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AHA: Delay compliance date for 340B GPO provision

April 3, 2013

The Health Resources and Services Administration should delay by at least six months the date by which certain hospitals participating in the 340B drug pricing program must comply with new HRSA guidance regarding the statutory prohibition against obtaining outpatient drugs through a group purchasing organization, the AHA told the agency today. “This delay would allow hospitals time to work with their vendors and wholesalers to address the many process and procedural challenges brought on by the Feb. 7 notice, to properly train staff to manage the new processes, and to ensure that these revised internal processes are working well,” wrote AHA Executive Vice President Rick Pollack. AHA expressed concern that the HRSA notice poses a significant departure from previous agency guidance regarding the statutory GPO prohibition and said HRSA should have allowed for public notice and comment regarding these policy changes.