Monday Roundup

SDOH

Monday Roundup

David Ermer–AHRQ, CDC, FDA, Generative AI, Medical / Rx research, Obesity, Patient safety, SDOH, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC,

  • Tomorrow at 10 am, the House Oversight and Accountability Committee will mark up several bills including the FEHB provisions in the DRUG Act, HR 6283. It’s unfortunate that the Committee did not hold a hearing on this disruptive bill. The FEHBlog will be listening to the markup.
  • The Federal Times informs us,
    • “A pair of contracts designed to improve the quality of care in Tricare’s civilian medical networks will take effect Jan. 1, 2025, according to defense officials.
    • “The contracts are moving forward following a Jan. 31 decision in the U.S. Court of Federal Claims affirming the Defense Health Agency’s choice of TriWest Healthcare Alliance as the Tricare West Region’s new manager, denying a protest lodged by incumbent contractor Health Net Federal Services last year.  * * *
    • “Humana Government Business, the incumbent contractor for Tricare’s East Region, will continue in that role under a new deal worth up to $70.8 billion.The new contracts for the two regions have a potential combined value of $136 billion over nine years.”
  • MedTech Dive lets us know
    • “FDA panel recommends new standards for pulse oximeters amid bias concerns.
    • “Studies have found that pulse oximeters overestimated oxygen saturation in people with dark skin pigmentation, resulting in delayed care.”
  • and
    • “Hologic has received regulatory clearance to sell an artificial intelligence (AI)-enabled cervical cancer screening system in the U.S. 
    • “The product, the Genius Digital Diagnostics System, creates digital images of Pap test slides and uses an AI algorithm to identify cells that cytologists and pathologists should review.
    • “Hologic’s clearance, announced on Thursday, comes days after BD partnered with Techcyte to promote a digital, AI-enabled cervical cancer screening test that is yet to come to market.”

From the public health and medical research front,

  • Beckers Hospital Review tells us,
    • “Eli Lilly’s ingredient for Type 2 diabetes medication Mounjaro and its new weight loss drug, Zepbound, significantly lowered patients’ blood pressure by up to 10.6 mmHg, according to a new study published Feb. 5. 
    • “The study recruited about 500 adult patients with a body mass index at or more than 27, or the overweight range. Compared to a placebo, tirzepatide — the active pharmaceutical ingredient of Mounjaro and Zepbound — reduced blood pressure for participants taking 5, 10 and 15 milligrams each week. The patients were not diabetic and either had normal blood pressure or high blood pressure that was under control.” 
  • STAT News reports,
    • “Amgen is trying a unique strategy with its obesity drug candidate: testing whether it can wean patients toward lower or less frequent doses over time.
    • “Very early data hints that Amgen’s candidate, called MariTide, may provide longer-lasting weight loss than highly popular obesity drugs on the market like Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound. Amgen is already seeing if that means its drug could also be dosed differently from Novo and Lilly’s products, which are costly and expected to be taken consistently for life.
    • “In an ongoing Phase 2 trial, Amgen’s researchers will first titrate participants up on MariTide, but then after some time, see if the drug can still be effective when transitioning patients to a less intensive dosing regimen, executives said in an interview.
    • “Could there be an opportunity for an induction maintenance-type of strategy for a molecule like MariTide?” said Narimon Honarpour, senior vice president of global development at Amgen, referring to a strategy used for anti-inflammatory drugs in which high, rapid doses are given at the start and then lower or less frequent doses are used for maintenance in the long run.”
  • HHS’s Agency for Healthcare Research and Quality released a rapid evidence report about deprescribing to reduce medical harms in older adults.
    • “Deprescribing has emerged as a clinical practice to reduce polypharmacy and use of potentially inappropriate medications (PIMs) and serve as a mechanism for quality improvement and increased patient safety. The purpose of this rapid response is to summarize recent literature on the use of deprescribing to improve the safety of medication use among older adults (age ≥ 65 years).”
  • CBS News reports,
    • “Preterm and early-term births in the U.S. have increased from 2014 to 2022, raising risks to babies, according to new data from the Centers for Disease Control and Prevention.
    • “Data released Wednesday from the CDC’s National Center for Health Statistics shows the preterm birth rate — meaning delivery before 37 completed weeks of pregnancy — rose 12% during that time period, while early-term birth rates, at 37 to 38 completed weeks, rose 20%. 
    • “This is compared to full-term births, which are those delivered at 39 to 40 weeks.
    • “Using data from the National Vital Statistics System, the analysis only looks at singleton births, since multiple births like twins and triplets tend to be born at earlier gestational ages, the authors note.
    • “Gestational age is a strong predictor of short- and long-term morbidity and early mortality,” the authors write. “Births delivered preterm are at the greatest risk of adverse outcomes, but risk is also elevated for early-term compared with full-term births.”
  • MedCity News points out,
    • “Mayo Clinic has entered into a collaboration with TruLite Health — Mayo is helping the Phoenix-based startup develop its software platform designed to address providers’ clinical bias. The health system said it chose to collaborate with TruLite because of the platform’s potential to mitigate health inequities and enhance patient outcomes at the point of care.”
  • Per Fierce Healthcare,
    • “Artificial intelligence can help identify easy to miss patients who might be good candidates for a palliative or hospice care referral, a recent pilot at Mass General Brigham (MGB) revealed.
    • “The results of the findings were presented Friday at the Value-Based Payment Summit.
    • “Timely end-of-life care benefits patients. Patients and their families may also be more open to a conversation about goals of care during a hospital stay, MGB said in presentation slides shown to Fierce Healthcare.” 

From the U.S. healthcare business front,

  • Per BioPharma Dive,
    • “Novo Holdings, the controlling shareholder of Danish drugmaker Novo Nordisk, will buy contract manufacturer Catalent for $16.5 billion in a take-private deal the companies announced Monday.
    • “In a related transaction, Novo Nordisk has agreed pay its parent company $11 billion to take over three Catalent plants in Italy, Belgium and Indiana to help expand production of its GLP-1 drugs Ozempic and Wegovy. Demand for the latter, which is approved in the U.S. for treating obesity, has greatly exceeded supply, forcing Novo Nordisk to restrict access.
    • “Novo Nordisk and Catalent already work together at the three sites, which employ more than 3,000 staff.”
  • and
    • “On Monday, Johnson & Johnson said one of its most closely watched experimental medicines appears to have positive effects on two autoimmune diseases, providing further support to a drug that, by the company’s estimates, could eventually generate billions of dollars in annual sales.
    • “J&J didn’t release any data, but rather said the drug hit the main goals of a mid-stage clinical trial testing it in patients with Sjögren’s disease as well as a late-stage study focused on generalized myasthenia gravis, a rare condition known in short as gMG. The company plans to present more detailed results from both studies at upcoming medical meetings, and to engage with regulators about the path to approval in gMG.”
  • Per Healthcare Dive,
    • “Cano Health filed for Chapter 11 bankruptcy late Sunday, as the beleaguered primary care chain works to bolster its financials. 
    • “The filing is part of a restructuring support agreement with the majority of its lenders. Cano said it expects to emerge from restructuring during the second quarter this year, adding that the process will help it reduce debt and allow it to search for a strategic partner or buyer.
    • “Cano also announced it reached an agreement to receive $150 million in debtor-in-possession financing to fund its operations during restructuring.”
  • and
    • “Medicare Advantage rate changes proposed by regulators last week are upsetting Humana’s funding expectations for 2025.
    • “If finalized as proposed, the MA changes will lower Humana’s benchmark funding by around 160 basis points compared to a flat rate environment, the health insurer disclosed in a filing with the Securities and Exchange Commissionon Monday.
    • “The discrepancy is because the CMS didn’t factor in persistently elevated medical costs into how it calculates rates, Humana said. However, regulators could do so in the final rule. Despite the uncertainty, the insurer reaffirmed its earnings outlook for 2025.”
  • Per Fierce Healthcare,
    • “Rural providers feel financially stable, with most planning to expand existing service lines to increase revenue, a new survey has found (PDF).
    • “The survey was conducted by accounting firm Wipfli and reached 106 rural healthcare organizations across 26 states. Respondents included a mix of critical access hospitals, rural health clinics and others.
    • “Overall, most respondents are cautiously or completely optimistic about their financial viability. About 40% said their financial stability is higher than it was a year ago, and the portion of those who think they are in a better place than they were five years ago also rose compared to 2023. Despite challenges like high inflation, dwindling COVID-19 relief funds and flat reimbursement rates, growing optimism suggests rural providers learned how to manage unpredictability during the pandemic, the report said. * * *
    • Entering 2024, rural healthcare leaders are most concerned about revenue capture, digital capabilities and people management.
  • HR Morning offers nine tips on maximizing core health benefits.
  • The Society for Human Resource Management discusses best practices for hybrid work models.

Tuesday Tidbits

David Ermer–CMS, COVID treatment, FDA, Obesity, OPM, Rx coverage, SDOH, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • The Department of Health and Human Services announced today that
    • “Sickle cell disease (SCD) will be the first focus of the Cell and Gene Therapy (CGT) Access Model, which was initially announced in February 2023. The model is designed to improve health outcomes, increase access to cell and gene therapies, and lower health care costs for some of the nation’s most vulnerable populations. * * *
    • “Gene therapies for sickle cell disease have the potential to treat this devastating condition and transform people’s lives, offering them a chance to live healthier and potentially avoid associated health issues,” said CMS Administrator Chiquita Brooks-LaSure. “Increasing access to these promising therapies will not only help keep people healthy, but it can also lead to savings for states and taxpayers as the long-term costs of treating sickle cell disease may be avoided.” * * *
    • “For additional information see the fact sheet – PDF and CGT model page.“
  • The American Hospital Association reports,
    • “Paxlovid may no longer be distributed with an emergency use label after March 8, the Food and Drug Administration announced. Providers may dispense unexpired Paxlovid labeled for emergency use to patients through March 8, after which Paxlovid labeled for emergency use must be returned to the manufacturer or disposed of in accord with regulations, the agency said.
    • “The FDA last May approved a new drug application for Pfizer’s Paxlovid to treat adults at high risk of progressing to severe COVID-19. Paxlovid labeled under the new drug application will continue to be authorized for emergency use to treat eligible pediatric patients, the agency said.”
  • Following up on Affordable Care Act FAQ 64, the U.S. Office of Personnel Management issued today a carrier letter no. 2024-03 on contraceptive coverage and patient education.
  • Reuters reports,
    • “Pharmaceutical companies are due to receive by Thursday the U.S. government’s opening proposal for what are expected to be significant discounts on 10 of its high-cost medicines, an important step in the Medicare health program’s first ever price negotiations.
    • “Five Wall Street analysts and two investors told Reuters they expect the negotiations over prices that will go into effect in 2026 to result in cuts ranging from the statutory minimum of 25% to as much as 60% when the final numbers are set in September.
    • “The drugmakers and the government are expected to wait until then to disclose them.” * * *
    • “Pharmaceutical companies and business groups have filed more than half a dozen lawsuits to stop the negotiations from taking place, saying that they are unlawful.
    • “Drug companies say the law’s costs will hurt drug development programs and patients.”
    • “The lawsuits have not slowed the implementation timeline.”
  • Axios points out that CMS’s recent prior authorization proposed rule do not apply to prescription drug claims.
  • The Federal Acquisition Regulation Council published in the Federal Register today a proposed rule
    • “would prohibit contractors and subcontractors from seeking and considering information about job applicants’ compensation history when making employment decisions for certain positions. Under the proposed policy and the proposed regulatory amendments, contractors and subcontractors would also be required to disclose the compensation to be offered to the hired applicant in job announcements for certain positions.”
  • The public comment period ends on April 1, 2024.

