Tuesday Report

CDC

Tuesday Report

David Ermer–CDC, Congress, COVID-19, COVID-19 vaccine, Electronic health records, FDA, Medical / Rx research, NIH, Obesity, OPM, U.S. Healthcare–

From Washington, DC,

Capitol Hill news

  • Roll Call reports,
    • “House Republicans are plowing ahead with a budget resolution markup on Thursday before the chamber’s scheduled one-week recess begins the following day. 
    • “The blueprint wasn’t finalized yet and leadership also has some work to do in preparation for the floor, with key holdouts looking for assurances on things like spending cuts and raising the statutory debt ceiling. 
    • “But Speaker Mike Johnson, R-La., said after the GOP conference’s weekly meeting Tuesday that the “intention” was to mark up the blueprint in committee on Thursday after hammering out the details Tuesday. “We’ll be rolling out the details of that probably by tonight,” Johnson said. “We are right on the schedule that we need to be on.”
    • “The Budget panel has a 24-hour notice rule for posting text before bringing the resolution up for a committee vote.
    • “By the end of the day, we’ll be able to have the final pieces to put the budget resolution along with the reconciliation instructions in play, because we have to communicate that in some detail when we mark it up,” House Budget Chairman Jodey C. Arrington, R-Texas, said Tuesday after the conference meeting.”
  • The House Budget Committee has scheduled “a markup for the Concurrent Resolution on the Budget for Fiscal Year 2025 which will be held on February 13, 2025, at 10 am.

White House news

  • The Washington Post reports,
    • “President Donald Trump on Tuesday signed an executive order that calls on federal agencies to work with the U.S. DOGE Service in a bid to cut their existing workforce and limit future hiring. Ahead of the signing, Trump was joined in the Oval Office by Elon Musk, his billionaire ally who is overseeing DOGE, an agency that Trump has empowered to find government efficiencies.”
  • The Office of Personnel Management has updated its Fork in the Road website for the legal developments that occurred yesterday

Medical Coding news

  • The ICD10 Monitor alerts us that 50 new ICD 10 PCS codes will become effective on April 1. 2025.
  • Per a recent government bulletin,
    • The Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (hereafter ASTP) Standards Bulletin 2025-1 (SB25-1) describes the development of the Draft United States Core Data for Interoperability Version 6 (Draft USCDI v6), which ASTP released on January 14, 2025. 
    • The USCDI sets the technical and policy foundation for the access, exchange, and use of electronic health information to support nationwide interoperable health information exchange and is a standard stewarded and adopted by ASTP on behalf of the U.S. Department of Health and Human Services (HHS). ASTP publishes new versions of USCDI annually, with a draft version released in January and a final version released in July to keep pace with clinical, technology, and policy changes that influence the use of clinical and related terminology. Draft USCDI v6 includes new data elements that seek to advance interoperability for patient care.
    • SB25-1 describes ASTP’s continued expansion of USCDI, following the same prioritization approach applied to USCDI Version 5. SB25-1 also reflects ASTP’s consideration of submissions for new data elements, comments on previously submitted data elements, and the evolving maturity of data elements through the USCDI+ Program.

From the public health and medical research front,

  • The University of Minnesota’s CIDRAP informs us,
    • “COVID-19 vaccination averted more than 5,000 US in-hospital deaths, 13,000 intensive care unit (ICU) admissions, and 68,000 hospitalizations in 7 months in 2023-2024, researchers from the US Centers for Disease Control and Prevention (CDC) estimated late last week in Vaccine, although with considerable uncertainty.
    • “The investigators estimated COVID-related deaths, ICU admissions, and hospitalizations prevented by vaccination from October 1, 2023, to April 21, 2024, using a novel multiplier model that used causal inference, conditional probabilities of hospitalization, and correlations between data elements in simulations.
    • “The U.S. Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) has used estimates of the potential benefits and risks to inform vaccine policy decisions, and burden averted estimates can be used to evaluate vaccine policy,” the study authors wrote.”
  • STAT News lets us know,
    • “We’ve talked a lot about how hospitals have been recording a lot more patient visits throughout 2024. One major component of that: There’s been a lot more little bundles of joy lately.
    • “Analysts at investment bank Leerink Partners looked at birth data across four states (Arizona, Colorado, Florida, and North Carolina) and found births in December were up almost 4% year over year. 
    • “There’s an especially interesting trend in Florida: 53% of all births are covered by commercial health insurance (either from the parents’ workplace or the Affordable Care Act exchanges). 
    • “Usually, Medicaid covers the majority of births, but this reversal is “a reflection of redeterminations,” in which states kicked people off Medicaid if they no longer met eligibility requirements that were loosened during the pandemic, Leerink analysts wrote to investors.”
  • The Washington Post reports,
    • “California-based Tri-Union Seafoods has issued a voluntary recall of canned tuna sold at Trader Joe’s, Safeway, Harris Teeter, Walmart, Costco and other major grocery stores in dozens of states.
    • “The recall centers on concerns that a manufacturing defect in the cans may cause “a potentially fatal form of food poisoning,” the company said in a statement Friday.
    • “Tri-Union Seafoods said the defect, located on the cans’ pull-tab lid, may compromise the integrity of the product seal, especially over time, causing it to leak or become contaminated with the clostridium botulinum bacterium, which causes botulism.
    • “While Tri-Union Seafoods has said no illnesses linked to the recalled products have been reported, the company warned consumers not to use the product, “even if it does not look or smell spoiled.” The manufacturing company asked consumers to instead return the recalled tuna for a full refund, throw it away or contact Tri-Union directly for a retrieval kit and a coupon for a replacement product.” * * *
    • “Tri-Union Seafoods issued the recall notice Friday on all tuna products sold under the Genova, Van Camp’s, H-E-B and Trader Joe’s brand names.” * * *
    • “Tri-Union’s statement includes UPCs, can codes and best-by dates you can check to determine if your tuna is affected by the recall. Consumers can contact Tri-Union Seafoods at support@thaiunionhelp.zendesk.comor 833-374-0171 to request a replacement product.”
  • The Wall Street Journal lets us know,
    • “We all know cigarettes cause cancer. The memo on booze hasn’t reached everyone.
    • “Doctors say many people are surprised to learn alcohol raises the risk of certain cancers, such as liver, colorectal and breast cancer. And cancer patients say they aren’t always aware of the increased risk until after they have been diagnosed.
    • “As awareness increases—the former U.S. surgeon general recently called for adding warning labels on alcoholic beverages—more people are rethinking their drinking habits. On social-media sites like Reddit, cancer patients talk about replacing alcohol with cannabis, although this, too, has health issues. Others opt for mocktails or nothing at all.”
  • Per Beckers Hospital Review,
    • “A phase 3 trial found that a combination of a Pfizer and Astellas drug, enfortumab vedotin, and Merck’s drug, pembrolizumab, has significantly improved survival rates for patients with advanced bladder cancer. 
    • “The latest results from the trial, which focused on patients with untreated, locally advanced or metastatic urothelial cancer, showed that the combination therapy reduced the risk of death by 49% compared to traditional chemotherapy.” 
  • Healio tells us,
    • “Women prescribed a GLP-1 receptor agonist up to 2 years before conception were less likely to develop hypertensive disorders of pregnancy, gestational diabetes, have a preterm birth or cesarean delivery, researchers reported.
    • “Relatively little is known how preconception GLP-1 receptor agonist use may impact pregnancy outcomes,” Christopher T. Nau, MD, assistant professor in the department of reproductive biology at Case Western Reserve University School of Medicine and the division of maternal fetal medicine at University Hospitals Cleveland Medical Center, told Healio. “This study suggests that [GLP-1s] may have potential to be a powerful tool to optimize preconception health.”
    • “The findings were published in the American Journal of Obstetrics and Gynecology.”
  • MedPage Today notes,
    • “[A] Plasma p-tau217 [blood test] successfully identified Alzheimer’s pathology in several neurodegenerative syndromes.
    • “This included disorders not typically associated with Alzheimer’s disease, like frontotemporal dementia.
    • “Alzheimer’s pathology in syndromes related to frontotemporal lobar degeneration correlated with worse cognitive performance.”
  • Per an NIH news release,
    • “National Institutes of Health (NIH) scientists and their colleagues report that a single dose of a broadly neutralizing antibody (bnAb) administered prior to virus exposure protects macaques from severe H5N1 avian influenza. Highly pathogenic avian influenza (HPAI) H5N1 viruses have sporadically spilled over from birds into many other animals, including humans and dairy cows, in recent years. Although it has not yet acquired the capacity to spread readily between people, H5N1 has pandemic potential, which has spurred efforts to develop effective treatments and other countermeasures.
    • “The investigators studied a bnAb called MEDI8852, which was discovered and developed by Medimmune, now part of AstraZeneca. MEDI8852 targets a portion of a key flu protein that is less prone to change than other parts of the virus and thus is capable of conferring protection against a wide range of flu viruses. In the new study, a group of macaques received an injection of MEDI8852 and were exposed to aerosolized HPAI H5N1 virus three days later. All the pre-treated animals survived and experienced no or very limited signs of disease. In contrast, a group of control macaques developed severe or fatal illness within a short time after virus exposure.
    • “Of note, the scientists determined that MEDI8852 remained in the body for a prolonged time after the injection. According to scientists, protection from severe disease would extend to weeks beyond antibody infusion, providing a realistic preventative window in the face of an H5N1 outbreak.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Humana brought in profit of $1.2 billion in 2024, down more than half from $2.5 billion in 2023 due to significantly higher spending on its members’ care in Medicare and Medicaid, according to financial results released Tuesday.
    • “Still, Humana’s performance in the fourth quarter capping off the year was better than expected given ongoing cost pressures in the government programs, analysts said.
    • “Humana said it expects to lose 550,000 members in privatized Medicare Advantage plans this year — roughly one-tenth of its individual MA footprint — from cutting unprofitable plans to improve margins. The size of the membership loss is notably larger than Humana’s prior expectations.”
  • STAT News adds,
    • “The most important number in health insurance, at least to Wall Street and the companies themselves, is the medical loss ratio.” * * *
    • Here’s how fourth-quarter MLRs have looked for insurers so far, and how they compared to Wall Street’s consensus estimates: Molina Healthcare (90.2% actual vs. 88.7% consensus), Oscar Health (88.1% actual vs. 86.9% consensus), Cigna (87.9% actual vs. 84.7% consensus), UnitedHealth (87.6% actual vs. 86.5% consensus).
    • “Centene (89.6% actual vs. 90% consensus) and Elevance Health (92.4% actual vs. 92.6% consensus) each barely had lower fourth-quarter MLRs than expected.”
  • Per BioPharma Dive,
    • “Novartis is wagering more than $3 billion that a startup it helped launch six years ago has developed a better blood thinner than what’s now available.
    • “The Swiss drugmaker on Tuesday announced a deal to acquire Anthos Therapeutics, a Boston-based startup it formed with Blackstone Life Sciences in 2019. Novartis will pay $925 million upfront,and could pay up to $2.15 billion more should the drug at the center of the deal hit certain regulatory and sales milestones. The deal should close in the first half of 2025.
    • “Through the acquisition, Novartis will regain a blood-thinning drug, called abelacimab, that’s currently in late-stage testing. Novartis originally discovered the compound, but in 2019 licensed it to Anthos, a startup Blackstone Life Sciences launched with $250 million. That deal gave Novartis a minority stake in Anthos, which went on to advance the drug into Phase 3 testing.
  • Fierce Pharma notes,
    • “Some two years into Leqembi’s launch, Eisai continues to go all-in on its Alzheimer’s disease-fighting antibody, which the company believes could be finally nearing a “growth expansion phase” despite slow sales so far in the U.S.
    • “All told, Leqembi brought home around 13.3 billion Japanese yen ($87 million) in the third quarter of Eisai’s 2024 fiscal year, which will wrap up on March 31. In the U.S. specifically, Leqembi grew roughly 30% quarter-over-quarter to 7.7 billion yen (nearly $51 million), Eisai said in a recent earnings presentation (PDF).
    • “Cumulatively, the antibody has generated total sales of 29.6 billion yen (about $194 million) over the last nine months of 2024, putting Leqembi on track to reach a 12-month sales target of 42.5 billion yen ($279 million), Eisai’s chairman and CEO, Tatsuyuki Yasuno, said in an interview with Fierce Pharma.”
  • Per Beckers Hospital Review,
    • “Warner Robbins and Perry, Ga.-based Houston Healthcare’s bid to join Emory Healthcare was approved by both boards, according to a Feb. 10 news release.
    • “Both boards finalized the terms of a definitive agreement outlining the specific details and provisions of Houston Healthcare to integrate into Atlanta-based Emory. The two organizations have been working on an agreement since August 2024, when they signed a nonbinding letter of intent to combine.
    • “Emory and Houston Healthcare are now focused on finalizing the regulatory reviews and approvals before closing the transaction in the “coming months,” according to the statement.”

Monday Report

David Ermer–CDC, COVID-19, FDA, Medical / Rx research, NIH, Obesity, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC,

White House News

  • Regulatory Focus considers how this Executive Order may impact the Food and Drug Administration.
  • The Regulatory Focus article notes that the Trump administration is in the process of updating the December 13, 2024, semi-annual regulatory agenda published by the Biden Administration.

Judicial News

  • Federal News Network reports,
    • President Donald Trump’s plan to downsize the federal workforce remains on hold after a courtroom hearing on Monday afternoon.
    • It’s the latest example of how the Republican president’s ambitious plans have become ensnared in the judicial system.
    • U.S. District Judge George O’Toole Jr. had paused the deferred resignation program, commonly described as a buyout, last week.
    • On Monday, he said the stay would remain in place until he issues a ruling. It’s unclear when that could happen.
    • Trump wants to use financial incentives to encourage government employees to quit. According to the White House, 65,000 workers had taken the government up on its offer as of Friday.

