Thursday Miscellany

SDOH

Thursday Miscellany

David Ermer–CDC, Congress, FDA, Medical / Rx research, Medicare, Mental health care, NIH, Rx coverage, SDOH, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC,

  • The U.S. National Guard Association informs us,
    • “More than 100,000 drilling National Guardsmen and Reservists who are full-time federal employees would be eligible to purchase TRICARE Reserve Select health care under legislation introduced in both the House and Senate last week.
    • “Most drilling Guardsmen and Reservists have been able to buy low-cost TRS for more than 15 years. But the 2008 law that created the current program excluded these service members from the more-expensive Federal Employees Health Benefits program. This exclusion includes the Guard and Reserve’s dual-status technicians. And while a provision in the fiscal 2020 National Defense Authorization Act lifts this prohibition, the change does not take effect until 2030.
    • “The Servicemember Healthcare Freedom Act of 2024 would allow federal employees to enroll in TRS once the legislation is enacted. The bill was introduced by Sen. Richard Blumenthal, D-Conn., and co-sponsored by Sens. Kyrsten Sinema, I-Ariz., Tina Smith, D-Minn., and John Fetterman, D-Pa., in the Senate. Reps. Jen Kiggans, R-Va., and Andy Kim, D-N.J., introduced the measure in the House. Kim is the Democratic co-chair of the House National Guard and Reserve Caucus.
    • “The legislation affects roughly 113,000 Guardsmen and Reservists, according to a fact sheet from Blumenthal’s office. This figure includes approximately 67,000 Guard and Reserve dual-status technicians, who must be drilling service members to maintain their full-time employment.
    • “Cost is often the big difference between TRS and FEHBP. For example, the widely used FEHBP Blue Cross Basic Option costs $150 a month for a single adult, per Blumenthal’s office. The same TRS coverage is $51.95 a month. The average family of four spent $657.04 each month on health care though FEHBP last year, according to the same fact sheet. Family plans through TRS cost $246.87 a month. * * *
    • “TRS also provides continuity of care during service members’ mobilizations and demobilizations.”
  • The Office of Personnel Management issued a press release about a “New Benefits Administration Letter to Promote the Integrity of the Federal Employees Health Benefits Program.” This was the action discussed in Federal Times and Federal News Network articles that the FEHBlog discussed yesterday. The press release adds,
    • “OPM has proposed legislation in its FY2025 Congressional Budget Justification which would enable OPM consistent access to funds from the Employee Health Benefits Fund to build a Central Enrollment system for the FEHB Program. Current FEHB eligibility determination and enrollment is highly decentralized and requires cooperation between nearly 100 employing offices responsible for determining eligibility and enrolling more than 8 million members. These benefits are delivered by 68 health insurance carriers in 2024.     
    • “Since 2022, and following passage of the Postal Service Reform Act, OPM began developing the Postal Service Health Benefits Program to include a centralized enrollment platform. The PSHB accounts for more than 20 percent of current FEHB enrollees. If funded, OPM could extend this same central enrollment system to all FEHB enrollments, which would allow OPM to manage and make consistent all FEHB enrollments and remove individuals who cease to be eligible for the program. ”   
  • OPM also should provide carriers with HIPAA 820 electronic enrollment rosters to systematically reconcile premiums to individual enrollees, thereby assuring that each enrollee is paying the appropriate premium.
  • WTW, a major consulting firm, posted an article about the final 2025 notice of benefits and payment parameters which calls attention to a point on which the FEHBlog has not yet focused.
    • CMS adopted a rule to remove the regulatory prohibition on issuers from including routine non-pediatric dental services as an essential health benefit (EHB). This change would allow states to update their EHB-benchmark plans to add routine adult dental services as an EHB, removing regulatory and coverage barriers to expanding access to adult dental benefits. 
    • If a self-insured [or any FEHB] plan adopts a state benchmark plan that covers non-pediatric dental as an EHB and that plan covers non-pediatric dental, then the plan could not impose annual or lifetime dollar limits on that coverage (unless the coverage meets the requirements to be an excepted benefit or limited scope dental).
  • The American Hospital Association News reports,
    • “The Federal Trade Commission, Justice Department and Department of Health and Human Services April 18 launched HealthyCompetition.gov, an online portal for the public to report potentially unfair and anticompetitive health care practices. The FTC and the Justice Department’s Antitrust Division plan to review complaints for the appropriate agency to investigate if it raises sufficient concern under antitrust laws or HHS authorities.”
  • HR Dive tells us,
    • “The U.S. Supreme Court held Wednesday that employees challenging discriminatory transfers at work do not need to prove they suffered “significant” harm under Title VII of the Civil Rights Act of 1964; instead, they need only prove harm was done. 
    • “To demand ‘significance’ is to add words to the statute Congress enacted,” the high court ruled in Muldrow v. City of St. Louis. “It is to impose a new requirement on a Title VII claimant, so that the law as applied demands something more than the law as written. That difference can make a real difference for complaining transferees.”
    • “In the case, a police sergeant alleged she was transferred out of the intelligence division because of her sex and given less “prestigious” duties, a worse schedule and fewer job perks.”
  • The U.S. Census Bureau reports,
    • “The percentage of adults age 65 and older covered by both private health insurance and Medicare decreased from 47.9% in 2017 to 39.6% in 2022, reflecting older adults’ increased reliance on Medicare coverage alone.
    • “Dual coverage rates decreased almost every year during that period, except from 2020 to 2021, while rates of Medicare coverage alone significantly increased during the same period, from 37.6% to 44.8%, according to a new analysis of data from the 2023 Current Population Survey Annual Social and Economic Supplement (CPS ASEC). 
    • “Much of the increase in the share of older adults relying solely on Medicare was driven by a drop in the share of those also receiving private coverage.”
  • Although OPM waited much too long to allow FEHB plans the opportunity to offer Part D EGWPs, OPM to its credit has not followed the lead of many private employers which leave their retirees to Medicare alone.
  • The Social Security Administration has made available an interview with its new Commissioner Martin O’Malley who discussed his top priorities: “1) Reduce call wait times, 2) Issue faster disability decisions, 3) Resolve inequities in overpayments and underpayments.”

From the public health and medical research front,

  • Per MedPage Today,
    • “The CDC and FDA are warning about a multistate outbreak of Salmonella typhimuriumopens in a new tab or window infections linked to fresh basil sold at Trader Joe’s stores in over two dozen states.
    • “Twelve cases have been reported across seven states as of April 17, including one hospitalization. Exposure to fresh organic basil from Trader Joe’s prior to illness was confirmed in seven of eight individuals with additional case information.
    • “Miami-based Infinite Herbs, which makes the basil, has agreed to a voluntary recall, and the herbs have been pulled from store shelves.
    • “If you already bought organic basil from Trader Joe’s and removed it from the packaging or froze it and cannot tell if it was Infinite Herbs-brand, do not eat or use it and throw it away,” the FDA said in its statementopens in a new tab or window.
    • “The product was sold in a 2.5-oz clamshell-style container at Trader Joe’s stores in Washington, D.C., and 29 statesopens in a new tab or window, with most east of the Mississippi River. Cases have been reported in Florida, Georgia, Minnesota, Missouri, New Jersey, Rhode Island, and Wisconsin.
    • “An investigation is ongoing to determine whether additional products are linked to the illnesses, the FDA noted.”
  • The NIH Director, in her blog, pointed out,
    • “Pregnancy and childbirth are often thought of as joyful times. Yet, we know that mental health conditions including perinatal depression, anxiety, and post-traumatic stress disorder (PTSD) are common complications during and after pregnancy, and this is contributing to a maternal health crisis in this country.
    • “Now, a trio of NIH-supported studies reported in the journal Health Affairs show that diagnosis and treatment of mental health conditions such as anxiety, depression, and PTSD during pregnancy and in the first year after giving birth rose significantly in Americans with private health insurance from 2008 to 2020. While these are encouraging signs of increasing mental health awareness and service use, these studies also showed that this increase hasn’t happened equally across all demographic groups and states, making it clear there’s more work to do to ensure that people from all walks of life have access to the care they need, regardless of their race, ethnicity, geographic location, financial status, or other factors. * * *
    • “It will be important to learn in future studies more about those who may still not be receiving the mental health care they need. The researchers report plans to look deeper into changes that have taken place at the state level and the impact of the pandemic and the rise of telehealth since 2020. Other recent NIH-supported research suggests that relatively straightforward interventions to reduce postpartum anxiety and depression can be remarkably effective. The key step will be not only identifying interventions that work, but also figuring out how to deliver effective treatments to the people who need them.”
  • According to BioPharma Dive,
    • “Cerevel Therapeutics, a biotechnology company in the midst of being acquired by AbbVie, on Thursday said a Parkinson’s disease treatment it’s developing succeeded in a late-stage clinical trial.
    • “The treatment, called tavapadon, helped keep the disease’s disruptive motor fluctuations at bay, extending the total time of symptom control by just over one hour, compared to a placebo. This difference in “on” time was statistically significant, Cerevel said.
    • “Tavapadon also significantly reduced the amount of “off” time that treated study participants experienced, meeting a secondary goal of the Phase 3 study. People with Parkinson’s often cycle between these “on” and “off” periods as the effects of mainstay drugs like levadopa and carbidopa wane. In Cerevel’s study, tavapadon was given as an adjunctive therapy, meaning it was added on top of levadopa.”
  • The Washington Post reports,
    • “The nation’s largest coalition of obstetricians issued an urgent warning Thursday calling on doctors to expand testing for syphilis during pregnancy amid a surge of cases in recent years.
    • “The American College of Obstetricians and Gynecologists updated its recommendations, advising a routine blood screening at the first prenatal visit and screenings in the third trimester of pregnancy and at birth. This contrasts with previous recommendations, which called for testing in the third trimester exclusively for individuals living in communities with high syphilis rates and for those at risk of syphilis exposure during pregnancy.
    • “We’re always trying to create healthier families, and some of the diseases that we can easily diagnose and treat are things that we should prioritize, especially when they can be devastating to a baby,” said Laura E. Riley, chair of the obstetrician coalition’s immunization work group. Riley helped write the guidance. * * *
    • “In April 2023, the Food and Drug Administration announced a shortage of penicillin in the United States attributed to increased demand.
    • “To combat the ongoing shortages, the FDA granted temporary approval for a French drug, Extencilline, which is used for syphilis treatment but is not FDA-approved. While the Food, Drug, and Cosmetic Act prohibits importing unapproved drugs into the United States, the secretary of Health and Human Services can authorize temporary importation and distribution of such drugs to address shortages until domestic production returns to normal levels.
    • “Riley said the updated guidance from the obstetricians group is essential because it makes physicians aware of the alternative treatment for syphilis amid the shortage.
    • “In June 2023, the maker of penicillin, Pfizer, said it would prioritize making the drug available, with the shortage expected to be relieved within the next few months of this year.”

From the U.S. healthcare business front,

  • Beckers Payer Issues relates,
    • “Elevance Health posted $2.2 billion in net income during the first quarter, a nearly 13% increase compared to the same period last year, according to the company’s earnings report published April 18.
    • “First quarter results reflect disciplined execution of our strategic initiatives during a dynamic time for our industry,” President and CEO Gail Boudreaux said. “We are making significant progress expanding Carelon’s capabilities, scaling our flywheel for enterprise growth, and delivering results for all stakeholders. Given the solid start to the year, we have increased our outlook for full year earnings.”
    • “Total revenues in the first quarter were $42.6 billion, a 1% increase year over year.
    • “Total expenses in the first quarter were $39.6 billion, a 0.2% increase.
    • “Net income was $2.2 billion in the first quarter, up 12.9% from the same period last year. 
    • “Elevance raised its full-year earnings outlook to $37.20 in earnings per share.”
  • Modern Healthcare lets us know,
    • “CVS Health is opening Oak Street Health primary care clinics at its retail pharmacy stores — a move that hasn’t always worked out for competitors.
    • “CVS acquired primary care provider Oak Street last May for $10.6 billion and announced plans to add 50 to 60 Oak Street clinics in 2024. Most of those clinics are expected to be standalone locations, including some located in closed CVS stores. But CVS also is piloting a setup that replaces much of the retail space in existing stores with clinics.
    • “Walgreens executives say they remain confident in the VillageMD investment, although the focus has shifted away from expansion and more toward ramping up profitability in VillageMD’s strongest markets.
    • “CVS may have a different experience. Its expansion plan for Oak Street has a slower pace than what Walgreens tried, said Jack Slevin, vice president of healthcare services equity research at Jefferies. CVS’ model is dedicating a lot of space to the Oak Street clinics and pharmacy operations, which would allow for more patient volume, he said.
    • “[CVS is] giving them enough space that it feels like a true Oak Street location,” Slevin said. “If you look at the Walgreens strategy on the square footage side, it was very much more bolting on a smaller Village practice to a Walgreens store that was going to look very much the same.”
  • The FEHBlog also ran across the following consulting firm opinion pieces that are worth a gander:
    • A Brown and Brown paper on the role of employers in advancing health equity.
    • A RAND paper discussing why employers delay coverage for FDA newly approved drugs.
      • FEHBlog takeaway :”The FDA has steadily increased the speed at which it approves new drugs over the last two decades. In 2023, the agency approved 55 new drugs, up from 21 in 2003. The great majority of drugs are now approved through its accelerated program, leaving the FDA wide open to criticism that its standards are too low and that it is simply acting as a rubber stamp for pharmaceutical companies. Under the accelerated program, the FDA grants approval for the drug to be put on the market and later grants full approval after clinical trials confirm a drug’s effectiveness.”
    • A McKinsey Health Institute paper on improving mental health services for children.
      • “As part of the McKinsey Health Institute’s (MHI’s) Conversations on Health series, Erica Coe and Kana Enomoto, coleaders at MHI, discussed this challenge and how to prioritize the mental health needs of children and adolescents with Zeinab Hijazi, PsyD, the global lead on mental health at UNICEF.”