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “People who are suffering from severe pain but don’t want to risk addiction to an opioid are closer to a new option for treatment.
    • “Vertex Pharmaceuticals on Tuesday reported positive study results for its closely watched non-opioid painkiller. The drug lowered the moderate-to-severe acute pain reported by study volunteers, a sign it could be the first in a new class of painkiller to be approved for use.
    • “But the experimental medicine is more likely to provide an alternative to opioids, rather than supplant them, because it didn’t work better than a widely used opioid drug sold under the brand name Vicodin.
    • “Vertex said it would file for approval from the U.S. Food and Drug Administration by the middle of this year.”
  • STAT News tells us,
    • “Drugs like Ozempic and Wegovy — already game changers for diabetes and obesity — are being studied to treat an entirely different growing health problem: mental health illnesses, including depression and bipolar disorder.
    • “Early data and anecdotes suggest that this class of GLP-1 drugs could help patients feel less depressed and anxious. The treatment may also fight the decline in cognitive and executive function that many people with mental health disorders experience, like worsening memory and losing the ability to focus and plan.
    • “If further research yields positive results, it could drive even more demand for the highly popular GLP-1 treatments, which have increasingly been shown to help with problems across the body, such as heart and kidney complications. And especially if the cognitive benefits are proven out, the GLP-1 drugs would plug a critical gap in current treatments for depression, since most depression drugs help with mood, but close to none address cognitive symptoms that affect memory and attention.”
  • and
    • “The U.S. syphilis epidemic isn’t abating, with the rate of infectious cases rising 9% in 2022, according to a new federal government report on sexually transmitted diseases in adults.
    • “But there’s some unexpected good news: The rate of new gonorrhea cases fell for the first time in a decade.
    • “It’s not clear why syphilis rose 9% while gonorrhea dropped 9%, officials at the U.S. Centers for Disease Control and Prevention said, adding that it’s too soon to know whether a new downward trend is emerging for the latter.
    • “They are most focused on syphilis, which is less common than gonorrhea or chlamydia but considered more dangerous. Total cases surpassed 207,000 in 2022, the highest count in the United States since 1950, according to data released Tuesday.”
  • MedTech Dive calls attention to “four heart device trends shaping the medtech sector in 2024. Medtronic, Boston Scientific and J&J are among the medtech companies advancing treatments in cardiac care for when medicines are not enough.
  • MedCity Dive discusses “How Food as Medicine is Becoming A Core Team Capability. As the food as medicine movement grows, some payers and healthcare organizations are carving out specific roles and teams dedicated to food and nutrition. Doing so can be beneficial considering the significant impact diet can have on health outcomes.”
  • The Washington Post notes,
    • “Older adults spend an average of three weeks every year on doctor’s appointments and other health care outside their homes, according to research published in the Annals of Internal Medicine.
    • “Of those 21 “health care contact days,” 17 involve ambulatory services, such as office visits with primary-care doctors or specialists, testing and imaging, procedures, treatments and therapy. The remaining four days included time spent in an emergency room, hospital, skilled nursing facility or hospice.
    • “The study also found that about 11 percent of people 65 and over spend even more time — 50 or more days each year (nearly one day a week) — obtaining routine health care away from home. The research was based on Medicare data from a nationally representative sample of 6,619 people 65 and older.
    • “The findings represent “not only access to needed care but also substantial time, efforts and cost, especially for older adults and their care partners,” the researchers wrote.”
  • Peterson – KFF Health System Tracker offers a study comparing U.S. life expectancy to other countries.

From the U.S. healthcare business front,

  • Pfizer released its full year 2023 results and reaffirmed its full year 2024 financial guidance provided on December 13, 2023. “The fourth-quarter 2023 earnings presentation and accompanying prepared remarks from management as well as the quarterly update to Pfizer’s R&D pipeline can be found at www.pfizer.com.”
  • Beckers Hospital Review reports,
    • “Nashville, Tenn.-based HCA Healthcare saw revenues of $17.3 billion in the fourth quarter of 2023, up from $15.5 billion over the same period in 2022, according to its financial report released Jan. 30.” 
  • and
    • “Nonprofit Hospitals’ operating margins are far below the pre-pandemic “magic number” of 3% and are in danger of a permanent reset in the 1%-2% range, according to a Jan. 29 report published by Fitch Ratings.
    • “This operating margin reset is worrying some investors, but “hospital downgrades en masse would be unlikely because many systems have built up robust balance sheets and learned to economize on capital spending to a certain degree,” Kevin Holloran, senior director and sector head at Fitch, said.

King Day Weekend Update

David Ermer–Congress, Medical / Rx research, SDOH, U.S. Healthcare–

Happy King Day. Dr. King would have been 95 years old today.

From Washington DC,

  • Roll Call adds
    • “House and Senate leaders have agreed to extend temporary government funding in two batches, through March 1 and March 8, according to a source familiar with the plan.
    • “The decision comes as lawmakers face a Friday, Jan. 19 deadline to clear a temporary spending bill for four of the dozen annual appropriations bills — Agriculture, Energy-Water, Military Construction-VA and Transportation-HUD. The remaining eight bills’ stopgap funds expire after Feb. 2 under the most recent interim spending law.”
  • The Wall Street Journal reports,
    • Medicare patients lining up to fill pricey prescriptions at the pharmacy counter this year will realize some good news: For the first time, there is a ceiling on how much they will pay in 2024 for their Part D drugs.
    • Changes brought about by the 2022 Inflation Reduction Act mean that people on Part D plans now pay no more than roughly $3,300 on drugs annually—a number that could shift a bit based on whether they take brand or generic medications. In 2025, that cap will change again to a flat $2,000.
  • Patient Engagement HIT informs us,
    • “Transportation access continues to be a leading social determinant of health, with new CDC data showing it affected 5.7 percent of adults over the course of 12 months.
    • “The report, which used 2022 data, also showed that women were more likely than men to face transportation access barriers, with 6.1 percent and 5.3 percent reporting as much, respectively. * * *
    • “Younger adults rather than older adults, for example, were more likely to face challenges related to transportation access, with 7 percent of 18-34-year-olds reporting problems compared to 4.5 percent of those over age 65. Odds of transportation-related barriers decreased with age, the CDC researchers said.
    • “Moreover, racial disparities persisted, with American Indian/Alaska Native adults being the most likely to report a lack of reliable transportation. Of those respondents, 17.1 percent said they faced barriers in the previous 12 months.
    • “That compares to 9.2 percent of Black respondents, 7.6 percent of other or multiple-race respondents, 6.9 percent of Hispanic respondents, 4.8 percent of White respondents, and 3.6 percent of Asian respondents who said the same.”

From the public health and medical research front,

  • The Washington Post and Consumer Reports tell us “How to prevent shingles and what to do if you get it.”
    • “Shingrix, a two-dose shingles vaccine that was approved by the Food and Drug Administration in 2017, can reduce the incidence of shingles and its complications significantly. “The vaccine, the one we have available today, is spectacularly effective,” says William Schaffner, an infectious-disease specialist at Vanderbilt University Medical Center in Nashville.
    • “But only about 30 percent of adults eligible for this vaccine have gotten it, according to 2022 report by the Government Accountability Office. If you’re wondering about the effects and risks of shingles and whether Shingrix is right for you, [the article provides] what you need to know.
  • The New York Times reports,
    • “Marijuana is neither as risky nor as prone to abuse as other tightly controlled substances and has potential medical benefits, and therefore, should be removed from the nation’s most restrictive category of drugs, federal scientists have concluded.
    • “The recommendations are contained in a 250-page scientific review provided to Matthew Zorn, a Texas lawyer who sued Health and Human Services officials for its release and published it online on Friday night. An H.H.S. official confirmed the authenticity of the document. * * *
    • “President Biden urged federal officials to “expeditiously” re-examine marijuana classification in October 2022, when he also issued pardons for those charged with marijuana possession under federal law.”
  • Fortune Well identifies “seven immune-boosting foods to eat when you’re sick with COVID or flu.”

From the U.S. healthcare business front

  • Benefits Pro points out,
    • “A new report from Humana finds that “value-based care,” which focuses on quality of care and patient experience with deeper patient engagement, that is provided to Medicare Advantage members kept patients healthier and lowers costs.
    • “The new report is part of an annual assessment of the model, which stresses a more personal approach, more time spent with patients, and more coordinated care than traditional fee-for-service models of care. The model also puts an emphasis on prevention and lifestyle changes to help patients manage their health.
    • “The tenth-annual report on the efficacy of the value-based model for Medicare Advantage members noted that the U.S. health system has faced some significant challenges in recent years, including the COVID pandemic, a stressed workforce, and growing awareness of inequities in health care. The Humana analysis acknowledges challenges remain but found better scores on measurements across the board for patients in the value-based care model.”
  • Per Forbes,
    • “On November 13, 2023, women’s health advocates – including entrepreneurs and investors – celebrated a positive step forward for the industry; that day, the White House announced the first-ever Initiative on Women’s Health Research. The goal of the Initiative is to engage the federal government and private and public sectors to fund women’s health, spur innovation, close research gaps, and improve diagnosis, disease prevention, education, treatment, and more.
    • “This Initiative, however, was not the only new and noteworthy event in women’s health recently. In 2023 alone, women’s health startups saw gains in their average deal sizes, in the percentage of healthcare venture capital funding they raised, and in the attention they received. If these trends continue, 2024 could be the long-awaited and much-needed transformative year, bringing attention, capital, and recognition to this historically overlooked, underinvested, and undervalued space.”

