Tuesday Report

Congress

Tuesday Report

David Ermer–CDC, Congress, Medical / Rx research, Obesity, OPM, Rx coverage, U.S. Healthcare–
OPM Headquarters a/k/a the Theodore Roosevelt Building
  • In a press release, OPM patted itself on the back for successfully launching the Postal Service Health Benefits Program.
  • Govexec adds,
    • “The Office of Personnel Management on Tuesday issued guidance to agencies reminding them of how to handle the pay and benefits of political appointees who are set to resign ahead of President-elect Trump’s inauguration on Jan. 20.
    • “In a memo to agency human resources directors, OPM associate director for workforce policy and innovation Veronica Hinton wrote that agencies should compensate appointees who are planning on resigning at noon on Inauguration Day—when Trump is slated to be sworn into office—for the hours they are scheduled to work before that time.” * * *
    • “Hinton’s memo also addresses the fact that Inauguration Day, which Washington, D.C., area federal workers receive as a holiday due to the congestion resulting from the proceedings, happens to fall on another federal holiday: Martin Luther King, Jr. Day.
    • “In short, there are no so-called “in-lieu-of” holidays entitling employees who typically work Mondays to an extra day off in light of the two holidays’ confluence. But if a D.C.-area employee’s normal work schedule does not include Mondays, they would receive one “in-lieu-of” holiday.”
  • Speaking of political appointees leaving on Inauguration Day, an HHS press release lets us know “United States Surgeon General Dr. Vivek Murthy released his Parting Prescription for America – PDF, weaving together reflections on his personal and professional experiences having spent six of the last ten years as our nation’s Surgeon General.”
  • Fierce Healthcare tells us,
    • “The Federal Consumer Financial Protection Bureau on Tuesday issued new regulations barring medical debts from American credit reports, enacting a major new consumer protection just days before President Joe Biden is set to leave office.
    • “The rules ban credit agencies from including medical debts on consumers’ credit reports and prohibit lenders from considering medical information in assessing borrowers.
    • “These rules, which the federal watchdog agency proposed in June, could be reversed after President-elect Donald Trump takes office Jan. 20. But by finalizing the regulations now, the CFPB effectively dared the incoming Trump administration and its Republican allies in Congress to undue rules that are broadly popular and could help millions of people who are burdened by medical debt.”
    • FEHBlog note — The rule does not take effect until early March. The FEHBlog hopes that the incoming Administration will cancel this rule making which is bound to disrupt the U.S. credit market.
  • Per a Senate press release,
    • Today, Senators Sheldon Whitehouse (D-RI) and Chuck Grassley (R-Iowa), in their respective capacities as Chairman and Ranking Member of the Senate Budget Committee during the 118th Congress, released a bipartisan staff report on the findings of their investigation into the ways in which private equity investment in health care has negative consequences for patients and providers. 
    • The Committee focused on two private equity firms—including the single-largest private equity investor in health care—that currently or previously invested in two prominent hospital operators.  Throughout the course of its investigation, the Committee reviewed more than one million pages of documents from Leonard Green & Partners, Prospect Medical Holdings, Medical Properties Trust, Apollo Global Management (Apollo), Lifepoint Health, and Ottumwa Regional Health Center, a for-profit Iowa hospital, that revealed new information about the business dealings of private equity-owned hospital operators.  Documents obtained by the Committee detailed how private equity’s ownership of hospitals earned investors millions, while patients suffered and hospitals experienced health and safety violations, understaffing, reduced quality of patient care, and closures. 
    • “Private equity has infected our health care system, putting patients, communities, and providers at risk,” said Chairman Whitehouse. “As our investigation revealed, these financial entities are putting their own profits over patients, leading to health and safety violations, chronic understaffing, and hospital closures.  Take private equity firm Leonard Green and hospital operator Prospect Medical Holdings: documents we obtained show they spent board meetings discussing profit maximization tactics—cost cutting, increasing patient volume, and managing labor expenses—with little to no discussion of patient outcomes or quality of care at their hospitals.  And while Prospect Medical Holdings paid out $645 million in dividends and preferred stock redemption to its investors—$424 million of which went to Leonard Green shareholders—it took out hundreds of millions in loans that it eventually defaulted on.  Private equity investors have pocketed millions while driving hospitals into the ground and then selling them off, leaving towns and communities to pick up the pieces.”
    • “The Ottumwa community has personally felt the impact of private equity on its health care system.  Under private equity ownership, wait times at Ottumwa Regional Health Center have gone up as patient experience has gone down. The diminishing quality of care, service availability and care capacity at the hospital is forcing Ottumwa residents to travel significant distances in order to receive appropriate treatment. Iowans deserve better,” Grassley said. “A dependable health care system is essential to the vitality of a community.  As always, sunshine is the best disinfectant.  This report is a step toward ensuring accountability, so that hospitals’ financial structures can best serve patients’ medical needs.”  
    • Read the full report here, and view the documents released by the Committee here and here.

From the public health and medical research front,

  • Here is a link to the Centers for Disease and Control and Prevention’s respiratory virus updates.
  • STAT News reports
    • “At Tufts University in Medford, Mass., researchers loaded a tiny 3D model of the human brain into a plastic shell resting atop a spring-loaded platform. Inside this polymer skull, the donut-shaped ball of living brain tissue floated in a warm, salty bath, its neurons whispering to each other in the darkness. Then a piston struck the platform, whipping it back and forth, and sending the mini-brain sloshing.
    • “Days later, as the team assessed the damage, the results were stark. Some of the human brain-like tissue had been housing a latent infection with a herpes virus, the type that causes cold sores. And the impact of the piston — intended to mimic a concussion — had woken that virus up. In those tissues, the researchers found lots of inflammation, newly formed plaques of sticky amyloid proteins, and all around them dying neurons — the signature marks of Alzheimer’s disease. Meanwhile, infection-free brain tissues recovered from the concussion with just a bit of lingering inflammation. 
    • “Decades of epidemiological data have shown that infections with herpes simplex virus type 1, or HSV-1 can raise the risk of Alzheimer’s disease in certain people. So can a history of head injury. The new research, published Tuesday in Science Signaling, is the first to connect the dots between them, and adds to mounting evidence that this most common form of dementia can be caused by an everyday microbe.”
  • Per Fierce Pharma,
    • “It’s now official: Johnson & Johnson’s combination of Rybrevant and Lazcluze has racked up an overall survival (OS) victory against AstraZeneca’s standard-of-care Tagrisso as a first-line treatment for advanced or metastatic non-small cell lung cancer (NSCLC).
    • “In reporting positive top-line results from the phase 3 MARIPOSA study in 1,074 patients with NSCLC with EGFR exon 19 deletions or L858R substitution mutations, J&J’s combo is expected to keep patients alive for at least a year longer than Tagrisso.
    • “The results, details of which are yet to be revealed, show a statistically significant and clinically meaningful improvement in OS, according to J&J.” 
  • BioPharma Dive points out,
    • “A landmark study hoping to find new treatments for ALS has notched two more failures, as experimental medicines from Denali Therapeutics and Calico Life Sciences proved no better than a placebo at slowing the nerve-destroying disease or keeping patients alive longer.
    • “Denali disclosed high-level results from the study Monday. After about six months, treatment with the company’s drug didn’t result in any significant changes in the severity of the disease, nor did it substantially help patients’ muscle strength or respiratory function.
    • “Denali plans to further examine the data and look at biological markers of the disease, including one, “neurofilament light chain,” that’s become increasingly important to researchers focused on amyotrophic lateral sclerosis. The company expects to conduct those analyses later this year.”
  • and
    • “Privately-held biotechnology startup Metsera said Tuesday a long-acting GLP-1 shot it’s developing helped people who are overweight or have obesity lose more weight than placebo recipients in a Phase 2 trial. 
    • “Study participants who received the shot, dubbed MET-097i, lost on average 11% more of their body weight than those who got a placebo over the course of 12 weeks. Placebo-adjusted weight loss also reached around 20% in those who received the highest dose, comparable to what was observed in tests of Eli Lilly’s Zepbound and Novo Nordisk’s Wegovy over a similar period.
    • “Metsera also said data from the trial support plans to test MET-097i as a monthly injection, less frequent than the weekly shots Zepbound and Wegovy require. The announcement is the latest step forward for a company that has raised more than half a billion dollars since launching last April to support a bid to challenge Lilly and Novo’s medicines.” 
  • Cardiovascular Business adds,
    • “Semaglutide is associated with significant cardiovascular benefits for overweight and obese patients who have previously undergone coronary artery bypass graft (CABG) surgery, according to new data published in the Journal of the American College of Cardiology.
    • “Semaglutide is a popular GLP-1 receptor agonist being sold by Novo Nordisk under the brand names Wegovy and Ozempic. GLP-1 receptor agonists were originally developed to treat diabetes, but they are being used more and more to help obese and overweight patients lose weight. 
    • “For this latest analysis, researchers tracked data from the SELECT trial, originally designed to examine semaglutide’s impact among overweight/obese patients without diabetes, and focused exclusively on more than 2,000 patients with a prior history of CABG. The patients had a mean age of 65 years old, 84.2% were men and the mean BMI was 31.9 kg/m2. A history of hypertension was seen in 85.6% of patients. The rates of pre-existing atrial fibrillation and heart failure were 12.5% and 33.4%, respectively. 
    • ‘The study’s results confirmed that CABG patients still face an elevated risk of ischemic cardiovascular events following treatment. And once again, researchers wrote, semaglutide has been linked to “significant and consistent reductions” in the risk of such events.” 
  • The Wall Street Journal reports,
    • “A new study is helping to answer a pressing nutrition question: Which ultra-processed foods are harming our health—and which might not be so bad? 
    • “The problem is the way many packaged foods are made, researchers believe. Products such as many frozen pizzas, cereals and chips pack more calories per gram than less-processed foods do. And most ultra-processed foods have combinations of salt, fat, sugar and carbohydrates that aren’t generally found in nature, which can make us crave them. Diets high in packaged foods without those traits—such as canned peaches or refried beans—don’t seem to lead people to overeat and gain weight, at least not as much.
    • “Those are the findings so far of a continuing study investigating how ultra-processed food affects our bodies. Scientists presented their interim data at a workshop put on by the National Institutes of Health and the U.S. Food and Drug Administration in December. 
    • “There might be a way to create the quote, unquote healthy ultra-processed food that’s still convenient,” said Kevin D. Hall, the principal investigator of the study and a scientist at the NIH, giving an example of a frozen meal with brown rice, beans and a lot of vegetables.” 

