Tuesday 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.

Tuesday Report

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

From Washington, DC

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

From the judicial front,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Monday Report

David Ermer–Uncategorized–
Photo by Sven Read on Unsplash

From Washington DC,

  • Roll Call discusses events occurring on Capitol Hill this week.
  • STAT News reports,
    • “Marty Makary, President Trump’s pick to be Food and Drug Administration commissioner, promised to step down as an adviser to various health tech, medical device, and telehealth startups if confirmed, and to sell off stock holdings in the companies as well, according to financial disclosures filed ahead of his confirmation hearing. 
    • “According to the disclosures, Makary does not hold stock in any large pharmaceutical companies, unlike some previous FDA commissioners, including the last individual to hold that office, Robert Califf. Makary’s financial ties include holdings in a telehealth company that sells compounded drugs, a clinical stage company developing drugs for tissue injury, and a medical device company focused on cataract surgery.” 
  • Govexec lets us know,
    • “Some federal agencies are continuing to fire their recently hired or newly promoted staff despite a court ruling that deemed the justification for those firings unlawful, while others are responding to that decision by rehiring those they had already terminated. 
    • “A federal judge last week said the Trump administration—through the Office of Personnel Managment—directing the mass firings of employees on their probationary periods was illegal, though the judge did not directly call for the terminations to cease or for agencies to recall those they had already let go. The ruling applied to only a handful of agencies whose employees were party to the case brought by the American Federation of Government Employees and other groups.”
  • Here’s a Dropbox link to the Court decision issued last Friday.  
  • Per a press release,
    • The Institute for Clinical and Economic Review (ICER) today posted a Special Report evaluating the evidence of two Chronic Obstructive Pulmonary Disease (COPD) treatments, Trelegy Ellipta® and Breo Ellipta®, that will be sent as its public comment submission to Centers for Medicare & Medicaid Services (CMS) as part of its work on Medicare drug price negotiations. Both of the inhaler therapies were developed by GSK.
    • Downloads: Final Report 
    • “Over 15 million people in the United States suffer from COPD. Our special report focuses on the medical evidence and value of these two inhalers, specifically for COPD,” said ICER’s President and CEO Sarah K. Emond, MPP. “We recognize that our report will be one of many inputs CMS may consider, and we hope that it will help them as they continue to build a reliable, value-based, transparent drug price negotiation process on behalf of the American people.”
  • Per Fierce Pharma,
    • “Over nearly the last three decades, Genentech has had the lone medicine on the market for the acute treatment of stroke. Monday, the Roche subsidiary added a second stroke treatment to its repertoire, gaining an FDA endorsement for TNKase (tenecteplase).
    • “The tissue plasminogen activator, clot-dissolving, thrombolytic medicine has been approved for adults with acute ischemic stroke (AIS). TNKase can be shot into the arm in five seconds, making it a faster treatment option compared to its forerunner, Activase (alteplase), which was approved for heart attack in 1987 and for stroke in 1996. Activase is administered as an IV bolus followed by a 60-minute infusion.
    • “TNKase is not a new treatment. It was approved in 2000 to reduce the risk of death from heart attack—acute ST elevation myocardial infarction—which is what happens when a coronary artery is completely blocked.
    • “Today’s approval is a significant step forward and underscores our commitment to advancing stroke treatment options for patients,” Levi Garraway, M.D., Ph.D., Genentech’s chief medical officer and head of global product development, said in a statement. “TNKase provides a faster and simpler administration, which can be critical for anyone who is dealing with an acute stroke.”

From the public health and medical research front,

  • The American Medical Association lets us know what doctors wish their patients knew about atrial fibrillation.
  • The Wall Street Journal reports,
    • “Emulsifiers, used to improve food texture, have been linked to health risks such as heart disease, Type 2 diabetes, and some cancers.
    • “Research suggests that emulsifiers alter the gut microbiome, leading to inflammation and potentially contributing to chronic diseases.
    • “Consumers can reduce the potential health risks of emulsifiers by avoiding ultra-processed foods and opting for certain natural emulsifiers like soy lecithin over synthetic ones like carboxymethylcellulose.”
  • Per an NIH news release,
    • “A clinical trial has found that the medication omalizumab, marketed as Xolair, treated multi-food allergy more effectively than oral immunotherapy (OIT) in people with allergic reactions to very small amounts of common food allergens. OIT, the most common approach to treating food allergy in the United States, involves eating gradually increasing doses of a food allergen to reduce the allergic response to it. Thirty-six percent of study participants who received an extended course of omalizumab could tolerate 2 grams or more of peanut protein, or about eight peanuts, and two other food allergens by the end of the treatment period, but only 19% of participants who received multi-food OIT could do so. Researchers attributed this difference primarily to the high rate of allergic reactions and other intolerable side effects among the participants who received OIT, leading a quarter of them to discontinue treatment. When the participants who discontinued therapy were excluded from the analysis, however, the same proportion of each group could tolerate at least 2 grams of all three food allergens.
    • ‘The findings were published in an online supplement to The Journal of Allergy and Clinical Immunology and presented at the 2025 American Academy of Allergy, Asthma & Immunology/World Allergy Organization Joint Congress in San Diego on Sunday, March 2, 2025.
    • “People with highly sensitive multi-food allergy previously had only one treatment option—oral immunotherapy—for reducing their allergic response to moderate amounts of those foods,” said Jeanne Marrazzo, M.D., M.P.H., director of NIH’s National Institute of Allergy and Infectious Diseases (NIAID), the study’s funder and regulatory sponsor. “This study shows that omalizumab is a good alternative because most people tolerate it very well. Oral immunotherapy remains an effective option if treatment-related adverse effects are not an issue.”
  • Per Health Day,
    • “Many young women entering menopause suffer needlessly from symptoms related to the transition, a new study suggests.
    • “More than half of women aged 30 to 35 have already developed moderate to severe symptoms of impending menopause, researchers found.
    • “These include mood swings, delayed or absent periods, hot flashes, vaginal dryness, painful sex, heart palpitations and frequent urination.
    • “Unfortunately, most wait decades before seeking treatment, under the mistaken belief that menopause symptoms that shouldn’t appear until their 50s, researchers said.”
  • NFP adds,
    • “Mayo Clinic research reveals that menopause-related symptoms cost an estimated $1.8 billion in lost work time annually in the US, with total costs reaching $26.6 billion when medical expenses are included.
    • “Understanding how menopause affects women in the workplace has become crucial, as the study found that 13% of women experienced adverse work outcomes related to menopause symptoms, with 11% missing workdays specifically due to these symptoms. 
    • “Despite affecting approximately 17.5% of the US workforce, menopause in the workplace remains one of the most overlooked aspects of workplace health policy. With substantial financial implications, this oversight of menopause employee benefits is no longer sustainable in today’s competitive talent market.”
  • Per Fierce Pharma,
    • “AstraZeneca and Daiichi Sankyo’s Enhertu has become the first HER2-directed drug to mount a patient survival benefit in a randomized clinical trial in second-line metastatic stomach cancer, the partners said on Monday.
    • “Enhertu significantly extended the lives of patients with previously treated HER2-positive unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma in the phase 3 Destiny-Gastric04 study, according to the partners’ press release. For the study, investigators pitted the HER2-targeted antibody-drug conjugate against Eli Lilly’s VEGFR inhibitor Cyramza and chemotherapy.
    • “An independent data monitoring committee noted the “statistically significant and clinically meaningful” overall survival improvement during a planned interim analysis and recommended unblinding the trial, the companies said Monday. 
    • ‘The latest trial win won’t affect Enhertu’s regulatory status in the U.S. Back in 2021, the FDA approved Enhertu in stomach cancer following prior treatment with a trastuzumab (Herceptin)-based regimen. That second-line nod was based on results from the phase 2 Destiny-Gastric01 trial in a third-line setting, which showed that Enhertu reduced the risk of death by 41% versus chemotherapy alone.”
  • and
    • “Already billed as a potential blockbuster, Amgen and AstraZeneca’s Tezspire has turned in strong clinical data in chronic rhinosinusitis with nasal polyps (CRSwNP). 
    • “Tezspire showed numerically better efficacy results in CRSwNP compared with two prominent rivals in the three drugs’ separate studies. However, separate teams of analysts at William Blair and Leerink Partners stopped short of handing Tezspire the crown in the indication, citing trial design differences that likely play into the cross-trial comparisons.
    • “As Amgen and AZ previously announced, Tezspire significantly improved total nasal polyp score (NPS) and nasal congestion score (NCS) in patients with CRSwNP compared with placebo after 52 weeks in the phase 3 Waypoint study.”

