Monday Report

Mental health care

Monday Report

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

From Washington, DC

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

From the judicial front,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Midweek Report

David Ermer–Congress, FDA, Medical / Rx research, Mental health care, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC,

  • The Wall Street Journal reports
    • “Senate Republicans said they would stick with their plan to vote on a narrow part of President Trump’s agenda focused on border security and military spending, brushing off his comments that he favored a broader approach led by House Republicans.
    • “Senate Majority Leader John Thune (R., S.D.) said the Senate’s budget blueprint, which is up for a vote starting on Thursday, would give Trump another way to enact his domestic agenda, positioning it as a backup plan if the broader House package stalls. The House framework also includes trillions of dollars for tax relief and partially offsetting spending cuts.” * * *
    • “House and Senate Republicans are using a process called reconciliation that allows them to pass their plan through the Senate with a simple majority rather than the 60 votes usually required, allowing them to bypass Democratic opposition. But they have been working on different tracks. Both chambers of Congress have been racing to finish their versions of the budget framework, one of which would need to be passed by both houses and signed into law by Trump before work begins on the nitty-gritty of the underlying bill.”
  • Modern Healthcare reports,
    • “Dr. Mehmet Oz has agreed to divest stakes worth millions of dollars in numerous healthcare companies, including UnitedHealth Group and HCA Healthcare, if he is confirmed as administrator of the Centers for Medicare and Medicaid Services.
    • “In an ethics agreement posted by the Office of Government Ethics Wednesday, President Donald Trump’s pick to lead CMS said he would end investments in many companies within 90 days of confirmation. He also said upon confirmation, he would resign from numerous advisory positions he holds.”
  • Healthcare Dive informs us,
    • “The Federal Trade Commission will continue to use stricter guidelines inked by the Biden administration in reviewing corporate mergers, FTC Chair Andrew Ferguson notified staff on Tuesday, in a setback for healthcare M&A.
    • “The guidelines finalized in 2023 raised the bar for antitrust review, and as such have been broadly opposed by the private sector. Their preservation complicates expectations that the Trump administration will take a looser stance toward combating consolidation.
    • “Ferguson said he felt the need to clarify the FTC’s M&A review process given a flood of new premerger filings the agency received after new submission requirements went into effect earlier this month.”

From the judicial front,

  • Per Modern Healthcare,
    • “The Federal Trade Commission’s legal action against the three largest pharmacy benefit managers will move forward after a federal judge rejected their bid to halt the case.
    • “In a court filing Tuesday, U.S. District Judge Matthew Schelp denied a request by CVS Health’s CVS Caremark, Cigna’s Express Scripts and UnitedHealth Group’s OptumRx for a preliminary injunction in the FTC’s in-house case examining their influence over insulin costs.”
  • The Wall Street Journal alerts us,
    • “The implementation of the Corporate Transparency Act, which requires millions of companies to disclose their true ownership to the government, is back on after a federal judge in Texas reversed an injunction he issued last month.
    • “The Treasury Department’s Financial Crimes Enforcement Network, which oversees the enforcement of the law, on Tuesday issued a notice that extended the filing deadline for most companies to March 21. FinCEN said it recognized that companies may need additional time to comply. 
    • “Judge Jeremy Kernodle of the Eastern District of Texas, in a ruling this week, granted the U.S. government’s request to stay a national injunction issued on Jan. 7. Kernodle cited a U.S. Supreme Court ruling in favor of the Treasury issued in January by Justice Samuel Alito, which overturned a lower court order that was blocking enforcement of the CTA in another case challenging the constitutionality of the law.”

