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Pharmaceuticals and Active Pharmaceutical Ingredients - Biden Administration Issues 100-Day Supply Chain Review Report

On June 8, 2021, four Executive Branch Departments issued reports mandated by President Biden’s February 24, 2021 Executive Order on America’s Supply Chains (the “America’s Supply Chains E.O.” or the “E.O.”). The E.O....more

New Risks, New Rewards, New Exposure

Value-Based Purchasing, Multiple Best Prices, Expanded Alternative URA, and other MDRP Drug Pricing Changes in Proposed Rule - On June 17, 2020, the Centers for Medicare & Medicaid Services (“CMS”) released a major...more

Medicare Part B Payment Redux

Another Presidential Administration Attempts to Change Part B Payment for Physician-Administered Drugs - On October 25, 2018, the Trump Administration released an Advance Notice of Proposed Rulemaking (“ANPRM”) entitled...more

New York Institutes New Medicaid Drug Price Control Measures

State Budget Includes Medicaid Drug Expenditure Cap - On April 20, 2017, New York Governor Andrew Cuomo signed into law certain cost-control measures that attempt to cap the state’s Medicaid drug spending, making New York...more

HRSA Issues Final Rule on Calculation of 340B Ceiling Prices and Manufacturer Civil Monetary Penalties

Critical 340B Drug Discount Program Strictures Placed on Manufacturers as Obama Team Departs - On January 5, 2016, the Health Resources and Services Administration (“HRSA”) published in the Federal Register a final rule...more

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