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the first date the person otherwise lia-
ble for such penalty knew, or exer-
cising reasonable diligence would have 
known, that such failure existed. 
‘‘(iii) OVERALL LIMITATION FOR UN-
INTENTIONAL FAILURES.—In the case of 
failures which are due to reasonable cause 
and not to willful neglect, the penalty im-
posed 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 sub-
paragraph (A) to the extent that the payment 
of such penalty would be excessive relative to 
the failure involved. 
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‘‘(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 1 year 
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 18 months after the date of enactment of 
this Act. 
SEC. 102. AMENDMENTS TO THE PUBLIC HEALTH SERVICE 
ACT. 
(a) AMENDMENTS RELATING TO THE GROUP MAR-
KET.— 
(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 be-
fore the semicolon the following: ‘‘except as pro-
vided in paragraph (3)’’; and 
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(B) by adding at the end the following: 
‘‘(3) NO
GROUP-BASED
DISCRIMINATION
ON 
BASIS OF GENETIC INFORMATION.—For purposes of 
this section, a group health plan, and health insur-
ance issuer offering group health insurance coverage 
in connection with a group health plan, may not ad-
just premium or contribution amounts for the group 
covered under such plan on the basis of genetic in-
formation.’’. 
(2) LIMITATIONS ON GENETIC TESTING; PROHI-
BITION 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 REQUIR-
ING 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 
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services to an individual to request that such indi-
vidual undergo a genetic test. 
‘‘(3) RULE OF CONSTRUCTION REGARDING PAY-
MENT.— 
‘‘(A) IN GENERAL.—Nothing in paragraph 
(1) shall be construed to preclude a group 
health plan, or a health insurance issuer offer-
ing 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 regu-
lations 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 re-
vised from time to time) consistent with sub-
section (a). 
‘‘(B) LIMITATION.—For purposes of sub-
paragraph (A), a group health plan, or a health 
insurance issuer offering health insurance cov-
erage in connection with a group health plan, 
may request only the minimum amount of in-
formation necessary to accomplish the intended 
purpose. 
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‘‘(4) RESEARCH EXCEPTION.—Notwithstanding 
paragraph (1), a group health plan, or a health in-
surance issuer offering health insurance coverage in 
connection with a group health plan, may request, 
but not require, that a participant or beneficiary un-
dergo a genetic test if each of the following condi-
tions is met: 
‘‘(A) The request is made pursuant to re-
search that complies with part 46 of title 45, 
Code of Federal Regulations, or equivalent Fed-
eral 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 ef-
fect on enrollment status or premium or 
contribution amounts. 
‘‘(C) No genetic information collected or 
acquired under this paragraph shall be used for 
underwriting purposes. 
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‘‘(D) The plan or issuer notifies the Sec-
retary in writing that the plan or issuer is con-
ducting activities pursuant to the exception pro-
vided for under this paragraph, including a de-
scription of the activities conducted. 
‘‘(E) The plan or issuer complies with such 
other conditions as the Secretary may by regu-
lation require for activities conducted under this 
paragraph. 
‘‘(d) PROHIBITION ON COLLECTION OF GENETIC IN-
FORMATION.— 
‘‘(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 infor-
mation for underwriting purposes (as defined in sec-
tion 2791). 
‘‘(2) PROHIBITION
ON
COLLECTION
OF
GE-
NETIC
INFORMATION
PRIOR
TO
ENROLLMENT.—A 
group health plan, and a health insurance issuer of-
fering health insurance coverage in connection with 
a group health plan, shall not request, require, or 
purchase genetic information with respect to any in-
dividual prior to such individual’s enrollment under 
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the plan or coverage in connection with such enroll-
ment. 