From the U.S. healthcare business front,

  • Fierce Healthcare announced its Fierce 15 [healthcare innovators] of 2025.
  • BioPharma Dive informs us,
    • “AbbVie is joining the industry’s rush to develop new obesity medicines, announcing Monday a deal with Denmark-based Gubra to license a drug that could compete with experimental therapies being developed by Novo Nordisk, Eli Lilly and Zealand Pharma.
    • “Per deal terms, AbbVie will pay Gubra $350 million up front and offer up to $1.9 billion in additional payments tied to the achievement of development and sales milestones. AbbVie will assume responsibility for development and commercialization.
    • “Gubra is developing a type of drug called an amylin analog that regulates appetite and blood sugar levels. If successful, these drugs could be used as alternatives to or in combination with marketed drugs like Novo’s Wegovy and Lilly’s Zepbound to increase weight loss or reduce side effects.”
  • Modern Healthcare reports,
    • “UnitedHealth Group is taking another step to refine its prior authorization requirements as it continues to face public frustration.
    • “The healthcare giant’s insurance business, UnitedHealthcare, plans to cut nearly 10% of prior authorizations this year, the company said in a notice Saturday.
    • “As part of the initiative, the insurer said it will remove pre-approval requirements for home health services managed by its home and community division. The changes will apply to Medicare Advantage and dual special needs plans in 36 states and Washington, D.C., starting April 1.”
  • and
    • “Mayo Clinic is investing nearly $1.9 billion in its Phoenix campus as part of the Bold. Forward. Unbound. strategy being implemented across the system’s multistate footprint.
    • “The project covers 1.2 million square feet, including a new procedural building, an expanded specialty care building, 11 new operating rooms and two new patient units that support 48 beds, according to a Monday news release.
    • “A two-story indoor promenade will wrap around the front of the campus, and complementary clinical services will be clustered together in so-called care neighborhoods, according to the release. Mayo Clinic is starting the design phase this year and expects to complete the project in 2031.
    • “The project will increase the campus’ clinical space by nearly 60%, Dr. Richard Gray, CEO of Mayo Clinic in Arizona, said in the release.”
  • Beckers Hospital Review offers an interesting interview. Here’s the background:
    • “Since 2021, St. Louis-based Ascension has reduced risk-adjusted mortality by more than 20% across 88 hospitals through its Recognize and Rescue initiative, a systemwide effort to support care teams in identifying high-risk conditions and intervening quickly to prevent clinical deterioration. 
    • “Over a three-year period, the program prevented more than 4,000 deaths, outpacing a group of nearly 1,100 peer hospitals by 12%, according to findings recently published in The Joint Commission Journal on Quality and Patient Safety.
    • “This is an incredible achievement for Ascension,” Mohamed Fakih, MD, Ascension’s chief quality officer, said. 
    • “Becker’s recently spoke to Dr. Fakih to learn more about how the health system implemented Recognize and Rescue, what made it successful and how its structure can be applied to other quality initiatives.”

Weekend Update

David Ermer–CDC, Congress, Medical / Rx research, Obesity, U.S. Healthcare–

From Washington, DC,

  • Committee hearings of note this week:
    • Senate Committee on Health, Education, Labor, and Pensions March 5 10:00 AM (EST) | 562 Dirksen Senate Office Building, Washington, D.C. Meeting: Hearings to examine the nomination of Jayanta Bhattacharya, of California, to be Director of the National Institutes of Health, Department of Health and Human Services.
    • Senate Committee on Health, Education, Labor, and Pensions March 6 10:00 AM (EST) | 562 Dirksen Senate Office Building, Washington, D.C. Meeting: Hearings to examine the nomination of Martin Makary, of Virginia, to be Commissioner of Food and Drugs, Department of Health and Human Services.
  • USA Today observes,
    • President Trump on Tuesday [March 4] will deliver his first address to a joint session of Congress since his reelection. While the speech shares many characteristics with a State of the Union address, this presentation is slightly different in nature.
    • Trump’s speech to Congress is expected to outline his legislative priorities for the upcoming term and highlight the work his administration has accomplished since taking office.
    • But since this is his first address in his second nonconsecutive term, the speech is not classified as a State of the Union.
  • The FEHBlog noticed today that on February 12, the Congressional Research Services released a legal sidebar titled Rescission of Executive Order 11246, Employment Opportunity”: Legal Implications.”
  • Per MedTech Dive,
    • “Tandem Diabetes Care received Food and Drug Administration clearance for its Control-IQ+ algorithm in Type 2 diabetes. The automated insulin delivery (AID) system can pull data from glucose monitors and integrate with Tandem’s insulin pumps, automatically calculating how much basal insulin patients should receive. 
    • “The expanded indication increases access for people with Type 2 diabetes who use Tandem’s t:slim X2 tubed pump and Tandem Mobi, a smaller form-factor pump.
    • “CEO John Sheridan told investors in a Wednesday earnings call that the expanded indication covers all people with Type 2 diabetes who take insulin, more than doubling Tandem’s total addressable market in the U.S.”

From the public health and medical research front,

  • The Washington Post reports,
    • Hospitals across the country have reported an increase in pediatric flu cases this season, with many children experiencing severe complications such as pneumonia, dehydration and organ failure. Hospital admissions for flu in children ages 5 to 17 increased by 145 percent, from 959 on Jan. 4 to 2,348 on Feb. 1, according to an analysis from the American Academy of Pediatrics.”
    • “Death is obviously the most severe outcome, but there is a huge spectrum between well and not well,” Patel said. “The flu can take a previously healthy kid and land them on a ventilator.”
    • “Doctors say early symptoms like dehydration or difficulty breathing should not be ignored, as they can indicate a more severe infection.
    • “Patel added that while cases at her hospital have started to decline, the tail end of this flu season could last a few more months.”
  • The Wall Street Journal discusses “The New Thinking on Concussions in Sports. Elite athletes are learning that the best way to recover from a sports-related concussion isn’t to shut down all physical activity. It’s to get back in a workout routine—and quickly.”
  • NPR Shots offers patient perspectives on two Alzheimer’s drugs — Leqembi and Kisunla. The FDA has approved “since 2023 that can clear the brain of sticky amyloid plaques, one of the hallmarks of Alzheimer’s.”
  • Fortune Wells points out “Nutritionists offer these six ways to get back to a healthy diet.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Prime Healthcare completed its acquisition of eight Ascension Illinois hospitals.
    • “The transaction closed March 1 and involves more than half of Ascension’s Illinois hospital network, along with several skilled nursing, home health and senior living facilities. Federal and state regulators signed off on the $375 million deal last year.
    • Prime, a for-profit system based in Ontario, California, pledged to invest $250 million in the facilities.
  • MedTech Dive lets us know,
    • “Teleflex will split into two publicly traded companies, with the new entity comprising its urology, acute care and OEM businesses. The remaining company will consist of the hospital-focused vascular access, interventional and surgical businesses.
    • “The separation positions each organization to accelerate growth under a simplified operating model and increased management focus, with a streamlined manufacturing footprint and better allocation of resources, Teleflex said in a Thursday announcement.
    • “In addition, Teleflex said it agreed to pay about 760 million euros (about $791 million) to acquire nearly all of Biotronik’s vascular intervention division. The company also announced the planned retirement of CFO Thomas Powell.”

Cybersecurity Saturday

David Ermer–Cybersecurity–

From the cybersecurity policy and law enforcement front,

  • Next week, House of Representatives will fast track approval of H.R. 872 – Federal Contractor Cybersecurity Vulnerability Reduction Act of 2025, as amended. This bill which would apply known exploited vulnerability (KEV) remediation rules to certain federal contractors has not received Senate consideration yet.
  • CISA explains “Binding Operational Directive (BOD) 22-01: Reducing the Significant Risk of Known Exploited Vulnerabilities established the Known Exploited Vulnerabilities Catalog as a living list of known Common Vulnerabilities and Exposures (CVEs) that carry significant risk to the federal enterprise. BOD 22-01 requires Federal Civilian Executive Branch (FCEB) agencies to remediate [CISA] identified vulnerabilities by the due date to protect FCEB networks against active threats. See the BOD 22-01 Fact Sheet for more information.”
  • Cyberscoop reports
    • “A push is gearing up to renew an expiring 10-year-old cybersecurity law that was viewed at its initial passage as the most significant cybersecurity legislation Congress had ever passed, and that advocates say now fosters several important threat-sharing initiatives.
    • “The 2015 Cybersecurity Information Sharing Act provides safeguards for companies that voluntarily share threat intelligence data with the government or each other, such as federal antitrust exemptions and shields against state and federal disclosure laws.
    • “Reauthorization of the law faces several hurdles, including uncertainty about who will take the lead on the bill in the House and Senate, potential privacy concerns, a tight timeline, and other competing priorities. There are also some who believe the law could use updates to fit today’s threats, potentially introducing further complications.
    • “But its renewal has some bipartisan support, including among leaders of committees important to its passage, and there is optimism among outside groups that it can win congressional approval. The push is in the very early stages, but there’s a “growing recognition” that it needs to be reauthorized, said Matthew Eggers, vice president of cybersecurity policy in the U.S. Chamber of Commerce’s cyber, intelligence and security division.
    • “We’re in a little bit of spring training in the sense that we haven’t advocated for this legislation for about 10-plus years,” he said. “A number of organizations, over the last 10 years, have probably taken for granted the work that’s been done to get the legislation passed.”
  • Cybersecurity Dive tells us,
    • “The Cybersecurity and Infrastructure Security Agency confirmed that Karen Evans was named executive assistant director for cybersecurity under the Department of Homeland Security. 
    • “Evans, who first joined CISA in January as a senior adviser, will be responsible for leading the agency’s cybersecurity efforts as the national coordinator for critical infrastructure security and resilience. 
    • “Starting in 2018, Evans served as assistant secretary for cybersecurity, energy security and emergency response at the Department of Energy. She was named chief information officer at DHS and served from March 2020 to January 2021. She also served as managing director of the Cyber Readiness Institute before joining CISA.”
  • Cyberscoop adds,
    • “President Donald Trump hasn’t yet selected an overall leader for CISA, although Sean Plankey has reportedly been in line for the Senate-confirmed job. But Evans’ appointment is the latest key position to get a name attached to it among top cyber jobs in the administration.
    • “The administration recently named Sean Cairncross as its pick for the Senate-confirmed position of national cyber director. It also picked Alexei Bulazel as senior director for cyber at the National Security Council.”
  • The National Institute of Standards and Technology is celebrating the first anniversary of its Cybersecurity Framework 2.0.
  • Dark Reading lets us know,
    • “The US Army soldier arrested for unlawful transfer of confidential phone records told a federal judge he intends to plead guilty to the charges.
    • “Cameron John Wagenius, who went by the online alias “Kiberphant0m,” was involved in the Snowflake hacking campaign alongside Connor Riley Moucka, known as “Judische,” who was arrested in October 2024.
    • “Wagenius was arrested after infiltrating 15 telecommunications providers while on active military duty. He then reportedly published the stolen AT&T call logs of high-ranking officials like President Donald Trump and former Vice President Kamala Harris on Dark Web forums.”

