people are accessing routine medical care and cancer screening, a significant 10 percentage-point downswing from a similar 2024 survey.
    • “There are numerous reasons patients miss their cancer screenings, but most generally center on public awareness and information, the survey continued. For example, 43% of respondents said they weren’t aware that they needed to be screened for a certain type of cancer. Likewise, 40% said they didn’t have any symptoms of disease and another 40% said they had no family history of the illness.”
  • Per Health Day,
    • “Stroke, dementia and depression share 17 common risk factors
    • “Improving any of the risk factors can improve odds against any of the three brain health problems
    • “High blood pressure and kidney disease had the biggest impact on risk.”
  • Per the American Journal of Managed Care,
    • “Newer glucose-lowering medications glucagon-like peptide-1 receptor agonists (GLP-1 RAs) and sodium-glucose cotransporter-2 (SGLT2) inhibitors significantly reduced the risk of major cardiovascular events and heart failure in older adults with type 2 diabetes (T2D), according to one study.1 The findings suggest these treatments outperform dipeptidyl-peptidase-4 (DPP-4) inhibitors, regardless of age, and support their use in clinical guidelines for elderly populations.”
  • Per MedCity News,
    • “Solu Therapeutics, a company developing a new type of antibody drug, unveiled $41 million in financing on Wednesday for clinical testing of a therapy with the potential to bring a safer and more effective approach to blood cancers.
    • “Boston-based Solu has already begun dosing patients in a Phase 1 test of lead program STX-0712 in resistant or refractory chronic myelomonocytic leukemia (CMML) and other hematologic malignancies. The target of the drug is CCR2, a receptor that plays a role in cancer development and progression. The Solu drug is intended to eliminate CCR2-positive cells. It does so in a novel way.”

From the U.S. healthcare business front,

  • The New York Times reports,
    • “Seniors across the country are wearing very expensive bandages.
    • “Made of dried bits of placenta, the paper-thin patches cover stubborn wounds and can cost thousands of dollars per square inch.
    • “Some research has found that such “skin substitutes” help certain wounds heal. But in the past few years, dozens of unstudied and costly products have flooded the market.
    • “Bandage companies set ever-rising prices for new brands of the products, taking advantage of a loophole in Medicare rules, The New York Times found. Some doctors then buy the coverings at large discounts but charge Medicare the full sticker price, pocketing the difference.
    • ‘Partly because of these financial incentives, many patients receive the bandages who do not need them. The result, experts said, is one of the largest examples of Medicare waste in history.
    • “Private insurers rarely pay for skin substitutes, arguing that they are unproven and unnecessary. But Medicare, the government insurance program for seniors, routinely covers them. Spending on skin substitutes exceeded $10 billion in 2024, more than double the figure in 2023, according to an analysis of Medicare data done for The Times by Early Read, a firm that evaluates costs for large health companies.
    • “Medicare now spends more on the bandages than on ambulance rides, anesthesia or CT scans, the analysis found.”
  • The KFF Peterson Health System Tracker identifies health spending issues to watch this year.
  • Fierce Pharma reports
    • “On the heels of similar investment pledges from Eli Lilly and Johnson & Johnson, Switzerland’s Novartis is stepping up to the plate with a major plan to grow its U.S. footprint.
    • “Novartis will spend $23 billion to build and expand 10 U.S. facilities over the next five years, the company said in a Thursday press release. Reuters first reported the news following an interview with Novartis’ CEO Vas Narasimhan.
    • “The outlay is the latest in a series of moves seemingly spurred on by the threat of import tariffs on pharmaceuticals under the second Trump administration.
    • “On the production front, Novartis will build four new manufacturing facilities in “soon-to-be-determined states,” plus establish new radioligand therapy plants in Florida and Texas. The company will also expand existing radioligand manufacturing facilities in Indiana, New Jersey and California.”
  • Per MedCity News,
    • “Teladoc Health, a virtual care company, unveiled its new Cardiometabolic Health Program on Tuesday to prevent the advancement of diabetes, hypertension and obesity.
    • “Purchase, New York-based Teladoc Health serves both employers and health plans. In addition to support for weight management and diabetes, it offers mental health care, primary care and specialty services.
    • “The new program provides a premium subscription to BetterSleep, an app that’s focused on improving sleep quality. Patients also gain access to one-on-one support with a registered dietitian, outreach from health coaches, at-home testing for cardiometabolic measures and health insights from connected devices (like blood glucose meters). The program is available to those with a body mass index of 25 or above.”
  • Healthcare Dive relates,
    • “Kandu Health and Neurolutions have merged and raised $30 million to support stroke recovery and rehabilitation, the companies said Tuesday.
    • “The merger brings together Neurolutions’ brain computer interface technology and Kandu Health’s telehealth services to try to improve stroke patients’ outcomes after they leave the hospital. 
    • “Patients will have access to Neurolutions’ IpsiHand, a device that is cleared for use in the U.S. The system translates brain signals to enable stroke patients to open and close their hands.”
  • Per Beckers Hospital Review,
    • “West Orange, N.J.-based RWJBarnabas Health and the Rutgers Cancer Institute of New Jersey plan to open the state’s first freestanding cancer facility in May.
    • “Three things to know:
      • “The $750 million, 520,000-square-foot project broke ground in 2021. It is a 12-story facility that will house inpatient and outpatient cancer services, along with research laboratories. 
      • “The freestanding cancer facility is adjacent to the Robert Wood Johnson University Hospital and Rutgers Cancer Institute of New Jersey campus in New Brunswick, N.J.
      • “The cancer pavilion is designed to serve as a leading model for cancer care on the East Coast, uniting research, education and patient care under one roof.”

