[United States Statutes at Large, Volume 122, 110th Congress, 2nd Session]
[From the U.S. Government Printing Office, www.gpo.gov]

122 STAT. 881

Public Law 110-233
110th Congress

An Act


 
To prohibit discrimination on the basis of genetic information with
respect to health insurance and [NOTE: May 21, 2008 -  [H.R.
493]] employment.

Be it enacted by the Senate and House of Representatives of the
United States of America in Congress [NOTE: Genetic Information Non-
discrimination Act of 2008. 42 USC 2000ff note.] assembled,
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

(a) Short Title.--This Act may be cited as the ``Genetic Information
Nondiscrimination Act of 2008''.
(b) Table of Contents.--The table of contents of this Act is as
follows:

Sec. 1. Short title; table of contents.
Sec. 2. Findings.

TITLE I--GENETIC NONDISCRIMINATION IN HEALTH INSURANCE

Sec. 101. Amendments to Employee Retirement Income Security Act of 1974.
Sec. 102. Amendments to the Public Health Service Act.
Sec. 103. Amendments to the Internal Revenue Code of 1986.
Sec. 104. Amendments to title XVIII of the Social Security Act relating
to medigap.
Sec. 105. Privacy and confidentiality.
Sec. 106. Assuring coordination.

TITLE II--PROHIBITING EMPLOYMENT DISCRIMINATION ON THE BASIS OF GENETIC
INFORMATION

Sec. 201. Definitions.
Sec. 202. Employer practices.
Sec. 203. Employment agency practices.
Sec. 204. Labor organization practices.
Sec. 205. Training programs.
Sec. 206. Confidentiality of genetic information.
Sec. 207. Remedies and enforcement.
Sec. 208. Disparate impact.
Sec. 209. Construction.
Sec. 210. Medical information that is not genetic information.
Sec. 211. Regulations.
Sec. 212. Authorization of appropriations.
Sec. 213. Effective date.

TITLE III--MISCELLANEOUS PROVISIONS

Sec. 301. Severability.
Sec. 302. Child labor protections.

SEC. 2. [NOTE: 42 USC 2000ff note.] FINDINGS.

Congress makes the following findings:
(1) Deciphering the sequence of the human genome and other
advances in genetics open major new opportunities for medical
progress. New knowledge about the genetic basis of illness will
allow for earlier detection of illnesses, often before symptoms
have begun. Genetic testing can allow individuals to take steps
to reduce the likelihood that they will contract

[[Page 882]]
122 STAT. 882

a particular disorder. New knowledge about genetics may allow
for the development of better therapies that are more effective
against disease or have fewer side effects than current
treatments. These advances give rise to the potential misuse of
genetic information to discriminate in health insurance and
employment.
(2) The early science of genetics became the basis of State
laws that provided for the sterilization of persons having
presumed genetic ``defects'' such as mental retardation, mental
disease, epilepsy, blindness, and hearing loss, among other
conditions. The first sterilization law was enacted in the State
of Indiana in 1907. By 1981, a majority of States adopted
sterilization laws to ``correct'' apparent genetic traits or
tendencies. Many of these State laws have since been repealed,
and many have been modified to include essential constitutional
requirements of due process and equal protection. However, the
current explosion in the science of genetics, and the history of
sterilization laws by the States based on early genetic science,
compels Congressional action in this area.
(3) Although genes are facially neutral markers, many
genetic conditions and disorders are associated with particular
racial and ethnic groups and gender. Because some genetic traits
are most prevalent in particular groups, members of a particular
group may be stigmatized or discriminated against as a result of
that genetic information. This form of discrimination was
evident in the 1970s, which saw the advent of programs to screen
and identify carriers of sickle cell anemia, a disease which
afflicts African-Americans. Once again, State legislatures began
to enact discriminatory laws in the area, and in the early 1970s
began mandating genetic screening of all African Americans for
sickle cell anemia, leading to discrimination and unnecessary
fear. To alleviate some of this stigma, Congress in 1972 passed
the National Sickle Cell Anemia Control Act, which withholds
Federal funding from States unless sickle cell testing is
voluntary.
(4) Congress has been informed of examples of genetic
discrimination in the workplace. These include the use of pre-
employment genetic screening at Lawrence Berkeley Laboratory,
which led to a court decision in favor of the employees in that
case Norman-Bloodsaw v. Lawrence Berkeley Laboratory (135 F.3d
1260, 1269 (9th Cir. 1998)). Congress clearly has a compelling
public interest in relieving the fear of discrimination and in
prohibiting its actual practice in employment and health
insurance.
(5) Federal law addressing genetic discrimination in health
insurance and employment is incomplete in both the scope and
depth of its protections. Moreover, while many States have
enacted some type of genetic non-discrimination law, these laws
vary widely with respect to their approach, application, and
level of protection. Congress has collected substantial evidence
that the American public and the medical community find the
existing patchwork of State and Federal laws to be confusing and
inadequate to protect them from discrimination. Therefore
Federal legislation establishing a national and uniform basic
standard is necessary to fully protect the public from
discrimination and allay their concerns about the potential

[[Page 883]]
122 STAT. 883

for discrimination, thereby allowing individuals to take
advantage of genetic testing, technologies, research, and new
therapies.

TITLE I--GENETIC NONDISCRIMINATION IN HEALTH INSURANCE

SEC. 101. AMENDMENTS TO EMPLOYEE RETIREMENT INCOME SECURITY ACT OF
1974.

(a) No Discrimination in Group Premiums Based on Genetic
Information.--Section 702(b) of the Employee Retirement Income Security
Act of 1974 (29 U.S.C. 1182(b)) is amended--
(1) in paragraph (2)(A), by inserting before the semicolon
the following: ``except as provided in paragraph (3)''; and
(2) by adding at the end the following:
``(3) No group-based discrimination on basis of genetic
information.--
``(A) In general.--For purposes of this section, a
group health plan, and a health insurance issuer
offering group health insurance coverage in connection
with a group health plan, may not adjust premium or
contribution amounts for the group covered under such
plan on the basis of genetic information.
``(B) Rule of construction.--Nothing in subparagraph
(A) or in paragraphs (1) and (2) of subsection (d) shall
be construed to limit the ability of a health insurance
issuer offering health insurance coverage in connection
with a group health plan to increase the premium for an
employer based on the manifestation of a disease or
disorder of an individual who is enrolled in the plan.
In such case, the manifestation of a disease or disorder
in one individual cannot also be used as genetic
information about other group members and to further
increase the premium for the employer.''.

(b) Limitations on Genetic Testing; Prohibition on Collection of
Genetic Information; Application to All Plans.--Section 702 of the
Employee Retirement Income Security Act of 1974 (29 U.S.C. 1182) is
amended by adding at the end the following:
``(c) Genetic Testing.--
``(1) Limitation on requesting or requiring genetic
testing.--A group health plan, and a health insurance issuer
offering health insurance coverage in connection with a group
health plan, shall not request or require an individual or a
family member of such individual to undergo a genetic test.
``(2) Rule of construction.--Paragraph (1) shall not be
construed to limit the authority of a health care professional
who is providing health care services to an individual to
request that such individual undergo a genetic test.
``(3) Rule of construction regarding payment.--
``(A) In general.--Nothing in paragraph (1) shall be
construed to preclude a group health plan, or a health
insurance issuer offering health insurance coverage in
connection with a group health plan, from obtaining and
using the results of a genetic test in making a
determination regarding payment (as such term is defined
for the purposes of applying the regulations promulgated
by the

[[Page 884]]
122 STAT. 884

Secretary of Health and Human Services under part C of
title XI of the Social Security Act and section 264 of
the Health Insurance Portability and Accountability Act
of 1996, as may be revised from time to time) consistent
with subsection (a).
``(B) Limitation.--For purposes of subparagraph (A),
a group health plan, or a health insurance issuer
offering health insurance coverage in connection with a
group health plan, may request only the minimum amount
of information necessary to accomplish the intended
purpose.
``(4) Research exception.--Notwithstanding paragraph (1), a
group health plan, or a health insurance issuer offering health
insurance coverage in connection with a group health plan, may
request, but not require, that a participant or beneficiary
undergo a genetic test if each of the following conditions is
met:
``(A) The request is made, in writing, pursuant to
research that complies with part 46 of title 45, Code of
Federal Regulations, or equivalent Federal regulations,
and any applicable State or local law or regulations for
the protection of human subjects in research.
``(B) The plan or issuer clearly indicates to each
participant or beneficiary, or in the case of a minor
child, to the legal guardian of such beneficiary, to
whom the request is made that--
``(i) compliance with the request is
voluntary; and
``(ii) non-compliance will have no effect on
enrollment status or premium or contribution
amounts.
``(C) No genetic information collected or acquired
under this paragraph shall be used for underwriting
purposes.
``(D) [NOTE: Notification.] The plan or issuer
notifies the Secretary in writing that the plan or
issuer is conducting activities pursuant to the
exception provided for under this paragraph, including a
description of the activities conducted.
``(E) The plan or issuer complies with such other
conditions as the Secretary may by regulation require
for activities conducted under this paragraph.

``(d) Prohibition on Collection of Genetic Information.--
``(1) In general.--A group health plan, and a health
insurance issuer offering health insurance coverage in
connection with a group health plan, shall not request, require,
or purchase genetic information for underwriting purposes (as
defined in section 733).
``(2) Prohibition on collection of genetic information prior
to enrollment.--A group health plan, and a health insurance
issuer offering health insurance coverage in connection with a
group health plan, shall not request, require, or purchase
genetic information with respect to any individual prior to such
individual's enrollment under the plan or coverage in connection
with such enrollment.
``(3) Incidental collection.--If a group health plan, or a
health insurance issuer offering health insurance coverage in
connection with a group health plan, obtains genetic information
incidental to the requesting, requiring, or purchasing of other
information concerning any individual, such request,
requirement, or purchase shall not be considered a violation

[[Page 885]]
122 STAT. 885

of paragraph (2) if such request, requirement, or purchase is
not in violation of paragraph (1).

``(e) Application to All Plans.--The provisions of subsections
(a)(1)(F), (b)(3), (c), and (d), and subsection (b)(1) and section 701
with respect to genetic information, shall apply to group health plans
and health insurance issuers without regard to section 732(a).''.
(c) Application to Genetic Information of a Fetus or Embryo.--Such
section is further amended by adding at the end the following:
``(f) Genetic Information of a Fetus or Embryo.--Any reference in
this part to genetic information concerning an individual or family
member of an individual shall--
``(1) with respect to such an individual or family member of
an individual who is a pregnant woman, include genetic
information of any fetus carried by such pregnant woman; and
``(2) with respect to an individual or family member
utilizing an assisted reproductive technology, include genetic
information of any embryo legally held by the individual or
family member.''.

(d) Definitions.--Section 733(d) of the Employee Retirement Income
Security Act of 1974 (29 U.S.C. 1191b(d)) is amended by adding at the
end the following:
``(5) Family member.--The term `family member' means, with
respect to an individual--
``(A) a dependent (as such term is used for purposes
of section 701(f)(2)) of such individual, and
``(B) any other individual who is a first-degree,
second-degree, third-degree, or fourth-degree relative
of such individual or of an individual described in
subparagraph (A).
``(6) Genetic information.--
``(A) In general.--The term `genetic information'
means, with respect to any individual, information
about--
``(i) such individual's genetic tests,
``(ii) the genetic tests of family members of
such individual, and
``(iii) the manifestation of a disease or
disorder in family members of such individual.
``(B) Inclusion of genetic services and
participation in genetic research.--Such term includes,
with respect to any individual, any request for, or
receipt of, genetic services, or participation in
clinical research which includes genetic services, by
such individual or any family member of such individual.
``(C) Exclusions.--The term `genetic information'
shall not include information about the sex or age of
any individual.
``(7) Genetic test.--
``(A) In general.--The term `genetic test' means an
analysis of human DNA, RNA, chromosomes, proteins, or
metabolites, that detects genotypes, mutations, or
chromosomal changes.
``(B) Exceptions.--The term `genetic test' does not
mean--

[[Page 886]]
122 STAT. 886

``(i) an analysis of proteins or metabolites
that does not detect genotypes, mutations, or
chromosomal changes; or
``(ii) an analysis of proteins or metabolites
that is directly related to a manifested disease,
disorder, or pathological condition that could
reasonably be detected by a health care
professional with appropriate training and
expertise in the field of medicine involved.
``(8) Genetic services.--The term `genetic services' means--
``(A) a genetic test;
``(B) genetic counseling (including obtaining,
interpreting, or assessing genetic information); or
``(C) genetic education.
``(9) Underwriting purposes.--The term `underwriting
purposes' means, with respect to any group health plan, or
health insurance coverage offered in connection with a group
health plan--
``(A) rules for, or determination of, eligibility
(including enrollment and continued eligibility) for
benefits under the plan or coverage;
``(B) the computation of premium or contribution
amounts under the plan or coverage;
``(C) the application of any pre-existing condition
exclusion under the plan or coverage; and
``(D) other activities related to the creation,
renewal, or replacement of a contract of health
insurance or health benefits.''.

