Thursday Miscellany

Thursday Miscellany

Photo by Josh Mills on Unsplash

From Washington DC,

  • Healthcare Dive reports,
    • “A group of bipartisan senators on Wednesday reintroduced a bill that aims to remove barriers to telemental healthcare for Medicarebeneficiaries.
    • “The legislation, introduced by Sens. Bill Cassidy, R-La., Tina Smith, D-Minn., John Thune, R-S.D., and Ben Cardin, D-Md., would remove requirements that telemental health patients see an in-person provider within six months of receiving services via telehealth.
    • “The senators warned the “arbitrary” requirement that patients be seen in-person will limit access to needed care, particularly in rural areas.”
  • The Senate Finance Committee lets us know,
    • “Senate Finance Committee Chair Ron Wyden, D-Ore., and Ranking Member Mike Crapo, R-Idaho, today announced their commitment to working on bipartisan health care legislation to prevent and mitigate shortages of critical generic drugs used by patients and providers in the United States.
    • “In a white paper released today, Wyden and Crapo outline concerns raised by experts at a hearing held in the Finance Committee on December 5, 2023, as well as areas of interest and ideas the Committee is exploring to address the factors contributing to shortages through modifications to the Medicare and Medicaid programs. * * *
    • The white paper can be found here.
  • and
    • “U.S. Senate Finance Committee Ranking Member Mike Crapo (R-Idaho) and Finance Committee Members Chris Coons (D-Delaware), Tom Carper (D-Delaware) and Thom Tillis (R-North Carolina), along with ten of their colleagues, wrote today to President Biden urging him to reject the proposal before the World Trade Organization (WTO) that would waive intellectual property (IP) protections for COVID-19 diagnostics and therapeutics.  Waiving protections afforded by the WTO Agreement on Trade-Related Aspects of IP Rights (TRIPS) could have unintended consequences for the development of new treatments for dangerous diseases, while doing little to improve access to medicine.”
  • HHS’s Human Resource & Services Administration tells us,
    • “Today, Health Resources and Services Administration (HRSA) Administrator Carole Johnson, joined by Rep. Lauren Underwood (D-IL), co-chair of the Black Maternal Health Caucus, launched a year-long Enhancing Maternal Health Initiative. The initiative will strengthen, expand, and accelerate HRSA’s maternal health work to address maternal mortality and maternal health disparities in partnership with mothers, grantees, community organizations, and state and local health officials across the country.
    • “The kick-off event at the Kaiser Family Foundation in Washington, DC, convened HRSA maternal health grantees from 11 states and the District of Columbia, as well as key national organizations and experts, providers, and individuals with lived experience. Attendees shared personal perspectives on maternal health care and support, the innovative ways HRSA grantees are making an impact on maternal health, and how they are addressing maternal mental health. * * * For more information on HRSA’s maternal health work, visit: www.hrsa.gov/maternal-health.”
  • The Government Accountability Office issued a report on OPM’s paid parental leave program.
    • “Starting October 1, 2020, most federal civilian employees became eligible to take up to 12 weeks of paid parental leave for the arrival of a new child whether by birth, adoption, or foster care.
    • “The Office of Personnel Management’s government-wide data showed that most federal employees were aware of the benefit, and the number of employees who took paid parental leave generally aligned with OPM’s initial estimates.
    • “However, OPM’s webpage for federal leave policies is outdated and doesn’t include information about the benefit. We recommended that OPM update guidance on its webpage to help ensure employees better understand their eligibility.”
  • FedWeek explains how to weigh the options if separating from a spouse before federal employee retirement eligibility.
  • Per Healthcare Dive,
    • “The Federal Trade Commission sued to block Novant Health’s $320 million acquisition of two North Carolina hospitals from Community Health Systems on Thursday, alleging the deal threatens to raise consumer prices and reduces incentives to provide quality care.
    • “The antitrust agency said the proposed deal, which was first announced in February of last year, would reduce competition in the region and “increase annual healthcare costs by several million dollars.”
    • “In response to the lawsuit, a representative from Winston-Salem, North Carolina-based Novant said the nonprofit system would “pursue available legal responses to the FTC’s flawed position.”
  • Per BioPharma Dive,
    • “The Food and Drug Administration this week convened a group of experts to discuss ways to develop new drugs for preventing spontaneous early births, a major health concern for which there are no good treatments.
    • “At the two-day workshop led by the FDA and and the Duke-Margolis Center for Health Policy, experts in maternal and fetal health, as well as advocates, discussed challenges to developing a medicine for preterm births, which affect 1 in every 10 babies in the U.S. and can jeopardize their health.”
  • Per MedTech Dive,
    • “Abbott received approval from the Food and Drug Administration for a rechargeable deep brain stimulation (DBS) system.
    • “Abbott claimed in the Thursday announcement its device, called Liberta RC, is the world’s smallest and has the longest charge of any DBS technology on the market. The company says the device only needs to be recharged 10 times per year under standard settings for most users. 
    • “Earlier this month, Medtronic also received approval for a new DBS system called Percept RC, which has sensing technology to track patients’ response to treatment.”

