Midweek Update

COVID-19

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.

Friday Factoids

David Ermer–ACA, CDC, COVID-19, COVID-19 vaccine, Generative AI, Medical / Rx research, NIH, Rx coverage, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC,

  • Perhaps the most convoluted provision in the Affordable Care Act is its individual non-discrimimination clause, Section 1557. The Obama Administration issued an implementing rule. The Trump Administration replaced the Obama Administration’s rule, and today the Biden Administration has replaced the Trump Administration rule.
    • Of note, “[f]or the first time, the Department will consider Medicare Part B payments as a form of Federal financial assistance for purposes of triggering civil rights laws enforced by the Department, ensuring that health care providers and suppliers receiving Part B funds are prohibited from discriminating on the basis of race, color, national origin, age, sex and disability.”
    • HHS will refer FEHB and FEDVIP complaints to OPM.
  • The Washington Post reports,
    • “Medtronic said Friday that the U.S. Food and Drug Administration has approved a new spinal-cord implant that relieves chronic pain, a bid to expand into a patient population that relies heavily on medications like opioids.
    • “The new device works by delivering an electrical pulse to the spinal cord, interrupting pain signals before they reach the brain in patients suffering from back, cervical and nerve damage. While earlier versions of the device provided a constant level of stimulation, Medtronic’s new product can read signals from nerve fibers and automatically adjust the intensity — a feature designed to avoid uncomfortable jolts when a patient sneezes, coughs or laughs.
    • “It’s like listening for whispers at a rock concert,” David Carr, a Medtronic vice president, said in an interview. * * *
    • “Medtronic’s Inceptiv contains a lithium battery that can be recharged through the skin, and two leads with electrodes — some to read the signals from nerve fibers, and others to deliver the electrical pulse. The device can adjust the level of stimulation 50 times a second, according to the company.
    • “Inceptiv is “the world’s smallest and thinnest fully implantable” spinal-cord stimulator, Medtronic said.”
  • Per BioPharma Dive,
    • “The Food and Drug Administration on Friday approved a new gene therapy for hemophilia, clearing Pfizer’s Beqvez for certain people with the less common “B” form of the bleeding condition.
    • “Beqvez is for adults with moderate to severe hemophilia B who currently use drugs to prevent bleeds or have repeated, spontaneous bleeding. Eligible individuals also must be tested to determine whether they have antibodies that neutralize Beqvez’s effects.
    • “Pfizer set the treatment’s list price at $3.5 million, a company spokesperson confirmed. That matches the cost of Hemgenix, the other available gene therapy for hemophilia B. Pfizer will offer insurers a warranty providing “financial protections” if Beqvez doesn’t work or its effects don’t last, the spokesperson wrote in an email, without providing details.”

From the public health and medical research front,

  • The Centers for Disease Control lets us know today,
    • “The amount of respiratory illness (fever plus cough or sore throat) causing people to seek healthcare continues to decrease across most areas of the country. This week, 0 jurisdictions experienced high activity compared to 1 jurisdiction experiencing high activity the previous week. No jurisdictions experienced very high activity. 
    • “Nationally, emergency department visits with diagnosed influenza are decreasing. Emergency department visits with COVID-19 and RSV remain stable at low levels.  
    • “Nationally, COVID-19, influenza, and RSV test positivity decreased compared to the previous week. 
    • “Nationally, the COVID-19 wastewater viral activity level, which reflects both symptomatic and asymptomatic infections, remains low.” 
  • American Hospital Association News adds,
    • “Adults age 65 and older are encouraged to receive an updated dosage of the COVID-19 vaccine, the Centers for Disease Control and Prevention announced April 25. The update provides protection against the JN.1 and other circulating variants of the virus, and should be administered at least four months following the previous dosage. The CDC’s Advisory Committee on Immunization Practices recommended the additional dose in February.”
  • On a related note, the CDC reports today
    • H5N1 bird flu is widespread in wild birds worldwide and is causing outbreaks in poultry and U.S. dairy cows with one recent human case in a U.S. dairy worker.
    • While the current public health risk is low, CDC is watching the situation carefully and working with states to monitor people with animal exposures.
    • CDC is using its flu surveillance systems to monitor for H5N1 activity in people.
  • Medscape tells us,
    • “The glucagon-like peptide 1 (GLP-1) receptor agonist semaglutide (Wegovy) not only induced weight loss but also improved knee pain in people with knee osteoarthritis (OA) and obesity, according to results from the STEP 9 study reported at the World Congress on Osteoarthritis (OARSI 2024).
    • “From baseline to week 68, the mean change in knee pain assessed using the Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain score was a reduction of 41.7 points for semaglutide and a decrease of 27.5 points for a matching placebo. The estimated treatment difference of 14.1 points between the groups was statistically significant (P < .001).
    • “As for weight loss, this also fell by a significantly greater amount in the people treated with semaglutide vs those given placebo, with respective reductions of 13.7% and 3.2% from baseline, with an estimated 10.5% greater weight loss with semaglutide.
    • “The interesting thing is whether there’s a specific action of GLP-1 receptor agonists on the joint, not through the weight loss but by itself,” principal study investigator Henning Bliddal, MD, DMSc, told Medscape Medical News ahead of reporting the results at OARSI 2024.”
  • The National Institutes of Health (“NIH”) Director writes in her blog,
    • “In Alzheimer’s disease, a buildup of sticky amyloid proteins in the brain clump together to form plaques, causing damage that gradually leads to worsening dementia symptoms. A promising way to change the course of this disease is with treatments that clear away damaging amyloid plaques or stop them from forming in the first place. In fact, the Food and Drug Administration recently approved the first drug for early Alzheimer’s that moderately slows cognitive decline by reducing amyloid plaques. Still, more progress is needed to combat this devastating disease that as many as 6.7 million Americans were living with in 2023.
    • Recent findings from a study in mice, supported in part by NIH and reported in Science Translational Medicine , offer another potential way to clear amyloid plaques in the brain. The key component of this strategy is using the brain’s built-in cleanup crew for amyloid plaques and other waste products: immune cells known as microglia that naturally help to limit the progression of Alzheimer’s. The findings suggest it may be possible to develop immunotherapies—treatments that use the body’s immune system to fight disease—to activate microglia in the brains of people with Alzheimer’s and clear amyloid plaques more effectively.
    • In their report, the research team—including Marco Colonna , Washington University School of Medicine in St. Louis, and Jinchao Hou, now at Children’s Hospital of Zhejiang University School of Medicine in Zhejiang Province, China—wrote that microglia in the brain surround plaques to create a barrier that controls their spread. Microglia can also destroy amyloid plaques directly. But how microglia work in the brain depends on a fine-tuned balance of signals that activate or inhibit them. In people with Alzheimer’s, microglia don’t do their job well enough.  * * *
    • [O]verall, these findings add to evidence that immunotherapies of this kind could be a promising way to treat Alzheimer’s. This strategy may also have implications for treating other neurodegenerative conditions characterized by toxic debris in the brain, such as Parkinson’s disease, amyotrophic lateral sclerosis (ALS), and Huntington’s disease. The hope is that this kind of research will ultimately lead to more effective treatments for Alzheimer’s and other conditions affecting the brain.
  • NIH announced
    • “One injected dose of an experimental malaria monoclonal antibody was 77% effective against malaria disease in children in Mali during the country’s six-month malaria season, according to the results of a mid-stage clinical trial. The trial assessed an investigational monoclonal antibody developed by scientists at the National Institutes of Health (NIH), and results appear in The New England Journal of Medicine.
    • “A long-acting monoclonal antibody delivered at a single health care visit that rapidly provides high-level protection against malaria in these vulnerable populations would fulfill an unmet public health need,” said Dr. Jeanne Marrazzo, director of the National Institute of Allergy and Infectious Diseases, part of NIH.”
  • and
    • “In a new analysis of genetic susceptibility to kidney cancer, an international team of researchers has identified 50 new areas across the genome(link is external) that are associated with the risk of developing kidney cancer. These insights could one day be used to advance our understanding of the molecular basis of kidney cancer, inform screening efforts for those at highest risk, and identify new drug targets. The study was led by scientists at the National Cancer Institute (NCI), part of the National Institutes of Health (NIH).”

From the U.S. healthcare business front,

  • Berkeley Public Health informs us,
    • “Does paying more to have your outpatient surgery done at a hospital, rather than at a freestanding surgical center, lead to better care? A new study led by James C. Robinson, professor of health economics at UC Berkeley School of Public Health, says no.
    • “In an investigation published in the April issue of The American Journal of Managed Care, Robinson and his team found that the higher prices typically charged by hospitals for four common surgeries were not justified by higher quality, as measured by the rate of post-surgical complications.
    • “The researchers analyzed more than 2 million national Blue Cross Blue Shield insurance claims from 2019-2020 for patients aged 18 to 65 who received a colonoscopy, knee or shoulder arthroscopy, or cataract removal surgery, and calculated the prices and rates of complications for each procedure.
    • “They found large differences in price, but very little difference in the rate of post-surgery complications.”
  • Health IT Analytics tells us about the top twelve ways that artificial intelligence will be used in healthcare.
  • HR Dive offers a tracker of state and local laws requiring employers to disclose pay or pay ranges.
    • “Pay disclosure laws have taken several forms. Some require employers to provide the minimum and maximum pay, or a pay range, for a given job upon the request of an applicant. Others mandate this practice without requiring candidates to ask first. The latest wave of laws now require employers to include this information in all applicable job postings.”
  • Per Biopharma Dive,
    • “U.S. Humira sales fell 40% year over year during the first three months of 2024, to about $1.8 billion, as biosimilar copycats put pressure on AbbVie’s top-selling drug, the company said Friday in its first quarter earnings report.
    • “The declines were “in line” with what the company had anticipated for its inflammatory disease drug, AbbVie commercial chief Jeffrey Stewart said in a call with investors. Humira now faces 10 copycat competitors in the U.S., the first of which launched Jan. 31, 2023.
    • “Stewart said the company also expected a recent decision by CVS Health, whose pharmacy benefit manager is the country’s largest by prescription claims, to remove Humira from its national pharmacy effective April 1. Although that has meant Humira’s market share dropped from 96% to 81% over two weeks, Stewart said some of the shift went to other branded medicines, like AbbVie’s products Skyrizi and Rinvoq.”
  • Beckers Payer Issues points out,
    • Centene reported nearly $1.2 billion in net income in the first quarter and a more than 18% decrease in Medicaid membership year over year, according to its first-quarter earnings posted April 26.
    • Total revenues in the first quarter were $40.4 billion, up 3.9% year over year.
    • Total net earnings in the first quarter were nearly $1.2 billion, up 2.9% since the same period last year.
    • The company raised its year-end adjusted EPS guidance to at least $6.80.
    • The company’s medical loss ratio was 87.1% in the first quarter and 87% during the same period last year.”
  • According to Fierce Healthcare,
    • “The new year is “off to a good start,” for Community Health Systems, which reported a somewhat narrowed $41 million net loss (-$0.32 per diluted share) and a solid uptick in operating revenues for its first quarter.
    • “The 71-hospital for-profit system had logged a $51 million net loss during the same period last year, which, at the time, CHS attributed to a bump in Medicare Advantage patient volume.
    • “After excluding adjustments related to impairment losses and business transformation costs, the company landed at a net loss of $0.14 per share, which was about in line with consensus estimates.
    • “However, CHS shared a rosier picture when it came to operating revenues. Its three-month net of $3.14 billion beat estimates by about $50 million and was a 1% increase over last year.”
  • Healthcare Dive reports,
    • “Universal Health Services delivered first quarter earnings results Wednesday that beat analysts’ estimates on stronger than expected revenue and volume metrics across its behavioral health and acute service lines.”Universal Health Services delivered first quarter earnings results Wednesday that beat analysts’ estimates on stronger than expected revenue and volume metrics across its behavioral health and acute service lines.
    • “UHS increased its same facility net revenues for its acute care and behavioral care service lines by 9.6% and 10.4%, respectively, during the first quarter of 2024 compared to the same period last year.
    • “However, the operator could suffer a “material” financial hit should the operator fail to lower a March $535 million judgment against a subsidiary, UHS disclosed in its earnings report. The for-profit health system is currently appealing the judgment in post-trial motions, said CFO Steve Filton during the earnings call.”

