Monday Report

David Ermer

I am an attorney who practices law in Washington DC. My practice has involved the Federal Employees Health Benefits Program since 1983.

Monday Report

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

From Washington, DC,

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

From the judicial front,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Weekend Update

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

From Washington, DC,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Cybersecurity Dive

David Ermer–Cybersecurity–

From the cybersecurity policy and law enforcement front,

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

From the cybersecurity breaches and vulnerabilities front,

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

From the ransomware front,

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

From the cybersecurity defenses front,

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

Friday Report

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

From Washington, DC.

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

From the Food and Drug Administration front,

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

From the judicial front,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Thursday Report

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

From Washington, DC,

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

In State government news,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Midweek Report

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

From Washington, DC

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

From the judicial front,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Tuesday Report

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

From Washington, DC

  • NBC News reports,
    • “Speaker Mike Johnson, R-La., is facing a growing rebellion from conservative hard-liners in the House as Republicans seek to take up a budget blueprint that was recently adopted by the Senate to pass President Donald Trump’s agenda.
    • “House GOP leaders are eyeing a vote this week on the measure, which would unlock the path for committees to craft a massive bill to cut taxes, boost immigration enforcement and defense spending and lift the debt limit without Democratic votes.
    • “But a slew of House conservatives have blasted the Senate’s version for requiring just $4 billion in spending cuts. The House’s version, by contrast, called for $1.5 trillion to $2 trillion in spending cuts while largely steering clear of specifics.”
  • CBS News informs us,
    • “The Centers for Disease Control and Prevention has begun redeploying staff to respond to the deadly outbreak of measles in Texas, a spokesperson said Monday, a week after steep layoffs at the agency impacted its response to the spread of the virus. 
    • “A team of three deployed yesterday to meet with county and state officials to assess the immediate needs to respond to this outbreak. The team is meeting with officials again today,” CDC spokesperson Jason McDonald said in an email. 
    • “Health and Human Services Secretary Robert F. Kennedy Jr. first said Sunday that the CDC would be redeploying to Texas at its governor’s request, after another unvaccinated child died in the measles outbreak. An 8-year-old girl was the second fatality there this year.
    • “Once the assessment is complete, more CDC staff will be sent to Texas per Sec. Kennedy’s order and the governor’s request. The first teams deployed to Texas arrived on March and returned to CDC on April 1,” McDonald said.”
  • Per MedPage Today,
    • The U.S. Preventive Services Task Force (USPSTF) still recommends primary care behavioral counseling for breastfeeding, mostly in line with its 2016 guidelines.
    • In the updated recommendation statement published in JAMA, USPSTF wrote that “providing interventions or referrals, during pregnancy and after birth, to support breastfeeding” received a B grade, indicating moderate certainty these interventions will have moderate net benefit.

From the judicial front,

  • The Wall Street Journal tells us,
    • “The Supreme Court lifted a lower-court order that directed the Trump administration to reinstate about 16,000 federal employees it fired, handing the White House the third victory in a row as it seeks the justices’ emergency action to stop district judges from slowing its policies. 
    • “The justices on Tuesday said that environmental groups and other nonprofit organizations who say they were harmed by the reduction in public services caused by the layoffs didn’t have legal standing to bring suit. 
    • “The brief order was unsigned, as is typical when the court acts on emergency requests. Two liberal justices, Sonia Sotomayor and Ketanji Brown Jackson, said they voted to deny the Trump administration’s request.” * * *
    • “The Supreme Court on Tuesday agreed with the Trump administration that the nonprofits lacked legal standing to bring the case. The court added, though, that the order didn’t address other plaintiffs in the suit, including several labor unions and the state of Washington. Alsup’s injunction wasn’t based on their claims, although those parties may face other questions regarding their standing to bring suit.
    • “Tuesday’s order doesn’t resolve broader legal disputes over the administration’s mass layoffs of federal employees.”
  • Bloomberg Law relates,
    • “A string of lawsuits targeting the use of artificial intelligence and algorithms in claims denials is raising risks for private health insurers and employers, even as the litigation encounters early obstacles.
    • “A California federal judge’s recent decision to partially allow a case to proceed over Cigna Corp.’s alleged use of algorithms to improperly deny benefits signals that automation tools come with legal hazards.” * * *
    • “To the extent that these tools are being used to block or deny coverage across the board for medically necessary services and to a large number of beneficiaries—if that is the case and that’s how these have been used, that could expose insurers to significant risk,” said David Greenberg, partner at ArentFox Schiff LLP.
    • “Courts have allowed several lawsuits to proceed, but plaintiffs still face significant challenges in making their cases. In some instances, the insurance companies denied that the plaintiffs’ medical claims were even handled by an algorithm. Proving otherwise can be difficult.”