From the public health and medical research front,

  • HCPLive alerts us,
    • “Despite being the leading cause of death in the US for more than a century, more than half of the respondents to a 2023 survey conducted on behalf of the American Heart Association (AHA) failed to identify heart disease as the leading killer of US adults, according to the AHA’s 2024 Heart Disease and Stroke Statistics report.
    • “Data from the report, which is created annually by the AHA and National Institutes of Health to spotlight the impact of heart disease and stroke in the US and abroad, highlight a lack of awareness surrounding the impact of cardiovascular disease, with additional statistics paint a picture where 51% failed to identify heart disease as the leading cause of death, but also spotlights how advances in care and education have caused death rates from cardiovascular disease to decline by 60% in the last 75 years.”
  • The Society for Human Resource Management offers advice on “a number of policies and strategies employers might want to turn to during this coronavirus and flu surge.”
  • Beckers Hospital Review informs us,
    • “The CDC has rejected findings from Ohio State University researchers that the JN.1 coronavirus variant is more severe than previous strains.
    • “While JN.1 currently accounts for almost 86% of current COVID-19 cases in the U.S., the CDC published a statement Jan. 22 saying that the agency has found “no evidence that it causes more severe disease,” adding that vaccines are still expected to increase protection against the variant as well.
    • “The Ohio State University research, published Jan. 8 in Cell, had focused on two subvariants: BA.2.86 and JN.1. Their study found that it “appears to have increased infectivity of human lung epithelial cells compared to all omicron variants…(which) raises a potential concern about whether or not this virus is more pathogenic,” Shan-Lu Liu, MD, PhD, senior author the study and a virology professor at OSU stated in a news release about the research.  
    • “Since JN.1 is an offspring of BA.2.86, OSU researchers found it had similar results.
    • “While the CDC does not align with this research, the agency did state it “is contributing to the spread of COVID-19 this winter.”
  • STAT News reports,
    • “Building off of some landmark discoveries published last year, researchers have mapped out the biological underpinnings of Parkinson’s disease, creating a framework for medicines that might treat the root of the disease rather than just its symptoms.
    • “Their work, published in the Lancet Neurology, stages Parkinson’s based on the accumulation of a misfolded protein called alpha-synuclein. Funded by the Michael J. Fox Foundation for Parkinson’s Research, the work expands on a 2023 publication that validated an alpha-synuclein diagnostic for the disease.
    • “The new framework still has some gaps, but the researchers believe they’ve set out a path that will allow scientists to discover and rigorously test treatments aimed at the biological causes of Parkinson’s, providing a reliable measure of disease severity that might accelerate the process of drug development.”
  • The Institute for Clinical and Economic Review posted,
    •  “its revised Evidence Repor assessing the comparative clinical effectiveness and value of xanomeline tartrate/trospium chloride (KarXT, Karuna Therapeutics) for the treatment of schizophrenia. 
    • “Schizophrenia is a serious mental illness that affects how a person thinks, feels, and behaves,” said ICER’s Chief Medical Officer, David Rind, MD. “Among the important side effects of current treatments is weight gain leading to metabolic syndrome. This, in turn, places patients at risk for cardiovascular events and death. KarXT has a novel mechanism of action and, at least in the short run, does not seem to cause weight gain. This may lead to major health benefits compared with existing treatments, however current evidence on benefits and harms is limited.”
    • “This Evidence Report will be reviewed at a virtual public meeting of the New England CEPAC (New England CEPAC) on February 9, 2024. The New England CEPAC is one of ICER’s three independent evidence appraisal committees comprising medical evidence experts, practicing clinicians, methodologists, and leaders in patient engagement and advocacy.”
  • Healio calls our attention to these study findings:
    • “Adults who lose weight in the year after being diagnosed with type 2 diabetes are more likely to achieve diabetes remission.
    • “Weight regain after remission increases the risk for returning to hyperglycemia.” 

From the U.S. healthcare business front,

  • The Raleigh (NC) News and Observer reports,
    • “Facing unsustainable costs, the NC State Health Plan’s board of trustees voted to end all plan coverage of popular weight-loss drugs beginning April 1. Board members met Thursday afternoon to consider options for how the plan could deal with rising costs. In October, the board imposed a moratorium on new prescriptions for one of the drugs, Wegovy, when made solely for weight-loss purposes. The moratorium began Jan. 1. At the conclusion of the lengthy meeting, the board voted 4-3 to exclude all coverage of obesity GLP-1 medications on April 1.
    • This will end coverage for plan members who were grandfathered in and already taking the medications as well. Usage of Wegovy, Saxenda and other drugs by plan members has increased significantly in recent years, as have costs incurred by the plan. The plan spent a projected $102 million on these drugs in 2023, or 10% of its roughly $1 billion in net pharmacy spending last year.
  • It stuns the FEHBlog that Novo Nordisk and Eli Lilly continue to raise prices for their GLP-1 drugs when they have blockbuster aales.
  • The American Hospital News notes,
    • “Hospitals and health systems are prioritizing preserving access to care for patients in rural America, including via access points like hospital outpatient departments that provide essential services for rural and low-income communities, according to a new AHA report released Jan. 25. The report details how hospitals have been a lifeline for struggling rural physician practices helping to keep their doors open, and HOPDs have remained convenient, high-quality access points for rural patients with more complex care needs. Among other findings, hospitals were two and a half times more likely to acquire physician practices in rural areas than other entities, including commercial insurers which are overwhelmingly focuse”d on larger and more profitable markets.”
  • Healthcare Dive points out,
    • “Humana on Thursday released a profit outlook for 2024 that fell well short of Wall Street’s already-diminished expectations, as the health insurer continues to be plagued by high medical spending on seniors.
    • “The Louisville, Kentucky-based payer expects to bring in $16 in adjusted earnings per share in 2024 — a whopping $13 short of analysts’ consensus expectations. In comparison, Humana brought in $26.09 in adjusted earnings per share this year.
    • “Humana also rescinded its earnings target for 2025. The health insurer’s stock plunged 15% in morning trade Thursday following the results.”
  • and
    • “Cleveland Clinic executives applauded the operator’s financial rebound in an annual State of the Clinic address, but signaled it would continue lean operations to chase sustained profitability.
    • “We sustain and advance Cleveland Clinic’s mission by serving patients and managing our resources,” said Tom Mihaljevic, Cleveland Clinic CEO and president, during the Wednesday address. “It is possible to use fewer resources while touching more lives.”
    • “Cleveland Clinic exceeded its revenue projections for 2023, drawing in over $14 billion in revenue on more than 14 million annual patient interactions, according to Mihaljevic.
    • “The Ohio-based nonprofit reported an operating margin of 0.4% for the year — an improvement on the prior year’s performance, when the Clinic reported an operating margin of -1.6% on a $1.2 billion net loss.” 

