Regulations and Notices

The following regulations are available through the ‘Related Links Outside CMS' section below.

1. CMS-1403-FC: Competitive Acquisition of Outpatient Drugs and Biologicals Under Part B – Final rule published on November 19, 2008.  [Please see page 73FR69753-73FR69754 to see the portion of the regulation preamble that addresses the CAP.]
2. CMS 1403-P: Competitive Acquisition of Outpatient Drugs and Biologicals Under Part B – Proposed rule published on July 7, 2008.  [Please see page 73FR38522-73FR38525 to see the portion of the regulation preamble that addresses the CAP.] 
3. CMS 1385-FC: Competitive Acquisition of Outpatient Drugs and Biologicals Under Part B – Final rule published on November 27, 2007.  [Please see page 72FR66260-66275 to see the portion of the regulation preamble that addresses the CAP.]
4. CMS 1385-P: Competitive Acquisition of Outpatient Drugs and Biologicals Under Part B – Proposed rule with comment period published on July 12, 2007.  [Please see page 72FR38153-38160 to see the portion of the regulation preamble that addresses the CAP.]
5. CMS 1325-IFC4 – Exclusion of Vendor Purchases Made Under the Competitive Acquisition Program (CAP) for Outpatient Drugs and Biologicals Under Part B for the Purpose of Calculating the Average Sales Price (ASP) – the rules were published on the Federal Register on August 18, 2006.  [Please see page 71FR48131-48132 to see the portion of the regulation preamble that addresses the CAP.]
6. CMS-1502-FC and CMS-1325-F - Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year 2006 and Certain Provisions Related to the Competitive Acquisition Program of Outpatient Drugs and Biologicals Under Part B - an interim final rule and a final rule were published in the Federal Register on November 21, 2005. [Please see pages 70FR70236 - 70260 for the portion of the regulation preamble that addresses the CAP. Note that the aspects of the CAP that were addressed are final.]
7. CMS-1325-IFC3 - Exclusion of Vendor Purchases Made Under the Competitive Acquisition Program (CAP) for Outpatient Drugs and Biologicals Under Part B for the Purpose of Calculating the Average Sales Price (ASP) - an interim final rule with comment period published in the Federal Register on November 21, 2005.  [Please see pages 70FR70479-70FR70481.]
8. CMS-1325-IFC2 - Medicare Program; Competitive Acquisition of Outpatient Drugs and Biologicals Under Part B: Interpretation and Correction -- An interpretation and correction of the interim final rule that was published in the Federal Register on September 6, 2005.  [Please see 70FR52930-70FR52935.]
9. CMS-1325-IFC - Medicare Program; Competitive Acquisition of Outpatient Drugs and Biologicals Under Part B -- A Interim final rule with comment period published in the Federal Register on July 6, 2005. This interim final rule with comment period implements provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 that require the implementation of a competitive acquisition program for certain Medicare Part B drugs not paid on a cost or prospective payment system basis.
10. CMS-1325-P - Medicare Program; Competitive Acquisition of Outpatient Drugs and Biologicals under Part B published in the Federal Register March 4, 2005.