Billy Wynne

Department Proposes to Modify its Regulations Regarding Medications for the Treatment of Opioid Use Disorder The Department of Health and Human Services (HHS) Substance Abuse and Mental Health Services Administration (SAMHSA) issued a notice of proposed rulemaking (NPRM) requesting public comment on its proposal to modify regulations regarding medications for the treatment of opioid use…

Committee Releases Final Report on Preparing for and Preventing the Next Public Health Emergency: Lessons Learned from the Coronavirus Crisis The Select Committee on the Coronavirus Crisis was established in April 2020 to investigate the effectiveness, efficiency and equity of the country’s response to the COVID-19 pandemic. The committee recently released its final report summarizing…

Agency Issues Request for Information on Creating a National Health Care System Action Alliance to Advance Patient Safety; Comments Due January 23 The Agency for Healthcare Research and Quality (AHRQ) issued a Request for Information (RFI) on creating a National Health Care System Action Alliance to Advance Patient Safety (Action Alliance) to support sustained improvements…

CY 2024 Notice of Benefit Payment Parameters Proposed Rule The Centers for Medicare and Medicaid Services (CMS) released the 2024 HHS Notice of Benefit Payment Parameters proposed rule (press release) – a wide-ranging rule affecting Marketplaces and qualified health plans in the individual and small group markets.   What it is. The proposed rule makes…

Report Finds that FDA Should Increase Oversight of Online Tobacco Retailers The Department of Health and Human Services (HHS) released a report finding that the Food and Drug Administration (FDA) should improve oversight of online tobacco retailers. OIG notes that online tobacco marketing and sales may be especially dangerous for youth tobacco use because of…

Commissioners React to Draft Medicare Payment Adequacy and Update Recommendations for 2024 On December 8-9, the Medicare Payment Advisory Commission (MedPAC) held a virtual public meeting at which it considered a series of draft payment update recommendations to Medicare payment systems in 2024 for inclusion in its March 2023 Report to Congress.   The Commission…

Commissioners Support Recommendation that Would Allow Medicaid to Leverage Medicare NCDs for Prescription Drugs The Medicaid and CHIP Payment and Access Commission (MACPAC) convened a session on Medicaid coverage drug coverage based on Medicare National Coverage Determinations (NCDs). Principal Analyst Chris Park offered the following policy recommendation for Commissioner consideration: Congress should amend § 1927(d)(1)(B)…

Agencies Launch an Updated Tool for Health App Developers to Learn About Relevant Federal Regulations The Department of Health and Human Services (HHS) Office of Civil Rights (OCR), HHS Office of the National Coordinator for Health Information Technology (ONC), Federal Trade Commission (FTC), and Food and Drug Administration (FDA) jointly created an updated tool to…

Proposed Rule Issued for Investigational New Drug Application Annual Reporting; Comments Due March 9 The Food and Drug Administration (FDA) issued a proposed rule to establish a new annual reporting requirement for investigational new drug applications (INDs), known as the FDA development safety update report (DSUR).  Additional details of the proposed rule follow: The FDA…

FNS Announces $60 Million in Round Two TEFAP Reach and Resiliency Grants The Department of Agriculture (USDA) Food and Nutrition Service (FNS) announced $60.58 million in funding for round two Reach and Resiliency grants in The Emergency Food Assistance Program (TEFAP). The funding will be used by state TEFAP agencies to better serve individuals in…