The Food Marketing Institute (FMI) appreciates the opportunity to comment on the Centers for Medicare and Medicaid Services (CMS) interim final rule with comment period that changes the definition of “multiple source drug” under the Medicaid program. FMI remains quite concerned about the impact of the Average Manufacturer Price provisions of the Deficit Reduction Act (DRA)—and particularly the revised Federal Upper Limits (FULs) for multiple source drugs. We are pleased that CMS has recognized the need to make changes to the regulatory framework that will affect pharmacy reimbursement for multiple source drugs under the Medicaid program going forward, but we believe that additional changes will be necessary to ensure that Medicaid beneficiaries continue to have convenient access to prescription medications at their local pharmacies. Moreover, we agree with the comments submitted by the National Association of Chain Drug Stores (NACDS) and the National Community Pharmacy Association (NCPA) that the specific change CMS has made does not accomplish the agency’s stated goal of conforming its definition of “multiple source drug” more closely with the Social Security Act. We are particularly concerned that CMS has chosen to place the burden on determining whether a drug is generally available in a state on that state and its pharmacies—contrary to the statutory direction that availability in each state should be determined before an FUL is imposed.

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