Weekend Update

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

Today is World Health Day.

  • McKinsey & Co. tells us,
    • “The good news: People are living longer. The bad news: People are spending more time in poor health. Global longevity has risen substantially in the past 60 years, increasing life spans by 20 years on average, but every additional year of life is paid for with an average of six months in ill health. According to a recent report from the McKinsey Health Institute (MHI), a focus on immediately influenceable interventions at the city level can add approximately 20 billion to 25 billion years of higher-quality life at a global level—that’s an average of five additional years per person living in urban areas. All organizations across sectors have a role to play to capture this opportunity, write McKinsey’s Hemant Ahlawat, Erica Hutchins Coe, Pooja Kumar, and Drew Ungerman.”
  • On April 5, 2024, “House Committee on Oversight and Accountability Chairman James Comer (R-Ky.) announced a markup will take place on Wednesday, April 10 at 10:00 am ET to consider a series of legislation,” including
    • H.R. 7868, the FEHB Protection Act: The bill requires federal agencies to verify that an employee is eligible to add a family member to their Federal Employees Health Benefits Program (FEHBP) health coverage plan. This bill also requires the Office of Personnel Management (OPM) to consider coverage of ineligible individuals when conducting FEHBP fraud risk assessments and requires a comprehensive audit be conducted of employee family members currently enrolled in the FEHBP. Finally, the bill requires OPM to disenroll any ineligible individual found to be receiving FEHBP coverage.
  • Congress should be including in H.R. 7868 a provision requiring federal agencies to use the HIPAA 820 electronic enrollment roster transaction which would allow carriers to systematically reconcile individual enrollees with their premium payments. None of the provisions in HR 7868 would provide a greater improvement in internal controls than implementing the HIPAA 820 because half of the FEHB enrollment is self only. Moreover, what is the sense of confirming family member enrollment if the enrollee in question is not paying for family coverage?
  • The current premium reconciliation process known as CLER was implemented in 2001, eleven years before the HIPAA 820 was introduced. The time has long passed for CLER to be replaced by the much more efficient HIPAA 820.

From the FEHB front,

  • FedWeek highlights how FEHB plans coordinate their benefits with other coverage.
  • Tammy Flanagan writing in Govexec discusses the importance of knowing Medicare and FEHB coordination of benefit rules before requesting agency help.
  • In the Federal Times, Reg Jones answers the following question “Will my spouse be covered once I qualify for Medicare Part B?

From the public health and medical research front,

  • The National Institutes of Health announced today,
    • “Adults with heart disease risks who received daily reminders or incentives to become more active increased their daily steps by more than 1,500 after a year, and many were still sticking with their new habit six months later, according to a study supported by the National Institutes of Health that published in Circulation(link is external).
    • “The improvements, which also resulted in an extra 40 minutes of moderate exercise each week, correlated with a 6% reduced risk of premature death and a 10% reduced risk of cardiovascular-related deaths, compared to data from prior studies. The Department of Health and Human Services recommends(link is external) that most adults should get at least 150 minutes of moderate aerobic exercise per week, such as brisk walking, or 75 minutes of vigorous exercise, like fast cycling, or a combination of the two, paired with twice-weekly strength sessions.
    • “Researchers found that while a simple daily reminder was effective in helping people move more, offering financial incentives or point-based rewards, such as in a game, was even more effective. However, combining the two incentives proved most effective. Participants who got both were still logging improvements in activity levels six months after the rewards stopped.
    • “Even moderate exercise can drastically reduce cardiovascular risk, so finding low-cost ways to get people moving and stay in a fitness program that they can do at home is a huge win for public health,” said Alison Brown, Ph.D., R.D., a program officer at the National Heart, Lung, and Blood Institute (NHLBI), part of NIH.”
  • The New York Times offers an interview with Dr. Nora Volkow, the director of the National Institute on Drug Abuse.
    • What’s the big picture on teens and drug use?
      • People don’t really realize that among young people, particularly teenagers, the rate of drug use is at the lowest risk that we have seen in decades. And that’s worth saying, too, for legal alcohol and tobacco.
    • What do you credit for the change?
      • One major factor is education and prevention campaigns. Certainly, the prevention campaign for cigarette smoking has been one of the most effective we’ve ever seen.
      • Some of the policies that were implemented also significantly helped, not just making the legal age for alcohol and tobacco 21 years, but enforcing those laws. Then you stop the progression from drugs that are more accessible, like tobacco and alcohol, to the illicit ones. And teenagers don’t get exposed to advertisements of legal drugs like they did in the past. All of these policies and interventions have had a downstream impact on the use of illicit drugs. * * *
      • “But we don’t want to become complacent. The supply of drugs is more dangerous, leading to an increase in overdose deaths. We’re not exaggerating. I mean, taking one of these drugs can kill you.”
  • Fortune Well explores the non-invasive colorectal cancer screening alternatives to a full blown colonoscopy.
  • The Washington Post reports,
    • “Black and White patients face significant disparities in access to kidney transplants depending on whether their residential neighborhoods and transplant centers were racially segregated, a recent study has found.
    • “The study, published in JAMA Internal Medicine, looked at 162,587 first-time live-donor kidney transplantation candidates in the national transplant registry from January 1995 through December 2021. Participants were tracked for an average of 1.9 years. * * *
    • “Overall, 7.1 percent of Black candidates in segregated neighborhoods received a live kidney transplant over a three-year period, while 9 percent of their Black counterparts in less segregated areas received a transplant. The percentage of White candidates who received similar transplants was similar in highly segregated neighborhoods and more diverse areas during the period — 19.7 percent and 20.1 percent, respectively. * * *
    • “The analysis adds to a growing body of literature about social disparities that affect Black patients’ access to kidney transplantation in the United States. Overall, Black patients are likelier to develop kidney failure than their White counterparts, yet they experience treatment delays and are less likely to get kidneys from live donors.”

From the U.S. healthcare business front,

  • Fierce Healthcare lets us know,
    • “Four in 10 therapists are planning to raise their fees in 2024, a new survey has found.
    • “Heard, a bookkeeping and accounting firm for therapy practices, surveyed more than 2,260 therapists across all 50 states and D.C. The findings were published in a report on the financial state of private practices. It found that half of therapists are somewhat or very concerned about the economy impacting their practice in the coming year.
    • “At the same time, in last year’s report, 64% of therapists said they were planning to raise their fees in 2023. Yet only a third did.
    • “Despite cash pay popularity, three-quarters of therapists still accept some form of insurance. Aetna was the most common payer with which therapists paneled, followed by Cigna, Blue Cross Blue Shield, Anthem and Oxford. Aetna also had the highest average reimbursement rate at $141 per session, while Humana had the lowest at $96.’ 

Midweek Update

David Ermer–Congress, Federal employment benefits, Medical / Rx research, Medicare, NIH, OPM, SDOH, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC

  • Federal News Network reports,
    • “The House passed a $460 billion package of spending bills Wednesday that would keep money flowing to key federal agencies through the remainder of the budget year. The Senate is expected to take up the legislation before a midnight Friday shutdown deadline.
    • “Lawmakers are negotiating a second package of six bills, including defense, in an effort to have all federal agencies fully funded before a March 22 deadline. In the end, total discretionary spending set by Congress is expected to come in at about $1.66 trillion for the full entire year. 
    • “A significant number of House Republicans have lined up in opposition to the spending packages, forcing House Speaker Mike Johnson, R-La., to use an expedited process to bring the bill up for a vote. That process requires two-thirds of the House to vote for the measure for it to pass.
    • “The House passed the measure by a vote of 339-85.”
  • The American Hospital Association News adds,
    • “The House March 5 voted 382-12 to pass the AHA-supported Preventing Maternal Deaths Reauthorization Act (H.R. 3838), bipartisan legislation that would reauthorize federal support for state-based committees that review pregnancy-related deaths to identify causes and make recommendations to prevent future mortalities. Passed by the House Energy and Commerce Committee last July, the bill also would require the Centers for Disease Control and Prevention to work with the Health Resources and Services Administration to disseminate best practices to prevent maternal mortality to hospitals and other health care providers.”
  • Per an HHS press release,
    • “Today, in support of President Biden’s Unity Agenda, the U.S. Department of Health and Human Services’ Health Resources and Services Administration (HRSA) announced the launch of nearly $50 million for HRSA’s Rural Opioid Treatment and Recovery Initiative and released the initiative’s funding application. Funding will support establishing and expanding comprehensive substance use disorder treatment and recovery services in rural areas, including by increasing access to medications for opioid use disorder, such as buprenorphine. Opioid use disorder is particularly concerning in rural communities and accessing treatment can be challenging due to geographic isolation, transportation barriers, and limited substance use disorder providers. This week, HRSA hosted more than 800 rural community leaders working at the grassroots level to build their communities’ capacity to turn the tide of the opioid epidemic. * * *
    • “Applications will be accepted through May 6, 2024, and the funding opportunity is posted at: https://grants.gov/search-results-detail/349409.
    • “To learn more about other programs under the Rural Communities Opioid Response Program, visit https://www.hrsa.gov/rural-health/opioid-response.”
  • Govexec tells us,
    • “Coming on the heels of debuting its new public-facing repository of high-ranking federal officials, the Office of Personnel Management released guidance last week outlining how agencies should report data to the website and how often. 
    • “The March 1 guidance details how agencies will comply with the Periodically Listing Updates to Management (PLUM) Act, which moved OPM away from maintaining the quadrennial Plum Book after this year to an annually updated website that offers information about senior agency leaders, Senior Executive Service members and other top or non-competitively appointed officials. 
    • “OPM officials launched the new website in January, phasing out the physical Plum Book that dated back to President Eisenhower’s 1952 request for a list of every position his administration would have to fill. 
    • “At the time of its launch, the PLUM reporting website possessed the names, roles and pay levels of more than 8,000 executives, with plans to grow to 10,000 with subsequent updates.”
  • The Hill notes,
    • “Alabama Gov. Kay Ivey (R) signed a bill Wednesday protecting in vitro fertilization (IVF) providers from the state Supreme Court’s recent ruling that frozen embryos are to be considered children. 
    • “The legislation, titled SB 159, will shield IVF providers from lawsuit or criminal charges over the “death or damage to an embryo,” during the IVF process. The bill passed by both the state Senate and House shortly before heading to Ivey’s desk Wednesday night.” 

From the FEHB front,

  • An expert, writing in Govexec, offers tips for federal retirees on making the decision whether or not to enroll in Medicare Part B. FEHBlog tip — Income adjusted Medicare Part B premiums usually are temporary while the Medicare Part B late enrollment penalty is forever.
  • Reg Jones, writing in FedWeek, discusses “Your Federal Benefits in Divorce.”