From the public health and medical research front,

  • Healthcare Dive tells us,
    • “U.S. hospitals are busier than they were before the COVID-19 pandemic, according to a study published Wednesday in JAMA Open Network. If occupancy trends continue to rise as expected, the nation could be on the brink of a bed shortage.
    • “Average hospital occupancy rates were up 11% in 2024 compared to 2019, due mostly to a declining supply of staffed beds rather than an increase in hospitalizations. The average supply of staffed beds fell from 802,000 beds between 2009 and 2019 to 674,000 beds between May 2023 and April 2024.
    • “Without changes to the projected hospitalization rate or existing bed supply, the U.S. is poised to experience an adult bed shortage by 2032, with some states experiencing a shortage before that time, according to the study.”
  • Per Healio,
    • “Antidepressants were more effective than placebo in reducing anxiety symptoms among adults with moderate to severe generalized anxiety disorder, according to a review published in Cochrane Database of Systematic Reviews.
    • “The research shows that antidepressants are highly effective at treating generalized anxiety disorder, at least in the specific circumstances seen in trials,” Giuseppe Guaiana, MD, MSc, PhD, FRCPC, associate professor of psychiatry in the Schulich School of Medicine & Dentistry at Western University in London, Ontario, Canada, and chief of psychiatry at St. Thomas Elgin General Hospital in St. Thomas, Canada, said in a press release. “For people with generalized anxiety disorder and no other conditions, we have good evidence that antidepressants lead to clinically meaningful improvements over a 1- to 3-month period compared to placebo.”
  • The National Cancer Institute lets us know,
    • “A form of nivolumab that can be injected under the skin (subcutaneous) has gained approval from the Food and Drug Administration (FDA). The approval allows the injectable version to be used for most of the same patient groups as the original formulation, which is given as an infusion through a vein (intravenous or IV).
    • “Experts say the injectable version of nivolumab, also called Opdivo Qvantig, will make the treatment quicker and easier for patients to get. The injection takes less than 5 minutes, compared with about 30 minutes for the infusion.” 
  • Per MedPage Today,
    • “Higher calcium intake was consistently associated with a reduced risk of colorectal cancer (CRC) across calcium sources and tumor sites, according to a cohort study using data from the NIH-AARP Diet and Health Study.
    • “Among over 470,000 participants who were cancer-free at baseline, higher total calcium intake was associated with a lower risk of CRC (HR 0.71, 95% CI 0.65-0.78, P<0.001 for trend), reported Erikka Loftfield, PhD, MPH, of the National Cancer Institute, and colleagues.
    • “Dairy, nondairy, and supplemental sources contributed a mean of 42.1%, 34.2%, and 23.7% of total calcium intake, respectively, they noted in JAMA Network Open.”

From the U.S. healthcare business front,

  • Healthcare Finance News reports,
    • “It remains a challenging time for the nation’s rural hospitals. The percentage of such hospitals operating with negative margins is slightly lower than it was last year, at about 46%.
    • “At the same time the number of rural hospitals deemed at risk of closure has increased.
    • “According to a new Chartis report, the national median operating margin for rural hospitals is 1%, but the median margin is negative in 16 states. At the state level, all three of Connecticut’s rural hospitals are operating in the red, and 87% of Kansas’ rural hospitals are in the red, followed by Washington (76%), Oklahoma (70%) and Wyoming (70%). 
    • “At the other end of the spectrum, Alaska (15%) and Wisconsin (19%) are the only states in which the percentage of rural hospitals in the red is less than 20%.”
  • Fierce Healthcare relates,
    • “Sutter Health will invest $1 billion to expand its services across Northern California’s East Bay region, including a new flagship campus in Emeryville.
    • “The health system announced Wednesday that the campus will feature a new medical center with up to 200 beds as well as a regional destination for ambulatory care. The plans also leave room for future expansion, according to the announcement.
    • “The ambulatory services complex at the 12-acre campus will feature a wide array of specialties and will offer imaging and laboratory services. It expects to welcome its first patients as early as 2028, Sutter said.
    • “The 335,000-square-foot medical center will include labor and delivery, surgical services, intensive care, emergency care and neonatal intensive care. The facility will be designed with the potential to add additional patient rooms in the future.
    • “Sutter is targeting a 2032-33 opening date for the medical center, according to the announcement.”
  • and
    • “Humana’s senior-focused primary care division is charting a course for further expansion throughout 2025, the company announced Wednesday.
    • “Those expansion plans include centers in four new markets: Augusta and Savannah in Georgia, North Carolina’s Triad Region and Wichita, Kansas. Between CenterWell and Conviva, the team plans to open between 20 and 30 new centers in existing markets, too, across 11 states.
    • “That number includes CenterWell facilities that are co-located at Walmart stores, with 11 remaining locations in that partnership set to open by the end of this year.
    • “With our expansion efforts, we’re taking a thoughtful approach to growth, seeking out communities that would benefit from our holistic and personalized senior care model,” said Sanjay Shetty, M.D., president of Humana’s CenterWell healthcare services segment, in a press release.”
  • Fierce Healthcare adds from the VIVE conference,
    • “Value-based care company Lumeris rolled out new AI technology for primary care doctors that produces personalized, next-best actions at both the patient and population levels. 
    • “Dubbed “Tom,” and described as a Primary Care as a Service solution embedded in clinical workflows and is designed to extend the primary care team’s reach across patient management areas including prevention and wellness, care coordination, social determinants of health, population health and chronic disease management.
    • “Tom reduces burnout by automating time-consuming tasks, according to the company, and the tech can support physicians to help health systems manage larger patient panels without sacrificing care quality. 
    • “Unlike traditional analytics-based systems, Lumeris’ AI tool executes next-best actions, including scheduling screenings and appointments, monitoring medication adherence, conducting post-discharge outreach, and sharing patient education, according to the company.
    • “The tech can initiate an interactive, patient-specific outbound call or text based on best next action such as following up post discharge, answer questions about medications and identify and reach out to close preventive gaps in care. The tech also will summarize patient text and voice interactions into relevant notes and actions into the practice’s workflow.”

