Average Manufacturer Price (AMP)
- Medicaid Program; Prescription Drugs, Final Rule with Comment
Period [CMS-2238-FC] [Plain text | Fed
Reg] --
-
- Medicaid Program: Prescription Drugs, Proposed
Rule [CMS-2238-P] [Plain
text | Fed Reg] -- 22 December 2006
-
- Implement sections of Deficit Reduction Act of 2005
pertaining to Medicaid prescription drug program
- CMS fact
sheet
- Comments
-
Average Sales Price (ASP)
ASP Pricing Methodology, including
exceptions (as described in Transmittal 1513):
- As announced
in late 2006, the CMS has been working further to ensure that accurate and
separate payment is made for single source drugs and biologicals as required by
section 1847A of the Social Security Act. As part of this effort, we have also
reviewed how we have operationalized the terms “single source drug,” “multiple
source drug,” and “biological product” in the context of payment under section
1847A. For the purposes of identifying “single source drugs” and “biological
products” subject to payment under section 1847A, generally CMS (and its
contractors) will utilize a multi-step process. We will
consider:
-
- The FDA
approval,
- Therapeutic
equivalents as determined by the FDA, and
- The date of
first sale in the United States.