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–ACA, CDC, FDA, Medical / Rx research, Obesity, Patient safety, Rx coverage, SCOTUS, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC

  • The Associated Press, Roll Call, Fierce Healthcare, and the FEHBlog agree based on today’s oral argument that the U.S. Supreme Court will not affirm the U.S. Court of Appeals for the Fifth Circuit’s holding that the members of the U.S. Preventive Services Task Force are principal officers of the United States who must be nominated by the President and confirmed by the Senate. The Supreme Court will issue its decision in June or early July.
  • STAT News reports,
    • “Hospitals, health insurers, and insurance agents are asking President Trump to pump the brakes on a regulation that would lead to potentially millions of people losing their health insurance.
    • “That’s not to say the health care industry disagrees with all of Trump’s proposals, which would make it more difficult for people to get health coverage through the Affordable Care Act’s marketplaces. But at a minimum, lobbyists are urging the White House not to enforce any new rules until 2027 at the earliest, according to a review of public letters that were due this month.” * * *
    • “One particular proposal puts insurers and providers at odds. In 2021, the Biden administration created monthly “special enrollment periods” that allow anyone who makes between 138% and 150% of the poverty line to enroll in an ACA plan. Usually, outside of losing a job or other special circumstances, people can only sign up for an ACA policy during the annual open enrollment window. The idea is to discourage people from getting insurance only when they get sick or injured.
    • The Trump administration wants to eliminate those monthly special enrollment periods immediately. Big insurers such as Centene and UnitedHealthcare, health insurance lobbying groups like America’s Health Insurance Plans and the Blue Cross Blue Shield Association, and broker groups like the National Association of Benefits and Insurance Professionals support that move. They contend some people, and brokers, are taking advantage of the continuous enrollment opportunities.
    • “Excessive [special enrollment periods] are administratively burdensome and create challenges for health plans to distribute enrollee risk,” Ceci Connolly, the CEO of the Alliance of Community Health Plans, told federal officials.” 
    • “Hospitals pushed back on the idea that people are abusing the process. They also have a lot to lose from Trump’s proposals. ACA plans pay more than Medicare and Medicaid plans, and if millions of people switch to Medicaid or become uninsured, hospitals risk losing tens of billions of dollars in revenue.”
  • Bloomberg Law tells us,
    • “With mass reductions in force across the federal government on the horizon, the AFL-CIO, federal workers’ unions, and advocacy groups have mobilized a network of more than 1,000 volunteer attorneys to provide legal services to laid off federal employees.
    • “Leaders behind the new Federal Workers Legal Defense Network launched last week say they saw a need for more federal-sector labor law resources based on the sheer number of federal workers being let go and the Trump administration’s response to lawsuits seeking to restore these jobs. More than 100,000 federal workers have left or been fired from the federal government so far.”
  • Per a Justice Department news release,
    • “The Justice Department, together with the Drug Enforcement Administration (DEA) and Department of Health and Human Services Office of Inspector General (HHS-OIG), today announced a $300 million settlement with Walgreens Boots Alliance, Walgreen Co., and various subsidiaries (collectively, Walgreens) to resolve allegations that the national chain pharmacy illegally filled millions of invalid prescriptions for opioids and other controlled substances in violation of the Controlled Substances Act (CSA) and then sought payment for many of those invalid prescriptions by Medicare and other federal health care programs in violation of the False Claims Act (FCA). The settlement amount is based on Walgreens’s ability to pay. Walgreens will owe the United States an additional $50 million if the company is sold, merged, or transferred prior to fiscal year 2032.” * * *
    • “In addition to the monetary payments announced today, Walgreens has entered into agreements with DEA and HHS-OIG to address its future obligations in dispensing controlled substances. Walgreens and DEA entered into a memorandum of agreement that requires the company to implement and maintain certain compliance measures for the next seven years.” * * *
    • “The civil settlement resolves four cases brought under the qui tam, or whistleblower provisions of the FCA by former Walgreens employees. The FCA authorizes whistleblowers to sue on behalf of the United States and receive a share of any recovery. It also permits the United States to intervene and take over such lawsuits, as it did here. The relators will receive a 17.25% share of the government’s FCA recovery in this matter.”
  • Fierce Healthcare adds,
    • ‘In a statement, Walgreens’ spokesperson Fraser Engerman said, “We strongly disagree with the government’s legal theory and admit no liability. Our pharmacists are dedicated healthcare professionals who care deeply about patient safety and continue to play a critical role in providing education and resources to help combat opioid misuse and abuse across our country.
    • “This resolution allows us to close all opioid related litigation with federal, state, and local governments and provides us with favorable terms from a cashflow perspective while we focus on our turnaround strategy that will benefit our team members, patients, customers, and shareholders,” Engerman said.”
  • The American Hospital Association (AHA) News relates,
    • “The Food and Drug Administration has issued alerts for issues with certain catheters made by BD and Conavi. 
    • “BD identified an increase in material fatigue leaks associated with certain PowerPICC Intravascular Catheters. The FDA sent a letter to affected consumers recommending unused catheters be removed from where they are used or sold, and in-use catheters have updated instructions.
    • “Conavi reported an incident where the sheath of its Novasight Hybrid catheter detached during use. Conavi sent all affected providers a recall notice recommending they return the product to the company.”
  • MedTech Dive informs us,
    • “Medtronic has received Food and Drug Administration approval for a version of its latest glucose sensor that can pair with the company’s insulin pumps.
    • “The device, called Simplera Sync, can be used with Medtronic’s MiniMed 780G insulin pumps as part of an automated insulin delivery system, the company said Friday.
    • “Medtronic is planning a limited launch of the sensor starting this fall. CEO Geoff Martha told investors in February that the company expects Simplera Sync, and a new glucose monitor being developed with Abbott, to grow the company’s U.S. diabetes business.”
  • and
    • “Precision Neuroscience received 510(k) clearance for an electrode array that can be implanted for up to 30 days to map brain activity, the company announced Thursday. 
    • “The clearance is a milestone for the New York-based startup, which plans to use the electrode array as part of a brain-computer interface that is currently in development.
    • “Precision Neuroscience said the decision was the first time a company developing a next-generation wireless BCI has received FDA clearance, as it competes with rivals including Elon Musk’s Neuralink and Synchron, whose backers include Jeff Bezos and Bill Gates.”

