CMS Pub. 100-18, ch. 9, § 50.7.3

42 C.F.R. §§ 422.503(b)(4)(vi)(G), 423.504(b)(4)(vi)(G)

Self-reporting of FWA and Medicare program noncompliance is voluntary. CMS

nonetheless strongly encourages self-reporting as an important practice in

maintaining an effective compliance program. Sponsors should self-report potential

FWA discovered at the plan level, and potential fraud and abuse by FDRs, as well as

significant waste and significant incidents of Medicare program noncompliance.

Where sponsors notify the MEDICs of potential FWA in accordance with the

guidelines described below, the MEDICs will refer potential FWA to law

enforcement when appropriate. Issues that are referred to the NBI MEDIC and are

determined not to be potential FWA will be returned to the sponsor to be addressed.

Sponsors are required to investigate potential FWA activity to make a

determination whether potential FWA has occurred. Sponsors must conclude

investigations of potential FWA within a reasonable time period after the activity is

discovered. If after conducting a reasonable inquiry, the sponsor (e.g., the

compliance officer or SIU) determines that potential FWA related to the Medicare

Parts C or D programs has occurred, the matter should be referred to the NBI

MEDIC promptly. Sponsors should also refer potential FWA at the FDR levels to

the NBI MEDIC so that the NBI MEDIC can help identify and address any scams

or schemes.

Sponsors should also consider reporting potentially fraudulent conduct to

government authorities such as the Office of Inspector General (through the OIG’s

Provider Self-Disclosure Protocol) or the Department of Justice. All health care

providers doing business with Medicare that want to disclose violations of law are

eligible to disclose fraudulent conduct under the Provider Self-Disclosure Protocol.

The Protocol offers a detailed step-by-step explanation of how a provider should

proceed in reporting and assessing the extent of potential fraud and how the OIG

will go about verifying irregularities.

Where a sponsor discovers an incident of significant Medicare program

noncompliance, the sponsor should report the incident to CMS as soon as possible

after its discovery. This will enable CMS to provide guidance to the sponsor on

mitigation of the harm caused by the incident of noncompliance. While no bright

line definition exists as to what is a “significant” or “serious” incident that should be

reported, sponsors should err on the side of over-reporting rather than under-reporting.

Self-reporting offers sponsors the opportunity to minimize the potential cost and

disruption of a full scale audit and investigation, to negotiate a fair monetary

settlement, and to potentially avoid an OIG permissive exclusion preventing the

entity from doing business with Federal health care programs.