FDA News

  • Per MedTech Dive,
    • “The Food and Drug Administration published an early alert on Thursday about a BD device linked to 30 serious injuries and four deaths.
    • “The FDA issued the alert one day after BD wrote to customers to recommend actions to mitigate the risks posed by a system used to break up and remove clots from arteries. 
    • “Stress, wear, high temperatures, friction or localized pressure can cause part of BD’s Rotarex device to break, the FDA said, and result in vessel injuries and severe bleeding.”
  • Reuters informs us,
    •  “AbbVie (ABBV.N) said on Friday that the U.S. Food and Drug Administration approved its drug for complicated intra-abdominal infections, including those caused by drug-resistant bacteria.
    • “AbbVie and co-developer Pfizer’s (PFE.N), opens new tab drug, Emblaveo, is approved in combination with an antibiotic medication for patients 18 years and older with such infections.
    • “Deaths from antibiotic-resistant bacteria, also known as superbugs, have been on the rise globally, and health regulators have called for the development of newer treatments as resistance to older antibiotics grows.”

From the public health and medical research front,

  • The American Hospital Association News tells us,
    • “At least 24 million people have had seasonal flu this season, according to estimates  from the Centers for Disease Control and Prevention. Nearly 49,000 patients were admitted to hospitals with the flu for the week ending Feb. 1. Emergency department visits due to the flu remain classified as “very high” and “increasing,” the agency said. ED visits for COVID-19 are “low” and “decreasing,” while visits for respiratory syncytial virus are “moderate” and “decreasing.” Overall respiratory illness activity causing people to seek health care is “very high.” 
  • The Washington Post reports,
    • “A Nevada dairy worker was infected with a version of bird flu that is known to have killed one person in the United States and severely sickened a teen in Canada, state and federal health authorities said Monday.
    • “This version of the virus was detected for the first time in dairy farms last month in Nevada. The Central Nevada Health District said Monday that an adult was exposed to infected dairy cattle while working at a farm in the northwestern part of the state. The Centers for Disease Control and Prevention said its genetic analysis confirmed that the virus in the Nevada person is the same as was detected in the Nevada dairy cows.
    • “The Nevada worker had conjunctivitis, commonly known as pink eye, but no other reported symptoms. The worker is recovering, the district said, and close contacts and other workers exposed at the farm are being contacted and monitored for symptoms. They are being offered personal protective equipment, testing and antiviral medication, the district said. No additional cases have been confirmed.”
  • Cardiovascular Business lets us know,
    • “The virus responsible for COVID-19 is associated with several long-term heart risks, according to a new analysis published in Radiology.[1] This appears to be true regardless of the patient’s age or health at the time of infection.
    • “COVID-19, caused by SARS-CoV-2, is initially characterized by acute lung injury and respiratory failure,” senior author Junbo Ge, MD, director of the cardiology department at Zhongshan Hospital in Shanghai, China, said in a statement. “However, emerging evidence indicates COVID-19 also involves an extreme inflammatory response that can affect the cardiovascular system.”
    • “Ge et al. examined coronary CT angiography (CCTA) data from more than 800 patients with a mean age of nearly 64 years old. More than 67% of patients were men. While 41% of patients underwent CCTA prior to the COVID-19 pandemic, the remaining patients underwent CCTA during the pandemic. One in four of patients imaged during the pandemic presented with an active SARS-CoV-2 infection. All patients underwent baseline and follow-up measurements over time, allowing researchers to follow different trends over time.
    • “Overall, after reviewing more than 2,500 coronary artery lesions, the group determined that plaque volumes grew much faster in SARS-CoV-2 patients. High-risk plaques (20.1% vs. 15.8%), coronary inflammation (27% vs. 19.9%) and target lesion failure were also significantly more common in patients infected with SARS-CoV-2”
  • Per Beckers Hospital Review,
    • “Patients aren’t the only ones turning to obesity drugs to manage health. More physicians are using GLP-1s too, The New York Times reported Feb. 10.
    • “While there are no studies documenting the number of physicians taking GLP-1s, a number of physicians told the Times that they’ve noticed many colleagues growing thinner and sharing similar eating habits.
    • “Physicians “are a good litmus test for drugs that are highly effective,” Robert Califf, MD, the former FDA chief, told the Times.” 
  • Per National Institutes of Health press releases,
    • “Eating gradually increasing doses of store-bought, home-measured peanut butter for about 18 months enabled 100% of children with peanut allergy who initially could tolerate the equivalent of at least half a peanut to consume three tablespoons of peanut butter without an allergic reaction, researchers report. This easy-to-implement treatment strategy could potentially fulfill an unmet need for about half of children with peanut allergy, who already can tolerate the equivalent of at least half a peanut, considered a high threshold. The findings come from a trial sponsored and funded by the National Institutes of Health’s National Institute of Allergy and Infectious Diseases (NIAID) and published today in the journal NEJM Evidence.
    • “Children with high-threshold peanut allergy couldn’t participate in previous food allergy treatment trials, leaving them without opportunities to explore treatment options,” said NIAID Director Jeanne Marrazzo, M.D., M.P.H. “Today’s report focuses on this population and shows that a very safe and accessible form of therapy could be liberating for many of these children and their families.”
  • and
    • “Influenza A virus particles strategically adapt their shape—to become either spheres or larger filaments—to favor their ability to infect cells depending on environmental conditions, according to a new study from National Institutes of Health (NIH) scientists. This previously unrecognized response could help explain how influenza A and other viruses persist in populations, evade immune responses, and acquire adaptive mutations, the researchers explain in a new study published in Nature Microbiology.”

From the U.S. healthcare business front,

  • BioPharma Dive tells us,
    • “Axsome Therapeutics gained more than $1 billion in market value Monday, after the brain drug developer disclosed a patent settlement with Teva Pharmaceuticals that will keep a generic copy of Axsome’s top drug at bay in the U.S. until at least 2038.
    • “Axsome had sued Teva for patent infringement when the generic drugmaker filed for approval of a knock-off version of Auvelity, a medicine for major depressive disorder that last year earned Axsome some $290 million in net sales.
    • “Per the settlement struck by the two companies, Teva will gain a license to sell generic Auvelity on or after March 31, 2039, should Axsome gain regulatory exclusivity for pediatric use of the drug. If Axsome doesn’t, Teva can enter the U.S. market with its copy on Sept. 30, 2038.”
  • Fierce Pharma adds,
    • “Incyte’s ruxolitinib franchise, made up of blockbuster JAK inhibitor Jakafi and its topical counterpart Opzelura, have been the company’s driving focus for years. Now, with Jakafi approaching a 2028 patent cliff, Opzelura is gaining momentum as several expansion opportunities take shape.
    • “The 2021-approved Opzelura grew sales by 50% during 2024, reaching $508 million on the back of its two approved indications in atopic dermatitis and vitiligo. Included in the fourth quarter’s $162 million revenue haul is $24 million from sales outside of the U.S., where Opzelura’s European launch is seeing positive momentum, Incyte said on its earnings presentation Monday. 
    • “Opzelura remains the only marketed topical JAK inhibitor, although Leo Pharma’s delgocitinib is vying for a nod in chronic hand eczema. Besides studies in prurigo nodularis and mild to moderate hidradenitis suppurativa, Incyte’s next move for Opzelura is an expected approval in pediatric atopic dermatitis in the second half of this year.”
  • Beckers Hospital Review relates
    • “As of September, there were 284,626 licensed nurse practitioners practicing in the U.S., though NP availability per capita varies significantly across states.
    • “The total number of practicing NPs has remained relatively unchanged since January 2024, according to KFF data. 
    • “To compare NP availability across states, Becker’s analyzed KFF data on the number of practicing NPs alongside U.S. Census Bureau population estimates to calculate the number of NPs per 100,000 residents in each state.”
    • FEHBlog note — The article provides lists the states from highest to lowest NP availability per capita. Tennessee is on top.

Friday Report

David Ermer–CDC, Congress, COVID-19, Medical / Rx research, OPM, Rx coverage, SDOH, U.S. Healthcare–

From Washington, D.C.

  • Roll Call reports,
    • “The Senate fiscal 2025 budget resolution released Friday gives instructions to nine authorizing committees to draft a filibuster-proof reconciliation bill aimed at strengthening border control, buttressing military spending and encouraging domestic energy production.
    • “The fiscal blueprint, written by Senate Budget Chairman Lindsey Graham, R-S.C., gives the authorizing committees until March 7 to fill in the details and provide their respective pieces of the package to the Budget Committee, which will then meld them into one bill.
    • “The plan, to be marked up by the committee Feb. 12 and 13, assumes $342 billion over four years divided between border security, the Pentagon and Coast Guard: $175 billion for the border, $150 billion for defense and $17 billion for the Coast Guard.
    • “The new funding would be fully paid-for, but how they do that specifically is up to the authorizing committees charged with drafting the implementing bill. Committees given instructions to come up with the offsets are given low targets — at least $1 billion — to provide them with maximum flexibility. But the expectation is those committees will exceed those targets.”
  • and
    • “House Republican leaders emerged late Thursday from a roughly three-hour meeting without an agreement on the contours of the massive budget reconciliation package they’ve been talking about for weeks.
    • “But they planned to work through the weekend ironing out details with a goal of marking up the blueprint needed for the filibuster-proof bill early next week.
    • “Speaker Mike Johnson said he’ll be working Saturday and through Sunday’s Super Bowl taking place in New Orleans — in his and Majority Leader Steve Scalise’s home state of Louisiana. President Donald Trump, who hosted House GOP leaders for several hours to discuss reconciliation earlier in the day, is slated to attend the game Sunday.
    • “We are almost there,” Johnson said. “A couple final details that we’ve got to work out.”
  • The Washington Post reports
    • A federal judge said Friday he will temporarily bar the U.S. Agency for International Development from putting 2,200 workers on paid leave as planned by the end of the day after employee groups filed a lawsuit challenging the Trump administration’s authority to shut down the agency.
    • U.S. District Judge Carl J. Nichols said after a hastily called hearing that he will enter a “limited” order in the lawsuit, brought Thursday, and was still weighing whether to order the government to undo the decision to place an additional 500 workers on paid leave.
    • Nichols said he would explain his decision in writing Friday evening, and cautioned that his freeze would be temporary while both sides flesh out their complex but hastily sketched-out claims.
  • OPM on its Fork in the Road webpage acknowledges the federal court order extending the “deadline for the Deferred Resignation Program, the deadline for federal employees to accept the program is being extended to Monday, February 10, at 11:59 pm ET.
  • MedTech Dive tells us,
    • “The American Hospital Association (AHA) has called for the Trump administration to exempt medical devices from tariffs on imports from Canada, China and Mexico.
    • “In a letter sent to President Donald Trump Tuesday, AHA CEO Richard Pollack said disruption to the supply of devices from China would curtail hospitals’ ability to perform life-saving surgeries, protect patients and healthcare workers from contagion, and diagnose and monitor patient conditions.
    • “The AHA is particularly concerned about products that are already in short supply despite ongoing efforts to strengthen the domestic supply chain, Pollack said.”
  • The Government Accountability Office released a report on the Postal Service today.
    • “The U.S. Postal Service is consolidating some of its mail processing facilities. Before doing so, USPS must give public notice of the proposed changes and provide information on how the changes will affect costs, employees, and mail service.
    • “But we found that USPS’s process for estimating the costs of these changes doesn’t align with best practices we considered. For example, USPS doesn’t document all the assumptions and methodologies it uses to develop cost estimates. This information would help decision-makers and oversight groups better understand any risks or uncertainty involved in the estimates.
    • ‘Our recommendations address this issue.

From the public health and medical research front,

  • Fierce Pharma points out,
    • “Since 1999, Feb. 7 has marked National Black HIV/AIDS Awareness Day, drawing attention to the disproportionate impact of HIV on Black communities.
    • “For ViiV Healthcare—the HIV-focused joint venture between GSK, Pfizer and Shionogi—the day represents a dual opportunity to both celebrate progress and plan next steps, according to Randevyn Pierre, ViiV’s head of national field engagement in external affairs.
    • “It’s the moment for us to remember those who have contributed so much to this fight to end HIV/AIDS, and it’s an opportunity for us to celebrate how far we’ve come in HIV treatment, advocacy, activism, research and community work, and also to use that as evidence of how far we can go to end HIV,” Pierre said in an interview with Fierce Pharma Marketing.”
  • The Centers for Disease Control and Prevention announced
    • “Seasonal influenza activity remains elevated and continues to increase across the country. COVID-19 activity is elevated in many areas of the country. RSV activity is declining in most areas of the country.
    • “COVID-19
      • “COVID-19 activity is elevated in many areas of the country. Though wastewater levels are high, emergency department visits are at low levels, and laboratory percent positivity is declining. Emergency department visits and hospitalizations are highest in older adults and emergency department visits are also elevated in young children.
      • “There is still time to benefit from getting your recommended immunizations to reduce your risk of illness this season, especially severe illness and hospitalization.
      • “CDC expects the 2024-2025 COVID-19 vaccine to work well for currently circulating variants. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.
    • “Influenza
    • ‘RSV
      • “RSV activity remains elevated but 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 are 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 informs us,
    • “Infection with the SARS-CoV-2 Omicron variant confers weak, short-term protection against reinfection, compared with the much more robust and durable protection provided by earlier variants, which highlights the need for periodic vaccine updates, a Cornell University Qatar–led study suggests.
    • ‘The researchers used a test-negative, case-control study design to compare the efficacy of SARS-CoV-2 Omicron infection against reinfection and poor outcomes in Qataris with that offered by infection with previously dominant strains such as Alpha, Beta, and Delta. COVID-positive people were matched with COVID-negative controls in a 1:2 ratio by sex, age-group, nationality, number of underlying medical conditions, vaccine doses received, week of COVID-19 test, testing method, and reason for testing.
    • “The results were published yesterday in Nature. today.”
  • and
    • “Researchers today in JAMA Network Open say children with previous COVID-19 infection have a 25% to 28% higher risk of developing new gastrointestinal (GI) tract symptoms for up to 2 years than kids who did not report SARS-CoV-2 infections.
    • “Studies in adults have shown that the risk of developing new GI symptoms, including abdominal pain, irritable bowel syndrome (IBS), and gastroesophageal reflux disease (GERD), is increased in the year following COVID-19 infection, but it is unknown if kids are at the same increased risk.” 
  • Beckers Clinical Leadership adds “Flu cases reach highest levels since 2009 pandemic: 6 respiratory virus updates.”
    • “Flu levels have surged to their highest levels since the 2009 swine flu pandemic, with influenza-related emergency department visits remaining very high across the U.S. 
    • “The flu continues to drive the most respiratory illness activity and officials warn that flu-related emergency department visits are expected to remain high in the coming weeks. “
  • The American Hospital Association News lets us know.
    • “A study by the Penn State Department of Nutritional Sciences found that low vitamin D levels in the first trimester of pregnancy are associated with higher rates of preterm birth and decreased fetal length.    
    • “More than 25% of women who are pregnant or lactating have lower than recommended levels of vitamin D,” said Alison Gernand, one of the study’s authors.   
    • “Women with higher levels of vitamin D were found to have experienced small but statistically significant increases in fetal length.”
  • The New York Times reports,
    • “Hospital and emergency room patients diagnosed with cannabis use disorder — defined as an inability to stop using cannabis even when the drug is causing harm — died at almost three times the rate of individuals without the disorder over the next five years, according to a study published on Thursday, the largest on the subject.
    • ‘Patients with cannabis use disorder were 10 times as likely to die by suicide as those in the general population. They were also more likely to die from trauma, drug poisonings and lung cancer. Those numbers suggest that cannabis use disorder is about half as dangerous as opioid addiction and slightly less dangerous than alcohol use disorder, the researchers said.
    • “A second report, published on Tuesday, found that more cases of schizophrenia and psychosis in Canada have been linked to cannabis use disorder since the drug was legalized.
    • “Many people think, ‘Oh, cannabis is not harmful — it’s organic, it’s natural; how great,’” said Dr. Laura Bierut, a psychiatrist at Washington University School of Medicine in St. Louis who is an author of an editorial accompanying the study of death risk. But the marijuana sold today is far more potent, and more harmful, than what baby boomers smoked in the 1960s and 1970s, she said.”
  • Per Healio,
    • “Central obesity measures of waist circumference and waist-to-hip ratio appear to be more accurate and consistent indicators of colorectal cancer incidence compared with BMI, according to a study published in JAMA Network Open.“
  • and
    • “A blood-based biomarker test may be a reliable method for predicting or ruling out Alzheimer’s disease-related pathology and subsequently for assisting clinicians in formulating a treatment plan for patients, according to new research.
    • “The clinical integration of blood biomarkers for AD holds promise in enabling the early detection of pathology and timely intervention,” Mark Monane, MD, MBA, senior medical adviser at C2N Diagnostics, which funded the study, and colleagues wrote in Diagnostics. “The use of a blood biomarker test that is scalable and accessible as well as acceptable and equitable may address the unmet need in diagnostic testing.”