(e) ERISA Enforcement.--Section 502 of the Employee Retirement
Income Security Act of 1974 (29 U.S.C. 1132) is amended--
(1) in subsection (a)(6), by striking ``(7), or (8)'' and
inserting ``(7), (8), or (9)'';
(2) in subsection (b)(3), by striking ``The Secretary'' and
inserting ``Except as provided in subsections (c)(9) and (a)(6)
(with respect to collecting civil penalties under subsection
(c)(9)), the Secretary''; and
(3) in subsection (c), by redesignating paragraph (9) as
paragraph (10), and by inserting after paragraph (8) the
following new paragraph:
``(9) Secretarial enforcement authority relating to use of
genetic information.--
``(A) General rule.--The Secretary may impose a
penalty against any plan sponsor of a group health plan,
or any health insurance issuer offering health insurance
coverage in connection with the plan, for any failure by
such sponsor or issuer to meet the requirements of
subsection (a)(1)(F), (b)(3), (c), or (d) of section 702
or section 701 or 702(b)(1) with respect to genetic
information, in connection with the plan.
``(B) Amount.--
``(i) In general.--The amount of the penalty
imposed by subparagraph (A) shall be $100 for each
day in the noncompliance period with respect to
each participant or beneficiary to whom such
failure relates.
``(ii) Noncompliance period.--For purposes of
this paragraph, the term `noncompliance period'
means, with respect to any failure, the period--

[[Page 887]]
122 STAT. 887

``(I) beginning on the date such
failure first occurs; and
``(II) ending on the date the
failure is corrected.
``(C) Minimum penalties where failure discovered.--
Notwithstanding clauses (i) and (ii) of subparagraph
(D):
``(i) In general.--In the case of 1 or more
failures with respect to a participant or
beneficiary--
``(I) which are not corrected before
the date on which the plan receives a
notice from the Secretary of such
violation; and
``(II) which occurred or continued
during the period involved;
the amount of penalty imposed by subparagraph (A)
by reason of such failures with respect to such
participant or beneficiary shall not be less than
$2,500.
``(ii) Higher minimum penalty where violations
are more than de minimis.--To the extent
violations for which any person is liable under
this paragraph for any year are more than de
minimis, clause (i) shall be applied by
substituting `$15,000' for `$2,500' with respect
to such person.
``(D) Limitations.--
``(i) Penalty not to apply where failure not
discovered exercising reasonable diligence.--No
penalty shall be imposed by subparagraph (A) on
any failure during any period for which it is
established to the satisfaction of the Secretary
that the person otherwise liable for such penalty
did not know, and exercising reasonable diligence
would not have known, that such failure existed.
``(ii) Penalty not to apply to failures
corrected within certain periods.--No penalty
shall be imposed by subparagraph (A) on any
failure if--
``(I) such failure was due to
reasonable cause and not to willful
neglect; and
``(II) such failure is corrected
during the 30-day period beginning on
the first date the person otherwise
liable for such penalty knew, or
exercising reasonable diligence would
have known, that such failure existed.
``(iii) Overall limitation for unintentional
failures.--In the case of failures which are due
to reasonable cause and not to willful neglect,
the penalty imposed by subparagraph (A) for
failures shall not exceed the amount equal to the
lesser of--
``(I) 10 percent of the aggregate
amount paid or incurred by the plan
sponsor (or predecessor plan sponsor)
during the preceding taxable year for
group health plans; or
``(II) $500,000.
``(E) Waiver by secretary.--In the case of a failure
which is due to reasonable cause and not to willful
neglect, the Secretary may waive part or all of the
penalty imposed by subparagraph (A) to the extent that
the payment of such penalty would be excessive relative
to the failure involved.

[[Page 888]]
122 STAT. 888

``(F) Definitions.--Terms used in this paragraph
which are defined in section 733 shall have the meanings
provided such terms in such section.''.

(f) Regulations and [NOTE: 29 USC 1132 note.] Effective Date.--
(1) Regulations.--The Secretary of Labor shall issue final
regulations not later than 12 months after the date of enactment
of this Act to carry out the amendments made by this section.
(2) Effective date.--The amendments made by this section
shall [NOTE: Applicability.] apply with respect to group
health plans for plan years beginning after the date that is 1
year after the date of enactment of this Act.
SEC. 102. AMENDMENTS TO THE PUBLIC HEALTH SERVICE ACT.

(a) Amendments Relating to the Group Market.--
(1) No discrimination in group premiums based on genetic
information.--Section 2702(b) of the Public Health Service Act
(42 U.S.C. 300gg-1(b)) is amended--
(A) in paragraph (2)(A), by inserting before the
semicolon the following: ``except as provided in
paragraph (3)''; and
(B) by adding at the end the following:
``(3) No group-based discrimination on basis of genetic
information.--
``(A) In general.--For purposes of this section, a
group health plan, and health insurance issuer offering
group health insurance coverage in connection with a
group health plan, may not adjust premium or
contribution amounts for the group covered under such
plan on the basis of genetic information.
``(B) Rule of construction.--Nothing in subparagraph
(A) or in paragraphs (1) and (2) of subsection (d) shall
be construed to limit the ability of a health insurance
issuer offering health insurance coverage in connection
with a group health plan to increase the premium for an
employer based on the manifestation of a disease or
disorder of an individual who is enrolled in the plan.
In such case, the manifestation of a disease or disorder
in one individual cannot also be used as genetic
information about other group members and to further
increase the premium for the employer.''.
(2) Limitations on genetic testing; prohibition on
collection of genetic information; application to all plans.--
Section 2702 of the Public Health Service Act (42 U.S.C. 300gg-
1) is amended by adding at the end the following:

``(c) Genetic Testing.--
``(1) Limitation on requesting or requiring genetic
testing.--A group health plan, and a health insurance issuer
offering health insurance coverage in connection with a group
health plan, shall not request or require an individual or a
family member of such individual to undergo a genetic test.
``(2) Rule of construction.--Paragraph (1) shall not be
construed to limit the authority of a health care professional
who is providing health care services to an individual to
request that such individual undergo a genetic test.
``(3) Rule of construction regarding payment.--

[[Page 889]]
122 STAT. 889

``(A) In general.--Nothing in paragraph (1) shall be
construed to preclude a group health plan, or a health
insurance issuer offering health insurance coverage in
connection with a group health plan, from obtaining and
using the results of a genetic test in making a
determination regarding payment (as such term is defined
for the purposes of applying the regulations promulgated
by the Secretary under part C of title XI of the Social
Security Act and section 264 of the Health Insurance
Portability and Accountability Act of 1996, as may be
revised from time to time) consistent with subsection
(a).
``(B) Limitation.--For purposes of subparagraph (A),
a group health plan, or a health insurance issuer
offering health insurance coverage in connection with a
group health plan, may request only the minimum amount
of information necessary to accomplish the intended
purpose.
``(4) Research exception.--Notwithstanding paragraph (1), a
group health plan, or a health insurance issuer offering health
insurance coverage in connection with a group health plan, may
request, but not require, that a participant or beneficiary
undergo a genetic test if each of the following conditions is
met:
``(A) The request is made pursuant to research that
complies with part 46 of title 45, Code of Federal
Regulations, or equivalent Federal regulations, and any
applicable State or local law or regulations for the
protection of human subjects in research.
``(B) The plan or issuer clearly indicates to each
participant or beneficiary, or in the case of a minor
child, to the legal guardian of such beneficiary, to
whom the request is made that--
``(i) compliance with the request is
voluntary; and
``(ii) non-compliance will have no effect on
enrollment status or premium or contribution
amounts.
``(C) No genetic information collected or acquired
under this paragraph shall be used for underwriting
purposes.
``(D) [NOTE: Notification.] The plan or issuer
notifies the Secretary in writing that the plan or
issuer is conducting activities pursuant to the
exception provided for under this paragraph, including a
description of the activities conducted.
``(E) The plan or issuer complies with such other
conditions as the Secretary may by regulation require
for activities conducted under this paragraph.

``(d) Prohibition on Collection of Genetic Information.--
``(1) In general.--A group health plan, and a health
insurance issuer offering health insurance coverage in
connection with a group health plan, shall not request, require,
or purchase genetic information for underwriting purposes (as
defined in section 2791).
``(2) Prohibition on collection of genetic information prior
to enrollment.--A group health plan, and a health insurance
issuer offering health insurance coverage in connection with a
group health plan, shall not request, require, or purchase
genetic information with respect to any individual prior to such
individual's enrollment under the plan or coverage in connection
with such enrollment.

[[Page 890]]
122 STAT. 890

``(3) Incidental collection.--If a group health plan, or a
health insurance issuer offering health insurance coverage in
connection with a group health plan, obtains genetic information
incidental to the requesting, requiring, or purchasing of other
information concerning any individual, such request,
requirement, or purchase shall not be considered a violation of
paragraph (2) if such request, requirement, or purchase is not
in violation of paragraph (1).

``(e) Application to All Plans.--The provisions of subsections
(a)(1)(F), (b)(3), (c) , and (d) and subsection (b)(1) and section 2701
with respect to genetic information, shall apply to group health plans
and health insurance issuers without regard to section 2721(a).''.
(3) Application to genetic information of a fetus or
embryo.--Such section is further amended by adding at the end
the following:

``(f) Genetic Information of a Fetus or Embryo.--Any reference in
this part to genetic information concerning an individual or family
member of an individual shall--
``(1) with respect to such an individual or family member of
an individual who is a pregnant woman, include genetic
information of any fetus carried by such pregnant woman; and
``(2) with respect to an individual or family member
utilizing an assisted reproductive technology, include genetic
information of any embryo legally held by the individual or
family member.''.
(4) Definitions.--Section 2791(d) of the Public Health
Service Act (42 U.S.C. 300gg-91(d)) is amended by adding at the
end the following:
``(15) Family member.--The term `family member' means, with
respect to any individual--
``(A) a dependent (as such term is used for purposes
of section 2701(f)(2)) of such individual; and
``(B) any other individual who is a first-degree,
second-degree, third-degree, or fourth-degree relative
of such individual or of an individual described in
subparagraph (A).
``(16) Genetic information.--
``(A) In general.--The term `genetic information'
means, with respect to any individual, information
about--
``(i) such individual's genetic tests,
``(ii) the genetic tests of family members of
such individual, and
``(iii) the manifestation of a disease or
disorder in family members of such individual.
``(B) Inclusion of genetic services and
participation in genetic research.--Such term includes,
with respect to any individual, any request for, or
receipt of, genetic services, or participation in
clinical research which includes genetic services, by
such individual or any family member of such individual.
``(C) Exclusions.--The term `genetic information'
shall not include information about the sex or age of
any individual.
``(17) Genetic test.--
``(A) In general.--The term `genetic test' means an
analysis of human DNA, RNA, chromosomes, proteins, or

