Billy Wynne

Generic Drug Work Plan Discussed; Commissioners Suggest Exploring Specialty Generics and Vertical Integration The Medicare Payment Advisory Commission (MedPAC) convened a session to discuss the Commission’s workplan to analyze generic drug prices in Medicare Part D. MedPAC staff detailed that the Commission is currently examining generic drug prescription drug event (PDE) data, as well as…

AHRQ Issues Supplemental Evidence and Data Request on Mental Health and Occupational Stress in the Emergency Medical Service and 911 Workforce The Agency for Healthcare Research and Quality (AHRQ) Evidence-based Practice Centers (EPC) Program issued a request for supplemental evidence and data submissions (SEADs) to inform its review on Mental Health and Occupational Stress in…

Agency Suggests That CMS Explore Policies to Reduce Prices of Biosimilars and Part B Biologics The Department of Health and Human Services (HHS) Office of the Inspector General (OIG) released a report showing that biosimilar competition has led to lower costs for the Medicare Part B program and enrollees. Part B drugs are usually large, complex…

Senate HELP Ranking Member Cassidy Seeks Stakeholder Input on NIH Reform; Due Oct. 27 On Friday, Senate Health, Education, Labor, and Pensions (HELP) Committee Ranking Member Bill Cassidy (R-OA) announced a request for stakeholder input to inform potential reforms to the National Institutes of Health (NIH) in areas such as increasing the pace of science, organizing NIH…

Agency Estimates CMMI Increased Federal Spending by $5.4 Billion From 2011 through 2020; Agency Expected to Increase Spending by $1.3 Billion from 2021 to 2030 The Congressional Budget Office (CBO) released an updated estimate that indicates the Center for Medicare and Medicaid Innovation (CMMI), established under the Affordable Care Act (ACA) to explore innovative health…

Agency Releases New Medicaid Information and Questions for Public Comment on Mental Health Parity, Due December 4th Today, the Centers for Medicare and Medicaid Services (CMS) released multiple pieces of information for states and stakeholders. The release, described in full below, includes a letter reinforcing the continuous eligibility requirement for individuals 19 and under; additional…

Proposed Rule Issued to Make Explicit that Lab Developed Tests (LDTs) Are Devices Under FDA Regulation; Comments Due Dec. 2 The Food and Drug Administration (FDA) issued a proposed rule to amend it regulations to make explicit that in vitro diagnostic products (IVDs) are devices under the Food, Drug, and Cosmetic (FD&C) Act, including when…

Agency Awards $42.6 Million to Support the Implementation of Evidence-based Prevention Strategies The Substance Abuse and Mental Health Services Administration (SAMHSA) announced $42.6 million in Strategic Prevention Framework – Partnerships for Success (SPF-PFS) grants for 17 states and 60 communities across the country. SPF-PFS grants were established to prevent substance use initiation and reduce the…

Biden-Harris Administration Announces Sweeping Initiatives and Over $103 Million in Funding to Tackle Maternal Health Crisis on HHS Maternal Health Day of Action As part of the Department of Health and Human Services (HHS) Maternal Health Day of Action, the Biden-Harris Administration announced a series of initiatives and funding totaling more than $103 million aimed…

Ranking Member Cassidy Seeks Stakeholder Input on CDC Reform; Due Oct. 20 Today, Senate Health, Education, Labor, and Pensions (HELP) Committee Ranking Member Bill Cassidy (R-OA) announced a request for stakeholder input to inform reforms to the Centers for Disease Control and Prevention (CDC) in areas such as data modernization, state and local coordination, and…