Tuesday Report

Rx coverage

Tuesday Report

David Ermer–CDC, CMS, FDA, Federal employment benefits, Medical / Rx research, OPM, Rx coverage, U.S. Healthcare–
OPM Headquarters a/k/a the Theodore Roosevelt Building

From Washington, DC

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Monday Report

David Ermer–ACA, CDC, Congress, COVID-19, FDA, Medical / Rx research, Obesity, OPM, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC,

  • Nextgov/FCW reports,
    • “Billionaire Elon Musk paid a visit to the Office of Personnel Management’s building on Friday, people familiar have confirmed to Nextgov/FCW.” * * *
    • “Amanda Scales, a former employee of Musk’s artificial intelligence company xAI, is OPM’s new chief of staff.” 
  • Fedscoop informs us,
    • “The Trump administration is giving agency leaders two weeks to submit plans for how they intend to comply with the presidential directive to return all eligible employees to full-time, in-person work, the latest salvo in the restructuring of the federal workforce.  
    • “In a memo sent to agency heads Monday, the acting directors of the Office of Personnel Management and the Office of Management and Budget set a Feb. 7 deadline for return-to-work implementation plans, which will be reviewed and approved by OPM and OMB.”
  • The Senate confirmed Scott Bessent to be Secretary of the Treasury today by a 68-29 vote. The Secretary of the Treasury along with the Secretary of Health and Human Services and the Secretary of Labor, are Affordable Care Act regulators.
  • Roll Call adds,
    • “Bessent, 62, will become the nation’s first openly gay Treasury secretary and the highest-ranking LGBTQ government official in the country’s history.” * * *
    • “He brings a wealth of private-sector experience in the economy and markets to his new role, as well as a concern for the needs of working Americans,” Senate Majority Leader John Thune, R-S.D., said on the floor Monday before the vote.
    • “Senate Finance Chairman Michael D. Crapo, R-Idaho, during the confirmation process similarly praised Bessent’s character, demeanor and experience, while defending him from Democratic attacks about the nominee’s handling of his taxes.”
  • Roll Call also tells us,
    • “The Senate keeps processing President Donald Trump’s nominees this week, but much of the congressional attention will be on South Florida, where House Republicans are gathering for their annual issues and strategy conference.
    • “The conference is taking place at Trump National Doral in Miami, the president’s own private golf club, and Trump is expected to address the assembled lawmakers Monday evening.
    • “Punchbowl News reported over the weekend that Vice President JD Vance is expected to join the retreat as a headliner on Tuesday.
    • “Much of the discussion will focus on trying to plot the way forward for a filibuster-proof budget reconciliation package — especially to try to implement Trump’s immigration and tax policy agenda.”
  • The acting HHS Secretary Dorothy Fink announced,
    • “For nearly 50 years, the Hyde Amendment has protected taxpayer funds administered by the Department from paying for elective abortion. Pursuant to the President’s Executive Order of Jan. 24 (Enforcing the Hyde Amendment) and guidance from Office of Management and Budget, the Department will reevaluate all programs, regulations, and guidance to ensure Federal taxpayer dollars are not being used to pay for or promote elective abortion, consistent with the Hyde Amendment. This review will be conducted consistent with guidance issued by the Office of Management and Budget.”
  • Per BioPharma Dive,
    • “The Food and Drug Administration has approved monthly maintenance dosing of Eisai and Biogen’s Alzheimer’s disease drug Leqembi.
    • “After taking Leqembi every two weeks for 18 months, patients can now transition to a monthly dose that the companies say is supported by modeling of data from Phase 2 and Phase 3 testing. Leqembi works by removing toxic aggregates of a protein from the brain.”