From the public health and medical research front,

  • The AHA News lets us know,
    • “Overall cancer death rates declined steadily among both men and women from 2018 through 2022, according to the National Institutes of Health’s latest annual report. Cancer death rates decreased an average of 1.7% per year for men and 1.3% per year for women. Progress in reducing cancer deaths overall is mostly due to declines in both incidence and death rates for lung cancer and other smoking-related cancers, but cancers associated with obesity have been increasing, researchers noted.”
  • STAT News points out,
    • “High blood pressure earned its reputation as the silent killer by causing heart attacks, heart failure, and strokes.
    • “It’s also been a suspect in dementia. Some studies have hinted at a correlation between lower blood pressure and fewer dementia cases, but they were too small and too short to lend statistical significance to the link. It’s also been noted that people with untreated high blood pressure carry a 42% higher risk of developing dementia. 
    • “Now a new study published Monday in Nature Medicine reports that intensive blood pressure control lowered the risk of dementia by 15% and cognitive impairment by 16%. The large, cluster-randomized trial in rural China once again illuminated the role of “village doctors,” the local term for community health workers, who outdid usual care.
    • “This is an incredibly important study,” Dan Jones, a past president of the American Heart Association, told STAT. He was not involved in the new research. “Here’s something tangible that now we can tell our patients. This is so important for motivating people to control their blood pressure and treating it intensively as well.”  
  • BioPharma Dive notes,
    • “A two-drug regimen involving AstraZeneca and Daiichi Sankyo’s Enhertu topped standard therapy in a large study in HER2-positive breast cancer, the companies said Monday.
    • “In a Phase 3 trial, a combination of Enhertu and the targeted therapy pertuzumab held tumors in check longer than THP, a regimen of chemotherapy and precision medicines that’s commonly used as an initial treatment for metastatic breast tumors expressing the HER2 protein. The companies didn’t provide specifics, but said the regimen displayed a “highly statistically significant and clinically meaningful effect” on so-called progression-free survival in the study, with benefits across all patient subgroups.
    • “Additionally, while it is too early to tell whether Enhertu and pertuzumab are extending lives, “an early trend” favors their impact on survival, the companies said. Investigators and patients also remain blinded to a different arm of the trial comparing Enhertu alone to THP. That part of the study will continue to a final analysis.
    • “Safety was consistent with what’s been observed in use of each individual therapy, the companies said. AstraZeneca and Daiichi will present the findings at a future medical meeting and share the results with regulators.”
  • Fierce Pharma adds,
    • “In the first phase 3 trial to show the superiority of a TROP2-targeted antibody-drug conjugate and an immunotherapy agent in first-line triple-negative breast cancer (TNBC), Gilead Sciences’ Trodelvy has notched a much-needed win.
    • “Trodelvy’s combination with Merck & Co.’s Keytruda was better than Keytruda and chemotherapy at prolonging the time before cancer returns or death in patients with previously untreated metastatic TNBC whose tumors express PD-L1, Gilead announced Monday.
    • ‘The readout came from the phase 3 Ascent-04, or Keynote-D19, trial, which sets PD-L1 positivity cutoff at a combined positive score of at least 10, the same population that got Keytruda-chemo its FDA nod in this setting in 2020.”
  • Per Infectious Disease Advisor,
    • “Neurologic manifestations of syphilis increased across demographic groups and among those with HIV infection from 2019 to 2022, suggesting the need to evaluate all patients with syphilis for evidence of neurologic signs and symptoms.”
  • The American Medical Association lets us know “what doctors wish patients knew about becoming a living kidney donor.”
  • Consumer Reports, writing in the Washington Post, shares “tools and tips to help make life easier when your eyes don’t work as well anymore.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Prospect Medical Holdings-owned Crozer Health plans to start closing facilities following a lengthy, but unsuccessful, battle to secure a buyer.
    • “Prospect Medical filed a motion Monday asking the U.S. Bankruptcy Court for the Northern District of Texas for an emergency hearing to approve an expedited closure for Upland, Pennsylvania-based Crozer’s hospitals and outpatient facilities.
    • “Crozer plans Wednesday to start diverting emergency cases to other facilities and to stop elective inpatient admissions, in addition to trauma, surgical, OB-GYN, burn, behavioral health, oncology and outpatient services. Next Monday, Crozer plans to close all ambulatory services, according to court documents.
  • Beckers Hospital Review adds,
    • “Mid Coast Medical Center Trinity (Texas) will close April 25, after months of attempting to secure facility long-term sustainability and financial stability. 
    • “El Campo, Texas-based Mid Coast Health System, which manages and operates the facility, pointed to “significant financial challenges experienced by hundreds of rural hospitals” that have been made worse by “delays in establishing Medicare and Medicaid billing with commercial health insurance” for the closure, according to an April 18 news release on the hospital’s Facebook page. 
    • “The health system also pointed to increased accounts payable for supplies and services, lower-than-expected revenue from collections owed on patient copays and insufficient local tax revenue for operational shortfalls.” 
  • The Washington Post reports,
    • “Americans spent an estimated $71.7 billion on GLP-1 drugs including Ozempic and Wegovy in 2023, a 500 percent increase from their spending on such drugs five years earlier, according to a research letter published in JAMA Network Open.”
  • Per BioPharma Dive,
    • Novo Nordisk asked the Food and Drug Administration to approve a pill version of its popular weight loss drug in obesity earlier this year, a spokesperson confirmed to BioPharma Dive. 
    • Novo first reported in 2023 that the drug, an oral form of semaglutide, succeeded in a Phase 3 trial, helping people on the highest dose lose about 15% of their body weight after 64 weeks. However, the Danish drugmaker didn’t seek approval immediately afterwards, instead focusing attention on other medicines that might improve upon the injectable drug it sells as Wegovy for obesity and Ozempic for diabetes. 
    • The approval filing comes as a race with rival Eli Lilly to develop a weight loss pill has intensified. Lilly last week said its oral GLP-1 pill succeeded in a large trial in diabetes. That drug, orforglipron, could be submitted to regulators if an ongoing study in obesity also meets its objectives. 
  • ABC News explains how pharmacies are speeding up home delivery of prescription drugs.
  • Per Modern Healthcare,
    • “Labcorp has completed its acquisition of North Mississippi Health Services’ ambulatory outreach laboratory business. 
    • “Tupelo-based North Mississippi will still operate its hospital and clinic labs, according to a Monday news release. Under the purchase agreement, Labcorp plans to open three patient service centers by mid-year in Tupelo, West Point and Amory, Mississippi. It also will become a referral laboratory for the health system’s hospitals and clinics. Financial terms were not disclosed.” 
  • Per Beckers Hospital Review,
    • Inadequate coordination of patient discharges was named among the top 10 threats to patient safety in 2025, according to a recent report from ECRI and the Institute for Safe Medication Practices. Gaps in communication, follow-up and medication management continue to put patients at risk after they leave the hospital.
    • To strengthen discharge processes and ensure safer transitions of care, hospitals are deploying more proactive, interdisciplinary approaches — from virtual medication reconciliation to integrated navigation platforms and social determinants of health screening.
    • Becker’s recently asked three hospital and health system leaders to share one key strategy their organization is implementing to improve discharge coordination and reduce safety risks.
    • Their responses are featured [in the article.]
  • and
    • “The American College of Obstetricians and Gynecologists is recommending “a paradigm shift” to prenatal care, opting for a more personalized and tailored approach to improve access and outcomes.” 
    • The article shares five things to know about this change.
  • Healthcare Dive reminds us,
    • “The healthcare industry is awash in consumer financing options, for everything from plastic surgery to teeth whitening to a Botox top-up and your dog’s mangled paw. 
    • “Dermatologists, vets and dentists – the domain of many elective procedures — are primary customers of medical financing. 
    • “Less common is low-cost financing for insured people facing an unexpected medical emergency or a $1,000 insurance deductible.
    • “As the U.S. health system has pushed more treatment costs onto patients through higher-cost deductible plans – and overall healthcare inflation – more people have fallen into arrears on medical bills, said Brandon Pace, chief legal officer at PayZen, a San Francisco startup that’s seeking to expand the buy now, pay later installment model into the medical field.”

Weekend Update

David Ermer–Congress, Generative AI, Medical / Rx research, SCOTUS–

From Washington, DC,

  • Congress remains on a District/State work break this week.
  • Tomorrow at 10 am ET. the U.S. Supreme Court will hear oral arguments in the Kennedy v. Braidwood Management, No. 24-316, case. Amy Howe provides background on the case here. The case considers the constitutional authority of the U.S. Preventive Services Task Force to make recommendations for no-cost coverage of preventive services under the Affordable Care Act.
  • MedPage Today points out,
    • “The need to revamp the Organ Procurement and Transplantation Network (OPTN) is dire. Nearly 25% of livers and 33% of kidneys collected for donation go unused. The average transplant wait time is 3-5 years, but it can stretch even longer in some parts of the country. Much of the network’s donation and recipient data collection is performed manually, prolonging pre-transplant procedures. All of this is unwelcome news for more than 100,000 people currently on the organ transplant waitlist. And many are running out of time.
    • “Despite these challenges, the U.S. organ transplant system still saves over 48,000 lives a year. And policymakers have been pushing to increase this numbers. The Health Resources and Services Administration (HRSA), the entity housed within HHS that oversees the transplant network, is tasked with modernizing the system and saving more lives. HRSA is working hard to close the gap between recipient identification, donor matching, and subsequent transplant surgeries.
    • “HRSA must continue to push modernization efforts aggressively, using operational and technology improvements and stakeholder collaboration to save more lives and increase public trust in the transplant system. Reform efforts should focus on three key areas: streamlining of responsibilities, technological upgrades, and transparency.”

