Under regulations issued by the Centers for Medicare and Medicaid Services (CMS) last spring, drug manufacturers that are new to the Medicare Part D program are required to have a Coverage Gap Discount Program agreement in place with CMS by January 30, 2013, to be eligible for inclusion on Part D formularies beginning January 1, 2014. New manufacturers with recently approved products, as well as existing manufacturers seeking to list their drug products on Part D formularies for the first time, should be keenly aware of this requirement.
What does this mean for manufacturers entering the Part D market for the first time?
If you miss the January 30, 2013, deadline to fully execute the Coverage Gap Discount Program agreement, your drug will be excluded from Part D reimbursement for 2014 and all of 2015. Depending upon the target patient market for your product, exclusion from Part D has the potential to significantly impair your go-to-market strategy and projected product revenues.
However, if you do miss the deadline, certain arrangements may be available to ensure that your product can be eligible for Part D coverage in 2014. In addition, for manufacturers seeking to enter the Part D market for 2013, other arrangements may be available to try to obtain formulary placement during the 2013 calendar year.
Information regarding CMS’ Coverage Gap Discount Program, as well as a copy of the regulations issued in April 2012, can be found here.
Please contact Mark McAndrew or other members of Taft’s Health & Life Sciences practice group for further information about contracting with CMS and Medicare Part D Plans, as well as other issues relating to managed care contracting and market access strategies.