CMS issues new rule on multiple-source drugs

April 14, 2008

The Centers for Medicare and Medicaid Services has issued a new definition of multi-source drugs

The Centers for Medicare & Medicaid Services issued a preliminary final rule that changes the definition of multi-source drugs. In December the National Community Pharmacists Association and National Association of Chain Drug Stores were granted a preliminary injunction stopping CMS from implementing the AMP (average manufacturer price) rule, which included a new definition of multiple-source drugs. In the lawsuit, the two pharmacy organizations charged that CMS’ definition of multiple-source drugs violated existing statutes. The new multiple-source drug rule concedes that CMS had erred in its definition as NACDS and NCPA charged in their suit. The new rule, however, shifts a new burden to pharmacists. With the rule CMS would assume a drug is available in each state unless pharmacists can prove otherwise. Since the new rule is an amendment to the final AMP rule, it is still subject to the court's decision.