[Federal Register: March 11, 2003 (Volume 68, Number 47)]
[Notices]
[Page 11554-11555]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11mr03-57]
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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
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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