[[Page 891]]
122 STAT. 891

metabolites, that detects genotypes, mutations, or
chromosomal changes.
``(B) Exceptions.--The term `genetic test' does not
mean--
``(i) an analysis of proteins or metabolites
that does not detect genotypes, mutations, or
chromosomal changes; or
``(ii) an analysis of proteins or metabolites
that is directly related to a manifested disease,
disorder, or pathological condition that could
reasonably be detected by a health care
professional with appropriate training and
expertise in the field of medicine involved.
``(18) Genetic services.--The term `genetic services'
means--
``(A) a genetic test;
``(B) genetic counseling (including obtaining,
interpreting, or assessing genetic information); or
``(C) genetic education.
``(19) Underwriting purposes.--The term `underwriting
purposes' means, with respect to any group health plan, or
health insurance coverage offered in connection with a group
health plan--
``(A) rules for, or determination of, eligibility
(including enrollment and continued eligibility) for
benefits under the plan or coverage;
``(B) the computation of premium or contribution
amounts under the plan or coverage;
``(C) the application of any pre-existing condition
exclusion under the plan or coverage; and
``(D) other activities related to the creation,
renewal, or replacement of a contract of health
insurance or health benefits.''.
(5) Remedies and enforcement.--Section 2722(b) of the Public
Health Service Act (42 U.S.C. 300gg-22(b)) is amended by adding
at the end the following:
``(3) Enforcement authority relating to genetic
discrimination.--
``(A) General rule.--In the cases described in
paragraph (1), notwithstanding the provisions of
paragraph (2)(C), the succeeding subparagraphs of this
paragraph shall apply with respect to an action under
this subsection by the Secretary with respect to any
failure of a health insurance issuer in connection with
a group health plan, to meet the requirements of
subsection (a)(1)(F), (b)(3), (c), or (d) of section
2702 or section 2701 or 2702(b)(1) with respect to
genetic information in connection with the plan.
``(B) Amount.--
``(i) In general.--
The [NOTE: Penalties.] amount of the penalty
imposed under this paragraph shall be $100 for
each day in the noncompliance period with respect
to each participant or beneficiary to whom such
failure relates.
``(ii) Noncompliance period.--For purposes of
this paragraph, the term `noncompliance period'
means, with respect to any failure, the period--
``(I) beginning on the date such
failure first occurs; and

[[Page 892]]
122 STAT. 892

``(II) ending on the date the
failure is corrected.
``(C) Minimum penalties where failure discovered.--
Notwithstanding clauses (i) and (ii) of subparagraph
(D):
``(i) In general.--In the case of 1 or more
failures with respect to an individual--
``(I) which are not corrected before
the date on which the plan receives a
notice from the Secretary of such
violation; and
``(II) which occurred or continued
during the period involved;
the amount of penalty imposed by subparagraph (A)
by reason of such failures with respect to such
individual shall not be less than $2,500.
``(ii) Higher minimum penalty where violations
are more than de minimis.--To the extent
violations for which any person is liable under
this paragraph for any year are more than de
minimis, clause (i) shall be applied by
substituting `$15,000' for `$2,500' with respect
to such person.
``(D) Limitations.--
``(i) Penalty not to apply where failure not
discovered exercising reasonable diligence.--No
penalty shall be imposed by subparagraph (A) on
any failure during any period for which it is
established to the satisfaction of the Secretary
that the person otherwise liable for such penalty
did not know, and exercising reasonable diligence
would not have known, that such failure existed.
``(ii) Penalty not to apply to failures
corrected within certain periods.--No penalty
shall be imposed by subparagraph (A) on any
failure if--
``(I) such failure was due to
reasonable cause and not to willful
neglect; and
``(II) such failure is corrected
during the 30-day period beginning on
the first date the person otherwise
liable for such penalty knew, or
exercising reasonable diligence would
have known, that such failure existed.
``(iii) Overall limitation for unintentional
failures.--In the case of failures which are due
to reasonable cause and not to willful neglect,
the penalty imposed by subparagraph (A) for
failures shall not exceed the amount equal to the
lesser of--
``(I) 10 percent of the aggregate
amount paid or incurred by the employer
(or predecessor employer) during the
preceding taxable year for group health
plans; or
``(II) $500,000.
``(E) Waiver by secretary.--In the case of a failure
which is due to reasonable cause and not to willful
neglect, the Secretary may waive part or all of the
penalty imposed by subparagraph (A) to the extent that
the payment of such penalty would be excessive relative
to the failure involved.''.

(b) Amendment Relating to the Individual Market.--

[[Page 893]]
122 STAT. 893

(1) In general.--The first subpart 3 of part B of title
XXVII of the Public Health Service Act (42 U.S.C. 300gg-51 et
seq.) (relating to other requirements) is amended--
(A) by redesignating such subpart as subpart 2; and
(B) by adding at the end the following:
``SEC. 2753. [NOTE: 42 USC 300gg-53.] PROHIBITION OF HEALTH
DISCRIMINATION ON THE BASIS OF GENETIC
INFORMATION.

``(a) Prohibition on Genetic Information as a Condition of
Eligibility.--
``(1) In general.--A health insurance issuer offering health
insurance coverage in the individual market may not establish
rules for the eligibility (including continued eligibility) of
any individual to enroll in individual health insurance coverage
based on genetic information.
``(2) Rule of construction.--Nothing in paragraph (1) or in
paragraphs (1) and (2) of subsection (e) shall be construed to
preclude a health insurance issuer from establishing rules for
eligibility for an individual to enroll in individual health
insurance coverage based on the manifestation of a disease or
disorder in that individual, or in a family member of such
individual where such family member is covered under the policy
that covers such individual.

``(b) Prohibition on Genetic Information in Setting Premium Rates.--
``(1) In general.--A health insurance issuer offering health
insurance coverage in the individual market shall not adjust
premium or contribution amounts for an individual on the basis
of genetic information concerning the individual or a family
member of the individual.
``(2) Rule of construction.--Nothing in paragraph (1) or in
paragraphs (1) and (2) of subsection (e) shall be construed to
preclude a health insurance issuer from adjusting premium or
contribution amounts for an individual on the basis of a
manifestation of a disease or disorder in that individual, or in
a family member of such individual where such family member is
covered under the policy that covers such individual. In such
case, the manifestation of a disease or disorder in one
individual cannot also be used as genetic information about
other individuals covered under the policy issued to such
individual and to further increase premiums or contribution
amounts.

``(c) Prohibition on Genetic Information as Preexisting Condition.--
``(1) In general.--A health insurance issuer offering health
insurance coverage in the individual market may not, on the
basis of genetic information, impose any preexisting condition
exclusion (as defined in section 2701(b)(1)(A)) with respect to
such coverage.
``(2) Rule of construction.--Nothing in paragraph (1) or in
paragraphs (1) and (2) of subsection (e) shall be construed to
preclude a health insurance issuer from imposing any preexisting
condition exclusion for an individual with respect to health
insurance coverage on the basis of a manifestation of a disease
or disorder in that individual.

``(d) Genetic Testing.--

[[Page 894]]
122 STAT. 894

``(1) Limitation on requesting or requiring genetic
testing.--A health insurance issuer offering health insurance
coverage in the individual market shall not request or require
an individual or a family member of such individual to undergo a
genetic test.
``(2) Rule of construction.--Paragraph (1) shall not be
construed to limit the authority of a health care professional
who is providing health care services to an individual to
request that such individual undergo a genetic test.
``(3) Rule of construction regarding payment.--
``(A) In general.--Nothing in paragraph (1) shall be
construed to preclude a health insurance issuer offering
health insurance coverage in the individual market from
obtaining and using the results of a genetic test in
making a determination regarding payment (as such term
is defined for the purposes of applying the regulations
promulgated by the Secretary under part C of title XI of
the Social Security Act and section 264 of the Health
Insurance Portability and Accountability Act of 1996, as
may be revised from time to time) consistent with
subsection (a) and (c).
``(B) Limitation.--For purposes of subparagraph (A),
a health insurance issuer offering health insurance
coverage in the individual market may request only the
minimum amount of information necessary to accomplish
the intended purpose.
``(4) Research exception.--Notwithstanding paragraph (1), a
health insurance issuer offering health insurance coverage in
the individual market may request, but not require, that an
individual or a family member of such individual undergo a
genetic test if each of the following conditions is met:
``(A) The request is made pursuant to research that
complies with part 46 of title 45, Code of Federal
Regulations, or equivalent Federal regulations, and any
applicable State or local law or regulations for the
protection of human subjects in research.
``(B) The issuer clearly indicates to each
individual, or in the case of a minor child, to the
legal guardian of such child, to whom the request is
made that--
``(i) compliance with the request is
voluntary; and
``(ii) non-compliance will have no effect on
enrollment status or premium or contribution
amounts.
``(C) No genetic information collected or acquired
under this paragraph shall be used for underwriting
purposes.
``(D) [NOTE: Notification.] The issuer notifies
the Secretary in writing that the issuer is conducting
activities pursuant to the exception provided for under
this paragraph, including a description of the
activities conducted.
``(E) The issuer complies with such other conditions
as the Secretary may by regulation require for
activities conducted under this paragraph.

``(e) Prohibition on Collection of Genetic Information.--
``(1) In general.--A health insurance issuer offering health
insurance coverage in the individual market shall not request,
require, or purchase genetic information for underwriting
purposes (as defined in section 2791).
``(2) Prohibition on collection of genetic information prior
to enrollment.--A health insurance issuer offering

[[Page 895]]
122 STAT. 895

health insurance coverage in the individual market shall not
request, require, or purchase genetic information with respect
to any individual prior to such individual's enrollment under
the plan in connection with such enrollment.
``(3) Incidental collection.--If a health insurance issuer
offering health insurance coverage in the individual market
obtains genetic information incidental to the requesting,
requiring, or purchasing of other information concerning any
individual, such request, requirement, or purchase shall not be
considered a violation of paragraph (2) if such request,
requirement, or purchase is not in violation of paragraph (1).

``(f) Genetic Information of a Fetus or Embryo.--Any reference in
this part to genetic information concerning an individual or family
member of an individual shall--
``(1) with respect to such an individual or family member of
an individual who is a pregnant woman, include genetic
information of any fetus carried by such pregnant woman; and
``(2) with respect to an individual or family member
utilizing an assisted reproductive technology, include genetic
information of any embryo legally held by the individual or
family member.''.
(2) Remedies and enforcement.--Section 2761(b) of the Public
Health Service Act (42 U.S.C. 300gg-61(b)) is amended to read as
follows:

``(b) Secretarial Enforcement Authority.--The Secretary shall have
the same authority in relation to enforcement of the provisions of this
part with respect to issuers of health insurance coverage in the
individual market in a State as the Secretary has under section
2722(b)(2), and section 2722(b)(3) with respect to violations of genetic
nondiscrimination provisions, in relation to the enforcement of the
provisions of part A with respect to issuers of health insurance
coverage in the small group market in the State.''.
(c) Elimination of Option of Non-Federal Governmental Plans To Be
Excepted From Requirements Concerning Genetic Information.--Section
2721(b)(2) of the Public Health Service Act (42 U.S.C. 300gg-21(b)(2))
is amended--
(1) in subparagraph (A), by striking ``If the plan sponsor''
and inserting ``Except as provided in subparagraph (D), if the
plan sponsor''; and
(2) by adding at the end the following:
``(D) Election not applicable to requirements
concerning genetic information.--The election described
in subparagraph (A) shall not be available with respect
to the provisions of subsections (a)(1)(F), (b)(3), (c),
and (d) of section 2702 and the provisions of sections
2701 and 2702(b) to the extent that such provisions
apply to genetic information.''.

(d) Regulations and [NOTE: 42 USC 300gg-1 note.] Effective Date.--
(1) Regulations.--Not later than 12 months after the date of
enactment of this Act, the Secretary of Health and Human
Services shall issue final regulations to carry out the
amendments made by this section.
(2) Effective date.--The [NOTE: Applicability.] amendments
made by this section shall apply--

[[Page 896]]
122 STAT. 896

(A) with respect to group health plans, and health
insurance coverage offered in connection with group
health plans, for plan years beginning after the date
that is 1 year after the date of enactment of this Act;
and
(B) with respect to health insurance coverage
offered, sold, issued, renewed, in effect, or operated
in the individual market after the date that is 1 year
after the date of enactment of this Act.
SEC. 103. AMENDMENTS TO THE INTERNAL REVENUE CODE OF 1986.

(a) No Discrimination in Group Premiums Based on Genetic
Information.--Subsection (b) of section 9802 of the Internal Revenue
Code of [NOTE: 26 USC 9802.] 1986 is amended--
(1) in paragraph (2)(A), by inserting before the semicolon
the following: ``except as provided in paragraph (3)''; and
(2) by adding at the end the following:
``(3) No group-based discrimination on basis of genetic
information.--
``(A) In general.--For purposes of this section, a
group health plan may not adjust premium or contribution
amounts for the group covered under such plan on the
basis of genetic information.
``(B) Rule of construction.--Nothing in subparagraph
(A) or in paragraphs (1) and (2) of subsection (d) shall
be construed to limit the ability of a group health plan
to increase the premium for an employer based on the
manifestation of a disease or disorder of an individual
who is enrolled in the plan. In such case, the
manifestation of a disease or disorder in one individual
cannot also be used as genetic information about other
group members and to further increase the premium for
the employer.''.

