Both CMS and OIG encourage providers to voluntarily disclose potential violations of the Federal law under CMS’ Self-Referral Disclosure Protocol (SRDP) and OIG’s Provider Self-Disclosure Protocol (SDP). Self-disclosure can give providers the opportunity to avoid the costs and disruptions associated with a government-directed investigations or litigation; however, providers should use these protocols carefully, and with legal counsel’s input, to consider the advantages and disadvantages of self-disclosure, as there are specific risks and responsibilities.
CMS published an updated SRDP in May 2011. The updated SDRP had very few changes from the original document first published in September 2010. The original SDRP was mandated under the Affordable Care Act (ACA), Section 6409, and required CMS to develop and implement a voluntary disclosure protocol that health care providers could use to disclose noncompliance with the Stark Law (e.g., physician self-referral law). Congress likely intervened in this matter because OIG had announced that it would not accept physician self-referral law disclosures in its SDP unless there was a “colorable Anti-Kickback Statute violation.”
OIG published an updated SDP in April 2013. The updated SDP replaced OIG’s original SDP, published in October 1998, and superseded OIG’s related open letters from 2006, 2008 and 2009. The original SDP was to establish a process for healthcare providers to voluntarily identify, disclose, and resolve instances of potential fraud under federal criminal, civil or administrative law (e.g., False Claims Act, Anti-Kickback Statute and laws relating to excluded individuals); and to provide guidance on how to investigate this conduct, quantify damages and report the conduct to OIG to resolve the provider’s liability under OIG’s civil monetary penalty (CMP) authorities. The updated SDP generally affirms OIG’s past position regarding voluntary disclosure; but it also makes some important changes which are summarized here.
Providers who wish to voluntary disclose information to OIG, can do so online.