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.”