From the U.S. healthcare business front,

  • Beckers Hospital Review lets us know,
    • “Oakland, Calif.-based Kaiser Permanente posted an operating income of $569 million (0.5% operating marin) in 2024, up from an operating income of $329 million (0.3% margin) in 2023, according to its Feb. 7 financial report. 
    • “Kaiser’s 2024 results include Risant Health, the Washington, D.C.-based nonprofit it formed to “to expand and accelerate the adoption of value-based care in diverse, multi-payer, multi-provider, community-based health system environments.” Risant closed the acquisition of its first health system, Danville, Pa.-based Geisinger, on March 31. It closed the acquisition of its second, Greensboro, N.C.-based Cone Health, on Dec. 1. 
    • “Kaiser reported operating revenues of $115.8 billion for the fiscal year ended Dec. 31, up from $100.8 billion in 2023. The system posted operating expenses of $115.2 billion, up from $100.5 billion in 2023. 
    • “The system posted a net income of $12.9 billion in 2024. Standard accounting rules required Kaiser and Risant to report the net value of unrestricted assets of the organizations that became part of Risant as one-time net income on its financial statements. A total of $6.8 billion of the $12.9 billion in the system’s net income was related to those acquisitions. The system posted a net income of $4.1 billion in 2023. 
    • “Kaiser reported capital spending of $3.7 billion in 2024, down from $3.8 billion in 2023. Its capital spending priorities in 2024 included preparations to meet California’s seismic safety standards by 2030 and supporting investments in leading-edge technologies and environmentally sustainable facilities. As of Dec. 31, Kaiser and Risant had 55 hospitals, 841 medical offices and 40 retail and employee clinics. “
  • Healthcare Dive reports,
    • “Verily, the life sciences arm of technology giant Alphabet, has reached a deal to sell its insurance subsidiary to Elevance, the payer confirmed to Healthcare Dive on Friday.
    • “The subsidiary, called Granular Insurance Company, provides stop-loss insurance for employers meant to protect them from catastrophically high medical costs.
    • “Terms of the deal were not disclosed.”
  • and
    • “A federal bankruptcy judge agreed to a deal on Thursday that places Prospect Medical’s struggling health system Crozer Health into a 30-day receivership.
    • “Under the terms, Pennsylvania regulators will provide Washington, D.C.-based FTI Consulting $20 million to act as an independent monitor and manager of Crozer while Prospect continues to search for a permanent buyer for the four-hospital health system.
    • “The deal isn’t the one Prospect originally intended to present before the Texas court. However, it will keep the lights on at Crozer for at least another 30 days.”
  • BioPharma Dive notes,
    • “Alumis and Acelyrin are merging, the biotechnology companies said Thursday afternoon, in an all-stock deal that leaves the combined company with a bigger cash balance and three drugs in clinical testing. 
    • “Per deal terms, Acelryin stockholders will receive 0.4274 shares of Alumis stock for each share they own, leaving them with about 45% of the combined company and Alumis equity holders with 55%. The new company, which will keep the Alumis name and be run by its executive team, would have $737 million in cash, enough to keep operating into 2027.  
    • “The merged entity will continue to develop Alumis’ two so-called TYK2 inhibitors, one of which is being developed for plaque psoriasis and lupus while the other is targeting neuroinflammatory conditions like multiple sclerosis. Acelyrin’s top prospect, a thyroid eye disease drug called lonigutamab, is part of the deal, too, but the program will be re-evaluated to “confirm its differentiation in a capital efficient manner,” the companies said.”

Thursday Report

David Ermer–CDC, CMS, Congress, Medical / Rx research, OPM, Rx coverage, Telehealth, U.S. Healthcare–

From Washington, DC

Photo by Josh Mills on Unsplash

From Capitol Hill

  • The Wall Steet Journal reports
    • “House Republicans wrapped up a more than four-hour meeting at the White House saying that they had closed gaps in their own internal disagreements over extending expiring tax cuts and cutting spending, and they indicated that they were on track to hold a key committee vote next week.
    • “We had a very productive meeting at the White House,” House Majority Leader Steve Scalise (R., La.) told reporters after lawmakers streamed into the Capitol. “We are narrowing down the areas of differences.”
    • “House Republicans from different factions of the party assembled at the White House, each hoping to get Trump’s support for their proposals and resolve disputes that have slowed the party’s progress on taxes, spending and immigration.”
  • The Senate press gallery tells us Thursday evening, “The Senate is considering the nomination of Russell Vought to be Director of the Office of Management and Budget, post cloture. If all time is used, a confirmation vote would occur at 7:00 p.m. We expect several procedural votes to follow the vote on the Vought nomination.”
  • The Washington Post adds,
    • “The Senate on Thursday confirmed Russell Vought as the next director of the powerful White House budget office, installing a conservative fiscal hawk who has promised to pursue sweeping spending cuts and empower President Donald Trump to conform the budget to his political views.
    • “Republicans marshaled a 53-47 vote in support of Vought, who immediately inherits the exceedingly complicated tasks of staving off a government shutdown and preventing a catastrophic debt default — with a political clash over the two critical fiscal deadlines just weeks away.”

From the White House,

  • The Wall Street Journal lets us know,
    • “The White House is working on an executive order to fire thousands of U.S. Department of Health and Human Services workers, according to people familiar with the matter.
    • “Under the order, the Food and Drug Administration, Centers for Disease Control and Prevention and other health agencies would have to cut a certain percentage of employees. 
    • “The order could come as soon as next week, people familiar with the matter said, after workers have an opportunity to take a buyout. The terms of the order haven’t been finalized, however, and the White House could still decide against going forward with the plans.
    • “The job cuts under consideration would affect the Department of Health and Human Services, which employs more than 80,000 people and includes the National Institutes of Health and the Centers for Medicare and Medicaid Services, in addition to the FDA and CDC.
    • “The agencies are responsible for a range of functions, from approving new drugs to tracing bird-flu outbreaks and researching cancer. A loss of staff could affect the efforts depending on which workers are cut and whether they are concentrated in particular areas.
    • ‘The White House on Thursday denied that there is an executive order related to HHS coming.”

From the judicial front,

  • The Wall Street Journal informs us,
    • “A federal judge paused a Thursday deadline for federal employees to decide whether to accept an offer from the Trump administration to resign their jobs voluntarily as the president and his allies attempt to shrink the government workforce.
    • “U.S. District Judge George O’Toole in Massachusetts scheduled a hearing for Monday on whether to grant a temporary restraining order that would block the program while the litigation challenging the offer proceeds.
    • “Employees had previously been told they had until the end of the day on Thursday to decide whether to accept the offer.”

From the Food and Drug Administration front,

  • Per Cardiovascular Business,
    • “The U.S. Food and Drug Administration (FDA) is warning patients with diabetes about the risk of missing critical safety alerts when using continuous glucose monitors, insulin pumps, automated insulin dosing systems and any other similar medical devices. 
    • “While smartphones have made it easier than ever for patients to track their own insulin levels, the convenient technology is far from infallible. In fact, the FDA has received multiple reports of smartphone-compatible medical devices failing to send expected health alerts. When this happens, the agency warned, it creates a risk of patients experiencing severe hypoglycemia, severe hyperglycemia, diabetes ketoacidosis or even death.
    • “Modern medical devices, such as diabetes devices that connect to a smartphone, can provide users with the convenience and flexibility to configure alerts that are personalized to them,” Courtney Lias, director of the Office of In Vitro Diagnostic Products in the FDA’s Center for Devices and Radiological Health, said in a statement. “However, users should stay aware of alert settings and monitor these devices to ensure they continue to receive critical alerts as expected. Even if configured correctly, certain hardware or software changes can interrupt the expected operation of these critical devices, which can lead to patient harm if undetected.”
  • Per a news release,
    • “The Institute for Clinical and Economic Review (ICER) today released a Draft Evidence Report assessing the comparative clinical effectiveness and value of sonpiretigene isteparvovec (Nanoscope Therapeutics) for the treatment of advanced retinitis pigmentosa.
    • “This preliminary draft marks the midpoint of ICER’s eight-month process of assessing this treatment, and the findings within this document should not be interpreted to be ICER’s final conclusions.“

From the Postal Service front,

  • Federal News Network reports,
    • “The Postal Service ended the first quarter of fiscal 2025 with a net profit — a rare moment in the black that Postmaster General Louis DeJoy says is evidence the agency is on the “right path” to overcome long-term financial challenges.
    • “USPS reported $144 million in net income for the first quarter of fiscal 2025, a dramatic reversal from the $2.1 billion net loss for the same quarter last year. The agency’s first quarter is usually its best all year.
    • “USPS, however, still anticipates ending FY 2025 with a $6.9 billion net loss.
    • “The last time USPS saw a net profit was in fiscal 2022, when it ended the year with a $56 billion net profit, ending a nearly 15-year streak of annual net losses.
    • “That sudden change, however, came from Congress passing the Postal Service Reform Act, which ended a mandate for USPS to pre-fund its retiree health benefits well into the future, and brought the agency back to a pay-as-you-go system. The legislation also forgave $57 billion in deferred payments to the retiree health fund.”

From the public health and medical research front,

  • The American Hospital Association News points out,
    • “The U.S. maternal mortality rate decreased to 18.6 deaths per 100,000 live births in 2023, down from 22.3 in 2022, according to new data from the Centers for Disease Control and Prevention. While the mortality rate decreased overall, the maternal mortality rate for Black women in 2023 was 50.3 deaths per 100,000 live births, significantly higher than rates for white (14.5), Hispanic (12.4) and Asian (10.7) women.” 
  • and
    • “The Centers for Disease Control and Prevention Feb. 6 released an advisory  about an outbreak of Ebola in Uganda caused by the Sudan virus disease. There are currently no suspected, probable or confirmed Ebola cases related to the outbreak that have been reported in the United States or outside of Uganda. The CDC recommends travelers monitor themselves for symptoms of SVD while in Uganda and 21 days after leaving.”
       
  • Healio adds
    • “Pregnant women are more likely to die of violence than any medical cause in the U.S. and are at greater risk for violent death compared with nonpregnant women, underscoring the need for intimate partner violence screening, data show. 
    • “In an analysis of CDC mortality data presented at The Pregnancy Meeting, researchers also found that domestic violence firearm legislation was associated with a reduction in homicide and firearm death in pregnancy.”
  • Modern Healthcare reports,
    • “Kaiser Permanente and Tufts University have launched a joint initiative aimed at improving nutritional and dietary health, the organizations said Thursday. 
    • “The Food is Medicine National Network of Excellence comprises Tufts University’s Food is Medicine Institute in Medford, Massachusetts, and Oakland, California-headquartered Kaiser, along with network members such as Blue Cross and Blue Shield of North Carolina, CVS Health, Devoted Health, Elevance Health, Geisinger Health and Highmark Health. 
    • “Network members will track patient outcomes following nutritional and dietary changes and use the data to instruct care delivery and promote food-is-medicine initiatives, according to a news release.”
  • Per the Health Care Cost Institute,
    • The Health Care Cost Institute (HCCI), in collaboration with West Health, conducted an analysis on the use of telehealth mental health services among people with employer-sponsored insurance (ESI). We found that telehealth played an outsized role in the delivery of mental health services starting in 2020, with over 40% of mental health visits occurring via telehealth from 2020-2022. Females, young adults, and people residing in the northeast and west coast received the highest share of mental health care via telehealth. Therapy was the most commonly received mental health service via telehealth.
  • Per AHA News,
    • The Centers for Disease Control and Prevention Feb. 6 released a report on emergency department use during the Los Angeles County wildfires that began Jan. 7. All-cause ED encounters in Los Angeles County initially decreased 9% after the start of wildfires, while wildfire-associated encounters increased eightfold. Wildfire-associated ED encounters peaked from the period of Jan. 7-12, aligning with worsened air quality deemed unhealthy for sensitive groups. The CDC said the initial decrease in all-cause visits could be due to evacuations; alterations in activity patterns; or residents seeking care in clinics, urgent care centers or EDs in neighboring counties.”

