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HHS/CMS RIN: 0938-AP67 Publication ID: Fall 2010 
Title: Medicaid Program; Withdrawal of Determination of Average Manufacturer Price, Multiple Source Drug Definition, and Upper Limits for Multiple Source Drugs (CMS-2238-F2) 
Abstract: In this rule, we withdraw two provisions that we published in a final rule, titled Medicaid Program; Prescription Drugs (referred to hereafter as AMP final rule) on July 17, 2007 in the Federal Register: the determination of Average Manufacturer Price (AMP), and the Federal upper limits (FULs) for multiple source drugs. We also withdraw the definition of multiple source drug as it was revised in the Medicaid Program; Multiple Source Drug Definition final rule published on October 7, 2008. The provisions of the AMP final rule and the definition of multiple source drug that we are proposing to withdraw were challenged in a lawsuit that was filed in November 2007. As a result of this action, the Court issued a preliminary injunction which prohibits the Center for Medicare and Medicaid Services (CMS) from undertaking any and all action to implement the AMP final rule to the extent such action affects Medicaid reimbursement rates for retail pharmacies under the Medicaid program and, subject to certain exceptions, prohibits CMS from posting any AMP data on a public website or otherwise disclosing any AMP data to any individual or entities. With the issuance of the preliminary injunction, CMS has been unable to implement certain provisions of the Deficit Reduction Act of 2005 (as regulated in the July 17, 2007 AMP final rule.) In the meantime, the challenged regulations have been superseded in significant part by the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, and the Education, Jobs and Medicaid Assistance Act. This document withdraws the regulatory provisions challenged in the aforementioned litigation. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Completed Actions 
Major: No  Unfunded Mandates: No 
CFR Citation: 42 CFR 447   
Legal Authority: 42 USC 1302   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  09/03/2010  75 FR 54073   
NPRM Comment Period End  10/04/2010    
Final Action  11/15/2010  75 FR 69591   
Final Action Effective  12/15/2010    
Regulatory Flexibility Analysis Required: No  Government Levels Affected: State 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Related RINs: Related to 0938-AP26 
Agency Contact:
Gail Sexton
Health Insurance Specialist
Department of Health and Human Services
Centers for Medicare & Medicaid Services
Mail Stop S2-14-26, 7500 Security Boulevard,
Baltimore, MD 21244
Phone:410 786-4583
Email: gail.sexton@cms.hhs.gov