Friday Factoids

David Ermer–ACA, CDC, Congress, COVID-19, Generative AI, Medical / Rx research, Rx coverage, SDOH, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC

  • Roll Call reports,
    • “Speaker Mike Johnson reiterated support Friday for the fiscal 2024 spending agreement he negotiated in the face of opposition from members of the House Freedom Caucus, who’ve been lobbying him to toss the deal. 
    • “Johnson, R-La., told reporters that while he is seeking feedback from across his conference, he is committed to the “strong” deal he negotiated with Senate Majority Leader Charles E. Schumer, D-N.Y.
    • “Our topline agreement remains; we are getting our next steps together, and we are working toward a robust appropriations process,” he said.”  * * *
    • “Next week, Congress will face a more pressing Jan. 19 spending deadline for agencies covered under four of the 12 annual appropriations bills. Schumer took the first procedural step needed for a stopgap spending bill Thursday, filing cloture on the motion to proceed to a shell vehicle. 
    • “The Senate’s continuing resolution is expected to last until March, sources familiar with the talks say. But while Johnson has said he is “not ruling out” the need for another continuing resolution, he has not yet said definitively whether or not he would support one. 
    • “And that stopgap measure will be essential to keep the government open, as Senate Appropriations Chair Patty Murray, D-Wash., and House Appropriations Chairwoman Kay Granger, R-Texas, are continuing to negotiate over the final subcommittee allocations, also known as 302(b)s. 
    • “Negotiators will need about a month to wrap up their work after those allocations are finalized, House Appropriations ranking member Rosa DeLauro, D-Conn., said Friday. “
  • Govexec tells us,
    • “The Office of Personnel Management made some of its best progress at reducing the number of pending retirement applications from federal workers last year, reducing the backlog by 34% in 2023 and breaking multiple recent records in the process.
    • “Long a source of frustration for the governmental HR agency, lawmakers and retirees alike, OPM’s inventory of pending retirement claims has been plagued by delays due to the still largely paper-based nature of federal employment records, staffing issues and other challenges. The COVID-19 pandemic exacerbated many of these issues, as the backlog climbed to a high of more than 36,000 pending claims in March 2022.
    • “But OPM moved on multiple fronts last year to improve the process. The agency released its long-awaited IT strategic plan, which includes plans to develop a “digital retirement system,” complete with electronic records and an online retirement application process.
    • “And officials launched a series of short-term fixes aimed at shoring up the current system, including a guide for retirees to follow as they navigate the retirement process, as well as staffing up and coordinating more actively with federal agencies to prepare for the annual wave of new retirement claims that occurs between January and March.”
  • Federal News Network informs us,
    • “The Postal Service says its competitive package business is growing, following its busy year-end holiday season.
    • “USPS says it delivered 130 million more packages in the “peak” first quarter of fiscal 2024, a nearly 7% increase, compared to the same period last year.
    • “USPS delivered more than 1.9 billion packages in the first quarter of fiscal 2023, which covers October through the end of December.
    • “Postmaster General Louis DeJoy, in a video message to employees, said growing the package business is the key to turning around the Postal Service’s long-term financial problems.”
  • KFF analyzes the Food and Drug Administration’s recent decision to allow Florida to import prescription drugs from Canada.
  • Per Fierce Healthcare, AHIP, among others, expressed opposition to the provision in the proposed 2025 Notice of Benefit and Payment Parameters Notice, reducing the number of non-standardized plans that an Affordable Care Act plan carrier can offer from four to two.
    • “AHIP is particularly concerned about the impact of non-standardized plan limits on issuers’ ability to offer broad networks for consumers that want access to a variety of providers and specialists, which is often a key factor in plan selection for those with chronic health conditions,” the lobbying group wrote in comments on the proposed rule.”
  • The U.S. Preventive Services Task Force offers a report on its 2023 accomplishments.

From the public health and medical research front,

  • Becker’s Hospital Review provides three updates on the predominant Omicron strain JN.1.
    • “Disease severity: New findings from a study led by researchers at the Ohio State University indicate BA.2.86 and its close relative, JN.1, may be linked to an increase in disease severity. The research focused on mutations in the spike protein of BA.2.86 and found it can infect human cells that line the lower lung, which is a feature linked to severe symptoms. Researchers emphasized additional research is needed to confirm the findings, since the study used pseudoviruses. 
    • “But from our past experience, we know that infectivity in human epithelial cell lines provides very important information,” Shan-Lu Liu, MD, Ph.D., senior study author and virology professor at OSU, said in a news release. “The concern is whether or not this variant, as well as its descendants including JN.1, will have an increased tendency to infect human lung epithelial cells similar to the parental virus that launched the pandemic in 2020.” 
    • “In late December, the WHO classified JN.1 as a “variant of interest” due to its rapid spread. At the time, the agency said the overall risk to public health posed by the strain remains low, since updated vaccines continue to offer protection against severe illness. The CDC published its latest update on JN.1 Jan. 5, stating, “At this time, there is no evidence JN.1 causes more severe disease.” 
  • The Centers for Disease Control points out,
    • “As seasonal flu activity remains elevated nationally, CDC is tracking when, where and what influenza viruses are spreading and their impact on the public’s health. So far this season, the most commonly reported influenza viruses are type A(H1N1) and type B viruses. According to CDC research, this could mean more severe outcomes among people who are hospitalized with flu.”
  • Here’s a link to the CDC’s latest Fluview report.
    • “Seasonal influenza activity remains elevated in most parts of the country.
    • “After several weeks of increases in key flu indicators, a single week of decrease has been noted.  CDC will continue to monitor for a second period of increased influenza activity that often occurs after the winter holidays.
    • “Outpatient respiratory illness has been above baseline1 nationally since November and is above baseline in all 10 HHS Regions.
    • “The number of weekly flu hospital admissions decreased slightly.”
  • The CDC also announced,
    • “On October 23, 2023, the Centers for Disease Control and Prevention (CDC) issued Health Alert Network (HAN) Health Advisory 499 to provide guidance for prioritization of nirsevimab given the limited supply. Nirsevimab (Beyfortus, Sanofi and AstraZeneca) is a long-acting monoclonal antibody immunization recommended for preventing RSV-associated lower respiratory tract disease in young children.
    • Given the recent increase in nirsevimab supply and the manufacturers’ plan to release an additional 230,000 doses in January, the CDC advises healthcare providers to return to recommendations put forward by the CDC and the Advisory Committee on Immunization Practices (ACIP) on the use of nirsevimab in young children. Infants and children recommended to receive nirsevimab should be immunized as quickly as possible. Healthcare providers should not reserve nirsevimab doses for infants born later in the season when RSV circulation and risk for exposure to RSV may be lower. RSV activity remains elevated nationwide and is continuing to increase in many parts of the country, though decreased activity has been observed in the Southeast.” 
  • Fierce Healthcare reports,
    • “Though prescriptions for antiviral influenza medications have declined somewhat since 2023, perhaps indicating that the United States might be less encumbered by the flu than in recent record-breaking years, healthcare providers still find themselves battling a surge above historic norms, according to data by the Evernorth Research Institute.
    • “Researchers there examined pharmacy claims for more than 32 million people during current and past flu seasons and found an increasing prevalence of antiviral medication prescriptions since Thanksgiving 2023, though that’s tapered off slightly recently. More individuals experience flu symptoms severe enough to send them to physicians’ offices for prescriptions, and most of many of those forced to do so did not get the flu vaccination. Evernorth, a Cigna subsidiary, tries to develop cost-effective delivery systems for pharmacy benefits.
    • “Urvashi Patel, M.D., vice president of the Evernorth Research Institute, told Fierce Healthcare in an email that “since the shift to remote work from the pandemic, many employees who used to get their flu vaccines at the office are no longer able to. This may change as more workers continue to return to the office, but it’s likely a contributor to lower vaccination rates.”
  • The Wall Street Journal shares an employee’s favorable experience with the powerful weight loss drug Mounjaro.
  • Health Day provides the following study notes:
    • “U.S. doctors are prescribing antifungal creams to patients with skin complaints at rates so high they could be contributing to the rise of drug-resistant infections, new research shows.
    • “These are “severe antimicrobial-resistant superficial fungal infections, which have recently been detected in the United States,” noted a team led by Jeremy Gold, a researcher at the U.S. Centers for Disease Control and Prevention.
    • “One of the biggest emerging threats: Drug-resistant forms of ringworm (a form of dermatophytosis).”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “UnitedHealth was slammed with medical costs as it closed out 2023. The health insurance behemoth still managed to exceed Wall Street’s financial expectations.
    • “UnitedHealth posted a medical loss ratio of 85% in the fourth quarter — its highest MLR since the COVID-19 pandemic began early 2020.
    • “MLR is a metric of how much payers shell out to cover their members’ medical expenses. Payers tried to shake the effects of higher medical costs all last year as patients who delayed healthcare during the pandemic returned to doctor’s offices.
    • “The bulk of higher costs in the fourth quarter was driven by more seniors using outpatient services, a trend that first appeared in the second quarter of 2023, said UnitedHealth CEO Andrew Witty on a Friday morning call with investors.”
  • Beckers Hospital Review offers an interview with Mayo Health System President “Prathibha Varkey, MBBS, [who] is excited about the future of healthcare,” and an analysis of nurse practitioner pay by specialty.
  • The Washington Post offers an interview with the American Medical Association President Jesse Ehrenfeld, MD.
  • Mercer Consulting offers guidance on network strategies to optimize patient care and save while its sister company, Oliver Wyman, peers into the crystal ball concerning the state of healthcare in 2035.
  • Beckers Payer Issues offers a look at ten updates to the 2024 Medicare Advantage landscape.
  • MedCity News discusses seven JP Morgan Conference news items that you don’t want to miss.
  • BioPharma Dive poses five questions facing the pharmaceutical industry this year. “Many drugmakers hope to compete with Novo and Lilly in obesity, while others seek to win oncology’s next era. Meanwhile, a contentious drug pricing law looms.”
  • Drug Channels shares a guest post titled “Repairing the Patient Journey: How Pharma Can Fix the Obvious–and Not So Obvious–Breaking Points of Nonadherence.”
  • The Wall Street Journal reports,
    • “CVS Health plans to close dozens of pharmacies inside Target stores at a time when pharmacy chains are struggling to grow retail profits.
    • “CVS will close the pharmacies between February and April this year, said a company spokeswoman. The closures are part of CVS’s efforts to pare down its retail footprint “based on our evaluation of changes in population, consumer buying patterns and future health needs,” she said. * * *
    • “CVS has operated pharmacies inside Target stores since late 2015 when it bought the business from the retailer for around $1.9 billion. It has pharmacies in around 1,800 of Target’s more than 1,950 U.S. stores. A Target spokeswoman declined to comment. The latest round of closures account for a small percentage of CVS’s pharmacies at Target stores.” 
  • Per Fierce Healthcare,
    • “Artificial intelligence was dominating CES 2024 this week. From assistive speech tools to pet wearables to AI-enabled pillows to prevent snoring, the majority of companies exhibiting at CES boasted the use of the technology as part of their products.
    • “Digital health companies at the show also are putting AI to use from Intuition Robotics’ AI-enabled ElliQ care companion robot to hearing eyewear.
    • “Amid all this hype, entrepreneur and investor Mark Cuban believes AI will be transformative for healthcare.
    • “There are two types of companies in the world — those who are great at AI and everyone else and either you know how to use it to your advantage or you’re in trouble,” he said during a digital health panel at CES on Thursday.
    • “He added, “I don’t think it will be dominated by five or six big models. I think there will be millions of models. I think we’ll find every company will have a model, every vertical will have its own model, individuals will have their own models, doctors have their own models, and trying to get to the point where it’s more democratic so that specific verticals will be used within healthcare is going to be an evolution and I don’t think we’ve figured all that out.”
  • Healthcare Dive adds
    • “Generative artificial intelligence can be used to pull social determinants of health data, like housing or employment status, from clinician notes to identify patients who need additional support, according to a new study.
    • “Large language models trained by researchers could identify 93.8% of patients with adverse social determinants of health, while official diagnostic codes include that data in only 2% of cases. 
    • “The finely tuned models were also less likely than OpenAI’s GPT-4 to change their determination when demographic information like race or gender was added. Algorithmic bias is a major concern for AI use in healthcare, amid fears the technology could worsen health inequities.” 

