Today, Health Resources and Services Administration (HRSA) released the long-awaited 340B Program Omnibus Guidelines (Mega-Guidance) for public viewing on the Federal Register website. According to the site, the Mega-Guidance will officially be published on Friday, August 28, 2015 and public comments should be submitted on or before TUESDAY, OCTOBER 27, 2015 (60 days after the Federal Register publication date). The pre-publication document can be found at:
http://www.reginfo.gov/public/jsp/EO/eoDashboard.jsp
If you remember, HRSA originally sent the 340B Omnibus Guidance (Mega-Guidance) to the Office of Management and Budget (OMB) on May 6, 2015 and on August 4, 2015, the OMB posted that the review of the Mega-Guidance was extended. Then, on August 17, 2015 OMB posted that they had concluded their review Mega-Guidance.
At first glance, the Mega-Guidance addresses the following areas of the 340B Drug Pricing Program:
340B Program Eligibility, Registration & Recertification
Drugs Eligible for Purchase Under 340B
Individuals Eligible to Receive 340B Drugs
Covered Entity Requirements and Responsibilities
Contract Pharmacy Arrangements
Manufacturer Responsibilities
Rebate Options for AIDS Drug Assistance Programs
Program Integrity
340B Definitions
SCA is working diligently to post a series of articles covering each of the areas above as referenced in the 340B Drug Pricing Program Omnibus Guidance and what effects this proposed Guidance could have on 340B covered entities participating in the 340B Program. Be on the lookout and subscribe to our blog so that you don't miss the next update!