From the cybersecurity vulnerabilities and breaches front,

  • Security Week informs us,
    • “CrowdStrike this week published its 2025 Global
Threat Report, which summarizes the latest adversary tactics and techniques, as well as important trends that defined 2024.
    • “The cybersecurity giant started tracking 26 new threat groups in 2024, which brought the total number of adversaries known by the company to 257. 
    • “CrowdStrike pointed out that China-linked activity surged, with a 150% increase seen across all sectors, and a rise of 200-300% in industries such as financial services, media, manufacturing, and industrials and engineering compared to 2023. 
    • “One interesting aspect that CrowdStrike has been tracking is breakout time, the time it takes threat actors to move from initial access to high-value assets. This breakout time is important because that is how much time defenders have to detect and respond to an attack before the hackers start establishing deeper control.
    • “In 2024, the average breakout time in the case of cybercrime intrusions dropped to 48 minutes, from 62 minutes in 2023, and the fastest breakout seen by CrowdStrike last year was just 51 seconds.
    • “Over half of the vulnerabilities seen by CrowdStrike last year were related to initial access, which the company says reinforces the need to secure exposed systems. It also noted that identity-based attacks are increasingly favored over traditional malware attacks.”  
  • Cyberscoop lets us know,
    • “Cybercriminals intentionally disrupted operations at a growing rate last year, Palo Alto Networks’ threat intelligence firm Unit 42 said in an annual incident response report released Tuesday.
    • “Of the nearly 500 major cyberattacks Unit 42 responded to last year, 86% involved business disruption, including operational downtime, fraud-related losses, increased operating costs and negative reputational impacts. 
    • “Unit 42 called this trend the “third wave of extortion attacks,” another point of potential leverage for threat groups to impose on targets in addition to encryption and data theft. 
    • “These disruptive attacks stand out for the pain, impact and broader ripple effects they inflict on society and the economy at large, said Sam Rubin, senior vice president of consulting and threat intelligence at Unit 42.
    • “This is what organizations need to be worried about from a threat perspective and from a defensive strategy standpoint,” Rubin said.” 
  • Cybersecurity Dive reports,
    • “Approximately 2,850 IP addresses are vulnerable to CVE-2025-22467, a critical stack buffer-overflow vulnerability that affects Ivanti Connect Secure VPNs, according to a post on X by the Shadowserver Foundation.
    • “Ivanti disclosed and patched CVE-2025-22467 on Feb. 11 and said it was not aware of any exploitation of the vulnerability prior to the public disclosure. Exploitation of the critical flaw can allow a remote authenticated attacker to achieve remote code execution.
    • ‘Shadowserver found the U.S. and Japan were the countries with the highest number of vulnerable IP addresses, with 852 and 384 instances, respectively.”
  • CISA added four known exploited vulnerabilities to its catalog this week.

From the ransomware front,

  • CSO points out five things to know about ransomware threats in 2025.
  • Per Security Week,
    • “Threat Intelligence firm Kela warns of a new ransomware group called Anubis operating as a RaaS service with an extensive array of options for affiliates.
    • “The group emerged as recently as late 2024, although the researchers believe that its members have experience in ransomware, both malware and operations. Information on Anubis comes from an analysis of the group’s dark web footprint rather than code analysis of the ransomware.
    • “As with most ransomware groups today, Anubis uses double extortion. The researchers suggest that “Anubis appears to be an emerging threat, highlighting different business models employed by modern extortion actors.”
  • Dark Trace discusses “Lynx ransomware, emerging in 2024, targets finance, architecture, and manufacturing sectors with phishing and double extortion.” 
  • Cybersecurity Dive lets us know,
    • “Researchers analyzed leaked chat logs from the infamous Black Basta ransomware gang and found references to 62 unique CVEs, 53 of which are known to have been exploited in the wild.
    • “Black Basta favored vulnerabilities in “widely adopted enterprise technologies” that included Microsoft products, Citrix Netscaler and Atlassian Confluence, as well as flaws in network edge devices from Fortinet, Cisco, F5 Networks and Palo Alto Networks, according to the findings by VulnCheck.
    • “VulnCheck’s research revealed that in many cases Black Basta members began discussing CVEs within days of security advisories being published, underscoring the importance of prompt patching and mitigations for critical flaws in widely used applications and devices.”
  • Cyberscoop adds,
    • “Black Basta’s inner workings reveal a cybercrime group rife with internal conflicts. Yet, the notorious ransomware-as-a-service group’s affiliates have wreaked havoc on organizations globally.
    • “Over a two-year period, the ransomware variant was used to encrypt and steal data from at least 12 of the 16 critical infrastructure sectors, impacting more than 500 organizations, according to the Cybersecurity and Infrastructure Security Agency. 
    • “The group pulled in at least $107 million in ransom payments by late 2023, research from Elliptic and Corvus Insurance found.
    • “The Black Basta leak followed a decrease in activities earlier this year, which was caused by key members defecting to other cybercriminal operations, like the Cactus ransomware group, according to Alptekin. “This exposure has further destabilized the group and impacted trust among its members,” he said.
    • “Rapid7 observed a resurgence of social engineering attacks linked to Black Basta operators in early October, but the group has been largely inactive this year.” 

From the cybersecurity defenses front,

  • The Wall Street Journal reports,
    • “Every company needs a cybersecurity strategy but getting the money to enact it can be complicated. 
    • “Benchmarks that compare cyber spending across companies relative to their revenues, overall tech budget or head count can validate funding choices, but they aren’t useful in establishing the security needs of an organization, chief information security officers say. 
    • “That tactic never worked for me,” said Selim Aissi, a cybersecurity consultant who has held executive cyber roles at companies including Intel, Visa and Blackhawk Network Holdings, which sells gift cards.
    • “The CEO, the CFO will shut you down immediately and say, ‘Who cares? We’re not [company] XYZ.’”
    • “Cybersecurity is a necessary expense. Attackers exploit new vulnerabilities within days of discovery and malware multiplies by the day. It takes just 48 minutes, on average, for a hacker to move through a corporate network after getting in, according to cyber company ReliaQuest. International Business Machines found the average cost of a data breach in the U.S. was $4.9 million last year. But companies are wary of paying for more protection than they need, and it falls on CISOs to justify the expense.
    • “Understanding the costs of disruption is a useful way to allocate spending, said Mike Anderson, chief digital and information officer of cyber company Netskope. Some business functions are more critical than others or will take more resources to fix if they are disrupted, he said. 
    • “You can’t treat everything exactly the same,” Anderson said. “I align the investments to the criticality.”
  • Here is a link to Dark Reading’s CISO Corner.

