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.”