Midweek Update

David Ermer–Congress, COVID-19, FDA, Medical / Rx research, Medicare, Mental health care, NIH, Obesity, Telehealth, U.S. Healthcare, Wellness–

From Washington, DC

  • Modern Healthcare tells us,
    • “Congress took the first step Wednesday to extend expiring telehealth rules, hospital at home services and other programs aimed at rural hospitals.
    • “The House Ways and Means Committee passed the Preserving Telehealth, Hospital, and Ambulance Access Act of 2024 by a vote of 31-0, setting it up for passage by the full House later this year. * * *
    • “One potentially controversial provision in the bill requires pharmacy benefit managers that work with Medicare Part D plans to de-link the compensationthey pay themselves from the rebates they secure based on drugs’ high list prices. Rep. Brad Schneider (D-Ill.) said the provision will save the government about $500 million, although official estimates were not yet available. The provision does not apply to the broader commercial market, though Schneider and Rep. Nicole Malliotakis (R-N.Y.) both called for expansion of the provision to the commercial market. Large PBMs oppose such provisions.”
  • Govexec lets us know,
    • “A new report from the Congressional Budget Office found that a gap between the combined pay and benefits of federal workers and their private sector counterparts has nearly disappeared between 2015 and 2022, raising new questions about President Biden’s proposed 2% average pay raise for the federal workforce in 2025.
    • “Federal policymakers generally rely on one of two reports comparing the compensation of federal and private sector workers. First is an annual analysis compiled by the Bureau of Labor Statistics for review by the Federal Salary Council, which compares only the wages of similar jobs, is the preferred citation of Democrats and federal employee unions. * * *
    • “CBO’s analysis, which is typically conducted every five years and is preferred by conservatives, compares “total compensation”—wages plus the cost of benefits like health care, paid leave and retirement—of federal and private sector employees with similar educational backgrounds. This model has traditionally concluded that the cost of federal employees’ pay and benefits is moderately higher than their counterparts in the private sector, although federal workers with master’s or professional degrees still tend to earn less.
    • “The latest version of CBO’s report, which was released last month, covers only 2022, rather than the traditional 2015-2020 period, due to the economic upheaval caused by the COVID-19 pandemic. It found that the total compensation gap between federal and private sector jobs cratered between 2015 and 2022, falling from 17% in its last analysis to just 5%.”
  • Per May 8 HHS press releases,
    • “The U.S. Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), is announcing the Increasing Organ Transplant Access (IOTA) Model. The proposed model, which would be implemented by the CMS Innovation Center, aims to increase access to kidney transplants for all people living with end-stage renal disease (ESRD), improve the quality of care for people seeking kidney transplants, reduce disparities among individuals undergoing the process to receive a kidney transplant, and increase the efficiency and capability of transplant hospitals selected to participate. This proposed model would build on the Biden-Harris Administration’s priority of improving the kidney transplant system and the collaborative efforts between CMS and the Health Resources and Services Administration (HRSA) to increase organ donation and improve clinical outcomes, system improvement, quality measurement, transparency, and regulatory oversight.” * * *
    • “The proposed rule on the Increasing Organ Transplant Access Model can be accessed from the Federal Register at https://www.federalregister.gov/public-inspection/current. Standard provisions are included in the proposed rule that would be applicable to all Innovation Center model participants that begin participation in a model on or after January 1, 2025.
    • “View – PDF a fact sheet on the Increasing Organ Transplant Access Model.
    • “More information on the Increasing Organ Transplant Access Model is available on the model webpage.”
  • and
    • “The U.S. Department of Health and Human Services (HHS), through the Substance Abuse and Mental Health Services Administration (SAMHSA), announced $46.8 million in notices of funding opportunities to promote youth mental health, grow the behavioral health workforce, improve access to culturally competent behavioral care across the country, and strengthen peer recovery and recovery support. President Biden made tackling the mental health crisis and beating the opioid epidemic key pillars in his Unity Agenda for the nation. Today’s announcement will help communities transform how they address behavioral health.”
  • Beckers Clinical Leadership notes,
    • “Starting this summer, rural health clinics seeking Medicare reimbursement can apply through a new accreditation program from The Joint Commission. 
    • “On May 7, The Joint Commission said it has received deeming authority from CMS for a new rural health clinic accreditation program, which is meant to support patient safety improvements by reducing variation and risks in the delivery of primary care and personal health services.” 