Thursday Miscellany

David Ermer–AHRQ, CDC, Congress, COVID-19, COVID-19 vaccine, Federal employment benefits, Medical / Rx research, No Surprises Act, SDOH, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC

  • Govexec informs us,
    • “President Biden on Thursday issued an executive order implementing his plan to provide civilian federal workers with an average 5.2% pay raise next month.
    • “As first proposed in his fiscal 2024 budget plan last March, the increase amounts to a 4.7% across-the-board boost to basic pay, alongside an average 0.5% increase in locality pay. As authorized in the fiscal 2024 National Defense Authorization Act, which Biden is expected to sign this week, military service personnel also will see an average 5.2% pay raise next year.
    • “An average 5.2% pay increase marks the largest authorized for federal workers since the Carter administration adopted a 9.1% average raise in 1980, as well as a 0.6% increase over last year’s raise, which itself marked a 20-year high.”
  • STAT News reports
    • “Lawmakers are facing down a Jan. 19 deadline to renew a variety of expiring health care programs, so they just tucked away an extra $1.8 billion in a Medicare reserve fund in the NDAA, a Senate aide confirmed. They achieved the savings by extending the Medicare sequester’s end date, and then used some of the funds to pay for World Trade Center Health Program policies to support 9/11 survivors and first responders.
    • “The additional savings went to the Medicare piggy bank, formally known as the Medicare Improvement Fund, referred to in wonky circles as the MIF. Lawmakers will be able to pull from the MIF early next year as they weigh how to fund community health centers and stave off pay cuts to safety-net hospitals. It’s not a fortune, but it’s also nothing to sneeze at, given hospitals are panicked about the prospect of a payment policy passing that would save the federal government $3.7 billion over the next decade. It also gives them some wiggle room if they need to do another short-term extension of the programs.”
  • The American Hospital Association News relates,
    • “The Departments of Health and Human Services, Labor and Treasury Dec. 15 reopened the federal independent dispute resolution portal to process all dispute types. Given the significant backlog resulting from the suspension of operations, the agencies today further extended the deadlines to March 14, 2024, for any IDR deadlines that fell in the suspension timeframe of Aug. 3 through Dec. 14, 2023, or currently have an initiation deadline between Dec. 15, 2023, and March 13, 2024. CMS announced extensions for additional dispute processes, including additional response time for requests for information, extension requests for offer submissions, and additional time to select a certified IDR entity for disputes.”
  • A bipartisan group of Senators sent a letter to the ACA regulators telling them
    • “We are writing in support of the recent decision from the U.S. District Court for the District of Columbia that vacated the 2021 Notice of Benefit and Payment Parameters (NBPP) Final Rule provision that permitted the use of copay accumulator adjustment programs (AAPs) and remanded to the U.S. Department of Health and Human Services (HHS) to interpret the definition of “cost-sharing.” * * *
    • We are disappointed in HHS’s decision to file a notice of appeal of the decision and HHS’s articulated intention to not take any enforcement action against health insurance issuers or health plans that fail to count copay assistance toward the patient’s maximum annual limitation on cost-sharing. Instead of appealing the court’s ruling, we urge you to adopt policies from the 2020 NBPP that strike the right balance of preserving a plan’s ability to control costs while also putting the patient first.”
  • The 2020 NBPP permitted copay accumulators as long as State law did not object. “To date, 19 states, the District of Columbia, and Puerto Rico have banned or limited the use of copay accumulators.
  • Bloomberg reports,
    • “Some of the largest US hospital chains and most prestigious academic medical centers have violated federal rules by not posting the prices they charge for care, according to records obtained by Bloomberg News.
    • “For-profit HCA Healthcare Inc., the nation’s largest hospital system, and big nonprofit operators including Ascension and Trinity Health have been cited for failing to make prices fully available to the public, enforcement letters Bloomberg obtained through a public records request show. So have marquee facilities such as New York Presbyterian Weill Cornell Medical Center, Emory University Hospital and the Hospital of the University of Pennsylvania.
    • “The records reveal the challenges US regulators face as they try to force long-hidden prices into the open to address decades of rising medical expenses. Since 2021, hospitals have been required to be more transparent about what they charge. However, government data show that among 1,750 hospitals regulators evaluated as of early December, about 1,300 facilities — nearly 20% of the hospitals in the US — have been warned they violated rules. 
    • “Most corrected errors after they were pointed out, and officials charged with enforcing the rules say they’ve seen more hospitals complying. Regulators are also working to make the price data more useful.”
  • The U.S. Preventive Services Task Force released a final research plan for prostate cancer screening. Its most recent March 2018 recommendation fell below the A or B level grades required for no-cost coverage when provided in-network. The next stage will be a proposed 2024 recommendation.
    • “The Task Force keeps recommendations as current as possible by routinely updating existing recommendations and developing new recommendations. A multistep process is followed for each recommendation. The Task Force uses gold standard methods to review the evidence and is transparent at each step of the recommendation development process.”

From the public health and medical research front,

  • HR Dive relates,
    • “Physical health in the U.S. has worsened since the onset of the COVID-19 pandemic, a shift that could have detrimental effects on employers, according to Gallup survey results released Dec. 14. 
    • “Both obesity and diabetes are on the rise, Gallup found. The percentage of U.S. adults Gallup determined to have diabetes is 38.4%, up 6 percentage points from 2019 and a hair behind the record high 39.9% recorded last year. The number of respondents who said they have diabetes hit a new high of 13.6%, an increase of 1.1 points since 2019, per Gallup. 
    • “These health effects have practical implications for the U.S. economy. After controlling for factors such as age, income and education, workers with poor physical health — and poor wellbeing generally — suffer greatly enhanced levels of unplanned absenteeism and healthcare utilization (and associated costs) than do their counterparts,” Dan Witters, research director of the Gallup National Health and Well-Being Index, said.”
  • Per Medscape,
    • “A new frontier of brain-based therapies — from GLP-1 agonist drugs thought to act on reward and appetite centers to deep brain stimulation aimed at resetting neural circuits — has kindled hope among [obese] patients like Smith and the doctors who treat them. The treatments, and theories behind them, are not without controversy. They’re expensive, have side effects, and, critics contend, pull focus from diet and exercise. 
    • “But most agree that in the battle against obesity, one crucial organ has been overlooked.
    • “Obesity, in almost all circumstances, is most likely a disorder of the brain,” said Casey Halpern, MD, an associate professor of neurosurgery at the University of Pennsylvania. “What these individuals need is not simply more willpower, but the therapeutic equivalent of an electrician that can make right these connections inside their brain.”
  • The Wall Street Journal similarly reports,
    • “What if the best way to treat your chronic back pain is by retraining your brain?
    • “That’s the premise of a novel approach to chronic pain. Many people feel pain even after a physical injury has healed or when doctors can’t find a physical cause. The approach, called “pain reprocessing therapy,” tries to train the brain not to send false pain signals. Some early results are promising.
    • “In a study published last year in JAMA Psychiatry, 66% of a group of people who did the therapy for a month were pain-free or nearly pain-free up to a year later.
    • “The treatment is still largely in the research stages and typically not covered by insurance, but is being performed in a growing number of centers, including the VA Eastern Colorado Health Care System, which plans to start two clinical trials of the technique next year.” 
  • The American Hospital Association News reports,
    • “A CDC study released Dec. 21 found low COVID-19 and flu vaccination coverage for most adults, and low RSV vaccination coverage for adults aged 60 and older. Antiviral treatments are also being underused, and COVID-19 rebound can happen whether patients receive any, the study said. Among other findings, the report said that most nursing home residents have not received an updated COVID-19 vaccine or RSV vaccine for residents aged 60 and older using shared clinical decision-making.”
  • Unfortunately, Patient Engagement HIT points out,
    • “Few Providers Use [ICD-10] Z-Codes to Document Social Determinants of Health.
    • “Use of Z-codes to document social determinants of health is low, and there are differences in which patients get a Z-code documented, two unrelated studies showed.

