Happy Lincoln’s Birthday

OPM

Happy Lincoln’s Birthday

David Ermer–CDC, CMS, Congress, COVID-19, FDA, Medicare, OPM, Rx coverage, SDOH, U.S. Healthcare–

Our greatest President

From Washington, DC

Capitol Hill News

  • The American Hospital Association (AHA) News tells us,
    • House Republicans Jan. 12 released a budget resolution for fiscal year 2025 focusing on the Trump administration’s agenda on border security, defense, energy and taxes. The budget resolution, which acts as an outline for the reconciliation process, calls for increasing the debt ceiling by $4 trillion and allows for $4.5 trillion in spending for tax cuts. It also would allocate $200 billion for border and defense spending. The resolution instructs seven committees to come up with no less than $1.502 trillion in mandatory cuts over ten years. 
    • Notably, for health care, the bill instructs the House Energy and Commerce Committee to cut mandatory spending by no less than $880 billion. The committee has primary jurisdiction over a number of health care programs, including Medicaid, and some proposals have been circulating that would enact significant cuts to Medicaid. The House is expected to mark up its budget resolution tomorrow. 
  • Politico adds,
    • “Senate Republicans easily pushed their budget resolution out of committee on Wednesday — the first step toward being able to enact President Donald Trump’s massive domestic policy agenda.
    • “The Senate Budget Committee voted 11-10, along party lines, to approve the fiscal framework meant to tee up a package of energy, border security and defense policy through the partisan budget reconciliation process. Across the Capitol, House GOP leaders struggled at the same time to rally their own around a far more expansive plan that would pave the way for legislation that would bundle those same policies alongside trillions of dollars in tax cuts.”
  • The Senate Invoked, 53-47: Motion to invoke cloture on Executive Calendar #17 Robert F. Kennedy, Jr. to be Secretary of HHS. The Senate is expected to confirm Mr. Kennedy’s nomination as HHS Secretary Thursday morning.
  • Fierce Healthcare lays out the “top policy issues for hospitals, payers, docs and tech” on Capitol Hill this year.

White House news

  • Here is a link to the President’s February 11 executive order captioned “IMPLEMENTING THE PRESIDENT’S “DEPARTMENT OF GOVERNMENT EFFICIENCY” WORKFORCE OPTIMIZATION INITIATIVE,” which was mentioned in Tuesday’s report.
  • The American Society of Pension Professionals and Actuaries lets us know,
    • “Daniel Aronowitz has been officially nominated by the White House to become next Assistant Secretary of Labor for the Employee Benefits Security Administration (EBSA). He is the President of Euclid Fiduciary (now Encore Fiduciary), a fiduciary liability insurance underwriting company for employee benefit plans.
    • “His experience in the professional liability industry includes expertise as a coverage lawyer and underwriter.”
  • The AHA News informs us, “Tom Engels is the new administrator for the Health Resources and Services Administration, according to its website. Engels previously held the same position in the first Trump administration from 2019 to 2021.”
  • Federal News Network updates us on federal agency efforts to bring their workforces back to office.

Judicial front

  • Federal News Network reports,
    • “The Trump administration is free to continue implementing its controversial deferred resignation program after a federal court in Massachusetts dissolved a restraining order that had delayed the program’s deadline by several days.
    • “In a written opinion Wednesday afternoon, Judge George O’Toole said he had determined that the three federal unions that had challenged the program lacked the standing they’d need in order to meet the legal standard for a temporary restraining order.” * * *
    • “Wednesday’s ruling does not completely end the legal challenge — it only affects the unions’ requests for a temporary pause in the deferred resignation program while their claims work their way through the litigation process. However, in denying a temporary restraining order and preliminary injunction, O’Toole said he had determined the unions were unlikely to succeed on the merits of their case.
    • “OPM is pleased the court has rejected a desperate effort to strike down the deferred resignation program. As of 7 p.m. tonight, the program is now closed,” said McLaurine Pinover, a spokeswoman for the office. “There is no longer any doubt: the deferred resignation program was both legal and a valuable option for federal employees. This program was carefully designed, thoroughly vetted, and provides generous benefits so federal workers can plan for their futures.”
    • In fact, the Fork in the Road program closed at 7:20 pm ET Wednesday night per its website.

FDA News

  • Fierce Pharma notes,
    • “More than 13 years after its initial FDA approval, Pfizer’s blood cancer drug Adcetris has nabbed another regulatory green light to treat large B-cell lymphoma (LBCL).
    • “The CD30-directed antibody-drug conjugate has been approved in combination with lenalidomide and rituximab for certain LBCL patients, the FDA said Wednesday. Eligible patients must have tried at least two prior lines of systemic therapy and be ineligible for an autologous hematopoietic stem cell transplant or a CAR-T therapy.
    • “Adcetris won the approval after showing it helped patients with heavily pretreated LBCL live longer in a phase 3 trial.”

From the public health and medical research front,

  • CBS News reports,
    • “For the first time since the beginning of the pandemic, more people in the U.S. died of influenza than from COVID-19 in the week ending on Jan. 25, according to weekly figures published by the Centers for Disease Control and Prevention.
    • “For the week ending on Jan. 25, nearly 1.7% of all deaths nationwide were attributed to the flu, compared to roughly 1.5% being the result of COVID-19, according to CDC data. Rates of influenza hospitalizations are more than three times higher than COVID-19 hospitalizations amid this season’s record wave of flu infections.”
  • and
    • “The U.S. confirmed at least a dozen deaths from whooping cough last year, according to preliminary figures released this week by the Centers for Disease Control and Prevention. That marks the most fatalities from the bacterial infection since a 2017 surge of the illness, which is also known as pertussis.
    • “Over the last month, pertussis infections have been rising again. While cases reported to the CDC by health departments dipped over the winter holidays, weekly infections have accelerated for a month straight since then.”
  • The New York Times adds,
    • “A worsening measles outbreak has taken root in Texas, sickening two dozen and hospitalizing nine on the western edge of the state, where childhood vaccination rates have dwindled in recent years.
    • “As of Tuesday, 22 children and two adults had been infected, all of whom were unvaccinated, local health officials said. * * *
    • “The Texas outbreak has so far been limited to residents of Gaines County, which borders New Mexico and has roughly 20,000 residents. Last year 82 percent of kindergarten students received the measles, mumps and rubella vaccine, according to state data. That figure is roughly 10 percentage points lower than the average vaccination rate in Texas public schools and far below the federal target of 95 percent for measles vaccination.”
  • Nature points out that “Dozens of new obesity drugs are coming; these are the ones to watch. Next-generation obesity drugs will work differently from Ozempic and Wegovy — aiming to deliver greater weight loss with fewer side effects.”
  • BioPharma Dive, on the other hand, lets us know “A small semaglutide trial suggests the medicine’s suppression of appetite may extend to alcohol, but larger trials are needed to establish a conclusive benefit.”
  • Per Fierce Healthcare,
    • “More than five years ago, Apple launched three medical studies to test how well its Apple Watch can track a person’s mobility and cardiovascular health, changes in hearing and women’s health and fertility.
    • “The tech company is now broadening its health research ambitions to use its devices, including iPhones, Apple Watch and AirPods along with third-party devices, for a longitudinal, virtual study to monitor changes in participants’ health, spanning a wide range of health and disease areas.
    • “Apple wants to tap into the devices and apps that individuals use every day to evaluate the connections between physical and mental health as well as social determinants, such as whether someone lives alone or with family, and how all these aspects of health factor into a person’s overall well-being.”

