While the implementation of compliance programs to encourage the development and use of internal controls to monitor adherence of the health care industry to applicable statutes, regulations, and program requirements has long been considered a best practice, the Patient Protection and Affordable Care Act (“ACA”) has made them mandatory. Sections 6102 and 6401 of the ACA mandate that skilled nursing facilities (“SNF”), nursing facilities (“NF”), and other health care providers and suppliers enrolled in Medicare, Medicaid, and the Children’s Health Insurance Program adopt compliance programs as a condition of enrollment by March 23, 2013.
The SNF/NF compliance program requirements are detailed in the statute and outline eight required components that generally mirror the obligations for compliance programs set forth in a series of voluntary compliance program guidance documents published by the Office of Inspector General (“OIG”) of the Department of Health and Human Services (“DHHS”) over the past 15 years directed at various segments of the health care industry.
The eight required components for SNF/NF compliance programs include:
- Establishment of compliance standards and procedures to be followed by employees and other agents;
- Designation of high-level personnel to oversee compliance with sufficient resources and authority to assure such compliance;
- Avoidance of delegating substantial discretionary authority to individuals whom the nursing facility knew or should have known have a “propensity to engage in criminal, civil, or administrative violations”;
- Communication of compliance standards and procedures to all employees and agents, including training programs or published materials;
- Adoption of monitoring and auditing systems as well as reporting systems that include anti-retaliation protections for employees who report suspected offenses;
- Consistent enforcement of standards through disciplinary action;
- Development of a process for investigation of suspected violations and reporting to the government and law enforcement authorities when necessary; and
- Periodic reviews of the compliance program to identify any necessary modifications.
Although the ACA required DHHS to promulgate regulations for SNF/NF compliance programs by March 23, 2012, DHHS has yet to do so. In the interim, SNFs and NFs may still look to the OIG Compliance Program Guidance for Nursing Facilities published in March 2000 (https://oig.hhs.gov/authorities/docs/cpgnf.pdf) and the OIG Supplemental Compliance Program Guidance for Nursing Facilities published in September 2008 (https://oig.hhs.gov/compliance/compliance-guidance/docs/complianceguidance/nhg_fr.pdf) until regulations are issued.
In contrast, Congress left much to DHHS’ discretion for other providers/suppliers as it did not provide details or set forth a timeline for the implementation of other provider/supplier compliance programs. However, as with SNFs and NFs, other providers can use the various OIG Compliance Program Guidance documents (i.e., physician groups, clinical labs, suppliers) applicable to the provider type. The OIG’s voluntary compliance program guidance documents can be found online at https://oig.hhs.gov/compliance/compliance-guidance/index.asp.
Mandatory compliance is here – are you prepared?