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Final Rule Closely Resembles Previously Withdrawn 2019 Proposed Rule - INTRODUCTION - On November 20, 2020, as part of a release of several drug pricing rules, the U.S. Department of Health and Human Services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

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

HHS Proposes Rule Challenging Drug Manufacturer Rebates to PBMs and Payors

The Proposed Rule Would Make Clear that the Anti-Kickback Statute’s Discount Safe Harbor Does Not Protect Manufacturer Rebates to PBMs or Payors, But Would Create New Safe Harbors for Rebates Passed Through to the...more

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