Friday Factoids

FDA

Friday Factoids

David Ermer–COVID-19, FDA, Government Contracting, Medical / Rx research, Mental health care, Obesity, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington DC,

  • Govexec informs us,
    • “According to the Biden administration’s quarterly update of its progress in fulfilling the President’s Management Agenda, released last month, the White House is keeping pace with its stated goals of strengthening the federal workforce and modernizing customer experience. 
    • “The latest Performance.gov post touts 5,800 new hires targeted for roles created by the Bipartisan Infrastructure Law and promises eight new pooled hiring efforts to support multi-agency hiring in fiscal 2024, amid other milestones situated across multiple strategy goals. 
    • “Likewise, the goal of making it easier for the public to interact with the federal government’s life experience services is progressing with the stand-up of several pilot programs, and its High Impact Service Providers are aligning operations and workforce capacity to eventually begin reporting customer feedback data.” 
  • BioPharma Dive reports,
    • “For the first time, the Food and Drug Administration has authorized a U.S. state to import prescription drugs from Canada, granting Florida preliminary clearance to bulk purchase medicines from wholesalers there.
    • “The decision is a major policy shift for the agency, which has long resisted drug importation efforts on grounds that it couldn’t ensure the safety and supply of medicines shipped from abroad. Supporters have argued that importing drugs from Canada, where medicines cost far less than in the U.S., could help rein in pharmaceutical costs. * * *
    • “The pharmaceutical industry, which has vehemently opposed importation plans, may also sue to block Florida’s plan.
    • “We are deeply concerned with the FDA’s reckless decision to approve Florida’s state importation plan,” a spokesperson for the industry lobby PhRMA said in an email. “PhRMA is considering all options for preventing this policy from harming patients.”
  • Note the FEHBlog is ambivalent about this decision.
  • The Federal Times discusses a contract protest related delay in implementing new TRICARE contracts.

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “Covid is surging again, four years after the pandemic began, as a new virus subvariant becomes dominant in the U.S. and as people gather indoors to escape cold weather.
    • “Rising wastewater virus levels and hospitalizations underscore the latest winter Covid surge. One driver is JN.1, the latest offshoot of the virus to take over in the U.S. and an Omicron subvariant. The Centers for Disease Control and Prevention on Friday estimated that JN.1 represents roughly 62% of cases nationwide.
    • “The good news is measures of severe illness—hospitalizations and deaths—remain below last winter’s highs and far lower than the pandemic’s peaks. But the virus remains dangerous for some and a major nuisance for many as people return to work and school after holiday breaks.
    • “The world has seen a steady cycle of new Omicron subvariants ever since that offshoot rapidly took over more than two years ago. When new versions become dominant, it indicates that they have some advantage, whether through their ability to evade immune defenses or easily spread from person to person.”
  • The FEHBlog credits Omicron for being an upper respiratory infection, which is much less dangerous than the initial waves of Alpha and Delta Covid, which were lower respiratory infections.
  • The CDC’s FluView notes,
    • “Seasonal influenza activity is elevated and continues to increase in most parts of the country.
    • “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 continues to increase.
    • “During Week 52, of the 651 viruses reported by public health laboratories, 581 (89.2%) were influenza A and 70 (10.8%) were influenza B. Of the 342 influenza A viruses subtyped during Week 52, 300 (87.7%) were influenza A(H1N1) and 42 (12.3%) were A(H3N2).”
  • Behavioral Health Business discusses
    • “How Fentanyl has changed Opioid Use Disorder Treatment,”
  • and
    • “Top behavioral health trends for 2024.”
  • The American Medical Association offers top health tips obesity medicine physicians want you to know.
  • The National Institutes of Health Director announced in her blog,
    • “Nearly 35 million people in communities across the U.S. have type 2 diabetes (T2D), putting them at increased risk for a wide range of serious health complications, including vision loss, kidney failure, heart disease, stroke, and premature death.1 While we know a lot about the lifestyle and genetic factors that influence diabetes risk and steps that can help prevent or control it, there’s still a lot to learn about the precise early events in the body that drive this disease.
    • “When you have T2D, the insulin-producing beta cells in your pancreas don’t release insulin in the way that they should. As a result, blood sugar doesn’t enter your cells, and its levels in the bloodstream go up. What’s less clear is exactly what happens to cause beta cells and the cell clusters where they’re found (called islets) to malfunction in the first place. However, I’m encouraged by some new NIH-supported research in Nature that used various large datasets to identify key signatures of islet dysfunction in people with T2D.”
  • The NIH further announced,
    • “Semaglutide, a highly popular medication approved by the U.S. Food and Drug Administration to treat obesity and manage type 2 diabetes, was associated with a 49% to 73% lower risk of first-time or recurring suicidal ideations compared to other medications for controlling obesity and type 2 diabetes that work via different mechanisms. These findings provide evidence that semaglutide – which helps regulate appetite and insulin levels by targeting glucagon-like peptide 1 receptors (GLP1R) in the body – does not appear to increase the risk of suicidal ideation, contrary to the claims of some anecdotal reports. Published today in Nature Medicine and paired with a related Research Briefing(link is external), the study was co-led by scientists at Case Western Reserve University and the National Institute on Drug Abuse (NIDA), National Institutes of Health.”
  • Per the American Medical Association,
    • “The AP (1/4, Neergaard) reports, “Seizures during sleep are a potential cause of at least some cases of sudden unexplained death in childhood, or SUDC, researchers at NYU Langone Health reported Thursday after analyzing home monitoring video that captured the deaths of seven sleeping toddlers.” The study “offers the first direct evidence of a seizure link,” although “scientists also have found that a history of fever-related seizures was about 10 times more likely among the children who died suddenly than among youngsters the same age.” The findings were published in the journal Neurology.”

From the U.S. healthcare business front,

  • Per Fierce Healthcare,
    • “The cost of treating a COVID-19 hospital patient in the hospital rose by 26% over the first two years of the pandemic, more than five times the rate of medical inflation during that time, according to a newly published analysis of 1.3 million admissions.
    • “On average and after adjustments, direct treatment costs for a COVID-19 hospital admission rose from $10,394 in March 2020 to $13,072 in March 2022, a gain that researchers said landed alongside increased use of breathing assistance machines.
    • “Such technologies proved to be costly; stays in which a COVID-19 patient required extracorporeal membrane oxygenation (ECMO), for instance, averaged $36,484 and increased by 35% over the course of the study period, they wrote in JAMA Network Open.
  • Forbes reports,
    • “Health insurance giant Elevance Health said it has agreed to acquire Paragon Healthcare, Inc., a provider of infusion services to patients.
    • “Elevance said Paragon provides infusion services to patients through its “omnichannel model of ambulatory infusion centers, home infusion pharmacies, and other specialty pharmacy services.” Financial terms of the deal for privately held Plano, Texas-based Paragon were not disclosed.
    • “It’s the latest effort by Elevance Health to bolster its specialty pharmacy business and pursue its strategy to treat the whole health of the person. Last year, Elevance Health, which operates Blue Cross and Blue Shield health plans in 14 states, closed on its acquisition of BioPlus, a specialty pharmacy.”
  • Healthcare Dive reports,
    • “Tom Cowhey, a financial executive at CVS who stepped into the interim CFO role late last year, has been permanently named to the post, the company announced on Friday.
    • “In October, Cowhey replaced Shawn Guertin, who served as CFO and president of health services. Guertin, who has been on a leave of absence due to family health reasons, will now officially leave CVS later this year, the company said. 
    • “Cowhey joined CVS in early 2022 after previously serving as CFO of Surgery Partners. Before that, he worked at Aetna in strategy and finance positions, before the health insurer was acquired by CVS.”
  • The American Medical Association lets us know,
    • “Significant changes in the Current Procedural Terminology (CPT®) code set for immunizations reflect the changing nature of how COVID-19 is being addressed as actions transition from a public health emergency response to combatting emerging variants much like the flu.
    • “One significant change involves the consolidation of more than 50 previous codes to streamline reporting of immunizations for COVID-19. A new vaccine-administration code, 90480, was approved for reporting the administration of any COVID-19 vaccine for any patient. This replaces all previously approved, product-specific vaccine-administration codes. * * *
    • “Additionally, the Vaccines and Related Biological Products Advisory Committee (VRBPAC), an advisory group of the FDA, recommended that the COVID-19 vaccine for the 2023–2024 vaccination season be a monovalent vaccine that contains the XBB.1.5 strain, and noted that a number of COVID-19 vaccine products will no longer be recommended for use. The streamlined structure brings greater alignment between CPT and the current COVID-19 vaccine reporting environment.
    • “The new coding system will allow for new vaccines for new variants whenever they come up without having to do a new code,” said Samuel “Le” Church, MD, MPH, a member of the CPT Editorial Panel and vice-chair of its Immunization Coding Caucus.”
  • Mercer Consulting offers seven breakthrough benefit strategies to explore this year.

