Tuesday Report

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Tuesday Report

David Ermer–Congress, COVID-19 testing, FDA, Federal employment benefits, Medical / Rx research, NIH, Obesity, OPM, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Michele Orallo on Unsplash

From Washington, DC

Capitol Hill News

  • The Wall Street Journal reports,
    • The House [of Representatives] narrowly approved a Republican proposal to fund the government into the fall, as GOP lawmakers remained largely united following a last-minute push from the White House, overcoming Democratic opposition and setting up a fight in the Senate. 
    • Funding for the federal government expires this weekend. The GOP proposal would extend funding through Sept. 30 at fiscal 2024 spending levels, but it includes $13 billion in cuts in nondefense spending and $6 billion in increased military spending. It allocates additional money for border enforcement and forces Washington, D.C., to cut $1 billion from its budget. 
    • The measure passed 217-213, with Rep. Thomas Massie of Kentucky being the only Republican to vote against it. Democrats were largely united in opposition, with one Democrat, Rep. Jared Golden of Maine, voting yes. * * *
    • “The matter now heads to the Senate, where Republicans will need Democratic support to advance the bill. Senate Democrats were wrestling over the matter Tuesday. Some saw the funding deadline as their only leverage to push back against GOP efforts to dismantle federal programs, while others were wary of playing hardball and triggering a government shutdown. 
    • The House left town after Tuesday’s vote, effectively giving the Senate the option of approving or blocking the House measure—but not revising it.” 
  • Fierce Healthcare adds,
    • “Rep. Greg Murphy, M.D., R-N.C., posted on X Monday night that Johnson and Senate Majority Leader John Thune have agreed to include a doc pay fix in Congress’ budget reconciliation, which is expected to be finished in May to align with President Donald Trump’s first 100 days.
    • “A doc pay fix, which would counteract a 2.83% cut to Medicare physicians’ payment rates that went into effect Jan. 1, has been a central focus for provider lobbying groups as well as for physician members of the legislature. It was seen as the driving force behind passing an expanded healthcare package.
    • “The Energy and Commerce committee has an $880 billion deficit reduction target. E&C will identify those cuts from programs within its jurisdiction like Medicaid and other healthcare programs. It could identify some of those savings from items in the December healthcare package that did not make it into last year’s funding bill, such as PBM reform.”
  • Per Govexec,
    • “Also on Tuesday, Sen. Jerry Moran, R-Kan., who chairs the Senate Veterans Affairs Committee, announced during a hearing he will put forward legislation that will also seek to put some constraints on the Trump administration’s efforts to remake the Veterans Affairs Department’s workforce. He said VA must work closely with Congress and stakeholders such as veterans service organizations when seeking to make staffing cuts. The Republican chairman added he has voiced his reservations to VA Secretary Doug Collins.”

HHS News

  • The Washington Post reports,
    • Robert F. Kennedy Jr. is making one of his first official moves aimed at increasing oversight of the chemicals found in the nation’s food supply — a key component of his “Make America Healthy Again” agenda to root out chronic disease and childhood illness.
    • On Monday, Kennedy, who serves as the nation’s top health official, announced he was directing the Food and Drug Administration to “explore potential rulemaking” to tighten a decades-old loophole allowing food companies to put chemicals in their products without notifying the nation’s food regulators.
    • The practice Kennedy is targeting, known as “generally recognized as safe” (GRAS), can occur when companies self-certify the safety of a food additive. Companies aren’t required to tell the FDA when they include some chemicals and substances in their products, meaning there are probably hundreds of such ingredients added to the food supply without government oversight.
  • Per a March 10, 2025, CMS news release,
    • “Today, the Centers for Medicare & Medicaid Services (CMS) released a proposed rule to address the troubling amount of improper enrollments impacting Affordable Care Act (ACA) Health Insurance Marketplaces across the country. CMS’ 2025 Marketplace Integrity and Affordability Proposed Rule includes proposals that take critical and necessary steps to protect people from being enrolled in Marketplace coverage without their knowledge or consent, promote stable and affordable health insurance markets, and ensure taxpayer dollars fund financial assistance only for the people the ACA set out to support.” * * *
    • “View the 2025 Marketplace Integrity and Affordability Proposed Rule (CMS-9884-P) here: https://www.cms.gov/files/document/MarketplacePIRule2025.pdf
    • “For additional information on the rule and its proposals, view the CMS fact sheet:  https://www.cms.gov/newsroom/fact-sheets/2025-marketplace-integrity-and-affordability-proposed-rule” 
  • Per Modern Healthcare,
    • “The U.S. Department of Health and Human Services increased its voluntary buyout offer for some employees for further layoffs this week as the agency faces pressure to reduce headcount, according to an email viewed by Bloomberg. 
    • “In addition to a $25,000 lump-sum buyout offer, some HHS workers would also receive around two months of paid administrative leave if they chose to accept the buyout. * * *
    • “The buyout offer was available to employees this week and expires Friday. The original buyout offer was extended to a “broad population of HHS employees,” according to an email. However, the Food and Drug Administration told staff Monday that employees responsible for reviewing drugs, medical devices and tobacco products aren’t eligible for the buyout program. 
    • “The HHS buyout offers are in addition to an early retirement program that relaxed service requirements for retirement.”
  • The U.S. Preventive Services Task Force issued a final recommendation on screening for food insecurity which received an inconclusive “I” grade.
    • “For children, adolescents, and adults:
      “The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for food insecurity on health outcomes in the primary care setting.”
  • Per Axios,
    • “The federal government’s free at-home COVID test distribution program has been suspended and is no longer accepting orders” as of March 9, 2025.
    • “For some previously distributed tests, expiration dates were extended to account for data that revealed a longer-than-expected shelf life.
    • “A full list of approved tests and their revised expiration dates is posted on the FDA website.”

FDA News

  • Per Cardiovascular Business,
    • “Google has received U.S. Food and Drug Administration (FDA) for Loss of Pulse Detection, a new smartwatch feature that detects when a person’s heart stops beating and then automatically alerts emergency services. 
    • “Loss of Pulse Detection asks the user if they are OK when it first detects the loss of pulse. If no response is provided, it triggers an audio alarm and countdown to when emergency services will be notified. If the countdown reaches zero, the alert is officially sent out.
    • “This feature is already available in 14 different countries. It will be made available in the United States for Google’s Pixel Watch 3 in the weeks ahead.”
  • Per Modern Healthcare,
    • “Siemens Healthineers has received clearance from the Food and Drug Administration for its Naeotom Alpha class of photon-counting computed tomography scanners.
    • “The company unveiled the two scanners in December, touting the Naeotom Alpha.Pro and Naeotom Alpha.Prime as more affordable options to its original Naeotom Alpha photon-counting CT, which received FDA clearance in September 2021.
    • “Photon-counting CT is a new technology that uses lower radiation doses than conventional CT and produces clearer images with fewer distortions.
    • “Siemens Healthineers’ photon-counting CTs are the only commercially available scanners of their kind available for clinical use but competitors are working to bring their versions to market.”

From the judicial front,

  • Govexec reports,
    • “A federal judge has ordered the acting head of the Office of Personnel Management to testify at a court hearing examining the legality of the Trump administration’s mass firings of federal employees, but the key workforce official has informed the court he will ignore the order. 
    • “Acting OPM Director Charles Ezell was slated to appear in a U.S. District Court in San Francisco on Thursday after Judge William Alsup ruled Monday on Monday that he must do so, but he will now face a to-be-determined sanction. The Trump administration had sought to block his testimony, saying it would raise constitutional concerns, but the judge rejected the argument. Ezell has already submitted written testimony, Alsup said, and now must be subject to cross examination. 
    • “After initial publication of this story, the Trump administration Tuesday evening informed the court Ezell would not testify and withdrew his written declaration suggesting he did not order the probationary firings across government. It called live testimony “not necessary” for Ezell or any other official. The plaintiffs in the case are seeking testimony from human resources personnel throughout government.” 

