Paused by the Pandemic: CMS Delays Affiliation Disclosure Requirements
On March 24, 2021, in an MLN Matters Special Edition Article SE21003 (the “Article”) CMS announced, “In light of the pandemic and various other factors, we will not begin updating the Form CMS-855 applications with affiliation disclosure sections for at least another 12 months.” However, CMS indicates it intends to implement and enforce the affiliation disclosure requirements on a discretionary basis.
This announcement delivers a substantial postponement of CMS’ affiliation disclosure requirements. On September 10, 2019, CMS issued a Final Rule endeavoring to “stop fraud before it happens by keeping problematic providers and suppliers out of our Federal health insurance programs.” Namely, the Final Rule, “Program Integrity Enhancements to the Provider Enrollment Process,” (CMS-6058-FC) created new obligations for Medicare providers and suppliers to disclose information on any affiliations with individuals or entities subject to “disclosable events” as defined in in 42 C.F.R. § 424.502, such as an uncollected debt to Medicare, Medicaid, or CHIP or any exclusion, suspension, or termination from federal healthcare programs. While CMS initially proposed requiring affiliation disclosures from all providers and suppliers on all initial and revalidation Medicare enrollment applications, the Final Rule adopted a "phased-in" approach to the affiliation disclosure provisions.
Pursuant the Article, CMS will issue affiliation disclosure requests on a case-by-case basis. CMS notes that it retains the authority to request that a provider or supplier disclose all applicable affiliations upon becoming aware that the provider or supplier likely has at least one potentially problematic affiliation and warns that CMS may become aware of an affiliation through internal data or other means. Nevertheless, CMS will not request routine affiliation disclosures until it revises Form CMS-855 applications – including online Provider Enrollment Chain and Ownership System (PECOS) applications – to include affiliation disclosure sections, which the Article suggests will not occur for at least 12 months.
As required under the Final Rule, a provider or supplier in receipt of a CMS request for affiliation disclosure must disclose any and all affiliations that it or any of its owning or managing employees or organizations has had within the previous 5 years with a currently or formerly enrolled Medicare, Medicaid, or CHIP provider or supplier that has a disclosable event.
The immediate impact of the Article, certainly, is that providers and suppliers are now afforded an additional 12 months to curate all requisite affiliation information in advance of a CMS affiliation disclosure request and/or the revised enrollment materials. It will behoove providers and suppliers to proactively define its own direct affiliations and determine its own disclosable events, while also requiring development of a process to collect and maintain this information from each of its direct affiliates, including investors, leaders, and professionals. It also demonstrates that CMS has not walked away from the Final Rule. Rather, the Article suggests that CMS fully intends to implement the Final Rule after the current Public Health Emergency subsides and normal operations resume.