From the Food and Drug Administration front,

  • BioPharma Dive reports,
    • “Geneoscopy received Food and Drug Administration approval for its Colosense noninvasive colorectal cancer screening test, the company said Monday.
    • “The stool-based test, which Labcorp will offer, is approved for screening people aged 45 years or older who are at average risk of developing colorectal cancer. The indication puts Geneoscopy in competition with Exact Sciences’ Cologuard test.
    • “Geneoscopy focused on the opportunity in people aged under 50 years in its statement about the approval. Around 2% of people in that cohort used a stool-based test in 2021, but Evercore ISI and TD Cowen analysts expect Colosense to have a limited impact on Exact.”
  • STAT News points out,
    • “The Apple Watch has secured a new qualification from the Food and Drug Administration that could make the smartwatch an appealing tool for medical device companies hoping to illustrate the benefits of a common heart procedure.
    • “Last week, the Apple Watch’s Atrial Fibrillation History feature became the first digital tool qualified under the Medical Device Development Tools (MDDT) program. Released in 2022, the feature estimates a user’s A-fib burden, or how much time they spend in atrial fibrillation, which is an irregular heart rhythm that can cause shortness of breath and fatigue, and is also linked to an increased risk of stroke.
    • “The qualification means that FDA has determined in advance that sponsors can use the feature as a secondary endpoint in clinical trials without having to do additional work. Specifically, the Apple Watch is qualified for use as a secondary endpoint in clinical trials for cardiac ablation devices, which reduce the electrical signals that cause A-fib by scarring the heart with extreme heat or cold energy. Pulsed field ablation is the latest version of the technology, using a controlled electric field to scar tissue rather than the riskier thermal energy.”
  • Regulatory Focus notes,
    • “The US Food and Drug Administration (FDA) is piloting a program to enhance communication between drugmakers, investigators, and its drug shortage team during inspections to prevent facilities from unnecessarily shutting down and potentially contributing to shortages of essential drugs, said Patrizia Cavazzoni, MD, director of the agency’s Center for Drug Evaluation and Research (CDER).
    • “Cavazzoni made these remarks during a webinar hosted by the Alliance for a Stronger FDA on Monday, during which, she said “we strongly encourage manufacturers not to stop manufacturing as the result of an inspection.” She added that manufacturers sometimes shut down production lines based on what they are hearing during the inspection, which she said could worsen shortages.”

From the public health and medical research front

  •  The Washington Post reports that “Olive oil use [is] associated with lower risk of dying from dementia. An observational study has found that regular olive oil consumption may have cognitive health benefits.”
    • “Vasilis Vasiliou, a professor and the chair of the department of environmental health sciences at Yale School of Public Health, said the Harvard study “has been done very carefully,” and there is a broader effort to try to “find a mechanism” as to why olive oil, or other parts of the plant, could be beneficial to cardiovascular or cognitive health.”Vasilis Vasiliou, a professor and the chair of the department of environmental health sciences at Yale School of Public Health, said the Harvard study “has been done very carefully,” and there is a broader effort to try to “find a mechanism” as to why olive oil, or other parts of the plant, could be beneficial to cardiovascular or cognitive health.
    • “We don’t believe it’s one compound or two. The olive oil has the phenolic antioxidants, which are very important for protecting against oxidative stress,” Vasiliou said. “But there is a lot of other stuff that’s going on there.”
  • Per MedPage Today,
    • “Use of cannabis and nicotine together during pregnancy was associated with higher risks for infant death and maternal and neonatal morbidity compared with no exposure to either substance, with dual-use risk estimates higher than with either substance alone, a retrospective population-based cohort study.
    • “Compared with use of neither substance, the risk of infant death was more than twice as high with combined use in pregnancy after controlling for possible confounders (adjusted risk ratio [aRR] 2.18, 95% CI 1.82-2.62), reported Jamie O. Lo, MD, MCR, of Oregon Health & Science University in Portland, and colleagues.
    • “By comparison, risks were 65% higher with cannabis use only (aRR 1.65, 95% CI 1.41-1.93) and 62% higher with nicotine use only (aRR 1.62, 95% CI 1.45-1.80) versus no exposure, the researchers detailed in JAMA Network Open.
    • “Lo told MedPage Today in an email that she and her colleagues were surprised to see the increased infant death rate in the combined cannabis and nicotine users compared with those using each substance alone.
    • “We also did not expect so many maternal and neonatal/infant outcomes to be worse with combined cannabis/nicotine use,” she added.”
  • The National Cancer Institute posted its periodic cancer information highlights.
  • The National Institutes of Health announced,
    • The National Institutes of Health (NIH) will launch clinical trials to investigate potential treatments for long-term symptoms after COVID-19 infection, including sleep disturbances, exercise intolerance and the worsening of symptoms following physical or mental exertion known as post-exertional malaise (PEM). The mid-stage trials, part of NIH’s Researching COVID to Enhance Recovery (RECOVER) Initiative, will join six other RECOVER studies currently enrolling participants across the United States testing treatments to address viral persistence, neurological symptoms, including cognitive dysfunction (like brain fog) and autonomic nervous system dysfunction. The new trials will enroll approximately 1,660 people across 50 study sites to investigate potential treatments for some of the most frequent and burdensome symptoms reported by people suffering from long COVID.
    • “People 18 years of age and older who are interested in learning more about these trials can visit trials.RECOVERCovid.org(link is external) or ClinicalTrials.gov and search identifiers NCT06404047, NCT06404060, NCT06404073, NCT06404086, NCT06404099, NCT06404112.” 
  • BioPharma Dive reports,
    • “A profoundly deaf baby who received Regeneron’s experimental gene therapy was able to hear normally within six months, the company announced Wednesday.
    • “The data, presented at a medical conference, build on initially promising research released in October. The baby was dosed at 11 months of age, one of the youngest children in the world to receive gene therapy for genetic deafness, Regeneron said. A second patient, treated at age 4, also showed hearing improvements at a six-week assessment, the company said.
    • “Both children suffer from a type of deafness caused by mutations in a gene known as otoferlin. The initial research on Regeneron’s DB-OTO therapy is part of an ongoing Phase 1/2 trial known as CHORD enrolling infants and children in the U.S., U.K. and Spain.