From the public health and medical research front,

  • Healio lets us know,
    • “The diabetes mortality rate in the U.S. dropped from 28.1 deaths per 100,000 people in 2000 to 19.1 deaths per 100,000 in 2019.
    • “Reductions in diabetes mortality were observed for all racial and ethnic groups.”
  • The Wall Street Journal reports,
    • “GLP-1s, including Ozempic, show promise in preventing age-related conditions like Alzheimer’s, osteoarthritis and certain cancers.
    • “GLP-1s work by suppressing appetite and reducing inflammation, potentially contributing to their preventive health benefits.
    • “While promising, more robust studies are needed to confirm the causal effects of GLP-1s on longevity and healthspan.”
  • The National Institutes of Health offers a research bulletin on the following topics: “Predicting preeclampsia | Liver gene editing | Mapping MS-like brain lesions.”
  • MedPage Today tells us five things that patients with low back pain need from their doctors and
    • “BMI was lower in kids whose mothers received a responsive parenting intervention in the INSIGHT randomized clinical trial.
    • “Across ages 3 to 9 years, children in a responsive parenting group had a lower mean BMI than those in a control group.
    • “The impact appeared significant only for girls.”
  • Per a news release,
    • “The Institute for Clinical and Economic Review (ICER) announced today that it will assess the comparative clinical effectiveness and value of brensocatib (Insmed Incorporated) for the treatment of non-cystic fibrosis bronchiectasis (NCFB).
    • “The assessment will be publicly discussed during a meeting of the CTAF in September 2025, where the independent evidence review panel will deliberate and vote on evidence presented in ICER’s report.
    • “ICER’s website provides timelines of key posting dates and public comment periods for this assessment.”
  • The National Cancer Institute informs us,
    • “For men with metastatic castration-resistant prostate cancer, an initial treatment that combines enzalutamide (Xtandi) and talazoparib (Talzenna)may help them live longer than just getting enzalutamide alone, according to updated results from a large clinical trial. Enzalutamide is a type of drug known as an androgen receptor antagonist and talazoparib is part of a group of drugs called PARP inhibitors.” * * *
    • “More information about the trial, which was funded by Pfizer, the maker of talazoparib, is available in this Cancer Currents story.”
  • Fierce Pharma adds,
    • “After Gilead Sciences’ lenacapavir made waves with stellar clinical results as a twice-yearly HIV prevention candidate, the drug has shown promise being dosed even further apart at only once a year.
    • “Two different once-yearly formulations of lenacapavir achieved blood concentrations that exceeded those associated with the strong HIV prevention efficacy that twice-yearly lenacapavir showed in phase 3 preexposure prophylaxis (PrEP) studies.
    • “The pharmacokinetic results came from a small phase 1 trial presented at the Conference on Retroviruses and Opportunistic Infections and simultaneously published in The Lancet.
    • “Based on the early-stage data, Gilead plans to start a phase 3 program for once-yearly lenacapavir in the second half of this year, with the potential for regulatory filings in 2027, Jared Baeten, M.D., Ph.D., Gilead’s vice president of HIV clinical development, told Fierce Pharma.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Hinge Health filed Monday for a proposed initial public offering.
    • “The virtual musculoskeletal health company, which contracts with employers, pharmacy benefit managers and large insurance companies to provide physical therapy and pain relief services, has been considered a potential IPO candidate since last year.”
  • and
    • “Tampa General Hospital and Mass General Brigham are teaming up to open a radiation oncology center in Florida.
    • “The 10,000-square-foot facility in Palm Beach Gardens will be co-branded and jointly owned. Tampa General will handle daily operations, while Mass General Brigham will provide oversight on quality and safety, according to a Tuesday news release.
    • “The center is scheduled to open in early 2026, the release said.”
  • Per Fierce Pharma,
    • “At its sprawling complex in Durham, N.C., Merck has opened a new $1 billion, 225,000-square-foot manufacturing plant slated to produce bulk substance for its megablockbuster HPV vaccine Gardasil.
    • “Merck built the new plant on the 262-acre campus it has occupied since 2004, where the pharma giant produces a variety of vaccines including shots to prevent chickenpox, measles and rubella.
    • “The complex manufactured more than 70 million doses last year, with the figure expected to increase this year, a Merck spokesperson said in an email. The campus now employs more than 1,000 people.”
  • Per STAT News,
    • “In the last two years, hundreds of businesses have cropped up to meet the surge in demand for the obesity and diabetes medications known as GLP-1s. The majority prescribe compounded copies of the drugs — a tenuous business strategy as shortages of the branded versions of the medications have come to an end. 
    • “Now, some businesses are setting their sights on another opportunity in compounding: hormones.
    • “Dozens of wellness and direct-to-consumer telehealth companies offering GLP-1s have begun marketing cash-pay hormone replacement therapy to women in perimenopause and menopause, and testosterone replacement therapy to men. Noom, best-known for its weight loss app and more recent GLP-1 offering, launched an HRT program for menopause in late February, and telehealth company Hims & Hers plans to roll out at-home testing over the next year to enable care for low testosterone, perimenopause, and menopause.
    • “Patients and physicians have long advocated for better access to hormone-based care. Men with low testosterone levels due to hypogonadism can face stigma as they seek care, and many women struggle to receive medically appropriate estrogen and progesterone to address serious hot flashes and help prevent osteoporosis. But clinicians and health policy researchers expressed concern that the emerging commodification of hormone replacement therapies — often marketed as a personalized fix for low energy, libido, and other age-related concerns — could lead to inappropriate prescriptions and put patients at risk.” 
  • Beckers Hospital Review points out,
    • “In August, Kaiser Permanente embarked on the largest rollout of generative AI in healthcare to date.
    • “The Oakland, Calif.-based health system offered Abridge, an ambient AI listening tool that drafts clinical notes for the EHR, to tens of thousands of providers.
    • “Becker’s caught up with Brian Hoberman, MD, executive vice president of IT and CIO at the Permanente Federation, at the HIMSS conference in Las Vegas to find out how the implementation is going.”
    • Here’s a link to that interview.
  • The Wall Street Journal adds,
    • “Last year, some cancer patients in Tennessee and Mississippi got a startling offer: Instead of videoconferencing with oncology specialists located hours away, they could see a hologram doctor, courtesy of the same special effects that have projected the Jonas Brothers and other celebrities at concerts and live events.
    • “The offer came from West Cancer Center & Research Institute, a health system that employs about 61 doctors and serves about 19,240 new patients a year across 12 locations in Tennessee, Mississippi and Arkansas. The system’s main clinic is in Germantown, Tenn., a suburb of Memphis.
    • “Its doctors typically spend hours on the road each week getting to the satellite clinics to see patients in more rural locations, while also relying heavily on videoconferencing for check-ins. Now, however, two of those clinics are replacing the video calls with life-size hologram-like displays, part of a cross-industry push to take videoconferencing to the next level.”

Wednesday Report

David Ermer–CDC, CMS, Congress, FDA, Medical / Rx research, Medicare, Mental health care, NIH, OPM, Telehealth, U.S. Healthcare–
Photo by Michele Orallo on Unsplash

From Washington, DC,

Capitol Hill News

  • Modern Healthcare reports,
    • “Lawmakers who support tough rules on pharmacy benefit managers reaffirmed their ambitions to reanimate legislation that nearly passed Congress in December.
    • “The House Energy and Commerce Committee’s Health Subcommittee relaunched the push at a hearing Tuesday that featured declarations from majority Republicans and minority Democrats that they will tackle high pharmaceutical prices and limited competition in the PBM market through bills that have lingered for more than a year without final action.
    • “I can tell you it is a priority of mine to ensure these commonsense and bipartisan policies become law,” Energy and Commerce Committee Chair Brett Guthrie (R-Ky.) said at the hearing.”
  • Per a Senate news release,
    • “In a Wall Street Journal letter to the editor, Sens. Chuck Grassley (R-Iowa) and Dick Durbin (D-Ill.) welcomed Health and Human Services Secretary Robert F. Kennedy Jr.’s support for enhanced transparency regarding direct-to-consumer (DTC) prescription-drug advertisements. Grassley and Durbin are leading bipartisan legislation to require price disclosures in DTC commercials.”
  • STAT News informs us,
    • “Once again, House lawmakers have introduced a bill to alter a key provision of the Inflation Reduction Act in response to arguments that the federal law is discouraging investment in developing so-called small molecule medicines.
    • “The legislation, known as the Ensuring Pathways to Innovative Cures Act, would allow Medicare to begin negotiating with pharmaceutical companies over the prices of small molecule medicines 13 years after they reach the market. Currently, negotiations begin after nine years and the legislation — which was re-introduced by Rep. Greg Murphy (R-N.C.) — would shift the timetable so that it is the same as for large molecule medicines, also known as biologics.
    • “By making this change, the legislation would remove what the pharmaceutical industry and its investors claim is a disincentive for pursuing small molecule drugs, since these medicines would have less time on the market before Medicare would be able to negotiate set prices. This process means there will be small returns on investments for small molecule drugs, according to those who support the bill.”
  • The American Hospital Association News (AHA) tells us,
    • “Both chambers of Congress have reintroduced AHA-supported legislation, the Conrad State 30 and Physician Access Reauthorization Act (S. 709]/H.R. 1585), to reauthorize and expand the program that allows foreign-born medical graduates to practice medicine in rural and underserved areas. The bipartisan legislation extends the program for three years and would increase current state allocations from 30 to 35 physicians per year. It would also provide flexibility to expand the number of waivers in states where demand exceeds that limit.” 

White House News

  • The AHA News lets us know,
    • “The White House yesterday issued an executive order that directs the Departments of Health and Human Services, Labor, and Treasury to improve upon and increase enforcement of the hospital and insurer price transparency requirements in the Hospital Price Transparency and Transparency in Coverage regulations. Specifically, the White House instructs the departments to “rapidly implement and enforce” the regulations, including by taking actions in the next 90 days to increase enforcement and standardization and ensure that “actual prices,” rather than estimates are disclosed.”
  • Beckers Payer Issues offers six notes for payers on this Executive Order.
  • Per Govexec,
    • “The Trump administration has given federal agencies until March 13 to deliver their plans to dramatically slash their workforces through layoffs as the Trump administration moves to the second phase of its initiative to cut federal employees. 
    • “The plans will focus on the “maximum elimination” of functions not required by law, Office of Management and Budget director and Office of Personnel Management acting Director Charles Ezell said in new guidance on Wednesday, and include a resulting “significant reduction” in employees. As a starting point for the cuts, Vought and Ezell said, agencies should focus on employees whose jobs are not required in statute and who face furloughs in government shutdowns—typically around one-third of the federal workforce, or 700,000 employees. 
    • “Pursuant to the president’s direction, agencies should focus on the maximum elimination of functions that are not statutorily mandated while driving the highest-quality, most efficient delivery of their statutorily required functions,” Vought and Ezell said.”
  • The Washington Post reports,
    • “The Trump administration is giving federal agencies until mid-April to suggest relocations of bureaus and offices out of the D.C. region, a move that would have widespread impacts on the local economy.
    • “In a guidance issued Wednesday to the heads of all executive departments and agencies, the directors of the Office of Management and Budget and the Office of Personnel Management laid out steps for compliance with President Donald Trump’s order to eliminate “waste, bloat and insularity” in the government. Part of that is a directive to submit “any proposed relocations of agency bureaus and offices from Washington, D.C. and the National Capital Region to less-costly parts of the country” by April 14.” * * *
    • “Also on Wednesday, Trump issued an executive order giving agencies seven days to submit an inventory of their real property and 30 days to identify all leases that can be terminated. Within 60 days, the order stated, the General Services Administration — the government’s real estate arm — must come up with a plan to dispose all property deemed “no longer needed.”
  • Bloomberg Law informs us,
    • “US health officials are reevaluating a $590 million contract for bird flu shots that the Biden administration awarded to Moderna Inc., people familiar with the matter said.
    • “The review is part of a government push to examine spending on messenger RNA-based vaccines, the technology that powered Moderna’s Covid vaccine. The bird flu shot contract was awarded to Moderna in the Biden administration’s final days, sending the company’s stock up 13% in the two days following the Jan. 17 announcement.”

CMS News

  • Fierce Healthcare notes,
    • “Just over 34.4 million people were enrolled in Medicare Advantage (MA) plans as of Feb. 1, representing fairly slim growth across the program’s annual enrollment period.
    • “Enrollment grew by 3.8% from February 2024 to February 2025, according to anticipated data released this week from the Centers for Medicare & Medicaid Services. This would make for the lowest growth rate in more than a decade, according to researchers at KFF.
    • “The KFF analysts said enrollment in MA has more than doubled since 2010.”
  • and
    • “While lobbyists are supplicating President Donald Trump and the Republican-led Congress to continue their leadership on telehealth and extend expiring flexibilities—which Trump began during the COVID-19 pandemic—they no longer are asking for a concrete timeline.
    • “Three hundred and fifty organizations signed a letter to congressional leadership Monday urging lawmakers to extend expiring Medicare telehealth flexibilities and to restore telehealth access lost by commercially insured patients in December.
    • “The organizations told Congress that they prefer to make the telehealth flexibilities permanent. However, in a messaging shift, the groups said they “recognize this could be a multi-year process” and asked Congress to consider a “long-term” extension.”

