Midweek Update

Telehealth

Midweek Update

David Ermer–CMS, Congress, FDA, Medical / Rx research, Mental health care, Obesity, OPM, Rx coverage, SCOTUS, Telehealth, U.S. Healthcare–

From Washington, DC

  • Per a House Oversight Committee press release,
    • “As part of the budget reconciliation process, the House Committee on Oversight and Government Reform held a markup today and passed budget legislation that advances President Trump’s agenda and saves American taxpayers over $50 billion. The Committee will now finalize its section of the budget legislation and transmit it directly to the House Committee on the Budget, which will compile and present the final package for consideration by the U.S. House of Representatives.”
  • Govexec provides details on the markup here.
  • Federal News Network tells us,
    • “Agencies are facing a roughly two-week deadline to show the Trump administration how they plan to implement coming changes for probationary employees.
    • “By May 16, agencies are expected to report their plans for adding a new “affirmative” certification requirement for probationary employees. Agencies are also expected to detail how they intend to train supervisors and HR practitioners on the coming changes, according to new guidance the Office of Personnel Management published Tuesday.
    • “The guidance outlines more detailed expectations for agencies to update how they manage probationary periods following President Donald Trump’s executive order last Thursday. That order called for the creation of “Civil Service Rule XI” and added a hurdle for probationary employees to clear before they become tenured employees. Agencies will now be required to review and actively sign off on probationary workers’ continued employment before they can reach a tenured employment status.”
  • Per Healthcare Dive,
    • “House Republicans are calling on the Center for Medicare and Medicaid Innovation to rethink its priorities under the Trump administration, including by improving transparency with providers and focusing on payment models that save the government money.
    • “In a letter sent this week by Republicans on the House Ways and Means Committee to CMS Administrator Dr. Mehmet Oz and CMMI Director Abe Sutton, lawmakers said they were “concerned” with the innovation center’s track record of creating models that often don’t improve care quality or reduce costs. 
    • “The legislators added that CMMI has also “promoted a political agenda ahead of its Congressionally mandated purpose,” like focusing on health equity instead of cost savings.” 

From the Food and Drug Administration front,

  • STAT News points out,
    • “Nearly 12% of Americans still smoke cigarettes, the leading cause of preventable death nationwide. Yet there are only two medications authorized by the Food and Drug Administration to help them quit — the more effective of which, varenicline, can come with unsavory side effects like nausea that make people less likely to stick with treatment.
    • “A new pill with fewer side effects could soon be available from the Washington state-based biotech Achieve Life Sciences. The company plans to file for FDA approval of its drug, called cytisinicline, in June. 
    • “Rick Stewart, Achieve’s co-founder and CEO, told STAT that he expects the drug to be approved in mid-2026 and to launch in the U.S. by the end of that year. “This will be the first new drug for nicotine dependence in nearly 20 years,” he said.” 
  • Fierce Healthcare informs us,
    • “While Johnson & Johnson isn’t the first to secure FDA approval for an FcRn-blocking antibody in myasthenia gravis, the New Jersey drugmaker is confident that a broad label will land its product an enviable market position in the long run.
    • “The FDA on Wednesday approved J&J’s nipocalimab under the brand name Imaavy as a new treatment option for generalized myasthenia gravis (gMG). The green light, which J&J says covers the “broadest population of people living with gMG,” includes patients ages 12 and older who are anti-acetylcholine receptor (AChR) or anti-muscle-specific kinase (MuSK) antibody positive.
    • “Anti-AChR and anti-MuSK antibody-positive people make up more than 90% of the total antibody-positive gMG population, J&J estimates. All told, the company figures gMG—which causes the communication between the body’s nerves and muscles to break down—affects around 700,000 people worldwide.”
  • Per MedTech Dive,
    • “Medtronic has won Food and Drug Administration approval for the Omniasecure defibrillation lead, the company said Friday.
    • “The lead connects to an implantable defibrillator and treats potentially life-threatening types of irregular heart rhythm. Medtronic said Omniasecure is the world’s smallest defibrillation lead.
    • “The approval limits the use of the lead to the right ventricle. Medtronic shared data on placing the lead in the left bundle branch last week but has yet to win FDA approval in that setting.
  • MedCity News lets us know,
    • “Patients with the most severe form of a certain inherited disease have skin that is susceptible to wounds, some that never fully heal. For years, the only treatment was supportive care, including laborious and frequent changes of wound dressings covering much of the body. Biotechnology research in this disease, epidermolysis bullosa (EB), has pursued therapeutic options. A personalized treatment that Abeona Therapeutics makes from a patient’s own skin cells is now approved by the FDA, marking the agency’s third approval in this rare disorder in the past two years.
    • “The regulatory decision announced Tuesday covers the treatment of wounds in adults and children who have recessive dystrophic epidermolysis bullosa (RDEB). The therapy, known in development as prademagene zamikeracel, or pz-cel for short, will be marketed under the brand name Zevaskyn. Cleveland-based Abeona expects Zevaskyn will become available in the third quarter of this year.
    • “We have heard from the RDEB community that there is a persistent, unmet need to meaningfully heal RDEB wounds, especially those that are chronic and prone to infection,” CEO Vishwas Seshdari said during a Tuesday morning conference call. “Through a single application, Zevaskyn can provide people with RDEB the opportunity for significant wound closure and pain reduction in even the most severe wounds.”

From the judicial front,

  • Federal News Network relates,
    • “The U.S. Supreme Court said Wednesday that federal employees who also are in the military reserve must be paid the equivalent of their civilian salaries when called to active duty during national emergencies.
    • “The 5-4 decision could affect hundreds of thousands of people, ensuring that they don’t suffer financially when they temporarily leave one form of government service for another.
    • “The justices ruled in an appeal filed by an air traffic controller who spent about five years on active duty in the Coast Guard at a pay rate lower than what he earns as a Federal Aviation Administration employee.”
  • Reuters reports,
    • “Genetic testing company 23andMe agreed on Tuesday to allow a court-appointed overseer to take charge of ensuring customers’ genetic data remains protected during the company’s bankruptcy, settling a dispute with several U.S. states.
    • “Those states had argued the company was not taking data security seriously enough.
    • “U.S. Bankruptcy Judge Brian Walsh approved the agreement at a court hearing in St. Louis, Missouri, ordering the appointment of a consumer protection ombudsman who will be empowered to review 23andMe’s handling of customers’ genetic information and its security policies.”

From the public health and medical research front,

  • CNBC reports,
    • “Aon researchers found that within two years, improved health outcomes for patients who were taking GLP-1 drugs lowers the growth rate of medical care costs. 
    • “Aon looked at medical claims data for 139,000 U.S.-based workers with employer health coverage who took GLP-1 medications between 2022 and 2024.
    • “Since 2023, GLP-1s have driven up employer spending on drugs at a faster pace than high-priced specialty drugs used to treat cancer and autoimmune conditions, according to an Evernorth study.”
  • Beckers Hospital Review considers what is driving increased use of GLP-1 drugs among children.
  • Per Cardiovascular Business,
    • “Drinking champagne may be associated with significant cardiovascular benefits, according to a new study published in the Canadian Journal of Cardiology.
    • “The study identified dozens of lifestyle changes that may help lower a person’s risk of sudden cardiac arrest (SCA). Some of the changes—eating more fruit, losing weight—were straightforward, but a few of the research team’s findings were unexpected. Drinking champagne and/or white wine, for example, was linked to a reduced SCA risk. The same was also true for spending more time at a computer—though that may tell us more about education levels than screen time.
    • “These findings all come from a new exposome-wide association study (EWAS) out of China. The study’s authors explored the UK Biobank study, focusing on data from more than 500,000 patients. They then looked for associations between SCA and 125 different modifiable lifestyle factors.
    • “To our knowledge, all previous studies on the risk factors of SCA were hypothesis-driven and focused on a limited number of candidate exposure factors grounded in previous knowledge or theoretical frameworks,” wrote first author Huihuan Luo, PhD, a researcher with Fudan University in Shanghai, China, and colleagues. “This might lead to publication bias distorting summary conclusions and might increase the likelihood of false positive findings resulting from inter-related exposures. More importantly, the hypothesis-driven approach might miss important exposures or relationships beyond the predefined hypothesis. To tackle these limitations, a hypothesis-free, data-driven EWAS has emerged as a robust analytical framework for simultaneously exploring hundreds of exposures. This data-driven approach does not rely on previous knowledge and facilitates the identification of novel or underexplored associations.” * * *
    • Click here for the full study.
  • Per Medscape,
    • “People with osteoarthritis are more likely to be diagnosed with other pain-related comorbidities such as fibromyalgia, chronic fatigue syndrome (CFS), gout, and irritable bowel syndrome and psychological comorbidities such as depression, according to observational data presented at the World Congress on Osteoarthritis (OARSI) 2025 Annual Meeting.
    • “The study also found that all these five conditions were themselves associated with an increased risk for incident osteoarthritis, and in the case of fibromyalgia, there may be a causal association.
    • “Physiotherapist and epidemiologist Subhashisa Swain, MPH, PhD, of the Nuffield Department of Primary Care Health Sciences at the University of Oxford, Oxford, England, presented an analysis of data from the multicenter European Comorbidities in Osteoarthritis (ComOA) study, which is examining electronic health records to identify associations between 61 different comorbidities with osteoarthritis and the clusters and trajectories of those comorbidities and osteoarthritis.”
  • The New York Times offers guidance on hip exercises.

