CMS Acknowledges Legal Concerns With Definition Of 'Multiple Source Drug', USA

Main Category: Pharmacy / Pharmacist
Also Included In: Medicare / Medicaid / SCHIP
Article Date: 08 Oct 2008 - 2:00 PDT

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The following is a statement issued today by National Community Pharmacists Association (NCPA) CEO and Executive Vice President Bruce Roberts, RPh, and National Association of Chain Drug Stores (NACDS) President and CEO Steven C. Anderson, IOM, CAE,, upon the release of the final rule to redefine a 'multiple source drug':

"NACDS and NCPA are pleased that after filing an interim final rule earlier this year, the Centers for Medicare & Medicaid Services (CMS) have acknowledged serious legal concerns about the agency's definition of 'multiple source drug,' and today issued the final rule. CMS acknowledges that it revised the definition in response to our lawsuit, which challenged the definition of multiple source drugs contained in the original rule July 17, 2007. We are reviewing the proposed revised rule to ensure that CMS will in fact comply with the Medicaid statute. If we determine that the revised rule does not comply with the statute we may need to raise the issue with the federal court that has jurisdiction over our ongoing lawsuit.

"It is important to note that this revised rule does not eliminate the lawsuit filed by NACDS and NCPA in November of 2007 to block the average manufacturers' price (AMP) rule, which would drastically cut reimbursement payments to community pharmacies that serve disadvantaged Americans in the Medicaid program. The December 19, 2007 injunction against the AMP rule remains in place.

"This rule does not address two other major arguments in the lawsuit: 1) the AMP rule does not comply with the Social Security Act's definition of AMP; and 2) the AMP rule improperly applies federal upper limits on reimbursement to non-equivalent drug products.

"While not a permanent solution, NACDS and NCPA worked with Congress this year to enact z delay the reimbursement implementation until October 2009. As we are hopeful for continued success in court, we will continue to encourage Congress to work with pharmacy to find more appropriate models for pharmacy reimbursement for generics under Medicaid."

The National Community Pharmacists Association, founded in 1898, represents the nation's community pharmacists, including the owners of more than 23,000 pharmacies. The nation's independent pharmacies, independent pharmacy franchises, and independent chains dispense nearly half of the nation's retail prescription medicines. To learn more go to http://www.ncpanet.org.

The National Association of Chain Drug Stores (NACDS) represents traditional drug stores, supermarkets, and mass merchants with pharmacies. Its more than 170 chain member companies include regional chains with a minimum of four stores to national companies. NACDS members also include more than 1,000 suppliers of pharmacy and front-end products, and nearly 90 international members representing 29 countries.

Chains operate 39,000 pharmacies, and employ a total of more than 2.5 million employees, including 118,000 pharmacists. They fill more than 2.5 billion prescriptions yearly, and have annual sales of over $750 billion.

National Association of Chain Drug Stores

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