From the U.S. healthcare business front,

  • STAT News reports,
    • “The advent of the first generic GLP-1 drugs could help Medicare negotiate a lower price for the highly sought after diabetes and obesity medication semaglutide, according to experts familiar with the price-negotiation program and STAT’s review of documents from the first round of negotiations.
    • “The Food and Drug Administration approved generics for the diabetes drugs exenatide and liraglutide in November and December. While those drugs don’t work as well as semaglutide, their much lower costs could give Medicare leverage to push for lower prices for semaglutide, two experts said.
    • “It’s hard to make an argument that liraglutide is not clinically comparable to the other GLP-1,” said Institute for Clinical and Economic Review President Sarah Emond.
    • “Both the nonpartisan Congressional Budget Office and academic experts expect semaglutide, sold by Novo Nordisk under the brand names Ozempic and Wegovy, to be among the next 15 drugs up for price negotiation. Medicare will announce that list by Feb. 1, and the negotiated prices will take effect in 2027.” 
  • Fierce Pharma notes,
    • “With COVID vaccine sales in the doldrums and a respiratory syncytial virus (RSV) vaccine market in “contraction”, Moderna CEO Stéphane Bancel had the unenviable task of trying to put a positive spin on a sharp stock decline in his annual shareholder letter.
    • “After an unexpectedly limited RSV vaccination recommendation from the CDC resulted in a “contraction” in the U.S. market, Moderna will adjust its financial reporting traditions to exclude products in their launch year, Bancel said Monday in his annual letter to shareholders.
    • “The company was “too optimistic about our ability to break into the market given the headwinds from a midyear approval and launch,” the Moderna CEO wrote about the RSV launch. “We are taking those learnings to heart and going forward, we will not include revenue from products in their launch year in our financial framework,“ he added.”
  • Per MedTech Dive,
    • “Stryker has agreed to acquire Inari Medical for approximately $4.9 billion, the company announced late Monday. The transaction is expected to close in the first quarter.
    • “Under the deal, Stryker would acquire all of Inari’s shares for $80 per share in cash, a premium of more than $30 over Friday’s closing price. Inari’s stock price closed at $65 Monday after surging by more than 30% in day trading.
    • “Inari would continue a busy year of dealmaking for Stryker in 2024, which included acquisitions of the artificial intelligence company Care.ai, the back pain device maker Vertos Medical and Nico Corporation, which makes devices to remove brain tumors and clots. Stryker did not disclose financial terms for the three deals.”
  • The Drug Channels Blog headlines “Inflation-Adjusted U.S. Brand-Name Drug Prices Fell for the Seventh Consecutive Year as a New Era of Drug Pricing Dawns.” Check it out.
  • Health Day relates,
    • “Patients have more access to their own medical test results than ever before, thanks to legislation requiring results be released as soon as they’re available.
    • “But that’s not necessarily a good thing, a new study warns.
    • “Many patients are reading test results in their electronic medical record before their doctor has had a chance to go over them, researchers say in a study published Jan. 2 in the Journal of the American Medical Association.
    • “This is provoking a lot of confusion and anxiety, mainly because medical reports contain a lot of jargon the average patient doesn’t understand, researchers said.
    • “For example, “a standard pathology report is written by a pathologist for a clinical specialist like a surgeon or a cancer doctor or for other pathologists to read,” lead researcher Dr. Cathryn Lapedis, a pathologist at University of Michigan Health, said in a news release from the college.
    • “To address this, Lapedis and her colleagues tested whether patients might benefit from pathology reports written in a way they would better understand.”

Monday Report

David Ermer–CDC, CMS, Congress, COVID treatment, FDA, Medical / Rx research, Rx coverage, U.S. Healthcare–

From Washington, DC.

  • The Wall Street Journal reports, “Congress quickly and smoothly certified President-elect Donald Trump’s election victory Monday, a contrast to four years earlier, when a pro-Trump mob stormed the Capitol and temporarily halted the confirmation of President Biden’s win.” 
  • Federal News Network confirms,
    • “President Joe Biden signed the Social Security Fairness Act into law Sunday afternoon, the final step needed for nearly 3 million public sector employees, retirees, spouses and surviving spouses to begin receiving larger monthly Social Security payments.
    • “The legislation repeals the Windfall Elimination Provision and Government Pension Offset — two longstanding provisions of Social Security that reduce or eliminate benefits for certain government retirees, including Civil Service Retirement System annuitants, as well as teachers, firefighters, police officers and others who have worked in a public sector position.”
  • The American Hospital Association News tells us,
    • “The Centers for Medicare & Medicaid Services Jan. 6 announced the 15 participants for its state Transforming Maternal Health Model: Alabama, Arkansas, California, Washington, D.C., Illinois, Kansas, Louisiana, Maine, Minnesota, Mississippi, New Jersey, Oklahoma, South Carolina, West Virginia and Wisconsin. The model will provide technical support and resources to state Medicaid agencies to develop programs that address new mothers’ physical health, mental health and social needs during pregnancy and postpartum. The model launched Jan. 1 and will run for 10 years.”
  • Per FiercePharma,
    • “In recent years, the FDA has amped up its supervision of accelerated approvals, including by requiring that confirmatory trials at least be underway at the time of these conditional nods. But, after hearing some mixed messaging from the agency, drugmakers were left wondering what exactly “underway” means in this context.
    • “Now, a new draft guidance document tries to clear the air on the agency’s interpretation of the term “underway.”
    • “The FDA on Monday posted a draft guidance document titled “Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway.” Although the guidance doc was uploaded by the Oncology Center of Excellence, which has issued the majority of accelerated approvals, the policies are slated to apply to the entire FDA.”
  • BioPharma Dive points out “five FDA decisions to watch in the first quarter of 2025. Over the next three months, the regulator could approve new medicines for pain, a deadly heart disease and a rare condition that’s long bedeviled drugmakers.”

From the public health and medical research front,

  • The New York Times reports,
    • “A Louisiana patient who had been hospitalized with severe bird flu has died, the first such fatality in the United States, state health officials reported on Monday.
    • “The patient was older than 65 and had underlying medical conditions, the officials said. The individual became infected with the bird flu virus, H5N1, after exposure to a backyard flock and wild birds.
    • “There is no sign that the virus is spreading from person to person anywhere in the country, and Louisiana officials have not identified any other cases in the state. Pasteurized dairy products remain safe to consume.
    • “I still think the risk remains low,” said Dr. Diego Diel, a virologist at Cornell University.
    • “However, it is important that people remain vigilant and avoid contact with sick animals, sick poultry, sick dairy cattle, and also avoid contact with wild birds,” he added.”
  • The Washington Post informs us,
    • “The rate of triplet and higher-order multiple births in the United States declined 62 percent from 1998 to 2023, according to the Centers for Disease Control and Prevention. 
    • “Most of the downturn occurred since 2009. Triplet and higher-order births are pregnancies involving three or more babies. Because maternal and infant health problems are more frequently associated with higher-order multiple births than with twins and single births, the increase was of public health concern, the CDC report noted.” * * *
    • “The period that preceded the current study, 1980 to 1998, saw an extraordinary fivefold increase in births of triplets and higher-order multiple births — from 37 per 100,000 births in 1980 to 194 births per 100,000 in 1998. Researchers attributed the spike to higher maternal age and increased use of fertility treatments. Since that period, the rates of multiple births have trended in the opposite direction.”
  • Medscape adds,
    • “Respiratory syncytial virus prefusion F vaccine significantly reduced severe RSV-related lower respiratory tract disease (LRTD) requiring hospitalization or emergency department (ED) visits in an older adult population, including substantial representation from the oldest age groups.”
  • In related news,
    • Per the New York Times, “Can Paxlovid treat long Covid? A new report suggests it might help some patients, but which patients might benefit remains unclear. The report, published Monday in the journal Communications Medicine, describes the cases of 13 long Covid patients who took extended courses of the antiviral drug. Results were decidedly mixed: Nine patients reported some improvement, but only five said it lasted. Four reported no improvement at all.”
    • Per Infectious Disease Advisor, “Nirmatrelvir/ritonavir (PaxlovidTM) reduced COVID-19-related hospitalization and all-cause death, as well as the duration of COVID-19 symptoms and utilization of health care resources among patients at high risk for severe diseases, according to study findings published in Clinical Infectious Diseases.”
  • The Institute for Clinical and Economic Review announced today “that it will assess the comparative clinical effectiveness and value of apitegromab (Scholar Rock) for the treatment of spinal muscular atrophy (SMA). ICER will also assess new evidence (since ICER’s 2019 Final Evidence Report) on the clinical effectiveness of nusinersen (Spinraza®, Biogen) and onasemnogene abeparvovec-xioi (Zolgensma®, Novartis), as well as the evidence for risdiplam (Evrysdi®, Genentech). Risdiplam was not evaluated in the 2019 report.”

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “All of the commercial prescriptions dispensed at CVS pharmacies will be processed through its CostVantage reimbursement model beginning this year, the healthcare giant announced on Monday.
    • “Under the model, prescriptions are priced based on the underlying cost with a delineated markup and dispensing fee to cover the services provided by CVS in the transaction. The company says that this model makes it less necessary to raise the cost for certain prescriptions to cover losses on other drugs.
    • “The model also seeks to increase transparency for insurers and pharmacy benefit managers, making it potentially easier for PBMs to establish their own more transparent programs for plans and clients.
    • “Prem Shah, group president for CVS Health, said that the team is also working with the Centers for Medicare & Medicaid Services to expand the program to Medicare and Medicaid prescriptions.”
  • Modern Healthcare relates,
    • “Although the pharmacy benefit manager market has long been controlled by three large, established players, many smaller PBMs are seeing a spike in interest. But the newer entrants will continue to face stiff competition this year as they seek more business.
    • “Smaller PBMs that advertise themselves as transparent have gained traction over the last few years as health insurers, employers and government entities look to deviate from the traditional spread pricing model. Many of these companies have said 2024 was their largest selling year, with an increasing number of large customers showing interest.”
    • “Companies that had never even spoken to us prior to this past year now are talking to us and are including us as a finalist,” said David Fields, president and CEO of Navitus Health Solutions, which serves employers with up to 500,000 workers and dependents. Navitus will manage pharmacy benefits for about 18 million people in 2025.”
  • McKinsey & Company notes,
    • Technology leaders and enthusiasts are convening in Las Vegas this week for CES—formerly known as the Consumer Electronics Show—to hear from industry leaders, get immersed in demos and interactives, and learn about the latest solutions to society’s greatest challenges. This year’s conference program features topics including artificial intelligence, digital health, vehicle technology and future mobility, and more. 
    • Whether you’re attending in-person or via livestream, prepare for #CES2025 by learning about the adoption, development, and effects of 15 top technology trends in an analysis by McKinsey’s Lareina Yee, Michael Chui, and Roger Roberts.

Weekend update

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

From Washington, DC

  • A joint session of Congress will be held tomorrow to counting the votes received from the Electoral College. Thereafter, the House of Representatives and the Senate will resume organizing the 119th Congress.
  • On January 3, the President issued a “Memorandum on the Designation of Officials of the Office of Personnel Management to Act as Director.” Such a memorandum has been issued in advance of Presidential Inauguration Day pursuant to the Federal Vacancies Act of 1998.
  • The FEHBlog understands
    • “The [Presidential] signing ceremony of HR 82, [the Social Security Fairness Act of 2023 which repeals certain laws that reduce Social Security benefits for individuals who receive other benefits, such as a pension from a state or local government, has been moved up to Sunday, January 5 at 4 PM Eastern time.  
    • “We still don’t know whether the ceremony will be broadcast or streamed, but one possible outlet if it is live is https://www.whitehouse.gov/live/
  • The President also signed another raft load of bills into law yesterday.

