On Friday, January 27, 2012, the Centers for Medicare & Medicaid Services ("CMS") released its long-awaited proposed rule to implement the provisions of the Affordable Care Act ("ACA") relating to pharmaceutical manufacturer payment of Medicaid rebates and limits on Medicaid reimbursement to pharmacies. The proposed rule addresses a number of important policy issues relevant to pharmaceutical manufacturers, pharmacies, and other providers, and also would pose significant operational challenges for pharmaceutical manufacturers with respect to the Medicaid Drug Rebate Program ("MDRP").… Continue Reading
On September 3, 2010, the Centers for Medicare & Medicaid Services ("CMS") published a Proposed Rule withdrawing certain provisions of the July 17, 2007 AMP Final Rule, and withdrawing the October 7, 2008 Final Rule defining "Multiple Source Drug." Specifically, the rule proposes to withdraw 42 C.F.R. § 447.504, "Determination of AMP," § 447.514, "Upper limits for multiple source drugs," and the definition of "Multiple Source Drug" in § 447.502. Conforming amendments are also proposed to other sections of the AMP Final Rule, generally by replacing references to the regulatory definition of AMP which is being deleted, with references to the statutory definition of AMP. As the rule explains, the withdrawal is being proposed in light of retail pharmacies' legal challenges to the definition of AMP and the multiple source drug provisions, and the passage of health care reform amendments which have effectively superseded the AMP provisions.… Continue Reading
