Since the inception of Medicare Part D in 2006, CMS has recognized six “clinical classes of concern” when reviewing Part D plan formularies. This so-called “six protected class rule” has been a mainstay of Medicare Part D and was developed carefully by CMS when the program began. Under the rule, Part D plan formularies must cover all or substantially all drugs in six “protected classes”: anti-psychotics; anti-depressants; anti-retrovirals; anti-convulsants; anti-neoplastic; andimmunosuppressants. Congresslater codified the rule in the Medicare Improvement for Patients and Providers Act of 2008 and further revised it in the Affordable Care Act. With eight years of experience with Part D, is it time to reconsider the protected class policy? On January 6, 2014, CMS issued a proposed rule that would make the first significant changes in the policy since 2006. CMS has developed a more detailed analysis for inclusion of drugs on the protected class list; this analysis will result in some classes of medications losing protected class status, including anti-depressants and immunosuppressants.

On Friday, January 10, the law firm of Foley Hoag LLP will host a one-hour webinar that analyzes the proposed rule.The webinar will address the following issues: The origination of the six protected class rule Statutory changes to the rule in 2008 and 2010 The January 6, 2014 proposed rule Policy discussion and opportunity to comment The webinar will be conducted by Foley Hoag LLP partner Thomas Barker, who served as general counsel of CMS when the six protected class rule was developed in 2005. Mr. Barker has followed the development of the rule since that time and will present the history and policy discussion during the webinar. He will be joined by Foley Hoag LLP attorney Ross Margulies. Mr. Barker and Mr. Margulies will also be available for questions on the call.