CMS Pub. 100-18, ch. 9, § 50.7.1

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

Sponsors must conduct a timely and well-documented reasonable inquiry into any

compliance incident or issue involving potential Medicare program noncompliance

or potential FWA.

Program noncompliance and FWA may occur at the level of the sponsor or its

FDRs. It may be discovered through a hotline, a website, an enrollee complaint,

during routine monitoring or self evaluation, an audit, or by regulatory authorities.

Regardless of how the noncompliance or FWA is identified, sponsors must initiate a

reasonable inquiry as quickly as possible, but not later than 2 weeks after the date

the potential noncompliance or potential FWA incident was identified.

A reasonable inquiry includes a preliminary investigation of the matter by the

compliance officer or a delegated member of his/her staff and/or the sponsor’s SIU.

If the issue appears to involve potential fraud or abuse and the sponsor does not

have either the time or the resources to investigate the potential fraud or abuse in a

timely manner, it should refer the matter to the NBI MEDIC within 30 days of the

date the potential fraud or abuse is identified so that the potentially fraudulent or

abusive activity does not continue.

Sponsors are responsible for monitoring for FWA and Medicare program

noncompliance within their organizations. When serious noncompliance or waste

occurs, CMS strongly encourages sponsors to refer the matter to CMS. When

potential fraudulent or abusive activity is identified, CMS strongly encourages

sponsors to refer the matter to the appropriate MEDIC (currently, the NBI

MEDIC).