From the public health and medical research front,

  • The American Hospital Association News points out,
    • The Centers for Disease Control and Prevention April 8 sent an alert to health care providers on measles prevention and treatment. The agency said that risk remains low for most individuals across the U.S. and that the measles, mumps and rubella vaccine is the best way to protect against the disease. 
  • and
    • “The incidence of invasive group A strep infections increased from 3.6 to 8.2 cases per 100,000 people from 2013 to 2022, according to a study authored by the Centers for Disease Control and Prevention published April 7 by JAMA. The authors concluded that accelerated efforts to prevent and control these infections are needed, especially among groups at highest risk of infection, which includes individuals 65 years or older, American Indian or Alaska Native persons, residents of long-term care facilities, people experiencing homelessness, and people who inject drugs.” 
  • Per Medscape,
    • “Around 38 million people in the United States — or slightly over 11% of the population — have diabetes, according to the National Diabetes Statistics Report. Experts only expect that number to increase, and research suggests that the burden will be especially significant in low to low-middle socioeconomic areas.
    • “Consider the Mississippi Delta, a swath of fertile land in the floodplain of the Mississippi River. It has a rich and diverse cultural heritage, with a minority-majority population, along with significant economic challenges and a persistently high poverty rate. The region also has one of the highest diabetes rates in the country, which has put the healthcare community on alert.
    • “We are more intensely screening almost everybody,” said Brent Smith, MD, a family physician in Greenville, Mississippi, and a member of the board of directors of the American Academy of Family Physicians.”
  • AP reports,
    • “Health care systems can reduce suicides through patient screening, safety planning and mental health counseling, a new study suggests, an important finding as the U.S. confronts it 11th leading cause of death.
    • “The “Zero Suicide Model” was developed in 2001 at Detroit-based Henry Ford Health, where the focus on people considering suicide included collaborating with patients to reduce their access to lethal means such as firearms and then following up with treatment.
    • “The approach made a difference, and for all of 2009, the health system saw no suicides among patients. The researchers then studied what happened when a different health system, Kaiser Permanente, adopted the program in four locations from 2012 through 2019.
    • “Suicides and suicide attempts fell in three of the locations, while the fourth maintained a low rate of suicides and attempts. Suicide attempts were tracked in electronic health records and insurance claims data. Suicides were measured using government death records.”‘
  • The Washington Post notes,
    • “Those who exercised the most had a 26 percent lower cancer risk than those who exercised the least in an analysis of biomedical data, according to research published in the British Journal of Sports Medicine.
    • “The article drew upon data from UK Biobank, a longitudinal study that enrolled 500,000 adults in Britain between 2006 and 2010. After enrolling, more than 106,000 adults were invited to participate in the sub-study on physical activity. The final sample, stratified into five groups, or quintiles, of physical activity levels, included about 85,000 participants with a median age of 63 years.” * * *
    • “The research identified an inverse relationship between overall daily physical activity and cancer risk, indicating that even modest increases in activity levels were sufficient to significantly reduce the risk of the 13 cancers. Individuals in the second-highest quintile of physical activity had a 16 percent lower risk compared with those in the lowest quintile. Higher levels of activity had a more protective effect.”
  • Per MedTech Dive,
    • “Johnson & Johnson said Monday it has enrolled the first patient in a pivotal study of a device for clearing “difficult-to-cross” coronary arteries.
    • “Like other products made by J&J’s Shockwave Medical, the Javelin intravascular lithotripsy catheter uses sound pressure waves to break up calcium deposits that are blocking blood flow. 
    • “The device is differentiated from other Shockwave products, and rival catheters from Abbott and Boston Scientific, because it emits waves from its tip. Other devices send waves from a balloon catheter that must cross the blocked part of the artery to be effective.” * * *