Food and Drug Administration News

  • The New York Times relates,
    • “The Food and Drug Administration has taken a crucial step toward expanding access to the antipsychotic medication clozapine, the only drug approved for treatment-resistant schizophrenia, among the most devastating of mental illnesses.
    • “The agency announced on Monday that it was eliminating a requirement that patients submit blood tests before their prescriptions can be filled.” * * *
    • “In 2015, federal regulators imposed a regimen known as risk evaluation and mitigation strategies, or REMS, that required patients to submit to weekly, biweekly and monthly blood tests that had to be uploaded onto a database and verified by pharmacists.
    • “Physicians have long complained that, as a result, clozapine is grossly underutilized.
    • “Dr. Frederick C. Nucifora, director of the Adult Schizophrenia Clinic at the Johns Hopkins School of Medicine, said he believed that around 30 percent of patients with schizophrenia would benefit from clozapine — far more than the 4 percent who currently take it.
    • “I have had many patients who were doing terribly, who struggled to function outside the hospital, and cycled through many medications,” he said. “If they go on clozapine, they really tend to not be hospitalized again. I’ve had people go on to finish college and work. It’s quite remarkable.”

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “A child who tested positive for measles died in West Texas, the state health department said, marking the first death in an outbreak that has sickened nearly 140 people. 
    • “The Texas Department of State Health Services said a school-age child died after being hospitalized in Lubbock. The child wasn’t vaccinated, the state health department said.
    • “The child’s death marked the first measles-related death in the U.S. since 2015.” * * *
    • “The reality of this outbreak is pushing more people to get vaccinated, said Katherine Wells, director of public health in Lubbock. The public-health department has administered around 100 more measles vaccines over the past week or two than they do normally. More than half of those went to children receiving the vaccine for the first time. School nurses also checked students’ vaccine records and alerted parents if their sons or daughters hadn’t received their second dose yet, Wells said.
    • “The goal right now is to find pockets of unvaccinated people who have not yet been exposed and just get our vaccination rates up as high as possible,” Wells said. “That’s what’s going to slow this down.”
  • CBS News points out,
    • “This season’s influenza vaccine may have been a poor match to a strain of the flu virus that caused many infections this winter, early data released by the Centers for Disease Control and Prevention suggests.
    • “The CDC’s latest data come as much of the U.S. is finally seeing signs of a slowdown in influenza activity after waves of illness this past fall and winter that climbed to the worst rates recorded from hospitals and doctor’s offices since the 2009 swine flu pandemic.”
  • The National Cancer Institute tells us whether “AI Help Predict Which Cancer Patients Should Be Treated with Immunotherapy?” and offers Cancer Information Highlights about “Metastatic Prostate Cancer | Prenatal Blood Test | Nivolumab via Injection.”
  • Health Day adds,
    • “Frequent exercise can help colon cancer survivors live longer, perhaps even outlasting average folks, a new study suggests.
    • “Colon cancer patients who were very physically active had three-year survival rates that were slightly higher than the general population, researchers report in the journal Cancer.
    • “This new information can help patients with colon cancer understand how factors that they can control — their physical activity levels — can have a meaningful impact on their long-term prognosis,” lead researcher Justin Brown, director of the Cancer Metabolism Program with the Pennington Biomedical Research Center at Louisiana State University, said in a news release.”
  • Per Healio,
    • “Pregnant women with low vitamin D levels during the first trimester were four times more likely to give birth prematurely compared with women with adequate vitamin D levels, researchers wrote in The American Journal of Clinical Nutrition.
    • “Testing for vitamin D status is not currently part of standard prenatal care in the U.S.,” Alison D. Gernand, PhD, MPH, RD, associate professor of nutritional sciences at Pennsylvania State University, told Healio. “Clinical care providers should consider talking to pregnant patients about vitamin D during the first prenatal visit — asking whether they have vitamin D-rich foods in their diet and how much vitamin D is in the supplement they are taking.”
  • and
    • “Among populations with low adherence to colorectal cancer screening, annual fecal immunochemical testing was the cheapest and most effective noninvasive screening method, according to a study published in JAMA Network Open“
  • BioPharma Dive lets us know,
    • “AstraZeneca said Wednesday that its experimental drug camizestrant delayed tumor progression in a Phase 3 testing its use as a first-line treatment in people with a certain type of breast cancer. The drug, an oral, hormone receptor protein-degrading therapy known as a SERD, was tested alongside an approved CDK4/6 inhibitor in people whose HR-positive, HER2-negative tumors have an “emergent” ESR1 mutation. People in the study were receiving standard hormone therapy and a CDK4/6 drug and then either continued, or swapped out the hormone treatment for camizestrant, once a tumor scan showed signs of an ESR1 mutation. The result was a “highly statistically significant and clinically meaningful improvement” in progression-free survival for camizestrant recipients, AstraZeneca said. Menarini Group’s similar drug Orserdu is available in the second line setting, while others from Arvinas, Eli Lilly and Roche are in advanced testing.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Drugmaker Eli Lilly plans to build four new manufacturing plants in the U.S., a $27 billion investment that the company expects will create 3,000 high-skilled jobs and employ 10,000 construction workers.
    • “Three of the new sites would produce active pharmaceutical ingredients for its drugs, and the fourth would produce sterile injectable medicines such as diabetes drug Mounjaro, Lilly said Wednesday. The company hasn’t picked the locations yet. It expects the plants to be making medicines within five years.
    • “The announcement, by one of the country’s biggest drugmakers, is the latest by a company outlining a major capital push in the U.S. while President Trump seeks to revive domestic manufacturing.
    • “It comes as Lilly and other pharmaceutical companies seek warm relations with the new administration and press it to pursue industry objectives, including the extension of corporate tax cuts enacted during the first Trump administration.
    • “We hadn’t built a new site in the U.S. in more than 40 years until the first set of Trump tax cuts, so we need to see those either extended or improved to support this,” Lilly Chief Executive David Ricks said in an interview.”
  • Per Modern Healthcare,
    • “Mobile medical units will deliver hospital-at-home care to patients in rural communities as part of a five-year pilot program aimed at expanding healthcare access in underserved areas.
    • “The Advanced Research Projects Agency for Health recently awarded an undisclosed amount of funding to Boston’s Mass General Brigham, University of Utah’s Huntsman Cancer Institute and Kentwood, Michigan-based Homeward Health to develop programs that will extend hospital-level care to patients in remote communities using mobile platforms.
    • “Health systems have used hospital-at-home as a way to ease overcrowding and free up beds. More than 380 hospitals have Medicare waivers allowing them to provide acute care to patients where they live at the same reimbursement rate as an inpatient stay. While the waiver is set to expire at the end of March, there has been bipartisan support to continue it and hospitals continue to launch in-home acute care programs.
    • “But the concept has not taken off in rural America, in part because the CMS waiver requires patients to live within 25 miles of a participating hospital. Staffing can also be a challenge, as well as patient buy-in.”
  • and
    • “Teladoc posted a net loss of just over $1 billion in 2024 related to ongoing struggles at its direct-to-consumer BetterHelp business that are expected to continue this year.
    • “The annual net loss of $1 billion, or $5.87 per share, reported Wednesday, compared with a 2023 loss of $220 million, or $1.34 per share. The company took a non-cash goodwill impairment charge of $790 million attributed to BetterHelp. Revenue tied to BetterHelp, which Teladoc acquired in June 2015 for $4 million, decreased 8% in 2024. Overall revenue declined 1%.
    • “Compared with a year ago, fourth-quarter revenue decreased 3% and its net loss was 68% worse.
    • “The outlook for this year isn’t encouraging. The company said it expects BetterHelp revenue to decline nearly 10%. Still, during an earnings call, CEO Chuck Divita was bullish on the direct-to-consumer segment and said Teladoc will pursue strategies to turn the company around.”
  • Tech Target discusses “How healthcare consumerism is driving provider revenue growth.”
    • “Sixty-five percent of healthcare executives are prioritizing growth strategies to increase revenue, according to the Deloitte Center for Health Solutions. And health system leaders expect consumers to play a major role in their organizations’ organic growth.
    • “The survey from Deloitte underscored a shift from merger and acquisition activity as a means of growing revenue to consumer attraction and retention. However, to attract new consumers and drive organic growth, over half of health system executives (and about half of health plan leaders) said they need to improve consumer engagement, trust and the overall patient experience.”

Tuesday Report

David Ermer–Congress, Medical / Rx research, Medicare, OPM, Telehealth, U.S. Healthcare–

From Washington, DC,

  • By a 217 – 215 vote, the House of Representatives tonight passed the White House’s “big, beautiful [reconciliation] bill” — H. Con. Res. 14 — “Establishing the congressional budget for the United States Government for fiscal year 2025 and setting forth the appropriate budgetary levels for fiscal years 2026 through 2034.”
  • Per a Senate news release,
    • “Sen. Chuck Grassley (R-Iowa), Chairman of the Senate Judiciary Committee and a former Chairman of the Senate Finance Committee, sent a letter to UnitedHealth Group Chief Executive Officer Andrew Witty demanding detailed information on the company’s Medicare billing practices.”
  • Govexec tells us,
    • “The Trump administration is reshaping the top ranks of federal agencies by making more employees politically appointed and ensuring those who remain in career roles are evaluated based on how well they implement the president’s agenda. 
    • “The Office of Personnel Management on Monday called on all agencies to redesignate some of their Senior Executive Service employees as political appointees, rather than reserving them for career staff. On Tuesday, it announced a new performance appraisal system for career executives, which will now give the most significant weight to how well the top-level supervisors carry out the president’s policies.”
  • Federal News Network informs us,
    • “The Office of Personnel Management is giving an ultimatum to remote and teleworking employees who are more than 50 miles away from their official duty stations.
    • “OPM is directing employees in this scenario to either report to their current duty station, agree to a “management-directed reassignment” and relocate to office space in another geographic region, or accept termination from their jobs.
    • “According to presentation slides shared with Federal News Network, these are the options employees more than 50 miles of their OPM facility will receive in a “Management Direct Reassignment” memo on Wednesday.
    • “OPM is giving employees until Friday, March 7 to respond.”
  • and
    • “Social Security beneficiaries impacted by the Windfall Elimination Provision and the Government Pension Offset may begin receiving their one-time retroactive payments as soon as this week.
    • “The Social Security Administration has significantly shortened its timeline to start distributing benefit payments to public sector workers whose Social Security benefits have been impacted by WEP and GPO. SSA said it began distributing the one-time retroactive payments this week, and most payments will process incrementally over the next month.
    • “The agency said in a press release Tuesday that most beneficiaries should receive their one-time retroactive payments by the end of March. The retroactive payments are backdated to January 2024.”
  • The American Hospital Association News continues to fill us in on its rural healthcare leadership conference.
  • Per Fierce Healthcare,
    • “The federal government under the Trump administration has turned its focus to cutting costs, and a new report from the Blue Cross Blue Shield Association highlights policy efforts it says could save nearly $1 trillion in healthcare costs over the next decade.
    • “The road map includes 10 policy proposals for stakeholders to consider, and BCBSA said these changes could drive federal savings of $524 billion, lower private insurance premiums by $389 billion and save patients $180 billion out-of-pocket.
    • “The largest potential area for savings, according to the analysis, is to adopt site-neutral payments in Medicare, which the paper estimates would save $484 billion over 10 years. The report also suggests that mandating a different provider identifier for off-campus facilities than what’s required for on-campus facilities could save an additional $11 billion.”