From the U.S. healthcare business front,

  • STAT News reports,
    • “A strange thing happened weeks before the Food and Drug Administration approved the first treatment made with CRISPR gene editing, an all-but cure for certain patients with sickle cell disease. CRISPR Therapeutics, the biotech that co-developed the therapy, laid off about 50 employees. “Everyone was dumbfounded,” said a scientist who was let go.
    • “It was one early sign that, for all the public accolades, the CRISPR revolution wasn’t exactly going according to plan. 
    • The gene editing tool, wrested out of bacteria 13 years ago by a fractious group of biochemists, was supposed to change medicine. Excitement surged through boardrooms, patient communities, and the press. No less an authority than a Nobel Prize committee announced, in 2020, that CRISPR “may make the dream of curing inherited diseases come true.” Billions were spent chasing that vision, along with treatments for cancer and other non-hereditary diseases, such as HIV.
    • “Few still talk that way. They sure don’t spend that way.
    • “Over the last 16 months, layoffs have hit nearly every major CRISPR public and private biotech. Eight public CRISPR stocks are down roughly 50% over the past year. Most are down over 75% from their 2021 peak, when near 0% interest rates and the enthusiasm around mRNA fueled a gene editing bubble. Buzzy startups have closed or merged out of existence, sometimes thunderously. In August, Tome Biosciences collapsed, just eight months after announcing $213 million in funding from biotech’s most prestigious investors and a plan to write “the final chapter in genomic medicines.” [See STAT’s updated CRISPR Tracker here.]“
  • From Beckers Payer Issues, we learn that “KLAS Research, a healthcare IT data and insights company, named its “Best in KLAS” payer tools for 2025.”
  • Healthcare Dive notes,
    • “Molina reported mixed fourth-quarter results on Wednesday, beating Wall Street expectations on revenue but missing on earnings. The payer also laid out earnings guidance for 2025 that was lower than analysts had anticipated.
    • “The fourth-quarter earnings miss was due to higher medical spending in Medicaid, with no help from the risk corridors that kept the worst of utilization jumps from hitting Molina’s bottom line earlier in 2024. Meanwhile, the lower earnings forecast for this year is because of implementation costs from recent contract wins in Medicaid and for individuals dually eligible for both the safety-net program and Medicare, according to the insurer.
    • “The results and 2025 outlook are “disappointing at face value,” but accretion from the contract wins could set Molina up well for 2026, J.P. Morgan analyst John Stansel said in a note Wednesday.”
  • Per BioPharma Dive,
    • “Bristol Myers Squibb is expanding its plan to cut costs, announcing alongside quarterly earnings on Thursday that it will slash an additional $2 billion in annual expenses by the end of 2027. 
    • “The announcement builds on cutbacks Bristol Myers announced last April and that affected about 2,200 employees. Bristol Myers didn’t say how many workers will be impacted by the new initiative, but Chief Financial Officer David Elkins told analysts on a conference call that cuts will drive “operational efficiencies across multiple areas of the business.” 
    • “Bristol Myers is already facing limited generic competition for one of its highest-grossing products, the multiple myeloma drug Revlimid. But it’s also bracing for the loss of billions in yearly revenue when patents expire for its cancer immunotherapy Opdivo and blood thinner Eliquis. The planned cuts announced Thursday will help Bristol Myers become a “leaner, more focused company” along the way, CEO Chris Boerner said.”
  • and
    • “Sales of Cobenfy, a new mind-stabilizing medicine, totaled $10 million in the final months of last year, results that fell in line with analyst expectations.
    • “Bristol Myers Squibb, which acquired Cobenfy through its $14 billion purchase of Karuna Therapeutics, gave a first look at the medicine’s launch in an earnings report released Thursday. Cobenfy comes as a capsule. It received Food and Drug Administration approval on Sept. 26 as a treatment for schizophrenia, then launched onto the U.S. market in late October.
    • “By Bristol Myers’ count, the number of filled Cobenfy prescriptions had climbed to around 1,000 per week by the end of January. Chief Commercial Officer Adam Lenkowsky told investors on an earnings call that the “launch is really off to a strong start” and the company has “made very good progress achieving our access goals.”

Monday Report

David Ermer–CDC, Congress, FDA, Medical / Rx research, Medicare, Obesity, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC,

  • This afternoon, a cloture petition on the nomination of Russell Vought to be Director of the Office of Management and Budget was filed with the Senate. The next step will be a vote on the cloture motion which requires 51 votes.
  • Per a Senate news release,
    • “U.S. Senate Finance Committee Chairman Mike Crapo (R-Idaho) and Finance Committee member Michael Bennet (D-Colorado), with Ranking Member Ron Wyden (D-Oregon) and Finance Committee member Tim Scott (R-South Carolina), reintroduced the Medicare Multi-Cancer Early Detection (MCED) Screening Coverage Act that would ensure Medicare beneficiaries’ access to cutting-edge tests capable of detecting multiple types of cancer before symptoms appear.  Bipartisan companion legislation (H.R. 842) was also introduced in the U.S. House of Representatives.” * * *
    • Bill text can be found here. 
  • Nature adds,
    • “US Preventive Services Task Force (USPSTF) guidelines recommend single-cancer screening for select cancers (e.g., breast, cervical, colorectal, lung). Advances in genome sequencing and machine learning have facilitated the development of blood-based multi-cancer early detection (MCED) tests intended to complement single-cancer screening. MCED tests can interrogate circulating cell-free DNA to detect a shared cancer signal across multiple tumor types. We report real-world experience with an MCED test that detected cancer signals in three individuals subsequently diagnosed with cancers of the ovary, kidney, and head/neck that lack USPSTF-recommended screening. These cases illustrate the potential of MCED tests to detect early-stage cancers amenable to cure.”
  • The New York Times reports,
    • The U.S. Food and Drug Administration has given the green light to two biotechnology companies for clinical trials that will transplant organs from genetically modified pigs into people with kidney failure. If successful, these studies could lead to the broader use of cross-species transplantation, a dream of medical scientists for centuries.
    • One of the companies, United Therapeutics Corporation, will begin its trial with six patients, but that number could eventually rise to 50. The other, eGenesis, said it would begin with three patients and grow the study from there.
    • “We are entering a transformative era in organ transplantation,” said Mike Curtis, the president and chief executive of eGenesis.
  • The Government Accountability Office released a report on food safety.
    • “Millions of Americans get sick from foodborne illness every year. While many cases are mild, some cases can result in hospitalization, long-lasting complications, or even death.
    • “In this Q&A, we reported that the safety and quality of the U.S. food supply is governed by at least 30 federal laws, collectively administered by 15 federal agencies. Federal agencies have developed some agency-specific and joint goals related to reducing foodborne illness, but most of these goals have not been met.
    • “A national food safety strategy could help ensure agencies are working together in an effective and efficient manner to reduce foodborne illness.”
  • AHIP offers for public download a report on Medicare Advantage Demographics. “The most recent demographic data [released last Friday January 31] show that MA continued to be a vital source of coverage for low-income Medicare enrollees and diverse populations.”

From the public health and medical research front,

  • The New York Times considers whether the “Bird Flu Could Become Airborne? Scientists were slow to recognize that Covid spreads through the air. Some are now trying to get ahead of the bird flu.”
  • BioPharma Dive adds, “Drugmakers prep for bird flu outbreak, despite continued low risk. While the virus hasn’t made a sustained leap into humans, vaccines and treatments are being developed ahead of an outbreak.”
  • The American Medical Association lets us know what doctors wish their patients knew about Alzheimer’s Disease.
  • The Washington Post informs us,
    • “Those who go hungry or worry about getting food while pregnant are at higher risk of complications such as preeclampsia and gestational diabetes, a new analysis suggests.
    • “The paper, published in JAMA Network Open, used data from an online health survey of more than 19,300 pregnant Kaiser Permanente Northern California members between June 2020 and September 2022. Researchers did not find similar risks among those who received food assistance while pregnant.”
  • Per MedPage Today,
    • “Just over half of patients with overweight or obesity discontinued their GLP-1 receptor agonist within 1 year, with rates even higher among the subset without type 2 diabetes, according to a retrospective cohort study.
    • “Among over 125,000 patients, 53.6% discontinued their GLP-1 receptor agonist by 1 year, and these rates were significantly higher for patients without versus with type 2 diabetes (64.8% vs 46.5%), reported Ezekiel J. Emanuel, MD, PhD, of the University of Pennsylvania in Philadelphia, and colleagues.
    • “Regardless of diabetes status, every 1% of body weight loss was tied to a 3% lower risk of discontinuation, they wrote in JAMA Network Open.
    • “Of the 41,792 patients who stopped treatment and had a weight measurement at discontinuation available, 47.3% and 36.3% of those with and without type 2 diabetes, respectively, restarted their GLP-1 agent at 1 year, and 57.3% and 46.4% restarted within 2 years. For every 1% of body weight regained after discontinuing treatment, there was a 2% to 3% increased hazard of restarting treatment.
    • “The high discontinuation rate did not come as much of a surprise, as prior studies have reported GLP-1 receptor agonist discontinuation rates of up to 81%, Emanuel’s group wrote. They added that the links between weight loss and discontinuation and between weight regain and reinitiation “suggest that weight management is an important factor regardless of type 2 diabetes status.”
  • Per BioPharma Dive,
    • “Adding Pfizer’s cancer drug Braftovi to standard treatments helped people with a form of colorectal cancer live longer without their disease worsening than those who got the typical care alone in a Phase 3 trial, the company said Monday.
    • “The result confirms earlier research from the study, called Breakwater, which had shown that trial volunteers receiving Braftovi were significantly more likely to see their tumors shrink or disappear. Those data were used to support an accelerated U.S. clearance for Braftovi in colorectal cancer in December.”

From the U.S. healthcare business front,

  • Healthcare Dive tells us,
    • “Health supply chain costs and pharmaceutical expenses are projected to rise modestly between July 2025 and June 2026, according to new research from healthcare services company Vizient.
    • “Pharmacy spend will rise 3.8%, driven in part by increased demand for specialty medications. AbbVie’s autoimmune disease drug Humira will continue to be the most popular drug by total spend, however popular GLP-1s like Ozempic, Wegovy and Mounjaro are projected to enter the top-10 list of medications by total spend.
    • “Supply chain costs will rise by approximately 2% during the period, following higher prices for raw materials, increased freight and shipping costs and tariffs on medical-surgical products, according to the report.”
  • Fierce Healthcare adds,
    • “Moody’s Ratings is downgrading the insurance industry’s credit outlook to negative as elevated medical costs continue to batter payers.
    • “Moody’s analysts noted in a report that spending in the commercial market alone is set to increase by 8% this year, the fastest rate recorded in 13 years. Spending in the individual market, meanwhile, is set to climb by 7.5%, another increase that’s higher than in recent years.
    • “Factors driving these spending hikes include inflation, prescription drug spending and higher utilization of behavioral health. Based on those trends, Moody’s projects spending in Medicare Advantage (MA) will also increase by between 5% and 7%.
    • “We are changing our outlook on the health insurance sector to negative from stable,” the Moody’s analysts wrote. “Although we expect EBITDA growth to remain in the low single digits, insurers will continue to grapple with medical costs in excess of reimbursement rates for MA and Medicaid, while commercial coverage also faces continued high medical costs.
  • Per Healthcare Dive,
    • “Cigna has released a plan it says will make healthcare more affordable and accessible for its members — including tying executive compensation to customer satisfaction — as health insurers continue to reckon with discontent with their industry since the killing of a major insurance executive late last year.
    • “Cigna plans to start linking bonus awards for high-level officers to the company’s net promoter score, a measure of customer loyalty and satisfaction, the Connecticut-based insurer said Monday.
    • “Cigna will also invest in more care advocates, pare back hurdles to receiving care and make it easier for doctors to update patients on the status of prior authorization requests. Cigna also plans to release an annual “customer transparency” report starting next year with information on its business practices, including data on prior authorization requests, appeals and denials.”
  • and
    • Bankrupt Prospect Medical Holdings said Friday it intends to sell Crozer Health, its four-hospital health system based in Pennsylvania, to an unnamed consortium of nonprofit healthcare operators.
    • Attorneys for Prospect said the proposed sale is the “only viable alternative to an immediate, forced shutdown of the Pennsylvania Hospitals” in documents filed in federal bankruptcy court on Friday.
    • Prospect will appear before the bankruptcy court on Thursday to seek approval for the transaction. As of Monday morning, the hospital operator had yet to file critical details about the sale to the court, including a proposed purchase price or the names of the possible buyers. However, a press release says the deal would include all Crozer hospitals, ambulatory surgery centers, clinics and physician offices.

Friday Report

David Ermer–CDC, Congress, COVID-19, FDA, Medical / Rx research, Medicare, OPM, Rx coverage, U.S. Healthcare–

From Washington, DC,

White House News

  • Per a White House fact sheet,
    • “ELIMINATING 10 REGULATIONS FOR EACH NEW REGULATION ISSUED: Today, President Donald J. Trump signed an Executive Order to unleash prosperity through deregulation. 
    • “The Order requires that whenever an agency promulgates a new rule, regulation, or guidance, it must identify at least 10 existing rules, regulations, or guidance documents to be repealed.  
    • “The Director of the Office of Management and Budget will ensure standardized measurement and estimation of regulatory costs.
    • “It requires that for fiscal year 2025, the total incremental cost of all new regulations, including repealed regulations, be significantly less than zero.'”
  • FEHBlog observation – The White House needs to turn its attention to subregulatory guidance.