From the U.S. healthcare business front,

  • Per Healthcare Dive,
    • “The labor outlook is stabilizing for U.S. nonprofit hospitals as employment increases and healthcare job openings decline, according toa new report from Fitch Ratings. 
    • “Hospital and ambulatory healthcare services payrolls have risen for 22 and 34 consecutive months respectively, according to the credit ratings agency. Wage growth has remained “relatively flat” at 4%. 
    • “Though the statistics indicate the hot labor market is cooling, Fitch said recruitment is still“hyper-competitive.” Health systems may need to offer higher salaries and better benefits to attract talent and dissuade skilled labor from seeking early retirement, the report said.” 
  • BioPharma Dive notes
    • “As ALS research booms, one treatment center finds itself in the spotlight.
    • “Mass General’s Healey Center is at the forefront of ALS research and care.
    • “Still, the complexities of the disease and of drug development have brought hard-felt losses.”
  • Per Fierce Healthcare,
    • “Two of southern California’s largest pediatric providers are planning to come together in 2024.
    • “The parent companies of Children’s Hospital of Orange County (CHOC) and Rady Children’s Hospital-San Diego announced Wednesday an agreement to merge under the new banner of Rady Children’s Health.
    • “The arrangement, which is subject to regulatory review, stands to help the organizations improve patient outcomes, increase access to care, accelerate treatment research and bolster their clinical and nonclinical workforces, the children’s hospitals said in their joint reveal.”

Tuesday Tidbits

David Ermer–Congress, FDA, NIH, No Surprises Act, Rx coverage, SDOH, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • Roll Call provides this wrap up.
    • “With no prospect for a border security deal in sight, the Senate was preparing to leave town for the holidays and punt an emergency war funding package into the new year.
    • “Majority Leader Charles E. Schumer, D-N.Y., acknowledged Tuesday that reaching a bipartisan deal on policies to stem the flow of migrants at the southern border would not come together in time for a vote this week. 
    • “While we’ve made important progress over the past week on border security, everyone understands that we have more work to do and it’s going to take more time,” Schumer said on the floor.”
  • The Census Bureau reports, “Births in 2023 once again began to outpace deaths in over half of U.S. states as mortality declined, inching closer to pre-pandemic levels, according to U.S. Census Bureau population estimates released today.”
  • The Food and Drug Administration tells us,
    • “Today, the FDA approved the first test that uses DNA in assessing whether certain individuals may have an elevated risk of developing opioid use disorder. As part of a clinical evaluation, the AutoGenomics Inc. AvertD test is intended to be used prior to first exposure to oral opioid pain medications in patients being considered for a 4-30 day prescription for the treatment of acute pain, such as in patients scheduled to undergo a planned surgical procedure. The AvertD test, a prescription-use only genetic laboratory test for patients 18 years and older, is to be used only with patients who consent to the test and have no prior use of oral opioid analgesics.
    • “Today, the FDA refreshed the Know Your Treatment Options for COVID-19 Consumer Update and reminded consumers that they have several treatment options to prevent hospitalization and other serious complications of COVID-19. The FDA has approved drug treatments for COVID-19 and has authorized others for emergency use. In addition, more therapies are being tested in clinical trials to evaluate whether they are safe and effective in treating COVID-19.” 
  • HHS’s Agency for Healthcare Research and Quality has issued its 2023 National Healthcare Quality and Disparities report.
  • The International Foundation of Employee Benefits Plans tells us,
    • “The Internal Revenue Service (IRS) released Notice 2024-01 providing the percentage increase for calculating the qualifying payment amounts (QPAs) for items and services furnished in 2024 under sections 9816 and 9817 of the Internal Revenue Code. These provisions, added by the No Surprises Act, provide protections against surprise medical bills in certain circumstances. The QPA calculation is required in the case of a plan or issuer that does not have sufficient information to calculate the median of the contracted rates for the same or similar item or service provided in a geographic region. 
    • “For such an item or service furnished in a subsequent year (before the first sufficient information year for the item or service with respect to such plan or coverage or before the first year for which an eligible database has sufficient information to calculate a rate under 29 CFR 2590.716-6(c)(3)(i), and 45 CFR 149.140(c)(3)(i) in the immediately preceding year), the plan or issuer must calculate the QPA by increasing the QPA amount determined for the item or service for the year immediately preceding the subsequent year, by the percentage increase in the U.S. city average consumer price index (CPI-U) over the preceding year.
    • “The percentage increase in the CPI-U for items and services provided in 2024 over the preceding year is the average CPI-U for 2023 over the average CPI-U for 2022. Pursuant to this calculation, the percentage increase from 2023 to 2024 is 1.0543149339. Plans and issuers may round any resulting QPAs to the nearest dollar.”
  • The American Hospital Association News informs us,
    • “The Department of Labor Dec. 19 [proposed to] rescind a 2018 final rule which modified the definition of “employer” under federal law such that more individuals, including sole proprietors, were eligible to participate in association health plans based on geography or industry. That provision was previously vacated by a federal judge in 2019 and was appealed by the Trump Administration. In 2021, a stay was requested by the Biden Administration while it worked on a proposed rule to rescind the 2018 final rule.” 
  • The New York Times offers an overview of the approaches the Congress is considering to ease prescription drug shortages.

From the public health and medical research front,

  • JAMA provides the following key points from a recent study,
    • “Question  What is the impact of dietary sodium intake on blood pressure in middle-aged to elderly individuals?
    • “Findings  In this prospectively allocated diet order crossover study of 213 individuals, 1 week of a low-sodium diet resulted in an average 8–mm Hg reduction in systolic blood pressure vs a high-sodium diet, with few adverse events. The low-sodium diet lowered systolic blood pressure in nearly 75% of individuals compared with the high-sodium diet.
    • “Meaning  In this trial, the blood pressure–lowering effect of dietary sodium reduction was comparable with a commonly used first-line antihypertensive medication.”
  • Newly installed NIH Director Monica Bertagnolli offers her first Director’s blog on the topic of “Turning Discoveries to Health for All.”
  • Axios reports, “The new highly effective class of anti-obesity drugs has often been talked about as an alternative to bariatric surgery — but medications like Wegovy are increasingly being paired with the procedure.”
    • “Between 20% and 35% of patients who receive the most commonly performed bariatric surgery gain back most of the weight or fail to hit a certain target for body mass index.
    • “Combining one of the GLP-1s with bariatric surgery or endoscopic bariatric therapy, which is a less invasive procedure, “provided significant weight loss” when compared with those procedures alone, according to a systemic review of 11 studies that was published in the Journal of the Endocrine Society this month.
    • “The drugs will revolutionize for sure the landscape of bariatric treatment,” Enrique Elli, a bariatric surgeon at the Mayo Clinic, told Axios. “As a surgeon, I welcome these drugs because I think that will make bariatric surgery even more effective.”
  • The Wall Street Journal points out, “Hemp Gummies Are Sending Hundreds of Kids to Hospitals. Surge of THC products, vapes has states struggling to regulate the booming market.”
    • “The market has boomed in recent years, especially since 2021. Estimates of its size vary, but research firm Whitney Economics approximates the hemp-derived cannabinoids market at $28 billion—about the same size as craft beer and legal marijuana. About 10% of that figure represents products containing cannabidiol, or CBD, which isn’t intoxicating. ***
    • “The FDA has warned that the intoxicating products are dangerous to children but has said it needs Congress to pass a new law that would allow it to regulate cannabis products generally.
    • “This is a serious public health issue, and a solution is urgently needed,” said Patrick Cournoyer, who helps lead the committee studying cannabis for the FDA.
    • “Federal lawmakers have asked cannabis experts and companies to weigh in on possible legislation. Many of those invested in the debate hope Congress will address the issue in the Farm Bill next year.”

From the U.S. healthcare business front,

  • Per Healthcare Dive,
    • “Federal antitrust agencies on Monday finalized stricter guidelines for mergers and acquisitions that could make it more difficult for healthcare deals to close.
    • “The guidelines lay out a framework that the Department of Justice and Federal Trade Commission use when reviewing proposed deals and that the courts can reference in overseeing challenges. However, the guidelines are not legally binding themselves.
    • “The final merger guidelines are not meaningfully different from draft guidelines the DOJ and FTC released in July, according to antitrust experts.”
  • KFF has posted a report captioned “Recent Trends in Medicaid Outpatient Prescription Drug Utilization and Spending.”
    • Key findings include:
      • Even though Medicaid enrollment reached historic levels during the continuous enrollment period, Medicaid prescription drug utilization remained below FY 2017 levels through FY 2022.
      • Net spending (spending after rebates) on Medicaid prescription drugs is estimated to have grown in recent years, increasing from $29.8 billion in FY 2017 to $43.8 billion in FY 2022, a 47% increase.
      • Despite lower utilization, Medicaid spending on prescription drugs has increased, and both states and the federal government continue to take action to combat rising costs.
    • These findings are noteworthy because, typically, Medicaid receives the lowest available prices for prescription drugs.

Monday Roundup

David Ermer–Congress, Generative AI, Medical / Rx research, No Surprises Act, SDOH, Telehealth, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC,

  • The New York Times reports,
    • “The prospects for passing legislation to speed military aid to Ukraine this year are fading, as Republicans balk at striking a quick deal on immigration policy changes they have demanded in exchange for allowing the bill to move forward.
    • “After a weekend of intensive bipartisan border talks yielded progress but no breakthrough, Senator Chuck Schumer, Democrat of New York and the majority leader, acknowledged on Monday that negotiators were still far from completing a deal.
    • “It’s going to take some more time to get it done,” he said on the Senate floor on Monday afternoon, laying out plans for the week that made no mention of any votes on the aid package for Ukraine.”
  • Govexec tells us that “The Senate on Monday voted 50-11 to confirm former Maryland Gov. Martin O’Malley as commissioner of the Social Security Administration, ending a drought of more than two years in which the embattled agency lacked a permanent leader at the helm.”
  • Fierce Healthcare informs us,
    • “The Biden administration on Monday released amended fees related to independent dispute resolution under the No Surprises Act.
    • “In the amended final rule, CMS said it will instead set an administrative fee of $115 for disputes that are subject to the rule. A separate rule, which is up for comment until Jan. 2, adjusts the fees for disputes initiated after Jan. 1, 2025. * * *
    • “In addition, CMS outlined ranges for certified IDR entity fees, which the arbiters charge for determinations. Under the rule, the agency finalized a range of between $200 and $840 for a single determination and between $268 and $1,173 for batch rulings.
    • “These fees are also set annually, and IDRs can request to update them once each year, which the feds must approve.”
    • The rule takes effect on January 20, 2023.