From the judicial front,

  • Fierce Pharma informs us,
    • “Compounding pharmacies aren’t surrendering their ability to create cheaper knockoff versions of Eli Lilly and Novo Nordisk’s weight loss drugs without a fight.
    • “In response to the FDA declaring on Friday that the shortage for Novo’s blockbuster GLP-1 treatments Ozempic, approved for diabetes and Wegovy, which has a license in obesity, was over and that compounders would have to stop producing them in the next 60 to 90 days, an organization which backs the pharmacies has filed a lawsuit (PDF) in U.S. District Court in Fort Worth, Texas.
    • “The complaint alleges that the U.S. regulator is “dismissing evidence that the shortage persists,” in removing the drugs from its shortage list “without notice-and-comment rulemaking.”
    • “It is the second lawsuit filed in the same court from the Outsourcing Facilities Association (OFA) and Texas-based FarmaKeio Superior Custom Compounding.
    • “In October, in a complaint that is still pending, they sued the FDA after it removed Lilly’s tirzepatide—the main ingredient in its diabetes and obesity blockbusters Mounjaro and Zepbound—from its shortage list.”

From the public health and medical research front,

  • Healthcare Finance reports,
    • “Fewer clinicians are entering into the primary care field, and investments in primary care are on the downswing, finds a new report from the American Academy of Family Physicians and Milbank Memorial Fund.
    • “According to the findings, years of neglect and chronic underinvestment by the healthcare system have left U.S. primary care in a position where it’s increasingly unable to meet patients’ needs, particularly in rural and other underserved communities.
    • “The combination of worsening primary care access and sicker patients has created a cycle whereby patients use more expensive services like emergency rooms, which raises healthcare costs and premiums, further reducing affordability and access, the report said. And overall healthcare spending continues to rise faster than economic indicators, with the primary care infrastructure only receiving a small fraction of that money.” * * *
    • “People are shifting away from traditional primary care providers, with about three in 10 forgoing primary care altogether between 2016 and 2022, according to FAIR Health’s 2023 analysis of private claims data.
    • “That number, though, ranged from a high of 43% in Tennessee to a low of 16% in Massachusetts, suggesting significant regional variations. Of the providers who performed primary care services in that time, 56% were physicians, while 44% were nonphysicians.” * * *
    • “People are increasingly turning to telehealth for their primary care needs. At 94%, the vast majority of patients are satisfied with their experience pursuing virtual primary care, and nearly four in five (79%) say it has allowed them to take charge of their health, according to a November 2022 survey released by Elevance Health.”
  • Per Healio,
    • “Obesity trends have stayed stable in the last couple years, whereas severe obesity has trended downward, a recently published report suggested.
    • “However, the percentage of people with a healthy weight has also decreased in the decade-plus”
    • “What stands out most is that younger adults experienced the greatest increase in BMI, while older adults saw a leveling off and even a decline in recent years,” Kristen Bartelt, RN, a research clinician with Epic Research, told Healio. “This shift suggests that different age groups may be experiencing unique influences when it comes to weight and health.”
  • MedPage Today adds,
    • “Higher adherence to the Mediterranean diet was associated with a 6% lower risk of obesity-related cancer over 15 years.
    • “Risks for colorectal, liver, and kidney cancers were significantly reduced in people with medium or high adherence to the top-ranked diet.
    • “Obesity-related cancer risk reduction was even greater among current and former smokers.”
  • What’s more, Rheumatology Advisor notes,
    • “Dietary predictors linked to reduced mortality among patients with rheumatoid arthritis included high intake of protein and fiber, along with reduced consumption of refined grains”
  • The NIH Research Matters bulletin covers “Boosting peanut tolerance | Artificial sense of touch | Scratching and skin inflammation”
  • BioPharma Dive lets us know,
    • “Ten of 11 children born profoundly deaf experienced some degree of hearing improvement after receiving an experimental gene therapy developed by Regeneron Pharmaceuticals.
    • “A few of the children can now hear sound at near-normal levels, like conversational speech. One, who was 10 months old when treated and has been followed for more than a year, correctly identified spoken words, like “mommy,” “cookies” and “airplane,” without visual cues in a formal test.
    • “The findings, disclosed by the company Monday alongside a presentation at a medical meeting, are a notable achievement in the development of gene therapies for congenital deafness. Other companies and groups, including Eli Lilly, France’s Sensorion and researchers at Fudan University in Shanghai, are working on similar treatments as Regeneron.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Health insurers wrapped up 2024 in rough shape, recording falling profits from insurance businesses and releasing guidance suggesting that medical costs could continue climbing this year.
    • “In the fourth quarter, payers continued to slog through elevated medical spending in Medicare and Medicaid. Higher costs popped up in once-safe commercially insured populations, too, suggesting American workers are sicker than before.
    • “All told, major publicly traded insurers’ medical loss ratios, key metrics of spending on patient care, rose an average of 2.8 percentage points from the fourth quarter of 2023 to the fourth quarter of 2024.” * * *
    • “Insurers are attempting to resuscitate their profits this year, including by shedding unprofitable MA members. During fourth-quarter calls, major Medicare insurers said they’ve successfully lost members that were dragging down their margins — and shunted other beneficiaries into plan designs that give more control over spending.”
  • The Wall Street Journal reports
    • “Eli Lilly LLY is expanding its offerings of its hit weight-loss drug Zepbound for people who want to pay cash instead of using their health plans and reducing prices for certain dosages.
    • “The pharmaceutical company said it would start selling higher dosages of its Zepbound drug, known as tirzepatide, through Lilly Direct, its direct-to-consumer business. The new dosages – in 7.5 and 10 milligram single-dose vials – will cost patients $599 per month and $699 per month, respectively.
    • “The price for both dosages goes down to $499 per month if patients refill their prescriptions within 45 days, as part of a type of customer loyalty program.
    • “The company also cut the per-month price of the lower dosages by about $50. The 2.5-mg vials will cost $349, down from $399; the 5-mg vials will be $499, down from $549.
    • “Lilly Direct allows patients to bypass insurers and traditional pharmacies. Lilly said it had received requests from many patients to offer the higher doses.
    • “We can’t wait until the complex healthcare system is offering access to anti-obesity medications like all other chronic diseases,” said Patrik Jonsson, president of Lilly’s cardiometabolic health unit. “But in the meantime, this is a response to patients’ requests.”
  • Fierce Pharma adds,
    • “Looking to avoid a repeat of the shortages that plagued Mounjaro and Zepbound during their initial rollouts, Eli Lilly is building supply of its oral GLP-1 contender orforglipron well before the drug’s expected approval in 2026.
    • “As of Dec. 31, Lilly had amassed pre-launch inventory worth $548.1 million that was “primarily related to orforglipron,” the company said in its annual report issued last week.
    • “When we believe that future commercialization is probable and the future economic benefit is expected to be realized, we capitalize prelaunch inventory prior to regulatory approval,” the company explained in its securities filing.”
  • MedCity News explains why “‘The Hardest Thing Is Separating the Wheat from the Chaff’: 5 Leaders on the State of Healthcare AI. Healthcare AI is developing at a rapid rate, and the industry’s attitude on how to best regulate and deploy this technology is evolving every day, according to leaders attending this year’s ViVE conference.”
  • Per MedTech Dive,
    • “Quest Diagnostics has struck a deal to buy kidney disease laboratory testing service assets from Fresenius Medical Care, the companies said Monday.
    • “The acquisition will add dialysis-related water testing to Quest’s portfolio. Quest will perform the tests and other end-stage kidney disease laboratory services for Fresenius Medical Care’s dialysis centers in the U.S.
    • “Quest, which has not disclosed the value of takeover, completed eight buyouts last year, but CEO Jim Davis recently told investors the company would “moderate” its dealmaking pace in 2025.” 
  • and
    • “Thermo Fisher Scientific agreed to pay about $4.1 billion in cash to acquire Solventum’s purification and filtration business.
    • “The technologies, used in the production of biologics and medical devices and for industrial applications, generated about $1 billion in revenue last year. The business employs about 2,500 people globally and will become part of Thermo Fisher’s life sciences solutions segment.
    • “The Solventum unit is highly complementary to Thermo Fisher’s bioproduction business that offers cell culture media and single-use technologies, Thermo Fisher CEO Marc Casper said in the Tuesday announcement.”

Thursday Report

David Ermer–CDC, Congress, COVID-19, FDA, Federal employment benefits, Medical / Rx research, Medicare, NCQA, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC,