From the public health and medical research front,

  • STAT News reports
    • “In 2022, about 40% of deaths in the U.S. were caused by cardiovascular heart disease, including heart disease and stroke, which kill more people in the U.S. than the next two biggest killers — all forms of cancer and accidental deaths — combined. That’s according to an annual update from the American Heart Association on heart disease and stroke statistics, published today in Circulation. 
    • “Cardiovascular disease is “common, catastrophic, and costly,” an accompanying editorial notes. Despite its dominance, the overall number of deaths is leveling out after the pandemic shot numbers upwards. Yet contributing risk factors like high blood pressure and obesity continue to rise. 
    • Here are some more interesting findings:
      • The percentage of high schoolers who are physically active for over an hour every day decreased from almost 29% to just under 24% between 2011 to 2021.
      • Nearly 47% of all Americans have high blood pressure. In 2022, the prevalence was worst in Mississippi at about 40% and best in Colorado, at just under 25%. 
      • The rate of gestational diabetes in the U.S. increased 38% from 2016 to 2021, to 8.3% of pregnancies.
  • and
    • “Almost a century after people living in certain neighborhoods around Seattle and Tacoma, Washington were systemically denied financial services — a discriminatory, racist practice known as redlining — young cancer patients in those areas are dying at higher rates than those who live in unaffected areas. 
    • “An association between historic redlining and survival of adult-onset cancers has already been shown, but the data on adolescent and young-adult cancers come from a study published today in CANCER. Researchers analyzed data from 2000 to 2019 in those Washington cities on more than 4,300 patients aged 40 or younger, along with homeowners’ loan data and recent census tracts. They found that five years and 10 years after diagnosis, fewer people in previously redlined neighborhoods were still alive than those unaffected. (That’s about 85% vs. 90% five years out and 81% vs. 88% after ten years.)
    • “The disparity in deaths remained even after adjusting for factors like poverty. It emphasizes the importance of contextualizing today’s health disparities, the authors write, as well as the impact discrimination can have generations down the line.”
  • The New York Times suggests “‘A Dangerous Virus’: Bird Flu Enters a New Phase. A pandemic is not inevitable, scientists say. But the outbreak has passed worrisome milestones in recent weeks, including cattle that may have been reinfected.”
  • KAKE News from Wichita, Kansas, reports,
    • “State public health officials are calling an ongoing tuberculosis outbreak in northeast Kansas “unprecedented.” 
    • “The Kansas Department of Health and Environment [KDHE] reports 66 active cases of tuberculosis and 79 infections in the Kansas City Metro area in 2024. As of this month, the number of active cases rose to 67.
    • “In a Senate Committee on Public Health and Welfare meeting on Tuesday, Deputy Secretary of KDHE Ashley Goss said the department is working collaboratively with the Centers for Disease Control and Prevention.
    • “Some of you are aware we have mobilized staff and resources addressing an unprecedented tuberculosis outbreak in one of our counties,” Goss said. “We are working collaboratively with the CDC on that. The CDC remains on the ground with us to support.” * * *
    • “According to the KDHE website, there are currently 60 active cases of TB in Wyandotte County and seven in Johnson County. 
    • “Despite this, the KDHE says the cases are “very low risk” to the general public, including surrounding counties. 
    • “We are trending in the right direction right now, more to come on that,” Goss said in the meeting. “Hopefully we can get it wound down quickly.” 
  • The American Medical Association lets us know what doctors wish their patients knew about contagious norovirus.
  • Per Healio
    • “The vast majority of people in a study with long COVID had experienced multiple SARS-CoV-2 infections over the course of a 4-year period, researchers reported.
    • “While it is possible that the causes of long COVID could be many and variable depending on the patient population studied, with this cohort the evidence is clear that by having COVID numerous times, patients became more at-risk for developing long COVID,” Sean Clouston, PhD, professor in Stony Brook University’s Renaissance School of Medicine, said in a press release.”
  • and
    • “An investigational blood-based test identified nearly 80% of individuals who had colorectal cancer, according to results of a large prospective trial presented at ASCO Gastrointestinal Cancers Symposium. 
