Medicaid Program: Withdrawal of Determination of Average Manufacturer Price, Multiple Source Drug Definition, and Upper Limits

Document ID: CMS-2010-0231-0002
Document Type: Proposed Rule
Agency: Centers For Medicare & Medicaid Services
Topics: Accounting, Administrative Practices and Procedures, Drugs, Grant Programs-Health, Health Facilities, Health Professions, Medicaid, Reporting and Recordkeeping Requirements, Rural Areas
Federal Register Number: 2010-22115
CFR Citation: 42 CFR Part 447
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Details Information

Abstract: In this rule, we are proposing to withdraw two provisions from the ‘‘Medicaid Program; Prescription Drugs’’ final rule (referred to hereafter as ‘‘AMP final rule’’) published in the July 17, 2007 Federal Register. The provisions we are proposing to withdraw are as follows: The determination of average manufacturer price (AMP), and the Federal upper limits (FULs) for multiple source drugs. We are also proposing to withdraw the definition of ‘‘multiple source drug’’ as it was revised in the ‘‘Medicaid Program; Multiple Source Drug Definition’’ final rule published in the October 7, 2008 Federal Register. 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. The challenged regulations have been superseded in significant part by the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, and the FAA Air Transportation Modernization and Safety Improvement Act. This document would withdraw the regulatory provisions challenged in the aforementioned litigation.
Document Subtype: Advance Notice of Proposed Rulemaking (ANPRM)
Received Date: September 03 2010, at 12:00 AM Eastern Daylight Time
Start-End Page: 54073 - 54076
Page Count: 4
Comment Start Date: September 3 2010, at 12:00 AM Eastern Standard Time
Comment Due Date: October 4 2010, at 11:59 PM Eastern Standard Time

Comments

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Total: 15
HDMA, VA
Posted: 10/06/2010     ID: CMS-2010-0231-0003

Oct 04,2010 11:59 PM ET
ESI,DC
Posted: 10/06/2010     ID: CMS-2010-0231-0004

Oct 04,2010 11:59 PM ET
Astellas Pharma US, Inc., IL
Posted: 10/06/2010     ID: CMS-2010-0231-0005

Oct 04,2010 11:59 PM ET
National Community Pharmacists Association, VA
Posted: 10/06/2010     ID: CMS-2010-0231-0006

Oct 04,2010 11:59 PM ET
Food Marketing Institute, VA
Posted: 10/06/2010     ID: CMS-2010-0231-0007

Oct 04,2010 11:59 PM ET

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