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  • Kalie E. Richardson

    • State Regulators Issue Pharmacy Law Waivers in COVID-19 ResponseMarch 30th, 2020

      As part of a larger COVID-19 outbreak response effort, many state pharmacy regulators have issued waivers or temporary suspensions of certain pharmacy laws. The California State Board of Pharmacy, State of Ohio Board of Pharmacy, Pennsylvania Department of State, and Texas State Board of Pharmacy …

    • In an Unusual Administrative Law Development, DOJ’s OLC States That FDA Has No Regulatory Authority Over Articles Used in Lawful ExecutionsMay 20th, 2019

      In a document as interesting for the “why” as the “what,” the Department of Justice, Office of Legal Counsel (“OLC”) recently issued a memorandum legal opinion concerning “Whether the Food and Drug Administration Has Jurisdiction over Articles Intended for Use in Lawful Executions.” The issuance of …

    • CMS Proposes Rule to Reduce Drug Costs Under Medicare Part D and Medicare AdvantageDecember 4th, 2018

      On November 30, CMS published in the Federal Register a proposed rule on Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses. This proposal is the latest in a series of CMS actions to implement the HHS Blueprint to Lower …

    • Trump Administration Takes a Turn at Medicare Part B Payment ReformNovember 7th, 2018

      On October 30, 2018, the Centers for Medicare and Medicaid Services (CMS) issued an Advanced Notice of Proposed Rulemaking (ANPRM) soliciting public feedback on a potential International Pricing Index (IPI) Model for payment of certain drugs covered under Medicare Part B. 83 Fed. Reg. 54546 …

    • Congress Expands Sunshine ReportingOctober 9th, 2018

      Last Wednesday, October 3, a wide-ranging opioid bill cleared its last legislative hurdle by passing the Senate, and is expected to be signed by the President in the near future. H.R. 6, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (“SUPPORT”) for Patients …