On April 17, 2013, the Office of Inspector General (OIG) of the United States Department of Health and Human Services (HHS) published the revised Provider Self-Disclosure Protocol (SDP), which replaces and supersedes the original SDP issued in 1998, as well as the three Open Letters providing additional guidance in 2006, 2008, and 2009. The SDP establishes a process for health care providers to voluntarily identify, disclose, and resolve instances of potential fraud involving federal health care programs, including guidance on how to investigate the conduct, quantify damages, and report the conduct. The revised SDP, which comes after the OIG’s June 18, 2012 solicitation for public comments, clarifies the eligibility requirements for participation in the process, sharpens the requirements for the disclosure submission, outlines methods of calculating damages, and expedites the time frame for the disclosing party to complete its internal investigation and damages calculation.
Among the “significant benefits” to an organization that self-discloses fraudulent conduct to the OIG, the revised SDP lists: (1) an institutional presumption against requiring integrity agreement obligations in exchange for a permissive exclusion release; (2) a lower multiplier (typically, 1.5 times) on single damages than would normally be required in resolving a government-initiated investigation; and (3) based on anticipated rule changes to be made by the Centers for Medicare & Medicaid Services (CMS), suspension of the obligation under Section 1128J of the Social Security Act to report overpayments so long as the SDP submission is timely made, and suspension of the obligation to return overpayments until the disclosure matter has been resolved.
Including a streamlined process and timely resolution of SDP events among the benefits of the program, the revised SDP shortens the time period for disclosing parties to complete their internal investigations and damages calculations. Under the new SDP, disclosing parties must submit their investigative findings and estimated damages within 90 days of making their initial submission under the SDP, instead of within 90 days of acceptance into the SDP.
Eligibility for the SDP
The revised SDP clarifies that the SDP is not limited to any particular industry, medical specialty, or type of service. All individuals or entities subject to the OIG’s Civil Monetary Penalties (CMP) authority, including pharmaceutical or medical device manufacturers, are eligible to use the SDP. If a disclosing party is already the subject of a government investigation, the party may still use the SDP, as long as the disclosure is made in good faith and is not an attempt to circumvent any ongoing inquiry. Parites under Corporate Integrity Agreements (CIA) may also use the SDP in addition to making any reports required in the CIA.
The SDP may be used to resolve liability for potential violations of federal criminal, civil, or administrative laws for which CMPs are authorized. The revised SDP specifies, however, that a disclosing party must acknowledge that the conduct is a potential violation, and explicitly identify the laws that were potentially violated. Conduct that is not eligible for the SDP includes: (1) matters exclusively involving overpayments or errors; (2) requests for OIG opinions as to whether actual or potential violations may have occurred; and (3) arrangements that involve only liability under the physician self-referral law (the Stark Law) and do not also include liability under the Anti-Kickback Statute (AKS).
As a condition for acceptance into the SDP, the disclosing party must agree to waive any statute of limitations defenses to any administrative actions related to the disclosed conduct (unless that defense would have been available on the date of submission). The disclosing party is also required to ensure that the conduct has ended and/or that corrective action will be taken.
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