Happy Presidents Day

David Ermer–CDC, COVID-19, FDA, Medical / Rx research, Mental health care, Obesity, Rx coverage, U.S. Healthcare–
Mount Rushmore Photo by Laura Nyhuis on Unsplash

From Washington, DC

  • Milliman explains how to navigate the new mental health parity rules which are under a legal challenge before the U.S. District Court for the District of Columbia.
  • Per Fierce Pharma,
    • “Pfizer’s two-year run with the only 5-in-1 meningococcal vaccine on the U.S. market has come to an end. Now, GSK is ready to play catch-up after nabbing its own FDA approval. 
    • “The FDA approved the British drugmaker’s Penmenvy vaccine to protect people ages 10 to 25 against meningococcal serogroups A, B, C, W and Y (MenABCWY), which together cause the most invasive meningococcal disease (IMD) cases globally. The shot mixes the antigenic components of GSK’s established meningococcal vaccines Bexsero and Menveo, which target MenB and MenACWY, respectively, to offer broader coverage in fewer doses.”
  • MedPage Today adds,
    • “The FDA approved insulin-aspart-szjj (Merilog) as the first rapid-acting insulin biosimilar product to treat adults and children with diabetes, the agency announced Friday [February 14].
    • “Like its reference counterpart, insulin aspart (Novolog), the biosimilar helps lower mealtime blood sugar spikes to improve glycemic control. The approval is for both a 3 mL single-patient-use prefilled pen and a 10 mL multiple-dose vial.
    • “For the millions of people who rely on daily injections of insulin for treatment of diabetes, having a biosimilar option for their rapid-acting insulin injection can truly make a difference, as biosimilar products have the potential to increase access to these life-saving medications,” said Sarah Yim, MD, director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research (CDER), in a statement.

