After the publication of the Research Article by Joshua Cohen, Brian Young, Stephanie Rochon and Laura Faden, Are Medicare plans complying with CMS regulation?, published in the April 2008 issue of Expert Review of Pharmacoeconomics and Outcomes Research (Expert Rev. Pharmacoeconomics Outcomes Res. 8[2], 133–139 [2008]), Joshua Cohen would like to add the following statement:
I have discussed the findings from our study of Medicare plan compliance with Centers for Medicare and Medicaid Services (CMS) guidance regarding six protected therapeutic categories with Jeffrey Kelman, chief medical officer for Part D at CMS. In our discussion, Kelman and I discovered the main cause of discrepancy between our respective assessment of Medicare plan compliance: In the Tufts CSDD study, we employed a comparatively broad therapeutic classification system, namely the one designed by the United States Pharmacopeia (USP) for Medicare Part D. CMS had commissioned USP to design a therapeutic classification system specifically for Medicare Part D. We presumed that the USP system applied to Part D in its entirety. However, very recently I learned from Kelman that CMS uses a much narrower therapeutic classification system for its ‘Part D six class requirement’ than it does for Part D generally, based on subregulatory guidance to which we (and the public) had no access. Therefore, to put it succinctly, although the conclusions we drew on noncompliance are essentially correct based on USP model guidelines, they are not correct if based on subregulatory guidance that more narrowly defines the categories in question.