  • The Wall Street Journal reports,
    • “Senate Republicans moved to take their first step Thursday toward funding new spending on border security and the military, while Democrats prepared to put GOP lawmakers on the record on uncomfortable issues at the start of President Trump’s new term.
    • ‘The Senate was set to start a series of votes related to Republicans’ budget blueprint aimed at unlocking $342 billion in spending—and the same amount of offsetting cuts—over four years, which is expected to culminate in the plan’s passage sometime Friday morning. 
    • “The process of debating and amending the budget resolution was slated to begin late Thursday. A budget resolution—if passed by both chambers—unlocks a process known as budget reconciliation, which allows the Senate to bypass its filibuster rules and pass legislation with a simple majority instead of the 60-vote threshold for most measures. The process would allow Republicans to pass Trump’s fiscal agenda later this year without needing Democratic help. The Senate and House then would have to agree on final legislation. 
    • “But the reconciliation process also will empower Democrats to propose as many amendments as they want, leading to what is expected to be an all-night “vote-a-rama.” While the amendments are nonbinding, they offer a rare chance for the minority party to force the majority to follow its lead.
    • “Democrats are going to hold the floor all day long—and all night long—to expose how Republicans want to cut taxes for billionaires while gutting things Americans care about most: healthcare, jobs, public safety, national security, housing, education,” Senate Minority Leader Chuck Schumer (D., N.Y.) said.”
  • Per a Senate news release,
    • “Sen. Chuck Grassley (R-Iowa), a senior member and former chairman of the Senate Finance Committee, joined Sen. Amy Klobuchar (D-Minn.) in reintroducing the Safe and Affordable Drugs from Canada Act. The bipartisan bill would allow Americans to safely import prescription drugs from Canada – lowering costs, increasing access and strengthening competition in the pharmaceutical market. 
    • “Congress must take an all-of-the-above approach to lowering the price of prescription drugs. Our commonsense, bipartisan bill would provide Americans increased access to safe, affordable prescription drugs available in Canada, while boosting much-needed competition in the pharmaceutical industry,” Grassley said. 
    • “Americans pay the highest prices in the world for prescription drugs,” Klobuchar said. “Our bipartisan legislation would save Americans money by allowing them to import their medications from pharmacies in Canada. Brand-name prescription drugs that we invent here in America cost more than twice as much in the United States as in Canada. Americans deserve better. Building on my legislation to allow Medicare to negotiate lower prescription drug costs, I will continue to work to increase competition in the pharmaceutical market, so Americans no longer get ripped off by Big Pharma.” 
    • “Find bill text HERE.” 
  • Fierce Pharma tells us,
    • “As the second Trump administration settles in, the U.S.’ top pharmaceutical trade group is drafting its ambitions for the next four years ahead of a planned meeting with the president on Thursday.
    • “The sit-down between President Donald Trump and leaders from the Pharmaceutical Research and Manufacturers of America (PhRMA) will provide the trade group’s head, Stephen Ubl, and CEOs from several of the world’s top drugmakers with a potential avenue to sway the commander in chief’s views on policies affecting the industry, Bloomberg reported, citing people close to the matter.
    • “In particular, the industry wants to garner support for adjustments to certain drug pricing provisions baked into 2022’s Inflation Reduction Act (IRA), the news service said.” * * *
    • “As for what that government-industry collaboration might look like, PhRMA this week released its 2025 policy agenda (PDF), which broadly seeks to promote pro-innovation regulatory and trade positions, challenge features of the IRA price negotiations, curb hospital drug markups and clamp down on pharma middlemen.”
  • Yesterday, the Congressional Research Service posted an In Focus paper on U.S. healthcare spending and coverage.
  • Tammy Flanagan, writing in Govexec, explains “What happens to my insurance when I leave the federal government?”
  • NCQA has opened its HEDIS measures public comment period.
    • “NCQA’s public comment period is open and ready for your input.
    • “NCQA seeks public feedback on proposed new measures, changes to existing measures and measure retirements, and NCQA acknowledges that the health care policy environment is rapidly evolving at this time. Reviewers are asked to submit comments to NCQA in writing via the Public Comment website by 5:00 p.m. (ET), Thursday, March 13. NCQA will take into account all comments received and the evolving environment as NCQA moves forward to prepare the final versions of these measures.
    • “NCQA seeks comments on the following:
      • “Three new HEDIS measures.
      • “Revising six HEDIS measures.
      • “Retiring one HEDIS measure.
      • “Cross-cutting item for HEDIS to align with federal standards for race and ethnicity.
      • “Three new measures for the Diabetes Recognition Program.” * * *
    • The public comment period ends at 5:00 p.m. (ET) on Thursday, March 13. Visit My NCQA to submit comments. For details on proposed changes, visit the NCQA website.
  • Per an HHS news release,
    • “Today, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) took action to support President Trump’s executive orders defending children and restoring biological truth in civil rights and health information privacy enforcement.
    • “As directed by President Trump’s Executive Order 14187, “Protecting Children from Chemical and Surgical Mutilation,” HHS OCR rescinded prior Administration guidance entitled “HHS Notice and Guidance on Gender Affirming Care, Civil Rights, and Patient Privacy,” issued March 2, 2022 (“2022 OCR Notice and Guidance”).  This rescission supports Administration policy in Executive Order 14187 that HHS will not promote, assist, or support “the so-called ‘transition’ of a child from one sex to another, and it will rigorously enforce all laws that prohibit or limit these destructive and life-altering procedures.”  This rescission also aligns with Administration policy in Executive Order 14168, “Defending Women from Gender Ideology Extremism and Restoring Biological Truth to the Federal Government.”
    • “Today’s rescission provides important notice to the regulated community that the 2022 OCR Notice and Guidance no longer represents the views or policies of HHS OCR,” said OCR Acting Director Anthony Archeval.  “The rescission is a significant step to align civil rights and health information privacy enforcement with a core Administration policy that recognizes that there are only two sexes:  male and female.”
    • “Under the prior Administration, HHS through OCR provided notice to the public of how OCR intended to interpret civil rights and health information privacy authorities to protect the chemical and surgical mutilation of children, what the prior Administration referred to as “gender-affirming care.” Section 5 of Executive Order 14187 specifically directs HHS to rescind this guidance.
    • “OCR’s action is part of a larger initiative to defend women and children and restore biological truth to the federal government.
    • “OCR’s rescission of the 2022 OCR Notice and Guidance is available here: https://www.hhs.gov/sites/default/files/ocr-rescission-february-20-2025-notice-guidance.pdf – PDF“

From the judicial front,

  • Govexec informs us,
    • “A federal judge on Thursday denied the National Treasury Employees Union and other federal employee unions’ request to block the mass firings of their members who are probationary employees, future large-scale layoffs across agencies pursuant to a Trump executive order and any renewal of the “deferred resignation” program for federal employees. 
    • “U.S. District Judge Christopher R. Cooper, an Obama appointee, said in his preliminary ruling that the unions likely must first bring their claims before the Federal Labor Relations Authority, whose chairwoman Trump recently fired ahead of the expiration of her term. 
    • “Although district court review may appear more efficient or convenient to NTEU, its preference does not insulate its claims from the [Federal Service Labor-Management Relations Statute] review scheme,” Cooper wrote.”
  • FEHBlog note — This is the same legal outcome that occurred in the preliminary injunction challenge to the Fork in the Road program in federal district court in Boston.
  • Reuters reports,
    • “Regeneron (REGN.O) has won a court ruling that will make it harder for U.S. authorities to win a lawsuit accusing it of paying illegal kickbacks through a charity to promote the use of its expensive eye drug Eylea.
    • In a unanimous opinion, on Tuesday, a three-judge panel of the 1st U.S. Circuit Court of Appeals found that the United States must prove that the alleged kickbacks directly caused Medicare, the federal health insurance program for Americans aged 65 and older, to make payments for Eylea that it otherwise would not have made.
    • “The government had argued that proving illegal kickbacks alone would be enough.
    • “We are pleased with the decision from the appellate court and look forward to presenting our case to a jury,” Regeneron said in a statement.”

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

  • ABC News lets us know,
    • “Nature versus nurture: Scientists are gathering more evidence on which has more of an impact on human well-being amid the aging process.
    • “While both environmental exposures and genetics are known to play important roles in shaping human aging, living conditions and lifestyle choices impact human health much more than genetics, according to a new study published Wednesday in Nature Medicine.
    • “Researchers from Oxford Population Health used data from nearly 500,000 participants in the U.K. to assess the influence of 164 environmental factors and genetic risk scores for 22 age-related diseases and premature death, according to the paper.
    • “The data showed that environmental factors accounted for 17% of the variation in risk of death, compared to less than 2% explained by genetic predisposition.
    • “Smoking, socioeconomic status, physical activity and living conditions had the most impact on mortality and biological aging, the study found.”
  • Per Medscape,
    • “A new analysis of long COVID patients has identified five distinct subtypes that researchers say will help doctors diagnose the condition.
    • “The new five-type index, developed by federal researchers with the National Institutes of Health’s RECOVER COVID Initiative, identified the most common symptoms in 14,000 people with long COVID, with data from an additional 4000 people added to the updated 2024 index.
    • “By using the index, physicians and researchers can better understand the condition, which is difficult to treat and diagnose because no standard definitions or therapies have been developed. Doctors can use the index to offer more targeted care and help patients manage their symptoms more effectively.”
  • STAT News relates,
    • “Four years after Apple announced a study to explore how its products could be used to support people with asthma, an application developed from that research is now available to the public.
    • “Called Asthma Tool, the free software allows users to track their symptoms and triggers and to use wearable devices to monitor vitals, like resting heart rate, for signs that asthma may be acting up.” * * *
    • “Asthma Tool is an outgrowth of Apple’s Asthma Digital Study with insurer Anthem (now Elevance Health) and researchers at the University of California Irvine School of Medicine. Apple announced the study alongside two other research projects in 2020, saying it hoped to investigate how the Apple Watch’s new feature for measuring blood oxygen could be used in future health applications. In 2023, the collaborators released preliminary data suggesting that the asthma study helped Medicaid beneficiaries stay out of the emergency department.
    • “Despite the promising data, Apple has so far chosen not to release an asthma product on its own. The new Asthma Tool was released by CareEvolution, a clinical trials software company that developed the app used in the asthma study. The product is available as a module through the company’s MyDataHelps platform that lets people collect data for personal tracking and allows them to participate in research. MyDataHelps can be used on the web and or as an app on Apple or Android smartphones.”
  • The American Journal of Managed Care points out,
    • “The rollout of 2 major interventions to prevent severe respiratory syncytial virus (RSV) in infants—the RSV prefusion F (RSVpreF; ABRYSVO) vaccine for pregnant individuals and the monoclonal antibody nirsevimab (Beyfortus) for newborns—has shown high uptake in a recent cohort study.
    • “Conducted at a single academic center, the study found that 64% of eligible pregnant individuals received the RSVpreF vaccine, while 70% of eligible infants received nirsevimab before hospital discharge.
    • “This retrospective cohort study is published in JAMA Network Open.“
  • Per Health Day,
    • “A blood test can help people with irritable bowel syndrome cut out specific trigger foods most likely to worsen their condition, a new study suggests.
    • “About 60% of IBS patients who followed a diet guided by the results of the blood test wound up suffering less stomach pain, researchers reported recently in the journal Gastroenterology.
    • “By comparison, 42% of IBS patients who didn’t get the blood test experienced a reduction in stomach pain, results show.
    • “The test “requires additional validation but could move us one step closer to a ‘precision nutrition’ approach, in which providers can offer personalized dietary recommendations to each patient with IBS,” researcher Dr. William Chey, chief of gastroenterology and hepatology at the University of Michigan, said in a news release.
    • “The blood test, called inFoods IBS, tests for the potential of 18 foods to worsen IBS symptoms in specific patients. These include wheat, oat, rye, whole egg, yeast, cow’s milk, black tea, cabbage, corn, grapefruit, honey, lemon and pineapple.
  • NBC News reports that “mRNA vaccines show promise in pancreatic cancer in early trial. Personalized mRNA vaccines show promise as pancreatic cancer treatment, a phase 1 clinical trial published Wednesday in Nature found.”
  • Per Healio,
    • “Patients with COPD had better inhaler adherence when invited to enroll in a program that lowers cost sharing for maintenance inhalers and offers medication management services, according to results published in JAMA Internal Medicine.
    • “These findings contribute to the limited evidence of interventions that can improve inhaler adherence in COPD, a disease with high morbidity whose costs are disproportionately incurred by Medicare, and the even more limited evidence addressing cost-related nonadherence, a growing concern given the high prices of inhalers,” Sumit D. Agarwal, MD, MPH, PhD, physician and health economist at Brigham and Women’s Hospital, and colleagues wrote.” * * *
    • “To better align insurance coverage with clinical benefit, insurers might consider selectively lowering cost sharing and providing medication management services for clinically effective, high-value services,” Agarwal and colleagues wrote.”

