Friday Factoids

FDA

Friday Factoids

David Ermer–CDC, COVID treatment, COVID-19, COVID-19 vaccine, FDA, Federal employment benefits, Medical / Rx research, Mental health care, No Surprises Act, Obesity, OPM, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC

  • The Federal Times reports,
    • “It took 13 years — with some stops, starts and stumbles in between — but as of today, the federal government now has a single website designed to deliver detailed, searchable information about all federal programs.
    • “The Office of Management and Budget flipped the switch Thursday on the new Federal Program Inventory, a platform it’s been building via various pilot efforts since December 2020. Officials acknowledge it doesn’t yet capture every single program: For now, only “domestic assistance” programs are included. But that broad category encompasses most federal spending, ranging from Social Security and Medicare to the smallest community block grant programs.
    • “As of now, the database includes spending and performance data on 2,388 programs, said Diedre Harrison, OMB’s deputy controller.”
  • The FEHBlog cannot locate the FEHBP in this database, FYI. What’s more,
    • “The Treasury Department and the IRS are calling on teleworking employees to return to the office for half of their workdays, starting in a few months.
    • “IRS Commissioner Danny Werfel told employees in an email Thursday that teleworking employees will need to return to the office 50% of the time, on any given month, starting on May 5.
    • “Our top priority, regardless of where employees are located at any point in time, will continue to be meeting our goals of serving taxpayers, ensuring tax compliance and maintaining our vital technology and operations,” Werfel wrote.
    • “The return-to-office plans will only impact IRS executives, managers and non-bargaining unit employees with telework agreements in the National Capital Region. The decision affects IRS headquarters, the agency’s New Carrollton Federal Building and other offices in the Washington, D.C. area.”
  • Healthcare Dive points out,
    • “The federal government received 13 times more surprise billing disputes in the first half of 2023 than it expected to receive in a full year, according to new CMS data.
    • “And the amount is growing each quarter, contributing to a growing backlog and straining the capacity of the system regulators set up to arbitrate disputes over medical bills between providers and health insurers.
    • “Of the 288,810 disputes filed in the first six months of 2023, fewer than half were closed, and arbiters rendered payment decisions in under a third of cases. Of those, providers won 77% of payment determinations, while health plans prevailed in 23% — noteworthy statistics given providers have argued the arbitration process is unfairly weighted toward insurers.”
  • The Commonwealth Fund discusses the status of creating a separate version of the No Surprises Act for ground ambulances.
  • Newfront fills us in on federal claim substantiation rules for flexible spending accounts, health reimbursement accounts, and health savings accounts.
  • The Wall Street Journal reports,
    • “Novartis and Roche Holding said the U.S. Food and Drug Administration approved their Xolair treatment to reduce allergic reactions following the exposure to one or more foods.
    • “The pharmaceutical companies on Friday said Xolair has been approved for patients aged one year and older with the IgE-mediated food allergy.
    • “Patients taking Xolair for food allergies should continue to avoid all foods they are allergic to, the companies added.
    • “Xolair, a prescription biologic medicine that is given as an injection, shouldn’t be taken as an emergency treatment for allergic reactions.”
  • BioPharma Dive adds,
    • “The Food and Drug Administration will decide by June 21 whether to loosen the restrictions surrounding use of Sarepta Therapeutics’ gene therapy for Duchenne muscular dystrophy, the company said Friday
    • “Sarepta’s gene therapy, Elevidys, was granted a conditional OK last June for children between 4 and 5 years of age who have Duchenne and can still walk. Sarepta aims to convert that nod to a full approval for all people with Duchenne and a confirmed mutation to a specific gene, even though Elevidys failed to hit its main goal in a study meant to confirm its benefits. 
    • “Sarepta, for its part, has argued that the collective evidence it’s accrued proves Elevidys is impacting the disease. Analysts appear optimistic of its chances, given the agency won’t convene a group of outside experts to review its request.”  

From the public health and medical research front,

  • The Centers for Disease Control tells us
    • In September 2023, CDC’s Advisory Committee on Immunization Practices recommended updated 2023–2024 (monovalent XBB.1.5) COVID-19 vaccination for all persons aged ≥6 months to prevent COVID-19, including severe disease. Many variants co-circulated during fall 2023; the JN.1 lineage became predominant in January 2024. Few estimates of updated 2023–2024 vaccine effectiveness (VE) are available.
    • What is added by this report?
    • Receipt of updated COVID-19 vaccine provided approximately 54% increased protection against symptomatic SARS-CoV-2 infection compared with no receipt of updated vaccine. Vaccination provides protection against JN.1 and other circulating lineages.
    • What are the implications for public health practice?
    • All persons aged ≥6 months should receive updated 2023–2024 COVID-19 vaccine. CDC will continue monitoring COVID-19 VE, including against severe disease and for expected waning.
  • The CDC called attention to its website on RSV prevention.
  • MedCity News offers
    • “Three Tips To Improve Health Plans’ Chronic Conditions Management 
    • “During a virtual panel, leaders from across the industry shared their advice on how health plans can do a better job of achieving their goals for chronic management. For example, one executive said health plans should utilize remote monitoring tools for centralized observation and be wary of using the wrong metrics.” 
  • Benefits Pro lets us know,
    • “Older Americans may forego elective surgeries because they are worried about out-of-pocket expenses and time away from work, along with potential exposure to COVID-19.
    • “This is according to a study by the University of Michigan Institute for Healthcare Policy and Innovation, which discovered that these factors tend to dissuade older Americans from going through with surgeries more than concerns about pain or the recovery process.
    • “Nearly half of those who said they were very concerned about cost and more than half of those who were very concerned about taking time off of work ended up not having a surgery they were considering, the study found. However, those who were concerned about surgery-related pain were just as likely as those with no concerns about pain to go ahead with surgery.”
  • Medscape calls attention to “How the New MRSA Antibiotic Cracked AI’s ‘Black Box.'”
    • “The MIT study is part of the Antibiotics-AI project, a 7-year effort to leverage AI to find new antibiotics. Phare Bio, a nonprofit started by MIT professor James Collins, PhD, and others, will do clinical testing on the antibiotic candidates.
    • “Even with the AI’s assistance, there’s still a long way to go before clinical approval.
    • “But knowing which elements contribute to a candidate’s effectiveness against MRSA could help the researchers formulate scientific hypotheses and design better validation, Lee noted. In other words, because they used explainable AI, they could be better positioned for clinical trial success.”
  • The New York Times reports,
    • “Growing numbers of children and adolescents are being prescribed multiple psychiatric drugs to take simultaneously, according to a new study by researchers at the University of Maryland. The phenomenon is increasing despite warnings that psychotropic drug combinations in young people have not been tested for safety or studied for their impact on the developing brain.
    • “The study, published Friday in JAMA Open Network, looked at the prescribing patterns among patients 17 or younger enrolled in Medicaid from 2015 to 2020 in a single U.S. state that the researchers declined to name. In this group, there was a 9.5 percent increase in the prevalence of “polypharmacy,” which the study defined as taking three or more different classes of psychiatric medications, including antidepressants, mood-stabilizing anticonvulsants, sedatives and drugs for A.D.H.D. and anxiety drugs.”
  • AP reports,
    • “Smoking has surpassed injecting as the most common way of taking drugs in U.S. overdose deaths, a new government study suggests.
    • “The Centers for Disease Control and Prevention called its study published Thursday the largest to look at how Americans took the drugs that killed them.
    • “CDC officials decided to study the topic after seeing reports from California suggesting that smoking fentanyl was becoming more common than injecting it. Potent, illicit versions of the painkiller are involved in more U.S. overdose deaths than any other drug.”

