Midweek Update

Midweek Update

From Washington, DC

Capitol Hill News

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

OPM News

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

From the judicial front,

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

From the Food and Drug Administration front,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Thursday Report

Photo by Josh Mills on Unsplash

From Washington, DC

Capitol Hills News

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

OPM News

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

FDA News,

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

Miscellany

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Midweek Update

From Washington, DC,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Tuesday Report

OPM Headquarters a/k/a the Theodore Roosevelt Building

From Washington, DC

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Thursday Report

Photo by Josh Mills on Unsplash

From Washington, DC

  • Per a Senate press release,
    • “U.S. Senate Democratic Whip Dick Durbin (D-IL) today delivered a speech on the Senate floor highlighting his Drug-price Transparency for Consumers (DTC) Act, a bill he is introducing with Senator Chuck Grassley (R-IA) that would require price disclosures on advertisements for prescription drugs in order to empower patients and reduce Americans’ colossal spending on medications. The Government Accountability Office (GAO) has found that prescription drugs advertised directly to consumers accounted for 58 percent of Medicare’s spending on drugs between 2016 and 2018, while a 2023 study in the Journal of the American Medical Association found that two-thirds of advertised drugs offered “low therapeutic value.” By requiring direct-to-consumer (DTC) advertisements for prescription drugs to include a disclosure of the list price, patients can make informed choices when inundated with drug commercials and pharmaceutical companies may reconsider their pricing and advertising tactics.  In recent years, the pharmaceutical industry has sued to keep the prices of their drugs out of their TV advertisements.”
  • Politico reports,
    • Republican funding leaders have made an opening offer to Democrats as the two parties launch negotiations toward a deal to fund the government before the mid-March shutdown deadline.
    • Congress’ top appropriators gathered privately Thursday evening in the Capitol for an hour-long “four corners” meeting — the first concrete step toward a bipartisan funding agreement as Republican leaders begin to embrace the idea of a cross-party accord that funds the government and raises the debt limit, while also potentially boosting disaster aid and border security funding. The beginning of negotiations follows months of inaction on a bipartisan government funding plan, after lawmakers first punted beyond the October start of the fiscal year and then again resorted to a stopgap measure in December, pushing the spending cliff into the first months of the new Trump administration.
  • Federal News Network tells us,
    • “Agencies have until the end of the day Friday to revise their telework policies and begin ordering federal employees to work onsite full-time, according to a return-to-office memo from the Office of Personnel Management Wednesday evening.
    • “OPM is recommending agencies target a 30-day deadline to be in full compliance with the return-to-office directive President Donald Trump signed on his first day in office. Trump’s executive order told agencies to return their federal employees to work at the office “as soon as practicable.” The order also called for agencies to end “remote work arrangements” and require employees to work in person full-time, while leaving room for some exemptions.”
  • FedSmith lets federal and postal employees know the best dates to retire in 2025.
  • Per an OFCCP news release,
    • On January 21, 2025, the White House and President Donald Trump issued an Executive Order: “Ending Illegal Discrimination and Restoring Merit-Based Opportunity”, which revoked Executive Order 11246. For 90 days from the date of this order, Federal contractors may continue to comply with the regulatory scheme in effect on January 20, 2025.  
    • The Office of Federal Contract Compliance Programs shall immediately cease:
      • Promoting “diversity”.
      • Holding Federal contractors and subcontractors responsible for taking “affirmative action”; and
      • Allowing or encouraging Federal contractors and subcontractors to engage in workforce balancing based on race, color, sex, sexual preference, religion, or national origin.
    • It is important to note that requirements under Section 503 of the Rehabilitation Act, 29 U.S.C. 793, and the Vietnam Era Veterans’ Readjustment Assistance Act (VEVRAA), 38 U.S.C. 4212, both enforced by OFCCP, are statutory and remain in effect.

From the judicial front,

  • MedPage Today informs us,
    • “Members of the family who own Purdue Pharma, the maker of oxycodone hydrochloride (OxyContin), and the company itself, agreed to pay up to $7.4 billion in a new settlement to lawsuits over the toll of the powerful prescription painkiller, New York Attorney General Letitia James announced Thursday.
    • “The deal, agreed to by Purdue Pharma, the Sackler family members who own the company, and lawyers representing state and local governments and thousands of victims of the opioid crisis, represents an increase of more than $1 billion over a previous settlement deal that was rejected last year by the U.S. Supreme Court.
    • “The Sacklers agreed to pay up to $6.5 billion, Purdue to pay $900 million, for a total of $7.4 billion.
    • “It’s among the largest settlements reached over the past several years in a series of lawsuits by local, state, Native American tribal governments, and others seeking to hold companies responsible for a deadly epidemic. Aside from the Purdue deal, others worth around $50 billion have been announced — and most of the money is required to be used to stem the crisis.
    • “The deal still needs court approval, and some of the details are yet to be ironed out. An arm of the Department of Justice opposed the previous settlement, even after every state got on board, and took the battle to the U.S. Supreme Court. But under President Donald Trump, the federal government is not expected to oppose the new deal.”
  • The Washington Post reports,
    • The Supreme Court cleared the way Thursday for a major corporate transparency law that requires millions of businesses to make new ownership disclosures in an effort to combat financial crimes.
    • The high court lifted a block on the enforcement of the Corporate Transparency Act while a federal Circuit Court of Appeals based in New Orleans weighs the law’s constitutionality.
    • “The act, which passed in 2021, requires most U.S. businesses to disclose which of its owners control more than 25 percent of the stock or hold a similar stake in equity. The law aims to expose bad actors who create shell companies to disguise their identities while carrying out money laundering, tax fraud, drug trafficking or the financing of terrorism. It would affect more than 32 million businesses.”
  • Per Fierce Healthcare,
    • “An arbitrator has determined Prime Therapeutics violated federal and state antitrust laws against the AIDS Healthcare Foundation (AHF) and independent pharmacies.
    • “In a ruling (PDF) handed down Jan. 17, the AHF was awarded more than $10 million and injunctive relief after Prime Therapeutics was found to engage in horizontal price-fixing with Cigna’s pharmacy benefit manager (PBM), Express Scripts.
    • “Prime is a PBM owned by Blue Cross Blue Shield state plans. It has more than 20 million patients in its network affected by the collaboration.
    • “Prime was told to end its reimbursement structure for drugs under a long-standing collaboration with Express Scripts and to reimburse underpayments since June 30. The cozy relationship between Prime and Express Scripts allowed Prime to reimburse drugs and services the AHF provides to health plans, where Prime is the PBM, at a lower rate.”