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

  • HR Morning offers employers guidance on how to improve employee health.
  • The National Institutes of Health announced,
    • “More than 70% of American Indian young adults aged 20-39 and 50% of American Indian teens have cholesterol levels or elevated fat in the blood that put them at risk for cardiovascular disease, suggests a study supported by the National Institutes of Health. In some cases, these levels — specifically high low-density lipoprotein (LDL) cholesterol, often thought of as “bad cholesterol,” — were linked to plaque buildup and cardiovascular events, such as heart attack and stroke.
    • “The findings, published in the Journal of the American Heart Association, came from a 19-year-review of the Strong Heart Family Study, part of the Strong Heart Study — the largest study of cardiovascular health outcomes and risk factors among American Indian adults. Researchers followed more than 1,400 participants, ages 15-39, between 2001-2003 and 2020. At the beginning of the study, 55% of participants ages 15-19 had abnormal cholesterol levels, as did 74% of those ages 20-29, and 78% of those ages 30-39.”
  • and
    • “Four children have remained free of detectable HIV for more than one year after their antiretroviral therapy (ART) was paused to see if they could achieve HIV remission, according to a presentation today at the 2024 Conference on Retroviruses and Opportunistic Infections (CROI) in Denver. The children, who acquired HIV before birth, were enrolled in a clinical trial funded by the National Institutes of Health in which an ART regimen was started within 48 hours of birth and then closely monitored for drug safety and HIV viral suppression. The outcomes reported today follow planned ART interruptions once the children met predefined virological and immunological criteria.”
    • “These findings are clear evidence that very early treatment enables unique features of the neonatal immune system to limit HIV reservoir development, which increases the prospect of HIV remission,” said NIAID Director Jeanne Marrazzo, M.D., M.P.H. “The promising signals from this study are a beacon for future HIV remission science and underscore the indispensable roles of the global network of clinicians and study staff who implement pediatric HIV research with the utmost care.”
  • and
    • “Long-acting, injectable antiretroviral therapy (ART) suppressed HIV replication better than oral ART in people who had previously experienced challenges taking daily oral regimens and was found safe in adolescents with HIV viral suppression, according to two studies presented today at the 2024 Conference on Retroviruses and Opportunistic Infections (CROI) in Denver. Both studies were sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, in collaboration with other NIH institutes.
    • “The HIV community is just beginning to unpack the enormous potential of long-acting antiretroviral medications for HIV treatment and prevention, and we need population-specific data for everyone to benefit,” said NIAID Director Jeanne Marrazzo, M.D., M.P.H. “These findings open up new possibilities for millions of people with HIV, particularly those whose health suffers due to challenges of daily pill taking.”
  • MedPage Today lets us know,
    • “Rates of emergency surgery, serious complications, and hospital readmissions were higher among Medicare patients living in primary care shortage areas, according to a cross-sectional retrospective cohort study of data from 2015 to 2019.
    • “Medicare beneficiaries living in areas with the most severe primary care shortages had higher rates of three types of emergency surgeries compared with those living in areas with the least severe shortages (37.8% vs 29.9%; risk ratio [RR] 1.26, 95% CI 1.17-1.37, P<0.001), reported Sara Schaefer, MD, of the University of Michigan in Ann Arbor, and co-authors.
    • “Those in areas with the most severe shortages were also more likely to have serious complications (14.9% vs 11.7%; adjusted RR 1.27, 95% CI 1.12-1.44, P<0.001) and readmissions (15.7% vs 13.5%; adjusted RR 1.16, 95% CI 1.01-1.33, P=0.03), they noted in Health Affairs.
    • “However, beneficiaries in areas with the most and least severe shortages had similar rates of 30-day mortality (5.6% vs 4.8%; adjusted RR 1.17, 95% CI 0.93-1.47, P=0.17) and any complications (25.9% vs 24.5%; adjusted RR 1.05, 95% CI 0.97-1.15, P=0.21).
    • “Schaefer told MedPage Today that what surprised her most about the study was the strength of the association for the primary endpoint. Across multiple iterations of analyses, the trend remained consistent, she said.”
  • Health Day relates that according to “researchers reported March 5 in the American Heart Association journal Circulation: Arrhythmia and Electrophysiology.”
    • “Sugary and diet drinks both appear to increase the risk of atrial fibrillation.
    • “Two liters weekly of diet drinks increased risk by 20%, and sugary drinks raised risk by 10%.
    • “Conversely, one liter weekly of unsweetened fruit or vegetable juice lowered risk by 8%.”

From the U.S. healthcare business front,

  • Per Fierce Healthcare,
    • “Pittsburgh-based UPMC, a 40-hospital system, has reported a 2023 operating loss of $198.3 million (-0.7% operating margin) on revenue of $27.7 billion. 
    • “Those figures compare with a $162.1 million operating gain on revenue of $25.5 billion in 2022. Expenses in 2023, totaling $27.9 billion, were approximately 10% up on 2022. That included a 13.6% jump in insurance claims expenses. 
    • “The healthcare system’s measure of inpatient activity grew 3% over the previous year while average outpatient revenue per workday rose 10% and average physician revenue per weekday grew by 9%.”
  • Beckers Hospital Review points out four U.S. hospitals with uncertain futures.
  • Beckers Hospital Review also reports,
    • “Mark Cuban Cost Plus Drug Co. plans to begin manufacturing epinephrine and norepinephrine this week at its 22,000-square-foot drug facility in Dallas, Mr. Cuban confirmed to Becker’s on March 5. 
    • “The $11 million drug manufacturing plant, which originally planned to start operating in late 2022, will focus on producing injectable drugs that often fall into shortages. 
    • “Epinephrine is an emergency treatment for severe allergy reactions, and norepinephrine is a blood pressure medication. Injection solutions of the former have been in unsteady supply since at least 2012. Neither the FDA nor the American Society of Health-System Pharmacists list norepinephrine as a current shortage. 
    • “Next on the docket are pediatric oncology drugs, according to Fortune and Politico.” 
  • Beckers Payer Issues calls attention to the fact that
    • “Twenty-six states [listed in the BPI article] now have more than half of their Medicare enrollees in Medicare Advantage plans, according to a March 5 report from Chartis, a healthcare advisory services firm. 
    • “Nationwide, half of Medicare-eligible beneficiaries are now enrolled in Medicare Advantage plans.” 

Happy Leap Day!

David Ermer–CDC, Congress, Cybersecurity, Government Contracting, Medicare, Mental health care, Obesity, SDOH, U.S. Healthcare–
Photo by Joe Caione on Unsplash

From Washington, DC,

  • Politico reports,
    • “The Senate approved a stopgap funding bill Thursday night for President Joe Biden’s signature, thwarting a partial government shutdown on Saturday and buying more time to finalize half a dozen spending bills that congressional leaders aim to pass next week.
    • “Congress now officially has until March 8 to clear that initial six-bill bundle, which leaders struck a deal on earlier this week. But they’re still working on an agreement to fund the rest of the government, including the military and some of the biggest domestic programs, before a second deadline on March 22. The upper chamber cleared the measure in a 77-13 vote, following votes on four Republican amendments that were defeated on the floor.”
  • The U.S. Preventive Services Task Force posted for public comment a draft research plan concerning Primary Care Interventions for Tobacco and Nicotine Use Prevention and Cessation in Children and Adolescents. The comment period ends on March 27, 2024.
  • The Labor Department’s Office of Federal Contract Compliance Programs created an updated website for the “The Vietnam Era Veterans’ Readjustment Assistance Act (VEVRAA) [which] is a law that prohibits federal contractors and subcontractors from discriminating in employment against protected veterans and requires employers take affirmative action to recruit, hire, promote, and retain these individuals.”
  • Yesterday, the Politico Pulse posted a story on a December 2022 Government Accountability Office report, released January 9, 2023, criticizing OPM’s internal controls over FEHB family member eligibility. Here is a link to the GAO’s website for the report which offers August 2023 updates on OPM’s efforts to implement GAO’s recommendations. Here’s are FEHBlog recommendations for GAO and OPM:
    • Family member eligibility hinges on the enrollee’s eligibility. OPM needs to have the payroll offices implement the HIPAA 820 enrollment roster electronic transaction which allows carriers to reconcile premiums to actual headcount. Use of the HIPAA 820 will be a huge step toward confirming the accuracy of family member eligibility and the 50% of FEHB enrollees who have self only coverage.
    • The Politico article suggests that the high cost of a family member eligibility audit discourages OPM from implementing one for the FEHBP. Auditors do their work based on samples. Arrange for a family member eligibility audit using statistically appropriate samples which will disclose, at the very least, the scope of the problem.

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

  • The New York Times reports,
    • “Long Covid may lead to measurable cognitive decline, especially in the ability to remember, reason and plan, a large new studysuggests.
    • “Cognitive testing of nearly 113,000 people in England found that those with persistent post-Covid symptoms scored the equivalent of 6 I.Q. points lower than people who had never been infected with the coronavirus, according to the study, published Wednesday in The New England Journal of Medicine.
    • “People who had been infected and no longer had symptoms also scored slightly lower than people who had never been infected, by the equivalent of 3 I.Q. points, even if they were ill for only a short time.
    • “The differences in cognitive scores were relatively small, and neurological experts cautioned that the results did not imply that being infected with the coronavirus or developing long Covid caused profound deficits in thinking and function. But the experts said the findings are important because they provide numerical evidence for the brain fog, focus and memory problems that afflict many people with long Covid.”
  • and
    • “Alcohol-related deaths surged in the United States by nearly 30 percent in recent years, with roughly 500 Americans dying each day in 2021, according to a new study published by the Centers for Disease Control and Prevention.
    • “The study chronicled a sustained spike in drinking during the Covid pandemic that continued to rise after the shock of the lockdowns of 2020. The incidence of alcohol-related deaths was higher in men, but among women the death rate shot up at a quicker pace.
    • “I think the results of this research are really alarming,” said Dr. Michael Siegel, who is a professor of public health at Tufts University School of Medicine and was not involved in the study. “It shows that there’s been a truly substantial increase in alcohol-related deaths over the last six years.”
  • and
    • “The 2022 outbreak of mpox, previously known as monkeypox, was curbed in large part by drastic changes in behavior among gay and bisexual men, and not by vaccination, according to a new analysis published on Thursday in the journal Cell.
    • “Public health response to outbreaks often relies heavily on vaccines and treatments, but that underestimates the importance of other measures, said Miguel Paredes, lead author of the new study and an epidemiologist at the Fred Hutchinson Cancer Center in Seattle.
    • “Although the Food and Drug Administration approved a vaccinefor mpox in 2019, getting enough doses produced and into arms proved challenging for many months after the outbreak began. Vaccines for new pathogens are likely to take even longer.
    • “The new analysis suggests an alternative. Alerting high-risk communities allowed individuals to alter their behavior, such as reducing the number of partners, and led to a sharp decrease in transmission, Mr. Paredes said. In North America, the outbreak began petering out in August 2022, when less than 8 percent of high-risk individuals had been vaccinated.
    • “Public health messaging can “be really powerful to control epidemics, even as we’re waiting for things like vaccines to come,” he said.”
  • Roll Call adds,
    • “Cases of measles are rising across the country and seem to be striking counties at random, but experts say there is one thing the public health system can do to turn the tide, and that’s to stem the post-pandemic vaccine lag and get parents to vaccinate their kids.
    • “General vaccination rates, including measles vaccination, declined during the COVID-19 pandemic, as people had less access to health care and kids were unable to access in-school vaccine clinics.
    • “That, combined with a new wave of vaccine skepticism and anti-vaccine sentiment has contributed to a wave of unvaccinated kids falling sick with the once-eradicated virus.”
  • MedPage Today tells us,
    • “The benefits of vaccination against respiratory syncytial virus (RSV) for adults ages 60 and older probably outweigh the small risk of vaccine-related Guillain-Barré syndrome (GBS), the CDC’s Advisory Committee on Immunization Practices (ACIP) reaffirmed.
    • “In a presentation on the second day of the ACIP’s 2-day meeting, Amadea Britton, MD, of the CDC’s RSV adult vaccination work group in Atlanta, noted that a small number of cases of Guillain-Barre syndrome had been observed in the clinical trials for both FDA-approved RSV prefusion F protein vaccines, but that it remained unclear whether those cases were actually caused by RSV vaccination or just chance occurrences.”
  • and
    • The CDC has issued new guidance —  its first since 1988 — on identifying and responding to clusters of suicide, as tens of thousands of lives are lost to suicide each year in the U.S.
    • Though suicide clusters are rare, they “can have unique characteristics and challenges,” and “are often highly publicized and can have considerable negative effects on the community, including prolonged grief and elevated fear and anxiety about further deaths,” Michael Ballesteros, PhD, of CDC’s National Center for Injury Prevention and Control (NCIPC), and colleagues wrote in Morbidity and Mortality Weekly Report (MMWR).
  • Beckers Hospital Review informs us,
    • “The CDC is anticipating a shortage of Td vaccines — which protect against tetanus and diphtheria — as the maker of one shot has discontinued production. 
    • “As a result, the CDC has updated guidance for providers and is recommending that they switch to administering Tdap vaccines, which protect against pertussis in addition to tetanus and diphtheria, whenever possible.  
    • “MassBiologics discontinued production of its TdVax shot, and while Sanofi also manufactures a Td vaccine and is working to boost supplies, the CDC anticipates the U.S. could see a shortage of the vaccines later this year. 
    • “Because not everyone can receive the Tdap vaccine, “the limited supply of Td vaccine needs to be preserved for those with a contraindication to receiving pertussis-containing vaccines,” the CDC said in its guidance.” 
  • Medscape notes,
    • “Injectable weight loss drugs like Wegovy, Saxenda, and Zepbound have been getting all the glory lately, but they’re not for everyone. If the inconvenience or cost of weight loss drugs isn’t for you, another approach may be boosting your gut microbiome.
    • “So how does one do that, and how does it work?
    • “In theory, all you have to do is boost your gut microbiome.
    • “There are a lot of different factors naturally in weight gain and weight loss, so the gut microbiome is certainly not the only thing,” said Chris Damman, MD, a gastroenterologist at the University of Washington. He studies how food and the microbiome affect your health. “With that caveat, it probably is playing an important role.”
  • STAT News adds,
    • “New obesity drugs like Wegovy and Zepbound are currently taken once a week, indefinitely. But what if they could be taken once a year instead, like a vaccine?
    • “That’s a question that Novo Nordisk, the pharma company behind Wegovy, is exploring as it faces increased competition from other drugmakers aiming to develop similar GLP-1-based treatments for obesity.
    • “We have a very early think tank on: what would it take us, from a technology point of view and from an ecosystem point of view, to make long-lasting GLP-1 molecules?” Marcus Schindler, Novo’s chief scientific officer, said in an interview with STAT Wednesday. “Could we think about vaccine-like properties, where imagine you had, once a year, an injection with an equivalent of a GLP-1 that really helps you to maintain weight loss and have cardiovascular benefits?”