    • “The test also had a specificity greater than 90% for advanced colorectal neoplasia (ACN) and negative-predictive value for ACN.
    • “This new blood test may provide a convenient, effective option for colorectal cancer screening in the intended-use population, and perhaps help us boost adherence to screening,” Aasma Shaukat, MD, MPH, director of outcomes research and Robert M. and Mary H. Glickman professor of medicine at NYU Grossman School of Medicine, said during a press briefing.
  • Per BioPharma Dive,
    • “Treatment with an experimental drug from Akero Therapeutics substantially reversed liver damage in a mid-stage study of people with cirrhosis due to metabolic dysfunction-associated steatohepatitis, a common disease that was formerly known as NASH.
    • “Announced Monday by Akero, the study results exceeded investor expectations, more than doubling the value of shares in the biotechnology company. They also helped to push up the stock of 89bio, a competitor developing a similar type of drug to Akero’s.
    • “While the Food and Drug Administration last year approved the first treatment for MASH, its use is limited to people whose livers aren’t yet cirrhotic. According to Akero, its drug is the first compound to show a significant reversal of cirrhosis due to MASH in clinical testing.”
  • The Wall Street Journal reports,
    • “Late-stage trial data for Roche’s drug against muscle-wasting Elevidys showed positive results after two years of treatment for male patients aged 4 or older with Duchenne muscular dystrophy.
    • “The data read-out reduced difficulties in standing, walking and running that were statistically significant, which increased between one year and two years after treatment, the company said. The safety profile was in line with the drug’s profile and no new safety signals were identified, it said.
    • “The treatment is on market for people living with Duchenne aged four years old and over regardless of their ambulatory status in the U.S., United Arab Emirates, Qatar, Kuwait, Bahrain and Oman. It is approved for the treatment of ambulatory individuals aged four through seven years in Brazil and Israel.
    • “Duchenne muscular dystrophy is a genetic disorder characterized by the progressive loss of muscle.”
  • STAT News relates,
    • “Right now, patients with obesity and cirrhosis have few treatments for their progressive liver disease, but a new study offers one available option: bariatric surgery. Weight loss operations significantly cut the long-term risk of developing serious liver complications when compared to standard nonsurgical therapy.
    • “The 62 patients with obesity and cirrhosis in the clinical trial who underwent bariatric surgery — either gastric bypass or gastric sleeve procedures — later had a 72% lower risk of developing more serious liver disease compared to the 106 patients who didn’t have surgery. After 15 years, 20.9% in the surgical group but 46.4% in the nonsurgical group developed one of the major complications of liver disease, including liver cancer and death. 
    • “We showed, regardless of the stage of disease, if we help people to lose weight, we can improve their outcomes. That can provide hope for patients and medical providers,” said Ali Aminian, director of the Bariatric and Metabolic Institute at the Cleveland Clinic and co-author of the study published Monday in Nature Medicine.  “We can change the trajectory of the disease.”
  • Per Beckers Hospital Review,
    • “An Alabama woman who received a gene-edited pig kidney transplant at NYU Langone in November is recovering well more than 60 days after the procedure. 
    • “On Nov. 25, a team of clinicians at the New York City-based health system successfully transplanted UKidney, a 10-gene-edited pig kidney into Towana Looney, 53. Ms. Looney was on a transplant waiting list for nearly eight years before physicians determined the probability of a safe human transplant was slim. 
    • “Now, Ms. Looney is the longest-living recipient of the four Americans who have received a gene-edited pig organ, having surpassed the two-month mark. 
    • “If you saw her on the street, you would have no idea that she’s the only person in the world walking around with a pig organ inside them that’s functioning,” Robert Montgomery, MD, PhD, director of NYU Langone’s Transplant Institute, told the Associated Press in a Jan. 25 report at NBC News. 
    • “Unlike previous xenotransplant patients, Ms. Looney was in better overall health at the time of her transplant, leaving experts optimistic about the potential for broader success in the emerging field of xenotransplantation. Earlier cases involved individuals who were critically ill when they underwent the experimental procedures.”