Friday Report

David Ermer–Uncategorized–
Photo by Sincerely Media on Unsplash

From Washington, DC

  • Fierce Healthcare tells us
    • “Friday morning, the HHS uploaded a policy statement that is set to be published in the Federal Register on March 3.
    • “Bylined by the secretary, it says the department is no longer required to undergo a public comment period it typically observes following the publication of proposed rulemaking in “matters relating to agency management or personnel or to public property, loans, grants, benefits or contracts.”
  • The FEHBlog has often wondered why CMS circulated draft Medicare Advantage call letters for public comment but OPM hasn’t circulated draft FEHB / PSHB call letters. This article explains why, but HHS is doing away with this practice.
  • Federal News Network informs us,
    • “SSA will offer employees voluntary separation incentives and early retirement options as part of a major reorganization.
    • “Through these massive reorganizations, offices that perform functions not mandated by statute may be prioritized for reduction-in-force actions that could include abolishment of organizations and positions, directed reassignments and reductions in staffing,” SSA stated in a Feb. 27 release. “The agency may reassign employees from non-mission critical positions to mission critical direct service positions (e.g., field offices, teleservice centers, processing centers). Reassignments may be involuntary and may require retraining for new workloads.”
    • “SSA says it’s looking to shed about 7,000 workers. The latest data from last March says SSA had 56,645 employees, up slightly from 2023 and down from 66,967 in 2010.”
  • Yesterday, OPM reminded FEHB plan carriers,
    • [A]n enrollee whose FEHB enrollment is terminated, other than by cancellation or discontinuance of the plan, is entitled to a 31-day extension of coverage without contributions by the enrollee or the Government. This applies to Self Only, Self Plus One, or Self and Family enrollments.   See 5 CFR 890.401(a)(1).  Carriers must provide the 31-day extension of coverage beyond the coverage end date provided by employing agencies in the SF-2810 action to all terminated enrollments cited in the regulation.”  
  • Cardiovascular Business lets us know,
    • “The U.S. Food and Drug Administration (FDA) has announced a new recall for the ablation catheters associated with Johnson & Johnson MedTech’s Varipulse pulsed field ablation (PFA) system. No devices need to be returned or removed from the market. Instead, the FDA is urging all customers to read updated instructions provided by Johnson & Johnson MedTech. 
    • “The recall comes after approximately 3% of patients treated with the device during the early stages of its U.S. rollout experienced a stroke or transient ischemic attack shortly after treatment. The expected stroke rate is closer to 1%, the FDA explained, prompting this action. 
    • “In total, four serious injuries have been linked to this issue.
    • “This is a Class I recall, which means the FDA believes patients face a risk of serious injury or death if they use the devices without reviewing the updated instructions.” 

From the public health and medical research front,

  • The Centers for Disease Control and Prevention announced today,
    • “Seasonal influenza activity remains elevated nationally but has decreased for two consecutive weeks. COVID-19 activity is declining nationally but elevated in some areas of the country. RSV activity is declining in most areas of the country.
    • “COVID-19
      • “COVID-19 activity is declining nationally but elevated in some areas of the country. Wastewater levels are moderate, emergency department visits are at low levels, and laboratory percent positivity is stable. Emergency department visits and hospitalizations are highest in older adults and emergency department visits are also elevated in young children.
      • “There is still time to benefit from getting your recommended immunizations to reduce your risk of illness this season, especially severe illness and hospitalization.
      • “CDC expects the 2024-2025 COVID-19 vaccine to work well for currently circulating variants. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.
    • “Influenza
      • “Seasonal influenza activity remains elevated nationally but has decreased for two consecutive weeks. Data to date suggests the season has peaked, however, flu-related medical visits, hospitalizations, and deaths remain elevated, and CDC expects several more weeks of flu activity.
      • “Additional information about current influenza activity can be found at: Weekly U.S. Influenza Surveillance Report | CDC
    • “RSV
      • “RSV activity is declining in most areas of the country. Emergency department visits and hospitalizations are highest in children and hospitalizations are elevated among older adults in some areas.
    • “Vaccination
      • “Vaccination coverage with influenza and COVID-19 vaccines is low among U.S. adults and children. Vaccination coverage with RSV vaccines remains low among U.S. adults. Many children and adults lack protection from respiratory virus infections provided by vaccines.
  • The University of Minnesota’s CIDRAP adds,
    • “Newly confirmed US Department of Agriculture (USDA) Secretary Brooke Rollins, JD, [on February 26] introduced new steps to battle avian flu in poultry and stabilize the egg supply, which includes $500 million to help poultry producers shore up biosecurity measures.
    • “Earlier this week, Rollins met with egg producers during a tour of an egg-laying facility in Texas, and today she detailed USDA’s strategy in an opinion piece in the Wall Street Journal. The USDA also detailed the plan today on its website.
    • “Since 2022, the H5N1 avian flu virus has led to the loss of more than 166 million poultry, including 19 million over the past 30 days. Outbreaks over the fall and winter have hit poultry farms hard, especially layer facilities in some of the top egg-producing states, such as Ohio.” 
  • The Wall Street Journal reports,
    • “Health and Human Services Secretary Robert F. Kennedy Jr. said ending the measles outbreak in Texas is a top priority for him and listed the steps his agency had taken to combat the spread of disease, including supporting the state’s vaccine efforts.
    • “I recognize the serious impact of this outbreak on families, children, and healthcare workers,” Kennedy wrote Friday in a post on X.
    • “There have been at least 155 measles cases linked to the outbreak across West Texas and New Mexico, local health officials said Friday. Twenty patients have been hospitalized, and one school-age child died this past week. Most of those sickened weren’t vaccinated, or their vaccination status wasn’t known. 
    • “Kennedy said HHS had provided lab support to track the virus, offered technical assistance to local public health officials and updated federal advice on doctors offering vitamin A to manage measles cases.
    • “HHS communicated about the disease in Low German to the affected population in Texas’ Gaines County, Kennedy said, where the outbreak was concentrated among Mennonites.”
  • Medscape relates,
    • “For decades, physicians had little to offer patients who have heart failure with preserved ejection fraction (HFpEF), which is a growing global health problem with a grim death rate in the 5 years after diagnosis. But that started to change in 2021, when a drug trial showed benefits in preventing hospitalization and death.
    • “And each year since, has brought a new clinical trial that shows the value of yet another drug for HFpEF.
    • “It’s so wonderful,” said Michelle Kittleson, MD, PhD, professor of cardiology at the Smidt Heart Institute at Cedars-Sinai in Los Angeles and chair of the writing committee for the latest American College of Cardiology (ACC) update to the HFpEF management pathway.”
  • The Wall Street Journal points out “New Treatments Give Hope to Patients with One of the Deadliest Cancers. Half of all pancreatic cancer patients live less than a year after diagnosis. But researchers say there is potential for change.”
  • The American Hospital Association News tells us,
    • “A study published Feb. 26 by JAMA Psychiatry found that female physicians died by suicide at more than 1.5 times the rate of female nonphysicians from 2017-2021. During the same time, male physicians had a lower suicide risk than male nonphysicians. The study also found that physicians who died by suicide had higher odds of depressed mood and mental health, job and legal problems preceding suicide compared to the general population. 
    • “The AHA has a dedicated webpage with resources on preventing suicide in the health care workforce.”
  • Per MedPage Today,
    • “Rates of pancreatitis and liver-related complications from alcohol have increased in teens and young adults.
    • “Males were most affected, yet young females had changes in rates that were higher than males.
    • “These findings suggest a need for addiction medicine training in gastroenterology.”
  • and
    • “Diabetes prevalence in U.S. adults over the past decade has remained stable, with a small non-significant increase.
    • “HbA1c and rates of glycemic control significantly worsened from 2017-2020 to 2021-2023, with changes concentrated in adults ages 20 to 44.
    • “The changes observed in HbA1c and glycemic control among these younger adults would be expected to increase their lifetime risk of cardiovascular events, according to the researchers.”
  • and
    • “To improve mental health, risk factors related to “social determinants” like food insecurity or inadequate housing need to be addressed, according to some health experts. But even doing that doesn’t go far enough upstream, said one psychiatrist here on Thursday.
    • “It’s not enough to intervene at the level of the risk factors — [if you do], you’re actually intervening too late,” said Ruth Shim, MD, MPH, a professor of cultural and clinical psychiatry at the University of California Davis in Sacramento. “So, I started looking into and trying to understand what is actually happening before the risk factor.”
    • “Those upstream factors are sometimes known as the “causes of the causes,” Shim said at an event sponsored by the Johns Hopkins Center for Mental Health and Addiction Policy. “What’s the context that’s going to set you further upstream from the risk factor?”
    • “The answer is that there are two “very fundamental issues,” she noted. “Social norms, or the belief in common society, about who in our society is worthy of value and who is less worthy of such value, who in our society deserves advantage, and who is less deserving of this advantage. And what are the public policies or the laws that we pass that reflect those belief systems? Because those laws that we pass then create unfair and unjust distribution of opportunity, which set into motion the social determinants of mental health, which then lead to the risk factor, which then leads to poor outcomes.”

From the U.S. healthcare business front,

  • Healthcare Dive lets us know,
    • “Universal Health Services’ net income soared in 2024, rising to $1.1 billion from $717.8 million in 2023 on strong demand for services, particularly in the operator’s behavioral health division.
    • ‘The Pennsylvania-based hospital operator plans to expand its behavioral health offerings next year to drive revenue growth, with a specific focus on outpatient services, executives said on a Thursday earnings call.
    • “UHS expects to take in between $17 billion and $17.4 billion in net revenue in 2025. However, the company is contending with several possible headwinds, including potential healthcare policy changes in Washington, which could impact the company’s bottom line.”
  • Beckers Payer Issues informs us,
    • “Blue Cross Blue Shield of Massachusetts reported a $400 million operating loss in 2024, driven by spending on GLP-1 medications and other rising medical costs. 
    • “The nonprofit insurer reported its financial results for 2024 on Feb. 28. The company posted a -4.3% operating margin in 2024, compared to a 0.4% margin in 2023. 
    • “In a news release, CFO Ruby Kam said medical costs are rising at the fastest rate in more than a decade. Costs are rising across almost every category of services, but GLP-1 drugs have had the single largest impact, she said. GLP-1 drugs accounted for nearly 20% of the insurers’ pharmacy spending in 2024. 
    • “The insurer is repricing its plans to reflect higher costs and cutting administrative spending, including through hiring freezes and eliminating some jobs, according to the release. 
    • “In a statement, CEO Sarah Iselin said the company does not expect the trend to change any time soon.” 