From the U.S. healthcare business front,

  • Per Beckers Hospital Review,
    • “Hospital average operating margins dropped from 3.4% in January to 2.5% in February, but are still above 2024 averages, according to Kaufman Hall’s “National Hospital Flash Report.”
    • “Kaufman Hall, a Vizient company, gathered financial performance data from 1,300 hospitals. The average operating margin dropped 11% month over month but grew 5% year over year. The average operating EBITDA margin decreased 7% month over month but grew 1% year over year.
    • “Net operating revenue per calendar day increased 8% year over year, driven by an 11% jump in inpatient revenue. Outpatient revenue grew just 8% compared to February 2024.
    • “Expenses were also on the rise, with total expenses also up 8% year over year driven by a 10% growth in supply expenses per calendar day. Drug expenses and non-labor expenses both jumped 9% while labor expenses grew 6% year over year. Purchased services expenses also increased 13% from February 2024.
    • “Patient volume held steady, as discharges per calendar day were up 6% year over year in February. Observation days dropped 9% and the average length of stay was flat compared to the same period last year. Emergency department visits increased 4%.”
  • Modern Healthcare adds,
    • “Health systems announced five hospital merger and acquisition proposals in the first three months of the year, the lowest quarterly amount in more than a decade.
    • “Providers were reluctant to wade into hospital transactions amid the uncertainty surrounding tariffs, federal funding concerns, state and federal regulatory changes and economic volatility, according to a new report from consultancy Kaufman Hall. Four of the five proposed hospital deals involved financially distressed facilities, the report found.”
  • Specifically, Fierce Healthcare reports,
    • “Northwell Health and Nuvance Health’s 28-hospital merger has cleared its final regulatory hurdle and is expected to close within the next 30 days.
    • “Tuesday, Connecticut’s Office of Health Strategy announced it had reached an agreement with the two health systems after just over two months of negotiations over their Certificate of Need application. The pair’s merger, announced 14 months ago, had received a similar all-clear from New York’s Public Health and Health Planning Council last September as well as sign-offs from each state’s attorneys general during the summer.
    • “Alongside price constraints tied in part to state and regional cost growth benchmark, Northwell—the acquirer—will invest at least $1 billion into Nuvance’s Connecticut and New York hospitals and refrain from any real estate sale leasebacks over a five-year period.”
  • Fierce Healthcare also lets us know,
    • “Rural hospital leaders are questioning whether they can continue to afford to do business with Medicare Advantage (MA) companies, and some say the only way to maintain services and protect patients is to end their contracts with the private insurers.
    • “MA plans pay hospitals lower rates than traditional Medicare, said Jason Merkley, CEO of the Brookings Health System in South Dakota. Merkley worried the losses would spark staff layoffs and cuts to patient services. So, last year, Brookings Health dropped all four contracts it had with major MA companies.
    • “I’ve had lots of discussions with CEOs and executive teams across the country in regard to that,” said Merkley, whose health system operates a hospital and clinics in the small city of Brookings and surrounding rural areas.
    • “Merkley and other rural hospital operators in recent years have enumerated a long list of concerns about the publicly funded, privately run health plans. In addition to the reimbursement issue, their complaints include payment delays and a resistance to authorizing patient care.
    • “But rural hospitals abandoning their MA contracts can leave local patients without nearby in-network providers or force them to scramble to switch coverage.”
  • Per Healthcare Dive,
    • “CVS Health named a new CFO Tuesday as the healthcare giant continues to shake up its leadership team. 
    • “Brian Newman, most recently CFO of shipping and logistics firm UPS, will start at CVS on April 21. Tom Cowhey, who took on the permanent CFO position at CVS early last year, will become a strategic advisor to CEO David Joyner, effective May 12. 
    • “In addition to the leadership change, CVS said it expects financial results for 2025 to meet or exceed its previously issued guidance. In February, the company reported expected adjusted earnings for the year between $5.75 and $6 a share.” 
  • Per Beckers Hospital Review,
    • “Walgreens Boots Alliance reported a $5.6 billion operating loss in its fiscal second quarter, an improvement from the $13.2 billion loss in the same period last year as the troubled retailer continues to prepare for a private equity buyout. 
    • “Operating losses included a $3 billion impairment charge tied to its Village MD business, according to an April 8 company news release. 
    • “Despite ongoing challenges, Walgreens reported better than expected results in sales, with sales rising 4% to $38.59 billion. In addition, pharmacy sales rose 12% while retail sales fell by 3%. 
    • “The company announced last month that it would be acquired by Sycamore Partners in a deal valued at $10 billion. Walgreens also recently suspended its quarterly dividend part of a broader cost cutting effort.”
  • Per Fierce Pharma,
    • “While much of the recent GLP-1 saga has been written in the U.S., Novo Nordisk continues to expand its semaglutide empire across the globe and make inroads into large markets like Brazil.
    • “Now, in a bid to boost its production capacity in Latin America’s most populous country, Novo is plugging 6.4 billion Brazilian reais (roughly $1.09 billion) into an expansion of its manufacturing plant in the Brazilian city of Montes Claros.
    • “The investment, which marks one of the largest ever for pharmaceuticals in Brazil, will “significantly” bolster the facility’s capacity to crank out a variety of injectables, including GLP-1 medicines like Ozempic and Wegovy, Novo said in a Portuguese-language press release.”

From the artificial intelligence front,

  • Cardiovascular Business reports,
    • “Powerful Medical, a New York-based artificial intelligence (AI) company, has received the FDA’s breakthrough device designation for its AI model designed to detect signs of an ST-elevation myocardial infarction (STEMI) in electrocardiography results.
    • “The company’s PMcardio STEMI AI ECG model, nicknamed “Queen of Hearts,” identifies STEMI and STEMI-equivalent patterns in a patient’s ECG. It was trained by Stephen W. Smith, MD, an emergency physician at Hennepin County Medical Center and founder of Dr. Smith’s ECG Blog.
    • “For the last 20 years, life-saving treatment exists for heart attack patients, yet far too many still don’t receive the urgent care they need due to delays in diagnosis and inefficient triage,” said Robert Herman, MD, PhD, chief medical officer of Powerful Medical, said in a statement. “By equipping physicians and allied providers with an AI-powered tool for accurate and immediate STEMI detection, available around the clock, we can bridge this gap, ensure timely treatment, and improve patient outcomes, often preventing avoidable deaths.”
  • and
    • “Artificial intelligence (AI)-assisted mammography may be able to predict a woman’s risk of developing cardiovascular disease, according to new data being presented at ACC.25, the American College of Cardiology’s annual conference.
    • “Breast artery calcifications are already visible when radiologists review mammograms, but nothing typically happens with those findings. Researchers aimed to see if AI could do some of the heavy lifting and help translate those findings into an easy-to-understand cardiovascular risk score.
    • “The group trained an advanced AI model to segment calcified vessels in mammography images and produce a risk score that calculates the patient’s risk of developing heart disease. To help make the new-look algorithm as accurate as possible, they developed it using mammography images and electronic health record data from more than 56,000 patients. The patients were all treated from 2013 to 2020 within the Emory Healthcare health system, and at least five years of follow-up data were available for each of them.
    • “Advances in deep learning and AI have made it much more feasible to extract and use more information from images to inform opportunistic screening,” lead author Theo Dapamede, MD, PhD, a postdoctoral fellow at Emory University in Atlanta, said in a statement.”
  • Per Beckers Clinical Leadership,
    • “An AI tool that analyzes nurses’ notes for subtle clinical changes helped reduce patient risk of death by 35.6%, length of stay by 11.2% and sepsis risk by 7.5%, according to research published April 2 in Nature. 
    • “In a yearlong, multisite study, researchers assessed the tool across 74 clinical units in two health systems. Among 60,893 hospital encounters, about half involved the early warning system and the other half did not. 
    • “The system, dubbed COmmnuticating Narrative Concerns Entered by RNs (CONCERN), is a machine learning algorithm that uses real-time nursing surveillance notes and data patterns to detect all-cause deterioration risks. 
    • ‘Other EWSs often “rely on late and noisy physiologic indicators of deterioration” such as lab results and vital signs, according to the researchers. In contrast, this tool leverages nurses’ “subtle, yet observable, clinical changes that may not be captured in physiological data or well displayed in EHRs,” including small changes in mental status from baseline or slower recovery of arterial blood pressure after turning a patient.” 

