[Code of Federal Regulations]

[Title 45, Volume 1]

[Revised as of October 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 45CFR160.203]



[Page 710-711]

 

                        TITLE 45--PUBLIC WELFARE

 

                    SUBTITLE A--DEPARTMENT OF HEALTH

                           AND HUMAN SERVICES

 

PART 160_GENERAL ADMINISTRATIVE REQUIREMENTS--Table of Contents

 

                    Subpart B_Preemption of State Law

 

Sec.  160.203  General rule and exceptions.



    A standard, requirement, or implementation specification adopted 

under this subchapter that is contrary to a provision of State law 

preempts the provision of State law. This general rule applies, except 

if one or more of the following conditions is met:

    (a) A determination is made by the Secretary under Sec.  160.204 

that the provision of State law:

    (1) Is necessary:

    (i) To prevent fraud and abuse related to the provision of or 

payment for health care;

    (ii) To ensure appropriate State regulation of insurance and health 

plans to the extent expressly authorized by statute or regulation;

    (iii) For State reporting on health care delivery or costs; or



[[Page 711]]



    (iv) For purposes of serving a compelling need related to public 

health, safety, or welfare, and, if a standard, requirement, or 

implementation specification under part 164 of this subchapter is at 

issue, if the Secretary determines that the intrusion into privacy is 

warranted when balanced against the need to be served; or

    (2) Has as its principal purpose the regulation of 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.

    (b) The provision of State law relates to the privacy of 

individually identifiable health information and is more stringent than 

a standard, requirement, or implementation specification adopted under 

subpart E of part 164 of this subchapter.

    (c) The provision of State law, including State procedures 

established under such law, as applicable, provides for the reporting of 

disease or injury, child abuse, birth, or death, or for the conduct of 

public health surveillance, investigation, or intervention.

    (d) The provision of State law requires a health plan to report, or 

to provide access to, information for the purpose of management audits, 

financial audits, program monitoring and evaluation, or the licensure or 

certification of facilities or individuals.



[65 FR 82798, Dec. 28, 2000, as amended at 67 FR 53266, Aug. 14, 2002]