From the U.S. healthcare business front,

  • Healthcare Dive reports
    • “CVS Health’s profits were nearly cut in half last year as the healthcare giant wrestled with elevated medical costs in its Aetna insurance business. 
    • “The company reported net income of $4.6 billion in 2024, compared with $8.4 billion in the prior year, according to earnings results released Wednesday. 
    • “But CVS showed signs of financial improvement in the fourth quarter, beating Wall Street expectations on earnings and revenue.” 
  • Bloomberg explains,
    • “In the insurance unit, CVS spent 94.8% of premium revenue on medical care in the quarter, less than analysts expected. Investors prefer a lower number. However, CVS said in a separate filing that high use of medical services will continue to pressure the business. 
    • “The company pointed in particular to high costs in its business that manages care for patients on Medicaid, the US health program for the poor. States have been cutting Medicaid rolls since the pandemic, often culling healthier patients in the program while sicker patients remain.” 
  • Fierce Healthcare adds,
    • “CVS Health CEO David Joyner went on the defense of the pharmacy benefit management industry on the company’s Q4 earnings call Wednesday morning.” * * *
    • “One of the most powerful forces helping to offset rising healthcare costs is PBMs like Caremark,” Joyner said. “These entities remain the only part of the drug supply chain and entirely focused on lowering costs, but have erroneously been subject to deceptive rhetoric and misinformation.”
    • “Joyner noted that branded pharmaceutical manufacturers “added $21 billion of annual gross drug spend through their price actions” in January. Drugs where PBMs lack tools to negotiate prices have seen prices rise more than twice as fast as other products, he said.
    • “In addition, Joyner said that “multiple well-known economists” have projected that PBMs create $100 billion in net value each year for the healthcare system.”
  • Per the AHA News,
    • The Council for Affordable Quality Healthcare Feb. 11 released a report  highlighting how the health care industry can save $20 billion by transitioning from manual to electronic workflows.  
    • In addition, it found that the industry could save $515 million annually on electronic prior authorizations and save providers and staff 14 minutes per transaction.
  • Per Fierce Healthcare,
    • “UnitedHealth Group and Amedisys outlined plans to divest a significant number of home health and hospice locations as they seek to close their $3.3 billion merger.
    • “In a court filing issued late last week, UHG said it intends to pursue a divestiture plan that would sell off “at minimum” 128 combined home health and hospice facilities. The company said in the filing that once the divestitures are completed it will operate only 10% of home health services in the U.S. and 4% of hospice services.
    • “UnitedHealth argued that leaves plenty of competition in this space, as it will still be up against 11,000 home health agencies and more than 5,000 hospice agencies across the U.S.
    • ‘The Department of Justice sued to block the deal in mid-November, arguing that it would hamper competition across multiple home health markets.”
  • Per JAMA Open,
    • “Question How have the proportion and absolute number of psychiatrists providing professional services to traditional Medicare enrollees changed as the field has grown?
    • “Findings In this cross-sectional study using data from 2014 to 2022, the nationwide proportion of psychiatrists billing Medicare Part B declined from 44% in 2014 to 33% in 2022. The number of psychiatrists billing Medicare Part B declined by 3772 during a time when the total number of active psychiatrists increased by 6076.
    • “Meaning These findings suggest that during a time of psychiatrist workforce growth, the proportion and number of psychiatrists accepting Medicare Part B decreased, further suggesting potential decreases in access to psychiatrist-led care for older adults and individuals with disabilities.”

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.”

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.”

Midweek Update

David Ermer–Congress, Federal employment benefits, Medical / Rx research, OPM, Rx coverage, Telehealth, U.S. Healthcare–

From Washington, DC

Capitol Hill News

  • The Senate Press Gallery tells us, “The Senate invoked cloture [this afternoon] on the nomination of Russell Vought to be Director of the Office of Management & Budget on a party line vote of 53-47.” 
  • Modern Healthcare reports,
    • “A package of healthcare bills including measures that targeted transparency, spread pricing and drug rebates fell off a government funding bill at the last minute after Trump objected to other aspects of the bill.
    • “But the ideas behind them remain popular, and these healthcare, business and labor interests want lawmakers to pick up where they left off by including the PBM policies in the next spending package, which Congress must pass by March 14 to prevent a partial shutdown.”

OPM News

  • The Wall Street Journal reports
    • More than 40,000 federal workers have raised their hands to resign, putting the Trump administration at risk of falling short of its target for slashing the government through voluntary measures. 
    • The Office of Personnel Management last week told workers that they have until Thursday to decide whether to take a buyout. People who do so can continue to be paid through September without working, OPM has said. Unions and a dozen attorneys general say the offer isn’t guaranteed. 
    • On a call Wednesday with agency officials, OPM officials said the number of federal workers who have accepted the resignation offer is more than 40,000, according to a person familiar with the matter. Another person confirmed the figure was above 40,000 as of Wednesday afternoon. The Trump administration is expecting numbers to rapidly increase in the final day before the deadline, a White House official said.
    • When it offered the deal last week, the White House said it expected between 5% and 10% of federal employees to accept, leading to about $100 billion in savings annually, without providing information on how the estimate was reached. Officials haven’t translated the percentage range into a specific target for the number of employees it hopes will resign. There are about two million Americans working for the federal government in civilian jobs, though some positions are exempted from the offer.

From the judicial front,

  • Federal News Network informs us,
    • “Three federal unions are asking a federal court to rule that the Trump administration’s “deferred resignation” program is illegal as currently structured, and to order the Office of Personnel Management to give federal workers at least two more months to decide whether to opt in to the unconventional workforce reduction program.
    • “In a lawsuit filed Tuesday, the American Federation of Government Employees, the American Federation of State, County and Municipal Employees and the National Association of Government Employees claim the offer — sent to most federal workers via last month’s “fork in the road” mass email — violates the Administrative Procedure Act (APA) and other federal laws. As currently designed, the program gives employees until Feb. 6 to decide whether or not to resign.
    • “In issuing the directive across the government barely a week after the new administration was sworn in, OPM did not conduct any analysis of which agencies were likely to experience high levels of resignations, the optimal number of resignations, or where staffing was already woefully insufficient such that soliciting resignations would be incontrovertibly harmful to government operations,” attorneys for the labor unions wrote.”
  • Nextgov/FCW adds,
    • “The Office of Personnel Management asked a federal judge Wednesday to dismiss a lawsuit alleging the agency illegally used a new server to send mass emails to federal employees.  
    • “The initial suit, filed in the Washington, D.C. District Court by two anonymous federal employees, claims OPM — working with Elon Musk and his Department of Government Efficiency — violated the 2002 E-Government Act by bypassing a required privacy impact assessment, or PIA, before standing up the email platform.  
    • “Specifically, the lawsuit targets emails related to the Trump administration’s workforce reduction efforts, including the “Fork in the Road” deferred resignation offer, claiming these were sent via the allegedly unauthorized server.”

