It appears that the Centers for Medicare & Medicaid Services ("CMS"), in its newly-released Final Guidance on Medicare Part D DIR Reporting Requirements for 2016, has begun addressing the lack of transparency surrounding Part D plan sponsors' collection of Direct and Indirect Remuneration ("DIR") fees from independent pharmacies.

DIR "clawback" fees are a contentious issue for pharmacies, who often face costly, after-the-fact recoupments by Plan D sponsors and their contracted PBMs. Attempts to advocate for greater oversight by CMS have been limited by the lack of data regarding those DIR fees collected from pharmacies. Although Plan D sponsors are required to report data about DIR fees to CMS, the accuracy of these reports, as they relate to fees collected by plan sponsors/PBMs from pharmacies, have been challenged.

In an apparent attempt to address this issue, CMS' new Guidance sets two new pharmacy-related DIR reporting requirements for sponsors: "Amounts Received from Pharmacies", and "Amounts Paid to Pharmacies." While not directly addressing the validity of various DIR fees collected by plan sponsors/PBMs, the hope is that the new reporting requirements will afford CMS a better understanding of the different types of DIR fees, and thus be able to eventually review and address these problematic "clawbacks."

If you have questions pertaining to DIR Fees or a PBM recoupment demand, feel free to contact our expert healthcare attorneys by phone at 212-668-0200 or by email at