Under what circumstances will HHS grant a State law preemption exception determination?
The Department of Health and Human Services (HHS) may, upon specific request from a State or other entity or person, issue a determination that a contrary State law which meets certain criteria will not be preempted by the Federal requirements. Only State laws that are “contrary” to the Federal requirements are eligible for an exemption determination. As defined by HIPAAs Administrative Simplification Rules, “contrary” means that it would be impossible for a covered entity to comply with both the State and Federal requirements, or that the State law is an obstacle to accomplishing the full purposes and objectives of the Administrative Simplification provisions of HIPAA. See 45 C.F.R. 160.202. A contrary State law is not preempted by the Federal requirements if the Secretary or designated HHS official determines that the request meets one or more of the following criteria, which are set forth in 45 C.F.R. 160.