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Humana beat earnings expectations for the first quarter and reaffirmed its 2025 guidance on Wednesday, after medical costs came in as predicted. It’s a positive development for the insurer, which has been rocked by higher spending in privatized Medicare plans and the safety-net Medicaid program.
    • “Humana attributed the results to higher Medicare and Medicaid premiums and membership growth in Medicare prescription drug plans and state contracts. Earnings were offset somewhat by an ongoing decline in Medicare Advantage membership after Humana culled underperforming plans to resuscitate margins this year.
    • “However, it’s still early in 2025, so Humana is remaining cautious when it comes to medical utilization, executives said. The payer’s outlook is also complicated by uncertainty stemming from its ongoing legal bid to improve MA quality ratings.”
  • The American Hospital Association News notes,
    • “The AHA April 30 released a report highlighting how hospitals and health systems continue to experience significant financial headwinds that can challenge their ability to provide care to their patients and communities. The report outlines the financial burden of heightened expenses hospitals have faced in recent years in caring for patients, as well as the increasing strain on the field.  
    • “It explains how hospitals have raised wages to recruit and retain staff amid workforce shortages and how Medicare and Medicaid continue to underpay hospitals for patient care as shortfalls worsen. Other findings include how practices of certain Medicare Advantage plans exacerbate hospitals’ financial burden, and that tariffs on medical imports could significantly raise costs for hospitals as nearly 70% of medical devices marketed in the U.S. are manufactured exclusively overseas. 
    • “This report should serve as an alarm bell that a perfect storm of rising costs, inadequate reimbursement, and certain corporate insurer practices are jeopardizing the ability of hospitals to deliver high-quality, timely care to their communities,” said AHA President and CEO Rick Pollack. “With so much at stake, policymakers must recommit to making preserving access to hospital care a national priority.” 
  • The Wall Street Journal reports,
    • “Trump’s executive order on drug prices is seen as a win for the pharmaceutical industry.
    • “Drugmakers spent millions lobbying against pharmacy-benefit managers (PBMs), blaming them for high drug prices.
    • “PhRMA funded various groups, including minority healthcare nonprofits, to criticize PBMs.”
  • Per Fierce Healthcare,
    • “UnitedHealth Group announced Tuesday that Patrick Conway, M.D., would take the helm of its Optum division.
    • “Conway, an insurance industry and health policy veteran, was previously the CEO of Optum’s pharmacy benefit management unit, Optum Rx. He also held leadership roles at the company’s healthcare delivery arm, Optum Health.
    • “Conway will step in as CEO of Optum on May 6. His prior work includes serving as the director of the Center for Medicare and Medicaid Innovation at the Centers for Medicare & Medicaid Services, which is responsible for developing critical payment models for government insurance programs.”
  • and
    • “Despite the poor financial performance of BetterHelp, whose revenue fell by 11% in Q1, Teladoc has grown its investment in virtual mental healthcare by acquiring UpLift in a $30 million all-cash transaction.
    • “The deal closed on April 30, the same day as Teladoc’s first quarter 2025 earnings call. The company fared worse than Wall Street expected in Q1, posting a net loss of $93 million, or $0.53 lost per share. Wall Street Analysts expected the company share price to decrease by $0.33.
    • “A significant upside to the acquisition is the new-found ability for BetterHelp customers to use insurance coverage for mental health services, a barrier that has kept some customers from signing up with the cash-pay mental health provider. UpLift will be included in the company’s BetterHelp reporting segment going forward, executives said.
    • “UpLift provides virtual mental health therapy, psychiatry and medication management services. It serves the health plan market and covers 100 million lives. It has a network of over 1,500 mental health providers.”
  • Per BioPharma Dive,
    • “Novartis will pay $800 million upfront to acquire Regulus Therapeutics, a San Diego biotechnology company that launched nearly two decades ago with plans to make drugs capable of targeting small strips of nucleic acid known as microRNA.
    • “Announced Wednesday, the acquisition will hand the Swiss pharmaceutical firm a drug prospect called farabursen, which recently completed a Phase 1b study in people with autosomal dominant polycystic kidney disease, or ADPKD.
    • “Per deal terms, Regulus shareholders will receive $7 in cash per share, a premium of more than 100% to the stock’s closing price Tuesday. Additionally, Novartis has committed to pay an additional $7 per share via a so-called contingent value right that’s linked to the achievement of an unspecified regulatory milestone.”
  • and
    • “Sales of BridgeBio’s new heart medicine Attruby blew past analyst expectations in the first quarter, as the company built by “science nerds” took on market behemoth Pfizer.
    • “Net product revenue reached $36.7 million in the period, surpassing the consensus analyst estimate of $12.6 million. The drug won Food and Drug Administration approval in November to treat a genetic condition known as transthyretin amyloidosis with cardiomyopathy.
    • “As of April 25, Attruby had 2,072 prescriptions written by 756 prescribers, BridgeBio said Tuesday after the market closed. That momentum built on encouraging numbers released in February and helped push the company’s shares up in early trading Wednesday.”
  • Per Beckers Hospital Review,
    • “Mark Cuban Cost Plus Drug Co. has secured another partnership targeting the specialty pharmaceutical market, according to an April 28 news release shared with Becker’s. 
    • “EverPharm, a specialty unit-dose medication company, is joining its portfolio with Cost Plus Drugs’ pricing model, which is the drug’s manufacturing cost plus a 15% markup and a $10 shipping and labor fee. On April 16, Cost Plus Drugs launched a similar partnership with Morris & Dickson, a full-line and specialty pharmaceutical distributor. 
    • “The partnership with EverPharm will roll out in phases, the release said, with an initial focus on offering key unit-dose medicines to pharmacies and healthcare providers through the Cost Plus Marketplace.” 

Tuesday Report

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

From Washington, DC,

  • The International Foundation of Employee Benefit Plans let us know,
    • Over a dozen bills that would amend the Internal Revenue Code of 1986 to expand health savings accounts (HSAs) have been introduced in Congress this year, according to the International Foundation’s [article]. If enacted, the bills aim to change the disadvantages of HSAs and/or high-deductible health plans (HDHPs) that make them inaccessible or undesirable to some people. If enacted, some bills would allow more people to own HSAs, contribute more annually, and use HSA dollars for more items and services. Other bills would change HDHPs to allow more than preventive services, such as chronic disease treatments, to be covered before the deductible.
  • Per a Senate Finance Committee news release,
    • “U.S. Senate Finance Committee Chairman Mike Crapo (R-Idaho) announced the Committee will hold a nomination hearing on Tuesday, May 6, 2025, at 10:00 AM to consider James O’Neill to be Deputy Secretary of the Department of Health and Human Services (HHS) and Gary Andres to be an Assistant Secretary of HHS.”  
  • Beckers Payer Issues offers five notes on the Trump Administration’s approach to Medicare Advantage so far.
  • Modern Healthcare adds,
    • “Leaders at the Centers for Medicare and Medicaid Services are exploring proposals to limit health insurers’ use of tactics that can delay medical care, people familiar with the discussions said. 
    • “The aim of the proposals would be to cut the number of medical procedures subject to “prior authorization,” meaning ones in which doctors have to fill out additional paperwork for ultimate approval. CMS is exploring making policies more uniform across different health insurance plans. 
    • “Another goal is automating coverage determinations so patients can get decisions faster, said the people, who weren’t authorized to speak publicly on the matter. The discussions are in preliminary stages, and the agency’s direction could change.”
  • Modern Healthcare also shares some health insurer associations’ deregulatory ideas offered to the Trump Administration.
    • “The Coalition Against Surprise Medical Billing, which includes the health insurance trade group AHIP and the Blue Cross Blue Shield Association, wants CMS to make the No Surprises Act out-of-network billing dispute resolution process more favorable to their members, it wrote the White House, HHS, the Treasury Department and the Labor Department last Tuesday.
    • “The Alliance of Community Health Plans, which represents insurers affiliated with nonprofit health systems, wants CMS to nix a variety of quality and performance reporting requirements, including for defunct programs such as the Medicare Advantage Value-Based Insurance Design model, which CMS shut down last year.
    • “The association also wants CMS to ease rules regarding beneficiary communications, such as requiring them to opt into digital communications. These mandates are the “epitome of administrative burdens,” Alliance of Community Health Plans President and CEO Ceci Connelly wrote to CMS April 9.”
  • MedPage Today’s editor in chief interviews the new FDA Commissioner Marty Makary, MD, here.

From the judicial front,

  • STAT News reports,
    • “The Supreme Court on Tuesday rejected hospitals’ argument that the federal government doesn’t pay them enough for treating low-income patients [by a 7-2 majority].
    • “The seven-justice majority instead sided with the Department of Health and Human Services’ interpretation of the law concerning disproportionate share hospital, or DSH, payments, which compensate hospitals for treating low-income patients. More than 200 hospitals brought the case, Advocate Christ Medical Center v. Kennedy, arguing the federal agency’s misreading of the law causes it to underpay them by well over $1 billion each year.” 

From the public health and medical research front,

  • The National Institutes of Health (NIH) announced,
    • adopting a new initiative to expand innovative, human-based science while reducing animal use in research. Developing and using cutting-edge alternative nonanimal research models aligns with the U.S. Food and Drug Administration’s (FDA) recent initiative to reduce testing in animals. While traditional animal models continue to be vital to advancing scientific knowledge, using new and emerging technologies can offer unique strengths that, when utilized correctly or in combination, can expand the toolbox for researchers to answer previously difficult or unanswerable biomedical research questions.
    • “For decades, our biomedical research system has relied heavily on animal models. With this initiative, NIH is ushering in a new era of innovation,” said NIH Director Dr. Jay Bhattacharya. “By integrating advances in data science and technology with our growing understanding of human biology, we can fundamentally reimagine the way research is conducted—from clinical development to real-world application. This human-based approach will accelerate innovation, improve healthcare outcomes, and deliver life-changing treatments. It marks a critical leap forward for science, public trust, and patient care.”
  • The current issue of NIH Research Matters covers the following topics: “Restoring speech after paralysis | CT scans and cancer risks | Visual information processing in the brain.”
  • Health Day tells us,
    • “A Kaiser Permanente colon cancer screening initiative put a huge dent in cancer cases and deaths over two decades, a new study says.
    • “The systematic outreach program doubled colon cancer screening rates, researchers are scheduled to report at the upcoming Digestive Disease Week meeting in San Diego.
    • “As a result, cancer cases were cut by a third and colon cancer deaths by half, researchers report.
    • “In addition, racial disparities in colon cancer outcomes nearly vanished as a result of the initiative, researchers said.
    • “By offering an effective screening approach equally to everyone, we were able to eliminate much of the disparity,” said lead investigator Dr. Douglas Corley, chief research officer with the Kaiser Permanente Division of Research in Northern California.
    • “Ten years ago, there were big gaps in cancer risk and death, especially among our Black patients,” he said in a news release. “Now, those differences are nearly gone.”
  • MedPage Today informs us,
    • “The addition of the pregnancy checkbox on death certificates in 2003 was responsible for most of the spike in maternal deaths since 2000.
    • “However, in 2021, adjusted maternal death rates peaked at 18.86 per 100,000 live births, in line with the COVID pandemic.
    • “Of note, both infant and fetal death rates per 1,000 live births declined across the study period.” * * *
    • “Our work is the first to quantitatively separate out the effect of change in data collection from actual trends in maternal mortality,” co-author Robin Park, MSc, also of the University of Oxford, told MedPage Today. “Adjusting for the change in data collection, we find that the rate of maternal mortality has been relatively constant since 2000.”
    • “Park noted that while the checkbox doesn’t change the definition of maternal death, “anecdotal evidence suggests that it makes coders more likely to add a maternal or pregnancy-related cause of death,” and thus it’s been difficult for researchers to “parse out the true trends from changes in data collection.”
  • Per MedTech Dive,
    • “Since its U.S. debut more than a year ago, pulsed field ablation continues to gain converts at a fast pace, with devices from Boston Scientific and Medtronic leading the way.
    • “The procedure is becoming physicians’ preferred ablation method for treating atrial fibrillation, an irregular rhythm that can lead to complications such as blood clots, stroke and heart failure. PFA delivers electrical pulses to targeted areas of the heart causing abnormal rhythms, offering a potentially safer approach than older treatments that use heat or extreme cold to ablate the tissue.
    • “In connection with the Heart Rhythm Society’s 2025 meeting in San Diego, which wrapped this weekend, Boston Scientific, Medtronic, Abbott and Johnson & Johnson all unveiled data supporting their devices.
    • “Truist analysts, in a note to clients Sunday, said physicians they spoke with at the event reported that the more efficient PFA procedures were allowing their institutions to perform at least 20% to 30% more cases.”