AI News

  • Fierce Healthcare reports,
    • “Last week at the ViVE conference in Nashville, two topics seemed to dominate most conversations—artificial intelligence and the impending snowstorm. (Music City got about two inches of snow.)
    • “According to many executives who attended the digital health-focused conference, AI took the main stage at ViVE and discussions about adoption and use of the technology in healthcare has evolved significantly in just the past year.
    • “Many conversations centered around AI agents and sophisticated prompt engineering. Compared to HLTH, where conversations felt more theoretical, vendors and healthcare customers were speaking about concrete use cases. For a while now people healthcare incumbents have had robotic process automation, then intelligent automation and now AI on their roadmaps. It seems we’ve finally arrived at the final destination and most are piloting different AI tech now,” Neil Patel, Redesign Health’s head of ventures told Fierce Healthcare.”
  • Per Healthcare Dive,
    • “A private-public partnership formed to create standards for artificial intelligence adoption in healthcare is launching a new registry for hospitals and developers to access and share information on AI tools.
    • “The hub, known as a model card registry, was unveiled by the Coalition for Health AI (CHAI) and health system members of the group, including Providence, Cleveland Clinic and Kaiser Permanente, on Friday. The goal of the registry is to make it easier for healthcare companies to evaluate and shop between validated AI products, CHAI said.
    • “AI companies and other developers can input their tools into the registry regardless of whether they’re a member of CHAI, according to a spokesperson. There’s no cost to upload model cards or access the registry, though it could include paywalled features in the future, they said.”
  • and
    • “Cloud-based software company Salesforce is rolling out a library of prebuilt artificial intelligence tools meant to make it easier for providers, payers and other healthcare companies to apply digital labor to time-consuming tasks.
    • “Salesforce’s “Agentforce for Health” relies on agentic AI, which unlike older AI assistants can operate relatively autonomously.
    • “The product includes patient access and services capabilities, including answering questions and checking patient eligibility with insurers; public health capabilities, like helping organizations monitor the spread of infections; and clinical capabilities to accelerate research and development for drugs and medical devices.”

Thursday Report

David Ermer–Congress, Medical / Rx research, U.S. Healthcare–

From Washington, DC,

  • Roll Call reports
    • “The Senate Health, Education, Labor and Pensions Committee on Thursday advanced the nomination of former Rep. Lori Chavez-DeRemer to be Labor secretary in a 14-9 vote.
    • “Chavez-DeRemer, a former one-term Republican member of the House from Oregon, is likely to be confirmed. She caused less worry among Democrats than some of President Donald Trump’s other nominees. 
    • “Committee Chair Bill Cassidy, R-La., laid out his hopes for a “pro-America agenda that puts workers first.”
    • “Over the last several weeks, Rep. Chavez-DeRemer demonstrated her commitment to this mission,” he said.
  • Per a Senate news release,
    • “Senate Finance Committee Members Chuck Grassley (R-Iowa) and Michael Bennet (D-Colo.) introduced bipartisan legislation to improve health care access for children with complex medical conditions. The Accelerating Kids’ Access to Care Act simplifies out-of-state Medicaid screening and enrollment processes for pediatric care providers, while retaining key safeguards to preserve the integrity of the program. Rep. Mariannette Miller-Meeks (R-Iowa) is leading companion legislation in the House of Representatives.
    • “Moms and dads seeking life-saving care for their kids should be able to access it quickly and wherever it’s available. Families shouldn’t have to trip over red tape to reach the most effective specialist, treatment or procedure, whether around the corner or across state lines. Our bill simplifies the process so parents can ensure children with a rare disease or cancer diagnosis get the right specialized medical care,” Grassley said.
    • “For children with complex medical conditions, bureaucratic red tape should not be an obstacle to care. This bipartisan legislation will make it easier for families to navigate our health care system and relieve some of the stress that they face to get their kids the care they need when they need it,” Bennet said.
    • “Click HERE for text of the legislation.”

From the judicial front,

  • The Washington Post reports,
    • “A federal judge on Thursday ordered [at a TRO hearing] the Office of Personnel Management to rescind directives that initiated the mass firing of probationary government workers in several agencies across the government, ruling that the terminations were probably illegal, as a group of labor unions argued in court. Civil Action No. 3:25-cv-01780 (N.D. Cal.)
    • “U.S. District Judge William Alsup [appointed by President Clinton] ordered OPM to rescind its prior directives to agencies including the Department of Defense, the Park Service, Bureau of Land Management, National Science Foundation, and others. The ruling is one of the biggest roadblocks so far to President Donald Trump’s effort to slash the federal workforce.
    • “Congress has given the authority to hire and fire to the agencies themselves. The Department of Defense, for example, has statutory authority to hire and fire,” Alsup said from the bench as he handed down the ruling Thursday evening in San Francisco federal court. “The Office of Personnel Management does not have any authority whatsoever under any statute in the history of the universe to hire and fire employees at another agency. They can hire and fire their own employees.”
  • The Court has not yet posted a written opinion.

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “Eleanor Maguire wasn’t great at navigating the streets of London, but it wasn’t until she was at home one night watching a movie in the mid-1990s that she started to think that the brains of the people who were expert navigators—the city’s famous cabdrivers—might actually be different than hers.
    • “The next morning, she burst into her lab at University College London, where she worked as a neuroscientist, and told her mentor, Chris Frith, that she’d just seen a movie called “The Knowledge” about a group of would-be London cabdrivers, and that it had given her an idea for a scientific study. Frith told her to go for it.
    • “Maguire, who had cancer and died Jan. 4 at age 54, specialized in the hippocampus, a part of the brain that plays a key role in memory. It was also known to play a role in navigation for rats, but early in her career, Maguire demonstrated that it played a role in navigation for humans as well. In a series of studies, she demonstrated that human memories aren’t movies that we replay in our minds the way we watch movies on TV. Rather, they are imperfect scenes that we construct in our minds. Similarly, when we’re thinking about where we want to go, our brains construct scenes that show us how to get there.”
    • RIP
  • MedPage Today informs us,
    • “Cervical precancer rates dropped precipitously among young women who underwent screening after the human papillomavirus (HPV) vaccine was first recommended in the U.S., CDC researchers reported.
    • “Among women ages 20 to 24 who were screened for cervical cancer from 2008 to 2022, rates of cervical intraepithelial neoplasia (CIN) grades 2-3 and adenocarcinoma in situ (AIS), defined as CIN2+, decreased by 79%, and rates of CIN grade 3 and AIS, defined as CIN3+, decreased by 80%, said Julia W. Gargano, PhD, of the CDC’s National Center for Immunization and Respiratory Diseases, and colleagues.
    • “Moreover, among women ages 25-29 who were screened over the same time period, rates of CIN3+ — the precancerous lesions most likely to progress to invasive cervical cancer — decreased by 37%, they noted in the Morbidity and Mortality Weekly Report.
    • “These data are consistent with considerable impact of HPV vaccination for preventing cervical precancers among women in the age groups most likely to have been vaccinated and support existing recommendations to vaccinate children at the routinely recommended ages as a cancer prevention measure,” Gargano and colleagues wrote.”
  • and
    • “During the current flu season, influenza-associated encephalopathy or encephalitis (IAE) was identified in 9 of 68 (13%) pediatric deaths, including four with acute necrotizing encephalopathy (ANE), a severe form IAE, CDC researchers reported.
    • “In comparison, the median proportion of pediatric influenza deaths with IAE during the 2010-11 through 2024-25 flu seasons was 9% (166 of 1,840), reported Amara Fazal, MD, of the CDC, and colleagues in Morbidity and Mortality Weekly Report. It is not known whether cases observed this season vary from expected numbers, they noted.”
  • Per an NIH press release,
    • “Using an animal model of multiple sclerosis (MS), researchers at the National Institutes of Health (NIH) have created a four-dimensional brain map that reveals how lesions similar to those seen in human MS form. These findings, published in Science, provide a window into the early disease state and could help identify potential targets for MS treatments and brain tissue repair.
    • “The researchers, led by postdoctoral fellow Jing-Ping Lin, Ph.D., and senior investigator Daniel S. Reich, M.D., Ph.D., both at NIH’s National Institute of Neurological Disorders and Stroke (NINDS), combined repeated MRI imaging with brain-tissue analysis, including gene expression, to track the onset and development of MS-like lesions. They uncovered a new MRI signature that can help detect brain regions at risk for damage weeks before any visible lesions occur. They also identified “microenvironments” within affected brain tissue based on observed patterns of neural function, inflammation, immune and support cell responses, gene expression, and levels of damage and repair.
    • “Identifying the early events that occur after inflammation and teasing apart which are reparative versus which are damaging, can potentially help us identify MS disease activity sooner and develop treatments to slow or stop its progression,” said Dr. Reich.”  
  • The U.S. Preventive Health Services Task Force posted for public comment a proposed research plan for evaluating “Tobacco Cessation in Adults: Interventions.” The public comment period ends on March 26, 2025.

