[Code of Federal Regulations]
[Title 45, Volume 1]
[Revised as of October 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 45CFR160.203]

[Page 672-673]
 
                        TITLE 45--PUBLIC WELFARE
 
                           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
    (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 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

[[Page 673]]

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.

    Effective Date Note: At 67 FR 53266, Aug. 14, 2002, in Sec. 160.203, 
paragraph (b) was amended by adding the words ``individually 
identifiable'' before ``health'', effective Oct. 15, 2002.