From Washington, DC,

• Govexec tells us,
  • Rep. Gerry Connolly, D-Va., died Wednesday morning after a battle with esophageal cancer. He was 75 years old.
  • Connolly is leaving behind a legacy as a legislator who fought for the federal workforce, government contractors and the economic development of his home region of Northern Virginia.
  • In April, Connolly announced he would not seek re-election in 2026 and would step down from his post as the ranking member of the House Oversight Committee. He first announced his diagnosis in November, shortly after easily winning a ninth term to the House.
• RIP, Congressman.

• The Wall Street Journal reports,
  • “House Republicans made a series of last-minute changes to their sprawling tax-and-spending bill, searching for a path that could unite the party’s warring wings headed into a nail-biter floor vote expected early Thursday.
  • “New language to assuage conservatives would accelerate new Medicaid work requirements to December 2026 from 2029 and end certain tax credits for wind energy and solar energy by 2028 instead of a slower phaseout through 2031. The updates would also formally lock in a $40,000 cap on the state and local tax deduction starting this year, up from a $30,000 cap in the prior plan; that change was designed to satisfy Republicans from high-tax states such as New York and New Jersey. 
  • “Lawmakers from states such as Florida and Texas that haven’t expanded Medicaid under Obamacare would get a favorable change to a funding formula, and border states would get $12 billion for security costs incurred during the Biden administration. An indoor-tanning excise tax that was eliminated in the original bill text would be maintained and a nuclear-energy tax break would be expanded. Federal land swaps in Nevada and Utah would be eliminated. Gun-rights supporters won changes to the tax treatment of suppressors. 
  • “The revised legislation advanced in an initial vote in the early hours of Thursday morning, with all Republicans except one in favor, and all Democrats opposed.” * * *
  • “I believe we are going to land this airplane,” Johnson said during a hectic day of legislating that saw the House Rules Committee start a hearing at 1 a.m. and continue past sunset. He is trying to finish the bill in the House before Memorial Day; it would then go to the Senate, and Republicans are aiming to get it to Trump’s desk by July 4.” 

• Per the New York Times,
  • “The House early Thursday narrowly passed a wide-ranging bill to deliver President Trump’s domestic agenda, after Speaker Mike Johnson put down several mini-rebellions in Republican ranks to muscle the legislation to its first major victory over unified Democratic opposition.
  • “The early morning vote was 215 to 214, mostly along party lines.”

• Fierce Healthcare adds,
  • “We have a tiny sliver that really matters to employers and working families,” said James Gelfand, president and CEO of The ERISA Industry Committee, a group representing large employers. “But I can say those provisions are monumental to us.”
  • “There’s a laundry list of items Gelfand and others are happy the bill, in its current form, includes.
  • “Employer-offered worksite clinics with free or discounted primary care services would now be available to employees on high-deductible health plans (HDHPs), even if they already have an HSA.” * * *
  • “Other changes allow HSA funds to be spent on gym memberships, increases the HSA contribution limit for some individuals, classifies bronze and catastrophic plans as a HDHP that can pair with an HSA and permits one spouse to contribute to an HSA even if the other spouse has a flexible spending account.” * * *
  • “The bill [further codifies a rule from 2019 creating the [ICHRA] program and lets employees use pretax dollars through a cafeteria plan to pay for on-exchange marketplace premiums, explains the KFF.
• and
  • “A bipartisan bill aiming to reform prior authorization has been reintroduced in the Senate.
  • “The Improving Seniors’ Timely Access to Care Act seeks to streamline the prior auth process in Medicare Advantage (MA), which would ease administrative burdens on providers and reduce delays in accessing care for patients.
  • “The bill is co-sponsored by Sens. Roger Marshall, R-Kan., and Mark Warner, D-Va., and is supported by dozens of senators on both sides of the aisle. A version of the legislation in the House is also backed by a bipartisan group.”
    
• Per an CMS news release,
  • “Today, the Centers for Medicare & Medicaid Services (CMS) announced a significant expansion of its auditing efforts for Medicare Advantage (MA) plans. Beginning immediately, CMS will audit all eligible MA contracts for each payment year in all newly initiated audits and invest additional resources to expedite the completion of audits for payment years 2018 through 2024.”
    
• The American Hospital Association News informs us,
  • “The Administration for Strategic Preparedness and Response today released a bulletin on workplace violence in health care that includes recommendations for strengthening security protocols, enhancing emergency preparedness, supporting workforce mental health and promoting information sharing.”

From the Food and Drug Administration front,

• BioPharma Dive points out,
  • “After discussions with the Food and Drug Administration, Moderna on Wednesday said it has voluntarily withdrawn its application for a combination COVID-19 and influenza shot in adults aged 50 years and older.
  • “The biotechnology company said it plans to resubmit its candidate later this year after it gathers data from an ongoing Phase 3 trial of a standalone seasonal influenza vaccine it’s developing. Earlier this month, Moderna had told investors the FDA would require efficacy data from this trial before considering approval of the combo vaccine.
  • “Moderna’s confirmation comes one day after the FDA announced new rules for COVID vaccine approvals, for which it will now require placebo-controlled studies for any clearance in healthy adults under 65 years old.”
• and
  • “Expert advisers to the Food and Drug Administration on Tuesday backed Johnson & Johnson’s Darzalex for people with an asymptomatic form of multiple myeloma that often progresses into more severe blood cancer.
  • “Members of the Oncologic Drugs Advisory Committee voted 6-2 that the benefits of Darzalex’s use in high-risk smoldering multiple myeloma outweighed its risks. However, panelists wrestled with some controversial aspects of the Phase 3 trial J&J is using to ask for an expanded approval. Namely, FDA staff had flagged the trial’s inclusion of patients that could be classified as having a lower risk of progression, as well as an unclear survival benefit following disease progression.
  • “The FDA isn’t required to follow the advice of its outside expert panels but usually does.”