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Walgreens Boots Alliance Inc. shares rose Thursday morning after a report that a potential take-private deal from Sycamore Partners would lead to a breakup of the drugstore chain.
    • “Sycamore, which has been reportedly exploring a purchase of Walgreens for months, is planning on splitting up the company’s U.S. and U.K. pharmacy businesses, as well as its specialty pharmacy unit, the Financial Times reported Thursday.”
  • Kauffman Hall considers implications of its National Hospital Flash Report for Hospital Operations.
  • Beckers Hospital Review tells us,
    • “Nashville, Tenn.-based HCA Healthcare has completed the purchase of Lehigh Acres, Fla.-based Lehigh Regional Medical Center, from Ontario, Calif.-based Prime Healthcare.
    • “This hospital and associated physician practices are a wonderful complimentary addition to our existing 17 hospitals within our division along Florida’s West Coast and will serve as a catalyst for growth as we further expand our services and programs in Lee County,” Jyric Sims, PhD, president of HCA Healthcare west Florida division, said in a Feb. 27 news release shared with Becker’s.” 

Wednesday Report

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

From Washington, DC,

Capitol Hill News

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

White House News

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

CMS News

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

Food and Drug Administration News

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Tuesday Report

David Ermer–Congress, Medical / Rx research, Medicare, OPM, Telehealth, U.S. Healthcare–

From Washington, DC,

  • By a 217 – 215 vote, the House of Representatives tonight passed the White House’s “big, beautiful [reconciliation] bill” — H. Con. Res. 14 — “Establishing the congressional budget for the United States Government for fiscal year 2025 and setting forth the appropriate budgetary levels for fiscal years 2026 through 2034.”
  • Per a Senate news release,
    • “Sen. Chuck Grassley (R-Iowa), Chairman of the Senate Judiciary Committee and a former Chairman of the Senate Finance Committee, sent a letter to UnitedHealth Group Chief Executive Officer Andrew Witty demanding detailed information on the company’s Medicare billing practices.”
  • Govexec tells us,
    • “The Trump administration is reshaping the top ranks of federal agencies by making more employees politically appointed and ensuring those who remain in career roles are evaluated based on how well they implement the president’s agenda. 
    • “The Office of Personnel Management on Monday called on all agencies to redesignate some of their Senior Executive Service employees as political appointees, rather than reserving them for career staff. On Tuesday, it announced a new performance appraisal system for career executives, which will now give the most significant weight to how well the top-level supervisors carry out the president’s policies.”
  • Federal News Network informs us,
    • “The Office of Personnel Management is giving an ultimatum to remote and teleworking employees who are more than 50 miles away from their official duty stations.
    • “OPM is directing employees in this scenario to either report to their current duty station, agree to a “management-directed reassignment” and relocate to office space in another geographic region, or accept termination from their jobs.
    • “According to presentation slides shared with Federal News Network, these are the options employees more than 50 miles of their OPM facility will receive in a “Management Direct Reassignment” memo on Wednesday.
    • “OPM is giving employees until Friday, March 7 to respond.”
  • and
    • “Social Security beneficiaries impacted by the Windfall Elimination Provision and the Government Pension Offset may begin receiving their one-time retroactive payments as soon as this week.
    • “The Social Security Administration has significantly shortened its timeline to start distributing benefit payments to public sector workers whose Social Security benefits have been impacted by WEP and GPO. SSA said it began distributing the one-time retroactive payments this week, and most payments will process incrementally over the next month.
    • “The agency said in a press release Tuesday that most beneficiaries should receive their one-time retroactive payments by the end of March. The retroactive payments are backdated to January 2024.”
  • The American Hospital Association News continues to fill us in on its rural healthcare leadership conference.
  • Per Fierce Healthcare,
    • “The federal government under the Trump administration has turned its focus to cutting costs, and a new report from the Blue Cross Blue Shield Association highlights policy efforts it says could save nearly $1 trillion in healthcare costs over the next decade.
    • “The road map includes 10 policy proposals for stakeholders to consider, and BCBSA said these changes could drive federal savings of $524 billion, lower private insurance premiums by $389 billion and save patients $180 billion out-of-pocket.
    • “The largest potential area for savings, according to the analysis, is to adopt site-neutral payments in Medicare, which the paper estimates would save $484 billion over 10 years. The report also suggests that mandating a different provider identifier for off-campus facilities than what’s required for on-campus facilities could save an additional $11 billion.”

From the judicial front,

  • Fierce Pharma informs us,
    • “Compounding pharmacies aren’t surrendering their ability to create cheaper knockoff versions of Eli Lilly and Novo Nordisk’s weight loss drugs without a fight.
    • “In response to the FDA declaring on Friday that the shortage for Novo’s blockbuster GLP-1 treatments Ozempic, approved for diabetes and Wegovy, which has a license in obesity, was over and that compounders would have to stop producing them in the next 60 to 90 days, an organization which backs the pharmacies has filed a lawsuit (PDF) in U.S. District Court in Fort Worth, Texas.
    • “The complaint alleges that the U.S. regulator is “dismissing evidence that the shortage persists,” in removing the drugs from its shortage list “without notice-and-comment rulemaking.”
    • “It is the second lawsuit filed in the same court from the Outsourcing Facilities Association (OFA) and Texas-based FarmaKeio Superior Custom Compounding.
    • “In October, in a complaint that is still pending, they sued the FDA after it removed Lilly’s tirzepatide—the main ingredient in its diabetes and obesity blockbusters Mounjaro and Zepbound—from its shortage list.”

