Weekend Update

Medicare

Weekend Update

David Ermer–Congress, FDA, Federal employment benefits, Generative AI, Medicare, Mental health care, Obesity, U.S. Healthcare–
Texas bluebonnets

From Washington, DC,

  • Roll Call reports,
    • “The Senate adopted a fiscal 2025 budget blueprint early Saturday mostly along party lines after a debate that began the night before, teeing up the House for a climactic final vote next week.
    • “Republicans beat back numerous amendments en route to adopting the measure on a 51-48 vote. 
    • “Rand Paul, R-Ky., voted “no” as he’s long promised due to the resolution’s allowance for raising the statutory debt limit by up to $5 trillion.
    • “Maine’s Susan Collins was the other GOP “no” vote, having earlier expressed concerns about potential Medicaid cuts later in the reconciliation process but not saying how she’ll vote. Collins is up for reelection in 2026 in a Democratic-leaning state.
    • “No Democrats voted for it.:
  • and
    • ​”Speaker Mike Johnson and his GOP leadership team on Saturday sought to tamp down a brewing revolt on the budget resolution that emerged even before the Senate adopted the plan in the wee hours and gained steam later in the morning.
    • “Johnson and the rest of the top four House Republican leaders sent a letter to the rank and file ahead of next week’s House vote on the Senate-revised budget blueprint assuring them that they will not accept watered-down spending cuts in the eventual filibuster-proof reconciliation bill the process is intended to unlock.
    • “We have and will continue to make it clear in all discussions with the Senate and the White House that —in order to secure House passage — the final reconciliation bill must include historic spending reductions while protecting essential programs,” the letter says.
    • “The leadership comments come after key figures in the conference, including House Budget Chairman Jodey C. Arrington, R-Texas; Freedom Caucus Chairman Andy Harris, R-Md., and Rep. Chip Roy, R-Texas, the Freedom Caucus policy chair, all expressed opposition to the Senate budget plan.” * * *
    • “The House GOP leadership letter Saturday * * * [laid] out a process they say will lead to a pre-negotiated settlement between the two chambers. 
    • “The reconciliation bill “must be drafted using a collaborative process that results in a single product that both chambers can pass, and President [Donald] Trump can sign into law,” the leadership wrote. “We have made it clear the House will NOT accept nor participate in an ‘us versus them’ process resulting in a take it or leave it proposition from the Senate.”
    • “The letter goes on to say that immediately after adopting the budget, House and Senate committees “will begin preparing together their respective titles of the reconciliation bill to be marked up in the next work period.”
    • ‘The process House GOP leaders laid out appears to follow what Democrats and then-President Joe Biden employed during the 117th Congress when they enacted two reconciliation bills. Both of those packages went through committee markups in the House, but not in the Senate; but senators were able to make their voices heard through amendment “vote-a-ramas” in that chamber.”
  • On April 9, 2025, at 10 am, the Senate Homeland Security and Governmental Affairs Committee will hold a “business meeting to consider the nominations of Scott Kupor, of California, to be Director of the Office of Personnel Management for a term of four years, and Eric Matthew Ueland, of Virginia, to be Deputy Director for Management, Office of Management and Budget.”
  • Federal News Network offers an interview with Kevin Moss about “the benefits and caveats to having both Medicare and FEHB. While enrolling in Medicare with FEHB coverage may seem like duplicating benefits, it can provide cost savings.”

From the public health and medical research front,

  • The Wall Street Journal reports,
    • A second child who was diagnosed with measles has died in Texas, marking another death in a growing measles outbreak that has so far sickened hundreds of people, hospitalized dozens and spread to nearby states. 
    • The school-age child was being treated for measles-related complications at UMC Health System in Lubbock, Texas, said the health system’s spokesman, Aaron Davis. The child, who died Thursday, wasn’t vaccinated, didn’t have any known underlying health conditions and died of “measles pulmonary failure,” according to the Texas Department of State Health Services.
    • “This unfortunate event underscores the importance of vaccination,” Davis said. * * *
    • “Health and Human Services Secretary Robert F. Kennedy Jr. traveled to Gaines County, Texas, the center of the measles outbreak, to console the two families who have lost children, he said in a post on X.” 
  • STAT News adds,
    • “Health secretary Robert F. Kennedy Jr. said Sunday that “the most effective way to prevent the spread of measles is the MMR vaccine,” his most direct statement yet on the issue, following the death of a second child of the condition in the outbreak in West Texas.” 
  • The Washington Post informs us,
    • Brandy Ellis [, a 49-year-old insurance compliance consultant] calls herself a cyborg.
    • Two small electrodes — thin metal wires — implanted deep inside her brain lead under her skin to a battery pack in her chest. Pulsing about 130 times a second, the deep brain stimulation (DBS) device, a kind of pacemaker, energizes an area that scientists say is key in regulating moods. * * *
    • “DBS is one of several emerging, high-tech therapeutic approaches — a.k.a. electroceuticals — that proponents say are extending psychiatry’s ability to help millions of patients. Increasingly over the past 20 years, testimonials to the potential of treatments that modulate brain functioning, such as DBS, transcranial magnetic stimulation, vagus nerve stimulation and, most recently, focused ultrasound, have been fueling new hope, despite considerable expense and hardship for patients, and mixed evidence of their effectiveness.
    • “Emory University neurologist and psychiatrist Patricio Riva Posse, one of Ellis’s therapists, describes the new trends — combined with ever more sophisticated brain-scanning technologies and new optimism about psychedelic drugs such as ketamine and psilocybin — as explosive progress.”
  • Per Medscape,
    • This patient case [discussed in the article] is a prime example of how, in some instances, losing weight with glucagon-like peptide 1 (GLP-1) agonists can impact muscle mass. To combat this health risk, more clinicians are now emphasizing on fat loss vs weight loss in patients taking GLP-1s. Weight loss refers to the overall decrease in weight from the body, which can include fat, muscle, and water, whereas fat loss refers only to the reduction of fat from the body.

From the U.S. healthcare business front,

  • BioPharma Dive provides us with an “M&A recap: Big pharma starts the year mostly avoiding billion-dollar deals. Big-ticket biotech buyouts have become scarce in recent months. U.S. policy upheaval threatens to keep it that way.”
  • Here is a link to Optum Rx’s Winter 2025 report on notable new drugs.
  • Per MedTech Dive,
    • “Eargo and Hearx have merged to create the over-the-counter hearing aid company LXE Hearing, the companies said Monday.
    • “Hearx, the maker of Lexie hearing aids, and Eargo competed for the OTC hearing aid market that the Food and Drug Administration created through the publication of a final rule in 2022. 
    • “Patient Square Capital, which took Eargo private in 2024, has invested $100 million in the combined company. LXE said the investment reflects confidence in the direct-to-patient hearing market.”
  • HR Dive relates,
    • “The U.S. Equal Employment Opportunity Commission has reached a settlement in two pregnancy discrimination cases and filed a new lawsuit on a third, the agency announced Thursday in a series of media releases.
    • “In the first settlement, an assisted living facility paid $20,000 to resolve allegations that it refused to schedule and then fired a temporary worker upon learning she was pregnant. In the second, a plant nursery paid $40,000 to resolve allegations it did not allow a worker to return after maternity leave. EEOC’s newly filed lawsuit alleged an employer refused to allow a worker with a high-risk pregnancy to work remotely to limit her exposure to COVID-19.  
    • “The actions highlight the agency’s continued interest in enforcing the relatively new Pregnant Workers Fairness Act. However, Acting Chair Andrea Lucas has expressed her opposition to aspects of the agency’s final rule, which was passed in April 2024.”

From the artificial intelligence front,

  • The Washington Post reports,
    • “In 2017, Ezekiel Emanuel, a well-known oncologist and health policy commentator, said radiologists would soon be out of work thanks to machine learning.
    • “That hasn’t happened, but although artificial intelligence isn’t replacing radiologists, it has significantly changed their field.
    • “More than three-quarters of the AI software cleared by the Food and Drug Administration for medical use is designed to support radiology practice, says Curtis Langlotz, a radiology professor at Stanford University and president of the Radiological Society of North America’s board of directors.
    • “Radiology is leading the way in the development and implementation of AI in clinical practice,” he adds. But AI isn’t reducing the need for human input.
    • “AI is not a better kind of intelligence, it’s just a different kind of intelligence,” Langlotz says. “A human plus a machine is better than either one alone. I would say that has been true since I began studying AI in the 1980s, and it continues to be true today.”

Friday Report

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

From Washington, DC,

  • The American Hospital Association News reports,
    • “The Senate over the weekend is expected to cast a final vote on its revised budget resolution for fiscal year 2025. Senate Republicans April 3 voted to proceed on the resolution which kicked off debate. Today the Senate was slated to debate and process a number of amendments before holding a final vote on the resolution. The budget resolution is expected to pass and move to the House for consideration next week.” 
  • Per a CMS fact sheet,
    • The Centers for Medicare & Medicaid Services (CMS) issued a final rule on April 4, 2025, that modernizes and improves Medicare Advantage (MA), Medicare Prescription Drug Benefit (Part D), Medicare cost plan, and Programs of All-Inclusive Care for the Elderly (PACE) programs. The Contract Year (CY) 2026 MA and Part D final rule implements changes related to prescription drug coverage, the Medicare Prescription Payment Plan, dual eligible special needs plans (D-SNPs), Star Ratings, and other programmatic areas, including the Medicare Drug Price Negotiation Program. This final rule also codifies existing sub-regulatory guidance in the MA and Part D programs. 
    • CMS is not finalizing certain provisions from the proposed rule at this time. CMS may address these proposals in future rulemaking, as appropriate. CMS is also announcing that it is not finalizing three provisions from the proposed rule (Enhancing Health Equity Analyses: Annual Health Equity Analysis of Utilization Management Policies, Procedures and Ensuring Equitable Access to Medicare Advantage Services—Guardrails for Artificial Intelligence, and Part D Coverage of Anti-Obesity Medications (AOMs) and Application to the Medicaid Program). 
    • This fact sheet discusses the major provisions of the CY 2026 MA and the Part D final rule. The final rule can be downloaded here: https://www.federalregister.gov/public-inspection/2025-06008/medicare-and-medicaid-programs-contract-year-2026-policy-and-technical-changes-to-the-medicare. 
  • The Wall Street Journal emphasizes,
    • “The Trump administration said Friday that Medicare and Medicaid won’t expand coverage of popular anti-obesity drugs, rejecting a proposal issued late last year by the Biden administration.
    • “The decision deals a blow, at least for now, to Americans who are covered by the government health-insurance programs and wanted their help paying for the popular but pricey drugs. 
    • “Yet the administration left open the possibility of revisiting the decision later.
    • “Expanding coverage of the obesity medications “is not appropriate at this time,” a Centers for Medicare and Medicaid Services spokeswoman said.
    • “She said CMS may reconsider the policy after more review of the drugs’ “potential benefits” and “relevant costs,” including costs to state Medicaid agencies.”
  • For perspective, STAT News pointed out last September
    • A new report from congressional budget experts this week estimated that it would cost Medicare an additional $35 billion over nine years if the program began covering GLP-1 drugs for obesity. But the report also noted that half of seniors who would qualify for obesity coverage already have access to the drugs for other conditions.
  • Per a House Budget Committee news release,
    • “House Budget Committee Chairman Jodey Arrington (R-Texas) today appointed Budget Committee Member Rep. Blake Moore (R-Utah) to chair the Committee’s Health Care Task Force. 
    • “The Task Force will build on its work from the 118th Congress by examining opportunities to modernize and personalize the health care system and support policies to fuel innovation and increase patient access to quality and affordable care. One of the initial areas of focus for the Budget Health Care Task Force will be examining the budgetary effects of chronic disease and opportunities to Make America Healthy Again.” 
  • Per an HHS news release,
    • “HHS Secretary Robert F. Kennedy, Jr. will embark [next Monday through Wednesday] on a multi-state tour to celebrate MAHA initiatives in the Southwest. He will meet with elected officials, tribal leaders, nutrition experts, and charter school visionaries as he works to fulfill President Trump’s promise to Make America Healthy Again.

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 to low levels. Wastewater levels and emergency department visits are at 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 AHA News tells us,
    • “There are 607 confirmed cases of measles across the U.S., according to the latest data released April 4 by the Centers for Disease Control and Prevention. The majority of cases are in Texas, as an outbreak in the state has grown to 481 cases, according to the Texas Department of State Health Services.  
    • “Cases have been reported by 21 states, with 93% being outbreak-associated, according to the CDC. The vaccination status of 97% of cases is classified as “unvaccinated or unknown.” 
  • Per Health Day,
    • “Strokes caused by an artery tear are landing five times as many Americans in the hospital these days, a new study says.
    • “Cervical artery dissection involves a small tear in the inner lining of an artery in the neck that supplies blood to the brain.
    • “Blood can clot at the site of the tear. If the clot breaks loose, it can travel to the brain and cause a stroke.
    • “Hospitalizations for this sort of stroke have increased nearly fivefold during the past 15 years, according to findings published April 2 in the journal Neurology.
    • “Cervical artery dissection is an important cause of stroke, especially in people under 50, so it is crucial to detect it right away,” senior researcher Dr. Shadi Yaghi, a vascular neurologist at Brown University in Providence, R.I., said in a news release.
    • “Strokes that are not fatal can lead to long-term disability, poor mental health and reduced quality of life,” he said. “Our research found a dramatic increase in the number of hospitalizations for cervical artery dissection, with rates rising steadily year over year.” 
    • “These sort of tears in the cervical artery are most often caused by a motor vehicle crash or other accident that causes neck strain, researchers said. However, activities as simple as heavy lifting has been known to cause a cervical artery tear in some people.”
  • The New York Times shares “10 Small Things Neurologists Wish You’d Do for Your Brain. Easy everyday habits can help keep you sharp. And it’s never too late to start them.”
  • Per MedTech Dive,
    • “Boston Scientific’s pulsed field ablation catheter, Farapulse, was noninferior to Medtronic’s Arctic Front cryoballoon in a randomized trial, researchers found in a study published in The New England Journal of Medicine.
    • “The study, which was published Monday and funded by a Swiss hospital, randomized 210 patients with symptomatic paroxysmal atrial fibrillation to undergo PFA or cryoablation. Atrial tachyarrhythmia, a heart rhythm disorder where the atria beat too fast, recurred in 39 patients in the PFA cohort and 53 people in the cryoablation group.
    • “Medtronic reported declines in its cryoablation business last year but said the losses were offset by growth of its PulseSelect single-shot catheter, which competes with Farapulse for the growing PFA market.”