From the public health and medical research front,

  • The New York Times reports,
    • “A study of more than 30,000 British adults diagnosed with attention deficit hyperactivity disorder, or A.D.H.D., found that, on average, they were dying earlier than their counterparts in the general population — around seven years earlier for men, and around nine for women.
    • “The study, which was published Thursday in The British Journal of Psychiatry, is believed to be the first to use all-cause mortality data to estimate life expectancy in people with A.D.H.D. Previous studies have pointed to an array of risks associated with the condition, among them poverty, mental health disorders, smoking and substance abuse.
    • “The authors cautioned that A.D.H.D. is substantially underdiagnosed and that the people in their study — most of them diagnosed as young adults — might be among the more severely affected. Still, they described their findings as “extremely concerning,” highlighting unmet needs that “require urgent attention.”
    • “It’s a big number, and it is worrying,” said Joshua Stott, a professor of aging and clinical psychology at University College London and an author of the study. “I see it as likely to be more about health inequality than anything else. But it’s quite a big health inequality.”
  • The American Hospital Association News notes,
    • “Perinatal mental health disorders affect countless mothers during pregnancy and postpartum, yet access to comprehensive care remains a challenge. Hospitals are stepping up to fill this gap, creating innovative programs that address the unique mental health needs of mothers during this critical period. A recent panel hosted by the AHA and the Policy Center for Maternal Mental Health highlighted the efforts of two trailblazing hospitals: Woman’s Hospital in Baton Rouge, La., and the University of Colorado Hospital Anschutz Medical Campus. READ MORE.” 
  • Per MedPage Today,
    • “Early Alzheimer’s pathology was not consistently linked to depressive symptoms in people without clinical dementia, cross-sectional data suggested.
    • “In people with normal cognition, depressive symptoms and amyloid pathology were not associated with each other (OR 1.13, 95% CI 0.90-1.40, P=0.29), reported Julie Oomens, PhD, of Maastricht University in the Netherlands, and co-authors.
    • “However, in people with mild cognitive impairment, the presence of depressive symptoms was tied to a lower likelihood of amyloid pathology (OR 0.73, 95% CI 0.61-0.89, P=0.001), Oomens and colleagues said in JAMA Psychiatry.
    • “The findings suggest that other mechanisms may underlie the previously seen associations between depressive symptoms and cognitive decline in late life, Oomens and colleagues observed.
    • “This large-scale study including data from 49 cohorts included in the Amyloid Biomarker Study shows that depressive symptoms were not consistently associated with a higher frequency of amyloid pathology in persons without dementia,” Oomens told MedPage Today. “This means that the earlier identified association between depressive symptoms and cognitive decline is likely not explained by Alzheimer’s disease pathology.”
  • and
    • Considering a risk score generated from multiple genetic variants linked to chronic obstructive pulmonary disease (COPD) caught undiagnosed cases of the disease better than conventional risk factors and respiratory symptoms alone, a study showed.
    • Adding the COPD polygenic risk score (PRS) to the Lung Function Questionnaire clinical risk score significantly improved the area under the curve by 0.03 to 0.06, suggesting a 3 to 6 percentage point increase in accuracy in identifying spirometry-defined, moderate to severe COPD, as researchers led by Matthew Moll, MD, MPH, of Brigham and Women’s Hospital and Harvard Medical School in Boston, reported in JAMA.
  • and
    • “Intermittent explosive disorder (IED), characterized by impulsive aggression and poorly regulated emotional control, was associated with multiple classes of comorbidities, an analysis of 117.7 million healthcare records showed.
    • “Of 30,000 individuals with an IED diagnosis during their lifetime, 95.7% had at least one other psychiatric diagnosis, reported Yanli Zhang-James, MD, PhD, of SUNY Upstate Medical University in Syracuse, and co-authors in JAMA Psychiatry.
    • “All psychiatric subcategories and 92% of psychiatric diagnoses were significantly associated with IED, with hazard ratios (HRs) ranging from 2.1 for substance use disorder to 76.6 for disorders of adult personality and behavior.”
  • Per tctMD,
    • “Patients who have hypertension while lying down, even if their blood pressure is normal while sitting up, have greater CVD and mortality risks in the decades to come, according to an analysis of the Atherosclerosis Risk in Communities (ARIC) study.
    • “Through more than 25 years of follow-up, supine hypertension was associated with greater risks of fatal and nonfatal coronary heart disease, heart failure, stroke, and all-cause death, lead author Duc Giao, MD (Harvard Medical School, Boston, MA), and colleagues report in a study published online Wednesday in JAMA Cardiology.
    • “The results didn’t differ based on whether patients were taking antihypertensive medications or whether they also had seated hypertension. Although risks of adverse outcomes were greatest in patients with both seated and supine hypertension, those with high supine BP alone carried greater hazards compared with those with elevations only when seated.
    • “Our conclusion was that not only is supine blood pressure an important risk factor for cardiovascular disease, but also it’s possible we could be missing a high-risk state by simply focusing on the seated position,” senior author Stephen Juraschek, MD, PhD (Beth Israel Deaconess Medical Center and Harvard Medical School), told TCTMD. “There might be more information to be gathered when we lie people flat and measure their blood pressure in the lying position.”

