NACDS, NCPA seek to amend CMS AMP complaint over “multiple source” definition

ALEXANDRIA, Va. National Association of Chain Drug Stores president and chief executive officer Steve Anderson and National Community Pharmacists Association chief executive officer and executive vice president Bruce Roberts submitted an amended complaint to their lawsuit regarding the definition of multiple source drugs filed against the Centers for Medicare and Medicaid Service in November.

Last week, the two chiefs submitted comments to CMS to withdraw the rule that revised the definition of multiple source drugs based on two legal concerns.

According to the groups, “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.”

Both organizations state that as a result of this as well as other “flaws,” Medicaid reimbursement to pharmacies will be improperly reduced and a “burden” will be left on pharmacies and states.

“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.”

This amended complaint will not have any impact on the lawsuit.