From Washington, DC

• Roll Call reports,
  • “Lawmakers are back to writing a full-year fiscal 2024 Homeland Security appropriations bill in a dramatic, last-minute shift following White House intervention over the weekend, sources familiar with the decision said Sunday night. 
  • “Appropriators had been working on a yearlong stopgap measure, negotiating necessary changes to the fiscal 2023 status quo to be included as “anomalies,” after talks on a full-year bill initially fell apart late last week. * * *
  • “While the situation remains fluid, the move back toward a full-fledged bill is ultimately a sign of forward momentum. However, release of text for the complete six-bill package is now expected Monday at the earliest, putting Congress on a compressed timeline to clear the legislation before Friday at midnight, when current stopgap funding lapses.
  • “House rules allot members 72 hours to read legislation before voting on it, and it usually takes the Senate a couple days to process any legislation. The package will also include the Defense, Labor-HHS-Education, Financial Services, Legislative Branch and State-Foreign Operations measures.” 

• The White House issued an Executive Order on Advancing Women’s Health Research and Innovation. Here is a link to the White House fact sheet.
  • “Today, President Biden is signing a new Executive Order that will direct the most comprehensive set of executive actions ever taken to expand and improve research on women’s health. These directives will ensure women’s health is integrated and prioritized across the federal research portfolio and budget, and will galvanize new research on a wide range of topics, including women’s midlife health.”

• The White House also announced,
  • “President Biden’s Cancer Moonshot is accelerating progress to prevent, detect, and treat cancer while boosting support for families facing cancer, including by undertaking an aggressive effort to protect families and workers from hazardous chemicals like known carcinogens. After more than three decades of inadequate protections, today the Environmental Protection Agency (EPA) is announcing a historic ban on ongoing uses of asbestos. This marks the first rule finalized under the nation’s updated chemical safety law, a milestone in the Biden-Harris Administration’s efforts to protect public health, advance environmental justice, and end cancer as we know it.”

From the Food and Drug Administration front,

• The FDA informed us,
  • “Today, the U.S. Food and Drug Administration approved Lenmeldy (atidarsagene autotemcel), the first FDA-approved gene therapy indicated for the treatment of children with pre-symptomatic late infantile, pre-symptomatic early juvenile or early symptomatic early juvenile metachromatic leukodystrophy (MLD). 
  • “Metachromatic leukodystrophy is a debilitating, rare genetic disease affecting the brain and nervous system. It is caused by a deficiency of an enzyme called arylsulfatase A (ARSA), leading to a buildup of sulfatides (fatty substances) in the cells. This buildup causes damage to the central and peripheral nervous system, manifesting with loss of motor and cognitive function and early death. It is estimated that MLD affects one in every 40,000 individuals in the United States. There is no cure for MLD, and treatment typically focuses on supportive care and symptom management.”

• MPR reports,
  • “The Food and Drug Administration (FDA) has approved Xhance^® (fluticasone propionate) nasal spray for the treatment of chronic rhinosinusitis without nasal polyps in patients 18 years of age and older. Previously, the treatment was only approved for adults with nasal polyps.
  • “Xhance is a drug-device combination therapy that delivers fluticasone, a corticosteroid, deep into difficult-to-access sinuses and sinonasal drainage tracts. The medication is delivered into the nose by actuating the pump spray into 1 nostril while simultaneously blowing (exhaling) into the mouthpiece of the device.”

From the public health and medical research front,

• MedPage tells us,
  • “Preventing SARS-CoV-2 infection in immunocompromised people hasn’t gotten any easier as the pandemic trundles on into its fifth year. * * *
  • “Vaccination against SARS-CoV-2 is now the key prevention strategy for this vulnerable population, and people who are immunocompromised should still get COVID boosters — but, given that they are less likely to generate an adequate immune response to the vaccines, the question is: how often? * * *
  • “Of three clinicians who treat moderately to severely immunocompromised patients and spoke with MedPage Today, all of them offered a similar recommendation: people who are immunocompromised should get a COVID vaccine about every 6 months, with the caveat that intervals between vaccine doses should be tailored to individual patient needs.”
• and
  • “Electronic nudges sent to patients failed to increase influenza vaccine uptake in one randomized clinical trial, while another trial found that slight increases in vaccination rates from letters emailed to patients failed to impact clinical outcomes.
  • “Neither portal nor text messages to remind patients to get an influenza vaccination were effective at a population level at improving vaccination uptake, Peter Szilagyi, MD, MPH, of the UCLA Mattel Children’s Hospital at the University of California in Los Angeles, and colleagues reported in JAMA Internal Medicine. Among patients who received care from 79 primary care practices in a large healthcare system, flu shot rates remained at approximately 47% whether patients received portal messages, text messages, or no reminders at all.
  • “And in an analysis of the Danish NUDGE-FLU trial, an about 1% boost in influenza vaccination associated with email letters encouraging patients to get vaccinated did not translate into improvements in cardiovascular, respiratory, or other clinical endpoints, Niklas Johansen, MD, of the Copenhagen University Hospital-Harlev and Gentofte in Denmark, and colleagues wrote in the Annals of Internal Medicine“

• Healio lets us know,
  • “A CDC program to distribute free HIV self-test kits has mailed nearly double the number of tests in its first year than expected.
  • “More than one-quarter of people receiving tests had never tested for HIV before.”