Tuesday Tidbits

Photo by Patrick Fore on Unsplash

From Washington, DC

  • Senator Chuck Grassley (R Iowa) announced that he and
    • Maria Cantwell (D-Wash.) are leading 12 of their colleagues in urging the Federal Trade Commission (FTC) to complete its investigation into the health care industry’s most powerful prescription drug middlemen. The bipartisan senators are also requesting a status update on the investigation, which has now been open for over 18 months.
    • “We support the [FTC’s] issuance of a Section 6(b) order and conducting a timely study of pharmacy benefits managers’ (PBM) business practices,” the senators wrote in their letter to FTC Chair Lina Khan. “With the FTC’s inquiry reaching its year-and-a-half mark, we urge the FTC to complete the study without delay. In the interim, we believe it is important to know the status of the study and therefore ask the FTC to issue a progress report.”  ***
    • Read the full letter HERE.
  • The Department of Health and Human Services informs us,
    • “On January 12th, U.S. Secretary of Health Xavier Becerra spoke with Canadian Health Minister Mark Holland regarding the recent announcement on commercial drug importation from Canada by U.S. states. During the call, they agreed to continue to discuss mechanisms and strategize on finding solutions to combat increasing drug prices to ensure that both Americans and Canadians have access to an affordable and stable drug supply.  Secretary Becerra and Minister Holland committed to keeping in close contact to ensure a mutually beneficial path forward.”
  • and
    • “On Monday, January 22, HHS and Pfizer leadership met virtually with health care provider groups, including the American Medical Association, American Academy of Family Physicians, and others – highlighting the pathways for a smooth transition of oral antivirals for COVID-19, including Paxlovid, to the commercial market and the importance of provider education and clear communication to consumers.
    • “During the call, HHS leadership reminded providers that no patient should be forced to pay the full out-of-pocket cost to access Paxlovid, regardless of their insurance status. Providers should take steps to ensure patients understand the full range of options when it comes to accessing these life-saving treatments and anyone who is facing difficulties at the pharmacy counter should be directed to the PAXCESS patient assistance program (PAP).”
  • Federal Manager tells us,
    • “The results from the fiscal year (FY) 2023 Human Capital Reviews show that Chief Human Capital Officers (CHCOs) want more resources, are making strides in implementing diversity, equity, inclusion, and accessibility (DEIA), and plan to use data more heavily in the future.
    • “The annual reviews probed CHCOs opinions in four areas: Workforce planning and analysis, Implementation of Executive Order 14035 (Advancing Diversity, Equity, Inclusion, and Accessibility), evaluation of system development, and innovation.”
  • Reg Jones, writing in FedWeek, discusses 2024 FEHB premiums and coverage.
  • BioPharma Dive points out,
    • “The makers of CAR-T cell therapies will need to warn about the risk of new blood cancer, the Food and Drug Administration said, following a review of reports involving so-called T cell malignancies following their use.
    • “In Jan. 19 letters to the manufacturers of six CAR-T therapies, the FDA said the prescribing information will need to include boxed warnings, the strongest type. In communication with industry executives, FDA officials have said they believe the benefits of these treatments, which are approved for types of lymphoma, leukemia and multiple myeloma, outweigh their risks.
    • “Since the FDA’s review began in late November, academic researchers have been probing the issue, too. One cell therapy advocacy group noted how the rate of 20 cases of T cell malignancies in roughly 34,000 CAR-T treated patients “is notably lower than that reported for more conventional alternative treatments.” The organization called for more studies to determine if some patients are at higher risk than others.”
  • The U.S. Preventive Services Task Force “concluded that the current evidence is insufficient to assess the balance of benefits and harms of screening for speech and language delay and disorders in children 5 years or younger.” The USPSTF previously gave the same recommendation to this service in 2015.

From the public health and medical research front,

  • Phrma, the drug manufacturer trade association, announced,
    • “2023 marked a five-year high for the number of new treatments and vaccines developed by the biopharmaceutical industry and approved by the U.S. Food and Drug Administration (FDA). According to new information from the FDA’s Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER), 71 novel treatments and vaccines were approved last year for people facing various cancers, certain rare diseases and more. Each new treatment represents new hope and progress for patients and their loved ones.”
  • CNN reports,
    • “Testing a person’s blood for a type of protein called phosphorylated tau, or p-tau, could be used to screen for Alzheimer’s disease with “high accuracy,” even before symptoms begin to show, a new study suggests.
    • “The study involved testing blood for a key biomarker of Alzheimer’s called p-tau217, which increases at the same time as other damaging proteins — beta amyloid and tau — build up in the brains of people with the disease. Currently, to identify the buildup of beta amyloid and tau in the brain, patients undergo a brain scan or spinal tap, which often can be inaccessible and costly.
    • “But this simple blood test was found to be up to 96% accurate in identifying elevated levels of beta amyloid and up to 97% accurate in identifying tau, according to the study published Monday in the journal JAMA Neurology.
    • “What was impressive with these results is that the blood test was just as accurate as advanced testing like cerebrospinal fluid tests and brain scans at showing Alzheimer’s disease pathology in the brain,” Nicholas Ashton, a professor of neurochemistry at the University of Gothenburg in Sweden and one of the study’s lead authors, said in an email.”
  • The Washington Post adds, “For some Alzheimer’s patients, vision problems may be an early warning. A large study brings fresh attention to a lesser-known variant of the disease called posterior cortical atrophy.”
  • The AP reports,
    • “New York City intends to wipe out more than $2 billion in medical debt for up to 500,000 residents, tackling a top cause of personal bankruptcy, Mayor Eric Adams announced Monday.
    • The city is working with RIP Medical Debt, a nonprofit that buys medical debt in bulk from hospitals and debt collectors for pennies on the dollar. The group targets the debt of people with low incomes or financial hardships and then forgives the amounts.
    • Under the program, the city will spend $18 million over three years.”

From the U.S. health care business front,

  • Beckers Hospital Review shares the latest HeathGrades top hospital lists.
    • “Healthgrades has recognized 250 hospitals nationwide for exceptional care via its “America’s Best Hospitals” awards, released Jan. 23.
    • “Three lists feature America’s 50, 100 and 250 best hospitals, which represent the top 1 percent, 2 percent and 5 percent of hospitals in the nation, respectively.”
  • STAT News reports,
    • “Steward Health Care, a for-profit health system that serves thousands of patients in Eastern Massachusetts, is in such grave financial distress that it may be unable to continue operating some facilities, according to public records and people with knowledge of the situation. The fast-moving crisis has left regulators racing to prevent the massive layoffs and erosion of care that could come if hospital services were to suddenly cease.
    • “Steward runs nine Massachusetts hospitals, mostly in Boston suburbs and underserved cities from the Merrimack Valley to the South Coast. But the national operator has shown escalating financial difficulties for at least the past three years, according to public records. This month, Steward’s landlord revealed in a news release that the health system hadn’t been paying its full rent for months and would contemplate selling off hospitals nationally.”
  • Healthcare Dive adds,
    • “Hospital Sisters Health System will close two hospitals and some health centers in Western Wisconsin following prolonged financial stress, the nonprofit system said Monday.
    • “HSHS will close St. Joseph’s Hospital and Sacred Heart Hospital around the end of the first quarter this year. The system also plans to close all the medical centers it operates in the region in partnership with multispecialty group Prevea Health by April 21, according to a release.
    • “The closures, which will impact roughly 1,400 HSHS and Prevea employees, will fully exit the faith-based heath system from the Western Wisconsin region.”
  • BioPharma Dive lets us know,
    • “Sanofi on Tuesday said it will acquire San Diego biotechnology company Inhibrx in a complex deal that could be worth up to $2.2 billion.
    • “The focus of the deal is an experimental drug Inhibrx is developing for a rare lung disease known as alpha-1 antitrypsin deficiency. Sanofi will acquire the drug via a buyout of Inhibrx following the spinout of the biotech’s other assets and employees into a new publicly traded company that will inherit the Inhibrx name.”
  • MedTech Dive notes that “Orthopedics leaders watch procedure backlog, new technologies in 2024. J&J, Medtronic and Smith & Nephew executives and orthopedic surgeons said they expect more procedures to move outpatient, while questions about pricing and procedure backlogs loom over the space.”
  • Per Beckers Hospital Review,
    • “Optum Perks, a prescription discount provider, has launched a new telehealth service that provides affordable healthcare and prescription treatments for conditions such as acne, cough and high blood pressure.
    • “The new service, with a starting cost of $25, allows patients to receive care at any time and can give them access to birth control, cold or flu medication and medication refills, without the need for scheduling or video chat, according to a Jan. 23 news release from Optum Perks. Optum Perks is part of RVO Health, a joint venture between Optum and Red Ventures.” 
  • Per Fierce Healthcare,
    • Bitewell, a food-as-medicine company, has launched a new digital food “farmacy” to encourage members to buy healthy groceries and pre-made meals.
    • “The online store personalizes the food shopping experience based on members’ health conditions and goals. Members can access the offering through a participating health plan, wellness program or provider.
    • Kelly’s Choice, a nutrition and health platform offering coaching and workplace wellness, is among the partners who will begin sponsoring Bitewell food farmacy memberships this month.”