From the U.S. healthcare business front,

  • Healthcare Dive informs us,
    • “CommonSpirit Health cut its operating losses in the three months ended Dec. 31by working with payers to speed the rate of reimbursement for services and implementing cost containment measures, according to earnings released on Thursday.
    • “The Chicago-based health system reported an operating income of $356 million for the quarter. Normalized for the California provider fee program, CommonSpirit logged an operating loss of $87 million. In the same period last year, CommonSpirit reported an operating loss of $440 million.
    • “CommonSpirit said supply and salary inflation continues to vex the system. Salaries and benefit expenses increased $413 million, or 9.3%, year over year, primarily due to higher salary costs.”
  • RevCycle Intelligence adds,
    • “Rural healthcare’s outlook just worsened, according to a new analysis from Chartis, a healthcare advisory firm.
    • “The updated analysis of key indicators such as rural hospital operating margin, facility closures, and loss of access to care and services paints a grim picture for rural hospitals in the US, particularly independent providers.
    • “Half of rural hospitals are operating in the red, the analysis found, and that percentage increased from 43 percent a year ago. More independent rural hospitals are operating at a loss at 55 percent, while 42 percent of health system-affiliated rural hospitals have a deficit. The analysis noted that almost 60 percent of rural hospitals in the US are now affiliated with a health system.
    • “With more rural hospitals facing revenue losses, 418 facilities are “vulnerable to closure,” the analysis showed.
    • “America’s rural hospitals have been battling against drivers of instability for more than a decade, but this newest research suggests this crisis has accelerated quickly to previously unseen levels,” Michael Topchik, national leader of The Chartis Center for Rural Health, said in a statement. “To learn the percentage of rural hospitals in the red has shifted 7 [percent] and now includes half of all rural hospitals is startling and should serve as an urgent call to action for everyone invested in rural healthcare.”
  • Per Fierce Healthcare,
    • “Nearly all healthcare executives believe new digital health technologies are worth the cost, even though they have yet to see a financial return from it, a new survey reveals.
    • “The inaugural Health Pulse Survey was conducted by Ernst & Young and reached more than 100 payer and provider administrative executives across the U.S. It found that the appetite for digital health solutions has risen, particularly since COVID-19. The pandemic was a catalyst for the industry.
    • “COVID prompted a lot of digital health tech investments by payers and providers—it was out of necessity,” Kaushik Bhaumik, EY’s U.S. health technology leader, told Fierce Healthcare. “People had to connect with their patients through digital channels.” 
  • Reuters reports,
    • “A small but rapidly growing number of U.S. adolescents began treatment with Novo Nordisk’s weight-loss drug Wegovy last year, a powerful new tool to address record rates of pediatric obesity, according to data shared exclusively with Reuters.
    • “In the first 10 months of 2023, 1,268 children ages 12 to 17 with an obesity diagnosis started taking Wegovy, according to U.S. insurance claims data compiled by health technology company Komodo Health.”

Happy Lincoln’s Birthday!

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

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

From Washington, DC,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Friday Factoids

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

From Washington, DC

  • The U.S. Office of Personnel Management released its call letter for benefit and rate proposals for 2025 FEHB and Postal Service Health Benefit (PSHB) plans. Not surprisingly, the 2025 call letter focuses on the launch of the PSHB Program on January 1, 2025. The next step will be for OPM to issue its technical guidance. The benefit and rate proposals are due on May 31, 2024.
  • Fierce Healthcare reports,
    • “A bipartisan group of senators announced Friday that it is working on new legislation for “long-term reforms” to physician payments under Medicare and other program changes.
    • “In a joint release, U.S. Sens. Catherine Cortez Masto, D-Nevada; Marsha Blackburn, R-Tennessee; John Barrasso, R-Wyoming; Debbie Stabenow, D-Michigan; Mark Warner, D-Virginia; and Minority Whip John Thune, R-South Dakota said they have formed a “Medicare payment reform working group.”
    • “The lawmakers plan to proposes changes to the physician fee schedule and “make necessary updates” to 2015’s Medicare Access and CHIP Reauthorization Act (MACRA), they said, and “in the coming weeks” will be seeking feedback from stakeholders.”
  • The Department of Health and Human Services announced,
    • “On Thursday, February 8, 2024, U.S. Department of Health and Human Services (HHS) Secretary Xavier Becerra addressed the National Press Club in Washington, D.C. for its historic Headliners Luncheon.
    • “During his address, he urged the nation to shift from an “illness-care system” to a “wellness-care system.” He also highlighted the Biden-Harris Administration’s work to increase access to quality, affordable health care, lower health care costs, including the cost of prescription drugs, and protect access to reproductive health care.”

From the public health and medical research front,

  • The Centers for Disease Control tells us,
    • What CDC knows
      • BA.2.87.1, a new variant of SARS-CoV-2, the virus that causes COVID-19, was identified in South Africa by the National Institute for Communicable Diseases. CDC is closely tracking this variant because of the large number of mutations when compared to previous variants. At this time, BA.2.87.1 has not been identified in clinical specimens outside South Africa. Because this is a newly emerging variant, there is not as much additional data about its potential impact. So far, the public health risk for this new variant appears low.
    • What CDC is doing
      • CDC continues to track the appearance and spread of new variants around the world through genomic surveillance. CDC is working closely with partners in South Africa to gather the latest information on BA.2.87.1. CDC and its partners are continually assessing potential impacts to vaccines, tests, and treatments.
    • Keep reading: CDC Tracks New SARS-CoV-2 Variant, BA.2.87.1
  • Here is a link to the CDC’s Covid Data Tracker.
  • ABC News adds,
    • “The flu virus is hanging on in the U.S., intensifying in some areas of the country after weeks of an apparent national decline. 
    • “Centers for Disease Control and Prevention data released Friday showed a continued national drop in flu hospitalizations, but other indicators were up — including the number of states with high or very high levels for respiratory illnesses.
    • ““Nationally, we can say we’ve peaked, but on a regional level it varies,” said the CDC’s Alicia Budd. “A couple of regions haven’t peaked yet.”
  • MedPage Today lets us know,
    • “The CDC has published its first comprehensive laboratory recommendations for syphilis testing.
    • “Published in the Morbidity and Mortality Weekly Reportopens in a new tab or window, the new recommendations include approaches for laboratory-based tests, point-of-care tests, sample processing, and how laboratories should report test results to clinicians and health departments.
    • “The recommendations are primarily for clinical laboratory or disease control personnel, but also for clinicians to understand how to collect and process specimens, interpret test results, and counsel and treat patients, according to CDC researchers led by John Papp, PhD, of the agency’s National Center for HIV, Viral Hepatitis, STD, and TB Prevention in Atlanta.”
  • Mercer Consulting suggests that rising cancer rates call for a comprehensive strategy.
    • “A comprehensive cancer strategy includes both support for employees as they cope with the physical and emotional stresses of a cancer diagnosis, and effective care management to help ensure the patient receives quality care quickly in the most appropriate setting — which can lead to better outcomes and better use of healthcare dollars. Just over a third of large employers (34%) provide a specialized cancer care management program. These programs assist with care coordination, support compliance with treatment regimens, find applicable clinical trials, and connect families to local community resources and to other solutions the employer offers.  
    • “Centers of Excellence or site-of-care navigation programs, offered by 24% of large employers, help ensure that members are treated by quality providers with relevant experience and expertise. Hotlines, caregiver and family advocacy services, and financial planning services can help employees and their families deal with the day-to-day challenges of the cancer journey.”
  • Milliman Consulting offers some use cases for AI in healthcare and their implications for health insurers.
  • Per BioPharma Dive,
    • Takeda Pharmaceutical plans to quickly begin late-stage testing of an experimental drug for narcolepsy, which, if successful, could help the company enter what Wall Street analysts see as a multibillion-dollar market.
    • There are two kinds of narcolepsy, with a key difference being that “Type 1” can involve a sudden loss of muscle control. Takeda has been testing its drug, known as TAK-861, as a potential treatment for both, and on Friday disclosed high-level results from a pair of studies that each focused on one type.
    • “Takeda said the Type 1 trial, which evaluated 112 patients, found those given its drug as opposed to a placebo experienced statistically significant and “clinically meaningful” improvements in wakefulness at the eight-week mark. The company now intends to begin Phase 3 trials in the first half of its fiscal year, which begins April 1.”

