The Office of the Inspector General (OIG) of the Department of Health and Human Services (HHS) along with other federal agencies who enforce the regulations that apply to diagnostic labs have called on these healthcare facilities to implement compliance plans.
What regulations are applicable?
Diagnostic labs need to abide by a number of federal regulations. Examples include the Anti-Kickback Statute (AKS), Stark Law and, most recently, the Eliminating Kickbacks in Recovery Act (EKRA). Additional state and local regulations may also apply.
What is the OIG looking for in a compliance plan?
The OIG states that compliance plans, in the least, should include written standards for the conduct of employees within the lab, clear communication with employees about the lab’s focus on compliance to avoid potential billing and marketing claims processing fraud, a clearly named chief compliance officer, education and training on compliance for all employees, use of internal audits to better ensure compliance and the ability for employees to anonymously report any failures to comply.
A privately run audit should include a review of the compliance policies as well as federal and state laws. Business leaders may need to update the policies within the compliance plan to reflect changes in applicable regulations. The OIG also encourages facilities to include a clear discipline structure for failures to abide by the plan.
What happens if the lab does not properly implement the plan?
A failure to implement a compliance plan can set a lab up for failure. This is because the presence of a plan can lead to a false sense of security if the provisions are not applied. The OIG has stated it “will be critical” of those who have, but fail to enforce, a compliance plan. As a result, diagnostic labs and their leadership team should take allegations of a violation seriously. Depending on the details of allegations of a violation, the government could pursue criminal penalties included fines and potential imprisonment.