From the U.S. public health and medical research front,

  • Beckers Clinical Leadership identifies America’s priciest health conditions.
  • Medscape notes,
    • “The CDC recommends everyone age 6 months or older get a flu vaccine, although so far this year, fewer adults have gotten the shot, compared to last year. The adult flu vaccination rate this season is 44%, down from 48% last season. According to the National Foundation for Infectious Diseases, “as long as influenza (flu) viruses are circulating in your community, it’s not too late to get vaccinated against flu.”
  • The New York Times offers “New Insights into Older Hearts. Heart disease is more common in people over 65, but treatments are better than ever. That can complicate decision-making for older heart patients.”
  • Consumer Reports, writing in the Washington Post, explains “How to keep your eyes healthy and your vision sharp. Cataracts, dry eyes, glaucoma and other eye problems become more common with age. Knowing the early signs and acting fast can make a difference.”
  • Per Healio,
    • There is evidence that GLP-1s can ameliorate psychiatric and neurologic symptoms.
    • More clinical trials on the direct and indirect effects of GLP-1s and their mechanisms of action are needed.
  • and
    • “American Indian and Alaska Native women face substantially higher risk for heart disease, particularly during reproductive-age years.
    • “Generational trauma, violence and racism have compounded [pregnancy] risks.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “CommonSpirit Health’s quarterly net patient revenue dipped for the first time in months.
    • “The health system saw net patient revenue of $8.9 billion in the second quarter of fiscal 2025, a 5% drop from the year-ago period, according to its earnings report released Friday. Net patient revenue, or revenue from providing healthcare services after contractual discounts, makes up most of providers’ total operating revenue and can have a big impact on the bottom line.
    • “The results were markedly different from last year, when CommonSpirit was one of several systems that saw big increases in net patient revenue due to higher utilization and improved payer rates.
  • Beckers Hospital Review shares more insights on CommonSpirit Health’s second quarter report.
  • Beckers Payer Issues discusses the adverse impact of the Inflation Reduction Act on payers.
  • Fierce Healthcare relates,
    • “As obesity rates rise across the U.S., a new study from UnitedHealthcare and the Health Action Council examines the financial costs that this growing “epidemic” may cause for employers.
    • “The report (PDF) notes that 75% of adults in U.S. are either overweight or obese, up from 50% in 1990. Obesity rates grew fastest among younger adults, according to the report.”The HAC represents about 230 self-funded employers, and, among its members, about a quarter (26%) have been diagnosed with obesity. The obese population accounts for 46% of the employers’ medical spend, according to the report.
    • “Per member per month costs for obese employees were more than double on average compared to those who were not obese, the study found. Per member per month costs for those with obesity averaged $973, compared to $421 for non-obese workers.”
  • and
    • “As both regulatory and market forces are pushing the industry toward more transparency in healthcare pricing, MultiPlan sees opportunities to be a bigger player in data and tech for providers, payers and employers.
    • “The data analytics company, which has been in the market for 45 years, launched a rebrand at the ViVE 2025 digital health conference on Monday.
    • “Rebranded Claritev, the company is focused on developing new products and technologies that provide data insights to a broader swath of the healthcare market. Providing “actionable insights” to healthcare organizations will be a key part of the company’s growth, Travis Dalton, chairman, CEO and president, told Fierce Healthcare in an interview in the lead-up to the ViVE 2025 event.”
  • MedTech Dive informs us,
    • “Medtronic has bought nano surface technology from Nanovis for use in its next-generation spine fusion implants.
    • “Nanovis, which disclosed the deal Tuesday [February 11], has developed nanotechnology to improve the speed and consistency of bone growth. The company has its own portfolio of spine devices.
    • “Medtronic will use the technology to develop PEEK interbody spine fusion devices that enhance implant fixation. The technology could help bone grow and fuse with the implant.”
  • The Wall Street Journal reports,
    • “If you need a prescription filled in the coming years, don’t be surprised if it flies in and lands in your backyard. 
    • “Hospitals and doctors are increasingly experimenting with the use of drones to deliver medications, lab tests and supplies to patients being treated at home. Some are testing whether drones can be used to deliver organs for transplant more quickly and cheaply. And in some cities, a 911 call today could set off a drone carrying a defibrillator, Narcan spray or tourniquet to the scene of an emergency ahead of the arrival of paramedics.” * * *
    • “One of the challenges in this space five to 10 years ago was that there wasn’t a really clear regulatory framework. Over the last 18 months this has solidified, especially in the U.S. There is now a clear path to scale,” says Adam Woodworth, chief executive officer of Wing, the drone-service unit of Google’s parent Alphabet GOOGL.

Thursday Report

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

From Washington, DC

Capitol Hills News

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

OPM News

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

FDA News,

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

Miscellany

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Midweek Update

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

From Washington, DC,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Thursday Report

David Ermer–Congress, Federal employment benefits, Government Contracting, Medical / Rx research, Mental health care, OPM, SCOTUS, U.S. Healthcare–
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.”



Tuesday Report

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

From Washington, DC,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Friday Report

David Ermer–CDC, CMS, Federal employment benefits, Medical / Rx research, Medicare, Mental health care, Obesity, OPM, Rx coverage, U.S. Healthcare–
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.”