From the public health and medical research front,

  • STAT News points out,
    • “As more data emerges that obesity drugs like Wegovy can reduce complications from heart and kidney problems as well, scientists have been wondering whether these benefits are driven by weight loss alone or also by other mechanisms.
    • “A new study suggests that one possible contributor is the drugs’ ability to reduce inflammation independent of weight loss.
    • “In mice experiments, scientists found that the treatments, known as GLP-1-based drugs, acted through the brain to reduce inflammation throughout the body. This was over a short period of time before the mice lost weight, according to the study, published Monday in Cell Metabolism.
    • “Though the researchers only studied mice, and didn’t look at how much the reduced inflammation translates to actual health benefits, they detailed a previously unknown mechanism of GLP-1 drugs that may help explain their effects on organs throughout the body.
    • “This is a new model for the anti-inflammatory actions of GLP-1” drugs, said Daniel Drucker, senior author of the study and a senior scientist at the Lunenfeld-Tanenbaum Research Institute.”
  • JAMA Pediatrics provides good news:
    • “Question  Is maternal influenza vaccination during pregnancy associated with a reduction in influenza-associated hospitalizations and emergency department (ED) visits in infants younger than 6 months?
    • “Findings  In this case-control study of 3764 infants younger than 6 months, maternal vaccination was associated with a reduction in influenza-associated hospitalizations and ED visits in infants. Vaccine effectiveness was highest among hospitalized infants, those younger than 3 months, and those born to mothers vaccinated in the third trimester.
    • “Meaning  The findings in this study indicate that maternal influenza vaccination during pregnancy provided important protection for the infant in the first few months of life before infants are eligible for vaccination.”
  • The American Medical Association shares what doctors wish their patients knew about social drivers of health.

From the U.S. healthcare business front,

  • Bloomberg reports
    • “We’re seeing wide price variation even in the same hospitals on the same day based upon the negotiated prices by the differing health insurance carriers or health plans,” said Cynthia Fisher, founder and chairman of the philanthropic group Patient Rights Advocate, , which provides free price data for nearly all of the more than 6,000 hospitals in the US. “For the employers, this is eye-opening.”
    • “Patient Rights Advocate on Dec. 11 introduced a hospital pricing search tool for the public. The organization pointed to prices for an injection of cancer drug Rituximab at Rush University Medical Center in Chicago that ranged from $899.33 for the Cigna Basic/Premier medical plan for Rush employees administered through Allegiance Benefit Plan Management Inc. by the Cigna Group, to $9,260.13 for the Cigna One Health HMO.
    • “If they’re able to offer it at a tenth of the price, why should one employer pay 10 times more?” Fisher said.
    • “Cigna didn’t respond to a request for comment, and a spokesman for Rush said the hospital wasn’t “in a position to speak to something that specific so rapidly.”
    • “Being able to easily compare prices will protect health plans from billing errors and fraud by hospitals and insurers, Fisher said. “The employers and unions that design health plans will be able to benefit from being well-informed about their choices and decisions to seek the best quality of care at the lowest possible prices,” she said.
  • Beckers Hospital Review identifies the thirteen out of twenty most popular prescription drugs that are in shortage and the 25 largest health systems by number of physicians.
  • Healthcare IT News calls attention to the fact that “Now that telemedicine is mainstream, artificial intelligence is helping healthcare providers with imperatives such as patient triage. Early results are promising.”
  • According to Reuters,
    • “High cost, logistical issues and the prospect of potential treatment advances are holding back adoption of the first gene therapies for hemophilia, experts said this week during the American Society of Hematology’s (ASH) annual meeting.
    • “Experimental options discussed at the San Diego meeting included personalized treatments and next-generation gene therapies, many still in the earliest stages of testing.”
  • Benefits Pro lets us know about a “Cigna report [that] outlines the benefits, challenges of value-based care. The Cigna paper suggests that physicians, patients, and health plans tend to recognize the good aspects of VBC, but that change has been slow nonetheless in the private sector.”
  • Per Fierce Healthcare,
    • “Kroger is piloting value-based primary care clinics as it joins a growing list of retailers looking to cash in on the booming sector of senior-focused medical care.
    • “The grocery chain has teamed up with Better Health Group, a provider network, to shift some of its in-store clinics, called The Little Clinic, into primary care centers for seniors, in addition to offering regular services.
    • “Better Health Group is rolling out the value-based model at eight of Kroger’s Altanta-area stores.
    • “The clinics today provide a full range of services from your acute, convenient care to primary care-like functions. About 60% of patients that we see in the clinic don’t have an assigned or designated primary care provider. So, there’s a huge opportunity just in general to serve patients and provide longitudinal care,” said Jim Kirby, chief commercial officer for Kroger Health, in an interview with Fierce Healthcare.”

Thursday Miscellany

David Ermer–CDC, Congress, COVID-19, Federal employment benefits, Medical / Rx research, Medicare, Mental health care, OPM, SDOH, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC,

  • Roll Call reports,
    • “The House [of Representatives] voted Thursday to clear the fiscal 2024 National Defense Authorization Act and send it to President Joe Biden for his signature.
    • “The conference report was considered under suspension of the rules, which requires a two-thirds majority. The bipartisan package easily cleared that threshold on a 310-118 vote. * * *
    • “The conference report is notable for authorizing a 5.2 percent pay raise for all military personnel, the biggest in two decades, as well as an increase in troops’ basic allowance for housing payments.”
  • Govexec adds that “Under a provision of the fiscal 2024 National Defense Authorization Act, federal agencies would be required to incorporate veterans’ military service when determining eligibility for paid leave.”
  • Back to Roll Call,
    • “The Senate planned to delay its holiday recess and stay in session next week as lawmakers signaled they could be close to a bipartisan border security deal that would clear a path for aid to Ukraine and Israel.
    • “The change in schedule came after several days of intense negotiations among senators of both parties and White House staff who were struggling to reach a deal on immigration policies designed to curb the flow of migrants at the southern border. Republicans have insisted on tougher border security as their price for additional Ukraine aid, part of a broader $110.5 billion supplemental funding package.
    • “We can get this done before we leave,” said Connecticut Sen. Christopher S. Murphy, the lead negotiator for Senate Democrats, after a Thursday morning negotiating session. “I just think if . . . the border is an emergency, if Ukraine is an emergency, then let’s act like it.” ***
    • “Even if the Senate can agree to a package combining border security with military aid to Ukraine and Israel, the measure is unlikely to become law this month. The House recessed for the year Thursday and Speaker Mike Johnson, R-La., appeared unlikely to call the chamber back into session before January.”
  • MedPage Today reviews several drug pricing developments that the Biden Administration announced this morning.
  • What’s more,
    • “HHS released a new data strategy to enhance data capabilities and accelerate progress on cancer moonshot goals,”
  • and
    • “The Biden-Harris Administration announced voluntary commitments from leading healthcare companies to harness the potential and manage the risks posed by AI.”
  • Govexec tells us,
    • “The Office of Personnel Management on Wednesday urged supervisors at federal agencies to take a more active role in managing the performance of new federal employees, including removing those who perform poorly and improving engagement to ensure they have the tools to succeed.”

