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HHS/CMS RIN: 0938-AN58 Publication ID: Fall 2004 
Title: ●Medicare Part B Competitive Acquisition of Outpatient Drugs and Biologicals (CMS-1325-P) 
Abstract: Section 303(d) of the Medicare Modernization Act requires the implementation of a competitive bidding program for Medicare part B drugs not paid on a cost or prospective payment system basis. Beginning January 1, 2006, physicians will be given a choice between purchasing these drugs and being paid by Medicare under the average sales price (ASP) system, or obtaining these drugs from vendors selected in a competitive bidding process. If the physician elects to obtain drugs from a competitive vendor, the vendor will bill Medicare for the drug. 
Agency: Department of Health and Human Services(HHS)  Priority: Economically Significant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Yes  Unfunded Mandates: Undetermined 
CFR Citation: 42 CFR 414   
Legal Authority: MMA of 2003, sec 303(d)   
Legal Deadline:
Action Source Description Date
Final  Statutory  MMA of 2003, section 303(d) or section 1847(B)(a)(1) of the Social Security Act.  01/01/2006 
Timetable:
Action Date FR Cite
NPRM  02/00/2005    
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
Agency Contact:
Edmund Erdvilas Kasaitis
Health Insurance Specialist
Department of Health and Human Services
Centers for Medicare & Medicaid Services
Center for Medicare Management, 7500 Security Boulevard, C4-01-26,
Baltimore, MD 21244
Phone:410 786-0477
Email: ekasaitis@cms.hhs.gov