The AMP Rule is out. Now we can move on because it is “final”. We know everything we need to comply with all the Medicaid Drug Rebate Program now, correct?
Not so fast. Final is an interesting adjective when applied to this rule. We can all agree that it is “finally” out after waiting over 3 years for a more definitive version than the proposed rule, but is it really final as in the end?
In the published document, the CMS declares that it is a “Final rule with comment period”. So the CMS seems to think it is mostly final, with the only part not final is where they are asking for comments on the handling of line extension drugs. Of course, while they are asking for this additional comment, they also recently required submission of additional details on line extension drugs starting with the July quarterly price filing even before comments are received. So definitely everything is not “the end” final with the rule for line extensions.
From the manufacturer’s perspective, the final rule is only a starting point. Now comes the hard work of examining classes of trade, drug categories, contract details, systems and procedures with an eye not only to the rule, but internal and external counsel and the guidance of industry experts in order to craft the changes necessary to comply with this not so final rule. They will also, in their spare time, need to start working out how to get the correctly characterized transaction data for sales to the US territories and to potentially pay the territories Medicaid rebates.
So, no the AMP Rule really isn’t final as in the end. It is final as in the end of the beginning and much more work remains.