From the U.S. healthcare business front,

  • Per a news release,
    • “The Institute for Clinical and Economic Review (ICER) announced today that it will assess the comparative clinical effectiveness and value of tirzepatide (Zepbound®, Eli Lilly & Co.) and semaglutide (Wegovy®, Novo Nordisk) for the treatment of obesity. ICER will also assess how these treatments affect additional obesity-related outcomes.
    • “The assessment will be publicly discussed during a meeting of the New England CEPAC in November 2025, where the independent evidence review panel will deliberate and vote on evidence presented in ICER’s report.
    • “ICER’s website provides timelines of key posting dates and public comment periods for this assessment.“
  • The Wall Street Journal reports,
    • “AstraZeneca’s core EPS rose to $2.49, revenue increased 10% to $13.59B, but shares fell over 4% amid legal challenges in China.
    • “The company reaffirmed its 2025 targets after oncology revenue grew 13% to $5.64B, driven by Tagrisso and Imfinzi.
    • “China revenue rose 3%, but the company faces potential fines in the country over alleged illegal drug imports.”
  • and
    • “Hims & Hers partners with Novo Nordisk to offer Wegovy for weight loss, with subscriptions starting at $599 a month.
    • “The collaboration includes clinical support and nutrition guidance via Hims & Hers’ platform and NovoCare Pharmacy.
    • “Novo and Lilly are partnering with telehealth providers amid competition in the weight-loss drug market.”
  • and
    • “Merck is investing $1 billion in a Delaware plant to expand its U.S. manufacturing, amid potential tariff concerns.
    • “The plant will produce biologic drugs and a new, easier-to-use version of Keytruda, the company’s blockbuster cancer drug.
    • “The facility is Merck’s first in-house U.S. site for Keytruda, ensuring domestic supply and creating at least 500 on-site jobs.”
  • Per Healthcare Dive,
    • “Universal Health Services reported earnings for the first quarter on Monday evening that came in below Wall Street’s expectations for revenue. The for-profit’s behavioral health business also underperformed compared to its acute care service line.
    • “Behavioral health adjusted admissions declined by 1.6% compared to the prior year, while acute care admissions grew by 2.4%. Executives blamed the leap year in 2024 and atypical winter weather in some markets for depressed patient days, noting adolescent behavioral care utilization rates were particularly impacted by weather-related school closures. 
    • “CEO Marc Miller told investors during a Tuesday morning earnings call that UHS could get its behavioral health unit back on track to grow patient day revenue by 2.5% to 3% by the end of the year. However, the executive declined to specify when investors could expect to see improvement and dodged questions about whether volumes are expected to improve in the second quarter or the back half of the year.”
  • Per Fierce Healthcare,
    • “Though it opted to stick with annual guidance numbers given in February, Tenet Healthcare’s “outstanding” first-quarter performance has the company pushing ahead on growth initiatives in the face of financial headwinds and policy uncertainties.
    • “Tuesday morning, the hospital and ambulatory surgical center operator shared a $406 million net income attributable to the company ($4.27 per diluted share) for the first three months of the year. Net operating revenues decreased year over year from $5.4 billion to $5.2 billion, largely reflecting hospital divestitures during the prior year.
    • “Its adjusted EBITDA of $1.16 billion was up 14% over the same period a year prior and “well above the high end of our guidance range,” Chief Financial Officer Sun Park said Tuesday.
    • “Tenet CEO Saum Sutaria, M.D., told analysts that the earnings growth stems from divesting low-margin facilities and recent years’ focus on operating discipline. It’s set the stage for Tenet to continue focusing on labor structure and supply standardization, to increase its operating leverage and to build out its portfolio of well-performing assets.”
  • and
    • “Telehealth company LifeMD bought assets from Optimal Human Health MD to accelerate its push into the women’s health market.
    • “The acquisition establishes a scalable clinical and operational foundation for a comprehensive virtual health program, set to launch this summer, focused on hormone health, bone density, metabolism and long-term wellness. LifeMD’s virtual women’s health platform will target areas such as menopause and osteoporosis.
    • “The company did not disclose financial details of the acquisition.”
  • Modern Healthcare reports,
    • “Dr. Shawn Griffin, president and CEO of URAC, has had a front row seat to AI’s evolution in healthcare and he’s worried there are not enough guardrails.
    • “There is an urgent need for standards to be developed and quickly, given the change in presidential administrations, said Griffin, who six years ago became the first physician to lead the nonprofit accreditation organization for hospitals, health plans, telehealth providers, pharmacies and other healthcare players.”
    • “Looking at the way that AI was coming into healthcare, we recognized that there was a need for some sort of verifiable standards to be implemented to protect patients and to look out for their best interests in this area that’s moving so fast,” Griffin said. “It’s been on our radar screen for a few years.”
    • In the fall, URAC plans to launch a healthcare AI accreditation program, making it one of several organizations initiating these specific types of accreditation programs.

Friday Report

David Ermer–CDC, COVID-19, FDA, Medical / Rx research, Patient safety, SCOTUS, Telehealth, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC,

  • Today, the Supreme Court held a conference of its justices at which the Court decided next steps with the Kennedy v. Braidwood Management case heard last Monday.
  • Bloomberg Law reports that following the conference,
    • “The Supreme Court ordered more briefing after arguments in a dispute over Obamacare’s preventative services mandate, which requires insurers to cover certain treatments like cancer screenings free of charge.
    • “In an order on Friday, the justices asked the parties to address whether the health secretary has the power to appoint the members of the US Preventive Services Task Force, which recommends services that should be covered under the Affordable Care Act. 
    • “The court wants to know “whether Congress has ‘by Law’ vested” the secretary with this authority.” * * *
    • “Additional briefs are due May 5. It’s rare but not unheard of for the court to request more briefing after a case has been argued.
    • “This occasionally occurs on issues that come up during argument if they weren’t initially briefed by the parties.”
    • FEHBlog note — That’s exactly what happened in the Braidwood Management case.
  • STAT News tells us,
    • “The federal health department is not creating a new registry of Americans with autism, a Department of Health and Human Services official said in a written statement Thursday. Instead, the official said, HHS will launch a $50 million research effort to understand the causes of autism spectrum disorder and improve treatments.
    • “The announcement arrives two days after National Institutes of Health Director Jay Bhattacharya announced the intent to create such a registry at an all staff meeting, kicking off a firestorm of panic and confusion among autism self-advocates and the broader research community. Much of the fear centered around Bhattacharya’s remarks that the government would pull health data from private sources, such as electronic health records maintained by health care providers, pharmacy data, insurance claims and even wearables like smart watches and fitness trackers.”
  • Science Soft Healthcare predicts that “”By the end of 2026, 25–30% of all medical visits in the United States will be conducted via telemedicine. Although the adoption rate of telemedicine has been low in 2024, it will grow considerably with regulatory support from the US Congress.”
    • “In 2023, telemedicine usage in mental health was over three times higher than in other medical specialties, according to Epic Research. We believe that the resilient demand for telemedicine in mental health indicates that the technology is here to stay.”
  • The American Hospital Association News informs us,
    • “The Food and Drug Administration published a notice from Amneal Pharmaceutical that said the company is recalling two lots of its Ropivacaine Hydrochloride Injection 500mg/100mL Infusion bags due to the products potentially containing inert polypropylene fibers. As of April 18, Amneal Pharmaceuticals said it received no reports of adverse events or injuries related to the recall. The recalled IV bags were distributed nationwide to wholesalers and distributors from April 23-Nov. 8, 2024.”

In other judicial news,

  • STAT News reports,
    • “Novo Nordisk has notched a major legal win against compounding pharmacies that make copies of its diabetes and obesity drug semaglutide, sold under the brand names Ozempic and Wegovy.
    • “A federal judge on Thursday ruled against a compounding trade group’s request for a preliminary injunction that would have prevented the Food and Drug Administration from taking action against its members for making copies of semaglutide.
    • “Compounding pharmacies are legally allowed to make versions of branded treatments if the drugs are deemed to be in shortage by the FDA. For the two years when Ozempic and Wegovy were recently in shortage, compounders rushed to make copies to meet the enormous demand for weight loss treatments. But when semaglutide was ultimately taken off the FDA’s shortage list in February, the compounding trade group, called the Outsourcing Facilities Association, quickly sued the agency, arguing that there were still in actuality shortages of the branded treatments.”

From the public health and medical research front,

  • The Centers for Disease Control and Prevention announced today:
    • “Seasonal influenza activity continues to decline. COVID-19 and RSV activity are declining nationally to low levels.
    • “COVID-19
      • “COVID-19 activity continues to decline nationally. Wastewater levels are at low levels, emergency department visits are at very low levels, and laboratory percent positivity is stable.
      • “Additional information about current COVID-19 activity can be found at: CDC COVID Data Tracker: Home
    • “Influenza
    • “RSV
      • “RSV activity continues to decline in most areas of the country.
    • “Vaccination
      • “Vaccination coverage with influenza and COVID-19 vaccines is low among U.S. adults and children. Vaccination coverage with RSV vaccines remains low among U.S. adults.
    • “Other Respiratory Illnesses
      • “Mycoplasma pneumoniae
        • Respiratory infections caused by the bacteria Mycoplasma pneumoniae have increased in some areas of the United States over the last few weeks as indicated by emergency department visits and test positivity. M. pneumoniae infections are generally mild but can sometimes be severe, causing what’s known as “walking pneumonia.” Most people will recover without medicine, but some need antibiotics to get better. Learn more: About Mycoplasma pneumoniae Infection | M. pneumoniae | CDC.
      • “Pertussis
        • “Reported cases of whooping cough (pertussis) continue to be elevated nationwide but preliminary case reports have been trending downward for the past several months. Whooping cough is very contagious and can spread easily from person to person. Babies younger than 1 year old are at highest risk of severe disease and complications. The best way to prevent complications from whooping cough is to get vaccinated. Learn more: About Whooping Cough | Whooping Cough | CDC.“
  • The University of Minnesota’s CIDRAP adds,
    • “Flu activity continues to ebb nationwide, with rates of influenza-like illness (ILI) dropping further last week, but flu-related deaths in children climbed to 204, up 6 from the previous week, the Centers for Disease Control and Prevention (CDC) said in its weekly update today.”
  • The AHA News lets us know,
    • “There have been 884 confirmed cases of measles nationwide so far this year, with cases reported by 29 states, according to the latest data from the Centers for Disease Control and Prevention. There have been 11 outbreaks, and 93% of confirmed cases (820 of 884) are outbreak-associated. The vaccination status of 97% of all cases is classified as “unvaccinated or unknown.”
    • “The CDC April 24 released a report that said increasing national and local measles, mumps and rubella vaccination coverage is essential to preventing measles cases and outbreaks. The report also said that cases this year are the second highest in 25 years. A JAMA study also released April 24 found that measles could become endemic again within another 25 years if current childhood vaccination rates remain the same.”
  • The University of Minnesota’s CIDRAP drills down on these measles statistics.
  • Eating Well reports,
    • “A recall on a popular brand of apple juice sold in 28 states was just announced, according to the Food and Drug Administration. This is due to a potential contamination with patulin, a mycotoxin that can cause internal organ damage when consumed in excess. Approximately 173,616 bottles are affected by this recall.
    • “The product impacted is Martinelli Apple Juice sold in its signature clear, round glass bottles with a white metal screw top lid. The recalled 10-ounce apple juice bottles were sold in 4-packs, contain a UPC of “0 41244 04102 2” and have a best-by date of December 5, 2026. They were sold at retail locations in the following states: Alabama, Arkansas, Arizona, California, Connecticut, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Michigan, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Texas, Utah, Virginia and Wisconsin.
    • “This recall was just classified as a Class II recall, meaning that drinking this apple juice can  “cause temporary or medically reversible adverse health consequences,” per the FDA.
  • Healio points out,
    • An estimated 24,499 people visited the ED for adverse events related to semaglutide in the 2 years after its approval for weight loss, according to a study published in Annals of Internal Medicine.
    • The most common symptoms included nausea, vomiting and diarrhea, which had been previously documented in clinical trials. However, researchers also discovered that 16% of ED visits involved hypoglycemia.
    • “What I see in clinical practice is that some patients end up in the ED due to these severe symptoms from semaglutide, and it is not recognized in the ED,” Pieter Cohen, MD, associate professor of medicine at Harvard Medical School and internist at Cambridge Health Alliance, told Healio. “It is really important to make sure we are asking our patients about the use of semaglutide when they have these symptoms, particularly since use is so prevalent these days.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Centene beat Wall Street expectations for earnings and revenue in the first quarter thanks to significant membership increases, especially in Affordable Care Act and Medicare prescription drug plans, according to results released Friday.
    • “Citing the strong enrollment, the St. Louis-based payer raised its revenue guidance and reiterated its earnings guidance for 2025.
    • “However, Centene signaled medical costs may also be increasing, raising the outlook for its full-year medical loss ratio — a marker of spending on patient care. Centene’s stock fell 7% in Friday morning trade following the results.”
  • Per BioPharma Dive,
    • “Gilead Sciences on Thursday reported $6.7 billion in revenue in the first quarter, missing consensus Wall Street estimates as its cancer drug sales fell short of analyst expectations.  
    • “Gilead’s oncology portfolio generated $758 million in sales over the first three months of the year, down about 4% compared to the same period in 2024. Slower-than-expected sales of Gilead’s breast cancer drug Trodelvy were the main culprit, though the company also blamed lower demand for a decline in cancer cell therapy revenue.
    • “Gilead’s HIV drug business, though, helped offset those losses, garnering $4.6 billion and climbing 6% year over year. The company expects further growth in the future, as by June 19 the Food and Drug Administration could significantly expand use of lenacapavir, a twice-yearly injectable medicine proven in testing to prevent HIV infections.
  • Beckers Payer Issues provides 101 things to know about Blue Cross Blue Shield.
  • Beckers Hospital Review offers a list of the 25 most expensive hospital drugs.
  • Fierce Healthcare tells us,
    • “HCA Healthcare reaffirmed its 2025 guidance following an opening quarter of solid care demand and better-than-expected earnings.
    • “The country’s largest for-profit health system announced Friday morning $1.61 billion of net income attributable to the company ($6.45 per diluted share) and revenues of $18.32 billion for the first quarter. Both are improvements over the prior year’s $1.59 billion ($5.93 per diluted share) and $17.34 billion.
    • “Adjusted EBITDA for the quarter was $3.73 billion, also up from $3.35 billion in the first quarter of 2024.”
  • Per Fierce Pharma,
    • “With the potential for pharmaceutical import tariffs spurring a rush of life sciences investments in the U.S., AbbVie is joining the trend with plans to spend billions in the country over the next decade.
    • “AbbVie aims to invest $10 billion in the U.S. through 2035 to support its current growth plans and expand into new areas like obesity, the Chicago drugmaker’s CEO, Rob Michael, said on a call with analysts Friday.
    • “AbbVie’s executives did not go into the fine details of the domestic investment plan on the call, though the company’s CFO Scott Reents noted that a portion of the sum will be earmarked to build four new U.S. production facilities devoted to active pharmaceutical ingredients (API), drug product, peptides and devices.”
  • and
    • “After unveiling a new drug substance facility in North Carolina in December, Amgen is doubling down on expanding its U.S. production presence with plans for a major upgrade at its plant in central Ohio.
    • “The new project represents the latest in a string of pharma investments in the U.S. as the Trump administration threatens to clamp down on the industry with sector-specific import tariffs.
    • “Amgen is plugging $900 million into an expansion of its biomanufacturing facility in New Albany, Ohio, the company said Friday. The project is expected to bring the total number of Amgen jobs in the state to 750 and increase the company’s overall investment in Ohio to more than $1.4 billion.”