From the U.S. healthcare business front,

  • Beckers Hospital CFO Report tells us,
    • “Cleveland Clinic served the largest number of patients in its history in 2024 with more than 15 million patient encounters worldwide, generating nearly $16 billion in revenue and ending the year with a 1.7% operating margin.  
    • “The year-end findings come from the annual State of the Clinic address made by CEO and President Tom Mihaljevic, M.D., on Jan. 27. 
    • “Years have passed since the COVID-19 pandemic and healthcare has not recovered. Today, about 40% of U.S. hospitals continue to lose money,” Dr. Mihaljevic said. “In the past, we could predict Cleveland Clinic’s financial health based on our productivity and expense management, but even that has changed.”
    • ‘Dr. Mihaljevic noted that despite the handling of more than 15 million patient encounters, the health system’s 1.7% operating margin fell short of its anticipated 2.7%. He attributed this shortfall to new financial pressures, including unexpected increase in charity care totaling $370 million, surging cost of malpractice insurance and rising costs of drugs due to smaller discounts on medications.”
  • Per Healthcare Dive,
    • “HCA Healthcare reported fourth quarter earnings on Friday that narrowly beat analysts’ expectations following back-to-back hurricanes this fall.
    • “The Nashville-based provider posted $18.3 billion in revenue for quarter, up 6% year over year. However, profit dipped compared to the same period last year, falling from $1.6 billion to $1.4 billion.
    • “Still, several analysts noted HCA’s financial guidance for 2025 is slightly more conservative than expected, raising concerns that Trump administration funding cuts to Medicaid and the Affordable Care Act could impact hospitals’ bottom lines.”
  • Modern Healthcare reports,
    • “Shares of Walgreens Boots Alliance tumbled today following a CNBC report that the Deerfield-based pharmacy chain was unlikely to sell itself to a private-equity firm.
    • “CNBC’s David Faber said on air this morning that sources say the possible deal in which Walgreens would sell itself to New York-based Sycamore Partners is “mostly dead.”
  • Fierce Pharma identifies the ten most anticipated drug launches of 2025.
  • McKinsey & Co. point out “Most top pharma companies derive more than 60 percent of their revenue from therapies for diseases that affect women uniquely, differently, or disproportionately, putting them in a prime position to close the sex- and gender-based health gap.”

Midweek Report

David Ermer–CMS, Congress, Government Contracting, Medical / Rx research, Obesity, Rx coverage, U.S. Healthcare–
Photo by Juliane Liebermann on Unsplash
  • From a Senate news release,
    • “U.S. Senate Finance Committee Chairman Mike Crapo (R-Idaho) will hold a nomination hearing on Wednesday, January 29, at 10:00AM to consider Robert F. Kennedy Jr. to be Secretary of the U.S. Department of Health and Human Services.” 
  • In the meantime, Dorothy Fink is serving as acting HHS Secretary.
  • FedWeek shares “the key portions of the guidance from OPM on the federal hiring freeze issued by the new Trump administration that addresses issues including general and special exceptions, movement and promotions of current employees and a prohibition on using contractors to fill vacated positions.”
  • The President issued an executive order revoking the affirmative action requirements of E.O. 11246 which President Lyndon Johnson signed in 1965. This action relieves federal government contractors and subcontractors with a contract valued at $100,000 or more and 50 employees or more of the burden to develop and implement a detailed affirmative action program. These businesses remain subject to federal and state laws prohibiting discrimination in employment, e.g., Title VII of the 1964 Equal Employment Opportunity Act.
  • The American Hospital Association News reports,
    • “The Department of Health and Human Services Health Resources and Services Administration is accepting applications until April 22 for its four-year Rural Maternity and Obstetrics Management Strategies Program. HRSA will award up to three cooperative agreements for up to $1 million per year for establishing rural obstetric networks to improve maternity care and access in rural communities. The program runs from Sept. 30, 2025, through Sept. 29, 2029.”

From the judicial front,

  • Per Fierce Healthcare,
    • “The feds intend to appeal a judge’s decision that would force them to recalculate UnitedHealthcare’s Medicare Advantage (MA) star ratings.
    • “The Centers for Medicare & Medicaid Services (CMS) submitted a filing Tuesday in Texas district court saying that it would appeal the November ruling to the Fifth Circuit Court of Appeals. Further details were not included in the court filing.
    • “Judge Jeremy Kernodle of Texas’ Eastern District Court ruled on Nov. 22 that the CMS would have to recalculate UnitedHealth’s MA scores. 
    • “At the center of the case is a single foreign language test phone call that was made to one of UnitedHealthcare’s call centers. The CMS categorized the call as “unsuccessful” because it was disconnected before the test caller could fully engage with a customer service agent, according to UnitedHealth’s lawsuit, which was filed in early October.“
  • The Groom Law Group discusses pending ERISA litigation.

