The OIG offers providers an opportunity to self-report certain violations under its Health Care Fraud Self-Disclosure Protocol.
If you uncover a violation of federal healthcare laws or requirements – through your own internal auditing process, a staff report, or another method – it is often the best course of action to self-report the violation instead of waiting for the OIG to take the next steps.
Benefits of OIG Self-Disclosure
The OIG does not guarantee immunity under its Self-Disclosure Protocol, merely stating the self-reporting “could be a mitigating factor” in their recommendation to prosecuting agencies.
However, the OIG Self-Disclosure Protocol generally benefits the provider in several ways:
- The OIG views a good-faith disclosure as an indication of a robust and effective compliance program. As a result, many self-disclosed violations are resolved through settlements that do not involve exclusion from participation in federal healthcare programs.
- The OIG believes that entities that self-disclose and cooperate deserve to pay a lower multiplier on damages than normally would be required in resolving an DOJ-led investigation.
- The Self-Disclosure Protocol may mitigate potential exposure under the Civil Monetary Penalties Law and the False Claims Act.
- Providers can expect a streamlined and less costly review and resolution process upon acceptance into the Self-Disclosure Protocol.
Which Providers Are Eligible for OIG’s Self-Disclosure Protocol?
All providers are eligible to use the Self-Disclosure Protocol. Being subject to an existing government inquiry does not automatically preclude you from participating. The disclosure, however, must be made in good faith and must not be an attempt to circumvent any ongoing inquiry.
If you do detect fraud within your organization, contact a healthcare fraud defense attorney who can guide you through the next steps.
Which Suspected Violations Are Eligible for OIG Self-Disclosure?
The Self-Disclosure Protocol is available to aid in the resolution of matters that potentially violate federal criminal, civil, or administrative laws and could result in civil monetary penalties.
Potential violations eligible for OIG’s Self-Disclosure Protocol include violations of these federal healthcare laws:
- False Claims Act
- Stark Law
- Anti-Kickback Statute
When making your disclosure, you must explicitly identify the laws that were potentially violated. The OIG emphasizes that referring broadly to “federal law” or “the False Claims Act” in the disclosure will be considered an unclear or incomplete submission. You will not generate the goodwill and benefits available by participating in the process unless you are specific.
Compliance issues that would not result in civil monetary penalties, such as overpayments or coding errors, should be reported to the Centers for Medicare & Medicaid Services (CMS) and are not eligible for the Self-Disclosure Protocol.
What About CMS’s 60-Day Rule?
The OIG Self-Disclosure Protocol is distinct from Medicare’s 60-day Rule. The 60-Day Rule requires Medicare providers and suppliers to report and return self-identified overpayments within 60 days of the discovery. The lookback period for the 60-Day Rule is six years.
The current rule states that a person has “identified” an overpayment when the person has or should have, through the exercise of reasonable diligence, determined that the person has received an overpayment and quantified the amount of the overpayment.
In its commentary on the final regulations concerning the 60-day Rule, CMS described "reasonable diligence" to include both "proactive compliance activities conducted in good faith by qualified individuals to monitor for the receipt of overpayments" and "investigations conducted in good faith and in a timely manner by qualified individuals in response to the receipt of credible information of a potential overpayment." CMS allows that these good-faith investigations may take up to six months to complete.
An overpayment retained by a person after the 60-day deadline becomes a False Claims Act violation and may then qualify for the OIG’s Self-Disclosure Protocol.
A healthcare fraud defense attorney can help you distinguish if your matter qualifies for OIG Self-Disclosure Protocol or the 60-day Rule, or may require some other proactive compliance strategy.
