After months of speculation and waiting, CMS yesterday released its final rule to revise Medicaid reimbursement for covered outpatient drugs and reform Medicaid drug rebate requirements. While we are still digesting what the rule means for drug manufacturers and other health care providers, we promise a full analysis of the final rule, as well as a Medicaid Rebate Program Final Rule Evaluation Checklist for manufacturers. Reed Smith partner Joe Metro will also participate with Huron Consulting in an upcoming CBI webinar to discuss the final rule and implications for drug companies. In the meantime, you can access the advance version of the final rule here. The official version of the rule will be published on February 1, 2016; comments on selected provisions of the rule related to the definition of line extension will be accepted until 60 days after publication. The final rule is effective on April 1, 2016; state Medicaid agencies are required to submit State Plan Amendments by June 30, 2017 to be effective no later than April 1, 2017.

This article is presented for informational purposes only and is not intended to constitute legal advice.