The statutory line extension provisions went into effect on January 1, 2010. It is the manufacturers' responsibility to identify their line extension drugs, calculate rebates, and pay the states consistent with the statute as of this effective date, regardless of the approval date of the drugs.
The line extension provisions that are finalized in the final rule with comment are effective prospectively as of April 1, 2016. CMS will not be setting up any special process for retroactive rebate calculations for line extension drugs; therefore, manufacturers of line extension drugs should ensure that all rebates for line extension drugs are calculated and paid appropriately to states as of January 1, 2010.
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Date
Sub Topic
FAQ ID
94826
FAQ Page
FAQ Question
Could you please confirm that manufacturers must use the alternative methodology in their Unit Rebate Amount (URA) calculations for quarters beginning January 1, 2010 for line extension drugs that were on the market as of that date, regardless of the approval date? For manufacturers of such drugs that have been waiting for the final rule before adjusting their rebates back to 1Q 2010, will CMS set up any special process for these retroactive rebate adjustments?