From the U.S. healthcare business front,

  • STAT News reports,
    • “UnitedHealth Group has named Tim Noel as the next CEO of UnitedHealthcare, replacing Brian Thompson, who was killed in New York City in December.
    • “Noel has been at the health care conglomerate since 2007 and most recently led UnitedHealthcare’s Medicare division — one of the company’s most important and profitable lines of health insurance. Its Medicare Advantage and Medigap supplemental plans made up almost half of UnitedHealthcare’s $300 billion of revenue last year.”
  • Per Healthcare Dive,
    • “Elevance’s profits took a serious hit in the fourth quarter of 2024, falling to $418 million — down more than half from $856 million in the prior-year period — amid higher medical costs in the safety-net Medicaid program, according to financial results released Thursday morning.
    • “Yet the insurer’s earnings were in line with analyst expectations after a hard year. Investors also found reason for optimism in revenue growth, with Elevance’s topline of $45 billion up about 6% year over year. Elevance’s stock, and shares in managed care peers, rose in Thursday morning trading following the results.
    • “Still, Elevance’s guidance for 2025 implies the insurer expects spending to remain elevated this year, and some market watchers are concerned about the health of Elevance’s growth outlook for privatized Medicare plans — another source of shrinking margins.”
  • On a related note, Kaufmann Hall discusses the “Next Phase of Inorganic Payer Growth.”
  • Modern Healthcare adds,
    • “The number of Chapter 11 bankruptcy filings in healthcare dropped significantly in 2024 from the previous year, though filings still hit historically high levels.
    • “Fifty-seven healthcare companies with more than $10 million in liabilities filed for bankruptcy protection in 2024, the second-highest level since 2019, according to a report released Thursday from Gibbins Advisors. But the 2024 total is still down from 79 filings in 2023.
    • “Pharmaceutical companies topped the list with 14 bankruptcy filings, followed by 11 senior care companies and 10 clinics and physician practices. Bankruptcy filings for clinics and physician practices hit the highest level in the past six years, according to the report.
    • “Five hospital groups filed for bankruptcy protection in 2024, compared with 12 groups in 2023. However, one of those groups, Steward Health Care, involved more than 30 hospitals and marked the largest bankruptcy in the hospital sector in decades, the report noted.”



Friday Report

OPM Headquarters a/k/a the Theodore Roosevelt Building

From Washington, DC,

  • OPM has posted on its website its January 15, 2025, call letter for 2026 FEHB benefit and rate proposals. Oddly enough, the 2018 call letter is dated January 11, 2017, while the 2022 call letter is dated February 17, 2021.
  • The 2026 letter fails to address carrier concerns / initiatives to lower benefit and administrative costs.
  • Govexec tells us,
    • “The Office of Personnel Management is updating the qualifications and characteristics used to select and assess members of the Senior Executive Service for the first time in more than 15 years. 
    • “OPM’s updates to the SES executive core qualifications, announced Wednesday, will take effect on July 1. 
    • “Acting OPM Director Robert Shriver wrote in a memo to agency heads that technological advances influenced the decision to make changes to the performance criteria.” 
  • The American Hospital Association News informs us,
    • “The Centers for Medicare & Medicaid Services Jan. 17 announced a record 24.2 million consumers selected health coverage through the Health Insurance Marketplace for the 2025 enrollment period that ended Jan. 15. The total more than doubled the number of enrollees from 2021, CMS said. Of this year’s total, 3.9 million consumers signed up for the first time.”
  • and
    • “The Department of Health and Human Services Jan. 17 announced 15 Medicare Part D drugs selected for the latest round of price negotiations. Negotiations will occur this year and any resulting prices will become effective in 2027. The drugs selected accounted for nearly $41 billion in total Part D gross covered prescription drug costs, or about 14%, between November 2023 and October 2024. 
    • “Drugmakers have until Feb. 28 to decide whether they will participate in negotiations. Prices for the first 10 drugs selected during the first round of negotiations were announced in August, with discounts ranging from 38% to 79% off list prices.”
  • BioPharma Dive adds,
    • “Semaglutide, the popular drug sold by Novo Nordisk as Ozempic for diabetes and Wegovy for weight loss, is among a group of widely used medicines selected by the U.S. government for the next round of price negotiations under a 2022 law aimed at curtailing pharmaceutical costs within Medicare.” * * *
    • “Also on the list are Xtandi, Ibrance, Calquence and Pomalyst, blockbuster drugs for cancers of the prostate, breast, blood and bone marrow. Trelegy Ellipta, an inhaler used for asthma and chronic obstructive sleep apnea, is included, as are Otezla, a psoriasis medicine, and Vraylar, an antipsychotic.”
  • Eli Liily’s semaglutide drugs sold as Mounjaro for diabetes and Zepbound for obesity are not on this list.
  • Per a Labor Department news release,
  • The Washington Post relates,
    • “National security officials are creating an independent panel to examine the origins of the coronavirus pandemic, as scientists and intelligence experts continue to wrestle over the highly charged issue of how the pandemic began.
    • “Jake Sullivan, the Biden administration’s national security adviser, on Sunday asked the Office of the Director of National Intelligence to assemble an outside panel of experts who would take a fresh look at the existing findings on the coronavirus and examine the government’s conclusions, according to two administration officials.
    • “Biden officials say the panel’s creation, coming days before the incoming Trump administration takes office, was driven by Sullivan’s desire to understand a virus that killed more than 1 million Americans and upended society.
    • “Sullivan also requested on Dec. 17 that intelligence agencies update their own assessments of the pandemic’s origins, according to one official who spoke on the condition of anonymity to describe national security matters.” * * *
    • “Republicans on Friday greeted the news with skepticism, calling it overdue and insufficient. Rep. Mariannette Miller-Meeks (R-Iowa), who sat on the House panel reviewing the nation’s coronavirus response, said Democrats had missed opportunities to investigate the virus’s origins during the past four years.”