Thursday Miscellany

Photo by Josh Mills on Unsplash

From Washington, DC

  • Roll Call brings us up to date on the FY 2024 appropriations discussions on Capitol Hill.
  • The Department of Health and Human Services announced,
    • “As part of continuing efforts by the Biden-Harris Administration to help people access comprehensive, high-quality health coverage, the U.S. Department of Health and Human Services (HHS) launched a new, online and user-friendly hub for partners to access critical Medicaid and Children’s Health Insurance Program (CHIP) renewal and transition resources.”
  • Tammy Flanagan, writing in Govexec, explains 2024 benefit changes for federal employees and annuitants.
  • Beckers Hospital Review tells us,
    • “The FDA has issued temporary authorization for the importation of a syphilis drug that’s been in short supply since last April. 
    • “Federal regulators have cleared French drugmaker Laboratoires Delbert to import penicillin G benzathine, Bloomberg reported Jan. 10. A shortage of Pfizer’s version of the drug, Bicillin L-A, is estimated to last through June and is the only treatment for congenital syphilis. 
    • “Last April, the CDC said syphilis rates are at their highest since 1950, with nearly 177,000 cases reported in 2021.” 
  • The Canadian Broadcasting Company (CBC) reports
    • “[Canadian] Health Minister Mark Holland says Florida’s plan to import cheaper Canadian pharmaceuticals is a non-starter and the federal government will use its regulatory power to ensure the national drug supply does not face any shortages due to actions by a foreign state.
    • “There is no way we will allow any jurisdiction, be it a state or another foreign jurisdiction, to endanger the Canadian drug supply. That is not an appropriate solution to whatever challenges they may be facing,” Holland said during an official announcement in Nova Scotia of a bilateral health-care deal with the province.
    • “We’re going to do everything in our power to make sure that another country cannot be given the ability to pillage our health system for its own benefit.”
    • “Holland said he will soon travel to Washington, D.C. to make it known to officials there that Canada will not stand idle if Florida or other U.S. states pursue bulk imports that threaten Canadians’ access to medication in any way.”
  • KFF analyzes the Affordable Care Act’s latest open enrollment period.

From the public health and medical research front,

  • The Wall Street Journal lets us know,
    • “Cancer is hitting more young people in the U.S. and around the globe, baffling doctors. Diagnosis rates in the U.S. rose in 2019 to 107.8 cases per 100,000 people under 50, up 12.8% from 95.6 in 2000, federal data show. A study in BMJ Oncology last year reported a sharp global rise in cancers in people under 50, with the highest rates in North America, Australia and Western Europe. 
    • “Doctors are racing to figure out what is making them sick, and how to identify young people who are at high risk. They suspect that changes in the way we live—less physical activity, more ultra-processed foods, new toxins—have raised the risk for younger generations.
    • “The patients are getting younger,” said Dr. Andrea Cercek, who co-directs a program for early-onset gastrointestinal cancer patients at Memorial Sloan Kettering Cancer Center in New York, where Keen was treated. “It’s likely some environmental change, whether it’s something in our food, our medications or something we have not yet identified.” 
  • The National Institutes of Health’s Directors Blog points out “A New Target to Improve the Health and Lives of Childhood Cancer Survivors: Diabetes Prevention.”
  • MedPage Today informs us,
    • “The CDC’s Advisory Committee on Immunization Practices (ACIP) has updated its adult immunization schedule for 2024 to include recommendations on new vaccines for respiratory syncytial virus (RSV) and meningitis, the mpox (formerly known as monkeypox) vaccine, and the updated COVID-19 vaccines.”
    • The article notes the 2024 changes in this schedule.
    • “In an accompanying editorial, Scott Ratzan, MD, and other members of the Council for Quality Health Communication offered scathing criticism of the CDC’s complex written and visual presentation of the recommendations.”
  • Per Fierce Healthcare,
    • “The Blue Cross Blue Shield Association will lead an effort to improve maternity care in about 600 acute care and pediatric hospitals across the nation, including a push to address racial and ethnic disparities.
    • “Health equity in maternal care will be added to the list of conditions that the insurer’s Blue Distinction Centers focus on, the company said in an announcement. The effectiveness of that care will be measured against industry standards. Blue Distinction Centers comprise hospitals and other providers that the insurer deems deliver high quality care.”
  • The National Institutes of Health announced,
    • “Researchers have linked a decade-long decline in the blood lead levels of American Indian adults to long-term cardiovascular health benefits, including reduced blood pressure levels and a reduction in a marker associated with hypertrophic cardiomyopathy and heart failure. The research, supported by the National Institutes of Health, found that adults who had the greatest reductions in blood lead levels saw their systolic blood pressure fall by about 7 mm Hg, an amount comparable to the effects of blood pressure-lowering medication. Lead exposure is known to harm the health of children by damaging the brain and nervous system and slowing growth and development. It has also been associated with increased risks for heart disease in adults. The findings published in the Journal of the American Heart Association.
    • “This is a huge win for public health, especially since many American Indians can face higher risks for elevated lead levels,” said Anne E. Nigra, Ph.D., the senior study author and an assistant professor of environmental health sciences at Columbia University Mailman School of Public Health, New York City. “Compared to the general U.S. population, American Indian communities experience both a higher burden of cardiovascular disease and elevated metal exposure. We saw that even small decreases in a person’s blood lead levels can have meaningful health outcomes.”
  • Medscape tells us,
    • “In addition to better-known risk factors such as diabetes, stroke, heart disease, and depression, findings of a large study suggested vitamin D deficiency, elevated C-reactive protein (CRP) levels and social isolation increase the risk for young-onset dementia (YOD).”