Thursday Miscellany

David Ermer–CDC, COVID-19, Medical / Rx research, Telehealth, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC,

  • The Wall Street Journal reports,
    • “American women are giving birth at record-low rates. 
    • “The total fertility rate fell to 1.62 births per woman in 2023, a 2% decline from a year earlier, federal data released Thursday showed. It is the lowest rate recorded since the government began tracking it in the 1930s. * * *
    • “Total fertility estimates the number of children a woman would give birth to in her lifetime. The estimates don’t account for what women actually decide in later years, said Brady Hamilton, a co-author of the report from the Centers for Disease Control and Prevention’s National Center for Health Statistics.
    • “The number of births last year was the lowest since 1979, according to provisional data. About 3.59 million children were born in the U.S. in 2023, a 2% drop compared with 3.66 million in 2022. 
    • “The figures are provisional and likely to adjust slightly when final data are released later this year.”
  • The Congressional Budget Office shared a new presentation that “provides a brief summary of CBO’s long-term projections of federal health care spending, the distribution of federal subsidies for health care, the drivers of cost growth in health care, and options for reducing federal spending on health care.”
  • The Internal Revenue Service released a fact sheet that “provides answers to frequently asked questions (FAQs) addressing the tax treatment of work-life referral services (sometimes also called caregiver or caretaker navigation services) provided by an employer to an employee. Under certain circumstances, the value of such referral services can be excluded from gross income and employment taxes as a de minimis fringe benefit.”

From the public health and medical research front,

  • The AP reports,
    • “It’s easier than ever for doctors to prescribe a key medicine for opioid addiction since the U.S. government lifted an obstacle last year. But despite the looser restrictions and the ongoing overdose crisis, a new study finds little change in the number of people taking the medication.
    • “Researchers analyzed prescriptions filled by U.S. pharmacies for the treatment drug buprenorphine. The number of prescribers rose last year after doctors no longer needed to get a special waiver to prescribe the drug, while the number of patients filling prescriptions barely budged.
    • “Buprenorphine, which helps with cravings, comes in a pill or film that dissolves under the tongue. It costs about $100 a month. A common version of buprenorphine is Suboxone. Nurse practitioners, physician assistants and doctors can prescribe it.
    • “People think this is a very complicated medicine and that it requires some sort of complex knowledge to use, when that’s just not the case,” said Dr. Ryan Marino of Case Western Reserve University School of Medicine in Cleveland who has treated hundreds of people with buprenorphine. He had no role in the study.”
  • MedPage Today lets us know,
    • “Taste dysfunction was gone 1 year after exposure to COVID-19, but smell loss remained for some people, a national cross-sectional study showed.
    • “Empirically measured taste function didn’t differ between individuals who had acute SARS-CoV-2 infection a year earlier and uninfected people, reported Shima Moein, MD, PhD, of Sensonics International in New Jersey and the University of Pennsylvania in Philadelphia, and co-authors.
    • “However, olfactory dysfunction was present in 30.3% of individuals with prior COVID-19 compared with 21% of those who had no history of COVID infection (OR 1.64, 95% CI 1.18-2.27), Moein and colleagues noted in JAMA Network Open.
    • “Long-term taste loss after COVID may reflect damage to olfactory epithelium, not taste buds, the researchers suggested. Olfactory deficits were greatest for those diagnosed with COVID when the original untyped and Alpha viral variants were prevalent.
    • “Our study sheds light on a critical yet often overlooked aspect of the COVID-19 pandemic: the pervasive impact of smell loss on affected individuals,” Moein told MedPage Today. “Despite its prevalence, smell loss has remained largely neglected by healthcare professionals and policymakers, leading to a lack of awareness and support for affected individuals.”
  • and
    • “A majority of pregnant individuals or those trying to become pregnant were interested in getting a maternal respiratory syncytial virus (RSV) vaccine once it became available, a nationwide survey found.
    • “Of 1,528 respondents, 54% said they were “very likely” to get an RSV vaccine during pregnancy, Jennifer Saper, MD, of the Ann & Robert H. Lurie Children’s Hospital in Chicago, and colleagues reported in Pediatrics.
    • “I am excited by the findings that over half of pregnant, or trying-to-be-pregnant people are interested in the RSV vaccine in pregnancy,” Saper told MedPage Today in an email. “This means to me that there are a lot of opportunities to try to protect infants against RSV.”
  • The Dana Farber Cancer Institute shares five things to know about advances in the treatment of multiple myeloma.

From the U.S. healthcare business front,

  • Per BioPharma Dive,
    • “Bristol Myers Squibb will cut 6% of its workforce in a restructuring meant to save $1.5 billion in costs by the end of next year. 
    • “The layoffs will affect some 2,200 employees, the company said Thursday. It’s also trimming its pipeline of experimental medicines, consolidating its array of offices and laboratories and reducing “third party” spending.
    • “Our focus remains on strengthening the company’s long-term growth profile,” said company CEO Christopher Boerner, in a statement on the restructuring, which was announced alongside earnings for the first quarter.” 
  • and
    • “AstraZeneca’s revenue and profits grew at a rapid clip over the first three months of the year, beating Wall Street expectations as use of the British drugmaker’s flagship cancer drugs widened. 
    • “Total company revenue climbed 17% to $12.7 billion and operating profit jumped 22% to $3.1 billion, compared to the first quarter last year, the company said.
    • “Both the revenue and profit figures surpassed consensus forecasts by 7%, according to a note from Leerink Partners analyst Andrew Berens. The strong earnings were a recovery from the fourth quarter, when lower-than-expected sales and higher costs meant AstraZeneca missed profit estimates.”
  • Per Fierce Healthcare,
    • “Evernorth’s Accredo arm will make a Humira biosimilar available to patients with no out-of-pocket costs, the company announced Thursday.
    • “Accredo is the specialty pharmacy segment within Evernorth Health Services, which also houses Express Scripts, eviCore data analytics and MDLIVE telehealth services. [Cigna owns Evernorth.] Beginning this June, the low- and high-concentration biosimilar will be produced for Evernorth’s private label distributor, Quallent Pharmaceuticals, in partnership with multiple manufacturers. * * *
    • “Most patients will be able to secure the biosimilar products for $0 out-of-pocket through the copay assistance programs offered at Quallent beginning in June, Evernorth said.”
  • and
    • “Walgreens is expanding its specialty pharmacy services to offer gene and cell therapy services, supported by a dedicated 18,000-square-foot center in Pittsburgh, the company announced Thursday.
    • “The service is part of the retail pharmacy company’s newly integrated business unit, Walgreens Specialty Pharmacy, that rolls up all its specialty pharmacy segment assets, including AllianceRx. The new business, formerly called AllianceRx Walgreens Pharmacy, is under the Walgreens U.S. retail pharmacy segment.
    • “Walgreens said its integrated model enables it to work with payers, health plans and pharma with a specialty pharmacy offering independent of pharmacy benefit managers (PBMs).”
  • Beckers Health IT informs us,
    • “UnitedHealth Group’s Optum Virtual Care is shutting down, Endpoints News reported April 24.
    • “News of the closure of the company’s telehealth business came shortly after Optum employees took to social media beginning April 18 regarding a reduction in force they say occurred across the organization.
    • “Virtual care has been and will continue to be a core part of our comprehensive, integrated care delivery model designed to provide care to people where, when and how they prefer,” an Optum spokesperson told Becker’s. “We continually review the capabilities and services we offer to meet the growing and evolving needs of our businesses and the people we serve. As always, we will support affected team members with job placement resources and seek to deploy them where possible to any open roles within the company.”

Friday Factoids

David Ermer–CDC, COVID-19, FDA, Federal employment benefits, Generative AI, Medical / Rx research, Medicare, Mental health care, Obesity, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC,

  • Healthcare Dive informs us,
    • “Providers and drugmakers are once again at odds over the 340B drug discount program: this time, over a rule finalized by the Biden administration on Thursday making changes to its dispute resolution process.
    • “The final rule, which will become effective in mid-June, is meant to make dispute resolution more accessible and efficient, according to the Health Resources and Services Administration, or HRSA, the agency that oversees 340B. Along with lowering barriers to enter the process, the rule requires parties to make a good faith effort to resolve disputes before bringing them to arbiters and creates an appeals process if either party doesn’t like the result.
    • “Provider groups the American Hospital Association and 340B Health said the rule should streamline the arbitration process and preserve the integrity of the controversial program. Meanwhile, pharmaceutical lobby PhRMA said the new process “panders to 340B hospitals” while ignoring drugmakers’ concerns.”
  • KFF lets us know,
    • “Federal data from 2019 shows just 4% of potentially eligible enrollees participated in the program, a figure that appears to have held steady through 2023, according to a Mathematica analysis. About 12,000 physicians billed Medicare under the CCM mantle in 2021, according to the latest Medicare data analyzed by KFF Health News. (The Medicare data includes doctors who have annually billed CCM at least a dozen times.)
    • “By comparison, federal data shows about 1 million providers participate in Medicare.
    • Even as the strategy has largely failed to live up to its potential, thousands of physicians have boosted their annual pay by participating, and auxiliary for-profit businesses have sprung up to help doctors take advantage of the program. The federal data showed about 4,500 physicians received at least $100,000 each in CCM pay in 2021. * * *
    • “This program had potential to have a big impact,” said Kenneth Thorpe, an Emory University health policy expert on chronic diseases. “But I knew it was never going to work from the start because it was put together wrong.”
    • “He said most doctors’ offices are not set up for monitoring patients at home. “This is very time-intensive and not something physicians are used to doing or have time to do,” Thorpe said.”
  • Reg Jones offers “A Refresher Course on FEGLI Life Insurance” in FedWeek.

