CMS Issues Subregulatory Guidance on ACA Medicaid Drug Pricing Policy
The ACA modified the statutory Federal Upper Limit (FUL) provisions pertaining to Medicaid reimbursement for multiple source drugs. Briefly, under the ACA, the Secretary was directed to calculate FULs as no less than 175% of the weighted average (determined on the basis of utilization) of the most recently reported monthly average manufacturer prices (AMP), effective October 1, 2010. CMS has not yet released its much-anticipated regulations to implement this provision. Last week, however, CMS issued for review and comment its draft FUL reimbursement files, including the draft methodology used to calculate the FULs in accordance with the ACA and the weighted average of monthly AMPs in a FUL group. The draft FUL prices are based on the manufacturer reported and certified July 2011 monthly AMP and AMP unit data. In releasing the files, CMS notes that the ACA requires the FUL amendments to take effect whether or not implementing regulations are issued. CMS is accepting comments on the draft FUL reimbursement framework, although a deadline is not specified.