Midweek Report

David Ermer–CDC, FDA, Generative AI, HIPAA Privacy and Security Rules, Medical / Rx research, Mental health care, NIH, Obesity, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC,

  • Per HHS press releases,
  • and
    • “The Substance Abuse and Mental Health Services Administration (SAMHSA), an agency within the U.S. Department of Health and Human Services (HHS), today released updated National Behavioral Health Crisis Care Guidance (National Guidance), comprised of three documents: 2025 National Guidelines for a Behavioral Health Coordinated System of Crisis Care; Model Definitions for Behavioral Health Emergency, Crisis, and Crisis-Related Services; and a draft Mobile Crisis Team Services: An Implementation Toolkit, which is being released today for public comment. The updated National Guidance now reflects the national transition to the 988 Suicide & Crisis Lifeline in 2022 and other progress and emerging needs related to behavioral health crisis care and provides a framework for transforming behavioral health crisis care systems in communities throughout the United States, at a time when the U.S. continues to face record high rates of suicide and overdose.”
  • and
    • “Today, the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) announced a settlement with South Broward Hospital District d/b/a Memorial Healthcare System (Memorial Healthcare System), a Florida health system, concerning a potential violation of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule. The settlement resolves litigation resulting from an investigation about a complaint alleging a lack of timely access to an individual’s protected health information (PHI). The HIPAA Right of Access provisions require that individuals or their personal representatives receive timely access to their health information for a reasonable cost. OCR’s investigation determined that Memorial Healthcare System failed to provide timely access within 30 calendar days. Memorial Healthcare System has agreed to pay $60,000. The agreement marks OCR’s 52nd Right of Access enforcement action.”
  • The American Hospital Association News informs us,
    • “The Department of Health and Human Services and Drug Enforcement Administration published a series of rules Jan. 15 related to telemedicine prescribing of controlled substances, including a special registration proposed rule and a final rule on telemedicine prescribing of buprenorphine. 
    • “The proposed rule for special registration outlines three types of registration to waive in-person visit requirements prior to virtual prescribing of controlled substances and a state registration for every state in which a patient is treated by the special registrant. Providers would need to apply for the special registrations. The DEA also proposes that providers be required to review nationwide prescription drug monitoring programs after three years. Comments on the proposed rule are due March 15. 
    • “The DEA’s final rule for the telemedicine prescribing of buprenorphine will enable practitioners to prescribe a six-month initial supply of Schedule III-V medications to treat opioid use disorder via audio-only telemedicine interaction without a prior in-person evaluation. Practitioners can then prescribe additional medication via other telemedicine encounters (real-time, two-way audio-visual) or after an in-person encounter. The agency finalized a stipulation that providers will need to complete a review of the PDMP for the state where the patient is located. Requirements for the special registration proposed rule would not apply to clinicians prescribing buprenorphine for OUD.”
  • and
    • “The Centers for Medicare & Medicaid Services announced Jan. 15 that 53.4% of people with Traditional Medicare are in an accountable care relationship with a provider, a 4.3% increase from last year. The agency said it is the largest increase since it began tracking accountable care relationships. 
    • “For 2025, CMS approved 228 applications for the Medicare Shared Savings Program, bringing the total number of accountable care organizations participating in MSSP to 476. Approved applicants included 55 new ACOs and 173 renewing or reentering ACOs, the most in the program’s history.  
    • “CMS said there was also a 16% increase from last year in federally qualified health centers, rural health clinics and critical access hospitals participating in the MSSP. In addition, 103 ACOs are continuing participation in CMS’ ACO Realizing Equity, Access, and Community Health Model, and 78 kidney contracting entities and 15 CMS Kidney Care First Practices are continuing participation in the Kidney Care Choices Model.”  
  • The Census Bureau has partnered with the Department of Defense to track how veterans fare in labor market when they return to civilian life. Check out their report.