From the public health and medical research front,

  • The Washington Post reports,
    • “Consuming more than eight alcoholic drinks a week is associated with brain injuries linked to Alzheimer’s disease and cognitive decline, a recent study in the journal Neurology suggests.
    • “The analysis looked for links between heavy drinking and brain health. Researchers used autopsy data from the Biobank for Aging Studies at the University of São Paulo Medical School in Brazil collected between 2004 and 2024. The team analyzed data from 1,781 people ages 50 or older at death. The average age at death was 74.9. * * *
    • The analysis showed that heavy drinkers and former heavy drinkers, respectively, had 41 percent and 31 percent higher odds of neurofibrillary tangles — clumps of the protein tau that accumulate inside brain neurons and have been associated with Alzheimer’s disease.
    • “Moderate, heavy and former heavy drinkers also had a higher risk of hyaline arteriolosclerosis, which thickens the walls of small blood vessels in the brain, impeding blood flow and causing brain damage over time. Though 40 percent of those who never drank had vascular brain lesions, they were more common in moderate (44.6 percent), heavy (44.1 percent) and former heavy drinkers (50.2 percent), the study found.”
  • Per Medscape,
    • “An investigational drug, currently known as AZD0780, lowers low-density-lipoprotein cholesterol (LDL-C) to target levels in most patients whose cholesterol is still over target despite statin therapy, results from the phase 2b PURSUIT trial show.
    • “AZD0780 inhibits PCSK9, a protein that regulates cholesterol metabolism. Inhibition of this protein has proven useful in lowering LDL-C. Current drugs in this class include two monoclonal antibodies, alirocumab and evolocumab, and a small interfering RNA, inclisiran. However, unlike current PCSK9 inhibitors, which must be injected, AZD0780 is an oral therapy.
    • “We’ve had PCSK9 inhibitors on the market in the United States for 10 years,” said investigator Michael Koren, MD, a cardiologist and CEO of the ENCORE Research Group in Jacksonville, Florida. However, “people are still not getting to goal,” he explained during his presentation of the results at the American College of Cardiology Scientific Session 2025 in Chicago, which were published simultaneously in the Journal of the American College of Cardiology.”
  • The Wall Street Journal informs us about “How Your Midlife Eating Habits Can Help You Live Longer and Healthier.”
    • “If you reach 70 years old healthy and disease-free, you might have your diet to thank, new research suggests.
    • “The study, which analyzed the health data of more than 100,000 people over the course of 30 years, is the first of its kind to examine how dietary patterns affect not only lifespan but also how well people age. The upshot: A diet emphasizing vegetables, fruits, healthy fats and some animal products such as fish and dairy over the long term was the most likely to make a difference in aging in good health.
    • “Sticking to a balanced diet with a moderate amount of healthy animal protein, in fact, outperformed following a more plant-based diet, in terms of healthy aging. The researchers also found that eating more ultra processed foods was linked to worse physical and cognitive health in older age.
    • “The study, published in Nature Medicine and led by researchers at Harvard University, the University of Copenhagen and the University of Montreal, adds to the growing body of research on human health spans—the number of years we live in good health—and the factors that can extend those years.” 

From the U.S. healthcare business front,

  • Tech Target identifies “13 AI healthcare companies to watch in 2025. These AI healthcare companies are using generative AI to enhance efficiency, improve patient care and innovate diagnostics. We also explore types of AI in the healthcare space.”
  • Per a press release,
    • “At HIMSS25, Performant Healthcare, Inc. (Nasdaq: PHLT), a leader in technology-enabled payment integrity, eligibility and related analytics services, conducted a targeted survey of nearly 150 healthcare technology leaders to better understand the key drivers behind healthcare technology decision-making. The findings point to a healthcare landscape increasingly shaped by innovation, efficiency and the imperative to deliver better outcomes for patients.
    • “This press release features multimedia. View the full release here
  • Per a press release,
    • U.S. Business Action to End HIV has been named one of Modern Healthcare’s 2025 Innovator Awards recipients.
    • Modern Healthcare’s Innovators program recognizes leaders and organizations driving innovation that improves care and achieves measurable results.
    • U.S. Business Action to End HIV is reimagining the role of businesses in ending HIV. The Coalition empowers companies to reduce stigma, increase access to care, support community organizations, and advocate for policy change.
  • Fierce Healthcare tells us,
    • “Despite growing awareness around fertility challenges, 77% of women have hidden or downplayed their fertility treatment at work. 
    • “So finds the latest survey from Maven Clinic, a virtual women’s and family health provider. The survey reached more than 1,000 U.S. women who have gone through the fertility journey. The fertility journey comes with many challenges, from financial to emotional. These are often hidden from public view, Maven executives argue.
    • “Financial cost remains one of the biggest barriers to fertility care, with 75% of people experiencing financial strain when navigating fertility. Nearly half of survey respondents felt unprepared for the cost, particularly around medications or hormonal treatments, genetic testing and diagnostic testing.
    • “Most respondents (83%) had to cut back on expenses, and more than half had to use their savings meant for other life goals to afford fertility care. A third of the people said they took on debt, while 59% took on extra work.
    • “At the same time, people going through the fertility journey must deal with the emotional toll it can take. Most (91%) said fertility challenges impact their mental health, the survey found. And 78% reported limiting social interactions, like weddings and family gatherings, due to the emotional stress.” 

Cybersecurity Saturday

David Ermer–Cybersecurity–

From the cybersecurity renewals, policy and law enforcement front,

  • Federal News Network reported on Tuesday,
    • “The Cybersecurity and Infrastructure Security Agency [CISA] has inked a last-minute funding extension for a key cyber vulnerability management program.
    • CISA’s contract with MITRE to manage the Common Vulnerabilities and Exposures, or CVE, program was set to expire on Wednesday. But after an outcry from the cybersecurity community, CISA executed an 11-month option period for MITRE’s contract on Tuesday night.
    • “The CVE program is invaluable to the cyber community and a priority of CISA,” a CISA spokesperson said on Wednesday. “Last night, CISA executed the option period on the contract to ensure there will be no lapse in critical CVE services. We appreciate our partners’ and stakeholders’ patience.”
    • The CVE program is a public database of known security vulnerabilities in software and hardware. It’s relied on by organizations across the world to manage cyber vulnerabilities in products and services. CISA’s “Known Exploited Vulnerabilities” database, for instance, relies on CVEs to prioritize how quickly federal agencies must patch bugs on the list.
  • Cybersecurity Dive adds,
    • “Two federal lawmakers today introduced a bipartisan bill that preserves key regulation that facilitates the sharing of cyber-threat data between private companies and the federal government. 
    • “The Cybersecurity Information Sharing Extension Act, introduced by U.S. Sens. Gary Peters (D-MI) and Mike Rounds (R-SD), would extend provisions of the Cybersecurity Information Sharing Act of 2015, which is due to expire in September. The law encourages businesses to share information about ongoing cybersecurity threats with the federal government and is one of few legislative actions that has actually had an impact on real-world cybersecurity, security experts said.
    • “Specifically, the Cybersecurity Information Sharing Act of 2015 gives incentives to companies to voluntarily share cybersecurity threat indicators, such as software vulnerabilities, malware or malicious IP addresses, with the Department of Homeland Security (DHS). It does this by providing legal protections for companies that do so by providing federal antitrust exemptions and precluding them from being held accountable for state and federal disclosure laws.”
  • CISA announced,
    • “Cyber threats across the globe have put into focus our country’s need for cyber talent. CISA leads and hosts the President’s Cup Cybersecurity Competition to identify, recognize, and reward the best cyber talent across the federal workforce. Participants are challenged to outthink and outwit their competitors in a series of tests designed to expand cyber skills that are based on real-world situations.  For President’s Cup 6, participants will compete in a maximum velocity metaverse full of mayhem and taking place in a world light years ahead of our own.  
    • “Want to see what it’s like to participate in the President’s Cup? Federal employees can visit the President’s Cup Practice Area to take on challenges from previous competitions and receive a certificate of completion. Anyone can visit the President’s Cup GitHub page to find descriptions, solution guides, virtual machine builds and other artifacts from challenges featured in previous President’s Cup competitions. ” 
  • The National Institute of Standards and Technology (NIST) let us know,
    • “A draft update to the NIST Privacy Framework will enable organizations to use it seamlessly with the agency’s Cybersecurity Framework, which received its own update last year. 
    • “Targeted changes to content and structure respond to stakeholder needs and make the document easier to use.”
    • “NIST is accepting public comments on the draft via privacyframework@nist.gov until June 13, 2025. A template for submitting comments can be found at the NIST Privacy Framework website. Following the comment period, NIST will consider additional changes and release a final version later this calendar year.”
  • The HHS Office for Civil Rights announced on April 17,
    • “Today, the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) announced a settlement with Guam Memorial Hospital Authority (GMHA), a public hospital on the U.S. Territory, island of Guam, concerning a potential violation of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Security Rule, following the receipt of two complaints alleging that the electronic protected health information (ePHI) of GMHA patients was impermissibly disclosed.” * * *
    • “Ransomware and hacking are the primary cyber-threats to electronic protected health information within the health care industry. Failure to conduct a HIPAA risk analysis puts this information at risk and vulnerable to future ransomware attacks and other cyber-threats,” said OCR Acting Director Anthony Archeval.
    • “Under the terms of the resolution agreement, GMHA agreed to implement a corrective action plan that will be monitored by OCR for three years, and paid OCR $25,000.” * * *
    • “The resolution agreement and corrective action plan may be found at: https://www.hhs.gov/sites/default/files/ocr-hipaa-recap-gmha.pdf, opens in a new tab [PDF, 228 KB]“
  • Per Bleeping Computer,
    • “The FBI warns that scammers impersonating FBI Internet Crime Complaint Center (IC3) employees offer to “help” fraud victims recover money lost to other scammers.
    • “Over the last two years, between December 2023 and February 2025, the FBI said it has received over 100 reports of fraudsters using this tactic.
    • “Complainants report initial contact from the scammers can vary. Some individuals received an email or a phone call, while others were approached via social media or forums,” the law enforcement agency warned in a Friday public service announcement.”

