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Provider Self Disclosure Protocol

What is the Provider Self-Disclosure Protocol?

The Provider Self-Disclosure Protocol (SDP) provides guidance to providers who voluntarily decide to disclose irregularities in their dealings with Federal health care programs. The SDP offers specific steps, including a detailed audit methodology and appropriate information to include in an investigative report, if providers wish to openly and cooperatively work with the OIG to quantify and resolve a particular problem. As part of the SDP, no limitations are set on the conditions under which a provider may disclose information to the OIG.

Why should I self-disclose any irregularities in dealing with federal health care programs?

OIG strongly believes that health care providers must be willing to police themselves, correct underlying problems, and work with the Government to resolve irregularities. Ultimately, this will encourage a higher level of ethical and lawful conduct in the health care industry.

Providers who demonstrate diligence, good faith, and ongoing cooperation throughout the self-disclosure process may pay lower settlement amounts. In some cases, OIG may also opt to forgo excluding providers from Federal health care programs if they have an effective compliance program or are willing to develop one.

Who can participate in the Provider Self-Disclosure Protocol?

The Provider Self-Disclosure Protocol (SDP) is open to all health care providers, whether individuals or entities, and is not limited to any particular industry, medical specialty, or type of services. There are no pre-disclosure requirements, applications for admission, or preliminary qualifying characteristics.

Providers cannot self-disclose an issue if it is already under investigation.

Which types of issues can or cannot be self-disclosed?

The Provider Self-Disclosure Protocol (SDP) is intended to facilitate the resolution of only matters that, in the provider’s reasonable assessment, potentially violate Federal criminal, civil, or administrative laws.

The SDP should not be used for mere billing errors or overpayments. Billing errors and overpayments should be reported to the contractor responsible for processing claims and issuing payments on behalf of the federal health care program.

Providers cannot self-disclose an issue if it is already under investigation.

Also, OIG no longer accepts disclosure that involves only liability under the physician self-referral law in the absence of a colorable anti-kickback statute violation. (To self-disclose potential violations of the self-referral law, visit the Self-Referral Disclosure Protocol section of the Centers for Medicare & Medicaid Services website.)

OIG will accept providers into the SDP if the disclosed conduct involves colorable violations of the anti-kickback statute, whether or not it also involves colorable violations of the physician self-referral law. A minimum $50,000 settlement is required to resolve kickback-related submissions.

How do I self-disclose an irregularity?

Initial disclosure begins with a written submission that provides the:

  • name, address, provider identification number(s), tax identification number(s), and fiscal intermediary name and contact information of the disclosing health care provider;
  • a description of the provider’s internal investigation or a commitment that it will be complete within 3 months;
  • an estimate of damages to the affected Federal health care programs and the methodology used to calculate that figure, or a commitment that such an estimate will be complete within 3 months;
  • whether the provider has knowledge that the matter is under current inquiry by the Government agency or contractor;
  • a full description of the conduct being disclosed, including the type of claim, transactions, or other conduct and the names and roles of those involved.
  • a statement of laws potentially violated by the self-disclosed conduct; and
  • a certification by the health care provider or authorized representative that the self-disclosure submission contains truthful information and is based on a good faith effort.

Once it receives the disclosure submission, OIG will verify all the received information. The extent of the verification effort will depend on the quality of the information received.

What types of penalties do I face for self-disclosure?

Because a provider’s disclosure can involve anything from a simple error to outright fraud, OIG cannot reasonably make firm commitments as to how a particular disclosure will be resolved or the specific benefits provided to the disclosing entity.

However, self-disclosure opens a dialogue between the OIG and the provider, which can assist in resolving any potential liabilities. Providers typically pay less to settle cases, avoid potential exclusion from Federal health programs or avoid a Corporate Integrity Agreement (link to Corporate Integrity Agreement on OIG site).

The degree of a provider’s cooperation is considered when determining the appropriate terms of an administrative settlement. Full cooperation and a timely self-assessment are essential to successful self-disclosure. OIG will not continue to work with a provider who attempts to circumvent an ongoing inquiry or fails to fully cooperate in the self-disclosure process.

What is the involvement of other Government agencies, including the Department of Justice?

OIG may confer with the Department of Justice to ensure that it is aware of each disclosure and has an opportunity to offer its opinion before the OIG accepts a provider into the Provider Self-Disclosure Protocol (SDP).

It is important to stress that the OIG’s agreement to resolve an SDP matter is not binding upon the DOJ.

OIG also consults with other affected Government agencies, as needed.

Where should I send a self-disclosure submission?

Disclosures must be made in writing and mailed to:
Assistant Inspector General
Office of Inspector General, Department of Health and Human Services
330 Independence Avenue, SW
Cohen Building, Room 5409
Washington DC 20201

Submissions are not accepted by telecopier, fax, email or other electronic media.

What resources can I use to learn about the Provider Self-Disclosure Protocol?

Office of Inspector General, U.S. Department of Health and Human Services | 330 Independence Avenue, SW, Washington, DC 20201