[Federal Register Volume 68, Number 47 (Tuesday, March 11, 2003)]
[Notices]
[Pages 11554-11555]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-5774]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office for Civil Rights


Notice of Address for Submission of Requests for Preemption 
Exception Determinations

AGENCY: Office for Civil Rights, HHS.

ACTION: Notification of address for submission of requests for 
preemption exception determinations.

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SUMMARY: This notice advises that, in accordance with the requirements 
of 45 CFR 160.204(b), a request to except a provision of State law from 
preemption by a federal standard, requirement, or implementation 
specification adopted under the Administrative Simplification title of 
the Health Insurance Portability and Accountability Act of 1996 
(HIPAA), Public Law 104-191, must be submitted in writing to the 
Director, Office for Civil Rights, Department of Health and Human 
Services, Mail Stop Room 506F, Hubert H. Humphrey Building, 200 
Independence Avenue, SW., Washington, DC 20201. The requirements for 
submission of a request for an exception determination are described in 
the Supplemental Information below, and can be found at 45 CFR 160.203-
205.

EFFECTIVE DATES: Requests for preemption exception determinations may 
be submitted a the designated address upon publication of this notice.

SUPPLEMENTAL INFORMATION: Section 1178(a)(1) of the Social Security Act 
(the Act), as added by section 262 of HIPAA, Public Law 104-191, 
establishes a general rule that State law provisions which are contrary 
to the standards, requirements, or implementation specifications 
adopted or established by the Secretary of Health and Human Services 
pursuant to the Administrative Simplification title of HIPAA are 
preempted by the Federal requirements. The Act, as amended, at sections 
1178(a)(2), 1178(b) and 1178(c) provides for certain exceptions to this 
general rule. Regulations implementing the preemption rule and its 
exceptions are codified at 45 CFR part 160, subpart B. This notice 
pertains to section 1178(a)(2)(A) of the Act, which sets forth the 
circumstances under which the Secretary of Health and Human Services, 
or his designee, may make a determination that a contrary provision of 
State law will not be preempted by the Administrative Simplication 
title of HIPAA.\1\
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    \1\ The Secretary does not have the legal authority to make 
determinations with respect to the exceptions to preemption in 
section 1178(a)(2)(B), 1178(b) and 1178(c) of the Act. Thus, the 
Secretary will not make exception determinations with respect to 
section 1178(a)(2)(B), which excepts from preemption contrary 
provisions of State law that relate to the privacy of individually 
identifiable health information and, under section 264(c)(2) of 
HIPAA, are ``more stringent'' than the federal requirements. 
Similarly, the Secretary does not have the legal authority to make 
determinations with respect to State laws that are excepted from 
preemption under sections 1178(b), concerning certain State laws 
providing for public health reporting, surveillance, investigation, 
or intervention, or 1178(c), concerning State laws requiring a 
health plan to report or provide access to information concerning 
management audits, financial audits, program monitoring or 
evaluation, or licensure or certificaiton of facilities or 
individuals.
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    Section 1178(a)(2)(A) of the Act provides that requests may be made 
for an exception to the general rule of Federal preemption, where the 
Secretary determines that a contrary provision of State law meets 
certain criteria. These criteria for a Secretarial exception 
determination are set forth at 45 CFR 160.203(a), as follows:
    ``(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.''
    In addition, only State laws that are ``contrary'' to the Federal 
requirements are subject to preemption, and thus eligible for an 
exception determination. See 45 CFR 160.203. As defined at 45

[[Page 11555]]

CFR 160.202, ``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 Administration Simplification provisions of 
HIPAA.
    The regulations also provide that a request to except a provision 
of State law from preemption under 45 CFR 160.203(a) must be submitted 
to the Secretary in writing. If the request is from a State, it must be 
submitted through its chief elected official, or his or her designee. 
The request must: (1) Identify the provision of State law for which the 
exception is requested; (2) identify the particular standard, 
requirement, or implementation specification for which the exception is 
requested; (3) specify the part of the standard or other provision that 
will not be implemented if the exception determination is made or the 
additional data to be collected based on the exception, as appropriate; 
(4) state how the exception determination would affect health care 
providers, health plans and other entities; and (5) the reasons why the 
State law should not be preempted, including how the contrary State law 
meets one or more of the specific criteria in 45 CFR 160.203(a). The 
Secretary may also request additional information that may be necessary 
for him to make the exception determination. See 45 CFR 160.204.
    This notice establishes that, for the purposes of 45 CFR 160.204, 
exception determination requests should be addressed to the Director, 
Office for Civil Rights, Department of Health and Human Services, Mail 
Stop Room 506F, Hubert H. Humphrey Building, 200 Independence Avenue, 
SW., Washington, DC 20201.\2\ To expedite handling, the envelope should 
also state: ``ATTN: Exception Determination Request.''
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    \2\ This notice identifies the address where all exception 
determinations should be submitted. The Secretary delegated to the 
Director of the Office for Civil Rights (OCR) the authority to make 
exception determinations as they may relate to the Privacy Rule. See 
65 FR 82381. The Secretary, or his designee, shall make exception 
determinations with respect to requests concerning the other 
Administrative Simplification Rules.
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    The Federal standard, requirement, or implementation specification 
remains in effect until an exception determination is made. When such 
determinations are made, we will promptly inform the public through 
publication of notice in the Federal Register and on the Department's 
websites, including the OCR Web site at www.hhs.gov/ocr/hipaa/.
    The OCR Web site and the Web site for the Centers for Medicare and 
Medicaid Services, http://www.cms.hhs.gov/hipaa/, may also be consulted 
for more information about the Administrative Simplification provisions 
(including the Privacy Rule). In addition, answers to frequently asked 
questions about preemption and exception determinations will be 
available on the OCR website soon.

FOR FURTHER INFORMATION CONTACT: Susan McAndrew, Office for Civil 
Rights, Department of Health and Human Services, Mail Stop Room 506F, 
Hubert H. Humphrey Building, 200 Independence Avenue, SW., Washington, 
DC 20201. Telephone number: (202) 205-8725.

    Dated: January 29, 2003.
Richard M. Campanelli,
Director, Office for Civil Rights.
[FR Doc. 03-5774 Filed 3-10-03; 8:45 am]
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