Capitol Hill news

  • Modern Healthcare reports,
    • “Doctors and some bipartisan allies on Capitol Hill advanced their campaign to boost Medicare physician reimbursements with the release of new legislation Friday.
    • “The Medicare Patient Access and Practice Stabilization Act of 2025 would give doctors a 6.6% rate increase through 2026 and be retroactive to the beginning of this year, when a 2.9% cut took effect.” * * *
    • “The next government funding bill, which must pass by March 14 to prevent a partial shutdown, is an obvious vehicle. Supporters would likely have a greater chance getting Medicare physician reimbursements into that legislation than into a broader bill with many billions in healthcare cuts that Trump and GOP leaders are drafting on a partisan track.”
  • Per a Senate press release,
    • “U.S. Senate Democratic Whip Dick Durbin (D-IL) and U.S. Senator Chuck Grassley (R-IA), a senior member and former chairman of the Senate Finance Committee, today sent a letter to the President and CEO of the Pharmaceutical Research and Manufacturers of America (PhRMA) urging them to embrace their bipartisan legislation, the Drug-price Transparency for Consumers (DTC) Act, to empower patients and providers and commit to voluntarily disclosing list prices in DTC advertisements. 
    • “The Senators wrote, “The United States is one of only two developed countries in the world that permits such pharmaceutical commercials. President Trump’s nominee for Health and Human Services Secretary has expressed interest in outright banning this practice. It would be wise for drug companies to adopt commonsense solutions to address the concerns that have been raised about DTC prescription drug advertising. As you are aware, the United States Senate previously voted unanimously to pass our measure to require that pharmaceutical companies disclose their list prices in DTC ads, and it is our hope that this policy will become law this Congress. This bipartisan legislation would ensure that when patients are bombarded with information about the newest wonder drug, the price is not kept secret. President Trump previously has issued regulations to advance this policy.” * * *
    • Full text of the letter is available here.

OPM News

  • OPM issued an addendum (FEHBlog Dropbox link) to its 2026 FEHB / PSHB call letter today which implements two of the President’s executive orders.
  • Federal News Network reports,
    • “Trump administration officials are taking major steps to cut down the size of the workforce and federal programs at the Office of Personnel Management.
    • “During an internal meeting Friday morning, Trump administration officials directed OPM senior career staff to begin making plans to cut the agency’s workforce and programs by 70%. Multiple sources with direct knowledge of the meeting confirmed the details of the meeting to Federal News Network.
    • “Sources who provided information to Federal News Network on the condition of anonymity said the political leadership at the agency also directed OPM leaders to stop work on anything that is not statutorily required.
    • “Trump administration officials told agency office leaders and associate directors at OPM to prepare briefs over the weekend detailing all of their work and programs that are statutorily required. By Monday, all OPM offices are expected to give political leaders organizational staffing charts with plans for an initial 30% reduction for both federal employees and contractors.”

Postal Service news

  • Federal News Network tells us
    • “The Postal Service’s regulator warns the next phase of a 10-year reform plan would slow mail delivery for a “significant portion of the nation,” but wouldn’t save USPS enough money to justify the changes.
    • “The Postal Regulatory Commission, in an advisory opinion on key parts of the USPS “Delivering for America” plan, found upcoming changes meant to cut billions of dollars each year wouldn’t do much to help the agency regain its long-term financial footing — but would lead to “disproportionate” cuts in service across rural communities.
    • “A PRC official told Federal News Network that nearly 40% of single-piece first-class mail — including letters and postcards — would see a service downgrade under these changes — and that the impact would be even greater in rural areas.
    • “The Commission urges the Postal Service to reconsider whether the speculative, meager gains from this proposal outweigh the certain downgrade in service for a significant portion of the nation,” the PRC wrote Friday.”

FDA News

  • MedPage Today informs us,
    • “The FDA approved an oral combination of meloxicam and rizatriptan (Symbravo) to treat adults with acute migraine with or without aura, Axsome Therapeutics announcedopens in a new tab or window.
    • “Meloxicam is a COX-2 preferential non-steroidal anti-inflammatory drug (NSAID) and rizatriptan is a 5-HT 1B/1D agonist (triptan). The newly approved drug uses a proprietary technology called MoSEIC to increase meloxicam’s solubility and speed of absorption after the drug is taken orally while maintaining its extended plasma half-life.
    • “A significant proportion of migraine patients experience inadequate efficacy with currently available acute treatments, leading to even greater suffering, and an increased risk of worsening of migraine pain and attack frequency,” said Richard Lipton, MD, of Albert Einstein College of Medicine in New York City, in a statement. “Results of multiple clinical trials demonstrate that Symbravo can provide rapid and long-lasting freedom from migraine pain, whether treatment is taken early in the attack while the pain is mild, or later in the attack when the pain may be severe.”

From the public health and medical research front,

  • The Centers for Disease Control and Prevention announced today
    • “Seasonal influenza activity remains elevated and continues to increase across the country. COVID-19 activity is elevated in many areas of the country. RSV activity is declining in many areas of the country.
    • “COVID-19
      • “COVID-19 activity is elevated in many areas of the country. Though wastewater levels are high, emergency department visits are at low levels, and laboratory percent positivity was similar to last week. Emergency department visits and hospitalizations are highest in older adults and emergency department visits are also elevated in young children.
      • “There is still time to benefit from getting your recommended immunizations to reduce your risk of illness this season, especially severe illness and hospitalization.
      • “CDC expects the 2024-2025 COVID-19 vaccine to work well for currently circulating variants. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.
    • “Influenza
    • “RSV
      • “RSV activity remains elevated but is declining in many 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 are 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.
  • News supplementing the CDC report
    • Health Day notes,
      • “People still see COVID-19 as an ongoing public health threat, even though the pandemic officially ended in 2023, according to a new HealthDay/Harris Poll.
      • “Nearly 3 in 4 people (72%) agree COVID is still a serious public health issue, including more than a third (35%) who strongly agree, the poll found.
      • “COVID has settled into the sort of ongoing health threat already posed by the seasonal flu, which had its turn as a pandemic back in 1918, Dr. Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, said.
      • “You’ll get hundreds of thousands of people hospitalized with influenza every year,” Offit told HealthDay TV. “You’ll get tens of thousands of people who die every year from influenza. I think that’s what COVID is now. I think this virus will be with us for decades, if not longer.”
    • The University of Minnesota’s CIDRAP lets us know
      • “The nation’s flu activity continued a steady rise last week, with 44 states at the high or very high level and that national test positivity just shy of 30%, the Centers for Disease Control and Prevention (CDC) said today in its weekly update.
      • “Outpatient visits for flulike illness have been above the national baseline for 9 weeks in a row. Of samples that tested positive for flu at public health labs, nearly all were influenza A, and subtyped influenza A samples were about evenly split between the H3N2 and 2009 H1N1 strains.
      • “On the CDC’s flu activity map, most of the country is awash in shades of red that reflect high or very high activity. However, some states are shaded purple, the highest level on the activity scale. They include Southeastern states such as Louisiana, South Carolina, and Tennessee, but also several in the Northeast, including Massachusetts, New Jersey, New York, and New Hampshire.
      • “The CDC reported 16 more pediatric flu deaths, which push the season’s total to 47. The deaths occurred between the middle of December and the week ending January 25. All involved influenza A, and, of 13 subtyped samples, 7 were H1N1 and 6 were H3N2. 
      • “For deaths overall, the level remained steady, with flu making up 1.6% of all deaths last week.
      • “Emergency department (ED) visits for flu are at the very high level and are increasing in all age-groups, making up 7% of all ED visits, the CDC said in its weekly respiratory virus snapshot. Meanwhile, hospitalizations for flu remain elevated and are likewise on the rise for all age-groups.”
  • Per STAT News,
    • “Researchers confirmed that antidepressants lead to a significant reduction in generalized anxiety
    • “The long-awaited update, published by the Cochrane Database of Systematic Reviews, considered by some to be the gold-standard of evidence-based health care, considered evidence from 37 unique randomized control trials with 12,226 participants and found that these drugs are effective compared to a placebo.
    • “The drugs’ long-term impacts are muddier, said Prof. Peter Tyrer, an emeritus psychiatry professor at Imperial College London who was not involved in the study. Some patients have difficulties stopping antidepressants because of withdrawal problems. 
    • “The main reason why antidepressants were preferred to benzodiazepines (drugs that are equally effective in treating generalised anxiety) was the dependence risk, we just seem to have shifted the problem of adverse effects from one class of drugs to another,” Tyrer said. 
  • and
    • “To create one of the most advanced immunotherapies in cancer, CAR-T cell therapies, scientists engineer immune T cells to carry a synthetic protein on their surfaces. This protein, called the chimeric antigen receptor or CAR, is what gives these engineered cells such potency against certain cancers and allows them to recognize and destroy malignant cells. In a new study, scientists have found that CAR-T cells are able to donate this synthetic protein to normal T cells, essentially arming other cells in the immune system with advanced technology to kill cancer.
    • “While this finding is fascinating scientists and cancer researchers, it’s not yet clear how sharing CARs between T cells might impact CAR-T therapy efficacy or influence the design of future synthetic receptors, experts told STAT. However, the work does reveal new biology around how T cells share proteins with one another and gives bioengineers some insights into how to manipulate that process.”

From the U.S. healthcare business front,

  • Beckers Payer Issues tells us,
    • “Aetna, Blue Shield of California and Centene’s Health Net have launched a shared, value-based payment model for reimbursing primary care physicians in California.
    • “The project, led by the California Quality Collaborative and the Integrated Healthcare Association, involves 11 providers across the state, covering about 17,000 patients. The single payment model went live on Jan. 1 and aims to address primary care reimbursement challenges, improve health equity, and boost health outcomes. The model focuses on small, independent practices and could eventually expand beyond California, according to a Jan. 30 news release.
    • “Instead of each health plan using its own payment system, the three insurers use a single, shared system that rewards physicians for providing high-quality care, especially among underserved populations. The CQC will help practices implement the new system, improve care coordination, and integrate mental and physical health services. A platform called Cozeva will provide data to help physicians track their performance and close care gaps.
    • “Participating providers are here. A full model guide is available here.“
  • Kauffman Hall offers an infographic about the state of rural healthcare.
  • BioPharma Dive considers the following — “After decades of research, Vertex Pharmaceuticals has an approved pain medicine. Can one of the most powerful biotechs contend with a healthcare system that’s long favored opioids?” The FEHBlog hopes so.
  • Per Fierce Pharma,
    • “One of the most important launches for Novartis in recent years is off with a bang.
    • “Following a broad FDA approval for the adjuvant treatment of HR-positive, HER2-negative early breast cancer in September, Novartis’ Kisqali grew U.S. sales by 65% year over year—or nearly 25% sequentially—to $549 million in the fourth quarter of 2024.
    • “A Novartis presentation released on Friday shows that Kisqali’s new patient starts jumped from an average of around 1,500 per month before the approval to about 2,200 in both October and November. Data for December were not yet available.”
  • and
    • “Two years after AbbVie’s loss of market exclusivity for Humira, those “How it Started and How it’s Going” memes are looking better each quarter for the Illinois drugmaker.
    • “On Friday, when AbbVie reported its quarterly earnings, the pharma giant jacked up its 2027 projected sales of Humira follow-ons Skyrizi and Rinvoq to a combined $31 billion. It is a $4 billion increase on the company’s previous guidance for the immunology duo.
    • “Chief commercial officer Jeff Stewart explained that the projection increase has come because of growing “share capture.” Skyrizi now holds 40% of the total prescription share of the biologics psoriasis market, he said.
    • “Of the $4 billion adjustment to the 2027 projection, $2 billion has been added to Skyrizi’s estimate in inflammatory bowel disease (IBD) and $500 million has been added to Rinvoq’s in the same indication.  
    • “Across the board, we’re seeing tremendous performance, particularly in IBD,” Stewart explained.”

Tuesday Report

David Ermer–CDC, CMS, FDA, Federal employment benefits, Medical / Rx research, OPM, Rx coverage, U.S. Healthcare–
OPM Headquarters a/k/a the Theodore Roosevelt Building

From Washington, DC

  • The Washington Post reports,
    • “The White House’s Office of Personnel Management sent an email blast Tuesday to civilian government employees offering them an easy way to quit with pay through Sept. 30, the most sweeping effort yet by the new Trump administration to shrink the ranks of the federal workforce.
    • “The email instructed employees to reply to the message saying they want to resign if they would like to take the offer, which would provide the incentive for workers who accept by Feb. 6, said an Office of Personnel Management spokesperson. Not all employees will be eligible, according to the spokesperson, who said some of the exemptions will be up to agency heads. Additional carveouts exist for immigration officers, some people in national security-focused roles, the Postal Service and the armed forces, the spokesperson said.”
  • Here is a link to OPM’s FAQs on its “Fork in the Road” program.
  • Federal News Network adds,
    • “Federal employees have filed a lawsuit against the Trump administration’s Office of Personnel Management, after the agency created and began testing an email system meant to deliver mass communications directly to federal employees’ inboxes.
    • “The lawsuit from two anonymous federal employees in the executive branch alleges OPM violated the 2002 E-Government Act by not releasing details of how the communication system will manage federal employees’ personal information stored in the system.
    • “Kel McClanahan, executive director of the National Security Counselors law firm, filed the pro bono lawsuit on behalf of the plaintiffs, alleging that the email system poses security risks for federal employees’ personal information.”
  • and
    • “President Donald Trump’s pick to oversee much of the federal government’s real estate portfolio is looking to significantly downsize the amount of office space that agencies occupy.
    • “Michael Peters, commissioner of Public Buildings Service within the General Services Administration, said the agency is looking at cutting up to half its total real estate portfolio over the coming years.
    • “I’m just getting ramped up, but I think our initial review says that number could be up to a 50% reduction on our square footage across the portfolio. We’re not going to do that in six months, but we’re going to try to do this as rapidly as we can,” Peters said Tuesday.
    • “Peters said a “disproportionate amount of that space” would come from the Washington, D.C. metro area — and will include GSA moving out of its own 1800 F Street headquarters.”
  • The President issued an executive order today announcing, “the policy of the United States that it will not fund, sponsor, promote, assist, or support the so-called “transition” of a child [including teenagers under age 19] from one sex to another, and it will rigorously enforce all laws that prohibit or limit these destructive and life-altering procedures.”
    • With respect to the FEHB Program
      • “The Director of the Office of Personnel Management, as appropriate and consistent with applicable law, shall:
        • “(a)  include provisions in the Federal Employee Health Benefits (FEHB) and Postal Service Health Benefits (PSHB) programs call letter for the 2026 Plan Year specifying that eligible carriers will exclude coverage for pediatric transgender surgeries or hormone treatments; and
        • “(b)  negotiate to obtain appropriate corresponding reductions in FEHB and PSHB p
          premiums.”
  • STAT News informs us,
    • “The Center for Medicare and Medicaid Innovation is continuing plans to implement a pilot project testing new ways for state Medicaid programs to pay for multimillion-dollar cell and gene therapies.
    • “The pilot was started during the Biden administration, following an executive order from former President Biden that directed the center to come up with new ideas to lower drug prices. President Trump rescinded that executive order on Inauguration Day, which initially left the future of the pilot unclear. 
    • “President Trump’s Executive Order never rescinded the work that was underway by the CMS Innovation Center on drug models,” a Department of Health and Human Services spokesperson said in an email to STAT.
    • “The pilot addresses an existential issue for state Medicaid programs: how to pay for cell and gene therapies that are highly effective, but expensive, on fixed budgets. 
    • “Two drug manufacturers that make treatments for sickle cell disease are participating: Bluebird Bio, which makes Lyfgenia, and Vertex Pharmaceuticals, which makes Casgevy. Lyfgenia’s list price is $3.1 million, and Casgevy’s list price is $2.2 million.” 
  • The Wall Street Journal lets us know,
    • “Novo Nordisk said the Food and Drug Administration approved the diabetes-drug Ozempic to be used to help kidney-disease patients.
    • “Ozempic, or semaglutide, can now be used to reduce the risk of worsening kidney disease or kidney failure in adults with type 2 diabetes and chronic kidney disease, the company said Tuesday.
    • “The approval makes Ozempic the most broadly indicated GLP-1 drug on the market, the Bagsvaerd, Denmark, company said. The FDA approved semaglutide for weight loss under the brand name Wegovy in 2021.”
  • BioPharma Dive adds,
    • “The Food and Drug Administration on Monday expanded use of AstraZeneca and Daiichi Sankyo’s Enhertu, allowing the drug to be given earlier and more broadly in people with an aggressive form of breast cancer.
    • Since 2022, Enhertu has been approved in the U.S. to treat advanced breast tumors expressing “low,” but still detectable, levels of the HER2 protein. With its new decision, the agency widened Enhertu’s availability to include treatment of tumors with “ultralow” HER2 expression. HER2 protein levels must be determined by an FDA-approved test, AstraZeneca and Daiichi said in a statement.”