From the Food and Drug Administration front,

  • Reuters points out,
    • “The U.S. Food and Drug Administration has approved Supernus Pharmaceuticals’ (SUPN.O), opens new tab drug-device combination to treat movement-related symptoms of Parkinson’s disease, the drugmaker said on Tuesday. * * *
    • “The treatment branded Onapgo will be available in the U.S. in the second quarter.
    • “The approval brings to an end the company’s years-long effort to secure the FDA’s nod. The agency had declined to approve Supernus’ application in 2022 and 2024, with the regulator last year requesting additional information related to product quality and the device.”
  • Per a news release, “The Institute for Clinical and Economic Review (ICER) today posted its revised Evidence Report assessing the comparative clinical effectiveness and value of suzetrigine (Vertex Pharmaceuticals) for the treatment of acute pain.” This is the non-opioid acute pain drug (brand name Journavx that the FDA approved last week.
    • “Rates of development of opioid use disorder (OUD) after short-term administration of opioids for acute pain are uncertain, as are rates of NSAID adverse effects (e.g., acute kidney injury, gastrointestinal bleeding, acute coronary syndrome) when used in the post-operative setting. There are also uncertainties in assessing the efficacy of suzetrigine because of lack of data on use of rescue medication in the Phase III trials, which studied the drug’s use after surgery, as well as the use of imputation for pain scores after rescue medication was used in the clinical trial.
    • “The above uncertainties inform ICER’s ratings that the evidence for suzetrigine for the treatment of acute pain in comparison with no systemic treatment, in comparison with opioid analgesics, and in comparison, with NSAIDs are all promising but inconclusive (P/I), meaning moderate certainty of a small or substantial net health benefit, with a small likelihood of a negative net health benefit. 
    • “The FDA approved suzetrigine for acute pain on January 30, 2025. The manufacturer announced a US price of approximately $232.50 for a one-week course of treatment for acute pain.
    • “When compared to treating with opioids, ICER expects the treatment to be cost-saving from a lifetime perspective because of cost offsets due to fewer patients developing OUD.”
  • The revised report “will be reviewed at a virtual public meeting of the Midwest CEPAC on February 28, 2025. The Midwest CEPAC is one of ICER’s three independent evidence appraisal committees comprising medical evidence experts, practicing clinicians, methodologists, and leaders in patient engagement and advocacy. Register here to watch the live webcast of the virtual meeting.”

From the public health and medical research front,

  • The New York Times reports,
    • “Dairy cows in Nevada have been infected with a new form of bird flu that is distinct from the version that has been spreading through herds over the last year, the U.S. Department of Agriculture announced on Wednesday.
    • “The finding indicates that the virus, known as H5N1, has spilled from birds into cows at least twice — leading to these two sets of infections — and that it could continue to do so. It also suggests that the virus may pose a persistent risk to cows and to the people who work closely with them.
    • “Before last year, scientists did not know that cows were susceptible to this type of influenza.
    • “This is not what anyone wanted to see,” said Louise Moncla, an evolutionary biologist who studies avian influenza at the University of Pennsylvania. “We need to now consider the possibility that cows are more broadly susceptible to these viruses than we initially thought.”
    • * * *”So far, at least, the spread of D1.1 to cows “doesn’t change the average person’s life,” Dr. Moncla said. But it poses risks for dairy workers and the dairy industry, experts said. It also suggests the possibility that cows already infected once with B.3.13 could become ill a second time with D1.1, Dr. Richard Webby, an influenza expert at St. Jude Children’s Research Hospital, said.
    • “It’s no longer just one virus,” he said. “This, to me, suggests that it’s going to be a lingering problem.”
  • and
    • “The idea was so tantalizing. Drugs in the GLP-1 class, which includes Wegovy and Ozempic, have proved miraculous in treating weight loss and other diseases. And some researchers hoped that the drugs could also help with some of the most difficult diseases to treat — those of the brain, like Parkinson’s.
    • “But now, at least for Parkinson’s, that hope seems dimmed. A rigorous study that randomly assigned Parkinson’s patients to take exenatide, a relative of Ozempic, showed absolutely no benefit or slowing of the course of the degenerative disease after 96 weeks.
    • “And there were no effect on patient symptoms, no effect on brain scans, no subgroup that showed any benefit. No matter how the researchers sliced the data the results were the same.
    • “The study, published Tuesday in The Lancet, is bad news for the half million Americans who have been diagnosed with Parkinson’s disease. Symptoms include tremors, stiffness and difficulty with balance. Patients also may develop dementia. Treatments, including medications and deep brain stimulation, can help with symptoms. But no treatment has been shown to slow the disease’s progress.”
  • Per STAT News,
    • “Nine patients with advanced kidney cancer who received an experimental vaccine tailored to their tumors’ specific mutations mounted an immune response to their disease and remained cancer-free for three years, an early-phase clinical trial has shown. 
    • “The study, published Wednesday in Nature, demonstrates the potential of personalized vaccines to change the course of certain cancer types, but larger, longer trials are needed to confirm this approach. Cancer vaccines developed with different molecular recipes are still in their early stages, before strong conclusions can be made, experts said.”
  • Per Cardiovascular Business,
    • “Adults who regularly floss their teeth may be significantly decreasing their risk of stroke or heart rhythm issues, according to new findings to be presented at the American Stroke Association’s International Stroke Conference 2025.
    • “Researchers focused on data from more than 6,000 study participants with an average age of 62 years old. The group was followed for up to 25 years as part of the Atherosclerosis Risk in Communities study. Over the course of the study, 434 participants had a stroke and 1,291 were diagnosed with atrial fibrillation (AFib).
    • ‘Overall, flossing at least once per week was associated with a 22% lower risk of ischemic stroke, a 44% lower risk of cardioembolic stroke and a 12% lower risk of AFib. Flossing more often appeared to lead to more significant risk reductions.
    • “The difference in AFib risk was unexpected, surprising researchers.”
  • and
    • “Forty-eight percent of all U.S. adults incorrectly believe that they should be taking low-dose aspirin every day to minimize their risk of experiencing a heart attack or stroke, according to a new survey out of the University of Pennsylvania.
    • “Yes, doctors did recommend that adults take daily aspirin to protect against cardiovascular disease (CVD) in the past—but that was quite some time ago. In 2019, the American College of Cardiology American Heart Association released new guidelines saying heathy older adults should not be taking low-dose aspirin due to certain risks, including gastrointestinal bleeding. The U.S. Preventive Services Task Force even published separate recommendations in 2022 saying patients 60 or older should not be taking daily aspirin to prevent CVD, highlighting the lack of any real benefits. 
    • “Now, however, many adults still seem to think daily low-dose aspirin is beneficial, even when they are facing no other health problems. * * *
    • “Habits backed by conventional wisdom and the past advice of healthcare providers are hard to break,” Kathleen Hall Jamieson, director of the Annenberg Public Policy Center and director of this survey, said in a statement. “Knowing whether taking a low-dose aspirin daily is advisable or not for you is vital health information.”
    • “Another key takeaway from the survey was that younger patients appear to know more about the benefits and risks of taking daily low-dose aspirin when healthy. For example, 29% of healthy respondents with no family history of CVD who are between the ages of 18 and 39 understand that the risks of daily aspirin outweigh the benefits for someone in their circumstances. That is only true for 11% of adults in that same situation between the ages of 40 and 59, however, and just 7% of adults ages 60 and older.”
  • BioPharma Dive reports,
    • “Novo Nordisk is planning a new Phase 3 trial of its next-generation obesity drug CagriSema that will test different doses and longer duration of treatment, the company said Wednesday.
    • “The announcement comes six weeks after the Denmark-based company released data from another Phase 3 trial that underperformed executives’ expectations on weight loss. Other studies are ongoing, including one with results due this quarter, and Novo plans in early 2026 to ask for regulatory approval of CagriSema.
    • “Novo, which pioneered the use of GLP-1 medicines like Wegovy for weight loss, is in a tight competition with Eli Lilly. The rivalry sharpened when Lilly’s drug Zepbound showed it helped people lose more weight than Wegovy in a head-to-head trial, a finding that put greater scrutiny on Novo’s pipeline.”