From the public health and medical research front,

  • The Centers for Disease Control reports today,
    • “The amount of respiratory illness (fever plus cough or sore throat) causing people to seek healthcare continues to decrease across most areas of the country. This week, 2 jurisdictions experienced high activity compared to 1 jurisdiction experiencing high activity the previous week. No jurisdictions experienced very high activity. 
    • “Nationally, emergency department visits with diagnosed influenza are decreasing. Emergency department visits with COVID-19 and RSV remain stable at low levels.  
    • “Nationally, COVID-19, influenza, and RSV test positivity decreased compared to the previous week. 
    • “Nationally, the COVID-19 wastewater viral activity level, which reflects both symptomatic and asymptomatic infections, remains low.” 
  • The National Institutes of Health announced,
    • “Despite Food and Drug Administration (FDA)-approval of seven next-generation antibiotics to fight infections caused by resistant “gram-negative” bacteria, clinicians frequently continue to treat antibiotic-resistant infections with older generic antibiotics considered to be less effective and less safe, according to a study by researchers at the National Institutes of Health’s (NIH) Clinical Center. Researchers examined the factors influencing doctors’ preference for newer antibiotics over traditional generic agents to shed light on the decision-making processes among clinicians when treating patients with challenging bloodstream infections caused by gram-negative bacteria and significant comorbidities.
    • “The study revealed that at a considerable proportion of hospitals, particularly smaller facilities located in rural areas, staff were reluctant to adopt newer antibiotics. Researchers identified a large cost disparity between older and newer classes of antibiotics; the newer drugs can cost approximately six times more than the older medications, which could disincentivize prescribing.
    • “Researchers also highlight that next-gen agents are prescribed more often at hospitals where lab results that show the medications are effective against a patient’s bacterial infection are reported to prescribers. Scientists suggest that earlier and more widespread availability of such lab testing might improve use. Additionally, authors recommend that future public health policies and economic strategies on further development and use of similar antibiotics should be designed to identify and overcome additional barriers.
    • “Gram-negative bacteria are a class of bacteria resistant to multiple drugs and increasingly resistant to most antibiotics. According to the Centers for Disease Control and Prevention, they are able to find new paths of resistant and pass along genetic material that enables other bacteria to become drug resistant.”
  • The American Hospital Association News adds,
    • “In clinical trials involving 220,000 patients at 59 HCA Healthcare hospitals, algorithm-driven computerized alerts helped clinicians better identify the appropriate antibiotic for 28% of patients with pneumonia and 17% of patients with urinary tract infections, according to studies funded by the Centers for Disease Control and Prevention published April 19 in JAMA. To reduce antibiotic resistance, physicians treating patients with a low risk for antibiotic-resistant bacteria were prompted to give standard-spectrum antibiotics.”In clinical trials involving 220,000 patients at 59 HCA Healthcare hospitals, algorithm-driven computerized alerts helped clinicians better identify the appropriate antibiotic for 28% of patients with pneumonia and 17% of patients with urinary tract infections, according to studies funded by the Centers for Disease Control and Prevention published April 19 in JAMA. To reduce antibiotic resistance, physicians treating patients with a low risk for antibiotic-resistant bacteria were prompted to give standard-spectrum antibiotics.
    • “Pneumonia and urinary tract infections are two of the most common infections requiring hospitalization and a major reason for overuse of broad-spectrum antibiotics,” said Sujan Reddy, M.D., medical officer in CDC’s Division of Healthcare Quality Promotion. “The INSPIRE trials have found a highly effective way to help physicians follow treatment recommendations to optimize antibiotic selection for each patient. These trials show the value of harnessing electronic health data to improve best practice.”
  • Health IT Analytics tells us,
    • “Artificial intelligence (AI)-driven tools can improve the skin cancer diagnostic accuracy of clinicians, nurse practitioners and medical students, according to a study published last week in npj Digital Medicine.
    • “The researchers underscored that AI-based skin cancer diagnostic tools are developing rapidly, and these tools are likely to be deployed in clinical settings upon appropriate testing and successful validation.”

From the U.S. healthcare business front,

  • Per BioPharma Dive,
    • “Alvotech and U.S. commercial partner Teva have signed a “long-term agreement” with an unspecified company to boost access to their biosimilar version of AbbVie’s blockbuster drug Humira, Alvotech said Friday. An Alvotech spokesperson declined to provide specifics.
    • “The deal comes seven weeks after the Food and Drug Administration approved Alvotech’s biosimilar, Simlandi, which the agency previously rejected multiple times. For patients to receive treatment, Alvotech and Teva must first cut deals with drug wholesalers, pharmacies and insurers that negotiate prices before agreeing to cover the therapy.
    • “CVS Health, whose pharmacy benefit manager is the country’s largest by prescription claims, removed Humira from its national formularyon April 1. Wall Street analysts have already reported substantial declines in Humira prescriptions over the last few weeks, when compared to the same period in 2023.”
  • According to Beckers Hospital Review,
    • “Change Healthcare has reinstated 80% of the functionality for its claims, payment and pharmacy services following a February ransomware attack, the company said.
    • “Those three areas represent most of Change Healthcare’s customers and continue to be restored, according to an April 16 earnings call from parent company UnitedHealth Group.
    • “Now we’ve still got work to do,” said Roger Connor, CEO of OptumInsight, the UnitedHealth unit that includes Change, during the call. “We’ve got another set of products coming online … in the coming weeks, but pleased with that progress.”
  • The AHA News reports,
    • “Patients went out-of-network 3.5 times more often to see a behavioral health clinician than a medical/surgical clinician in 2021, and up to 20 times more often for certain behavioral health visits, according to a new study by RTI International. For example, patients went out-of-network 8.9 times more often to see a psychiatrist, 10.6 times more often to see a psychologist, 6.2 times more often for acute behavioral inpatient care, and 19.9 times more often for sub-acute behavioral inpatient care.”
  • The Wall Street Journal reports,
    • “Social media is displacing physicians as the trusted authorities on whether patients should take one of the medicines. People are not only deciding to take a weight-loss drug—called GLP-1s— based on posts by friends and influencers but sometimes also skipping their doctor to go with one mentioned online.
    • “The virtual word-of-mouth can come across as authentic and accessible. People say they appreciate the tips and support they get from other online users. But many influencers and friends on social media play up all the pounds a person lost while playing down side effects that can be nasty, such as painful headaches and bouts of vomiting. Some omit the risks altogether.
    • “Unlike company drug advertisements, social-media posts don’t have to describe a drug’s side effects, suggest other resources or tell people to speak with their doctors.”
  • Ruh roh. This is why health plans are offering coaching services to these folks.

OPM Director Resigns

David Ermer–AHRQ, Congress, COVID-19 vaccine, Medical / Rx research, Medicare, Mental health care, OPM, Rx coverage, U.S. Healthcare–
OPM Headquarters a/k/a the Theodore Roosevelt Building

From Washington, DC,

  • Federal News Network reports,
    • Kiran Ahuja, director of the Office of Personnel Management, will be stepping down from her position in early May, OPM announced Tuesday. * * *
    • Ahuja decided to leave the position due to ongoing health concerns and a recent death in the family, an agency spokesperson said. Once Ahuja vacates her position as the top-most OPM official in the coming weeks, OPM Deputy Director Rob Shriver will begin serving as acting director. * * *
    • “Kiran leaves an incredible legacy as a strong and indefatigable champion of the 2.2 million public servants in the federal workforce,” OPM’s Shriver said in a statement. “Under Kiran’s leadership, OPM has bounced back stronger than ever and partnered with agencies across government to better serve the American people. Kiran represents the very best of the Biden-Harris administration, and I am honored to call her a dear colleague and friend.”
  • Here are links to today’s relevant House of Representatives Committee hearings — one “Examining Health Sector Cybersecurity in the Wake of the Change Healthcare Attack” and the other “ERISA’s 50th Anniversary: the Path to Higher Quality, Lower Cost Health Care.”
  • STAT News reports,
    • “President Joe Biden’s administration will help 50 countries identify and respond to infectious diseases, with the goal of preventing pandemics like the Covid-19 outbreak that suddenly halted normal life around the globe in 2020.
    • “U.S. government officials will offer support in the countries, most of them located in Africa and Asia, to develop better testing, surveillance, communication, and preparedness for such outbreaks in those countries.
    • “The strategy will help “prevent, detect and effectively respond to biological threats wherever they emerge,” Biden said in a statement Tuesday.
    • “The Global Health Security Strategy, the president said, aims to protect people worldwide and “will make the United States stronger, safer, and healthier than ever before at this critical moment.”
  • The Congressional Budget Office issued a report about past performance and future directions of Medicare Accountable Care Organizations.
  • One Digital tells us,
    • “The 2023 EEO-1 Component 1 data collection window opens on April 30, 2024 and ends June 4, 2024. Private-sector employers with 100 or more employees or federal contractors with 50 or more employees must submit workforce demographic data. The EEO-1 Component 1 report is a mandatory annual data collection. Covered employers must submit data by job category and sex and race or ethnicity to the Equal Employment Opportunity Commission (EEOC). Updates to the data collection will be posted to the EEOC’s dedicated EEO-1 Component 1 website.
    • “The 2023 EEO-1 Component 1 Instruction Booklet and 2023 EEO-1 Component 1 Data File Upload Specifications are available on the EEOC’s dedicated EEO-1 Component 1 website. Employers must file their information through the EEO-1 Component 1 Online Filing System (OFS) either through manual data entry or data file upload. The EEO-1 Component 1 online Filer Support Message Center (i.e., filer help desk) will also be available on Tuesday, April 30, 2024, to assist filers with any questions they may have regarding the 2023 collection.”