From the U.S. healthcare business front,

  • STAT News, Fierce Healthcare, and Precision Medicine Online offer summaries of the fourth and final day of the JP Morgan Healthcare Conference, which was held in San Francisco.
  • The Wall Street Journal reports,
    • Novartis has backed away from its pursuit of Cytokinetics putting a damper on the prospects of a deal for the promising heart-drug developer. 
    • “The Swiss drug giant had been closing in on a purchase of South San Francisco-based Cytokinetics, with an agreement expected as soon as this week, The Wall Street Journal reported Monday. But Novartis, which had been pursuing the biotech for several months, backed away sometime in the past day or two, according to the people.” 
  • The Segal Company offers a helpful white paper on key factors impacting healthcare costs. trends.
  • Beckers Hospital Review notes,
    • “The Cigna Group is getting ready to launch a new program that offers employers and health plan sponsors a way to manage obesity, diabetes and cardiovascular disease using weight loss drugs, or GLP-1s.
    • EncircleRx is set to launch in the first quarter of 2024 under Evernorth, Cigna’s health services arm. On the company’s website, it describes the program as “the first-ever GLP-1 financial guarantee from a PBM.”
    • “The program works to target the individuals who are at the highest risk, would have the most benefit from meaningful changes from access to the GLP-1, and supports it with the right ongoing clinical and behavioral support,” Eric Palmer, CEO of Evernorth, told investors at the JPMorgan Healthcare Conference Jan. 9. “[The program] makes sure that an individual is prepared to work through all of the effects of going through this kind of life-changing set of therapies and is also set up with the right value-based reimbursement as well.”
  • Per Healthcare Dive,
    • Billing for patient messages sent to providers has risen in the wake of the COVID-19 pandemic, according to a study published in JAMA. 
    • “Charging for e-visits, or asynchronous messages that require medical decision making and take at least five minutes of clinician time over the course of a week, spiked at the beginning of the pandemic as health systems shifted to virtual care. But billing fell after the early pandemic peak before beginning to steadily increase again in mid-2021. 
    • “More than 470 healthcare organizations billed at least 50 e-visits in the third quarter of 2022, an increase of nearly 40% compared with the same period in the previous year. The upturn suggests organizations now see e-visits as a long-term source of potential revenue, researchers said.” 

Midweek Update

Thanks to ACK15 for sharing their work on Unsplash.

From Washington, DC

  • Govexec informs us,
    • “A new website has made available a database of anyone serving in a top-ranking position in the federal government, offering new insight that advocates said will boost transparency and better prepare new administrations to transition into power.  
    • “The Office of Personnel Management launched the site to comply with the Periodically Listing Updates to Management (PLUM) Act, which so far includes the names, roles and pay levels of more than 8,000 executives in government.
    • “OPM said that figure will grow to 10,000 as it ensures compliance and updates the list over the coming months. It will include senior leaders at every federal agency, including all 4,000 political appointees, Senior Executive Service members and other top or non-competitively appointed officials. “
  • The Department of Health and Human Services tells us,
    • On Wednesday, January 3, U.S. Department of Health and Human Services (HHS) Secretary Xavier Becerra met virtually with long-term care facility (LTCF) leaders to express concerns about low vaccination rates among nursing home residents and remind industry leaders of their obligations to offer the COVID-19 vaccine to residents and staff.
    • Today’s conversation was a follow-up call from a previous HHS virtual meeting on December 21 with LTCF leaders to discuss the Centers for Disease Control and Prevention’s (CDC) December 2023 report finding that just 33% of long-term care facility residents were up to date with their COVID-19 vaccinations. The Centers for Medicare & Medicaid Services (CMS) requires all nursing homes to offer COVID-19 vaccines to residents and staff and educate them on their benefits.
  • FedWeek notes,
    • “Fraud against the federal retirement program is continuing, an inspector general report has said, with lack of reporting to OPM on the deaths of beneficiaries the most common means.
    • “These unreported deaths may allow payments to continue because of program vulnerabilities or intentional fraud on the part of bad actors. Sometimes, CSRS or FERS improper payments continue for years and cost tens of thousands of dollars before discovery,” says the IG’s latest summary of its investigative activities.”
  • FEHBlog note — The government needs a better system to keep track of deaths.

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

  • The New York Times reports,
    • “The holidays have come and gone, and once again Americans are riding a tide of respiratory ailments, including Covid. But so far, this winter’s Covid uptick seems less deadly than last year’s, and much less so than in 2022, when the Omicron surge ground the nation to a halt.
    • “We’re not seeing the signs that would make me think that we’re heading into another severe wave,” said Caitlin Rivers, an epidemiologist at the Johns Hopkins Center for Health Security. “So far, we’re in relatively good shape.”
    • “Still, * * * just a fraction of the most vulnerable people have received the latest Covid shots, she noted.
    • “It’s not too late,” Dr. Rivers added. “We have not even reached peak yet for Covid, and once you reach peak, you still have to get down the other side.” That leaves plenty of time for the vaccine to provide some protection.”
  • Beckers Hospital Review adds,
    • “COVID-19 and flu admissions continue to climb across the country, with the majority of states now reporting high levels of respiratory virus activity. 
    • “Overall, 31 states reported high levels of respiratory virus activity for the week ending Dec. 23. Included in this total are a growing number of states seeing “very high” activity levels: Alabama, California, Colorado, Georgia, Louisiana, Mississippi, Nevada, New Jersey, New Mexico, North Carolina, South Carolina, Tennessee, Virginia and New York City. Two weeks ago, just five states reported very high levels.” 
  • Medscape notes
    • “While COVID has now claimed more than 1 million lives in the United States alone, these aren’t the only fatalities caused at least in part by the virus. A small but growing number of Americans are surviving acute infections only to succumb months later to the lingering health problems caused by long COVID.
    • “Much of the attention on long COVID has centered on the sometimes debilitating symptoms that strike people with the condition, with no formal diagnostic tests or standard treatments available, and the effect it has on quality of life. But new figures from the US Centers for Disease Control and Prevention (CDC) show that long COVID can also be deadly.
    • “More than 5000 Americans have died from long COVID since the start of the pandemic, according to new estimates from the CDC.”
  • STAT News alerts us,
    • “One in three heart patients live with anxiety, depression, and ongoing stress, according to a 2023 meta-analysis of over 100 studies. But even in the age of 24/7 monitoring via implantable loop recorders and wearables, many patients are without professional support for the mental and emotional social aspects of coping with heart disease.
    • “The technology of cardiology is locked down. People get that. What’s not locked down is the patient experience,” said Sam Sears, professor of health psychology at East Carolina University, and the author of over 200 research studies on psychological interventions for heart health. “The human factors in all this just don’t get addressed as a standard of care.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • Cigna is in advanced talks to sell its Medicare business in an about-face for the health-insurance giant, which had been expanding its footprint in the fast-growing sector. 
    • “Cigna, which has been running an auction for the business, known as Medicare Advantage, is now in exclusive talks to sell it to Health Care Service Corp. for between $3 billion and $4 billion, according to people familiar with the matter. 
    • “Should there be a deal, it would mark a major expansion for HCSC, a big nonprofit health insurer that is the parent of Blue Cross Blue Shield plans in five states including Texas and Illinois. HCSC has long been a powerful player in its home states, but the deal would give it a significant Medicare business and far broader reach. Cigna is offering Medicare plans in 29 states for 2024.
  • Drug Channels offers its annual “reality check on U.S. drug pricing.”
  • Per Fierce Healthcare,
    • Solera Health, a chronic condition management platform for payers and employers, is expanding its platform to include virtual specialty care facilitated by several new clinical partners.
    • “Solera’s HALO Platform is an omni-condition management tool that aims to address high-cost chronic conditions, mostly serving commercial populations. The latest expansion into virtual specialty care furthers the company’s value-based care mission by widening access to specialist docs in a low-cost setting, executives told Fierce Healthcare.
    • “The new capabilities leverage partnerships with two new partners, 9am.health and Vori Health, as well as an existing partner, Oshi Health.
    • “Each partner specializes in addressing high-cost conditions, from obesity and diabetes to musculoskeletal pain to GI conditions. They offer a health coach, nutritionist, peer support and other support services while also coordinating with a patient’s primary or in-person care doc.”
  • Health Payer Intelligence looks at employer-sponsored plan trends for 2024.

