The Current Status of Safe Harbor Protection for Rebates: Is the End Near?

Please note this online program is not accredited for continuing pharmacy education (CPE) credit. 

Release Date:  March 27, 2019

Activity Fee:  Member:  Free        Non-Member: $30

Target Audience: Pharmacists who practice in managed care settings.  

Program Description

The Department of Health and Human Services (HHS) Office of Inspector General recently introduced a sweeping proposal that would eliminate safe harbor protections in the Anti-Kickback Statute for rebates offered by manufacturers to certain managed care organizations or their contracted pharmacy benefit management organizations (PBMs). If finalized, the rule would have a major impact on current drug supply chain transactions and could result in significant cost transfers in the Medicare and Medicaid programs. 

Removal of safe harbor protection for rebates between pharmaceutical manufacturers and managed care organizations has previously been identified as a potential opportunity to increase discounts to patients at the point of sale by the Trump Administration. In announcing the recently released proposed rule, HHS Secretary Alex Azar described it as: “the single biggest change to the way Americans’ drugs are priced at the pharmacy counter, ever.” 

As stakeholders debate the relative merits of the proposal, there remains significant controversy on the anticipated impact of the rule. Will manufacturers lower their list prices in response to the rule? 
How will price concessions be implemented by managed care organizations, including PBMs and health plans? How will the proposal impact the Medicare Part D program, the Medicaid program, and commercial markets? 

This session will provide an up-to-date summary of this important issue and what managed care organizations can expect in the near future. 

Learning Objectives:

  1. Describe the rationale for the removal of safe harbor protection of rebates under the Anti-Kickback Statute.
  2. Summarize the impact of the proposal to remove safe harbor protection for managed care organizations.
  3. Describe vulnerabilities to Medicare Part D, Medicaid, and the commercial markets in the proposed rule and what a legal challenge might look like.

Schedule of Educational Activity

This online program consists of an audio recording and a specific activity evaluation. 

Online Education Requirements:   

Please note this online program is not accredited for continuing pharmacy education (CPE) credit.


Jane Guo, PharmD, MBA | Managed Market Liaison | Otsuka Pharmaceuticals | New York, New York.

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