From the U.S. healthcare business front,

  • Fierce Healthcare informs us,
    • “Rural areas are quickly losing independent physicians and medical practices amid the corporatization of healthcare, a new report finds.
    • “The report was commissioned by the Physicians Advocacy Institute (PAI), a nonprofit advocacy organization focused on fair and transparent payment policies. The research, conducted by Avalere Health, used the IQVIA OneKey database, which contains physician and practice location information on health system ownership.
    • “The number of independent doctors in rural areas fell 43% from January 2019 to January 2024, with rural areas losing 5% of all practicing physicians. Meanwhile, people in rural areas had access to 11% fewer medical practices as of January 2024.
    • “Nearly 9,500 doctors left independent practice in rural areas, predominantly in the Midwest and Northeast. States like Indiana, Massachusetts, New Jersey and Ohio lost more than 50% of independent docs.
    • “This decline in rural healthcare providers has been primarily driven by a drop in independent docs and practices as well as the acquisition of these practices by hospitals and corporate entities, the report said.” 
  • Beckers Hospital Review lets us know,
    • “South Bend, Ind.-based Beacon Health System has signed a definitive agreement to acquire Ascension Michigan’s southwest region, which includes four hospitals, 35 outpatient clinics and an ambulatory surgery center.
    • “The hospitals include:
      • “Ascension Borgess Hospital (Kalamazoo)
      • “Ascension Borgess Allegan Hospital
      • “Ascension Borgess-Lee Hospital (Dowagiac)
      • “Ascension Borgess-Pipp Hospital (Plainwell)
    • “Expanding our reach deeper into southwest Michigan broadens access to high-quality, affordable care for communities served by Ascension, extends our service area and provides growth opportunity to further strengthen the health system,” Beacon Health CEO Kreg Gruber said in an April 3 news release. “This acquisition will create a bright future for these communities by ensuring access to quality healthcare services for generations.”
  • Per Fierce Pharma,
    • “With a label expansion for Uplizna pushing the drug into an untouched rare disease market, Amgen is getting its money’s worth out of another drug from its $27.8 billion Horizon Therapeutics buy. 
    • “Uplizna is the first drug to win an FDA approval for immunoglobulin G4-related disease (IgG4-RD), a chronic inflammatory condition that can present in multiple organs and cause fibrosis and permanent organ damage, with or without symptoms.
    • “The CD19-targeted therapy made strides in treating the disease in its phase 3 MITIGATE trial. In the study, Uplizna demonstrated an 87% reduction in the risk of IgG4-RD flares over placebo during the 52-week placebo-controlled period, with 10.3% of those on Uplizna experiencing a flare-up compared to 59.7% of those taking placebo.
    • “With the approval, patients and physicians now have a “proven treatment that targets a key driver of the disease, reducing the risk of flares and reliance on harmful long-term steroid use,” Amgen’s executive vice president of R&D Jay Bradner, M.D., said in a company release. “This approval underscores Amgen’s ongoing commitment and leadership in developing innovative treatments targeting CD19+ B-cells across multiple therapeutic areas.”
    • “Now, the road ahead for Amgen’s success in IgG4-RD lays in raising awareness of the rare disease, which was only recently established with an International Classification of Diseases code in 2023. About 20,000 people are estimated to have the disease in the U.S., but the exact number is hard to pinpoint due to limited data, according to Amgen.”
  • and
    • “As the respiratory syncytial virus (RSV) vaccine field grapples with a significantly reduced market size thanks to regulatory uncertainties, GSK and Pfizer have decided to lay to rest their patent feud.
    • “GSK and Pfizer have moved to scrap a patent lawsuit around their respective RSV vaccines, according to a filing in the U.S. District Court in Delaware.
    • “The settlement comes after a U.K. high court in November sided with Pfizer, ruling that two GSK RSV vaccine patents were invalid.”

From the artificial intelligence front,

  • Beckers Payer Issues discusses how health plans can use “AI to Drive Patient Outcomes & Health Plan ROI.”
  • Modern Healthcare adds,
    • “Artificial intelligence and other cutting-edge innovations could radically reshape how care is delivered, but tapping technology’s full potential and getting a return on investments is far off, according to industry executives.
    • “We need enduring, ambitious vision,” said Dr. Vivek Garg, chief medical officer at Humana’s CenterWell healthcare services division, during Modern Healthcare’s 2030 Playbook conference in Nashville Wednesday. “You’re going to need the leadership and the board to make trade-offs and to make investments. …They’ve got to do it because they know what they stand for, and they want to see what they can become and how much further they can go in their vision.” * * *
    • “More collaboration between payers and providers is imperative, said Mike Bennett, chief strategy and transformation officer at Highmark Health.
    • “If we both don’t start working together and using the tools we both have, we’re going to end up leaving [our populations] behind,” Bennett said. “AI doesn’t care whether you’re a payer or provider.”

Friday Report

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

From Washington, DC

  • Fierce Healthcare lets us know,
    • Bipartisan lawmakers have introduced a bill that aims to more closely align Medicare insurers’ prior authorization denials with medical need, as determined by board-certified specialist physicians.
    • The Reducing Medically Unnecessary Delays in Care Act of 2025 was introduced in the House Thursday by Rep. Mark Green, M.D., R-Tennessee, and referred to committee. It is a reintroduction of similar bills brought by the lawmaker in 2023 and 2022.
    • Green—along with Reps Greg Murphy, M.D., R-North Carolina, and Kim Schrier, M.D., D-Washington, who also backed the bill—said the legislation will help streamline necessary care and reduce administrative burden and burnout among providers.
  • Roll Call tells us,
    • “President Donald Trump on Friday threw his support behind the funding fix needed to allow the District of Columbia’s government to avoid $1.1 billion in budget cuts squeezed in the remaining half of the fiscal year, all but ensuring House passage of legislation the Senate passed two weeks ago.
    • “The full-year stopgap spending law, drafted by House Republicans, did not include the typical provision that would allow the D.C. government to tap into its fiscal 2025 budget for operating costs. This would force D.C. to go back to the previous year’s funding levels for the remainder of the fiscal year, which runs through Sept. 30, which local officials say would require steep cuts in critical services like law enforcement and education.”
  • STAT News reports,
    • “Peter Marks, the top Food and Drug Administration official who oversaw vaccines, gene therapies, and the blood supply, resigned Friday after being told by Trump administration officials he would be fired if he did not step down, according to people familiar with the situation.”
  • and
    • “President Trump has selected Sara Carter, a conservative journalist and Fox News contributor, as the nation’s next drug czar.” * * *
    • “If confirmed by the Senate, Carter would oversee the White House Office of National Drug Control Policy, an executive office housed across the street from the West Wing that makes policy recommendations and coordinates efforts between various federal agencies focused on substance use, both from a law enforcement and public health perspective.” 
  • Per an HHS news release,
    • “U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. today joined West Virginia Governor Patrick Morrisey for a press conference at the St. Joseph School in Martinsburg, WV, to celebrate the signing of new legislation banning seven types of harmful food dyes from school lunches beginning August 2025. Governor Morrisey announced at the event that he intends to request a waiver to restrict taxpayer funds from being used to purchase soda through the SNAP program.”

From the judicial front,

  • Healthcare Dive points out,
    • “The Department of Justice agrees that Claritev, formerly known as MultiPlan, conspired with health insurers to underpay doctors for medical care, according to a statement of interest filed by antitrust regulators on Wednesday in the consolidated lawsuit from providers against the cost management firm.
    • “Lawyers for the providers said the DOJ’s position affirms the validity of their case, while Claritev reiterated that it believes the lawsuits are without merit.
    • “The DOJ’s interest in the case signals antitrust regulators, including in the Trump administration, are still closely scrutinizing exchanges of potentially sensitive information between companies, along with their use of pricing algorithms.”

From the Food and Drug Administration front,

  • Per Fierce Pharma,
    • “After much delay, Novartis has finally won a key FDA go-ahead for Pluvicto, opening up the radioligand therapy to a much broader prostate cancer population.
    • “The new approval, which triples Pluvicto’s eligible patient population, allows the radiopharmaceutical to treat PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) before taxane-based chemotherapy, Novartis said Friday. Patients will have to have been treated with an androgen receptor pathway inhibitor (ARPI) to be considered.
    • “Pre-chemo mCRPC represents the most important indication in Novartis’ plan for Pluvicto to achieve more than $5 billion in peak sales. Initially cleared by the FDA in 2022 in the post-chemo setting, Pluvicto’s revenue is currently annualizing at about $1.5 billion based on its most recent quarterly number.”
  • and
    • Over the last three years, the FDA has approved six new hemophilia drugs, including three gene therapies.
    • Into this crowded treatment landscape comes another new medicine as the FDA has signed off on Sanofi’s Qfitlia (fitusiran), which sets itself apart as the only treatment for all types of hemophilia.
    • Not only is Qfitlia for those with hemophilia A and B, but unlike most treatments for the disorder, it also can be used by patients regardless of their inhibitor status.
  • Per an FDA press release,
    • “Today, the U.S. Food and Drug Administration granted marketing authorization to Visby Medical for the Visby Medical Women’s Sexual Health Test. This is the first diagnostic test for chlamydia, gonorrhea and trichomoniasis that can be purchased without a prescription and performed entirely at home. The test is intended for females with or without symptoms and delivers results in approximately 30 minutes.
    • “Home tests can give people information about their health from the privacy of their home. This can be particularly important for sexual health tests for which patients may experience fear or anxiety, possibly resulting in delayed diagnosis or treatment,” said Courtney Lias, Ph.D., director of the Office of In Vitro Diagnostic Devices in the FDA’s Center for Devices and Radiological Health. “Expanding access to tests for sexually transmitted infections is an important step toward earlier and increased diagnosis, which can result in increased treatment and reduced spread of infection.” * * *
    • “This announcement follows last year’s authorization of the first at-home syphilis test, as well as the authorization of the first diagnostic test for chlamydia and gonorrhea with at-home sample collection in 2023, which was the first FDA-authorized test with at-home sample collection for any sexually transmitted infection other than HIV.”
  • Per Managed Health Executive,
    • “Fresenius announced today [March 27, 2025] that the FDA has approved the biologics licensing applications (BLA) for denosumab biosimilars Conexxence (denosumab-bnht) and Bomyntra (denosumab-bnht), according to a news release. Prolia, the reference product for Conexxence, and Xgeva, the reference product for Bomyntra, were both developed by Amgen. As a result of a global settlement between Fresenius and Amgen, both biosimilars are expected to launch in the United States in mid 2025 and in the second half of 2025 in Europe.
    • “Bomyntra and Conexxence are the fourth pair of denosumab biosimilars. Other Prolia biosimilars include Jubbonti, Ospomyv and Stoboclo. Additional Xgeva biosimilars include Wyost, Xbryk and Osenvelt.
    • “Although the active drug ingredient in Conexxence and and Bomyntra is deosumab, they have different indications.
    • ‘Conexxence is approved for patients at high risk for fractures, including osteoporosis patients and patients undergoing cancer treatments that affect bone density. It comes as a 60 mg/mL single-dose prefilled injection to be administered every six months via subcutaneous injection. Adverse reactions varied by indication.”

From the public health and medical research front,

  • The Center for Disease Control and Prevention announced today,
    • “COVID-19
      • “COVID-19 activity is declining nationally to low levels. Wastewater levels and emergency department visits are at 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
      • “Seasonal influenza activity continues to decline; however, CDC expects several more weeks of flu activity.
      • “Additional information about current influenza activity can be found at: Weekly U.S. Influenza Surveillance Report | CDC
    • “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 Association News adds,
    • “There are 483 confirmed cases of measles in 19 states across the country, according to the latest data from the Centers for Disease Control and Prevention. The agency said 93% of the cases are outbreak-associated. The vaccination status of 97% of cases is classified as “unvaccinated or unknown.”
  • NBC News adds,
    • “We are experiencing an extremely concerning decline in measles vaccination in the very group most vulnerable to the disease,” said Benjamin Rader, a computational epidemiologist at Boston Children’s Hospital, an assistant professor at Harvard Medical School and the author of a recent study that looked at children’s vaccination rates.” * * *
    • “Rader said that the true MMR vaccination rate among young children can be misrepresented by publicly reported numbers, because MMR surveillance is drawn from older children who are already in kindergarten.
    • “Younger children under the age of 5 are not fully captured in surveillance data because they have not reached kindergarten age — although a 2021 estimate from the CDC notes a subset of younger children, namely those who received at least one MMR dose by 24 months, were 90.6% vaccinated for measles.
    • “In Rader’s study, published online in February in the American Journal of Public Health, his team surveyed approximately 20,000 parents of children under 5 from July 2023 through April 2024, finding only 71.8% reported that their children received at least 1 dose of MMR vaccine — much lower than CDC estimates.
    • “The researchers used a digital surveillance platform that the CDC has used to estimate things like at-home Covid testing, he said.  
    • “Rader downplayed the difference in numbers between his findings and the CDC data, emphasizing that, while accurate, the CDC data does not provide a complete picture — despite its best intentions.
    • “Dr. Scott Roberts, associate medical director of infection prevention at the Yale School of Medicine in New Haven, Connecticut, who was not part of the research, called the findings “worrisome.”   
  • Health Day relates,
    • “Tobacco control measures like anti-smoking campaigns and cigarette taxes have prevented nearly 4 million lung cancer deaths during the past five decades, a new American Cancer Society study estimates.
    • “More than 3.8 million lung cancer deaths were averted due to substantial reductions in smoking, gaining a little more than 76 million years of extra life among Americans, researchers say in CA: A Cancer Journal for Clinicians.
    • “The substantial estimated numbers of averted lung cancer deaths and person-years of life gained highlight the remarkable effect of progress against smoking on reducing premature mortality from lung cancer,” lead investigator Dr. Farhad Islami, the ACS’ senior scientific director for cancer disparity research, said in a news release. 
    • “In fact, the number of averted lung cancer deaths accounts for roughly one-half of all cancer deaths that were prevented in recent decades, researchers said.
    • “However,” Islami added, “Despite these findings, lung cancer is still the leading cause of cancer death in the United States, and smoking-attributable morbidity and mortality from other cancers or diseases remain high.”
  • Per Healio,
    • “There were 69 nonfatal fentanyl exposures in 2015 and 893 in 2023.
    • “Two-thirds of adolescents who were exposed to fentanyl used it intentionally.” * * *
    • “According to the researchers, nearly 39.4% of all overdoses and 65.7% of those among adolescents involved intentional misuse or abuse. In contrast, 81.7% of overdoses among younger children were reported to be unintentional.
    • “It was surprising that a large portion of adolescents used fentanyl intentionally,” Palamar said. “We often think of pediatric exposures to fentanyl as being unintentional.”

