Industry Requests CMS Delay Implementation of AMP Final Rule

PhRMA, the Biotechnology Industry Organization and the Generic Pharmaceutical Association sent a letter Sept. 18 to Kerry Weems, acting administrator of the Centers for Medicare & Medicaid Services (CMS), requesting that the agency delay implementation of its final rule on Medicaid average manufacturer price (AMP) reporting.

“This delay is essential to allowing the time needed to accomplish the large-scale systems changes and validation needed to support accurate data reporting and to avoid significant program disruptions,” the trade groups wrote.

When the CMS published the rule earlier this year, it established an Oct. 1 implementation date. It also set a six-month comment period for two aspects of the rule: the definition of AMP and the elimination of any drug from the AMP calculation priced significantly lower than other drugs in their category.

The trade groups are asking CMS to delay the implementation date until the quarter following the end of the comment period, Jan. 2, 2008.

Compliance with the rule requires extensive changes in reporting systems and algorithms, and the deadline does not allow sufficient time to validate system changes, the groups said, potentially leading to unreliable and noncompliant data being submitted to the agency.

Use of such data could lead to repeated errors and corrections, creating confusion and inappropriately exposing stakeholders to liabilities, the groups said. In addition, reporting unreliable data to the agency may compromise the integrity of the Medicaid program, considering AMPs will be published.

The CMS did not respond to a request for comment by press time.