From the judicial front,

  • Biopharma Dive reports,
    • “CMS’s selection [of Ozempic and Wegovy for its price negotiation list] triggered a lawsuit from Novo, citing CMS inclusion of multiple products by way of selecting one active ingredient.
    • “That suit could provide an opportunity, albeit a long shot, to exempt Wegovy and Rybelsus from this round of price negotiations. CMS in its guidance said it applies price negotiations across products using the same active ingredient or moiety because it reduces the incentive for companies to engage in “product hopping,” or making small changes in drug formulation to extend patent-protected exclusivity.
    • “Novo claimed the guidance went beyond what the IRA allowed because it interpreted the law’s call for price negotiations on “drug products” and “biological products” to mean all those with the same active moiety or ingredient. By grouping together all of Novo’s insulin products, CMS invoked negotiations on more than the 10 products permitted by the IRA in the initial round, Novo argued.”
  • The Wall Street Journal points out,
    • “A group representing 100 large employers sued the Labor Department over Biden administration rules aimed at ensuring mental-health treatment is covered like conditions such as cancer and heart disease. 
    • “Filed in federal court Friday, just days before Donald Trump’s inauguration, the suit seeks to block the regulations. It argues the Biden-era rules overstep a 2008 law requiring health plans to cover mental-health and addiction care on par with other medical care. 
    • “The lobbying group behind the suit—the Erisa Industry Committee, or ERIC—hopes that stopping enforcement now will give the new Trump administration room to revise or issue new regulations, said Tom Christina, executive director of the ERIC Legal Center. Unlike an executive order, which can be rescinded with the stroke of a pen, agency-issued regulations must go through a lengthy process to be revoked or revised.
    • “ERIC’s lead lawyer in the case is Eugene Scalia, who served as Secretary of Labor in Donald Trump’s first presidential term and is now an attorney with Gibson Dunn. The approximately 100 companies it represents, which include brands such as PepsiCo, Comcast and L’Oréal USA, are subject to the regulations because they sponsor health-insurance plans for their employees.” * * *
    • “ERIC’s members support the goals of 2008 law and recognize America’s mental-health and substance-abuse crises, Christina said. But the group believes the latest rule crosses the line into mandating mental-health benefits. Connie Garner, a former Senate policy director who helped draft the 2008 law, said new efforts to improve upon it should give priority to boosting the quality of care and the size of the mental-health workforce rather than focusing on analysis and compliance requirements.”
  • Good luck ERIC in your challenge to this ridiculously complicated regulation.
  • The Wall Street Journal adds,
    • “The U.S. Justice Department has filed suit against Walgreens, accusing the company of helping to fuel the opioid crisis by filling millions of unlawful prescriptions.
    • “The pharmacy and retail chain since August 2012 filled prescriptions that lacked a legitimate medical purpose, were invalid or weren’t issued in professional practice, the Justice Department said Friday. These prescriptions included excessive quantities and early refills of opioids, as well as the “trinity,” a drug composed of an opioid, a benzodiazepine and a muscle relaxant, according to the complaint.
    • “We are asking the court to clarify the responsibilities of pharmacies and pharmacists and to protect against the government’s attempt to enforce arbitrary ‘rules’ that do not appear in any law or regulation and never went through any official rule-making process,” a Walgreens spokesperson said.
    • “The company added that it stands behind its pharmacists, all of whom it said are “dedicated healthcare professionals who live in the communities they serve, filling legitimate prescriptions for FDA-approved medications written by DEA-licensed prescribers in accordance with all applicable laws and regulations.”
  • Per Fierce Healthcare,
    • “MultiPlan and its partner health insurers are pushing back against antitrust allegations from numerous provider organizations, filing Thursday a motion to dismiss their collective lawsuit against the data company. 
    • “Individual health systems and the American Medical Association (see below) have filed cases against MultiPlan in recent months, leading to multidistrict litigation consolidating dozens of plaintiff complaints. They accuse the company of forming agreements with insurers—UnitedHealth Group, Elevance Health, Aetna and Cigna are listed as “co-conspirators”—to set out-of-network prices using a common collective data set and methodology, as opposed to competing with each other individually.”
    • “MultiPlan and the insurers, in their Thursday filing, argued that the plaintiffs do not plausibly allege antitrust standing, an antitrust conspiracy or the standalone product that could be fixed. The company’s out-of-network reimbursement-recommendation product uses common, publicly available data sources, not competitor data, when making its recommendations to managed care organizations and third-party administrators. 
    • “Legal representation for MultiPlan and the partner insurers also noted that “numerous” similar lawsuits brought against MultiPlan in the past—including by some of the consolidated complaint—have been dismissed for failing to make an antitrust case.”
  • Good luck, Multiplan and partners.
  • Per Healthcare Dive,
    • “The Federal Trade Commission has reached a deal with Welsh, Carson, Anderson and Stowe limiting the private equity firm’s influence in the U.S. anesthesia market.
    • “The settlement released Friday comes after the FTC threatened Welsh Carson with another lawsuit — this time in the agency’s own administrative court — after regulators failed to triumph in federal proceedings last year over the PE firm’s alleged anticompetitive behavior in Texas.
    • “The deal is relatively toothless, including no monetary penalties or admission of wrongdoing for Welsh Carson. However, Welsh Carson will have to limit its involvement with its anesthesia business that’s been accused of suppressing competition and notify the FTC of any acquisitions or investments in anesthesia and other hospital-based physician practices in the future.”
  • and
    • “The Department of Justice recorded over $2.9 billion in settlements and judgments under the False Claims Act in 2024, with the majority of settlements coming from healthcare.
    • “Healthcare settlements totaled $1.67 billion. The money will go toward restoring defrauded federal healthcare programs, including Medicare, Medicaid and the military health program Tricare, according to Wednesday’s release.
    • “The DOJ once again said fraud enforcement in Medicare Advantage is of “critical importance.” Concerns about MA fraud have grown in recent years as the program has increased in popularity.”