(b) Limitations on Genetic Testing; Prohibition on Collection of
Genetic Information; Application to All Plans.--Section 9802 of such
Code is amended by redesignating subsection (c) as subsection (f) and by
inserting after subsection (b) the following new subsections:
``(c) Genetic Testing.--
``(1) Limitation on requesting or requiring genetic
testing.--A group health plan may not request or require an
individual or a family member of such individual to undergo a
genetic test.
``(2) Rule of construction.--Paragraph (1) shall not be
construed to limit the authority of a health care professional
who is providing health care services to an individual to
request that such individual undergo a genetic test.
``(3) Rule of construction regarding payment.--
``(A) In general.--Nothing in paragraph (1) shall be
construed to preclude a group health plan from obtaining
and using the results of a genetic test in making a
determination regarding payment (as such term is defined
for the purposes of applying the regulations promulgated
by the Secretary of Health and Human Services under part
C of title XI of the Social Security Act and section 264
of the Health Insurance Portability and Accountability
Act of 1996, as may be revised from time to time)
consistent with subsection (a).

[[Page 897]]
122 STAT. 897

``(B) Limitation.--For purposes of subparagraph (A),
a group health plan may request only the minimum amount
of information necessary to accomplish the intended
purpose.
``(4) Research exception.--Notwithstanding paragraph (1), a
group health plan may request, but not require, that a
participant or beneficiary undergo a genetic test if each of the
following conditions is met:
``(A) The request is made pursuant to research that
complies with part 46 of title 45, Code of Federal
Regulations, or equivalent Federal regulations, and any
applicable State or local law or regulations for the
protection of human subjects in research.
``(B) The plan clearly indicates to each participant
or beneficiary, or in the case of a minor child, to the
legal guardian of such beneficiary, to whom the request
is made that--
``(i) compliance with the request is
voluntary; and
``(ii) non-compliance will have no effect on
enrollment status or premium or contribution
amounts.
``(C) No genetic information collected or acquired
under this paragraph shall be used for underwriting
purposes.
``(D) [NOTE: Notification.] The plan notifies the
Secretary in writing that the plan is conducting
activities pursuant to the exception provided for under
this paragraph, including a description of the
activities conducted.
``(E) The plan complies with such other conditions
as the Secretary may by regulation require for
activities conducted under this paragraph.

``(d) Prohibition on Collection of Genetic Information.--
``(1) In general.--A group health plan shall not request,
require, or purchase genetic information for underwriting
purposes (as defined in section 9832).
``(2) Prohibition on collection of genetic information prior
to enrollment.--A group health plan shall not request, require,
or purchase genetic information with respect to any individual
prior to such individual's enrollment under the plan or in
connection with such enrollment.
``(3) Incidental collection.--If a group health plan obtains
genetic information incidental to the requesting, requiring, or
purchasing of other information concerning any individual, such
request, requirement, or purchase shall not be considered a
violation of paragraph (2) if such request, requirement, or
purchase is not in violation of paragraph (1).

``(e) Application to All Plans.--The provisions of subsections
(a)(1)(F), (b)(3), (c), and (d) and subsection (b)(1) and section 9801
with respect to genetic information, shall apply to group health plans
without regard to section 9831(a)(2).''.
(c) Application to Genetic Information of a Fetus or Embryo.--Such
section is further amended by adding at the end the following:
``(f) Genetic Information of a Fetus or Embryo.--Any reference in
this chapter to genetic information concerning an individual or family
member of an individual shall--
``(1) with respect to such an individual or family member of
an individual who is a pregnant woman, include genetic

[[Page 898]]
122 STAT. 898

information of any fetus carried by such pregnant woman; and
``(2) with respect to an individual or family member
utilizing an assisted reproductive technology, include genetic
information of any embryo legally held by the individual or
family member.''.

(d) Definitions.--Subsection (d) of section 9832 [NOTE: 26 USC
9832.] of such Code is amended by adding at the end the following:
``(6) Family member.--The term `family member' means, with
respect to any individual--
``(A) a dependent (as such term is used for purposes
of section 9801(f)(2)) of such individual, and
``(B) any other individual who is a first-degree,
second-degree, third-degree, or fourth-degree relative
of such individual or of an individual described in
subparagraph (A).
``(7) Genetic information.--
``(A) In general.--The term `genetic information'
means, with respect to any individual, information
about--
``(i) such individual's genetic tests,
``(ii) the genetic tests of family members of
such individual, and
``(iii) the manifestation of a disease or
disorder in family members of such individual.
``(B) Inclusion of genetic services and
participation in genetic research.--Such term includes,
with respect to any individual, any request for, or
receipt of, genetic services, or participation in
clinical research which includes genetic services, by
such individual or any family member of such individual.
``(C) Exclusions.--The term `genetic information'
shall not include information about the sex or age of
any individual.
``(8) Genetic test.--
``(A) In general.--The term `genetic test' means an
analysis of human DNA, RNA, chromosomes, proteins, or
metabolites, that detects genotypes, mutations, or
chromosomal changes.
``(B) Exceptions.--The term `genetic test' does not
mean--
``(i) an analysis of proteins or metabolites
that does not detect genotypes, mutations, or
chromosomal changes, or
``(ii) an analysis of proteins or metabolites
that is directly related to a manifested disease,
disorder, or pathological condition that could
reasonably be detected by a health care
professional with appropriate training and
expertise in the field of medicine involved.
``(9) Genetic services.--The term `genetic services' means--
``(A) a genetic test;
``(B) genetic counseling (including obtaining,
interpreting, or assessing genetic information); or
``(C) genetic education.
``(10) Underwriting purposes.--The term `underwriting
purposes' means, with respect to any group health plan, or
health insurance coverage offered in connection with a group
health plan--

[[Page 899]]
122 STAT. 899

``(A) rules for, or determination of, eligibility
(including enrollment and continued eligibility) for
benefits under the plan or coverage;
``(B) the computation of premium or contribution
amounts under the plan or coverage;
``(C) the application of any pre-existing condition
exclusion under the plan or coverage; and
``(D) other activities related to the creation,
renewal, or replacement of a contract of health
insurance or health benefits.''.

(e) Enforcement.--
(1) In general.--Subchapter C of chapter 100 of the Internal
Revenue Code of 1986 (relating to general provisions) is amended
by adding at the end the following new section:
``SEC. 9834. ENFORCEMENT.

``For the imposition of tax on any failure of a group health plan to
meet the requirements of this chapter, see section 4980D.''.
(2) Conforming amendment.--The table of sections for
subchapter C of chapter 100 of such Code is amended by adding at
the end the following new item:

``Sec. 9834. Enforcement.''.

(f) Regulations and [NOTE: 26 USC 9802 note.] Effective Date.--
(1) Regulations.--The Secretary of the Treasury shall issue
final regulations or other guidance not later than 12 months
after the date of the enactment of this Act to carry out the
amendments made by this section.
(2) Effective date.--The [NOTE: Applicability.] amendments
made by this section shall apply with respect to group health
plans for plan years beginning after the date that is 1 year
after the date of the enactment of this Act.
SEC. 104. AMENDMENTS TO TITLE XVIII OF THE SOCIAL SECURITY ACT
RELATING TO MEDIGAP.

(a) Nondiscrimination.--Section 1882(s)(2) of the Social Security
Act (42 U.S.C. 1395ss(s)(2)) is amended by adding at the end the
following:
``(E) An issuer of a medicare supplemental policy
shall not deny or condition the issuance or
effectiveness of the policy (including the imposition of
any exclusion of benefits under the policy based on a
pre-existing condition) and shall not discriminate in
the pricing of the policy (including the adjustment of
premium rates) of an individual on the basis of the
genetic information with respect to such individual.
``(F) Rule of construction.--Nothing in subparagraph
(E) or in subparagraphs (A) or (B) of subsection (x)(2)
shall be construed to limit the ability of an issuer of
a medicare supplemental policy from, to the extent
otherwise permitted under this title--
``(i) denying or conditioning the issuance or
effectiveness of the policy or increasing the
premium for an employer based on the manifestation
of a disease or disorder of an individual who is
covered under the policy; or
``(ii) increasing the premium for any policy
issued to an individual based on the manifestation
of a disease

[[Page 900]]
122 STAT. 900

or disorder of an individual who is covered under
the policy (in such case, the manifestation of a
disease or disorder in one individual cannot also
be used as genetic information about other group
members and to further increase the premium for
the employer).''.

(b) Limitations on Genetic Testing and Genetic Information.--
(1) In general.--Section 1882 of the Social Security Act (42
U.S.C. 1395ss) is amended by adding at the end the following:

``(x) Limitations on Genetic Testing and Information.--
``(1) Genetic testing.--
``(A) Limitation on requesting or requiring genetic
testing.--An issuer of a medicare supplemental policy
shall not request or require an individual or a family
member of such individual to undergo a genetic test.
``(B) Rule of construction.--Subparagraph (A) shall
not be construed to limit the authority of a health care
professional who is providing health care services to an
individual to request that such individual undergo a
genetic test.
``(C) Rule of construction regarding payment.--
``(i) In general.--Nothing in subparagraph (A)
shall be construed to preclude an issuer of a
medicare supplemental policy from obtaining and
using the results of a genetic test in making a
determination regarding payment (as such term is
defined for the purposes of applying the
regulations promulgated by the Secretary under
part C of title XI and section 264 of the Health
Insurance Portability and Accountability Act of
1996, as may be revised from time to time)
consistent with subsection (s)(2)(E).
``(ii) Limitation.--For purposes of clause
(i), an issuer of a medicare supplemental policy
may request only the minimum amount of information
necessary to accomplish the intended purpose.
``(D) Research exception.--Notwithstanding
subparagraph (A), an issuer of a medicare supplemental
policy may request, but not require, that an individual
or a family member of such individual undergo a genetic
test if each of the following conditions is met:
``(i) The request is made pursuant to research
that complies with part 46 of title 45, Code of
Federal Regulations, or equivalent Federal
regulations, and any applicable State or local law
or regulations for the protection of human
subjects in research.
``(ii) The issuer clearly indicates to each
individual, or in the case of a minor child, to
the legal guardian of such child, to whom the
request is made that--
``(I) compliance with the request is
voluntary; and
``(II) non-compliance will have no
effect on enrollment status or premium
or contribution amounts.

[[Page 901]]
122 STAT. 901

``(iii) No genetic information collected or
acquired under this subparagraph shall be used for
underwriting, determination of eligibility to
enroll or maintain enrollment status, premium
rating, or the creation, renewal, or replacement
of a plan, contract, or coverage for health
insurance or health benefits.
``(iv) The issuer notifies the Secretary in
writing that the issuer is conducting activities
pursuant to the exception provided for under this
subparagraph, including a description of the
activities conducted.
``(v) The issuer complies with such other
conditions as the Secretary may by regulation
require for activities conducted under this
subparagraph.
``(2) Prohibition on collection of genetic information.--
``(A) In general.--An issuer of a medicare
supplemental policy shall not request, require, or
purchase genetic information for underwriting purposes
(as defined in paragraph (3)).
``(B) Prohibition on collection of genetic
information prior to enrollment.--An issuer of a
medicare supplemental policy shall not request, require,
or purchase genetic information with respect to any
individual prior to such individual's enrollment under
the policy in connection with such enrollment.
``(C) Incidental collection.--If an issuer of a
medicare supplemental policy obtains genetic information
incidental to the requesting, requiring, or purchasing
of other information concerning any individual, such
request, requirement, or purchase shall not be
considered a violation of subparagraph (B) if such
request, requirement, or purchase is not in violation of
subparagraph (A).
``(3) Definitions.--In this subsection:
``(A) Family member.--The term `family member' means
with respect to an individual, any other individual who
is a first-degree, second-degree, third-degree, or
fourth-degree relative of such individual.
``(B) Genetic information.--
``(i) In general.--The term `genetic
information' means, with respect to any
individual, information about--
``(I) such individual's genetic
tests,
``(II) the genetic tests of family
members of such individual, and
``(III) subject to clause (iv), the
manifestation of a disease or disorder
in family members of such individual.
``(ii) Inclusion of genetic services and
participation in genetic research.--Such term
includes, with respect to any individual, any
request for, or receipt of, genetic services, or
participation in clinical research which includes
genetic services, by such individual or any family
member of such individual.
``(iii) Exclusions.--The term `genetic
information' shall not include information about
the sex or age of any individual.
``(C) Genetic test.--