From the public health and medical research front,

  • Fortune Well explains why it is particularly important for adults and children to receive the flu vaccine. What’s more,
    • “Don’t worry if you missed the unofficial “vaccine before Halloween” memo. We’re in the thick of cold and flu season and any protection you can provide yourself, your loved ones, and your community will benefit public health, says Dr. Robert Hopkins Jr., medical director of the National Foundation for Infectious Diseases.
    • “It’s not too late,” Hopkins told Fortune in December. “It is not a bad time when we’ve got risk in front of us. And I would certainly prefer that people were vaccinated earlier, but I’m not going to make perfection the enemy of the good.”
  • The Washington Post reports,
    • “People who receive physical therapy shortly after suffering concussions have better outcomes than those who wait longer to start rehabilitation programs, a recent analysis suggests.
    • “Published in the Physical Therapy & Rehabilitation Journal, the study reports on a randomized trial of 203 adults diagnosed with a mild traumatic brain injury, or concussion, who were within two to 12 weeks from their injury.
  • NPR Shots shares “nine unexpected things we learned about mental health and our brains in 2024.”
  • A commentator in the Wall Street Journal shares her personal experience with chronic pain. For context, she writes
    • “[W]e do know that relentless chronic pain is destabilizing,” says Dr. Scott Fishman, a pain specialist at the University of California, Davis, who founded its Center for Advancing Pain Relief, a rare center that focuses on both the treatment and prevention of pain. 
    • It would be absurd to say that chronic pain drives sufferers to become murderers; the only people pain patients are at any heightened risk of killing is themselves. Yet Fishman likens the effects of enduring pain to “driving on a slippery road. It puts everyone at risk.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Health tech companies focused on behavioral health are confident that reimbursement trends favor them in 2025.
    • “Payment flexibilities for telehealth, hospital-at-home care and remote prescribing have been temporarily extended until March 31. The changes will prolong COVID-19-era payment for remote care across all specialties.
    • “For many in mental health tech, new reimbursement codes from the Centers for Medicare and Medicaid Services’ November physician payment rule are an even bigger deal.
    • “The codes reimburse providers for using digital mental health treatment applications or devices that have been cleared or granted De Novo authorization by the Food and Drug Administration.
    • “While the codes are narrow in scope, analysts said the move signifies a larger recognition among CMS and commercial insurers that virtual platforms treating mental health should be reimbursed.”

Friday Report

David Ermer–CDC, Congress, COVID-19, FDA, Medical / Rx research, NIH, Rx coverage, U.S. Healthcare–
Photo by Josh Mills on Unsplash

Public service notice — January 3 is the statute of limitations for wishing another person Happy New Year, according to Larry David.

From Washington, DC,

  • The Wall Street Journal reports,
    • “Incumbent Mike Johnson won re-election as speaker of the House on the first ballot, after President-elect Donald Trump pressured GOP holdouts to change their votes, handing the Louisiana Republican the narrow majority needed to claim the gavel.
    • “Johnson’s dramatic victory clears the way for Republicans to charge headlong into Trump’s second term, taking on an ambitious agenda of tax cuts and border security. While Johnson avoided a repeat of the GOP’s calamitous January 2023 speaker vote, the tally underscored how little room he has to maneuver with the party’s razor-thin margin. It also showed the power of any small group of dissidents to derail the party’s plans.
    • “Working together, we have the potential to be one of the most consequential congresses in the history of this great nation,” Johnson said.
    • “The chain of events previewed how Trump and Johnson will need to move in lockstep to get legislation across the finish line and tamp down dissent, even though the party controls both chambers of Congress and the White House.”
  • Roll Call adds,
    • “A last-minute insertion into House Republicans’ rules package for the 119th Congress substantially raises the bar for voting on legislation under suspension of the rules late in the week or over the weekend, in a concession to conservatives upset about recent deals with Democrats on big-ticket spending bills.
    • “The change requires the House to adopt a special rule to consider bills under suspension of the rules — which bars amendments but requires the support of two-thirds of members present and voting for passage — on any days other than Mondays, Tuesdays or Wednesdays.” * **
    • The House adopted the new rules package on a 215-209 vote late Friday.
  • The Wall Street Journal tells us,
    • “The U.S. surgeon general said alcoholic beverages should carry cancer warnings to increase awareness that the drinks are a leading cause of preventable cancers.
    • “An act of Congress would be required to change the existing warning labels on bottles of beer, wine and liquor. Today, federal rules require only a warning against drunken driving and drinking while pregnant, as well as a general warning that alcohol “may cause health problems.”
    • “Alcohol is a well-established, preventable cause of cancer responsible for about 100,000 cases of cancer and 20,000 cancer deaths annually in the United States,” Dr. Vivek Murthy said in his advisory issued Friday. “Yet the majority of Americans are unaware of this risk.”
  • Per a Health and Human Services Department press release,
    • “Today, the U.S. Department of Health and Human Services (HHS) announced it would award $306 million dollars to continue its H5N1 Avian Flu response. While CDC’s assessment of the risk of avian influenza to the general public remains low, USDA and HHS continue to closely collaborate with Federal, State, local, industry and other stakeholders to protect human health, animal health, and food safety.
    • “While the risk to humans remains low, we are always preparing for any possible scenario that could arise. These investments are critical to continuing our disease surveillance, laboratory testing, and monitoring efforts alongside our partners at USDA,” said Secretary Xavier Becerra. “Preparedness is the key to keeping Americans healthy and our country safe. We will continue to ensure our response is strong, well equipped, and ready for whatever is needed.”
  • MedTech Dive informs us that the “FDA closed 2024 with string of early alerts on device safety risks. Olympus advised providers to stop using an endoscope accessory due to an infection risk linked to 120 injuries and one death.”

From the judicial front,

  • Fierce Healthcare lets us know,
    • “Aetna is taking legal action against Pfizer, Novartis, Teva Pharmaceuticals and others, saying the list of drugmakers conspired to overcharge the insurer, consumers and the federal government for generic drugs.
    • “The complaint, filed Dec. 31, claims the drugmakers communicated secretly at trade conferences or through phone calls, beginning in 2012, to determine the market share, prices and bids of certain drugs. If communication was in writing, they destroyed the evidence, Aetna claimed.
    • “They effectuated their market allocation by either refusing to bid for particular customers or providing outrageously high cover bids,” the complaint said. “This created an artificial equilibrium that enabled the conspirators to then collectively raise and/or maintain prices for a particular generic drug.”
    • “Aetna said that drug purchasers, predominantly insurers, suffered as a result of these actions. Insurers place generic drugs on their formularies to lower costs but instead were paying unfairly high prices for these products.”

From the public health and medical research front,

  • The Centers for Disease Control and Prevention announced today,
    • “COVID-19 activity is increasing in most areas of the country. Seasonal influenza activity continues to increase and is elevated across most of the country. RSV activity is very high in many areas of the country, particularly in young children.
    • “COVID-19
      • “COVID-19 activity is increasing in most areas of the country, with high COVID-19 wastewater levels and increasing emergency department visits and laboratory percent positivity. Based on CDC modeled estimates of epidemic growth, we predict COVID-19 illness will continue to increase in the coming weeks as it usually does in the winter.
      • “There is still time to benefit from getting your recommended immunizations to reduce your risk of illness this season, especially severe illness and hospitalization.
      • “CDC expects the 2024-2025 COVID-19 vaccine to work well for currently circulating variants. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.
    • “Influenza
    • “RSV
      • “RSV activity is very high in many areas of the country, particularly in young children. Emergency department visits and hospitalizations are highest in children and hospitalizations are elevated among older adults in some areas.
    • “Vaccination
      • “Vaccination coverage with influenza and COVID-19 vaccines are low among U.S. adults and children. COVID-19 vaccine coverage in older adults has increased compared with the 2023-2024 season. Vaccination coverage with RSV vaccines remains low among U.S. adults. Many children and adults lack protection from respiratory virus infections provided by vaccines.”
  • Following up on the Surgeon General’s advisory, the Wall Street Journal considers,
    • “How much drinking is bad for you?
    • “Though more people are calling themselves sober-curious or are trying zero-proof replacements for alcohol, drinking is a regular part of social life for most of us. A coupe of champagne can add fun to a celebration. A cocktail can take the edge off a tough day. And a cold beer can liven up a sports game. 
    • “Yet scientists’ warnings about the potential health problems of even small amounts of alcohol are growing more dire. For moderate drinkers, it can be hard to know what’s actually OK to consume: Is two a day that much worse than one? Are two drinks over a week the same as two in a day? 
    • “Averaging no more than about one drink a day is relatively low risk, according to scientists who study alcohol. They warn the risk of cancer rises significantly when you exceed that. Studies have suggested that alcohol contributes to about half a dozen types of cancers, including breast and colorectal, as well as heart and liver disease, among other conditions.” 
  • Per MedTech Dive,
    • “The Food and Drug Administration said a literature review found no safety concerns associated with tampon use and contaminant exposure.
    • “FDA officials commissioned the independent review in September in response to a study that found tampons may expose users to metals. After seeing the findings, the agency continues to recommend FDA-cleared tampons as a safe option for use as a menstrual product.
    • “The FDA is still running an internal bench laboratory study designed to show if metals from tampon materials are released or absorbed in the body. That study will better enable the FDA to complete a risk assessment, the agency said in a Dec. 23 statement.”
  • The Wall Street Journal notes,
    • Researchers have identified a focal point for the forces they suspect of driving up cancer cases in young people: the gut. They are searching people’s bodies and childhood histories for culprits.
    • Rates of gastrointestinal cancers among people under 50 are increasing across the globe. In the U.S., colorectal cancer is the leading cause of cancer death in men under 50 and second for women behind breast cancer. Each generation born since the 1950s has had higher risk than the one before. 
    • “Everything you can think of that has been introduced in our society since really the 1960s, the post-World War II era, is a potential culprit,” said Dr. Marios Giannakis, a gastrointestinal oncologist at the Dana-Farber Cancer Institute in Boston.
    • “Robert F. Kennedy Jr., President-elect Donald Trump’s pick for Health and Human Services secretary, has pointed to ultra-processed foods and chemicals in medicines and the environment. Cancer doctors share some of his suspicionsabout diet and exposure to contaminants such as microplastics, shards that make their way from packaging or clothing into our bodies through water and food. They are scrutinizing those and other potential hazards including “forever chemicals” and even light.   
    • “We’re all concerned and want to do something quickly and act quickly, but we want to do so based on sound science,” said Dr. Andrew Chan, director of epidemiology at Mass General Cancer Center in Boston.” 
  • Per HealthDay,
    • “Not sure what’s causing your child’s asthma?
    • “A new quick-and-easy nasal swab test for kids can diagnose the specific immune system drivers behind their asthma, potentially opening the door to better treatments, researchers say.
    • “The test diagnoses a child’s asthma subtype, also called an endotype.
    • “Because asthma is a highly variable disease with different endotypes, which are driven by different immune cells and respond differently to treatments, the first step toward better therapies is accurate diagnosis of endotype,” senior researcher Dr. Juan Celedon, chief of pulmonary medicine at the UPMC Children’s Hospital of Pittsburgh, said in a news release from the hospital.”
  • A National Institutes of Health news release points out,
    • “A novel class of antibodies that binds to a previously untargeted portion of the malaria parasite could lead to new prevention methods, according to a study from researchers at the National Institutes of Health (NIH) published today in Science. The most potent of the new antibodies was found to provide protection against malaria parasites in an animal model. The researchers say antibodies in this class are particularly promising because they bind to regions of the malaria parasite not included in current malaria vaccines, providing a potential new tool for fighting this dangerous disease.
    • Malaria is a life-threatening disease caused by Plasmodium parasites, which are spread through the bites of infected mosquitoes. Although malaria is not common in the United States, its global impact is devastating, with 263 million cases and 597,000 deaths estimated by the World Health Organization in 2023. Of the five species of Plasmodium that cause malaria, Plasmodium falciparum is the most common in African countries where the burden of malaria is largest and where young children account for the majority of malaria deaths. Safe, effective countermeasures are critical for reducing the immense burden of this disease. * * *
    • “Findings from the study will inform future strategies for the prevention of malaria and may facilitate the development of new antibodies and vaccines against the disease, the researchers indicate. The scientists also note that more research is needed to examine the activity and effectiveness of the newly identified antibody class and epitope, according to their paper. The approach used in this study could also aid the development of a new generation of countermeasures against other pathogens, in addition to malaria.”  