Midweek Report

David Ermer–CDC, Congress, Medical / Rx research, Mental health care, Obesity, Rx coverage, SCOTUS, U.S. Healthcare–
Thanks to Alexandr Hovhannisyan for sharing their work on Unsplash.

From Washington, DC

  • The Wall Street Journal reports
    • “President Trump told Republicans wavering on the party’s fiscal framework to “close your eyes and get there.” GOP opponents of the plan say they are heading into the budget showdown with eyes wide open, and some appear willing to block the president’s push, setting up a too-close-to-call vote late Wednesday.
    • “Trump and House GOP leaders have routinely melted internal party opposition this year with promises and appeals to Republican unity. This time, they face dug-in critics of the budget passed by the Senate on Saturday.
    • “Republican leaders are optimistic they can get the measure through the House, and Speaker Mike Johnson (R., La.) told reporters that he thought it would pass. The House advanced the measure past a procedural hurdle in a 216-215 tally, setting up the final debate and vote. That procedural vote contained an unrelated provision that will make it harder this year for the House to reverse Trump’s tariffs.”
  • Politico adds,
    • “House Republican leaders canceled a vote on the Senate’s budget resolution Wednesday night, as Speaker Mike Johnson came to terms with what had been clear for many hours: Too many Republicans would vote in opposition and the measure was bound to fail.” * * *
    • “Lawmakers are slated to head back to their districts Thursday for a two-week recess, meaning that the president could have to wait to see any forward motion on his “big, beautiful bill” if a compromise can’t be reached soon.
    • “Johnson said Wednesday night that House leadership will now explore either amending the Senate-adopted budget or going straight to conference with the Senate and working out differences there.
    • “We’re going to make that decision,” he told reporters just after the resolution was pulled.”
  • The American Hospital Association News tells us,
    • “President Trump announced on April 9 (https://tinyurl.com/2t463edy) that reciprocal tariffs that went into effect after midnight for certain nations will be paused for 90 days, while tariffs for China would be increased to 125%. A 10% universal tariff on imported goods from all countries that began April 5 remains in effect.”
  • and
    • “The Office of Management and Budget April 9 released a notice seeking public input on rules to potentially be rescinded, requesting detailed reasons for their rescission. Comments must be received by OMB no later than 30 days after publication of the notice in the Federal Register. The notice will be published April 11. Comments can be submitted at www.regulations.gov.”

From the judicial front,

  • Federal News Network lets us know,
    • “For the second time in as many days, a higher court has paused a judicial ruling that ordered the reinstatement of federal employees who were fired en masse, leaving thousands of probationary workers vulnerable once again to potential termination.
    • “In a 2-1 ruling Wednesday, a three-judge panel of the Fourth U.S. Circuit Court of Appeals temporarily set aside a Maryland judge’s injunction that had ordered agencies to reinstate employees in 19 states and the District of Columbia. The majority found the government was likely to succeed in proving that the Maryland district court had no jurisdiction over the states’ claims that federal agencies had engaged in an illegal Reduction in Force (RIF).
    • “The panel’s ruling comes one day after the Supreme Court issued a separate stay that had a similar effect on a California court’s ruling that had also ordered the reinstatement of some agencies’ fired probationary workers. In that case, the high court, in an unsigned order Tuesday, also put the preliminary injunction on hold while claims of illegal firing work their way through the appeals process.” * * *
    • “And in California, the judge is considering whether to issue another preliminary injunction that could withstand the ruling the Supreme Court issued Tuesday. In that order, the justices found that the outside organizations harmed by the mass firings didn’t have standing to sue, but explicitly left open the possibility that other plaintiffs, including federal unions, could win an injunction of their own.
    • “In a San Francisco courtroom Wednesday, Judge William Alsup heard arguments over whether unions had standing to sue and win another injunction. However, he postponed issuing a ruling until attorneys in the case provide more information, including data about how many employees were affected by the mass terminations, their relationships with the union plaintiffs, and possible evidence that would show that agencies’ firing decisions were made at the behest of the Office of Personnel Management.”
  • Bloomberg Law points out,
    • “US Chief Justice John Roberts let President Donald Trump temporarily oust top officials at two independent agencies while the Supreme Court decides how to handle a new showdown over presidential power.
    • “Roberts’ order Wednesday puts on hold a federal appeals court decision that had let National Labor Relations Board member Gwynne Wilcox and Merit Systems Protection Board member Cathy Harris go back to work. Roberts said his order will last until either he or the full court issues a longer-term decision.
    • “The case is testing a 1935 Supreme Court ruling that let Congress shield high-ranking officials from being fired, paving the way for the independent agencies that now proliferate across the US government. The legal wrangling ultimately could affect whether Trump has the power to fire Federal Reserve Chair Jerome Powell.”
  • Beckers Payer Issues notes, “A New York federal [district] judge dismissed an antitrust lawsuit against UnitedHealthcare and MultiPlan that alleged the companies conspired to reduce reimbursement rates for an anesthesia services provider.”