Thursday Miscellany

David Ermer–AHRQ, CDC, COVID treatment, COVID-19, FDA, Medical / Rx research, Obesity, OPM, Rx coverage, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC,

  • Govexec informs us,
    • “Published last month, OPM’s annual report to Congress covers the 2022 fiscal year, which ended in September 2022, meaning it covers a period of time when agencies were developing and beginning implementation of re-entry plans after a two-year period of maximum telework during the COVID-19 pandemic, but before the Biden administration’s concerted push beginning last spring to increase “meaningful in-person work” across government.
    • “In a message accompanying the report, OPM Director Kiran Ahuja acknowledged that the snapshot of telework as represented by the data may not be current, given the shift in the last year toward more in-person work, but she stressed that changes made this year will improve agencies’ data collection and OPM’s analysis going forward.
    • “With COVID-19 no longer the primary driver in workforce decisions, federal agencies are closely examining the balance of in-person and virtual work to maximize mission delivery—including making increases to meaningful in-person work while also utilizing flexible work arrangements as a strategic tool to enhance organizational performance,” she wrote. “To support this work, OPM has been engaging with agencies to improve the quality of government-wide and agency-specific telework data. OPM anticipates that future reports will reflect these improvements.”
  • HHS’s Agency for Healthcare Research and Quality issued a report about the value of respectful maternity care.
  • BioPharma Dive points out five Food and Drug Administration decisions to watch out for this first quarter of 2024.
    • “The agency could approve a closely watched Alzheimer’s disease drug, as well as what could be the first medicine for a prevalent liver disease and a new kind of cancer therapy. Also on deck are verdicts for a drug at the heart of a multibillion dollar buyout and a linchpin asset for one biotech’s oncology plans.”

From the public health and medical research front,

  • The New York Times reports,
    • “As Covid rises again, killing about 1,500 Americans each week, medical researchers are trying to understand why so few people are taking Paxlovid, a medicine that is stunningly effective in preventing severe illness and death from the disease.
    • “A study of a million high-risk people with Covid found that only about 15 percent who were eligible for the drug took it. If instead half of the eligible patients in the United States had gotten Paxlovid during the time period of the research, 48,000 deaths could have been prevented, the authors of the study, conducted by the National Institutes of Health, concluded.
    • “It’s not because people don’t know about the drug — most do — but the reluctance seems to come from doctors worried about interactions with other drugs and people wary of a possible rebound case or the metallic aftertaste.” * * *
    • “Reasons for not prescribing or taking it have varied: Doctors balk at the long list of medications not to be mixed with Paxlovid, including common drugs meant to lower blood pressure or prevent blood clots. Patients tend to complain about the drug’s metallic aftertaste. Many wave off the drug in the early days of Covid, when symptoms tend to be mildest, bypassing the chance to limit early viral growth. * * *
    • “Federal officials still have more than one million free doses out to pharmacies, and the medication will be free through 2024 for Medicaid and Medicare patients. But in recent weeks, officials have handed distribution of the drug off to Pfizer, which has priced it at about $1,400 per course, though private insurers are expected to cover some portion of the price and Pfizer is offering co-payment assistance.“
  • Fierce BioTech tells us,
    • “Researchers at Roche have developed a novel antibiotic with the ability to fight a dangerous drug-resistant bacteria that kills in up to 60% of infections.
    • “In a pair of articles published Jan. 3 in Nature, Roche and Harvard University scientists described how they developed a new antibiotic that is effective against carbapenem-resistant acinetobacter baumannii—also known as CRAB—in mice. The drug, zosurabalpin, works by interrupting construction of the bacteria’s outer membrane.
    • “The ongoing research into zosurabalpin, as well as a second novel class of antibiotics being developed by Roche in human clinical studies, will help uncover new biology about the construction of bacterial membranes,” Michael Lobritz, M.D., Ph.D., global head of infectious diseases at Roche Pharma Research & Early Development, said in a statement provided to Nature. “Our goal is to contribute new innovations to overcome antimicrobial resistance, one of the biggest infectious disease challenges to public health.”
    • “CRAB is a common culprit in hospital-acquired sepsis and other infections, and is at the top of the list of both the World Health Organization’s and the Centers for Disease Control’s “priority pathogens” for which new drugs are urgently needed.” 

From the U.S. healthcare business front,

  • BioPharma Dive points out,
    • “Eli Lilly wants to make it easier for people to access its medicines for obesity, diabetes and migraine, announcing Thursday the launch of a website designed to support home delivery of drugs like its in-demand weight loss treatment Zepbound.
    • “The company’s new service, dubbed LillyDirect, relies on online pharmacy providers like Eversana and Truepill to deliver prescribed Lilly medicines. A website provides access to telehealth services through which people can consult with an independent physician. If prescribed a Lilly medicine, LillyDirect is also meant to help patients more easily access the company’s savings cards.
    • “LillyDirect currently supports 14 of the pharmaceutical company’s medicines, 12 of which are various formulations and types on insulin. Notably, the service also offers Zepbound, which the FDA approved for weight loss in November, and Lilly’s migraine medicine Emgality.”
  • Reuters reports
    • “CVS Health (CVS.N) said on Wednesday it will remove AbbVie’s (ABBV.N) blockbuster rheumatoid arthritis drug Humira from some of its lists of preferred drugs for reimbursement as of April 1, and will recommend biosimilar versions of the medicine instead.
    • “CVS said Hyrimoz and an unbranded version of Humira, both from Swiss drugmaker Sandoz (SDZ.S), will be covered across all its formularies, while branded and unbranded near copies of the drug from India’s Biocon (BION.NS) will be covered on some reimbursement lists.
    • “CVS also announced that AbbVie and CVS-owned company Cordavis, which launched in August, will produce a co-branded version of Humira that will be made available to customers in the second quarter of this year. While most biosimilars are near copies of the branded drug, the Cordavis version will be identical to Humira in its formulation, CVS said.”
  • Healthcare Dive notes,
    • “Walgreens beat Wall Street expectations on earnings per share and revenue in its first quarter, as the pharmacy giant continues to push through “growing pains” amid its shift to healthcare services, according to CEO Tim Wentworth.
    • “The chain’s U.S. Healthcare segment posted sales of $1.9 billion compared with $989 million in the prior-year period, boosted by primary care chain VillageMD’s acquisition of Summit Health and growth in other business units. But the segment still reported a $96 million adjusted operating loss, compared with a $152 million loss last year. 
    • “Walgreens is nearly halfway through its plan to close 60 VillageMD clinics as the provider focuses on density in “high opportunity” markets, Wentworth said during an earnings call.” 
  • The Wall Street Journal reports,
    • “Health insurance companies say they want to offer more services directly to customers. But that requires dropping the cumbersome technology that has defined the industry in favor of the smartphone-app experience users have come to expect.
    • “Kaiser Permanente Chief Digital Officer Nari Gopala said he is working to remove friction from the company’s digital-pharmacy experience, including introducing prescription-refill reminders. “The experience itself is like what you’re used to as a consumer in other industries, like how you order your coffee or groceries,” Gopala said.
    • “Kaiser, an integrated health system with insurance and hospital components, is one of a number of firms revamping technology in the hopes of encouraging more people to get their medications through the mail rather than picking them up in retail pharmacies.”
  • United Healthcare discusses, “Recently launched initiatives by Optum Rx enable more than 26,000 in-network community and independent pharmacies with expanded support to strengthen access to care and improve outcomes for the patients they serve.”
  • Beckers Hospital Review lets us know,
    • “Since launching in January 2021 with about 100 generics, Mark Cuban Cost Plus Drug Co. now offers more than 2,000 drugs, including about a dozen brand-name medications. 
    • “The company has also grown to offer discounted drug prices through more than 4,000 affiliated pharmacies, including those in Kroger and Meijer grocery stores. 
    • “Cost Plus Drugs is targeting inflated drug prices through multiple lenses. It markets medications at their acquisition cost and adds a $5 shipping fee, a $5 pharmacy labor fee and a 15% markup. Other pharmaceutical companies are taking notice of the transparency marketing effect. 
    • “The company’s conservative drug pricing model is buttressed with a “yes, and” approach to its collaborations and partnerships, which include four pharmacy benefit managers. 
    • “In recent months, Cost Plus Drugs has struck collaboration deals with an elderly care business, two fertility health companies, a digital health company and a mail-order pharmacy.” 
  • Per Fierce Healthcare,
    • “A “pivotal year for price transparency” closed out with most—but not all—of the healthcare industry publishing their data publicly and at a higher quality, price transparency data startup Turquoise Health wrote in a state-of-the-industry report released Thursday.
    • “Across a total of 6,357 hospitals, 5,763 (90.7%) posted a machine-readable file (MRF) with at least some necessary service rates in 2023. This was an increase of 562 hospitals over the end of 2022, with Turquoise noting that most of the additions “were individual hospitals, often with unique MRF formats.”
    • “Turquoise gave 2,634 of the hospitals posting MRFs a five-star rating for publishing “a complete MRF that contains cash, list and negotiated rates for a significant quantity of items and services,” the group wrote. That list of top scorers grew 24% from the end of 2022, and now represent more than half of the total hospital field. * * *
    • “The number of payers publishing their data has grown from an initial 67 back in July 2022 to 170 in January 2023, and now to 205 as of November 2023, according to the report. Turquoise also noted that “the quality and breadth of their files have also improved” over the past several months — welcome news for researchers and other stakeholders who previously critiqued payers’ unwieldy data releases.”  