From the U.S. healthcare business front,

  • Per Healthcare Dive,
    • “Primary care providers Indianapolis-based Marathon Health and Denver-based Everside Health completed their merger on Thursday, and will operate as Marathon Health.
    • “The Marathon executive team — CEO Jeff Wells and executive chairman Ben Evans — will stay intact post-merger, while Everside Health CEO Chris Miller will depart the company, according to a company spokesperson. Marathon declined to disclose financial details of the deal.
    • “The new Marathon Health will have a physical presence in 41 states at 680 health centers and provide virtual healthcare in all 50 states.” 
  • and
    • “One Medical is closing several offices and moving its chief financial officer to a role focused on growth as Amazon attempts to reallocate internal resources to cut costs.
    • “One Medical plans to close offices in New York City, Minneapolis and St. Petersburg, Florida, by the end of February, according to an internal email obtained by Business Insider. The company will also downsize its San Francisco office space to one floor.
    • “An Amazon spokesperson confirmed the changes to Healthcare Dive and said the company is reducing its investment in corporate office space given many One Medical corporate employees work remotely.”
  • MedTech Dive informs us,
    • “Fresenius Medical Care has received 510(k) clearance for its high-volume hemodiafiltration dialysis therapy system, the company said Thursday.
    • “The device, the 5008X Hemodialysis System, uses both diffusion and convection to remove waste products from the blood of kidney disease patients. Using diffusion, the standard mechanism for hemodialysis, and convection is intended to improve the removal of larger waste products.
    • “Fresenius plans to start a broad market launch next year and push to establish hemodiafiltration, which is already widely used in Europe, as the new standard of care in the U.S.”
  • Health Payer Intelligence points out “KLAS Report Reveals Top-Performing Vendors for Payer Services. The top-performing vendors varied across payer services, with Zelis ranking high for payment accuracy and integrity and ZeOmega succeeding in care management.”

Tuesday’s Tidbits

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

From Washington, DC,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Monday Roundup

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

From Washington, DC,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Happy Groundhog Day

David Ermer–CDC, CMS, Congress, COVID-19, FDA, NIH, Telehealth, U.S. Healthcare–

From Gobbler’s Notch, PA, NPR informs us,

  • “Punxsutawney Phil, the renowned groundhog who’s been predicting when winter will end since 1887, says things are about to warm up.
  • “Glad tidings on this Groundhog Day. An early spring is on the way,” a proclamation was read out at Gobbler’s Knob, elating a crowd of thousands of people who had weathered dark and cold to see the famous rodent.”

From Washington, DC

  • Rep. James Comer, the Chair of the House of Representatives Oversight and Accountability Committee announced that the full Committee will be marking up several bills next Tuesday at 10 am, including
    • “H.R. 6283, the Delinking Revenue from Unfair Gouging Act: Adds a new section to the Federal Employees Health Benefits Act which would make changes to Pharmacy Benefit Manager (PBM) pricing, including implementing de-linking policies and requiring a PBM to only charge a flat fee for drug placement versus letting them continue to charge a percentage of the drug.”
    • The markup will be open to the public and press [at 2154 Rayburn House Office Building”] and will be live streamed online at https://oversight.house.gov/.
  • Govexec tells us,
    • “The federal government added 11,000 jobs in January, an usually high number but in line with recent trends under the Biden administration. 
    • “Including the U.S. Postal Service, federal agencies have seen robust growth of 86,000 jobs over the last year. Not counting decennial census years when the government hires hundreds of thousands of temporary workers, total federal employment reached its highest level in at least 20 years, according to Bureau of Labor Statistics data. The last year saw the most non-census hiring of any 12-month period over the same two-decade period. 
    • “Of the 11,000 jobs gained in January, about 4,500 were for the Postal Service and 6,500 went toward the rest of federal government. Only a handful of non-census months over the last 20 years have seen such significant federal job growth. Federal employment has increased in 16 of the last 17 months.” 
  • mHealth Intelligence points out,
    • “The Department of Health and Human Services (HHS) published a final rule on February 2 that significantly expands access to medications for opioid use disorder (OUD), including allowing treatment initiation through telehealth.”The Department of Health and Human Services (HHS) will publish a final rule on February 2 that significantly expands access to medications for opioid use disorder (OUD), including allowing treatment initiation through telehealth.
    • “This final rule updates certain provisions of regulations related to Opioid Treatment Program (OTP) accreditation, certification, and standards for treating OUD with medications. These are the first substantial changes to the rules governing OTPs in 20 years.”
  • Healthcare Finance delves into the 2025 Advance Notice for the Medicare Advantage and Medicare Part D Prescription Drug Programs released Wednesday.
  • The Affordable Care Act regulators issued ACA Frequently Asked Question 65 which seeks to resolve a Transparency in Coverage compliance issue.
  • “On Thursday, the FDA advised consumers in the Don’t Overuse Acetaminophen Consumer Update to be cautious not to exceed the daily maximum recommended dose of acetaminophen, which can lead to overdose and severe liver damage. Over 600 medications – both prescription and nonprescription – have acetaminophen to help relieve pain and reduce fever.”
  • The Hill reports that Perigo expects to have its Opill over the counter female contraceptive pills on pharmacy shelves in the first quarter of 2024. Perigo has not accounced Opill’s retail price, “with a spokesperson saying it is committed to making sure its product is ‘accessible to people who need it.'”