From the U.S. healthcare business and cybersecurity issues front,

  • Beckers Hospital Review informs us,
    • “Optum’s Change Healthcare confirmed Feb. 29 that it was hacked by a ransomware gang after the group claimed to have stolen massive amounts of data.
    • “Change Healthcare can confirm we are experiencing a cybersecurity issue perpetrated by a cybercrime threat actor who has represented itself to us as ALPHV/Blackcat,” an Optum spokesperson emailed Becker’s on Feb. 29. “We are actively working to understand the impact to members, patients and customers.” * * *
    • “ALPHV/Blackcat, aka BlackCat, claimed responsibility for the hack, posting on its dark web leak site that it stole 6 terabytes worth of Change Healthcare data involving “thousands of healthcare providers, insurance providers, pharmacies, etc,” Bleeping Computer reported Feb. 28. The allegedly stolen data includes medical records, patient Social Security numbers, and information on active military personnel (Change serves some military healthcare facilities).
    • “But as Politico noted Feb. 28: “Ransomware groups, which demand extortion payments in exchange for restoring or not publishing stolen data, often exaggerate their exploits as a negotiating tactic.”
    • “ALPHV/Blackcat, which has been linked to Russia, has been targeting the U.S. healthcare industry since December after the FBI disrupted its operations.”
  • STAT News adds,
    • “The outage caused by the Change Healthcare cyberattack could last weeks, a top UnitedHealth executive suggested in a Tuesday conference call with hospital cybersecurity officers, according to a recording obtained by STAT.
    • “UnitedHealth Group Chief Operating Officer Dirk McMahon said the company is setting up a loan program to help providers who can’t submit insurance claims while Change is offline. He said that program will last “for the next couple of weeks as this continues to go on.”
    • “McMahon’s remarks about the loan program highlight the scope of UnitedHealth’s damage control. UnitedHealth maintained it has “not determined the [cyberattack] incident is reasonably likely to materially impact our financial condition or results of operations,” according to its annual report to investors this week. But doctors and pharmacists are scrambling to find ways to get patients what they need, and to get paid. As of 2022, Change facilitated $1.5 trillion in health care transactions.”
  • HR Brew lets us know,
    • “The cost of healthcare went up last year, according to a new report from Marsh McLennan Agency (MMA), a US-based subsidiary of global brokerage Marsh. The amount that employers spent on health benefits per employee grew by 5.2%, while the estimated cost of employer contributions to premiums increased by more than $1,400, to $11,762.
    • “Healthcare inflation can affect employees, as well, the report noted, with 38% of Americans reporting they put off medical treatment in the last year due to cost concerns. MMA noted that “delayed care is associated with worse health outcomes and higher costs for patients and benefit providers.”
    • “Younger workers appear to be feeling the pinch of high health costs the most, with 74% of millennial and 56% of Gen Z patients canceling doctors’ visits because of high costs, compared to 13% of Baby Boomer patients. Putting off behavioral healthcare, in particular, can be costly for younger age groups, said Monte Masten, chief medical officer with MMA. Given these trends, employer investment in incentives may be warranted, he told HR Brew.”
  • Drug Store News alerts us,
    • “Walgreens’ VillageMD is closing six Chicago clinic locations—five standalone and one co-located with a Walgreens store, per a Telehealth & Telecare Aware report.
    • “The closures in Walgreens’ home state are set to take place April 19. These closures follow on the heels of news last week that VillageMD exited the Florida market.” 
  • Per Fierce Healthcare,
    • “Telemedicine clinic Virta Health believes its members can achieve significant and sustained improvement in weight loss, even if a patient has stopped taking a GLP-1 drug, a newly released paper in Diabetes Therapy shows.
    • “According to the company, it is a first-of-its-kind study offering an opposing viewpoint against clinical trials showing GLP-1 deprescription leading to weight regain. The results have potentially major implications for employers and plans looking to help its members improve health outcomes and fight obesity but that are concerned about rising costs amid increasing demand.
    • “This is unheard of,” said Sami Inkinen, Virta Health CEO and co-founder. “To my knowledge, nobody has published or shown this kind of data to date.”
  • Beckers Health Payer Issues points out five health insurers that “are making commitments to advance a White House initiative to end hunger and reduce diet-related disease by 2030.” 
  • Per BioPharma Dive,
    • “Kenai Therapeutics, a San Diego-based biotechnology company, has raised $82 million to support its work developing cell therapies for nervous system disorders.
    • “Cure Ventures, a new venture capital firm founded by three longtime biotech investors, co-led the Series A round announced Thursday, alongside Alaska Permanent Fund Corporation and The Column Group. The investment is the first announced by Cure since it debuted last year with a $350 million fund. Euclidean Capital and Saisei Ventures also participated in the round.
    • “Previously known as Ryne Bio, Kenai’s research aim is to create so-called off-the-shelf cell therapies that replace neurons. The company’s most advanced medicine is made from genetically reprogrammed stem cells and designed to treat Parkinson’s disease by restoring dopamine production.
    • “The medicine has “displayed robust survival, innervation, and behavioral rescue in preclinical models of Parkinson’s disease,” according to Kenai, which claims it could work in inherited forms of the disease as well as in cases where the exact cause isn’t understood.
    • “The company said the funding proceeds will be enough to push the medicine, named RNDP-001, into human testing and through early-stage clinical trials, which should start within the year.”

Midweek Update

David Ermer–Congress, Federal employment benefits, Medical / Rx research, Medicare, Mental health care, NIH, OPM, SDOH, Telehealth, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC,

  • Politico reports,
    • “Congress is out of town this week and facing another government shutdown deadline with major health care implications.
    • “Lawmakers are confronted with two deadlines — March 1 for funding for the FDA and the VA and March 8 for HHS funding.
    • “It’s a key week for Congressional appropriators. How much progress they make now will determine whether lawmakers have to turn to another temporary spending package.
    • E”ven though Congress is away, negotiations continue, and key lawmakers are “encouraged” about the prospect of reaching a deal.
    • “But as POLITICO’s Caitlin Emma and Jennifer Scholtes report, there’s skepticism about whether the progress is being made quickly enough, according to sources familiar with the talks. Legislative text for some fiscal 2024 measures should ideally be finalized by this weekend to allow time for the Congressional Budget Office to pore over the bills and top lawmakers to calculate their next steps.”
  • Govexec offers a Kevin Moss article about OPM’s recent call letter for 2024 benefit and rate proposals for FEHB and PSHBP coverage. Bear in mind that the article does not appreciate the fact the Part D EGWP plans integrate Medicare and FEHB / PSHB coverage so that if Medicare does not cover a particular drug, like an obesity treatment, the FEHB / PSHB coverage will kick in.
  • FEDWeek discusses an OPM Inspector General report criticizing OPM’s FEHB disputed claims resolution process. The FEHBlog thinks that OPM does a good job with this process. Of course, any process can be improved but at what cost?
  • Healthcare Dive tells us,
    • “The CMS finalized a rule on Tuesday recalculating disproportionate share hospital payments, or reimbursements for hospitals serving a high proportion of low-income patients. Under the new definition, hospitals can only receive reimbursements for services rendered to beneficiaries for whom Medicaid is their primary insurer. 
    • “Congress tasked the CMS with clarifying DSH calculations in its Consolidated Appropriations Act of 2021. The final rule aims to reduce DSH overpayments by limiting hospitals’ ability to receive government and private payer funds for the same service, according to the rule.
    • I”n total, the CMS’ new calculations will result in an $8 billion reduction in DSH payments annually from fiscal year 2024 to 2027, according to the rule.” 
  • Assistant Secretary of Labor for Employee Benefit Security, Lisa Gomez, posted a blog entry about how to use your employer sponsored health benefits to improve heart health.
  • The Government Accountability Office issued a report on maternal health.
    • “Hundreds of women in the U.S. die each year from complications related to pregnancy and childbirth—a crisis exacerbated by COVID-19. The Department of Health and Human Services is working to address the crisis and meet long-term goals such as increasing women’s access to high-quality maternal care.
    • “As of September 2023, HHS hasn’t determined how it’ll measure progress toward achieving its maternal health goals. Following key performance measurement practices—such as setting near-term goals and establishing timeframes for results—would allow the agency to better understand if its efforts are effective. We recommended that HHS do so.”
  • The National Institutes of Health announced,
    • “launch[ing] a clinical trials network to evaluate emerging technologies for cancer screening. The Cancer Screening Research Network (CSRN) will support the Biden-Harris administration’s Cancer Moonshot℠ by investigating how to identify cancers earlier, when they may be easier to treat. Eight groups have received funding from the National Cancer Institute (NCI), part of NIH, to carry out the initial activities of the network.
    • “There are many cancers we still cannot reliably detect until it is so late that they become extremely difficult to treat,” said W. Kimryn Rathmell, M.D., Ph.D., director of NCI. “Emerging technologies such as multi-cancer detection tests could transform cancer screening and help to extend the lives of many more people. We need to be sure that these technologies work and understand how to use them so they benefit everyone.”
    • “Studies are needed, for example, to evaluate the benefits and harms of promising new technologies for cancer screening and to determine how best to incorporate these technologies into the standard of care.”
    • “In 2024, the network will launch a pilot study, known as the Vanguard Study on Multi-Cancer Detection, to address the feasibility of using multi-cancer detection (MCD) tests in future randomized controlled trials. MCDs are blood tests that can screen for several types of cancers. The study will enroll up to 24,000 people to inform the design of a much larger randomized controlled trial. This larger trial will evaluate whether the benefits of using MCD tests to screen for cancer outweigh the harms, and whether they can detect cancer early in a way that reduces deaths.”

From the public health and medical research front,

  • KFF informs us,
    • The United States is knee-deep in what some experts call the opioid epidemic’s “fourth wave,” which is not only placing drug users at greater risk but is also complicating efforts to address the nation’s drug problem.
    • These waves, according to a report out today from Millennium Health, began with the crisis in prescription opioid use, followed by a significant jump in heroin use, then an increase in the use of synthetic opioids like fentanyl.
    • The latest wave involves using multiple substances at the same time, combining fentanyl mainly with either methamphetamine or cocaine, the report found. “And I’ve yet to see a peak,” said one of the co-authors, Eric Dawson, vice president of clinical affairs at Millennium Health, a specialty laboratory that provides drug testing services to monitor use of prescription medications and illicit drugs. * * *
    • Methamphetamine, a highly addictive drug often in powder form that poses several serious cardiovascular and psychiatric risks, was found in 60% of fentanyl-positive tests last year. That is an 875% increase since 2015. * * *
    • Among the report’s other key findings:
      • The nationwide spike in methamphetamine use alongside fentanyl marks a change in drug use patterns.
      • Polydrug use trends complicate overdose treatments. For instance, though naloxone, an opioid-overdose reversal medication, is widely available, there isn’t an FDA-approved medication for stimulant overdose.
      • Both heroin and prescribed opioid use alongside fentanyl have dipped. Heroin detected in fentanyl-positive tests dropped by 75% since peaking in 2016. Prescription opioids were found at historic low rates in fentanyl-positive tests in 2023, down 89% since 2013.
  • MedPage Today points out,
    • “Annual breast cancer screening at ages 40 to 79 resulted in the greatest reduction in mortality, according to a study comparing various screening scenarios.
    • “Using Cancer Intervention and Surveillance Modeling Network (CISNET) estimates of breast cancer screening outcomes published in 2009, 2016, and 2023, mortality was reduced by 41.7% with annual screening starting at age 40 and continuing up to age 79, reported Debra L. Monticciolo, MD, of Dartmouth-Hitchcock Medical Center in Lebanon, New Hampshire, and colleagues.”
  • AP reports,
    • “Emily Hollenbeck lived with a deep, recurring depression she likened to a black hole, where gravity felt so strong and her limbs so heavy she could barely move. She knew the illness could kill her. Both of her parents had taken their lives. 
    • “She was willing to try something extreme: Having electrodes implanted in her brain as part of an experimental therapy.
    • “Researchers say the treatment —- called deep brain stimulation, or DBS — could eventually help many of the nearly 3 million Americans like her with depression that resists other treatments. It’s approved for conditions such as Parkinson’s disease and epilepsy, and many doctors and patients hope it will become more widely available for depression soon.”
  • Fierce Healthcare lets us know,
    • “Given the impact that social factors have on overall health, employers can better manage costs and outcomes by embracing deeper, population-level data analysis, according to a new white paper.
    • “UnitedHealthcare and the Health Action Council (HAC), a nonprofit that represents large and midsize employers, dug into community health data from HAC’s plan sponsors representing 217,779 workers. The analysis found that 52% of adults have at least one social determinant of health risk.
    • “Of that group, 10% faced three or more risks, and 16% had two risk factors. Twenty-six percent have one SDOH risk factor, according to the report.
    • “Craig Kurtzweil, chief data and analytics officer for UnitedHealthcare Employer and Individual, told Fierce Healthcare that the study “gives us a first of its kind sort of view of all the different variables that are impacting the health of various communities and employers.”
    • “As you dive a little bit further, it just becomes a bit remarkable how much of an impact those factors are making,” he said.”
  • Becker’s Hospital Review brings us up to date on prescription drug shortages.