Tuesday Tidbits

David Ermer–FDA, Federal employment benefits, Generative AI, Medical / Rx research, Mental health care, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • The U.S. Census Bureau informs us,
    • “[T]he U.S. population [was projected to be] 335,893,238 on New Year’s Day, an annual increase of 1,759,535 or 0.53%.
    • “In January 2024, the United States is expected to experience a birth every 9.0 seconds and one death every 9.5 seconds. Meanwhile, net international migration is expected to add one person to the U.S. population every 28.3 seconds. The combination of births, deaths and net international migration increases the U.S. population by one person every 24.2 seconds.
    • “The projected world population on Jan. 1, 2024, is 8,019,876,189, up 75,162,541 (0.95%) from New Year’s Day 2023. During January 2024, 4.3 births and 2.0 deaths are expected worldwide every second.”
  • The Internal Revenue Service released the Employers’ Tax Guide to Fringe Benefits for use in 2024.
  • Federal News Network discusses four ways federal pay practices have changed for 2024.
  • The Food and Drug Administration accounts for its recent actions.

From the public health and medical research front,

  • Medscape explains the other health conditions, besides diabetes and obesity, that GLP-1 drugs might treat. It’s an impressive list.
  • STAT News reports,
    • “Reducing or eliminating alcohol consumption reduces the risk of developing oral cavity and esophagus cancers, according to a special report from the International Agency for Research on Cancer. But more data are needed to conclude whether the same is true for several other cancer types, including colorectal, breast, and liver cancer.
    • “Even so, it is likely that reducing or ceasing to drink alcohol will lessen the risk of these cancers, said Farhad Islami, a cancer epidemiologist at the American Cancer Society and an author of the report. “Given that many of these cancers have similar mechanistic pathways, we think we will see a similar association with reduction or cessation,” he said. “That’s why we recommend more studies, so we can have stronger evidence.”
  • BioPharma Dive points out ten clinical trials that are worth watching in the first half of 2024.

From the U.S. healthcare business front,

  • Healthcare Dive tells us,
    • “BJC HealthCare and Saint Luke’s Health System closed their merger on Monday, about seven months after the Missouri-based systems announced plans to combine.The combined organization will operate under the BJC HealthCare brand in its eastern region, serving St. Louis and southern Illinois. The Kansas City region will retain the Saint Luke’s brand name. The new system has a combined workforce of 44,000 employees, according to a Tuesday announcement.”
  • MedTech Dive notes,
    • “Roche reached an agreement to acquire LumiraDx’s point-of-care testing technology, the companies announced on Dec. 29.
    • “Roche will pay $295 million upfront and an additional amount up to $55 million to fund Lumira’s point-of-care technology platform business until the acquisition closes. 
    • “The acquisition comes as Lumira faces a potential delisting amid declining revenue.”
  • Health Payer Intelligence identifies trends in health insurer strategies for 2024. “In 2024, payer strategies will include improving health equity partnerships, differentiating their Medicare Advantage plans, and offering care navigation.”
  • Healthcare IT News offers an interview with “[t]wo investment bankers discuss the players in the telehealth sector, the main financial backers, the dynamics between venture capital and private equity, and more.
  • Beckers Hospital Review tells us,
    • “Feeling blue? Your employer might have an AI app for that, The Wall Street Journal reported Dec. 27. 
    • “Workplaces increasingly are offering employees access to digital mental health tools, including AI chatbots meant to mimic therapists and wellness apps that diagnose mental health conditions, the report said. Over the summer, a survey of 457 U.S. companies conducted by professional services company WTW found that about one-third offer a “digital therapeutic” for mental health support. Another 15% were considering adding one by 2025. 
    • “The capabilities and goals of these services vary. Amazon gives employees free access to the app Twill, which uses AI to track users’ moods and create “personalized mental-health plan(s).” A construction workers’ union in Ohio will begin offering access to Wysa, a self-described “emotionally intelligent” AI chatbot that encourages users to “vent or just talk through negative thoughts and emotions” and “let it help you cope with pandemic anxiety and lockdowns.” 

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.

Friday Factoids

David Ermer–FDA, HSA, Medical / Rx research, NIH, No Surprises Act, Rx coverage, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC,

  • The American Hospital Association News tells us,
    • “The Departments of Health and Human Services, Labor, and the Treasury Dec. 15 reopened the federal independent dispute resolution portal to process all dispute types, including previously initiated batched disputes, new batched disputes, and new single disputes involving air ambulance services. The departments also have extended the applicable deadlines to initiate new batched disputes and new single disputes involving air ambulance services, resubmit disputes determined by certified IDR entities to be improperly batched, and select or reselect a certified IDR entity. For details, see the [lengthy] announcement. 
  • In Department of Health and Human Services news,
  • and
    • “A paper published today in JAMA Network Open addresses the use of healthcare algorithms and provides the healthcare community with guiding principles to avoid repeating errors that have tainted the use of algorithms in other sectors. * * *
    • “The paper, Guiding Principles to Address the Impact of Algorithm Bias on Racial and Ethnic Disparities in Health and Health Care, may be found in JAMA Network Open is available here. The journal also links to an accompanying podcast interview of panel co-chairs Marshall Chin, MD, MPH, and Lucila Ohno-Machado, MD, PhD, MBA. The final EPC report, Impact of Healthcare Algorithms on Racial and Ethnic Disparities in Health and Healthcare, can be found here.”