From the AI front,

  • Per an NSF news release,
    • “Powered exoskeletons that enable humans to move faster or lift heavy objects more easily have been envisioned for decades. In science fiction, advanced exoskeletons such as the power loader in the movie “Aliens” or Marvel Comics’ Iron Man’s suit provide the wearer with superhuman capabilities with nearly zero limitations.
    • “There are exoskeletons in use today, but current technology falls short of the vision laid out in science fiction, and widespread use of exoskeletons is hampered because to work properly, a suit must be tested and adapted to work with each user individually, a complicated and lengthy process.
    • “Now, engineering researchers supported by the U.S. National Science Foundation have made a breakthrough, creating a new method that takes advantage of artificial intelligence and computer simulations to improve the process of enabling users and exoskeletons to work together. This framework is compatible with a variety of assistive devices and could improve the lives of millions of able-bodied and mobility-impaired individuals.
    • “This marks a major advance in exoskeleton engineering by eliminating one of its biggest hurdles: individualized calibration,” said Alexander Leonessa, program director for the NSF Mind, Machine and Motor Nexus program. “Using AI and human-robot simulations, the team developed a scalable, adaptable system that assists a wide range of users without lengthy setup. It is a key step toward making exoskeletons practical, versatile and accessible for both industry and mobility-impaired individuals – smart, human-centered engineering at its best.”

From the U.S. healthcare business front,

  • FiercePharma reports,
    • “A rival bidder has emerged to acquire struggling gene therapy specialist bluebird bio.
    • Ayrmid has offered to buy bluebird for $4.5-apiece upfront, plus a one-time contingent value right (CVR) of $6.84 per share tied to a sales milestone, bluebird said Friday.
    • “The upfront tag is 50% higher than the $3-per-share selling price that bluebird has previously penned with Carlyle and SK Capital Partners. That private equity duo’s buyout offer also includes a $6.84-per-share CVR.
    • “For now, bluebird’s board has not changed its mind and the company remains bound by the original merger agreement. But it’s willing to look at the new unsolicited non-binding written proposal.
    • “Consistent with its fiduciary duties, the bluebird Board of Directors is carefully reviewing the Ayrmid proposal in consultation with its legal and financial advisors,” the Massachusetts biopharma said Friday.”
  • Beckers Hospital Review tells us,
    • “Insight Hospital and Medical Center Trumbull and Hillside Rehabilitation Hospital, both in Warren, Ohio, paused all inpatient, outpatient and emergency room services March 27 due to ongoing bankruptcy and financial disruptions from former owner Dallas-based Steward Health Care.
    • “Tom Connelly, local president of the American Federation of State, County and Municipal Employees, told NBC affiliate WFMJ March 28 that the hospitals also laid off the director of nursing, the assistant director of nursing, the administrative secretary and the human resources coordinator.
    • “A spokesperson for Insight Health refuted the claims to Becker’s and denied upper management layoffs.
    • “Existing patients at both Insight hospitals are being transferred, with appointments being canceled to protect patient safety, an Insight Health spokesperson said in a March 27 statement shared with Becker’s.
  • Beckers Payer Issues informs us,
    • “Enrollment in provider-sponsored Medicare Advantage plans declined by nearly 60,000 members for 2025, according to a report from Chartis. 
    • “The healthcare consulting firm published an analysis of CMS Medicare Advantage enrollment data March 25. 
    • “Overall, Medicare Advantage plans gained 1.3 million new enrollees, a smaller growth rate than the program has seen in previous years. 
    • “Kaiser Permanente saw the largest membership growth for 2025 among provider-sponsored plans, gaining 58,000 new members. Trinity Health and UPMC Health Plan each added 11,000 MA members.” 

Happy Pi Day!

David Ermer–CDC, CMS, Congress, COVID-19, FDA, Government Contracting, Medical / Rx research, Medicare, Obesity, U.S. Healthcare–

From Washington, DC

  • The American Hospital Association (AHA) News lets us know,
    • “The Senate March 14 approved by a vote of 54-46, a continuing resolution to fund the government through Sept. 30. The House passed, by a vote of 217-213, the bill earlier in the week. President Trump is expected to sign the measure.
    • “The bill extends certain key health care provisions that were set to expire at the end of March, including eliminating Medicaid disproportionate share hospital cuts, and extending the enhanced low-volume adjustment and Medicare-dependent hospital programs; key telehealth waivers; the hospital-at-home program; the Work Geographic Index Floor program; and add-on payments for ambulance services.”
  • Upshot — No government shutdown.
  • Fierce Healthcare adds,
    • “A last-ditch effort to pass a bipartisan healthcare package pushed aside at the end of 2024 that includes telehealth extensions and pharmacy benefit manager reform, reverses doc pay cuts and addresses the opioid crisis has failed.
    • “That legislation was brought to the floor by Senators Ron Wyden, D-Oregon and Bernie Sanders, I-Vermont, March 14 ahead of a key procedural vote [on the continuing resolution]. The senators’ bill required unanimous consent, or it would not advance. Sen. Rick Scott, R-Florida, quickly rejected the bill.”
  • Per a Senate news release,
    • “Today, the Senate overwhelmingly voted to pass the Halt All Lethal Trafficking of (HALT) Fentanyl Act. The bipartisan legislation, led by Judiciary Chairman Chuck Grassley (R-Iowa), Health, Education, Labor and Pensions Chairman Bill Cassidy, M.D. (R-La.) and Sen. Martin Heinrich (D-N.M.), would permanently classify fentanyl-related substances before their temporary Schedule I status expires on March 31, 2025. 
    • “Last month, the HALT Fentanyl Act was passed out of the Senate Judiciary Committee by a bipartisan vote of 16-5. Attorney General Pam Bondi has endorsed the legislation. President Trump’s Office of Management and Budget has confirmed that, if Congress passes the bill in its current form, the president will sign it. The legislation now heads to the House of Representatives.
    • “The HALT Fentanyl Act is a critical step towards ending the crisis that’s killing hundreds of thousands of precious American lives. I thank my Senate colleagues for passing this bill with broad, overwhelming support. I urge my House colleagues to swiftly pass the Senate version of this battle-tested, bipartisan bill to save lives, advance research and support our brave men and women in blue,” Grassley said.: * * *
    • “Download bill text HERE and a fact sheet HERE.”
  • The AHA News tells us,
    • “The Senate Finance Committee March 14 held a confirmation hearing on Mehmet Oz’s nomination for administrator of the Centers for Medicare & Medicaid Services. Oz, a doctor and former television show host, indicated that some of his priorities in the position, if confirmed, would be to reduce health care spending by improving poor health, increasing use of technology, incentivizing providers, and stopping wasteful spending, fraud and abuse. The committee will soon schedule a vote on whether to advance his nomination to the full Senate.”
  • The Wall Street Journal adds,
    • “Mehmet Oz, the Trump administration’s nominee to lead the Medicare agency, said some actions by private insurers in the Medicare Advantage program amounted to fraud and cheating, and he intended to go after them as head of the Centers for Medicare and Medicaid Services. 
    • “His comments, during his Senate confirmation hearing on Friday, were focused on industry practices that can boost insurers’ Medicare Advantage payments by documenting more diagnoses in their patients. Medicare Advantage insurers get higher payouts when patients have certain conditions. 
    • “There’s a new sheriff in town,” said Oz, a heart surgeon known for his long-running television show. He criticized “upcoding” in Medicare Advantage and said, “I pledge if confirmed I will go after it.”
  • Per Senate news releases,
    • “Sen. Chuck Grassley (R-Iowa), a senior member and former chairman of the Senate Finance Committee, laid out his health care priorities during a hearing to consider Dr. Mehmet Oz’s nomination to be Administrator of the Centers for Medicare and Medicaid Services (CMS). Oz committed to supporting Grassley’s efforts to lower prescription drug costs, strengthen rural health care, help kids with exceptional medical needs, preserve transitional health plans and improve the agency’s responsiveness to Congress.”
  • and
    • “At a U.S. Senate Finance Committee hearing to consider the nomination of Dr. Mehmet Oz to be Centers for Medicare and Medicaid Services (CMS) Administrator, Chairman Mike Crapo (R-Idaho) highlighted Dr. Oz’s wealth of firsthand experience as an accomplished physician and his clear vision for creating a healthier nation.  Crapo and Dr. Oz discussed how he would address the nation’s chronic disease epidemic, as well as how he might approach reforming payment programs to improve efficiency.
    • “Crapo concluded the hearing with, “There is no doubt you are qualified to serve as the next Administrator of [CMS], and I look forward to voting in favor of your nomination and am urging all of my colleagues to do the same.”
  • The AHA News informs us,
    • “The Medicare Payment Advisory Commission March 13 released its March report to Congress that includes recommendations for hospital and other Medicare payment systems for fiscal year 2026. Among the recommendations, MedPAC urged Congress to update the base payment rate for hospitals by current law plus 1%.  
    • “An update above current law is necessary given the combination of providers’ continued financial pressures, and almost two decades of sustained and substantial negative Medicare margins,” AHA wrote in a January letter to MedPAC. “Simply put, even after the recommended payment update, Medicare’s payments to hospitals would remain inadequate.” 
  • Per a Food and Drug Administration news release,
    • “Today, a study co-authored by U.S. Food and Drug Administration scientists was released showing the agency’s youth e-cigarette prevention campaign, “The Real Cost,” successfully reduced e-cigarette use among youth. The campaign, which launched in 2018 under the leadership of President Trump, was found to have prevented an estimated 444,252 American youth (age 11 to 17 at study recruitment) from starting to use e-cigarettes between 2023 and 2024.
    • “The new study, published in the peer-reviewed scientific journal American Journal of Preventive Medicine, found evidence that the campaign contributed to the nearly 70% decline in e-cigarette use among American youth that has occurred since 2019. According to the National Youth Tobacco Survey, the number of U.S. middle and high school students who currently use e-cigarettes has declined from 5.38 million in 2019 to 1.63 million in 2024, the lowest level in a decade.”

From the judicial front,

  • Politico reports,
    • “A federal appeals court has given President Donald Trump’s administration the go-ahead to enforce a pair of controversial executive orders that seek to root out diversity, equity and inclusion efforts in federal agencies and government contractors.
    • “The three-member appeals panel — including two judges appointed by Democratic presidents — lifted a lower court’s injunction that had put the policy on hold last month.
    • The ruling Friday from the panel of the Richmond, Virginia-based 4th Circuit Court of Appeals is not a final decision on the legality of Trump’s anti-DEI policy. It merely allows the government to administer the policy while litigation continues.
    • “In separate opinions explaining their votes, the three judges suggested the Trump administration should be allowed to demonstrate that it will abide by anti-discrimination laws and respect First Amendment rights as it implements the executive orders, which Trump issued on the first two days of his new term.”

From the public health and medical research front,

  • The Center for Disease Control and Prevention announced today,
    • “Seasonal influenza activity remains elevated nationally but has decreased for four consecutive weeks. COVID-19 activity is declining nationally but elevated in some areas of the country. RSV activity is declining in most areas of the country.
    • “COVID-19
      • “COVID-19 activity is declining nationally but elevated in some areas of the country. Wastewater levels and emergency department visits are at 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
      • “Seasonal influenza activity remains elevated nationally but has decreased for four consecutive weeks. Data to date suggest the season has peaked, however, flu-related medical visits, hospitalizations, and deaths remain elevated, and CDC expects several more weeks of flu activity.
      • “Additional information about current influenza activity can be found at: Weekly U.S. Influenza Surveillance Report | CDC
    • “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 University of Minnesota’s CIDRAP reports,
    • “The measles outbreak in Texas has risen by 36 cases, pushing the US case count for the year past the number for all of 2024.
    • “The outbreak of the highly contagious virus, which began in late January and is centered in the western part of the state, now stands at 259 cases, according to the latest update from the Texas Department of State Health Services (DSHS). Of those patients, 257 are either unvaccinated or have unknown vaccination status, and 201 are children ages 17 or younger. Thirty-four patients have been hospitalized, with one death in an unvaccinated child who had no known underlying conditions.
    • “Eleven counties to date have reported cases, but two thirds of the cases (174; 67%) are in Gaines County, which has one of the highest rates of school-aged children in Texas who have opted out of at least one vaccine. The county is home to a large Mennonite community with low vaccination rates.
    • “DSHS officials said they have determined that three of the case-patients previously listed as vaccinated were not vaccinated. Two had received their measles, mumps, and rubella (MMR) vaccine doses 1 to 2 days before their symptoms started and after they had been exposed to the virus. The third had a vaccine reaction that mimicked a measles infection and has been removed from the case count.”
  • The University of Minnesota CIDRAP also notes,
    • “The US Food and Drug Administration (FDA) yesterday announced the strains it recommends manufacturers include in seasonal flu vaccines for the 2025-26 flu season, and [as usual] they mirror recommendations announced by the World Health Organization (WHO) last month.” 
  • Gallup reports,
    • “Americans’ assessments of their mental and physical health are the least positive they have been in Gallup’s 24-year trend, reflecting a decadelong decline that began around 2013 and accelerated sharply with the onset of the COVID-19 pandemic in 2020.
    • “Three in four U.S. adults in Gallup’s latest annual reading rate their mental health (75%) and, separately, their physical health (76%) as either “excellent” or “good.” This contrasts with a record-high 89% rating their mental health positively as recently as 2012, and a high of 82% for physical health in 2003.
    • “As fewer Americans have rated their mental and physical health positively, most of the change has been in the percentages rating each aspect “excellent” — shrinking to 31% for mental health and 24% for physical health.”
  • The National Science Foundation points out,
    • “A team of researchers led by the recipient of a U.S. National Science Foundation Faculty Early Career Development grant has developed a new storage method for protein-based drugs that could potentially eliminate the need for refrigeration of important medicines. Using an oil-based solution and a molecule acting as a coating to enclose the proteins in these drugs, researchers demonstrated a technique to prevent the proteins from degrading rapidly — a protection that traditionally requires refrigeration.
    • “The research is led by Scott Medina at Pennsylvania State University and published in Nature Communications. It demonstrates a possible practical application to eliminate the need to refrigerate hundreds of life-saving medicines like insulin, monoclonal antibodies and viral vaccines.
    • “The work could eventually reduce the cost of refrigerating such drugs throughout the supply chain and enable greater use of protein-based therapies where constant refrigeration isn’t possible, including military environments. 
    • “Over 80% of biologic drugs and 90% of vaccines require temperature-controlled conditions. This approach could revolutionize their storage and distribution, making them more accessible and affordable for everyone,” says Medina.”
  • Per a National Institutes of Health news release,
    • “Researchers at the National Institutes of Health (NIH) have determined that dermatitis resulting from topical steroid withdrawal (TSW) is distinct from eczema and is caused by an excess of an essential chemical compound in the body. Scientists from NIH’s National Institute of Allergy and Infectious Diseases (NIAID) identified treatments that could be studied in clinical trials for the condition based on their potential to lower levels of the chemical compound—called nicotinamide adenine dinucleotide (NAD+), a form of vitamin B3. The findings were published today in the Journal of Investigative Dermatology.
    • “Dermatitis is characterized by inflammation, itching, or burning sensations on the skin, and can result from various conditions including TSW and eczema. Eczema, also known as atopic dermatitis, is a common cause of dermatitis and affects 10 to 30% of children and 2 to 10% of adults each year in the United States. Topical steroids—specifically glucocorticoids or topical corticosteroids—have long been used as a first-line treatment for dermatitis caused by eczema because the drugs are safe, effective, easy to apply, and considered well-tolerated.” * * *
    • “The scientists provisionally established criteria that can be used by health care providers to identify TSW in people. People who have stopped topical steroid treatment and meet the criteria may be diagnosed by practitioners as having TSW. The researchers suggest that patients identified as having TSW could be treated using the proposed mitochondrial complex I-blocking drugs.
    • “The results of this study may help practitioners identify TSW in patients and work towards developing safe and effective treatments. According to the researchers, more research is needed to determine whether all patients with TSW have an excess of NAD+, or if there are other features that define TSW. Additionally, the diagnostic criteria will help health care providers and researchers to better understand the prevalence of TSW and evaluate the effects of using topical steroids.”