[[Page 902]]
122 STAT. 902

``(i) In general.--The term `genetic test'
means an analysis of human DNA, RNA, chromosomes,
proteins, or metabolites, that detects genotypes,
mutations, or chromosomal changes.
``(ii) Exceptions.--The term `genetic test'
does not mean--
``(I) an analysis of proteins or
metabolites that does not detect
genotypes, mutations, or chromosomal
changes; or
``(II) an analysis of proteins or
metabolites that is directly related to
a manifested disease, disorder, or
pathological condition that could
reasonably be detected by a health care
professional with appropriate training
and expertise in the field of medicine
involved.
``(D) Genetic services.--The term `genetic services'
means--
``(i) a genetic test;
``(ii) genetic counseling (including
obtaining, interpreting, or assessing genetic
information); or
``(iii) genetic education.
``(E) Underwriting purposes.--The term `underwriting
purposes' means, with respect to a medicare supplemental
policy--
``(i) rules for, or determination of,
eligibility (including enrollment and continued
eligibility) for benefits under the policy;
``(ii) the computation of premium or
contribution amounts under the policy;
``(iii) the application of any pre-existing
condition exclusion under the policy; and
``(iv) other activities related to the
creation, renewal, or replacement of a contract of
health insurance or health benefits.
``(F) Issuer of a medicare supplemental policy.--The
term `issuer of a medicare supplemental policy' includes
a third-party administrator or other person acting for
or on behalf of such issuer.''.
(2) Application to genetic information of a fetus or
embryo.--Section 1882(x) of such Act, as added by paragraph (1),
is further amended by adding at the end the following:
``(4) Genetic information of a fetus or embryo.--Any
reference in this section to genetic information concerning an
individual or family member of an individual shall--
``(A) with respect to such an individual or family
member of an individual who is a pregnant woman, include
genetic information of any fetus carried by such
pregnant woman; and
``(B) with respect to an individual or family member
utilizing an assisted reproductive technology, include
genetic information of any embryo legally held by the
individual or family member.''.
(3) Conforming amendment.--Section 1882(o) of the Social
Security Act (42 U.S.C. 1395ss(o)) is amended by adding at the
end the following:
``(4) The issuer of the medicare supplemental policy
complies with subsection (s)(2)(E) and subsection (x).''.

[[Page 903]]
122 STAT. 903

(c) Effective Date.--The [NOTE: Applicability. 42 USC 1395ss
note.] amendments made by this section shall apply with respect to an
issuer of a medicare supplemental policy for policy years beginning on
or after the date that is 1 year after the date of enactment of this
Act.

(d) Transition [NOTE: 42 USC 1395ss note.] Provisions.--
(1) In general.--If the Secretary of Health and Human
Services identifies a State as requiring a change to its
statutes or regulations to conform its regulatory program to the
changes made by this section, the State regulatory program shall
not be considered to be out of compliance with the requirements
of section 1882 of the Social Security Act due solely to failure
to make such change until the date specified in paragraph (4).
(2) NAIC standards.--If, [NOTE: Deadline.] not later than
October 31, 2008, the National Association of Insurance
Commissioners (in this subsection referred to as the ``NAIC'')
modifies its NAIC Model Regulation relating to section 1882 of
the Social Security Act (referred to in such section as the 1991
NAIC Model Regulation, as subsequently modified) to conform to
the amendments made by this section, such revised regulation
incorporating the modifications shall be considered to be the
applicable NAIC model regulation (including the revised NAIC
model regulation and the 1991 NAIC Model Regulation) for the
purposes of such section.
(3) Secretary standards.--If the [NOTE: Deadline.] NAIC
does not make the modifications described in paragraph (2)
within the period specified in such paragraph, the Secretary of
Health and Human Services shall, not later than July 1, 2009,
make the modifications described in such paragraph and such
revised regulation incorporating the modifications shall be
considered to be the appropriate regulation for the purposes of
such section.
(4) Date specified.--
(A) In general.--Subject to subparagraph (B), the
date specified in this paragraph for a State is the
earlier of--
(i) the date the State changes its statutes or
regulations to conform its regulatory program to
the changes made by this section, or
(ii) July 1, 2009.
(B) Additional legislative action required.--In the
case of a State which the Secretary identifies as--
(i) requiring State legislation (other than
legislation appropriating funds) to conform its
regulatory program to the changes made in this
section, but
(ii) having a legislature which is not
scheduled to meet in 2009 in a legislative session
in which such legislation may be considered, the
date specified in this paragraph is the first day
of the first calendar quarter beginning after the
close of the first legislative session of the
State legislature that begins on or after July 1,
2009. For purposes of the previous sentence, in
the case of a State that has a 2-year legislative
session, each year of such session shall be deemed
to be a separate regular session of the State
legislature.
SEC. 105. PRIVACY AND CONFIDENTIALITY.

(a) In General.--Part C of title XI of the Social Security Act is
amended by adding at the end the following new section:

[[Page 904]]
122 STAT. 904

``application of hipaa regulations to genetic information


``Sec. 1180. (a) In General.--The [NOTE: 42 USC 1320d-
9.] Secretary shall revise the HIPAA privacy regulation (as defined in
subsection (b)) so it is consistent with the following:
``(1) Genetic information shall be treated as health
information described in section 1171(4)(B).
``(2) The use or disclosure by a covered entity that is a
group health plan, health insurance issuer that issues health
insurance coverage, or issuer of a medicare supplemental policy
of protected health information that is genetic information
about an individual for underwriting purposes under the group
health plan, health insurance coverage, or medicare supplemental
policy shall not be a permitted use or disclosure.

``(b) Definitions.--For purposes of this section:
``(1) Genetic information; genetic test; family member.--The
terms `genetic information', `genetic test', and `family member'
have the meanings given such terms in section 2791 of the Public
Health Service Act (42 U.S.C. 300gg-91), as amended by the
Genetic Information Nondiscrimination Act of 2007.
``(2) Group health plan; health insurance coverage; medicare
supplemental policy.--The terms `group health plan' and `health
insurance coverage' have the meanings given such terms under
section 2791 of the Public Health Service Act (42 U.S.C. 300gg-
91), and the term `medicare supplemental policy' has the meaning
given such term in section 1882(g).
``(3) HIPAA privacy regulation.--The term `HIPAA privacy
regulation' means the regulations promulgated by the Secretary
under this part and section 264 of the Health Insurance
Portability and Accountability Act of 1996 (42 U.S.C. 1320d-2
note).
``(4) Underwriting purposes.--The term `underwriting
purposes' means, with respect to a group health plan, health
insurance coverage, or a medicare supplemental policy--
``(A) rules for, or determination of, eligibility
(including enrollment and continued eligibility) for, or
determination of, benefits under the plan, coverage, or
policy;
``(B) the computation of premium or contribution
amounts under the plan, coverage, or policy;
``(C) the application of any pre-existing condition
exclusion under the plan, coverage, or policy; and
``(D) other activities related to the creation,
renewal, or replacement of a contract of health
insurance or health benefits.

``(c) Procedure.--The [NOTE: Notice. Federal
Register, publication. Deadline. Effective date.] revisions under
subsection (a) shall be made by notice in the Federal Register published
not later than 60 days after the date of the enactment of this section
and shall be effective upon publication, without opportunity for any
prior public comment, but may be revised, consistent with this section,
after opportunity for public comment.

``(d) Enforcement.--In addition to any other sanctions or remedies
that may be available under law, a covered entity that is a group health
plan, health insurance issuer, or issuer of a medicare supplemental
policy and that violates the HIPAA privacy regulation (as revised under
subsection (a) or otherwise) with respect to the use or disclosure of
genetic information shall be subject to the

[[Page 905]]
122 STAT. 905

penalties described in sections 1176 and 1177 in the same manner and to
the same extent that such penalties apply to violations of this part.''.
(b) Regulations; [NOTE: 42 USC 1320d-9 note.] Effective Date.--
(1) Regulations.--Not [NOTE: Deadline.] later than 12
months after the date of the enactment of this Act, the
Secretary of Health and Human Services shall issue final
regulations to carry out the revision required by section
1180(a) of the Social Security Act, as added by subsection (a).
The Secretary has the sole authority to promulgate such
regulations, but shall promulgate such regulations in
consultation with the Secretaries of Labor and the Treasury.
(2) Effective date.--The amendment made by subsection (a)
shall take effect on the date that is 1 year after the date of
the enactment of this Act.
SEC. 106. [NOTE: Memorandum. 42 USC 300gg-1 note.] ASSURING
COORDINATION.

Except as provided in section 105(b)(1), the Secretary of Health and
Human Services, the Secretary of Labor, and the Secretary of the
Treasury shall ensure, through the execution of an interagency
memorandum of understanding among such Secretaries, that--
(1) regulations, rulings, and interpretations issued by such
Secretaries relating to the same matter over which two or more
such Secretaries have responsibility under this title (and the
amendments made by this title) are administered so as to have
the same effect at all times; and
(2) coordination of policies relating to enforcing the same
requirements through such Secretaries in order to have a
coordinated enforcement strategy that avoids duplication of
enforcement efforts and assigns priorities in enforcement.

TITLE II--PROHIBITING EMPLOYMENT DISCRIMINATION ON THE BASIS OF GENETIC
INFORMATION

SEC. 201. [NOTE: 42 USC 2000ff.] DEFINITIONS.

In this title:
(1) Commission.--The term ``Commission'' means the Equal
Employment Opportunity Commission as created by section 705 of
the Civil Rights Act of 1964 (42 U.S.C. 2000e-4).
(2) Employee; employer; employment agency; labor
organization; member.--
(A) In general.--The term ``employee'' means--
(i) an employee (including an applicant), as
defined in section 701(f) of the Civil Rights Act
of 1964 (42 U.S.C. 2000e(f));
(ii) a State employee (including an applicant)
described in section 304(a) of the Government
Employee Rights Act of 1991 (42 U.S.C. 2000e-
16c(a));
(iii) a covered employee (including an
applicant), as defined in section 101 of the
Congressional Accountability Act of 1995 (2 U.S.C.
1301);

[[Page 906]]
122 STAT. 906

(iv) a covered employee (including an
applicant), as defined in section 411(c) of title
3, United States Code; or
(v) an employee or applicant to which section
717(a) of the Civil Rights Act of 1964 (42 U.S.C.
2000e-16(a)) applies.
(B) Employer.--The term ``employer'' means--
(i) an employer (as defined in section 701(b)
of the Civil Rights Act of 1964 (42 U.S.C.
2000e(b)));
(ii) an entity employing a State employee
described in section 304(a) of the Government
Employee Rights Act of 1991;
(iii) an employing office, as defined in
section 101 of the Congressional Accountability
Act of 1995;
(iv) an employing office, as defined in
section 411(c) of title 3, United States Code; or
(v) an entity to which section 717(a) of the
Civil Rights Act of 1964 applies.
(C) Employment agency; labor organization.--The
terms ``employment agency'' and ``labor organization''
have the meanings given the terms in section 701 of the
Civil Rights Act of 1964 (42 U.S.C. 2000e).
(D) Member.--The term ``member'', with respect to a
labor organization, includes an applicant for membership
in a labor organization.
(3) Family member.--The term ``family member'' means, with
respect to an individual--
(A) a dependent (as such term is used for purposes
of section 701(f)(2) of the Employee Retirement Income
Security Act of 1974) of such individual, and
(B) any other individual who is a first-degree,
second-degree, third-degree, or fourth-degree relative
of such individual or of an individual described in
subparagraph (A).
(4) Genetic information.--
(A) In general.--The term ``genetic information''
means, with respect to any individual, information
about--
(i) such individual's genetic tests,
(ii) the genetic tests of family members of
such individual, and
(iii) the manifestation of a disease or
disorder in family members of such individual.
(B) Inclusion of genetic services and participation
in genetic research.--Such term includes, with respect
to any individual, any request for, or receipt of,
genetic services, or participation in clinical research
which includes genetic services, by such individual or
any family member of such individual.
(C) Exclusions.--The term ``genetic information''
shall not include information about the sex or age of
any individual.
(5) Genetic monitoring.--The term ``genetic monitoring''
means the periodic examination of employees to evaluate acquired
modifications to their genetic material, such as chromosomal
damage or evidence of increased occurrence of mutations, that
may have developed in the course of employment due to exposure
to toxic substances in the workplace,

[[Page 907]]
122 STAT. 907

in order to identify, evaluate, and respond to the effects of or
control adverse environmental exposures in the workplace.
(6) Genetic services.--The term ``genetic services'' means--
(A) a genetic test;
(B) genetic counseling (including obtaining,
interpreting, or assessing genetic information); or
(C) genetic education.
(7) Genetic test.--
(A) In general.--The term ``genetic test'' means an
analysis of human DNA, RNA, chromosomes, proteins, or
metabolites, that detects genotypes, mutations, or
chromosomal changes.
(B) Exceptions.--The term ``genetic test'' does not
mean an analysis of proteins or metabolites that does
not detect genotypes, mutations, or chromosomal changes.
SEC. 202. [NOTE: 42 USC 2000ff-1.] EMPLOYER PRACTICES.