From the U.S. healthcare business front,

  • Healthcare Dive relates,
    • “Community Health Systems’ losses widened in 2024 to $516 million, up from $133 million in 2023, as the health system struggled with cost pressures, including rising medical specialist fees and payer denials.
    • “The system also attributed its losses to divestitures. CHS has been chasing at least $1 billion in profits from hospital sales as it looks to pay down debt, but sales have dinged the provider’s operating income.
    • “This year, CHS expects to take in between $12.2 billion and $12.6 billion in revenue, with adjusted earnings before interest, taxes, depreciation and amortization ranging from $1.5 billion to $1.6 billion. The health system could upwardly revise its EBITDA projections if state supplemental payment programs are approved as planned, CHS CFO Kevin Hammons told investors Wednesday morning.”
  • Beckers Hospital CFO Report adds,
    • “Franklin, Tenn.-based Community Health Systems expects to offload two North Carolina hospitals and two Florida hospitals in the first quarter for about $540 million in gross proceeds, executives said during the company’s fourth-quarter earnings call on Feb. 19.
    • “CHS plans to sell ShorePoint Health Port Charlotte (Fla.) and certain assets of ShorePoint Health Punta Gorda to Altamonte Springs, Fla.-based AdventHealth for $265 million in cash. The deal is expected to close in the first quarter, subject to regulatory approvals and closing conditions.
    • “The for-profit system also plans to sell Lake Norman Regional Medical Center in Mooresville, N.C., to Duke University Health System. Durham, N.C.-based Duke aims to purchase the 123-bed hospital and its related assets for about $280 million.”
  • Modern Healthcare reports,
    • “CVS Health’s MinuteClinic is collaborating with Emory Healthcare Network to extend primary care services to more patients in Georgia.
    • “With the new partnership, MinuteClinic now offers in-network primary care services at all 35 clinics in the state to most payers through Emory’s integrated network. Patients also have access to Emory’s network of acute care, specialty care, labs, radiology and diagnostic services, according to a Thursday news release.
    • “A CVS spokesperson said the Emory collaboration marks the first time MinuteClinic has expanded into primary care services in partnership with a health system. The 35 locations are co-branded.”
  • Per a Talkspace news release,
    • “We closed out 2024 with a strong fourth quarter, delivering revenue and adjusted EBITDA growth as expected. We continued to broaden our reach, drive awareness and adoption, enhance the provider and member experience, and deliver high-quality care. I’m proud of all that Talkspace has accomplished this year to build a sustainable, profitable business,” said Dr. Jon Cohen, CEO of Talkspace.
    • “Dr. Cohen continued, “Over the last three years, we’ve undergone a significant strategic shift, focusing on the payor market and growing our total covered lives to nearly 200 million. We’ve leveraged our well-known brand to drive awareness of Talkspace as an affordable way to access care for not just commercially insured adults, but also teens, seniors, and active members of the military. Talkspace has established a clear competitive advantage in the marketplace with the comprehensive nature of our solution, and we remain dedicated to meeting the escalating demand for accessible, high-quality behavioral health services in the U.S.”
  • From a Him and Hers news release,
    • “Hims & Hers today announced its plans to introduce at-home lab testing through its platform. The new capability will empower customers to take control of their health with deeper insights and enable providers to access a breadth of data and biomarkers that can help identify risk of disease before it develops, for more precise clinical decision-making. 
    • “The company has acquired an at-home lab testing facility, Sigmund NJ LLC marketed as Trybe Labs, which will allow Hims & Hers to support at-home blood draws and more comprehensive whole-body testing. The acquisition will broaden the company’s ability to offer a wide range of personalized treatments, supplements and medications and accelerate the expansion into new high-impact clinical categories including low testosterone, perimenopausal and menopausal support.”

Thursday Report

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

From Washington, DC

Photo by Josh Mills on Unsplash

From Capitol Hill

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

From the White House,

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

From the judicial front,

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

From the Food and Drug Administration front,

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

From the Postal Service front,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Midweek Update

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

From Washington, DC

Capitol Hill News

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

OPM News

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

From the judicial front,

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

From the Food and Drug Administration front,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Friday Report

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

From Washington, DC

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

From the judicial front,

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

From the public health and medical research front,

  • The Center for Disease Control and Prevention announced today,
    • Seasonal influenza activity remains elevated across the country and is increasing in most areas. COVID-19 activity is elevated in many areas of the country. RSV activity has peaked in many areas of the country.
    • COVID-19
      • COVID-19 activity is elevated in many areas of the country, though wastewater levels are moderate, emergency department visits are at low levels, and laboratory percent positivity has declined in the last week. Emergency department visits and hospitalizations are highest in older adults and emergency department visits are also elevated in young children.
      • There is still time to benefit from getting your recommended immunizations to reduce your risk of illness this season, especially severe illness and hospitalization.
      • CDC expects the 2024-2025 COVID-19 vaccine to work well for currently circulating variants. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.
    • Influenza
      • Seasonal influenza activity remains elevated across the country and is increasing in many areas.
    • RSV
      • RSV activity has peaked in many areas of the country. Emergency department visits and hospitalizations are highest in children and hospitalizations are elevated among older adults in some areas.
    • Vaccination
      • Vaccination coverage with influenza and COVID-19 vaccines are low among U.S. adults and children. COVID-19 vaccine coverage in older adults has increased compared with the 2023-2024 season. Vaccination coverage with RSV vaccines remains low among U.S. adults. Many children and adults lack protection from respiratory virus infections provided by vaccines.
  • BioPharma Dive relates,
    • “An experimental obesity drug from Novo Nordisk helped people lose an average of up to 22% of their body weight over 36 weeks in an early-stage trial, results that, if reproduced in further testing, could rival medicines Eli Lilly has on the market and in development.  
    • ‘Novo said Friday it is planning “further clinical development” of the drug, called amycretin, but didn’t specify the design of additional trials or when they might begin. Amycretin affects the same two targets as a Novo drug called cagrisema that recently missed expectations in a Phase 3 trial but does so in a single molecule rather than a two-drug combination.”
       
  • Per Healio,
    • “Integrating lifestyle care into low back pain management resulted in greater improvements in disability, weight loss and physical quality of life vs. just guideline-recommended care, a randomized study showed.
    • “The findings, published in JAMA Network Open, “could influence future updates to back pain guidelines,” Emma Mudd, PhD, senior research officer at the University of Sydney in Australia and the analysis’ lead author, said in a press release. “Patients valued the holistic support, and the outcomes speak for themselves.”
  • Earlier this week, the CVS Health Foundation announced $4 million in grants related to its health aging initiative.

From the U.S. healthcare business front,

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

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.

Tuesday Report

David Ermer–ACA, AHRQ, CDC, Congress, FDA, Generative AI, Medical / Rx research, NIH, No Surprises Act, Obesity, OPM, Rx coverage, Telehealth, U.S. Healthcare–
OPM Headquarters a/k/a the Theodore Roosevelt Building

From Washington, DC

  • Today, the U.S. Office of Personnel Management released a list of its accomplishments during the Biden-Harris administration.
  • Here is a link to Andreessen Horowitz bio of Scott Kupor who is President elect Trump’s designee for OPM Director.
  • The Washington Post is maintaining a website outside its paywall providing comprehensive news on Mr. Trump’s nominations.
  • The Wall Street Journal reports,
    • “Two vaccine skeptics who had been advising Robert F. Kennedy, Jr. as he prepares to become health secretary have been sidelined by Trump transition officials, people familiar with the matter said, underscoring a split over immunizations in the “Make America Healthy Again” movement.
    • “Adviser Stefanie Spear and lawyer Aaron Siri had asked prospective administration hires about their beliefs around vaccines even if they were interviewing for posts that had little to do with immunizations, people familiar with the interviews said. Kennedy, whose hearings to lead the Department of Health and Human Services could start on Capitol Hill as early as next week, also lobbed questions related to inoculation, the people said.
    • “The questions were different from those asked in separate meetings with President-elect Donald Trump’s staff, according to some of the people. Trump’s team asked about topics traditionally important to conservatives, such as the size of government and deregulation.
    • “Siri is no longer advising the presidential transition, a transition spokeswoman confirmed, and people familiar with the matter said his vaccine stances played a role. Spear, who had told others she would be Kennedy’s chief of staff, was passed over for that post in favor of a veteran of the first Trump administration—in part because of her vaccine priorities and in part because of her lack of experience, according to people familiar with the matter.”
  • The No Surprises Act regulators, which group includes OPM, released FAQ 69 which concerns an important opinion from the U.S. Court of Appeals for the Fifth Circuit handed down October 30, 2024. The Court has not issued its mandate in the case while it considers the Texas Medical Association’s motion for rehearing and rehearing en banc. The FAQ also includes compliance advice about the No Surprises Act anti-gag clause.
  • Per a Federal Trade Commission news release,
    • “The Federal Trade Commission today published a second interim staff report on the prescription drug middleman industry, which focuses on pharmacy benefit managers’ (PBMs) influence over specialty generic drugs, including significant price markups by PBMs for cancer, HIV, and a variety of other critical drugs.
    • “Staff’s latest report found that the ‘Big 3 PBMs’—Caremark Rx, LLC (CVS), Express Scripts, Inc. (ESI), and OptumRx, Inc. (OptumRx)—marked up numerous specialty generic drugs dispensed at their affiliated pharmacies by thousands of percent, and many others by hundreds of percent. Such significant markups allowed the Big 3 PBMs and their affiliated specialty pharmacies to generate more than $7.3 billion in revenue from dispensing drugs in excess of the drugs’ estimated acquisition costs from 2017-2022. The Big 3 PBMs netted such significant revenues all while patient, employer, and other health care plan sponsor payments for drugs steadily increased annually, according to the staff report.” 
  • STAT News adds,
    • “In response to the latest report, a CVS spokesperson wrote that “any proposed policy regulating PBMs should face a simple test: will this increase or decrease drug costs? Nearly all recently proposed ‘anti-PBM’ policies would ultimately increase U.S. drug costs and serve as a handout to the pharmaceutical industry. Instead of focusing on the impact to consumers and organizations that pay for prescription drugs, the FTC has prioritized comments from the conflicted pharmaceutical and pharmacy industries that would profit from a weakened PBM guardrail.”
    • “The company also argued it is “inappropriate and misleading to draw broad conclusions from cherry-picked” generic drugs. Between 2017-2022, specialty generic products have represented less than 1.5% of total spending on medicines by health plans contracted with CVS. In contrast, branded specialty products represent more than 50% of total spending.
    • “A spokeswoman for Cigna, which owns Express Scripts, wrote to say “this is another set of misleading conclusions based on a subset of medications that represent less than 2% of what our health plans spend on medications in a year — much like their first interim report that the FTC itself has already said is ‘limited’ and ‘tentative’. Nothing in the FTC’s report addresses the underlying cause of increasing drug prices, or helps employers, unions, and municipalities keep prescription benefits affordable for their members. We look forward to continuing to address the blatant inaccuracies in the Commission’s reports.”
    • “One Wall Street analyst maintained the FCC report does not tell the complete PBM story. TD Cowen analyst Charles Rhyee wrote in an investor note that “the fundamental issue with the FTC’s claims… is that they use only data on specialty generics, a small subset of the overall drug market – 0.9% of total drug spending – and is not representative of the value that the PBM industry delivers as a whole.”
  • Per a Food and Drug Administration press release,
    • “Today, the U.S. Food and Drug Administration is announcing an important step to provide nutrition information to consumers by proposing to require a front-of-package (FOP) nutrition label for most packaged foods. This proposal plays a key role in the agency’s nutrition priorities, which are part of a government-wide effort in combatting the nation’s chronic disease crisis. If finalized, the proposal would give consumers readily visible information about a food’s saturated fat, sodium and added sugars content—three nutrients directly linked with chronic diseases when consumed in excess.  
    • “The proposed FOP nutrition label, also referred to as the “Nutrition Info box,” provides information on saturated fat, sodium and added sugars content in a simple format showing whether the food has “Low,” “Med” or “High” levels of these nutrients. It complements the FDA’s iconic Nutrition Facts label, which gives consumers more detailed information about the nutrients in their food.” * * *
    • “Comments on the proposed rule can be submitted electronically to http://www.regulations.gov by May 16, 2025.”
       