Tuesday Tidbits

Photo by Patrick Fore on Unsplash

From Washington, DC,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Thursday Miscellany

Photo by Josh Mills on Unsplash

From Washington, DC

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Midweek Update

From Washington, DC,

  • Govexec informs us
    • “So, 2023 is just about history. And Congress, having spent most of our last trip around the sun in political paralysis not surprisingly ran out the year’s clock in the same hardly decorous manner. 
    • “And, frankly, for feds that’s the good news. How so? Each year federal retirees and Social Security recipients get a cost-of-living adjustment that is carefully—if imperfectly—tabulated using a formula that crunches hard inflation data from the wider economy. Current federal employees, on the other hand, get their pay boost—if any—only by way of a political process. This process is governed under the Federal Employees Pay Comparability Act, or FEPCA. And when Congress does not act on this matter in a given year, then the federal pay adjustment comes from a stroke of the president’s pen. 
    • “This year, since Congress took its final recess without passing the customary appropriations bill, the White House almost certainly will issue an alternative pay plan along the lines President Biden proposed months ago: 4.7% base increase and, taking into account locality pay, an average pay boost of 5.2%.” 
  • Per Fierce Healthcare,
    • “The number of people signing up for coverage on Healthcare.gov has crossed 15 million, according to new data from the Biden administration.
    • “The Department of Health and Human Services said Wednesday that as of Dec. 15, 15.3 million people have chosen plans on the Affordable Care Act’s exchanges, surpassing previous records. On that day alone, 745,000 secured marketplace plans, the highest single day ever.
    • “Centers for Medicare & Medicaid Services Administrator Chiquita Brooks-LaSure said in a release that sign-ups are currently up 33% year-over-year.
    • “Dec. 15 was the deadline to secure a plan that kicks in on Jan. 1.”
  • The National Academies of Science posted August 2023 workshop proceedings about “Dietary Patterns to Prevent and Manage Diet-Related Disease Across the Lifespan.”

From the public health and medical research front,

  • CBS News reports
    • “The World Health Organization announced Tuesday it would step up its classification of the new COVID-19 variant JN.1 to a standalone “variant of interest” after tracking the strain’s rapid ascent around the world. Health officials have been careful to say that JN.1 has so far not been found to lead to different or more severe symptoms compared to previous variants.
    • “However, the WHO said JN.1’s “rapidly increasing spread” in multiple parts of the world was enough to warrant ungrouping the strain from its slower-moving ancestor BA.2.86.
    • “JN.1 continues to be reported in multiple countries, and its prevalence has been rapidly increasing globally and now represents the vast majority of BA.2.86 descendent lineages reported,” the WHO wrote.”
    • The article adds that the variant will receive a Greek letter if it is promoted to a variant of concern.
  • The Wall Street Journal adds,
    • “Vaccine makers PfizerModerna and Novavax have said their updated Covid-19 shots generate immune responses against JN.1’s close parent, BA.2.86. 
    • “Data shows that all of the antibodies are a really good fit, luckily, for JN.1,” said Jeremy Kamil, a virologist at Louisiana State University Health Shreveport. “That’s really good news.”
    • “Kamil pointed out that Covid-19 vaccine uptake has been low this season, some 18% of adults having gotten a shot, according to the CDC.”
  • Health Day informs us,
    • “Standard artificial intelligence (AI) models improve diagnostic accuracy, but systematically biased AI models reduce this accuracy, according to a study published in the Dec. 19 issue of the Journal of the American Medical Association.”
  • Beckers Hospital Review notes,
    • “Amid the rise of the OzempicWegovy and Mounjarno, older weight loss drugs are making a comeback in 2023, just like ripped jeans.
    • “The popular new weight loss drugs gaining attention still remain inaccessible for many due to pricing, insurance coverage or lack thereof, and shortages, which is why some adults are now turning to older weight loss drugs instead, CNN reported Dec. 20.
    • “As a result, there have been increasing prescriptions for drugs that are more within grasp. According to CNN, prescriptions for bupropion — an antidepressant medication used also to aid patients in quitting smoking with a side effect of weight loss — went up 29% between 2017 and 2023. Additionally, prescriptions for another drug, phentermine — a weight loss drug approved by the FDA in 1959 — rose 34% during the same time frame, according to the outlet.”

From the U.S. healthcare business front,

  • The International Foundation of Employee Benefit Plans has named this year’s top six benefit trends.
  • Per Healthcare Dive,
    • “Philadelphia-based Jefferson Health and Allentown, Pennsylvania-based Lehigh Valley Health Network announced on Monday they signed a non-binding letter of intent to combine.
    • “If approved, the merger would join Jefferson’s hospital system with Lehigh’s 13 facilities to form a 30-hospital system with more than 62,000 employees. 
    • “Jefferson Health’s chief executive, Joseph Cacchione,will remain at the helm of the new enterprise, according to the release.”
  • and
    • “Froedtert Health and ThedaCare have finalized their merger, the systems announced Tuesday. The combined Wisconsin health system will launch on Jan. 1, 2024. * * *
    • “ThedaCare’s medical network includes eight hospitals and a medical network that serve residents in 17 counties in northeast and central Wisconsin. Froedtert provides healthcare services in southeast Wisconsin through ten hospitals and 45 health centers and clinics.”
  • and
    • “UnitedHealth and its pharmacy benefit manager OptumRx are being sued by an independent pharmacy for allegedly strong-arming pharmacies into agreeing to “unconscionable” performance-based fees, threatening their financial health.
    • “Those fees, called DIR or direct remuneration fees, allow PBMs to retroactively adjust how much pharmacies are reimbursed based on their quality performance. Osterhaus Pharmacy in Iowa is suing OptumRx for allegedly coercing the pharmacies to accept one-sided contracts including the fees — which at times force pharmacies to dispense prescriptions at a loss — or lose access to the millions of beneficiaries with pharmacy benefits through the PBM.
    • “The suit seeks class action status to include thousands of independent pharmacies with similar contracts with OptumRx. Osterhaus brought a similar suit against CVS in September.”

