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The Food and Drug Administration (FDA) issued draft guidance on optimizing the dosage of human prescription drugs and biological products for the treatment of oncologic diseases.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

The Centers for Medicare & Medicaid Services (CMS) announced today an increase in providers and beneficiaries participating in three leading accountable care programs for 2023. Overall, CMS reported that 700,000 health care providers and organizations will participate in at least one of the three initiatives and will provide care to over 13.2 million beneficiaries. The three accountable care initiatives are:… (LaRosa, January 17, 2023) #Accountable Care Organizations, #Delivery Reform, #Demonstration Programs, #Value-Based Purchasing

The Medicare Payment Advisory Commission (MedPAC) convened a session to present an annual status report of the Medicare Part D program and discuss trends in program operations indicators. MedPAC staff highlighted Part D-related provisions in the Inflation Reduction Act of 2022 (IRA), including how the redesigned Part D benefit structure will lower Medicare reinsurance and lead to higher plan liability… (Colocho, January 13, 2023) #Cost-Sharing, #Delivery Reform, #Drug Pricing, #Health Equity, #Insurance Reform, #Public Option

The Medicare Payment Advisory Commission (MedPAC) convened a session to preview their findings for a mandated report on beneficiary and clinician’s use and experience of telehealth. Staff presented their findings, which will be featured in a chapter for the Commission’s forthcoming June 2023 report to Congress. Staff discussed findings related to Medicare telehealth spending by service and clinician type, utilization… (LaRosa, January 13, 2023) #Physicians, #Program Integrity, #Telehealth