"Medicaid Program; Withdrawal of Determination of Average Manufacturer Price, Multiple Source Drug Definition, and Upper Limits for Multiple Source Drugs"

October 4, 2010 Centers for Medicare and Medicaid Services Department of Health and Human Services Room 445-G Hubert H. Humphrey Building 200 Independence Avenue, SW Washington, D.C. 20201 Subject: Medicaid Program: Withdrawal of Determination of AMP, Multiple Source Drug Definition, and Upper Limits for Multiple Source Drugs (CMS 2238-P2; RIN 0938-AP67) To Whom It May Concern: The National Community Pharmacists Association (NCPA) is writing to support the proposed regulation to modify the final regulation "Medicaid Program: Prescription Drugs" that was published in the Federal Register on July 7, 2007. The sections that are proposed to be withdrawn are Section 447.504, "Determination of AMP; Section 447.514, "Upper Limits for Multiple Source Drugs"; and the definition of multiple source drug in Section 447.502, as it was amended by the multiple source drug rule published on October 7, 2008. NCPA represents the owners and operators of approximately 23,000 independent community pharmacies in the United States. We believe that it is appropriate that CMS withdraw these sections of the regulation, as Congress recently amended several sections of Section 1927 in the Patient Protection and Affordable Care Act (PPACA, P.L. 111-148) that will require that CMS promulgate new proposed regulations regarding these particular issues. NCPA has long held that in the final 2007 regulation, CMS did not implement the provisions of the Deficit Reduction Act (DRA) of 2005 consistent with Congressional intent. Among our concerns were the inappropriate definition of AMP to include prices not paid by community retail pharmacies and the use of a definition of "multiple source drug" that was inconsistent with the statute. Several independent economists certified that CMS's planned implementation of the original DRA law would have closed some 11,000 community retail pharmacies – some 20 percent of all pharmacies – and many independent pharmacies. When issuing a new