From the U.S. healthcare business front,

  • The New York Times reports,
    • “It’s easy to make a medical case for blockbuster weight loss drugs like Wegovy and Zepbound, which have been shown to prevent heart attacks and strokes and save lives.
    • “But for the employers and government programs being asked to pay for the medications, the financial case for them is less clear. Are the drugs’ benefits worth their enormous cost?
    • “The answer right now is no, according to a new study published on Friday in the journal JAMA Health Forum, by researchers at the University of Chicago.
    • “To be considered cost effective by a common measure used by health economists, the price of Novo Nordisk’s Wegovy would need to be cut by over 80 percent, to $127 per month, the researchers concluded. And Eli Lilly’s Zepbound would be cost effective only if its price fell by nearly a third, to $361 per month. (Zepbound warranted a higher price, the researchers said, because it produced greater benefits in clinical trials.)”
  • Per STAT News,
    • “Biotech company Altimmune announced in an investor call yesterday that it will study its obesity drug, which targets receptors of the GLP-1 and glucagon hormones, in alcohol use disorder, as mounting evidence supports the potential of GLP-1 drugs to help with addiction.
    • “Altimmune executives think that their molecule, called pemvidutide, could be particularly helpful for liver conditions, since there are glucagon receptors located in the liver. The company has already been studying the drug in weight loss and in the liver disease MASH, and are now expanding into alcohol-related conditions.
    • “The company plans to start a study in alcohol use disorder in the second quarter of this year, and another study in alcohol-related liver disease in the third quarter.
    • “Eli Lilly has also started studying mazdutide, a GLP-1/glucagon drug it’s developing with Chinese biotech Innovent, in alcohol use disorder. Lilly CEO Dave Ricks has said the company also plans to test obesity drugs in other areas of addiction, like nicotine and drug use disorders.
    • “Novo Nordisk is running a study of its obesity drugs in alcohol-related liver disease but has not yet started any trials in addiction.”
  • Per Beckers Hospital CFO Report,
    • As healthcare organizations continue to navigate shifting financial and operational landscapes, new data from Kaufman Hall and Strata highlights significant trends in physician productivity, compensation, and costs.
    • In the fourth quarter, median work relative value units per full-time physician varied across specialties, with medical specialties leading at 7,139 wRVUs. Physician compensation followed a similar pattern, with surgical specialists earning the highest median paid compensation at $491,000 per FTE.
    • Despite an encouraging increase in net revenue per physician, rising expenses remain a challenge. These figures underscore the mounting financial pressures and workforce challenges facing healthcare organizations. For executives, balancing rising costs, evolving productivity demands, and compensation structures will be critical in sustaining financial stability and operational efficiency.
  • Beckers Hospital Review points out ten drugs poised to be top sellers next year.

Midweek Report

David Ermer–CDC, CMS, Congress, FDA, Generative AI, Medical / Rx research, Medicare, NIH, Obesity, Patient safety, U.S. Healthcare–

From Washington, DC

  • The Wall Street Journal reports,
    • “Senate Minority Leader Chuck Schumer (D., N.Y.) threw a wrench into a Republican plan to avert a government shutdown this weekend, saying there wasn’t enough Democratic support to advance the measure funding federal agencies through Sept. 30.
    • “Republicans “do not have the votes in the Senate,” to move the resolution forward, Schumer said on the Senate floor, indicating that his party was prepared to block it. He blamed Republicans, saying they “chose a partisan path” in their bill without any input from congressional Democrats.  
    • “As an alternative, Schumer floated a shorter-term plan that would fund the government for a month. “I hope my Republican colleagues will join us to avoid a shutdown on Friday,” he said.
    • “Government funding will lapse at 12:01 a.m. Saturday if Congress doesn’t act. The GOP-led House left town after it approved Republicans’ resolution on Tuesday, effectively giving the Senate no time to revise the bill—but to simply pass it or reject it.”
  • The Hill adds,
    • Some Democrats floated the idea that an amendment vote on the 30-day CR, which would fail, could be won in exchange for the requisite number of votes to advance the GOP bill. Some Republicans could support it, according to Sen. Tim Kaine (D-Va.), but not enough that it would be adopted. 
    • “It remains unclear whether Republicans would go along with that though. Senate Majority Leader John Thune (R-S.D.) did not fully shoot down the idea. 
    • “I think there would have to be some understanding,” he told The Hill on Wednesday evening. “We’ll see. I’m not sure exactly what their demand is — if they just need a vote on that, and if in exchange for that they’ll give us the votes to fund the government.”
    • “Thune added that discussions are “going on right now” on a path forward, but he also panned the idea of a full shift to a 30-day CR in order to finish 2025 appropriations bills.”
  • The Wall Street Journal further tells us,
    • “The Centers for Medicare and Medicaid Services plans to terminate four demonstration projects at the end of 2025, closing out models affecting primary care, kidney care and healthcare payments in the state of Maryland.
    • “The agency will also make changes to other projects, including dropping a planned initiative that would offer certain generic drugs to Medicare enrollees for $2. CMS said its planned terminations would save nearly $750 million, and an agency official said the projects would affect millions of patients.”
  • Per Modern Healthcare,
    • “Johnson & Johnson MedTech said Wednesday its Monarch Quest robotic platform received clearance from the Food and Drug Administration.
    • “Robotic-assisted bronchoscopy is a minimally invasive technique that allows surgeons to reach airways and suspicious lung nodules.”

From the public health and medical research front,

  • The New York Times reports,
    • “Measles continues to spread in West Texas and New Mexico, with more than 250 people infected — many unvaccinated school-age children. Two cases in Oklahoma, for which state officials have not provided a location, have also been linked to these outbreaks. Twelve other states have reported isolated measles cases, typically linked to international travel.”
  • The American Medical Association lets us know what doctors wish patients knew about measles.
  • STAT News reminds us,
    • “The 2020s have inarguably been Covid-19’s decade. 
    • “Since the coronavirus outbreak was acknowledged as a pandemic exactly five years ago, the pandemic has killed well over 1 million Americans, derailed the global economy, and sparked political upheaval that continues today. It also yielded what many hail as the greatest scientific accomplishment in human history: the development of effective vaccines in under a year. 
    • “Yet in dominating the early 2020s, Covid-19 also distracted from what is arguably a more significant public health emergency. Even at the height of the pandemic, more young Americans died of drug overdose than Covid. And in the last year, the overall death toll from the country’s drug crisis has exceeded the Covid-19 pandemic as the deadliest health event this generation.”
  • MedPage Today notes,
    • “Using only targeted models of syphilis screening in the emergency department (ED) would miss large proportions of active syphilis cases as well as new HIV diagnoses and acute HIV cases, according to new research.
    • “Only screening patients for syphilis who came to the ED for gonorrhea and chlamydia testing would have missed 76.4% of positive syphilis screens as well as 68.7% of new HIV diagnoses, reported Kimberly Stanford, MD, MPH, of the University of Chicago Medical Center.”
  • Healio informs us,
    • “An increase in depressive symptoms was observed among U.S. teenagers without, rather than with, behavioral risk factors, underscoring the need for greater screening in this population, data show. 
    • “Over the last decade, national survey data has revealed a sharp rise in depressive symptoms among U.S. adolescents,” Tanner J. Bommersbach, MD, MPH, child and adolescent psychiatrist and assistant professor at the University of Wisconsin School of Medicine and Public Health, told Healio regarding the research presented in The Lancet Regional Health Americas. “Yet, surprisingly little is known about what is driving this increase and which adolescents are most affected.”
  • Consumer Reports, writing in the Washington Post, explains what to do about ear pain.
  • Per a National Institutes of Health press release,
    • “The antiviral drug tecovirimat used without other antivirals did not reduce the time to clinical resolution of clade II mpox lesions or improve pain control among adults in an international clinical trial sponsored by the National Institutes of Health (NIH). The trial enrollment was stopped in late 2024 when an interim analysis showed that tecovirimat monotherapy was ineffective in the study population. Detailed results were presented at the 2025 Conference on Retroviruses and Opportunistic Infections (CROI) in San Francisco.
    • “This study brought us a step forward in better understanding mpox disease and potential treatment strategies,” said Jeanne Marrazzo, M.D., M.P.H., director of NIH’s National Institute of Allergy and Infectious Diseases (NIAID), which sponsored and funded the trial. “We are grateful to the study team and participants for their contributions to groundbreaking research on a disease that we still do not know enough about.”
  • The National Cancer Institute’s Cancer Information Highlights cover the following topics this week: “AI and Immunotherapy | Breast Reconstruction | Multiple Myeloma Research.”
  • Food Safety Magazine alerts us,
    • “The U.S. Centers for Disease Control and Prevention (CDC) has released a summary analyzing the causes of foodborne illness outbreaks that occurred between 2014 and 2022. Data included in the analysis was drawn from the Foodborne Disease Outbreak Surveillance System (FDOSS), via the National Outbreak Reporting System (NORS).
    • “According to CDC, approximately 800 foodborne illness outbreaks occur in the U.S. each year, causing an estimated 15,000 illnesses, 800 hospitalizations, and 20 deaths, annually.
    • “An overall trend revealed in the FDOSS data for 2014–2022 included that many foodborne illness outbreaks occur because of contamination of food by an animal or environmental source before arriving at the point of final preparation. Additionally, most viral outbreaks are caused by contamination from ill food workers. The data showed that common contributing factors to bacterial outbreaks are 1) allowing foods to remain out of temperature control for a prolonged period, and 2) inadequate time and temperature control during cooking.”
  • The American Hospital Association News relates,
    • “The AHA and Press Ganey March 12 released a new report showing hospital and health system patients reporting improvements in overall care experience and perception of safety alongside gains in key safety outcomes. It also shows that the health care workforce has had a rebound in their reported experience, resilience and perceptions of safety culture.
    • “The insights report, “Improvement in Safety Culture Linked to Better Patient and Staff Outcomes,” highlights how hospitals that foster a strong culture of safety also report a better experience for patients and the health care workforce.
    • “Key report findings include: 
      • “13 million patients surveyed after hospital stays report improvements in their overall care experience and perception of safety.
      • “Surveys of 1.7 million members of the health care workforce show a rebound in their reported experience, resilience and perceptions of safety culture, following the enormous strain of the COVID-19 pandemic.
      • “Improvements in key safety outcomes like falls and infections across more than 25,000 units in 2,430 hospitals.”
  • Per MedTech Dive,
    • “Capstan Medical says it has notched a first in the treatment of structural heart disease, employing a robot to implant two people with mitral valve replacement devices.
    • “Current treatment options for heart valve disease exclude too many patients who are not good candidates for existing procedures, said Capstan CEO Maggie Nixon, and the company hopes its approach will provide them with a new alternative.
    • “The Santa Cruz, California-based startup is developing a valve implant, catheter and robotic delivery platform to expand structural heart intervention to a broader group of people.
    • “There need to be more percutaneous, minimally invasive options to help treat valve disease,” Nixon said in an interview.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Blue Shield of California President and CEO Lois Quam is out at the company two months after taking the helm.
    • “The company declined to explain the circumstances of Quam’s immediate departure.
    • “Chief Financial Officer Mike Stuart will serve as interim president and CEO until the board names a permanent successor, the company said in a news release Tuesday. Stuart has worked at the nonprofit insurer for more than a decade, the company said.
    • “Quam joined the company as president in August after having served as CEO of Pathfinder, a nonprofit global health organization. She was named CEO in early January as part of a corporate restructuring and was touted as its first female CEO.”
  • Fierce Healthcare reports,
    • “Health technology company Innovaccer launched a new platform that seeks to make it easier for insurers to manage risk adjustment and quality improvements.
    • “On Wednesday, Innovaccer unveiled the 360-Degree Gap Closure Solution, which assist payers in improving coding accuracy and patient outcomes. The tool comes at a time when the industry is under significant scrutiny from regulators over coding practices.
    • “The platform enables better engagement across different care settings, greater automation and data governance, Innovaccer said. Health plans can deploy one-click campaigns that address care gaps in a way that reaches provider offices, pharmacies and home healthcare.”
  • Per BioPharma Dive,
    • “Roche has raised its bet on obesity, agreeing to pay Zealand Pharma $1.65 billion to license an experimental shot the Danish company put into a Phase 2b trial in December, Zealand said Wednesday.
    • “Per deal terms, Roche will pay $1.4 billion immediately and $250 million in anniversary payments to license petrelintide. With further milestone payments, Zealand could receive up to $5.3 billion. Roche and Zealand will co-commercialize the shot in the U.S. and Europe, and share in any profits and losses.
    • “The deal gives Roche access to a type of experimental drug known as an amylin analog, a class the Swiss pharmaceutical company didn’t obtain when it acquired Carmot Therapeutics 15 months ago. Roche plans on testing petrelintide with one of those drugs, for which Zealand could reimburse Roche $350 million.”
  • Per MedTech Dive,
    • “Labcorp will pay up to $225 million to acquire the oncology diagnostics businesses of BioReference Health, a subsidiary of Opko Health, to expand its portfolio of tests used in cancer care.
    • “The deal, announced Tuesday, includes $192.5 million to be paid at closing and a payment of up to $32.5 million based on performance. 
    • “The assets, including certain customer accounts, generate about $85 million to $100 million in annual revenue, according to the announcement. Labcorp expects the acquisition to be accretive to earnings in the first year after closing.”
  • Healthcare Dive relates,
    • “Hospital operator Landmark Holdings of Florida filed for Chapter 11 bankruptcy protections on March 9, becoming the latest in a growing number of embattled providers to restructure amid financial headwinds. 
    • “In first day court filings, Landmark, which owns or operates six long-term acute care hospitals across three states, said rising labor and pharmaceutical costs, as well as stagnating Medicare reimbursements, had dinged Landmark’s profitability and threatened the provider’s ability to make timely loan repayments.”
    • “Still, Landmark told the court it expects to have enough cash on hand to keep its hospitals open through the bankruptcy process.:
  • STAT News lets us know,
    • While there are no official statistics on the number of end-of-life doulas in the United States as this emerging field is still largely unregulated, Fortune reports that the National End-of-Life Doula Alliance (NEDA) has significantly grown its membership, especially after the pandemic. In 2024, NEDA had over 1,500 registered members, compared to about 250 in 2019. 
    • “The term “end-of-life-doula” was first formally used in the early aughts. In 2001, the Jewish Board of Family and Children’s Services launched the “Doula to Accompany and Comfort Program,” a pilot program that trained volunteers to aid and support people who would otherwise die alone. 
    • “Sometimes known as “death doulas,” [these] professionals * * *help people navigate what can be a confusing and overwhelming time.”