From the Food and Drug Administration front,

  • The Wall Street Journal reports
    • “Eli Lilly said it received Food and Drug Administration approval for its treatment for moderate to severely active Crohn’s disease, an inflammatory bowel disease that causes chronic abdominal pain.
    • “The treatment, developed by the pharmaceutical company under the brand name Omvoh, is now approved to treat two types of inflammatory bowel disease in the U.S., the Indianapolis company said Wednesday. The drug was previously approved to treat ulcerative colitis in adults in October 2023.
    • “Omvoh’s approval as a treatment for Crohn’s disease was based on results from a study in which 53% of patients treated with the drug achieved clinical remission, and 46% of patients had visible healing of the intestinal lining, at one year.”
  • and
    • The Food and Drug Administration is banning the use of Red No. 3, an artificial dye linked to cancer in animals, from food and ingested drugs.
    • The move will impact thousands of food products on the market in the U.S., including Betty Crocker’s loaded mashed potatoes and MorningStar Farms plant-based bacon strips. It is even in products that aren’t red, such as Brach’s candy corn. 
    • Food manufacturers will have until early 2027 to reformulate products that use Red 3. Consumer advocates pushed the agency to revoke authorization for the additive after two studies linked it to cancer in male laboratory rats. 
  • Roll Call adds,
    • “The Food and Drug Administration unveiled a proposal on Wednesday to limit the amount of nicotine allowed in cigarettes and some other combustible tobacco products, a final step for the agency before the Trump administration takes over next week.
    • The FDA first announced it would pursue regulatory changes to maximum nicotine levels in combustible smoking products in 2022 in an effort to reduce the public health effects related to addiction and minimize youth uptake.
    • “The agency is seeking public comment on the rule, but the proposal’s fate is unclear given the coming change in administration.”
  • STAT News described the last two FDA steps along with Tuesday’s proposal putting nutrition labels on the front of food packages as springing into Making America Healthy Again.

From the judicial front,

  • Beckers Payer Issues lets us know that insurer lawsuits over Medicare Advantage Star ratings are piling up.
  • STAT News relates,
    • “After years of sparring, the Biden administration and Gilead Sciences have settled a contentious lawsuit over patents for a pair of HIV prevention pills in a case that raised questions about the extent to which government-funded research should lead to affordably priced medicines.
    • “At issue was a battle over patents for Truvada and a newer, upgraded version called Descovy — two highly effective and lucrative medications — as well as the role played by the federal government in making it possible to prevent transmission of a highly infectious disease that plagued the American public for decades.
    • “The Centers for Disease Control and Prevention, which had funded academic research into HIV prevention that later formed the basis for the pills, maintained that Gilead infringed its patent rights. The U.S. Department of Health and Human Services also contended that the company had refused to reach a licensing agreement despite several attempts to strike a deal.
    • “Gilead, however, maintained it had invented the pills and that the concept of using Truvada to prevent HIV was well-known by the time the CDC tried to obtain its patents. The company also insisted it negotiated in good faith with the government. After a May 2023 trial, a jury sided with Gilead, finding it did not infringe on patents held by the CDC and, moreover, that those patents were invalid. The Biden administration, which sought $1 billion in royalties, subsequently appealed the decision.
    • “In a statement, the company said Wednesday that it will receive a license to “certain” current and future patents concerning HIV prevention that “will protect Gilead’s freedom to operate for years to come.” Any additional terms were not disclosed, although a Gilead spokeswoman wrote to say the settlement does not contain any payments from Gilead or the federal government.”