From the public health and medical research front,

  • AP reports,
    • “A day care facility in a Texas county that’s part of the measles outbreak has multiple cases, including children too young to be fully vaccinated, public health officials say.
    • “West Texas is in the middle of a still-growing measles outbreak with 505 cases reported on Tuesday. The state expanded the number of counties in the outbreak area this week to 10. The highly contagious virus began to spread in late January and health officials say it has spread to New Mexico, Oklahoma, Kansas and Mexico. 
    • “Three people who were unvaccinated have died from measles-related illnesses this year, including two elementary school-aged children in Texas. The second child died Thursday at a Lubbock hospital, and Health Secretary Robert F. Kennedy Jr. attended the funeral in Seminole, the epicenter of the outbreak. 
    • “As of Friday, there were seven cases at a day care where one young child who was infectious gave it to two other children before it spread to other classrooms, Lubbock Public Health director Katherine Wells said.”
  • Per Newsweek,
    • “Cabot Creamery is recalling 1,700 pounds of butter after testing found elevated levels of coliform bacteria in the product, a marker of potential fecal contamination.
    • “The voluntary recall, initiated by Agri-Mark Inc, Cabot Creamery’s parent company, affects the brand’s 8-ounce Extra Creamy Premium Sea Salted Butter and was distributed in seven states.”
  • The New York Times reports,
    • “During a recent five-year period, a substantial portion of maternal deaths in America — almost one-third — took place more than six weeks after childbirth, at a time when most new mothers think they are in the clear, researchers reported on Wednesday.
    • “The study, published in JAMA Network Open, is one of the first to track maternal health complications during pregnancy and in the year after delivery.
    • “Pregnancy-related death rates in the United States rose almost 28 percent from 2018 to 2022, the researchers found, surging at the height of the Covid-19 pandemic in 2021 before subsiding somewhat.
    • “Our study illustrates why we can’t take our eyes off maternal health,” said Dr. Rose L. Molina, an associate professor of obstetrics, gynecology and reproductive biology at Harvard Medical School and one of the study’s authors.
    • “Women need “access to high-quality care from the moment of conception to a full year after birth,” she added. While there has been a growing emphasis on care in the year after childbirth, “we’re not there yet.”
  • The National Cancer Institute’s Cancer Information Highlights discusses “Targeting a Gene Fusion | Fat Cells to Starve Tumors | TIL Shrinks Solid Cancers.”
  • Per an NIH news release,
    • “In a massive scientific effort funded by the National Institutes of Health (NIH), hundreds of researchers have helped to map the connections between hundreds of thousands of neurons in the mouse brain and then overlayed their firing patterns in response to visual stimuli. This breakthrough is a critical piece of foundational science to build toward understanding how our brains process visual information to reconstruct the images we see every day.
    • “Information processing in the human brain occurs via electrical firing of 86 billion neurons that make trillions of connections with each other. The secrets of how our brain enable us to think, feel, and act lie hidden in the complexity of its wiring diagram and the barrage of electrical signals that move across it in millisecond time frames. While the current findings focus on a tiny fraction of the brain, they reveal the complex connections between the cells and show how those connections are wired to produce functional responses. This information, which was previously beyond our reach, could help us understand how the brain functions normally and offer a guide to what goes wrong as the result of various disorders or injuries.”  
  • Per UPI,
    • “Emergency room visits attributed to popular weight loss drugs such as Ozempic and Wegovy remain quite rare overall, but do show an unexpected link to hypoglycemia, according to a study released Monday.
    • “Semaglutide brand names include Ozempic, Rybelus, and Wegovy, all made by Novo Nordisk, and Mounjaro from Eli Lilly.
    • “The study, led by the Centers for Disease Control and Prevention and Cambridge Health Alliance, was published in the Annals of Internal Medicine. It provides reassuring evidence that serious adverse events associated with the burgeoning use of the drugs are uncommon.
    • “That’s impressive given the overwhelming popularity of semaglutides, which are among a class of “wonder drugs” known as GLP-1 agonists.”
  • STAT New informs us,
    • Since 2021, when the information blocking rules kicked in, health systems and patients have been reckoning with the impact of electronic medical records that allow instant access to test results — good, bad, and in between — sometimes before a doctor has ever seen them. Patients overwhelmingly prefer having their health information as soon as possible, even before it’s interpreted. But there’s a tradeoff between medical transparency and the worry that can be caused when a result is unclear, or even inaccurate.
    • A new study published in JAMA Network Open on Tuesday aims to understand how health systems might find the right balance. “We were curious if refresh, refresh, refresh behavior could be measured,” said senior author Trent Rosenbloom, who directs the patient portal at Vanderbilt University Medical Center. Over two years, researchers and physicians at Vanderbilt tracked how 290,000 patients at the medical center viewed their test results online. In 2022 and 2023, more than 100,000 patients — 37% of the total — refreshed the portal as they waited for results to appear. Some patients clicked to check their results as many as 16 times.  * * *
    • “Across health systems, information officers are working on other ways to ensure automatic test results are more of a benefit than a burden. At Stanford Medicine, said chief medical information officer Christopher Sharp, every primary care practice now uses large language models to generate interpretations of test results, which a doctor can sign off on to send to a patient. The system is also being piloted in specialties with more high-sensitivity results, and Stanford hopes to have it implemented across the entire organization by September.”