From the public health and medical research front,

  • The Centers for Disease Control issued a health alert.
    • “to alert healthcare providers to low vaccination rates against influenza, COVID-19, and RSV (respiratory syncytial virus). Low vaccination rates, coupled with ongoing increases in national and international respiratory disease activity caused by multiple pathogens, including influenza viruses, SARS-CoV-2 (the virus that causes COVID-19), and RSV, could lead to more severe disease and increased healthcare capacity strain in the coming weeks. In addition, a recent increase in cases of multisystem inflammatory syndrome in children (MIS-C) following SARS-CoV-2 infection in the United States has been reported
    • “Healthcare providers should administer influenza, COVID-19, and RSV immunizations now to patients, if recommended. Healthcare providers should recommend antiviral medications for influenza and COVID-19 for all eligible patients, especially patients at high-risk of progression to severe disease such as older adults and people with certain underlying medical conditions.
    • “Healthcare providers should also counsel patients about testing and other preventive measures, including covering coughs/sneezes, staying at home when sick, improving ventilation at home or work, and washing hands to protect themselves and others against respiratory diseases.”
  • Mercer Consulting notes,
    • “With the release in August of the first orally administered medication for postpartum depression, now is a good time to review plan coverage and overall employer support for maternal health. While there are risk factors, postpartum mental health issues can happen to anyone within a year of birth and are often made worse by a lack of social support, including from the workplace. Sadly, the Centers for Disease Control and Prevention reported that mental-health conditions have become the leading cause of maternal death, contributing to nearly one in four pregnancy-related deaths.” 
  • The Robert Wood Johnson Foundation shares its five best health equity stories of 2023.
  • EHR Intelligence adds, “The Regenstrief Foundation has awarded LOINC and Health Data Standards at Regenstrief Institute a $4.4 million grant to support a global initiative to standardize social determinants of health (SDOH) data into EHR systems.”
  • The CDC reports about “Teenagers in the United States: Sexual Activity, Contraceptive Use, and Childbearing, 2015–2019.”
    • “In 2015–2019, 40.5% of never-married female teenagers (3.8 million), and 38.7% of never-married male teenagers (3.8 million) had ever had vaginal intercourse with an opposite-sex partner. For females this percentage was stable across the four time points, but for males this percentage decreased from the 2002 (45.7%) and 2011–2015 (44.2%) time points.
    • “For teen males, use of any contraception at first sex increased across the four time points, from 82.0% in 2002 to 92.1% in 2015–2019, while no consistent trend was seen for teen females.
    • “Nearly four out of five female teenagers (77.3%) in 2015–2019 used a method of contraception at first sex. Among female teenagers, ever-use of long-acting reversible contraception, which includes intrauterine devices and contraceptive implants, increased from 5.8% to 19.2% from 2011–2015 to 2015–2019.”
  • Beckers Hospital Review lets us know,
    • “Results from a phase 2 trial found a drug-vaccine combination developed by Merck and Moderna cut the risk of recurrence or death in patients with severe melanomas by 49%.
    • “The experimental therapy involves an mRNA vaccine from Moderna in combination with Merck’s cancer drug Keytruda. Patients with resected stage 3 or 4 melanoma who received the combination therapy were 49% less likely to die or have their cancer return within three years, compared to those who received only Keytruda.
    • “The findings build on results from an earlier phase study that followed patients for two years, the drugmakers said in a Dec. 14 news release.” 
  • Bloomberg Prognosis informs us,
    • “Obesity researchers are only beginning to explore what happens after people lose weight with GLP-1 drugs such as Wegovy or Zepbound. Most trials of the drugs have only lasted a year or so. While some type of long-term drug therapy is likely to be needed — just as it is with other diseases like high blood pressure — exactly what form it will take is a big unknown, says Robert Kushner, an obesity doctor at Northwestern University Feinberg School of Medicine.
    • “This whole idea of maintenance is a huge black hole,” Kushner told my colleague Madison Muller in a recent interview. “We’re going into this area but we don’t have the long-term game figured out.”
  • Per Medscape,
    • “For researchers involved with sleep disorders, developing a pharmacologic treatment for obstructive sleep apnea (OSA) is a bit like searching for the holy grail. P K Schweitzer and colleagues have published the results of the randomized MARIPOSA study assessing a combination of two medicinal products known as AD109, one of the products having an antimuscarinic effect (aroxybutynin), and the other a noradrenergic effect (atomoxetine), in treating this condition. These molecules increase the activity of the dilator muscles in the upper airways by activating the genioglossus muscle with a synergic effect on the upper respiratory tract during sleep. * * *
    • [T]hese results herald important scientific benefits if we consider that Colin Sullivan’s original 1981 research paper, which ushered in the CPAP era, presented the results of just five participants. 
  • The Wall Street Journal reports,
    • “A year and a half of treatment with the new Alzheimer’s drugs has been shown to reduce the chance of progression to mild stage dementia by about 10%. This benefit comes with notable risks, including small patches of brain bleeding and swelling, which can cause falls and confusion and may require stopping the drug. And there are other barriers. The new Alzheimer’s therapies are very expensive—one year of lecanemab therapy is priced at $26,500. They are difficult to deliver, require an extensive work-up to determine eligibility and involve intensive monitoring for side effects. As many as 8 million Americans are estimated to be living with mild cognitive impairment, but only about 8% to 17.4% will meet all the criteria to take one of these drugs, according to a study published last month in the journal Neurology.”

From the U.S. healthcare business front,

  • Merck Consulting looks back at top benefit trends from 2023 that it expects to carry over into 2024.
  • Beckers Hospital Review explains
    • “Healthcare leaders have been talking about the transition to value-based care for years, but without significant movement away from fee for service. That could all change in the next three years.
    • “The current economic climate, with tightening margins and increased costs, is pushing health systems to finally make a move.
    • “We will continue to see margin pressure resulting from reimbursement rates not keeping pace with inflationary trends that are escalating staffing and supply chain costs,” said Cliff Megerian, MD, CEO of University Hospitals in Cleveland. “As a result, you will see health systems optimizing their operations, which may include footprint re-evaluation, increasing focus on value-based care and greater utilization of digital technology, such as remote monitoring and telehealth services.”
    • “Dr. Megerian also sees more partnerships and expanded services as the growth mechanism for health systems instead of the traditional brick-and-mortar projects and acquisitions.”
  • Per Fierce Healthcare,
    • “Most insurer markets are highly concentrated, including many regions where a single payer dominates at least half of the market share, according to a new analysis from the American Medical Association.
    • “The AMA [hardly a neutral observer] released an updated look at concentration in payer markets and found that across product lines, 73% of metropolitan statistical areas were highly concentrated in 2022. In most (90%) regions, a single payer owns a 30% market share, and in 48% of markets, one payer controls at least 50% of the share.
    • “In 11% of markets, a single insurer has a 70% or higher market share, according to the report.”
  • Per Healthcare Dive,
    • “Private equity firm KKR is in talks to buy a 50% stake in healthcare data analytics firm Cotiviti from Veritas Capital, according to The Wall Street Journal. 
    • “The deal, which sources familiar said could be finalized in the coming weeks, would value the health technology company at about $11 billion. Veritas acquired Cotiviti in a take-private deal valued at $4.9 billion in 2018. 
    • “If the purchase is finalized, it would also rate among the largest U.S. private equity deals announced this year, according to the WSJ.” 

Midweek update

David Ermer–Congress, COVID-19, Federal employment benefits, Medical / Rx research, NIH, OPM, Rx coverage, SDOH, U.S. Healthcare–
Photo by Hugo Clément on Unsplash

From Washington, DC

  • STAT New reports,
    • “The White House is throwing its support behind a controversial authority that allows the government to claw back patents for certain high-priced medicines, according to three sources familiar with the plans. It’s an early step that could have major ramifications for the American pharmaceutical industry, depending on whether and how federal officials actually use the authority.
    • “The administration will on Thursday issue a framework for the National Institutes of Health to more broadly use so-called “march-in rights” — a policy that allows it to seize patents from drugmakers whose products rely on federally funded research, according to the three people familiar with the plans. The framework will lay out when the agency might assert this authority, and endorse using a drug’s price in that determination, the sources said. * * *
    • “[T]he framework will likely include a number of conditions limiting its use, two sources said. The public — including pharmaceutical companies — will also get the chance to weigh in on the idea before it is finalized.”
    • Neverthless, the FEHBlog hears the litigation turbobillers revving up.
  • American Hospital Association News tells us,
    • “A bipartisan group of senators this week introduced the Protect Rural Seniors’ Access to Care Act, AHA-supported legislation that would prohibit the Health and Human Services Secretary from finalizing a proposed rule on minimum staffing for long-term care facilities.
    • “AHA has urged the Centers for Medicare & Medicaid Services not to finalize the rule and instead develop more patient- and workforce-centered approaches focused on ensuring a continual process of safe staffing in nursing facilities.
    • “Over 90 organizations have endorsed the bill, introduced by Sens. Deb Fischer, R-Neb., Roger Marshall, R-Kan., Jon Tester, D-Mont., James Lankford, R-Okla., Joe Manchin, D-W.Va., Roger Wicker, R-Miss., Kyrsten Sinema, I-Ariz., Susan Collins, R-Maine, and Angus King, I-Maine.
    • “Rep. Michelle Fischbach, R-Minn., introduced a House version of the bill in September.”
    •  Fingers crossed for the bill to enacted. The HHS rule is short sighted.

In FEHB Open Season news, Govexec, Federal News Network, and FedWeek offer tips for last-minute shoppers as we approach the end of the Federal Benefits Open Season next Monday. What’s more, FedWeek offers advice on protecting your survivor’s access to FEHB coverage.

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “Covid-19 test positivity rates increased over the summer and then stabilized earlier this fall. They have recently ticked back up, rising 1.2% for the latest week, according to the CDC’s most recent data. Emergency department visits and hospitalizations are up about 10% over the same period. 
    • “Scientists and public-health officials say that data understates the current virus spread and point to elevated levels of the virus detected in wastewater. Wastewater levels are an early warning for infections, with levels up nationally since mid-October. * * *
    • [Variant] JN.1 * * * is growing rapidly on a global level, says Jesse Bloom, a virologist and professor at Fred Hutchinson Cancer Center in Seattle. It has quickly spread in countries such as France and England. JN.1 has been detected in the U.S., though only as a blip.
    • Epidemiologist Katelyn Jetelina, a scientific adviser to the CDC and author of the “Your Local Epidemiologist” newsletter [available on Substack], says that while JN.1 isn’t growing as fast as the original Omicron in the winter of 2021-22, its current rate of growth could fuel a wave in Covid-19 cases. 
    • “If that rate continues, we should see dominance in the U.S. around Christmastime, which means that it would really jump-start a wave around New Year’s,” she says.
    • The good news, says Bloom, is that research indicates the new booster—developed to protect against the XBB variants that were dominant this summer—appears to work for the more mutated newer variants, too.
  • Here’s a link to the National Cancer Institute’s research newsletter.
  • Beckers Hospital Review informs us,
    • “More than a third of mothers — around 40 million women — are affected by lingering health issues after giving birth, according to a new study published Dec. 6 in The Lancet Global Health.
    • “However, many of the issues they report experiencing after giving birth extend long after they stop receiving postpartum care, which is where the major issues lie, according to the researchers.
    • “The authors found that after giving birth, 32% of women report low back pain, 19% experience anal incontinence, 11% experience perineal pain, 8-31% are affected by urinary incontinence, and around 11% are affected by secondary infertility issues. Mental health issues like anxiety and depression are also pervasive.”

