The Department of Health and Human Services (HHS) Office of the Inspector General (OIG) released a report examining the challenges faced by the Centers for Disease Control and Prevention (CDC) and the Substance Abuse and Mental Health Services Administration (SAMHSA) in compiling and reporting performance data for the National Drug Control Strategy (NDCS). The report focuses on the agencies’ submissions… (Eisen, December 4, 2024) #Mental and Behavioral Health

The Department of Health and Human Services (HHS) Office of the Inspector General (OIG) released a report evaluating the effectiveness of the Office for Civil Rights’ (OCR) HIPAA audit program. This audit was prompted by increasing concerns about cyberattacks on healthcare organizations and the protection of electronic protected health information (ePHI). The report assessed whether OCR’s audits, guidance, and enforcement… (Eisen, December 4, 2024) #Health Information Technology, #Privacy

The Centers for Medicare and Medicaid Services (CMS) announced that two manufacturers of sickle cell disease treatments will participate in the Center for Medicaid and Medicaid Innovation (CMMI) Cell and Gene Therapy (CGT) Access Model. Additional details follow. Manufacturer Participants: CMS details that bluebird bio, Inc., which manufactures LYFGENIA™, and Vertex Pharmaceuticals, which manufacture CASGEVYTM, have entered into agreements with… (Slifer, December 4, 2024) #Demonstration Programs, #Drug Pricing, #Prescription Drugs

The U.S. Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS) Innovation Center, finalized the Increasing Organ Transplant Access (IOTA) Model (press release/ fact sheet/full proposal).  The IOTA Model aims to increase access to life-saving kidney transplants for patients living with kidney disease and reduce Medicare expenditures by transplanting more patients and removing… (Lewis, December 3, 2024) <span style="font-size:90%;

The Substance Abuse and Mental Health Services Administration (SAMHSA) released new resources to help address the trauma caused by and mental health impact of gun violence. These resources include guides for coping with grief, behavioral health best practices for trauma-informed care, and lessons from SAMHSA’s ReCAST program, which supports youth and families affected by violence. Funded by the Bipartisan Safer… (Joyce, December 2, 2024) #Mental and Behavioral Health, #Pediatrics, #Public Health

The Food and Drug Administration (FDA) released draft guidance entitled “Notifying FDA of a Permanent Discontinuance in the Manufacture or an Interruption of the Manufacture of an Infant Formula.  What is it. The FDA details that under the Food, Drug, and Cosmetic Act (FD&C Act), a manufacturer of a critical food, including infant formula must notify FDA of a permanent… (Slifer, December 2, 2024) #Food and Drug Administration