In Food and Drug Administration news,

  • From Bio-Pharma Dive,
    • “The Food and Drug Administration on Thursday broadened use of a drug Merck & Co. acquired in a $1 billion buyout four years ago, clearing Welireg for use in people whose kidney tumors have progressed following treatment with two other types of medicines. 
    • “Approval was based on a trial that compared Welireg to an older therapy called everolimus. Merck’s drug reduced the risk of cancer progression or death by 25% compared with everolimus and shrank or eliminated tumors in 22% of people who received it. Welireg hasn’t yet proven it can help kidney cancer patients live longer, however. 
    • “Merck inherited Welireg when it bought biotechnology company Peloton Therapeutics. Since then, the drug’s been cleared for use in a rare condition called von Hippel-Lindau disease and now kidney cancer. Merck is studying its potential in other settings as well.”
  • From MedTech Dive,
    • “Glaukos Corporation received Food and Drug Administration approval for a drug-releasing implant that is designed to reduce intraocular pressure in patients with ocular hypertension or open-angle glaucoma. The implant was approved for single administration per eye.
    • “The device continuously delivers a formulation of travoprost, an established treatment for high pressure in the eye, to provide patients with an alternative to eye drops and remove the risk that noncompliance with the treatment regimen will affect outcomes.
    • “Glaukos failed to secure approval for repeat dosing but plans to work with the FDA to change the label. The wholesale acquisition cost (WAC) is $13,950 per dose, or implant, well above analysts’ expectations. William Blair analysts estimated the price would fall in a range of from $3,000 to $4,000 per implant, while BTIG analysts said they modeled a price of $5,000.”
  • and
    • “Medtronic has gained the first approval from the Food and Drug Administration for a pulsed field ablation (PFA) system to treat atrial fibrillation (AFib), pulling ahead of other medtech companies in the race to bring the technology to the U.S. market.
    • “The treatment approach has garnered attention as a safer alternative to radiofrequency and cryoablation techniques for addressing the abnormal heart rhythm, and Boston Scientific and Johnson & Johnson are pursuing the market.
    • “Medtronic, in announcing the FDA’s approval for its PulseSelect PFA system, said the device has demonstrated a 0.7% safety event rate and clinical success rates of 80% in both paroxysmal and persistent AFib patients.”

From the public health and medical research front,

  • The New York Times offers readers’ perspectives on its article about the high and climbing number of pedestrian deaths occurring at night. “Readers share concerns like headlight glare, streetlight design and the aging of American motorists.”
  • HealthDay informs us,
    • “Diabetes drugs, including Ozempic, do not appear to increase the risk of birth defects
    • “Babies born of moms using drugs to control their type 2 diabetes had no greater risk of birth defects than those whose moms used insulin.
    • “Diabetes medications have grown in popularity over the past decade, particularly those in Ozempic’s class.”
  • The Director of the National Institute of Diabetes and Digestive and Kidney Diseases posted his Winter 2023 report.
  • Per Medscape,
    • “Living in food deserts and food swamps — areas with no access to healthy food, and areas with a plethora of unhealthy food options — may raise the risk of dying from postmenopausal breast cancer, a novel ecological study has found. 
    • “Food deserts and food swamps are both bad, but it’s worse in food swamps,” Malcolm Bevel, PhD, MSPH, with Augusta University in Georgia, told Medscape Medical News. 
    • “He presented his research here at the San Antonio Breast Cancer Symposium (SABCS) 2023.” 

From the U.S. healthcare business front,

  • KFF unveiled its updated
    • “Health Spending Explorer, an interactive tool that allows users to explore trends in health spending by federal and local governments, insurers, nursing care, hospital, and other service providers, and consumers.
    • “The tool captures just-released 2022 data from the federal government, when national health expenditures totaled nearly $4.5 trillion. Overall spending rose 4.1% in 2022, with almost all categories of health spending experiencing growth. This rise was muted by lower federal public health spending related to the pandemic. Meanwhile, consumers’ out-of-pocket costs rose 6.6%, a large but less dramatic increase than in 2021.”
  • The Health Care Cost Institute reports,
    • “Healthcare spending continues to grow, and prices are the primary driver. Without addressing high and growing prices, efforts to make care more affordable will not be successful. One way to understand what is going on with prices in employer-sponsored insurance (ESI) is to compare negotiated rates paid in that market to Medicare payments for the same services. New analysis from the Health Care Cost Institute finds that, in 2021, ESI payments for outpatient services were, on average, 287 percent higher than Medicare payments.”
  • Beckers Hospital Review identifies the 25 largest health systems in the U.S. by number of beds, and provides the reasons for fourteen hospital closures.
  • Using the American Medical Association’s health insurance market concentration report, Beckers Payer Issues identifies the cities with the most competitive Medicare Advantage markets.
  • Reuters reports,
    • “Bluebird bio (BLUE.O) said on Thursday a large insurer had agreed to cover its newly approved sickle cell disease gene therapy, easing some investor worries about resistance from other payers over the high price of the treatment.
    • “Bluebird’s treatment, Lyfgenia, was approved along with another gene therapy Casgevy from partners Vertex Pharmaceuticals (VRTX.O) and CRISPR Therapeutics (CRSP.BN).
    • “Bluebird’s price of $3.1 million is nearly $1 million higher than its rival, despite Lyfgenia having a serious safety warning about blood cancer risk. That had raised concerns over whether it would get enough coverage from insurers versus its rival.”
  • and
    • “Drugmaker Novo Nordisk paid U.S. medical professionals at least $25.8 million over a decade in fees and expenses related to its weight-loss drugs, a Reuters analysis found. It concentrated that money on an elite group of obesity specialists who advocate giving its powerful and expensive drugs to tens of millions of Americans.”
  • The Employee Benefit Research Institute factors health savings accounts into the retirement funding picture for Americans.
  • Per Fierce Healthcare,
    • “Two months ago, Elevance Health and Blue Cross and Blue Shield of Louisiana hit the pause button on a potential $2.5 billion merger in the midst of regulatory scrutiny.
    • “The insurers brought the deal back to life this week, though, with BCBSLA filing an updated application on Thursday seeking to reorganize as a for-profit, which would allow it to be purchased by Elevance Health. Per the New Orleans Times-Picayune, many of the plan’s initial proposals remain, but BCBSLA has made changes to the planned nonprofit foundation that will roll out should it be finalized.
    • “The newspaper reported that the Accelerate Louisiana Initiative will receive 91% of the proceeds from the merger.
    • “In a joint statement to Fierce Healthcare, the companies said that the new “filing reflects the input and vision of our communities to ensure that we deliver on these commitments.”
  • and
    • “While its merger with Humana may have fallen through for now, Cigna is attracting plenty of interest for the rumored sale of its Medicare Advantage business, Bloomberg reported.
    • Sources close to the matter told the outlet that Health Care Service Corp. and Elevance Health are “competing” to scoop up the MA segment. Cigna is expecting that the final bids will be submitted next week, according to the report.
    • “Cigna’s Medicare Advantage unit could sell for more than $3 billion, according to Bloomberg. The article noted that talks with HCSC and Elevance Health may not ultimately lead to a sale.
    • “That Cigna was shopping for a potential buyer for its MA business was first reported in early November by Reuters. That report mentioned that Cigna could ultimately elect to hang on to the MA unit if it didn’t find an appealing deal.
  • The Institute for Clinical and Economic Review listed their top ten stories of 2023.