Weekend Update

David Ermer–CDC, CMS, Congress, HSA, Medicare, NIH, Rx coverage, U.S. Healthcare–
Thanks to ACK15 for sharing their work on Unsplash.

From Washington, DC

  • On Saturday, the House Appropriations Committee unveiled “The Full-Year Continuing Appropriations and Extensions Act, 2025.”
  • The Wall Street Journal adds,
    • “House lawmakers are expected to vote on the proposal, termed a continuing resolution or CR, as soon as Tuesday, with a majority needed to pass it. But even if House Republicans manage to stay united and pass the proposal over Democratic opposition, it will need at least 60 votes in the Senate, which has only 53 Republican lawmakers. 
    • “Funding for federal agencies runs out on Friday night. With no new legislation, many federal employees would be furloughed, while others would continue to report to work with no pay.” 
  • The Senate will be voting to confirm the President’s nominee for Secretary of Labor Lori Chavez-DeRemer Monday afternoon.
  • Committee meetings of note:
    • Committee: House Oversight and Government Reform
      Subcommittee: House Oversight and Government Reform Subcommittee on Government Operations
      Subject: “Shifting Gears: Moving from Recovery to Prevention of Improper Payments and Fraud”
      Date: 03/11/2025 (10:00 AM Local Time)(Add to My Calendar)
      Location: 2247 Rayburn House Office Building, Washington, D.C.
    • Committee: Senate Health, Education, Labor, and Pensions. Subject: Business meeting to consider the nominations of Jayanta Bhattacharya, of California, to be Director of the National Institutes of Health, and Martin Makary, of Virginia, to be Commissioner of Food and Drugs, both of the Department of Health and Human Services, and other pending calendar business
      Related Items: PN12-2, PN12-28
      Date: 03/13/2025 (9:30 AM Local Time)   (Add to My Calendar)
      Location: 562 Dirksen Senate Office Building, Washington, D.C.
    • Committee Senate Finance Committee Subject: Hearing to consider the nomination of Dr. Mehmet Oz to be CMS Administrator
      Witness: Dr. Mehmet Oz 
      Date: Friday, March 14, 2025, 10:00 AM Local Time)
      Location: 215 Dirksen Senate Office Building, Washington, DC
  • The AP explains “How a health savings account fits into your retirement strategy.”

From the public health front,

  • The Wall Street Journal explores how “One Couple in Their 90s Confronts a Stark Reality: Aging at Different Speeds; Lifelong partners grapple with how and whether to stay together when one can’t care for the other.”
  • The New York Times points out six sources of protein that are not meat and answers questions about fentanyl.
  • Beckers Hospital Review notes,
    • Researchers from the University of Texas Health Science Center at San Antonio have developed a drug that more than doubled median survival time and progression-free time for patients with glioblastoma during a clinical trial.
    • Patients who received the drug Rhenium Obisbemeda, or 186RNL, also experienced no dose-limiting toxic effects, according to a March 7 news release from UT Health San Antonio.
    • Glioblastoma is the most common form of brain tumor, with more than 90% of patients experiencing recurrence. If standard treatment fails, the median survival time is about eight months, the release said. \
    • “Glioblastoma has needed durable treatments that can directly target the tumor while sparing healthy tissue,” Andrew Brenner, MD, PhD, professor and chair of neuro-oncology research with Mays Cancer Center at UT Health San Antonio, said in the release. “This trial provides hope, with a second phase under way and planned for completion by the end of this year.”

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “Higher volumes, more favorable reimbursement rates and more efficient labor spending helped Providence cut its 2024 operating losses nearly in half.
    • “On Thursday the nonprofit system reported a $644 million operating loss (-2.1% operating loss) across 2024, a stark improvement over the $1.17 billion operating loss (-4.1% operating margin) of the year prior. The 2024 tally includes $183 million in reconstruction costs “related to asset rationalization, employee reductions and other items,” according to its filing.
    • “Operating revenues across the system grew 7% year over year to $30.7 billion (5% when excluding a $426 million net gain in the first quarter), with management noting in its filing that the growth was spread across all of its operating categories.”
  • and
    • “Earlier this week, Eli Lilly partnered up with telehealth providers LifeMD and Teladoc Health to offer its lower cost, single-vial Zepbound (tirzepatide) to patients in the virtual care companies’ full-service weight loss management programs.
    • “The companies are directly contracting with Eli Lilly’s self-pay pharmacy, GiftHealth. The move could be a boon for telehealth weight loss programs, which have proved lucrative for virtual primary care companies. Many of the chronic condition management programs, including for weight loss, also offer remote monitoring, access to dietitians and health coaches, as well as the ability to be prescribed medication for weight loss, including older medications.
    • “The announcement follows Eli Lilly’s partnership with telehealth platform Ro three months ago. The pharmaceutical company launched its own direct-to-consumer telehealth offering for weight loss in January 2024. Now, it seems to be creating a marketplace of access.”
  • Beckers Payer Issues ranks Medicare insurers by the quality of their mobile applications.

Friday Report

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

From Washington, DC

  • Govexec tells us,
    • “Lawmakers are pursuing two different paths to keep the government funded past March 14, though the Republican majority in both chambers is hoping to pass a measure to keep agencies funded at their current levels through September. 
    • “The year-long continuing resolution would allow for only a small number of changes to existing spending levels, which are currently at the same total that agencies received in fiscal 2024. Democratic appropriators are hoping to instead buy more time with a short-term stopgap bill that would allow negotiators to come to a bipartisan agreement on full-year fiscal 2025 funding measures.
    • “House Speaker Mike Johnson, R-La., has said he will release the text of a continuing resolution to cover the remainder of fiscal 2025 in the coming days and put it to a vote on the House floor early next week. Johnson will face a narrow margin to pass the measure, particularly as the most conservative members of his caucus rarely vote for CRs of any duration. House Democrats have indicated they will not support the measure. 
    • “President Trump is pushing for the year-long stopgap option and the White House has lobbied Republicans to support that bill. 
    • “Despite Johnson’s plans, top appropriators from both parties in the House and Senate have continued to meet and are closing in on a deal to set the top-line funding levels for regular appropriations bills, according to a source familiar with the talks. They are hoping to finalize that agreement in the coming days to demonstrate that a full-year CR is not the only viable option to avert a shutdown.”
  • Medical Economics lets us know,
    • “The Medicare Payment Advisory Commission (MedPAC) is inching closer to a recommendation on revising how doctors get paid through the Medicare Physician Fee Schedule.
    • “On March 6, MedPAC opened its latest two-day meeting with almost 90 minutes of discussion of the best ways to balance beneficiary access and costs, physician pay, taxpayer resources, and overall costs to the U.S. Department of Health and Human Services (HHS).
    • “While the members had suggestions about the nuances of physician pay and the language to describe it, there was general agreement on two draft recommendations to Congress:
      • Congress should replace the current law updates to the physician fee schedule with an annual update based on a portion of the growth in the Medicare Economic Index (MEI). An example could be: MEI minus 1 percentage point.
      • Congress should direct the HHS secretary to improve the accuracy of relative payment rates for clinician services by updated costs data regularly, and ensuring the methodology used to determine payment rates for different services reflects the settings in which clinicians practice medicine.
    • “Depending on commissioner feedback, MedPAC could vote on the recommendations in April to be included in its June 2025 report to Congress.”
  • Per MedTech Dive,
    • “The Federal Trade Commission has challenged a private equity firm’s attempt to buy Surmodics for approximately $627 million, the regulator said Thursday.
    • “Surmodics provides outsourced hydrophilic coatings for devices. GTCR, the private equity group that is attempting to buy Surmodics, owns a majority stake in another coating company, Biocoat.
    • “The FTC said the buyout “would lead to a highly concentrated market for outsourced hydrophilic coatings and eliminate significant head-to-head competition between Biocoat and Surmodics.”

From the judicial front,

  • The Hill informs us,
    • “A federal judge has effectively ended the ability of compounding pharmacies to make their own copies of Eli Lilly’s weight loss and diabetes drugs Zepbound and Mounjaro. 
    • “In a sealed decision filed late Wednesday, Judge Mark Pittman of the Northern District of Texas declined to issue an injunction to stop the Food and Drug Administration (FDA) from declaring there was no longer a shortage of the medicines’ active ingredient, tirzepatide.” * * *
    • “Eli Lilly in a statement said the decision “marks the end of the road for mass compounding of risky, unapproved knockoffs that threaten the health and safety of Americans.” 
    • “Any company that continues mass compounding tirzepatide “is breaking the law, and we will work with regulators and law enforcement to stop it,” a company spokesperson said.  
    • “A similar OFA lawsuit against the FDA for removing from the shortage list semaglutide, the active ingredient in Ozempic, is pending.”

