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Provider Self-Disclosure Protocol

Overview

If an organization detects evidence of possible fraud, it may voluntarily make a report under the OIG Provider Self-Disclosure Protocol (SDP). 63 Fed. Reg. 58,399 (Oct. 30, 1998). On April 15, 2008, the OIG issued an Open Letter to Health Care Providers regarding clarifications to the SDP in an effort to increase the efficiency of self-disclosures. See http://oig.hhs.gov/fraud/docs/openletters/OpenLetter4-15-08.pdf. Later, on March 24, 2009, the OIG wrote an “Open Letter” to health care providers containing what the agency has described as “refinements” to the OIG's SDP (the 2009 Open Letter). See http://oig.hhs.gov/fraud/docs/openletters/OpenLetter3-24-09.pdf. In the 2009 Open Letter the OIG announced two policy changes that serve to: (i) clarify when the SDP should be used to address potential physician self-referral (Stark Law) violations (e.g., only when combined with colorable Anti-Kickback Statute noncompliance); and (ii) narrow the applicability of the OIG's April 24, 2006, Open Letter, in which the OIG had encouraged providers to utilize the SDP to voluntarily disclose potential violations under both the Stark Law and the Anti-Kickback Statute. In the 2009 Open Letter, the OIG also announced that it will impose a minimum civil monetary penalty of $50,000 for noncompliance with the Stark Law and the Anti-Kickback Statute reported under the SDP.

Authority

The 2009 Open Letter is the OIG's latest step aimed at encouraging providers' voluntary compliance with federal program standards. It comes at a time when other developments, along with political and economic conditions, have made the stakes higher than ever for providers' compliance programs. On the federal level, both relators and the government are becoming more aggressive and expansive in their interpretation of the scope of the Stark Law and the Anti-Kickback Statute and using them as a predicate.

Excerpt from Janine Sarti, Asha B. Scielzo, Navigating the Compliance and Governance Landscape: A Glossary of Key Terms, Fundamentals of Health Law (American Health Lawyers Association Nov. 2011).

Future Direction

On September 23, 2010, the Department of Health and Human Services (HHS), in cooperation with the OIG, issued its Voluntary Self-Referral Disclosure Protocol (SRDP). OMB Control No. 0938-1106.http://www.healthlawyers.org/News/Health Lawyers Weekly/Pages/Forms/DispForm.aspx?ID=7490 - _edn2 The SRDP was developed in response to a mandate in the Affordable Care Act (ACA), Pub. L. No. 111-148, 124 Stat. 119, to be codified as amended in various sections of 42 U.S.C, directing the Secretary of HHS (Secretary) to establish a Medicare self-referral protocol that articulates a process for providers and suppliers to self-disclose actual or potential violations of the Stark Law.

The Secretary notes that the SRDP “is intended to facilitate the resolution of . . . actual or potential violations of the physician self-referral law.” It reinstates an option for dealing with possible Stark Law violations—voluntary disclosure to HHS—that has not existed for pure Stark Law violations since March 24, 2009, when the OIG limited its program to cases involving colorable violations of the Anti-Kickback Statute.

Section 6409 of the ACA gave the Secretary authority to reduce the amount due and owing for all violations of the Stark Law with no particular requirement to tie the settlement or amount of payment to the value of submitted claims or any other particular benchmark. Congress provided, however, that the Secretary may consider the following when resolving disclosed matters:

• the nature and extent of the improper or illegal practice;

• the timeliness of the disclosure;

• the cooperation of the disclosing party in providing additional information related to the disclosure; and

• such other factors as the Secretary deems appropriate.

Section 6409(a)(3) of the ACA confirms that the SRDP is separate from the established advisory opinion process. 42 C.F.R. §§ 411.370 – 389. A provider or supplier may not disclose circumstances under the SRDP while simultaneously requesting an advisory opinion relating to the same circumstances.

The SRDP is available to all healthcare providers of services and suppliers, whether individuals or entities. It is not limited to any industry, medical specialty, or type of service. A disclosing party that is already subject to government inquiry through investigations, audits, or routine oversight may still avail itself of the SRDP in good faith. A disclosing party that endeavors to circumvent an ongoing inquiry or fails to fully cooperate in the self-disclosure process, however, will be removed from the SRDP.

The SRDP is limited to actual or potential violations of the Stark Law. The OIG Protocol remains available to address potential liabilities under other federal criminal, civil, or administrative laws. If conduct that is an actual or potential Stark Law violation also presents Civil Monetary Penalty or Anti-Kickback Statute risks, it should be disclosed through the OIG Protocol, and not the SRDP. Parties should not attempt to use both protocols simultaneously.

Excerpt from Gerald Griffith and Frank Sheeder, Jones Day, The New Stark Voluntary Disclosure Protocol—Does It Help Providers?, Health Lawyers Weekly, vol. 8, no. 38 (Oct. 1, 2010).