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.”

• NBC News points out,
  • A pill developed by GSK was found to be safe and effective in treating gonorrhea in a late-stage clinical trial, according to a study published Monday in The Lancet. If approved, it would become the first new class of antibiotic for the sexually transmitted infection in more than two decades.
  • The pill, called gepotidacin, was approved by the Food and Drug Administration in March to treat uncomplicated urinary tract infections in women and girls 12 and up — the most common type of infection in women. The drug is sold under the name Blujepa.
  • A new treatment option is important, experts say, because bacteria that commonly cause STIs are increasingly becoming resistant to the standard antibiotics, making treatment more difficult.

• 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.”