From the public health and medical research front,

  • The Center for Disease Control and Prevention announced today,
    • “Seasonal influenza activity remains elevated across the country. COVID-19 activity has increased in most areas of the country. RSV activity has peaked in many areas of the country.
    • “COVID-19
      • “COVID-19 activity has increased in most areas of the country, with high COVID-19 wastewater levels and elevated emergency department visits and laboratory percent positivity. Emergency department visits and hospitalizations are highest in older adults and emergency department visits are also elevated in young children.
      • “There is still time to benefit from getting your recommended immunizations to reduce your risk of illness this season, especially severe illness and hospitalization.
      • “CDC expects the 2024-2025 COVID-19 vaccine to work well for currently circulating variants. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.
    • “Influenza
      • “Seasonal influenza activity, including outpatient and emergency department visits, hospitalizations, and deaths, remains elevated across the country. Additional information about current influenza activity can be found at: Weekly U.S. Influenza Surveillance Report | CDC
    • “RSV
      • “RSV activity has peaked in many areas of the country. Emergency department visits and hospitalizations are highest in children and hospitalizations are elevated among older adults in some areas.
    • “Vaccination
      • “Vaccination coverage with influenza and COVID-19 vaccines are low among U.S. adults and children. COVID-19 vaccine coverage in older adults has increased compared with the 2023-2024 season. Vaccination coverage with RSV vaccines remains low among U.S. adults. Many children and adults lack protection from respiratory virus infections provided by vaccines.”
  • The Wall Street Journal reports,
    • Moderna secured a $590 million package from the U.S. Health and Human Services Department to accelerate the development of its bird influenza vaccine as concerns grow about a bird flu pandemic in humans.
    • “The financial package will fund the expansion of clinical studies for up to five additional subtypes of bird influenza and provide additional support for late-stage development and licensure of prepandemic mRNA-based vaccines, the biotechnology company said Friday.
    • “Highly pathogenic avian influenza has been rampant in poultry farms in the U.S., and there have been several recent human cases in dairy and poultry workers, according to the Centers for Disease Control and Prevention.
    • “The current public-health risk is low, but the CDC is watching the situation carefully and working with states to monitor people with animal exposure.
    • “The financial support from the federal government comes ahead of President-elect Donald Trump’s inauguration on Monday, and while Moderna is preparing to advance its mRNA-1018 investigational pandemic influenza vaccine into a Phase 3 trial.
    • “The company plans to present the data at a coming medical meeting.”
  • The Washington Post discusses, “What to know about genetic testing for cancer, and when to request it. Genetic testing is recommended for those with personal and family histories of several types of cancer — including pancreatic and breast cancer.”
  • Cardiovascular Business lets us know,
    • “A “vascular fingerprint” located at the back of the eye can help predict a person’s stroke risk, according to new data published in Heart. Researchers noted that this new approach could be just as effective as more traditional risk factors. 
    • “The study focused on an advanced artificial intelligence (AI) algorithm trained to evaluate more than 100 different details about a patient’s retinal blood vessels using high-quality photos of the inside of their eye. The AI model assessed data from more than 45,000 participants with an average age of 55 years old. More than 700 of those participants experienced a stroke over an average follow-up period of 12.5 years. All data came from the large-scale UK Biobank study, which tracks lifestyle and health information about hundreds of thousands of participants.
    • “Overall, 29 different parameters were linked to directly influencing a participant’s stroke risk. Changes in some of those parameters increased the risk of stroke by up to 19%.
    • “The performance of this vascular fingerprint, combined with the participant’s age and sex, was found to be comparable to more traditional risk factors.
    • “Given that age and sex are readily available, and retinal parameters can be obtained through routine fundus photography, this model presents a practical and easily implementable approach for incident stroke risk assessment, particularly for primary healthcare and low-resource settings,” wrote Mayinuer Yusufu, a researcher with the department of surgery at The University of Melbourne in Australia, and colleagues.
    • “The group added that retinal analysis sets the stage for “easier, more accessible stroke risk screening, especially in primary care settings.”
  • Per STAT News,
    • “A high dose of Novo Nordisk’s obesity drug Wegovy led patients to lose substantial weight in a clinical trial, but still less than what’s been seen with competitor Eli Lilly’s Zepbound.
    • “In a 72-week study, a 7.2-milligram dose of Wegovy led patients with obesity to lose 18.7% of their weight, when looking at all participants regardless of how well they adhered to treatment. That compared with 15.6% weight loss among people taking the currently approved 2.4-mg dose, and 3.9% among people taking placebo, Novo said Friday.
    • Zepbound led to 20.9% weight loss over 72 weeks in its pivotal trial.

From the U.S. healthcare business front,

  • Beckers Payer Issues tells us,
    • “The medical cost challenges that have challenged insurers in 2024 will not be going away in 2025, UnitedHealth Group executives said
    • “The nation’s largest insurer reported its fourth-quarter and full-year 2024 earnings Jan. 16. UnitedHealth Group’s medical loss ratio was 85.5% in 2024, up from 83.2% in 2023. * * *
    • “The company said it expects its medical loss ratio to increase to around 86.5%. UnitedHealth also expects to see similar medical costs in 2025 to 2024, Mr. Rex told investors. The Inflation Reduction Act and continued risk adjustment changes in Medicare Advantage will also contribute to the rising expenses, he said. 
    • “The company has cut its operating costs as medical costs rise, Mr. Rex said.
    • “Some of these advances are the result of the very early-stage impacts we are beginning to realize from AI-driven initiatives to help our customer service representatives respond to consumers’ needs more effectively and quickly,” he said. “We see continuing opportunities, both in the near term, with operating costs for ’25 improving further, and well beyond, given the rapidly expanding scope and impact of these initiatives.” 
  • MedTech Dive provides its own “JPM25 recap: Robotics, PFA and OTC glucose sensors in the spotlight. CEOs from Medtronic, Intuitive Surgical, Boston Scientific and Dexcom were on hand this week in San Francisco to discuss the year ahead at the J.P. Morgan Healthcare Conference.”
  • Beckers Hospital Review calls attention to “10 healthcare billing fraud cases that Becker’s has reported since Dec. 27.”

Friday Report

From Washington, DC.