• The National Institutes of Health announced,
  • “Using advanced imaging techniques and in-depth clinical assessments, a research team at the National Institutes of Health (NIH) found no significant evidence of MRI-detectable brain injury, nor differences in most clinical measures compared to controls, among a group of federal employees who experienced anomalous health incidents (AHIs). These incidents, including hearing noise and experiencing head pressure followed by headache, dizziness, cognitive dysfunction and other symptoms, have been described in the news media as “Havana Syndrome” since U.S. government personnel stationed in Havana first reported the incidents. Scientists at the NIH Clinical Center conducted the research over the course of nearly five years and published their findings in two papers in JAMA today.
  • “Our goal was to conduct thorough, objective and reproducible evaluations to see if we could identify structural brain or biological differences in people who reported AHIs,” said Leighton Chan, M.D., chief, rehabilitation medicine and acting chief scientific officer, NIH Clinical Center, and lead author on one of the papers. “While we did not identify significant differences in participants with AHIs, it’s important to acknowledge that these symptoms are very real, cause significant disruption in the lives of those affected and can be quite prolonged, disabling and difficult to treat.”
• and
  • “Fenoprofen, a nonsteroidal anti-inflammatory drug (NSAID), successfully alleviated pain and inflammation in a rodent model of endometriosis, according to researchers funded by the National Institutes of Health (NIH). They chose the drug after using a computer algorithm to evaluate nearly 1,300 existing compounds for their ability to reverse gene expression related to endometriosis disease. The study was funded by NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
  • “Analysis by researchers at the University of California, San Francisco, using publicly available data from people with endometriosis, returned 299 candidate compounds with seven considered top candidates. These drugs included commonly used treatments for the disease, such as aspirin, as well as those not yet studied for this purpose. The researchers chose fenoprofen for further evaluation because it returned the highest gene expression reversal score and belongs to a drug class—NSAIDS—that is one of the first-line treatments for endometriosis.
  • “Fenoprofen is a prescription drug approved for the relief of mild to moderate pain and is often prescribed for arthritis. The researchers analyzed electronic medical records from five University of California healthcare institutions and found that the drug had been prescribed for less than 1% of patients with endometriosis or related conditions. They then tested fenoprofen in a rodent model of the disease, observing that it successfully alleviated vaginal hyperalgesia, a surrogate marker for endometriosis-related pain.
  • “If future studies in people confirm these findings, the researchers suggest that fenoprofen could be prescribed more frequently to treat endometriosis pain. Their work also supports continued use of their computer-based approach to repurpose other existing drugs as potential therapeutic candidates for endometriosis.”

From the U.S. healthcare business front,

• Beckers Hospital Review updates us on the Change Healthcare situation. UHC updated its Change Healthcare cyberattack response website today.

• The Washington Post considers whether the millions of dollars that Medicare pays for remote vital signs monitoring is worthwhile.
  • “While some small studies show remote monitoring can improve patient outcomes, researchers say it is unclear which patients are helped most and how long they need to be monitored.
  • “The research evidence is not as robust as we would like to show that it is beneficial,” said Ateev Mehrotra, a Harvard Medical School researcher.
  • “A January report by the Bipartisan Policy Center, a D.C. think tank, warned about “a lack of robust evidence on the optimal use of remote monitoring” and said some policy and medical experts “question whether we are effectively ‘rightsizing’ the use of these services, ensuring access for patients who need it most, and spending health care dollars in effective ways.”

• Beckers Hospital Review lets us know the fifteen best and worst states for doctors.
  • “Montana, South Dakota and Nebraska are the top three states for physicians to practice in the U.S., according to WalletHub’s 2024 ranking published March 18. Hawaii, Rhode Island and New Jersey were deemed the worst.
  • “The annual ranking is based on two key dimensions: opportunity and competition, and medical environment.”

• Per Fierce Healthcare,
  • “Highmark Health recorded $27.1 billion in revenue and a net income of $533 million for 2023, the company announced during its fourth-quarter results Monday.
  • “The company reported an operating margin of $338 million, though there was an operating loss of of $117 million during 2023 for the Allegheny Health Network as the system recovers from the pandemic. That was offset by gains seen in health insurance and other investments.
  • “According to a press release, Highmark holds $11 billion in cash and investments, and Highmark Health Plans reported an operating gain of approximately $400 million in 2023. It remains the largest insurer in Pennsylvania, Delaware, Virginia and western New York, said CEO David Holmberg. It was also selected to provide Medicaid to eligible members in West Virginia.
  • “He said Highmark’s annual revenue has grown 72% and Highmark Health Plan’s membership has grown 32% since 2013.
  • “We have transformed from a successful regional insurer into an innovative, diversified health organization, comprehensive solutions and national influence,” he said.”

• The Washington Post relates,
  • “AstraZeneca is capping out-of-pocket costs for inhalers and related medication at no more than $35 per month, the drugmaker announced Monday.
  • “The Britain based pharma giant said the expanded savings are intended to help vulnerable patients with asthma or chronic obstructive pulmonary disease, especially those without health insurance. The price cap takes effect June 1.”

• Beckers Hospital Review adds,
  • “First-time prescriptions for Eli Lilly’s Zepbound surpassed those for Novo Nordisk’s Wegovy in early March, according to data cited by Reuters. 
  • “For the week ending March 8, 77,590 new prescriptions were filled for Zepbound and about 71,000 were filled for Wegovy. It’s the first time Zepbound, a chronic weight management therapy approved in early November and released in December, eclipsed Novo Nordisk’s blockbuster weight loss drug.”