From the U.S. healthcare business front,

  • Healthcare Dive lets us know,
    • “Healthcare access and affordability is Americans’ top public health concern, followed by ensuring safe food and water and reducing chronic disease, according to a new survey published by Gallup and Emory University’s Rollins School of Public Health. 
    • “Republicans were more likely than Democrats to list ensuring safe food and water as their top public health priority and less likely to list the Centers for Disease Control and Prevention as one of their top three sources of trusted health information.
    • “However, both Democrats and Republicans support federal action on their top priority public health concerns, with 60% of Republicans and more than 75% of Democrats indicating a preference for federal leadership over state action.”
  • The Wall Street Journal reports,
    • “Novo Nordisk shares rose after the drugmaker reported strong sales growth for its blockbuster obesity and diabetes drugs and issued a forecast for full-year 2025 results that topped analysts’ expectations.
    • ‘Novo’s shares were up 3% in European trading, and its American depositary shares were up 3.4% in premarket U.S. trading Wednesday after Novo reported fourth-quarter earnings. Investors who had become concerned about an obesity market slowdown, as well as Novo’s competitive position, breathed a sigh of relief.
    • “The story continues to be about market expansion for obesity,” said David Moore, president of Novo Nordisk’s U.S. unit, on a conference call with analysts.”
  • Fierce Pharma tells us,
    • “Less than a decade since it secured its first FDA approval for a biosimilar, Amgen’s portfolio of the copycat drugs is growing and making strong contributions to the company’s top line.
    • “In 2024, when Amgen generated $33.4 billion in revenue, more than $2.2 billion came from sales of its biosimilars. It was a 16% increase from Amgen’s biosimilar sales in 2023 and the company appears ready to top that figure this year.
    • “Less than three months ago, Amgen became the first company in the U.S. to launch a biosimilar version of Regeneron and Bayer’s eye disease blockbuster Eylea. Then last month, Amgen brought to the market a knockoff of Johnson & Johnson immunology powerhouse Stelara.
    • “In the last nine weeks of last year, Amgen’s Eylea biosimilar, Pavblu, generated $31 million in sales.
    • “The current feedback from retina specialists that we’ve been talking to is very enthusiastic, very positive,” Murdo Gordon, Amgen’s global commercial operations chief, said Tuesday during a quarterly conference call. “They are pleased that Amgen is bringing yet another high-quality biosimilar in a very easy-to-use prefilled syringe.”
  • “Beckers CFO Reports informs us,
    • “Burlington, Mass.-based Tufts Medicine recorded an operating loss of $28.9 million (-4.1% operating margin) in the first quarter of 2025, down from an operating loss of $6.5 million (-0.9% margin) in the same quarter last year, according to its Feb. 3 financial report. 
    • “Tufts Medicine’s management said in the report that last year’s first quarter operating loss was reduced by “two significant one-time items.” The system received $41 million in one-time grants from the state and the federal government, and $24 million in revenue from a 340B settlement. Excluding those two items, the system would have seen an operating loss of $71.5 million in the first quarter of 2024. 
    • “Eliminating these one-time items from each fiscal year would show an improvement of $43 million,” management said in the report. 
    • “Tufts reported total operating revenue of $710.7 million in the three months ended Dec. 31, up from $701.5 million reported in the same period last year.” 
  • Per Healthcare Dive,
    • “Teladoc Health has signed a definitive agreement to acquire virtual preventive care provider Catapult Health for $65 million, the telehealth vendor said Wednesday.
    • “The deal, which is expected to close in the first quarter, will help Teladoc catch members’ health conditions early and funnel patients toward the telehealth vendor’s other offerings, including therapists and primary care providers, according to a press release.
    • “Catapult clinicians will also be able to directly enroll eligible members in Teladoc’s chronic condition management programs for diabetes, hypertension, pre-diabetes and weight management — a key area of investment for the telehealth vendor, executives said last month at the J.P. Morgan Healthcare Conference.”
  • and
    • “Molina has closed its $350 million acquisition of ConnectiCare, the health insurer announced Tuesday.
    • “The deal adds $1.4 billion in annual premiums to Molina’s topline and 140,000 additional Medicare, Affordable Care Act marketplace and commercial members to the insurer’s rolls.
    • “The acquisition, which was announced last summer, also brings Molina into the state of Connecticut for the first time. ConnectiCare was previously a subsidiary of New York-based nonprofit health plan EmblemHealth.”
  • and
    • “Kroger pharmacies are once again back in Express Scripts’ network, two years after the grocer kicked the massive pharmacy benefit manager to the curb over its allegedly unsustainable pricing model.
    • “Kroger Health, the grocer’s healthcare subsidiary, said on Wednesday it had reached a new agreement with the Cigna-owned PBM that allows customers in Express Scripts’ Medicare prescription drug and Tricare plans for military members to fill prescriptions at Kroger pharmacies.
    • “The new agreement also allows Express Scripts’ commercial and Medicaid clients to add Kroger pharmacies to their networks, according to the announcement. Express Scripts customers can also receive healthcare at Kroger clinics, which offer low-acuity services like vaccinations and preventive care.”

Tuesday Report

David Ermer–CMS, Congress, FDA, OPM, U.S. Healthcare–

From Washington, DC,

Capitol Hill News

  • Healthcare Dive tells us,
    • “A key congressional committee voted Tuesday to advance to a full Senate vote the nomination of prominent vaccine skeptic Robert F. Kennedy Jr. as the next U.S. health secretary.
    • “The 14-13 vote by the Senate Finance Committee was along party lines, with all 14 Republicans on the panel voting in favor of Kennedy. Among them was Sen. Bill Cassidy, R-La., a physician who said in a hearing last week that he was “struggling” with his vote because of Kennedy’s claims about vaccines.
    • “Cassidy said on social media platform X he voted yes after “very intense conversations” with Kennedy and the White House over the weekend.
    • “With the serious commitments I’ve received from the administration and the opportunity to make progress on the issues we agree on like healthy foods and a pro-American agenda, I will vote yes,” he said.”
  • The American Hospital Association News adds, “The Senate Feb. 4 confirmed Doug Collins as the new Department of Veterans Affairs secretary by a 77-23 vote.”
  • Per a Senate news release,
    • “U.S. Senate Finance Committee Chairman Mike Crapo (R-Idaho) released the following statement after meeting with Dr. Mehmet Oz, President Trump’s nominee to be Centers for Medicare and Medicaid Services (CMS) Administrator:
    • “I had a constructive meeting with Dr. Oz, where we discussed his approach to health care policy and vision for CMS.  I value his advocacy for consumer choice and his commitment to expanding Americans’ access to affordable, high-quality health care.  I look forward to considering his nomination before the Finance Committee.”
  • Politico reports, “President Donald Trump’s nominee for attorney general, Pam Bondi, was confirmed by the Senate Tuesday evening, 54-46.

OPM News

  • Govexec informs us,
    • “With just two days remaining before the deadline for federal workers to accept or reject the Trump administration’s so-called deferred resignation program, agencies are again defending its legality and increasingly coaxing feds to take the deal.
    • “Federal workers have until Thursday to respond to one of a series of emails offering what Trump officials are calling “buyouts,” in which a federal worker is paid their current salary and benefits until Sept. 30 though will have effectively quit by the end of February. Administration officials say employees who accept the deal will be placed on paid administrative leave—in an apparent effort to circumvent the $25,000 cap on Voluntary Separation Incentive Payments—while the Office of Personnel Management has already begun granting agencies Voluntary Early Retirement Authority for eligible federal workers.
    • “But according to Axios, only 20,000 feds have thus far accepted the deal, which has been widely panned by Democrats and federal employee groups as illegal and unenforceable. That accounts for less than 1% of the 2.3 million federal workers, and well below the White House’s reported target of 10%.” * * *
    • “OPM on Tuesday issued new guidance seeking to defend the offer’s legality, insisting that the agreement resigning federal workers will sign legally binds agencies into maintaining their pay and benefits until September.”
  • Federal News Network points out,
    • “Agencies have until Noon on Wednesday to send the Office of Personnel Management a list of employees on probation and say whether or not they want to keep them.
    • “Federal sources confirm OPM asked agencies to submit their lists and gave them a 200-character limit to explain why the employee should stay in government.” * * *
    • “Data on how many employees are under a probationary period is not readily available. The latest data from Fedscope is from March 2024 and shows more than 220,000 federal employees were within their one-year probationary period. That number may indicate generally how many newly hired employees are in the federal workforce at any given time.”