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “St. Louis-based Ascension Healthcare brought in $231 million in operating income during its second quarter 2024 ended Dec. 31, compared to an operating loss of $291 million during the prior-year period.
    • “Ascension attributed its operational improvement in part to volume growth. Inpatient admissions increased 0.5% in thesix months ended Dec. 31, with same-facility admissions increasing 1.2% for the same period year over year.
    • “The health system said it slowed the pace of expense growth during the quarter. Total salaries, wages and benefits decreased $152 million in the six months ended Dec. 31, totaling $54.9 million for the quarter, as Ascension outsourced lab services and continued retention programs to reduce dependence on pricey staffing agencies.”
  • STAT News notes,
    • “DarioHealth, which makes apps for managing chronic diseases, today announced it will acquire digital mental health company Twill for $10 million in cash plus stock valued at over $20 million at the end of Tuesday trading. The move is a bet that a consolidated offering can attract a critical mass of large customers in a market where profits have been elusive.
    • “Founded in 2011, Dario started with a diabetes app targeted at consumers before expanding it to hypertension and weight management. It still maintains that direct-to-consumer business but has since shifted its focus to selling its suite of offerings, including a musculoskeletal care program it acquired in 2021, to health plans and employers in the hopes of reaching much larger patient populations. Recent updates aimed at making itself attractive to clients include a new offering built around popular, and expensive, GLP-1 weight loss drugs, and published real world data suggesting its tools can save clients money on downstream health care costs. With Twill, Dario adds a mental health app and related services, addressing a top demand of employers.”
  • Per Fierce Healthcare,
    • “Teladoc offered a weaker-than-expected forecast for 2024, projecting slower revenue growth as the telehealth market has become crowded with digital health players.
    • “The virtual care giant pulled in $661 million in revenue in the fourth quarter of 2024, up 4% from $638 million in the same period a year ago. Access fees revenue grew 4% to $574 million, and other revenue grew 3% to $87 million. U.S. revenue grew 2% to $565 million, and international revenue grew 15% to $96 million.
    • “The company’s BetterHelp virtual mental health business saw flat growth in the fourth quarter, bringing in $277 million. The weakness in BetterHelp sales was the result of lower direct-to-consumer marketing yield.
  • Beckers Payer Issues offers an interview with an Aetna Executive about the company’s Medicare Advantage business.
  • MedCity News calls our attention to a continuing interoperability problem.
    • “The healthcare industry has notoriously struggled with disconnected data systems and a lack of interoperability. When health information cannot be easily exchanged between different systems and providers, it leads to fragmented care, medical errors and delays in treatment — not to mention an incredible amount of frustration and inconvenience for both providers and patients.
    • “Software developers have been working hard in recent years to create tools and data sharing standards that foster a more cohesive and integrated approach. However, these tools have a serious adoption problem, experts said last week during a virtual panel held by Reuters Events.
    • “Alistair Erskine, Emory Healthcare’s chief information and digital officer, pointed out that most provider referrals are still done by fax, even though there are tools available to send them digitally. Most providers use EHRs that are able to pull a patient’s health information and transport it to the EHR of the new provider to whom they’ve been referred, he said.
    • “Despite data sharing standards like FHIR and DICOM — and despite “the fact that the data has already been digitized” — completing a provider referral is still not a smooth process, Erskine remarked. He stated that 98% of referrals are done by fax even though they could “of course” be done electronically.
    • “Even though the standards are there, we have to make sure that people safely log into their systems, and we have to make sure that people are able to find their patient in their systems. And if you navigate from one system to the next, that presents a barrier to entry. It’s easier to just take a piece of paper, write what you need and send it in a fax,” Erskine explained.”

Tuesday Tidbits

David Ermer–Congress, COVID-19, Medical / Rx research, Mental health care, NIH, No Surprises Act, Rx coverage, SDOH, Telehealth, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • Beckers Health IT informs us,
    • “U.S. lawmakers introduced bipartisan legislation Feb. 16 to better match patients with their EHRs.
    • “U.S. Reps. Mike Kelly, R-Pa., and Bill Foster, PhD, D-Ill., sponsored the Patient Matching and Transparency in Certified Health IT, or MATCH IT, Act of 2024.
    • “Patient matching errors have led to unnecessary expenses, medical mistakes, and even patient deaths,” Mr. Kelly said in a Feb. 16 news release. “This bipartisan legislation works to improve interoperability between healthcare systems and decrease these fixable matching errors, all while protecting patient privacy.”
  • STAT News tells us,
    • “Nearly four decades after its first conception, the first TIL therapy, an immunotherapy that harvests cancer-fighting immune cells from the patient’s own body, received accelerated approval from the Food and Drug Administration for advanced melanoma. The therapy, called Amtagvi or lifileucel from Iovance, is the first cell therapy approved for a solid tumor.
    • “It’s so exciting and gratifying,” said Allison Betof Warner, a cell therapy researcher and physician at Stanford University who has worked on Amtagvi. “This is a game-changing moment for our field. We’ve seen huge success of cellular therapy for hematologic malignancies, and we’ve yet to capitalize on that for solid tumors. This is hopefully the first of many to come.”
    • “In a Phase 2 clinical trial, titled C-144-01, 153 patients who had already been on a median of three prior lines of therapy received lifileucel, and 31% of them responded to therapy. “These are in very late line patients. They’ve exhausted every standard care option,” Betof Warner said. “The most promising part of this therapy for me is that 42% of patients who responded were still responding for 18 months or longer. It’s truly incredible.”
    • “The therapy is not expected to work for every patient, partially because the regimen has high toxicity. It will also be expensive. The therapy is expected to be priced at $515,000.”
  • Beckers Hospital Review adds, “Buzz for gene therapies is loud, but drugmakers struggle to get treatments off the ground.”
    • “A major barrier for many companies in the space is sheer cost to develop these advanced medical therapies. Though the Biden administration and CMS announced Jan. 30 plans to bring down prices for gene edited therapies, progress will take time. 
    • “The number of patients being treated with the existing gene therapies that are approved and available on the market is expected to decline year over year by nearly 33%, according to Bloomberg.”
  • Per the Food and Drug Administration,
    • “On Friday, the FDA published an Outbreak Advisory for an investigation of E. coli O157:H7 linked to raw cheddar cheese. The FDA recommends that consumers, restaurants, and retailers do not eat, sell, or serve Raw Farm-brand Raw Cheddar Cheese (block or shredded) and to throw it away. This is an ongoing investigation and the FDA will update the Advisory should additional consumer safety information become available.”
  • BioPharma Dive reports,
    • “AstraZeneca’s targeted cancer therapy Tagrisso can now be used alongside chemotherapy to treat a common type of locally advanced or metastatic lung tumor, following a Food and Drug Administration approval Friday.
    • “The FDA cleared Tagrisso together with chemotherapy based on results showing the combination reduced the risk of disease progression or death versus Tagrisso alone, which is currently the first-line standard for non-small cell lung cancer that harbors mutations in a gene known as EGFR.
    • “Over the weekend, meanwhile, AstraZeneca reported new clinical trial data showing Tagrisso outperformed placebo following chemoradiotherapy for Stage 3 EGFR-mutated non-small cell lung cancer that couldn’t be surgically removed. The results, which AstraZeneca will share with regulators, could further support early use of Tagrisso.”

From the public health and medical research front,

  • Axios points out,
    • “More than half of U.S. newborns now appear to be protected by new RSV vaccines, according to updated Centers for Disease Control and Prevention data.
    • “Why it matters: The virus is considered the second leading cause of death worldwide during the first year of a child’s life. The data suggests demand was strong despite broader vaccine skepticism and the potential for confusion over more childhood immunization options.”
  • The Wall Street Journal discusses a related RSV vaccine (Beyfortus) shortage — “A new antibody that protects babies from a deadly virus proved far more popular than drugmaker Sanofi expected.”
    • Beyfortus seller Sanofi in March last year set aggressive targets for how many doses to make, yet still underestimated demand. Some pediatricians delayed ordering immunizations because they didn’t know whether insurers would cover the $495 doses. And the U.S. government decided in August—months after Sanofi had locked in the number of doses it would make—to add the shot to the Vaccines for Children program, a federal initiative that covers children who are uninsured or on Medicaid, buying more than half of the doses.
    • Sanofi said it sought to distribute its shots equitably in the face of “unprecedented” demand and is working to increase supply for the next RSV season. 
  • HHS’s Agency for Healthcare Quality and Research issued a Medical Expenditure Panel Survey about “Characteristics of Young Adults Aged 18-24 Who Had Ever Used an Electronic Nicotine Product, 2021.”
    • “Nearly one-third (30.6 percent) of U.S. adults ages 18-24 reported ever having used an electronic nicotine product.
    • “More than one-third (38.3 percent) of non-Hispanic White young adults reported ever having used an electronic nicotine product, nearly double the rate for Hispanic young adults and 12 percentage points higher than for non-Hispanic Black young adults.”
  • Medpage Today notes,
    • “Nearly all medication abortions obtained via telehealth, whether via video or secure text messaging, were completed without further intervention and without adverse events, the prospective CHAT study found.
    • “Among over 6,000 abortions, 97.7% (95% CI 97.2-98.1) were completed without further intervention, and the completion rate was similar for patients who had video calls (98.3%) or used text messaging (97.4%), reported Ushma Upadhyay, PhD, MPH, of the University of California San Francisco, and colleagues.
    • “Less than 1% of patients had a serious abortion-related adverse event (0.25%) or were treated for an ectopic pregnancy (0.16%), and 1.3% of abortions were followed by emergency department visits, the authors wrote in Nature Medicine.”
  • The FEHBlog has subscribed to a Substack series called “Your Local Epidemiologist.”
    • “Your Local Epidemiologist (YLE)” is written by Dr. Katelyn Jetelina, M.P.H. Ph.D.—an epidemiologist, wife, and mom of two little girls. During the day, she is a senior scientific consultant to several organizations, including CDC. At night, she writes this newsletter. Her main goal is to “translate” the ever-evolving public health world so that people will be well-equipped to make evidence-based decisions. This newsletter is free, thanks to the generous support of fellow YLE community members.”
    • Check it out.
  • Medpage Today offers an expert medical opinion concerning
    • “News surfaced last week suggesting a potential shift in COVID-19 isolation guidanceopens in a new tab or windowfrom the CDC. The planned guidance, which is expected to be released this spring for public comment, indicates a significant switch in how COVID-19 is conceptualized. The guidance would bring COVID-19 into line with how other common respiratory viruses are managed: with isolation recommended until the individual has mild and improving symptoms, and is fever-free (without pharmaceutical aid) for 24 hours.”
    • “With the news of the proposed guidance, many voices rose up to immediately attack the proposed guidance as a capitulation and not evidence-based. This was similar to the refrain from opponents when the federal or state governments dropped or loosened mask requirements or guidance.
    • “I was not one of themopens in a new tab or window.
    • “Indeed, I welcome the proposed guidance change because it reflects the progress that has been made in the management of COVID-19. When evaluating this guidance, it is critical to understand that SARS-CoV-2, the cause of COVID-19, is situated among the myriad respiratory viruses that infect humans.”
  • Medscape lets us know,
    • “Availability of telehealth services for mental healthcare varies widely from state to state, a new study shows. One fifth of all facilities contacted reported no mental telehealth options and wait times for those that did ranged from 4 days to > 2 months, depending on the state.”
  • The National Institutes of Health announced,
    • “To prevent an emerging genomic technology from contributing to health disparities, a scientific team funded by the National Institutes of Health has devised new ways to improve a genetic testing method called a polygenic risk score. Since polygenic risk scores have not been effective for all populations, the researchers recalibrated these genetic tests using ancestrally diverse genomic data. As reported in Nature Medicine, the optimized tests provide a more accurate assessment of disease risk across diverse populations.
    • “Genetic tests look at the small differences between individuals’ genomes, known as genomic variants, and polygenic risk scores are tools for assessing many genomic variants across the genome to determine a person’s risk for disease. As the use of polygenic risk scores grows, one major concern is that the genomic datasets used to calculate the scores often heavily overrepresent people of European ancestry.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “After federal legislation protecting consumers from surprise medical bills was implemented, a growing number of medical claims were in network, according to a new analysis.
    • “The No Surprises Act went into effect on Jan. 1, 2022. From the fourth quarter of 2021 to the first quarter of 2022, in-network care as a percentage of all claim lines nationally increased 2.3%, according to the study by nonprofit Fair Health.
    • “It’s the latest research suggesting No Surprises has been successful in lowering the amount of unexpected out-of-network bills, though the rollout of the law has been tied up in lawsuits, and regulators currently face a backlog of billing disputes between payers and providers.”
  • and
    • “Insurers brace for continued Medicare Advantage medical costs. The big question coming out of the health insurance earnings season is how much elevated utilization among seniors is carrying over into 2024.”
  • EndPoint News points out,
    • “Cigna’s venture unit just made a bet on a startup focused on cardiometabolic conditions that wants to play a role in prescribing GLP-1 medications.
    • “9amHealth said on Tuesday it raised $9.5 million in a Series A extension led by The Cigna Group Ventures. It adds to $16 million from the Series A raised in April 2022 by the startup, which provides virtual visits, prescriptions and lab tests related to conditions like hypertension, type 2 diabetes and weight management.”
    • “Cigna’s investment comes as health plans and pharmacy benefit managers (the PBM Express Scripts is a subsidiary of Cigna) are grappling with how to cover the high cost of GLP-1 medications for conditions like type 2 diabetes and weight loss. It’s among the first investments from an insurance company’s venture arm into a startup prescribing the drugs, which have turned into huge blockbusters and prompted broad conversations about their cost — and benefit — to the healthcare system.”
  • The Wall Street Journal reports,
    • “Pharmaceutical companies are spending billions of dollars to develop drugs that can target cancer like guided missiles.
    • “Therapies known as antibody-drug conjugates, which help deliver chemotherapy directly to tumors, have gotten most of the attention and are farthest along: 
    • “Pfizer’s $43 billion acquisition of biotech Seagen Inc. last year underscored how hot the field has become. 
    • “More quietly, a concept known as radiopharmaceuticals is also gaining ground. In recent months, interest in this space has led to a rise in dealmaking. The idea is similar to ADCs in that a patient receives an old treatment—in this case, a radioactive particle instead of chemotherapy drugs—but it is bound with a molecule that can chase down tumor cells. The technology is at a more nascent stage, but a steady growth of venture capital money and acquisitions by large pharmaceutical companies means this could well become a key part of the fight against cancer in the next decade or so.”
  • HR Dive discusses an EEOC lawsuit against a Georgia retirement community “for firing a 78-year-old receptionist after repeatedly asking her to retire. “The right to decide a retirement age lies with an employee, not their employer,” an EEOC official said.