From the cybersecurity vulnerabilities and breaches front,

  • Cyberscoop reports,
    • “A House panel has concluded that the U.S. government should double down on export controls and other tools to slow down the progress of Chinese AI companies like DeepSeek, while also preparing for a future where those efforts fail.
    • “In a report released Wednesday, the House Select Committee on the Chinese Communist Party further fleshes out the financial and technological resources that went into building DeepSeek’s R1 reasoning model, as well as its potential risks to U.S. economic and national security.
    • “The authors conclude that the DeepSeek website and app “acts as a direct channel for foreign intelligence gathering on Americans’ private data.”
  • Dark Reading adds,
    • “One of China’s major state-funded espionage groups has created or otherwise upgraded various malware programs, signaling a notable arsenal refresh that defenders need to be aware of.
    • “Mustang Panda (aka Bronze President, Stately Taurus, and TA416) is an advanced persistent threat (APT) believed to be sponsored by the People’s Republic of China (PRC). It has long been known for spying on targets of interest to the PRC, including: military and government organizations, nongovernmental organizations (NGOs), think tanks, minority groups, and corporations in major industries, primarily around East and Southeast Asia but also in the West.
    • “Recently, the group attacked an organization based in Myanmar. In the process, researchers from Zscaler uncovered four previously unknown attack tools the group is now using. They include two keyloggers, a tool for facilitating lateral movement, and a driver used to evade endpoint detection and response (EDR) software. Besides that, the group has also upgraded its signature backdoor, “Toneshell.”
  • Per Cybersecurity Dive,
    • “Lemonade Inc. has begun sending notification letters to about 190,000 people after their driver’s license numbers were transmitted unencrypted, according to regulatory filings by the company. 
    • “The company said a technical issue in its online application process for car insurance led to the exposure of data in an application programming interface call to a third-party data provider, according to an April 9 filing with the Securities and Exchange Commission. 
    • “As part of the online application process, certain information is sent between a server and a user’s browser, according to the filing. This includes data used to generate an insurance quote.  
    • “Lemonade said it learned of the issue on March 14 and said the exposures likely lasted from April 2023 through March 2024, according to a notice filed with the California Attorney General’s office.”
  • and
    • “Hertz Corp. confirmed a threat actor gained access to sensitive personal data in a breach linked to vulnerabilities in Cleo file-transfer software, according to a filing Friday with the Maine Attorney General’s office. 
    • “Hertz said it learned on Feb. 10 that an unauthorized third party obtained the data in connection with an attack spree that took place between October and December 2024. Hertz completed an analysis of the stolen data on April 2. 
    • “Importantly, to date, our investigation has found no evidence that Hertz’s own network was affected by this event,” a Hertz spokesperson said via email. 
  • CISA added four known exploited vulnerabilities to its catalog this week.
  • April 16, 2025
    • CVE-2021-20035 SonicWall SMA100 Appliances OS Command Injection Vulnerability
      • Cybersecurity Dive discusses this KVE here.
  • April 17, 2025
    • CVE-2025-31200 Apple Multiple Products Memory Corruption Vulnerability
    • CVE-2025-31201 Apple Multiple Products Arbitrary Read and Write Vulnerability
    • CVE-2025-24054 Microsoft Windows NTLM Hash Disclosure Spoofing Vulnerability
      • Dark Reading discusses the Apple KVEs here.
      • Hacker News discusses the Microsoft KVE here.
  • Cybersecurity Dive adds,
    • “Huntress on Monday published research that showed exploitation of CVE-2025-30406, a deserialization vulnerability in Gladinet’s CentreStack enterprise file-sharing platform for managed service providers (MSPs). The cybersecurity vendor said seven organizations were compromised via the zero-day flaw, which involves a hardcoded cryptographic key that can be used to gain remote code execution.
    • “Huntress warned that Gladinet’s Triofox product also relies on a hardcoded key and is vulnerable to CVE-2025-30406. Triofox is an on-premises file-sharing server designed for larger enterprises, according to Gladinet.
    • “CISA added CVE-2025-30406 to its known exploited vulnerabilities catalog on April 9. Gladinet first disclosed the flaw on April 3 and warned that exploitation had already been observed in the wild.”

From the ransomware front,

  • Cybersecurity Dive reports,
    • “DaVita has been hit by a ransomware attack that’s affecting operations, the kidney care provider said Monday. 
    • “The dialysis company discovered the attack, which encrypted parts of its network, on Saturday, according to a securities filing. Davita then activated its response plans and isolated affected systems.
    • “The company did not disclose how its operations are being affected or how long the disruption will last, but said patient care is continuing.” 
  • and
    • “Ahold Delhaize confirmed Thursday that certain files from its U.S. operations were stolen in a November cyberattack after a threat group claimed credit for the incident.
    • “The threat group, tracked as Inc Ransom, claimed in a Wednesday post on its leak site to have up to 6 TB of sensitive data from the Netherlands-based supermarket operator’s U.S. division and threatened to release the information if its demands are not met, according to researchers at Arctic Wolf. The attackers have not said what those demands are.
    • “Since the incident was detected, our teams have been working diligently to determine what information may have been affected,” Ahold Delhaize USA said in a statement.”
  • Per Security Week,
    • “The Oregon Department of Environmental Quality (DEQ) is the regulatory agency in charge of the quality of air, land and water in the state. The organization revealed on April 9 that it had launched an investigation into a cyberattack that forced it to shut down networks as part of containment efforts.
    • “The DEQ has been issuing updates every day since, and several of the updates pointed out that the agency had found no evidence of a data breach. 
    • “The incident disrupted email and help desk services, as well as vehicle inspection stations. The agency said its environmental data management system is hosted on a separate server and has not been impacted.
    • “After the regulator’s repeated denials about suffering a data breach, the notorious Rhysida ransomware group took credit for the attack on Monday, claiming to have stolen 2.5 Tb of files, including employee data.” 
  • Bleeping Computer points out,
    • “The Interlock ransomware gang now uses ClickFix attacks that impersonate IT tools to breach corporate networks and deploy file-encrypting malware on devices.
    • “ClickFix is a social engineering tactic where victims are tricked into executing dangerous PowerShell commands on their systems to supposedly fix an error or verify themselves, resulting in the installation of malware.
    • “Though this isn’t the first time ClickFix has been linked to ransomware infections, confirmation about Interlock shows an increasing trend in these types of threat actors utilizing the tactic.
    • “Interlock is a ransomware operation launched in late September 2024, targeting FreeBSD servers and Windows systems.
    • “Interlock is not believed to operate as a ransomware-as-a-service model. Still, it maintains a data leak portal on the dark web to increase pressure on victims, demanding payments ranging from hundreds of thousands of dollars to millions.”
  • The Register adds,
    • “Ransomware operators jack up their ransom demands by a factor of 2.8x if they detect a victim has cyber-insurance, a study highlighted by the Netherlands government has confirmed.
    • “For his PhD thesis [PDF], defended in January, Dutch cop Tom Meurs looked at 453 ransomware attacks between 2019 and 2021. He found one of the first actions intruders take is to search for documents with the keywords “insurance” and “policy.” If the crooks find evidence that the target has a relevant policy, the ransom more than doubles on average.
    • “In double-extortion attacks, where intruders threaten to publish data stolen from the victim unless the ransom is paid, those with insurance on average are quoted 5.5x more than those who don’t.” * * *
    • “According to the research, firms with a proper backup system were 27x less likely to pay criminals off, for the simple reason that they usually don’t need to. Even then, surprisingly, some do.
    • “In roughly 5 out of 100 cases in which a payment is made, victims do have the option to recover in a way other than paying, but they still choose to pay – for example to recover faster or to prevent reputational damage,” he said.
    • “In the remaining 95 cases, there is no other option to recover. In those cases, their entire IT infrastructure is broken and can no longer be repaired, making paying the ransom the only option to avoid bankruptcy.”