From the public health and medical research front,

  • Healthcare Finance reports,
    • “Fewer clinicians are entering into the primary care field, and investments in primary care are on the downswing, finds a new report from the American Academy of Family Physicians and Milbank Memorial Fund.
    • “According to the findings, years of neglect and chronic underinvestment by the healthcare system have left U.S. primary care in a position where it’s increasingly unable to meet patients’ needs, particularly in rural and other underserved communities.
    • “The combination of worsening primary care access and sicker patients has created a cycle whereby patients use more expensive services like emergency rooms, which raises healthcare costs and premiums, further reducing affordability and access, the report said. And overall healthcare spending continues to rise faster than economic indicators, with the primary care infrastructure only receiving a small fraction of that money.” * * *
    • “People are shifting away from traditional primary care providers, with about three in 10 forgoing primary care altogether between 2016 and 2022, according to FAIR Health’s 2023 analysis of private claims data.
    • “That number, though, ranged from a high of 43% in Tennessee to a low of 16% in Massachusetts, suggesting significant regional variations. Of the providers who performed primary care services in that time, 56% were physicians, while 44% were nonphysicians.” * * *
    • “People are increasingly turning to telehealth for their primary care needs. At 94%, the vast majority of patients are satisfied with their experience pursuing virtual primary care, and nearly four in five (79%) say it has allowed them to take charge of their health, according to a November 2022 survey released by Elevance Health.”
  • Per Healio,
    • “Obesity trends have stayed stable in the last couple years, whereas severe obesity has trended downward, a recently published report suggested.
    • “However, the percentage of people with a healthy weight has also decreased in the decade-plus”
    • “What stands out most is that younger adults experienced the greatest increase in BMI, while older adults saw a leveling off and even a decline in recent years,” Kristen Bartelt, RN, a research clinician with Epic Research, told Healio. “This shift suggests that different age groups may be experiencing unique influences when it comes to weight and health.”
  • MedPage Today adds,
    • “Higher adherence to the Mediterranean diet was associated with a 6% lower risk of obesity-related cancer over 15 years.
    • “Risks for colorectal, liver, and kidney cancers were significantly reduced in people with medium or high adherence to the top-ranked diet.
    • “Obesity-related cancer risk reduction was even greater among current and former smokers.”
  • What’s more, Rheumatology Advisor notes,
    • “Dietary predictors linked to reduced mortality among patients with rheumatoid arthritis included high intake of protein and fiber, along with reduced consumption of refined grains”
  • The NIH Research Matters bulletin covers “Boosting peanut tolerance | Artificial sense of touch | Scratching and skin inflammation”
  • BioPharma Dive lets us know,
    • “Ten of 11 children born profoundly deaf experienced some degree of hearing improvement after receiving an experimental gene therapy developed by Regeneron Pharmaceuticals.
    • “A few of the children can now hear sound at near-normal levels, like conversational speech. One, who was 10 months old when treated and has been followed for more than a year, correctly identified spoken words, like “mommy,” “cookies” and “airplane,” without visual cues in a formal test.
    • “The findings, disclosed by the company Monday alongside a presentation at a medical meeting, are a notable achievement in the development of gene therapies for congenital deafness. Other companies and groups, including Eli Lilly, France’s Sensorion and researchers at Fudan University in Shanghai, are working on similar treatments as Regeneron.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Health insurers wrapped up 2024 in rough shape, recording falling profits from insurance businesses and releasing guidance suggesting that medical costs could continue climbing this year.
    • “In the fourth quarter, payers continued to slog through elevated medical spending in Medicare and Medicaid. Higher costs popped up in once-safe commercially insured populations, too, suggesting American workers are sicker than before.
    • “All told, major publicly traded insurers’ medical loss ratios, key metrics of spending on patient care, rose an average of 2.8 percentage points from the fourth quarter of 2023 to the fourth quarter of 2024.” * * *
    • “Insurers are attempting to resuscitate their profits this year, including by shedding unprofitable MA members. During fourth-quarter calls, major Medicare insurers said they’ve successfully lost members that were dragging down their margins — and shunted other beneficiaries into plan designs that give more control over spending.”
  • The Wall Street Journal reports
    • “Eli Lilly LLY is expanding its offerings of its hit weight-loss drug Zepbound for people who want to pay cash instead of using their health plans and reducing prices for certain dosages.
    • “The pharmaceutical company said it would start selling higher dosages of its Zepbound drug, known as tirzepatide, through Lilly Direct, its direct-to-consumer business. The new dosages – in 7.5 and 10 milligram single-dose vials – will cost patients $599 per month and $699 per month, respectively.
    • “The price for both dosages goes down to $499 per month if patients refill their prescriptions within 45 days, as part of a type of customer loyalty program.
    • “The company also cut the per-month price of the lower dosages by about $50. The 2.5-mg vials will cost $349, down from $399; the 5-mg vials will be $499, down from $549.
    • “Lilly Direct allows patients to bypass insurers and traditional pharmacies. Lilly said it had received requests from many patients to offer the higher doses.
    • “We can’t wait until the complex healthcare system is offering access to anti-obesity medications like all other chronic diseases,” said Patrik Jonsson, president of Lilly’s cardiometabolic health unit. “But in the meantime, this is a response to patients’ requests.”
  • Fierce Pharma adds,
    • “Looking to avoid a repeat of the shortages that plagued Mounjaro and Zepbound during their initial rollouts, Eli Lilly is building supply of its oral GLP-1 contender orforglipron well before the drug’s expected approval in 2026.
    • “As of Dec. 31, Lilly had amassed pre-launch inventory worth $548.1 million that was “primarily related to orforglipron,” the company said in its annual report issued last week.
    • “When we believe that future commercialization is probable and the future economic benefit is expected to be realized, we capitalize prelaunch inventory prior to regulatory approval,” the company explained in its securities filing.”
  • MedCity News explains why “‘The Hardest Thing Is Separating the Wheat from the Chaff’: 5 Leaders on the State of Healthcare AI. Healthcare AI is developing at a rapid rate, and the industry’s attitude on how to best regulate and deploy this technology is evolving every day, according to leaders attending this year’s ViVE conference.”
  • Per MedTech Dive,
    • “Quest Diagnostics has struck a deal to buy kidney disease laboratory testing service assets from Fresenius Medical Care, the companies said Monday.
    • “The acquisition will add dialysis-related water testing to Quest’s portfolio. Quest will perform the tests and other end-stage kidney disease laboratory services for Fresenius Medical Care’s dialysis centers in the U.S.
    • “Quest, which has not disclosed the value of takeover, completed eight buyouts last year, but CEO Jim Davis recently told investors the company would “moderate” its dealmaking pace in 2025.” 
  • and
    • “Thermo Fisher Scientific agreed to pay about $4.1 billion in cash to acquire Solventum’s purification and filtration business.
    • “The technologies, used in the production of biologics and medical devices and for industrial applications, generated about $1 billion in revenue last year. The business employs about 2,500 people globally and will become part of Thermo Fisher’s life sciences solutions segment.
    • “The Solventum unit is highly complementary to Thermo Fisher’s bioproduction business that offers cell culture media and single-use technologies, Thermo Fisher CEO Marc Casper said in the Tuesday announcement.”

Monday Report

David Ermer–Congress, COVID treatment, FDA, Medical / Rx research, Mental health care, OPM, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC

  • The Hill reminds us,
    • “The calendar will officially turn to March this week, putting Congress in the same month as the looming March 14 government shutdown deadline. Despite that date fast-approaching, however, lawmakers in both parties have still not struck a deal to keep the lights on in Washington past the middle of next month — raising the possibility of a shutdown.”
  • Federal News Network notes,
  • HUB International discusses the Labor Department and CMS 2023 Mental Health Parity Compliance reports.
    • While not an exclusive or comprehensive list of all possible violations, the [article’s] list provides some guidance on the types of issues the Departments view as violations (particularly on the NQTL side). Employers should review their plan designs for any potential MHPAEA violations based on the [article’s] enforcement data and work with their providers to rectify any noncompliant design elements.
  • The Labor Department’s Inspector General released a report on Mental Health Parity Enforcement encouraging more resources be given to the enforcers. The FEHBlog believes that this additional cost can be avoided by simplifying the Mental Health Parity rule.
  • The HHS Inspector General reports “Medicare Part D Spending for 10 Selected Diabetes Drugs [including GLP-1 drugs] Totaled $35.8 Billion in 2023, an Increase of 364 Percent From 2019.”
  • MedPage Today tells us,
    • “The FDA approved adaptive deep brain stimulation (DBS) technology (BrainSense adaptive DBS and BrainSense electrode identifier) for people with Parkinson’s disease, Medtronic announced Monday.
    • “Like other DBS devices, the newly approved technology uses a surgically implanted neurostimulator to transmit electrical signals. The adaptive feature adjusts therapy based on a patient’s neural activity in real time, reducing the need to manually adjust stimulation.
    • “Adaptive deep brain stimulation will help revolutionize the approach to therapeutic treatment for patients with Parkinson’s disease,” said Helen Bronte-Stewart MD, MSE, of Stanford University School of Medicine in California, in a statement. “The transformative personalized care we can achieve through automatic adjustment greatly benefits patients receiving therapy that adapts to their evolving needs.”

From the judicial front,

  • Per Govexec,
    • “An independent federal oversight agency has deemed at least some of President Trump’s mass firings of probationary period employees unlawful, creating a pathway for those employees to regain their jobs. 
    • “The Office of Special Counsel, the agency responsible for investigating illegal actions taken against federal employees, issued its decision for six employees, each at different agencies. While the decision was technically limited in scope, it could have immediate impact on all terminated staff at those six agencies and could set a wide-ranging precedent across government. It has not been made public and was provided to Government Executive by a source within the government. OSC, which did not provide the document to Government Executive, verified its authenticity. 
    • “OSC has turned the case over to the quasi-judicial Merit Systems Protection Board for enforcement of its findings and is so far requesting a 45-day stay on the firing decisions. The agency said it will use that time to further investigate the dismissals and determine the best way to mitigate the consequences from the apparent unlawful actions. 
    • “MSPB has three business days to issue a decision on the stay request. If it does not act by that deadline, the stay will go into effect.”
  • It’s worth adding that the Scotusblog explains
    • “The Supreme Court on Friday [February 21] left in place for now an order by a federal judge in Washington, D.C., that instructed President Donald Trump to temporarily reinstate the head of an independent federal agency [the Office of Special Counsel] tasked with protecting whistleblowers from retaliation. The justices did not act on a request from the Trump administration to block the order by U.S. District Judge Amy Berman Jackson, which had restored Hampton Dellinger as head of the Office of Special Counsel for 14 days, beginning on Feb. 12. Instead, the justices explained in a brief order, they put the government’s request on hold until Jackson’s order expires on Feb. 26.”
  • Per Healthcare Dive,
    • “Express Scripts, Caremark and Optum Rx are turning to an appeals court to try to reverse a legal setback in their ongoing feud with the Federal Trade Commission.
    • “The PBMs said on Friday they will ask the 8th Circuit Court of Appeals to halt the agency’s suit against them for allegedly inflating the cost of insulin, three days after a Missouri district judge ruled the FTC’s case could move forward.
    • “The PBMs — known as the “Big Three” for their outsized control of the U.S. prescription drug market — also asked the district judge again for an injunction halting the FTC’s suit pending their appeal. Express Scripts, Caremark and Optum Rx intend to ask the 8th Circuit for an injunction in one week unless the district court complies.”