Thursday Miscellany

David Ermer–ACA, CMS, Employee Wellness Programs, Mental health care, OPM, SDOH, U.S. Healthcare, Wellness–

As you may be able to tell, it’s a late FEHBlog post because the FEHBlog was returning home to Dripping Springs, TX, last night from our Nation’s capital.

In case, here are some highlights from Washington DC.

  • The GAO released a troubling report on our country’s fiscal health this week. Here’s a link to a Wall Street Journal Opinion Watch podcast about the report. The podcast is about 20 minutes long, and it may make your hair stand on edge.
  • Mercer Consulting discusses changes to the RxDC reports due annually on June 1.
    • “CMS released instructions for the third prescription drug data collection (RxDC) reports due June 1, 2024 – and they may cause plan sponsors to reconsider whether they need to make “plan level” submissions, instead of relying on their vendors to make “aggregate” submissions on their behalf. The good news is that the instructions largely mirror prior versions, so plan sponsors should be able to build off prior RxDC reporting efforts. However, for the first time, CMS plans to enforce the “aggregation restriction”—a provision in the 2021 regulations that CMS suspended for the first two reporting cycles. As explained [in the article], the reinstated aggregation restriction may cause headaches for some plan sponsors, who find that they can no longer rely on their PBM’s aggregate submission of pharmacy data but must instead submit plan level data. Other plan sponsors may welcome the opportunity to do a plan level submission so they can obtain otherwise unavailable prescription drug data.”
  • Per Govexec,
    • “With federal budget talks still unresolved less than a month away from Congress’ latest deadline, the Office of Personnel Management said Friday that the decade-long pay freeze for senior political appointees like Vice President Kamala Harris and others will remain in effect.
    • “In a Feb. 9 post, OPM Director Kiran Ahuja said that under January’s continuing resolution that extended federal funding to agencies until March 1 and 8, certain senior political appointees will continue to see their payable pay rates remain at current levels at least through the latter budget deadline, when Congress will have to decide whether it will continue to fund the federal government. 
    • “Future Congressional action will determine whether the pay freeze continues beyond March 8, 2024,” Ahuja said. “Until such time, the OPM guidance issued on Dec. 21, 2023, regarding the pay freeze for certain senior political officials continues to be generally applicable in applying the pay freeze in 2024.”

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “There isn’t a silver bullet to maintaining mental acuity or warding off dementia [as we age], scientists of aging say. But a combination of genetics, healthy lifestyle habits and factors such as cleaner air and good education have been linked to prolonged mental agility.  * * *
    • “Genetics is thought to play a role in brain maintenance, as does diet, exercise and a person’s risk of vascular disease. More education, mental stimulation and social connectivity have been associated with improved cognitive reserve.
    • “Better brain maintenance and cognitive reserve might help keep symptoms of dementia at bay. Almost 50% of people 40 and older think they will likely develop dementia, according to a 2021 AARP survey. The actual number of U.S. adults 65 and older with dementia is closer to 10%, a 2022 study found. * * *
    • “Sleeping too little—or too much—can also lead to cognitive problems. Activities including yoga and tai chi, the Chinese martial art, could help improve cognitive function, research suggests. 
    • “Hearing loss is a risk factor for dementia, too. Lost hearing might cause the brain to atrophy more quickly and can make people more isolated, said Dr. Dung Trinh, chief medical officer of the Healthy Brain Clinic. Hearing aids can help preserve mental fitness.”
  • AHA News adds,
    • “About half of U.S. health care workers have witnessed racial discrimination against patients and say discrimination against patients is a crisis or major problem, according to a survey released Feb. 15 by the Commonwealth Fund and African American Research Collaborative. Younger workers and workers of color were more likely than their older or white counterparts to say they witnessed discrimination, as were workers at facilities with more patients of color. About six in 10 Black health care workers and four in 10 Latino, Asian American and Pacific Islander workers say they have been discriminated against because of their race or ethnicity. 
    • “While most health care workers see positive efforts from employers to address discrimination, a majority of Black, Latino, and AAPI workers worry about retaliation if they raise discrimination concerns. When asked about potential solutions, more than two-thirds of health care workers thought the following could help: providing an easy way to anonymously report situations involving racism or discrimination; creating opportunities to listen to patients and health care professionals of color; examining treatment of non-English-speaking patients; and training health care staff to spot discrimination.” 
  • Employee Benefit News offers three suggestions on how employers can help employees hold cancer at bay with preventive screenings.
    • “A new report from healthcare platform Color Health shows that although 80% of employers are concerned by rising cancer costs and 96% of benefits leaders agree early detection is the best solution, the majority of focus is devoted to post-diagnosis treatment, rather than evidence-based screenings. 
    • “According to the report, three out of four employers say they are placing more emphasis on screening, early detection and risk prevention efforts, but they are going to have to go beyond their current benefits setup: Only a quarter believe their current health plans meet the screening needs of their workforce, and three-quarters say employees are not being adequately screened by their primary care provider. Leaders report that 40% of employees are not compliant with screenings in general, and for the most deadly forms of cancer — lung and bronchus — the American Lung Association reports that only 6% of people eligible get screened. 
    • “The assumption [has been that] if we cover mammograms and colonoscopies and lung CTs, then people will actually get them, and that’s turned out to be false,” says Othman Laraki, Color Health’s CEO. “The big driver for that is that for non-acute care services, availability is not the same thing as access.” 

Midweek Update

David Ermer–Congress, OPM, Rx coverage, SDOH, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC

  • The American Hospital Association News reports,
    • “The House Energy and Commerce Subcommittee on Health Feb. 14 held a hearing on AHA-supported legislation to reauthorize through 2029 the Dr. Lorna Breen Health Care Provider Protection Act (H.R. 7153), which provides grants to help health care organizations offer behavioral health services for front-line health care workers. The bill also would reauthorize a national campaign that provides hospital leaders with evidence-based solutions to support worker well-being. Without congressional action, the law will expire at the end of this year.  
    • “Among other measures, the hearing highlighted legislation (H.R. 6960) to reauthorize the Emergency Medical Services for Children Program, which provides funding for equipment and training to help hospitals and paramedics treat pediatric emergencies. AHA advocated for funding the program at $28 million for fiscal year 2024.”
  • According to HHS press releases,
    • “On Wednesday, February 14, 2024, U.S. Department of Health and Human Services (HHS) Secretary Xavier Becerra and leaders from across HHS met with state leaders and representatives from the National Governors Association (NGA) to announce the launch of HHS Secretary’s Postpartum Maternal Health Collaborative. The six states that have agreed to participate in the Postpartum Maternal Health Collaborative are Iowa, Massachusetts, Maryland, Michigan, Minnesota, and New Mexico.
    • “This new collaborative seeks to bring together state experts, local providers, community partners, and federal experts to develop a better understanding of the challenges being experienced among the postpartum population and support new solutions that will improve postpartum mortality. In conjunction with this new HHS collaborative, the National Governors Association launched their Improving Maternal and Child Health in Rural America State and Territory Policy Learning Collaborative. This new initiative will focus on implementing policy changes to improve maternal and child health outcomes in rural America.”
  • and
  • and
  • Meritalk adds,
    • “The Office of Personnel Management (OPM) today released its 2023 Equity Action Plan, which spotlights data as a tool to better understand barriers and advance diversity, equity, inclusion, and accessibility (DEIA) in the Federal workforce.
    • “OPM plans to advance the equitable participation of Federal employees in the Federal Employees Health Benefits (FEHB) Program by conduct a mixed methods study that will access and analyze data to identify barriers and potential solutions to accessing health benefits.”
  • Per BioPharma Dive,
    • “The Food and Drug Administration has approved a new regimen for pancreatic cancer, clearing Ipsen’s Onivyde to be used with chemotherapy in treating recently diagnosed metastatic tumors, the company announced Tuesday.
    • “Onivyde, which Ipsen bought from Merrimack Pharmaceuticals seven years ago, has been available for second-line use in pancreatic cancer, after tumor progression. The new OK will give physicians the option to use it earlier.
    • “The FDA’s decision was based on results from a Phase 3 trial Ipsen ran involving 770 people with metastatic pancreatic cancer. The data showed that Onivyde plus the chemo regimen FOLFOX improved survival and delayed tumor progression for longer than a combination of the drugs Abraxane and gemcitabine.”
  • Beckers Hospital Review informs us,
    • “On Feb. 14, the FDA approved Aurlumyn, the nation’s first treatment for severe frostbite. 
    • “Severe frostbite, which is estimated to affect 1% of the general population, happens when the skin and underlying tissue are frozen and blood flow is stopped. Aurlumyn (iloprost) is an injection that works by opening blood vessels, preventing blood from clotting.
    • “The skin damage from severe frostbite sometimes requires finger and toe amputations. In a trial of 47 patients, a bone scan after one week predicted that zero of the 16 study participants who received iloprost alone would need an amputation, compared to 3 of the 16 who received the drug with another experimental frostbite therapy and 9 of 15 who received another unapproved therapy alone. 
    • “Actelion Pharmaceuticals US received the drug approval.” 
  • STAT News tells us,
    • “An advisory panel to the Food and Drug Administration voted in favor of a new device from Abbott meant to treat patients with tricuspid heart valve disease. All but one of the 14 panelists said the treatment’s benefits outweighed its risks. The FDA tends to follow advisory panel recommendations.
    • “If we can help symptoms with this at a low cost in terms of risk, I think it makes a lot of sense,” said James Blankenship, a panelist and cardiologist at the University of New Mexico. 
    • “The device is called the TriClip, and it addresses a disease called tricuspid regurgitation: a heart condition that causes blood to leak backward through the tricuspid heart valve. The condition impacts 1.6 million people in the United States. Symptoms include fatigue, swelling, and atypical heart rhythms. In severe cases, the condition can lead to heart failure. 
    • “Current treatment options are drugs to reduce extra fluids or correct heart rhythm, or in more serious cases, surgery to correct the valve. Abbott hopes to cater to patients for whom medications are ineffective and surgery is too risky. The device, which clips together the disparate parts of the valve, is delivered via a catheter rather than open heart surgery.” 
  • Per an HHS press release,
    • “Today the Federal Trade Commission (FTC) and the U.S. Department of Health and Human Services (HHS) jointly issued a Request for Information to understand how the practices of two types of pharmaceutical drug middlemen groups—group purchasing organizations (GPOs) and drug wholesalers—may be contributing to generic drug shortages.
    • “In the Request for Information (RFI) – PDF, the FTC and HHS are seeking public comment regarding market concentration among large health care GPOs and drug wholesalers, as well as information detailing their contracting practices. The joint RFI seeks to understand how both GPOs and drug wholesalers impact the overall generic pharmaceutical market, including how both entities may influence the pricing and availability of pharmaceutical drugs. The joint RFI is asking these questions to help uncover the root causes and potential solutions to drug shortages.”
  • Per Govexec,
    • “Last December, lawmakers included a new provision in the 2024 National Defense Authorization Act clarifying that “honorable” active duty military service will count toward the FMLA’s eligibility requirements, and in turn to the federal workforce’s paid parental leave benefit.
    • “In a memo to agency heads Tuesday, OPM Director Kiran Ahuja outlined how federal agencies should implement the tweak. Specifically, federal employees whose military service would put them over a year of federal service should “immediately” become eligible for the two forms of leave, dating back to Dec. 22, 2023, the day President Biden signed the NDAA into law.”