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

  • The University of Minnesota’s CIDRAP reports,
    • “After declining trends over the past few weeks, flu activity rose in some parts of the country, while COVID-19 and respiratory syncytial virus (RSV) levels continued overall declines, according to the latest updates today from the US Centers for Disease Control and Prevention (CDC).
    • “Though flu indicators declined following the winter holidays, the CDC has said that it is watching for a second peak that sometimes occurs after the winter holidays. In its respiratory virus snapshot, the CDC said some regions are seeing rising flu indicators, especially in the Midwest and South-Central regions.
    • “Also, the percentage of respiratory samples that were positive for flu at clinical labs rose last week to 16.2%, compared to 14.2% the previous week, the CDC said in its weekly flu update. Influenza A is still dominant, with 60.4% of subtyped samples belonging to the 2009 H1N1 subtype. There were increases in the percentages of H3N2 and influenza B detections compared to the previous week.
    • “Outpatient visits for flulike illness held steady and have been above the national baseline since November. However, CDC surveillance shows a rise for one age-group: people ages 5 to 24 years.”
  • The Center for Disease Control adds,
    • “According to insurance claims data for adults 18 years and older, as of January 13, 2024, the number of flu vaccination doses given so far this season in pharmacies and medical offices is lower compared with last season by about 7 million doses (from 66 million to 59 million doses, or about a 10% percent decline). There were drops in the number of doses given in both pharmacies and medical offices this season compared with last season.”
  • The National Institutes of Health’s Director explains in her blog why “Findings in Tuberculosis Immunity Point Toward New Approaches to Treatment and Prevention.”
  • Precision Vaccinations discusses why HIV vaccine development is rekindling in 2024.
  • Mercer Consulting lets us know,
    • “Black Americans represent approximately 12% of the U.S. population but account for 40% of people with HIV. The rate of new HIV infections among Black women is 10 times that of white women and four times that of Latina women. While HIV can affect anyone regardless of sexual orientation, race, ethnicity, gender, age, or where they live, some population groups have higher rates of HIV in their communities, thus raising the risk of new infections.  
    • “Black communities have made great progress in reducing HIV. Yet racism, discrimination, and mistrust in the health care system may affect whether Black people seek or receive HIV prevention services. These issues may also reduce the likelihood of engaging in HIV treatment and care.
    • “National Black HIV AIDS Awareness Day on February 7 is an opportunity to increase HIV education, testing, community involvement, and treatment among Black communities. We encourage employers to use this as a call to action to educate your workforce about HIV, to reduce stigma and create workplaces where everyone feels they belong, as well as help make employees aware of the HIV prevention and treatment resources available to them.”
  • Fierce Healthcare adds,
    • “There are significant health disparities among people with employer coverage, but plan sponsors still have work to do to fully address those issues, according to a new analysis.
    • “The report comes from Morgan Health, the healthcare arm of banking giant JPMorgan Chase. It identifies some critical disparities in the employer-sponsored sector and suggests strategies employer can use to tackle these challenges.
  • NPR interviews an anatomy professor who explains why a person’s appendix is useful.
    • “It turns out that the appendix appears to have two related functions. The first function is supporting the immune system. The appendix has a high concentration of immune tissue, so it’s acting to help the immune system fight any bad things in the gut. 
    • “The second function that it serves is what we refer to as the safe house. So this was a hypothesis that was put forward by a team from Duke University in 2007. And they argued that the appendix may serve as a safe reservoir for the beneficial gut bacteria that we have.” 

From the U.S. healthcare business front,

  • Beckers Payer Issues reports,
    • “The Cigna Group is projecting $235 billion in revenue by the end of 2024 and recorded double-digit growth in the fourth quarter across its core lines of business at Evernorth Health Services and Cigna Healthcare, according to the company’s year-end earnings report published Feb. 2.
    • “Total revenues in the fourth quarter were $51.1 billion, up 12% year over year. Total revenues in 2023 were $195.3 billion, up 8%.
    • “In the fourth quarter, net income was more than $1 billion, down 14% from nearly $1.2 billion year over year. Year-end net income was nearly $5.2 billion, down 23% year over year. 
    • “Evernorth revenues rose 12% year over year to $40.5 billion in the fourth quarter. Operational earnings in the fourth quarter were nearly $1.5 billion, and $4.8 billion in 2023.
    • “The insurance side of the business, Cigna Healthcare, reported fourth-quarter revenues of nearly $13 billion, up 16% from the previous year. Operational income in the fourth quarter was $925 million, and $4.2 billion in 2023.
    • “The company’s medical loss ratio was 82.2% in the fourth quarter, compared to 83.8% during the same period last year. In 2023, the company’s MLR was 81.3%.”
  • Healthcare Dive adds,
    • “Cigna on Friday defended its decision to sell its Medicare division, with management telling investors the health insurer will emerge from the divestiture as a leaner and more focused organization.
    • “On a call to discuss Cigna’s fourth-quarter earnings, analysts peppered the payer’s C-suite with questions about the trajectory of its business following the sale, which some had criticized for seeming to undervalue Cigna’s Medicare lives.
    • “Cigna still likes Medicare as an expansion area, but is more interested in providing services like pharmacy benefits to other Medicare Advantage organizations than offering plans itself, according to CEO David Cordani. “We were really pleased with the nature of the transaction we were able to structure,” Cordani said on the call. ”We see it as a win-win.”
  • Per Fierce Healthcare,
    • “When Florida Blue announced this week that it’s partnering with Sanitas Medical Center in Jacksonville to deliver primary care, officials with the company considered it in keeping with a healthcare system that’s evolving from one based on volume to one based on value.
    • “The healthcare system has largely been fee-for-service,” Elana Schrader, M.D., senior vice president of Florida Blue healthcare services and president of sister company GuideWell Health, told Fierce Healthcare. “Now, we’re talking about paying for services that help us achieve better outcomes. It’s a whole new value equation. Value-based care has been around, but it’s growing and growing.
    • “She added that in the future the health plan hopes that most, if not all, of the care provided will be based on value not volume. The umbrella of what can be described as primary care at the Jacksonville center is a large one under which resides, according to a press release, “preventive and primary care, onsite pharmacy dispensing, chronic condition management, mental health services, labs and imaging, and a community use space for patient and community education and social engagement and wellness classes and activities.”
  • and
    • “Optum Perks is rolling out a new telehealth solution that aims to make it easier for patients to secure their prescriptions at a low cost.
    • “Optum Perks is a part of the RVO Health umbrella, which is jointly backed by Red Ventures and UnitedHealth Group’s Optum. Its sister, Optum Store, is also within RVO Health. Optum Perks offers prescription discounts to consumers and is building on that foundation through the new virtual platform.
    • “Users can access care on demand starting at $25 for hundreds of conditions and needs including acne, birth control, cold and flu, high blood pressure and more. It services are available for people with or without insurance.”
  • Per Healthcare Dive,
    • “Telehealth availability for mental healthcare varies widely from state to state, suggesting some patients may face “several hurdles” when booking appointments for services, according to a study published Friday in JAMA Health Forum.
    • “The analysis, conducted by nonprofit research institute Rand Corporation, found less than half of mental health treatment facilities in Mississippi and South Carolina offered telehealth care, while all facilities contacted in Delaware, Maine, New Mexico and Oregon did. Researchers were also unable to reach one in five facilities when attempting to inquire about telehealth options, the study found.” 
  • Beckers Hospital Review lists emergency department visit times by state.
    • “Patients in Washington, D.C., had the highest median time spent in the emergency department, while patients in North Dakota had the lowest, CMS data shows.
    • “The agency’s “Timely and Effective Care” dataset, updated Jan. 31, tracks the average median time patients spend in the emergency department before leaving. The measures apply to children and adults treated at hospitals paid under the Inpatient Prospective Payment System or the Outpatient Prospective Payment System, as well as those that voluntarily report data on relevant measures for Medicare patients, Medicare managed care patients and non-Medicare patients. 
    • “Data was collected from April 2022 through March 2023. Averages include data for Veterans Health Administration and Department of Defense hospitals. Learn more about the methodology here.
    • “Nationwide, the median time patients spent in the ED was 162 minutes, up from 159 minutes in the 12-month period ending in March 2022, according to CMS data. In the same period ending in 2021, this figure sat at 149 minutes.”

