Thursday, September 10, 2015

A Roundup of 340B Omnibus Guidance Analyses

In Manufacturers: The Government Wants to Use 340B to Oversee and Publish Your Specialty Channel Strategy, I highlight one area of significant concern in the Omnibus Guidance for the 340B Drug Pricing Program from the Health Resources and Services Administration (HRSA).

To provide perspective on other elements, below I provide links to more comprehensive reviews from four major law firms. Each provides a different spin on key topics in the proposed guidance—patient definition, duplicate discounts, covered entity requirements, contract pharmacy oversight, manufacturer responsibilities, and more.

Hope these analyses temporarily satiate your 340B desires.

The following articles are listed in alphabetical order, by law firm name.

1) HRSA Issues Proposed Omnibus 340B Guidance, Arnold & Porter

2) The Just-Released 340B Guidance: Clarity for Covered Entities and their Contract Pharmacies (For Better or For Worse), Bass Berry + Sims

3) 340B Program: HRSA Releases Proposed “Omnibus” or “Mega” Guidance, Which Lives Up To Its Name, Hogan Lovells

4) HRSA Publishes Proposed 340B Drug Pricing Program Omnibus Guidance, King & Spalding


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