Monday Report

David Ermer–CMS, Congress, FDA, Medical / Rx research, Medicare, Mental health care, NIH, Rx coverage, SCOTUS, U.S. Healthcare–
Photo by Sven Read on Unsplash
  • The Wall Street Journal reports,
    • “House Republicans’ moves to advance President Trump’s “one big, beautiful bill” this week have been cast into doubt by defections from GOP lawmakers worried that spending cuts are being pushed aside in a rush to enact tax reductions.
    • “Republican leaders want to vote on a fiscal framework that would unlock a fast track to legislation carrying many Trump priorities, including tax cuts and new spending on border security and the military. Trump and House Speaker Mike Johnson (R., La.) are hoping to show progress on extending expiring tax cuts to counteract the market chaos sparked in recent sessions by Trump’s tariff rollout.” 
  • and
    • The Trump administration will substantially increase payment rates for Medicare insurers next year, generating more than $25 billion in additional revenue for the industry and doubling the boost proposed in January.
    • The rate increase of 5.06%, compared with 2.23% in the earlier proposal from the Biden administration, overshoots even optimistic expectations from many Wall Street analysts, and will likely lead to a rally in the shares of big Medicare insurers such as UnitedHealth Group, Humana and CVS Health, parent of Aetna.
    • The Centers for Medicare and Medicaid Services announced the increase for 2026 payment rates on Monday. Investors are expected to view the bump as a sign of the Trump administration’s support for Medicare Advantage, the program under which private insurers administer the benefits of the federal program for older and disabled Americans. 
      The Medicare agency said the increase in the planned payment rate reflected rising medical costs, and that more recent data had led to the steeper final rise compared with the January proposal. 
  • Here are links to the CMS Medicare Advantage and Medicare D 2026 rate announcement, the related CMS fact sheet, and a CMS fact sheet about final 2026 Part D program redesign instructions:
    • “In CY 2026, the structure of the Part D benefit will be updated to reflect provisions of the IRA that become effective on January 1, 2026. The CY 2026 updates include the following:
    • “The CY 2026 annual out-of-pocket (OOP) threshold of $2,100, which is the original 2025 out-of-pocket cap of $2,000, adjusted based on the annual percentage increase in average expenditures for covered Part D drugs in the U.S. for Part D eligible individuals in the previous year (API).
    • “Changes to the liability of enrollees, sponsors, manufacturers, and CMS in the new standard Part D benefit design, specifically to account for the start of negotiated prices taking effect with respect to selected drugs for initial price applicability year 2026 under the Negotiation Program; and
    • “The establishment of the selected drug subsidy program.” * * *
    • “With the enhancements to the Part D benefit under the IRA, the current simplified determination methodology no longer reflects actuarial equivalence with defined standard Part D coverage. Accordingly, CMS has developed a revised simplified determination methodology that better reflects actuarial equivalence with the richer Part D defined standard benefit under the IRA. For CY 2026 only, non-RDS group health plans are permitted to use either the existing simplified determination methodology or the revised simplified determination methodology to determine whether their prescription drug coverage is creditable. Under the revised simplified determination methodology, the group health plan coverage must be designed to pay at least 72% of participants’ prescription drug expenses, versus 60% under the existing methodology.” 
  • In another surprising Medicare development, STAT News informs us,
    • “Medicare’s financial future unexpectedly got a lot rosier, at least according to some federal budget wonks. 
    • “The Congressional Budget Office recently published its long-term predictions of the federal budget and buried a big surprise for people who follow the Medicare program. The government’s primary piggy bank that pays for Medicare [Part A hospital and other facility] benefits won’t be depleted until 2052 — 17 years later than what CBO analysts predicted last year. 
    • “Quite a few responded they don’t believe it,” he said. “But they [CBO] do have their justification there. And of course this is a long-term projection, and a lot can change.”
  • The New York Times reports,
    • “Health Secretary Robert F. Kennedy Jr. kicked off a tour through southwestern states on Monday by calling on states to ban fluoride in drinking water supplies, a move that would reverse what some medical experts consider one of the most important public health practices in the country’s history.
    • “The announcement came at a news conference in Utah, the first state to enact such a ban into law. The state’s new law is set to take effect in early May, despite concerns from public health experts who consider fluoridation of water core to preventing tooth decay.
    • “It makes no sense to have it in our water supply,” Mr. Kennedy said, echoing a position he took during the 2024 presidential campaign. “I’m very, very proud of this state for being the first state to ban it, and I hope many more will come.”
    • “The Centers for Disease Control and Prevention, which Mr. Kennedy oversees as health secretary, has listed fluoridation as one of the 10 great public health achievements of the 20th century. After the news conference, Stefanie Spear, Mr. Kennedy’s principal deputy chief of staff, said Mr. Kennedy would direct the C.D.C.’s community preventative services task force to study fluoride and make a new recommendation.”
  • Per FedSmith,
    • “Retirement planning is a complex process for federal employees, requiring careful attention to eligibility rules and regulations. Among the many requirements that determine post-retirement benefits, the 5-year rule plays a crucial role in three key programs: Federal Employees Health Benefits (FEHB), Federal Employees’ Group Life Insurance (FEGLI), and Roth Thrift Savings Plan (Roth TSP). Understanding these rules can ensure a smooth transition into retirement while maintaining access to critical benefits.”
    • The article provides an understanding of these important rules.