Food and Drug Administration News

  • The Hill reports
    • “The Food and Drug Administration has upgraded its classification of a broccoli recall initially reported in late December, labeling it as “Class I” — the agency’s most serious recall category.
    • “Braga Fresh, of Salinas, California, had initially issued an “advisory” for a specific lot of Marketside Broccoli Florets in late December, after Health and Human Services workers discovered Listeria monocytogenes in “multiple samples” from a Texas Walmart.
    • “The broccoli had been distributed to Walmart stores in 20 states: Alaska, Arkansas, Arizona, California, Colorado, Idaho, Illinois, Indiana, Kentucky, Louisiana, Michigan, Montana, Nevada, Ohio, Oklahoma, Oregon, Texas, Utah, Washington and Wyoming.
    • “No illnesses had been reported at the time of the initial advisory. Consumers were advised to throw away the potentially affected product and contact Braga Fresh with any other concerns.
    • “In late January, however, the FDA upgraded the recall to a Class I, the FDA’s website shows.
    • “Class I, the FDA says, involve “a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”
  • Per Fierce Pharma
    • “Seven months after the FDA signed off on a reintroduction of Roche’s eye implant Susvimo, the U.S. regulator has broadened its label as a treatment for diabetic macular edema (DME), which is the leading cause of diabetes-related blindness.
    • “The nod is the second indication for Susvimo, an alternative to regular eye injections that was originally approved to treat wet age-related macular degeneration in October 2021.
    • “Twelve months later, however, Susvimo was pulled because of manufacturing problems with the seal on the port delivery device. By July of last year, Roche had ironed out the issues and earnedendorsement from the FDA to put it back on the market. 
    • ‘Susvimo is the size of a grain of rice and is surgically implanted under the upper eyelid. The device provides a customized formulation of Lucentis (ranibizumab), which needs refilling just twice a year.”
  • STAT News reports,
    • “Amgen said Tuesday that the Food and Drug Administration has ordered a hold on a study of the company’s early-stage obesity candidate, another potential setback in the company’s efforts to join the booming weight loss drug market.
    • “Amgen has so far said little about the drug, dubbed AMG 513, and has not described the drug’s mechanism. On a call with analysts, Amgen executives did not explain why AMG 513 is on a clinical hold, other than to say “it’s not related to the drug” and that discussions are underway to reopen the study.” 

Miscellany

  • The Social Security Administration has created a set of online FAQs about the Social Security Fairness Act.
  • The Groom Law Group discusses the CMS simplified prescription drug creditable coverage methodology proposed on January 10. “Comments on the Draft CY 2026 Part D Redesign Program Instructions are due to CMS no later than February 10, 2025. and must be submitted to PartDRedesignPI@cms.hhs.gov with the subject line “Draft CY 2026 Part D Redesign Program Instructions.”

From the public health and medical research front,

  • Healio lets us know,
    • “World Cancer Day [is] Feb. 4.
    • “Union for International Cancer Control (UICC) created World Cancer Day in 2000 to educate the public about the importance of early detection and treatment, encourage elected representatives to commit ample resources to reduce cancer mortality, and increase awareness that lifestyle behaviors have a considerable effect on cancer risk.
    • “This year’s World Cancer Day is the first of a 3-year campaign with the theme “United by Unique.” The campaign is designed to promote the need for “a fundamental shift in cancer care and health systems” around the world toward a people-centered approach, according to a UICC press release.
  • and
    • “SGLT2 inhibitors confer greater risk reductions for major adverse cardiovascular events in older adults with type 2 diabetes compared with younger adults, according to findings from a systematic review and meta-analysis published in JAMA.” * * *\
    • “Age should not be a barrier to treatment with SGLT2 inhibitors in patients who are likely to benefit from reduced CV risk,” Peter Hanlon, PhD, clinical senior research fellow in the School of Health and Wellbeing at University of Glasgow in the U.K., told Healio. “It also suggests that for these treatments that have a proven CV benefit, change in blood glucose may be a poor indicator of the protective effect on CV outcomes.”
  • The Wall Street Journal discusses “The Right White Noise for a Good Night’s Sleep. Plus, some of our favorite products for blocking annoying sounds.

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “On Tuesday, Centene touted healthy membership growth in Affordable Care Act plans, while arguing that Medicaid and Medicare — businesses that proved rocky last year — will stabilize in 2025.
    • “Already the largest marketplace carrier, Centene now has upwards of 5 million ACA members paying premiums, executives told investors during a call to discuss its fourth-quarter results. That’s compared to 4.8 million members at the end of 2024.
    • “Growth in ACA members was a major contributor to Centene’s $3.3 million in profit last year, according to the company. However, Centene expects enrollment to peak in the first quarter before sliding back down over the year, in part from efforts to improve program integrity, CEO Sarah London said.”
  • Per Fierce Pharma,
    • “The continued decline of Merck & Co.’s HPV vaccine Gardasil in China has come to a head as the New Jersey drug giant is halting shipments to the world’s second-most populous country.
    • “Thanks to ongoing market challenges, Merck is temporarily cutting off Gardasil deliveries to China from February through at least the middle of 2025. The move should help the drugmaker clear out excess doses of the vaccine cluttering its inventory, Merck said (PDF) in an earnings presentation Tuesday.
    • “Over the last three months of 2024, Gardasil generated $1.6 billion in sales globally, signaling an 18% decline compared to the same period in 2023. For the full year, during which Merck generated total revenues of $64.2 billion, Gardasil sales dropped 3% to $8.6 billion.”
  • Per Healthcare Dive,
    • “HCA Healthcare completed its $110 million purchase of Manchester, New Hampshire-based Catholic Medical Center on Feb. 1, a spokesperson confirmed to Healthcare Dive. The deal is the latest in a growing trend of hospital acquisitions motivated by financial distress.
    • “HCA received regulatory approval to purchase CMC in January, after the New Hampshire attorney general’s office determined CMC was on the brink of bankruptcy and could soon close its 330-bed acute care facility without a buyer.
    • “Regulators imposed significant conditions on the sale and will monitor HCA for compliance over 10 years. For example, HCA will be required to invest $200 million to expand healthcare capacity in New Hampshire and preserve critical service lines for the duration of the monitoring period, including pregnancy care.”
  • and
    • Prospect Medical Holdings said Monday it has a deal to sell its two hospitals in Rhode Island — collectively called CharterCARE Health Partners — for approximately $160 million to the Centurion Foundation, a nonprofit healthcare operator based in Georgia. 
    • The deal precedes Prospect’s January Chapter 11 bankruptcy filing. Prospect and Centurion signed a definitive agreement in 2022, and Rhode Island regulators approved the sale last year. However, the attorney general’s office placed 40 closing conditions on the sale. In first day bankruptcy motions, Prospect said the terms were too onerous for the cash-strapped system to meet.
    • In a statement to Healthcare Dive, a spokesperson for the Rhode Island attorney general’s office was steadfast, saying the parties “must comply” with the regulators’ terms as laid out last year. “We are reviewing their filing carefully to determine whether their proposed sale does so,” the spokesperson said.