• MedTech Dive adds,
  • “Teal Health published data Monday from a trial of its cervical cancer screening sample self-collection device in JAMA Network Open.
  • “The paper describes a trial of 599 people who both self-collected samples and underwent standard clinician collection. Self-collection correctly identified 95.2% of the positive samples.
  • “Teal won Food and Drug Administration approval for the self-collection device in early May, setting the company up to start shipping the product to customers in June.”

• The New York Times provides helpful background information about the Alzheimer’s Disease blood test that the FDA approved for marketing last week.
  • “The test, manufactured by Fujirebio Diagnostics, is intended to be used only by specialists in Alzheimer’s, the F.D.A. said. Its mouthful of a name — Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio — describes what the test measures: levels of two proteins, amyloid and tau, that are hallmarks of Alzheimer’s disease.
  • “In people who develop Alzheimer’s, amyloid begins to accumulate and form plaques in the brain more than 20 years before any symptoms of cognitive impairment. Tau accumulates later, forming tangles in the brain, and is much more closely correlated with cognitive decline.” * * *
  • “The F.D.A., and Alzheimer’s experts, emphasized that the blood test should be given only to people who are already experiencing cognitive decline and are ages 55 and older. Moreover, it should not be used on its own to diagnose or to rule out Alzheimer’s.”

From the public health and medical research front,

• The Wall Street Journal reports,
  • “Biden’s cancer diagnosis has sparked a debate over prostate-cancer screening guidelines.
  • “Increased diagnoses of later-stage cancers are suspected to be linked to changing screening guidance.
  • “Some prostate-cancer specialists said that there has also been a shift in how they manage lower-risk prostate cancer.”

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

• Healio notes,
  • “Increased dietary fiber was associated with reduced likelihood of stroke, especially small-vessel stroke, in addition to reduced all-cause mortality and improved poststroke survival, researchers reported.
  • “Data on the link between daily dietary fiber intake and odds of stroke and adverse stroke outcomes were published in Stroke.”

From the U.S. healthcare business front,

• The Wall Street Journal lets us know,
  • “Sanofi will acquire Vigil Neuroscience for $470M, potentially reaching $600M with milestone payments.
  • “The deal centers on neurology, adding VG-3927, an Alzheimer’s treatment, to Sanofi’s pipeline.
  • “Vigil’s VGL101 molecule will return to Amgen before the Sanofi acquisition closes in Q3.”

• Fierce Healthcare reports,
  • “Digital physical therapy company Hinge Health priced its IPO at $32 per share on Wednesday, at the top of the company’s expected price range.
  • “The company said it raised $437 million by selling 13,666,000 million shares of its Class A common stock, according to a press release issued Wednesday. Hinge Health said it sold 8.5 million shares and 5.1 million shares are being sold by existing shareholders.
  • “Hinge Health will begin trading tomorrow morning on the New York Stock Exchange under the ticker symbol “HNGE.” The offering is expected to close May 23.”
    
• Fierce Pharma relates,
  • “Cigna’s Evernorth is rolling out a new pharmacy benefit management program that caps members’ monthly cost for key GLP-1 drugs.
  • “Evernorth said in an announcement that through its Express Scripts arm it negotiated directly with the manufacturers for Wegovy and Zepbound—Novo Nordisk and Eli Lilly, respectively—to cap patients’ monthly costs at $200. The company said this could save as much as $3,600 per year compared to savings patients receive through direct-to-consumer discount programs.
  • “Evernorth added that the costs will contribute toward a patient’s deductible as well.

• CNBC adds, “Evernorth’s new weight loss pricing program will begin in the second half of the year, as employers begin to make decisions about coverage for next year’s plans.”
  
• Per STAT News,
  • “Five years after launching, a unique nonprofit drug company has published data showing that consumers and health plans saved considerable money on a generic cancer medicine thanks to its “transparent” pricing model. And it maintains that the findings validate plans to distribute and — eventually — manufacture still more copycat medicines for the U.S. market.
  • “The company — CivicaScript — was created as a vehicle to combat stubbornly high drug prices even after dominant brand-name medicines lost patent protection and generic competitors entered the market. Backed mostly by 18 Blue Cross Blue Shield plans, the nonprofit made its first drug available — a generic version of the Zytiga prostate cancer treatment — in August 2022.
  • “The initial wholesale price was $160, plus an $11 dispensing fee paid to pharmacies, but uptake was slow until it was accepted by pharmacy benefit managers and other health plans. But eventually, the gambit worked: Between September 2023 and December 2023, patients saved 64% and payers saved 92% by purchasing the generic distributed by CivicaScript, according to a new analysis.”

• Beckers Payer Issues offers the view of eleven payer “leaders to learn what’s overhyped in healthcare.”