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Ardent Health has acquired 18 facilities from urgent care provider NextCare, following through on its plan to expand its urgent and ambulatory care presence.
    • “The for-profit health system, which went public in July, said Friday it acquired six facilities in New Mexico and 12 in Oklahoma. Financial details and terms of the agreement were not disclosed.
    • “An Ardent spokesperson said the deal was part of a larger growth strategy and the system planned to acquire more ambulatory facilities.”
  • Beckers Payer Issues relates,
    • UnitedHealth Group is the world’s largest insurer by net premiums written for a 10th year in a row, according to AM Best’s annual ranking published Jan. 2.
    • In 2025, UnitedHealth expects revenues of up to $455 billion and adjusted net earnings of $29.50 to $30.00 per share.
    • Top four insurers ranked by 2023 NPW:
      • UnitedHealth Group
      • Centene
      • Elevance Health
      • Kaiser Permanente
  • Per Beckers Hospital Review,
    • “The Women’s Choice Award has recognized 457 hospitals on its annual list of the Best Hospitals for Patient Safety.
    • “To compile the ranking, the organization analyzed hospitals’ performance on 13 surgical complication and infection measures from CMS, including central-line associated bloodstream infections, sepsis and serious blood clots after surgery. Hospitals had to report on at least six measures to be included in the analysis and could not rank worse than the national average on any measure.  
    • “Hospitals on the patient safety list were among the top 10% of organizations nationwide with the lowest incidence of adverse medical events and infections. See the full list of winners here.” 

Thursday Report

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

From Washington, DC,

  • According to the House of Representatives and Senate press galleries, each body will assemble before noon to adjourn the 118th Congress sine die and at noon will convene for the start of the 119th Congress.
  • Govexec tells us,
    • “Current federal employees, retirees and others impacted by widespread breach of personal data maintained by the Office of Personnel Management took advantage of only a small portion of the money made available in a settlement agreement following the 2015 hack. 
    • “Plaintiffs in the class action lawsuit reached a settlement in 2022 with the government that made $63 million available for those who could demonstrate financial hardship as a result of the breach. A federal judge closed out the case last month after OPM and the Treasury Department doled out just $4.8 million to just more than 5,000 individuals. The remaining $58.2 million is set to go back to the Treasury on Thursday, according to court documents last month.” 

From the public health and medical research front,

  • The Washington Post reports, “More children are getting kidney stones. Experts think it’s their diet.”
    • “Some research suggests that genetic predisposition may play a role, but experts say the increase more likely reflects dietary habits and lifestyle.
    • “A North Carolina doctor detected a potential culprit: salt-laden diets. Sodium intake has increased significantly among children in the past few decades.
    • “There is so much added salt to the American diet today, and when the kidney is excreting the sodium, it pulls calcium with it and increases the risk of calcium-based stones,” John S. Wiener, a pediatric urologist at Duke Health, said.”
  • The American Medical Association discusses “Raw milk: Questions patients may have and how to answer.” Econtalk host Russ Roberts chats with Brown University economist Emily Oster about raw milk and similar public health issues in his latest podcast.
  • HealthDay lets us know,
    •  “Alzheimer’s disease experts have updated their diagnosis guidelines for the first time in more than 20 years, laying out how family doctors and brain specialists can best detect dementia.
    • “The guidelines call for the use of three general criteria to assess a person’s brain health, according to a report published Dec. 23, 2024, in the journal Alzheimer’s & Dementia:
      • “The patient’s overall level of cognitive impairment
      • “Specific symptoms they’re suffering, which can involve memory, reasoning, language or mood
      • “Brain diseases most likely to be causing these symptoms
    • “These three areas of diagnosis were intentionally left broad, so that new tests can be incorporated into the guidelines as researchers learn more about dementia and Alzheimer’s, Dr. Alireza Atri, a lecturer on neurology at Harvard Medical School, said in a news release from the Alzheimer’s Association.”
  • Per National Institutes of Health news releases,
    • “Based on new brain mapping research funded by the National Institutes of Health (NIH), scientists have discovered that not all cell types in the brain age in the same way. They found that some cells, such as a small group of hormone-controlling cells, may undergo more age-related changes in genetic activity than others. The results, published in Nature, support the idea that some cells are more sensitive to the aging process and aging brain disorders than others.
    • “Aging is the most important risk factor for Alzheimer’s disease and many other devastating brain disorders. These results provide a highly detailed map for which brain cells may be most affected by aging,” said Richard J. Hodes, M.D., director of NIH’s National Institute on Aging. “This new map may fundamentally alter the way scientists think about how aging affects the brain and also provide a guide for developing new treatments for aging-related brain diseases.”
    • “Scientists used advanced genetic analysis tools to study individual cells in the brains of 2-month-old “young” and 18-month-old “aged” mice. For each age, researchers analyzed the genetic activity of a variety of cell types located in 16 different broad regions — constituting 35% of the total volume of a mouse brain.”
  • and
    • ‘In a small clinical trial, a CAR T-cell therapy—a type of immunotherapy that uses a patient’s own immune cells to fight cancer—shrank tumors in several children and young adults with diffuse midline gliomas. This fast-growing form of brain and spinal cord cancer typically causes death within a year of diagnosis.
    • “In the trial, several participants were still alive 2 years or more after receiving the treatment.” * * *
    • “This study breaks new ground,” said study co-investigator Crystal L. Mackall, M.D., of Stanford Medicine. “It demonstrates that CAR T cells can have real, meaningful benefit for solid cancers, something that many people have not believed [was possible].”  
    • “In the trial, 9 of 11 patients who received the GD2 CAR T-cell therapy had neurological improvement. Of those, 7 had tumor shrinkage and in some cases the effects were quite dramatic. As patients’ tumors shrank, their symptoms improved and many regained physical functions they had lost from the disease, such as hearing, walking, and taste sensation. 
    • “Participants lived a median of nearly 2 years after treatment, with two patients still alive past the study’s 2.5-year follow-up period. One of these patients had a complete disappearance of his tumor and remains cancer free 4 years after his diagnosis. 
    • “It’s really remarkable,” said Rosandra N. Kaplan, M.D., of NCI’s Center for Cancer Research, who is also running a GD2 CAR T-cell therapy clinical trial but was not involved in this study. “This is a tumor for which nothing has ever worked. I think this is the start of a revolution in understanding how to treat these patients.”   
  • The Hill reported yesterday
    • “Broccoli sold at Walmart stores in 20 states has been recalled.
    • “Braga Fresh last week issued a voluntary and precautionary advisory for 12-ounce bags of Marketside Broccoli Florets that may be contaminated with Listeria monocytogenes.” * * *
    • “According to the U.S. Food and Drug Administration (FDA), which posted the advisory Tuesday, the pathogen can cause “serious and sometimes fatal infections” in young children, elderly people and others with weakened immune systems.” * * *
    • “It was distributed to stores in Alaska, Arkansas, Arizona, California, Colorado, Idaho, Illinois, Indiana, Kentucky, Louisiana, Michigan, Montana, Nevada, Ohio, Oklahoma, Oregon, Texas, Utah, Washington and Wyoming.
    • “No illnesses have yet been reported in connection with the product, the advisory said.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Sanford Health closed its merger with Marshfield Clinic Health System on Wednesday.
    • “The combined system, led by Sanford President and CEO Bill Gassen, has more than $10 billion in revenue and operates 56 hospitals across seven states, in addition to two health plans with roughly 425,000 members. It has almost 56,000 employees, including about 13,000 employees from Marshfield, according to a Thursday news release.“
  • and
    • “CareSource has completed its acquisition of Common Ground Healthcare Cooperative, the nonprofit health insurers announced in a news release Thursday.
    • “Privately held CareSource, which has 2 million Medicare, Medicaid and health insurance exchange members, gains 54,000 marketplace customers in Wisconsin through the deal. Common Ground CEO Cathy Mahaffey remains as chief executive of Common Ground Healthcare Cooperative and was named CareSource market president for the Badger State.”
    • “Common Ground had been one of three remaining member-owned cooperative health insurers supported with funding from the Affordable Care Act of 2010.” * * *\
    • “Of the 23 co-ops that debuted on the exchanges in 2013, only Community Health Options in Maine and Mountain Health CO-OP in Idaho, Montana and Wyoming are still in operation.”
  • Beckers Hospital Review lists “the hospitals patients are most likely to recommend in every state using Hospital Consumer Assessment of Healthcare Providers and Systems data from CMS.”
  • Beckers Payer Issues identifies the fifteen insurers exiting Medicare Advantage markets in 2025.
  • BioPharma Dive points out “ten clinical trials to watch in the first half of 2025. Expected readouts in diabetes, cancer and depression headline a series of study results that could help the biotechnology sector regain its footing after a shaky year.”
  • Forbes reports,
    • “The anti-obesity drug Zepbound made by Eli Lilly & Co. could be one of the biggest cost drivers for health insurers, employers and government health programs that cover it this year.
    • “Already, GLP-1 weight loss prescriptions Wegovy, Rybelsus and Saxenda—along with Ozempic—are the “single biggest driver” of employer health costs, adding 1% to the total premium expense for 2025, data released last fall from the benefits consultancy Aon said.
    • ‘These GLP-1 drugs are adding to general healthcare inflation that is projected to increase employer-sponsored health insurance coverage by 9%, eclipsing $16,000 per employee in 2025. The spike in premiums, which is higher than the 6.4% increase employers faced in 2024 and in 2023, comes before any “cost savings strategies” are implemented, Aon said.
    • “But a new report from GlobalData indicates Zepbound is poised to overtake other GLP-1 drugs.
    • “Zepbound’s superior efficacy and strategic market expansion suggest that the drug will dominate the obesity market, surpassing Novo Nordisk’s Wegovy (semaglutide),” GlobalData said in a report the market research firm released Tuesday.”
  • Per BioPharma Dive,
    • “Neumora Therapeutics, a well-funded biotechnology company, lost more than 80% of its value Thursday because its most advanced drug failed a major test.
    • “After seeing positive signs in a smaller study in 2023, Neumora pushed the drug into a trio of late-stage clinical trials to evaluate it as a treatment for the most common type of depression. The company just released data from the first of those trials, which found the drug no better than a placebo at alleviating depression.
  • and
    • “Pfizer won’t move forward with asking regulators to approve a gene therapy for hemophilia A and instead will hand back rights to development partner Sangamo Therapeutics in a blow to the California-based biotechnology company. In a Dec. 30 statement, Sangamo CEO Sandy Macrae said his company was “surprised and extremely disappointed” by Pfizer’s decision, which comes some five months after the treatment met its goal in a Phase 3 study of people with the inherited bleeding disorder. Sangamo plans to search for an “optimal path” forward, which could include partnering with another company. Pfizer has steadily retreated from gene therapy, although it sells a hemophilia B gene therapy called Beqvez that it obtained from Spark Therapeutics.”
  • and
    • “After many years of effort, Novartis has obtained positive results from a Phase 3 study for a form of its spinal muscular atrophy gene therapy Zolgensma that’s delivered via spinal injection rather than intravenous infusion. Data from the study, called Steer, showed treatment improved motor abilities in people with the neuromuscular disease who were two years of age or older and could still sit but had never walked independently. U.S. regulators suspended testing of the intrathecal formulation in late 2019 over safety concerns, but in August 2021 permitted Novartis to begin the Steer study. Novartis plans to share the new data with health authorities to support approval of the gene therapy in a broader range of people with spinal muscular atrophy.”