From the public health and medical research front,

  • The Centers for Disease Control and Prevention announced today,
    • “Seasonal influenza activity remains elevated nationally but has decreased for three consecutive weeks. COVID-19 activity is declining nationally but elevated in some areas of the country. RSV activity is declining in most areas of the country.
    • “COVID-19
      • “COVID-19 activity is declining nationally but elevated in some areas of the country. Wastewater levels are moderate, emergency department visits are at 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
      • “Seasonal influenza activity remains elevated nationally but has decreased for three consecutive weeks. Data to date suggest the season has peaked, however, flu-related medical visits, hospitalizations, and deaths remain elevated, and CDC expects several more weeks of flu activity.
      • “Additional information about current influenza activity can be found at: Weekly U.S. Influenza Surveillance Report | CDC
    • “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 Washington Post reports,
    • “An unvaccinated New Mexico adult who tested positive for measles has died, the second death in a growing outbreak centered along the Texas-New Mexico border, officials said Thursday.
    • “The individual did not seek medical care before death, New Mexico health department officials said. The official cause of death is under investigation by New Mexico’s Office of the Medical Investigator. However, the state health department scientific laboratory has confirmed the presence of the measles virus in the person, the state health department said.
    • “The person was a resident of Lea County, where at least 10 cases of measles have been reported. Lea County is just over the border from Gaines County, Texas, where the outbreak is centered.
    • “Six of the Lea County cases are among adults, and four are in children. Seven of the 10 were unvaccinated, and three have unknown vaccination histories.”
  • The American Hospital Association News relates,
    • “Cigarette smoking by adults has dropped to its lowest level in 60 years, the Centers for Disease Control and Prevention reported today. Despite that, tobacco is the leading cause of preventable death in the U.S., the agency said. 
    • “From 2017-2023, an approximate 6.8 million decrease in adults who exclusively smoke cigarettes was offset by a 7.2 million increase in adults who exclusively smoke e-cigarettes. Cigarette smoking overall by U.S. adults decreased from 42.4% in 1965 to 11.6% in 2022.”
  • Per Aunt Minnie,
    • “Breast and colorectal cancer screening in 2023 rebounded from declines during the COVID-19 pandemic and surpassed pre-pandemic screening estimates, according to findings published March 5 in JAMA.
    • “Yet researchers led by Jessica Star from the American Cancer Society in Atlanta, GA, also found that cervical cancer screening numbers are still below pre-pandemic estimates, and that improvements in cancer screening rates were mostly seen in individuals with higher socioeconomic status.
    • “Improving patient communication around cancer screening and providing patient navigators to assist with the structural and cost barriers to screening are two ways health systems can help with successful screening rebounds,” Star told AuntMinnie.com.”
  • Medscape assesses Alzheimer’s Disease diagnosis and care.
  • The National Cancer Institute lets us know,
    • “How doctors treat a form of liver cancer called intermediate-stage hepatocellular carcinoma (HCC) is likely to change, based on updated findings from two large clinical trials. Both trials tested a procedure called TACE in combination with immunotherapy drugs and treatments called angiogenesis inhibitors. TACE, or transarterial chemoembolization, involves using a catheter to deliver chemotherapy directly to the liver.”
  • Per Healio,
    • “After rising over a 35-year period, thyroid cancer incidence in the U.S. plateaued from 2010 to 2019, according to findings published in The Lancet Diabetes & Endocrinology.
    • “In a retrospective analysis of data from the National Cancer Institute’s Surveillance, Epidemiology and End Results (SEER) and National Center for Health Statistics databases, researchers found no changes in metastasis or mortality rates for adults diagnosed with thyroid cancer from 1975 to 2019, despite a rising incidence rate during that time. These findings reveal thyroid cancer may have been over-diagnosed in more recent years, according to Zachary Zumsteg, MD, associate professor of radiation oncology and biomedical sciences, and radiation oncology director of the head and neck oncology disease research group at Cedars-Sinai. However, Zumsteg noted the plateau of thyroid cancer incidence in the past 10 years of the study may be indicative of a change in diagnostic practices.”
  • Per BioPharma Dive,
    • Johnson & Johnson is terminating some research for an experimental drug that the company previously predicted could be a multibillion-dollar product.
    • In a statement released Thursday afternoon, J&J said it will stop developing the drug, called aticaprant, as an add-on therapy for patients with major depressive disorder. Over the past few years, a series of large, late-stage clinical trials tested aticaprant in adults who have hard-to-treat MDD and moderate-to-severe cases of a defining symptom of the disorder, anhedonia, which presents as a loss of interest or an inability to experience joy.
    • “While the drug continues to look safe and well-tolerated, the program has shown “insufficient efficacy in the target patient population,” according to J&J. Aticaprant may still have potential, however, so the company plans to “explore future development opportunities” in other “areas of high unmet need.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Not much has gone right for Walgreens Boots Alliance in the past decade. 
    • “Customers bought more and more household items online at sites such as Amazon.com, instead of Walgreens’s more than 8,000 stores across the U.S. The pharmacy chain inked deals with other drug suppliers and doctors’ offices, but stood pat while rivals, including CVS and Express Scripts, merged with big health insurers, gaining control of the medical-reimbursement purse strings that were squeezing pharmacies.
    • “Walgreens cash flow sagged, its debt piled up and shares sank. And on Thursday, Walgreens was sold to private-equity firm Sycamore for $10 billion, down a staggering 91% from its $106 billion peak in 2015.
    • “The storied pharmacy chain—which became a ubiquitous seller of everything from diabetes injections to nail files as retailers consolidated across the U.S.—fell after it neglected to keep up with customer preference to buy online and failed to navigate the fierce competition and intense cost pressures of healthcare.
    • “It could shrink more after its sale. Sycamore, a New York-based firm that specializes in retail and consumer investments and, more recently, is better known for smaller deals, is expected to sell off pieces of the business or work with partners to turn it around, The Wall Street Journal reported.
    • “Globally, the transaction ranks as one of the largest leveraged buyouts in the past decade.”
  • The Journal also tells us about “The Walgreens Billionaire Watching His Empire Come Apart
  • From Monaco, Stefano Pessina built a retailer valued at about $100 billion. It agreed to be taken private this week for roughly $10 billion.”
  • BioPharma Dive points out,
    • “Optum Rx, a pharmacy benefit manager owned by one of the country’s largest insurance companies, UnitedHealth Group, has added a new, much-anticipated pain drug to some of its commercial formularies.
    • “Sold as Journavx, the drug received U.S. approval in late January as a treatment for the short-lived “acute” pain typically felt after an operation or accident. Journavx works differently than other available medications, and its developer, the biotechnology juggernaut Vertex Pharmaceuticals, has positioned it as an important, non-opioid option for pain management.”
  • Beckers Hospital Review lists 18 health systems with strong finances.

Wednesday Report

David Ermer–Congress, COVID-19 vaccine, Medical / Rx research, Medicare, NIH, Rx coverage, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC

  • The New York Times lets us know,
    • “Dr. Jay Bhattacharya, Donald J. Trump’s nominee to lead the National Institutes of Health, told senators at his confirmation hearing on Wednesday that studies had not shown a link between vaccines and autism, even as he urged more research on the question.” * * *
    • “Dr. Bhattacharya [,a Stanford University health economist,] burst into the news at the height of the pandemic in October 2020, when he co-wrote an anti-lockdown treatise, the Great Barrington Declaration, that argued for “focused protection” — a strategy that would focus on protecting the elderly and vulnerable while letting the virus spread among younger, healthier people.
    • ‘The nation’s medical leadership, including Dr. Francis S. Collins and Dr. Anthony S. Fauci, then director of the National Institute of Allergy and Infectious Diseases, denounced the plan. Referring to Dr. Bhattacharya and his co-authors as “fringe epidemiologists,” Dr. Collins wrote in an email that “there needs to be a quick and devastating takedown of its premises.”
    • ‘Dr. Collins, who later stepped down as the N.I.H. director to pursue his laboratory research, retired last week in anticipation of Dr. Bhattacharya’s arrival. At Wednesday’s hearing, Senator Pete Ricketts, Republican of Nebraska, introduced Dr. Bhattacharya by praising him for having “great intellectual honesty and courage” to offer an alternative approach to handling the pandemic.”
  • The Wall Street Journal reports
    • “Rep. Sylvester Turner, a Texas Democrat who was just sworn into the House in January, died on Tuesday night.” * * *
    • “Turner’s sudden death will also have an immediate consequence in the political body in which he had served: House Republicans now have slightly more cushion as Democrats await a special election to fill the seat. With his death, the majority now stands at 218-214.
    • “The House GOP majority math is so slim that the confirmation of Rep. Elise Stefanik (R., N.Y.) to serve as U.S. Ambassador to the United Nations has been held up as Republicans wait to fill the seats of former Reps. Matt Gaetz (R., Fla.) and Mike Waltz (R., Fla.). The special elections for both Florida seats are set to take place on April 1. Stefanik has continued to serve in the House for now.” * * *
    • “It wasn’t immediately clear when Texas Gov. Greg Abbott will call a special election for Turner’s seat.” 
  • MedTech Dive informs us,
    • “Philips stopped selling an implant used to repair damaged arteries after reports of 20 injuries and some devices needing to be removed.
    • “The Food and Drug Administration said in a Monday recall notice that all customers should stop using Philips’ Tack Endovascular System immediately. The agency classified the recall as Class I, the highest risk category.
    • “Philips is not aware of serious harm or death accompanying the use of the device, a company spokesperson wrote in an email. The FDA said no deaths were reported.”

From the judicial front,

  • Modern Healthcare reports,
    • “The Justice Department under President Donald Trump is defending the federal government’s position in several Medicare Advantage lawsuits challenging policies that originated during President Joe Biden’s term.
    • “Given Trump’s overall repudiation of the Biden years and Republicans’ generally favorable disposition toward Medicare Advantage and preference for light regulation, Wall Street expected the new administration to take it easier on health insurance companies. So far, in court at least, that’s not what’s happening.
    • “Since Trump returned to the White House in January, the Justice Department has filed briefs supporting the Biden administration’s defenses against companies such as Humana and eHealth in Medicare Advantage cases regarding the Star Ratings quality assessment program, marketing rules and the risk-adjustment system.”
  • and
    • “A health system at the center of a legal dispute over emergency abortions notified a federal court Tuesday that the Justice Department is dropping its challenge to Idaho’s anti-abortion laws.
    • “President Joe Biden’s administration contended that hospitals in states with restrictive abortion laws nevertheless are required to provide the procedure in emergencies to preserve the life and health of pregnant patients under the Emergency Medical Treatment and Active Labor Act of 1986, known as EMTALA. President Donald Trump, who opposes abortion rights, was expected to change course and now has, according to Boise, Idaho-based St. Luke’s Health System.
    • “St. Luke’s submitted a brief to the U.S. District Court for the District of Idaho on Tuesday saying its attorneys received an email on Monday from an unnamed federal official informing them that the Justice Department intends to withdraw its case against the Idaho laws.”

From the public health and medical research front,

  • MedPage Today tells us,
    • “Over half of adults and a third of kids and teens around the world will have overweight or obesity by 2050, according to two reports using data on 204 countries and territories.
    • “If observed trends over the past 30 years continue, the total number of adultsopens in a new tab or window ages 25 and older living with overweight (body mass index [BMI] 25 to <30) or obesity (BMI ≥30) will reach 3.8 billion by 2050 — more than half of the likely global adult population at that time.
    • “Meanwhile, 356 million young people ages 5 to 14 years and 390 million young people ages 15 to 24 years are projected to have overweight or obesity by 2050, reported the Global Burden of Disease (GBD) Study 2021 Adult and Adolescent BMI Collaborators in The Lancet.
    • “This polycrisis will cause more avertable adverse health outcomes in the coming decades than any other modifiable risk at an individual level,” the researchers wrote. “Urgent, bold, and comprehensive initiatives are imperative to enable multisectoral collaboration and propel structural reforms to address drivers of overweight and obesity at individual and population levels. Although new-generation antiobesity medications appear promising, tactful, whole-system, public health strategies will continue to be crucial to achieving widespread and sustainable impact.”
  • Per an NIH press release,
    • A research team funded by the National Institutes of Health (NIH) has developed a medication that shows promise in treating acute and chronic pain. The drug, known as VIP36, targets the body’s cannabinoid receptor type 1 (CB1). It was found to be effective in three different animal models for pain and does not appear to cause the harmful side effects that have frustrated other efforts to target CB1. These results enhance understanding of how to design safer and more effective drugs targeting cannabinoid receptors and are an important step towards developing novel, non-addictive treatments for pain.
  • Cardiovascular Business reports,
    • Transcatheter aortic valve replacement (TAVR) is associated with better in-hospital outcomes than surgical aortic valve replacement (SAVR), according to a new analysis published in The Annals of Thoracic Surgery.[1] However, researchers noted, SAVR was linked to superior long-term outcomes, including a lower stroke risk, for both low- and intermediate-risk patients.
    • The newly published study included data from nearly 160,000 patients 65 to 85 years old who underwent aortic valve replacement from 2018 to 2022. All data came from the U.S. Centers for Medicare and Medicaid Services database. While 124,897 patients underwent TAVR, another 34,215 underwent first-time SAVR. The median follow-up period was 2.7 years.
    • Using Society of Thoracic Surgeons mortality risk scores as their primary guide, researchers determined if each study participant was a low-, intermediate- or high-risk patient. The low-risk group was represented by more than 36,000 TAVR patients and more than 1,400 SAVR patients. The intermediate-risk group, meanwhile, was represented by more than 44,000 TAVR patients and more than 9,000 SAVR patients. The high-risk group was represented by 44,000 TAVR patients and nearly 10,000 SAVR patients. 
    • In all three risk groups, TAVR patients were older and more likely to present with a history of heart failure or coronary artery disease than SAVR patients
  • MedPage Today relates,
    • Patients using GLP-1 drugs had no difference in the odds of postoperative aspiration pneumonia versus non-users.
    • There was also no significant difference in the odds of acute respiratory failure.
    • Findings support guidance recommending that a GLP-1 agent hiatus is not necessary before surgery.
  • Per Healio,
    • “Children were around half as likely to develop one or more long COVID symptoms if they were vaccinated.
    • “Vaccinated children were 75% less likely to experience long COVID symptoms that affected daily function.”
  • Per Health Day,
    • “Physical activity can improve the mental well-being of women living with chronic pelvic pain disorders like endometriosis and uterine fibroids, a new study says.
    • “Activities like brisk walking or aerobic exercise caused measurable improvements in women with pelvic pain, researchers reported in the Journal of Pain Research.
    • “Chronic pelvic pain disorders are incredibly complex and burdensome for those affected, yet we still have very few effective treatment strategies,” said senior researcher Ipek Ensari, an assistant professor of artificial intelligence and human health at the Icahn School of Medicine at Mount Sinai in New York City.
    • “Our research suggests that physical activity could be an important tool for improving mental health in these patients, offering them a proactive way to enhance their well-being,” Ensari added in a news release.” * * *
    • “We were particularly intrigued to find that the positive effects of exercise seem to lag by a few days, meaning the mental health benefits may build up gradually,” Ensari said. “This insight is vital for both patients and health care providers, as it underscores the importance of consistency in physical activity.”
    • “As women’s mental health improved, they also experienced improvements in physical function and reductions in pain, results show.”