Thursday Miscellany

Photo by Josh Mills on Unsplash

From Washington, DC,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Weekend update

From Washington, DC,

  • The American Medical Association reports,
    • “As of today, patients and physicians have a clear-eyed view on how to protect Medicare from injurious cuts. A bipartisan group of House members— led by Reps. Greg Murphy, M.D., (R-N.C), Danny Davis, (D-Ill.), Brad Wenstrup, D.P.M. (R-Ohio), Jimmy Panetta (D-Calif.), Larry Bucshon, M.D. (R-Ind.) and Michael Burgess, M.D. (R-Texas)—introduced HR 6683 that would eliminate the pending 3.37 percent cuts to Medicare payments. These cuts threaten healthcare access for seniors as well as the viability of physician practices, including many in rural and underserved areas. Canceling the cut is a good new year’s resolution.”
  • The Federal Benefits Open Season ends tomorrow, December 11.
    • OPM explains that “The Federal Benefits Open Season ends at 11:59 pm Eastern Time on Monday, December 11, 2023, for the Federal Employees Dental and Vision Insurance Program (FEDVIP) and the Federal Flexible Spending Account Program (FSAFEDS). Open Season for the Federal Employees Health Benefits Program (FEHB) ends at 11:59 pm, in the location of your electronic enrollment system, on Monday, December 11, 2023.”

From the public health front,

  • Fortune Well provides background on pneumonia, the lung disease that is the number one cause of hospital admission in children and adults.
  • Bloomberg Prognosis delves into the old saying, “Feed a cold and starve a fever,” which dates back to the 16th century. Well, it turns out that your best bet is to feed colds and fevers according to Bloomberg.
  • The Washington Post reports,
    • “The Centers for Disease Control and Prevention on Friday warned clinicians and the public about an outbreak of a rare but deadly tick-borne disease that hospitalized five patients in Southern California, killing three of them, after they traveled to or lived in a Mexican border city in recent months.
    • “Rocky Mountain spotted fever (RMSF) is transmitted by the bite of infected ticks that live primarily on dogs. It’s rare in the United States but it has emerged at epidemic levels in northern Mexico, where more than 2,000 cases, resulting in hundreds of deaths, have been reported in the past five years.
    • “In a health advisory issued late Friday, the CDC said the five patients had been diagnosed since late July. All had traveled to or lived in the city of Tecate, in the northern Mexican state of Baja California, within two weeks of getting sick. All five sought care in hospitals in Southern California, including four pediatric patients. CDC officials declined to provide more details about the individuals to protect their privacy. Three of the patients were U.S. residents, and two were siblings who lived in Mexico. Two deaths were pediatric patients and one was an adult, CDC officials said.”
  • The Post also discusses nitazenes, a street opioid more potent than fentanyl.
    • “Naloxone, the commonly used overdose reversal drug, can revive nitazene users. But nitazenes may complicate rescue efforts if users or medical personnel do not know the drugs have been consumed. In a study published in August, researchers found that a small group of emergency room patients who had taken nitazenes needed more naloxone than people overdosing on fentanyl. Two patients who ingested a compound known as metonitazene suffered heart attacks. One died, according to the study in JAMA Network Open.
    • “The concerns about nitazenes being more potent than fentanyl were confirmed by the study,” said Alex F. Manini, a study co-author and a professor of emergency medicine at the Icahn School of Medicine at Mount Sinai in New York.”

We have big news from the U.S. healthcare business front.

  • The Wall Street Journal reported this afternoon,
    • Cigna abandoned its pursuit of a tie-up with  Humana that would have created a roughly $140 billion giant in the health-insurance industry.
    • “The companies couldn’t come to an agreement on price and other financial terms, according to people familiar with the matter. In the near term, Cigna is turning its focus toward smaller, so-called bolt-on acquisitions. * * *
    • “Instead, Bloomfield, Conn.-based Cigna plans an additional $10 billion of stock buybacks, bringing its total planned repurchases to $11.3 billion. * * *
    • “Humana, the No. 2 Medicare insurer, remains in the midst of its own succession handoff. Humana said in October that Jim Rechtin—previously chief executive of Envision Healthcare—would take over as president and chief operating officer, effective Jan. 8. Rechtin is then to take over as chief executive officer from Bruce Broussard in the back half of 2024.” 

Friday Factoids

Photo by Sincerely Media on Unsplash

From Washington, DC,

  • Endpoints informs us,
    • “In a landmark moment for genetic medicine and sickle cell disease patients, the FDA on Friday approved not just one but two gene therapies for the disease: Vertex Pharmaceuticals’ and CRISPR Therapeutics’ Casgevy, marking the first-ever approval of a CRISPR-based medicine in the US, and Lyfgenia, bluebird bio’s lentiviral gene therapy.
    • “The treatments are approved for sickle cell disease patients 12 years of age and older who experience painful attacks associated with the disease. Vertex will charge $2.2 million in the US for Casgevy, while bluebird will charge $3.1 million for Lyfgenia.
    • “This is the very first time that some patients have ever imagined that they might not have to live their entire lifespan with the consequences of sickle cell disease,” Alexis Thompson, the chief of the division of hematology at Children’s Hospital of Philadelphia and investigator on the clinical trials that led to the therapies’ approvals, told Endpoints News ahead of the announcement.” * * *
    • “ICER, a drug pricing watchdog, has suggested the therapies could be cost-effective at $2 million in the US. Bluebird bio markets a gene therapy as Zynteglo for transfusion-dependent beta thalassemia as well in the US, for which it charges $2.8 million.”
  • Per Fierce Healthcare,
    • “New polling suggests voters would rather work to improve the current U.S. healthcare system and keep the Affordable Care Act in place, rather than drastically overhaul the system in favor of a national public option or Medicare for All.
    • “Three-quarters of survey respondents said they prefer fixing the current health insurance system versus starting fresh with a Medicare for All system, while 64% said Medicare should begin at the age of 60 instead of 65 and 58% believe people should be allowed to purchase health insurance beginning at the age of 50.
    • “Repealing the ACA struck a chord with respondents as just 32% of voters and only 44% of GOP voters said they support repealing the ACA. When asked if ACA subsidies should be extended, 60% said they should while only 41% of Republicans agreed.
    • “Notably, the survey was conducted on behalf of the Partnership for America’s Health Care Future, an industry group created in 2018 comprised of America’s Health Insurance Plan, the American Hospital Association, BlueCross BlueShield Association, the Federation of American Hospitals, PhRMA and other major hospital systems, payers and healthcare advocacy groups that seek to quell support and prevent passage of Medicare for All.” 
  • Healthcare Dive tells us,
    • “Hospitals are up in arms over a bill in the U.S. House of Representatives that would equalize payments for drugs administered in outpatient clinics, regardless of ownership.
    • The American Hospital Association and the Federation of American Hospitals sent separate letters to Congress this week urging legislators to vote against the bill over the site-neutral provision, arguing it would threaten access to care by cutting hospitals’ Medicare payments.
    • “The bipartisan Lower Costs, More Transparency Act is scheduled to come up for a House vote the week of Dec. 11.”
  • Fierce Healthcare offers more information on this bill (HR 5378).
    • [T]he legislation would ban spread pricing in Medicaid, force PBMs and providers to adopt President Trump-era transparency rules, push closer toward site-neutral payment reform, extend a federal program due to expire and approve funding increases for community health centers.
  • The American Hospital Association News points out,
    • The Medicare Payment Advisory Commission Dec. 8 discussed draft payment update recommendations for 2025, which the commission will vote on in January. The draft recommendations call for Congress to update Medicare payment rates for hospital inpatient and outpatient services by the current law amount plus 1.5%, and transition to a safety-net index policy that would distribute an additional $4 billion to safety-net hospitals. They also propose that Congress:
      • Update 2025 Medicare payments for physicians and other health professional services by 50% of the Medicare Economic Index increase, and enact a non-budget-neutral add-on payment under the physician fee schedule to services provided to low-income Medicare beneficiaries.
      • Reduce the 2025 payment rate for home health agencies by 7%.
      • Reduce the 2025 payment rate for skilled nursing facilities by 3%.
      • Reduce the 2025 payment rate for inpatient rehabilitation facilities by 5%.
  • On December 6, the Biden Administration’s latest semi-annual regulatory agenda was posted. Here is a link to OPM’s agenda. Here are the FEHB rulemakings in process:
    • OPM Proposed Rule Stage Federal Employee Health Benefits Program: Effective Date of Coverage RIN 3206-AO47
    • OPM Proposed Rule Stage Postal Service Health Benefits Program: Additional Requirements and Clarifications RIN 3206-AO59
    • OPM Proposed Rule Stage Federal Employee Health Benefits Program: Decreasing Enrollment Type to Self Only RIN 3206-AO62
    • OPM Final Rule Stage Requirements Related to Air Ambulance, and Agent, and Broker Services, and Provider Enforcement RIN 3206-AO28
    • OPM Final Rule Stage Postal Service Health Benefits Program RIN 3206-AO43
  • Readers can research these rulemakings on regulations.gov by referencing the RIN.