From the cybersecurity defenses front,

  • The American Hospital Association News tells us,
    • “The Cybersecurity and Infrastructure Security Agency April 17 released guidance to reduce risks associated with a reported breach of Oracle cloud services. CISA said the scope and impact of the breach is unconfirmed and that credentials may be exposed that could be reused across unaffiliated systems or embedded. The guidance lists recommendations for organizations and individual users to mitigate the risk of potential compromise. 
    • “This alert not only contains practical guidance to mitigate the potential breach related to Oracle but also provides valuable guidance and best practices for general cloud security,” said John Riggi, AHA national advisor for cybersecurity and risk. “Generally speaking, we continue to see that most of the cyber risk exposure that hospitals and health systems face originates from insecure third-party technologies, service providers and the supply chain. It is vitally important for mission-critical third parties to share timely threat intelligence and adversary tactics with the federal government and affected clients. This is necessary to prevent potential cyberattacks, which could compromise sensitive data and risk patient safety.” 
  • Dark Reading asks “Are We Prioritizing the Wrong Security Metrics? True security isn’t about meeting deadlines — it’s about mitigating risk in a way that aligns with business objectives while protecting against real-world threats.”
  • Cyberscoop considers whether “Ivanti is the problem or a symptom of a systemic issue with network devices? Exploited vulnerabilities have turned up in Ivanti products 16 times since 2024. That’s more than any other vendor in the network edge device space.”
  • Bleeping Computer suggests “7 Steps to Take After a Credential-Based cyberattack.”
    • “When credentials fall into the wrong hands and hackers breach your systems, every minute counts — but having a well-rehearsed incident response plan will allow you to minimize damage and recovery time.”
  • Here is a link to Dark Reading’s CISO corner.

Friday Report

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

From Washington, DC,

  • Federal News Network tells us,
    • “Agencies will not be able to fill or create any federal jobs for another three months, after President Donald Trump extended the current federal hiring freeze until July 15.
    • “But even after the hiring freeze lifts later this summer, agencies will still be limited in how many new employees they can hire, and how many new positions they can create. The White House said it will cap agencies to one new hire for every four federal employees who leave the civil service.”
    • Here’s a fact sheet on the hiring freeze extension.
  • Fierce Healthcare adds,
    • “President Donald Trump and the Office of Personnel Management (OPM) are moving forward with “Schedule F,” a policy to make it easier to remove workers from federal agencies like the Department of Health and Human Services (HHS), Fierce Healthcare has confirmed.
    • “Implementing Schedule F will deprive 50,000 federal employees of civil service protections by classifying them as “at-will” workers. Once a final rule is issued, another executive order will be released to directly move positions under the final rule’s authority.
    • “The OPM’s proposed rule will give authority to the government to cut workers over performance that does not align with the administration’s priorities without procedural delays.”
    • The proposed rule appeared in the Federal Register’s public inspection list today. The proposed rule will be published in the Federal Register on April 23, 2025.

In Food and Drug Administration news,

  • BioPharma Dive informs us,
    • “The Food and Drug Administration will aim to limit the participation of industry experts in the advisory committees that the agency consults for some regulatory decisions, Martin Makary, the FDA’s new commissioner, announced Thursday.
    • “Advisory committees, which the FDA typically convenes for additional input on high-profile reviews or thorny clinical and regulatory issues, regularly include an industry representative alongside a dozen or so independent experts.
    • “These representatives don’t vote on questions put to the committee. They are meant to share the perspective of their industry broadly, rather than of the specific company that employs them. There are also usually patient or consumer representatives on the panels.
    • “Now, when not explicitly required by statute, the FDA will restrict industry representatives from taking part as a committee member.”
  • Per Fierce Pharma,
    • “On its way to generating sales of $14 billion in just its seventh full year on the market, Sanofi and Regeneron’s Dupixent has experienced few setbacks. One came in 2023, however, when the FDA rejected the immunosuppressant as a treatment for chronic spontaneous urticaria (CSU), asking for more data.
    • “Eighteen months later—and backed by more conclusive results—the companies have convinced the U.S. regulator to sign off on Dupixent for the difficult-to-treat skin condition. With the nod, Dupixent becomes the first new medicine for CSU in more than a decade. 
    • “The approval clears Dupixent to be used by those age 12 and older who remain symptomatic despite using histamine-1 (H1) antihistamines. It’s a population of more than 300,000 among the roughly 3 million in the U.S. who have CSU, the companies said in a release.”
  • Per Medscape,
    • “The US Food and Drug Administration (FDA) has granted marketing authorization to CT-132 (Click Therapeutics), an adjunctive, first-in-class prescription digital therapeutic for the preventive treatment of episodic migraine in adults, its development company announced in a statement.
    • “The mobile smartphone app uses biological, psychologic, and behavioral approaches to target pain processing and includes such tools as an eDiary tracker and short daily lessons. It is intended for use alongside other acute and preventive treatments for migraine. 
    • “The marketing authorization, which was reviewed through the FDA’s de novo pathway for medical devices, is based on results from two recent clinical trials: the phase 3 ReMMi-D trial and the ReMMiD-C bridging study. As reported by Medscape Medical News, the findings were presented at the recent American Academy of Neurology (AAN) 2025 Annual Meeting.”

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 continues to decline nationally. Wastewater levels are at low levels, emergency department visits are at very low levels, and laboratory percent positivity is stable.
      • “Additional information about current COVID-19 activity can be found at: CDC COVID Data Tracker: Home
    • “Influenza
    • RSV
      • “RSV activity continues to decline in most areas of the country.
    • Vaccination
      • “Vaccination coverage with influenza and COVID-19 vaccines is low among U.S. adults and children. Vaccination coverage with RSV vaccines remains low among U.S. adults.”
  • The University of Minnesota CIDRAP adds,
    • “The CDC confirmed 10 new pediatric flu deaths, bringing the season’s total to 198. This compares with 207 deaths last flu season. Nine of the new deaths were from influenza A and 1 from influenza B. Of the 8 influenza A cases for which scientists performed subtyping, 5 were caused by the H1N1 strain, and 3 were H3N2.”
  • The American Hospital Association (AHA) News tells us,
    • “The Centers for Disease Control and Prevention April 18 announced there have been 800 reported cases of measles across the country this year. Twenty-four states have reported cases and there have been 10 outbreaks. Most cases (94%) have been outbreak-associated. 
    • “Texas, which has the largest outbreak of any state, April reported a total of 597 cases. Michigan also reported an outbreak yesterday — the state’s first since 2019 — with three cases. CDC data shows that 11% of all cases have been hospitalized. The vaccination status of 96% of all cases is classified as “unvaccinated or unknown.”
  • The New York Times adds,
    • “As the United States struggles to contain a resurgence of measles that has swept through swaths of the Southwest, neighboring countries are responding to their own outbreaks.
    • “Canada has reported more than 730 cases this year, making this one of the worst measles outbreaks in the country since it declared the virus “eliminated” in 1998. Mexico has seen at least 360 measles cases and one death, most of them in the northern state of Chihuahua, according to Mexican health authorities.
    • “Many of the communities grappling with measles have large Mennonite populations that public health officials have linked to outbreaks. The multinational resurgence has concerned epidemiologists, who fear that simultaneous outbreaks near the U.S. border will make it more difficult to contain the virus.
    • “It’s just a line on the map that separates them — we share air, we share space,” said Lisa Lee, an epidemiologist at Virginia Tech.”
  • Medscape lets us know,
    • “Five classic risk factors for cardiovascular disease — high blood pressure, high cholesterol, obesity, diabetes, and smoking — at age 50 can reduce life expectancy by more than 10 years. This is the conclusion of an international study led by German researchers and presented at the 2025 American College of Cardiology Scientific Session.
    • “These five factors account for approximately 50% of the global burden of cardiovascular diseases. Our central question was how many additional years of life are possible if these factors are absent or modified in middle age,” said Christina Magnussen, MD, PhD, deputy director of the Department of Cardiology at the University Medical Center Hamburg-Eppendorf, Hamburg, Germany, during her presentation in Chicago.
    • “The findings, also published in The New England Journal of Medicine, show that lifestyle changes and risk management in middle age can make a significant difference. Lowering blood pressure and quitting smoking had the most significant impacts.”
  • Diagnostic Imaging points out,
    • “Emerging research suggests that prior mammography screening within five years of breast cancer diagnosis for seniors significantly reduces the risks of later-stage diagnosis and breast cancer-specific mortality.
    • “For the study, recently published in JAMA Network Open, researchers reviewed data from the Surveillance, Epidemiology, and End Results (SEER)-Medicare database for 13,028 women who had screening mammography-detected breast cancer. Over 77 percent of the cohort had at least one mammography screening in a five-year period prior to diagnosis and over 69 percent were in their 70s, according to the study. The researchers also noted that over 29 percent were diagnosed with later-stage (T2+ or N1+) disease.
    • “Multivariable analysis revealed that women having at least one mammography screening in the five years prior to diagnosis had a 54 percent lower risk of a later-stage presentation at diagnosis. The study authors found that these women also had a 36 percent lower risk of breast cancer-specific death.”
  • Per HealthDay,
    • “People might think they can reduce their risk of cancer by occasionally swapping their cigarettes for a vape pen — but they would be wrong, a new study says.
    • “So-called “dual users” — folks who both smoke and vape – are exposed to the same levels of nicotine and cancer-causing toxins as those who only smoke cigarettes, researchers reported in the journal Nicotine and Tobacco Research.”
  • Per the AHA News,
    • “A study published April 17 by JAMA Otolaryngology Head and Neck Surgery found that up to 32% of dementia cases from 2011-2019 could be attributed to hearing loss confirmed through testing. Self-reported hearing loss was not associated with higher dementia risk.”