From the public health and medical research front,

  • The Washington Post reports,
    • “A new strain of avian influenza has been identified for the first time in the United States, raising concerns that the virus is transforming in a way that could eventually cause wider outbreaks among humans.
    • “U.S. officials disclosed the discovery of the virulent H5N9 strain at a California duck farm in a report in recent days to the World Organization for Animal Health, which maintains a database of animal disease threats.
    • “That disclosure comes as the United States confronts a growing outbreak of another bird flu strain, H5N1, that is spreading in poultry farms across the nation and has infected dairy cows for the first time. Human cases have been sporadic and confined mostly to dairy workers exposed to sick animals.
    • “The H5N9 strain itself does not pose a grave threat to humans, officials and experts said.”
  • The American Hospital Association News tells us,
    • “Dementia cases in the U.S. are expected to double by 2060, reaching 1 million new cases per year, according to a study released Jan. 13 by NYU Langone Health. The study found that the risk of developing dementia any time after age 55 is 42%, more than double the risk reported in prior studies. The study authors attributed previous underestimates of dementia risk to unreliable documentation in health records and on death certificates, minimal surveillance of early-stage dementia cases and underreporting of cases by race.” 
  • The New York Times relates,
    • “Rates of sudden unexpected infant death in the United States increased by nearly 12 percent from 2020 to 2022, according to new research published on Monday in the journal JAMA Pediatrics.
    • “Though the study offered some good news — overall infant mortality rates dropped by 24 percent from 1999 to 2022 — it also raised questions about why more babies appear to be dying during sleep, and why rates of sleep-related death remain notably higher among Black, Native American and Pacific Islander babies than among white and Asian infants.
    • “Dr. Elizabeth Wolf, an associate professor of pediatrics with Children’s Hospital of Richmond at Virginia Commonwealth University who was among the new study’s authors, called the findings “pretty alarming.”
    • “The death of an infant from SIDS or SUID is unbelievably horrific,” Dr. Wolf continued, using two acronyms that describe sleep-related deaths among infants. “And we as a public health community need to do everything we can to try and reduce the risk factors as much as possible.”
  • Cardiovascular Business relates,
    • “Cannabis use is on the rise throughout the United States, but it is not as harmless as some people may believe. In fact, according to a new in-depth analysis in Nature Reviews Cardiology, regular cannabis use increases a person’s risk of multiple adverse cardiovascular outcomes, including myocardial infarction, arrhythmias and cardiomyopathy.[1]
    • “The study’s authors, a group of researchers with the Stanford Cardiovascular Institute, explored a wide variety of topics, including ongoing policy trends related to cannabis and the science behind why it appears to make such a significant impact on the cardiovascular system. The group also emphasized that it will be important to learn more about the long-term impact of cannabis use as time goes on. 
    • “Cannabis is emerging as a risk factor for adverse cardiovascular health,” wrote first author Mark Chandy, MD, PhD, who is now an assistant professor at Western University in Ontario, Canada, and colleagues. “With changing public perceptions and an overall decline in tobacco use, cannabis is poised to replace tobacco as a legal drug of choice. Previous restrictions are ending with the widespread decriminalization and legalization of cannabis, boosting use of the drug. A public perception that cannabis is harmless and therapeutically beneficial persists, despite mounting evidence from preclinical and clinical studies showing that cannabis use can harm the cardiovascular system and pose other serious health problems, not unlike tobacco.”
  • Per Beckers Hospital Review,
    • “Cedars-Sinai experts are advocating for patients to have access to GLP-1 medications such as semaglutide as a key component to caring for and preventing cardiovascular disease. 
    • “Physicians are now able to improve multiple “downstream” conditions, such as heart disease, by prescribing one medication “upstream,” according to a Jan. 10 news release from Los Angeles-based Cedars Sinai. 
    • “Amanda Velazquez, MD, director of obesity medicine at the health system, said in the release that semaglutide has enabled patients with high blood pressure to reduce their antihypertensive medications.
    • “Martha Gulati, MD, director of preventive cardiology and the Anita Dann Friedman Chair in Women’s Cardiovascular Medicine and Research at Cedars-Sinai, said although semaglutide has been associated with blood pressure and cholesterol level improvements, it does not replace statins. 
    • ‘Dr. Gulati also said the effectiveness of the drug class raises the important question: “Do we want patients to get CVD and only then treat them? Or should we treat them earlier so we can prevent CVD events?”
  • The Wall Street Journal discusses “The Scientific Fight Over Whether Aging Is a Disease.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Drugmakers raised the list prices of more than 800 prescription drugs for blood pressure, cancer and other conditions by a median 4% at the start of this year.
    • “The modest size of the annual increases could help companies avoid criticism of gouging from President Trump while seeking his administration’s support for such priorities as taking aim at the rebates given to middlemen and altering a federal program providing discounts to certain hospitals. Last year’s median price increase was 4.5%.”
  • Fierce Healthcare points out,
    • “The National Community Pharmacists Association (NPCA) is warning the feds that independent pharmacists are likely to face significant financial hardship due to Medicare drug price negotiations.
    • “In comments submitted on the latest Medicare advance notice, the organization says it conducted a survey of 8,000 pharmacy owners and managers about the drug price negotiation program and found that 93.2% have either decided not to stock drugs under negotiation or are considering not stocking these products.
    • “The survey found that 32.8% of independent pharmacists have already made the decision to not stock one or more of the 10 drugs in the first round of negotiations. In addition, 60.4% of those surveyed said they are considering similar steps.
    • “The NCPA said this is because they’re concerned about “financial losses” through the program.
    • “That will be devastating to the program,” said NCPA CEO B. Douglas Hoey in a press release. “Patients who need these prescriptions will be unable to get them, because their pharmacies cannot participate in the program.'”
  • Per Beckers Hospital Review,
    • “In less than a year, Mark Cuban’s Cost Plus Marketplace has expanded its portfolio to more than 6,000 medicines. 
    • ‘Mark Cuban Cost Plus Drug Co. launched the Marketplace in February 2024, which at the time had more than 4,000 medicines in short supply to directly sell to healthcare facilities. 
    • ‘Since then, customers have realized savings between 40% and 60% compared to traditional wholesalers, according to Chief Commercial Officer Alan Bowe. 
    • “The Marketplace now sells to thousands of hospitals, clinics, ambulatory surgery centers, long-term care sites, dialysis centers and retail pharmacies in all 50 states, Mr. Bowe told Becker’s Jan. 23.”
  • Beckers also brings us up to date on current drug shortages.
  • Fierce Healthcare lets us know,
    • CVS Health is rolling out a new customer app that aims to make it simpler and more convenient for users to manage health benefits, pharmacy benefits and prescriptions.
    • Within the application, users can monitor prescriptions for themselves as well as family members across CVS’ pharmacies, Caremark mail orders and CVS Specialty. This includes “full transparency” into the status of a prescription order and the cost, CVS said.
    • In addition, users can schedule key immunizations for their entire family, and access spending and benefits details from both Aetna and Caremark through the app.
  • Beckers explains the new normal in hospital capacity and announces
    • “UNC Health and Duke University Health System, based in Chapel Hill, N.C., and Durham, N.C., respectively, are uniting to build a comprehensive healthcare campus, featuring the state’s first freestanding children’s hospital.
    • “The two institutions filed legal documents Jan. 28 with the state to establish a nonprofit entity, North Carolina Children’s, according to a joint news release. 
    • NC Children’s will feature a 500-bed children’s hospital on a 100-plus-acre campus at a yet-to-be-identified site in the Research Triangle region.
    • “The new campus will also include a children’s behavioral health center, outpatient clinics, research and teaching facilities, hospitality houses (e.g., Ronald McDonald House) and mixed-use infrastructure to accommodate hotels, restaurants and retail stores, according to the release.”

Monday Report

David Ermer–ACA, CDC, Congress, COVID-19, FDA, Medical / Rx research, Obesity, OPM, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC,

  • Nextgov/FCW reports,
    • “Billionaire Elon Musk paid a visit to the Office of Personnel Management’s building on Friday, people familiar have confirmed to Nextgov/FCW.” * * *
    • “Amanda Scales, a former employee of Musk’s artificial intelligence company xAI, is OPM’s new chief of staff.” 
  • Fedscoop informs us,
    • “The Trump administration is giving agency leaders two weeks to submit plans for how they intend to comply with the presidential directive to return all eligible employees to full-time, in-person work, the latest salvo in the restructuring of the federal workforce.  
    • “In a memo sent to agency heads Monday, the acting directors of the Office of Personnel Management and the Office of Management and Budget set a Feb. 7 deadline for return-to-work implementation plans, which will be reviewed and approved by OPM and OMB.”
  • The Senate confirmed Scott Bessent to be Secretary of the Treasury today by a 68-29 vote. The Secretary of the Treasury along with the Secretary of Health and Human Services and the Secretary of Labor, are Affordable Care Act regulators.
  • Roll Call adds,
    • “Bessent, 62, will become the nation’s first openly gay Treasury secretary and the highest-ranking LGBTQ government official in the country’s history.” * * *
    • “He brings a wealth of private-sector experience in the economy and markets to his new role, as well as a concern for the needs of working Americans,” Senate Majority Leader John Thune, R-S.D., said on the floor Monday before the vote.
    • “Senate Finance Chairman Michael D. Crapo, R-Idaho, during the confirmation process similarly praised Bessent’s character, demeanor and experience, while defending him from Democratic attacks about the nominee’s handling of his taxes.”
  • Roll Call also tells us,
    • “The Senate keeps processing President Donald Trump’s nominees this week, but much of the congressional attention will be on South Florida, where House Republicans are gathering for their annual issues and strategy conference.
    • “The conference is taking place at Trump National Doral in Miami, the president’s own private golf club, and Trump is expected to address the assembled lawmakers Monday evening.
    • “Punchbowl News reported over the weekend that Vice President JD Vance is expected to join the retreat as a headliner on Tuesday.
    • “Much of the discussion will focus on trying to plot the way forward for a filibuster-proof budget reconciliation package — especially to try to implement Trump’s immigration and tax policy agenda.”
  • The acting HHS Secretary Dorothy Fink announced,
    • “For nearly 50 years, the Hyde Amendment has protected taxpayer funds administered by the Department from paying for elective abortion. Pursuant to the President’s Executive Order of Jan. 24 (Enforcing the Hyde Amendment) and guidance from Office of Management and Budget, the Department will reevaluate all programs, regulations, and guidance to ensure Federal taxpayer dollars are not being used to pay for or promote elective abortion, consistent with the Hyde Amendment. This review will be conducted consistent with guidance issued by the Office of Management and Budget.”
  • Per BioPharma Dive,
    • “The Food and Drug Administration has approved monthly maintenance dosing of Eisai and Biogen’s Alzheimer’s disease drug Leqembi.
    • “After taking Leqembi every two weeks for 18 months, patients can now transition to a monthly dose that the companies say is supported by modeling of data from Phase 2 and Phase 3 testing. Leqembi works by removing toxic aggregates of a protein from the brain.”

