Friday Factoids

David Ermer–FDA, HSA, Medical / Rx research, NIH, No Surprises Act, Rx coverage, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC,

  • The American Hospital Association News tells us,
    • “The Departments of Health and Human Services, Labor, and the Treasury Dec. 15 reopened the federal independent dispute resolution portal to process all dispute types, including previously initiated batched disputes, new batched disputes, and new single disputes involving air ambulance services. The departments also have extended the applicable deadlines to initiate new batched disputes and new single disputes involving air ambulance services, resubmit disputes determined by certified IDR entities to be improperly batched, and select or reselect a certified IDR entity. For details, see the [lengthy] announcement. 
  • In Department of Health and Human Services news,
  • and
    • “A paper published today in JAMA Network Open addresses the use of healthcare algorithms and provides the healthcare community with guiding principles to avoid repeating errors that have tainted the use of algorithms in other sectors. * * *
    • “The paper, Guiding Principles to Address the Impact of Algorithm Bias on Racial and Ethnic Disparities in Health and Health Care, may be found in JAMA Network Open is available here. The journal also links to an accompanying podcast interview of panel co-chairs Marshall Chin, MD, MPH, and Lucila Ohno-Machado, MD, PhD, MBA. The final EPC report, Impact of Healthcare Algorithms on Racial and Ethnic Disparities in Health and Healthcare, can be found here.”

In Food and Drug Administration news,

  • From Bio-Pharma Dive,
    • “The Food and Drug Administration on Thursday broadened use of a drug Merck & Co. acquired in a $1 billion buyout four years ago, clearing Welireg for use in people whose kidney tumors have progressed following treatment with two other types of medicines. 
    • “Approval was based on a trial that compared Welireg to an older therapy called everolimus. Merck’s drug reduced the risk of cancer progression or death by 25% compared with everolimus and shrank or eliminated tumors in 22% of people who received it. Welireg hasn’t yet proven it can help kidney cancer patients live longer, however. 
    • “Merck inherited Welireg when it bought biotechnology company Peloton Therapeutics. Since then, the drug’s been cleared for use in a rare condition called von Hippel-Lindau disease and now kidney cancer. Merck is studying its potential in other settings as well.”
  • From MedTech Dive,
    • “Glaukos Corporation received Food and Drug Administration approval for a drug-releasing implant that is designed to reduce intraocular pressure in patients with ocular hypertension or open-angle glaucoma. The implant was approved for single administration per eye.
    • “The device continuously delivers a formulation of travoprost, an established treatment for high pressure in the eye, to provide patients with an alternative to eye drops and remove the risk that noncompliance with the treatment regimen will affect outcomes.
    • “Glaukos failed to secure approval for repeat dosing but plans to work with the FDA to change the label. The wholesale acquisition cost (WAC) is $13,950 per dose, or implant, well above analysts’ expectations. William Blair analysts estimated the price would fall in a range of from $3,000 to $4,000 per implant, while BTIG analysts said they modeled a price of $5,000.”
  • and
    • “Medtronic has gained the first approval from the Food and Drug Administration for a pulsed field ablation (PFA) system to treat atrial fibrillation (AFib), pulling ahead of other medtech companies in the race to bring the technology to the U.S. market.
    • “The treatment approach has garnered attention as a safer alternative to radiofrequency and cryoablation techniques for addressing the abnormal heart rhythm, and Boston Scientific and Johnson & Johnson are pursuing the market.
    • “Medtronic, in announcing the FDA’s approval for its PulseSelect PFA system, said the device has demonstrated a 0.7% safety event rate and clinical success rates of 80% in both paroxysmal and persistent AFib patients.”

From the public health and medical research front,

  • The New York Times offers readers’ perspectives on its article about the high and climbing number of pedestrian deaths occurring at night. “Readers share concerns like headlight glare, streetlight design and the aging of American motorists.”
  • HealthDay informs us,
    • “Diabetes drugs, including Ozempic, do not appear to increase the risk of birth defects
    • “Babies born of moms using drugs to control their type 2 diabetes had no greater risk of birth defects than those whose moms used insulin.
    • “Diabetes medications have grown in popularity over the past decade, particularly those in Ozempic’s class.”
  • The Director of the National Institute of Diabetes and Digestive and Kidney Diseases posted his Winter 2023 report.
  • Per Medscape,
    • “Living in food deserts and food swamps — areas with no access to healthy food, and areas with a plethora of unhealthy food options — may raise the risk of dying from postmenopausal breast cancer, a novel ecological study has found. 
    • “Food deserts and food swamps are both bad, but it’s worse in food swamps,” Malcolm Bevel, PhD, MSPH, with Augusta University in Georgia, told Medscape Medical News. 
    • “He presented his research here at the San Antonio Breast Cancer Symposium (SABCS) 2023.” 

