On April 17, 2013, the US Department of Health and Human Services, Office of Inspector General (HHS-OIG) released an updated provider self-disclosure protocol (SDP). The updated SDP supersedes and replaces the original 1998 SDP and various HHS-OIG Open Letters that amended the 1998 SDP.
View a copy of the April 17 protocol
To assist providers contemplating a voluntary disclosure, the new SDP offers specific guidance with respect to three of the most common types of disclosures: (1) disclosures involving false billing, (2) disclosures involving items or services furnished by excluded persons (3) and disclosures involving the federal health care program anti-kickback statute and the federal physician self-referral (Stark) law.
The revised SDP notes that HHS-OIG's general practice is to require a minimum multiplier of 1.5 times the single damages at issue (although in each case, the agency determines whether a higher multiplier would be appropriate). HHS-OIG generally applies this multiplier to the amount paid by the Federal health care programs in question, and not to the amount claimed. There are, however, certain minimum settlement amounts: $50,000 for kickback-related submissions and $10,000 for all other submissions.
The revised SDP discusses the overpayment rule proposed by the Centers for Medicare & Medicaid Services (CMS) back in February 2012 (which has not yet been finalized). Consistent with the CMS proposed rule, the HHS-OIG notes that the time for repayment of an identified overpayment will be tolled for the disclosing party. However, HHS-OIG expects disclosing parties to disclose with a good faith willingness to resolve all liability within the CMPL's six year statute of limitations. Moreover, HHS-OIG requires disclosing parties, as a condition precedent to the HHS-OIG's acceptance into the SDP, to waive and not plead statute of limitations, laches, or any similar defenses to any administrative action filed by HHS-OIG to the disclosed conduct.
According to HHS-OIG, the SDP is not available to providers with respect to:
- matters that do not involve potential violations of Federal criminal, civil, or administrative law, such as matters exclusively involving overpayments or errors;
- requests for an HHS-OIG opinion as to whether an actual or potential violation has occurred; or
- arrangements that implicate the (civil) Stark law only, and do not appear to trigger potential liability under the federal health care program anti-kickback statute AKS. (Stark law matters should be disclosed to the CMS.)
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