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HRSA Releases Final Rule Establishing Dispute Resolution Process for the 340B Program

USA - December 22 2020 On December 10, 2020, the U.S. Department of Health and Human Services ("HHS"), Health Resources and Services Administration ("HRSA") issued a…

Deborah Kantar Gardner, Margaux J. Hall, Robert G. Baxter, Ryan B. Marcus.

Cutting Out the “Middleman”? HHS Resurrects Anti-Rebate Rule for Medicare Part D

USA - December 9 2020 On November 20, 2020 the Department of Health and Human Services ("HHS") and the HHS Office of Inspector General ("OIG") issued a final rule ("Final…

Alexis Kral, Margaux J. Hall, Ryan B. Marcus.

Is International Drug Pricing Suddenly at Our Doorstep? Seven Take-Aways from the Interim Final Rule

OECD, USA - November 23 2020 On Friday, November 20, the Centers for Medicare & Medicaid Services (CMS) released an interim final rule (IFR) with comment period that implements a…

Douglas Hallward-Driemeier, Margaux J. Hall, Meredythe Ryan, Scott Falin, Stephanie A. Webster.

Sunlight on Drug Prices Negotiated by Health Plans: The “Transparency in Coverage” Final Rule

USA - November 12 2020 On October 29, 2020, the Department of Health and Human Services ("HHS"), the Department of Labor ("DOL"), and the Department of the Treasury ("DOT")…

Christina A. Ravelo, Margaux J. Hall, Ryan B. Marcus.

Compliance Dates Delayed for Information Blocking and Other Health IT Requirements Under the 21st Century Cures Act

USA - November 2 2020 On October 29, 2020, the United States Department of Health and Human Services ("HHS") Office of the National Coordinator for Health Information…

Christine Moundas, Gideon Zvi Palte.