Thursday Miscellany

David Ermer–COVID-19 vaccine, FDA, HSA, Medical / Rx research, Medicare, Mental health care, Rx coverage, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC

  • STAT News reports
    • “The Biden administration is making its opening offers to pharmaceutical companies in its brand-new Medicare drug price negotiation program on Thursday, administration officials said. And that’s about all they said.
    • “The offers will not be made public unless a manufacturer chooses to publicly disclose information about the talks, a senior administration official said. Companies have until March 2 to either accept the government’s offer or propose a counteroffer. The Biden administration will publish the final prices by Sept. 1 of this year after the negotiation process ends. 
    • “The negotiated prices won’t take effect until 2026. 
    • “The first 10 drugs up for negotiation are Bristol Myers Squibb’s blood thinner Eliquis, Boehringer Ingelheim and Eli Lilly’s diabetes drug Jardiance, Johnson & Johnson’s blood thinner Xarelto, Merck’s diabetes drug Januvia, AstraZeneca’s diabetes drug Farxiga, Novartis’ heart failure treatment Entresto, Amgen’s rheumatoid arthritis drug Enbrel, Johnson & Johnson and AbbVie’s blood cancer treatment Imbruvica, J&J’s anti-inflammatory medicine Stelara, and Novo Nordisk insulins that go by names including Fiasp and NovoLog.”
  • Here is a link to PhRMA’s views on the development.
    • “The bottom line: This process is a black box that allows a few government bureaucrats to make politicized decisions about the value of medicines and with no accountability to patients or the public.”
  • BioSpace adds,
    • “A federal court in Delaware heard arguments Wednesday in a key lawsuit challenging Medicare drug-negotiation provisions of the Inflation Reduction Act (IRA). Reportsfrom inside the courtroom suggested that the judge was skeptical of the arguments raised by plaintiff AstraZeneca, though experts told BioSpace this is just an early step in what could be a protracted series of legal battles.
    • “While no ruling on AstraZeneca’s motion for summary judgment is expected for about a month, court activity will heat up over the next few weeks, as a total of 10 cases from pharma companies and groups have challenged various aspects of the IRA’s Medicare drug-pricing provisions. Other plaintiffs include Merck, Novartis, Johnson & Johnson, Bristol Myers Squibb, Boehringer Ingelheim, Novo Nordisk and the lobbying group Pharmaceutical Research and Manufacturers of America (PhRMA).

From the public health and medical research front,

  • MedPage reports,
    • “The updated 2023-2024 COVID-19 vaccine was approximately 54% effective against symptomatic SARS-CoV-2 infection in adults, and was also effective against the JN.1 variant, which became predominant in January, CDC researchers said.
    • “Overall, vaccine effectiveness against symptomatic COVID was 57% for people ages 18 to 49 years and 46% for people ages 50 and older, reported Ruth Link-Gelles, PhD, of the CDC’s National Center for Immunization and Respiratory Diseases, and colleagues in the Morbidity and Mortality Weekly Report.”
  • and
    • “Military personnel stationed at Camp Lejeune from 1975 to 1985 had at least a 20% higher risk for a number of cancers than those stationed elsewhere, federal health officials said Wednesdayin a long-awaited study about the North Carolina base’s contaminated drinking water.
    • “Federal health officials called the research one the largest ever done in the U.S. to assess cancer risk by comparing a group who live and worked in a polluted environment to a similar group that did not.”
  • American Hospital Association News tells us,
    • “The Substance Abuse and Mental Health Services Administration Jan. 31 updated it Overdose Prevention and Response Toolkit, which includes basic information on overdose prevention and treatment as well as specific guidance and resources for health care providers and prescribers.”
  • The Institute for Clinical and Economic Review released
    • “its revised Evidence Report assessing the comparative clinical effectiveness and value of iptacopan (Novartis) and danicopan (Alexion Pharmaceuticals) for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). While important health benefits for patients were shown in clinical trials for both agents, there is uncertainty about long-term efficacy and safety. ICER’s model for iptacopan, which is already FDA-approved, using a shared-savings approach (described in more detail below), suggests that the drug would need to be priced 70% lower than the current list price to meet commonly accepted thresholds. For danicopan, which is not yet FDA-approved, ICER’s model suggests the price would need to be between $12,300 and $13,100 per year to achieve common thresholds for cost-effectiveness.
    • “This Evidence Report will be reviewed at a virtual public meeting of the California Technology Assessment Forum (CTAF) on February 16, 2024.”
  • NPR discusses aging.
    • I used to flinch at the topic of aging. Is there anything we can do about the inevitable?
    • But recently I’ve been digging into a new wave of longevity research that is making it an exciting time to be an aging human — which is all of us.
    • It turns out, we all age at varying rates. Super-agers may have great genes, but research shows our habits and routines — everything from what we eat and how we move our bodies to who we spend our time with — matter a lot, when it comes to aging well.
    • Now, the next frontier is to target the basic biology of aging and come up with new interventions to slow it down.
    • Many scientists are optimistic that we’re on the cusp of breakthroughs. Not only to help us live longer, but — more importantly — to extend the number of years we live with good health.
    • This is the goal of researchers at the Human Longevity Lab at the Northwestern University Feinberg School of Medicine. They’re recruiting study participants so they can test what kinds of interventions may slow the rate of aging.
  • The reporter describes participating in this study.
  • HealthDay informs us,
    • “Adolescent substance use is associated with psychiatric symptoms, including suicidal thoughts, according to a research letter published online Jan. 29 in JAMA Pediatrics.
    • “Brenden Tervo-Clemmens, Ph.D., from the University of Minnesota in Minneapolis, and colleagues examined associations between commonly used substances and psychiatric symptoms among adolescents in two samples: students from 36 Massachusetts high schools who completed the 2022 to 2023 Substance Use and Risk Factor (SURF) Survey and analogous self-reported items from the 2021 Youth Risk Behavior Survey (YRBS). Data were included for 15,626 SURF participants and 17,232 YRBS participants.
    • “The researchers found significant, moderate dose-dependent associations for alcohol, cannabis, and nicotine use with worse psychiatric symptoms, including suicidal thoughts in SURF and YRBS, depressive or anxiety symptoms and inattention or hyperactivity in SURF, and general mental health in YRBS.” 
  • Memory Care Business notes,
    • “A new global effort is underway to accelerate the prevention, diagnosis and management of Alzheimer’s and other forms of dementia. 
    • “The effort, dubbed the Alzheimer’s Moonshot, was announced by StartUp Health in partnership with the Alzheimer’s Drug Discovery Foundation’s Diagnostics accelerator and Gates Ventures, the private office of entrepreneur Bill Gates. 
    • “The Alzheimer’s effort is among a new series of “moonshots” from StartUp Health. The efforts also have taken aim at other health challenges, such as Type 1 diabetes, with the goal of bringing together like-minded company founders and researchers in those spaces.”
  • The Washington Post reports,
    • “An international team led by scientists at Stanford University has discovered a probable explanation for a decades-old biological mystery: why vastly more women than men suffer from autoimmune diseases such as lupus and rheumatoid arthritis.
    • “Women account for about 80 percent of the people afflicted with autoimmune diseases, a collection of more than 100 ailments that burden a combined 50 million Americans, according to the nonprofit Autoimmune Association. In simple terms, these illnesses manipulate the body’s immune system to attack healthy tissue.
    • “In a paper published Thursday in the journal Cell, researchers present new evidence that a molecule called Xist — pronounced like the word “exist” and found only in women — is a major culprit in these diseases.
    • “Better understanding of this molecule could lead to new tests that catch autoimmune diseases sooner and, in the longer term, to new and more effective treatments, researchers said.”