Tuesday Tidbits

David Ermer–AHRQ, CDC, Congress, FDA, Medical / Rx research, No Surprises Act, Rx coverage, U.S. Healthcare, Uncategorized–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • The Hill reports,
    • “Congress is struggling to lock down a deal on government funding with just days until lawmakers are set to leave town for the rest of the year, as both chambers appear to have given up on passing their own spending bills.
    • “Lawmakers had been hopeful leadership would strike a deal last week on an overall top-line level for government funding in fiscal 2024 as part of the annual appropriations process. But as negotiations continue, lawmakers say leadership is cutting it close. Congress is staring down a shutdown deadline next month, with little legislative time on the calendar.” 
  • Healthcare Dive explains the features of the Lowers Costs, More Transparency bill passed last night by the House of Representatives. The wide bi-partisan margin supporting the bill gives it more likelihood of success in the Senate.
  • American Hospital Association News tells us,
    • “The House Dec. 12 voted 386-37 to pass AHA-supported legislation (H.R. 4531) that would reauthorize key SUPPORT Act programs for patients with substance use disorder and permanently extend required Medicaid coverage for medication-assisted treatments. The Senate Health, Education, Labor & Pensions Committee today advanced its own SUPPORT Act reauthorization bill (S. 3393).”
  • Healthcare Dive informs us,
    • “Nationwide health data exchange under TEFCA, the Trusted Exchange Framework and Common Agreement, is now operational, the HHS’ Office of the National Coordinator for Health Information Technology announced on Tuesday.
    • “Five Qualified Health Information Networks, or QHINs, completed the onboarding process and are ready for data exchange: eHealth Exchange, Epic Nexus, Health Gorilla, KONZA and MedAllies.
    • “The go-live marks a significant milestone that’s been years in the making, HHS leaders said at a signing event. “I feel like we’re watching the Big Bang occur in 2023,” said Secretary Xavier Becerra.”
  • Yippee! Now, true interoperability begins. Bye, bye fax machines.
  • HHS also announced,
    • “release[ing] HHS’s National Plan to Address Alzheimer’s Disease: 2023 Update – PDF. The National Plan is a roadmap of strategies and actions of how HHS and its partners can accelerate research, expand treatments, improve care, support people living with dementia and their caregivers, and encourage action to reduce risk factors. It highlights the progress made in 2023, which was an historic year for the treatment of Alzheimer’s disease and related dementias (ADRD) and care for people with this condition.”
  • The U.S. Preventive Services Task Force is proposing to retain its Grade B recommendation that
    • “Clinicians provide or refer children and adolescents age six years or older with a high body mass index (BMI) (≥95th percentile for age and sex) to comprehensive, intensive behavioral interventions.”
    • The public comment period is open until January 16, 2024.
  • MedPage adds that
    • “To reap the “moderate net benefit,” kids should have 26 or more contact hours with the behavioral interventions for up to a year, [the USPSTF] advised.
    • “USPSTF fell short of recommending pharmacologic therapy, citing a lack of evidence. This did not mean the group recommended against this type of treatment; however, behavioral interventions should be the primary effective intervention for kids’ weight loss, the task force said.”
  • The CDC offers five healthy eating tips for the holidays.
  • The GAO issued a report on the rocky implementation of the No Surprises Act’s independent dispute resolution process.

From the public health and medical research front,

  • Beckers Hospital Review points out the fifteen states (and New York City), up from ten the previous week, with the highest rates of respiratory disease.
    • “Two states — Louisiana and South Carolina — reported “very high” respiratory virus activity levels. Thirteen states — Alabama, California, Colorado, Florida, Georgia, Mississippi, Nevada, New Jersey, New Mexico, North Carolina, Tennessee, Texas and Wyoming — and New York City reported “high” activity levels, which are a measure of the weekly percentage of visits to an outpatient healthcare provider or emergency department for fever and cough or sore throat.” 
  • Per STAT News,
    • “The sickle cell community has for the past few days been buzzing with news of the first-ever approved gene therapies for the devastating disease. Meanwhile, researchers at the American Society of Hematology meeting on Tuesday are reporting advances in a less expensive and more established strategy proven to cure patients: bone marrow transplant.
    • “This approach has been around for decades but required patients to have a well-matched donor and endure a hefty dose of chemotherapy, ruling out transplant as an option for the vast majority of patients. In a mid-stage trial, however, researchers said sickle cell patients who were given a gentler course of chemo and an infusion of half-matched cells fared well: They had less pain, and 95% of participants were alive two years after transplant and only 7% of recipients experienced a severe reaction caused by transplanted immune cells attacking their new home.”
  • and
    • “One of the toughest subtypes of acute leukemia involves a genetic alteration in the KMT2A gene. Many cancers with this genetic alteration end up relapsing or don’t respond to treatment, but new data presented at the annual American Society of Hematology meeting offer hope of a new targeted therapy for these patients.
    • “The study, called the Phase 2 Augment-101 trial, tested Syndax’s revumenib in patients with relapsed or refractory leukemia with these KMT2A genetic rearrangements. Overall, about 63% of the patients responded to the treatment, with many able to receive a potentially curative stem cell transplant later on, which is often the ultimate goal for patients with relapsed or refractory patients, said Ibrahim Aldoss, a hematologist-oncologist at City of Hope and the study’s presenter, in an interview.”
  • The New York Times asks why since 2009 pedestrian deaths at night continue climb?
    • “[P]ut together, it’s clear that there’s been a particularly American mix of technological and social changes over the past decade and a half. And they have all come on top of a road system and an ingrained culture that prioritizes speed over safety. Whatever has happened over this time has reversed years of progress on daytime pedestrian fatalities, too, leading to a modest increase in deaths. Nighttime, however, has the potential to amplify so many of these new risks.
    • “A transportation system that’s safer by design — as in many European countries — might better absorb any one of these dangers. Distracted drivers are safer at lower speeds. People out at night are safer with well-lit crosswalks.”
  • The New York Times furthermore reports,
    • “Zepbound, the newly approved weight loss drug, hit the market this month. People seeking out the medication may have to stay on it for the foreseeable future — potentially, for the rest of their lives — if they want to keep the weight off, new research confirms.
    • “A study published Monday followed 670 people who had taken tirzepatide, the compound in Zepbound and the diabetes drug Mounjaro, for 36 weeks. Eli Lilly, the company that makes both drugs, funded the study. Tirzepatide regulates insulin levels and slows down the emptying of the stomach. It also acts on areas of the brain that control hunger and appetite. As a result, people can lose significant weight: On average, the study participants lost around 20 percent of their body weight during that time.
    • “After that, half of the participants continued to take a high dose of tirzepatide for a year while the other half received a placebo shot. Those in the study also underwent lifestyle counseling, ensuring that they were eating fewer calories and exercising regularly.
    • “People who continued taking tirzepatide for an additional year lost, on average, another 5.5 percent of their body weight. Those who were switched to the placebo, however, gained 14 percent of their body weight on average. Those on the placebo also tended to have higher cholesterol, blood sugar and blood pressure than they did while taking tirzepatide, said Dr. Louis Aronne, the lead author on the study and the director for the Comprehensive Weight Control Center at Weill Cornell Medicine.”

From the U.S. healthcare business front,

  • Per Fierce Healthcare,
    • “Optum Rx is launching a new weight management program aimed at improving outcomes and addressing affordability.
    • “The cost of GLP-1 drugs amid continued high demand is a key focus for pharmacy benefit managers and plan sponsors, especially as individual therapies can top $10,000 per year. Through the Optum Rx Weight Engage program, the PBM is aiming to support employers and other clients in designing benefits for their membership.
    • “The team will review the client’s goals to build a tailored program that will deploy clinical solutions as well as patient monitoring and motivation and support tools, the company said. Members can connect to an obesity management specialist who will direct them to the appropriate clinical services.”
  • Healthcare Dive reports,
    • “Healthcare prices typically rise faster than inflation, but 2023 may have bucked that trend.
    • “The cost of shoppable medical services at hospitals increased 2% in the first three quarters of the year, according to new data from Turquoise Health released Tuesday. That’s in line with the 1.9% overall growth of the economy.
    • “The findings — some of the first from new price transparency data disclosing the once-secret negotiated rates between health insurers and providers — illustrate how overall economic inflation could be catching up to faster health cost growth.”
  • STAT News notes,
    • “In its latest bid to police the pharmaceutical industry, the U.S. Federal Trade Commission sought to block Sanofi from licensing a Pompe disease treatment made by another drug company. And in response, Sanofi is ending the deal.
    • “Sanofi sought the rights to the medication from Maze Therapeutics, but the regulator argued the deal — valued at $775 million — would eliminate a “nascent competitor” that could, otherwise, challenge the monopoly Sanofi has in the market for Pompe disease treatments, according to an FTC statement. The agency had filed a complaint in a federal court in Boston and also planned to seek a preliminary injunction.”
  • BioPharma Dive adds,
    • “The scuttled deal came on the same day that the regulator gave final clearance to Pfizer’s $43 billion acquisition of Seagen, which had faced close scrutiny from the antitrust regulator. To ease the FTC’s concerns, Pfizer has agreed to donate royalties from sales of the cancer drug Bavencio to the American Association for Cancer Research.”
  • Beckers Hospital Review points out six innovative hospitals.
  • According to BioPharma Dive,
    • “AstraZeneca on Tuesday reached a deal to acquire vaccine developer Icosavax in a deal worth up to $1.1 billion. 
    • “Per deal terms, AstraZeneca will acquire Icosavax’s shares at $15 apiece, and could add another $5 per share to the buyout if certain milestones and sales targets are met. The upfront payment from AstraZeneca represents an equity value of about $838 million and a premium of about 43% to Icosavax’s closing price on Monday. The acquisition would reach $1.1 billion if AstraZeneca eventually makes the future payouts, which are known as “contingent value rights.”  
    • “Icosavax has been developing an experimental shot that simultaneously targets respiratory syncytial virus and human metapneumovirus, another lung infection. The biotech released Phase 2 study results on Tuesday showing the vaccine spurred an immune response against both viruses without causing any serious adverse events. AstraZeneca will now take over late-stage development, and, if successful, commercialization.”  