From the judicial front,

  • Govexec relates,
    • “There’s a quorum again on the board that hears appeals of firings and suspensions of federal employees after a majority of judges on the U.S. Court of Appeals for the D.C. Circuit vacated an earlier decision that temporarily enabled President Donald Trump to remove a Democratic appointee to the Merit Systems Protection Board. 
    • “Trump in February attempted to fire Cathy Harris, a Biden appointee, from the MSPB. A district judge blocked the removal, but that order was paused on March 28 in a 2-1 decision by a three-judge panel of the D.C. Circuit while it heard the Trump administration’s appeal. 
    • “On Monday, however, a majority of D.C. circuit court judges overruled that decision through en banc reconsideration, which is a rare process that can be utilized if a litigant feels a circuit panel didn’t adhere to Supreme Court precedent. Such reconsideration involves all circuit judges who are in regular active service rather than the usual three-judge panel. 
    • “The circuit court judges were split 7-4 in granting the motion for en banc reconsideration. 
    • “At issue in this case is Humphrey’s Executor, a 1935 Supreme Court decision that found the president doesn’t have unfettered authority to remove officials on multimember, quasi-judicial bodies.” * * *
    • “Monday’s decision, as well as the overturned March 28 order, also apply to Gwynne Wilcox, a Biden appointee to the National Labor Relations Board who Trump similarly fired but who was later reinstated by a district court. 
    • “In a brief, lawyers for the Trump administration said they would seek emergency relief from the Supreme Court if Wilcox and Harris were allowed to return to their positions.”  
  • Bloomberg Law reports,
    • “A federal judge in Texas on Monday vacated a Biden administration rule that would have required about 75% of US nursing homes to add direct-care workers or face administrative penalties and fines.
    • “In his order granting a motion for summary judgment for the plaintiffs, the American Health Care Association, Judge Matthew J. Kacsmaryk of the U.S. District Court for the Northern District of Texas, said the nation’s nursing homes suffer from “failures,” including “inadequate staffing levels, poor infection control, failures in oversight and regulation, and deficiencies that result in actual patient harm.” All of which “deserve an effectual response,” he wrote.
    • “But any regulatory response must be consistent with Congress’s legislation governing nursing homes. The Final Rule’s challenged provisions are not,” Kacsmaryk declared of the varied requirements of the mandate, which included that facilities have a registered nurse on site around the clock. “Though the Final Rule attempts to remedy chronic nursing home deficiencies, it does so deficiently.” 
    • “Although “rooted in laudable goals, the Final Rule still must be consistent with Congress’s statutes,” Kacsmaryk added. “To allow otherwise permits agencies to amend statutes though they lack legislative power. Separation of powers demands more than praiseworthy intent.”

From the public health and medical research front,

  • The American Hospital Association News clarifies,
    • “A second Texas child died from measles April 3 amid an ongoing outbreak in the state, the Texas Department of State Health Services announced April 6. The child was not vaccinated and had no reported underlying conditions, the agency said. The latest death follows a child that died Feb. 26. An unvaccinated adult in New Mexico that died in March also tested positive for measles after their death, but measles was not confirmed as the official cause of death.”
  • The American Medical Association News lets us know what doctors wish their patients knew about improving their mental health.
  • Per MedPage Today,
    • “Biomarker and cognitive data supported treatment with the anti-amyloid agent lecanemab (Leqembi) for up to 36 months in early Alzheimer’s disease, initial findings from the CLARITY AD open-label extension study suggested.
    • “Continuous treatment led to greater changes in plasma amyloid-beta 42/40 levels, reported Christopher van Dyck, MD, of Yale University in New Haven, Connecticut, in a poster presented at the American Academy of Neurologyopens (AAN) annual meeting.” * * *
    • “Serious adverse events occurred in 20.5% of the total sample of 1,616 people in the core CLARITY AD trial and the open-label extension study who received lecanemab. Amyloid-related imaging abnormalities with edema (ARIA-E) occurred in 14.7%, ARIA with hemosiderin deposits (ARIA-H) occurred in 23.8%, and intracerebral hemorrhage (ICH) occurred in 0.7%. Three deaths concurrent with ARIA or ICH occurred.
    • “These findings provide the first evidence for a continued benefit of lecanemab and disease modification over the long term, out to 36 months,” van Dyck told MedPage Today.
    • “They also suggest that individuals with lower pathology — no or low tau, or low amyloid — experience a particularly robust stabilization of symptoms,” he continued. “These results collectively underscore the importance of early initiation and continued long-term treatment.”
  • and
    • “In a study of people without a history of cancer, comorbidities in midlife were associated with an overall risk of cancer.
    • “There was a stronger association between comorbidities and risk of multiple individual cancer types.
    • “The findings support the incorporation of formal comorbidity screening and/or risk assessment as a routine aspect of cancer screening visits.”
  • AHA News tells us,
    • “The National Institutes of Health April 7 released a study that found twins — smaller at birth on average than singletons — develop slower in early pregnancy than what was previously known. The ultrasound study found that twins have less fat tissue and muscle mass than singletons beginning at 15 weeks. Scientists believe the smaller size could be a way of adapting to accommodate more resources for two fetuses later in pregnancy. The NIH said confirmation of the findings in additional research could help guide physicians in monitoring and managing twin pregnancies.”
  • Per BioPharma Dive,
    • “Rhythm Pharmaceuticals on Monday said its drug for rare obesity conditions met the main goal of a Phase 3 clinical trial, helping people with weight gain triggered by brain injury lose about one-sixth of their body weight over one year of treatment.
    • The company plans to ask U.S. and European regulators to expand approval of the drug, called setmelanotide. The once-daily shot is marketed as Imcivree after being authorized in the U.S. in 2020 to treat people with genetically driven forms of obesity.
    • Imcivree earned $130 million in 2024 sales across its currently approved uses. Stifel analyst Paul Matteis wrote in a note to clients that the new indication is “a blockbuster opportunity with the potential for a fast ramp” in sales, adding that the weight loss data look “very strong.”