From the U.S. healthcare business front,

  • Beckers Payer Issue lets us know,
    • “Blue Cross and Blue Shield of North Carolina reported a net income of $69 million in 2024, Business North Carolina reported April 7. 
    • “The company recorded $11.9 billion of revenue in 2024, compared to $12.2 billion in 2023.
    • “Claims and medical expenses increased 7.2% to $10.4 billion in 2024, and the company’s reserves are equal to 3.3 months of claims and administrative expenses.”
  • Per Beckers Hospital Review,
    • “Despite economic volatility, Fitch still expects healthcare providers to experience a “modest margin expansion” this year due to easing inflationary pressures and reimbursement increases, according to an April 9 report.
    • “The firm anticipates healthcare providers will see Medicare and commercial rate bumps 3% to 4% this year as rates increase and the volume of high acuity cases grows with the aging population.
    • “The workforce challenges plaguing healthcare providers over the last several years are lessening as well, according to the report.
    • “Chronic personnel shortages will continue to ease, suppressing wage inflation and reducing reliance on costlier external agency labour,” the report notes. “Wages are unlikely to exert pressure on provider margins in 2025, with revenue growth likely to match or exceed wage growth.”
    • “The healthcare providers in a more stable financial situation will be in the best position to grow over the next few years. Struggling hospitals will continue to have challenges, and some may seek merger or acquisition partners to stay operational.”
  • Per Modern Healthcare,
    • “A court ruling striking down a federal nursing home staffing mandate brought a sigh of relief from nursing home operators even as the industry still faces financial uncertainty.
    • “An end to the mandate could bring stability to nursing home budgets and valuations. However, some nursing homes still face challenges, such as tougher state staffing minimums, as well as the threat of potential Medicaid rate cuts.
    • “A federal judge in Texas on Monday tossed the controversial nursing home mandate the Biden administration rolled out last year that required nursing homes to have a registered nurse onsite 24 hours a day, seven days a week. The court also blocked a requirement that nursing homes provide at least 3.48 hours of care per resident, per day.
    • “The Health and Human Services Department said in an email it does not comment on legal matters when asked about a possible appeal. However, many in the industry had been expecting the Trump administration to roll back the regulation.”
  • and
    • “Nonprofit health insurance company CareSource has invested more than $400 million to buy struggling nonprofit insurer Commonwealth Care Alliance. 
    • “The deal adds nearly 50,000 Dual Special Needs Plan members who are eligible for both Medicaid and Medicare to CareSource’s book of business, the companies said in a news release Wednesday. CareSource also acquired Commonwealth Care Alliance’s two primary care clinics and its home care practice through the transaction. CareSource counts 2 million Medicaid, Medicare and exchange plan enrollees across seven states.
    • “CareSource CEO Erhardt Preitauer will take over as head of Commonwealth Care Alliance, replacing current CEO Chris Palmeri, who will depart the company. Palmeri currently serves on the board of directors of the insurance lobbying group AHIP. At the start of the year, he stepped down from his role as board chair of the Association of Community Affiliated Plans, a nonprofit Medicaid insurer trade group.
    • “The deal had not been previously announced.”