From the public health and medical research front,

  • The National Institutes of Health explains,
    • “Women who receive an mRNA-based COVID-19 vaccination or booster during pregnancy can provide their infants with strong protection against symptomatic COVID-19 infection for at least six months after birth, according to a study from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. These findings, published in Pediatrics(link is external), reinforce the importance of receiving both a COVID-19 vaccine and booster during pregnancy to ensure that infants are born with robust protection that lasts until they are old enough to be vaccinated.
    • “COVID-19 is especially dangerous for newborns and young infants, and even healthy infants are vulnerable to COVID-19 and are at risk for severe disease. No COVID-19 vaccines currently are available for infants under six months old. Earlier results from the Multisite Observational Maternal and Infant COVID-19 Vaccine (MOMIv-Vax) study revealed that when pregnant volunteers received both doses of an mRNA COVID-19 vaccine, antibodies induced by the vaccine could be found in their newborns’ cord blood. This suggested that the infants likely had some protection against COVID-19 when they were still too young to receive a vaccine. However, researchers at the NIAID-funded Infectious Diseases Clinical Research Consortium (IDCRC), which conducted the study, did not know how long these antibody levels would last or how well the infants would actually be protected. The research team hoped to gather this information by following the infants through their first six months of life.”
  • STAT News lets us know,
    • “Public health messages have told us for decades that if you smoke, you should quit. And if you don’t smoke, don’t start. But a new study suggests smoking may be even worse than we thought.
    • “The study, published Wednesday in Nature, underscores the importance of never lighting up that first cigarette, based on its conclusion that smoking has much longer harmful effects on immune responses than previously understood.
    • “People who quit smoking soon regained normal function of their immune system’s power to mount fast and general innate responses to bacteria or viruses. But researchers also found that slower, more targeted adaptive T cell defenses remembered from past pathogens did not come back so soon after that last cigarette.
    • “We could see that the effect of active smoking on inflammatory responses to bacterial stimulation were lost when individuals quit smoking,” senior study author Darragh Duffy of the Institut Pasteur said about the innate response on a call with reporters. “In contrast, the effect on the T cell response was maintained for many years after the individuals quit smoking.”
  • STAT News further reports
    • “The HPV vaccine is a success story in some countries, including the U.K., where it beat estimates of how long it would take to nearly eliminate cervical cancer, the disease it is designed to prevent, among young women. And that was more than two years ago. Last month, a study in Scotland found no cases of cervical cancer in women who were vaccinated before age 14. In the U.S., it’s still a work in progress. A CDC report out today tells us that 39% of children age 9 to 17 had received at least one dose of the HPV vaccine, with rates rising with age from 7% in the youngest kids  to 57% in the oldest. Some differences in who got vaccinated:
      • “By insurance: Private health insurance (42%), Medicaid (37%), other government coverage (30%), and no insurance (21%).
      • “By neighborhood: Large central metropolitan areas (4o%), large fringe metropolitan areas (41%), and medium and small metropolitan areas (39%), and nonmetropolitan areas (30%).” 

From the U.S. healthcare business front,

  • Fierce Healthcare points out,
    • “Elevance Health’s $2.5 billion acquisition of Blue Cross and Blue Shield of Louisiana is on pause yet again amid concerns about the impact on competition.
    • “BCBSLA posted a statement on its website Wednesday, saying that while the insurer wants to find a “strong partner” that can support it into the future, the team has also heard the skepticism in the Pelican State.
    • “We continue to hear from our stakeholders that they want Blue Cross and Blue Shield of Louisiana to remain their trusted partner in their healthcare journey, and we pursued this transaction to help us do exactly that — by changing for the better,” the insurer said. “However, it is clear that our stakeholders need more time and information to understand the benefits of the changes we have proposed.”
    • “This is why we have decided to again pause the process in our proposed transaction with Elevance Health,” BCBSLA said.”
  • BioPharma Dive notes,
    • “Sage Therapeutics said its new medicine, the first oral treatment for postpartum depression, is off to an encouraging start, with signs of demand from prescribing doctors.
    • “Sage and partner Biogen began selling the drug, Zurzuvae, in mid-December and on Wednesday Sage shared the first data from an estimated 10 days when doctors’ offices were open at the end of the month. During that time, physicians wrote about 120 prescriptions for the drug and 50 prescriptions were shipped and delivered to patients.”

Happy Lincoln’s Birthday!

David Ermer–CDC, Congress, FDA, Generative AI, Medical / Rx research, SDOH, U.S. Healthcare–

Our greatest President, Abraham Lincoln, was born on February 12, 1809, in Hodgenville, Kentucky.  RIP.

From Washington, DC,

  • The Federal Times reports,
    • “By the second week in February lawmakers are supposed to be busy picking apart the White House’ budget request with an eye towards policy debates in coming months. But the process hasn’t worked that way in recent years.
    • “Administration officials earlier this month announced their fiscal 2025 budget proposal would arrive more than a month late — on March 11 — marking the fourth consecutive year that Biden has missed the statutory deadline for a spending plan in early February.”
  • Federal News Network explains,
    • “For decades, Federal Executive Boards have been at the forefront of bridging together the nationwide federal workforce. Stretching from Honolulu, Hawaii, to Boston, Massachusetts — Seattle, Washington, to South Florida, and many places in between, FEBs have a large network already underway. Even so, recent changes to the decades-old program will refresh how FEBs function moving forward.
    • “Federal News Network has spent months connecting with FEB leaders all across the country to learn more about what they do, the impact they have had in their local areas, and their plans in store for the future. Over the next week, we’ll be focusing on four different regions of the country — one per day:
    • “Eastern Region (Feb. 12) | Southern Region (Feb. 13) | Central Region (Feb. 14) | Western Region (Feb. 15).”
    • Check it out.
  • According to this press release,
    • “The U.S. Department of Health and Human Services (HHS), through the Office of the National Coordinator for Health Information Technology (ONC), announced today that two additional organizations—CommonWell Health Alliance and Kno2—have been designated as Qualified Health Information Networks™ (QHINs™) capable of nationwide health data exchange governed by the Trusted Exchange Framework and Common AgreementSM (TEFCASM). ONC has led a multi-year, public-private process alongside its Recognized Coordinating Entity®, The Sequoia Project, Inc., to implement TEFCA, which was envisioned by the 21st Century Cures Act to support nationwide interoperability. TEFCA became operational in December 2023 with the designation of the first five QHINs—eHealth Exchange, Epic Nexus, Health Gorilla, KONZA, and MedAllies.
    • “CommonWell Health Alliance and Kno2 can immediately begin supporting the exchange of data under the Common Agreement’s policies and technical requirements along with the other designated QHINs. QHINs are the pillars of TEFCA network-to-network exchange, providing shared services and governance to securely route queries, responses, and messages across networks for health care stakeholders including patients, providers, hospitals, health systems, payers, and public health agencies.”
  • STAT News reports,
    • “A federal district judge [in Austin, Texas] on Monday granted the Biden administration’s request to dismiss a lawsuit challenging Medicare’s new drug price negotiation program from the drug industry lobbying organization PhRMA. * * *
    • “However this [decision] wasn’t about the substance of those groups’ arguments. The Texas judge dismissed one of the co-plaintiffs, the National Infusion Center Association, from the case because it didn’t have subject matter jurisdiction to bring the lawsuit. And because NICA was the only party to the lawsuit in Texas, the whole case got tossed.
    • “That means the Biden administration still has to brace for battles in Washington D.C., New Jersey, and Delaware, where a judge recently heard arguments in an AstraZeneca suit against the negotiation plan.”

From the public health and medical research front,

  • MedPage Today points out,
    • “Blood protein profiles predicted future dementia in healthy adults, a large longitudinal study showed.
    • “Blood samples from over 50,000 people in the U.K. Biobank showed that four proteins — glial fibrillary acidic protein (GFAP), neurofilament light (NfL), growth differentiation factor-15 (GDF-15), and latent-transforming growth factor beta-binding protein 2 (LTBP2) — consistently were associated with subsequent all-cause dementia, Alzheimer’s disease, or vascular dementia over 14 years, according to Jin-Tai Yu, MD, PhD, of Fudan University in Shanghai, and co-authors.”
  • The Hill reports,
    • A report from the Centers for Disease Control and Prevention (CDC) found that the rate of preterm births rose by 12 percent nationally between 2014 and 2022. 
    • Manisha Gandhi, chair of the American College of Obstetricians and Gynecologists Clinical Practice Guidelines Committee, told The Hill’s Alejandra O’Connell-Domenech that several factors could be at play. 
    • “We are seeing more patients with obesity, higher risks for hypertension or preeclampsia … seeing more diabetes,” Gandhi said. “Potentially some of those risk factors that lead to earlier delivery could be playing a role.” 
    • Environmental factors such as exposure to hormone-disrupting chemicals and air pollution may also be contributing to the rise in preterm births. 
  • The Wall Street Journal lets us know,
    • “Uterine is the only cancer for which survival has fallen in the past four decades, the American Cancer Society said. The disease will kill some 13,250 women in the U.S. this year, the group estimates, surpassing ovarian cancer to become the deadliest gynecologic cancer. 
    • “Case rates have been increasing by about 1% annually over the past decade, with steeper rises for Black and Hispanic women. Rising obesity rates are partly to blame because excess weight increases estrogen levels that can fuel the cancer, researchers said. And fewer women are getting their uteruses removed to treat abnormal bleeding or noncancerous fibroids, leaving them exposed to the risk cancer develops in the organ as they age.
    • “But those factors alone don’t explain the rise. The disease, more common after menopause, is rising across age groups including in women under 50 for reasons that aren’t completely clear. * * *
    • “Uterine cancer, also called endometrial cancer, comes in two forms. The more common one is slow-growing, linked to elevated estrogen levels, and curable when caught early. The rarer type isn’t hormonal and is harder to treat. Cases of this more aggressive kind are increasing faster and driving rising death rates. 
    • “Chemical hair straighteners have been linked to uterine cancer risk. The Food and Drug Administration plans in July to propose a ban on formaldehyde in hair straightening or smoothing products. 
    • “I don’t think it’s just hair products, sadly,” said Dr. Premal Thaker, a gynecologic surgeon at Siteman Cancer Center in St. Louis. “There’s more diabetes, more obesity, and there’s probably something else that we just don’t know.” 
  • Per Fierce Healthcare,
    • “An “overwhelming” 88% of respondents reporting healthcare discrimination in a new screening initiative were Black, according to a new Humana study.
    • “The report focused on the structural determinants of health as opposed to the more common social determinants of health. While such social determinants center on the conditions in which people live, work, play, learn and worship, structural determinants focus on the economic and social experiences and policies that influence health such as discrimination and health literacy. Both social and structural determinants are often interrelated, according to the study authors. 
    • “The study, published in the American Journal of Managed Care, is the first of its kind by a U.S. insurer to focus on the structural determinants of health, aspects which are “critical” but often overlooked, Humana said.
    • “The healthcare discrimination finding was somewhat problematic given a small sample size and how exactly to frame and ask questions but was nevertheless quite instructive, said co-author J. Nwando Olayiwola, M.D., chief health equity officer and senior vice president at Humana.” 
  • According to an NIH press release,
    • “Scientists have identified an area within the brain’s frontal cortex that may coordinate an animal’s response to potentially traumatic situations. Understanding where and how neural circuits involving the frontal cortex regulate such functions, and how such circuits could malfunction, may provide insight about their role in trauma-related and stress-related psychiatric disorders in people. The study, led by scientists at the National Institute on Alcohol Abuse and Alcoholism (NIAAA), a part of the National Institutes of Health, was published in Nature.
    • “Experiencing traumatic events is often at the root of trauma-related and stress-related psychiatric conditions, including alcohol use disorder (AUD),” said the study’s senior author, Andrew Holmes, Ph.D., senior investigator in NIAAA’s Laboratory of Behavioral and Genomic Neuroscience. “Additionally, witnessing others experience traumatic events can also contribute to these disorders.”
  • MedPage Today explains how patients are using artificial intelligence tools.
    • “It’s no secret that patients have been using Dr. Google for years. The introduction of ChatGPT is ushering in a new era. ChatGPT and other types of artificial intelligence have their drawbacks. Still, they can offer a range of benefits to healthcare providers and patients alike.”

