The Centers for Medicare and Medicaid Services (“CMS”) has released its Final Rule regarding the disclosure of affiliations in the provider enrollment process. This rule took effect on November 4, 2019. This rule permits the Secretary to revoke or deny enrollment based on the disclosure of any affiliations that CMS determines poses an undue risk of fraud, waste, or abuse. Although this rule will eventually be applicable to all providers, CMS is starting out with a phase-in approach, where the rule will only be applied to initially enrolling or revalidating providers that CMS has specifically determined may have one or more applicable affiliations.
The Final Rule requires providers and suppliers to disclose any current or previous direct or indirect affiliation with a provider or supplier that has a “disclosable event.” The Final Rule defined a disclosable event as: (1) when the provider or supplier has an uncollected debt; (2) the provider or supplier has been or is currently subject to a payment suspension under a federal health care program; (3) the provider or supplier has been or is currently excluded by the Office of Inspector General (“OIG”) from Medicare, Medicaid, or CHIP; or (4) the provider or supplier has had its Medicare, Medicaid, or CHIP billing privileges denied or revoked.
If an entity or individual is affiliated with a provider or supplier with any of the above-mentioned disclosable events, the Secretary is authorized to deny enrollment when it is determined that this affiliation poses an undue risk of fraud, waste, or abuse. To determine the existence of undue risk, CMS will consider: (1) the length and period of the affiliation; (2) the nature and extent of the affiliation; and (3) the type of disclosable event and when it occurred.