From the U.S. healthcare business front,

  • MedCity News informs us,
    • “About a third of employers are integrating value-based care into their employer-sponsored insurance, according to a new survey. Another third of employers are determining the “best-fit strategies for their organization” when it comes to accountable care.
    • “The report was published Sunday by the Milken Institute with support from Morgan Health, a JPMorgan Chase healthcare unit for employer-sponsored insurance. The Milken Institute is a nonprofit think tank focused on financial, physical, mental and environmental health. The survey received responses from 72 employers of varying sizes and industry types.
    • “The researchers found that when making health benefit decisions, expanding preventive care, improving access to primary care and focusing on whole-person health are the top three tenets of accountable care. The lowest-ranked tenets are reducing health outcome disparities and increasing access to digital care.”
  • Fierce Healthcare adds,
    • “Employers are in a strong position to lead the charge in changing the conversation around obesity care, according to a new report from the Milken Institute.
    • “The group released a how-to guide employers of all sizes can use to push for obesity to be recognized as a chronic condition, driving a more multifaceted model for care and addressing the stigma that exists around weight.
    • “The guidebook notes that obesity and conditions related to it are having a major impact on healthcare costs, accounting for $425.5 billion in costs for the civilian workforce, according to a recent study. This includes higher medical costs for both employers and employees as well as costs related to absenteeism.
    • “Sarah Wells Kocsis, director of the Center for Public Health at the Milken Institute and one of the paper’s authors, told Fierce Healthcare that employers are starting to take notice of this issue and lead a conversation that’s “decades in the making.”
    • “We’re really at an inflection point,” she said. “Our goal here is to put this in writing and explain what a strong case there is to think about obesity as a chronic disease.”
  • HealthDay explains,
    • “Worries over health-related costs are plaguing the minds of older Americans of all backgrounds, a new poll suggests.
    • “Five of the six health-related issues that most people found very concerning had to do with health care costs, according to results from the University of Michigan National Poll on Healthy Aging. 
    • “And the sixth issue – financial scams and fraud – also had to do with money, results show.
    • “In this election year, these findings offer a striking reminder of how much health care costs matter to older adults,” Dr. John Ayanian, director of the University of Michigan Institute for Healthcare Policy and Innovation, where the poll is based, said in a news release. The poll is supported by AARP and Michigan Medicine, U-M’s academic medical center.
    • “Overall, 56% of people over 50 said they’re concerned about the cost of medical care for older adults, poll results show.”
  • Per mHealth Intelligence,
    • New research reveals that a text message and telephone-based virtual care approach can improve rates of screening, identification, and treatment of maternal mental health conditions.
    • Published in Health Affairs, the study assessed an intervention that addresses various barriers to adopting maternal mental health screening and referral to treatment. Medical University of South Carolina researchers noted that perinatal mental health disorders, perinatal substance use disorders (SUDs), and intimate partner violence are common during pregnancy and the postpartum year. According to data from the Mental Health Leadership Alliance, maternal mental health conditions affect 800,000 families each year in the United States.
  • BioPharma Dive offers a helpful database of patent expiration dates for thirty top-selling medicines.