From Washington, DC,

• The New York Times reports,
  • A troubled heart pump that has now been linked to 49 deaths and dozens of injuries worldwide will be allowed to remain in use, despite the Food and Drug Administration’s decision to issue an alert about the risk that it could puncture a wall of the heart.
  • The tiny Impella pumps, about the width of a candy cane, are threaded through blood vessels to take over the work of the heart in patients who are undergoing complex procedures or have life-threatening conditions. * * *
  • “When reporting on outsize bleeding rates related to the Impella devices, Dr. Desai, of Yale, has also noted that its payments are far higher than the balloon pump, creating an urgent need for rigorous studies of how to best treat patients.
  • “You hate to think this is part of that story, but I think we would be naïve to think that that couldn’t be part of the story,” he said.”

• The Labor Department’s Office of Federal Contractor Compliance Programs announced,
  • “Contractors that meet certain jurisdictional thresholds have an obligation to develop and maintain written Affirmative Action Programs (AAPs).
  • “The Contractor Portal is OFCCP’s platform where covered federal contractors and subcontractors must certify, on an annual basis, whether they are meeting their requirement to develop and maintain annual AAPs. The portal allows multiple users from individual organizations to register, manage records, and certify each establishment and/or functional/business unit, as applicable.
  • “Beginning April 1, 2024, federal contractors will be able to certify the status of their AAPs for each establishment and/or functional/business unit, as applicable. The deadline for certifying compliance is July 1, 2024.”

From the public health and medical research front,

• The Centers for Disease Control tells us,
  • “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, 9 jurisdictions experienced high activity compared to 10 jurisdictions experiencing high or very high activity the previous week. This 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, COVID-19 wastewater viral activity levels, which reflects both symptomatic and asymptomatic infections, remains low.
  • “Reported on Friday, March 29th, 2024.“

• The Hill informs us,
  • “Tuberculosis rates in the U.S. rose by 16 percent in 2023, marking the third year that cases went up following nearly 30 years of decline.
  • In the most recent Morbidity and Mortality Weekly Report from the Centers for Disease Control and Prevention (CDC), the number of TB cases in 2023 totaled at 9,615, a jump of 1,295 over 2022.
  • “The last time annual TB cases in the U.S. were higher than 9,500 was in 2012, when 9,906 were detected. As the report noted, TB cases had declined for 27 years, reaching a record low of 7,171 in 2020 before creeping back up.
  • “While there is a vaccine for tuberculosis, the CDC notes that it’s mostly used in countries with a high prevalence of TB and isn’t recommended for use in the U.S. due to low risk of infection.
  • “In a January report to Congress, the United States Agency for International Development attributed the rise in TB cases globally to the disruptions brought on by the COVID-19 pandemic.
  • “After two years of COVID-19-related disruptions to TB prevention, diagnosis, and treatment efforts, 2023 had the highest number of people diagnosed and started on treatment since the beginning of the disease’s global monitoring in 1995 that affected access to and provision of health services – due in part to concerted efforts to recover from the pandemic’s devastating global impact,” the agency said.”

• The Washington Post reports,
  • “The Centers for Disease Control and Prevention issued a health advisory Thursday [March 27] about a rise in rare but severe forms of meningococcal infections. These bacterial infections can cause potentially life-threatening inflammation of the membranes surrounding the brain and spinal cord.
  • “The CDC says 422 cases were reported in 2023, the highest annual number seen since 2014. Of the 94 cases with known outcomes, 17 died. Since March 25, 143 cases have been reported to the CDC — 62 more cases than what was seen over the same time period in 2023.
  • “The spike is notable in part because infections are disproportionately affecting people ages 30 to 60, as well as African American individuals and those with HIV. Typically, infants younger than 1, teenagers and young adults ages 16 to 23 as well as individuals older than 85 have a higher risk of contracting meningococcal disease.
  • “The agency says health-care experts should increase monitoring for meningitis symptoms, and the public should take steps to prevent its spread.
  • “We’re not recommending any unusual precautions,” said Lucy McNamara, an epidemiologist in the meningitis and vaccine-preventable diseases branch at the CDC.
  • “We would like for the general public to be aware of the symptoms of meningococcal disease and to contact their health-care provider if they or members of their family have those symptoms,” she said, adding that officials also “want to make sure that they’re up to date for meningococcal vaccinations.”

• Per BioPharma Dive,
  • “Bristol Myers Squibb’s cancer pill Krazati helped people with a certain kind of non-small cell lung cancer live longer without their disease progressing and shrank tumors at a higher rate than those given chemotherapy, the company said Thursday.
  • “The data could help Bristol Myers persuade the Food and Drug Administration to convert Krazati’s conditional approval into a full clearance, potentially giving it an advantage over Amgen’s rival drug Lumakras. Amgen’s bid to gain confirmatory approval was unsuccessful, and the company has four years to complete another trial testing its pill.
  • “Both Krazati and Lumakras target tumors harboring a mutation in a gene called KRAS — a long-sought goal of drugmakers. While their uptake is currently modest, both Bristol Myers and Amgen are working to expand their use into earlier lines of treatment and other types of cancer.”