Thursday Report

David Ermer–CDC, CMS, Congress, COVID-19, FDA, Medical / Rx research, Mental health care, NIH, OPM, SCOTUS, Telehealth, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC

  • The American Hospital Association (AHA) News lets us know,
    • “Senate Health, Education, Labor, and Pensions Committee Chairman Bill Cassidy, M.D., R-La., today released a report detailing findings from an investigation into how covered entities use and generate revenue from the 340B Drug Pricing Program. As part of his investigation, Cassidy requested information from hospitals, Federally Qualified Health Centers, contract pharmacies and drug manufacturers.  
    • “Cassidy said the “investigation underscores that there are transparency and oversight concerns that prevent 340B discounts from translating to better access or lower costs for patients,” and the report outlines potential reforms needed to improve the program to better serve patients.   
    • “In a statement shared with media, AHA President and CEO Rick Pollack said, “The AHA appreciates Senator Cassidy’s leadership on 340B issues. As his report correctly observes, the 340B program was created to help hospitals reach more eligible patients and provide more comprehensive services. Even this investigation — which the report recognizes was ‘limited in scope’ given the variety of 340B hospitals across the country — demonstrates that hospitals use 340B savings to provide financial assistance to low-income patients and to maintain programs that enhance patient services and access to care. In short, 340B is vital in advancing health in communities across the country.”  
  • The President signed an executive order strengthening probationary periods in the federal civil service. Here’s a link to a fact sheet.
  • Govexec tells us, “Ex-feds launch websites to help unemployed civil servants find new jobs. Many federal employees are looking for positions outside of government following reductions in force and the Trump administration’s push for workers to take separation incentives.”
  • Per a Drug Enforcement Administration news release,
    • DEA’s National Prescription Drug Take Back Day is your chance to rid your medicine cabinet of unneeded and unwanted medications. Start your spring cleaning this year on April 26 by visiting a collection site near you.
    • Mark your calendar for this upcoming event! Participating drop-off sites will be open from 10 a.m. to 2 p.m. (local time) on Saturday, April 26. Collection sites are located around the country and will be collecting:
      • Tablets
      • Capsules
      • Patches
      • Other solid forms of prescription drugs.
  • The U.S. Preventive Services Task Force posted for public comment a draft research plan for evaluating a measure regarding “Vision in Children Ages 6 Months to 5 Years: Screening.” The public comment deadline is May 21, 2025.
  • Per the AHA News,
    • “The Food and Drug Administration has identified a Class I recall of Q’Apel Medical 072 Aspiration System after the company submitted three device event reports that included a tip detachment, a vessel rupture and a vasospasm.”

From the judicial front,

  • Professor Katie Keith wrote an article in Health Affairs Forefront about the Kennedy v. Braidwood Management oral argument presented to the Supreme Court last Monday.
  • Fierce Pharma informs us,
    • “Halozyme is not holding back against Merck & Co. in the companies’ injectable Keytruda patent dispute, having now escalated a verbal warning into a lawsuit.
    • “In a lawsuit filed Thursday in a New Jersey federal court, Halozyme alleges that a proposed subcutaneous formulation of Merck’s popular cancer drug Keytruda infringes 15 of its patents.
    • “Those intellectual properties belong to a Halozyme patent family called Mdase, which covers a large group of modified human hyaluronidases. A hyaluronidase protein may allow for under-the-skin administration of otherwise intravenously infused drugs.
    • “Halozyme is seeking an injunction to block Merck’s planned commercialization of subcutaneous (SC) Keytruda, which is under FDA review with a decision expected by Sept. 23. The San Diego drug delivery expert is also asking for monetary relief and “an enhancement of damages,” because the alleged infringement is said to be willful, according to its complaint.
    • “Even though SC Keytruda has not reached the market, Merck opened itself to patent litigation after publicly laying out its intention to launch the product this year pending FDA approval.”

In State government news,

  • Mercer offers a roundup of selected state healthcare developments in the first quarter of 2025.

From the public health and medical research front,

  • CNN reports,
    • “The United States has seen progress in reducing certain cancer risks, as overall smoking rates remain on a decline. But for other risk factors, such as those tied to cervical cancer, there is room for improvement, according to a new American Cancer Society report.
    • “The prevalence of people smoking fell from about 14% in 2019 to 11% in 2023, according to the report published Wednesday in the journal Cancer Epidemiology, Biomarkers & Prevention. Cigarette smoking is known to significantly increase the risk of developing cancer. It’s estimated to cause about 1 out of every 3 cancer deaths in the US. * * *
    • “The prevalence of people being up-to-date on recommended cervical cancer screenings has dropped from 74.8% in 2019 to 73.4% in 2021 among ages 21 to 65, the report found, leaving more women at risk of not detecting disease early. The reported noted that the decrease is alarming as HPV vaccination rates have remained “statistically unchanged” in recent years. In 2023, 61.4% of adolescents ages 13 to 17 were up-to-date for the HPV vaccination series, similar to 61.7% in 2021 and up from 54.2% in 2019.
    • “HPV or human papillomavirus is a group of more than 150 viruses that can cause certain types of cancer. Spread primarily through sexual contact, most cases of HPV clear on their own within two years, but when the infection does not go away, health problems like cancer may occur – which is why preventing these infections with vaccination has been key.”
  • The National Cancer Institute announced,
    • “Researchers have discovered what appears to be a critical biological driver of the most common form of ovarian cancer. The discovery, they believe, could spearhead the development of approaches for finding ovarian cancer at its earliest stages or preventing the disease from taking hold in the first place.
    • “Multiple studies have shown that high-grade serous ovarian cancer arises from precancerous growths called serous tubal intraepithelial carcinoma (STIC) lesions in the fallopian tubes. These lesions can eventually travel into the ovaries and transform into full-blown tumors.
    • “In this new study, Lan Coffman, M.D., Ph.D., of the University of Pittsburgh School of Medicine, and her colleagues showed that STIC lesions appear to arise and turn into tumors in the ovaries with the assistance of a type of stem cell that they called high-risk mesenchymal stem cells (MSCs).
    • “These high-risk MSCs—which have specific characteristics that appear to help their cancer-fueling capabilities—were abundant in the tissue, or stroma, immediately underneath STIC lesionsExit Disclaimer in fallopian tube tissue samples from women without cancer. They were also sometimes present in normal tissue. 
    • “When the researchers implanted high-risk MSCs along with healthy fallopian tube cells into mice, some developed ovarian cancer, including, in some cases, metastatic cancer, the researchers reported March 14 in Cancer Discovery.
    • “It’s not yet clear if high-risk MSCs are the primary instigator that causes healthy fallopian cells to transform into high-grade serous ovarian cancer, Dr. Coffman said, but the group’s findings support the idea that these cells are intimately involved. 
    • “What we believe we’re seeing is that [high-risk MSCs] are a supportive ‘soil’ for cancer initiation,” she said.”
  • Beckers Hospital Review adds,
    • “Some early-onset colorectal cancers may be caused by exposure to a bacterial toxin within the first 10 years of life, according to a study published April 23 in Nature.
    • “An international research team, led by Ludmil Alexandrov, PhD, from the University of California San Diego, analyzed 981 colorectal cancer genomes from patients across 11 countries for the study.” 
  • STAT News points out “Studies zoom in on clues to why Lyme disease persists and which antibiotic to prescribe. Cellular debris lingering in the liver and and a penicillin relative are identified.”
  • The AHA News tells us,
    • “A study published April 8 by the Public Library of Science’s Journal of Global Public Health found that driving while infected with COVID-19 raises the risk of an accident by 25%. The study analyzed public health and transportation data from seven states from 2020-2023. The results showed a significant association between acute COVID-19 infections and an increase in vehicle crashes.”
  • The Wall Street Journal reports,
    • A new study by French researchers found that some combinations of food additives were associated with a higher risk of Type 2 diabetes.
    • Researchers found that combinations of emulsifiers, colors and sweeteners increased the diabetes risk beyond what could be explained by individual substances alone.
    • Food-industry representatives defended combinations of what they said were safe ingredients, which they said are important for food safety and quality.
  • WTW notes, “Therapeutic alliance, the bond between client and therapist, is a game-changer in mental health programs. Employers must focus on measuring to predict better results and reduce dropout rates.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • Merck’s first-quarter net income increased, driven by Keytruda sales, reaching $5.08 billion, or $2.01 a share, up from $4.76 billion year-over-year.
    • Despite sales of Keytruda rising 4% to $7.2 billion, Merck cut its 2025 adjusted earnings projection, citing tariffs and a license agreement.
    • Sales of HPV vaccine Gardasil fell 41% due to lower Chinese demand, while animal-health product sales rose 5% to $1.6 billion.
  • and
    • “Roche’s Q1 sales beat estimates due to demand for drugs like Ocrevus and Hemlibra.
    • “Roche is boosting its U.S. manufacturing to avoid potential tariffs, investing $50 billion over five years.
    • “Roche maintains its full-year guidance, anticipating mid-single-digit sales growth.”
  • Healthcare Dive adds,
    • “Molina beat analyst expectations for earnings and revenue in the first quarter, with a topline of $11.1 billion, up 12% year over year, and net income of $298 million, down 1% year over year, according to results released Wednesday.
    • “The California-based insurer said its medical costs increased moderately in the quarter, mostly due to utilization of long-term supports and services, expensive drugs and behavioral health, along with more spending on seasonal illnesses like the flu. However, costs were generally in line with what Molina had predicted, a bright spot after UnitedHealth, the largest private insurer in the U.S., reported an unexpected spike in spending earlier this month.
    • “Molina’s results can be viewed as “good enough,” TD Cowen analyst Ryan Langston wrote in a note on the insurer’s first quarter performance.”
  • Per BioPharma Dive,
    • Sanofi’s first-quarter sales and profit exceeded analyst expectations, but the company held tight on its full-year guidance amid looming threats of new tariffs from the Trump administration and regulatory uncertainty.
    • Sales climbed 9.7% to 9.9 billion euros, or $11.3 billion, in the period, beating the consensus analyst estimate of 9.6 billion euros. Earnings for the core business rose almost 16% to 1.79 euros a share, topping the consensus expectation of 1.70 euros a share.
    • The French drugmaker benefited from the launch of new drugs and the continuing growth of Dupixent, a blockbuster medicine used to treat conditions including asthma, eczema and chronic obstructive pulmonary disease. The drug’s sales jumped 20% to 3.5 billion euros in the quarter, Sanofi said Thursday.
  • Per MedTech Dive,
    • Medtronic is seeking Food and Drug Administration clearance for an interoperable version of its latest insulin pump, an important step in the manufacturer’s collaboration with diabetes technology rival Abbott. 
    • Medtronic said on Thursday that it made two 510(k) submissions to the FDA: one for its MiniMed 780G insulin pump as an alternate controller enabled device, and another for its SmartGuard insulin dosing algorithm as an interoperable automated glycemic controller.
    • The clearances would allow Medtronic’s technology to be part of an automated insulin delivery system, which can adjust insulin dosing to patients based on real-time readings from glucose monitors, using components made by other companies.
  • and
    • Edwards Lifesciences maintained full-year financial forecasts on Wednesday, projecting sales of its heart valves would offset hits from tariff and acquisition costs.
    • First-quarter sales of transcatheter aortic valve replacements, Edwards’ largest business, were better than the company expected, executives said on an earnings call.
    • Edwards’ TAVR sales were stifled last year by capacity constraints as heart teams performed more mitral and tricuspid valve procedures with the company’s newest devices. Hospitals are now addressing capacity issues by expanding capabilities for handling increased volumes, said Larry Wood, group president of TAVR and surgical structural heart. 
  • Modern Healthcare reports,
    • “Health systems have been shouldering the cost of mobile integrated healthcare programs for at-risk patients, but some insurers may be ready to start picking up the tab as providers prove they can save money.
    • “UMass Memorial Health, Geisinger, Prisma Health and others that operate these at-home care programs say the service saves millions of dollars by preventing emergency room visits and rehospitalizations of chronically ill patients. Government and private insurers have been covering little to none of the cost, but that could be changing as systems get information to prove the programs are effective.”
  • Mobihealth News informs us,
    • San Francisco-based Hinge Health, a digital musculoskeletal care platform, announced it is partnering with Cigna Healthcare to offer the health insurance company’s self-insured clients access to Hinge’s digital musculoskeletal (MSK) care platform. 
    • Hinge offers individuals with MSK conditions access to a multidisciplinary care team, including health coaches, orthopedic surgeons and physical therapists, as well as to digital tools like surgery decision support.
    • The company also provides a pelvic health program tailored for women and Enso, its FDA-cleared wearable that delivers electrical pulses to help alleviate everyday pain.
    • Cigna’s members who choose to enroll will have access to Hinge Health through Cigna’s condition-specific care program Pathwell Bone & Joint Solution.
    • Hinge touts that it is now an MSK provider for the five largest national health plans in the U.S. by self-insured lives. 
  • Per Fierce Healthcare,
    • “Health insurers can’t lose sight of improvements to the consumer experience as they find ways to reduce and manage rising costs, according to a new report from Forrester.
    • “The analysts offered one broad takeaway for payers: “Cut costs, not corners.” They noted that the industry is at a key crossroads where it’s critical to improve consumer experience and boost trust and consider those challenges as they build strategies around cost.
    • “Health insurers must improve CX, build consumer trust, and find innovative ways to create more sustainable cost structures and better economics for customers,” they wrote. “But the thirst for cost efficiency can’t cloud insurers’ strategic visions to create better health outcomes.”
  • Per Fierce Pharma,
    • “With the threat of Trump administration’s tariffs swirling and biopharma companies bracing for impact, many are announcing their intention to strengthen their presence in the U.S.
    • “The latest to hop on the invest-in-USA bandwagon is Thermo Fisher Scientific. The Massachusetts-based producer of medical instruments, diagnostics and pharmaceuticals will spend an additional $2 billion in the U.S. over the next four years “strengthening American innovation, manufacturing and economic competitiveness,” the company said in a release.
    • “Three-quarters of the pledge will bolster Thermo Fisher’s manufacturing operations, while the remaining $500 million will expand its R&D efforts.”