From the public health and medical research front,

  • USA Today reports,
    • “The beer, spirits and wine industries were already prepared for a continued lull in sales for 2025, then came the U.S. surgeon general’s call for cancer warning labels on alcoholic beverages.
    • “Add that buzz kill to a flight of other challenges facing the booze business: Dry January – and its sober-curious companion in fall, Sober October – along with the thriving year-round embrace of lower-alcohol and non-alcohol options, especially by younger consumers.
    • “Suddenly, moderation is sweeping the nation. Nearly half of Americans (49%) say they plan to drink less in 2025 – up from 41% who said that was their plan in 2024, according to a new survey, released Tuesday, commissioned by advertising and sales measurement technology firm NCSolutions.”
  • STAT News tells us,
    • “Immune checkpoint inhibitors, drugs that can help make the immune system recognize and destroy cancer more aggressively, are one of the most important medicines in cancer treatment today. Merck’s Keytruda has been used against dozens of different cancers in millions of patients, making it the top-selling drug in the world, with over $25 billion in revenue in 2023. Opdivo, from Bristol Myers Squibb, earned $10 billion in 2023.
    • “Now, a new class of drugs may be emerging to challenge the dominance of these first-generation checkpoint inhibitors. Experts said a certain type of bispecific antibody seems to have hit upon a crucial combination of two cancer targets: the proteins VEGF and either PD-1 or PD-L1. “It’s exactly that,” said Özlem Türeci, the CMO and co-founder of BioNTech. “I think that the anti-PD-1 or PD-L1 and VEGF concept can be a very broad, pan-tumor platform: the next-generation checkpoint modulator.”
  • MedPage Today informs us,
    • “Beneficial pediatric obesity treatment response was associated with a reduced risk of obesity-related events in young adults, a nationwide prospective cohort study in Sweden showed.
    • “Compared with poor response, good response to obesity treatment was associated with lower risk of type 2 diabetes (adjusted HR [aHR] 0.42, 95% CI 0.23-0.77), dyslipidemia (aHR 0.31, 95% CI 0.13-0.75), and bariatric surgery (aHR 0.42, 95% CI 0.30-0.58), reported Emilia Hagman, PhD, of the Karolinska Institute in Sweden, and colleagues.”
    • “Obesity remission showed similar reduced risks, as well as reduced risk of hypertension (aHR 0.40, 95% CI 0.24-0.65). Good response in obesity treatment or obesity remission was associated with a reduced risk of mortality (aHR 0.12, 95% CI 0.03-0.46), though treatment response was not associated with reduced risk for depression or anxiety, they noted in JAMA Pediatrics.
    • “The long-term effects of treating obesity in childhood were largely unknown,” Hagman told MedPage Today in an email. “Many people believe that because maintaining weight loss is so challenging, early treatment might not make a real difference in reducing the risk of serious health problems like type 2 diabetes, high blood pressure, or heart disease later in life. Our research helps answer this critical question and shows the importance of addressing obesity early.”
  • HCPLive adds,
    • “Patient factors, including sociodemographic, healthcare, and clinical elements, were linked to the initiation of semaglutide, a glucagon-like peptide-1 receptor agonist (GLP-1 RA), in a population with obesity without type 2 diabetes (T2D).1
    • “Among more than 97,000 commercially insured adults in a recent cohort study, approximately 2.0% began semaglutide treatment within 6 months of an obesity diagnosis, with sex, insurance plan, and medication use found to be relevant factors for medication initiation.
    • “The association of these factors with semaglutide initiation were quantified using multivariable logistic regression, and use of common medications, insurance plan structure, employer industry type, and sex were all significantly associated with semaglutide initiation,” wrote the investigative team, led by Andrew C. Stokes, PhD, department of global health, school of public health, Boston University.”