From the public health and medical research front,

  • STAT News reports
    • “In 2022, about 40% of deaths in the U.S. were caused by cardiovascular heart disease, including heart disease and stroke, which kill more people in the U.S. than the next two biggest killers — all forms of cancer and accidental deaths — combined. That’s according to an annual update from the American Heart Association on heart disease and stroke statistics, published today in Circulation. 
    • “Cardiovascular disease is “common, catastrophic, and costly,” an accompanying editorial notes. Despite its dominance, the overall number of deaths is leveling out after the pandemic shot numbers upwards. Yet contributing risk factors like high blood pressure and obesity continue to rise. 
    • Here are some more interesting findings:
      • The percentage of high schoolers who are physically active for over an hour every day decreased from almost 29% to just under 24% between 2011 to 2021.
      • Nearly 47% of all Americans have high blood pressure. In 2022, the prevalence was worst in Mississippi at about 40% and best in Colorado, at just under 25%. 
      • The rate of gestational diabetes in the U.S. increased 38% from 2016 to 2021, to 8.3% of pregnancies.
  • and
    • “Almost a century after people living in certain neighborhoods around Seattle and Tacoma, Washington were systemically denied financial services — a discriminatory, racist practice known as redlining — young cancer patients in those areas are dying at higher rates than those who live in unaffected areas. 
    • “An association between historic redlining and survival of adult-onset cancers has already been shown, but the data on adolescent and young-adult cancers come from a study published today in CANCER. Researchers analyzed data from 2000 to 2019 in those Washington cities on more than 4,300 patients aged 40 or younger, along with homeowners’ loan data and recent census tracts. They found that five years and 10 years after diagnosis, fewer people in previously redlined neighborhoods were still alive than those unaffected. (That’s about 85% vs. 90% five years out and 81% vs. 88% after ten years.)
    • “The disparity in deaths remained even after adjusting for factors like poverty. It emphasizes the importance of contextualizing today’s health disparities, the authors write, as well as the impact discrimination can have generations down the line.”
  • The New York Times suggests “‘A Dangerous Virus’: Bird Flu Enters a New Phase. A pandemic is not inevitable, scientists say. But the outbreak has passed worrisome milestones in recent weeks, including cattle that may have been reinfected.”
  • KAKE News from Wichita, Kansas, reports,
    • “State public health officials are calling an ongoing tuberculosis outbreak in northeast Kansas “unprecedented.” 
    • “The Kansas Department of Health and Environment [KDHE] reports 66 active cases of tuberculosis and 79 infections in the Kansas City Metro area in 2024. As of this month, the number of active cases rose to 67.
    • “In a Senate Committee on Public Health and Welfare meeting on Tuesday, Deputy Secretary of KDHE Ashley Goss said the department is working collaboratively with the Centers for Disease Control and Prevention.
    • “Some of you are aware we have mobilized staff and resources addressing an unprecedented tuberculosis outbreak in one of our counties,” Goss said. “We are working collaboratively with the CDC on that. The CDC remains on the ground with us to support.” * * *
    • “According to the KDHE website, there are currently 60 active cases of TB in Wyandotte County and seven in Johnson County. 
    • “Despite this, the KDHE says the cases are “very low risk” to the general public, including surrounding counties. 
    • “We are trending in the right direction right now, more to come on that,” Goss said in the meeting. “Hopefully we can get it wound down quickly.” 
  • The American Medical Association lets us know what doctors wish their patients knew about contagious norovirus.
  • Per Healio
    • “The vast majority of people in a study with long COVID had experienced multiple SARS-CoV-2 infections over the course of a 4-year period, researchers reported.
    • “While it is possible that the causes of long COVID could be many and variable depending on the patient population studied, with this cohort the evidence is clear that by having COVID numerous times, patients became more at-risk for developing long COVID,” Sean Clouston, PhD, professor in Stony Brook University’s Renaissance School of Medicine, said in a press release.”
  • and
    • “An investigational blood-based test identified nearly 80% of individuals who had colorectal cancer, according to results of a large prospective trial presented at ASCO Gastrointestinal Cancers Symposium. 
    • “The test also had a specificity greater than 90% for advanced colorectal neoplasia (ACN) and negative-predictive value for ACN.
    • “This new blood test may provide a convenient, effective option for colorectal cancer screening in the intended-use population, and perhaps help us boost adherence to screening,” Aasma Shaukat, MD, MPH, director of outcomes research and Robert M. and Mary H. Glickman professor of medicine at NYU Grossman School of Medicine, said during a press briefing.
  • Per BioPharma Dive,
    • “Treatment with an experimental drug from Akero Therapeutics substantially reversed liver damage in a mid-stage study of people with cirrhosis due to metabolic dysfunction-associated steatohepatitis, a common disease that was formerly known as NASH.
    • “Announced Monday by Akero, the study results exceeded investor expectations, more than doubling the value of shares in the biotechnology company. They also helped to push up the stock of 89bio, a competitor developing a similar type of drug to Akero’s.
    • “While the Food and Drug Administration last year approved the first treatment for MASH, its use is limited to people whose livers aren’t yet cirrhotic. According to Akero, its drug is the first compound to show a significant reversal of cirrhosis due to MASH in clinical testing.”
  • The Wall Street Journal reports,
    • “Late-stage trial data for Roche’s drug against muscle-wasting Elevidys showed positive results after two years of treatment for male patients aged 4 or older with Duchenne muscular dystrophy.
    • “The data read-out reduced difficulties in standing, walking and running that were statistically significant, which increased between one year and two years after treatment, the company said. The safety profile was in line with the drug’s profile and no new safety signals were identified, it said.
    • “The treatment is on market for people living with Duchenne aged four years old and over regardless of their ambulatory status in the U.S., United Arab Emirates, Qatar, Kuwait, Bahrain and Oman. It is approved for the treatment of ambulatory individuals aged four through seven years in Brazil and Israel.
    • “Duchenne muscular dystrophy is a genetic disorder characterized by the progressive loss of muscle.”
  • STAT News relates,
    • “Right now, patients with obesity and cirrhosis have few treatments for their progressive liver disease, but a new study offers one available option: bariatric surgery. Weight loss operations significantly cut the long-term risk of developing serious liver complications when compared to standard nonsurgical therapy.
    • “The 62 patients with obesity and cirrhosis in the clinical trial who underwent bariatric surgery — either gastric bypass or gastric sleeve procedures — later had a 72% lower risk of developing more serious liver disease compared to the 106 patients who didn’t have surgery. After 15 years, 20.9% in the surgical group but 46.4% in the nonsurgical group developed one of the major complications of liver disease, including liver cancer and death. 
    • “We showed, regardless of the stage of disease, if we help people to lose weight, we can improve their outcomes. That can provide hope for patients and medical providers,” said Ali Aminian, director of the Bariatric and Metabolic Institute at the Cleveland Clinic and co-author of the study published Monday in Nature Medicine.  “We can change the trajectory of the disease.”
  • Per Beckers Hospital Review,
    • “An Alabama woman who received a gene-edited pig kidney transplant at NYU Langone in November is recovering well more than 60 days after the procedure. 
    • “On Nov. 25, a team of clinicians at the New York City-based health system successfully transplanted UKidney, a 10-gene-edited pig kidney into Towana Looney, 53. Ms. Looney was on a transplant waiting list for nearly eight years before physicians determined the probability of a safe human transplant was slim. 
    • “Now, Ms. Looney is the longest-living recipient of the four Americans who have received a gene-edited pig organ, having surpassed the two-month mark. 
    • “If you saw her on the street, you would have no idea that she’s the only person in the world walking around with a pig organ inside them that’s functioning,” Robert Montgomery, MD, PhD, director of NYU Langone’s Transplant Institute, told the Associated Press in a Jan. 25 report at NBC News. 
    • “Unlike previous xenotransplant patients, Ms. Looney was in better overall health at the time of her transplant, leaving experts optimistic about the potential for broader success in the emerging field of xenotransplantation. Earlier cases involved individuals who were critically ill when they underwent the experimental procedures.”

From the U.S. healthcare business front,

  • Beckers Hospital CFO Report tells us,
    • “Cleveland Clinic served the largest number of patients in its history in 2024 with more than 15 million patient encounters worldwide, generating nearly $16 billion in revenue and ending the year with a 1.7% operating margin.  
    • “The year-end findings come from the annual State of the Clinic address made by CEO and President Tom Mihaljevic, M.D., on Jan. 27. 
    • “Years have passed since the COVID-19 pandemic and healthcare has not recovered. Today, about 40% of U.S. hospitals continue to lose money,” Dr. Mihaljevic said. “In the past, we could predict Cleveland Clinic’s financial health based on our productivity and expense management, but even that has changed.”
    • ‘Dr. Mihaljevic noted that despite the handling of more than 15 million patient encounters, the health system’s 1.7% operating margin fell short of its anticipated 2.7%. He attributed this shortfall to new financial pressures, including unexpected increase in charity care totaling $370 million, surging cost of malpractice insurance and rising costs of drugs due to smaller discounts on medications.”
  • Per Healthcare Dive,
    • “HCA Healthcare reported fourth quarter earnings on Friday that narrowly beat analysts’ expectations following back-to-back hurricanes this fall.
    • “The Nashville-based provider posted $18.3 billion in revenue for quarter, up 6% year over year. However, profit dipped compared to the same period last year, falling from $1.6 billion to $1.4 billion.
    • “Still, several analysts noted HCA’s financial guidance for 2025 is slightly more conservative than expected, raising concerns that Trump administration funding cuts to Medicaid and the Affordable Care Act could impact hospitals’ bottom lines.”
  • Modern Healthcare reports,
    • “Shares of Walgreens Boots Alliance tumbled today following a CNBC report that the Deerfield-based pharmacy chain was unlikely to sell itself to a private-equity firm.
    • “CNBC’s David Faber said on air this morning that sources say the possible deal in which Walgreens would sell itself to New York-based Sycamore Partners is “mostly dead.”
  • Fierce Pharma identifies the ten most anticipated drug launches of 2025.
  • McKinsey & Co. point out “Most top pharma companies derive more than 60 percent of their revenue from therapies for diseases that affect women uniquely, differently, or disproportionately, putting them in a prime position to close the sex- and gender-based health gap.”

Friday Report

David Ermer–CDC, CMS, Congress, COVID-19, FDA, Generative AI, Medical / Rx research, Medicare, SCOTUS, Telehealth, U.S. Healthcare–
Photo by JOSHUA COLEMAN on Unsplash

From Washington, DC

  • Govexec tells us,
    • “A 50-page document, compiled by GOP members of the House Budget Committee and first reported by Politico, outlines a list of provisions that could be included in the [budget reconciliation] package, which would not be subject to the Senate’s 60-vote filibuster threshold, includes a litany of proposals increasing federal workers’ contribution to their retirement and health care benefits, in exchange for worse payouts.” * * *
    • “On health care benefits, the House GOP proposes replacing the current system, by which the federal government pays for a percentage of health care premiums through the Federal Employees Health Benefits Program and the new Postal Service Health Benefits program, with a “voucher model.”
    • “Under this option, the FEHB and PSHB programs would be reformed by replacing the current premium-sharing structure with a voucher, which would not be subject to income and payroll taxes,” the document states.
    • “And the document calls for enactment of a bill introduced last year to require the Office of Personnel Management to audit FEHBP for improper enrollments. But OPM has said that under the current “decentralized” nature of the program, the agency does not have the capabilities to conduct such an audit.
    • “Prior to the presidential transition, then-President Biden’s OPM sent Congress a legislative proposal, drawn on lessons learned in launching the PSHB program this year, to revamp how it administers FEHBP so that it can conduct better oversight.”
    • FEHBlog observation — Better oversight starts with giving FEHBP and FEDVIP carriers the HIPAA 820 enrollment roster transactions that would allow them to reconcile individual enrollees with premiums paid.
  • MedPage reports,
    • “Legislation providing more scrutiny for pharmacy benefit managers (PBMs) that failed to make it through Congress in the waning days of 2024 seems to still be viable for passage this year, according to a House staff member.
    • “I think there’s plenty of political will there; that’s what I’ve seen from members,” Preston Bell, a professional staff member on the House Ways & Means Committee, said Thursday at an event sponsored by the American Enterprise Institute (AEI) on the future of the Medicare prescription drug benefit. “I do think there are disparate ideas across Congress as to how much intervention within the PBM market is appropriate. What you’ve seen come through Congress in the [massive continuing resolution] package [released and rejected in December 2024] is probably the litmus test, or maximum, of what is feasible for that type of reform.”
  • Healthcare Dive informs us,
    • “Sara Brenner, a Food and Drug Administration official in the agency’s medical device division, has been named the FDA’s acting commissioner, according to an update made online to the regulator’s leadership biography page. * * *
    • “Brenner will lead the agency until a permanent commissioner is installed. President Donald Trump has nominated Johns Hopkins surgeon Marty Makary as FDA commissioner, but he has not yet been confirmed by the Senate. Confirmation hearings for Robert F. Kennedy Jr., who, as Trump’s pick to run the Department of Health and Human Services, would be Makary’s boss, are scheduled for Jan. 29 and Jan. 30.
    • “Brenner worked in the FDA’s medical devices branch, most recently as chief medical officer for in vitro diagnostics and associate director for medical affairs. A preventive medicine physician, Brenner has been at the agency since 2019, according to her LinkedIn page, and helped coordinate diagnostic standards and policy as part of HHS’ COVID-19 response. 
    • “Brenner was previously a senior policy advisor at the White House Office of Science and Technology Policy under the first Trump administration.”
  • The Hill lets us know,
    • “The Food and Drug Administration (FDA) has withdrawn a rule that would have banned menthol cigarettes and flavored cigars, putting a formal end to a policy that had been indefinitely delayed under the Biden administration. 
    • “A regulatory filing showed the rule had been “withdrawn” on Jan. 21, President Trump’s second day in office. The move is a significant blow to public health groups who said banning menthol had the potential to save hundreds of thousands of lives, particularly among Black smokers.”
  • The IRS released its 2024 tax return edition of Publication 969 which concerns health savings accounts and other tax favored health plans.

From the judicial front,

  • Bloomberg Law reports,
    • “A former Johnson & Johnson executive’s allegations that the drug company overpaid for prescription drug benefits are “speculative and hypothetical,” and injuries she did suffer cannot be resolved by the court, a New Jersey federal judge ruled.
    • “The decision Friday dismissed most of Ann Lewandowski’s high-profile class action that argued the pharmaceutical giant violated its fiduciary duties under the Employee Retirement Income Security Act by not negotiating better drug prices with its pharmacy benefit manager, Express Scripts, or switching to a different PBM. 
    • “The lawsuit is one of several recent [actually it was the first] attempts to hold employers responsible through ERISA for monitoring and reducing health-care costs. The claims against J&J reveal that not even large drug companies are immune to complaints over high drug prices.
    • “Judge Zahid N. Quraishi in the US District Court for the District of New Jersey concluded that Lewandowski lacked standing to sue in dismissing two of her three claims. Lewandowski’s argument that J&J’s plan forced her to pay higher premiums and cost her higher wages was speculative “at best,” he said.
    • “And while Lewandowski did show that her copays for some drugs exceeded prices offered by other health plans, the court could not fulfill a key requirement for standing by making her whole, the judge said. Any amount refunded to her would have to go through the health plan for money it spent after she hit her out-of-pocket limit, Quraishi said.
    • “In straightforward terms, a favorable decision would not be able to compensate Plaintiff for the money she already paid,” he wrote.
    • “The judge did find that Lewandowski has standing to pursue her claim against J&J for not providing more information she requested around the plan’s drug prices, including the contract with Express Scripts, which was not a party to the suit. Quraishi invited Lewandowski to amend her complaint.”
  • The Wall Street Journal points out,
    • “Enforcement of the Corporate Transparency Act, which requires millions of companies to disclose their true ownership, remains on hold despite a U.S. Supreme Court ruling in favor of the Treasury Department. 
    • “The Supreme Court on Thursday overturned a lower court order that was blocking enforcement of the CTA. However, a separate national injunction issued earlier this month by a federal judge apparently remains in place and continues to block the law’s implementation.
    • “The Treasury’s Financial Crimes Enforcement Network, which is overseeing the law’s implementation, issued an alert Friday confirming compliance with the CTA isn’t mandatory while the injunction remains in force.” 
  • Fierce Healthcare relates,
    • “The Centers for Medicare & Medicaid Services has changed course on plans to appeal a court ruling that determined it must recalculate UnitedHealthcare’s Medicare Advantage star ratings.
    • “The agency submitted a filing in Texas district court earlier this week saying it intended to file an appeal to the Fifth Circuit Court. In new court documents filed Friday, CMS has withdrawn its notice of appeal.”