From the U.S. healthcare business front,

  • CBS News reports,
    • “Blue Cross Blue Shield of Massachusetts says it will soon stop covering popular drugs for weight loss, like Ozempic and Wegovy.
    • “The medications have skyrocketed in price and popularity, but they’re now being blamed for crippling budgets in the public and private sector. As one of the fastest growing classes of medications, GLP-1 weight-loss drugs were originally brought on the market to treat diabetes. But their secondary use as a way for users to suppress diets and slim down sent sales through the roof. 
    • “Blue Cross announced Thursday that starting on January 1, 2026, standard coverage plans will not cover GLP-1s for weight loss. The company will continue to cover patients who are using the drugs for diabetes treatment. 
    • “Studies suggest nearly 1 in 8 people have used GLP-1s as the drugs become more common. That’s given drug companies the reason to increase prices.” 
  • FEHB premiums continue to reverberate from OPM’s sudden decision in January 2023 to require all FEHB plans to cover GLP-1 drugs for obesity. Traditionally, OPM announces a mandate in the call letter for benefit proposals and allows the carrier to raise its premiums in advance of the mandate. OPM should stick with tradition and in any event curb its mandate habit. The FEHBlog wonders whether Lilly’s GLP-1 pill will reduce overall costs on obesity drugs.
  • Modern Healthcare relates,
    • Hospitals are zeroing in on alternative care models to improve the nursing work experience and patient outcomes while lowering costs.
    • Eight in 10 nurse leaders are piloting new care models in their organizations, ranging from virtual nursing to home health, according to a recent study by healthcare solutions company Wolters Kluwer.
  • Per an ICER news release,
    • “This week, ICER released a Draft Evidence Report assessing the comparative clinical effectiveness and value of tolebrutinib (Sanofi) for the treatment of secondary progressive multiple sclerosis (SPMS).
    • “This preliminary draft marks the midpoint of ICER’s eight-month process of assessing this treatment, and the findings within this document should not be interpreted to be ICER’s final conclusions. The report will be open to public comment until May 13th. Click here for information on submitting a public comment.“
  • Per Beckers Hospital Review,
    • “Several large health systems reported operating losses in 2024, underscoring ongoing financial strain despite rising patient volumes and revenue growth. While inpatient revenue is climbing, expense pressures, cybersecurity disruptions and shifting care dynamics continue to weigh on margins — leaving even some of the nation’s largest systems in the red.
    • “In February, average hospital operating margins fell to 2.5%, down from 3.4% in January, according to Kaufman Hall’s latest “National Hospital Flash Report.” Despite the dip, margins remained above 2024’s year-to-date average, suggesting that while performance has improved compared to recent years, financial stability remains fragile.
    • “In the early months of 2025, volumes remain strong across the board,” Erik Swanson, managing director and data and analytics group leader at Kaufman Hall, said in an April 8 report.  “Emergency visits are rising, which is leading to challenges with ED boarding for many organizations. Data also show that inpatient revenue is growing while outpatient revenue has slowed, which points to the rapid growth in outpatient care in the last few years reaching its peak.”
    • The article describes the results for 11 health systems.

Thursday Report

David Ermer–Electronic health records, FDA, Government Contracting, NCQA, Obesity, Rx coverage, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC

  • Yesterday, the President signed an executive order titled “Ensuring Commercial, Cost-Effective Solutions in Federal Contracts.” Here are links to a fact sheet and a Govexec commentary titled “The President’s procurement order offers a real opportunity. Let’s not squander it.” Amen to that sentiment.
  • STAT News notes regarding the President’s April 15 executive order on lowering drug costs,
    • There also is no specific mention of the rebate rule from Trump’s first term that attempted to eliminate the safe harbor for rebates in anti-kickback law for Medicare Part D and Medicare Advantage. The goal was to force insurers to pass rebates to patients directly, instead of using them to lower premiums or provide other benefits. However, the order calls for re-evaluating the role of drug middlemen known as pharmacy benefits managers.
    • [Former Sen. Wyden stafer Anna] Kaltenboech said there is less need to eliminate rebates when Medicare negotiation lowers the list price from which rebates are negotiated. 
  • Healthcare Dive relates,
    • “Surescripts’ data exchange has been designated a Qualified Health Information Network under the federal government’s health information sharing framework, the e-prescribing giant said Tuesday. 
    • “As a QHIN, Surescripts will be able to transfer health data through the Trusted Exchange Framework and Common Agreement, or TEFCA, a framework created by the HHS’ Assistant Secretary for Technology Policy to facilitate the exchange of health records among providers, patients, payers and public health agencies. 
    • “Surescripts’ addition brings the total number of QHINs to nine, according to the Sequoia Project, the recognized coordinating entity that oversees TEFCA.”
  • NCQA released its policy recommendations to the Trump Administration on April 15, 2025.
    • The fragmented U.S. health care system makes it challenging for people to navigate treatment and receive high-quality care. Advancements in quality measurement, care integration and interoperability are essential for creating a more efficient and accountable health care system.
    • NCQA developed recommendations for the Trump administration in three core areas.
      • Implementation of value-based care models that prioritize care integration.
      • A strong digital health infrastructure that facilitates seamless data exchange, promotes adoption of digital quality measures and maximizes the full potential of interoperable health care data.
      • Integration of behavioral and physical care and removal of barriers to behavioral health and substance-use disorder treatment.

From the public health and medical research front,

  • The Wall Street Journal reports,
    • The first GLP-1 weight-loss pill is a step closer to hitting the market.
    • Eli Lilly said its experimental pill met its goals in a pivotal study, helping diabetes patients lower blood sugar—and even reduce weight, bringing an oral version of the booming class of drugs closer to patients seeking to lose weight.
    • Physicians and patients have been hoping for pill versions of popular GLP-1s for weight loss. Approved versions are all given by injection, and a pill would be a more convenient option. 
    • “It really gives us an opportunity to reach many more patients than you can reach with an injectable,” said Jeffrey Emmick, senior vice president of product development at Lilly Cardiometabolic Health. * * *
    • “Thursday’s results are the first from several studies of the daily pill, called orforglipron, expected this year from Lilly in patients with Type 2 diabetes and obesity.” * * * 
    • “The orforglipron results showed the drug worked safely in adults with Type 2 diabetes compared with subjects who received a placebo after 40 weeks, according to Lilly. Orforglipron showed promising safety and efficacy results consistent with current injectable GLP-1 drugs on the market, Lilly said. 
    • “The study measured weight loss as a secondary goal. The drug reduced weight by an average of 16 pounds, or 7.9%, at the highest dose, without reaching a weight plateau at the time the study ended, Lilly said. The most common side effects were gastrointestinal-related and were generally mild to moderate in severity, Lilly said. 
    • “Late-stage study results evaluating orforglipron in obese patients are expected later this year. 
    • “Lilly expects to submit the drug for approval from global regulatory agencies for weight loss by the end of this year, and for Type 2 diabetes treatment next year.”
  • The American Journal of Managed Care tells us,
    • “Healthy dietary patterns reduce GI cancer risk and mortality, while unhealthy patterns increase risk, particularly for colorectal and liver cancers.
    • “PCA-derived dietary patterns show stronger associations with GI cancer risk than RRR-derived patterns, despite some methodological limitations.
    • “High intake of fruits, vegetables, whole grains, and legumes may improve survival post-GI cancer diagnosis due to their protective properties.
    • “Further research is needed on specific cancer biomarkers and dietary changes post-diagnosis to better understand diet’s role in cancer prevention.”
  • Per Health Day,
    • “Long brisk walks might lower a person’s risk for heart rhythm problems, a new study says.
    • “Folks who stride faster than 4 miles per hour have a 43% lower risk of developing an abnormal heart rhythm, compared with those who amble at a pace of less than 3 miles an hour, researchers reported April 15 in the journal Heart.
    • “The time spent walking also influenced risk, with people who spent more time at an average or brisk pace enjoying a 27% lower risk of heart rhythm problems, researchers said.”
  • and
    • “An experimental blood test might be able to help doctors predict whether someone will recover their mobility following a spinal cord injury.
    • “The test looks for fragments of spinal cord DNA floating freely in a person’s blood, researchers recently reported in the Journal of Clinical Investigation.
    • “Higher levels of this DNA is associated with more severe spinal cord injuries that cause paralysis, researchers found.
    • “If you have a spinal cord injury, your main question is simple: Am I going to walk again?” lead researcher Dr. Tej Azad, neurosurgery chief resident at Johns Hopkins University School of Medicine, said in a news release.
    • “With the new blood test, we are trying to bring a precision medicine framework to spinal cord injury with something that tells you about injury severity and can hopefully predict neurological recovery,” he continued.”
  • The Wall Street Journal offers an essay on eating disorder which is worth a gander.