From the U.S. healthcare business front,

  • Healthcare Dive relates,
    • “Johnson & Johnson on Wednesday reported modestly higher-than-expected earnings for the fourth quarter, while cautioning that unfavorable currency exchange rates would temper sales growth this year.
    • “Adjusted earnings per share reached $2.04 in the fourth quarter, higher than the Wall Street consensus of $2.01 and Leerink Partners’ estimate of $1.96, Leerink analyst David Risinger wrote in a note to clients. The company’s sales rose 5.3% to $22.5 billion during the quarter, in line with estimates
    • “Full-year 2024 revenue increased to $88.8 billion from $85.2 billion in 2023. For this year, J&J expects revenue to climb to between $89.2 billion and $90 billion, with a mid-point of $89.6 billion, less than the consensus estimate of $91.1 billion. Shares of the company dropped about 3% in early trading Wednesday, even as the overall market rose.”
  • BioPharma Dive adds,
    • “Johnson & Johnson expects changes in Medicare’s prescription drug benefit will negatively impact its sales by about $2 billion this year, a modest headwind for a pharmaceuticals division the company anticipates will otherwise continue growing.
    • “The changes are the result of a redesign under the Inflation Reduction Act to Medicare’s Part D benefit, which covers outpatient drug treatment. The 2022 law capped annual out-of-pocket spending by people enrolled in Part D to $2,000 beginning this year, and required drugmakers provide additional discounts within certain phases of coverage, among other tweaks.
    • “J&J provided its estimate of the redesign’s financial impact Wednesday alongside earnings for the fourth quarter. In doing so, the company follows Pfizer, which late last year forecast the changes would have a $1 billion net negative impact on 2025 revenue.
    • “The Part D redesign brought on by the Inflation Reduction Act is proving consequential to drugmakers’ business even as the law’s provisions allowing Medicare to negotiate certain drug prices get more attention. Three drugs marketed in whole or in part by J&J were picked by the Biden administration for the first round of negotiations that wrapped up last summer.”
  • The American Hospital Association News points out,
    • “Baxter notified customers on Jan. 22 that allocations for two sodium chloride IV solutions have been increased to 100%. According to Baxter, the products will have a one- to two-week lag time while they progress through the full distribution network after implementing changes. AHA members have notified the association of two- to three-week lag times in some cases following previous allocation updates.”
  • Per Fierce Healthcare,
    • “Credit downgrades for nonprofit hospitals again outpaced upgrades across 2024, though the difference between the two narrowed compared to the year before, according to a review of three credit agencies’ rating actions published Wednesday.
    • “Moody’s, S&P and Fitch collectively issued 95 downgrades and 37 upgrades in 2024, as opposed to 116 and 33 in 2023, wrote Kaufman Hall Managing Director Lisa Goldstein.
    • “She and her firm expect the trend to continue into 2025 “given a growing reliance on government payers, labor challenges and a competitive environment.”
    • “Policy and funding changes will also cast uncertainty into the mix in 2025 and may cause credit deterioration in future years,” she wrote on Kaufman Hall’s website.”
  • Healthcare Dive adds, “Providers to target efficiency, supply chain resilience in 2025. Health systems will work to expand their supply chains and ink nontraditional partnerships in 2025, while trimming excessive AI programs and nonclinical staff.”
  • Meanwhile MedTech Dive notes, “AI in medtech is taking off. Here are 4 trends to watch in 2025. New documents clarify how the FDA plans to regulate AI-enabled devices, experts say, but several important questions remain around insurance coverage and generative AI.”
  • Per a news release,
    • The Institute for Clinical and Economic Review (ICER) today announced a new analysis it plans to release on an annual basis titled the “Launch Price and Access Report” which will examine launch pricing for FDA-approved treatments. This report will review the affordability and access of the treatments and their value to the overall health system.
    • “There is no better time to provide an independent analysis on trends in launch pricing – both list and net – and patient access,” stated ICER’s Vice President of Research Foluso Agboola, MBBS, MPH. “ICER typically evaluates promising treatments that pose potential affordability challenges for the U.S. health system. Through this work, ICER will continue to work towards a health system where the pricing of innovative treatments are tied to value, while still ensuring affordability and access for patients.”  * * *
    • “The report is expected to be released in the fourth quarter of 2025.”
  • Alan Fein, in his Drug Channels blog, discusses “The Big Three PBMs’ 2025 Formulary Exclusions: Humira, Stelara, Private Labels, and the Shaky Future for Pharmacy Biosimilars.”

Friday Report

David Ermer–CDC, CMS, Federal employment benefits, Medical / Rx research, Medicare, Mental health care, Obesity, OPM, Rx coverage, U.S. Healthcare–
OPM Headquarters a/k/a the Theodore Roosevelt Building

From Washington, DC,

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

From the judicial front,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Midweek Report

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

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the judicial front,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

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.”

Friday Report

David Ermer–CDC, CMS, COVID-19 vaccine, FDA, Federal employment benefits, Generative AI, Medical / Rx research, NIH, OPM, Rx coverage, SCOTUS, U.S. Healthcare–

From Washington, DC.

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

From the judicial front,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

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.”

Tuesday Report

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Monday Report

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

From Washington, DC.

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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