From the U.S. healthcare business front,

  • Per Fierce Healthcare,
    • “Tenet Healthcare has disclosed a pair of new and completed hospital transactions alongside projections that next week’s 2023 financial report “will be above the high end” of its guidance.”
  • and
    • “New Jersey providers Saint Peter’s Healthcare System and Atlantic Health System have taken the first step toward a merger they said would include “significant investments” in the Catholic system’s service area.”
  • and
    • “Hospitals and health systems closed out the year on a high note with margins up more than 15% from 2022, according to Kaufman Hall.”
    • “The firm’s latest sector-wide monthly report pointed to an increase in year-to-date operating margin index, from 1.9% through November to 2.3% at the end of the year. On a single-month basis, the operating margin index rose from 3.2% to 4.6% at the same cutoffs.
    • “These improved margins indicate that hospitals and health systems are taking the necessary steps to adapt to this new environment,” Erik Swanson, senior vice president of data and analytics with Kaufman Hall, said in a release. “While finances are approaching historic levels, today’s care and business models look very different. Organizations have had to adjust how and where they’re delivering services to better meet patient preferences.”
  • Healthcare Dive lets us know,
    • “Healthcare executives prioritize data considerations when it comes to using generative artificial intelligence, which could prevent them from successfully integrating the hot button technology, according to a report by consultancy Deloitte. 
    • “While 82% of 60 respondents rated data availability, quality and reliability as a top consideration for implementing generative AI, only 45% cited mitigating biases or patient education on the technology and its risks as their greatest considerations when implementing the technology.
    • “Data is important, but the industry needs a “robust overarching framework” that focuses equally on governance, consumer needs and worker concerns, the report’s authors wrote.”
  • STAT News reports,
    • Merck reported earnings for the fourth-quarter and 2023. On 2024 guidance, Merck said it expects sales in the range of $62.7-$64.2 billion, or a 6% increase at the midpoint. Current Street consensus is $63.5 billion. Adjusted earnings are forecast to be between $8.44 and $8.59 per share.
    • More pharma earnings from Roche and Sanofi.
  • and
    • “Novavax, the company whose corporate missteps repeatedly sidelined an effective Covid-19 vaccine, is relying on demand for booster doses to remain solvent. And the latest update isn’t exactly encouraging.
    • “The company said yesterday that it would lay off another 12% of its staff, expanding on a cost-cutting plan disclosed last year. In the end, Novavax will have reduced its workforce by about 30% compared to 2023, part of an effort to reduce its expenses in the months to come.”
  • NewFront offers guidance on correcting mistaken health savings account distributions.


 

Midweek update

David Ermer–Congress, COVID treatment, FDA, Medical / Rx research, Medicare, Mental health care, NIH, Obesity, OPM, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC,

  • Roll Call informs us
    • “House leadership smoothed the path for consideration of a $78 billion family and business tax break deal Wednesday by committing to a floor vote as soon as next week on a separate bill to boost the state and local tax deduction cap for married couples.”
  • and later
    • “The House on Wednesday night passed a $79 billion family and business tax break bill after several days of uncertainty, teeing it up for consideration in the Senate. 
    • “The package negotiated by House Ways and Means Chairman Jason Smith, R-Mo., and Senate Finance Chair Ron Wyden, D-Ore., easily mustered the two-thirds majority needed to pass, despite GOP drama earlier in the week and previous criticism from Democrats. 
    • “It’s a strong, commonsense, bipartisan step forward in providing urgent tax relief for working families and small businesses,” Smith said on the floor ahead of the 357-70 vote. “Parents in Main Street communities across this country will see lower taxes, more opportunity and greater financial security after we pass this legislation.”
  • Here is a link to today’s hearing held by the House Energy and Commerce Committee’s Health Subcommittee about national healthcare expenditures.
  • Fierce Healthcare tells us,
    • “Medicare Advantage (MA) payments are set to decrease yet again in 2025 as the feds phase in significant changes to risk adjustment.
    • “As those overhauls begin to take effect, benchmark payments are set to decline by about 0.2% on average, according to the latest advance notice released by the Centers for Medicare & Medicaid Services (CMS).
    • “Despite this, the feds said Wednesday that payments to MA plans are expected to increase by 3.7% in 2025, a $16 billion increase over 2024. The payment rate announced today could change by the time the final rate announcement is published, no later than April 1.”
  • The CY 2025 Advance Notice may be viewed by going to: https://www.cms.gov/Medicare/Health-Plans/MedicareAdvtgSpecRateStats/Announcements-and-Documents and selecting “2025 Advance Notice.”
  • A fact sheet discussing the provisions of the CY 2025 Advance Notice, as well as frequently asked questions, can be viewed here: https://www.cms.gov/newsroom/fact-sheets/2025-medicare-advantage-and-part-d-advance-notice-fact-sheet.
  • Beckers Payer Issues adds,
    • “A bipartisan group of lawmakers is urging CMS to maintain “payment and policy” stability in Medicare Advantage. 
    • “In a letter to CMS Administrator Chiquita Brooks-LaSure, the group of 60 senators asked the agency to “consider the ongoing implementation of program reforms finalized last year and provide stability for the Medicare Advantage program in 2025.”  * * *
    • “The letter comes after two lawmakers, Sen. Elizabeth Warren and Rep. Pramila Jayapal, wrote to the agency urging more action on curbing overpayments to the program. 
    • “Read the full letter here. “
  • Today, OPM posted on the Federal Register website a proposed FEHB rule that “would allow FEHB and PSHB coverage to become effective at the beginning of the pay period that the employee in pay status has an initial opportunity to enroll. This change would occur when the employee becomes eligible for FEHB or PSHB coverage, provided an appropriate request to enroll is received by the employing office within the initial pay period that the employee becomes eligible.”
  • American Hospital News reports,
    • “The Substance Abuse and Mental Health Services Administration Jan. 31 issued a final rule that updates certain regulations for Opioid Treatment Programs and the standards for treatment of opioid use disorder. The rule makes some COVID-19-related flexibilities permanent, including take-home doses of methadone, the ability of an OTP to prescribe medication for OUD via telehealth without an initial in-person physical evaluation, and the removal of certain requirements for admission to an OTP to better align with evidence-based practice.”
  • KFF shares three charts about Medicare drug price negotiations.
  • Federal News Network reports,
    • “The Postal Service is looking to cut $5 billion from its operating costs and grow its revenue by the same amount over the next two years to overcome its long-term financial challenges.
    • “Postmaster General Louis DeJoy is telling the White House and Congress that implementing these plans is necessary to keep USPS from running out of cash in the coming years.
    • “DeJoy, in a Jan.10 letter obtained by Federal News Network, told President Joe Biden and congressional leaders that USPS is “utilizing all of the self-help tools that are available to us,” and trying to get back on track with its “break-even” goal, after years of billion-dollar net losses.
    • “It is evident that to break even and avoid running out of cash in the next several years, we must press ahead on our financial improvement initiatives over the next two years,” DeJoy wrote. “While we have already achieved historic reductions, they are simply not enough to make us financially sustainable.”

