340B Guidance: Eight Key Points Covered Entities Should Consider

September 11, 2015

Nita Garg, Lindsay Holmes, Dena Kessler, and Lee Rosebush of BakerHostetler (JDSupra, 9/11) commented that the Health Resources and Services Administration’s "proposed" 340B guidance is intended to clarify a number of issues for covered entities participating in the 340B Drug Pricing Program, and “[w]hile the Guidance covers a number of proposed changes and ‘clarifications’ in some depth, there are several key areas for providers and manufacturers to consider.” The authors provide eight points on these key areas to give Covered Entities an analysis of the guidance. The eight points, which are expanded on in the article, are as follows:

  1. “Child Site” Registration and Eligibility

  2. Exception to GPO Prohibition

  3. Definition of Eligible Patient

  4. Prohibition of Duplicate Discounts

  5. Contract Pharmacy Arrangements

  6. Manufacturer Responsibilities

  7. Rebate Option for AIDS Drug Assistance Program

  8. Program Integrity