  • The Wall Street Journal adds,
    • “It is unclear how the incoming Trump administration will view the rule. Robert F. Kennedy Jr., the prospective next head of U.S. health policy, is a critic of processed foods and has been outspoken about his view that U.S. food companies are partly to blame for sickening Americans.
    • “Consumer advocacy groups and public health organizations cheered the rule, though some said they hoped the Trump administration would consider labels similar to those adopted in other countries that bear more pointed warnings.
    • “Industry groups have warned the FDA that they could sue to challenge mandatory front-of-package labels. Such labels, they said, could threaten First Amendment rights—because companies could consider them a form of forced speech—and only Congress has the authority to require them.” 
  • The New York Times reports,
    • “Among both men and women, drinking just one alcoholic beverage a day increases the risk of liver cirrhosis, esophageal cancer, oral cancer and various types of injuries, according to a federal analysis of alcohol’s health effects issued on Tuesday.
    • “Women face a higher risk of developing liver cancer at this level of drinking, but a lower risk of diabetes. And while one alcoholic drink daily also reduces the likelihood of strokes caused by blood clots among both men and women, the report found, even occasional heavy drinking negates the benefits.
    • “The report, prepared by an outside scientific review panel under the auspices of the Department of Health and Human Services, is one of two competing assessments that will be used to shape the influential U.S. Dietary Guidelines, which are to be updated this year.”
  • Monica M. Bertagnolli, M.D., issued a statement on ending her tenure as NIH director January 17, 2025. The FEHBlog has enjoyed her Director’s blog entries.

From the public health and medical research front,

  • The U.S. Preventive Services Task Force today gave B grades to the following recommended preventive services:
    • “The USPSTF recommends screening for osteoporosis to prevent osteoporotic fractures in women 65 years or older.”
    • “The USPSTF recommends screening for osteoporosis to prevent osteoporotic fractures in postmenopausal women younger than 65 years who are at increased risk for an osteoporotic fracture as estimated by clinical risk assessment.”
  • and an inconclusive grade to the following preventive service
    • “The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for osteoporosis to prevent osteoporotic fractures in men.”
  • The USPSTF notes,
    • “This recommendation updates the 2018 USPSTF recommendation on screening for osteoporosis. In 2018, the USPSTF recommended screening for osteoporosis with bone measurement testing to prevent osteoporotic fractures in women 65 years or older and in postmenopausal women younger than 65 years who are at increased risk of osteoporosis, as determined by a formal clinical risk assessment tool.45 For the current recommendation, the USPSTF has noted that screening can include DXA BMD, with or without fracture risk assessment. The current recommendation is otherwise generally consistent with the 2018 recommendation.”
  • The Journal of the American Medical Association expands on this USPSTF note in an editorial comment.
    • “At first glance, the updated US Preventive Services Task Force (USPSTF) Recommendation Statement on osteoporosis screening1 appears nearly identical to the previous 2018 statement, especially regarding the recommendation for universal screening in women 65 years or older and insufficient evidence to support a recommendation for or against screening in men. However, subtle revisions to the 2018 recommendation2 may result in substantive changes in screening of younger postmenopausal women in clinical practice. While a B recommendation for higher-risk postmenopausal women younger than 65 years is common to both statements, the 2018 statement recommended assessing risk of osteoporosis in these women using a formal clinical risk assessment tool, whereas the 2024 Recommendation Statement1 recommends screening those at increased risk for an osteoporotic fracture as estimated by clinical risk assessment. Additionally, the screening test for both younger and older postmenopausal women in the 2018 recommendation is specified broadly as bone measurement testing. By contrast, the 2024 statement is more specific and defines screening as central (hip or lumbar spine) dual-energy x-ray absorptiometry (DXA) bone mineral density (BMD) testing with or without fracture risk assessment.
    • “In postmenopausal women younger than 65 years, osteoporosis screening presents several challenges. While time is often limited and resources scarce in the overstretched primary care practice environment, the USPSTF recommends a 2-step process to identify women in this age group who warrant screening. The clinician first determines whether traditional osteoporosis risk factors such as low body weight or tobacco use are present. For women with 1 or more risk factors, the USPSTF then advises risk assessment with a clinical risk assessment tool (eg, the Osteoporosis Self-Assessment Tool [OST], the Osteoporosis Risk Assessment Instrument [ORAI], or the Fracture Risk Assessment Tool [FRAX]) calculated without BMD information to further select women who warrant BMD testing. Primary care clinicians should be aware that the OST and ORAI were designed to identify osteoporosis (BMD T score ≤−2.5), while FRAX was developed to estimate 10-year absolute probabilities of hip and major osteoporotic fracture. Use of the OST or ORAI entails a simple calculation with few inputs (e.g., the OST is based on age and weight alone), whereas use of FRAX requires entering information on 11 clinical risk factors into a web-based algorithm. Table 2 in the Recommendation Statement1 provides “frequently used thresholds for increased osteoporosis risk” for OST (score <2) and ORAI (score ≥9), indicating that these thresholds identify women for whom central DXA BMD testing is suggested. In contrast to the 2011 and 2018 recommendations, the 2024 USPSTF Recommendation Statement1 does not suggest a specific FRAX threshold to define increased osteoporosis risk.
  • Per a National Cancer Institute news release,
    • “Feeding fructose to lab animals with cancer made their tumors grow faster, a new study has shown. But the tumors didn’t directly consume fructose, the researchers found. Instead, the liver converted it into a type of fat that cancer cells gobbled up.
    • “Studies have suggested that diets containing excess fructose—which is found in high-fructose corn syrup and table sugar—can help tumors grow. But how this common dietary sweetener might do so has been a bit of a mystery. The researchers believe their study provides some important answers. 
    • “The NIH-funded study, published December 4 in Nature, showed that several types of cancer cells lacked the enzyme needed to use fructose directly. However, liver cells have the necessary enzyme, called KHK, and used it to convert fructose into fats called lipids. 
    • “The findings could open up a new avenue for potential cancer treatments, said the study’s senior researcher, Gary Patti, Ph.D., of Washington University in St. Louis. A drug that blocks the KHK enzyme slowed fructose-fueled tumor growth in mice, the scientists showed.”
  • The National Institutes of Health released an NIH research matters bulletin concerning “Cancer prevention and screening | Improving flu vaccines | LDL structure.”
  • AP reports,
    • “A group of global experts is proposing a new way to define and diagnose obesity, reducing the emphasis on the controversial body mass index and hoping to better identify people who need treatment for the disease caused by excess body fat. 
    • “Under recommendations released Tuesday night, obesity would no longer be defined solely by BMI, a calculation of height and weight, but combined with other measurements, such as waist circumference, plus evidence of health problems tied to extra pounds. 
    • “Obesity is estimated to affect more than 1 billion people worldwide. In the U.S., about 40% of adults have obesity, according to the U.S. Centers for Disease Control and Prevention. 
    • “The whole goal of this is to get a more precise definition so that we are targeting the people who actually need the help most,” said Dr. David Cummings, an obesity expert at the University of Washington and one of the 58 authors of the report published in The Lancet Diabetes & Endocrinology journal.”
  • Per MedPage Today,
    • “Integrating smoking cessation into a lung cancer screening program had the biggest benefit for patients who wanted to quit, a randomized trial showed.
    • “Self-reported tobacco abstinence was greater at both 3 and 6 months with higher levels of integration of smoking cessation assistance in the lung cancer screening program, reported Paul Cinciripini, PhD, of the University of Texas MD Anderson Cancer Center in Houston, and colleagues in JAMA Internal Medicine.”
  • and
    • “Antiviral drugs commonly used to treat non-severe influenza appeared to have little or no effect on key clinical outcomes, except for baloxavir (Xofluza), according to a systematic review and meta-analysis of 73 randomized trials.”