  • STAT News reports,
    • “The Biden administration’s [last] regulation affecting the Medicare Advantage industry would come with a much lighter touch than the past two years.
    • “President Biden’s Centers for Medicare and Medicaid Services on Friday proposed to increase the average benchmark payment to private Medicare Advantage plans by 2.2% for 2026. That compares to cuts of 0.2% for this year and 1.1% in 2024, although the Biden administration gave the Medicare Advantage industry one of the largest-ever payment hikes in 2023.
    • “The proposed rule was rolled out weeks earlier than normal, as the Trump administration gets ready to take over the White House and federal agencies later this month. It’s unclear what, if any, changes President Trump’s team will make to the proposal. Trump has picked Mehmet Oz to lead CMS, but it’s possible that the Senate won’t confirm him before the final rule is published by the beginning of April.
    • “But the Biden White House at least appears worried Trump will undo the latest proposal, warning that any “pauses” to some of its changes to how Medicare Advantage insurers are paid would result in an extra $10 billion windfall for the industry.”
  • Per HHS press releases,
    • “Today, U.S. Department of Health and Human Services (HHS) Secretary Xavier Becerra declared a Public Health Emergency (PHE) for California to address the health impacts of the ongoing wildfires in Los Angeles County.
    • “The declaration follows President Biden’s major disaster declaration and gives the Centers for Medicare & Medicaid Services’ (CMS) health care providers and suppliers greater flexibility in meeting emergency health needs of Medicare and Medicaid beneficiaries.
    • “We will do all we can to assist California officials with responding to the health impacts of the devastating wildfires going on in Los Angeles County,” said Secretary Becerra. “We are working closely with state and local health authorities, as well as our partners across the federal government, and stand ready to provide public health and medical support. My thoughts and prayers are with the people impacted in my home state.”
  • and
    • “The U.S. Department of Health and Human Services (HHS) has issued its AI Strategic Plan (hereafter referred to as “Strategic Plan” or “Plan”). The Plan establishes both the strategic framework and operational roadmap for responsibly leveraging emerging technologies to enhance HHS’s core mission, while maintaining our commitment to safety, effectiveness, equity, and access. Additionally, the Plan outlines the ways in which HHS will deliver on its goal of being a global leader in innovating and adopting responsible AI that achieves unparalleled advances in the health and well-being of all Americans.
    • “At HHS, we are optimistic about the transformational potential of AI,” said Deputy Secretary Andrea Palm. “These technologies hold unparalleled ability to drive innovation through accelerating scientific breakthroughs, improving medical product safety and effectiveness, improving health outcomes through care delivery, increasing access to human services, and optimizing public health. However, our optimism is tempered with a deep sense of responsibility. We need to ensure that Americans are safeguarded from risks. Deployment and adoption of AI should benefit the American people, and we must hold stakeholders across the ecosystem accountable to achieve this goal.”
  • The Wall Street Journal reports,
    • “New divisions have emerged among U.S. intelligence agencies over whether foreign adversaries have been developing devices that led to the illness known as Havana Syndrome, according to an intelligence report released Friday. 
    • “Most of the U.S. intelligence community still believes it is very unlikely that the wide range of symptoms that have been reported by more than 1,500 U.S. government employees since the first cases emerged in Havana in late 2016 were caused by a foreign power. 
    • “But in a notable shift, two intelligence agencies now say there is a “roughly even chance” U.S. adversaries have been developing a novel weapon that could cause the illness.
    • “One of the dissenting agencies says it might have already been used to harm a small number of American personnel and dependents who have reported Havana Syndrome symptoms, the report said. 
    • “Havana Syndrome is a set of unexplained medical symptoms that include dizziness, headache, fatigue, nausea, anxiety, cognitive difficulties and memory loss of varying severity.”
  • Per Federal News Network,
    • “The Office of Personnel Management’s retirement claims backlog remained basically the same in December as compared to November, but the number of days it took to process those claims ticked up to 57 from 55 days.
    • “OPM also hit a new low in retirement claims received last month with 5,020. This is the lowest amount of claims received since November 2023.”
  • Govexec tells us,
    • “The Office of Personnel Management on Wednesday sent guidance to agency heads outlining transition authorities that President-elect Donald Trump could use to immediately place his nominees in temporary positions at federal agencies and departments. 
    • “Although Trump is pushing Senate Republicans to expeditiously confirm his picks, he will have the authority to appoint individuals, for up to 30 days, to advisory or consultative senior executive service positions while they’re awaiting confirmation. 
    • “Likewise, cabinet-level agencies will be able to make five noncareer SES appointments and other agencies can institute up to three such appointments, which is standard. Such appointments must be made by Feb. 15 and also can only last for 30 days.”

From the judicial front,

  • Bloomberg informs us,
    • “The US Supreme Court agreed [today] to review a lower court ruling that found some Obamacare coverage requirements for preventative services unlawful, but kept them enforceable nationwide.
    • “In an order Friday, the court said it will hear the Biden administration’s appeal of that decision by the US Court of Appeals for the Fifth Circuit holding the structure of the US Preventive Services Task Force unconstitutional under the Appointments Clause.
    • “The task force is charged with recommending some of the medical services health insurers must cover free-of-charge under the Affordable Care Act.
    • “Task force members “are principal officers under Article II of the Constitution who must be—yet have not been—nominated by the President and confirmed by the Senate,” the Fifth Circuit said.”
  • FEHBlog note: It drives the FEHBlog nuts that the Biden Administration or Congress failed to moot the 5th Circuit opinion by making USPSTF recommendations subject to approval by the Centers for Disease Control and Prevention’s director.