Tuesday Report

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

From Washington, DC,

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

From the judicial front,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Thursday Report

David Ermer–CMS, Congress, Medical / Rx research, OPM, Telehealth–
Photo by Josh Mills on Unsplash

From Washington, DC

  • The FEHBlog watched today’s confirmation hearing for the President’s nominee for OPM Director, Scott Kupor. Clearly, Mr. Kupor is on a glide path to Senate confirmation. The next step toward that goal will occur at a business meeting of the Senate Homeland Security and Government Affairs Committee on Wednesday April 9 at 10 am.
  • The American Hospital Association News tells us,
    • “The Senate April 3 by a vote of 53-45 confirmed Mehmet Oz as the new administrator for the Centers for Medicare & Medicaid Services.” 
  • The Wall Street Journal reports,
    • “Health and Human Services Secretary Robert F. Kennedy Jr. said he would reinstate some programs and federal workers cut earlier this week as part of his sweeping reorganization of the department.
    • “Some programs that were cut, they’re being reinstated,” Kennedy said Thursday. “Personnel that should not have been cut were cut. We’re reinstating them.”
  • Per Senate news releases,
  • and
    • “Senate Judiciary Committee Chairman Chuck Grassley (R-Iowa) led a markup on six bipartisan Grassley-backed bills to boost competition in the pharmaceutical industry and improve access to more affordable prescription drugs. All six bills advanced in committee by voice vote.” Five of the six bills target pharma, while the sixth bill requests an FTC study of consolidation in the PBM industry.
  • Healthcare Dive reports,
    • “AdvaMed, one of the medical device industry’s largest trade groups, reiterated its opposition to broad-based tariffs Wednesday, saying the actions would hurt innovation, cost jobs and increase healthcare costs, after the Trump administration announced new duties on most U.S. trading partners.
    • “The medtech industry should be exempted from these tariffs,” CEO Scott Whitaker said in a statement.” * * *
    • “Meanwhile, providers have been bracing for the impact of tariffs after the American Hospital Association, alongside the Healthcare Distribution Alliance, also failed to secure carve-outs for critical medical supplies, despite months of lobbying.”
  • Stars and Stripes informs us,
    • “The Department of Defense has scheduled “listening sessions” at three U.S. military bases in Japan next week to collect feedback on a pilot program designed to connect DOD civilians with Japanese health care providers.  Anyone who has used the program — the Health Insurance Enhancement for DOD Civilian Employees in Japan — is encouraged to participate at sessions at Misawa Air Base, Camp Foster and Yokosuka Naval Base, according to a March 28 email distributed by the Defense Health Agency’s National Capital Region.”
  • The Government Accountability Office released a report about DOD’s Actions to Address Challenges with Accessing Health Care in Japan and Guam.
    • The Department of Defense relies on its civilian employees and contractors in Japan and Guam to provide services such as engineering, food service, and teaching. They may receive health care at military facilities but only on a space-available basis—after active-duty service members and their families.
    • Accessing health care through local providers can be difficult. For example, in Japan, they face language barriers and must pay for care up front. DOD started a program intended to help them find providers and pay bills. In Guam, DOD has a working group to address issues that may arise from planned growth of the civilian population on Guam.

From the judicial front,

  • Modern Healthcare reports,
    • “Federal Trade Commission Chair Andrew Ferguson said he will get involved in the agency’s [internal] legal action against the leading pharmacy benefit managers.
    • “In a post shared Thursday on the social media platform X, Ferguson said he no longer is recusing himself from the matter.” * * *
    • “Ferguson, a critic of PBMs, recused himself due to his prior role in advising Virginia’s attorney general on the decision to file an amicus brief in a class-action lawsuit against PBMs, he wrote Thursday in a statement shared on the social media platform. He said his stance had changed to “ensure that the case can continue.”
    • “He said he consulted with the agency’s ethics attorneys when making the decision to involve himself.
    • “The FTC did not immediately respond to questions about next steps. In the Tuesday order pausing the case, FTC General Counsel Lucas Croslow said the pause would remain in effect for at least 105 days, and an evidentiary hearing date would be scheduled 225 days after the stay is lifted.”
  • Fierce Healthcare relates,
    • “The Department of Justice is urging the courts to reject a legal expert’s report that puts its longstanding challenge to UnitedHealthcare’s Medicare Advantage billing practices in jeopardy.
    • “In a memorandum issued this week, DOJ argues that the court-appointed special master’s report, which was released in March, erred in determining that the agency had not presented enough evidence to support the main claims in the case. 
    • “In addition, DOJ alleges that the special master is also pushing to make California’s Central District Court “the first and only court in the nation to read a new requirement into the reverse False Claims Act.” In the report, it interprets a key phrase in the FCA as requiring “proof of an affirmative act of deception,” which DOJ says is “inconsistent with the text, structure and purpose of the FCA.” * * *
    • “In a statement, UnitedHealth emphasized that its “business practices have always been transparent, lawful and approved by our regulator, CMS.”
    • “After more than a decade of DOJ’s wasteful and expensive challenge to our Medicare Advantage business, the Special Master concluded there was no evidence to support the DOJ’s claims we were overpaid or that we did anything wrong,” the company said.
    • “A judge will now be tasked with ruling on whether the case will move forward.”

From the public health and medical research front,

  • Cardiovascular Business offers key takeaways from the 2025 conference of the American Association of Cardiologists.
  • Per an NIH news release,
    • “An artificial intelligence (AI)-driven screening tool, developed by a National Institutes of Health (NIH)-funded research team, successfully identified hospitalized adults at risk for opioid use disorder and recommended referral to inpatient addiction specialists. The AI-based method was just as effective as a health provider-only approach in initiating addiction specialist consultations and recommending monitoring of opioid withdrawal. Compared to patients who received provider-initiated consultations, patients with AI screening had 47% lower odds of being readmitted to the hospital within 30 days after their initial discharge. This reduction in readmissions translated to a total of nearly $109,000 in estimated healthcare savings during the study period.
    • “The study, published in Nature Medicine, reports the results of a completed clinical trial, demonstrating AI’s potential to affect patient outcomes in real-world healthcare settings. The study suggests investment in AI may be a promising strategy specifically for healthcare systems seeking to increase access to addiction treatment while improving efficiencies and saving costs.
    • “Addiction care remains heavily underprioritized and can be easily overlooked, especially in overwhelmed hospital settings where it can be challenging to incorporate resource-intensive procedures such as screening,” said Nora D. Volkow, M.D., director of NIH’s National Institute on Drug Abuse (NIDA). “AI has the potential to strengthen implementation of addiction treatment while optimizing hospital workflow and reducing healthcare costs.”
  • Per Cardiovascular Business,
    • “New research shows early-pregnancy blood pressure trajectories are strongly associated with new-onset hypertension years after pregnancy. This may help better stratify risk for targeted surveillance and early interventions, and improve the prediction of cardiovascular disease risk in women later in life. The study was published in the American Heart Association Journal Hypertension this week.[1]
    • “Blood pressure patterns observed in the first half of pregnancy, even among women without hypertensive disorders of pregnancy (HDP), can identify women at greater risk of developing hypertension up to 14 years after giving birth. The new findings are from a large observational study supported by the National Institutes of Health (NIH). Among groups of women who did not develop HDP, those with higher-risk blood pressure patterns, including elevated-stable patterns during early pregnancy, were still 11 times more likely to develop hypertension years later than those women with less risky blood pressure patterns.”  
  • Per HCP Live,
    • “Bariatric surgery improves survival and is cost-effective for patients with obesity and cirrhosis, compared to lifestyle modifications alone.
    • “Sleeve gastrectomy and Roux-en-Y gastric bypass show increased expected survival and quality of life benefits, despite higher initial costs.
    • “The study emphasizes the need for greater awareness and uptake of bariatric surgery, given its long-term health improvements and potential reductions in obesity-related comorbidities.”
  • Fierce Pharma tells us,
    • “The interim results of a phase 3 trial of Merck’s pulmonary arterial hypertension (PAH) treatment Winrevair were so conclusive that the company not only halted the study for efficacy but did the same two months later in another trial of the first-in-class activin signaling inhibitor.
    • “Merck has revealed data from the study, providing further evidence of the value of Winrevair, which has been approved in more than 40 countries, including in the U.S. a year ago. 
    • “The Zenith trial included 172 patients at the highest risk of mortality—those in the World Health Organization Functional Class (FC) III or IV—and achieved its primary endpoint of time to clinical worsening to first morbidity or mortality event.”
  • Medscape reports,
    • “A low-density lipoprotein cholesterol (LDL-C) level below 70 mg/dL was associated with a 26% reduced risk of all-cause dementia and a 28% lower risk of Alzheimer’s disease-related dementia (ADRD), with statin use further decreasing that risk, a new study suggests.
    • “While earlier research had suggested lower LDL levels may offer a protective advantage against dementia, these findings provide a specific target number, which investigators said could prove helpful in clinical practice. 
    • “These findings emphasize the importance of targeted LDL-C management as part of dementia prevention strategies, with potential integration into clinical guidelines,” lead investigator Yerim Kim, MD, PhD, Department of Neurology, Kangdong Sacred Heart Hospital, Hallym University College of Medicine, Seoul, South Korea, and colleagues wrote.”

