Billy Wynne

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…

Agency Finds That Only 18% of Medicare Beneficiaries With Opioid Use Disorder Received Medication Treatment The Department of Health and Human Services (HHS) Office of the Inspector General (OIG) released a report on the percentage of Medicare enrollees who receive medication to treat their opioid use disorder (OUD).OIG highlights that opioid-related overdose deaths remain at a…

Departments Finalize IDR Administrative Fee Amount and Methodology, Certified IDR Entity Fee Ranges The Departments of Treasury, Labor, and Health and Human Services (HHS) (the Departments) released a final rule to establish the independent dispute resolution (IDR) administrative fee amount and methodology, and the certified IDR entity fee ranges for single and batched determinations. The…

Commissioners Discuss MMPs and the Future of Integrated Plans for Dually Eligible Beneficiaries The Medicaid and CHIP Payment and Access Commission (MACPAC) convened a panel discussion to consider the transition from Medicare-Medicaid Plans (MMPs) to Dual Eligible Special Needs Plans (D-SNPs) and the future of integrated care for individuals who are dually eligible for Medicare…

Commission Staff Presents Data Update on Unwinding the Continuous Coverage Provisions The Medicaid Payment and Access Commission (MACPAC) held a meeting to review reporting requirements related to the unwinding of the continuous coverage requirements in Medicaid and an update on data to monitor state progress. Background: Principal Analyst and Research Advisor Martha Heberlein presented the…

Agency Releases Toolkit to Help MA Organizations Identify Diagnosis Codes That Are At High Risk of Being Miscoded The Department of Health and Human Services (HHS) Office of the Inspector General (OIG) released a toolkit to help Medicare Advantage (MA) organizations identify and evaluate high-risk diagnosis codes to ensure proper payments and provide better care…