The attorneys at DiRuzzo & Company represents health care providers in submitting self-disclosures the U.S. Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) and the Centers for Medicare & Medicaid Services (“CMS”) for potential civil Anti-Kickback Law, Stark Laws, and civil False Claim Act violations.

HHS has established a health care provider Self-Disclosure Protocol, which provides for a process for health care providers to voluntarily identify, disclose, and resolve instances of potential fraud involving the federal health care programs (as defined at 42 U.S.C. § 1320a–7b(f)). The Provider Self-Disclosure Protocol provides guidance on how to investigate this conduct, quantify damages, and report the conduct to OIG to resolve a health care provider’s liability under OIG’s Civil Monetary Penalties Law. See 42 U.S.C. § 1320a–7a; 42 C.F.R. § 1003.102.

All health care providers, suppliers, or other individuals or entities who are subject to OIG’s Civil Monetary Penalties authorities found at 42 C.F.R. Part 1003 are eligible to use the Self-Disclosure Protocol. The Self-Disclosure Protocol is not limited to any particular industry, medical specialty, or type of service. The Self-Disclosure Protocol is available to facilitate the resolution of matters that, in the disclosing party’s reasonable assessment, potentially violate federal criminal, civil, or administrative laws for which Civil Monetary Penalties are authorized.

The Self-Disclosure Protocol provides potential significant benefits to health care providers.

First, good faith disclosure of potential fraud and cooperation with OIG’s review and resolution process are typically indications of a robust and effective compliance program. As a result, the OIG has instituted a presumption against requiring integrity agreement obligations in exchange for a release of OIG’s permissive exclusion authorities in resolving a Self-Disclosure Protocol matter.

Second, the OIG typically takes the position that individuals or entities that use the Self-Disclosure Protocol and cooperate with OIG during the Self-Disclosure Protocol process deserve to pay a lower multiplier on single damages than would normally be required in resolving a Government-initiated investigation. The specific multiplier that the OIG accepts may vary depending on the facts of each case. OIG’s general practice in Civil Monetary Penalties Law settlements of Self-Disclosure Protocol matters is to require a minimum multiplier of 1.5 times the single damages, although the OIG determines in each individual case whether a higher multiplier may be warranted.

Third, the OIG typically takes the position that using the Self-Disclosure Protocol may mitigate potential exposure under 42 U.S.C. 1320a-7k(d), which requires that a Medicare or Medicaid overpayment be reported and returned by the later of (1) the date that is 60 days after the date on which the overpayment was identified or (2) the date any corresponding cost report is due, if applicable. Any retained overpayment may create liability under the Civil Monetary Penalties Law and the civil False Claims Act, 31 U.S.C. 3729.

However, the Self-Disclosure Protocol is not available for a matter that does not involve potential violations of Federal criminal, civil, or administrative law for which Civil Monetary Penalties are authorized, such as one exclusively involving overpayments or errors. Additionally, the Self-Disclosure Protocol is not available to request an opinion from OIG regarding whether an actual or potential violation has occurred. For example, a disclosure that broadly describes a business arrangement and requests a determination from OIG regarding whether the arrangement violates the Anti-Kickback Statute, 42 U.S.C. § 1320a-7b, is not appropriate for the Self-Disclosure Protocol. The Advisory Opinion process is the only vehicle to obtain an OIG opinion. Finally, the Self-Disclosure Protocol is not available for disclosure of an arrangement that involves only liability under physician self-referral statute (a/k/a the Stark Law, 42 U.S.C. § 1395nn; 42 C.F.R. § 411.353 et seq.), without accompanying potential liability under the federal Anti-Kickback Statute for the same arrangement. Disclosing parties must analyze each arrangement involving a physician to determine whether it raises potential liability under the federal Anti-Kickback Statute, the Stark Law, or both laws. Stark-only conduct is disclosed to the CMS through its Self-Referral Disclosure Protocol.

The Patient Protection and Affordable Care Act (“ACA”) required CMS to establish a Self-Referral Disclosure Protocol that sets forth a process to enable providers of services and suppliers to self-disclose actual or potential violations of the Stark Law. The Self-Referral Disclosure Protocol is open to all health care providers of services and suppliers, whether individuals or entities, and is not limited to any particular industry, medical specialty, or type of service.

The Self-Referral Disclosure Protocol is intended to facilitate the resolution of only matters that, in the disclosing party’s reasonable assessment, are actual or potential violations of the Stark Law. Thus, a health care provider makes a submission under the Self-Referral Disclosure Protocol with the intention of resolving the health care provider’s overpayment liability exposure for the self-identified improper conduct. If a health care provider complies with the Self-Referral Disclosure Protocol, CMS will suspend the 60-day deadline to refund overpayment until a settlement agreement is entered into with CMS.

In establishing the amount by which an overpayment resulting from an actual or potential violation(s) may be reduced, the following factors are considered: the nature and extent of the improper or illegal practice; the timeliness of such disclosure; the cooperation in providing additional information related to the disclosure; and such other factors as the Secretary considers appropriate. Section 6409(a)(3) of the ACA explicitly states that the Self-Referral Disclosure Protocol is separate from the advisory opinion process set forth in 42 C.F.R. §§ 411.370 - 411.389. Thus, a provider of services or supplier may not disclose an actual or potential violation(s) through the Self-Referral Disclosure Protocol and request an advisory opinion for conduct underlying the same arrangement(s) concurrently.

However, it is important to note that the Federal Anti-Kickback Statute and the False Claims Act are federal statutes enforced by the OIG and the Department of Justice, respectively. Liability under those laws is not released under the Self-Referral Disclosure Protocol.