From the U.S. healthcare business front,

  • Fierce Healthcare takes a five year look back at the COVID 19 pandemic and how it impacted healthcare.
  • Beckers Payer Issues offer thoughts about “From volume to value: The shift in healthcare that’s helping put patients first.”
  • Plan Adviser lets us know,
    • “Research and investment provider Devenir LLC reported that health savings account balances rose 19% in 2024 from 2023 levels, reaching almost $147 billion. The number of accounts grew 5% last year, according to the firm’s year-end survey.
    • “The sustained growth in both assets and participation demonstrates a growing awareness among consumers and employers of HSAs’ long-term value in managing healthcare costs,” said Jon Robb, a Devenir senior vice president of research and technology, in a statement.”
  • Per Beckers Hospital Review
    • “California has the highest hourly mean wage for registered nurses in the U.S., and Oregon has the highest hourly mean wage for RNs after adjusted for cost of living, according to data published April 2 by the Bureau of Labor Statistics.
    • “[In the article you will find] the mean hourly and annual wages for nurses in 49 states and Washington, D.C., adjusted for cost of living. Becker’s calculated these figures using May 2024 salary data from BLS and 2024 cost of living index data from the World Population Review.” 
  • and
    • “Heritage Valley Kennedy Hospital in Kennedy Township, Pa., will close on June 30 due to declining patient volume and reduced insurance reimbursements, according to an April 2 news release shared with Becker’s.
    • “Following the closure, emergency care, outpatient surgery, and diagnostic services will shift to Heritage Valley’s Sewickley and Beaver locations, according to the report. Some services, including a walk-in clinic, X-rays and physical rehabilitation, will remain available at the adjacent medical office building.
    • “Heritage Valley said it is in talks with Encompass Rehabilitation about its leased 12-bed unit at Kennedy Hospital and is exploring partnerships to sustain behavioral health services in the area.”

Weekend Update

David Ermer–CDC, CMS, Congress, FDA, Medical / Rx research, OPM, Telehealth–
Texas bluebonnets now blooming in central Texas

From Washington, DC,

  • On April 3, 2025, at 10 am, ET, the Senate Homeland Security and Governmental Affairs Committee will hold a confirmation hearing for Scott Kupor, the President’s nominee for the position of OPM Director. The FEHBlog looks forward to Mr. Kupor’s confirmation.
  • Fierce Healthcare reports,
    • “Over three dozen healthcare associations and organizations penned a letter this week calling on House and Senate leaders for action on a bill bolstering foreign-born physician recruitment to underserved regions.
    • “The letters—which include the American Medical Association, the American Hospital Association and the Association of American Medical Colleges as signatories—speak to the Conrad 30 Waiver Program and its role in alleviating the nation’s worsening clinical workforce shortage.
    • “It allows foreign students who come to the U.S. for medical training immediately begin practicing in the U.S. by foregoing visa requirements that would force them to return to their home country for at least two years. In exchange, program participants are required to work full-time for at least three years in a medically underserved community.” * * *
    • “A pair of bills introduced in the House and Senate late last month and referred to their respective judiciary committees would reauthorize and “make necessary updates to strengthen the program,” the groups said.”
  • CMS is holding a virtual town hall meeting on April 30, 2025, from 10 am to 3 pm ET “for clinicians and researchers as well as other interested parties, such as patient advocacy organizations, patients, and caregivers, to share input relevant to the clinical considerations related to drugs selected for the second cycle of negotiations [under the Inflation Reduction Act].”

From the judicial front,

  • Govexec reports,
    • “President Trump can once again fire a key appointee who hears appeals of firings and suspensions of federal employees, putting the board on which she sits at risk of losing its functionality as the administration is pushing out large swaths of the federal workforce. 
    • “Cathy Harris, a Democrat nominated to the Merit Systems Protection Board by President Biden, was fired by Trump last month but quickly won reinstatement from a district judge. On Friday, a panel on the U.S. Court of Appeals for the D.C. Circuit in a 2-1 decision paused the lower court’s decision and said Trump could fire Harris. 
    • “The decision also applied to Gwynne Wilcox, a member of the National Labor Relations Board who Trump had fired, and a district court also reinstated. 
    • “If Harris is removed, MSPB would be left without a quorum. From 2017 to 2022, the board also lacked a quorum, which created a 3,500-case backlog that was only just recently eliminated. Due to an interim final rule established that same year, MSPB can conduct some actions without a quorum, though it cannot issue final decisions appealed to its central board.
    • “Zac Kurz, an MSPB spokesman, confirmed Friday evening that that the central board no longer has a quorum. While regional administrative judges can still issue initial rulings, the central board can no longer hear appeals of those rulings.”  

From the public health and medical research front,

  • The New York Times reports,
    • “As many as one in five people — an estimated 64 million in the United States — have elevated levels of a tiny particle in their blood. It can greatly increase the risk of heart attacks and strokes.
    • “But few know about it, and almost no doctors test for it, because there was not much to be done. Diet does not help. Neither does exercise. There have been no drugs.
    • “But in the near future, that may change.
    • “On Sunday [today], cardiologists announced that an experimental drug made by Eli Lilly, lepodisiran, could lower levels of the particle, Lp(a), by 94 percent with a single injection. The effects lasted for six months and there were no significant side effects.
    • “But it is not yet confirmed that reducing Lp(a) levels also reduces the risk of heart attacks and strokes. That awaits large clinical trials that are now underway.
    • “The Lilly research was presented Sunday at the annual meeting of the American College of Cardiology and simultaneously published in the New England Journal of Medicine. At least four other companies are also testing innovative drugs that block the body’s production of Lp(a), a mix of lipids and a protein.
    • “Dr. David Maron, a preventive cardiologist at Stanford not involved in the Lilly research, said the evidence of profound and long-lasting reduction in lipoprotein levels with lepodisiran was “thrilling.”
    • “Dr. Martha Gulati, a preventive cardiologist at Cedars-Sinai Medical Center also not involved in the trial, said the study was “really elegant.”
  • and
    • “Many people use a smartwatch to monitor their cardiovascular health, often by counting the number of steps they take over the course of their day or recording their average daily heart rate. Now, researchers are proposing an enhanced metric, which combines the two using basic math: Divide your average daily heart rate by your daily average number of steps.
    • “The resulting ratio — the daily heart rate per step, or DHRPS — provides insight into how efficiently the heart is working, according to a study conducted by researchers at the Feinberg School of Medicine at Northwestern University and published today in the Journal of the American Heart Association.
    • “The study found that people whose hearts work less efficiently, by this metric, were more prone to various diseases, including Type II diabetes, hypertension, heart failure, stroke, coronary atherosclerosis and myocardial infarction.
    • “It’s a measure of inefficiency,” said Zhanlin Chen, a third-year medical student at the Feinberg School of Medicine at Northwestern University and lead author of the new study; his coauthors included several Feinberg faculty physicians. “It looks at how badly your heart is doing,” he added. “You’re just going to have to do a tiny bit of math.”
  • NPR Shots tells us,
    • “As a measles outbreak in West Texas and New Mexico continues to grow, and other states report outbreaks of their own, some pediatricians across the U.S. say they are seeing a new trend among concerned parents: vaccine enthusiasm.
    • “Our call center was inundated with calls about the MMR [measles, mumps, rubella] vaccine,” says Dr. Shannon Fox-Levine, a pediatrician in Broward County, Fla. She says parents are asking if their child is up to date on their vaccinations. Or “should they get another vaccine? Should they get an extra one? Can they get it early?” * * *
    • “Interest in vaccinations has ramped up ahead of the spring break travel season, says Dr. Susan Sirota, a primary care pediatrician in the Chicago area.
    • “We have many patients calling us because they are traveling to either Texas or places near Texas, or states where they suspect that vaccination rates are lower than we have in Illinois,” Sirota says. “Many families are requesting early MMR [vaccines].” 
  • MedPage Today lets us know, “Transcatheter aortic valve replacement (TAVR) continued to hold its own against surgery for younger patients at low surgical risk, with the Evolut Low Risk trial now halfway to its goal of 10-year follow-up.”
  • Per Medscape,
    • “GSK said on Tuesday that it is studying a group of more than a million older adults in the UK to examine whether its best-selling shingles vaccine lowers the risk of dementia.
    • “The British drugmaker is using the health data of some 1.4 million people, aged 65 to 66, some of whom received its Shingrix shot and some who did not. 
    • “GSK’s chief scientific officer Tony Wood said the data, from the state-run National Health Service’s (NHS) large database, is a unique set of information because due to a tweak in the UK’s shingles immunization program there is effectively a naturally randomized trial already taking place.”
  • and
    • “High-dose oral cholecalciferol (vitamin D3) supplementation significantly reduced disease activity in patients with clinically isolated syndrome (CIS) suggestive of multiple sclerosis (MS) in the randomized, controlled D-Lay MS trial.
    • “Combined with data from previous studies on vitamin D as an add-on therapy, the results of the D-Lay MS trial, which show a stronger effect of vitamin D in patients with vitamin D deficiency compared to others, strongly suggest that patients with vitamin D deficiency should be supplemented, regardless of whether they are already under disease-modifying therapy,” Eric Thouvenot, MD, PhD, University Hospital of Nimes, Neurology Department, Nîmes, France, told Medscape Medical News.
    • “The study was published online on March 10 in JAMA.” 

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Health Care Service Corp. was limited to selling Blue Cross and Blue Shield policies, including Medicare Advantage plans, in Illinois, Montana, New Mexico, Oklahoma and Texas before the deal.
    • “After the Cigna acquisition, Health Care Service Corp. has a much bigger footprint and can offer Medicare Advantage in 25 more states and the District of Columbia, Part D nationally, and Medigap in 48 states and the District of Columbia. The insurer now counts 830,000 Medicare Advantage members, about four times as many as prior to the Cigna purchase.” * * *
    • “Moving up a weight class means facing dominant for-profit Medicare Advantage carriers such as UnitedHealth Group subsidiary UnitedHealthcare, Humana and CVS Health subsidiary Aetna head on. Those three insurers collectively cover 57% of Medicare Advantage enrollees, according to an analysis of Centers for Medicare and Medicaid Services data the investment bank Stephens published in February.”
  • Beckers Payer Issues adds,
    • “Moody’s has downgraded Health Care Service Corporation’s insurance financial strength rating to A3 from A2 following the company’s acquisition of Cigna’s Medicare business on March 19.
    • “Moody’s cited likely challenges with the integration of the MA business into the company’s primarily commercial insurance operations, along with ongoing headwinds within the MA industry more broadly.  
    • “Another concern is the limited experience the company has with making and integrating major acquisitions in the recent past,” analysts wrote. “The company expects to invest an estimated $1 billion over the next two years into updating systems and for working capital to ensure its success, but this may prove to be insufficient.”
  • Kauffman Hall explains how health systems can create a sustainable approach to corporate shared services.