From the U.S. healthcare business front,

  • Fierce Healthcare points out,
    • “Emergency department use has nearly recovered to prepandemic levels, but rising acuity, insufficient capacity and a laundry list of financial roadblocks are straining their viability and threatening patients’ access to care, according to a new report from RAND’s healthcare research arm.
    • “The nonprofit, nonpartisan organization’s nearly 200-page report (PDF)—sponsored by the Emergency Medicine Policy Institute (EMPI)—paints a distressing picture of the current state of EDs, which are among the few settings where patients receive 24/7 unscheduled acute care regardless of payment thanks to the federal Emergency Medical Treatment and Labor Act (EMTALA).
    • “EDs, the report notes, have lately faced more complex and sicker patients. Steady increases in demand and limited capacity have led to an increase in ED crowding (referred to as boarding), longer waits and potentially violence toward healthcare workers, which compromise care quality and emergency care worker attrition due to burnout. At the same time, EDs are providing more uncompensated care and expanding the scope of their work into specialties like geriatric care and care coordination.”
  • Per BioPharma Dive,
    • “Labcorp is now offering a blood-based biomarker test in the U.S. to support the diagnosis of Alzheimer’s disease.
    • “The immunoassay measures the ratio of ptau-217 and beta amyloid 42, two distinct biomarkers of Alzheimer’s, according to the Wednesday announcement. The Global CEO Initiative on Alzheimer’s Disease has called ptau-217 one the most promising blood-based biomarkers for amyloid status.
    • “Manufacturers of Alzheimer’s drugs have identified blood tests as a way to reduce the reliance on imaging and cerebrospinal fluid assays and to accelerate diagnosis and treatment.”
  • and
    • “GSK is betting potentially billions of dollars that a smaller drug company’s technology can help create new treatments for brain-corroding diseases.
    • “Through a licensing deal announced Sunday, GSK has gained access to drug delivery technology from South Korea’s ABL Bio. This “Grabody-B” platform is designed to shuttle medicines across arguably the trickiest obstacle in neuroscience — the blood-brain barrier or “BBB” — by using a protein that normally shepherds an important growth hormone across the divide.
    • “The platform had already caught the attention of another pharmaceutical giant, Sanofi, which in 2022 entered a collaboration with ABL to develop new therapies for diseases like Parkinson’s.”
  • KFF Health News tells us,
    • “Underscoring the massive scale of America’s medical debt problem, a New York-based nonprofit has struck a deal to pay off old medical bills for an estimated 20 million people.
    • “Undue Medical Debt, which buys patient debt, is retiring $30 billion worth of unpaid bills in a single transaction with Pendrick Capital Partners, a Virginia-based debt trading company. The average patient debt being retired is $1,100, according to the nonprofit, with some reaching the hundreds of thousands of dollars.
    • “The deal will prevent the debt being sold and protect millions of people from being targeted by collectors. But even proponents of retiring patient debt acknowledge that these deals cannot solve a crisis that now touches around 100 million people in the U.S.
    • “We don’t think that the way we finance health care is sustainable,” Undue Medical Debt chief executive Allison Sesso said in an interview with KFF Health News. “Medical debt has unreasonable expectations,” she said. “The people who owe the debts can’t pay.”
    • “In the past year alone, Americans borrowed an estimated $74 billion to pay for health care, a nationwide West Health-Gallup survey found. And even those who benefit from Undue’s debt relief may have other medical debt that won’t be relieved.
    • “This large purchase also highlights the challenges that debt collectors, hospitals, and other health care providers face as patients rack up big bills that aren’t covered by their health insurance.”

From the artificial intelligence front,

  • Modern Healthcare interviewed Pat Geraghty, Guidewell’s CEO, who discusses the use of AI in prior authorization approvals
    • “How do you educate consumers about the value of prior authorization? 
    • “There’s been a lot of noise around this topic recently. 
    • “We don’t want to come out and say, “let me just explain prior auth to you.” What we’re trying to do is say, “We know we can be better. We can use technology to help us be better. We can make the process quicker and smoother, and we’re going to do that and we’re committing to that.”
    • “We also want to be clear about the rest of the issues around prior auth. There is some clarification and explaining that is appropriate, but it’s not the lead thing. The lead thing is making sure we’re taking the hassle out of the process.
    • “How are you using technology to improve the process? 
    • “We use AI to say yes, not deny, and that allows us to get a very quick answer to the provider. We had 2.4 million authorizations last year that were done in just seconds. About 80% of our prior authorizations are on an automated basis.
    • “But the more complex the issue is, the more it really does involve the oversight of a clinician who understands the area that is being reviewed. You wouldn’t want to give up those kinds of dialogues. Oftentimes the discussions may end up with a modified treatment plan that’s best for all involved. It also is one of the ways we have a check on fraud, waste and abuse.
    • “The thing we find that drives the highest volume for denials is when a service is not covered by the health plan.”
  • The Washington Post reports, “AI is coming to skin cancer detection. Technology is already assisting with diagnoses, but experts predict better tools for non-experts will become available in the not-too-distant future.”