From the U.S. healthcare business front,

  • Healthcare Dive informs us,
    • “UnitedHealth underperformed earnings and revenue expectations in the first quarter and lowered its earnings guidance for the full year, two signs of waning performance that analysts said were uncharacteristic of the healthcare behemoth.
    • “The company’s first quarter problems were centered in two segments: its insurance division UnitedHealthcare, which has struggled to control heightened costs in Medicare Advantage and saw utilization spike even higher in the quarter; and its care delivery unit Optum Health, which saw patient profitability fall and was hit hard by policy changes enacted by the Biden administration.
    • “UnitedHealth executives said both trends were addressable over the course of the year. Still, the Minnetonka, Minnesota-based healthcare giant slashed its 2025 outlook for adjusted earnings per share to between $26 and $26.50, almost 12% below the company’s original guide.”
  • Modern Healthcare adds,
    • “Elevance Health will beat its earnings guidance for the first quarter despite high Medicare Advantage costs, the company announced Thursday.
    • “The health insurer reported that while Medicare Advantage spending was elevated during the period, it fell within the range the company anticipated. Elevance Health affirmed its guidance in a filing to the Securities and Exchange Commission after leading Medicare Advantage carrier UnitedHealth Group disclosed it underperformed in the first quarter, triggering a sell-off of health insurance stocks.”
  • Healthcare Dive notes,
    • “Cone Health has purchased the remaining ownership of HealthTeam Advantage from Novant Health, leaving Cone the sole owner of the Medicare Advantage payer.
    • “HealthTeam Advantage has 22,000 members across six MA plans in North Carolina. The ownership change shouldn’t affect their coverage or provider networks, Brendan Hodges, HealthTeam Advantage’s CEO, said in a statement.
    • “Financial terms of the deal were not disclosed.”
  • Fierce Healthcare lets us know,
    • “The tortoise (Eli Lilly) has caught the hare (Novo Nordisk), according to a report from BMO Capital Markets, which cites the superior commercial and clinical portfolios of the Indianapolis company compared to those of its Danish rival.
    • “In pronouncing the change of the guard, BMO has downgraded Novo’s shares from “outperform” to “market perform.” Translation: The analysts are advising investors to hold Novo shares rather than buying more of them.
    • “The report comes as Lilly and Novo remain the two fastest-growing large pharmaceutical companies, based largely on booming sales of their diabetes and obesity products. With their surges over the last few years, Lilly and Novo have become the drugmakers with the largest market caps in the U.S. and Europe, respectively, with Lilly’s value nearly twice that of second-place Johnson & Johnson.”
  • and
    • “Twenty-six rural hospitals have banded together to form the Ohio High Value Network (OHVN), a clinically integrated network that will serve more than 2.5 million patients.
    • “The network announced Thursday morning is an effort to coordinate care, share operational best practices, reduce contracting costs and lighten member hospitals’ administrative burdens.
    • “The member hospitals are spread across 37 of Ohio’s counties, with an additional hospital in bordering West Virginia. The group said in a release it “is in discussions” with other rural Ohio hospitals that are interested in joining.” 
  • KFF shares “10 Things to Know About Rural Hospitals.”

Midweek Report

David Ermer–CDC, CMS, Medical / Rx research, Medicare, Mental health care, Rx coverage, U.S. Healthcare–
Photo by Thought Catalog on Unsplash

From Atlanta, Georgia

  • MedPage Today brings us news from the April 15-16 ACIP meeting,
    • “Last June, CDC’s Advisory Committee on Immunization Practices (ACIP) unanimously recommended that all adults ages ≥75 years and adults ages 60 to 74 years who are at increased risk of severe RSV disease receive a single dose of RSV vaccine; the committee did not endorse one vaccine over another. That vote supplanted the committee’s earlier recommendation that adults ages 60 and older may receive RSV vaccination “after engaging in shared clinical decision making with their healthcare provider.”
    • Today, “[t]he ACIP voted 14-0, with one abstention, on Wednesday to recommend that high-risk patients ages 50 to 59 be vaccinated for respiratory syncytial virus (RSV) and also added a new option for meningococcal vaccination.
    • “I don’t think I can say it enough, but [we need] more studies in moderate-to-severe immunocompromised patients who are at highest risk for RSV disease,” ACIP member Mini Kamboj, MD, of Weill Cornell Medical College, in New York City, said after she voted for the recommendation. This is “a call to action,” she said.”
  • and
    • “The CDC’s vaccine advisors [also] are considering options that would narrow the recommendations for the fall COVID vaccine to only include groups at higher risk for severe illness.
    • Seasonal COVID shots are currently recommended for everyone 6 months and older, but CDC’s Lakshmi Panagiotakopoulos, MD, MPH, presented findings from a recent poll of the ACIP COVID-19 Work Group showing that 76% of its members supported a non-universal (risk-based) recommendation for the 2025-2026 respiratory virus season.
  • and
    • At its meeting on Tuesday, the [ACIP] considered whether the U.S. should move to single-dose human papillomavirus (HPV) vaccination instead of the currently recommended schedule.
    • At present, the U.S. recommends two doses of HPV vaccine if they are started before age 15, and three doses if they are started at age 15 or older, and for people who are immunocompromised. Routine vaccination starts at age 11 or 12 — though it can be started at age 9 — while catch-up vaccination is recommended through age 26. Shared clinical decision making is advised for those 27 to 45.
    • “However, global HPV vaccination schedules have shifted in recent years, with the World Health Organization recommending in 2022 a two-dose schedule for those 9 and older, with an option for a one-dose schedule for those between 9 and 20. The U.K. and Australia have adopted this schedule, too.”
  • and
    • “The number of cases reported in the ongoing measles outbreak in the southwestern U.S. is likely an undercount, according to the CDC scientist leading the response to the outbreak.
    • “We do believe there’s quite a large amount of cases that are not reported,” David Sugerman, MD, CDC’s senior scientist for the 2025 measles response, said during the Advisory Committee on Immunization Practices meeting on Tuesday.”

From the judicial front,

  • Federal News Network tells us,
    • “A federal judge on Tuesday issued a preliminary injunction that prevents the U.S. Department of Labor from requiring government contractors and grant recipients to certify they do not operate any diversity, equity and inclusion programs that run afoul of anti-discrimination laws until further order from the court.
    • “Judge Matthew Kennelly of the U.S. District Court for the Northern District of Illinois issued the ruling in response to a lawsuit filed by Chicago Women in Trades, a nonprofit dedicated to training and retaining women in skilled construction trades that receives several grants from the Department of Labor.
    • “The certification provision is a key part of President Donald Trump’s executive orders aimed at curbing DEI programs because contractors and grant recipients could be subjected to crippling financial penalties under the False Claims Act if they are found in violation of it.” * * *
    • “Kennelly had already issued a temporary restraining order against the Labor Department last month that was shorter in duration. His order is limited in scope because he declined to extend the injunction to other federal agencies beyond DOL.”
  • The American Hospital News informs us,
    • “A Minnesota state court April 15 dismissed a lawsuit filed by PhRMA challenging the state’s law protecting 340B pricing for contract pharmacy arrangements. The court ruled that the state law is not preempted by federal law, does not engage in unconstitutional extraterritorial regulation and that the law does not violate Minnesota’s Single Subject and Title Clause.
    • “The AHA filed an amicus brief in the case last year and filed others in similar cases for multiple states, in defense of those states’ 340B contract pharmacy laws.”
  • Beckers Payer Issues reports,
    • “CMS has denied an appeal from Humana to raise its 2025-star ratings, the company disclosed in an April 15 court filing. 
    • “Humana saw its Medicare Advantage star ratings drop significantly from 2024 to 2025, which will hurt the company’s 2026 revenues. Star ratings determine the bonuses CMS pays to MA plans. 
    • “Humana filed its lawsuit in October 2024 challenging the ratings in federal district court in Texas.”
  • In September 2019, WHYY, a Philadelphia PBS news outlet, reported
    • “Seventeen local defendants, including five medical professionals, are among those ensnared in a coordinated health care fraud enforcement action across Pennsylvania, New Jersey, New York, Connecticut and Washington, D.C., involving more than $800 million in loss and the distribution of over 3.25 million opioid pills in so-called pill mill clinics, the U.S. Justice Department said Thursday.”
    • A Justice Department press release states that on April 15, 2025, “a federal jury convicted a medical doctor [who was one of the medical professionals ensnared in September 2019], for his participation in conspiracies to commit health care fraud and wire fraud and to unlawfully distribute controlled substances.” Those crimes impacted FEHB plans, among other health plans.
  • Govexec points out,
    • As federal employees continue to face widespread layoffs, unions and advocacy groups on Wednesday launched a network to provide legal advice to government workers. 
    • The goal of the Rise Up: Federal Workers Legal Defense Network is to recruit attorneys to provide individual guidance to federal employees who fear losing their jobs or have already lost them. 
    • “Our network is already fighting back against illegal firings and other abuse of federal workers, but thousands of federal workers still need legal advice and representation,” according to the coalition’s website. “That means we need thousands of lawyers to help.” * * *
    • Federal employees can request legal assistance here.