Weekend update

David Ermer–CDC, Congress, COVID treatment, FDA, Medical / Rx research, Obesity, Telehealth, U.S. Healthcare–

From Washington, DC,

  • Roll Call adds,
    • Both the House and Senate come back from recess this week to begin a busy three-week period that’s expected to focus on Republicans’ budget reconciliation agenda, including extending and expanding tax cuts and tightening immigration policy.
    • The top items on the House agenda this week, meanwhile, will include more measures to overturn Biden administration rules. And the Senate will continue to vote on more of President Donald Trump’s nominations. The headliners this week are the nominees to lead the National Institutes of Health and the Food and Drug Administration.
    • With a stopgap spending law now in effect through Sept. 30, the Republican majorities in both the House and Senate can fully turn their attention to their budget reconciliation agenda.
    • This work period on Capitol has just three weeks, followed by the traditional two-week recess that coincides with Easter and Passover. By then, House and Senate Republicans will want to make progress on resolving differences on how to execute the process that allows them to pass legislation without the risk of filibusters in the Senate.
  • Roll Call also gives us the 119th Congress in numbers, mid-March edition.
  • On Tuesday morning at 10 am, the House Oversight and Government Reform Committee will mark up the following batch of bills,
    • H.R. 1295, the Reorganizing Government Act of 2025; 2) H.R. 1210, the Protecting Taxpayers’ Wallet Act; 3) H.R. ___, the Preserving Presidential Management Authority Act; 4) H.R. 2174, the Paycheck Protection Act; 5) H.R. 2193, the FEHB Protection Act of 2025; 6) H.R. ___, the Federal Accountability Committee for Transparency (FACT) Act; 7) H.R. 2056, District of Columbia Federal Immigration Compliance Act; 8) H. Res. 187, Of inquiry requesting the President to transmit certain information to the House of Representatives referring to the termination, removal, placement on administrative leave, moved to another department of Federal employees and Inspectors General of agencies; 9) H. Res. 186, Of inquiry requesting the President to transmit certain documents to the House of Representatives relating to the conflicts of interest of Elon Musk and related information.
  • Healthcare Dive tells us,
    • “A postponed meeting of vaccine advisers to the Centers for Disease Control and Prevention is now scheduled to take place in April, a spokesperson for the Department of Health and Human Services confirmed.
    • “The Advisory Committee on Immunization Practices, or ACIP, had originally been scheduled to meet Feb. 26 to Feb. 28, but was unexpectedly delayed soon after Robert F. Kennedy Jr., a longtime critic of U.S. vaccination policies, took office as health secretary. At that time, an HHS spokesperson said the rescheduling was to allow extra time for public comment.” * * *
    • “ACIP, which includes outside vaccine experts as well as federal health officials, will now convene on April 15 and April 16, Andrew Nixon, HHS’ director of communications, wrote in an email to BioPharma Dive.” 
    • “A notice posted Friday ahead of publication Monday in the federal register indicated that advisers will discuss the current measles outbreak, as well as vaccines for COVID-19, human papillomavirus, monkeypox, respiratory syncytial virus and other pathogens.”
  • The New York Times reports,
    • “Robert F. Kennedy Jr., the nation’s health secretary, on Saturday instructed leaders of the nonprofit he founded to take down a web page that mimicked the design of the Centers for Disease Control and Prevention’s site but laid out a case that vaccines cause autism.
    • “The page had been published on a site apparently registered to the nonprofit, the anti-vaccine group Children’s Health Defense. Mr. Kennedy’s action came after The New York Times inquired about the page and after news of it ricocheted across social media.
    • “The page was taken offline Saturday evening.” 
  • Pharmacy Practice News informs us,
    • “The Drug Enforcement Administration (DEA) recently alerted healthcare providers to a concerning trend: hackers tapping into patient electronic health records (EHRs) to steal doctors’ DEA registration numbers. Armed with those numbers, the thieves have been able to generate tens of thousands of bogus prescriptions and sell them online, the agency explained in a YouTube video.
    • “Electronic prescription fraud is a real emerging trend that we’re seeing all across the country,” said Erin Hager, a DEA diversion investigator in the Phoenix-Tucson Tactical Division Squad. “What’s happening is … bad actors … who have been conducting prescription drug fraud are now utilizing the internet and electronic health record platforms to create electronic prescriptions that they can then send nationwide.”
    • “These activities can result in “a thousand fraudulent prescriptions using an unsuspecting doctor’s DEA number within a 14-hour time frame,” Ms. Hager said.”

From the public health and medical research front,

  • The New York Times reports, “Dementia May Not Always Be the Threat It Is Now. Here’s Why. The number of cases will increase, but the rates seem to be declining with every birth cohort that reaches advanced ages, researchers said.”
    • Eric Stallard, an actuary and co-director of the Biodemography of Aging Research Unit at Duke University, read the [recent dementia] study and thought the team “seemed very competent at their analysis” of individual risk.
    • But when it came to the projection that cases would double, which assumed that the incidence of dementia would remain stable over the next 40 years, “I don’t believe it,” Mr. Stallard said.
    • “The notion that the number of people with dementia will double over the next 25, 30 or 35 years due to the aging of baby boomers is widespread, it’s pervasive — and it’s wrong,” he added.
    • “He and two other Duke researchers recently published a commentary in JAMA pointing out that the age-specific prevalence of dementia in this country had steadily declined for 40 years.
    • “If your risks are lower than your parents’ risks and this trend continues, you won’t see the doubling or tripling of dementia that’s been projected,” said Dr. Murali Doraiswamy, director of the Neurocognitive Disorders Program at Duke and a co-author of the JAMA article.
    • “To be clear, experts agree that the number of people with dementia will climb in coming decades, simply because the disorder rises so steeply with age and the number of older adults in the United States will increase.
    • “But Mr. Stallard estimates that the increase will be more like 10 to 25 percent by 2050. “It will still be a significant challenge for the health system in the U.S.,” he said.”
  • The University of Minnesota CIDRAP lets us know,
    • Another study is raising questions about whether compliance with a federally mandated hospital protocol aimed at improving sepsis care and management is associated with better outcomes.
    • The study, published this week in JAMA Network Open, found that sepsis patients who received care that was noncompliant with the Centers for Medicare and Medicaid Services (CMS) Severe Sepsis and Septic Shock Management Bundle (SEP-1) tended to be older, have more comorbidities, and have more complex clinical presentation than those who received compliant care. When those factors were accounted for, SEP-1 compliance was no longer associated with improved mortality.
    • The study comes on the heels of a systematic review and meta-analysis, published last month in the Annals of Internal Medicine, that found no evidence that SEP-1 compliance was associated with improved mortality.
  • and
    • “People who started taking the antiviral drug ensitrelvir within 72 hours after a household member tested positive for COVID-19 were significantly less likely to be infected, according to results from an international phase 3 clinical trial presented last week at the Conference on Retroviruses and Opportunistic Infections in San Francisco.
    • “Made by Japanese pharmaceutical firm Shionogi, ensitrelvir is approved in Japan for the treatment of mild to moderate COVID-19.  * * *
    • “In addition to vaccination, post-exposure prophylaxis with timely use of an oral antiviral would be a valuable way to help prevent COVID-19 illness in people who have been exposed, especially people at high risk for severe disease,” Frederick Hayden, MD, a University of Virginia School of Medicine professor emeritus who helped design the trial and presented the findings, said in a university news release.
    • “This is the first clinical trial of an oral antiviral drug to show significant protection against COVID-19 [infection],” he added. “If approved by the [US] Food and Drug Administration for this purpose, it would be an important addition to current preventive strategies.”
  • A Wall Street Journal reporter tells us “A Year After I Stopped Taking a [GLP-1} Weight-Loss Drug, I’ve Lost 20 More Pounds. I’m one of the millions of people trying to keep the weight off without taking expensive drugs like Mounjaro or Ozempic for life. It wasn’t easy, but I found ways.”
    • “My first mistake in stopping the medicine [after reaching his target weight in five months] was that I didn’t wean myself off it more slowly. I stopped cold turkey, and my hunger pangs and food noise came back with a vengeance. Some doctors and researchers have begun to recommend stopping more gradually, as well as taking appetite suppressants like phentermine to ease the transition. This has helped reduce weight regain in some patients.
    • “My second mistake was not having a structured nutrition plan at the ready. The medicine had helped winnow my bad habits down to a number I could actually manage, from perhaps 25 or 30 entrenched eating behaviors (really!) down to more like five or six (I still can’t shake my addiction to impulsive runs to the 7-Eleven, for example). But even a few bad habits—when they meet with what feels like insatiable hunger—can do a lot of damage.
    • “After a few months, I found a highly structured nutrition program, one with expert coaching that focused on a low-carb diet. While the transition was difficult, it eventually helped me bring my cravings under control. 
    • “Virta Health, a startup I turned to for a few months, has users test their blood daily. The results, which measure glucose levels and another indicator of dietary compliance, are beamed through an app to a nutrition coach. Being aware that someone was watching—and would know if I had cheated—was immensely helpful as I sought to improve my nutrition and manage hunger.
    • “Without wading into the nutrition wars over the keto or Atkins or Mediterranean diet or any other, I’ve found that I have generally been far less hungry when I’ve eaten more protein, fiber and healthy fats. Meanwhile, drastically limiting carbohydrates has had another benefit: forcing me to eat more vegetables. Gobs and gobs of them.” 

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “The Longevity Business Is Booming—and Its Scientists Are Clashing. The antiaging movement has raced ahead amid fierce debates; critics of a grandfather of the field, Leonard Guarente, include former protégés and rivals.”
  • and
    • “Doctors Are Just as Frustrated as You by Our Messed-Up Healthcare System. Trust between doctors and patients is fraying, but there are ways to mend it.”
      • “One of doctors’ biggest gripes: largely corporate institutions that effectively set patient quotas and require extensive documentation. One physician said he and other doctors are allowed 15 minutes with patients; exceeding that leads to poor performance reviews and “being out of compliance.”
      • “These doctors think patients lose trust because they don’t understand who or what is in control. “Physicians have lost autonomy,” says Dr. Corinne Rao, an internal medicine physician and hospitalist. “Their decisions are subject to the financial interests of their employer.” 
      • “Doctors also say that trust—and respect—go both ways. “It’s like a marriage,” says Dr.  James Schouten, a family physician. Each side has to give 100%. Implying that a loss of trust is entirely the doctor’s fault, he says, suggests the patient has no role in establishing or maintaining trust.
      • “They do, he and others say.”

Tuesday Report

David Ermer–Congress, COVID-19 testing, FDA, Federal employment benefits, Medical / Rx research, NIH, Obesity, OPM, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Michele Orallo on Unsplash

From Washington, DC

Capitol Hill News

  • The Wall Street Journal reports,
    • The House [of Representatives] narrowly approved a Republican proposal to fund the government into the fall, as GOP lawmakers remained largely united following a last-minute push from the White House, overcoming Democratic opposition and setting up a fight in the Senate. 
    • Funding for the federal government expires this weekend. The GOP proposal would extend funding through Sept. 30 at fiscal 2024 spending levels, but it includes $13 billion in cuts in nondefense spending and $6 billion in increased military spending. It allocates additional money for border enforcement and forces Washington, D.C., to cut $1 billion from its budget. 
    • The measure passed 217-213, with Rep. Thomas Massie of Kentucky being the only Republican to vote against it. Democrats were largely united in opposition, with one Democrat, Rep. Jared Golden of Maine, voting yes. * * *
    • “The matter now heads to the Senate, where Republicans will need Democratic support to advance the bill. Senate Democrats were wrestling over the matter Tuesday. Some saw the funding deadline as their only leverage to push back against GOP efforts to dismantle federal programs, while others were wary of playing hardball and triggering a government shutdown. 
    • The House left town after Tuesday’s vote, effectively giving the Senate the option of approving or blocking the House measure—but not revising it.” 
  • Fierce Healthcare adds,
    • “Rep. Greg Murphy, M.D., R-N.C., posted on X Monday night that Johnson and Senate Majority Leader John Thune have agreed to include a doc pay fix in Congress’ budget reconciliation, which is expected to be finished in May to align with President Donald Trump’s first 100 days.
    • “A doc pay fix, which would counteract a 2.83% cut to Medicare physicians’ payment rates that went into effect Jan. 1, has been a central focus for provider lobbying groups as well as for physician members of the legislature. It was seen as the driving force behind passing an expanded healthcare package.
    • “The Energy and Commerce committee has an $880 billion deficit reduction target. E&C will identify those cuts from programs within its jurisdiction like Medicaid and other healthcare programs. It could identify some of those savings from items in the December healthcare package that did not make it into last year’s funding bill, such as PBM reform.”
  • Per Govexec,
    • “Also on Tuesday, Sen. Jerry Moran, R-Kan., who chairs the Senate Veterans Affairs Committee, announced during a hearing he will put forward legislation that will also seek to put some constraints on the Trump administration’s efforts to remake the Veterans Affairs Department’s workforce. He said VA must work closely with Congress and stakeholders such as veterans service organizations when seeking to make staffing cuts. The Republican chairman added he has voiced his reservations to VA Secretary Doug Collins.”