From the U.S. public health front,

  • STAT News adds,
    • “Since society rebounded from the pandemic, Teladoc Health has gone from a soaring rocket ship considered an emblem of the potential of health tech to a cautionary tale about overblown hype. Its telehealth services are now viewed by many as an interchangeable commodity in a crowded market.
    • “In his first prominent public appearance as CEO of the virtual care giant, Chuck Divita showed up [at the JPM Conference] and played the part — promising growth and stability and reminding investors of the company’s strong foundation.”
  • Beckers Hospital Review points out,
    • Eli Lilly is leading a push with other pharmaceutical companies to request a pause in the Biden administration’s drug pricing negotiations, even as officials prepare to release a new list of medications to be targeted for price reductions, Bloomberg reported Jan. 13. 
    • Speaking at the JPMorgan HealthCare Conference in San Francisco, Eli Lilly CEO Dave Ricks emphasized the need for changes to the Inflation Reduction Act before additional drugs are included in the program. 
  • MedCity News relates, “Nvidia announced four new partnerships focused on scaling AI models across the healthcare industry. The company is teaming up with Mayo Clinic, Illumina, IQVIA and Arc Institute” at JPM Conference.
  • BioPharma Dive lets us know,
    • “Eli Lilly on Tuesday said the company’s revenue in 2024 totaled about $45 billion, a 32% jump on 2023’s total but less than what it had estimated in October.
    • “Third quarter sales of Mounjaro and Zepbound, its GLP-1 drugs for diabetes and obesity, were below Wall Street analysts’ expectations at $3.5 billion and $1.9 billion, respectively. CEO David Ricks said GLP-1 market growth was slower than the company anticipated.
    • “Shares of the Indianapolis-based company fell by as much as 8% in morning trading, shaving tens of billions of dollars from its market valuation. Since hitting a high of $960 apiece in late August, shares have tumbled in value by about one-fifth as Zepbound sales have fallen short of forecasts.”
  • McKinsey & Company explains “How healthcare entities can use M&A to build and scale new businesses.”

Thursday Report

David Ermer–CDC, CMS, Congress, FDA, Generative AI, Medical / Rx research, Obesity, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC

  • Tammy Flanagan, writing in Govexec, discusses, “The Social Security Fairness Act: What we know so far.  It may take time to implement this new law — here’s what you should know for now.”
    • “It will undoubtedly take time to implement this new law as it impacts about two million beneficiaries who have their earned Social Security benefits reduced because of the WEP, and close to 750,000 individuals who have had spousal and widow’s benefits payable based on the Social Security work record of their current, former or deceased spouse.  
    • “The repeal of the WEP and GPO will increase the Social Security benefit entitlements of the government worker or retiree who is receiving a pension from work not covered by Social Security. For most of you reading today’s column, this would be the CSRS employees and retirees who are married or were married to a spouse who paid Social Security taxes and the CSRS employee or retiree who earned their own Social Security retirement benefit in addition to receiving a CSRS retirement benefit.  
    • “The WEP can also affect CSRS Offset employees and retirees as well as some employees or retirees who transferred to FERS after more than five years of creditable service under CSRS.”
  • The American Hospital Association News tells us,
    • The Centers for Medicare & Medicaid Services will host a webinar Jan. 16 at 1 p.m. ET to provide an update on the No Surprises Act Good Faith Estimate requirements for uninsured and self-pay patients. Experts will discuss the recent GFE FAQs with a focus on implications for providers and facilities. REGISTER NOW” 

From the public health and medical research front,

  • Per Medical Economics,
    • Screening for physical inactivity during routine medical visits can play a pivotal role in the identification of patients at risk for chronic diseases, according to a study published in Preventing Chronic Disease, a journal of the U.S. Centers for Disease Control and Prevention (CDC). Using the Exercise Vital Sign (EVS), researchers found that patients screened for physical activity had healthier profiles and fewer comorbid conditions than those who were not screened.
  • WTW Consulting informs us,
    • More and more evidence show that GLP-1 medications are good for losing weight and reducing the amount of metabolic disease in people with obesity. But only about 52% of employers currently cover these drugs for obesity, and these employers are facing rising costs.
    • Previous research has shown that the cost of these drugs will exceed any medical cost savings, as is true for most medical interventions. For example, medical plans don’t save money by treating cancer or providing dialysis for patients with kidney failure.
    • JAMA Network Open recently published a study that showed that healthcare spending could decrease based on the type of weight loss seen with use of GLP-1 medications. However, the study demonstrates once again that even with their impressive impacts on patient weight and health, an employer-sponsored health insurance plan should not expect net medical savings from these medications.
    • The researchers looked at medical claims from over 13,000 commercially insured adults from the Medical Panel Expenditure Survey from 2001 to 2020 and found that medical spending was lower in those who weighed less. Therefore, cost effectiveness of an effective weight loss drug would be much higher in those with higher BMIs, especially in those with diabetes. 
    • However, the study didn’t evaluate people who had lost weight, but rather examined differences in costs based on BMI. Those who lose weight won’t necessarily have the same lower level of expense as those who weren’t previously obese. Even if their estimate of cost “savings” is correct, the net cost of semaglutide or tirzepatide is around $9,000 annually, which is more than the delta in costs for a person with diabetes who loses 25% of their body weight.
    • Implications for employers: 
      • An employer-sponsored health insurance plan should not expect net medical savings from these medications, even with their impressive impacts on patient weight and health.
      • The decision to cover these medications should be based on the benefit they offer, and not the hope of lower medical expenses. Lower prices would allow more people to benefit from these medications.
  • The Wall Street Journal warns us,
    • Wildfires in California aren’t all wild anymore. They often burn in urban areas, creating a toxic soup of smoke, ash and noxious substances that can be dangerous, even deadly. 
    • In Los Angeles this week, wildfires have burned buildings and roadways. Incinerating the plastics, metals and other materials that these structures are built from releases hazardous chemicals and gases into the air, doctors and public-health experts say. 
    • Wildfires which tear through urban landscapes release chemicals from human-made fuels, construction materials, household products and generate emissions which are chemically different from wildland fires, according to a 2022 report from the National Academies of Sciences, Engineering and Medicine. About 70,000 communities and 43 million homes are at risk from fires that could burn through both wild and urban landscapes, the report stated.
    • “The combination of wildfire smoke in conjunction with human elements might be even more dangerous,” said Dr. Sanjay Rajagopalan, chief of cardiovascular medicine at University Hospitals Harrington Heart & Vascular Institute in Cleveland. “When you burn plastic, for instance, or you burn rubber, you get some pretty nasty stuff.”
    • Smoke from the Los Angeles wildfires could have far-reaching effects. Depending on weather patterns and geographic conditions, smoke can travel vast distances. Tens of thousands of Los Angeles County residents have already been ordered to evacuate.
  • BioPharma Dive points out,
    • “An experimental menopause drug from Bayer succeeded in a late-stage trial in women taking drugs to treat or prevent breast cancer, the company said Thursday.
    • “Bayer said the drug, elinzanetant, significantly reduced the frequency of hot flashes and improved sleep for women with breast cancer, or who are at high risk of developing it, and whose symptoms are caused by hormone therapy. The study randomized 474 women to receive treatment or a placebo and measured the effects after four and 12 weeks.
    • “The announcement represents the fourth positive late-stage study result for elinzanetant, but the first that isn’t in menopausal women. Bayer has already submitted the drug for U.S. approval in postmenopausal women, and the Food and Drug Administration accepted its application in October. If cleared by regulators, the drug would compete with Astellas Pharma’s Veozah.”
  • Per Fierce Pharma,
    • “Trailing Johnson & Johnson’s powerhouse Darzalex by roughly five years in its development timeline has made it challenging for Sanofi’s Sarclisa—the only other CD38 antibody on the market for multiple myeloma—to compete in the indication.
    • “But with an on-body delivery system (OBDS) to deliver its subcutaneous (SC) formulation of Sarclisa, Sanofi may be finding the edge it needs.
    • “The company has taken a major step in the development of its OBDS as a phase 3 trial has met its primary co-endpoints, showing non-inferiority to intravenous (IV) Sarclisa. The company reported the trial result in a press release Thursday.”

From the U.S. healthcare business front,

  • Health Dive relates,
    • “Blue Shield of California, one of the largest plans in the state, has revamped its corporate structure and named its first-ever female CEO.
    • “Blue Shield created a parent company called Ascendiun to oversee the insurer, along with its managed Medicaid subsidiary and clinical services firm Altais, starting Jan. 1, the company announced Wednesday. Ascendiun also includes a newly created health services business called Stellarus, which aims to scale and sell Blue Shield’s pharmacy and technology offerings to other insurers.
    • “Lois Quam, who has been Blue Shield’s president since last year, will step up as chief executive of the insurer. Quam will be the first woman to serve as Blue Shield’s CEO in the organization’s 86 years of operation. Paul Markovich, Blue Shield’s CEO for over a decade, will become president of Ascendiun and will also lead Stellarus on an interim basis.”
  • and
    • “Amwell is selling its virtual psychiatric care business to fellow telehealth provider Avel eCare for about $21 million in cash, the company said Thursday. 
    • “The divestiture, which includes an additional earn-out payment for Amwell if the business meets financial targets, includes the psychiatric care segment’s technology and personnel along with Asana, a clinical network that employs and contracts with the unit’s clinicians. 
    • “Amwell CEO Ido Schoenberg said in a statement the sale strengthens the telehealth firm’s balance sheet and “fortifies our confidence” to reach positive cash flow in 2026.”
  • The American Hospital Association announced,
    • “The AHA today released its 2025-2027 Strategic Plan, approved by the AHA Board of Trustees in November. The plan is rooted in four core disciplines — advocacy and representation, thought leadership, knowledge exchange, and agents of change. It also includes nine principles that serve as the foundation of the AHA’s work and strategies to help the field make progress on its mission of advancing health in America. View the 2025-2027 Strategic Plan for more information.”
  • Modern Healthcare notes,
    • Oakland, California-based Kaiser Permanente led a $275 million Series F funding round for Innovaccer, a company that sells technology to unify patient data across health systems.
    • Innovaccer said the round will help it introduce new artificial intelligence and cloud capabilities. The company also said the new capital will help it to continue scaling a developer ecosystem that can allow health systems to implement AI tools with other third-party vendors.
  • NCQA suggests “Health Care Trends to Watch in 2025.”
  • Per Fierce Healthcare,
    • “A new report from Press Ganey highlights the close relationship between patient experience and health plan star ratings.
    • “Researchers polled 450,000 people across 200 plans and combined those survey results with its database of 5.5 million patient encounters. It found that people who gave poor scores for safety and privacy in surveys following a visit to their primary care providers also frequently awarded their health plan one star on quality and access to needed care on Medicare consumer services.
    • “The report noted these are critical data for plans to consider, as they have traditionally focused on making improvements to customer service, benefit design and patient engagement. It suggests they should also be considering ways to address safety.
    • “In addition, the survey found that patients expect easy access to primary care, but their ability to reach specialists is a key differentiator. Plans that earned four or more stars connected a higher proportion of their members with specialty care.”
  • MedTech Dive points out “five medtech trends to watch in 2025. After a busy 2024, experts called out competition in soft tissue robotics, uncertainty from a Trump White House and continued success for pulsed field ablation as trends to watch this year.”