(a) Discrimination Based on Genetic Information.--It shall be an
unlawful employment practice for an employer--
(1) to fail or refuse to hire, or to discharge, any
employee, or otherwise to discriminate against any employee with
respect to the compensation, terms, conditions, or privileges of
employment of the employee, because of genetic information with
respect to the employee; or
(2) to limit, segregate, or classify the employees of the
employer in any way that would deprive or tend to deprive any
employee of employment opportunities or otherwise adversely
affect the status of the employee as an employee, because of
genetic information with respect to the employee.

(b) Acquisition of Genetic Information.--It shall be an unlawful
employment practice for an employer to request, require, or purchase
genetic information with respect to an employee or a family member of
the employee except--
(1) where an employer inadvertently requests or requires
family medical history of the employee or family member of the
employee;
(2) where--
(A) health or genetic services are offered by the
employer, including such services offered as part of a
wellness program;
(B) the employee provides prior, knowing, voluntary,
and written authorization;
(C) only the employee (or family member if the
family member is receiving genetic services) and the
licensed health care professional or board certified
genetic counselor involved in providing such services
receive individually identifiable information concerning
the results of such services; and
(D) any individually identifiable genetic
information provided under subparagraph (C) in
connection with the services provided under subparagraph
(A) is only available for purposes of such services and
shall not be disclosed to the employer except in
aggregate terms that do not disclose the identity of
specific employees;
(3) where an employer requests or requires family medical
history from the employee to comply with the certification

[[Page 908]]
122 STAT. 908

provisions of section 103 of the Family and Medical Leave Act of
1993 (29 U.S.C. 2613) or such requirements under State family
and medical leave laws;
(4) where an employer purchases documents that are
commercially and publicly available (including newspapers,
magazines, periodicals, and books, but not including medical
databases or court records) that include family medical history;
(5) where the information involved is to be used for genetic
monitoring of the biological effects of toxic substances in the
workplace, but only if--
(A) the employer provides written notice of the
genetic monitoring to the employee;
(B)(i) the employee provides prior, knowing,
voluntary, and written authorization; or
(ii) the genetic monitoring is required by Federal
or State law;
(C) the employee is informed of individual
monitoring results;
(D) the monitoring is in compliance with--
(i) any Federal genetic monitoring
regulations, including any such regulations that
may be promulgated by the Secretary of Labor
pursuant to the Occupational Safety and Health Act
of 1970 (29 U.S.C. 651 et seq.), the Federal Mine
Safety and Health Act of 1977 (30 U.S.C. 801 et
seq.), or the Atomic Energy Act of 1954 (42 U.S.C.
2011 et seq.); or
(ii) State genetic monitoring regulations, in
the case of a State that is implementing genetic
monitoring regulations under the authority of the
Occupational Safety and Health Act of 1970 (29
U.S.C. 651 et seq.); and
(E) the employer, excluding any licensed health care
professional or board certified genetic counselor that
is involved in the genetic monitoring program, receives
the results of the monitoring only in aggregate terms
that do not disclose the identity of specific employees;
or
(6) where the employer conducts DNA analysis for law
enforcement purposes as a forensic laboratory or for purposes of
human remains identification, and requests or requires genetic
information of such employer's employees, but only to the extent
that such genetic information is used for analysis of DNA
identification markers for quality control to detect sample
contamination.

(c) Preservation of Protections.--In the case of information to
which any of paragraphs (1) through (6) of subsection (b) applies, such
information may not be used in violation of paragraph (1) or (2) of
subsection (a) or treated or disclosed in a manner that violates section
206.
SEC. 203. [NOTE: 42 USC 2000ff-2.] EMPLOYMENT AGENCY PRACTICES.

(a) Discrimination Based on Genetic Information.--It shall be an
unlawful employment practice for an employment agency--
(1) to fail or refuse to refer for employment, or otherwise
to discriminate against, any individual because of genetic
information with respect to the individual;
(2) to limit, segregate, or classify individuals or fail or
refuse to refer for employment any individual in any way

[[Page 909]]
122 STAT. 909

that would deprive or tend to deprive any individual of
employment opportunities, or otherwise adversely affect the
status of the individual as an employee, because of genetic
information with respect to the individual; or
(3) to cause or attempt to cause an employer to discriminate
against an individual in violation of this title.

(b) Acquisition of Genetic Information.--It shall be an unlawful
employment practice for an employment agency to request, require, or
purchase genetic information with respect to an individual or a family
member of the individual except--
(1) where an employment agency inadvertently requests or
requires family medical history of the individual or family
member of the individual;
(2) where--
(A) health or genetic services are offered by the
employment agency, including such services offered as
part of a wellness program;
(B) the individual provides prior, knowing,
voluntary, and written authorization;
(C) only the individual (or family member if the
family member is receiving genetic services) and the
licensed health care professional or board certified
genetic counselor involved in providing such services
receive individually identifiable information concerning
the results of such services; and
(D) any individually identifiable genetic
information provided under subparagraph (C) in
connection with the services provided under subparagraph
(A) is only available for purposes of such services and
shall not be disclosed to the employment agency except
in aggregate terms that do not disclose the identity of
specific individuals;
(3) where an employment agency requests or requires family
medical history from the individual to comply with the
certification provisions of section 103 of the Family and
Medical Leave Act of 1993 (29 U.S.C. 2613) or such requirements
under State family and medical leave laws;
(4) where an employment agency purchases documents that are
commercially and publicly available (including newspapers,
magazines, periodicals, and books, but not including medical
databases or court records) that include family medical history;
or
(5) where the information involved is to be used for genetic
monitoring of the biological effects of toxic substances in the
workplace, but only if--
(A) the employment agency provides written notice of
the genetic monitoring to the individual;
(B)(i) the individual provides prior, knowing,
voluntary, and written authorization; or
(ii) the genetic monitoring is required by Federal
or State law;
(C) the individual is informed of individual
monitoring results;
(D) the monitoring is in compliance with--
(i) any Federal genetic monitoring
regulations, including any such regulations that
may be promulgated by the Secretary of Labor
pursuant to the Occupational Safety and Health Act
of 1970 (29 U.S.C.

[[Page 910]]
122 STAT. 910

651 et seq.), the Federal Mine Safety and Health
Act of 1977 (30 U.S.C. 801 et seq.), or the Atomic
Energy Act of 1954 (42 U.S.C. 2011 et seq.); or
(ii) State genetic monitoring regulations, in
the case of a State that is implementing genetic
monitoring regulations under the authority of the
Occupational Safety and Health Act of 1970 (29
U.S.C. 651 et seq.); and
(E) the employment agency, excluding any licensed
health care professional or board certified genetic
counselor that is involved in the genetic monitoring
program, receives the results of the monitoring only in
aggregate terms that do not disclose the identity of
specific individuals.

(c) Preservation of Protections.--In the case of information to
which any of paragraphs (1) through (5) of subsection (b) applies, such
information may not be used in violation of paragraph (1), (2), or (3)
of subsection (a) or treated or disclosed in a manner that violates
section 206.
SEC. 204. [NOTE: 42 USC 2000ff-3.] LABOR ORGANIZATION PRACTICES.

(a) Discrimination Based on Genetic Information.--It shall be an
unlawful employment practice for a labor organization--
(1) to exclude or to expel from the membership of the
organization, or otherwise to discriminate against, any member
because of genetic information with respect to the member;
(2) to limit, segregate, or classify the members of the
organization, or fail or refuse to refer for employment any
member, in any way that would deprive or tend to deprive any
member of employment opportunities, or otherwise adversely
affect the status of the member as an employee, because of
genetic information with respect to the member; or
(3) to cause or attempt to cause an employer to discriminate
against a member in violation of this title.

(b) Acquisition of Genetic Information.--It shall be an unlawful
employment practice for a labor organization to request, require, or
purchase genetic information with respect to a member or a family member
of the member except--
(1) where a labor organization inadvertently requests or
requires family medical history of the member or family member
of the member;
(2) where--
(A) health or genetic services are offered by the
labor organization, including such services offered as
part of a wellness program;
(B) the member provides prior, knowing, voluntary,
and written authorization;
(C) only the member (or family member if the family
member is receiving genetic services) and the licensed
health care professional or board certified genetic
counselor involved in providing such services receive
individually identifiable information concerning the
results of such services; and
(D) any individually identifiable genetic
information provided under subparagraph (C) in
connection with the services provided under subparagraph
(A) is only available for purposes of such services and
shall not be disclosed

[[Page 911]]
122 STAT. 911

to the labor organization except in aggregate terms that
do not disclose the identity of specific members;
(3) where a labor organization requests or requires family
medical history from the members to comply with the
certification provisions of section 103 of the Family and
Medical Leave Act of 1993 (29 U.S.C. 2613) or such requirements
under State family and medical leave laws;
(4) where a labor organization purchases documents that are
commercially and publicly available (including newspapers,
magazines, periodicals, and books, but not including medical
databases or court records) that include family medical history;
or
(5) where the information involved is to be used for genetic
monitoring of the biological effects of toxic substances in the
workplace, but only if--
(A) the labor organization provides written notice
of the genetic monitoring to the member;
(B)(i) the member provides prior, knowing,
voluntary, and written authorization; or
(ii) the genetic monitoring is required by Federal
or State law;
(C) the member is informed of individual monitoring
results;
(D) the monitoring is in compliance with--
(i) any Federal genetic monitoring
regulations, including any such regulations that
may be promulgated by the Secretary of Labor
pursuant to the Occupational Safety and Health Act
of 1970 (29 U.S.C. 651 et seq.), the Federal Mine
Safety and Health Act of 1977 (30 U.S.C. 801 et
seq.), or the Atomic Energy Act of 1954 (42 U.S.C.
2011 et seq.); or
(ii) State genetic monitoring regulations, in
the case of a State that is implementing genetic
monitoring regulations under the authority of the
Occupational Safety and Health Act of 1970 (29
U.S.C. 651 et seq.); and
(E) the labor organization, excluding any licensed
health care professional or board certified genetic
counselor that is involved in the genetic monitoring
program, receives the results of the monitoring only in
aggregate terms that do not disclose the identity of
specific members.

(c) Preservation of Protections.--In the case of information to
which any of paragraphs (1) through (5) of subsection (b) applies, such
information may not be used in violation of paragraph (1), (2), or (3)
of subsection (a) or treated or disclosed in a manner that violates
section 206.
SEC. 205. [NOTE: 42 USC 2000ff-4.] TRAINING PROGRAMS.

(a) Discrimination Based on Genetic Information.--It shall be an
unlawful employment practice for any employer, labor organization, or
joint labor-management committee controlling apprenticeship or other
training or retraining, including on-the-job training programs--
(1) to discriminate against any individual because of
genetic information with respect to the individual in admission
to, or employment in, any program established to provide
apprenticeship or other training or retraining;

[[Page 912]]
122 STAT. 912

(2) to limit, segregate, or classify the applicants for or
participants in such apprenticeship or other training or
retraining, or fail or refuse to refer for employment any
individual, in any way that would deprive or tend to deprive any
individual of employment opportunities, or otherwise adversely
affect the status of the individual as an employee, because of
genetic information with respect to the individual; or
(3) to cause or attempt to cause an employer to discriminate
against an applicant for or a participant in such apprenticeship
or other training or retraining in violation of this title.

