On Tuesday, March 24, 2009, the OIG released a new Open Letter to Health Care Providers that narrows the scope of matters that will be accepted into the OIG’s Self-Disclosure Protocol (SDP) by excluding matters that only involve liability under the physician self-referral law (Stark). The Open Letter made clear, however, that the OIG will continue to accept providers into the SDP to resolve conduct involving colorable violations of the anti-kickback statute even if the matter also involves colorable violations of Stark. In addition, citing efforts to "better allocate" provider and OIG resources, the OIG announced that the SDP will require a minimum $50,000 settlement amount to resolve the matter, which the OIG based on its statutory authority to impose a penalty of up to $50,000 for each kickback and an assessment of up to three times the remuneration.

Despite this new Open Letter, providers should still consider the SDP as an available option for resolving problematic arrangements involving physicians where the underlying facts can be characterized as a possible anti-kickback violation. While the OIG’s exclusion of matters involving strictly Stark violations from the SDP is a new development, from a settlement perspective, it has always been advantageous to characterize problematic arrangements with physicians disclosed under the SDP as anti-kickback violations where possible. Characterization as an anti-kickback violation is often advantageous because a settlement under the civil monetary penalty law (CMPL) for an anti-kickback violation will typically be significantly lower than a Stark settlement under the CMPL.

While the OIG has closed its doors for self-disclosures of matters that involve purely colorable Stark violations and no colorable violation of the anti-kickback statute, other avenues have always been and remain available for resolving such matters. Other options include disclosures to the Department of Justice, the local Attorney General, and the Medicare contractor, depending on the individual facts and circumstances involved. In addition, while the OIG will no longer accept disclosures involving purely Stark violations through the SDP, in the new Open Letter, the OIG urges providers “not to draw any inferences about the Government’s approach to enforcement of the physician self-referral law” as a result of the OIG’s narrowing of the scope of the SDP. This statement clarifies that providers must continue to comply with the Stark Law or face possible enforcement action for Stark violations, even though the SDP is no longer available for Stark violations.

The complete Open Letter is available at http://www.oig.hhs.gov/fraud/openletters.asp.