From the public health and medical research front,

  • Check out this JAMA Open article to learn why “Paxlovid Is Effective but Underused—Here’s What the Latest Research Says About Rebound and More.”
  • Per Fierce Healthcare,
    • “As artificial intelligence advances in different areas of healthcare, there are concerns that technology and AI-based chatbots will replace the human connections between patients and practitioners.
    • “But, a new study finds promising potential for AI and large language models to enhance mental health therapy at scale by being able to analyze millions of text-based counseling messages to shine a light on what works.
    • “Researchers used AI to analyze more than 20 million text conversations of counseling sessions and successfully predicted patient satisfaction and clinical outcomes, according to a study published this week in the Journal of The American Medical Association (JAMA) Open.”
  • The National Institutes of Health announced,
    • An analysis conducted by the National Institutes of Health’s National Center for Complementary and Integrative Health (NCCIH) reveals a substantial increase in the overall use of complementary health approaches by American adults from 2002 to 2022. The study, published in the Journal of the American Medical Association, highlights a surge in the adoption of complementary health approaches for pain management over the same period.
    • Researchers utilized data from the 2002, 2012, and 2022 National Health Interview Survey (NHIS) to evaluate changes in the use of seven complementary health approaches, including yoga, meditation, massage therapy, chiropractic care, acupuncture, naturopathy, and guided imagery/progressive muscle relaxation.
    • The key findings include:
      • The percentage of individuals who reported using at least one of the seven approaches increased from 19.2% in 2002 to 36.7% in 2022.
      • The use of yoga, meditation, and massage therapy experienced the most significant growth from 2002 to 2022.
      • Use of yoga increased from 5% in 2002 to 15.8% in 2022.
      • Meditation became the most used approach in 2022, with an increase from 7.5% in 2002 to 17.3% in 2022.
      • Acupuncture, increasingly covered by insurance, saw an increase from 1% in 2002 to 2.2% in 2022.
    • Additionally, the analysis showed a notable rise in the proportion of U.S. adults using complementary health approaches specifically for pain management. Among participants using any of the complementary health approaches, the percentage reporting use for pain management increased from 42.3% in 2002 to 49.2% in 2022.
    • Despite the findings, the authors acknowledge study limitations, including decreasing NHIS response rates over time, possible recall bias, cross-sectional data, and differences in survey wording.
  • and
    • “Researchers at the National Institutes of Health detected abnormal proteins in the spinal fluid of people with amyotrophic lateral sclerosis (ALS) and frontotemporal dementia (FTD), which could help improve diagnosis of these diseases. The findings were published in Science Translational Medicine.
    • “The proteins in question are built from “cryptic” exons—abnormal portions of RNA, the cell’s instructions for how to build proteins. Cryptic exons occur when TDP-43, a protein that regulates how RNA is processed, stops functioning normally. TDP-43 dysfunction is linked to ALS, FTD, Alzheimer’s disease, and Limbic Associated TDP-43 Encephalopathy (LATE).
    • “The study showed that these mis-spliced sections of RNA can sometimes generate new proteins from the cryptic sequence. The findings advance our understanding of how cryptic exons may be involved in the dementia disease process and could help identify diseases involving TDP-43 dysfunction before symptoms appear. Currently, TDP-43 aggregates in the brain can only be detected at autopsy.”  
  • MedPage Today points out, “Getting clinicians to commit to the Choosing Wisely recommendations somewhat reduced low-value care for older adults in common scenarios, a cluster randomized trial found.”

From the U.S. healthcare business front,

  • Per BioPharma Dive,
    • “Novo Nordisk has resumed shipping starter doses of its weight-loss drug Wegovy, nearly nine months after manufacturing problems forced it to restrict distribution to maintenance shots in order to ensure that people who had already started taking it could continue, the company said Wednesday.
    • “The resumption of the starter doses, which begin at 0.25 milligrams per week, comes two months after obesity rival Eli Lilly gained U.S. approval for a competing drug, Zepbound, that could threaten to eat away at Novo’s sizable lead in weight-loss treatment.”
  • The Wall Street Journal adds,
    • “Nearly every employer in the country is now grappling with how—and whether—to pay for new weight loss drugs. Needless to say, such decisions are highly important to patients struggling with obesity.
    • “But for Eli Lilly and Novo Nordisk, it actually doesn’t matter, for now, from a financial perspective. They are selling every injection they can make. It won’t change anytime soon.” ***
    • While the companies are both moving as fast as possible, expanding the manufacturing of injectables is complicated. 
    • “You’re talking about billions of pens. That’s not a trivial exercise,” says Guggenheim analyst Seamus Fernandez. “Producing pens is a very complex process that requires precision and lots of attention to safety.” 
    • “That is one reason why developing pills such as Lilly’s orforglipron, which is undergoing clinical trials, is so crucial, he adds. Figuring out how to make oral versions well-tolerated is a challenge, though.”
  • MedTech Dive tells us about the top medtech trends in 2024. “Experts said M&A, orthopedic procedure backlogs and emerging cardiac markets were among the top trends to watch in the medical device industry this year.”
  • Per Healthcare Dive,
    • “Cigna has agreed to sell its Medicare business to Health Care Service Corporation for roughly $3.7 billion, the health insurer announced Wednesday.
    • “HCSC is acquiring Cigna’s Medicare Advantage, supplemental benefits and Medicare Part D plans, along with CareAllies, a division that helps providers transition to value-based care. In total, the plans cover 3.6 million people on Medicare.
    • “The companies said they expect the deal — which includes $3.3 billion in cash and $400 million in capital Cigna expects to be freed up — to close in the first quarter of 2025, subject to regulatory approval.”
  • and
    • “Humana plans to expand its primary care network for seniors this year, as the insurer looks to lean on provider capabilities to boost its beleaguered Medicare Advantage business.
    • “In 2024, CenterWell Senior Primary Care plans to enter three new markets in North Carolina and Louisiana, and add additional centers in eight of its current markets in the U.S., the payer announced on Tuesday.
    • “Humana is one of many health insurers racing to build out a provider network to provide convenient access to primary care for its members. But for Humana, this strategy is more important than it might be for its rivals with a broader variety of plans, given Humana has made such a significant bet on Medicare Advantage, said Arielle Trzcinski, a healthcare analyst at market research firm Forrester.”
  • BioPharma Dive lets us know,
    • In 2021, the Food and Drug Administration for the first time approved a medicine meant to slow the progression of Alzheimer’s disease. Developed by partners Biogen and Eisai, the medicine, called Aduhelm, was viewed initially as a needed new treatment option by patients and a potential blockbuster product by Wall Street analysts.
    • “Now, less than three years since that approval, Biogen is fully giving up on the drug. The company said Wednesday it is handing rights to back to Aduhelm’s original developer, Neurimmune, and will redirect much of the money spent on the drug toward other Alzheimer’s therapies in its business.
    • “Biogen is reprioritizing resources to build a leading franchise to address the multiple pathologies of the disease and patient needs,” said Christopher Viehbacher, the company’s CEO, in a statement.”
  • Per Beckers Payer Issues,
    • “The share of U.S. employees in healthcare plans funded by their employer rose from 2015 to 2021, a study published in the January issue of Health Affairs found. 
    • “In 2015, 55% of employees were enrolled in self-funded plans, compared to 60% of employees in 2021. Most of the growth occurred in states and counties with lower levels of self-funded enrollment, the study found. 
    • “Groups of rapid growth in self-funded plans were concentrated in Arkansas, New York, Northern California, Pennsylvania and Utah, the study found. 
    • “Elevance Health is the largest administrator of self-funded plans, with around 19% of the total market, according to the study. CVS Health claimed the fastest growing self-funded enrollment from 2015 to 2021. “

Tuesday Tidbits

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

From Washington, DC,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Monday Roundup

David Ermer–CDC, CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, No Surprises Act, OPM, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC,