From the public health and medical research front,

  • Value Penguin lets us know,
    • “Some much-needed good news for U.S. citizens: Between the first quarters of 2021 and 2023, the national age-adjusted death rate fell by 17.7%, according to the latest ValuePenguin study.
    • “Our study also looked at death rates by cause and the leading causes by state. Perhaps unsurprisingly given increased vaccination access and herd immunity, COVID-19 deaths fell most precipitously over that time. Deaths from most other causes showed a decline, too.”
  • HHS’s Agency for Healthcare Quality and Research released a Medical Expenditure Panel Survey with the following highlights
    • “In 2021, the top 1 percent of the population ranked by their healthcare expenditures accounted for 24 percent of total healthcare expenditures, while the bottom 50 percent accounted for less than 3 percent.
    • “Persons in the top 1 percent expenditure tier had an average of $166,980 in healthcare expenditures in 2021, nearly $30,000 higher than in 2019 or 2018. In 2020, persons in the top 1 percent expenditure tier had average expenditures that were more than $20,000 higher than in 2019 or 2018.
    • “Persons aged 65 and older and non-Hispanic Whites were disproportionately represented in the top expenditure tiers. 
    • “Inpatient stays accounted for about 26 percent of healthcare expenses for persons in the top 5 percent expenditure tier.
    • “More than three-quarters of aggregate expenses for persons in the top 5 percent expenditure tier were paid for by private insurance or Medicare.
    • “Among adults in the top 5 percent expenditure tier, 78.1 percent had two or more priority conditions.”
  • MedPage Today relates,
    • “Independent reviewers confirmed a causal relationship between the first mRNA COVID-19 vaccines and myocarditis, and also determined that, more broadly, intramuscular shots can cause a series of shoulder injuries.
    • “At the same time, the National Academies of Sciences, Engineering, and Medicine (NASEM) committee rejected a causal relationship between the Pfizer-BioNTech BNT162b2 and Moderna mRNA-1273 (Comirnaty and Spikevax, respectively) mRNA COVID vaccines and female infertility, Guillain-Barré syndrome, Bell’s palsy, thrombosis with thrombocytopenia syndrome (TTS), and myocardial infarction.”
  • According to the University of Minnesota’s CIDRAP,
    • “A study yesterday in JAMA Internal Medicine demonstrates that 22% of hospitalized adults aged 50 years or older with respiratory syncytial virus (RSV) infection experienced an acute cardiac event—most frequently acute heart failure (16%). Moreover, 1 in 12 of infected patients (8.5%) had no documented underlying cardiovascular disease.
    • “RSV is associated with annual totals of up to 160,000 US hospitalizations, 10,000 deaths, and $4 billion in direct healthcare costs among adults age 65 years or older.
    • “Despite evidence of considerable RSV-associated morbidity, mortality, and health care expenditure, the potential severity of RSV infection in adults has historically been underappreciated by public health professionals and clinicians,” the authors write. RSV is rarely tested for in the clinical settings, and symptoms usually mirror other respiratory diseases, they add.” 
  • and
    • “New research conducted at US primary and urgent care sites shows that antibiotics didn’t provide any benefit for patients with a cough caused by an acute lower respiratory tract infection (LRTI).
    • “In fact, the findings, published yesterday in the Journal of General Internal Medicine, show that receipt of an antibiotic was associated with a small but significant increase in the duration of cough overall compared with those who didn’t receive an antibiotic. Even for those patients with a confirmed bacterial infection, the time until illness resolution was the same whether or not the patients received an antibiotic.
    • “Patients who received an antibiotic also had a higher overall disease severity over the entire course of their illness compared with those who didn’t.
    • “The study authors say the results of the Enhancing Antibiotic Stewardship in Primary Care (EAST-PC) study, which is the largest observational study to date on LRTIs in US primary and urgent care settings, are yet another indication that clinicians should be more prudent about using antibiotics for LRTIs.”
  • BioPharma Dive informs us,
    • “An antipsychotic drug from Intra-Cellular Therapies appears to also work as an add-on therapy for depression, according to clinical trial results the New York-based biotechnology company released Tuesday.
    • “The large trial enrolled almost 500 patients with major depression and hit its main goal as well as “key secondary endpoints,” the company said in a statement. It found that, over a six-week period, depressive symptoms significantly declined in study volunteers given Intra-Cellular’s drug plus antidepressants compared to those given a placebo and antidepressants.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “UnitedHealth estimates costs from the Change Healthcare cyberattack could reach $1.6 billion this year, executives said on Tuesday. However, the managed care giant maintained its full-year earnings guidance, suggesting the financial fallout from the attack on the massive claims clearinghouse may be less serious than feared.
    • “The hit comes from direct response efforts like recovering Change’s clearinghouse platform and paying higher medical costs after its insurance arm suspended some utilization management processes, in addition to the loss of Change’s revenue.
    • “In the first quarter alone, the cyberattack cost UnitedHealth $872 million, according to financial results posted Tuesday.”
  • Beckers Payer Issues adds,
    • “Rising medical cost trends aren’t going down, but they are stabilizing, UnitedHealth Group executives say. 
    • “CEO Andrew Witty told investors April 16 that pent-up demand and increased health system capacity following the COVID-19 pandemic drove rising costs through 2023, but the trend was a “one-off.” 
    • “We don’t see anything like that. We see much more stabilization. We haven’t seen a step-down from that trend, but we certainly see that kind of sustained activity without aggressive acceleration,” Mr. Witty said. 
    • “Every major insurer reported rising costs in the Medicare Advantage population in the last months of 2023. While a few insurers, including Humana and CVS Health, cut their 2024 earnings guidance based on the trend, UnitedHealth Group maintained it can weather the storm. 
    • “The company reported its first-quarter earnings April 16. UnitedHealthcare’s medical loss ratio was 84.3% in the first quarter, compared to 82.2% the year prior and down from 85% in the fourth quarter of 2023.”
  • and
    • “UnitedHealth Group plans to bring Change Healthcare back stronger than it was before it suffered the largest cyberattack in the history of the U.S. healthcare system. 
    • “On an April 16 call with investors, UnitedHealth Group CEO Andrew Witty said it is “important for the country” that UnitedHealth Group owns Change. 
    • “Without UnitedHealth Group owning Change Healthcare, this attack likely would still have happened. It would have left Change Healthcare, I think, extremely challenged to come back,” Mr. Witty said. “Because it is a part of UnitedHealth Group, we’ve been able to bring it back. We’re going to bring it back much stronger than it was before.” 
  • Medscape offers a slideshow on 2023 physician compensation.
  • Beckers Payer Issues notes,
    • “Elevance Health will enter a partnership with private equity firm Clayton, Dubilier & Rice to develop advanced primary care models. 
    • “The joint effort will operate across multiple states and commercial, individual, Medicare and Medicaid markets, according to an April 15 news release. The payer-agnostic platform will serve more than 1 million members, the companies said. 
    • “The deal is financed primarily “through a combination of cash and our equity interest in certain care delivery and enablement assets of Carelon Health,” according to the news release. The two companies did not disclose the financial terms of the deal, and it is not expected to have a material impact on Elevance’s 2024 earnings. 
    • “The partnership will bring together two CD&R assets, digital platform Apree Health and Florida-based provider group Millennium Physician Group, and Carelon Health. Several Carelon Health clinics, part of Elevance Health, will provide care to members with chronic and complex conditions.” 
  • Beckers Hospital Review lets us know,
    • “About nine months after the FDA fully approved an Alzheimer’s drug for the first time, the medicine is trudging through insurance barriers and hesitations from potential patients, the Chicago Tribune reported April 12. * * *
    • “One of its manufacturers, Eisai, predicted 10,000 patients would begin treatment by the end of March. Eisai executives have since backed away from that forecast, but they say sales are increasing, according to the Tribune. 
    • “CMS covers Leqembi, and so do about 75% of commercial plans in the U.S., a spokesperson for the drugmaker said. But, for the upwards of 6 million Americans who are diagnosed with Alzheimer’s disease, the medication has not made a splash as patients worry about side effects and contraindications.”
  • and
    • “Multiple April bankruptcy court filings revealed that Camp Hill, Pa.-based Rite Aid has plans to shutter 53 additional locations across nine states after it filed for Chapter 11 bankruptcy and shared it will close 154 locations last October. 
    • “The “notice of additional closing stores” filings, obtained by Becker’s, revealed the stores are located in Pennsylvania, New Jersey, New York, Ohio, California, Massachusetts, Michigan, Virginia and Maryland.” 

Monday Roundup

David Ermer–Congress, COVID-19 vaccine, FDA, Medical / Rx research, Mental health care, NIH, OPM, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC,

  • Federal News Network tells us,
    • “The Biden administration has now ended many of the policies that previously dictated agencies’ health and safety responses to the COVID-19 pandemic. But for federal employees, the administration is still offering some on-the-job flexibility for the foreseeable future.
    • “One of the few remaining policies from a series of 2021 executive orders lets federal employees still take up to four hours of paid administrative leave to get COVID-19 vaccine booster shots, the Office of Personnel Management said in an April 12 memo.
    • “The administration strongly encourages federal employees to get recommended doses of updated COVID-19 vaccines even when receiving those vaccines is not a job requirement,” OPM Director Kiran Ahuja said in the memo addressed to agency heads. “Vaccines remain the best tool we have in our toolbox to combat COVID-19. They are safe, effective and free.”
    • “For federal employees, the offered administrative leave will cover the time it takes to get the COVID-19 booster shot, as well as feds’ travel time to and from the vaccination site. As is standard, employees should get approval from their supervisors before taking leave for this purpose, OPM said. Four hours is the maximum OPM is allotting, but federal employees should only take off as much time as they actually need to get the shot.”
  • OPM should take the same approach with cancer screening services, such as colonoscopies and mammographies.
  • The American Hospital Association News reports,
    • “The Change Healthcare cyberattack was a significant event that caught many off guard, said the Centers for Medicare & Medicaid Services Administrator Chiquita Brooks-LaSure, reiterating the agency’s commitment to supporting impacted hospitals. Brooks-LaSure stated the Administration is listening to stakeholders and when possible, facilitating solutions, noting the importance of meeting the needs of providers.
    • “In addition, Brooks-LaSure celebrated important improvements CMS made to promote greater transparency for prior authorization criteria. CMS took steps earlier this year finalizing new regulations to streamline and reduce burden associated with the prior authorization process in Medicare Advantage and fee-for-service and managed care programs for Medicaid and the Children’s Health Insurance Program.  
    • “CMS continues to hear from patients and providers over some commercial insurer prior authorization denials and delays, Brooks-LaSure said, noting that the volume of frustration has “just exploded.” The private sector, she said, has an opportunity to step up with solutions of their own to address concerns.
    • “I’ve told the health plans this: it doesn’t have to all be regulated [by the federal government], there may be things that they can do,” Brooks-LaSure said.”
  • Beckers Payer Issues adds,
    • “AHIP’s chief executive criticized the hospital lobby’s response to the Change Healthcare cyberattack as “opportunistic” and “maintaining the status quo.”
    • “AHIP President and CEO Mike Tuffin pointed to comments that hospital lobbyists made to the media about the hack being “another talking point” to prevent health systems from implementing site-neutral payments, as well as an industry association’s opposition to cybersecurity mandates.
    • “Insisting on maintaining the status quo simply makes the healthcare system a more inviting target for the ever-more sophisticated hacking operations targeting the sector,” Mr. Tuffin wrote in the April 12 article. “Instead of taking a constructive leadership role in what can be done to protect consumers and the system moving forward, the hospital lobby chooses to use the moment to point fingers and shirk responsibility.”
    • “Rather than “playing politics,” all industry stakeholders should be focusing on preventing and preparing for future healthcare cyberattacks, he said.”
  • HR Dive reports,
    • “The U.S. Equal Employment Opportunity Commission announced on Monday its final rule implementing the Pregnant Workers Fairness Act, clarifying that abortion is included under “pregnancy, childbirth or related medical conditions” that are protected under the PWFA.
    • “EEOC said this interpretation of the law’s text is “consistent with the Commission’s and courts’ longstanding interpretation of the same phrase in Title VII.” It also noted that employees are entitled to the law’s provisions even if they have not worked for an employer for a specific length of time.
    • “EEOC had originally slated the rule for publication at the end of 2023, but the commission’s deadline passed without a rule in place. The rule is scheduled to be published in the Federal Register Friday, and will take effect 60 days after publication, approximately mid-June.”
  • The Government Accountability Office released a report on selected States regulation of pharmacy benefit managers.

From the public health and medical research front,

  • The Washington Post considers why
    • “Rural Americans ages 25 to 54 — considered the prime working-age population — are dying of natural causes such as chronic diseases and cancer at wildly higher rates than their age-group peers in urban areas, according to the report. * * *
    • “The USDA researchers analyzed mortality data from the Centers for Disease Control and Prevention from two three-year periods — 1999 through 2001, and 2017 through 2019. In 1999, the natural-cause mortality rate for rural working-age adults was only 6 percent higher than that of their city-dwelling peers. By 2019, the gap had widened to 43 percent.” * * *
    • “The USDA’s findings were shocking but not surprising, said Alan Morgan, CEO of the National Rural Health Association. He and other health experts have maintained for years that rural America needs more attention and investment in its health care systems by national leaders and lawmakers.”
  • “MedPage Today editor-in-chief Jeremy Faust, MD, talks with Monica Bertagnolli, MD, the 17th director of the National Institutes of Health (NIH), about the day-to-day work at the NIH on pandemic preparedness, the importance of looking for new approaches to testing, and the status of long COVID research.”
  • Healio points out,
    • “Physical activity patterns that included vigorous exercise, housework or walking were associated with lower stroke risk.
    • “Watching TV and commuting were linked to higher risk for stroke.”
  • Per Medscape,
    • “Low- to moderate-intensity physical exercise in patients with severe mental illness is linked to improved medication adherence, regardless of medication type or duration of illness, new research shows.
    • “The positive association between adherence and moderate physical activity emphasizes that physical activity improves overall health and functional status. Promoting physical activity can be a valuable and integrated strategy that can be easily implemented into our routine clinical practice,” said study investigator Rebecca Silvestro, MD, Department of Psychiatry, Università degli studi della Campania Luigi Vanvitelli in Naples, Italy.
    • “The findings were presented at the European Psychiatric Association 2024 Congress.” 