Weekend update

David Ermer–Congress, U.S. Healthcare–

From Washington, DC

  • On December 23, 2024, President Biden signed a raft load of Congressionally approved bills into law.
  • The 119th Congress convenes on Friday January 3, 2025. Here are links to the 2025 House of Representatives calendar and the 2025 Senate calendar.
  • Per Govexec,
    • Jimmy Carter, the 39th president of the United States and arguably the most dedicated to reforming the operations of the government, died on Dec. 29 at his home in Plains, Georgia. He was 100.

From the public health and medical research front,

  • Pew Research tells us,
    • “The number of Americans ages 100 and older is projected to more than quadruple over the next three decades, from an estimated 101,000 in 2024 to about 422,000 in 2054, according to projections from the U.S. Census Bureau. Centenarians currently make up just 0.03% of the overall U.S. population, and they are expected to reach 0.1% in 2054.
    • The number of centenarians in the United States has steadily ticked up since 1950, when the Census Bureau estimates there were just 2,300 Americans ages 100 and older. (The Census Bureau uses calculated estimates for years prior to the 1990 census because it has identified large errors in the census counts of centenarians for those years.)
    • “In the last three decades alone, the U.S. centenarian population has nearly tripled. The 1990 census counted around 37,000 centenarians in the country.”
  • The Wall Street Journal reports,
    • “The rich get richer—and older. People with high salaries and net worth tend to live longer lives, research shows.
    • “Once Americans make it to their late 50s, the wealthiest 10% live to a median age of around 86 years, roughly 14 years longer than the least wealthy 10%, according to a study published earlier this year in JAMA Internal Medicine.
    • “People with more money can afford healthier food, more healthcare and homes in safer, less-polluted neighborhoods, says Kathryn Himmelstein, a co-author of the study and a medical director at the Boston Public Health Commission.
    • “Though you can’t add more months or years to your online shopping cart yet, health and aging researchers say there are ways to spend money to improve your chances of living longer. They suggest favoring purchases that help you track your health, stay active and reduce stress.”
  • Medscape points out,
    • A booster dose of recombinant pertussis vaccines provides sustained immunity in adolescents and young adults even after 5 years, with pertussis toxin (PT)–neutralizing antibody levels remaining 2.5- to 3-fold higher than pre-vaccination levels. 
  • Per MedPage Today,
    • A study presented at the American Society of Hematology (ASH) annual meeting revealed that multiple myeloma patients with higher socioeconomic deprivation, as measured by the Area Deprivation Index (ADI), experienced poorer outcomes, emphasizing the need for targeted interventions.

From the U.S. healthcare business front,

  • The Wall Street Journal lets us know,
    • “Since the assassination of his top lieutenant Brian Thompson on Dec. 4, Andrew Witty has been keeping long difficult hours at the Minnesota headquarters of the giant company he runs, UnitedHealth Group.
    • “Witty has been telling company executives during meetings and rank-and-file employees in videos that the work they do is important, lifesaving and deeply appreciated following the killing of Thompson, who had run the company’s health-insurance division.
    • ‘More quietly, Witty is telling executives that the company is expecting to hit financial records by the end of the year. 
    • “It is up to Witty, a knighted former pharmaceutical chief who went on to a rare second act running the even larger and more powerful healthcare conglomerate that is UnitedHealth, to steer through one of the worst corporate crises imaginable: the targeted killing of one of its own executives.
    • “Witty must ease the concerns of his company’s anxious 440,000 employees following Thompson’s assassination, and keep its complex business humming, while also responding to a wave of outrage over health-insurance practices since the killing in Midtown Manhattan.”
  • Per Beckers Payer Issues,
    • “UnitedHealth Group and home health company Amedisys have agreed to extend the deadline for a planned $3.3 billion merger due to a legal challenge by the Department of Justice.
    • “In a Dec. 26 regulatory filing, the two companies waived their right to terminate the agreement if it does not occur before an agreed-upon date: either 10 business days after a final court ruling that blocks the merger or December 31, 2025. They also made adjustments to the terms, including a potential penalty fee of up to $325 million if regulatory conditions aren’t met.
    • “UnitedHealth’s Optum first announced its plans to merge with Amedisys in June 2023. The Baton Rouge, La.-based company was founded in 1982 and provides home health, hospice and high-acuity care services across more than 500 care centers in 37 states and the District of Columbia.
    • “In November, the Justice Department sued to block the deal in a Maryland federal court, citing concerns of lessened competition in the home health market because the two companies are “direct competitors.” The lawsuit claims the purchase could increase home healthcare prices across 23 states and in Washington, DC. The Attorneys General of Maryland, Illinois, New Jersey, and New York have also joined the complaint.
    • “The proposed merger has been under an antitrust review by the DOJ since August 2023. In March 2024, Oregon regulators opened their own review after a preliminary report found the deal could hurt competition in the state’s home health markets.”

Friday Report

David Ermer–CDC, Congress, COVID-19, Federal employment benefits, NCQA, U.S. Healthcare–
Hanukkah greeting template. Nine candles and wishing. Hand drawn sketch illustration. White, yellow and blue colors

From Washington, DC,

  • The Washington Examiner reports,
    • Debate within the intelligence community over the origins of COVID-19 ran much deeper than previously known, particularly within the Pentagon’s Defense Intelligence Agency. 
    • Three scientists at the National Center for Medical Intelligence, a branch of the Defense Intelligence Agency, conducted a scientific investigation in the summer of 2021, concluding that COVID-19 was likely manipulated in a biolaboratory. But the information was suppressed by the Pentagon and not included in White House briefings on the virus, according to a new report from the Wall Street Journal.”  * * *
    • “The National Center for Medical Intelligence examines global health threats, including infectious diseases and bioweapons, to determine what threats could endanger troops. The agency received a significant boost in funding in the immediate aftermath of the 9/11 attacks on the World Trade Center as the threat of biowarfare increased in the 21st century. 
    • “Three scientists at the medical intelligence center determined through genetic testing that a segment of the novel bat coronavirus, known as the spike protein, had been manipulated to infect human cells. They argued these changes indicated that Chinese scientists at the Wuhan Institute of Virology were engaging in gain-of-function experiments to see if they could make the virus more dangerous for humans.” * * *
    • “Sen. Rand Paul (R-KY) has promised to pick up where the House investigation left off and said he plans to use his new chairmanship of the Senate Homeland Security and Governmental Affairs Committee to delve deeper into what happened at the Wuhan Institute of Virology and what occurred behind closed doors within federal public health agencies.”
  • NCQA shares its insights about a December 9, 2024, White House listening session concerning the ongoing opioid crisis.
  • Federal News Network lets us know,
    • “With an incoming presidential administration and a new Congress both starting up at the beginning of 2025, there are many unknowns about what’s to come for the federal workforce.
    • “But at least one thing is for certain — telework for the federal workforce will remain a high-priority topic for agencies, employees, lawmakers, unions and many others.
    • “Already, key Republicans in Congress are looking ahead to further investigations into telework options for federal employees. House Oversight and Accountability Committee Chairman James Comer (R-Ky.) announced plans to hold a hearing on federal telework once the 119th Congress begins.”