From the U.S. healthcare business front,

  • Bloomberg reports,
    • “Eli Lilly & Co.’s new weight-loss drug Zepbound is now available at US pharmacies, offering an alternative to rival medications like Novo Nordisk A/S’s Wegovy as supply issues persist. 
    • “Zepbound was approved by the US Food and Drug Administrationin early November as a treatment for people with obesity. Patients with a prescription from their doctor will now be able to get the drug, which was added to the list of available drugs for Express Scripts and Cigna Healthcare this month, Lilly said in a statement Tuesday.”
  • BioPharma Dive points out,
    • “AbbVie is restocking its drug pipeline in a big way, announcing Wednesday an $8.7 billion deal to buy neuroscience-focused Cerevel Therapeutics, just days after agreeing to a similar sized acquisition of the cancer biotechnology company ImmunoGen.
    • “Per the deal, AbbVie will pay $45 per share of Cerevel, which is developing medicines for schizophrenia, dementia and Parkinson’s disease. The buyout price is 22% higher than Cerevel stock’s closing price Wednesday and 73% above what shares closed at Friday, before rumors of a pending deal emerged. 
    • “Both companies’ boards of directors have agreed to the acquisition, which they expect will close sometime around the middle of next year.”
  • Per Fierce Healthcare,
    • “Elevance Health’s pharmacy benefit manager is launching a new digital pharmacy that aims to make it easier for members to track their prescriptions.
    • “CarelonRx Pharmacy will launch on Jan. 1, and members will be able to connect with pharmacists via text, chat or phone around the clock. The platform will also allow them to check the price of medications for comparison and track their prescriptions throughout the order process, similar to how a customer may follow a pizza order.
    • “The pharmacy will also use push notifications to keep members up-to-date on their prescriptions and will allow them to use text messaging to connect directly with representatives.”
  • and
    • “Many of the past year’s buzziest topics and omnipresent struggles will likely rear their heads as major talking points across 2024, per the year-ahead predictions of Deloitte’s healthcare industry heads.
    • “A disruptive pandemic, rapid digital transformation and mounting cost pressures have taken their toll on the industry’s decisionmakers, Deloitte’s healthcare sector leader Tina Wheeler and senior manager of its health solutions center Wendy Gerhardt wrote in a Wednesday outlook writeup.
    • “The pair highlighted a recent annual survey of 60 executives that found that only 3% of health system executives and 7% of health plan executives had a “positive” outlook for the coming year—down from the respective 15% and 40% of the prior year’s survey.
    • “However, there are some bright spots to consider as the industry undergoes convergence,” which the authors described as “the disruption of traditional health care stakeholders, entrance of new players like retailers and tech companies and the reassembly of a new ecosystem that creates opportunities.”
  • Health Payer Intelligence lets us know,
    • “Cardiovascular, diabetes, and obesity treatments are a critical part of women’s health, and employers can take steps to ensure that women have access to information and care related to their hearts, a flipbook from Northeast Business Group on Health (NEBGH) emphasized.
    • “With women comprising more than half of today’s workforce, employers are making women’s health and well-being a top priority, and rightfully so,” Candice Sherman, chief of executive officer of NEBGH, said in the press release.
    • “Cardiovascular disease in women is underdiagnosed and undertreated. Employers can play an important role in raising awareness and educating employees about heart disease and risk factors like diabetes and obesity as well as providing wellness and benefit programs that support women’s health. We developed this guide to give employers a tool to develop ways to improve the overall heart health of their workforce.”

Friday Factoids

David Ermer–CDC, COVID-19, COVID-19 vaccine, FDA, Federal employment benefits, OPM, SDOH, U.S. Healthcare–

From Washington, DC,

  • The Washington Post reports,
    • President Biden on Friday named W. Kimryn Rathmell to be the next director of the National Cancer Institute, where the prominent researcher will help oversee several White House-backed initiatives intended to reduce cancer deaths and accelerate clinical breakthroughs.
    • Rathmell, an expert in kidney cancer, is the chair of medicine at Vanderbilt University Medical Center in Nashville. The Stanford University-trained physician and scientist has been a member of the National Cancer Institute’s board of scientific advisers since 2018, providing guidance to the institute’s leaders on its scientific research and operations. Rathmell’s new role as head of the cancer institute, which the White House said would begin in December, does not require Senate confirmation.
  • Federal News Network tells us,
    • “The Office of Personnel Management faces a tight deadline to set up a new health insurance marketplace for Postal Service employees and retirees to enroll in new plans, starting next year.
    • “Now OPM is addressing watchdog concerns about whether the IT infrastructure supporting this new USPS marketplace is following federal cybersecurity requirements.
    • “OPM’s Office of Inspector General, in a flash audit released Friday, raised concerns about the cybersecurity steps OPM took before launching the IT systems that will run the Postal Service Health Benefits (PSHB) Program.”
  • Govexec tells us,
    • The Office of Personnel Management this week proposed new regulations delegating its authority to waive the caps on recruitment and relocation incentive payments to federal employees and job candidates to the agencies themselves, a move the federal government’s HR agency says will ease administrative burdens and accelerate the hiring process. * * *
    • “Under the new process, each agency would be required to designate an official who would be tasked with reviewing and adjudicating waiver requests. Additionally, the new regulations would eliminate the minimum service period required to receive an incentive payment. Currently set at six months, OPM argued that removal of the minimum time period would allow short-term, yet still difficult to fill positions such as paid internships to become eligible for recruitment and relocation incentives.
    • “Retention incentive payments would not change under the regulatory proposal, as OPM reported that such changes would require the passage of legislation by Congress.”
  • The Government Accountability Office issued a report on the composition of the federal workforce.
    • “The federal government aims to hire and promote a workforce that reflects the diversity of the U.S. population.
    • “We looked at a decade of federal employment trends. For example, from 2011-2021 there were minor changes in the representation of historically disadvantaged racial groups—like Black or African American and Asians—in the federal workforce. But several of these groups made gains in senior executive service positions.
    • “The percentage of Hispanic federal workers also increased. But in FY 2021, Hispanic individuals made up 10% of the federal workforce, even though they represented 18% of the civilian labor force.”
  • Reuters reports,
    • “The U.S. Centers for Disease Control and Prevention said on Thursday it has expedited the release of more than 77,000 additional doses of Sanofi (SASY.PA) and AstraZeneca’s (AZN.L) respiratory syncytial virus (RSV) drug Beyfortus.
    • “The additional doses, which the CDC said will be distributed immediately to physicians and hospitals, will help improve the availability of the drug at a time when a surge in cases of the disease is outpacing supply.
    • “Beyfortus was approved earlier this year to prevent the disease in infants and toddlers.
    • “CDC said the agency, along with the U.S. Food and Drug Administration, will continue to be in close contact with the manufacturers to ensure availability of additional doses through the end of this year and early 2024 to meet the demand.”

In FEHB News, Federal News Network offers a lengthy and informative exchange with Kevin Moss from Consumer Checkbook.

From the public health and medical research front,

  • STAT News points out,
    • “Flu activity in many parts of the United States is starting to rise more rapidly, signaling that flu season is on the horizon, the Centers for Disease Control and Prevention reported Friday.
    • “With Americans set to travel for Thanksgiving gatherings next week, people who’ve been waiting to get a flu shot should think about acting now, Alicia Budd, the CDC’s team lead for domestic flu surveillance, told STAT.
    • “Really what we’re seeing is a more sharp increase in activity, week over week, and we know from experience when that happens often times we are entering into that period of even more increased activity,” Budd said. “It’s a great time for people to get vaccinated, if they’ve been holding off.”
  • ABC News states,
    • An estimated 36 million adults in the United States have received the updated COVID-19 vaccine as of Monday according to new data from the federal government.  Additionally, about 3.5 million children have also gotten the updated shot, according to the survey, which is a sample size of the U.S. population, from the Centers for Disease Control and Prevention. This is roughly equal to the number of Americans who had received the bivalent booster — which was targeted against different COVID variants — by this time last year.
  • The Wall Street Journal reports,
    • “The Food and Drug Administration said it is screening cinnamon shipments from several countries as part of its investigation of illnesses potentially linked to pouches of cinnamon-flavored applesauce.
    • “The federal agency said this week it believes the cinnamon used in these products could be the source of lead contamination. There have been 34 reports of lead-related illnesses potentially tied to the recalled products. 
    • “The FDA, which has been investigating the lead illnesses since October, said they are potentially linked to contaminated children’s fruit puree and applesauce pouches. WanaBana,  Weis Markets and Schnucks brands have recalled cinnamon-flavored fruit puree and applesauce pouches.”
  • CNN reports,
    • “The rate of premature birth in the United States remains high, especially in the southern region of the country, according to the infant and maternal health nonprofit March of Dimes.
    • “The group’s annual “report card” on US maternal and infant health, released Thursday, says that the nation’s preterm birth rate – the rate of babies born before 37 weeks gestation – was 10.4% in 2022, down only 1% from 2021’s rate, which was the highest in more than a decade.
    • “We went from 10.5% to 10.4%. It’s flat,” said Dr. Elizabeth Cherot, president and chief executive officer of March of Dimes. “A slight change is just not big enough in that direction.”
  • Per NBC News,
    • The rate of child and teen cancer deaths in the U.S. fell 24% from 2001 to 2021, according to a CDC report released Thursday. The report looked at death rates, for Black, Hispanic and non-Hispanic whit youths up to 19 years old. These groups comprised 92% of all youth cancer deaths in 2021, the report noted.
  • Per STAT News, while Wegovy and Zepbound ride high, interest in weight loss drugs that preserve muscle is surging.
    • [B]iotech startups are hoping to use those [earlier Johns Hopkins] findings to create what they believe will be better weight loss medications. In the last several months, multiple companies have disclosed they are testing drugs that preserve or grow muscle while reducing fat, as shown in the updated STAT Obesity Drug Tracker. They hope that their drugs, possibly when used in conjunction with existing obesity treatments, will result in healthier weight loss.

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • Rochester, Minnesota-based Mayo Clinic reported increased year-over-year operating revenue and income in its third-quarter earnings, on higher outpatient visits and surgical cases.
    • The nonprofit posted $4.5 billion in operating revenue, up 8.2% year over year, and $302 million in operating income. Operating expenses rose 4.8% year over year, totaling nearly $4.2 billion.
    • The earnings mark the third quarter Mayo has posted net income after the operator struggled last year. The health system reported profits last year that were half its 2021 returns, after contract labor expenses increased 37% year over year. 
  • and
    • For-profit operator Tenet Healthcare has agreed to sell three of its hospitals in South Carolina for about $2.4 billion in cash to Winston-Salem, North Carolina-based Novant Health. 
    • Proceeds from the deal, which is expected to close in the first quarter in 2024, will primarily go toward paying debt, Tenet said in a news release. 
    • Under the agreement, Dallas-based Tenet’s financial services subsidiary Conifer Health Solutions will also provide revenue cycle management for the hospitals and their related operations under an expanded 15-year contract. 
  • and
    • CommonSpirit Health reported a $441 million operating loss in the first quarter of the 2024 fiscal year on increased expenses.
    • The system expects a California assistance fund — due to be approved later this fall — to offset its operational losses slightly. However, CommonSpirit’s net loss ballooned to $738 million in the quarter as investments faltered, compared to a $413 million loss same time last year, according to its earnings report filed Wednesday
    • In the report, CommonSpirit also outlined plans to expand its ambulatory care footprint next year after a string of recent outpatient acquisitions in multiple states, despite liquidity concerns.