From the U.S. healthcare business front,

  • Per Fierce Healthcare,
    • “Kaiser Permanente wrapped up its fiscal year with $329 million of operating income (0.3% operating income), net income of $4.1 billion and more than $100 billion in both operating revenues and expenses, the Oakland, California-based nonprofit announced Feb. 9.
    • “The rebound performance follows sizable losses during 2022, when the system logged a $1.3 billion operating loss (-1.3% operating income) off of $95.4 billion in operating revenues and $96.7 billion in operating expenses. It had also weathered a net loss of $4.5 billion due to a $3.2 billion loss across “other income,” which largely reflected down investments.
    • “I want to thank the people of Kaiser Permanente for their hard work in 2023 to provide members and patients with a positive experience at all touch points while also embracing new ways to drive efficiencies, improve access, and advance health outcomes,” said Chair and CEO Greg A. Adams said in a press release sharing the year’s top-line financial results. “Together, we navigated another challenging year and are on a path to deliver on our mission and bring our distinct brand of value-based care to more people.”
  • Per BioPharma Dive,
    • “Gilead Sciences will acquire CymaBay Therapeutics and the biotechnology company’s liver disease drug in a $4.3 billion deal announced Monday.
    • “The proposed buyout would hand Gilead an experimental medicine for primary biliary cholangitis, or PBC, a chronic condition characterized by the toxic build-up of bile acid in the liver. CymaBay disclosed Monday that the Food and Drug Administration has accepted its application for the drug, called seladelpar, and will decide on approval by mid-August.”
  • Health IT Analytics notes,
    • “The American Health Information Management Association (AHIMA) has launched its AI Resource Hub to provide healthcare and health information (HI) stakeholders with knowledge around the use of non-clinical artificial intelligence (AI) tools.
    • “In response to the rise of AI utilization in healthcare, AHIMA partnered with Alazro Consulting to interview experts in the space and AI implementers representing over 200 hospitals and 1,000 clinics across the United States. These structured interviews were then used to develop AHIMA’s newest white paper, upon which the AI Resource Hub is based.  
    • “One of the white paper’s major findings is that the use of AI in healthcare is growing as organizations turn to the technology to optimize efficiency and workflows. These tools are often deployed to support health information management, clinical care, operations, and revenue cycle management.”
  • Fierce Healthcare identified its Fierce 15 of 2024.
    • “This year’s 15 honorees recognized a significant gap in the market, whether it’s for personalized GI care, opening up access to mental health or addressing loneliness among seniors with a robot companion. They then set to work to build forward-thinking solutions to address a specific problem.
    • “They are all taking a fresh angle to long-standing problems in healthcare, such as harnessing AI to streamline clinical documentation or using virtual care to treat the root causes of obesity.”

Tuesday’s Tidbits

David Ermer–CDC, Congress, FDA, Medical / Rx research, NCQA, Obesity, SDOH, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • The FEHBlog listened to the House Oversight and Accountability Committee’s markup of HR 6283, the Delinking Revenue from Unfair Gouging Act. Is there such as thing as fair gouging? In any case, the FEHBlog was relieved by the amount of bipartisan opposition to the bill. However, as explained in this STAT News article, the Committee Chairman James Comer (R Ky) steered an amended version of the original bill through his Committee this morning. Like Committee members with doubts about the bill, the FEHBlog looks forward to the Congress Budget Office report on the measure.
  • The American Hospital Association (AHA) News reports
    • “In a statement submitted to the House Ways and Means Committee for a hearing Feb. 6 on chronic drug shortages, AHA recommended Congress enact legislation to diversify manufacturing sites and sources for critical pharmaceutical ingredients; support an increase in end-user and supply chain inventories for critical medications; develop a rating system for drug maker quality management processes; identify essential drugs needing more domestic manufacturing capacity; and require drug makers to disclose where their products are made and when demand for essential drugs spikes.” 
  • and
    • “The Health Resources and Services Administration Feb. 6 requested vendor proposals to support changes to governance, technology and operation of the Organ Procurement and Transplantation Network, as authorized by Congress last year. HRSA also directed the current OPTN vendor, the United Network for Organ Sharing, to standardize and update data reporting for greater accountability and equity in organ procurement and transplant practices. HRSA indicates that the scope and scale of the contract awards will be contingent on final 2024 appropriations.”
  • The Department of Health and Human Services announced,
    • releasing the National Public Health Strategy to Prevent and Control Vector-Borne Diseases in People (VBD National Strategy). As directed by the 2019 Kay Hagan Tick Act—named after the U.S. Senator who died due to complications from a tickborne illness—HHS led a four-year process with civilian agencies and defense departments to deliver this strategy. Co-led by the HHS Office of the Assistant Secretary for Health and the Centers for Disease Control and Prevention, the strategy identifies and describes federal priorities to detect, prevent, respond to, and control diseases and conditions caused by vectors in the United States.
    • “Vector-borne diseases are a global threat, with national security, economic, and health implications for the United States. As the federal government continues to proactively strengthen its response to this threat, HHS and CDC plan to develop future iterations of the VBD National Strategy with opportunities for public engagement. Read the VBD National Strategy.”
  • Beckers Hospital Review tells us,
    • “Respiratory syncytial virus vaccinations could soon extend to adults aged 50-59. 
    • “Arexvy, which was initially approved by the FDA in May 2023 for administration in adults over 60, has been granted priority review in the U.S. for use in adults ages 50-59.
    • “If approved, it will become the first RSV vaccine available for the age group, according to a Feb. 6 news release. 
    • “The FDA is slated to make a decision on the drug’s approval for the new age group by June 7.”

From the public health and medical research front,

  • Medscape informs us,
    • “Lowering the recommended age for baseline prostate-specific antigen (PSA) would reduce prostate cancer deaths by about 30% in Black men without significantly increasing the rate of overdiagnosis, according to new screening guidelines from the Prostate Cancer Foundation.
    • “Specifically, baseline PSA testing in Black men should begin at age 40-45, sooner than current guidelines recommend, and should be followed by regular screening intervals, preferably annually, at least until age 70, a multidisciplinary panel of experts and patient advocates determined based on a comprehensive literature review.”
  • Per the Food and Drug Administration,
    • On Monday, the FDA issued an outbreak advisory warning consumers not to eat, sell, or serve recalled brands of cheeses, sour creams (cremas), or yogurts manufactured by Rizo Lopez Foods, Inc. The FDA and CDC, in collaboration with state and local partners, are investigating illnesses in a multi-year, multistate outbreak of Listeria monocytogenes infections linked to queso fresco and cotija cheeses manufactured by Rizo Lopez Foods, Inc., of Modesto, California. There are 26 illnesses with 23 hospitalizations in 11 states. The firm has recalled several dairy products and has temporarily ceased the production and distribution of these products while their investigation is ongoing. The FDA’s investigation is ongoing, and the FDA will continue to update this advisory as information becomes available.”
  • Per KFF,
    • “About 1 in 5 adolescents report symptoms of anxiety or depression, according to a KFF analysis of a new federal survey of teen health.
    • “While some teens are getting mental health care, a significant share say they are not receiving the therapy they need due to costs, fear of what others will think, and/or not knowing how to get help.”
  • The American Medical Association lets us know what doctors wish their patients knew about iron deficiency.
  • Healio notes,
    • “Infants aged younger than 3 months and children with a history of prematurity experience the highest rates of hospitalization for respiratory syncytial virus, according to study findings published in Pediatrics.
    • “Last year, two new tools became available to combat RSV, the leading cause of infant hospitalization in the United States: a vaccine for pregnant people and a new monoclonal antibody.” * * *
    • “Most RSV-associated hospitalizations occurred in healthy, term infants,” Meredith L. McMorrow, MD, MPH,a researcher in the CDC’s Coronavirus and Other Respiratory Viruses Division said. “This is why allbabies need protection from either maternal RSV vaccination or nirsevimab during their first RSV season.”
  • Beckers Hospital Review offers five Ozempic updates.

From the U.S. healthcare business front,

  • BioPharma Dive reports,
    • “Sales of Eli Lilly’s diabetes drug Mounjaro exceeded $5 billion in 2023, its first full year on the market, the company said Tuesday, in the latest sign of surging demand for the therapy and other medicines of its kind.
    • “Mounjaro’s fast launch helped drive Lilly’s revenue last year to $34 billion, a 20% increase over 2023. Fourth quarter revenue of $9.4 billion eclipsed analysts’ consensus expectations by 5%, Leerink Partners’ David Risinger wrote in a note to clients.
    • “Lilly said Mounjaro now accounts for 27% of total prescriptions in the U.S. for injectable “incretins,” the fast-selling group of drugs that work by modulating hormones that control insulin production. Sales of an older drug in this class, Lilly’s Trulicity, fell 4% in 2023 to $7 billion, but still led Lilly’s business.
    • “The obesity drug Zepbound, which contains the same active ingredient as Mounjaro, launched in the fourth quarter and brought in sales of $176 million through Dec. 31.”
  • STAT News adds,
    • “Eli Lilly reported during its fourth-quarter earnings call that tirzepatide, which is sold commercially as Mounjaro or Zepbound, succeeded in a Phase 2 test as a treatment for the liver disease MASH. Around 74% of adults in the trial taking the drug were free of MASH after 52 weeks, compared to approximately 13% of the placebo group.”
  • Wait, there’s more from Bloomberg,
    • “Eli Lilly & Co.’s blockbuster diabetes drug Mounjaro, which is commonly used off-label for weight loss, is again in short supply due to increased demand.
    • “There will be limited availability of higher doses of the treatment through early March, according to a US Food and Drug Administration database that tracks shortages. So far, the FDA doesn’t list Mounjaro’s sister drug Zepbound, which is approved for weight loss, on its shortage list, though the two contain the same active ingredient.
    • “The company is continuing to ship all doses to wholesalers, but anticipates intermittent backorders of higher doses over the next month, a Lilly spokesperson said in an emailed statement. 
    • “We recognize this situation may cause a disruption in people’s treatment regimens and we are moving with urgency to address it,” the spokesperson said.”
  • BioPharma Dive points out
    • “The Japan-based pharmaceutical firm Eisai had hoped that, by the end of March, 10,000 patients in the U.S. would be taking its closely watched drug for Alzheimer’s disease. But that goal now seems lofty, following updates in the company’s latest earnings report.
    • “Eisai developed the drug, called Leqembi, in partnership with Biogen, and is leading its commercialization. As with an earlier Alzheimer’s therapy from the two companies, Leqembi’s launch started off slow. Yet Eisai and Biogen have argued that recent decisions from drug regulators and insurers should significantly increase both prescriptions and sales.
    • “Still, growth doesn’t appear to be coming as quickly as the companies want. Eisai recorded 1.1 billion yen, or roughly $7.4 million, in revenue from Leqembi between October and December — around half of what Wall Street analysts had generally expected, according to Michael Yee of the investment bank Jefferies.
    • The company also said Leqembi had been administered to a total of 2,000 U.S. patients as of Jan. 26, with another 8,000 or so on a waiting list. Eisai maintains the 10,000 patient milestone could be hit in a few months, though the team at Jefferies believes it might take longer “given launch dynamics have been slow to begin with.”
  • Beckers Hospital Review reports,
    • “San Francisco-based UCSF Health has signed a $100 million definitive agreement with San Francisco-based Dignity Health to take on two of its hospitals: Saint Francis Memorial Hospital and St. Mary’s Medical Center, both of which are in the city.”San Francisco-based UCSF Health has signed a $100 million definitive agreement with San Francisco-based Dignity Health to take on two of its hospitals: Saint Francis Memorial Hospital and St. Mary’s Medical Center, both of which are in the city.
    • UCSF Health began acquisition talks with Dignity Health, part of Chicago-based CommonSpirit Health, for the two hospitals in July. 
    • “Under the acquisition, which UCSF Health hopes to close by this spring, the hospitals will be renamed UCSF Health Saint Francis Hospital and UCSF Health St. Mary’s Hospital, respectively, according to a Feb. 5 UCSF news release.”
  • Per Healthcare Dive,
    • “Providence will refund payments and forgive outstanding medical debt for nearly 100,000 low-income Washington residents to settle a 2022 lawsuit alleging the health system skirted its charity care obligations, according to a Thursday announcement from Washington Attorney General Bob Ferguson.
    • “The Renton, Washington-based operator will refund approximately $20 million to over 30,000 patients who were billed improperly and forgive $137 million for more than 65,000 additional patients, in what the AG called the “largest resolution of its kind in the country.”
    • “The settlement is the latest win for the AG, who has successfully brought other health systems into compliance with the state’s charity care law, which offers reduced or free medical care for approximately half of Washingtonians based on financial status.”
  • and
    • “Centene has become the second major health insurer to warn investors of an impending funding decrease in Medicare Advantage — if regulators finalize 2025 rates as proposed.
    • “New payment parameters released by the CMS last week would cause Centene’s MA rate to fall 1.3%, CFO Drew Asher said during a Tuesday morning call discussing the payer’s fourth-quarter earnings results.
    • “However, this dip is before Centene risk scores its enrollees, a process which should result in an overall increase in MA reimbursement next year, Asher said. Humana disclosed similar concerns in a filing with the Securities and Exchange Commission on Monday.”