From the public health and medical research front,

  • The Centers for Disease Control and Prevention announced today,
    • “Due to the holidays, a short summary of this week’s respiratory virus illness findings is presented here, and updated data are provided in subsequent pages. No additional data summaries will be provided this week. Regular updates will resume on Friday, January 3, 2025.
    • “COVID-19, seasonal influenza, and RSV activity continue to increase across the country.
    • ‘COVID-19
      • “COVID-19 activity is increasing in most areas of the country, with high COVID-19 wastewater levels and increasing emergency department visits and laboratory percent positivity. Based on CDC modeled estimates of epidemic growth, we predict COVID-19 illness will continue to increase in the coming weeks as it usually does in the winter.
      • “There is still time to benefit from getting your recommended immunizations to reduce your risk of illness this season, especially severe illness and hospitalization.
      • “CDC expects the 2024-2025 COVID-19 vaccine to work well for currently circulating variants. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.
    • “Influenza
    • “RSV
      • “RSV activity is high and continues to increase in most areas of the country, particularly in young children. Emergency department visits and hospitalizations are increasing in children and hospitalizations are increasing among older adults in some areas.
    • “Vaccination
      • “Vaccination coverage with influenza and COVID-19 vaccines are low among U.S. adults and children. COVID-19 vaccine coverage in older adults has increased compared with the 2023-2024 season. Vaccination coverage with RSV vaccines remains low among U.S. adults. Many children and adults lack protection from respiratory virus infections provided by vaccines.”
  • The University of Minnesota CIDRAP adds,
    • “The genetic analysis of the H5N1 avian flu virus in specimens from the nation’s first severely ill hospitalized patient in Louisiana reveals mutations that may enable upper-airway infection and greater transmission, concludes a technical summary from the Centers for Disease Control and Prevention (CDC).
    • ‘But the authors of the report, released late yesterday afternoon, say the risk of an influenza pandemic amid the ongoing outbreak remains low.
    • “In related news, Los Angeles County and Stanislaus County this week announced their first human H5N1 cases in two dairy workers. Both workers had mild symptoms and are recovering after receiving antiviral drugs. No related cases have been identified. 
    • “California, which has reported a total of 37 cases, recently announced a public health emergency for H5N1 to free up more resources with the virus now spreading to dairy farms beyond the Central Valley and further south.
    • “The US total for human cases is now at 65.”
  • The Washington Post reports,
    • “Whooping cough continues to surge in the United States, with reported cases soaring to more than 32,000 this year — nearly five times the 6,500 cases recorded during the same period last year — marking the highest levels in a decade.
    • “Health experts cite as main culprits for the increase waning vaccination rates and a loss of broad immunity tracing to coronavirus lockdown protocols.
    • “The disease, caused by the bacterium Bordetella pertussis, is highly transmissible from person to person through the air. Because of their immature immune systems, infants younger than 1 year old are at highest risk of contracting whooping cough — also known as pertussis — and are at most significant risk of severe illness.
    • “Vaccination rates with the DTaP shot — which protects against diphtheria, tetanus and pertussis — declined from March through September 2020 at the height of the coronavirus pandemic. But because people were following pandemic protocols such as masking and social distancing, cases did not soar. Some children who missed getting their shots during that period may never have received them, experts have said.”
  • The Wall Street Journal informs us about “What Your ‘Face Age’ Can Tell Doctors About Your Health Scans of face photos are estimating people’s ‘biological age’ and even predicting how long they’ll live.”
    • “The FaceAge test is an artificial intelligence model trained on tens of thousands of photos from patients and public-image databases to look for signs of aging in the face. [Dr. Raymond] Mak and his team ran a study that found that the algorithm did a better job than doctors at predicting how long cancer patients would live. 
    • “Their hope is that one day, the tool could be a standard part of assessing health. Already, separate versions of face-age tests exist online where anybody can upload a selfie and get an estimate of their biological age. 
    • “Your face reflects the wear and tear of your lifetime,” says Mak, a radiation oncologist at Brigham and Women’s Hospital, who co-led the study alongside other Mass General Brigham researchers. “We viewed this as a way to quantify a doctor’s clinical intuition.”
  • Per STAT News,
    • “Blood stem cell transplants have been central players in treating blood cancers for decades. These procedures can improve patients’ chances of survival and can even offer the opportunity for a cure in some cases.
    • “But over the last decade, physicians say they’ve started doing transplants for fewer cancer types, particularly lymphomas, and are instead reaching first for newer immune or targeted therapies that are safer and often more effective.
    • “That’s progress that experts hope will continue. “I know from my days as a transplanter, there was nothing better than when a patient didn’t have to be transplanted,” said Andy Kolb, the president and CEO of the Leukemia and Lymphoma Society. “Because it’s toxic.”
  • Per HealthDay,
    • “When supplies of certain generic, platinum-based cancer chemotherapies dwindled in 2023, oncologists feared it might lead to under-treatment and many more cancer deaths.
    • “Fortunately, that did not turn out to be the case, a new study published recently in the Journal of the National Cancer Institute shows.
    • “When we looked at the data on prescribing practices over the shortage period, compared to the previous year, we found that although reporting of the shortages was widespread, it didn’t affect as many patients as we had feared,” said lead study author Dr. Jacob Reibel. He’s a third-year fellow in hematology-oncology at Penn Medicine’s Abramson Cancer Center in Philadelphia.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “National health expenditures in 2025 are forecast to rise 2.2% over 2024 levels, according to the Centers for Medicare and Medicaid Office of the Actuary. But some analysts say the predictions should be taken with a measure of skepticism.
    • “The predictions, released annually from CMS actuaries, project changes to healthcare spending by governments, businesses and households several years into the future. The report’s methodology acknowledges limitations, including relying on law and government policy in force at the time the projections were made.
    • “The office, which is independent from CMS leadership, predicts personal healthcare spending — which includes provider and retail revenue from medical goods and services — will increase 2.3% in 2025.
    • “Kevin Holoran, a senior director with data and analytics firm Fitch Group, said the projected 1.7% increase in spending on hospital care “feels a little low.” In December, Fitch Ratings released a 2025 outlook for nonprofit hospitals and health systems suggesting the sector would benefit from boosted cash flows and improved equity market returns.
    • “The Office of the Actuary predicted a 4.5% increase in prescription drug spending. Fitch Senior Director Mark Pascaris — who, along with Holoran, is a lead nonprofit hospital analyst at the firm — said those projections are consistent with growth in the sector, which Fitch expects to continue in 2025. Actuaries’ predicted 3.7% boost in home healthcare spending also makes sense, Pascaris said.
    • “The personal healthcare spending category additionally includes dental services; nursing home and continual care facilities; durable and non-durable medical products; other health, residential and personal care; and “other” professional services not included in the other subcategories.”
  • and
    • “Per diem nursing is replacing travel nursing as the preferred solution to providers’ staffing issues.” * * *
    • “Many employers, including Franklin, Tennessee-based Community Health Systems and Dallas-based Tenet Healthcare have said they’ve lowered their contract labor costs. And a June survey from employment firm Incredible Health found 67% of health executives did not increase travel nurse positions in 2024. The survey also found nurse interest in travel work dropped by 22% in 2024.
    • “Per diem nurses typically operate “on-demand,” picking up shifts for permanent staff who call out, are on a short leave or when a hospital needs extra help when a patient population is high. They are usually local residents and do not require long-term contracts, compared with travel nurses who often require relocation assistance and guaranteed pay regardless of whether a facility needs extra nurses.”
  • The Healthcare Cost Institute updated its assessment of no value care in the employer sponsored and traditional Medicare health insurance markets.
    • “In this brief, we calculated the prevalence and spending among a subset of “no value care” services between 2018 and 2022 among the employer-sponsored insurance and Traditional Medicare populations.
    • “Vitamin D Screening in administrative claims accounted for nearly $708 million in ESI and $312 million in Traditional Medicare spending in 2022. In that year, we estimate that 23% of all Vitamin D Screenings had no evidence of clinical benefit in administrative claims data among those with Employer Sponsored Insurance, much higher than the estimated 4% no value tests among those with Traditional Medicare. The prevalence of arthroscopic knee surgeries for osteoarthritis amounted to $389 million in ESI and $30 million Traditional Medicare spending in 2022.
    • “Our analysis focused just on these three services and, accordingly, does not speak to the prevalence of “no value care” in the employer-sponsored insurance and Traditional Medicare population broadly. Due to absence of clinical and health care operation data elements, we are not able to identify and measure most “no value care” or related challenges, such as medical mistakes, preventable infections, lack of care coordination, and lack of access to care.”
  • Beckers Payer Issues explains why Premera Blue Cross wants its employees to get creative with artificial intelligence.
  • Beckers Hospital Review shares what’s on pharmacy leaders’ radar screens for 2025 and its updated list of 2024 hospital closures which merited a Beckers report.

Weekend Update

David Ermer–Congress, FDA, Medical / Rx research, Mental health care–

Jingle bells! The FEHBlog will be on a holiday break until next Thursday December 26.

From Washington, DC

  • The President signed into law yesterday the skinny continuing resolution (H.R. 10545) funding the federal government through March 14, 2025, and creating funding for disaster relief and farmers. No shutdown. No PBM “reform.”
  • Healthcare Finance adds,
    • “Acute hospital-care-at-home and telehealth temporary waivers were continued but were not given the long-term extensions that were included in a Dec. 18 bipartisan resolution. Both received short-term extensions until March 31.
    • “The original bill extended telehealth for two years and acute hospital care at home by five years.
    • “Stripped out of the bill is a provision to prevent the Medicare pay cut to physicians. This means physicians get a 2.8% Medicare payment cut on January 1, 2025. 
    • Also excluded from the CR is a provision extending the ability of high deductible health plans to cover telemedicine services before the deductible beyond December 31, 2024.
  • The Senate also passed the Social Security Fairness Act on Saturday which benefits federal, state, and local government employees who receive Social Security retirement income. That bill now goes to the President for his signature. 
  • The 118th Congress has completed its work. The 119th Congress will be gaveled in on January 3, 2024.

In Food and Drug Administration News,

  • The New York Times shares the story of a woman “fighting to avoid her mother’s fate [early onset dementia], for her daughters’ sake. A mutant gene is coming to steal Linde Jacobs’s mind. Can she find a way to stop it?” Fascinating.
  • Per FDA press releases,
    • “The U.S. Food and Drug Administration approved Symvess [December 20], the first acellular tissue engineered vessel indicated for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization (restoration of blood flow) is needed to avoid imminent limb loss, and autologous vein graft is not feasible.
    • “Vascular trauma occurs when a blood vessel is injured such as a rupture of an artery in the extremities, which can lead to serious, life-threatening complications such as hemorrhage or blood clotting. When damage to an artery in the extremity occurs, urgent surgical repair is needed to restore normal blood flow. The current standard of care for patients with extremity vascular injuries can include procedures such as autologous vein grafting (surgical repair using the patient’s own blood vessels) or implantation of a synthetic graft. These treatments are not suitable or available for every patient.
    • “Today’s approval provides an important additional treatment option for individuals with vascular trauma, produced using advanced tissue engineering technology,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research (CBER). “The FDA remains committed to facilitating the development of innovative products that offer potentially life-saving benefits for patients with severe injuries.” 
  • and
    • “Today, the U.S. Food and Drug Administration approved Ryoncil (remestemcel-L-rknd), an allogeneic (donor) bone marrow-derived mesenchymal stromal cell (MSC) therapy indicated for the treatment of steroid-refractory acute graft-versus-host disease (SR-aGVHD) in pediatric patients 2 months of age and older.
    • “Ryoncil is the first FDA-approved MSC therapy. It contains MSCs, which are a type of cell that can have various roles in the body and can differentiate into multiple other types of cells. These MSCs are isolated from the bone marrow of healthy adult human donors. 
    • “Today’s decision marks an important milestone in the use of innovative cell-based therapies to treat life-threatening diseases with devastating impacts on patients, including children,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research (CBER). “This first mesenchymal stromal cell therapy approval demonstrates the FDA’s commitment to supporting the development of safe and effective products that could improve the quality of life for patients with symptoms that are unresponsive to other therapies.”

From the public health and medical research front,

  • Fortune Well tells us,
    • “A drug already FDA-approved for people with a rare form of breast cancer has now been shown to improve patients’ long-term survival, new clinical trial data suggest.
    • “Lynparza (olaparib), a product of Fortune 500 pharmaceutical firm Merck and Fortune 500 Europe company AstraZeneca, exhibited clinically meaningful improvements in overall survival, among other promising findings, in people with germline BRCA-mutated (gBRCAm), HER2-negative high-risk early breast cancer. About 87.5% of patients treated with the drug were alive after six years, compared to 83.2% who received a placebo. Long-term results of the OlympiA phase 3 trial were presented Dec. 11 at the San Antonio Breast Cancer Symposium.
    • “The durable long-term efficacy seen in the OlympiA study reinforces Lynparza as an important treatment option for those living with this truly challenging, very aggressive form of breast cancer,” Dr. Eliav Barr, senior vice president, head of global clinical development, and chief medical officer of Merck Research Laboratories, said in a news release about the findings.”
  • A mother, writes in the Washington Post, about having a stroke soon after giving birth. According to the article, “postpartum strokes happen more often than you’d think.”
  • The Wall Street Journal lets us know,
    • Dabbing has emerged in recent years as a popular way to consume marijuana, especially among youths. But it is dangerous. Like other new forms of marijuana use that have proliferated in recent years, dabbing involves highly potent concentrates of cannabis.
    • Health authorities are sounding the alarm, warning that dabbing could addict users and is sending teenagers to emergency rooms with seizures, cyclical vomiting or psychosis. Some users and doctors call a cannabis overdose, with the accompanying sweaty nausea and disorientation, a “green out,” a term believed to be a play on “black out.” 
    • “People are consuming extremely high doses of THC,” the psychoactive component of cannabis, said Dr. Nora Volkow, director of the National Institute on Drug Abuse. “People can become psychotic.”
  • and
    • “California OnTrack uses a skills-based therapy program called coordinated specialty care, which is offered through at least 381 programs in all 50 states. The program substantially reduces symptoms of psychosis, as well as hospitalizations and homelessness compared with traditional treatment, according to published studies.
    • “The premise of the treatment is simple: Teach people with psychosis to live with their imagined voices, hallucinations and false memories. With practice, such symptoms can be managed or ignored. The techniques taught in the program, in conjunction with medication, diminish symptoms over time and keep new ones at bay.
    • “People who enroll in the treatment within two years of their first psychotic episode fare the best, studies found. People with longer-term psychosis also improved but to a lesser degree.
    • “It’s not like a switch where all the symptoms subside. It’s like a dimmer switch,” said Carlos Larrauri, who completed a similar treatment in Florida after being diagnosed with schizophrenia in 2011 at age 24. He has since finished law school, trained as a nurse practitioner, married and now works as a lawyer.
    • “For more than a decade, the federal government and the American Psychiatric Association have identified coordinated specialty care as the gold standard to treat early psychosis. Yet few people know about it, and fewer still have a chance to benefit from it. Three of the largest private insurers only recently began covering the treatment, which has largely been limited to Medicaid patients. California OnTrack is one of the few providers in the U.S. that has secured coverage from private insurance.” 