From the U.S. healthcare business front,

  • STAT News reports,
    • “The number of new prescriptions written for biosimilar versions of the Humira rheumatoid arthritis treatment, one of the best-selling medicines in the U.S., surged to 36% from just 5% during the first week of April, thanks to the expanding reach that CVS Health has over the prescription drug market.
    • “The big jump was attributed to one particular biosimilar called Hyrimoz, which is manufactured by Sandoz, a former unit of Novartis that is a leading supplier of generic and biosimilar medicines. However, Hyrimoz is jointly marketed with Cordavis, a new subsidiary that CVS created last August specifically to sell any number of biosimilar medicines in the U.S.
    • “This connection is crucial to the sudden jump in Hyrimoz prescriptions. How so? On April 1, CVS Caremark, which is one of the largest pharmacy benefit managers in the U.S., removed Humira from its major national formularies for health plans that cover about 30 million lives. Formularies are the lists of medicines that are covered by health insurance.
    • “The move quickly shifted market share to Hyrimoz. During the week ending March 29, the number of new prescriptions written for the biosimilar was about 640, but rose to nearly 8,300 in the week ending April 5, according to a report to investors by Evercore ISI analyst Elizabeth Anderson. That pushed the share for all Humira biosimilars to 36%, with Hyrimoz contributing 93% of the growth.”
  • Health Leaders Media discusses three ways that independent physician practices can maintain their independence.
  • According to BioPharma Dive,
    • “Roche’s new dual-acting blood cancer drug Columvi combined with chemotherapy helped people with a type of lymphoma live longer than people given Rituxan and chemo, the company said Monday. The data could help Roche persuade the Food and Drug Administration to convert Columvi’s conditional OK into a full approval.
    • “Roche didn’t disclose full data from the Phase 3 “Starglo” trial in people with diffuse large B-cell lymphoma whose disease advanced after initial treatment and who weren’t eligible for stem cell transplants. The results will be presented at an upcoming medical meeting, the company said.
    • “Columvi is a new type of drug called a “bispecific” antibody that triggers an immune response to cancer cells. A competitor developed by Genmab and AbbVie has also gained accelerated approval and could have confirmatory data later this year, while the FDA rejected a bispecific from Regeneron because its confirmatory trial isn’t far enough advanced.”
  • MedTech Dive reports,
    • “Abbott is recalling thousands of Heartmate II and Heartmate 3 left ventricular assist systems because biological material can build up and obstruct the devices, making them less effective at pumping blood, the Food and Drug Administration said Monday.
    • “Reports of 273 injuries and 14 deaths have been linked to the problem, with the material typically taking two or more years to accumulate, according to the recall notice. The FDA identified the action as a Class I recall, the most serious type.
    • “Heartmate devices are used to support patients with severe left ventricular heart failure who are awaiting a heart transplant, or the device can be permanently implanted when a transplant isn’t an option. In February, Abbott told customers in an urgent correction letter there is no need to return any products to the company.”

Friday Factoids

David Ermer–CDC, COVID-19, FDA, Generative AI, HSA, Medical / Rx research, Obesity, OPM, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC

  • The Washington Post reports,
    • On Thursday, FDA Commissioner Robert Califf appeared before the panel for the first time this Congress, facing a roughly four-hour grilling on a wide range of issues, from the infant formula crisis to tobacco regulation to an abortion pill. 
    • * * * Of note,
      • “The composition of a highly pathogenic strain of bird flu doesn’t appear to be resistant to current treatments already on the market for the flu, Califf said. This comes after a dairy worker in Texas was recently treated for bird flu, which has been identified in dairy cattle for the first time. 
      • “It’s always the case that when you have an actual illness you have to empirically prove that it works,” Califf said. “Fortunately right now, there’s really only one infected human that we know of, so it’s not something that we can test. But it looks good at this point.”
  • House Budget Committee Health Care Task Force (HCTF) Chair Rep. Michael C. Burgess, M.D. (R-TX) wrote an op-ed in the Hill about how to pay for 21st Century medicine.
    • “Medical advances have opened a new world of hope for patients suffering from serious and life-threatening diseases. We need to match our 21st century science with 21st century payment models and offer patients hope without breaking the budget.
    • “My legislation, the Preventive Health Savings Act, offers another new tool to help Congress identify the long-term savings generated by some of these novel therapies and assist in implementing new payment pathways.
    • “We can keep marching forward and saving lives, or we can turn the clock back. Congress needs to address these challenges by anticipating the future instead of wallowing in the past.”
  • Fierce Healthcare adds,
    • Instead of enacting public option plans, states should target reinsurance programs, a new report from the Partnership for America’s Health Care Future argues.
    • The group includes a collection of health plans, hospital groups and pharma companies brought together largely to oppose Medicare for All. This study was authored by three policy experts with the Hoover Institution at Stanford University.
  • OPM could encourage Congress to create a reinsurance pool for gene therapy treatments within FEHBP and PSHBP using the unused portion of the 1% surcharge on FEHB premiums intended to fund OPM’s FEHB / PSHB administrative costs.
  • Assistant Secretary of Labor for Employee Benefit Security Lisa Gomez wrote in her blog about how to unlock the power of prevention in the fight against cancer.
  • The Washington Post points out,
    • “Covid forced the public health field and health-care sector to work toward a shared goal of keeping people from becoming so ill that they overwhelm hospitals. Now, a group of health-care leaders — the Common Health Coalition, which represents physicians, hospitals and insurers — is trying to build upon these collaborations to better prepare localities for future health threats.”
  • Govexec.com informs us,
    • “The Office of Personnel Management issued a final rule Friday that would cull Social Security numbers from any mailed document in an effort to prevent fraud. 
    • “The rule, which was published in the Federal Register, is part of the implementation of the 2017 Social Security Number Fraud Prevention Act and is designed to help protect the identifiers, which can be used in various forms of identity theft. 
    • “The theft and fraudulent use of SSNs can result in significant repercussions for the SSN holder, as well as the entities from which SSNs were stolen,” OPM officials said in the Federal Register notice. “This direct final rule formalizes in regulation OPM’s current practice of safeguarding SSNs in mailed documents and will support efforts to protect individual privacy.”

From the public health and medical research front,

  • The Centers for Disease Control let us know earlier today,
    • “The amount of respiratory illness (fever plus cough or sore throat) causing people to seek healthcare continues to decrease across most areas of the country. This week, 1 jurisdiction experienced high activity compared to 6 jurisdictions experiencing high activity the previous week. [The outlier jurisdiction is North Dakota.]  No jurisdictions experienced very high activity. 
    • “Nationally, emergency department visits with diagnosed influenza are decreasing.  Emergency department visits with COVID-19 and RSV remain stable at low levels.  
    • “Nationally, COVID-19, influenza, and RSV test positivity decreased compared to the previous week. 
    • Nationally, the COVID-19 wastewater viral activity level, which reflects both symptomatic and asymptomatic infections, remains low.”
  • The Washington Post offers detailed background on prostate cancer following former NIH Director Francis Collins announced that he has the disease.
  • The Wall Street Journal reports,
    • “The European Union’s drug regulator found no link between the class of medicines behind 
    • “Novo Nordisk’s blockbuster Ozempic and Wegovy treatments and reports of suicidal thoughts in patients.
    • “A study by a European Medicines Agency committee had been looking at potential links between the popular weight-loss and diabetes drugs and reports of suicidal and self-harming thoughts from people using them, but it said Friday that the evidence doesn’t support a causal association.
    • “The U.S. Food and Drug Administration came to the same conclusion in January while British health authorities are carrying out their own review.”
  • Today, the FEHBlog heard an OptumRx speaker at a local conference describe the following demographic characteristics of members of employer sponsored plans who use GLP-1 weight loss drugs.
    • 4 out of 5 are women
    • Average age range is 35-54 with a concentration in the 45 to 54 age range.
    • Average BMI is 35. According to the Cleveland Clinic, “Class III obesity, formerly known as morbid obesity, is a complex chronic disease in which a person has a body mass index (BMI) of 40 or higher or a BMI of 35 or higher and is experiencing obesity-related health conditions.”
  • Bear in mind that most employer sponsored plans do not cover retirees while the FEHBP does. The FEHBlog expects that the speaker provided a useful perspective on GLP-1 use among active employees participating the FEHP. KFF remind us the there are plenty of Medicare beneficiaries using GLP-1 drugs for diabetes.
    • In 2022, Medicare gross total spending reached $5.7 billion on Ozempic (semaglutide), Rybelsus (semaglutide), and Mounjaro (tirzepatide), all of which it covered for diabetes that year, according to just-released Medicare drug spending data [before manufacturer rebates]. That was up from $57 million in 2018. 
  • The Optum speaker also remarked that biosimilar competition caused Abbvie to lower the price of its blockbuster Humira drug by 30% in 2023. He explained that it takes time for biosimilars to gain market share when the brand drug drops its price substantially.
  • Per Fierce Healthcare,
    • “Approximately 40,000 women die of breast cancer in the U.S. each year.
    • “One way of reducing that number is ensuring access to preventive screenings such as mammograms. But health-related social needs can have an impact on a woman’s chance of being up to date with her mammogram. For example, women are less likely to get a mammogram if they feel socially isolated, have lost a job or don’t have reliable transportation, according to a recent Centers for Disease Control and Prevention (CDC) Vital Signs report.”
  • The New York Times provides expert opinions on whether artificial intelligence mammograms are worth the cost.
    • “The Food and Drug Administration has authorized roughly two dozen mammography A.I. products. Some of these are being rolled out to patients in a small number of clinics and tested by other hospitals that want to be certain of the value these tools provide before offering them to patients. 
    • “There is currently no billing code that radiologists can use to charge insurance providers for the technology. That means some centers may punt the cost to patients, charging between $40 to $100 out of pocket for an A.I. analysis. Other hospitals may absorb the cost and offer the additional analysis for free. Still others may keep the technology for research until they are more certain of the value it can provide to patients.
    • “It will take some time for A.I. to become part of routine care, which would lead insurance companies to consider reimbursing their cost. Until then, most patients don’t need A.I. for their mammograms, said Dr. Katerina Dodelzon, a radiologist who specializes in breast imaging at NewYork-Presbyterian/Weill Cornell Medical Center, though it might provide some extra reassurance for those who are particularly anxious about their results.”
  • Medscape tells us,
    • “Early data suggested that several new multicancer early detection (MCED) tests in development show promise for identifying cancers that lack routine screening options.
    • “Analyses presented during a session at the American Association for Cancer Research annual meeting, revealed that three new MCED tests — CanScan, MERCURY, and OncoSeek — could detect a range of cancers and recognize the tissue of origin with high accuracy. One — OncoSeek — could also provide an affordable cancer screening option for individuals living in lower income countries.
    • “The need for these noninvasive liquid biopsy tests that can accurately identify multiple cancer types with a single blood draw, especially cancers without routine screening strategies, is pressing. 
    • “We know that the current cancer standard of care screening will identify less than 50% of all cancers, while more than 50% of all cancer deaths occur in types of cancer with no recommended screening,” said co-moderator Marie E. Wood, MD, of the University of Colorado Anschutz Medical Campus, in Aurora, Colorado.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “More than three-fourths of all U.S. doctors are now employed by hospitals, health insurers, private equity or other corporate entities, as rampant consolidation continues to shrink the number of independent physicians, according to new data.
    • “Between 2019 and 2024, more than 44,000 medical practices were acquired, according to the report published Thursday by Avalere Health, commissioned by the Physicians Advocacy Institute. As a result, nearly 60% of medical practices are now owned by corporations.
    • “As of January 2024, physician practice ownership by corporations — including health insurers, pharmacy chains and PE firms — exceeded ownership by hospitals and health systems for the first time, 30.1% to 28.4%. However, hospitals employ more than half of all U.S. physicians, while other corporations employ a little over one-fifth.”
  • MedTech Dive informs us,
    • “Roche has received the Food and Drug Administration’s breakthrough device designation for a blood test to support earlier diagnosis of Alzheimer’s disease, the Swiss drug and diagnostics company said Thursday.
    • “The test, once approved, could help healthcare providers identify whether amyloid pathology, a marker for Alzheimer’s disease, is present or absent in patients.
    • “The Elecsys pTau217 plasma biomarker test is being developed as part of an ongoing partnership between Roche and Eli Lilly. * * *
    • “New and emerging Alzheimer’s therapies aimed at slowing cognitive decline in the earlier stages of the disease call for confirmation of amyloid pathology, yet the only methods currently cleared for that task are cerebrospinal fluid (CSF) tests and amyloid positron emission tomography, or PET, scan imaging, according to Roche.”
  • Per BioPharma Dive, while “new postpartum depression drugs are here, diagnosis, treatment hurdles still stand in the way. Two Sage Therapeutics medicines are approved for the condition. But uptake of the first has been minimal, while the launch of the second [which is a pill] is still getting off the ground.”
  • The Employee Benefit Research Institute made available a new paper on high deductible health plans with health savings accounts.
    • “The purpose of this paper is to examine the impact of plan type on use of health care services and spending. The analysis focuses on enrollees in HSA plans and PPO enrollees who are in health plans with deductibles large enough to be HSA eligible as a way of isolating the impact of the HSA on use of health care services.”