Happy Groundhog Day

David Ermer–Congress, OPM, U.S. Healthcare–

The Weather Channel reports, “Before a huge crowd filled with excitement and anticipation, and bundled up against temperatures in the 20s, t​he groundhog known as Punxsutawney Phil saw his shadow Sunday morning in central Pennsylvania. That means we could see six more weeks of winter, at least according to Groundhog Day lore.”

From Washington, DC

  • Capitol Hill News
  • The full Senate will begin to take up the nomination of Russell Vought to be Director of the Office of Management and Budget tomorrow afternoon.
  • Per a Senate news release,
    • “U.S. Senate Finance Committee Chairman Mike Crapo (R-Idaho) announced [today] the Committee will mark up the nomination of Robert F. Kennedy Jr. to be Secretary of the U.S. Department of Health and Human Services (HHS) during an executive session on Tuesday, February 4, 2025, at 10:00AM ET.” 
  • On Wednesday February 5 at 10 am ET the House Oversight Committee will hold a hearing about
    “Rightsizing Government.”

OPM News

  • Federal News Network reports,
    • “The Office of Personnel Management’s blanket offer for federal employees to accept its “deferred resignation” offer is starting to narrow.
    • “Some agencies are notifying employees in certain critical positions that they are exempt from OPM’s offer. In other cases, agency leaders have told employees who already accepted the offer that they must keep working, regardless of what they have already been told by OPM.”
  • and
    • “The Office of Personnel Management is giving agencies the authority to offer early retirement to federal employees — in addition to the “deferred resignation” offer sent to most federal employees in a mass email earlier this week.
    • “OPM is approving VERA authority so eligible employees may receive VERA if they accept the deferred resignation officer,” OPM Acting Director Chuck Ezell wrote in an email obtained by Federal News Network. “If your full retirement eligibility data falls within the 2025 calendar year, the agency may extend your deferred resignation period to the date of your full retirement eligibility.”
    • “An OPM spokesperson confirmed to Federal News Network the VERA extends governmentwide.
    • “Federal and postal employees under the Civil Service Retirement System (CSRS) and Federal Employees Retirement System (FERS) are eligible for voluntary early retirement if they’re at least 50 years of age, with at least 20 years of service, or any age with at least 25 years of service.
    • “Voluntary Early Retirement Authority doesn’t always come with a financial incentive. But in cases agencies do offer money, the incentive is capped at $25,000.”

From the U.S. healthcare business front,

  • Beckers Hospital Review offers executive insights on the impact that the President’s February 1, 2025, tariff program may have on healthcare.
  • Beckers also tells us,
    • “Healthgrades has recognized 250 U.S. hospitals as part of its 2025 America’s Best Hospitals Awards.
    • “The top 50 hospitals [which are listed in the article] represent the 1% of U.S. hospitals providing the highest level of quality care, according to a Jan. 28 news release. 
    • “Healthgrades evaluated the clinical performance of approximately 4,500 hospitals across more than 30 common procedures and conditions, the release said. Read more about the methodology here.”
  • Fierce Healthcare informs us,
    • “Medicare Advantage patients treated in value-based care models saw better outcomes than those treated in fee-for-service models, according to a new study.
    • “Researchers led by a team at Optum examined claims data on nearly 5.3 million person-years from 2016-19 across 20 different measurements and found that patients in accountable care models were 9% less likely to be admitted to the hospital and 9% less likely to visit the emergency department.
    • “The study found that value-based patients were also 22% less likely to be admitted to the hospital for concerns related to chronic conditions like chronic obstructive pulmonary disorder or asthma, including an 18% reduction in admissions related to hypertension.
    • “In addition, patients treated in the value-based models were 9% less likely to be admitted to the hospital from the emergency room, the study found.:

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.”

Thursday Report

David Ermer–CMS, Congress, FDA, Federal employment benefits, Mental health care, OPM, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC

Capitol Hills News

  • Modern Healthcare reports,
    • “Robert F. Kennedy Jr.’s chances of confirmation as Health and Human Services secretary appeared to hinge Thursday on convincing a handful of Senate Republicans that he would adhere to accepted science when it comes to vaccines. * * *
    • “Three key Republicans pressed the prominent vaccine critic to moderate his past positions and unequivocally endorse vaccinations, starting with HELP Committee Chair Dr. Bill Cassidy (R-La.). Cassidy likewise challenged Kennedy during the Senate Finance Committee’s confirmation hearing Wednesday.
    • “Cassidy declined to declare support for President Donald Trump’s nominee to be the nation’s highest-ranking health official during the hearing or when questioned afterward. GOP Sens. Susan Collins (Maine) and Lisa Murkowski (Alaska) also have not declared support for Kennedy.” * * *
    • “Kennedy could lose up to three Republicans and still be confirmed. The nominee needs 51 votes, and Republicans have a 53-47 advantage over Democrats in the Senate. If necessary, Vice President JD Vance would break a 50-50 tie in his constitutional capacity as president of the Senate.
    • “If Cassidy, Collins, Murkowski and McConnell all vote nay, Kennedy would be one vote short, assuming every Democrat opposes him. Yet a few Democrats have not declared their positions on the nominee, such as Sens. Cory Booker (N.J.) and John Fetterman (Pa.).
    • “The Finance Committee will vote whether to recommend confirmation to the Senate, while the HELP Committee will not. The Finance Committee vote has not been scheduled but may come as soon as next week. Cassidy sits on the Finance Committee, while Collins, Murkowski and McConnell do not.”
  • Roll Call tells us,
    • “Senate Budget Committee Republicans approved Russ Vought’s nomination to serve as President Donald Trump’s budget director on Thursday, overcoming the absence of Democrats on the panel who boycotted the markup.
    • “The 11-0 party-line vote clears the way for Vought’s nomination to go to the full Senate. The Senate Homeland Security and Governmental Affairs Committee, which shares jurisdiction over the Office of Management and Budget, approved Vought’s selection in a party-line vote last week.
    • “Thanks to Democrats’ boycott, Republicans had to wait for all 11 GOP panel members to trickle in from their other obligations due to rules requiring a quorum of committee members before taking a vote.”

OPM News

  • Federal News Network informs us,
    • “The Office of Personnel Management is sharing initial details with internal employees on what the federal return-to-office mandate will look like for OPM’s own staff members.
    • “Starting March 3, OPM employees are expected to report to work on-site full-time, OPM Acting Director Charles Ezell told employees Wednesday evening in an all-staff email, obtained by Federal News Network.
    • “Ezell described his email as a “preview” of the agency’s return-to-office plans, adding that OPM will host a town hall next week to share more details with employees.
    • “As with any operational change, we know we will encounter challenges, but I am confident that you will bring the same diligence and innovation to this process as you have countless other efforts we have undertaken at OPM,” Ezell wrote in the email to OPM employees.
    • “Ezell’s email comes in response to a Jan. 23 memo outlining how agencies are expected to respond to President Donald Trump’s directive to end remote work in the federal workforce. The OPM guidance clarified that the mandate applies to both teleworkers and remote workers, but that there are exemptions for employees with disabilities, qualifying medical conditions or other “compelling reasons.”
    • “Emerging return-to-office plans may vary by agency, but agencies in the executive branch are expected to similarly issue implementation plans to return their employees to the office full-time.”
  • Tammy Flanagan, writing in Govexec, offers advice figuring out the Fork in the Road program.