Weekend Update

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

From Washington, DC,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

From the artificial intelligence front,

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

Cybersecurity Saturday

David Ermer–Cybersecurity–

From the cybersecurity policy front,

  • Nextgov/FCW reports,
    • “Rep. Eric Swalwell, the House Homeland Security Committee’s leading Democratic voice on cybersecurity matters, suggested Wednesday that government contractors could be deployed to conduct offensive cybersecurity operations against foreign adversaries.
    • “Speaking at an Axonius event in Washington, D.C., the California congressman said the concept is worth exploring, in part, because “the federal government does not have the resources to protect every company that gets hit,” and that the moves could deter adversaries like Russia from targeting low-resourced critical infrastructure sectors.
    • “The remarks make Swalwell one of the first Democrats to publicly suggest that the private sector take a broader role in hacking back against foreign rivals. The dynamic has been floated in recent months largely by Republicans as a way to respond to headline-making Chinese intelligence intrusions into U.S. telecom systems and other infrastructure.”
  • Per a news release,
    • “Incident response is a critical part of cybersecurity risk management and should be integrated across organizational operations. The six Functions of the NIST Cybersecurity Framework (CSF) 2.0 all play vital roles in incident response.
    • “NIST has finalized Special Publication (SP) 800-61r3 (Revision 3), Incident Response Recommendations and Considerations for Cybersecurity Risk Management: A CSF 2.0 Community Profile, which describes how to incorporate incident response recommendations into cybersecurity risk management activities in alignment with CSF 2.0. This guidance will help organizations reduce the number and impact of incidents that occur and improve the efficiency and effectiveness of their incident detection, response, and recovery activities.
    • “SP 800-61r3 supersedes SP 800-61r2 (Revision 2), Computer Security Incident Handling Guide.
    • “Readers of SP 800-61r3 are encouraged to utilize the resources on NIST’s Incident Response project page in conjunction with this document to implement these recommendations and considerations.” 
  • The American Hospital Association News tells us,
    • “The House Energy and Commerce Oversight and Investigations Subcommittee April 1 discussed cybersecurity threats in legacy medical devices during a hearing. The subcommittee heard from experts on the dangers of outdated devices as the hardware can last several years longer than software.”

From the cyber vulnerabilities and breaches front,

  • The Cybersecurity and Infrastructure Security Agency added three known exploited vulnerabilities to its catalog this week.
  • Cybersecurity Dive reports on April 2,
    • A recent surge in login attempts targeting Palo Alto Networks’ PAN-OS GlobalProtect portals mainly located in the U.S. could be a precursor to a large-scale exploitation of unpatched or zero-day vulnerabilities, researchers have found. 
    • The threat activity means defenders with exposed Palo Alto Networks VPN systems should review March 2025 logs and consider engaging in detailed threat hunting to detect signs of compromise.
    • Over the last 30 days, nearly 24,000 unique IP addresses have attempted to access these portals, activity that suggests a coordinated effort to identify exposed or vulnerable systems for targeted abuse of flaws, according to a report released this week from security intelligence firm GreyNoise.
  • HelpNet Security points out “Attackers are targeting CrushFTP vulnerability with public PoC (CVE-2025-2825).”
    • “Exploitation attempts targeting the CVE-2025-2825 vulnerability on internet-facing CrushFTP instances are happening, the Shadowserver Foundation has shared on Monday, and the attackers have been leveraging publicly available PoC exploit code.”

