The Patient Protection and Affordable Care Act (PPACA) modifies the statutory provisions that establish a Federal Upper Limit (FUL) for multiple source drugs. The Social Security Act was revised to require that the Secretary calculate FULs as no less than 175 percent of the weighted average (determined on the basis of manufacturer utilization) of the most recently reported monthly average manufacturer prices (AMP). As a step in implementing this change, CMS has issued the first Draft Affordable Care Act FUL reimbursement files and draft methodology for review and comment.
CMS notes that the PPACA specifies that the FULs amendments shall take effect without regard to whether final regulations to carry out the amendments have been promulgated.
Comments on the draft PPACA FULs and the methodology used the calculate the FUL may be submitted to CMS at FUL@cms.hhs.gov. CMS will consider all comments received, but does not plan to respond to individual comments. Following a period of releasing the FULs in draft format, CMS plans to publish the final FULs. For more information on the Draft PPACA FULs, please contact one of our health care and pharmacy law attorneys, Anne O'Brien.
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