By Paul Weidenfeld and Catalina Jandorf
The new Final Rule issued by CMS revising the conditions of participation for home health agencies (HHAs) requires that providers “must ensure” that agencies providing services under arrangement have not been excluded from Medicare, Medicaid or any other federal health care program. Effective July 17, 2017, the rule also states that providers must ensure that such agencies have not had their billing privileges revoked, and that they have not been terminated or been debarred from participating in any government program. In making these requirements a condition of participation, CMS has created an affirmative screening obligation under which they have enforcement authority.
Compliance as a Condition of Participation
By making compliance with exclusion regulations a condition of participation, CMS has raised the stakes for failing to properly screen the exclusion status of vendors or contractors for HHAs while reaffirming the agency’s longstanding concerns about the participation of excluded persons in the Medicare Program. Specifically, CMS has a wide assortment of administrative remedies that can be imposed for failing to meet conditions of participation – including even the ability to terminate a provider from participation in the program itself – all of which are independent from the OIG’s enforcement authorities for exclusion violations.
Guidance that Doesn’t Guide
Under the Final Rule, CMS may now hold an HHA liable for a State Exclusion in addition to a Federal Exclusion, by including Medicaid exclusion screening as a condition of participation. However, as there is no universal list of all Medicaid excluded entities and individuals and the newly published final rule provides no guidance on how this requirement can be met, CMS has created an affirmative obligation without any guidance on how to fulfill it.
In the response to a commenter’s concerns about the difficulties involved in meeting these requirements CMS stated that it “appreciates the opportunity to clarify [the] requirement” but it did not actually speak to the State issue. The agency discussed the Federal exclusion lists but failed to address how an HHA could screen for a Medicaid exclusion. It provided that self-certification is an appropriate mechanism in identifying denial of Medicare or Medicaid enrollment or in verifying debarment from government programs, but maintained that an HHA will still be held responsible for failing to properly screen a contracted entity that is providing “services under arrangement”. This lack of guidance in screening requirements could be potentially problematic for a home health agency that relies solely on self-certification or just screening the Federal exclusion lists to weed out excluded entities.
We think it is clear at this point that the mandated screening requirements consist of checking the List of Excluded Individuals and Entities (LEIE) and the System for Award Management (SAM) for a Medicare exclusion upon hire and every 30 days thereafter. However, since the final rule does not clearly articulate what agencies must do to meet these requirements – particularly insofar as they involve Exclusions imposed by State and their Medicaid Fraud Control Units – home health agencies are left without clear guidance as to how to meet this requirement and are well advised to employ a broad exclusion screening protocol.
The best way to remain in compliance and avoid a Medicare or Medicaid Exclusion is to screen all employees, contractors, and vendors every month against all 41 state lists in addition to the LEIE and SAM.
Are you taking the necessary precautions to ensure you are not working with an excluded entity? We know it can be difficult to screen every Federal and State exclusion list. Call Exclusion Screening at 1-800-294-0952 or fill out the form below to hear about our cost-effective solution and for a free quote and assessment of your needs.
Paul Weidenfeld is a nationally recognized expert in health care fraud litigation and the Federal False Claims Act. A former Department of Justice National Health Care Fraud Coordinator, he is currently in private representing health care providers and individuals, and a co-founder of Exclusion Screening, LLC.
Catalina Jandorf is a 3L at American University Washington College of Law. She has experience working in health care as a law clerk at the Department of Health and Human Services Office of Counsel to the Inspector General and Inova Health System Office of the General Counsel.