September 1, 2015
HRSA Issues Proposed "Omnibus 340B Guidance"
Arnold & Porter Advisory
On Friday, August 28, 2015, the Health Resources and Services Administration (HRSA) published long-anticipated proposed "omnibus guidance" concerning the 340B program in the Federal Register. The proposed guidance covers many of the issues that have confronted the 340B program for many years, including the patient definition, so-called "child sites" or "satellite facilities," contract pharmacy arrangements, restricted distribution networks, a refund process to address Medicaid pricing restatements, and many others. Although the proposed "omnibus guidance" is not notice-and-comment rulemaking, HRSA seeks stakeholder comments by October 27, 2015.
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