Midweek Update

David Ermer–CDC, Congress, COVID-19, FDA, Medicare, Mental health care, No Surprises Act, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC,

  • The Senate Finance Committee announced,
    • Senate Finance Committee Chairman Ron Wyden, D-Ore., will convene a committee hearing on Tuesday, December 5, 2023 titled “Drug Shortages: Examining Supply Challenges, Impacts, and Policy Solutions from a Federal Health Program Perspective.” The hearing will take place at 10:00 a.m. in Room 215 of the Dirksen Senate Office Building.
  • The American Hospital Association News notes,
    • “The House Energy and Commerce Subcommittee on Health Nov. 29 held a hearing  to explore how medical devices and hospitals are using artificial intelligence and what Congress should consider as AI in health care evolves.”
  • BioPharma Dive reports,
    • “The Food and Drug Administration’s top scientist Namandjé Bumpus will assume the role of principal deputy commissioner when longtime agency leader Janet Woodcock retires from that role in early 2024, according to an announcement Thursday.
    • “Among Bumpus’ priorities when she assumes the role will be “creating a new model” for the FDA’s Office of Regulatory Affairs, the branch that conducts inspections, monitors drug imports, and issues recalls, market withdrawals and safety alerts, Commissioner Robert Califf said in a memo to agency staff.”
  • Sequoia reminds us,
    • “Beginning in 2024, group health plans and carriers will be required to include all covered items and services in their self-service internet-based price comparison tool, as required under the Transparency in Coverage (TIC) Final Rules.
    • “As background, plans must provide participants and beneficiaries with out-of-pocket cost estimates via a user-friendly online self-service tool (and by paper upon request). The intent of this requirement is to provide individuals with real-time cost-sharing information to support making informed health care decisions. Implemented in two phases, the first phase of the price comparison tool required the first 500 items and services (as defined by the DOL) to be published in the tool effective for plan years beginning on or after January 1, 2023, and the second phase will require all other services covered by the plan to be included in the tool effective for plan years beginning on or after January 1, 2024.”

From the public health and medical research front,

  • The Centers for Disease Control announced,
    • “CDC’s National Center for Health Statistics released two reports today examining provisional mortality data from 2022. While analysis shows the number and rate of suicides increased for the second year in a row from, overall life expectancy at birth increased by just over a year. This increase regains some of the 2.4 years of life expectancy lost between 2019 and 2021.
    • “The findings are featured in two new reports, “Provisional Life Expectancy Estimates for 2022” and “Provisional Estimates of Suicide by Demographic Characteristics: United States, 2022. * * *
    • “The increase of 1.1 years in life expectancy from 2021 to 2022 primarily resulted from decreases in mortality due to COVID-19, heart disease, unintentional injuries, cancer, and homicide. Declines in COVID-19 mortality accounted for approximately 84% of the increase in life expectancy. * * *
    • “The percentage increase in the number of suicides was greater for females (4%) than males (2%), but the provisional 2022 suicide number for males (39,255) was nearly four times that of females (10,194).”
  • Health Day points out,
    • “The prevalence of a highly mutated COVID variant has tripled in the past two weeks, new government data shows.
    • “Now, nearly 1 in 10 new COVID cases are fueled by the BA.2.86 variant, the U.S. Centers for Disease Control and Prevention reported Monday.
    • “The variant is spreading the fastest in the Northeast: Just over 13% of cases in the New York and New Jersey region are blamed on BA.2.86. * * *
    • “So far, preliminary data on the variant suggests it does not trigger more severe illness than previous variants, the WHO said in a recent risk evaluation, but the international agency still noted a recent and “substantial rise” in BA.2.86 cases.
    • “The CDC also noted that BA.2.86 variant poses a “low” public health risk.”
  • and
    • “Personal trainers can help people increase their strength and their fitness.
    • “Could a “brain coach” be just as useful in preventing Alzheimer’s’ disease?
    • “A new study suggests that personalized health and lifestyle changes can delay or even prevent memory loss for older adults at high risk of Alzheimer’s or dementia.
    • “People who received personal coaching experienced a 74% boost in their thinking and memory tests compared with those who didn’t receive such attention.
    • “This is the first personalized intervention, focusing on multiple areas of cognition, in which risk factor targets are based on a participant’s risk profile, preferences and priorities, which we think may be more effective than a one-size-fits-all approach,” said co-lead researcher Dr. Kristine Yaffe, vice chair of research in psychiatry at the University of California, San Francisco (UCSF).”
  • Healio informs us,
    • “One in four adults relied solely on medications to manage chronic pain, highlighting an opportunity to increase use of nonpharmacologic therapies, particularly in men, older adults and those with public insurance, according to researchers.
    • “Findings from this study contribute important information about use of over-the-counter pain relievers, prescriptions nonopioids and exercise, which were found to be some of the most common pain management therapies used by adults with chronic pain,” Stephanie Michaela Rikard, PhD, a health scientist at the CDC, told Healio.

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Cigna and Humana are in talks for a combination that would create a new powerhouse in the health insurance industry.
    • “The companies are discussing a stock and cash deal that could be finalized by the end of the year, assuming the talks don’t fall apart, according to people familiar with the matter.”
  • and
    • “A law designed to protect patients from surprise medical bills is contributing to the financial distress of some medical-service providers, which say lengthy billing disputes and payment delays with insurers are hurting their ability to stay afloat. 
    • “The No Surprises Act, which took effect last year, aims to protect patients from surprise medical bills from out-of-network healthcare providers when there are disagreements over reimbursements between insurers and providers. Previously, providers often billed patients to make up for the amounts insurers were unwilling to pay. 
    • “Numerous healthcare businesses, some owned by private equity, said the legislation is contributing to delays and reductions in payments by insurance companies, hurting their cash flows and earnings. A handful of major healthcare-service providers already have filed for chapter 11 protection this year, specifically naming the law as a major reason for their bankruptcies. These include physician-staffing companies Envision Healthcare and American Physician Partners as well as helicopter-ambulance operator Air Methods.”
  • and
    • “There are five tech companies valued at over $1 trillion. In healthcare, the closest contender is  Eli Lilly. 
    • .”This year it became the first big pharmaceutical to surpass a market capitalization of $500 billion thanks to the popularity of its obesity and diabetes medications and, to a lesser extent, its experimental Alzheimer’s drug. But hanging over Lilly and rival  Novo Nordisk is a reality that puts the brakes on big pharma’s ascent: the patent cliff.
    • “There are several reasons why there isn’t a big pharma company in the trillion-dollar club, but the boom-and-bust nature of drug development is high on the list. Unlike Apple, which hypothetically can make huge margins off the iPhone for perpetuity, U.S. drug companies have a limited period from which to profit from their innovation. As their patents expire and generic competitors enter the market, sales plunge. Pharma executives, overly focused on short-term growth, don’t often prepare their companies for that.”
  • FEHBlog notes on the Journal articles,
    • Cigna and Humana are undoubtedly aware of the firebreathing nature of anti-trust enforcers in the federal government. Cigna is focused on the commercial market while Humana currently is pulling out of that market to focus on government business. Time will tell.
    • Out-of-network doctors and air ambulance companies flying the pirate flag can avoid No Surprises Act problems by joining health plan networks.
    • Lilly’s recent growth has been impressive.
  • Reuters tells us,
    • “UnitedHealth Group on Tuesday forecast 2024 profit broadly in line with Wall Street expectations, indicating that medical costs are likely to remain elevated for the health insurance giant.
    • “The healthcare sector has this year seen a recovery in demand, especially among older patients who started returning to doctors’ clinics and hospitals for procedures they had delayed during the COVID-19 pandemic.”
  • Healthcare Dive adds,
    • “Healthcare insurers could get a slight respite from rising medical costs next year. Global costs are expected to rise 9.9% year over year in 2024, down from a 10.7% increase in 2023, according to a new survey from consultancy WTW released on Tuesday.
    • “However, that decline might not last long. Nearly three-fifths of insurers surveyed anticipate higher medical cost growth over the next three years as new medical technologies, overuse of care and members’ poor health habits drive increased spend.
    • “Many insurers told WTW they are leaning on deductibles, contracted provider networks and telehealth options to manage costs. Others are excluding coverage for healthcare such as fertility treatments or gender re-affirming care.”
  • Beckers Hospital CFO Report identifies the states with the most rural hospital closures.
    • “Since 2005, 104 rural hospitals have closed and more than 600 additional rural hospitals — 30% of all rural hospitals in the U.S. — are at risk of closing in the near future, according to the Center for Healthcare Quality and Payment Reform.”
  • Beckers Hospital Review calls attention to this development,
    • “Mayo Clinic’s board of trustees has given the green light to an initiative dubbed “Bold. Forward. Unbound.,” which involves a $5 billion redesign of Mayo Clinic’s downtown Rochester, Minn., campus. 
    • “The redesign will introduce new facilities that incorporate innovative care approaches and digital technologies, according to a Nov. 28 news release from Mayo, with a pivotal element of these being specialized “neighborhoods.” According to the health system, the neighborhood concept will offer patients a centralized location for all required services related to their specific condition, eliminating the need for navigating between different departments.”
  • Per Fierce Healthcare,
    • “Accountable care organizations do not positively influence treatment and outcomes for chronic mental health conditions for Medicare patients, according to a study in Health Affairs.
    • “For patients newly enrolled in ACOs, they saw no improvements in their depression and anxiety symptoms after one year. These patients were also 24% less likely to have their depression or anxiety treated than patients unenrolled in ACOs, and 9.8% less likely to have an evaluation and management visit for depression or anxiety with a primary care clinician.
    • “Since mental health conditions in Medicare patients are often underdiagnosed and undertreated, some have suspected that mental health illnesses are ideal conditions for ACOs to handle, but the study found that there were no significant differences in any other measures of mental health treatment.”
  • Beckers Hospital Review also names the winners of Forbes 30 under 30 in healthcare for 2024.