From the U.S. healthcare business front,

  • Fierce Healthcare brings us the latest on the HIMMS conference ongoing in Las Vegas.
  • Beckers Hospital Review notes,
    • “Rochester, Minn.-based Mayo Clinic reported an operating income of $1.3 billion (6.5% operating margin) in 2024, up from an operating income of $1.1 billion (6% margin) in 2023, according to its March 5 financial report.
    • “The health system recorded revenue of $19.8 billion in the 12 months ended Dec. 31, up from $17.9 billion in the same period last year. Mayo Clinic reported medical service revenue of $16.6 billion in 2024, up from $15 billion in 2023. 
    • “Operating expenses totaled $18.5 billion in 2024, up from $16.9 billion in 2023. Salaries and benefits totaled $10.5 billion, up from $9.7 billion in 2023. Supply and service expenses totaled $6.7 billion, up from $6 billion in the prior year. 
    • “Mayo Clinic’s success in 2024 reflects the innovative spirit of our exceptional staff and their dedication to meeting our patients’ changing needs,” Mayo Clinic President and CEO Gianrico Farrugia, MD, said. 
  • STAT News reports
    • “Novo Nordisk will start selling its obesity drug Wegovy directly to patients at a reduced price, following a similar move from Eli Lilly as the two drugmakers compete for market share and try to draw patients away from compounding pharmacies that have been making cheaper copies of weight loss drugs.
    • “Wegovy normally carries a list price of about $1,350 a month, but Novo will sell the treatment through its new direct-to-consumer offering called NovoCare Pharmacy at $499 a month for all doses to cash-paying patients, meaning patients who are paying on their own without insurance.
    • “Orders will be fulfilled by CenterWell Pharmacy, a subsidiary of Humana that offers home delivery services.”
  • Per Healthcare Dive,
    • Bankrupt Prospect Medical Holdings may need to find another buyer for its Connecticut hospital portfolio, after Yale New Haven Health, which originally signed an agreement to acquire the three facilities in 2022, called the deal “impossible” in a statement to Healthcare Dive.
    • A spokesperson for Yale New Haven said the deal was unworkable due to Prospect’s failure to pay vendors on time, disinvestment in the facilities and record of mismanagement. 
    • Connecticut Gov. Ned Lamont said in a press conference on Monday that Prospect has found possible buyers located in Connecticut and out of state that could be named in the coming weeks, according to a report from the Register Citizen.
  • Per BioPharma Dive,
    • “Jazz Pharmaceuticals is expanding its foothold in cancer drug research, announcing Wednesday it will pay $935 million to buy Chimerix and an experimental medicine under Food and Drug Administration review for treatment of a form of the brain cancer glioma.
    • “Per deal terms, Chimerix investors will receive $8.55 a share, a 72% premium on Tuesday’s closing price. Jazz expects the deal to close in the second quarter of 2025. The deal is all in cash, which Jazz will draw from holdings and investments that amounted to $3 billion at the end of 2024.
    • “If approved, Chimerix’s drug would join five other marketed cancer medicines in Jazz’s portfolio, potentially helping the Dublin-based company diversify revenue away from its biggest seller, the sleep drug Xywav.
    • “Called ONC201 or dordaviprone, the drug has been submitted for accelerated FDA approval in people who have gliomas with a mutation called H3 27M. A small 2014 study suggests that such mutations are common in people under the age of 50 who are diagnosed with glioma.”

Tuesday Report

David Ermer–CDC, Congress, COVID-19, COVID-19 vaccine, FDA, Federal employment benefits, Medicare, NIH, OPM, Rx coverage, U.S. Healthcare–

From Washington, DC

  • The Wall Street Journal offers a summary of seven takeaways from the President’s speech on Tuesday night.
  • Bloomberg Law tells us,
    • “A battle over legislation that would make it easier for Medicare cancer patients to get their drugs may reignite this week when a key Republican lawmaker is expected to reintroduce the proposal.
    • “The measure (H.R. 5526) was passed in the House in September 2024 but stalled in the Senate amid opposition from the pharmacy industry. Rep. Diana Harshbarger (R-Tenn.), a pharmacist, said in a statement to Bloomberg Law the legislation “is one of my top healthcare priorities, and I expect to reintroduce it this week.”
    • “This legislation had strong bipartisan support in Congress last year because it would greatly benefit the lives of countless seniors who need life-saving medications but might not be able to access them easily,” Harshbarger said. “I’m looking at all legislative opportunities to advance this bill and get it enacted into law.”
    • “The legislation, and S. 3458 introduced last Congress by former Sen. Kyrsten Sinema (I-Ariz.), would have amended the physician self-referral law and restored a Covid-19 pandemic-era waiver that allowed Medicare patients to receive their oral cancer medications through the mail, by courier, or via pick-up by family members.”
  • Wolters Kluwer lets us know,
    • “On March 2, 2025 the United States Department of the Treasury announced that with respect to the Corporate Transparency Act (CTA), it will not enforce any penalties or fines associated with the beneficial ownership information reporting (BOIR) rule under the current deadlines, and it will further not enforce any penalties or fines against United States citizens or domestic reporting companies or their beneficial owners after a forthcoming rule change takes effect. 
    • “The Treasury Department also announced that it will be issuing a proposed rulemaking that will narrow the scope of the BOI reporting rule to foreign reporting companies only. Treasury stated that it was taking this step “in the interest of supporting hard-working American taxpayers and small businesses and ensuring that the rule is appropriately tailored to advance the public interest.”
    • The Treasury Department’s press release can be read in full here: https://home.treasury.gov/news/press-releases/sb0038“
  • Federal News Network tells us,
    • “The Trump administration’s Office of Personnel Management has revised its guidance on probationary employees, now stating that OPM was not directing agencies to fire federal workers.
    • “An update to OPM’s Jan. 20 memo on Tuesday adds a paragraph clarifying that any decision to fire employees should be left to individual agencies.
    • “Please note that, by this memorandum, OPM is not directing agencies to take any specific performance-based actions regarding probationary employees,” the updated memo states. “Agencies have ultimate decision-making authority over, and responsibility for, such personnel actions.”
  • Kevin Moss, writing in Federal News Network, discusses how federal annuitants can control their FEHB premiums.
  • Per an FDA news release,
    • On Monday, the FDA approved the first generics of Xarelto (rivaroxaban), 2.5 mg, tablets to reduce the risk of major cardiovascular events in adult patients with coronary artery disease (CAD) and to reduce the risk of major thrombotic vascular events in adult patients with peripheral artery disease (PAD), including patients who have recently undergone a lower extremity revascularization procedure due to symptomatic PAD. Anticoagulants (blood thinners) are among the most commonly prescribed medications in the U.S., and Monday’s approval of the first generics of rivaroxaban, 2.5 mg, tablets will make a direct impact on American patients who rely on anticoagulant medications. Approving safe and effective generics to help provide patients more treatment options continues to be a priority for the FDA.

From the judicial front,

  • Per Fierce Healthcare,
    • “UnitedHealth Group notched a major court win in a legal challenge over its Medicare Advantage (MA) billing practices that is stretching into its second decade.
    • “The suit was first filed by a whistleblower in 2011, and the Department of Justice (DOJ) joined the case in 2017. The court-appointed special master released its report this week, in which, after reviewing the evidence, it determined “that the government is lacking any evidence in support of two essential elements of its False Claim Act and related common law claims.”
    • “The suit alleges that UnitedHealth conducted reviews of patients’ medical records that allowed it to identify underpayments while ignoring instances of overbilling. This would enable the company to juice its risk scores and thus its MA payouts.” * * *
    • “In the lawsuit, the feds argue that the billing practices allowed UHG to pocket $2.1 billion. The special master rebuffed an analysis from a government expert who identified 1.97 million codes among 28 million that were allegedly unsupported by the patients’ diagnoses.
    • “The special master noted in its report that the expert did not review medical charts before making this determination.” * * *
    • “The special master’s report recommends that the courts grant UHG a summary judgement and reject the DOJ’s request for partial summary adjudication.”

From the public health and medical research front,

  • Katelyn Jetelina, a/k/a Your Local Epidemiologist, remarks
    • “If you’re 65+ or moderately/severely immunocompromised, a spring Covid-19 vaccine is available. Last October, CDC recommended a second dose of the 2024-2025 Covid-19 vaccine for this spring. It’s a 6-month recommended interval, so the first people will be eligible this week.
    • “Are they still working? Yes. Data published last week showed Covid-19 vaccines provided 45% additional protection against hospitalizations this winter.”
  • The Wall Street Journal points out that the Health and Human Services Department under its new leadership is heightening its scrutiny of vaccines.
  • In this week’s online Research Matter, NIH discusses “Tracking diet from stool samples | Diabetes & antibiotic resistance | Cancer cell cooperation.”
  • Per an NIH news release,
    • An observational study supported by the National Institutes of Health (NIH) found that infants who had more diverse bacteria in their gut had lower childhood blood pressure, and this protective association was stronger if they were breastfed for at least six months. The findings published in the Journal of the American Heart Association.
    • For the research, investigators reviewed data from 526 children enrolled in a prospective study in Denmark. They looked for connections between infant gut bacteria, which can be influenced by nutrition and supports a variety of health functions, and childhood blood pressure. To assess this, they collected fecal samples to analyze bacteria in the infants’ intestines during their first week, month, and year of life. Three and six years later, they measured the children’s blood pressure.
    • The researchers found children with more diverse gut bacteria at one month had lower blood pressure six years later. They then assessed the influence of breastfeeding, which was measured in this study for durations of at least six months. They discovered that among children breastfed for at least six months, the blood-pressure lowering effect of having more diverse bacteria in their gut was even stronger. Specifically, those with a greater diversity of gut bacteria throughout the first month of life had systolic blood pressure that was about 2 mm Hg lower six years later if they were breastfed for at least six months.
  • The National Cancer Institute points out,
    • “A new study has identified a group of genetic changes that are likely involved in the development of cancer in children. According to the findings, genomic changes affecting large pieces of DNA, called structural variants, contribute to an estimated 1% to 6% of pediatric solid tumors.” * * *
    • “Overall, the researchers estimated that structural variants are involved in the development of 1% to 6% of neuroblastomas, Ewing sarcomas, and osteosarcomas. That is a rough estimate limited by the relatively small number of children in the study and the exclusion of certain types of structural variants due to technical limitations, the team noted.”
  • STAT News reports,
    • “It’s easy to think cervical cancer could be 100% preventable. Along with lung, breast, and colorectal cancer, it has screening tests to find precancerous changes that can be treated before full-blown cancer develops. Even more, there is a highly effective vaccine against HPV, the virus that causes most cervical cancer diagnoses.
    • “Still, those two forms of prevention are not enough if people aren’t getting them, a research letter published Monday in JAMA Network Open reports. The cross-sectional study found incidence and mortality rates have been climbing in rural counties in the United States since 2012, going in the wrong direction after declining since 2001. Cases were 25% higher and deaths were 42% higher in rural counties compared to urban counties through 2019. 
    • “Researchers said those jumps in incidence and mortality showing up in rural areas may be a result of lower screening, diagnosis, and treatment rates, all an offshoot of reduced options for care outside cities.
    • “There was also a trend toward higher incidence among Black women starting in 2017, but that rise was not statistically significant. Other research, from the American Cancer Society, has concluded the mortality rate for Black women is roughly 65% higher than the rate for white women.”
  • BioPharma Dive relates,
    • “Merck & Co.’s cancer immunotherapy Keytruda is one of the pharmaceutical industry’s biggest successes. The drug’s arrival in 2014 introduced a new way of treating cancer and, over time, it became standard therapy for a panoply of different tumors. Clinical achievements brought about commercial performance, making Keytruda the world’s best-selling medicine.
    • “After the repeated failure of past attempts to improve on Keytruda, a new class of drugs might finally offer a better backbone for immunotherapy’s next decade.
    • “Last September, biotechnology companies Summit Therapeutics and Akeso revealed clinical trial results showing one of these drugs significantly outperformed Keytruda. Called ivonescimab, it cut the risk of lung cancer progression in half compared to Keytruda in a Phase 3 study — a result so striking it sparked a wave of investment in oncology research practically overnight.
    • “This really was a ‘black swan’ event,” said Allen Yang, Summit’s chief medical officer. “It’s clearly what everybody’s been looking for.”

From the U.S. healthcare business front,

  • Fierce Healthcare shares news from this week’s HIMSS conference being held in Las Vegas.
  • Healthcare Dive adds,
    • “Lightning-fast evolution in artificial intelligence and growing adoption of the models is giving rise to concerns that AI could exacerbate existing divides between technological haves and have-nots in the healthcare industry.
    • “But all types of providers — regardless of location or finances — can adopt AI, experts said Monday at the HIMSS conference in Las Vegas.
    • “It’s just a question of knowing how.
    • “Rural hospitals, smaller systems and health clinics without a massive IT infrastructure should reach out to AI companies to discuss potential partnerships, said Graham Walker, co-director of advanced development at Kaiser Permanente’s medical group, during a panel.”
  • The Wall Street Journal reports,
    • “Walgreens Boots Alliance is closing in on a deal with private-equity firm Sycamore Partners that would take the struggling drugstore chain off the public market for around $10 billion, according to people familiar with the matter. 
    • “The sides are aiming to complete a deal as soon as Thursday, assuming a last-minute snag doesn’t delay the talks or end them entirely, the people said. 
    • “They have been discussing Sycamore paying between $11.30 a share and $11.40 a share in cash, the people said. The deal could also include contingent value rights that would increase the value if certain targets are later reached, they added. 
    • “Should Sycamore complete the deal for the whole company, it is expected to maintain the core U.S. retail business and sell off or take public the other parts of the company, the people said.”
  • Modern Healthcare informs us,
    • “CVS Health has dealt its Medicare Shared Savings Program accountable care organization business to Wellvana, the companies announced Tuesday.
    • “As part of the all-stock transaction, CVS Health took a minority stake in Wellvana, a privately held physician-enablement vendor. The companies did not disclose the terms of the deal and did not immediately respond to interview requests.”
  • Beckers Payer Issues lets us know,
    • “Blue Cross Blue Shield of Michigan reported a loss of $1.02 billion on enterprise revenue of $40.6 billion in 2024, driven by rising utilization of expensive medical services and costs for prescription and specialty drugs.
    • “The company reported an underwriting loss of $1.7 billion in 2024, resulting in a negative operating margin of -4.2%. These losses were partly offset by strong performance from the company’s investment portfolio. 
    • “In 2024, Blue Cross saw an increase of $3 billion for medical and pharmacy claims costs compared to 2023. There was an increase of $900 million in pharmacy claims costs, including $544 million for specialty drugs, of which $215 million was for new indications on autoimmune drugs. GLP-1 drugs alone produced $1.1 billion in claims in 2024, a 29% increase from 2023.
    • “Total membership stands at 5.1 million. There are 663,000 Medicare Advantage members, 286,000 Medicaid members, and 160,000 ACA members.”
  • Healthcare Dive tells us,
    • “Winston-Salem, North Carolina-based Novant Health and Durham, North Carolina-based Duke University Health System will partner to build an unspecified number of new campuses across North Carolina, according to a Monday press release.
    • “The partnership aims to increase patient access to primary care and advanced specialty treatment, as well as shorten wait times for care.
    • “Construction on the first sites will begin this summer, and facilities will open approximately 18 months after work begins, according to the news release.” 

