The Government Accountability Office (GAO) released a report on the early results of the Research to Accelerate Cures and Equity for Children (RACE) Act. The RACE Act was included in the Food and Drug Administration (FDA) Reauthorization Act of 2017 to facilitate the development of new, safe, and effective drugs to treat children. Effective August 18, 2020, the Act requires… (McClurg, February 2, 2023) #Pediatrics

The Government Accountability Office (GAO) released a report on supplemental benefits offered by Medicare Advantage (MA) plans. About 49 percent of Medicare enrollees are enrolled in private MA plans which have the flexibility to offer additional or supplemental benefits not covered under traditional Medicare. These supplemental benefits can include health-related benefits such as dental and vision, new primarily health-related benefits… (McClurg, February 2, 2023) #Dental Health, #Medicare Advantage, #Nutrition

The Centers for Medicare and Medicaid Services (CMS) announced the Contract Year (CY) 2024 Advance Notice for Medicare Advantage (MA) an Part D (fact sheet). What it is. The Advance Notice addresses a wide array of MA and Part D-related policies and includes the estimated net rate update for MA plans. Why it’s important for you. The Advance Notice proposes… (Slifer, February 1, 2023) #Drug Pricing, #Medicare Advantage, #Medicare Part D, #Risk Adjustment

The Department of Health and Human Services (HHS) Office of the Inspector General (OIG) released two reports on COVID-19 vaccination program efforts. The first report highlights early challenges and areas for improvement within programs, and the second report discusses challenges with federal vaccination data for state and local immunization programs. Challenges to COVID-19 Immunization OIG highlights that the Centers for… (McClurg, February 1, 2023) #COVID-19

On February 13th and 14th, 2023 the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) will meet to examine the requirements for clinical studies submitted for CMS coverage under Coverage with Evidence Development (CED). The meeting was originally scheduled to take place in December (see our note appended below), but CMS pushed back the meeting in response to public comments… (Testa, January 30, 2023) #Coverage Decisions

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