Thursday Miscellany

David Ermer–CDC, CMS, Congress, COVID-19 vaccine, Medical / Rx research, Medicare, NIH, OPM, Patient safety, Telehealth, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC

  • This morning, the Senate Finance Committee held a hearing to “discuss how to update and strengthen Medicare’s guarantee of high-quality health benefits for the next generation of America’s seniors.”
  • Healthcare Dive informs us,
    • “Lawmakers lauded the benefits of telehealth during a hearing Wednesday, but House members also raised questions about cost, quality and access that still need to be answered as a year-end deadline looms.
    • “As a December deadline draws closer, legislators are working to hash out details about extending or making pandemic-era telehealth flexibilities in Medicare permanent. 
    • “During an hours-long House Energy and Commerce subcommittee hearing, lawmakers considered 15 different legislative proposals surrounding telehelath access, noting changes in Medicare will impact decisions of private insurers.
    • “There’s an urgent need to extend these flexibilities because it’s going to run out,” said Rep. Anna Eshoo, D-Calif. “We need to take action on this.” 
  • STAT News adds,
    • “More than a quarter of outpatient antibiotics are inappropriately prescribed, and telehealth could exacerbate the problem: Studies have suggested that virtual visits, on average, result in more antibiotic prescribing than in-person visits. But not all telehealth is created equal — and research is beginning to untangle which approaches are more likely to result in unnecessary antibiotics. In turn, national telehealth guidelines and standards are fighting back by prioritizing safe and effective virtual prescribing practices.
    • “It’s hard to draw conclusions about antibiotic prescribing via telehealth because it comes in so many flavors, said Guillermo Sanchez, a physician assistant and epidemiologist with the office of antibiotic stewardship at the Centers for Disease Control and Prevention. Telemedicine can be provided by direct-to-consumer companies in one-off visits or by large, integrated health systems; via message, phone, or video.
    • “In a recent literature review, Sanchez and his colleagues found studies showing antibiotics were prescribed similarly in virtual and in-person appointments, as well as research that showed higher prescribing in virtual visits — especially for upper respiratory infections that rarely need antibiotics.
    • “But one thing is clear: There’s plenty of room for improvement.”
  • American Hospital Association News tells us,
    • “The Centers for Disease Control and Prevention April 11 updated its strategy to improve data exchange with health care organizations and other public health authorities to better detect and monitor public health threats. Among other priorities for 2024-2025, the strategy calls for using the Office of the National Coordinator for Health Information Technology’s Trusted Exchange Framework and Common Agreement to enable faster sharing of data between health care and public health; expanding core data sources to detect and monitor threats, including wastewater, hospitalization and hospital bed capacity; and prioritizing data to address health disparities and promote health equity.”
  • STAT News reports,
    • “Medicare for the first time has estimated that a new Alzheimer’s treatment could cost the program billions of dollars by next year — well beyond what Wall Street or even the drug’s manufacturer has projected — according to a document obtained by STAT.
    • “Medicare’s actuaries expect the drug Leqembi, made by the Japanese drugmaker Eisai and sold in partnership with Biogen, to cost the traditional Medicare program around $550 million in 2024, and the entire Medicare program $3.5 billion in 2025, a spokesperson for the Centers for Medicare and Medicaid Services confirmed to STAT. That projection forecasts a large increase in uptake over the next year and a half.
    • “The estimate was buried in a new CMS document that addressed questions about next year’s payments for Medicare Advantage plans, which cover more than 33 million people and serve as the alternative to the traditional Medicare program.
    • “I think CMS’ estimates demonstrate an incredible demand for Alzheimer’s treatments and possibly suggest broader use than I think was originally conceived,” said Ameet Sarpatwari, an assistant professor of medicine at Harvard Medical School who studies pharmaceutical costs and outcomes. “That raises the question: What are we, as taxpayers, willing to spend on this drug with limited resources?”
  • The U.S. Office of Personnel Management announced,
    • “The U.S. Office of Personnel Management (OPM) issued a final rule today on the Pathways Programs designed to significantly expand opportunities for early career talent in the federal government. The final rule is one of the most significant actions the federal government has taken since the program’s inception 14 years ago. Updates include expanding skills-based hiring through qualifying career programs, raising the ceiling for starting salaries for recent graduates, and easing the path for interns to be converted into permanent positions, including lowering the number of hours required to convert and expanding the time given to agencies to complete such a conversion.  
    • “In addition, OPM will soon release new web-based guidance, an updated Pathways Program Handbook, an updated Pathways Toolkit for federal managers and supervisors, and will host a series of webinars and office hours targeted at HR professionals, hiring managers, educational institutions, and other key stakeholders.”  

From the public health and medical research front,

  • MedPage Today tells us,
    • “The hunt for a signal of excess sudden cardiac deaths among young people after COVID-19 vaccination left Oregon health officials empty-handed, they reported.
    • “Investigators searched death certificates for Oregon residents 16-30 years old who died from cardiac or undetermined causes of death from June 2021 to December 2022 and tried to match these deaths with mandatory statewide records of mRNA COVID vaccination, according to Juventila Liko, MD, and Paul Cieslak, MD, both of the Oregon Health Authority’s Public Health Division in Portland, in the CDC’s Morbidity and Mortality Weekly Report.”
  • The NIH Director in her blog lets us know,
    • “Colorectal cancer is a leading cause of death from cancer in the United States. We know that risk of colorectal cancer goes up with age, certain coexisting health conditions, family history, smoking, alcohol use, and other factors. Researchers are also trying to learn more about what leads colorectal cancer to grow and spread. Now, findings from a new study supported in part by NIH add to evidence that colorectal tumor growth may be driven by a surprising bad actor: a microbe that’s normally found in the mouth.
    • :The findings, reported in Nature, suggest that a subtype of the bacterium Fusobacterium nucleatum has distinct genetic properties that may allow it to withstand acidic conditions in the stomach, infect colorectal tumors, and potentially drive their growth, which may lead to poorer patient outcomes. The discoveries suggest that the microbe could eventually be used as a target for detecting and treating colorectal cancer.”
  • Beckers Hospital Review points out,
    • “The number of ongoing drug shortages in the U.S. is at its highest since 2001 — when the American Society of Health-System Pharmacists began tracking data. There are now 323 medications in low supply. 
    • “The reasons for 3 in 5 shortages are unknown, the ASHP said in a report released April 11. Supply and demand are cited for 14% of shortages, manufacturing problems for 12%, business decisions for 12% and raw material issues for 2%. 
    • “Basic and life-saving products are in short supply, including oxytocin, Rho(D) immune globulin, standard of care chemotherapy, pain and sedation medications and ADHD [attention-deficit/hyperactivity disorder] medications,” the ASHP said. 
    • “The top five drug classes in shortages are central nervous system agents, antimicrobials, hormone agents, chemotherapies, and fluid and electrolyte therapies.” 
  • Mercer Consulting alerts us,
    • “Are you ready for the 75-year plus workforce? That’s the question Dr. Charlotte Yeh from AARP Services Inc. asked our webcast participants when she sat down with Mercer’s Kate Brown to discuss how longevity is changing workforce demographics.
    • “In the last 100 years, the 65+ age group has grown five times faster than the rest of the population. What’s even more surprising are projections that people aged 75+ will constitute the fastest-growing age band in the civilian workforce between now and 2030! As an employer, are you prepared for these changing demographics?
    • “In this conversation, Dr. Yeh debunks common myths about older workers – including their inability to use technology to perform essential job functions. In fact, studies show that age-diverse workforces contribute to increased revenue and profit margins – perhaps not surprising given that people 50 and older, contribute $8.3 trillion dollars to the economy. At the same time, working later in life can provide seniors with purpose and social connections, both essential to health and happiness.”

From the U.S. healthcare business front,

  • Per Fierce Healthcare,
    • “Hospitals and health systems have kicked off the calendar year with a flurry of merger and acquisition deals reflecting several different strategic trends driving providers in 2024.
    • “Twenty transactions were unveiled in the first quarter, marking the highest volume of dealmaking Kaufman Hall’s seen within the sector since 2020, according to a report from the healthcare consulting firm released Thursday.
    • “The deals involved organizations of varying sizes and types, the firm wrote, and appeared motivated by a combination of new and old health system trends — for instance, smaller community systems flocking to larger organizations with stable finances, or portfolio realignments among for-profit and non-profit systems alike.”
  • According to Beckers Hospital Review,
    • “Less than 20% of the nation’s hospitals were recognized for excellent patient safety ratings and the highest level of adherence to federal price transparency rules. 
    • “On April 9, the Health Transformation Alliance, The Leapfrog Group and Turquoise Health honored 472 hospitals across 42 states. Each of the organizations received a Leapfrog “A” safety rating and the highest price transparency score from Turquoise Health. 
    • “We encourage all hospitals to look to these industry leaders in both patient safety and price transparency as a model for how to provide patient-centered, high-quality care,” Robert Andrews, CEO of Health Transformation Alliance, said in a news release. “In following their example and commitment to safety and price transparency, we believe the healthcare industry can collectively strive towards better health outcomes for all.”