Wednesday Report

David Ermer–CDC, CMS, Congress, FDA, Medical / Rx research, Medicare, Mental health care, NIH, OPM, Telehealth, U.S. Healthcare–
Photo by Michele Orallo on Unsplash

From Washington, DC,

Capitol Hill News

  • Modern Healthcare reports,
    • “Lawmakers who support tough rules on pharmacy benefit managers reaffirmed their ambitions to reanimate legislation that nearly passed Congress in December.
    • “The House Energy and Commerce Committee’s Health Subcommittee relaunched the push at a hearing Tuesday that featured declarations from majority Republicans and minority Democrats that they will tackle high pharmaceutical prices and limited competition in the PBM market through bills that have lingered for more than a year without final action.
    • “I can tell you it is a priority of mine to ensure these commonsense and bipartisan policies become law,” Energy and Commerce Committee Chair Brett Guthrie (R-Ky.) said at the hearing.”
  • Per a Senate news release,
    • “In a Wall Street Journal letter to the editor, Sens. Chuck Grassley (R-Iowa) and Dick Durbin (D-Ill.) welcomed Health and Human Services Secretary Robert F. Kennedy Jr.’s support for enhanced transparency regarding direct-to-consumer (DTC) prescription-drug advertisements. Grassley and Durbin are leading bipartisan legislation to require price disclosures in DTC commercials.”
  • STAT News informs us,
    • “Once again, House lawmakers have introduced a bill to alter a key provision of the Inflation Reduction Act in response to arguments that the federal law is discouraging investment in developing so-called small molecule medicines.
    • “The legislation, known as the Ensuring Pathways to Innovative Cures Act, would allow Medicare to begin negotiating with pharmaceutical companies over the prices of small molecule medicines 13 years after they reach the market. Currently, negotiations begin after nine years and the legislation — which was re-introduced by Rep. Greg Murphy (R-N.C.) — would shift the timetable so that it is the same as for large molecule medicines, also known as biologics.
    • “By making this change, the legislation would remove what the pharmaceutical industry and its investors claim is a disincentive for pursuing small molecule drugs, since these medicines would have less time on the market before Medicare would be able to negotiate set prices. This process means there will be small returns on investments for small molecule drugs, according to those who support the bill.”
  • The American Hospital Association News (AHA) tells us,
    • “Both chambers of Congress have reintroduced AHA-supported legislation, the Conrad State 30 and Physician Access Reauthorization Act (S. 709]/H.R. 1585), to reauthorize and expand the program that allows foreign-born medical graduates to practice medicine in rural and underserved areas. The bipartisan legislation extends the program for three years and would increase current state allocations from 30 to 35 physicians per year. It would also provide flexibility to expand the number of waivers in states where demand exceeds that limit.” 

White House News

  • The AHA News lets us know,
    • “The White House yesterday issued an executive order that directs the Departments of Health and Human Services, Labor, and Treasury to improve upon and increase enforcement of the hospital and insurer price transparency requirements in the Hospital Price Transparency and Transparency in Coverage regulations. Specifically, the White House instructs the departments to “rapidly implement and enforce” the regulations, including by taking actions in the next 90 days to increase enforcement and standardization and ensure that “actual prices,” rather than estimates are disclosed.”
  • Beckers Payer Issues offers six notes for payers on this Executive Order.
  • Per Govexec,
    • “The Trump administration has given federal agencies until March 13 to deliver their plans to dramatically slash their workforces through layoffs as the Trump administration moves to the second phase of its initiative to cut federal employees. 
    • “The plans will focus on the “maximum elimination” of functions not required by law, Office of Management and Budget director and Office of Personnel Management acting Director Charles Ezell said in new guidance on Wednesday, and include a resulting “significant reduction” in employees. As a starting point for the cuts, Vought and Ezell said, agencies should focus on employees whose jobs are not required in statute and who face furloughs in government shutdowns—typically around one-third of the federal workforce, or 700,000 employees. 
    • “Pursuant to the president’s direction, agencies should focus on the maximum elimination of functions that are not statutorily mandated while driving the highest-quality, most efficient delivery of their statutorily required functions,” Vought and Ezell said.”
  • The Washington Post reports,
    • “The Trump administration is giving federal agencies until mid-April to suggest relocations of bureaus and offices out of the D.C. region, a move that would have widespread impacts on the local economy.
    • “In a guidance issued Wednesday to the heads of all executive departments and agencies, the directors of the Office of Management and Budget and the Office of Personnel Management laid out steps for compliance with President Donald Trump’s order to eliminate “waste, bloat and insularity” in the government. Part of that is a directive to submit “any proposed relocations of agency bureaus and offices from Washington, D.C. and the National Capital Region to less-costly parts of the country” by April 14.” * * *
    • “Also on Wednesday, Trump issued an executive order giving agencies seven days to submit an inventory of their real property and 30 days to identify all leases that can be terminated. Within 60 days, the order stated, the General Services Administration — the government’s real estate arm — must come up with a plan to dispose all property deemed “no longer needed.”
  • Bloomberg Law informs us,
    • “US health officials are reevaluating a $590 million contract for bird flu shots that the Biden administration awarded to Moderna Inc., people familiar with the matter said.
    • “The review is part of a government push to examine spending on messenger RNA-based vaccines, the technology that powered Moderna’s Covid vaccine. The bird flu shot contract was awarded to Moderna in the Biden administration’s final days, sending the company’s stock up 13% in the two days following the Jan. 17 announcement.”

CMS News

  • Fierce Healthcare notes,
    • “Just over 34.4 million people were enrolled in Medicare Advantage (MA) plans as of Feb. 1, representing fairly slim growth across the program’s annual enrollment period.
    • “Enrollment grew by 3.8% from February 2024 to February 2025, according to anticipated data released this week from the Centers for Medicare & Medicaid Services. This would make for the lowest growth rate in more than a decade, according to researchers at KFF.
    • “The KFF analysts said enrollment in MA has more than doubled since 2010.”
  • and
    • “While lobbyists are supplicating President Donald Trump and the Republican-led Congress to continue their leadership on telehealth and extend expiring flexibilities—which Trump began during the COVID-19 pandemic—they no longer are asking for a concrete timeline.
    • “Three hundred and fifty organizations signed a letter to congressional leadership Monday urging lawmakers to extend expiring Medicare telehealth flexibilities and to restore telehealth access lost by commercially insured patients in December.
    • “The organizations told Congress that they prefer to make the telehealth flexibilities permanent. However, in a messaging shift, the groups said they “recognize this could be a multi-year process” and asked Congress to consider a “long-term” extension.”

Food and Drug Administration News

  • The New York Times relates,
    • “The Food and Drug Administration has taken a crucial step toward expanding access to the antipsychotic medication clozapine, the only drug approved for treatment-resistant schizophrenia, among the most devastating of mental illnesses.
    • “The agency announced on Monday that it was eliminating a requirement that patients submit blood tests before their prescriptions can be filled.” * * *
    • “In 2015, federal regulators imposed a regimen known as risk evaluation and mitigation strategies, or REMS, that required patients to submit to weekly, biweekly and monthly blood tests that had to be uploaded onto a database and verified by pharmacists.
    • “Physicians have long complained that, as a result, clozapine is grossly underutilized.
    • “Dr. Frederick C. Nucifora, director of the Adult Schizophrenia Clinic at the Johns Hopkins School of Medicine, said he believed that around 30 percent of patients with schizophrenia would benefit from clozapine — far more than the 4 percent who currently take it.
    • “I have had many patients who were doing terribly, who struggled to function outside the hospital, and cycled through many medications,” he said. “If they go on clozapine, they really tend to not be hospitalized again. I’ve had people go on to finish college and work. It’s quite remarkable.”

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “A child who tested positive for measles died in West Texas, the state health department said, marking the first death in an outbreak that has sickened nearly 140 people. 
    • “The Texas Department of State Health Services said a school-age child died after being hospitalized in Lubbock. The child wasn’t vaccinated, the state health department said.
    • “The child’s death marked the first measles-related death in the U.S. since 2015.” * * *
    • “The reality of this outbreak is pushing more people to get vaccinated, said Katherine Wells, director of public health in Lubbock. The public-health department has administered around 100 more measles vaccines over the past week or two than they do normally. More than half of those went to children receiving the vaccine for the first time. School nurses also checked students’ vaccine records and alerted parents if their sons or daughters hadn’t received their second dose yet, Wells said.
    • “The goal right now is to find pockets of unvaccinated people who have not yet been exposed and just get our vaccination rates up as high as possible,” Wells said. “That’s what’s going to slow this down.”
  • CBS News points out,
    • “This season’s influenza vaccine may have been a poor match to a strain of the flu virus that caused many infections this winter, early data released by the Centers for Disease Control and Prevention suggests.
    • “The CDC’s latest data come as much of the U.S. is finally seeing signs of a slowdown in influenza activity after waves of illness this past fall and winter that climbed to the worst rates recorded from hospitals and doctor’s offices since the 2009 swine flu pandemic.”
  • The National Cancer Institute tells us whether “AI Help Predict Which Cancer Patients Should Be Treated with Immunotherapy?” and offers Cancer Information Highlights about “Metastatic Prostate Cancer | Prenatal Blood Test | Nivolumab via Injection.”
  • Health Day adds,
    • “Frequent exercise can help colon cancer survivors live longer, perhaps even outlasting average folks, a new study suggests.
    • “Colon cancer patients who were very physically active had three-year survival rates that were slightly higher than the general population, researchers report in the journal Cancer.
    • “This new information can help patients with colon cancer understand how factors that they can control — their physical activity levels — can have a meaningful impact on their long-term prognosis,” lead researcher Justin Brown, director of the Cancer Metabolism Program with the Pennington Biomedical Research Center at Louisiana State University, said in a news release.”
  • Per Healio,
    • “Pregnant women with low vitamin D levels during the first trimester were four times more likely to give birth prematurely compared with women with adequate vitamin D levels, researchers wrote in The American Journal of Clinical Nutrition.
    • “Testing for vitamin D status is not currently part of standard prenatal care in the U.S.,” Alison D. Gernand, PhD, MPH, RD, associate professor of nutritional sciences at Pennsylvania State University, told Healio. “Clinical care providers should consider talking to pregnant patients about vitamin D during the first prenatal visit — asking whether they have vitamin D-rich foods in their diet and how much vitamin D is in the supplement they are taking.”
  • and
    • “Among populations with low adherence to colorectal cancer screening, annual fecal immunochemical testing was the cheapest and most effective noninvasive screening method, according to a study published in JAMA Network Open“
  • BioPharma Dive lets us know,
    • “AstraZeneca said Wednesday that its experimental drug camizestrant delayed tumor progression in a Phase 3 testing its use as a first-line treatment in people with a certain type of breast cancer. The drug, an oral, hormone receptor protein-degrading therapy known as a SERD, was tested alongside an approved CDK4/6 inhibitor in people whose HR-positive, HER2-negative tumors have an “emergent” ESR1 mutation. People in the study were receiving standard hormone therapy and a CDK4/6 drug and then either continued, or swapped out the hormone treatment for camizestrant, once a tumor scan showed signs of an ESR1 mutation. The result was a “highly statistically significant and clinically meaningful improvement” in progression-free survival for camizestrant recipients, AstraZeneca said. Menarini Group’s similar drug Orserdu is available in the second line setting, while others from Arvinas, Eli Lilly and Roche are in advanced testing.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Drugmaker Eli Lilly plans to build four new manufacturing plants in the U.S., a $27 billion investment that the company expects will create 3,000 high-skilled jobs and employ 10,000 construction workers.
    • “Three of the new sites would produce active pharmaceutical ingredients for its drugs, and the fourth would produce sterile injectable medicines such as diabetes drug Mounjaro, Lilly said Wednesday. The company hasn’t picked the locations yet. It expects the plants to be making medicines within five years.
    • “The announcement, by one of the country’s biggest drugmakers, is the latest by a company outlining a major capital push in the U.S. while President Trump seeks to revive domestic manufacturing.
    • “It comes as Lilly and other pharmaceutical companies seek warm relations with the new administration and press it to pursue industry objectives, including the extension of corporate tax cuts enacted during the first Trump administration.
    • “We hadn’t built a new site in the U.S. in more than 40 years until the first set of Trump tax cuts, so we need to see those either extended or improved to support this,” Lilly Chief Executive David Ricks said in an interview.”
  • Per Modern Healthcare,
    • “Mobile medical units will deliver hospital-at-home care to patients in rural communities as part of a five-year pilot program aimed at expanding healthcare access in underserved areas.
    • “The Advanced Research Projects Agency for Health recently awarded an undisclosed amount of funding to Boston’s Mass General Brigham, University of Utah’s Huntsman Cancer Institute and Kentwood, Michigan-based Homeward Health to develop programs that will extend hospital-level care to patients in remote communities using mobile platforms.
    • “Health systems have used hospital-at-home as a way to ease overcrowding and free up beds. More than 380 hospitals have Medicare waivers allowing them to provide acute care to patients where they live at the same reimbursement rate as an inpatient stay. While the waiver is set to expire at the end of March, there has been bipartisan support to continue it and hospitals continue to launch in-home acute care programs.
    • “But the concept has not taken off in rural America, in part because the CMS waiver requires patients to live within 25 miles of a participating hospital. Staffing can also be a challenge, as well as patient buy-in.”
  • and
    • “Teladoc posted a net loss of just over $1 billion in 2024 related to ongoing struggles at its direct-to-consumer BetterHelp business that are expected to continue this year.
    • “The annual net loss of $1 billion, or $5.87 per share, reported Wednesday, compared with a 2023 loss of $220 million, or $1.34 per share. The company took a non-cash goodwill impairment charge of $790 million attributed to BetterHelp. Revenue tied to BetterHelp, which Teladoc acquired in June 2015 for $4 million, decreased 8% in 2024. Overall revenue declined 1%.
    • “Compared with a year ago, fourth-quarter revenue decreased 3% and its net loss was 68% worse.
    • “The outlook for this year isn’t encouraging. The company said it expects BetterHelp revenue to decline nearly 10%. Still, during an earnings call, CEO Chuck Divita was bullish on the direct-to-consumer segment and said Teladoc will pursue strategies to turn the company around.”
  • Tech Target discusses “How healthcare consumerism is driving provider revenue growth.”
    • “Sixty-five percent of healthcare executives are prioritizing growth strategies to increase revenue, according to the Deloitte Center for Health Solutions. And health system leaders expect consumers to play a major role in their organizations’ organic growth.
    • “The survey from Deloitte underscored a shift from merger and acquisition activity as a means of growing revenue to consumer attraction and retention. However, to attract new consumers and drive organic growth, over half of health system executives (and about half of health plan leaders) said they need to improve consumer engagement, trust and the overall patient experience.”