From Washington, DC —

• The American Hospital Association reports,
  • “Medicare will cover new Alzheimer’s drugs that receive traditional approval from the Food and Drug Administration when a beneficiary is diagnosed with mild cognitive impairment or Alzheimer’s disease dementia and has a physician participating in a registry with an appropriate clinical team and follow-up care, the Centers for Medicare & Medicaid Services announced June 22. CMS called the approach consistent with its 2022 national coverage determination for the first monoclonal antibodies targeting amyloid to treat Alzheimer’s. “
• For those interested, Fierce Healthcare offers a more detailed explanation of this development.

• The International Foundation of Employee Benefit Plans tells us,
  • “The Internal Revenue Service (IRS) has released Notice 2023-37 on the high deductible health plan (HDHP) preventive care safe harbor specific to 1) COVID-19 testing and 2) recommendations with an “A” or “B” rating by the United States Preventive Services Task Force (USPSTF). 
  • COVID-19 testing and screening
    • “IRS has determined that, with the end of the COVID-19 National Emergency and the Public Health Emergency, the relief described in Notice 2020-15 is no longer needed. Accordingly, Notice 2020-15 applies only with respect to plan years ending on or before December 31, 2024. For subsequent plan years, an HDHP is not permitted to provide health benefits associated with testing for and treatment of COVID-19 without a deductible or with a deductible below the minimum deductible (for self-only or family coverage) for an HDHP, except as otherwise provided in this notice. 
    • “IRS Notice 2023-37 states that the preventive care safe harbor, as described in Notice 2004-23, does not include COVID-19 testing effective June 23, 2023, although HDHPs may continue to provide benefits related to testing for COVID-19 before satisfaction of the applicable minimum deductible for plan years ending on or before December 31, 2024.”
  • Recommendations with an “A” or “B” rating by the USPSTF
    • “Consistent with the position taken in Question and Answer 7 of DOL FAQs Part 59, IRS Notice 2023-37 provides that items and services recommended with an “A” or “B” rating by the USPSTF on or after March 23, 2010, are treated as preventive care for purposes of the HDHP safe harbor, regardless of whether these items and services must be covered, without cost sharing, referencing pending litigation (Braidwood v. Becerra).”

• MedPage Today informs us,
  • “The CDC’s Advisory Committee on Immunization Practices (ACIP) agreed unanimously on Thursday to include the 20-valent pneumococcal conjugate vaccine (PCV20; Prevnar) as an option for U.S. children.”

• The U.S. Census Bureau announced,
  • “The nation’s median age increased by 0.2 years to 38.9 years between 2021 and 2022, according to Vintage 2022 Population Estimates released today by the U.S. Census Bureau. Median age is the age at which half of the population is older and half of the population is younger.
  • “A third (17) of the states in the country had a median age above 40.0 in 2022, led by Maine with the highest at 44.8, and New Hampshire at 43.3. Utah (31.9), the District of Columbia (34.8), and Texas (35.5) had the lowest median ages in the nation. Hawaii had the largest increase in median age among states, up 0.4 years to 40.7.
  • “No states experienced a decrease in median age. Four states — Alabama (39.4), Maine (44.8), Tennessee (39.1), West Virginia (42.8), and the District of Columbia (34.8) — had no change in their median age from 2021 to 2022.”

• From the public health front —

• MedPage Today relates,
  • “While in-hospital delivery-related maternal mortality has decreased, severe maternal morbidity increased, according to a retrospective cross-sectional study.
  • “Among over 11 million hospital discharges from 2008 to 2021, regression-adjusted maternal mortality per 100,000 discharges decreased from 10.6 deaths in 2008 to 4.6 deaths in 2021, reported Dorothy Fink, MD, of the Department of Health and Human Services in Rockville, Maryland, and colleagues.
  • “Each subsequent year after 2008 had an 11% decrease in odds of death compared with the previous year (adjusted OR 0.89, 95% CI 0.87-0.92), they noted in JAMA Open Network.
  • “This large national study found a decreasing trend of in-hospital delivery-related maternal mortality during 2008 to 2021, regardless of racial or ethnic group, age, or mode of delivery, likely demonstrating the impact of national and local strategies focused on improving the maternal quality of care provided by hospitals during delivery-related hospitalizations,” Fink and team wrote.”