  • Govexec reports,
    • “Key congressional negotiators have reached an agreement on how to divvy up funding for the fiscal 2024 spending bills, clearing a major threshold that will allow appropriators to finalize those measures. 
    • “The deal, confirmed by a source familiar with talks, was hammered out after weeks of negotiations between Sen. Patty Murray, D-Wash., and Rep. Kay Granger, R-Texas, who respectively chair the Senate and House Appropriations Committees, and establishes how much money will be allocated to each of the 12 bills Congress must pass to fund government each year. With those allocations set, lawmakers can now complete their work of setting line-by-line funding for every program and office in agencies across government.”
  • Federal News Network tells us,
    • “The Office of Personnel Management is issuing a final rule to bar the government from considering a person’s current or past pay when determining their salary for federal employment. Administration officials said this step will help limit pay discrimination and ensure compensation is based on an applicant’s skills, experience and expertise.
    • “A similar proposal will offer protections to those employed by federal contractors.
    • “The Federal Acquisition Regulatory Council is issuing a proposal to prohibit federal contractors and subcontractors from seeking and considering information about a job applicant’s compensation history when hiring or setting pay for anyone who works on a government contract.
    • “The proposal also requires contractors and subcontractors to disclose salary ranges in job postings.
    • “Administration officials said the proposal would help federal contractors recruit, diversify and retain talent, improve job satisfaction and performance and reduce turnover.”
  • The Department of Health and Human Services is holding a virtual summit this Wednesday January 31 “for policymakers, advocates, researchers, and a wide variety of stakeholders with equities in the Food is Medicine space to engage in a substantive conversation about why food is medicine is important, what actions are being taken to promote this concept, and what stakeholders can do to bolster this work.”
  • The Centers for Medicare and Medicaid Services informs us about
    • “Increased participation in CMS’ accountable care organization (ACO) initiatives in 2024, which will increase the quality of care for more people with Medicare. Of note, CMS is announcing that 19 newly formed accountable care organizations (ACOs) in the Medicare Shared Savings Program (Shared Savings Program) are participating in a new, permanent payment option beginning in 2024 that is enabling these ACOs to receive more than $20 million in advance investment payments (AIPs) for caring for underserved populations. An additional 50 ACOs are new to the program in 2024, and 71 ACOs renewed their participation, bringing the total to 480 ACOs now participating in the Shared Savings Program, the largest ACO program in the country. CMS also announced that 245 organizations are continuing their participation in two CMS Innovation Center models — ACO Realizing Equity, Access, and Community Health (ACO REACH) and the Kidney Care Choices (KCC) models.”
  • Bloomberg reports,
    • “Justice Department investigators are scrutinizing the healthcare industry’s use of AI embedded in patient records that prompts doctors to recommend treatments.
    • “Prosecutors have started subpoenaing pharmaceuticals and digital health companies to learn more about generative technology’s role in facilitating anti-kickback and false claims violations, said three sources familiar with the matter. It comes as electronic health record vendors are integrating more sophisticated artificial intelligence tools to match patients with particular drugs and devices.
    • “It’s unclear how advanced the cases are and where they fit in the Biden administration’s initiative to spur innovation in healthcare AI while regulating to promote safeguards. Two of the sources—speaking anonymously to discuss ongoing investigations—said DOJ attorneys are asking general questions suggesting they still may be formulating a strategy.”
  • Per Healthcare Dive,
    • “Federal legislation holding patients blameless for surprise medical charges prevented more than 10 million unexpected bills in the first nine months of 2023, according to a new analysis by health insurance groups.
    • “The survey of U.S. payers from AHIP and the Blue Cross Blue Shield Association also highlighted a “growing and troubling trend” — an increasing number of claims going through the payment negotiation process set up by the No Surprises Act.
    • “Regulators forecast that 17,000 claims would go through that process, called independent dispute resolution, each year. However, AHIP and BCBSA estimate almost 670,000 claims were submitted to IDRbetween January and September 2023 alone.”
  • Per BioPharma Dive,
    • “Philips has agreed to stop selling new sleep therapy devices or other respiratory care products in the U.S., roughly two-and-a-half years after launching its massive recall of related products, the company said Monday. 
    • “The company agreed to the action as part of a consent decree it is entering into with the U.S. Department of Justice, representing the Food and Drug Administration. Philips has been negotiating the decree in light of the quality problems that led to its recall of more than 15 million sleep therapy and respiratory care devices. The decree is now being finalized ahead of its submission to a U.S. court for approval.
    • “Philips shared details of the agreement as part of its fourth-quarter earnings call.”

From the public health and medical research front,

  • ABC News reports,
    • “The Centers for Disease Control and Prevention (CDC) is warning clinicians to remain on alert for measles cases due to a growing number of infections.
    • “Between Dec. 1, 2023, and Jan. 23, 2024, there have been 23 confirmed cases of measles including seven cases from international travelers and two outbreaks with five or more infections each, according to an email sent this week.
    • “Cases have been reported in Pennsylvania, New Jersey, Delaware and the Washington, D.C. area so far.
    • “Most of these cases were among children and adolescents who had not been vaccinated against measles, despite being eligible.
    • “According to the CDC, most measles cases in the U.S. occur when unvaccinated or partially vaccinated Americans travel internationally, contract the disease and then spread it to those who are unvaccinated upon their return.”
  • Bloomberg offers background on the effective measles vaccine.
    • “The measles, mumps and rubella combined vaccine is so effective that in the US, thanks to a widely accepted vaccine campaign, measles was declared eliminated in 2000.
    • “But the disease has made a comeback. A now-discredited studypublished in the journal The Lancet in 1998 suggested that the MMR vaccine was linked to autism. This is not true, but some parents became reluctant to immunize their children. Dahl’s letter about the measles vaccine has had an online revival multiple times in the past decade, as measles spread repeatedly in children who’d never gotten their shots.
    • “The disease is flaring up again now, this time in Europe, where the World Health Organization waved a warning flag last week. The region reported more than 40,000 cases between January and November of last year, compared to 942 in 2022. The havoc the Covid-19 pandemic wreaked on basic preventative care is partly to blame.”
  • The National Institutes of Health provides us with an emotional wellness tookit.
  • MedPage Today points out,
    • A multiparametric blood test for prostate cancer showed potential to avoid more than half of unnecessary biopsies without sacrificing accuracy, a large prospective study showed.
    • In a comparison against the current PSA testing standard of ≥4 ng/mL, the Stockholm3 biomarker, which incorporates a PSA cutoff of 15 ng/mL with other proteins and genomic information, would have spared 56% of men from biopsies for grade group (GG) 1 or benign disease. The standard PSA cutoff would have avoided 19% of unnecessary biopsies, decreasing to 10% with a cutoff of ≥3 ng/mL.
    • Sensitivity, specificity, and predictive values with the multicomponent test either approximated or surpassed those achieved with conventional PSA testing, reported Scott Eggener, MD, of the University of Chicago, at the Genitourinary Cancers Symposium

From the U.S. healthcare business front,

  • Health Payer Intelligence notes,
    • “UnitedHealth Group saw revenue growth of over 14 percent in 2023, while adding 1.7 million new consumers to its Medicare and commercial offerings, executives shared during the UnitedHealth Group Fourth Quarter and Full Year 2023 Earnings Conference Call.
    • “Last year was a “year of balanced, sustainable growth for UnitedHealth Group,” according to Andrew Witty, CEO of UnitedHealth Group.”
  • Beckers Payer Issues lets us know,
    • “Though Medicare Advantage enrollment keeps climbing, the program may not have the profitability it once did for insurers. 
    • “In a January analysis shared with Becker’s, Moody’s analysts wrote that the program “seems to be losing some of its luster,” facing a significant increase in medical costs and lower reimbursement rates from CMS. 
    • “Earnings in Medicare Advantage shrunk by 2.1% among the insurers Moody’s rated from 2019 to 2022, despite premiums and members growing by 40% in the same time period.”
  • and
    • After a called-off merger between Humana and Cigna, executives at both companies say the companies are focused on staying on their existing courses. 
    • Neither company has directly addressed the called-off merger, but they have each fielded questions from investors on the outlook for the future. 
  • Beckers Hospital Review explains how the Ozempic boom affects hospital pharmacies.