From the U.S. healthcare business front,

  • KFF unveiled its updated
    • “Health Spending Explorer, an interactive tool that allows users to explore trends in health spending by federal and local governments, insurers, nursing care, hospital, and other service providers, and consumers.
    • “The tool captures just-released 2022 data from the federal government, when national health expenditures totaled nearly $4.5 trillion. Overall spending rose 4.1% in 2022, with almost all categories of health spending experiencing growth. This rise was muted by lower federal public health spending related to the pandemic. Meanwhile, consumers’ out-of-pocket costs rose 6.6%, a large but less dramatic increase than in 2021.”
  • The Health Care Cost Institute reports,
    • “Healthcare spending continues to grow, and prices are the primary driver. Without addressing high and growing prices, efforts to make care more affordable will not be successful. One way to understand what is going on with prices in employer-sponsored insurance (ESI) is to compare negotiated rates paid in that market to Medicare payments for the same services. New analysis from the Health Care Cost Institute finds that, in 2021, ESI payments for outpatient services were, on average, 287 percent higher than Medicare payments.”
  • Beckers Hospital Review identifies the 25 largest health systems in the U.S. by number of beds, and provides the reasons for fourteen hospital closures.
  • Using the American Medical Association’s health insurance market concentration report, Beckers Payer Issues identifies the cities with the most competitive Medicare Advantage markets.
  • Reuters reports,
    • “Bluebird bio (BLUE.O) said on Thursday a large insurer had agreed to cover its newly approved sickle cell disease gene therapy, easing some investor worries about resistance from other payers over the high price of the treatment.
    • “Bluebird’s treatment, Lyfgenia, was approved along with another gene therapy Casgevy from partners Vertex Pharmaceuticals (VRTX.O) and CRISPR Therapeutics (CRSP.BN).
    • “Bluebird’s price of $3.1 million is nearly $1 million higher than its rival, despite Lyfgenia having a serious safety warning about blood cancer risk. That had raised concerns over whether it would get enough coverage from insurers versus its rival.”
  • and
    • “Drugmaker Novo Nordisk paid U.S. medical professionals at least $25.8 million over a decade in fees and expenses related to its weight-loss drugs, a Reuters analysis found. It concentrated that money on an elite group of obesity specialists who advocate giving its powerful and expensive drugs to tens of millions of Americans.”
  • The Employee Benefit Research Institute factors health savings accounts into the retirement funding picture for Americans.
  • Per Fierce Healthcare,
    • “Two months ago, Elevance Health and Blue Cross and Blue Shield of Louisiana hit the pause button on a potential $2.5 billion merger in the midst of regulatory scrutiny.
    • “The insurers brought the deal back to life this week, though, with BCBSLA filing an updated application on Thursday seeking to reorganize as a for-profit, which would allow it to be purchased by Elevance Health. Per the New Orleans Times-Picayune, many of the plan’s initial proposals remain, but BCBSLA has made changes to the planned nonprofit foundation that will roll out should it be finalized.
    • “The newspaper reported that the Accelerate Louisiana Initiative will receive 91% of the proceeds from the merger.
    • “In a joint statement to Fierce Healthcare, the companies said that the new “filing reflects the input and vision of our communities to ensure that we deliver on these commitments.”
  • and
    • “While its merger with Humana may have fallen through for now, Cigna is attracting plenty of interest for the rumored sale of its Medicare Advantage business, Bloomberg reported.
    • Sources close to the matter told the outlet that Health Care Service Corp. and Elevance Health are “competing” to scoop up the MA segment. Cigna is expecting that the final bids will be submitted next week, according to the report.
    • “Cigna’s Medicare Advantage unit could sell for more than $3 billion, according to Bloomberg. The article noted that talks with HCSC and Elevance Health may not ultimately lead to a sale.
    • “That Cigna was shopping for a potential buyer for its MA business was first reported in early November by Reuters. That report mentioned that Cigna could ultimately elect to hang on to the MA unit if it didn’t find an appealing deal.
  • The Institute for Clinical and Economic Review listed their top ten stories of 2023.