FDA News,

  • BioPharma Dive reports,
    • “The movement to steer pain treatment away from opioids notched a major victory Thursday, as the Food and Drug Administration approved a new, highly anticipated drug from Vertex Pharmaceuticals.
    • “The culmination of decades of work, Vertex’s Journavx is now cleared to treat the short-lived “acute” pain usually felt after an accident or a surgery. Vertex hopes to eventually get the drug approved for chronic pain as well, though clinical trials testing it in that setting have produced mixed results.
    • “Acute pain is often treated with a combination of acetaminophen, anti-inflammatory agents like ibuprofen and, if necessary, opioids, which pose an addiction risk because they act directly on the brain and stimulate pleasure centers. Despite the dangers, insurance companies, pharmacy managers and drugmakers like Purdue Pharma for years pushed for the use of opioids in pursuit of immense profits. The resulting overdose crisis has killed hundreds of thousands of people in the U.S. alone.”

Miscellany

  • Beckers Payer Issues points out,
    • “An organization representing Medicare Advantage insurers is asking CMS to pause any policy changes to the program not required by law in 2026. 
    • “In a Jan. 28 press release, the Better Medicare Alliance, a pro-MA group backed by several major insurers, urged the agency to prioritize “stability” in its 2026 proposed rule. 
    • “In November, the Biden administration pitched several major regulatory changes for 2026, including requiring Medicare to cover GLP-1 drugs for individuals with obesity.” 

From the public health and medical research front,

  • MedPage Today lets us know,
    • An online dementia prevention program improved cognition in a trial of 6,100 older adults.
    • Scores in complex attention, executive function, and memory improved.
    • Women versus men and people ages 55-65 versus 66-77 benefited more from the program.
  • Per Fortune Well,
    • “The myth that cannabis is harmless because it’s natural has been further debunked—by scientists in a pot-friendly state. New research from the University of Colorado Anschutz Medical Campus shows that heavy lifetime cannabis use may harm working memory in young adults.
    • “In what the university calls the largest study of its kind, researchers used brain imaging technology to explore the effects of recent and lifetime cannabis use on brain function among more than 1,000 people ages 22 to 36. During a task assessing working memory—the short-term storage of information that can be applied to activities such as reasoning and problem-solving—the majority of recent (68%) and heavy lifetime (63%) cannabis users showed reduced brain activity. The findings were published Jan. 28 in the journal JAMA Network Open.”
  • and
    • “How many times a day do you touch your phone? It’s pretty easy to lose count, as it seems like our cell phones never leave our side—even when we use the bathroom. You might want to rethink your toilet doom scrolling, though, as your phone can be one of the worst breeding grounds for fecal bacteria and other viruses.
    • “Several studies of health care workers show the high level of bacterial and microorganism growth on their mobile phones—but it’s not just in clinical settings that bacteria thrives on smartphones. A 2017 study of high school students’ phones found the presence of over 17,000 bacterial gene copies per phone—the more gene copies, the greater potential for faster bacteria growth.
    • “Most jarringly, researchers at the University of Arizona found that cell phones carry 10 times more bacteria than a toilet seat, including E.coli, Salmonella, norovirus, staph, and gonorrhea. That can add up to a lot of bacterial exposure, as a Reviews.org survey reports that Americans check their phones a whopping 205 times a day.
    • “People’s phones are out when urinating and defecating, exposing the phones to bacteria,” says Dr. Suraj Saggar, chief of infectious disease at Holy Name Medical Center in New Jersey. “Then put it into a pocket or purse that is dark, allowing bacteria to grow.”
    • “[In the article], experts tell Fortune how worried you should be about potential pathogens on your phone and the best way to keep it clean.”

From the U.S. healthcare business front,

  • Healthcare Dive relates,
    • “Cigna closed out 2024 on shaky footing, posting fourth-quarter results below Wall Street’s expectations due to a rise in medical costs. Meanwhile, top executives pledged changes to medical and pharmacy plans amid widespread discontent with health insurance companies.
    • On Thursday, the Connecticut-based company reported revenue of $65.7 billion, up 29% year over year, and income of $1.4 billion, up 38% year over year. However, adjusted income from operations, which Cigna believes is a better metric of how the company performs, fell 8% year over year to $1.8 billion, well below analyst forecasts.
    • Cigna CEO David Cordani told investors Thursday morning the company will work to make receiving medical and pharmacy care cheaper and easier for its customers, amid criticism that insurers and pharmacy benefit managers are profiteering at the expense of the American consumer.”
  • Bloomberg Law adds,
    • “Cigna’s health benefits division spent 87.9% of premium revenue on medical expenses in the fourth quarter, more than analysts were expecting from that key measure. Management blamed it on “stop loss” plans, which employers use to guard against costly medical claims.
    • “Cigna’s management said the problem was increased use of cancer drugs like Keytruda, which is priced at around $200,000 a year, and multiple sclerosis treatment Ocrevus, listed at around $80,000 annually. Expensive hospital stays for cancer and heart surgeries also drove up medical spending, management said.”
  • Per Fierce Healthcare,
    • “Cigna executives said that the company is on track to close the sale of its Medicare Advantage business in the first quarter of 2025, in line with its expectations.
    • “The insurer announced plans to sell off its MA plans to Health Care Service Corporation in January 2024 in a deal valued at $3.7 billion. Chief Financial Officer Brian Evanko said that all federal antitrust approvals have been received, as have all but one state approval.”
  • MedTech Dive reports,
    • “Zimmer Biomet has agreed to buy Paragon 28, an orthopedics company focused on foot and ankle implants, for an equity value of approximately $1.1 billion.
    • “Zimmer will purchase all outstanding shares of Paragon 28 for $13 per share, according to the Tuesday announcement. The amount is a slight premium over Paragon’s Tuesday closing price of $12; however, its shares fell below $5 as recently as October. The deal is expected to close in the first half of 2025.
    • “Needham analysts, in a Wednesday note to investors, wrote they have viewed Paragon as a potential acquisition target for a long time and were “surprised by the small premium that [Zimmer] is paying.” The analysts expect Zimmer to pull off more acquisitions, potentially outside of orthopedics.”

Midweek Update

David Ermer–CMS, Congress, Federal employment benefits, Medical / Rx research, Medicare, Mental health care, OPM, Rx coverage, U.S. Healthcare–
Photo by Pascal Debrunner on Unsplash

