On Friday, June 23, 2017, CMS released the Final Medicare Part D DIR Reporting Requirements for 2016.  Part D sponsors may begin submitting their DIR information on June 30, 2017 and must finish their submissions by the end of July 31, 2017.  As explained in our earlier post, CMS publishes Part D DIR Reporting requirements each year and sets the deadline for DIR submissions.

These DIR Reporting Requirements are the first to require Part D plan sponsors to report as DIR price concessions from and additional contingent payments to network pharmacies that could not reasonably be determined at the point of sale.  This change is caused by the update to the definition of “negotiated prices” that was effective January 1, 2016.  Not surprisingly, most of the comments and responses included in CMS’s Reporting Requirements focus on this change.  Additional topics addressed in the comments and responses include, but are not limited to: (i) plan sponsors no longer being able to report negative amounts in the rebate fields, (ii)  the timeliness of the DIR data submitted by July 31, 2017; and (iii) confidentiality of DIR data reported to CMS.

Yesterday, CMS released the Proposed Part D DIR (Direct and Indirect Remuneration) Reporting Requirements for 2016 and postponed the 2016 DIR Reporting deadline.

Each year, CMS releases Proposed Part D DIR Reporting Requirements for interested parties to review and comment on. The DIR Reporting Requirements tend to change slightly from year-to-year as the Part D program has developed and CMS gains further understanding of rebates and price concessions that a Part D plan sponsor may receive or pay.  Additionally, some changes in DIR Reporting Requirements are the result of changes to Part D regulations.  After reviewing the comments, CMS publishes the Final Part D DIR Reporting Requirements, typically in late May, and then plan sponsors submit their DIR Report by June 30th.

These Proposed DIR Reporting Requirements are the first that reflect the change in the definition of “negotiated prices” as set forth at 42 C.F.R. § 423.100. Although the discussion regarding changing the definition of negotiated prices started multiple years ago and was finalized in 2014, the change was not effective until January 1, 2016.  CMS’s proposed changes related to the updated definition of negotiated prices are captured in Summary DIR Report columns DIR #8 and DIR #9.

The deadline for submitting comments is June 2, 2017.

Typically, Part D plan sponsors must submit their DIR reports to CMS by June 30th of the year following the close of the plan year (June 30, 2017 for 2016 DIR).  CMS is postponing the deadline for 2016 DIR submission so that it has time to review the comments it receives and so that Part D plan sponsors have adequate time to analyze and categorize their data in the manner required by the upcoming Final Part D DIR Reporting Requirements.  CMS will announce the 2016 DIR submission deadline in the Final Part D DIR Reporting Requirements for 2016 and it appears that plan sponsors will have approximately 30 days to analyze and categorize their data.