‘‘(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 in-
formation concerning any individual, such request, 
requirement, or purchase shall not be considered a 
violation of paragraph (2) if such request, require-
ment, 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 sub-
section (b)(1) and section 2701 with respect to genetic in-
formation, 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 EM-
BRYO.—Any reference in this part to genetic information 
concerning an individual or family member of an indi-
vidual shall— 
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‘‘(1) with respect to such an individual or fam-
ily member of an individual who is a pregnant 
woman, include genetic information of any fetus car-
ried by such pregnant woman; and 
‘‘(2) with respect to an individual or family 
member utilizing an assisted reproductive tech-
nology, include genetic information of any embryo le-
gally held by the individual or family member.’’. 
(4) DEFINITIONS.—Section 2791(d) of the Pub-
lic 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 indi-
vidual; and 
‘‘(B) any other individual who is a first-de-
gree, second-degree, third-degree, or fourth-de-
gree relative of such individual or of an indi-
vidual described in subparagraph (A). 
‘‘(16) GENETIC INFORMATION.— 
‘‘(A) IN GENERAL.—The term ‘genetic in-
formation’ means, with respect to any indi-
vidual, information about— 
‘‘(i) such individual’s genetic tests, 
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‘‘(ii) the genetic tests of family mem-
bers of such individual, and 
‘‘(iii) subject to subparagraph (D), 
the manifestation of a disease or disorder 
in family members of such individual. 
‘‘(B) INCLUSION OF GENETIC SERVICES.— 
Such term includes, with respect to any indi-
vidual, any request for, or receipt of, genetic 
services (including genetic services received pur-
suant to participation in clinical research) by 
such individual or any family member of such 
individual. 
‘‘(C) EXCLUSIONS.—The term ‘genetic in-
formation’ shall not include information about 
the sex or age of any individual. 
‘‘(D) APPLICATION TO FAMILY MEMBERS 
COVERED UNDER SAME PLAN.—Information de-
scribed in clause (iii) of subparagraph (A) shall 
not be treated as genetic information to the ex-
tent that such information is taken into account 
only with respect to the individual in which 
such disease or disorder is manifested and not 
as genetic information with respect to any other 
individual. 
‘‘(17) GENETIC TEST.— 
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‘‘(A) IN
GENERAL.—The term ‘genetic 
test’ means an analysis of human DNA, RNA, 
chromosomes, proteins, or metabolites, that de-
tects genotypes, mutations, or chromosomal 
changes. 
‘‘(B) EXCEPTIONS.—The term ‘genetic 
test’ does not mean— 
‘‘(i) an analysis of proteins or metabo-
lites that does not detect genotypes, 
mutations, or chromosomal changes; or 
‘‘(ii) an analysis of proteins or me-
tabolites that is directly related to a mani-
fested disease, disorder, or pathological 
condition that could reasonably be detected 
by a health care professional with appro-
priate 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 obtain-
ing, interpreting, or assessing genetic informa-
tion); or 
‘‘(C) genetic education. 
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‘‘(19) UNDERWRITING
PURPOSES.—The term 
‘underwriting purposes’ means, with respect to any 
group health plan, or health insurance coverage of-
fered in connection with a group health plan— 
‘‘(A) rules for, or determination of, eligi-
bility (including enrollment and continued eligi-
bility) for benefits under the plan or coverage; 
‘‘(B) the computation of premium or con-
tribution 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 cre-
ation, 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 de-
scribed in paragraph (1), notwithstanding the 
provisions of paragraph (2)(C), the succeeding 
subparagraphs of this paragraph shall apply 
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100 
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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 sec-
tion 2702 or section 2701 or 2702(b)(1) with 
respect to genetic information in connection 
with the plan. 
‘‘(B) AMOUNT.— 
‘‘(i) IN
GENERAL.—The amount of 
the penalty imposed under this paragraph 
shall be $100 for each day in the non-
compliance period with respect to each par-
ticipant or beneficiary to whom such fail-
ure relates. 
‘‘(ii) NONCOMPLIANCE PERIOD.—For 
purposes of this paragraph, the term ‘non-
compliance 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 fail-
ure is corrected. 
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