From the ransomware front,

  • The Wall Street Journal reports,
    • “The Federal Trade Commission in March identified impostor scams—in which someone impersonates a loved one, colleague or government official—as the most-reported type last year, resulting in losses of nearly $3 billion. 
    • “Criminals increasingly use generative AI to mimic a loved one’s voice, making these kinds of scams more believable, the Federal Bureau of Investigation has warned. It takes just three seconds of audio to clone a voice with 85% accuracy, according to the security-software firm McAfee, whose survey of 7,000 people globally found that more than half regularly share voice content online.
    • “Criminals can also use AI to approximate the voice of someone of any age, gender or dialect. During a high-stress situation, a generic voice of a young woman could be confused for the voice of a daughter, according to cybersecurity experts.”
  • Per Cybersecurity Dive,
    • “The FBI, the Cybersecurity and Infrastructure Security Agency and a group of international partners on Thursday [April 3] warned that cyber threat groups are using a technique called “fast flux” to hide the locations of malicious servers, posing a significant threat to national security.
    • “Authorities warned that both criminal and state-linked threat groups have used fast flux to obfuscate the locations of these servers using fast-changing Domain Name System records. They also can create highly resilient command and control (C2) infrastructure to conceal their malicious operations, particularly in connection with botnets.
    • “Fast flux techniques are not only used for C2 communications but also in phishing campaigns to protect social engineering websites from being blocked or taken down, authorities said.” 
    • “Authorities did not specify whether there is an active campaign using fast flux or directly name any threat actor currently using the technique. However, they did reference past activity, noting that fast flux has been used in previous ransomware attacks linked to Hive and Nefilim. Additionally, a Russia-backed threat actor known as Gamaredon has also used fast flux to mask threat activities, according to the advisory.”
    • “Authorities did not specify whether there is an active campaign using fast flux or directly name any threat actor currently using the technique. However, they did reference past activity, noting that fast flux has been used in previous ransomware attacks linked to Hive and Nefilim. Additionally, a Russia-backed threat actor known as Gamaredon has also used fast flux to mask threat activities, according to the advisory.” 
  • Beckers Health IT informs us on March 31,
    • “The FBI is investigating a cyberattack on Oracle’s computer systems in which hackers stole patient data to extort multiple U.S. healthcare providers, Bloomberg reported March 28.
    • “Oracle notified some healthcare customers earlier this month that the breach occurred sometime after Jan. 22. According to a notice sent to clients and obtained by Bloomberg, hackers accessed company servers and copied patient data to an external location.
    • “A person familiar with the matter, who spoke on condition of anonymity, told the publication that cybercriminals attempted to demand ransom from affected medical providers. The total number of targeted providers and stolen patient records remains unknown.
    • “Oracle did not respond to Bloomberg’s request for comment. An FBI spokesperson also declined to comment.”
  • Per Bleeping Computer,
    • “​Port of Seattle, the U.S. government agency overseeing Seattle’s seaport and airport, is notifying roughly 90,000 individuals of a data breach after their personal information was stolen in an August 2024 ransomware attack.
    • “The agency disclosed the attack on August 24, saying the resulting IT outage disrupted multiple services and systems, including reservation check-in systems, passenger display boards, the Port of Seattle website, the flySEA app, and delayed flights at Seattle-Tacoma International Airport.
    • “Three weeks after the initial disclosure, the Port confirmed that the Rhysida ransomware operation was behind the August 2024 breach.
    • “After the incident, the Port also decided not to give in to the cybercriminals’ demands to pay for a decryptor even though they threatened to publish stolen data on their dark web leak site.
    • “We have refused to pay the ransom demanded, and as a result, the actor may respond by posting data they claim to have stolen on their darkweb site,” the Port of Seattle said on September 13, 2024.
    • “Our investigation of what data the actor took is ongoing, but it does appear that some Port data was obtained by the actor in mid-to-late August. Assessment of the data taken is complex and takes time.”
  • Forta discusses,
    • “HellCat [which] is the name of a relatively new ransomware-as-a-service (RaaS) group that first came to prominence in the second half of 2024. Like many other ransomware operations, HellCat breaks into organisations, steals sensitive files, and encrypts computer systems – demanding a ransom payment for a decryption key and to prevent the leaking of stolen files.”
  • GTSC brings us up to date on the Medusa ransomware gang.
    • The Medusa ransomware gang is a ransomware-as-a-service (RaaS) operation first identified in June 2021. Since then, it has targeted over 300 victims across various critical infrastructure sectors, including medical, education, legal, insurance, technology, and manufacturing. ​
  • Per SC Media,
    • “A threat actor using a combination of AI-powered vishing, the more conventional remote access tool Microsoft Quick Assist, and living-off-the-land techniques has demonstrated how a simple vishing attack can escalate into a full compromise.
    • “In an April 1 blog post, researchers from Ontinue reported that the techniques observed in this recent campaign align with those previously attributed to Storm-1811, a threat actor identified by Microsoft known for leveraging vishing, MS Quick Assist, and social engineering via MS Teams to gain network access.
    • “SC Media first reported on this group last May, in which it was reported the group abused Quick Assist to deploy the BlackBasta ransomware.”

From the cybersecurity defenses front,

  • Cyberscoop reports,
    • “Businesses don’t always get what they pay for in cybersecurity. Some of the most expensive cloud network firewall vendors are among the worst performers against exploits and evasions, according to the most comprehensive, independent testing CyberRatings.org has conducted to date.
    • “Cisco, by far the most expensive cloud network firewall offering across the top 10 vendors on price per megabits per second, ranked seventh with an overall security effectiveness score of 53.5%, according to CyberRatings.org research released Wednesday. 
    • “The trio of big cloud providers — Amazon Web Services, Microsoft Azure and Google Cloud Platform — fared even worse, each landing at the bottom of the pack with a 0% security effectiveness score. 
    • “We’ve been told to use cloud-native technologies, that they’re better suited than using bolt-ons. Well, that’s clearly not the case here,” CyberRatings.org CEO Vikram Phatak told CyberScoop.”
  • Dark Reading explains “How an Interdiction Mindset Can Help Win War on Cyberattacks. The US military and law enforcement learned to outthink insurgents. It’s time for cybersecurity to learn to outsmart and outmaneuver threat actors with the same framework.”
  • In email news
    • Bleeping Computer lets us know “Google rolls out easy end-to-end encryption for Gmail business users.”
    • Dark Reading informs us “Microsoft Boosts Email Sender Rules for Outlook. Beginning on May 5, the tech giant will enforce new email authentication protocols for Outlook users who send large volumes of email.”
  • Per a NIST news release, here are “7 Tips to Keep Your Smart Home Safer and More Private, From a NIST Cybersecurity Researcher.”
  • Here is a link to Dark Reading’s CISO Corner.