Section 6409 of the Patient Protection and Affordable Care Act (PPACA) required CMS to develop a Medicare Self-Referral Disclosure Protocol (SRDP) to facilitate the resolution of potential Stark violations. The SRDP was published on September 23, 2010 with two caveats:

1.         Despite the fact that potential violations or situations might violate more than just the Stark Act, such as the Anti-Kickback Statute or the False Claims Act, SRDP applies only to Stark Violations. 

2.         The Self-Referral Disclosure Protocol is not a replacement or substitute for the advisory opinion process, which remains available and is described by 42 CFR §§ 411.37 through 411.389.

The required elements in the process for participating in SRDP are described in the proposed protocol. You should be aware that electing to participate in SRDP waives all other appeal rights, unless a mutually satisfactory settlement cannot be arrived at or you withdraw from participation in SRDP.