From the legal news front,

  • Biopharma Dive reports,
    • “The U.S. Department of Justice on Wednesday accused Regeneron of defrauding Medicare by knowingly inflating the average sales price for its top-selling eye drug Eylea.
    • “In a lawsuit filed in U.S. District Court in Massachusetts, prosecutors alleged Regeneron failed to disclose hundreds of millions of dollars in price concessions given to drug distributors in the form of credit card fee reimbursements. As a result, they said, the average sales price for Eylea, which Medicare uses to set payment to doctors, was higher than it should have been.
    • “Regeneron’s tactics also gave it an unfair competitive advantage over rivals, the Justice Department said. Eye clinics were able to get Regeneron’s drug for the discounted cash price while at the same time reaping the benefits of credit card rewards such as “cash back.” At some practices, doctors took turns using their personal credit cards to buy the drug, the lawsuit said. * * *
    • “In a statement to BioPharma Dive, Regeneron said it believes the allegations are “without merit” and show a “fundamental misunderstanding of drug price reporting standards.” The company added that it will defend itself in court.” 
  • The U.S. Attorney for the Southern District of Florida announced,
    • “On April 10, a substance abuse facility owner was sentenced to four years in federal prison, followed by three years of supervised release, and ordered to pay $4,444,417.65 in restitution, for defrauding the Federal Employees Health Benefits Program (FEHBP) of over $4 million. The sentence comes after the defendant entered a guilty plea in February.
    • “Joseph Toro, 39, of Jupiter, Florida, owned and operated Reawakenings Wellness Center (RWC), a substance abuse facility that treated patients, including FEHBP beneficiaries, from 2013 until January 2018, when RWC was evicted from their location in Miramar, Florida. After the RWC eviction, Toro continued to submit FEHBP insurance claims, using personal identifying information of former RWC patients, for substance abuse treatment that was never provided. To do so, he called the FEHBP hotline, impersonated former patients, and changed their mailing addresses to addresses that he controlled so he could obtain the fraudulent insurance reimbursement checks. For over a year, Toro submitted fraudulent claims on behalf of 29 former RWC patients for over $6.7 million in substance abuse treatment that he knew RWC never provided. As a result of Toro’s fraudulent claims, he obtained nearly $4.2 million in proceeds from the FEHBP. Toro also applied for and obtained a $150,000 Economic Injury Disaster Loan (EIDL) from the U.S. Small Business Administration (SBA) during the COVID-19 pandemic. That application misrepresented that RWC had five employees and grossed over $1.4 million in 2019, when in truth RWC had shut down years prior.”

Tuesday Tidbits

David Ermer–CDC, COVID-19, Cybersecurity, FDA, Medical / Rx research, Obesity, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • The American Hospital News reports,
    • “Health care leaders and other officials April 9 discussed challenges to rural health care access and potential solutions during an event in Washington, D.C. sponsored by the Coalition to Strengthen America’s Health Care: Protecting 24/7 Care. The AHA is a founding member of the Coalition, which recently rebranded to reflect its renewed focus to protect and strengthen patients’ access to 24/7 care. 
    • “Today’s event hosted by Punchbowl News involved discussions on a range of topics including access, the importance of telehealth, health care innovations and Medicare underpayment, among others. 
    • “You can watch a video of today’s event here. “
  • The Wall Street Journal lets us know,
    • “The U.S. Postal Service said Tuesday it is seeking to raise the price of a stamp by 5 cents, in what would be the fourth increase since the start of 2023. 
    • “The proposed price of 73 cents, up 7.4% from the current price of 68 cents, would still need to be approved by the Postal Regulatory Commission. 
    • “The last increase happened in January 2024, when the cost of a stamp rose from 66 cents to 68 cents. Before that, the agency hiked prices in July 2023 by 3 cents. * * *
    • “The new 5-cent increase would go into effect July 14, the Postal Service said. 
    • “The Postal Service said it also wants to raise prices for other services, including sending a letter outside the U.S., which would cost $1.65, up from $1.55. Mailing a postcard within the U.S. would cost 3 cents more at 56 cents. And sending metered letters, a service used by small businesses, would cost 5 cents more at 69 cents.”
  • MedTech Dive relates,
    • “The Department of Justice filed a consent decree of permanent injunction against Philips on Tuesday in response to the company’s ongoing recall of sleep apnea and respiratory devices.
    • “The settlement would restrict Philips from producing or selling new continuous positive airway pressure (CPAP) and bi-level positive airway pressure (BiPAP) machines and other devices in the U.S. until the company meets certain requirements. Philips also faces restrictions on exporting devices that are being provided to patients impacted by the recall “to help ensure remediation of U.S. patients is prioritized over export for commercial distribution.” 
    • “Philips is required to implement a recall remediation plan that the Food and Drug Administration must agree on, including providing patients with new or reworked devices, or a partial refund. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a Tuesday statement that the finalization of the decree is a “significant milestone.” 

From the public health and medical research front,

  • KFF notes,
    • “Rates of long COVID have begun to flatten. About 1 in 10 adults with COVID have reported having long COVID since rates fell in 2023, according to a KFF analysis of the latest data from the Centers for Disease Control and Prevention. If the rate continues to hold steady, new forms of prevention or treatment may be important to achieve future reductions in long COVID.
    • “As of March 2024, 7% of all adults (17 million people) reported that they have long COVID. Among the 60% of adults who reported ever having had COVID, roughly 3 in 10 reported having long COVID at some point and about 1 in 10 reported currently having it. The ongoing gap between the two long COVID rates indicates that people are continuing to recover, even as rates stabilize.”
  • US News and World Report informs us,
    • “Measles infections have continued to spread in pockets of the U.S., as the latest nationwide count shows the number of cases have now reached more than 100.
    • “A total of 113 cases have been reported across 17 states as of April 5, according to the most recent figures from the Centers for Disease Control and Prevention, nearly double the total of 58 that for all of 2023.
    • “So far, seven outbreaks have occurred – defined by the CDC as three or more related cases – up from four in 2023. More than 70% of all cases this year have been associated with an outbreak, and approximately half of patients are children under the age of five.
    • “More than 80% of measles infections are among those who are either unvaccinated or with an unknown vaccination status, according to the CDC, while 12% of cases are those who have received only one dose of the measles, mumps and rubella vaccine.
    • “Chicago has had the majority of U.S. cases, with 58 infections as of April 8, according to the most recent figures from the Chicago Department of Public Health.
    • “The majority of measles infections in Chicago have been tied to an outbreak at one of the city’s largest migrant shelters.
    • “In an update released on April 5, CDPH stated measles cases were decreasing in the city, with a total of five new cases reported during the week of March 31 through April 5, compared to 23 infections reported from March 24 through March 30.”
  • The Wall Street Journal reminds us,
    • The fight against dementia actually starts in your 40s.
    • Midlife, not your 70s or 80s, is when brain changes start to occur that can pave the way toward dementia, Alzheimer’s disease and cognitive decline later, according to a growing body of research. 
    • Intervening earlier to improve brain health—and studying the midlife brain more closely—might help people stay sharper in their later years, researchers say. Regular exercise, getting enough sleep and doing activities that keep your brain stimulated are all steps that can help you combat dementia later in life.
    • “Middle age is an opportune time to make lifestyle choices and obtain treatment that will bring an enormous return on investment in old age,” says Terrie Moffitt, a professor of psychology and neuroscience at Duke University.
    • More scientists are looking for clues in the midlife brain because efforts to target dementia in older people have largely failed, says Ahmad Hariri, a professor of psychology and neuroscience also at Duke.
  • Beckers Hospital Review points out,
    • “Surprise pregnancies may be an unexpected side effect experienced by women who use Ozempic or other GLP-1 medications, The Washington Post reported April 5.”Surprise pregnancies may be an unexpected side effect experienced by women who use Ozempic or other GLP-1 medications, The Washington Post reported April 5.
    • “Numerous social media platforms include posts and discussions about unplanned pregnancies while on Ozempic or similar drugs. Although the reports of a possible Ozempic “baby boom” are anecdotal, it is a phenomenon researchers and experts are watching closely. 
    • “Experts speculate that weight loss drugs may impact the absorption of contraceptives, causing birth control failures or that they can affect ovulation and fertility. Others say losing weight can improve chances of pregnancy.”
  • According to Fierce Healthcare,
    • “Supplemental benefits administrator Avesis and Elevance Health subsidiary Amerigroup Georgia have teamed up with Uber Health in a pilot project to tackle the state’s maternal health crisis.
    • “Utilizing community health partners like the Georgia Primary Care Association and federally qualified health centers (FQHCs), hundreds of Amerigroup’s Medicaid members in December 2022 started receiving two individualized nutritional counseling sessions, a scale and $300 of Uber Eats vouchers.
    • “Though the program’s results have not been shared yet, Avesis Senior Manager of Care Transformation Don Trainor said the program has had promising results so far.”
  • The AHA News tells us,
    • “Women with health-related social needs such as food insecurity, housing instability and lack of transportation were less likely to report receiving a mammogram in the past two years when surveyed in 2022, according to a report  released April 9 by the Centers for Disease Control and Prevention. About 66% of women aged 50-74 with at least three health-related social needs were up to date with their mammograms, compared with 83% of women with no health-related social needs. Mammography use also was lower among women without health insurance and a usual source of care.”  

From the U.S. healthcare business front,

  • United Health Group has refreshed its response to the cyberattack against Change Healthcare website.
  • Per Fierce Healthcare,
    • “Artificial intelligence categorization can help stem the flood of patient messages that would otherwise demand physicians’ expensive time, Kaiser Permanente researchers report.
    • “In a recently published JAMA Network Open research letter, members of the system’s research division and medical group outlined a strategy that used real-time natural language processing (NLP) algorithms to attach category labels to messages and then direct them to an appropriate respondent.
    • “The approach, they wrote, allowed 31.9% of the more than 4.7 million patient messages reviewed by program staff to be resolved before reaching the inbox of a specific physician. Instead, these messages were handed by a “regional team” made up of medical assistants or teleservice representatives, pharmacists and other doctors.”
  • and
    • “Consumers expect a simple and easy digital experience, and health plans have plenty of room to improve on that front, according to a new report.
    • “J.D. Power released its inaugural U.S. Health Insurance Experience Study on Tuesday, where it found that 42% of adults with insurance ran into issues using their plan’s website and/or mobile app in the past year.
    • “The study is based on responses from more than 5,500 people enrolled in the 14 largest Medicare Advantage (MA) plans and 15 largest commercial plans. It was conducted alongside Corporate Insight.”
  • Beckers Hospital Review names the “25 drugs at Mark Cuban’s online pharmacy with biggest cost reductions.”

Friday Factoids

David Ermer–CDC, CMS, Congress, COVID-19, FDA, Medical / Rx research, Medicare, Rx coverage, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC

