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 HIPAA's 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. 160.203(a):
- The provision of State law is necessary
- to prevent fraud and abuse related to the provision of or payment for health care,
- to ensure appropriate State regulation of insurance and health plans to the extent expressly authorized by statute or regulation,
- for State reporting on health care delivery and costs, or
- for purposes of serving a compelling public health, safety, or welfare need, and, if a Privacy Rule provision is at issue, if the Secretary determines that the intrusion into privacy is warranted when balanced against the need to be served; or
- The principal purpose of the provision of State law is to regulate the manufacture, registration, distribution, dispensing, or other control of any controlled substances (as defined in 21 U.S.C. 802), or that is deemed a controlled substance by State law.
Thus, States and other persons may request in writing that HHS except certain contrary provisions of State law from preemption by the Privacy Rule. The request for exception must explain how the State law in question is actually contrary to the Federal requirements, and how the contrary State law meets one or more of the specific criteria for which exceptions may be granted. Title 45 C.F.R. Part 160, Subpart B, sets forth the specific requirements related to preemption of State law and the criteria and process for requesting exception determinations.
HHS will not make determinations as to whether a provision of State law is "more stringent" than a provision of the HIPAA Privacy Rule, and will not determine whether a provision is "contrary" to the Privacy Rule, except in the context of, and as necessary to, making an exception determination.
See 45 C.F.R. Part 160, Subpart B, for specific requirements related to preemption of State law. An unofficial version of the Privacy Rule and the preemption requirements may be accessed at http://www.hhs.gov/ocr/combinedregtext.pdf (PDF - 2.8MB).
Date Created: 03/12/2003
Last Updated: 12/11/2006