On December 28, 2022, the New York State Office of the Medicaid Inspector General (“OMIG”) finalized a significant set of new compliance-related regulations. The rules were initially proposed on July 13, 2022 (see our prior Client Alert on the proposed rules here: https://www.garfunkelwild.com/insights/omig-proposes-significant-new-compliance-program-regulations). The final rules contain minimal revisions to the proposed regulations.
The newly adopted regulations repeal the existing rules governing provider compliance programs (found in 18 NYCRR Part 521), and replace them with three new subparts concerning, respectively: (i) Compliance Programs (18 NYCRR Subpart 521-1); (ii) Medicaid Managed Care Organization Fraud, Waste and Abuse Prevention (18 NYCRR Subpart 521-2); and (iii) OMIG’s Self-Disclosure Program (18 Subpart 521-3).
Enforcement of the compliance program regulations under Subparts 521-1 and 521-2 will commence 90 days after the December 28, 2022 effective date of the regulations (i.e., March 28, 2023).
Some notable changes/clarifications in the final rule include:
- Clarification on the definition of “Effective compliance program”. The final regulations provide that an “effective compliance program” is one that, among other things, “is designed to be compatible with the provider’s characteristics (i.e., size, complexity, resources and culture) ….” In other words, an “effective compliance program” will not be the same for every provider, but needs to take into account individual provider characteristics.
- Revision to Contractual Requirements. Significantly, the final regulations also require that contracts that required providers have with their “contractors” (meaning contractors, agents, subcontractors and independent contractors) specify that the contractors are subject to the required provider’s compliance program, to the extent that they are affected by the required provider’s risk areas (and only within the scope of the contracted authority and affected risk areas). In addition, such contracts must also include termination provisions for failure to adhere to the required provider’s compliance program requirements.
The new regulations also address many other issues – including, for example, important definitional changes, the responsibilities of the compliance officer and the compliance committee, the risk areas to which a compliance program must apply, certification, written policies and procedures, training and education, lines of communication, disciplinary standards, auditing and monitoring, OMIG reviews of provider compliance programs, and more.
A copy of the final regulations and a copy of the summary of assessment of public comment may be found here: https://omig.ny.gov/information-resources/laws-and-regulations.
Garfunkel Wild is available to review your current compliance program and to assist in making any revisions that may be necessary. We are also available to help create and implement compliance programs for those who do not currently have one.