One Hundred Tenth Congress
of the
United States of America
AT THE SECOND SESSION
Begun and held at the City of Washington on Thursday,
the third day of January, two thousand and eight
An Act
To prohibit discrimination on the basis of genetic information with
respect to health insurance and employment.
Be it enacted by the Senate and House of Representatives of the United
States of America in Congress 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.
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. 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. 210. Medical information that is not genetic information.
Sec. 212. Authorization of appropriations.
Sec. 213. Effective date.
TITLE III--MISCELLANEOUS PROVISIONS
Sec. 302. Child labor protections.
SEC. 2. 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 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 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:
`(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 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) 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 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.
`(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.
`(8) GENETIC SERVICES- The term `genetic services' means--
`(B) genetic counseling (including obtaining, interpreting, or assessing
genetic information); or
`(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.
`(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--
`(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.
`(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
`(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.
`(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 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 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:
`(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 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) 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.
`(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.
`(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.
`(18) GENETIC SERVICES- The term `genetic services' means--
`(B) genetic counseling (including obtaining, interpreting, or assessing
genetic information); or
`(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.
`(i) IN GENERAL- The 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
`(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.
`(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
`(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-
(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. 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.
`(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) 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 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 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 amendments made by this section shall apply--
(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 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:
`(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).
`(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) 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 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 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.
`(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--
`(B) genetic counseling (including obtaining, interpreting, or assessing
genetic information); or
`(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--
`(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.'.
(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 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 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 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-
`(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.
`(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.
`(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--
`(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).'.
(c) Effective Date- The 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 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, 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 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.
(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
(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:
`APPLICATION OF HIPAA REGULATIONS TO GENETIC INFORMATION
`Sec. 1180. (a) In General- The 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 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 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; Effective Date-
(1) REGULATIONS- Not 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. 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. DEFINITIONS.
(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);
(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).
(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, 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--
(B) genetic counseling (including obtaining, interpreting, or assessing
genetic information); or
(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. 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;
(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 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. 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 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;
(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--
