Billy Wynne

Task Force on Maternal Mental Health Issues Questions for Public Comment, Responses Due January 31 The Task Force on Maternal Mental Health, a subcommittee under the Substance Abuse and Mental Health Services Administration (SAMHSA) Advisory Committee for Women’s Services (ACWS), is soliciting public input on a series of questions related to the prevention and treatment…

Nominations for MedPAC Commissioners Due February 9 The Government Accountability Office (GAO) issued a request for letters of nomination and resumes for the Medicare Payment Advisory Commission (MedPAC). MedPAC is an independent congressional agency that advises Congress on issues affecting the Medicare program. MedPAC is made up of 17 commissioners with expertise in health care delivery and financing. The…

Agency Approves Florida Prescription Drug Importation Program Proposal Today, the Food and Drug Administration (FDA) approved Florida’s Section 804 Importation Program (SIP) application, which will allow the state to import certain prescription drugs from Canada (press release). Background. In 2020, the Trump Administration issued a final rule that would allows states and Indian Tribes to import…

CMS Releases Summaries of States’ Activities to Strengthen Medicaid Home and Community-Based Services The Centers for Medicare & Medicaid Services (CMS) released summaries of state spending plans related to section 9817 of the American Rescue Plan Act of 2021 (ARP). Section 9817 provides a temporary 10 percentage point increase to the federal medical assistance percentage…

Report Describes Agency Oversight of Medical Device Cybersecurity The Government Accountability Office (GAO) released a report on the cybersecurity of medical devices as directed by the Consolidated Appropriations Act of 2023. In this report, GAO examines the extent to which relevant non-federal entities are facing challenges in accessing federal support for medical device cybersecurity, how…

Department Requests Stakeholder Input on Access and Benefit Sharing Implications in WHO’s Pandemic Preparedness Agreement; Comments Due January 22 The Department of Health and Human Services (HHS) is seeking public input on issues being discussed at World Health Organization (WHO) negotiations concerning pandemic response strategies. WHO members are currently in talks to establish an international…

Nominations for Task Force Due March 15 The U.S. Preventive Services Task Force (USPSTF) issued a request for nominations to serve as members of the Task Force. The USPSTF is seeking nominees with expertise and national leadership in the following areas: The critical evaluation of research published in peer-reviewed literature and in the methods of…

Guidance Released on Direct-to-Consumer TV and Radio Advertisement Requirements for Prescription Drugs Final Rule  The Food and Drug Administration (FDA) released a set of questions and answers (Q&As) relevant to the Direct-to-Consumer (DTC) Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner final rule. The agency states that the guidance…

NIST Seeks Comprehensive Input to Fulfill Executive Order Mandates on AI Standards and Risk Mitigation; Comments Due February 2, 2024 The National Institute of Standards and Technology (NIST) issued a Request for Information (RFI) in line with its obligations outlined in President Biden’s Executive Order (EO) concerning Artificial Intelligence (AI). The RFI specifically pertains to…

Agencies Issue Final Merger Guidelines Aimed at Preserving Competition and Protecting Consumers The Department of Justice (DOJ) and the Federal Trade Commission (FTC) jointly released the 2023 Merger Guidelines, which outline and guide their review of mergers and acquisitions (M&A) to ensure compliance with federal antitrust laws (press release). The Merger Guidelines aim to better…