From the U.S. healthcare business front,

• CNN calls our attention to the fact
  • “For the first time, women in the US can walk into a store and buy a supply of birth control pills right off the shelf, without the need for a prescription or health insurance.
  • “Opill, the first oral contraceptive approved by the US Food and Drug Administration for over-the-counter use, has arrived at most stores in certain retail pharmacy chainssuch as CVS, Walgreens and Walmart.
  • “The product is “is now available at CVS.com and through the CVS Pharmacy app and is arriving at more than 7,500 CVS Pharmacy stores in the coming weeks,”spokesperson Matt Blanchette said in an email. “For added privacy and convenience, customers will be able to choose same-day delivery or buy online and pick-up in store.”
  • “Walgreens began offering Opill in late March, spokesperson Samantha Stansberry said.
  • “The product “will be available at Walgreens nationwide in the family planning aisle and behind the pharmacy,” Stansberry said in an email. “Customers can also purchase the product online for 30-minute Pickup, 1-hour Delivery, or ship to home.”
  • “At Walmart, “it is currently available on walmart.com and will be in stores in early April,” spokesperson Tricia Moriarty said in an email.”

• Kaufmann Hall issued its March National Hospital Flash Report on March 27.
  • “Key Takeaways
    • “Margins this month were at 3.96%, continuing a strong start to 2024. However, data
      this month do not reflect the full impact of the Change Healthcare outage, which
      began February 21st.
    • “Gross revenue continues to rise at a faster rate than net revenue, highlighting payer
      mix changes. Bad debt and charity care have also risen over the last few years.
    • “Revenue growth is primarily being driven from the outpatient setting. There
      continues to be a decline in inpatient revenue and increase in outpatient revenue.”

• STAT News lets us know,
  • “Diabetes drugs are too expensive in the U.S., and insulin is infamously six to 13 timesmore expensive here than in comparable high-income countries. And blockbuster GLP-1 drugs, too, could be a lot less expensive, according to an investigationpublished this week in JAMA Network Open, with a simple change: robust generic competition.
  • “The study, led by Melissa Barber, a Yale postdoctoral fellow, and conducted in collaboration with Doctors Without Borders, a nonprofit medical organization working in low-resource and emergency settings, found that making a generic vial of insulin could cost $61 to $111 per year — 97% less than than the current market price in the U.S., based on an estimate that factors in a 10% to 50% profit margin. * * *
  • “Findings for the cost of making GLP-1 biosimilars were along the same lines. Researchers calculated that the cost of producing a patient’s monthly supply of a GLP-1 drug would range from $0.75 to $72.50; currently, Ozempic costs about $1,000 a month in the U.S, $155 in Canada, and less than $60 in Germany, according to a statement by Sen. Bernie Sanders, who cited the study as evidence of pharmaceutical overpricing and called on Novo Nordisk to lower the price of Ozempic.”
• and
  • “The staff of the Institute for Clinical and Economic Review, or ICER, are known as the nerds of the drug industry: bespectacled killjoys who emerge a few times a year to scold drugmakers for pricing their latest cancer or MS advance far beyond reason.
  • “But last year, they sat down and concluded a forthcoming treatment was worth up to $3.9 million — more than any medicine in history, more than a 45-year supply of Humira, the autoimmune drug often held up as an emblem of America’s runaway drug spending. 
  • “It was a testament to the power of a new class of gene therapies to deliver something pharma so rarely does: Genuine cures. The treatment, approved last week as Lenmeldy, may allow some babies born with an ultra-rare neurodegenerative disease called metachromatic leukodystrophy, or MLD, to grow up and live essentially normal lives.
  • “David Rind, ICER’s chief medical officer, compared Lenmeldy to Zolgensma, a gene therapy approved in 2019 for spinal muscular atrophy that the nonprofit estimated could be worth up to $2.1 million. * * *
  • “Lenmeldy, Rind said, is still overpriced. Orchard Therapeutics, Lenmeldy’s developer, is tacking on an additional $325,000, for a $4.25 million total. But its price falls closer to those estimates, as a percentage, than the vast majority of medicines it reviews.”

• Healthcare Dive brings us “inside CVS Health’s push to transform customer experience. The transformation, led by Deloitte Digital, focused on increasing customer feedback to identify pervasive issues and closing the loop on customer inquiries.”

• Beckers Payer Issues relates,
  • “UnitedHealth Group has named CFO John Rex as president of the company. 
  • “Mr. Rex is taking over the president role from COO Dirk McMahon, who plans to retire. UnitedHealth Group has not announced a successor in the COO role. Mr. McMahon spent 20 years in various leadership positions at UnitedHealth Group, and was named president and COO in 2021.  
  • “According to a March 28 regulatory filing, Mr. Rex will assume the president role April 1, in addition to his current position as CFO.”