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 is intended to help small entities understand and comply with the standards of the final rule. Highlights from the… (Slifer, January 3, 2024) #Food and Drug Administration, #Prescription Drugs, #Transparency

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 NIST’s responsibilities outlined in Sections 4.1, 4.5, and 11 of the EO (Impact Health summary). These responsibilities include evaluating and auditing capabilities related to AI… (Colocho, December 19, 2023) #Health Information Technology, #Quality, #Transparency

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 reflect the impact of mergers on competition in the modern economy and to evaluate proposed mergers in… (Colocho, December 19, 2023) #Hospitals, #Subsidies, #Transparency, #Workforce

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 near all-time high with 83,827 deaths in 2022. Most of the deaths involved synthetic opioids. OIG developed this report to… (McClurg, December 19, 2023) #Opioids

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 final rules are effective January 20, 2024 (30 calendar days after publication of the final rule in the… (Llamas, December 18, 2023) #Coverage Decisions, #Hospitals, #Physicians

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 and Medicaid. Panelists included Tim Engelhardt, Director of the Medicare-Medicaid Coordination Office (MMCO), Michael Monson, Chief Executive Officer… (McClurg, December 15, 2023) #Dual Eligibles, #Program Integrity

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 most recently released data from the Centers for Medicare and Medicaid Services (CMS) on renewal outcomes,… (Colocho, December 15, 2023) #Coverage Decisions, #Insurance Coverage, #Public Health, #Transparency

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 for enrollees. The toolkit will help MA organizations use OIG’s techniques to improve the accuracy of their submitted diagnoses that are at high… (McClurg, December 15, 2023) #Medicare Advantage, #Program Integrity

The House Energy and Commerce (E&C) Committee convened a hearing to examine how federal agencies can leverage sector-specific expertise to navigate the evolving landscape of artificial intelligence (AI). Members discussed with Administration officials AI’s diverse applications across the health care, energy, and communications industries, weighing the advantages and potential risks associated with AI adoption, such as safety, security, bias, and… (Colocho, December 15, 2023) #Health Information Technology, #Hospitals, #Physicians, #Privacy, #Transparency

The Centers for Medicare and Medicaid Services (CMS) released revised guidance (Part B Guidance and Part D Guidance) for the Medicare Prescription Drug Inflation Rebate Program (press release, fact sheet). Overall, CMS provides clarity on the identification of rebatable drugs, as well as units to include in the calculation of inflation rebate amounts. The agency also addresses how rebates will… (Slifer, December 14, 2023) #Drug Pricing, #Medicare Part D, #Prescription Drugs