(b) Acquisition of Genetic Information.--It shall be an unlawful
employment practice for an employer, labor organization, or joint labor-
management committee described in subsection (a) to request, require, or
purchase genetic information with respect to an individual or a family
member of the individual except--
(1) where the employer, labor organization, or joint labor-
management committee inadvertently requests or requires family
medical history of the individual or family member of the
individual;
(2) where--
(A) health or genetic services are offered by the
employer, labor organization, or joint labor-management
committee, including such services offered as part of a
wellness program;
(B) the individual provides prior, knowing,
voluntary, and written authorization;
(C) only the individual (or family member if the
family member is receiving genetic services) and the
licensed health care professional or board certified
genetic counselor involved in providing such services
receive individually identifiable information concerning
the results of such services; and
(D) any individually identifiable genetic
information provided under subparagraph (C) in
connection with the services provided under subparagraph
(A) is only available for purposes of such services and
shall not be disclosed to the employer, labor
organization, or joint labor-management committee except
in aggregate terms that do not disclose the identity of
specific individuals;
(3) where the employer, labor organization, or joint labor-
management committee requests or requires family medical history
from the individual to comply with the certification provisions
of section 103 of the Family and Medical Leave Act of 1993 (29
U.S.C. 2613) or such requirements under State family and medical
leave laws;
(4) where the employer, labor organization, or joint labor-
management committee purchases documents that are commercially
and publicly available (including newspapers, magazines,
periodicals, and books, but not including medical databases or
court records) that include family medical history;
(5) where the information involved is to be used for genetic
monitoring of the biological effects of toxic substances in the
workplace, but only if--
(A) [NOTE: Notification.] the employer, labor
organization, or joint labor-management committee
provides written notice of the genetic monitoring to the
individual;

[[Page 913]]
122 STAT. 913

(B)(i) the individual provides prior, knowing,
voluntary, and written authorization; or
(ii) the genetic monitoring is required by Federal
or State law;
(C) the individual is informed of individual
monitoring results;
(D) the monitoring is in compliance with--
(i) any Federal genetic monitoring
regulations, including any such regulations that
may be promulgated by the Secretary of Labor
pursuant to the Occupational Safety and Health Act
of 1970 (29 U.S.C. 651 et seq.), the Federal Mine
Safety and Health Act of 1977 (30 U.S.C. 801 et
seq.), or the Atomic Energy Act of 1954 (42 U.S.C.
2011 et seq.); or
(ii) State genetic monitoring regulations, in
the case of a State that is implementing genetic
monitoring regulations under the authority of the
Occupational Safety and Health Act of 1970 (29
U.S.C. 651 et seq.); and
(E) the employer, labor organization, or joint
labor-management committee, excluding any licensed
health care professional or board certified genetic
counselor that is involved in the genetic monitoring
program, receives the results of the monitoring only in
aggregate terms that do not disclose the identity of
specific individuals; or
(6) where the employer conducts DNA analysis for law
enforcement purposes as a forensic laboratory or for purposes of
human remains identification, and requests or requires genetic
information of such employer's apprentices or trainees, but only
to the extent that such genetic information is used for analysis
of DNA identification markers for quality control to detect
sample contamination.

(c) Preservation of Protections.--In the case of information to
which any of paragraphs (1) through (6) of subsection (b) applies, such
information may not be used in violation of paragraph (1), (2), or (3)
of subsection (a) or treated or disclosed in a manner that violates
section 206.
SEC. 206. [NOTE: 42 USC 2000ff-5.] CONFIDENTIALITY OF GENETIC
INFORMATION.

(a) Treatment of Information as Part of Confidential Medical
Record.--If an employer, employment agency, labor organization, or joint
labor-management committee possesses genetic information about an
employee or member, such information shall be maintained on separate
forms and in separate medical files and be treated as a confidential
medical record of the employee or member. An employer, employment
agency, labor organization, or joint labor-management committee shall be
considered to be in compliance with the maintenance of information
requirements of this subsection with respect to genetic information
subject to this subsection that is maintained with and treated as a
confidential medical record under section 102(d)(3)(B) of the Americans
With Disabilities Act (42 U.S.C. 12112(d)(3)(B)).
(b) Limitation on Disclosure.--An employer, employment agency, labor
organization, or joint labor-management committee shall not disclose
genetic information concerning an employee or member except--

[[Page 914]]
122 STAT. 914

(1) to the employee or member of a labor organization (or
family member if the family member is receiving the genetic
services) at the written request of the employee or member of
such organization;
(2) to an occupational or other health researcher if the
research is conducted in compliance with the regulations and
protections provided for under part 46 of title 45, Code of
Federal Regulations;
(3) in response to an order of a court, except that--
(A) the employer, employment agency, labor
organization, or joint labor-management committee may
disclose only the genetic information expressly
authorized by such order; and
(B) if the court order was secured without the
knowledge of the employee or member to whom the
information refers, the employer, employment agency,
labor organization, or joint labor-management committee
shall inform the employee or member of the court order
and any genetic information that was disclosed pursuant
to such order;
(4) to government officials who are investigating compliance
with this title if the information is relevant to the
investigation;
(5) to the extent that such disclosure is made in connection
with the employee's compliance with the certification provisions
of section 103 of the Family and Medical Leave Act of 1993 (29
U.S.C. 2613) or such requirements under State family and medical
leave laws; or
(6) to a Federal, State, or local public health agency only
with regard to information that is described in section
201(4)(A)(iii) and that concerns a contagious disease that
presents an imminent hazard of death or life-threatening
illness, and that the employee whose family member or family
members is or are the subject of a disclosure under this
paragraph is notified of such disclosure.

(c) Relationship to HIPAA Regulations.--With respect to the
regulations promulgated by the Secretary of Health and Human Services
under part C of title XI of the Social Security Act (42 U.S.C. 1320d et
seq.) and section 264 of the Health Insurance Portability and
Accountability Act of 1996 (42 U.S.C. 1320d-2 note), this title does not
prohibit a covered entity under such regulations from any use or
disclosure of health information that is authorized for the covered
entity under such regulations. The previous sentence does not affect the
authority of such Secretary to modify such regulations.
SEC. 207. [NOTE: 42 USC 2000ff-6.] REMEDIES AND ENFORCEMENT.

(a) Employees Covered by Title VII of the Civil Rights Act of
1964.--
(1) In general.--The powers, procedures, and remedies
provided in sections 705, 706, 707, 709, 710, and 711 of the
Civil Rights Act of 1964 (42 U.S.C. 2000e-4 et seq.) to the
Commission, the Attorney General, or any person, alleging a
violation of title VII of that Act (42 U.S.C. 2000e et seq.)
shall be the powers, procedures, and remedies this title
provides to the Commission, the Attorney General, or any person,
respectively, alleging an unlawful employment practice in
violation of this title against an employee described in section
201(2)(A)(i), except as provided in paragraphs (2) and (3).

[[Page 915]]
122 STAT. 915

(2) Costs and fees.--The powers, remedies, and procedures
provided in subsections (b) and (c) of section 722 of the
Revised Statutes of the United States (42 U.S.C. 1988), shall be
powers, remedies, and procedures this title provides to the
Commission, the Attorney General, or any person, alleging such a
practice.
(3) Damages.--The powers, remedies, and procedures provided
in section 1977A of the Revised Statutes of the United States
(42 U.S.C. 1981a), including the limitations contained in
subsection (b)(3) of such section 1977A, shall be powers,
remedies, and procedures this title provides to the Commission,
the Attorney General, or any person, alleging such a practice
(not an employment practice specifically excluded from coverage
under section 1977A(a)(1) of the Revised Statutes of the United
States).

(b) Employees Covered by Government Employee Rights Act of 1991.--
(1) In general.--The powers, remedies, and procedures
provided in sections 302 and 304 of the Government Employee
Rights Act of 1991 (42 U.S.C. 2000e-16b, 2000e-16c) to the
Commission, or any person, alleging a violation of section
302(a)(1) of that Act (42 U.S.C. 2000e-16b(a)(1)) shall be the
powers, remedies, and procedures this title provides to the
Commission, or any person, respectively, alleging an unlawful
employment practice in violation of this title against an
employee described in section 201(2)(A)(ii), except as provided
in paragraphs (2) and (3).
(2) Costs and fees.--The powers, remedies, and procedures
provided in subsections (b) and (c) of section 722 of the
Revised Statutes of the United States (42 U.S.C. 1988), shall be
powers, remedies, and procedures this title provides to the
Commission, or any person, alleging such a practice.
(3) Damages.--The powers, remedies, and procedures provided
in section 1977A of the Revised Statutes of the United States
(42 U.S.C. 1981a), including the limitations contained in
subsection (b)(3) of such section 1977A, shall be powers,
remedies, and procedures this title provides to the Commission,
or any person, alleging such a practice (not an employment
practice specifically excluded from coverage under section
1977A(a)(1) of the Revised Statutes of the United States).

(c) Employees Covered by Congressional Accountability Act of 1995.--
(1) In general.--The powers, remedies, and procedures
provided in the Congressional Accountability Act of 1995 (2
U.S.C. 1301 et seq.) to the Board (as defined in section 101 of
that Act (2 U.S.C. 1301)), or any person, alleging a violation
of section 201(a)(1) of that Act (42 U.S.C. 1311(a)(1)) shall be
the powers, remedies, and procedures this title provides to that
Board, or any person, alleging an unlawful employment practice
in violation of this title against an employee described in
section 201(2)(A)(iii), except as provided in paragraphs (2) and
(3).
(2) Costs and fees.--The powers, remedies, and procedures
provided in subsections (b) and (c) of section 722 of the
Revised Statutes of the United States (42 U.S.C. 1988), shall be
powers, remedies, and procedures this title provides to that
Board, or any person, alleging such a practice.

[[Page 916]]
122 STAT. 916

(3) Damages.--The powers, remedies, and procedures provided
in section 1977A of the Revised Statutes of the United States
(42 U.S.C. 1981a), including the limitations contained in
subsection (b)(3) of such section 1977A, shall be powers,
remedies, and procedures this title provides to that Board, or
any person, alleging such a practice (not an employment practice
specifically excluded from coverage under section 1977A(a)(1) of
the Revised Statutes of the United States).
(4) Other applicable provisions.--With respect to a claim
alleging a practice described in paragraph (1), title III of the
Congressional Accountability Act of 1995 (2 U.S.C. 1381 et seq.)
shall apply in the same manner as such title applies with
respect to a claim alleging a violation of section 201(a)(1) of
such Act (2 U.S.C. 1311(a)(1)).

(d) Employees Covered by Chapter 5 of Title 3, United States Code.--
(1) In general.--The powers, remedies, and procedures
provided in chapter 5 of title 3, United States Code, to the
President, the Commission, the Merit Systems Protection Board,
or any person, alleging a violation of section 411(a)(1) of that
title, shall be the powers, remedies, and procedures this title
provides to the President, the Commission, such Board, or any
person, respectively, alleging an unlawful employment practice
in violation of this title against an employee described in
section 201(2)(A)(iv), except as provided in paragraphs (2) and
(3).
(2) Costs and fees.--The powers, remedies, and procedures
provided in subsections (b) and (c) of section 722 of the
Revised Statutes of the United States (42 U.S.C. 1988), shall be
powers, remedies, and procedures this title provides to the
President, the Commission, such Board, or any person, alleging
such a practice.
(3) Damages.--The powers, remedies, and procedures provided
in section 1977A of the Revised Statutes of the United States
(42 U.S.C. 1981a), including the limitations contained in
subsection (b)(3) of such section 1977A, shall be powers,
remedies, and procedures this title provides to the President,
the Commission, such Board, or any person, alleging such a
practice (not an employment practice specifically excluded from
coverage under section 1977A(a)(1) of the Revised Statutes of
the United States).

(e) Employees Covered by Section 717 of the Civil Rights Act of
1964.--
(1) In general.--The powers, remedies, and procedures
provided in section 717 of the Civil Rights Act of 1964 (42
U.S.C. 2000e-16) to the Commission, the Attorney General, the
Librarian of Congress, or any person, alleging a violation of
that section shall be the powers, remedies, and procedures this
title provides to the Commission, the Attorney General, the
Librarian of Congress, or any person, respectively, alleging an
unlawful employment practice in violation of this title against
an employee or applicant described in section 201(2)(A)(v),
except as provided in paragraphs (2) and (3).
(2) Costs and fees.--The powers, remedies, and procedures
provided in subsections (b) and (c) of section 722 of the
Revised Statutes of the United States (42 U.S.C. 1988), shall be
powers, remedies, and procedures this title provides

[[Page 917]]
122 STAT. 917

to the Commission, the Attorney General, the Librarian of
Congress, or any person, alleging such a practice.
(3) Damages.--The powers, remedies, and procedures provided
in section 1977A of the Revised Statutes of the United States
(42 U.S.C. 1981a), including the limitations contained in
subsection (b)(3) of such section 1977A, shall be powers,
remedies, and procedures this title provides to the Commission,
the Attorney General, the Librarian of Congress, or any person,
alleging such a practice (not an employment practice
specifically excluded from coverage under section 1977A(a)(1) of
the Revised Statutes of the United States).