HHS News

  • The Washington Post reports,
    • Robert F. Kennedy Jr. is making one of his first official moves aimed at increasing oversight of the chemicals found in the nation’s food supply — a key component of his “Make America Healthy Again” agenda to root out chronic disease and childhood illness.
    • On Monday, Kennedy, who serves as the nation’s top health official, announced he was directing the Food and Drug Administration to “explore potential rulemaking” to tighten a decades-old loophole allowing food companies to put chemicals in their products without notifying the nation’s food regulators.
    • The practice Kennedy is targeting, known as “generally recognized as safe” (GRAS), can occur when companies self-certify the safety of a food additive. Companies aren’t required to tell the FDA when they include some chemicals and substances in their products, meaning there are probably hundreds of such ingredients added to the food supply without government oversight.
  • Per a March 10, 2025, CMS news release,
    • “Today, the Centers for Medicare & Medicaid Services (CMS) released a proposed rule to address the troubling amount of improper enrollments impacting Affordable Care Act (ACA) Health Insurance Marketplaces across the country. CMS’ 2025 Marketplace Integrity and Affordability Proposed Rule includes proposals that take critical and necessary steps to protect people from being enrolled in Marketplace coverage without their knowledge or consent, promote stable and affordable health insurance markets, and ensure taxpayer dollars fund financial assistance only for the people the ACA set out to support.” * * *
    • “View the 2025 Marketplace Integrity and Affordability Proposed Rule (CMS-9884-P) here: https://www.cms.gov/files/document/MarketplacePIRule2025.pdf
    • “For additional information on the rule and its proposals, view the CMS fact sheet:  https://www.cms.gov/newsroom/fact-sheets/2025-marketplace-integrity-and-affordability-proposed-rule” 
  • Per Modern Healthcare,
    • “The U.S. Department of Health and Human Services increased its voluntary buyout offer for some employees for further layoffs this week as the agency faces pressure to reduce headcount, according to an email viewed by Bloomberg. 
    • “In addition to a $25,000 lump-sum buyout offer, some HHS workers would also receive around two months of paid administrative leave if they chose to accept the buyout. * * *
    • “The buyout offer was available to employees this week and expires Friday. The original buyout offer was extended to a “broad population of HHS employees,” according to an email. However, the Food and Drug Administration told staff Monday that employees responsible for reviewing drugs, medical devices and tobacco products aren’t eligible for the buyout program. 
    • “The HHS buyout offers are in addition to an early retirement program that relaxed service requirements for retirement.”
  • The U.S. Preventive Services Task Force issued a final recommendation on screening for food insecurity which received an inconclusive “I” grade.
    • “For children, adolescents, and adults:
      “The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for food insecurity on health outcomes in the primary care setting.”
  • Per Axios,
    • “The federal government’s free at-home COVID test distribution program has been suspended and is no longer accepting orders” as of March 9, 2025.
    • “For some previously distributed tests, expiration dates were extended to account for data that revealed a longer-than-expected shelf life.
    • “A full list of approved tests and their revised expiration dates is posted on the FDA website.”

FDA News

  • Per Cardiovascular Business,
    • “Google has received U.S. Food and Drug Administration (FDA) for Loss of Pulse Detection, a new smartwatch feature that detects when a person’s heart stops beating and then automatically alerts emergency services. 
    • “Loss of Pulse Detection asks the user if they are OK when it first detects the loss of pulse. If no response is provided, it triggers an audio alarm and countdown to when emergency services will be notified. If the countdown reaches zero, the alert is officially sent out.
    • “This feature is already available in 14 different countries. It will be made available in the United States for Google’s Pixel Watch 3 in the weeks ahead.”
  • Per Modern Healthcare,
    • “Siemens Healthineers has received clearance from the Food and Drug Administration for its Naeotom Alpha class of photon-counting computed tomography scanners.
    • “The company unveiled the two scanners in December, touting the Naeotom Alpha.Pro and Naeotom Alpha.Prime as more affordable options to its original Naeotom Alpha photon-counting CT, which received FDA clearance in September 2021.
    • “Photon-counting CT is a new technology that uses lower radiation doses than conventional CT and produces clearer images with fewer distortions.
    • “Siemens Healthineers’ photon-counting CTs are the only commercially available scanners of their kind available for clinical use but competitors are working to bring their versions to market.”

From the judicial front,

  • Govexec reports,
    • “A federal judge has ordered the acting head of the Office of Personnel Management to testify at a court hearing examining the legality of the Trump administration’s mass firings of federal employees, but the key workforce official has informed the court he will ignore the order. 
    • “Acting OPM Director Charles Ezell was slated to appear in a U.S. District Court in San Francisco on Thursday after Judge William Alsup ruled Monday on Monday that he must do so, but he will now face a to-be-determined sanction. The Trump administration had sought to block his testimony, saying it would raise constitutional concerns, but the judge rejected the argument. Ezell has already submitted written testimony, Alsup said, and now must be subject to cross examination. 
    • “After initial publication of this story, the Trump administration Tuesday evening informed the court Ezell would not testify and withdrew his written declaration suggesting he did not order the probationary firings across government. It called live testimony “not necessary” for Ezell or any other official. The plaintiffs in the case are seeking testimony from human resources personnel throughout government.” 

From the public health and medical research front,

  • Healio lets us know,
    • “The diabetes mortality rate in the U.S. dropped from 28.1 deaths per 100,000 people in 2000 to 19.1 deaths per 100,000 in 2019.
    • “Reductions in diabetes mortality were observed for all racial and ethnic groups.”
  • The Wall Street Journal reports,
    • “GLP-1s, including Ozempic, show promise in preventing age-related conditions like Alzheimer’s, osteoarthritis and certain cancers.
    • “GLP-1s work by suppressing appetite and reducing inflammation, potentially contributing to their preventive health benefits.
    • “While promising, more robust studies are needed to confirm the causal effects of GLP-1s on longevity and healthspan.”
  • The National Institutes of Health offers a research bulletin on the following topics: “Predicting preeclampsia | Liver gene editing | Mapping MS-like brain lesions.”
  • MedPage Today tells us five things that patients with low back pain need from their doctors and
    • “BMI was lower in kids whose mothers received a responsive parenting intervention in the INSIGHT randomized clinical trial.
    • “Across ages 3 to 9 years, children in a responsive parenting group had a lower mean BMI than those in a control group.
    • “The impact appeared significant only for girls.”
  • Per a news release,
    • “The Institute for Clinical and Economic Review (ICER) announced today that it will assess the comparative clinical effectiveness and value of brensocatib (Insmed Incorporated) for the treatment of non-cystic fibrosis bronchiectasis (NCFB).
    • “The assessment will be publicly discussed during a meeting of the CTAF in September 2025, where the independent evidence review panel will deliberate and vote on evidence presented in ICER’s report.
    • “ICER’s website provides timelines of key posting dates and public comment periods for this assessment.”
  • The National Cancer Institute informs us,
    • “For men with metastatic castration-resistant prostate cancer, an initial treatment that combines enzalutamide (Xtandi) and talazoparib (Talzenna)may help them live longer than just getting enzalutamide alone, according to updated results from a large clinical trial. Enzalutamide is a type of drug known as an androgen receptor antagonist and talazoparib is part of a group of drugs called PARP inhibitors.” * * *
    • “More information about the trial, which was funded by Pfizer, the maker of talazoparib, is available in this Cancer Currents story.”
  • Fierce Pharma adds,
    • “After Gilead Sciences’ lenacapavir made waves with stellar clinical results as a twice-yearly HIV prevention candidate, the drug has shown promise being dosed even further apart at only once a year.
    • “Two different once-yearly formulations of lenacapavir achieved blood concentrations that exceeded those associated with the strong HIV prevention efficacy that twice-yearly lenacapavir showed in phase 3 preexposure prophylaxis (PrEP) studies.
    • “The pharmacokinetic results came from a small phase 1 trial presented at the Conference on Retroviruses and Opportunistic Infections and simultaneously published in The Lancet.
    • “Based on the early-stage data, Gilead plans to start a phase 3 program for once-yearly lenacapavir in the second half of this year, with the potential for regulatory filings in 2027, Jared Baeten, M.D., Ph.D., Gilead’s vice president of HIV clinical development, told Fierce Pharma.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Hinge Health filed Monday for a proposed initial public offering.
    • “The virtual musculoskeletal health company, which contracts with employers, pharmacy benefit managers and large insurance companies to provide physical therapy and pain relief services, has been considered a potential IPO candidate since last year.”
  • and
    • “Tampa General Hospital and Mass General Brigham are teaming up to open a radiation oncology center in Florida.
    • “The 10,000-square-foot facility in Palm Beach Gardens will be co-branded and jointly owned. Tampa General will handle daily operations, while Mass General Brigham will provide oversight on quality and safety, according to a Tuesday news release.
    • “The center is scheduled to open in early 2026, the release said.”
  • Per Fierce Pharma,
    • “At its sprawling complex in Durham, N.C., Merck has opened a new $1 billion, 225,000-square-foot manufacturing plant slated to produce bulk substance for its megablockbuster HPV vaccine Gardasil.
    • “Merck built the new plant on the 262-acre campus it has occupied since 2004, where the pharma giant produces a variety of vaccines including shots to prevent chickenpox, measles and rubella.
    • “The complex manufactured more than 70 million doses last year, with the figure expected to increase this year, a Merck spokesperson said in an email. The campus now employs more than 1,000 people.”
  • Per STAT News,
    • “In the last two years, hundreds of businesses have cropped up to meet the surge in demand for the obesity and diabetes medications known as GLP-1s. The majority prescribe compounded copies of the drugs — a tenuous business strategy as shortages of the branded versions of the medications have come to an end. 
    • “Now, some businesses are setting their sights on another opportunity in compounding: hormones.
    • “Dozens of wellness and direct-to-consumer telehealth companies offering GLP-1s have begun marketing cash-pay hormone replacement therapy to women in perimenopause and menopause, and testosterone replacement therapy to men. Noom, best-known for its weight loss app and more recent GLP-1 offering, launched an HRT program for menopause in late February, and telehealth company Hims & Hers plans to roll out at-home testing over the next year to enable care for low testosterone, perimenopause, and menopause.
    • “Patients and physicians have long advocated for better access to hormone-based care. Men with low testosterone levels due to hypogonadism can face stigma as they seek care, and many women struggle to receive medically appropriate estrogen and progesterone to address serious hot flashes and help prevent osteoporosis. But clinicians and health policy researchers expressed concern that the emerging commodification of hormone replacement therapies — often marketed as a personalized fix for low energy, libido, and other age-related concerns — could lead to inappropriate prescriptions and put patients at risk.” 
  • Beckers Hospital Review points out,
    • “In August, Kaiser Permanente embarked on the largest rollout of generative AI in healthcare to date.
    • “The Oakland, Calif.-based health system offered Abridge, an ambient AI listening tool that drafts clinical notes for the EHR, to tens of thousands of providers.
    • “Becker’s caught up with Brian Hoberman, MD, executive vice president of IT and CIO at the Permanente Federation, at the HIMSS conference in Las Vegas to find out how the implementation is going.”
    • Here’s a link to that interview.
  • The Wall Street Journal adds,
    • “Last year, some cancer patients in Tennessee and Mississippi got a startling offer: Instead of videoconferencing with oncology specialists located hours away, they could see a hologram doctor, courtesy of the same special effects that have projected the Jonas Brothers and other celebrities at concerts and live events.
    • “The offer came from West Cancer Center & Research Institute, a health system that employs about 61 doctors and serves about 19,240 new patients a year across 12 locations in Tennessee, Mississippi and Arkansas. The system’s main clinic is in Germantown, Tenn., a suburb of Memphis.
    • “Its doctors typically spend hours on the road each week getting to the satellite clinics to see patients in more rural locations, while also relying heavily on videoconferencing for check-ins. Now, however, two of those clinics are replacing the video calls with life-size hologram-like displays, part of a cross-industry push to take videoconferencing to the next level.”

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.”