Friday Report

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

From Washington, DC

  • The Wall Street Journal reports,
    • “The Republican-led House approved stopgap spending legislation to avert a government shutdown and provide more than $100 billion in disaster and farm aid, sending the measure to the Senate just hours ahead of the midnight deadline.
    • “Lawmakers voted 366 to 34 to approve the proposal, well above the two-thirds threshold needed under special fast-track procedures. 
    • “The bill marked House Speaker Mike Johnson’s third attempt to combine a three-month funding extension with emergency aid this week, after wrestling with competing demands from President-elect Donald Trump, his billionaire efficiency czar Elon Musk, internal GOP critics and Democrats.”
  • Govexec adds,
    • “The continuing resolution now heads to the Senate and Senate Majority Leader Chuck Schumer, D-N.Y., has indicated he is supportive of the bill. The White House has told lawmakers President Biden will sign it. Incoming Senate Majority Leader John Thune, R-S.D., said he expected his chamber could move the bill before the midnight deadline.” 
  • Fierce Healthcare lets us know,
    • “The Centers for Medicare and Medicaid Services announced Friday that 64 Part B drugs will have a reduced price for Medicare patients at the pharmacy counter in the first quarter of 2025.
    • “CMS said patients may save between $1 and $10,818 per day on co-insurance costs for the Part B drugs included on the list.
    • “As part of the Inflation Reduction Act, drug manufacturers must give rebates to the federal government for single source drugs and biological products, including certain biosimilar biological products, whose price increased more than the rate of inflation. The list of discounted drugs changes each quarter.
    • “The 64 drugs (PDF) with reduced co-insurance costs for Medicare patients include Kepivance, which treats mouth sores caused by chemotherapy, Talvey, used to treat patients with multiple myeloma, and Yescarta for recurrent or treatment-resistant blood cancer.”
  • Per HHS press releases,
    • “Today, the U.S. Department of Health and Human Services’ (HHS) launched the Let’s Get Real campaign to cut through the noise of misinformation and give parents the balanced information they need about childhood vaccines. The campaign provides verifiable facts so parents can get the information they want to make informed vaccine decisions, and it shares stories from doctors and peers on why most of us rely on vaccines to protect our children. Let’s Get Real also offers tools for health care professionals with pediatric patients.”
  • and
    • “Today, the U.S. Department of Health and Human Services (HHS), through the Office of Global Affair’s (OGA) U.S. Section of the U.S. – Mexico Border Health Commission (Commission), released Healthy Border 2030 – PDF.
    • “This framework includes an assessment of health data and priority issues that affect the health of the population on the U.S. side of the border as well as high-level strategic recommendations for federal, state and local governments, and community-based stakeholders on how to take action to address them. Building on previous reports in 2010 and 2020, the recommendations in the 2030 framework focus on the U.S. context and consider, when feasible, the importance of a binational approach in improving the health and well-being for populations along the U.S. southern border.”

In Food and Drug Administration News,

  • The New York Times reports,
    • “The Food and Drug Administration on Friday approved the weight loss drug Zepbound to treat obstructive sleep apnea. It is the first prescription medication approved to treat the common sleep disorder.
    • ‘The drug’s maker, Eli Lilly, announced that the agency authorized Zepbound for people with obesity and moderate to severe obstructive sleep apnea. Millions of Americans have the condition, and many of them also have obesity. The company said that the drug should be used with a reduced-calorie diet and increased physical activity. 
    • “When people have obstructive sleep apnea, they struggle to breathe properly during sleep and can wake up gasping for air. If untreated, obstructive sleep apnea raises the risk for a range of health issues, including cardiovascular problems, diabetes, stroke and dementia.
    • “In June, two studies found that people who took the drug saw a greater improvement in sleep apnea symptoms, including fewer interruptions in sleep, than those who took a placebo. Eli Lilly funded both studies.”

From the public health and medical research front,

  • The Centers for Disease Control and Prevention announced today,
    • “COVID-19 activity is increasing from low levels in some areas of the nation. Seasonal influenza activity is moderate and continues to increase across the country. RSV activity is high and continues to increase in most areas of the United States, particularly in young children.
    • “COVID-19
      • “COVID-19 activity, including wastewater levels, emergency department visits, and laboratory percent positivity, is increasing from low levels in some areas of the nation. Based on CDC modeled estimates of epidemic growth, we predict COVID-19 illness to increase in the coming weeks as it usually does in the winter.
      • “There is still time to benefit from getting your recommended immunizations to reduce your risk of illness this season, especially severe illness and hospitalization.
      • “CDC expects the 2024-2025 COVID-19 vaccine to work well for currently circulating variants. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.
    • “Influenza
    • “RSV
      • “RSV activity is high and continues to increase in most areas of the United States, particularly in young children. Emergency department visits and hospitalizations are increasing in children and hospitalizations are increasing 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.
    • “Season Outlook
      • “As of December 19, CDC continues to expect the fall and winter virus season will have a similar or lower peak number of combined hospitalizations from COVID-19, influenza, and RSV compared to last year. However, peak hospitalizations from all respiratory viruses remain likely to be much higher than they were before the emergence of COVID-19.
      • “CDC has updated the outlook this week. This update uses historical data and COVID-19 scenario modeling to assess when peak hospital demand may occur nationally and regionally. Additional updates will occur if there are big changes in how COVID-19, flu, or RSV are spreading. Read the entire 2024-2025 Respiratory Season Outlook- December Update. (12/20/2024).”
  • The University of Minnesota’ CIDRAP tells us based on two new studies that “6% of US adults have long COVID, and many have reduced quality of life.”
  • Per Health Day,
    • “The sicker a senior becomes, the more likely they’re going to develop kidney problems on top of their other health challenges.
    • “A new study published Dec. 17 in Journal of the American Geriatrics Society (JAGS) shows that as a person’s number of chronic illnesses increases, a decline in their kidney function becomes both more likely and steeper.
    • “This is particularly true of people with many heart problems, and people with a large number of chronic illnesses that require lots of medication and treatments.
    • “Our findings emphasize the importance of a comprehensive assessment that considers not only the overall chronic disease burden, but also the complex interplay between diseases when evaluating the risk of kidney function decline in older adults,” said lead researcher Giorgi Beridze, a doctoral student in geriatric epidemiology with the Karolinska Institute.”
  • and
    • “Knee arthritis could become easier to detect and diagnose thanks to a new test involving the lubricating fluid inside the joint.
    • “A new study shows that arthritis of the knee often is diagnosed in its late stages, after cartilage has degraded and bones are rubbing against each other in the joint.
    • “At that point, it’s tough to tell whether knee arthritis has been caused by natural wear and tear, or if an inflammatory disease is behind a person’s joint problems, the researchers noted in a new study published Dec. 18 in the Journal of Orthopaedic Research.
    • “But a new test involving two markers found in the synovial fluid of patients’ joints might be able to help docs suss all this out more promptly.
    • “The test “addresses an unmet need for objective diagnosis of osteoarthritis to improve clinical decision-making and patient outcomes,” researcher Daniel Keter with CD Diagnostics, a division of Zimmer Biomet, said in a journal news release.”

From the U.S. healthcare business front,

  • HCPLAN shares summaries of reports presented at its recent summit.
  • Kaufmann Hall points out four trends to help health systems accelerate their 2025 strategies.
  • The Wall Street Journal reports,
    • “Novo Nordisk’s big bet to improve on the success of its weight-loss drug franchise hit a stumbling block Friday, wiping out nearly $100 billion of the drugmaker’s stock-market value.
    • “The Danish company—which had become Europe’s biggest by market capitalization on booming sales of Ozempic and Wegovy—reported disappointing results of a closely watched clinical trial testing an experimental anti-obesity treatment that the company hoped would be its next big weight-loss product.
    • ‘The two-drug combination, dubbed CagriSema, helped study volunteers lose a significant amount of weight, some 22.7% on average after more than a year’s treatment. And the drug might still make it to market. But the magnitude of weight loss it induced in the study fell short of the company’s and investors’ expectations.”
  • The American Hospital News informs us,
    • “After incurring damage from Hurricane Helene on Sept. 27, Baxter reports that as of Dec. 19, nearly all of its manufacturing lines in its North Cove, N.C., facility have been restarted. The producer of IV and peritoneal dialysis solutions says that the lines represent 85% of the site’s total pre-hurricane capacity.  
    • “Baxter officials say they expect production across the plant to rise to pre-hurricane levels early in the first quarter of 2025. “Note that it will take some time for product to flow through the distribution channels,” according to the Baxter website.”

Thursday Report

David Ermer–CDC, CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, Medicare, NIH, No Surprises Act, OPM, U.S. Healthcare, Uncategorized–

From Washington, DC,

  • This evening, the House of Representatives turned down the President-elect approved, 121-page long version of the Continuing Resolution this evening. The Wall Street Journal adds that “Talk circulated among lawmakers about a possible weeklong funding extension, which would push the shutdown deadline past Christmas. But that too would need bipartisan support to get through the Senate.” The current CR funding the federal government expires at 12:01 AM on December 21.
  • Govexec informs us,
    • “The House passed a compendium of veterans care proposals, packaged into a single bill, on Monday, sending it to the president’s desk in the waning days of the congressional session. 
    • “The Senator Elizabeth Dole 21st Century Veterans Healthcare and Benefits Improvement Act (S.141) — which provides the Veterans Affairs Department with everything from community care improvements to expanded home care and educational assistance benefits — cleared the chamber in a 382-12 vote Monday night after previously passing the Senate by unanimous consent on Dec. 12.
    • “The legislation serves as an omnibus package of previous House and Senate bills designed to improve VA community care offerings, quality care standards and other programs, while offering benefit increases for veterans and some providers. 
    • “We worked hard to craft this legislation to put veterans – not government bureaucracy – at the core of it,” said House Veterans Affairs Committee Chairman Mike Bost, R-Ill., in a statement. “The Dole Act will do that by expanding economic opportunities, simplifying the disability claims process, reforming services for aging veterans, opening more doors for mental health support and a lot more.”
  • Federal News Network lets us know,
    • “Federal agencies will be closed on Tuesday, Dec. 24, President Joe Biden announced, giving federal employees an extra day off the day before Christmas.
    • “The president made the announcement via an executive order that he signed Thursday.
    • “All executive departments and agencies of the Federal Government shall be closed and their employees excused from duty on Tuesday, December 24, 2024, the day before Christmas Day,” the executive order states.”
  • Modern Healthcare reports,
    • “A mandatory hospital payment model finalized this year by the Centers for Medicare and Medicaid Services could make earnings uncertain for providers, researchers said.
    • “Under the Transforming Episode Accountability Model, or TEAM, hospitals could lose out on an average of $500 per episode of care covered in the model, according to a December report from the Institute for Accountable Care. But the forecast results vary widely: Hospitals in the Minneapolis-St. Paul region could gain an average of $900 per episode of included care, the report said, while Denver providers stand to lose $1,300 per episode, on average. 
    • Beginning in 2026, TEAM sets 30-day episode-based payments for lower-extremity joint replacements, femur fracture surgeries, spinal fusions, coronary artery bypass grafts and major bowel procedures. CMS will set bundled payments for these services based on regional benchmarks. In other words, hospitals will need to reduce spending for select care to a threshold set by their neighbors, or risk having to make up the difference.  
    • “It creates a really strong incentive” to manage costs, said Rob Mechanic, executive director of the Institute for Accountable Care, an independent nonprofit initially funded by the National Association of ACOs. On the flip side, he said, the regional benchmarks mean hospitals can significantly reduce their costs but still lose money.
    • The government selected 741 hospitals to participate in the five-year model, which gives safety-net hospitals extra time to prepare before taking on downside risk. Since the model is mandatory, hospitals can’t opt out. Ambulatory surgical centers are not included. According to the IAC report, the covered services represent about 15% of Medicare revenue, on average, for participating hospitals.