• STAT News reports,
  • Color Health wants to take away any reason you might have for skipping screenings for cancer. 
  • The Silicon Valley company, which pivoted from cancer genomics to Covid-19 testing on a large and hugely profitable scale, has a new program that incorporates both its roots in cancer testing and its logistical experience from the pandemic. Called, simply, the Cancer Prevention and Screening Program, and built in partnership with the American Cancer Society, the program aims to make it easy to get the appropriate screenings, whether at a clinic or at home.” * * *
  • “Research has shown that outreach and navigation can improve participation, screening, follow-up,” said Samir Gupta, a cancer researcher and gastroenterologist at the University of California, San Diego, who does not work with Color. “But we haven’t been able to come up with sustainable models for how that work gets paid for. This is interesting because it’s a market solution for the lack of resources that exist helping people complete screening and follow-up.” * * *
  • “Color does already work with a wide range of customers, including large employers, workers’ unions, and government entities. Many of those existing customers will receive the cancer screening and prevention service from Color, which will officially launch in October.”

From the Rx coverage front

• STAT News points out.
  • An experimental pill from Eli Lilly led to 14.7% weight loss on the highest dose in a 36-week trial, heating up the growing competition among drugmakers to develop an effective oral obesity therapy.
  • The mid-stage results for orforglipron match the estimates of 14-15% weight loss that Lilly gave in an investor call late last year. The full results, published Friday in the New England Journal of Medicine, were presented here to a packed conference room at the American Diabetes Association conference.
  • By the end of the trial, the authors said, participants’ weight loss had not plateaued, suggesting the potential for even greater weight loss over a longer treatment period.
  • Orforglipron, taken daily, is a GLP-1 drug, a type of medication that mimics the effects of the glucagon-like peptide 1 hormone that helps people feel full after eating. This class of drugs has exploded in popularity, with the injectable GLP-1s Wegovy and Mounjaro showing up to 15% and 21% weight loss in trials, respectively. If pills can ultimately prove to work as well, they could be more accessible and more attractive to many patients for their convenience.

• Fierce Healthcare notes,
  • “Optum Rx will add two more Humira biosimilars to its formulary later this summer.
  • “The pharmacy benefit manager—one of the three largest in the market—will place Boehringer Ingelheim’s Cyltezo and Sandoz’s Hyrimoz on its formulary at parity with Humira starting July 1. Optum added Amgen’s Amjevita to its formulary at parity with Humira earlier this year.
  • “Humira, manufactured by AbbVie, is an injectable treatment for a range of conditions, including rheumatoid arthritis, ankylosing spondylitis and others. It’s a high source of cost, and PBMs have had high hopes that biosimilars coming to market could be critical in addressing those expenses.”

From the U.S. healthcare business front —

• Healthcare Dive reports,
  • “Deal volumes for health services are holding steady in 2023, even as the sector faces headwinds like high-interest rates, increased regulatory scrutiny and other macroeconomic concerns, according to a report by consulting firm PwC. 
  • “The analysis found deal volumes declined 4% in the 12 months ending May 15, 2023, compared with 2022, and deal value declined 15%. 
  • “However, the firm is “optimistic” about healthcare merger and acquisition activity for the rest of 2023, arguing corporate and private equity players have plenty of cash to spend and health services companies face a climate that demands adaptation and change.”

• Fierce Healthcare adds.
  • “Ochsner Health and the University of Texas MD Anderson Cancer Center are partnering to build an integrated cancer care program in southeastern Louisiana, the organizations announced Thursday.
  • “Called the Ochsner MD Anderson Cancer Center, their collaboration is the first to bring MD Anderson’s best practices and clinical leadership to the state’s cancer patients. It is the seventh such arrangement MD Anderson has with major health systems.”

• MedCity News tells us.
  • “There are a lot of administrative hurdles behavioral health providers have to go through to join an insurer’s network. That’s why the industry needs something similar to the “Common App” for applying to be in-network with insurers, said Cara McNulty, president of behavioral health and mental wellbeing at CVS Health. The Common App allows students to apply to multiple colleges through one application.”