Alexandria, Va. – The National Association of Chain Drug Stores (NACDS) and the National Community Pharmacists Association (NCPA) today submitted an amended complaint to United States District Judge Royce C. Lamberth regarding the lawsuit filed in November 2007 against the Centers for Medicare and Medicaid Services (CMS). The complaint challenges the interim final rule that revised the definition of a “multiple source drug.”

Last week, NACDS President and CEO Steven C. Anderson and NCPA Executive Vice President Bruce Roberts submitted comments to CMS to withdrawal the rule based on two critical legal concerns with the revised definition. The amended complaint submitted to today is based on those comments.

The first concern is that the rule was not subject to the normal notice and comment rulemaking process in accordance with the Administrative Procedure Act, which requires public notice and a comment period prior to such rule changes.

Second, the Social Security Act provides that a drug is not a multiple source drug unless two or more equivalent drug products are “sold or marketed in the State,” - that is, whether particular drug products are generally available to the public through retail pharmacies in each state. CMS did not comply with this law in its interim final rule.

As a result of these and other flaws regarding the interim final rule, Medicaid reimbursement to pharmacies for multiple source drugs will be improperly reduced and a major new burden will be imposed on pharmacies and states.

It is important to note that inclusion of the amended complaint based on these two legal issues will not impair the lawsuit. The preliminary injunction will remain in place and both NACDS and NCPA will continue to assert existing claims against the AMP rule.

America's pharmacies are at risk of improper and inadequate Medicaid reimbursements due to the AMP rule and the revised definition,” said Anderson and Roberts, “This lawsuit amendment furthers our commitment to getting the formula right on AMP so pharmacists and their patients will not have to suffer.”