 

Tuesday Tidbits

David Ermer–ACA, FDA, No Surprises Act, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • This morning, the federal government filed a notice appealing to the D.C. Circuit the HIV and Hepatitis Foundation’s successful challenge to the Trump administration’s co-pay accumulator rule.
  • Yesterday, the federal government moved for the district court to modify its decision to state that the Trump administration rule would remain effective until the ACA regulators reconsidered it in compliance with the court’s order. The plaintiffs reportedly oppose the government’s motion. 
  • The ACA regulators issued
  • The FAQs concern the claims batching limitations under the No Surprises Act and the update to CLAS requirements that health plans, including FEHB plans must use in certain plan publications. The FEHBlog noticed that the ACA regulators have added new languages to CLAS requirements. The CLAS changes will take effect for the 2025 plan year.
  • The American Hospital Association News adds,
    • In response to recent court decisions that set aside certain regulations implementing the No Surprises Act’s Independent Dispute Resolution process, the Centers for Medicare & Medicaid Services Nov. 28 released [ACA] FAQs [63] explaining how certified IDR entities may determine whether a dispute is appropriately batched and clarifying certain other provisions and its policy for extending existing IDR deadlines once the federal IDR portal reopens to all batched disputes and single disputes involving air ambulance services. CMS also rescheduled to Nov. 30 at 3 p.m. ET its webinar to review the FAQs for health care providers and insurers submitting batched or air ambulance claims. To attend the webinar, register here.
  • Get a load of this other AHA News item,
    • A bipartisan group of House members Nov. 28 introduced AHA-supported legislation that would prohibit health insurers from charging fees for standard electronic fund transfers to pay health care providers for services. Commercial insurers often automatically charge health care providers a percentage-based fee for EFT payments. 
    • FEHBlog note — EFT transactions are not free. If the entire cost is shifted onto the insurer, then premiums go up.

From the public health and medical research front,

  • BioPharma Dive informs us,
    • “The Food and Drug Adminsitration is investigating whether CAR-T cell therapies like Novartis’ Kymriah or Gilead’s Yescarta are linked to the risk of new blood cancers after receiving reports of so-called T cell malignancies in people who have received the treatments.
    • “In a statement Tuesday, the agency said it’s weighing “the need for regulatory action” in response to the reports, which came from both clinical testing and safety monitoring tied to commercial use. The identified risk is applicable to all approved CAR-T therapies, although the agency noted that “the overall benefits of these products continue to outweigh their potential risks for their approved uses.”
  • The Wall Street Journal reports,
    • “The U.S. Food and Drug Administration warned of an emerging safety issue involving a continuous positive airway pressure, or CPAP, machine made by Philips.
    • “The FDA issued a safety communication about thermal issues with the Philips Respironics’ DreamStation 2 CPAP machines, which are used to treat forms of sleep apnea, and recommended patients monitor machines.
    • “The agency said it had received reports of issues such as fire, smoke, burns and other signs of overheating. The FDA said it is in discussions with the company about strategies to address the safety issue.”
  • The Washington Post points out,
    • “Scientists have discovered a new type of stem cell in the spine that appears crucial to resolving a long-standing mystery: why far more cancer cells spread to the spine than to other bones in the body.
    • “When breast, lung and prostate cancers metastasize to multiple bones in the body, three to five times more cancer winds up in the spine than in the lower and upper limbs. Scientists have known of this disparity for decades, but the reason for it has remained unclear.
    • “One theory held that differences in blood flow might be the cause. But the new findings suggest an alternative that could have implications for cancer care, spine fusion surgery and osteoporosis, a bone-weakening disease that afflicts about 10 million Americans.”
  • The Institute for Clinical and Economic Review (ICER) announced,
    • “releasing a Draft Evidence Report assessing the comparative clinical effectiveness and value of xanomeline tartrate/trospium chloride (KarXT, Karuna Therapeutics) for the treatment of schizophrenia. This preliminary draft marks the midpoint of ICER’s eight-month process of assessing these treatments, and the findings within this document should not be interpreted to be ICER’s final conclusions.“
  • The ICER announcement also explains how to submit public comments and participate in virtual public meeting on February 9, 2024.

From the U.S. healthcare business front,

  • The Business Group on Health issued a report on nine healthcare cost trends to watch in 2024.
  • Beckers Hospital Review tells us,
    • “Hospitals’ median operating margin was 1.2% through October, marking the third straight month with the same year-to-date median and signaling growing stability.  
    • “The latest figure comes from Kaufman Hall’s November “National Hospital Flash Report,” which is based on data from more than 1,300 hospitals. 
    • “Kaufman Hall said the 1.2% year-to-date median operating margin for October reflects “continued stabilization” among hospitals. In the first 10 months of 2023, hospitals’ net operating revenue per calendar day was up 6%, and total expense per calendar day was up 4% compared to the same time period in 2022.”