From the public health and medical research front,

  • The Washington Post reports,
    • “Cardiovascular disease remains the leading cause of death in the United States and accounted for 941,652 deaths in 2022, according to a report published by the American Heart Association.
    • “In the United States in 2022, heart disease and stroke killed more people than all forms of cancer and accidental deaths. Coronary heart disease was the leading cause of death attributable to cardiovascular disease (39.5 percent), followed by stroke (17.6 percent), other cardiovascular diseases (17 percent), hypertensive diseases (14 percent), heart failure (9.3 percent) and diseases of the arteries (2.6 percent), the AHA said. More people died of cardiovascular causes in 2022 than 2021, when there were 931,578 cardiovascular deaths, according to the report.
    • “The report also notes that between 2017 and 2020, nearly half of U.S. adults (48.6 percent) had some form of cardiovascular disease. According to the AHA, 59 percent of non-Hispanic Black women and 58.9 percent of non-Hispanic Black men had cardiovascular disease.
    • “Advances in clinical diagnosis and treatment have lessened the burden of heart disease over time, but more needs to be done to treat major risk factors, including obesity, high blood pressure and diabetes, said Keith Churchwell, a physician and clinical professor of medicine at the Yale School of Medicine who serves as volunteer president of the American Heart Association.”
  • The American Medical Association lets us know “what doctors wish patients knew about cancer screening and prevention.”
  • Healio informs us,
    • “Paxlovid may not decrease the risk for hospitalization or death in older adults vaccinated against COVID-19 as much as previously thought, according to research published in JAMA.
    • “Since the strongest predictor of severe COVID-19 is advanced age, it has been crucial to obtain evidence on whether the results of the Pfizer trials” — which showed Paxlovid reduced COVID-19 hospitalizations and deaths in unvaccinated adults — “generalized to older and vaccinated populations,” John Mafi, MD, MPH, associate professor-in-residence of medicine at the David Geffen School of Medicine at UCLA, said in a press release.
    • “At best, Mafi and colleagues wrote, Paxlovid could reduce COVID-19-related hospitalization by 1.3 percentage points, or 4 times less than the 5.5 percentage-point risk reduction reported in Pfizer’s original trial among unvaccinated adults.
    • “Our study effectively rules out the notion that Paxlovid causes large reductions in hospitalization in vaccinated older adults,” Mafi said. “While we cannot rule out a small reduction in COVID-19 hospitalization, our results indicate that, at best, Paxlovid’s potential effect on COVID-19 hospitalization among vaccinated older adults is four times weaker than the effect originally reported in Pfizer’s 2022 clinical trial.”
  • Consumer Reports< writing in the Washington Post, explores “How to keep your bones strong. Worried about osteoporosis? Here are the tests, moves, meds and foods you need to know about.”
  • The Wall Street Journal reports,
    • Frozen shakes served in hospitals and nursing homes have been recalled after being linked to a deadly outbreak of listeria, resulting in 12 deaths and sickening at least 38 people in 21 states.
    • The shakes, sold under the brands Lyons ReadyCare and Sysco Imperial, were made in the same facility in Fort Wayne, Ind., and have been recalled by both companies.
    • Listeria can cause serious illness, especially in newborns, older people, and those with weakened immune systems, and can survive on surfaces for long periods.
  • and
    • “Red-light therapy, a treatment involving exposure to low levels of red or near-infrared light, is gaining popularity for its purported benefits in weight loss, antiaging and mood balance.
    • “While some research shows promise in areas like dermatology and mood disorders, more evidence is needed to confirm its broader health benefits.
    • “Consumers should be cautious when purchasing red-light therapy devices, as there are no established standards for wavelength, intensity and length of treatment, and some products may not be effective or safe.”

From the U.S. healthcare business front,

  • The American Hospital Association News fills us in on its ongoing rural healthcare leadership conference.
  • Per BioPharma Dive,
    • “Summit Therapeutics and Pfizer on Monday said they will test an experimental Summit immunotherapy with Pfizer’s antibody drug conjugates in trials evaluating two of the sector’s most closely watched types of cancer medicines.
    • “Pfizer will oversee the clinical trials, which will involve Summit’s ivonescimab and multiple different Pfizer ADCs against certain solid tumors. The two companies will retain commercialization rights to their respective products, Summit said.
    • “According to Summit, the deal “will allow us to quickly advance beyond our promising late-stage development plan,” which already includes multiple studies in lung cancer. The companies didn’t provide specifics, but said the trials will begin in the middle of the year and aim to find “potentially landscape-changing combinations.”
  • Beckers Payer Issues relates,
    • Bon Secours Mercy Health and Cigna Healthcare will be out of network across eight Virginia hospitals [listed in the article] on April 1.
    • Almost all of Cigna’s business with Bon Secours is through employer-sponsored plans that are self-funded. If Bon Secours Mercy Health leaves our network, OAP and PPO members will be affected.
  • Beckers Hospital Review discusses “the twofold challenge of an older population — and how systems are adapting.”
    • “In less than a decade, older Americans are projected to outnumber children for the first time in U.S. history, sparking conversations about the need for age-friendly healthcare. 
    • “At the same time, declining birth rates and longer life expectancies — half of babies born in 2020 are expected to live past 100 years — pose potential workforce challenges.
    • “Becker’s connected with four health system leaders [in this article] to explore the challenges this demographic shift presents and how they are preparing to address it.”

Weekend Update

David Ermer–CDC, Congress, Generative AI, U.S. Healthcare–

From Washington, DC

  • Roll Call updates on this week’s activities on Capitol Hill/

From the public health front,

  • The Wall Street Journal reports,
    • “Measles outbreaks across Texas and New Mexico have sickened nearly 100 people, with more cases expected, according to state health officials.
    • “The disease has spread through the South Plains region of Texas since late January, the Texas Department of State Health Services said Friday. Ninety cases have been identified to date in the state. Five patients were vaccinated, and the rest were unvaccinated or their status was unknown, the agency reported. 
    • “Due to the highly contagious nature of this disease, additional cases are likely to occur in the outbreak area and the surrounding communities,” the agency said. 
    • “The disease has been found across several counties in Texas, but the largest cluster of patients, 51, has been in Gaines County on the western border, according to health department data.  
    • “The New Mexico Department of Health has reported a measles outbreak that has infected nine people in Lea County, which borders Gaines County in Texas. The agency has begun contact tracing among those who developed symptoms to try to minimize the spread and has offered free vaccinations. 
    • “Among the 90 known cases in Texas, 77 were among people under 17 years old. Sixteen patients had to be hospitalized, the state said. 
    • “Last year, the Centers for Disease Control and Prevention reported 285 cases of measles nationwide, across 33 states that included Texas and New Mexico. The CDC counted 16 outbreaks, defined as three or more related cases, that accounted for about 198 out of the 285 people who fell ill. By comparison, in 2023, four outbreaks were reported among 59 individual illnesses.”
  • The New York Times lets us know six things E.R. doctors wish you’d avoid.
  • The Washington Post informs us,
    • “Forty-four percent of rural Medicare patients must drive an hour or more for surgery, a recent analysis in JAMA finds. The study shows that patients in rural areas typically drive 55 minutes to a hospital — far longer than their counterparts in more populous areas.
    • “The research used beneficiary data from Medicare to identify patients 65 to 99 years old who had any of a list of common surgeries between 2010 and 2020. The study looked at about 12.3 million surgery admissions overall, 2.6 million of which were in rural areas.
    • “The number of rural Medicare beneficiaries who traveled more than 60 minutes for their procedure rose from 36.8 percent in 2010 to 44.1 percent in 2020, with the median travel time climbing from 47 minutes to 55 minutes. Among nonrural Medicare beneficiaries, travel times were lower, with a median of 20 minutes’ travel in 2010 vs. 23 minutes in 2020.
    • “Travel times depended on the risk involved in surgery; median times for low-risk procedures such as appendectomies and hernia repair were lower than for higher-risk surgeries like aortic valve repair or a liver resection.”
  • The Wall Street Journal discusses the growing lack of public trust in the medical profession. It strikes the FEHBlog that health insurers can contribute toward restoring that trust by encouraging the use of primary care physicians and reducing prior authorization requirements.

From the U.S. healthcare business front,

  • The Washington Post explains why GLP-1 weight loss drugs also are reshaping the economy.
  • Per Healthcare Dive,
    • “Orlando Health will close Rockledge Hospital and four outpatient facilities in Brevard, Florida on April 22, just months after buying the 298-bed facility from bankrupt Steward Health Care. 
    • “The health system blamed the closure on Steward, saying in a statement that “years of neglect” had left the Rockledge’s electrical, plumbing and heating, ventilation and air conditioning systems failing. 
    • “Orlando plans to demolish Rockledge and replace it with a new facility, as it would cost more to renovate and repair Rockledge than to build a hospital from the ground up, the system said.”
  • Per BioPharma Dive,
    • “Bluebird bio, a pioneering gene therapy developer that in recent years has struggled to stay afloat, has agreed to be acquired and taken private in a deal with investment firms Carlyle Group and SK Capital.
    • “Under an agreement announced Friday, Bluebird will sell to the two firms for $3 per share upfront. Bluebird shareholders could receive an additional $6.84 per share via a so-called contingent value right, should its currently marketed gene therapies reach $600 million in net yearly sales by the end of 2027.
    • “The deal values Bluebird at just over $29 million upfront, and potentially about $96 million if the CVR is redeemed.”
  • Per Modern Healthcare,
    • “Hartford HealthCare, which operates seven hospitals and a network of physicians, behavioral health services and other providers in Connecticut, is partnering with the artificial intelligence-driven virtual health provider K Health to improve access to primary care. On April 1, the organizations will launch HHC 24/7, a virtual health platform powered by K Health, designed to make “comprehensive, personalized primary care available anytime and anywhere.” The service will be fully integrated with Hartford HealthCare. Terms of the partnership were not disclosed.”