FDA Fully Approves New Alzheimer’s Drug Leqembi
The Food and Drug Administration (FDA) granted full approval to Leqembi, setting up the stage for the Alzheimer’s treatment drug to become the first to receive broad coverage under Medicare. The announcement comes after months of lobbying by Alzheimer’s disease patients and advocates to make the drug more widely available through full approval. Developed by Eisai and Biogen, the drug slows the progression of Alzheimer’s disease by targeting amyloid plaques in the brain. However, Leqembi has faced controversy for its high $26,500 price tag that could lead to higher Medicare premiums, as well as reports of side effects like brain bleeding and swelling. CMS will require any physician who prescribes Leqembi to submit a patient’s medical information to a registry that will be used to evaluate the drug’s benefits or harms.
CMS Updates Guidance on Drug Price Negotiations
The Center for Medicare and Medicaid Services (CMS) recently issued revised guidance for the Medicare Drug Price Negotiation Program, likely in response to several lawsuits challenging the program. A component of the Inflation Reduction Act, the drug price negotiations are set to take course through next year. Since the IRA became law, the US Chamber of Commerce, Bristol Myers Squibb, Merck, and PhRMA have filed lawsuits against CMS that allege the program violates the First, Fifth and Eighth amendments of the Constitution. The new guidance offers relief for drug manufacturers who choose not to participate in the negotiation program by setting up a program for drugmakers to leave Medicare and avoid excise taxes.
Home Health Providers Sue CMS over Payment Cuts
The National Association for Home Care & Hospice (NAHC) filed a lawsuit against CMS that challenges a 3.925% payment cut for calendar year2023 that applies to home health providers. The lawsuit comes just days after CMS proposed a 2.2% cut in its calendar year 2024 Home Health Prospective Payment System proposed rule. The lawsuit alleges CMS put forth an invalid methodology to determine whether payment model changes are budget neutral. According NAHC, lower payments are forcing home care providers to close their doors, resulting in fewer patients receiving care. To address payment cuts, Sens. Debbie Stabenow (D-MI) and Susan Collins (R-ME) recently introduced legislation to take away some of CMS’s rate-setting authority.
JAMA: Maternal Mortality Rates Double
Maternal mortality rates have more than doubled between 1999 and 2019, according to a new study published by the Journal of the American Medical Association (JAMA). While the study found an increase in pregnancy-related deaths across all racial and ethnic groups, Black and Native American women were observed to have the highest death rates. Additionally, states in the South, the Midwest and the Great Plains saw the highest increases. Common causes of maternal death include mental health conditions, hemorrhages, hypertension, and blood clots. According to the study’s authors, increasing access to health care could prevent many pregnancy-related deaths.
ICYMI: It’s Summer Movie Season on the National Mall
“Summer Movies on the Lawn” officially returns next week with the screening of “Willy Wonka and the Chocolate Factory” (1971) on July 13. Started in 2017 by the Library of Congress, the summer movie series on the National Mall provides an opportunity for visitors to watch the National Film Registry in a scenic setting. The 2023 series will conclude on August 10 with the screening of “Jaws” (1975).