From the public health and medical research front,

  • The Hill reports,
    • “Respiratory illnesses are spreading throughout the U.S., causing multiple states to see a spike in hospital visits. The latest data shows another virus, known as HMPV, has also been spiking in some parts of the country. 
    • “The Centers for Disease Control and Prevention previously confirmed it was monitoring a spike in cases of HMPV, or human metapneumovirus, in China’s northern provinces. The agency noted the cases of the virus, which is not new, were not a “cause for concern in the U.S.” and that rates of infection nationwide are at typical “pre-pandemic” levels.
    • “HMPV is considered relatively common, with most infected before age 5, according to Dr. Eileen Schneider, an epidemiologist with the CDC. It often circulates during flu season and causes symptoms similar to the common cold, including coughing, wheezing, congestion and shortness of breath.” * * *
    • “Across Iowa, Kansas, Missouri and Nebraska, more than 5.8% of tests submitted for HMPV tested positive through the first week of the year, data shows. That’s more than double the positivity rate across the next-highest region — Alaska, Washington, Oregon and Idaho — which sits at around 2.7%.” * * *
    • “HMPV is typically diagnosed based on symptoms, the Cleveland Clinic explains, and not testing, unless you have serious symptoms.
    • “There are no vaccines or treatment therapies for HMPV, which makes preventing the spread of HMPV especially important. Health experts recommend washing your hands often and avoiding contact with those who are infected with HMPV if possible.”
  • Becker Hospital Review tells us,
    • “The latest data from the American Society of Health-System Pharmacists reports that the active number of drug shortages in the U.S. has decreased to 271, down from a high of 323 in the first quarter of 2024. However, despite this decline, ongoing challenges continue to burden healthcare providers.” 
  • and
    • “Eli Lilly expects its experimental weight loss pill, orforglipron, to receive approval as early as next year, CEO David Ricks told Bloomberg Jan. 13.
    • “The company is preparing to release key late-stage trial data on the drug by mid-2025. The weight loss pill aims to compete with popular injectable treatments like Eli Lilly’s own Zepbound and Novo Nordisk’s Wegovy, which currently dominate the space. 
    • “If approved, orforglipron would offer a pill alternative to the current injectables, making it easier for patients to use while also addressing manufacturing challenges. 
    • “In mid-stage trials, the drug helped patients lose up to 14.7% of body weight, compared to just 2.3% for those who took a placebo.”
  • The National Cancer Institute points out,
    • “For people with a history of smoking, a diagnosis of lung cancer can cause feelings of guilt and shame due to the stigma that’s often associated with the disease. This stigma can hinder open communication between patients and health care providers and hinder patients’ use of tobacco cessation counseling. Researchers at Memorial Sloan Kettering Cancer Center have developed a training program to help health care providers reduce lung cancer–related stigma. In this interview, the trial’s leaders, Smita Banerjee, Ph.D., a behavioral scientist, and Jamie Ostroff, Ph.D., a psychologist, discuss the impact of stigma on people with lung cancer and an NCI-supported clinical trial that’s evaluating the training program.”

From the U.S. healthcare business front,

  • Fierce Healthcare reports “As deadly fires continue to rage in Los Angeles, healthcare companies far and wide are stepping up to serve those affected. At least 24 people have died from the fires, and dozens remain missing.” Bravo.  
  • STAT News notes,
    • “When Eli Lilly last year started offering lower-priced vials of its blockbuster obesity drug Zepbound, which were previously sold in injectable pens, it framed the move as a way to expand patient access. But some experts weren’t convinced, noting that Lilly was only offering the lowest doses in vials, and the new prices, $399 or $549 a month, are still prohibitive for many patients.
    • “CEO Dave Ricks said Lilly is now considering expanding the vial offering. “We’d like to lower the entry cost, and we’d like to have more doses available. That’s not something we’re announcing today, but we see that as an option,” he said Tuesday at a taping of ”The Readout LOUD,” STAT’s biotech podcast.”
  • Kaufmann Hall shares its “Winter 2025 Kaufman Hall Report: Highlights from the 2024 Healthcare Leadership Conference.”
  • Per Healthcare Dive,
    • “Teladoc Health is joining an Amazon marketplace that aims to connect consumers with health benefits programs, the telehealth vendor said Monday.
    • “Now, eligible users can find and enroll in Teladoc’s diabetes, hypertension, pre-diabetes and weight management programs through Amazon’s Benefits Connector.
    • “The program could help drive enrollment in Teladoc’s chronic care offerings, executives said at the J.P. Morgan Healthcare Conference in San Francisco on Monday. “I wouldn’t count on it bringing revenue for us very quickly, but it is certainly something that we will continue to pursue in terms of growing our chronic care program,” Teladoc CFO Mala Murthy said.”
  • Medical Economics explains why 2024 was a ‘blockbuster year’ for concierge medicine.
  • Fierce Pharma offers news from the third day of JP Morgan healthcare conference.
  • Healthcare Dive discusses top healthcare technology trends in 2025. The shape of AI regulation will be uncertain under the Trump administration this year, while healthcare companies will continue bolstering cyber defenses to withstand increasing attacks, experts say.

Weekend update

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

From Washington, DC

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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