From the public health and medical research front,

  • The CDC did not have time to update its weekly respiratory illnesses report due to the unexpected federal holiday for President Carter’s Day of Mourning yesterday. This week’s report will be posted on Monday January 13.
  • The University of Minnesota’s CIDRAP relates, “A first dose of COVID-19 vaccine accelerated relief of long-COVID symptoms such as fatigue and muscle aches in UK adults, but flu vaccination did not, suggests an observational University College London–led study published yesterday in the Journal of Infection.”
  • Per MedPage Today, “Hospitals doing fewer operative vaginal deliveries (OVDs) had higher rates of adverse perinatal outcomes for these cases than higher volume centers did, according to a population-based retrospective cohort study from California.”
  • The NIH Director, Dr Monica Bertagnolli, writes in her blog,
    • “Millions of people in the U.S. have an autoimmune disease, from type 1 diabetes to inflammatory bowel disease, in which the immune system attacks the body’s own organs, tissues, or cells to cause damage. While treatments that tamp down the immune system can help, they can increase risk for infection or cancer due to systemic immune suppression. Similarly, for people who’ve received an organ or tissue transplant, immunosuppressants used to prevent rejection can leave the whole body vulnerable. What if there was a way to suppress the immune system only right where it’s needed, in tissues or organs at risk for immune attack?
    • “An NIH-supported study reported in Science describes a way to do just that by using a cell-based therapy approach. The therapeutic approach involves taking a blood sample from a patient, modifying certain immune cells in the laboratory, and then reintroducing the engineered cells back into the body. Such cell-based therapeutics can be designed to recognize specific molecules to target tissues. This approach is already used to treat many cancers, utilizing a patient’s own engineered immune cells, known as CAR T cells, to attack and kill their cancer. Inspired by the success of the CAR T-cell example, the researchers behind this new work see the technology they’re developing as a potential platform for tackling many types of immune dysfunction.” * * *
    • “While much more study is needed, the researchers suggest that such synthetic suppressor T cells could serve as a readily customizable platform to potentially treat many autoimmune conditions. Engineered immune suppressor cells could also be used to fine-tune CAR T-cell therapies for cancer so that they only attack tumors and not normal tissues, making them less toxic. This paves the way for a future in which there may be many more possibilities for precisely tamping down the immune system in ways that could prove life-changing for transplant recipients and those with type 1 diabetes, as well as many other autoimmune conditions.”
  • Per BioPharma Dive,
    • “Pfizer on Friday said its PD-1 inhibitor sasanlimab, when combined with standard therapy in people with bladder cancer, delayed death and disease complications longer than standard therapy alone. The Phase 3 trial could give Pfizer’s subcutaneous immunotherapy an edge over rival drugs, like Merck & Co.’s Keytruda and Bristol Myers Squibb’s Opdivo, which are approved to treat people with more advanced disease. Pfizer tested sasanlimab with an immunotherapy called Bacillus Calmette-Guérin in people whose cancer hadn’t spread beyond the bladder lining after surgery. If sasanlimab wins Food and Drug Administration approval, it could be the fourth PD-1 or PD-L1 inhibitor cleared as an under-the-skin shot. The FDA has already approved subcutaneous versions of Roche’s Tecentriq and Opdivo, and Merck has positive Phase 3 data in hand for under-the-skin Keytruda” 

From the U.S. healthcare business front,

  • Beckers Hospital Review identifies “100 great neuro and spine programs.”
  • The Wall Street Journal reports,
    • AbbVie on Friday said it will post a $3.5 billion impairment charge related to last year’s $8.7 billion bet on Cerevel Therapeutics following the failure of the deal’s key drug candidate.
    • AbbVie in November said the Cerevel drug, emraclidine, missed the key goal in a pair of mid-stage studies in schizophrenia, prompting the North Chicago, Ill., biopharmaceutical company to begin an evaluation of the emraclidine intangible asset for impairment.
    • AbbVie, in announcing the Cerevel deal in late 2023, said it believed emraclidine had the potential to transform the schizophrenia treatment landscape and represented a multibillion-dollar peak sales opportunity.
  • The American Hospital Association News tells us,
    • “Prices for the top 25 brand-name Medicare Part D drugs have increased by an average of 98% since entering the market, according to a report released Jan. 9 by the AARP Public Policy Institute. That price growth has often exceeded yearly rates of inflation, the organization said. The drugs highlighted in the report have not yet been selected for the Medicare Drug Price Negotiation program. The drugs accounted for nearly $50 billion in total Part D spending in 2022.”
  • Healthcare Dive informs us,
    • “Walgreens’ first quarter earnings were notably better than Wall Street feared, though the retail pharmacy operator continues to suffer heavy losses as it works to right the ship.
    • “On Friday, Walgreens posted financial results that beat analyst expectations with revenue of $39.5 billion, up 7.5% year over year. Still, Walgreens reported a net loss of $265 million, larger than its $67 million loss same time last year, mainly due to costs stemming from ongoing store closures and asset sales.
    • “Walgreens’ market value has plummeting in recent years, leading the company to explore a private equity buyout, according to the Wall Street Journal. Executives didn’t address the speculation on a call with investors Friday morning, but said Walgreens made progress on its $1 billion cost-cutting initiative in the quarter, including a pending sale of beleaguered medical chain VillageMD and closures of 70 underperforming retail stores.”

Friday Report

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 levelsaccording 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.

FEHBlog Extra

From Washington, DC,

  • Federal News Network reports,
    • “President-elect Donald Trump has announced plans to nominate a new leader for the Office of Personnel Management.
    • “On Sunday evening, Trump’s team shared in a press email that Scott Kupor, currently a managing partner at venture capital firm Andreessen Horowitz, is the planned pick for OPM director in Trump’s second term.
    • “Scott will bring much needed reform to our federal workforce,” Trump said in a statement on Sunday.
    • “Prior to his current role at Andreessen Horowitz, Kupor served as chairman of the National Venture Capital Association from 2014 to 2018, according to his LinkedIn profile. Kupor has also worked as vice president and general manager of technology company Hewlett-Packard (HP) and held various other executive management roles in the private sector. * * *
    • “Kupor graduated Phi Beta Kappa from Stanford University with a bachelor’s degree in public policy with honors and distinction. He also holds a law degree with distinction from Stanford University and is a member of the State Bar of California.”
  • and
    • “President Joe Biden has finalized a 2% federal pay raise for the General Schedule, but the increases federal employees across the country will see when they open their first paycheck of 2025 will look a little different.
    • “That’s because the 2% federal pay raise is an average — it will vary slightly depending on where federal employees work and their locality pay area.
    • “Biden’s 2% raise includes a 1.7% across-the-board boost that most civilian employees on the General Schedule will get, as well as an average of a 0.3% locality pay adjustment. The 0.3% portion of the raise accounts for the variations in next year’s federal pay raise. Starting in January, some feds’ raises will be slightly above the 2% average raise, while others will see slightly less than the average.
    • “For 2025, the spread of raises ranges from a high of 2.35% in the San Francisco-San Jose-Oakland locality pay area, and a low of 1.88% in the Cleveland locality pay area, according to the General Schedule pay tables the Office of Personnel Management published Monday afternoon. Federal employees working in the national capital region will get a 2.22% raise next year.”
  • Bloomberg reports,
    • “The Biden administration on Monday withdrew a proposed rule that, if finalized, would have expanded access to birth control coverage offered under the Affordable Care Act.
    • “The ACA guarantees coverage of women’s preventive services, like birth control and contraceptive counseling, at no cost for women enrolled in group health plans or individual health insurance coverage. In 2018, new regulations expanded exemptions for religious beliefs and moral convictions that allow private health plans and insurers to deny coverage of contraceptive services.
    • “The [February 2, 2023] proposal—from the departments of Health and Human Services (RIN: 0938-AU94), Labor (RIN: 1210-AC13), and Treasury (RIN: 1545-BQ35)—would have removed the moral exemption waiver, but retained the current religious exemption, the Centers for Medicare & Medicaid Services said previously.”

