Sens. Chuck Grassley (R-IA) and Maria Cantwell (D-WA) reintroduced legislation aimed at increased transparency of pharmacy benefit managers (PBMs). Additional details on each bill follows: The Pharmacy Benefit Manager Transparency Act (summary) – The bill features the following provisions: Pricing Practices: Prohibits PBMs from engaging in spread pricing, a practice in which PBMs charge health plans and payers more for… (Slifer, January 30, 2023) #Drug Pricing, #Transparency

The Food and Drug Administration (FDA) issued draft guidance on recommendations for evaluating donor eligibility using individual risk-based questions to reduce the risk of Human Immunodeficiency Virus (HIV) transmission by blood and blood products. The draft guidance is intended to provide blood establishments that collect blood or blood components, including Source Plasma, the following for individuals with increased risk of… (Slifer, January 27, 2023) #Food and Drug Administration, #Health Equity, #Prescription Drugs

The Centers for Medicare and Medicaid Services (CMS) issued guidance outlining new requirements for state Medicaid and CHIP programs in Consolidated Appropriations Act of 2023 (CAA, P.L. 117-328)  regarding the unwinding of continuous coverage requirements and conditions for receipt of the temporary FMAP increase. CMS also discusses reporting requirements, enforcement activities, and implications of CAA for certain COVID-19 Public Health… (Llamas, January 27, 2023) #Coverage Decisions, #COVID-19

The Food and Drug Administration (FDA) issued immediately in effect final guidance on compounding certain ibuprofen oral suspension products in outsourcing facilities for administration in hospitals and health systems. The agency details that the FDA has received reports related to increased demand for pediatric fever-reducing medication, including ibuprofen oral suspension products, along with health systems and hospitals experiencing challenges in… (Slifer, January 24, 2023) #Food and Drug Administration, #Hospitals, #Prescription Drugs

The Center for Medicaid and CHIP Services (CMCS) issued manufacturer guidance that addresses the impact of certain changes on pricing metrics for drug manufacturer covered outpatient drugs (CODs) required to be reported under the Medicaid Drug Rebate Program (MDRP). The guidance addresses how each of the following policy changes impact a manufacturers’ average manufacturer price (AMP) and Medicaid best price:… (Slifer, January 23, 2023) #Prescription Drugs

The Department of Agriculture (USDA) Food and Nutrition Service (FNS) announced $25 million in funding for Supplemental Nutrition Assistance Program (SNAP) healthy incentive initiatives. FNS will select up to three states to receive funding and support to run an Electronic Healthy Incentives Pilot (eHIP) for SNAP participants. The eHIP projects will improve food and nutrition security by making it easier… (McClurg, January 20, 2023) #Nutrition

The Government Accountability Office (GAO) released a report on public health preparedness finding that the Department of Health and Human Services (HHS) needs to improve oversight of research involving potential pandemic pathogens to ensure the safety of conducting such research. HHS oversees high-risk research involving potential pandemic pathogens, which are defined as likely highly transmissible and virulent pathogens, and capable… (Colocho, January 19, 2023) #COVID-19, #Public Health

The Food and Drug Administration (FDA) issued draft guidance on optimizing the dosage of human prescription drugs and biological products for the treatment of oncologic diseases. The guidance is intended to assist sponsors in identifying the optimal dosage during clinical development prior to submitting an application for approval for a new indication and usage. The FDA notes that dosage optimization… (Slifer, January 18, 2023) #Food and Drug Administration, #Prescription Drugs

The Centers for Medicare and Medicaid Services (CMS) announced new actions to reduce the inappropriate use of antipsychotic medications and to increase transparency about nursing home citations. Additional details on each action follows: Reinforcement of Safeguards Against Unnecessary Medications and Treatments – CMS details that beginning this month, the agency will conduct targeted, off-site audits to determine whether nursing homes… (Slifer, January 18, 2023) #Quality, #Skilled Nursing Facilities

The Substance Abuse and Mental Health Services Administration (SAMHSA) announced funding opportunities for five grants related to substance misuse and treating substance use disorder(SUD). SAMHSA highlights that 46.3 million people aged twelve or older had a SUD in 2021. Additionally, 94 percent of people aged twelve or older who had a SUD in 2021 did not receive any treatment. SAMHSA’s… (McClurg, January 17, 2023) #Mental and Behavioral Health, #Opioids