In State government news,

  • STAT News reports,
    • “Arkansas Gov. Sarah Sanders has signed a first-in-the-nation law (HB 1150) that prohibits pharmacy benefit managers from operating both retail and mail-order pharmacies, a move designed to eliminate a conflict of interest that has been blamed for boosting the price of medicines and forcing independent pharmacies to close.
    • “At issue is an ongoing concern that the largest pharmacy benefit managers — which are controlled by CVS Health, Cigna, and UnitedHealth Group — favor their own pharmacy operations. Critics say that by doing so, these companies not only dominate the design of health plans for tens of millions of Americans but also distort the distribution and pricing for prescription medicines.” * * *
    • “The Arkansas bill has gone further than other states. The legislation would force the owners of the pharmacy benefit managers to make a choice — continue operating these industry middlemen or relinquish the right to run retail or mail-order pharmacies that operate in the state. By doing so, state lawmakers have argued they will reduce costs for state residents.”
  • KARK, a Little Rock television station, adds,
    • “CVS Health welcomes a good faith discussion with policy makers in Arkansas and across the country on ways to make medicine more affordable and accessible,” CVS shared in a statement. “Unfortunately, HB1150 is bad policy that accomplishes just the opposite: it will take away access to pharmacy care in local communities, hike prescription drug spending across the state by millions of dollars each year, and cost hundreds of Arkansans their jobs.”
    • “According to CVS, they have 23 pharmacies across the state. They also noted that this law will close more than 100 mail-order pharmacies in Arkansas.”

From the public health and medical research front,

  • Per BioPharma Dive, “New research kindles excitement around stem cell therapies for Parkinson’s Disease. Two studies published in Nature found stem cell-derived products can not only be safely transplanted into the brain but also show promising — albeit unproven — signs of efficacy.”
  • The National Academy of Sciences announced,
    • Oral health is an essential part of overall health, but issues around insurance coverage, workforce, and more, are leaving millions of Americans without sufficient oral health care. The @NASEM Health and Medicine Division hosted a workshop in November 2024 to address some of the barriers to care. Read a recap of the event here: https://tinyurl.com/5epd9rcs
  • Per MedCity News,
    • “Drugs have been the standard migraine treatment for decades. The severe headaches, nausea, and other problems associated with this common disorder now have a digital treatment option, a mobile app developed by prescription digital medicines startup Click Therapeutics.
    • “The FDA marketing authorization announced Tuesday permits use of the Click digital therapeutic for the prevention of episodic migraine in patients age 18 and older. Episodic migraine is defined as having fewer than 15 headache days per month. The Click migraine app, known in development as CT-132, does not replace migraine drugs. The FDA authorization covers use of the app as an adjunct to standard migraine treatments, which is how it was evaluated in clinical trials.
    • “Click’s research is based on mapping of the entire brain. The company has found faulty brain circuits implicated in many diseases, Chief Medical Officer Shaheen Lakan said in a 2023 interview. For various indications, the New York-based startup develops software that takes users through a series of tasks that have the effect of retraining and rewiring the brain over the course of weeks.”
  • Per Cancer Network
    • The incidence of pancreatic and colorectal adenocarcinoma has increased among young adults, highlighting a need for heightened awareness of this trend when evaluating younger patients with possible symptoms, according to findings from a retrospective cohort study published in JAMA Network Open.1
    • Findings from the trial revealed that a total of 275,273 patients with pancreatic adenocarcinoma were reported between 2000 and 2021, 51.8% of whom were male and 87.1% of whom were 55 years or older. An overall increasing incidence trend was noted, with the highest annual percentage change (APC) observed in those aged 15 to 34 years (4.35%; 95% CI, 2.03%-6.73%). The APC for the aforementioned age group was significantly higher than in those 55 years or older (1.74%; 95% CI, 1.59%-1.89%; P = .007) and those aged 35 to 54 years (1.54%; 95% CI, 1.18%-1.90%; P = .004).
  • Medscape lets us know,
    • “Can long-term physical activity influence mortality and biological aging? Researchers at the University of Jyväskylä in Jyväskylä, Finland, set out to answer this question and uncovered a surprising finding: Moderate physical activity had the most significant positive effect on longevity, reducing mortality by 7% over a 30-year period.
    • “Interestingly, higher levels of physical activity did not confer additional mortality benefits. The study was published in the European Journal of Epidemiology.”

From the U.S. healthcare business front,

  • Beckers Payer Issues tells us why “patient expectations will push healthcare to evolve by 2030, according to 21 payer executives.” 
  • Fierce Healthcare informs us,
    • “The Peterson Center on Healthcare released a new report that recommends policymakers narrow payment guidelines for a service they think could rocket spending in the public sector. 
    • “The costs of remote monitoring on Medicare have grown significantly in the years since the codes became available to providers, from $6.8 million in 2019 to $194.5 million in 2023. The services can be used for a host of chronic conditions that many Americans suffer from, including diabetes, hypertension and heart disease. 
    • “The Peterson Center takes issue with the increasing number of Medicare, Medicaid and Medicare Advantage patients who have been prescribed remote monitoring and the increasing amount of time their providers keep them using the technology. 
    • The report finds that chronic conditions only benefit from intense monitoring by providers for a short period of time, which varies by condition. Without additional guardrails, the report says public spending on remote monitoring could increase dramatically.
    • Under the current requirements for remote monitoring, CMS does not dictate which conditions should be monitored or for how long. Because CMS currently does not limit the amount of time that a provider can charge Medicare, Peterson calls them “forever codes.” 
    • The codes have only been in existence since 2019, but Peterson recommends policymakers steer providers towards high-value services and away from ongoing monitoring with no discernible clinical benefit.
  • Healthcare Dive notes,
    • “Ascension Health has inked a definitive agreement to acquire full ownership of a Texas hospital and its ancillary businesses from Community Health Systems for $460 million, the health system said Tuesday.
    • “Ascension Seton, a subsidiary of Ascension Texas, will purchase the remaining 80% stake in 126-bed Cedar Park Regional Medical Center. Although the system already owned a minority interest in Cedar Park, Ascension said acquiring full ownership would represent a “significant step” toward expanding medical services and care access in the Central Texas community.
    • “The deal is expected to close this summer, subject to regulatory approvals.
  • Per Modern Healthcare,
    • “The Permanente Medical Group and Northwest Permanente said Wednesday they have formed an affiliation.
    • “The medical groups will remain separate but will collaborate clinically and share innovations as part of the agreement. The groups will work together on telehealth, population health and workforce wellness, in addition to pursuing more subspecialty partnerships and scaling IT initiatives, a spokesperson said.” * * *
    • “The Permanente Medical Group and Northwest Permanente are independent, physician-led groups that partner with the Kaiser Foundation Health Plan to serve patients in Oregon, Washington and California. The Permanente Medical Group has nearly 10,000 physicians across 116 specialties, while Northwest Permanente has more than 1,300 physicians across 54 specialties. The groups collectively care for 5.2 million members.”
  • and
    • “Abbott Laboratories will make new investments in U.S. manufacturing, with the impact of tariffs on medical devices and diagnostics looming over the industry.
    • “It expects to spend $500 million on two facilities, located in Illinois and Texas, Abbott said in a statement Wednesday. The investments are to expand existing plants and boost U.S. research and development, a spokesperson said. The company will hire as many as 200 people in Illinois and as many as 100 people in Texas to support the work.”
  • Beckers Clinical Leadership relates,
    • “Mark Cuban’s latest move to disrupt the pharmaceutical supply chain is expanding — this time, tackling the injectable drug market through a new partnership with distributor Morris & Dickson.
    • “His company, Mark Cuban Cost Plus Drug Co., is partnering with Morris & Dickson, a full-line and specialty pharmaceutical distributor, to improve access to injectables nationwide. 
    • “The collaboration, announced April 14, aims to mitigate drug shortages, streamline procurement and provide equitable access to providers of all sizes. It also promotes sourcing flexibility by removing volume commitments, according to a news release.”

Tuesday Report

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

From Washington, DC,

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

From the judicial front,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

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.