Monday Roundup

David Ermer–CMS, Congress, FDA, Federal employment benefits, Generative AI, Medical / Rx research, Medicare, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC,

  • Roll Call offers a preview of Congress’s actions over the next month, after which point the first session of this 118th Congress will come to a close.
  • Bloomberg provides an update on ongoing efforts to revamp the Nation’s organ transplant system. Here are the highlights:
    • “First contract bid solicitations from HHS expected this fall, and
    • “Multiple vendors to run transplant system for first time.”
  • The Centers for Medicare and Medicaid Services published in today’s Federal Register corrections to its Section 111 reporting civil monetary penalty rule which was issued on October 11, 2023. CMS asserts that the corrections fix “typographical and technical errors in the final rule, and it does not make substantive changes to the policies or the implementing regulations that were adopted in the final rule.”
  • The Department of Health and Human Services announced,
    • “As part of the inaugural meeting of the White House Council on Supply Chain Resilience, President Biden and Secretary of Health and Human Services Xavier Becerra today announced new efforts to bolster the domestic supply chain for essential medicines and medical countermeasures.
    • “President Biden will issue a Presidential Determination broadening HHS’ authorities under Title III of the Defense Production Act (DPA) to enable investment in domestic manufacturing of essential medicines, medical countermeasures, and other critical inputs that have been deemed by the President as essential to the national defense. In addition, HHS will designate a new Supply Chain Resilience and Shortage Coordinator for efforts to strengthen the resilience of critical medical product and food supply chains, and to address related shortages.”
  • The Food and Drug Administration announced,
    • “approv[ing] Ogsiveo (nirogacestat) tablets for adult patients with progressing desmoid tumors who require systemic treatment. Ogsiveo is the first drug to be approved for the treatment of patients with desmoid tumors, a rare subtype of soft tissue sarcomas.
    • “Desmoid tumors are non-cancerous but can be locally aggressive. The tumors may invade into surrounding structures and organs, resulting in pain, issues with being able to move, and decreased quality of life. Although surgical removal has historically been the treatment of choice, there is a high risk that the tumor will return or that other health challenges will occur after removal; therefore, systemic therapies (cancer treatment targeting the entire body) are being increasingly evaluated in clinical trials.” 
  • The HHS Inspector General concluded that “The Risk of Misuse and Diversion of Buprenorphine for Opioid Use Disorder in Medicare Part D Continues to Appear Low: 2022.”
  • Govexec tells us,
    • “The U.S. Postal Service is planning to hire just 10,000 temporary employees during the current holiday season as part of a new approach that management has acknowledged comes with some risks. 
    • “The seasonal hiring marks a 64% reduction from the employees brought on in 2022 during what USPS calls its “peak season” when the agency made 28,000 temporary hires. The agency had said it would bring on just 20,000 seasonal workers that year, but a recent USPS inspector general report found it reached a higher tally. 
    • “This will mark the second consecutive year in which the Postal Service significantly reduces its seasonal hiring. In 2021, USPS added 45,000 non-permanent staff for the holiday rush. Postmaster General Louis DeJoy has said additions to the permanent, career workforce has lessened the need for such a surge. In the last two years, the agency has converted 150,000 employees from part-time workers to full-time, career personnel.”
  • Federal News Network informs us,
    • “Participants in [OPM’s] Thrift Savings Plan felt less content with the TSP this year, according to the latest results of the Federal Retirement Thrift Investment Board’s annual satisfaction survey.
    • “Currently, 82% of TSP participants are satisfied with the plan, compared with an 87% satisfaction rate in 2022, the board’s survey of tens of thousands of TSP participants showed.
    • “The slumping satisfaction scores may not come as a surprise after the TSP’s tumultuous transition to a new recordkeeper in June 2022. The 2023 survey, conducted between March and May of this year, was the first time the major update was reflected in the annual participant satisfaction survey.”

From the public health and medical research front,

  • Precision Vaccinations points out,
    • “The World Health Organization (WHO) today reported that the multi-country mpox outbreak continues at a low transmission level in the European Region and the Americas.
    • “The 30th WHO Situation Report, published on November 25, 2023, offers insights regarding the latest epidemiology and a particular focus on the ongoing and evolving epidemiology of mpox in the Democratic Republic of the Congo (DRC).
    • “The WHO confirmed that from January 2022 through October 31, 2023, a cumulative total of 91,788 laboratory-confirmed cases of mpox, including 167 deaths, have been reported from 116 countries/territories/areas.
    • “The countries that have reported the highest cumulative number of mpox cases are the United States (30,771), Brazil (10,967), and Spain (7,647).”
  • Healio notes,
    • “Eating disorder claims in the United States rose 65% as a percentage of all medical claims over the last 5 years, according to a report from FAIR Health, a health care claims repository.
    • “Researchers at FAIR Health evaluated more than 43 billion private health care claims records to investigate trends in eating disorders from 2018 to 2022 based on regional and national levels, demographic and socioeconomic factors and other health conditions. * * *
    • “Key takeaways:
      • “Patients aged 14 to 18 years accounted for most eating disorder claims in 2022.
      • “Overall, 72% of patients with eating disorders were diagnosed with at least one co-occurring mental illness.”
  • Beckers Hospital Review lets us know,
    • “Eli Lilly’s Mounjaro helped patients lose weight more effectively than Novo Nordisk’s Ozempic, according to a preprint study that included more than 40,000 patients. 
    • “The research evaluated 41,223 EHRs of overweight or obese patients taking Mounjaro (tirzepatide) or Ozempic (semaglutide) for Type 2 diabetes. The cohort was restricted to patients with available weight data and those who had not received a glucagon-like peptide-1 receptor agonist prior to May 2022.
    • “Although about 77% of the patients took Ozempic, those who took Mounjaro “were significantly more likely to achieve 5%, 10% and 15% weight loss and experience larger reductions in weight at 3, 6, and 12 months,” the study found.
    • “Truveta, a healthcare data company that collects EHR information from more than 30 systems, conducted the research. It is the first real-world comparative effectiveness study between Mounjaro and Ozempic, Truveta said in a Nov. 27 news release.” 
  • STAT News reports,
    • “The inflammation-targeting therapy Dupixent succeeded in a Phase 3 trial in patients with the chronic lung disease COPD, its developers said Monday, results that could propel the blockbuster medicine into a massive new market.
    • “Dupixent, which is jointly developed by Sanofi and Regeneron Pharmaceuticals, has already racked up approvals for several indications, including asthma, atopic dermatitis, and eosinophilic esophagitis. If approved for COPD, it would be the first biologic treatment for the condition.
    • “The trial, dubbed Notus, was the second Phase 3 trial for Dupixent in COPD, with the companies announcing similarly positive results from the Boreas trial earlier this year. The full data from Boreas were published in the New England Journal of Medicine.”

From the U.S. healthcare business front,

  • Employee Benefit News offers tips on PBM contracting.
  • Per Fierce Healthcare,
    • “Mark Cuban Cost Plus Drug Company has inked its latest partnership, joining forces with Expion Health to address the rising cost of specialty drugs.
    • “Cost Plus Drugs’ pricing model will integrate into Expion’s dynamic pricing technology, harnessing the power of both for speciality medications. Expion’s tool and Cost Plus Drugs’ approach together “equips payers with a sophisticated tool for navigating this modern landscape,” the companies said in the announcement.”
  • and
    • “Ayble Health, a digital health platform for patients with chronic gastrointestinal conditions, has announced a new collaboration with the Mayo Clinic.
    • “Ayble is working with the Mayo Clinic Complex Care Program to offer a hybrid care model that matches patients with the appropriate virtual and in-person care based on acuity and need.
    • “By matching the right care for a patient at the right time, the two hope to improve outcomes and costs for digestive diseases. The collaboration is available for large employers and health plans.” 
  • MedCity News calls to our attention,
    • “AI startup Hoppr teamed up with AWS to launch a new foundation model to help bring more generative AI solutions into medical imaging, the companies announced on Sunday at RSNA 2023, the annual radiology and medical imaging conference in Chicago.
    • “The new product, named Grace, is a B2B model designed to help application developers build better AI solutions for medical images — and to build them more quickly. Along with the launch of Grace, Hoppr also announced that it received “a multi-million dollar investment” from Health2047, the American Medical Association’s venture studio.”
  • Per Healthcare Dive,
  • “Advocate Health’s financial performance dipped in the third quarter despite rising patient volumes as the major nonprofit health system navigated higher expenses and declining investment returns.
  • “The operator reported a nine-month operating income of $79.4 million, down from the $85.7 million Advocate recorded through the first half of the year.
  • “Advocate’s investment income also took a hit, falling more than a third from midyear. Overall, the nonprofit’s bottom line dropped to $721.2 million, 28% lower than midyear. * * *
  • “Formed out of a merger between Illinois-based Advocate Aurora Health and North Carolina-based Atrium Health last year, the health system is comprised of three divisions: Advocate Aurora Health, Atrium Health’s Charlotte-Mecklenburg Hospital Authority and Atrium Health Wake Forest Baptist. Together, the divisions operate more than a thousand care sites, including 67 hospitals.”

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.