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Implementation of Final Rule Excluding PBM Rebates from Discount Safe Harbor Delayed Until 2023

Pharmaceutical Care Management Association (“PCMA”) lawsuit results in delayed implementation of Final Rule while Biden Administration review is ongoing - Pursuant to a Court Order, implementation of the U.S. Dept. Health...more

Final Rule on VBP, Patient Assistance and Line Extensions Presents Opportunity and Risk for Drug Manufacturers

Trump Administration Finalizes Rulemaking on Value-Based Purchasing, Multiple Best Prices, Expanded Alternative URA, and other MDRP Drug Pricing Changes - On December 21, 2020, the Centers for Medicare & Medicaid Services...more

HHS Finalizes Rule Challenging Drug Manufacturer Rebates to PBMs and Payors

Final Rule Closely Resembles Previously Withdrawn 2019 Proposed Rule - INTRODUCTION - On November 20, 2020, as part of a release of several drug pricing rules, the U.S. Department of Health and Human Services (“HHS”)...more

CMS Issues Final Rule Requiring the Disclosure of Drug List Prices in Direct-to-Consumer Television Ads

The Final Rule Requires Manufacturers to Disclose List Prices of Prescription Drugs and Biological Products in Television Advertisements - On May 8, 2019, the U.S. Department of Health and Human Services (HHS or the...more

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