  • Healthcare Dive informs us
    • “The Senate continued to probe the impact of private equity on healthcare delivery this week, launching both an inquiry into PE’s emergency department management practices and holding a subcommittee field hearing on “corporate greed” and PE’s impact on patient care.
    • “The field hearing and request for information come as private equity has increased its investment in healthcare. As of January, more than a quarter of the nation’s rural hospitals and 460 total hospitals in the U.S. were owned by private equity firms, according to a tracker produced by nonprofit watchdog, the Private Equity Stakeholder Project. 
    • “PE-backed physician staffing groups operate nearly one-third of emergency departments across the country, according to letters sent Monday to some of the nation’s largest private equity companies by Sen. Gary Peters, D-Mich., and chair of the Senate’s Homeland Security Committee. * * *
    • “PE firms acquire assets and then seek to sell them for profit, typically within a three- to five-year time frame. The investors may also have limited direct knowledge of healthcare, and the funds are subject to fewer regulations than public companies, according to a 2023 report from the CommonWealth Fund. As a result, the firms tend to have fewer patient-centric guardrails in place compared to traditional healthcare owners and investors.”
  • Fierce Healthcare tells us,
    • “Centers for Medicare & Medicaid Services finalized a host of actions ranging from broker compensation, health equity, mental health, supplemental benefits and biosimiliars, in the Contract Year 2025 Medicare Advantage and Part D final rule Thursday night.
    • “Technical experts and industry execs warned the changes will be consequential for MA plans.
    • “Yesterday’s 2025 Final Rule was one of the more impactful that I can recall in my two-plus decades in the industry,” said Sean Libby, president at BeneLynk. “It is clear that MA plans need a roadmap for health related social needs and health equity.”
    • “It is difficult to put words to the extent and impact of changes codified today,” saidMelissa Newton Smith, senior advisor for Oliver Wyman. “Every MA leadership team needs to be thoughtfully redesigning your stars and quality approach in order to earn quality bonus payments in 2025.”
    • “The primary winners are behavioral health providers, namely Arcadia Healthcare and Universal Health Systems,” said global strategy firm Capstone in a new analysis.
  • Per BioPharma Dive,
    • “The Food and Drug Administration has cleared Bristol Myers Squibb and 2seventy Bio’s multiple myeloma cell therapy for earlier use treating the blood cancer, approving the CAR-T medicine for patients who have previously received at least two previous drug regimens.
    • “The OK comes three weeks after a panel of FDA advisers agreed the benefit of earlier treatment outweighed the risks, including a concern raised by agency reviewers over data indicating an elevated risk of death among treated study participants in the first year of the companies’ main trial.
    • “Overall, trial results showed the CAR-T therapy, Abecma, reduced the risk of disease progression or death by about half, compared to standard regimens. Bristol Myers cited patient crossover from the control arm to treatment as confounding survival data, while the advisory panel noted complications with the “bridging” therapy used prior to CAR-T treatment.”
  • Fierce BioTech lets us know,
    • “As new cancer vaccines—led by Moderna and Merck’s mRNA-4157—near pivotal trial readouts, the FDA’s vaccines czar Peter Marks, M.D., Ph.D., said the agency is ready to review the shots despite AI-related unknowns.
    • “We are ready to review—we’re open for business,” Marks, director of the FDA’s Center for Biologics Evaluation and Research, said of cancer vaccines at the 2024 World Vaccine Congress (WVC).
    • “We have therapeutic cancer vaccines coming in; I think we would review them very much like we could review potentially a CAR-T cell or other therapeutic products,” Marks said.”
  • Per an FDA press release,
    • “Today, the FDA issued an emergency use authorization (EUA) for CorDx, Inc.’s CorDx TyFast Flu A/B & COVID-19 At Home Multiplex Rapid Test, a single use test intended to detect and differentiate influenza A and B (commonly known as flu) and SARS-CoV-2 (the virus that causes COVID-19), in individuals with signs and symptoms of respiratory infection consistent with COVID-19 within the first five days of symptom onset when tested at least twice over three days with at least 48 hours between tests. Validation data to support the EUA of this test was gathered through the National Institutes of Health (NIH) Independent Test Assessment Program (ITAP), established as a collaboration between the FDA and the NIH. The test can be used for people aged 14 years or older with a self-collected nasal swab specimens and aged 2 years or older when an adult collects the nasal swab specimens.”
  • The Washington Post reports,
    • “A group of public health experts and scientists is calling on the Food and Drug Administration to rescind its controversial approval of a DNA test that promises to predict genetic risk of opioid addiction.
    • “In a letter sent to the agency on Thursday, 31 experts in genetics, addiction, psychiatry and medical-device regulation called the approval of AvertD a mistake that relied on faulty science and puts patients at risk. The group sent a separate letter to the Centers for Medicare and Medicaid Services urging the agency, which oversees government health insurance programs, to deny coverage for the prescription-only test.
    • “The Washington Post last month highlighted concerns about the test’sreliability and the unintended consequences of false results. The letters said a negative test could give patients a false sense of security, or lead doctors to “refrain from prescribing opioids to patients who test positive, even in situations where opioids are beneficial.”
  • MedTech Dive lets us know,
    • “Smiths Medical is recalling more than 2,900 emergency ventilators in the U.S. after receiving reports of a fault linked to eight serious injuries, the Food and Drug Administration said Thursday.
    • “The fault can cause patients to receive the wrong amount of ventilation or too little oxygen, as well as a complete or partial airway obstruction. The FDA categorized the event as a Class I recall because of the risk of serious injury or death.
    • “Smiths Medical, which has faced a series of regulatory actions in recent years, told customers to continue using the Pneupac Parapac Plus 300 and 310 Ventilator Kits but to take precautions.”

From the public health and medical research front,

  • The Centers for Disease Control announced today,
    • “The amount of respiratory illness (fever plus cough or sore throat) causing people to seek healthcare remains elevated nationally but is decreasing across many areas of the country. This week, 6 jurisdictions experienced high activity compared to 10 jurisdictions experiencing high activity the previous week. No jurisdictions experienced very high activity. 
    • “Nationally, emergency department visits with diagnosed COVID-19, influenza, and RSV are decreasing.   
    • “Nationally, COVID-19, influenza, and RSV test positivity decreased compared to the previous week. 
    • “Nationally, the COVID-19 wastewater viral activity level, which reflects both symptomatic and asymptomatic infections, remains low.
  • STAT News reports,
    • “The Centers for Disease Control and Prevention urged medical practitioners on Friday to be on the lookout for people who might have contracted H5N1 bird flu from cows. The agency also urged state health departments to rapidly assess any suspected human cases, and recommended that dairy farms with confirmed or suspected outbreaks require workers to use personal protective equipment.
    • “The recommendations were outlined in a health alert network advisory, or HAN in CDC parlance. The advisory is in response to the outbreak of H5N1 avian influenza in at least 16 dairy herds in six states across the country, which has led to at least one human infection so far.
    • “Health care providers should ask themselves “Could this be an H5N1 infection?” if they are faced with a patient with what CDC called a relevant exposure history — for instance, someone who works with dairy cows or lives with someone who works with dairy cows.”
  • Medscape notes,
    • “Cognitive assessments administered via a smartphone app are a reliable and valid way to detect frontotemporal dementia (FTD) in high-risk individuals, new research showed.
    • “Cognitive tests administered remotely on the phone “showed similar findings as our gold standard in-clinic cognitive tests and brain imaging,” study investigator Adam M. Staffaroni, PhD, with the Memory and Aging Center, University of California San Francisco, told Medscape Medical News.
    • “We also provided evidence that these assessments may be useful for detecting early symptoms of the disease at a level that is on par, or perhaps slightly better, than our gold standard in-person tests,” Staffaroni said.
    • “The study was published online on April 1 in JAMA Network Open.

From the U.S. healthcare business front,

  • CNBC reports,
    • “CVS Health on Thursday said its drug plans will cover the first over-the-counter birth control pill in the U.S. at no cost for many health plan sponsors, a decision that could open the door for more people to prevent unintended pregnancies without a prescription. 
    • “The company’s pharmacy benefit manager, CVS Caremark, said the pill will be added to its preventive services oral contraceptives list and will be covered at zero cost for many sponsors. The drug, known as Opill from Perrigo, was available at pharmacies starting April 1, according to a pharmacy update from CVS Caremark dated last week and viewed by CNBC.
    • “Pharmacy benefit managers, or PBMs, maintain lists of drugs covered by health insurance plans and negotiate drug discounts with manufacturers. At most stores, Opill has a retail price of $19.99 for a one-month supply and $49.99 for a three-month supply.” 
    • FEHBlog note — Smart move, CVS Health.
  • The President of the Institute for Clinical and Economic Review comments,
    • “Yesterday Amylyx announced it would remove Relyvrio, a treatment for amyotrophic lateral sclerosis (ALS), from the market. The drug was originally approved in 2022 based on a small phase II trial, well ahead of the conclusion of its phase III trial. The results of that phase III trial were reported last month and unfortunately, the therapy failed to provide any benefit to patients. Historically, a failed trial following FDA approval has not resulted in an automatic revocation of FDA approval or withdrawal of the drug from the market, and post-marketing trial requirements are not consistently used to assess the regulatory status of all approved products. Despite this hole in regulation, Amylyx made the responsible decision to discontinue this drug, and is being rightly lauded for the choice. 
    • “Of course, everyone hopes that treatments approved early with limited evidence will prove effective. But when they don’t, this is how it is supposed to play out: patients get early access to a potentially promising treatment, and then when all the data come in and the benefits fall short, the manufacturer removes the drug from the market. What’s missing from this story though is price: since 2022, the health system paid a steep price for a drug with no proven benefit to patients. When ICER reviewed Relyvrio (prior to FDA approval), we recommended that the manufacturer consider setting the launch price, “close to the cost of production until the benefits of treatment can be adequately evaluated.” Amylyx priced the drug at $158,000 per year, far beyond ICER’s recommended price of $9,100 to $30,700 per year, a price range based on the benefits shown in the small phase II trial. The fact is, that when our health care system allows pricing of treatments far above any reasonable alignment with the benefits they have demonstrated for patients, we do real harm to unseen people in the health care system. Costs increase for everyone without making anyone healthier. And as costs increase, more people forgo care or drop their health insurance all together. 
    • “Even though the story played out as planned this time, the system can be improved to protect all patients and ensure affordability for everyone.”
  • BioPharma Dive relates,
    • “Johnson & Johnson has agreed to acquire Shockwave Medical for approximately $13.1 billion, the companies announced Friday morning. The deal values Shockwave at $335 per share.
    • “J&J said in a statement that Shockwave will expand its “cardiovascular portfolio into two of the highest-growth, innovation-oriented segments of cardiovascular intervention – coronary artery disease and peripheral artery disease.”
    • “Both companies’ boards have approved the transaction, and J&J expects the deal to close in mid-2024.”
  • and
    • “Boehringer Ingelheim is laying off staff in response to sluggish adoption of its Humira biosimilar Cyltezo, a company spokesperson confirmed to BioPharma Dive. Stat first reported the news Thursday.
    • “The German company said it will trim its customer-facing teams in favor of a hybrid in-person and virtual sales model by June 30, but didn’t specify how many jobs are affected. Pharmacy benefit managers, or PBMs, have kept Humira on their coverage lists, resulting in cheaper copycats like Cyltezo falling below their “anticipated potential,” the spokesperson said.
      • “Humira, a blockbuster immune disease drug sold by AbbVie, began facing biosimilar competition in the U.S. last year. Launched in July,Cyltezo is one of more than half a dozen Humira biosimilars now available, but holds an advantage due to its “interchangeable” designation, which allows pharmacists to substitute it for Humira.”
  • Per Healthcare Dive,
    • “Teladoc Health’s long-time chief executive officer Jason Gorevic is leaving the virtual care giant effective immediately, the company said Friday.
    • “Gorevic has been CEO since 2009 and oversaw a period of exponential growth for Teladoc during the COVID-19 telehealth boom. However, he’s departing after the telehealth company struggled to sustain that momentum as the pandemic waned. Teladoc’s stock has sunk significantly since early 2021, and recently hit an eight-year low.
    • “The leadership change is probably coming at the right time, as the company focuses on a longer-term profit growth strategy, Leerink Partners analysts Michael Cherny, Daniel Clark and Ahmed Muhammad wrote in a Friday note.”
  • and
    • “Telehealth company Amwell is in trouble with the New York Stock Exchange for its stock price trading below the minimum standard for listing.
    • “Amwell was a high-flying stock during COVID-19, as the value of telehealth companies soared due to demand for virtually provided medical care. The price of Amwell’s shares peaked at $42.80 in January 2021. However, for the past 30 days, Amwell’s shares have closed at less than $1, sparking a warning notice from the NYSE.
    • “NYSE rules give Amwell six months to regain compliance. In a Thursday release, Amwell said it plans to effect a reverse stock split — when existing shares are consolidated into fewer but more valuable shares, boosting a company’s stock price. Amwell’s board and shareholders will vote on the proposal at an annual meeting later this year.” 
  • In this regard, the FEHBlog heard a health system executive comment at the ABA’s Health Law Section’s Emerging Healthcare Law Issues conference —
    • While the amount of telehealth services has returned a little higher than pre-pandemic 2019 levels, telehealth vendors that hang on will be a lifesaver in the looming physician shortage crisis.