From Washington, DC,

  • Per a CMS press release issued today,
    • “Lowering the cost of prescription drugs for Americans is a top priority of President Trump and his Administration. In accordance with the statutory requirements of the Inflation Reduction Act, the Centers for Medicare and Medicaid Services (CMS) released the list of 15 drugs selected for the second cycle of the Medicare Drug Price Negotiation Program on January 17, 2025. As the second cycle begins under the Trump Administration, CMS is committed to incorporating lessons learned to date from the program and to considering opportunities to bring greater transparency in the Negotiation Program. CMS intends to provide opportunities for stakeholders to provide specific ideas to improve the Negotiation Program, consistent with the goals of achieving greater value for beneficiaries and taxpayers and continuing to foster innovation.”
  • The American Hospital Association (AHA) News tells us,
    • The AHA Jan. 28 voiced support for bipartisan legislation to reauthorize for five years the Dr. Lorna Breen Health Care Provider Protection Act, which provides grants to help health care organizations offer behavioral health services for front-line health care workers. Introduced yesterday by Sens. Tim Kaine, D-Va., Roger Marshall, R-Kan., Jack Reed, D-R.I., and Todd Young, R-Ind., the bill also would reauthorize a national campaign that provides hospital leaders with evidence-based solutions to support worker well-being. 
  • Federal News Network informs us,
    • “A significant majority of federal employees who took a Federal News Network survey say they don’t plan on accepting the Office of Personnel Management’s offer to resign and go on paid administrative leave.
    • “In a survey of 4,619 federal employees, more than three-quarters of respondents said they don’t intend to accept the deal OPM sent to most civil federal workers in a mass email Tuesday afternoon.” * * *
    • “More than 500 respondents — about 11% of those who took the poll — said they intend to accept the deal.
    • “Among those who expect to accept the offer, 54% said they already had plans to retire from federal service soon or leave for a job outside the federal workforce.” * * *
    • “About 70% of respondents said they don’t have enough information from OPM to make their decision either way. Many said OPM hasn’t provided enough details on what accepting the deal would mean for their health and life insurance plans, or whether it would impact their pensions.”
  • ICD10 Monitor relates,
    • “The Centers for Medicare & Medicaid Services (CMS) have issued the display copy of the Final Rule interpreting the 60-day Refund Rule for Medicare Parts A/B (Traditional Medicare) and C/D (Medicare Advantage, or MA, and the Prescription Drug Plans) established by the Patient Protection and Affordable Care Act.
    • “The Final Rule became effective as of Jan. 1, 2025. The 60-day Refund Rule is included as part of the 3,000+-page 2025 Physician Fee Schedule Final Rule. 
    • “The federal Overpayment Statute requires any person who receives or retains Medicare or Medicaid funds to which they are entitled to report and return any overpayment to the appropriate government official or contractor within 60 days after “identification” of the overpayment, per Section 1128J(d) of the Social Security Act, 42 U.S.C. § 1320a-7k(d).
    • “Failure to report and return an “identified” overpayment in a timely manner could create a false claim situation subject to the False Claims Act (FCA). The False Claims Act, among other things, addresses individuals who knowingly conceal or avoid an obligation to pay or refund money to the federal government.”

From the public health and medical research front,

  • STAT News reports,
    • In July 2022, 988 launched as the number anyone across the country could dial in a mental health crisis. It’s one entryway to a sprawling system of mental health care options, but new research shows that since then, critical crisis services have not become more available — a key objective of the nationwide rollout, designed to strengthen an underfunded, patchwork system that left many people alone in times of crisis. 
    • While calls to the national hotline have continued to increase, fewer psychiatric facilities are offering emergency psychiatric walk-in services, mobile crisis response units, and suicide prevention services, according to a study published Wednesday in JAMA Psychiatry.
    • “988 isn’t going to reach its full potential until there’s a full system of crisis services in every single community,” said Hannah Wesolowski, chief advocacy officer at the National Alliance on Mental Illness.”
  • and
    • From plant-based chocolate milk to fizzy reduced-sugar drinks courtesy of Michelle Obama, the beverage market is always introducing new offerings to appeal to kids. But new dietary recommendations from several major health organizations say that children should really stick with drinking water and plain pasteurized milk.
    • The recommendations for children ages 5-18, released Wednesday, come from the Academy of Nutrition and Dietetics, the American Academy of Pediatric Dentistry, the American Academy of Pediatrics, and the American Heart Association. 
    • Their advice is in keeping with broader draft dietary guidelines created by an advisory committee to the U.S. government at the end of last year, which also said water should be the main thing that people of all ages drink. But the report is notable in carving out specific stances on the wide range of beverage options marketed to families, including plant-based milk and drinks containing non-sugar sweeteners. 
  • Per MedPage Today,
    • Fluctuating cholesterol levels were tied to higher dementia risks in a large study of older adults.
    • Relationships were seen for variability in both total cholesterol and LDL-C levels.
    • Links with dementia were independent of baseline values or whether trends were up or down.
  • Per Healio,
    • The addition of high-dose IV vitamin C to standard chemotherapy nearly doubled overall survival for patients with advanced pancreatic cancer, according to results of a randomized phase 2 trial.
    • Vitamin C also delayed the impact of adverse events and improved quality of life.
  • Per Medscape,
    • “Low-dose aspirin reduced colorectal cancer (CRC) recurrence rates by more than half in patients with tumors harboring mutations in the PI3K signaling pathway, according to findings from the phase 3 ALASCCA trial.
    • “These results stress “the importance of upfront genomic testing” in patients with CRC, said Anna Martling, MD, PhD, from Karolinska Institutet, Stockholm, Sweden, who reported the findings at the American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium 2025 in San Francisco.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “A big-business coalition is using hospital, insurer and employer healthcare cost information to help companies negotiate the price of services and coverage for employees.
    • “The Purchaser Business Group on Health will combine healthcare price transparency data and other information from providers and insurers with claims data from five large employers to analyze the cost and quality of care across 10 markets, the group said in a Wednesday news release.
    • “We are developing a new level of transparency and analysis that does not currently exist for the commercial market,” PBGH Chief Operating Officer Won Andersen said in the news release. “The project represents a pivotal step toward enhancing transparency and accountability in healthcare spending and purchasing.”
  • Beckers Payer Issues lets us know,
    • “Express Scripts, The Cigna Group’s pharmaceutical benefit manager, will implement new policies designed to prevent members from paying the full list price for drugs. 
    • “Most Express Scripts patients spend less than $100 out-of-pocket for their prescriptions each year, but some patients in high-deductible plans may pay the full list price for medications, according to a Jan. 29 news release. 
    • “Evernorth, Cigna’s health services arm, which manages Express Scripts, will shift its standard offerings to protect patients from paying the list price for medications. The company will also implement better predictability in drug pricing for patients, especially those in high deductible plans, according to the release.” 
  • Per Fierce Healthcare,
    • “Amazon One Medical continues to build out its health system partnerships to expand its network of primary care clinics.
    • “Montefiore Health System is now partnering with the company to open up access to primary and specialty care in New York’s Westchester County and surrounding areas.
    • “Amazon, which bought primary care company One Medical in a $3.9 billion deal in 2023, will open its first primary care offices in Westchester County in affiliation with Montefiore next year, the companies announced Wednesday.
    • “The primary care office will offer same and next-day appointment availability, on-site lab services and wraparound virtual care support for members, Amazon said.
    • “This new relationship will enable patients to have increased access to seamless coordinated care through Amazon One Medical’s innovative care model and Montefiore’s high-quality network of specialists, hospitals, and facilities.
    • ‘Montefiore and Amazon One Medical will determine where to open new facilities over the next several years, executives said.”
  • The Wall Street Journal observes,
    • If obesity is a chronic disease, like kidney or heart conditions, demand for GLP-1 drugs shouldn’t ebb and flow with the seasons. But the weight-loss market is far from typical.
    • After analyzing data going back to 2016, one analyst thinks he has identified a seasonal pattern in demand for drugs such as Eli Lilly’s LLY Zepbound and Novo Nordisk’s NOVO.B Wegovy: The drugs have stellar growth in initial sign-ups in the first half of the year followed by slower gains in the second half. 
    • This pattern resembles the cyclical nature of gym memberships rather than the steady trajectory of most pharmaceutical markets, and for good reason: At the start of the year, people often make resolutions to lose weight, exercise or start new diets. It stands to reason that some of these resolutions might also lead to increased demand for weight-loss prescriptions such as GLP-1 drugs.
    • If the logic is even half-right, it could help explain Eli Lilly’s back-to-back misses [in the second half of 2024] that have confounded Wall Street.
  • MedTech Dive offers “four robotic surgery trends to watch in 2025. Intuitive Surgical will face competition this year from Medtronic and smaller companies like CMR Surgical and Moon Surgical coming to the U.S. market with robotic surgery systems.”