In judicial news,

  • Reuters lets us know,
    • “A federal judge in Texas ruled that Democratic President Joe Biden’s administration likely exceeded its authority by issuing a rule strengthening privacy protections for women seeking abortions and for patients who receive gender transition treatments.
    • “U.S. District Judge Matthew Kacsmaryk in Amarillo on Sunday [December 22] agreed to block the U.S. Department of Health and Human Services from enforcing the rule against a Texas doctor who through lawyers at a conservative Christian legal group challenged the regulation as unlawful.
    • “The ruling by Kacsmaryk, who was appointed by Republican President-elect Donald Trump in his first term, issued the preliminary injunction a day before a Monday deadline for the doctor, Carmen Purl and her business to comply with the rule.”
    • FEHBlog observation: As noted in the article, the preliminary injunction applies only to the plaintiff.

In Food and Drug Administration news,

  • Per an FDA press release,
    • “Today [December 23], the U.S. Food and Drug Administration approved the first generic referencing Victoza (liraglutide injection) 18 milligram/3 milliliter, a glucagon-like peptide-1 (GLP-1) receptor agonist indicated to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes as an adjunct to diet and exercise.
    • “The FDA approved the first generic in this class of medications last month with the approval of a generic referencing Byetta (exenatide).
    • “Liraglutide injection and certain other GLP-1 medications are currently in shortage. The FDA prioritizes assessment of generic drug applications for drugs in shortage to help improve patient access to these medications.
    • “The FDA supports development of complex generic drugs, such as GLP-1s, by funding research and informing industry through guidance as part of our ongoing efforts to increase access to needed medications,” said Iilun Murphy, M.D., director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research. “Generic drugs provide additional treatment options which are generally more affordable for patients. Today’s approval underscores the FDA’s continued commitment to advancing patient access to safe, effective and high-quality generic drug products.”
  • STAT News reports,
    • “The FDA just approved Alyftrek, a once-daily medicine for a small slice of cystic fibrosis patients that carry certain mutations, including F508del. It’s a triple combination CFTR modulator that works across 31 other mutations, and outperformed Trikafta — another popular Vertex drug for cystic fibrosis — in its ability to reduce sweat chloride levels. This is the company’s fifth CFTR modulator to win U.S. approval.
    • “Vertex said that the drug offers simpler dosing for existing patients taking its drugs — but will be beneficial for an additional 150 U.S. patients with the disease, whose mutations are now treatable.”
  • Per Fierce Pharma,
    • “Undeterred by last year’s rejection and the recent approval of a close rival from Pfizer, Novo Nordisk has pushed its once-daily hemophilia injection across the regulatory finish line days before we hit 2025. 
    • “Late last week, Novo revealed that the FDA approved its tissue factor pathway inhibitor (TFPI) antagonist concizumab as a once-a-day treatment to prevent or curb the frequency of bleeding episodes in patients ages 12 and older who have hemophilia A or B with inhibitors.
    • “The prophylactic, which comes in prefilled, premixed pens for subcutaneous injection, will be marketed under the commercial title Alhemo, Novo said in a release.”

From the public health and medical research front,

  • Beckers Clinical Leadership offer five updates on the respiratory illness surge and six developments on bird flu as we head into the new year.
  • The American Medical Association fills us in on what doctors wish their patients knew about pneumonia.
  • Consumer Reports, writing in the Washington Post, relates “Things to do, and not to do, when you have a cut. Don’t “air it out.” Put down the hydrogen peroxide. Don’t bother with the antibiotic ointment. But do wash it and cover it.”

From the U.S. healthcare business front

  • Per Fierce Healthcare,
    • “Despite significant headwinds coming to bear over the past several years, healthcare executives are expecting a favorable 2025, according to a new survey from Deloitte.
    • “Deloitte’s Center for Health Solutions polled 80 C-level leaders at healthcare organizations, including 40 from health systems and 40 from health plans. Close to 60% said they believe the outlook for the coming year is favorable, increasing from 52% in last year’s survey.
    • “A majority (69%) said they believe revenues will grow in 2025, and 71% said they expect greater profitability.
    • “Two major themes emerged from executives in both sectors, according to Deloitte: growth and consumer affordability. In addition, insurance executives said they were gearing up for a year of regulatory change and new technological advancements, while health system leaders said they expect continued workforce challenges and enhancements to core business technologies.
  • Bloomberg reports,
    • “Republicans have a new chance to expand health savings accounts offered by employer plans when Congress reconvenes in 2025, revisiting a divisive policy that some Democrats support even as others denounce it as a tax break for the wealthy.
    • “Health savings accounts let high-deductible health plan enrollees use tax-free dollars on certain medical expenses. The money rolls over annually and can be invested tax-free for higher returns. Twenty-two percent of employers surveyed by the Kaiser Family Foundation offered HSA-eligible plans in 2024.
    • “Advocates see the tax-advantaged accounts as a vehicle to increase both health care access and conscious spending for high-deductible plan members, who pay more out-of-pocket before insurance kicks in. Lawmakers from both parties have proposed bills to allow patients to use HSAs for everything from gym memberships and menstrual products to funeral expenses and veterinary bills.” * * *
    • “Labeling HSAs as tools for the wealthy is a “mischaracterization,” said Johns Hopkins University accounting and health policy professor Ge Bai, pointing to data that show the majority of HSA holders live in zip codes where the median income is below $100,000. Loosening requirements around the accounts could be particularly useful for gig workers who lack insurance, she said.”
  • Beckers Hospital Review shares Mark Cuban’s plans for the new year.

Thursday Report

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.”