(f) Prohibition Against Retaliation.--No person shall discriminate
against any individual because such individual has opposed any act or
practice made unlawful by this title or because such individual made a
charge, testified, assisted, or participated in any manner in an
investigation, proceeding, or hearing under this title. The remedies and
procedures otherwise provided for under this section shall be available
to aggrieved individuals with respect to violations of this subsection.
(g) Definition.--In this section, the term ``Commission'' means the
Equal Employment Opportunity Commission.
SEC. 208. [NOTE: 42 USC 2000ff-7.] DISPARATE IMPACT.

(a) General Rule.--Notwithstanding any other provision of this Act,
``disparate impact'', as that term is used in section 703(k) of the
Civil Rights Act of 1964 (42 U.S.C. 2000e-2(k)), on the basis of genetic
information does not establish a cause of action under this Act.
(b) Commission.--On [NOTE: Effective date. Establishment.] the
date that is 6 years after the date of enactment of this Act, there
shall be established a commission, to be known as the Genetic
Nondiscrimination Study Commission (referred to in this section as the
``Commission'') to review the developing science of genetics and to make
recommendations to Congress regarding whether to provide a disparate
impact cause of action under this Act.

(c) Membership.--
(1) In general.--The Commission shall be composed of 8
members, of which--
(A) 1 member shall be appointed by the Majority
Leader of the Senate;
(B) 1 member shall be appointed by the Minority
Leader of the Senate;
(C) 1 member shall be appointed by the Chairman of
the Committee on Health, Education, Labor, and Pensions
of the Senate;
(D) 1 member shall be appointed by the ranking
minority member of the Committee on Health, Education,
Labor, and Pensions of the Senate;
(E) 1 member shall be appointed by the Speaker of
the House of Representatives;
(F) 1 member shall be appointed by the Minority
Leader of the House of Representatives;
(G) 1 member shall be appointed by the Chairman of
the Committee on Education and Labor of the House of
Representatives; and

[[Page 918]]
122 STAT. 918

(H) 1 member shall be appointed by the ranking
minority member of the Committee on Education and Labor
of the House of Representatives.
(2) Compensation and expenses.--The members of the
Commission shall not receive compensation for the performance of
services for the Commission, but shall be allowed travel
expenses, including per diem in lieu of subsistence, at rates
authorized for employees of agencies under subchapter I of
chapter 57 of title 5, United States Code, while away from their
homes or regular places of business in the performance of
services for the Commission.

(d) Administrative Provisions.--
(1) Location.--The Commission shall be located in a facility
maintained by the Equal Employment Opportunity Commission.
(2) Detail of government employees.--Any Federal Government
employee may be detailed to the Commission without
reimbursement, and such detail shall be without interruption or
loss of civil service status or privilege.
(3) Information from federal agencies.--The Commission may
secure directly from any Federal department or agency such
information as the Commission considers necessary to carry out
the provisions of this section. Upon request of the Commission,
the head of such department or agency shall furnish such
information to the Commission.
(4) Hearings.--The Commission may hold such hearings, sit
and act at such times and places, take such testimony, and
receive such evidence as the Commission considers advisable to
carry out the objectives of this section, except that, to the
extent possible, the Commission shall use existing data and
research.
(5) Postal services.--The Commission may use the United
States mails in the same manner and under the same conditions as
other departments and agencies of the Federal Government.

(e) Report.--Not later than 1 year after all of the members are
appointed to the Commission under subsection (c)(1), the Commission
shall submit to Congress a report that summarizes the findings of the
Commission and makes such recommendations for legislation as are
consistent with this Act.
(f) Authorization of Appropriations.--There are authorized to be
appropriated to the Equal Employment Opportunity Commission such sums as
may be necessary to carry out this section.
SEC. 209. [NOTE: 42 USC 2000ff-8.] CONSTRUCTION.

(a) In General.--Nothing in this title shall be construed to--
(1) limit the rights or protections of an individual under
any other Federal or State statute that provides equal or
greater protection to an individual than the rights or
protections provided for under this title, including the
protections of an individual under the Americans with
Disabilities Act of 1990 (42 U.S.C. 12101 et seq.) (including
coverage afforded to individuals under section 102 of such Act
(42 U.S.C. 12112)), or under the Rehabilitation Act of 1973 (29
U.S.C. 701 et seq.);
(2)(A) limit the rights or protections of an individual to
bring an action under this title against an employer, employment
agency, labor organization, or joint labor-management committee
for a violation of this title; or

[[Page 919]]
122 STAT. 919

(B) [NOTE: Applicability.] provide for enforcement of, or
penalties for violation of, any requirement or prohibition
applicable to any employer, employment agency, labor
organization, or joint labor-management committee subject to
enforcement for a violation under--
(i) the amendments made by title I of this Act;
(ii)(I) subsection (a) of section 701 of the
Employee Retirement Income Security Act of 1974 as such
section applies with respect to genetic information
pursuant to subsection (b)(1)(B) of such section;
(II) section 702(a)(1)(F) of such Act; or
(III) section 702(b)(1) of such Act as such section
applies with respect to genetic information as a health
status-related factor;
(iii)(I) subsection (a) of section 2701 of the
Public Health Service Act as such section applies with
respect to genetic information pursuant to subsection
(b)(1)(B) of such section;
(II) section 2702(a)(1)(F) of such Act; or
(III) section 2702(b)(1) of such Act as such section
applies with respect to genetic information as a health
status-related factor; or
(iv)(I) subsection (a) of section 9801 of the
Internal Revenue Code of 1986 as such section applies
with respect to genetic information pursuant to
subsection (b)(1)(B) of such section;
(II) section 9802(a)(1)(F) of such Act; or
(III) section 9802(b)(1) of such Act as such section
applies with respect to genetic information as a health
status-related factor;
(3) apply to the Armed Forces Repository of Specimen Samples
for the Identification of Remains;
(4) limit or expand the protections, rights, or obligations
of employees or employers under applicable workers' compensation
laws;
(5) limit the authority of a Federal department or agency to
conduct or sponsor occupational or other health research that is
conducted in compliance with the regulations contained in part
46 of title 45, Code of Federal Regulations (or any
corresponding or similar regulation or rule);
(6) limit the statutory or regulatory authority of the
Occupational Safety and Health Administration or the Mine Safety
and Health Administration to promulgate or enforce workplace
safety and health laws and regulations; or
(7) require any specific benefit for an employee or member
or a family member of an employee or member under any group
health plan or health insurance issuer offering group health
insurance coverage in connection with a group health plan.

(b) Genetic Information of a Fetus or Embryo.--Any reference in this
title to genetic information concerning an individual or family member
of an individual shall--
(1) with respect to such an individual or family member of
an individual who is a pregnant woman, include genetic
information of any fetus carried by such pregnant woman; and

[[Page 920]]
122 STAT. 920

(2) with respect to an individual or family member utilizing
an assisted reproductive technology, include genetic information
of any embryo legally held by the individual or family member.

(c) Relation to Authorities Under Title I.--With respect to a group
health plan, or a health insurance issuer offering group health
insurance coverage in connection with a group health plan, this title
does not prohibit any activity of such plan or issuer that is authorized
for the plan or issuer under any provision of law referred to in clauses
(i) through (iv) of subsection (a)(2)(B).
SEC. 210. [NOTE: 42 USC 2000ff-9.] MEDICAL INFORMATION THAT IS
NOT GENETIC INFORMATION.

An employer, employment agency, labor organization, or joint labor-
management committee shall not be considered to be in violation of this
title based on the use, acquisition, or disclosure of medical
information that is not genetic information about a manifested disease,
disorder, or pathological condition of an employee or member, including
a manifested disease, disorder, or pathological condition that has or
may have a genetic basis.
SEC. 211. [NOTE: Deadline. 42 USC 2000ff-10.] REGULATIONS.

Not later than 1 year after the date of enactment of this title, the
Commission shall issue final regulations to carry out this title.
SEC. 212. [NOTE: 42 USC 2000ff-11.] AUTHORIZATION OF
APPROPRIATIONS.

There are authorized to be appropriated such sums as may be
necessary to carry out this title (except for section 208).
SEC. 213. [NOTE: 42 USC 2000ff note.] EFFECTIVE DATE.

This title takes effect on the date that is 18 months after the date
of enactment of this Act.

TITLE III--MISCELLANEOUS PROVISIONS

SEC. 301. [NOTE: 42 USC 2000ff note.] SEVERABILITY.

If any provision of this Act, an amendment made by this Act, or the
application of such provision or amendment to any person or circumstance
is held to be unconstitutional, the remainder of this Act, the
amendments made by this Act, and the application of such provisions to
any person or circumstance shall not be affected thereby.
SEC. 302. CHILD LABOR PROTECTIONS.

(a) In General.--Section 16(e) of the Fair Labor Standards Act of
1938 (29 U.S.C. 216(e)) is amended to read as follows:
``(e)(1)(A) Any [NOTE: Penalties.] person who violates the
provisions of sections 12 or 13(c), relating to child labor, or any
regulation issued pursuant to such sections, shall be subject to a civil
penalty not to exceed--
``(i) $11,000 for each employee who was the
subject of such a violation; or
``(ii) $50,000 with regard to each such
violation that causes the death or serious injury
of any employee under the age of 18 years, which
penalty may be doubled where the violation is a
repeated or willful violation.

[[Page 921]]
122 STAT. 921

``(B) For purposes of subparagraph (A), the term `serious injury'
means--
``(i) permanent loss or substantial impairment of one of the
senses (sight, hearing, taste, smell, tactile sensation);
``(ii) permanent loss or substantial impairment of the
function of a bodily member, organ, or mental faculty, including
the loss of all or part of an arm, leg, foot, hand or other body
part; or
``(iii) permanent paralysis or substantial impairment that
causes loss of movement or mobility of an arm, leg, foot, hand
or other body part.

``(2) Any person who repeatedly or willfully violates section 6 or
7, relating to wages, shall be subject to a civil penalty not to exceed
$1,100 for each such violation.
``(3) In determining the amount of any penalty under this
subsection, the appropriateness of such penalty to the size of the
business of the person charged and the gravity of the violation shall be
considered. The amount of any penalty under this subsection, when
finally determined, may be--
``(A) deducted from any sums owing by the United States to
the person charged;
``(B) recovered in a civil action brought by the Secretary
in any court of competent jurisdiction, in which litigation the
Secretary shall be represented by the Solicitor of Labor; or
``(C) ordered by the court, in an action brought for a
violation of section 15(a)(4) or a repeated or willful violation
of section 15(a)(2), to be paid to the Secretary.

``(4)
Any [NOTE: Deadline. Notification. Regulations.] administrative
determination by the Secretary of the amount of any penalty under this
subsection shall be final, unless within 15 days after receipt of notice
thereof by certified mail the person charged with the violation takes
exception to the determination that the violations for which the penalty
is imposed occurred, in which event final determination of the penalty
shall be made in an administrative proceeding after opportunity for
hearing in accordance with section 554 of title 5, United States Code,
and regulations to be promulgated by the Secretary.

``(5) Except for civil penalties collected for violations of section
12, sums collected as penalties pursuant to this section shall be
applied toward reimbursement of the costs of determining the violations
and assessing and collecting such penalties, in accordance with the
provision of section 2 of the Act entitled `An Act to authorize the
Department of Labor to make special statistical studies upon payment of
the cost thereof and for other purposes' (29 U.S.C. 9a). Civil penalties
collected for violations of section 12 shall be deposited in the general
fund of the Treasury.''.

[[Page 922]]
122 STAT. 922

(b) Effective Date.--The [NOTE: 29 USC 216 note.] amendments made
by this section shall take effect on the date of the enactment of this
Act.

Approved May 21, 2008.

LEGISLATIVE HISTORY--H.R. 493 (S. 358):
---------------------------------------------------------------------------

HOUSE REPORTS: No. 110-28, Pt. 1 (Comm. on Education and Labor), Pt. 2
(Comm. on Ways and Means), and Pts. 3 and 4 (Comm. on Energy and
Commerce).
SENATE REPORTS: No. 110-48 accompanying S. 358 (Comm. on Health,
Education, Labor, and Pensions).
CONGRESSIONAL RECORD:
Vol. 153 (2007):
Apr. 25, considered and passed
House.
Vol. 154 (2008):
Apr. 24, considered and passed
Senate, amended.
May 1, House concurred in Senate
amendment.
WEEKLY COMPILATION OF PRESIDENTIAL DOCUMENTS, Vol. 44 (2008):
May 21, Presidential remarks.