From the public health and medical research front,

  • The Center for Disease Control and Prevention announced today,
    • Seasonal influenza activity remains elevated across the country and is increasing in most areas. COVID-19 activity is elevated in many areas of the country. RSV activity has peaked in many areas of the country.
    • COVID-19
      • COVID-19 activity is elevated in many areas of the country, though wastewater levels are moderate, emergency department visits are at low levels, and laboratory percent positivity has declined in the last week. 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 across the country and is increasing in many areas.
    • RSV
      • RSV activity has peaked in many 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 are low among U.S. adults and children. COVID-19 vaccine coverage in older adults has increased compared with the 2023-2024 season. Vaccination coverage with RSV vaccines remains low among U.S. adults. Many children and adults lack protection from respiratory virus infections provided by vaccines.
  • BioPharma Dive relates,
    • “An experimental obesity drug from Novo Nordisk helped people lose an average of up to 22% of their body weight over 36 weeks in an early-stage trial, results that, if reproduced in further testing, could rival medicines Eli Lilly has on the market and in development.  
    • ‘Novo said Friday it is planning “further clinical development” of the drug, called amycretin, but didn’t specify the design of additional trials or when they might begin. Amycretin affects the same two targets as a Novo drug called cagrisema that recently missed expectations in a Phase 3 trial but does so in a single molecule rather than a two-drug combination.”
       
  • Per Healio,
    • “Integrating lifestyle care into low back pain management resulted in greater improvements in disability, weight loss and physical quality of life vs. just guideline-recommended care, a randomized study showed.
    • “The findings, published in JAMA Network Open, “could influence future updates to back pain guidelines,” Emma Mudd, PhD, senior research officer at the University of Sydney in Australia and the analysis’ lead author, said in a press release. “Patients valued the holistic support, and the outcomes speak for themselves.”
  • Earlier this week, the CVS Health Foundation announced $4 million in grants related to its health aging initiative.

From the U.S. healthcare business front,

  • Beckers Hospital Review notes,
    • “Mayo Clinic’s chief executive said at the World Economic Forum’s annual meeting in Davos, Switzerland, that he is fully committed to the adoption of artificial intelligence in healthcare, the Rochester (Minn.) Post Bulletin reported.
    • “I personally would not want to have my healthcare, in some specialties, without AI because I firmly believe I will get a better outcome,” said Gianrico Farrugia, MD, president and CEO of the Rochester-based health system, according to the newspaper’s coverage of the event Jan. 22.
    • “Mayo Clinic has been at the forefront of developing and deploying healthcare AI, with 320 algorithms in use, the news outlet reported.”
  • Beckers Payer Issues adds,
    • Insurers do not have to own every part of the healthcare system to improve connection, according to Jim Boyman, vice president of GuideWell Health. 
    • GuideWell is the parent company of Florida Blue. In December, the company launched an initiative to manage cancer care for Florida Blue ACA members. Through a partnership with Cerritos, Calif.-based The Oncology Institute and primary care organization Sanitas, Florida Blue members diagnosed with cancer will be connected with an oncology team to manage a personalized treatment plan. 
    • “Everyone talks about how fragmented healthcare is,” Mr. Boyman told Becker’s. “This shows how you don’t necessarily have to own all parts of the system to reduce that fragmentation. You can use technology and relationships to collaborate and overcome fragmentation through programs like this.” 
  • Fierce BioTech reports,
    • “Neomorph is building out its supply of Big Pharma partnerships, this time stamping down an option-to-license pact with AbbVie that centers around the biotech’s molecular glue platform.
    • “AbbVie will pay the San Diego biotech an undisclosed upfront sum and offer up to $1.64 billion in option fees and milestones, plus royalties, according to a Jan. 23 release.
    • “The new partners will look to develop molecular glue degraders—a novel class of small molecules designed to selectively degrade proteins that drive disease—for multiple targets across oncology and immunology.
    • “Protein degraders represent a groundbreaking advancement in the field of drug discovery and at AbbVie we are committed to advancing this technology forward,” Steven Elmore, Ph.D., AbbVie’s vice president of small molecule therapeutics and platform technologies, said in the release. “We are excited to collaborate with Neomorph to develop novel molecular glue degraders that could pave the way for new, effective therapies in the treatment of immune disorders and cancer.”
    • “Neomorph emerged in 2020 and quickly garnered a neuro deal worth up to $1.45 billion in biobucks with Biogen, plus a partnership with Novo Nordisk that offers up to $1.46 billion.” 
  • Per Fierce Healthcare,
    • “Self-funded employer health plan Centivo is announcing Centivo Care, a tech-forward virtual primary care platform integrated with behavioral health specialists.
    • “Centivo’s virtual offerings, which will be available in states where the company operates, are increasingly desired by its clients’ members, said Wayne Jenkins, M.D., chief medical officer for Centivo and president of Centivo Care, in an interview with Fierce Healthcare.
    • “He said at first, just 5% to 10% of people preferred the virtual option, but now it’s closer to 20%. For some employers, they see an even higher adoption rate. One of its clients, JetBlue Airlines, sees high utilization since their employees travel so often and can more easily text with a physician or schedule a video call than attend an appointment in person.
    • “Centivo Care is one of few primary care practices to earn a Patient-Centered Medical Home accreditation from the National Committee for Quality Assurance, the company said in a news release. These virtual appointments are free, and members receive personalized care plans, after-visit summaries, preventive care reminders and more.”
  • Per Beckers Hospital Review,
    • Telehealth utilization grew across most U.S. regions in October 2024, with the Midwest as the sole exception, according to FAIR Health’s monthly telehealth regional tracker.
    • Nationally, telehealth claim lines increased from 4.80% of medical claim lines in September to 4.89% in October, marking a 2% rise. Regional increases varied, with the West seeing the largest growth at 2.8%, while the Midwest experienced a 3.7% decrease.
    • Here are four things to know about telehealth utilization, according to FAIR Health’s tracker:
      • Psychiatric nurses moved up to the second-most common telehealth specialty nationally in October, overtaking family practice, which fell to fourth place.
      • Mental health conditions remained the leading telehealth diagnostic category nationally and regionally. 
      • The tracker revealed modest differences in telehealth costs compared to office visits. For instance, the median cost for a nutritional therapy reassessment was typically $1 to $2 lower via telehealth than in-office, except in the West, where telehealth costs were slightly higher.
      • Telehealth usage was highest among patients aged 31–40, followed by those aged 19–30, a pattern consistent across all regions.

Tuesday Report

David Ermer–CDC, Congress, COVID treatment, FDA, Medical / Rx research, Mental health care, U.S. Healthcare–

From Washington, DC,

  • The Hill reports, “Senate Republicans hit their full 53-member majority on Tuesday as Sens. John Husted (R-Ohio) and Ashley Moody (R-Fla.) were sworn into office by Vice President Vance.” 
  • Fierce Healthcare reviews how yesterday’s executive orders and other actions impact healthcare.
  • The U.S. Preventive Services Task Force highlights its most recent final recommendations.
  • Fierce Pharma tells us,
    • “Already on its way to becoming a blockbuster drug, Johnson & Johnson’s Spravato has received another potential boost as the FDA has blessed the nasal spray to be used as a monotherapy for major depressive disorder (MDD).
    • “Spravato was originally approved in 2019 to be used along with an oral antidepressant for patients who have not seen results with other antidepressant medications.
    • “In 2020, the U.S. regulator tacked on another nod for Spravato to be used by patients with MDD who experience acute suicidal thoughts or behavior.
    • “The standalone endorsement allows patients to use Spravato without taking oral antidepressants. Spravato can work as quickly as 24 hours, Bill Martin, Ph.D., who heads up J&J neuroscience, said in a release.
    • “Treatment-resistant depression can be very complicated, especially for patients who do not respond to oral antidepressants or cannot tolerate them,” Martin added. “For too long, healthcare providers have had few options to offer patients much-needed symptom improvement.”
  • and
    • “After hitting a regulatory roadblock in 2022, Sanofi’s consumer healthcare business Opella has secured the FDA’s blessing to move forward with its ambition to convert its erectile dysfunction med Cialis into an over-the-counter product.
    • “The agency previously placed a clinical hold on the company’s planned actual use trial (AUT) for the conversion, citing problems with protocol design. AUTs are a key step in the FDA’s process for switching drugs from prescription to OTC products and are meant to prove that consumers can adequately diagnose and treat themselves without the help of a healthcare provider.
    • “Now, after a review, the FDA’s green light marks a “significant step forward in Opella’s data-driven efforts to switch a PDE-5 inhibitor like Cialis,” Opella’s chief science officer Josephina Fubera, Ph.D., said in a company release.
    • “We look forward to continuing our work to bring safe and expanded access to the many consumers who will benefit from nonprescription Cialis,” Fubera added.”

From the public health and medical research front,

  • The University of Minnesota’s CIDRAP lets us know today,
    • “Over the past few days, the US Department of Agriculture (USDA) confirmed more H5N1 avian flu outbreaks in poultry from eight states, including the first at a commercial farm in Georgia.
    • “Meanwhile, the Food and Drug Administration (FDA) and the USDA on January 17 announced new steps to step up the safety of raw pet food, following recent reports of H5N1 infections in household cats.”
  • and
    • “A new real-world study published in PLOS Medicine that looked at outcomes of 703,647 patients with COVID-19 seen at 34 US clinics in 2022 and 2023 found that Paxlovid use was correlated with lower rates of hospitalization and death, particularly among older patients. 
    • “Both vaccinated and unvaccinated patients benefitted from Paxlovid when administered within 5 days of COVID-19 infection confirmation, the authors said. But researchers observed lower rates of use among Black and Hispanic patients than among White patients. 
    • “The study was based on the National COVID Cohort Collaborative’s (N3C) electronic health record database. While clinical trials showed as high as an 88.9% reduction in the risk of COVID-related hospitalization or death among those who received Paxlovid compared to those who received placebos, limited real-world data has been gathered in the post-Omicron era on Paxlovid efficacy.”
  • Consumer Reports, writing in the Washington Post, discusses “What to look for — and what to avoid — in an energy bar. Many are little more than candy bars and don’t deliver the health benefits you might expect.”

From the U.S. healthcare business front,

  • RAND opines,
    • “The typical cost of developing new medications may not be as high as generally believed, with a few ultra-costly medications skewing public discussions about the cost of pharmaceutical research and development, according to a new RAND study.
    • “Using a novel method to assess spending on research and development for 38 drugs that were recently approved by the U.S. Food and Drug Administration, researchers found that the mean, or average, cost of developing a new drug was much higher than the mid-point (median) cost of development.
    • “Researchers estimated a median direct research and development cost of $150 million compared to a mean of $369 million.
    • “Costs were higher after adjusting for earnings drug developers could have made if they had invested these amounts in other activities and for drugs that never made it to the market. With these adjustments, researchers estimated a median research and development cost of $708 million across the 38 drugs examined, with the average cost rising to $1.3 billion driven by a small number of high-cost outliers.
    • “The average cost of developing a new drug was 26 percent lower when excluding just two drugs, dropping from $1.3 billion to $950 million. The findings are published in the journal JAMA Network Open.”
  • Employee Benefit News explains why “costly gene therapy is top of mind for benefits administrators.” Check it out.
  • Per Fierce Healthcare,
    • “Healthcare technology company Innovaccer announced its acquisition of Humbi AI, an actuarial software, services and analytics company used by providers, payers and life sciences companies.
    • “Innovaccer’s cloud powers a slew of healthcare AI features like an AI-assisted care management system, contract management, ambient documentation, pre-visit summary and AI-suggested differential diagnoses.
    • “Financial details of the deal were not disclosed.
    • “The Humbi AI acquisition will help build out Innovaccer’s data analytics capabilities. The Nashville-based company combines healthcare data analytics and actuarial consulting to help healthcare organizations improve value-based contracts, manage risk and design benefits.
    • “Humbi AI’s actuarial capabilities will be an integral component of Innovaccer’s cloud platform, and the company plans to launch its own actuarial copilot, executives said in a press release.”
  • Modern Healthcare adds,
    • “Digital health companies at last week’s J.P. Morgan Healthcare Conference weren’t just looking for investors. They were looking for dance partners.
    • “The desire of digital health companies to scale through mergers and acquisitions or partnerships was one of the most buzzed-about topics at the conference. Marissa Moore, principal at venture capital firm Omers Ventures, said potential buyers and sellers were trying to size up prospects during the event.
    • “People were soliciting us, ‘Hey, we’re trying to spin off this asset, do you know any good buyers?’ Every conversation we were having [at JPM] was an M&A conversation,” Moore said. “We were approached by corporate development executives from big tech companies…you could tell they were trying to get a pulse on what was struggling and what might fit into their growing portfolios, and where there might be an opportunity to partner.”
    • “That search was particularly active for companies selling digital health solutions to employers, a market that has become challenged as employers grapple with the rising cost of healthcare and low usage rates of their offerings. Employers are looking to reduce the number of companies they contract with to reduce costs and simplify the experience for their employees, said Jim Winkler, chief strategy officer at Business Group on Health, an industry group that represents large employers.”