From the public health and medical research front,

  • The Department of Health and Human Services announced
    • “In first-of-its-kind research to examine racial and ethnic disparities in the medical costs of smoking in the United States, the Department of Health and Human Services’ Agency for Healthcare Research and Quality (AHRQ) found that adults from some racial and ethnic populations benefit substantially more than others from tobacco control policies. The research, published today in the journal Tobacco Control, supports President Joe Biden’s April 2023 Executive Order calling for policymakers to examine distributional effects in cost-benefit analyses required in the rulemaking process.  This study helps inform such analyses and will benefit other research in this area.
    • “The study shows that even though adults in specific racial and ethnic populations have a lower ever-smoked rate than White adults and make more attempts to quit, their medical spending associated with smoking was twice as high, with a 41% higher rate of having multiple chronic conditions associated with smoking. * * *
    • “Disparities in medical spending, as well as adverse health outcomes, are continuing to increase over time,” said AHRQ co-author Dr. William Encinosa. “AHRQ’s results indicate that racial and ethnic populations benefit substantially from tobacco control policies, such as tobacco product regulations.”
    • “The article, “Racial and Ethnic Disparities in the Healthcare Costs and Outcomes of Smoking in the United States: 2008-2019,” is published in Tobacco Control and may be found at: https://tobaccocontrol.bmj.com/lookup/doi/10.1136/tc-2023-058136
  • Medscape notes,
    • “Patients receiving semaglutide for weight loss show a significantly higher rate of continuing the medication at 1 year compared with less effective anti-obesity drugs. However, even among those patients, continuation declines to fewer than half of patients.
    • “We now have effective US Food and Drug Administration-approved anti-obesity medications; [however], this study shows that in a real-world setting, the vast majority of patients discontinued their prescription fills within the first year,” said first author Hamlet Gasoyan, PhD, lead author of the study and a researcher with Cleveland Clinic’s Center for Value-Based Care Research, said in a press statement.
    • “The study was published online today in the journal Obesity.”
  • HR Morning fills us in on cancer benefit trends in 2024 and how employers can support employees fighting cancer.
  • Per MedPage Today,
    • “An outbreak of Clade I mpox virus is currently spreading in the Democratic Republic of the Congo (DRC), and clinicians should be aware of the potential for transmission from people traveling from the Central African country, the CDC said Thursday in a Health Alert Network advisoryopens in a new tab or window.
    • “Of the two distinct mpox subtypes, Clade I is endemic in Central Africa, and appears to be more transmissible and causes more severe infections than the Clade II subtype. So far, no Clade I mpox infections have been detected in the U.S. during surveillance testing. The current threat for Clade I mpox in travelers remains low, the CDC said, in part because there are no direct commercial flights to the U.S. from the DRC.”

From the U.S. healthcare business front,

  • Becker’s Payer Issues explains how BCBS plans are using price transparency data.
    • “It’s been nearly two years since payers have been required to publish the costs of their in-network provider rates for covered items and services, and now Blue Cross Blue Shield plans are using that data to create actionable insights for stakeholders across the healthcare system.
    • “Much of that work is being done by Blue Health Intelligence, the data and analytics arm of the BCBS Association that is collectively owned by 17 BCBS affiliates. Becker’s sat down with BHI CEO Bob Darin to learn how Blues plans around the country are utilizing price transparency data, and the major challenges that still lie ahead.”
  • Check out the interview.
  • HR Dive reports,
    • “The U.S. government published its fall regulatory agenda Wednesday, sharing its rulemaking plans for the remainder of 2023 and early 2024.
    • “Of interest to HR professionals are U.S. Department of Labor updates on wage and hour law, workplace safety and retirement plans. Perhaps most notably, the DOL plans to finalize overtime regulations in April 2024. Final regulations for independent contractor classification — under the Fair Labor Standards Act — hang in the balance, as they were slated to be published in November, per the DOL.
    • “Separately, the U.S. Equal Employment Opportunity Commission said it will finalize Pregnant Workers Fairness Act rules in December.”
  • The Society for Human Resource Management advises
    • “With the end of the year quickly approaching, HR and benefits leaders have yet one more task to add on to their busy end-of-year checklist: reminding employees about approaching deadlines to use up remaining cash in their health care flexible spending accounts (FSAs). ***
    • “So how should employers share end-of-year news about FSAs? And what should they say?
    • “One of the best ways to remind employees is to send multiple emails during the remainder of the year, Dinich said, adding that if company leaders simply raise the issue in a company meeting, anyone who is on leave or out sick won’t get that reminder.
    • “Make sure to reiterate any terms and conditions within that email and advise on checking which expenses are eligible, so that employees can refer back to this when making claims before the end of the year,” he said. “Also ensure that it’s clear when the expiry date is, as some plans are tied to specific dates rather than defaulting to the end of the year.”