From the judicial front,

  • The Wall Street Journal reports,
    • “Federal prosecutors charged ex-Ivy Leaguer Luigi Mangione with murder and stalking Thursday for the Dec. 4 shooting of UnitedHealth executive Brian Thompson, alleging he was arrested with a notebook stating an intent to “wack” the CEO of an insurance company.” * * *
    • “The latest charges, brought by the Manhattan U.S. attorney’s office, mean federal prosecutors could pursue a death-penalty case against him.” * * *
    • The new federal charges capped a whirlwind day that began in Pennsylvania, where Mangione agreed at a hearing to waive his right to contest his transfer to New York. He had been detained in Pennsylvania since his arrest last week.”

In Food and Drug Administration News,

  • Healthcare Dive relates,
    • “The Food and Drug Administration on Thursday reaffirmed its assessment that Mounjaro and Zepbound, popular drugs for diabetes and obesity, are no longer in shortage,
    • “The agency’s decision will largely prevent so-called compounding pharmacies from making off-brand copies of the drug, closing a lucrative market niche that had opened as Eli Lilly, the drug’s maker, found itself unable to meet skyrocketing demand.
    • “However, the FDA won’t take enforcement action against compounding pharmacies until early next year, a grace period the agency said is to “avoid unnecessary disruption to patient treatment.”
  • Per STAT News,
    • “Ionis Pharmaceuticals on Thursday won Food and Drug Administration approval for a therapy that treats patients with a rare and deadly genetic disease that impedes the body’s ability to break down fats, setting the stage for the company to kick off the first solo drug launch in its 35-year history.
    • “The treatment, Tryngolza, also known by its scientific name of olezarsen, was approved for patients with familial chylomicronemia syndrome, or FCS, on the basis of late-stage trial results showing the therapy lowered triglyceride levels and was generally safe. Patients on the drug were less likely to develop an inflamed pancreas, an excruciating and sometimes life-threatening complication.
    • “Ionis executives believe the drug could also help patients with more common forms of sky-high triglycerides and have ongoing trials aiming to show that. If the drug is approved for more common conditions, market analysts have forecasted that Tryngolza could bring in $1.8 to $2 billion in peak sales.”
  • and
    • “Spinal cord injuries dramatically reduce a person’s mobility and independence, but a new device could aid rehabilitation efforts.
    • “Onward Medical received Food and Drug Administration clearance on Thursday for its non-invasive spinal cord stimulator, the ARC-EX. In a recent trial, the stimulator boosted hand sensation and strength in 72% of participants. While the treatment cannot replace rehabilitative therapy, device users rave about its effects.
    • “They tell patients the golden window of recovery is that first year or two,” said Sherown Campbell, one of the trial participants who signed up after he broke his neck wrestling in 2014. “I’ve made significant progress since then. I didn’t think that I would be able to move as much as I do, or I guess, as close to normal as I am.”
  • Per an FDA press release,
    • “Today, the U.S. Food and Drug Administration is announcing a final rule to update the definition of the nutrient content claim “healthy.” There is an ever-growing crisis of preventable, diet-related chronic diseases in the U.S. that requires immediate action. The updated “healthy” claim marks an important step in fulfilling the FDA’s nutrition priorities, which are part of a whole-of-government approach to address this crisis. This rule will help ensure that consumers have access to more complete, accurate, and up-to-date nutrition information on food labels.
    • “The “healthy” claim has been updated to help consumers find foods that are the foundation of a healthy dietary pattern and could also result in the development of healthier foods. Manufacturers can voluntarily use the “healthy” claim on a food package if a product meets the updated definition.”
  • The Wall Street Journal adds,
    • “Under the updated claim, eggs, nuts and seeds, olive oil and higher-fat fish such as salmon will now qualify to use the “healthy” claim. Examples of products that qualified as healthy under the original claim but not the updated one include fortified white bread, highly sweetened yogurt, and highly sweetened cereals.
    • The agency said it would work with interested parties to support use of the updated claim, adding it had entered a partnership with grocery-delivery company Instacart to help shoppers find products.
    • Both the original and updated claims have limits on saturated fat and sodium. The updated claim has a limit on added sugars, while ending the limit on total fat.

From the public health and medical research front,

  • The American Hospital News lets us know,
    • “Life expectancy in the U.S. grew an average of 10.8 months in 2023, to 75.8 years for men and 81.1 years for women, according to a report by the Centers for Disease Control and Prevention. The overall death rate declined by 6%.  
    • “The 10 leading causes of death were unchanged from 2022, with heart disease, cancer and unintentional injuries remaining the top three. COVID-19 dropped from fourth to 10th, which moved stroke up to fourth, followed by chronic lower respiratory diseases, Alzheimer’s disease, diabetes, kidney disease, and chronic liver disease and cirrhosis.”
  • Per Healio,
    • “As many as 15 million adults in the United States have a 10% or greater risk for heart failure, results of a research letter published in Annals of Internal Medicine showed.
    • “The majority of those at higher risk for heart failure (HF) had uncontrolled modifiable risk factors for the condition, including obesity and hypertension, according to the researchers.
    • “Identifying populations at such a risk, along with implementing prevention strategies, “has the potential for dramatic public health impact,” the researchers wrote.”
  • The National Institutes of Health Director, Dr. Monica Bertagnolli, writes in her blog,
    • “Clinical trials are essential for advancing new treatments that improve patient care and lives. But far too many clinical trials face challenges in identifying and enrolling eligible trial participants. Now, an NIH-led team has introduced an artificial intelligence (AI) tool that promises to speed up the process of matching patients to clinical trials to help boost enrollment. They call it TrialGPT.
    • “As reported in Nature Communications, TrialGPT takes advantage of large language models, a type of AI that can generate human-like responses to questions and explanations familiar to users of ChatGPT. The research team adapted it for matching patients to thousands of possible clinical trials in a data-efficient and transparent way. While earlier studies have shown the potential for using this type of AI for answering clinical questions, designing clinical trials, and retrieving initial lists of potential trials, TrialGPT is the first end-to-end solution, generating a list of potential trials before more precisely matching and ranking them. The team’s preliminary testing of this tool suggests TrialGPT can achieve a high degree of accuracy while cutting the time required of clinicians for screening patients. * * *
    • “In a pilot user study conducted at NCI, the researchers compared patient-trial evaluations based on short summaries about six patients made by one medical expert with TrialGPT and another who made the same evaluation manually without TrialGPT. Both experts conducted evaluations with and without AI to account for any differences in their speed or skill. The study found that clinicians using TrialGPT could generate similarly accurate lists of trial options in 40% less time.
    • “More study is needed to assess TrialGPT’s practical application in real-world settings across diverse groups of patients. But these findings already show the remarkable potential of AI technology for connecting patients to relevant trial opportunities, with tremendous potential for speeding trial recruitment and treatment advances while giving clinicians more time for other tasks only humans can do, including caring for their patients.”
  • The National Heart, Lung and Blood Institute offers an update featuring the “latest research on hypertension, educational resources on blood donation, and more.”
  • The Wall Street Journal reports,
    • “Roche said a Parkinson’s disease experimental drug missed its primary goal in a mid-stage trial, the second setback this week for candidate treatments for the neurodegenerative condition.
    • “The update from the Swiss pharmaceutical giant came after Belgian peer said a similar drug candidate for Parkinson’s developed jointly with Novartis failed to meet key goals in a clinical trial.
    • “Roche said Thursday that its drug candidate, prasinezumab, didn’t delay progression of motor symptoms in the trial, which included early-stage Parkinson’s patients, to an extent considered statistically significant.
    • “However, the company said the drug did show potential clinical efficacy, as well as positive trends on several other goals of the trial and was well tolerated. Roche will continue to evaluate the data and work together with health authorities to decide on next steps, it said.”
  • Per BioPharma Dive,
    • “Merck & Co. has long been dominant in cancer immunotherapy, with its drug Keytruda earning 40 approvals en route to becoming the world’s best-selling medicine. But the New Jersey-based drugmaker has had difficulty finding a successor, and a Monday announcement is the latest evidence.
    • “In a statement, Merck said it will end development of two experimental cancer drugs that are currently in late-stage testing. One, called vibostolimab, is aimed at a target called TIGIT. The other, favezelimab, homes in a protein named LAG-3. Both were being evaluated in combinations with Keytruda and have been touted by Merck as a way to extend Keytruda’s market advantage beyond 2028, when its main U.S. patent will expire.”

From the U.S. healthcare business front,

  • The Wall Street Journal explores the question “Why Are Americans Paying So Much More for Healthcare Than They Used To?”
    • “National healthcare spending increased 7.5% year over year in 2023 to $4.867 trillion, or $14,570 per person, according to data released Wednesday by the Centers for Medicare and Medicaid Services. 
    • “Total spending on healthcare goods and services, everything from prescription drugs to back surgeries, accounted for 17.6% of gross domestic product, a measure of goods and services produced by the U.S. economy.
    • “The 7.5% rise represented a much faster pace of growth than the 4.6% increase in 2022. It came as pandemic federal funding for the healthcare sector expired and private health insurance enrollment increased. More people with insurance led to increased demand for medical procedures, and spending on hospital care grew at the fastest pace since 1990. Spending on drugs also rose, including for medications to treat diabetes and obesity.  
    • “A full 92.5% of Americans were covered by insurance last year, and 175.6 million, or just over half the population, got it through their employer, according to the government’s new annual data. 
    • “Over 65 million Americans are on Medicare, a government health-insurance program mainly for people ages 65 and older, and nearly 92 million are on Medicaid, a state-federal program for the low-income and disabled.”
  • STAT News relates,
    • “Most of the formularies run by some of the largest health plans in the U.S. generally provide “fair access” to 11 treatments for several serious diseases, although transparent coverage information is often lacking for some medicines, a new analysis has found.
    • “Almost uniformly, the 11 formularies made the drugs available fairly when judged on three criteria: eligibility based on clinical data, restrictions placed on prescribers, and step therapy, which requires patients to try other medicines before insurers approve a prescription. The formularies are run by health plans, pharmacy benefit managers, and the U.S. Department of Veterans Affairs.
    • “But only 81% of the formularies scored well on a fourth criterion: cost-sharing, which is the portion of expenses paid by insured individuals. Although there is a caveat: This particular metric was based on a subset of just three drugs that were deemed to be fairly priced based on a cost-effectiveness assessment — the Mounjaro type 2 diabetes treatment, and the Wegovy and Qsymia obesity drugs.
    • “Meanwhile, transparency into coverage information for three gene therapies — Zynteglo for combating beta thalassemia, the Hemgenix hemophilia B treatment, and Roctavian for treating hemophilia A — remains less than optimal. Of the six formularies covering the therapies, 83% provided clinical criteria, cost-sharing information was only available in two or three, and none provided site of care information.”
  • Per Fierce Healthcare,
    • “Tech platform Uno Health is rolling out a self-service guide that shows users financial savings they could be eligible to obtain.
    • “The tool boasts of its ability to save the average user $4,500 a year after asking just a few questions. It is designed to improve accessibility and simplify the application process for everything ranging from federal and state health programs, heating bills, phone and internet services and the Supplemental Nutritional Assistance Program.
    • ‘These programs and benefits can be difficult for individuals to sift through, potentially leaving hundreds, or thousands, of dollars on the table if they do not enroll. Uno Health CEO Anna de Paula Hanika, formerly at Clover Health and Google, says the tool is an encapsulation of the company’s broader offerings.
    • “She said at least 50% of Medicare members are eligible for, but not enrolled in, other financial assistance programs. That figure increases to nearly 90% for Medicaid members. Unused benefits strain health programs and insurers.”