110 HR 1424 EH: Genetic Information Nondiscrimination Act of
U.S. House of Representatives
0
text/xml
EN
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1.Organization of Act into
divisions; table of contents
(a)This
Act is organized into two divisions as follows:
(1)Division A—Paul Wellstone Mental Health and
Addiction Equity Act of 2008.
(2)Division B—Genetic Information
Nondiscrimination Act of 2008.
(b)The table of contents of this Act is as follows:
Sec. 1. Organization of Act into divisions; table of
contents.
Division A—Paul Wellstone Mental Health and Addiction Equity
Act of 2008
Sec. 101. Short title.
Sec. 102. Amendments to the Employee Retirement Income Security
Act of 1974.
Sec. 103. Amendments to the Public Health Service Act relating to the group
market.
Sec. 104. Amendments to the Internal Revenue Code of
1986.
Sec. 105. Medicaid drug rebate.
Sec. 106. Limitation on Medicare exception to the prohibition
on certain physician referrals for hospitals.
Sec. 107. Studies and reports.
Division B—Genetic Information Nondiscrimination Act of
2008
Sec. 100. Short title; 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. Guarantee agency collection retention.
Sec. 302. Severability.
APaul Wellstone
Mental Health and Addiction Equity Act of 2008
101.This division may be
cited as the Paul Wellstone Mental Health and Addiction Equity Act of
2008
.
102.Amendments to the
Employee Retirement Income Security Act of 1974
(a)Extension of
parity to treatment limits and beneficiary financial
requirementsSection 712 of the Employee Retirement Income
Security Act of 1974 (29 U.S.C. 1185a) is amended—
(1)in subsection (a),
by adding at the end the following new paragraphs:
(3)In the case of a group
health plan that provides both medical and surgical benefits and mental health
or substance-related disorder benefits—
(A)If the plan or coverage does not include a treatment limit
(as defined in subparagraph (D)) on substantially all medical and surgical
benefits in any category of items or services, the plan or coverage may not
impose any treatment limit on mental health or substance-related disorder
benefits that are classified in the same category of items or services.
(B)If the plan or coverage includes a treatment limit on
substantially all medical and surgical benefits in any category of items or
services, the plan or coverage may not impose such a treatment limit on mental
health or substance-related disorder benefits for items and services within
such category that is more restrictive than the predominant treatment limit
that is applicable to medical and surgical benefits for items and services
within such category.
(C)Categories of
items and services for application of treatment limits and beneficiary
financial requirementsFor purposes of this paragraph and
paragraph (4), there shall be the following five categories of items and
services for benefits, whether medical and surgical benefits or mental health
and substance-related disorder benefits, and all medical and surgical benefits
and all mental health and substance related benefits shall be classified into
one of the following categories:
(i)Items and services not described in clause (v)
furnished on an inpatient basis and within a network of providers established
or recognized under such plan or coverage.
(ii)Inpatient,
out-of-networkItems and
services not described in clause (v) furnished on an inpatient basis and
outside any network of providers established or recognized under such plan or
coverage.
(iii)Items and services
not described in clause (v) furnished on an outpatient basis and within a
network of providers established or recognized under such plan or
coverage.
(iv)Outpatient,
out-of-networkItems and
services not described in clause (v) furnished on an outpatient basis and
outside any network of providers established or recognized under such plan or
coverage.
(v)Items and services, whether furnished on an inpatient or
outpatient basis or within or outside any network of providers, required for
the treatment of an emergency medical condition (as defined in section 1867(e)
of the Social Security Act, including
an emergency condition relating to mental health or substance-related
disorders).
(D)For purposes of this paragraph, the term treatment
limit means, with respect to a plan or coverage, limitation on the
frequency of treatment, number of visits or days of coverage, or other similar
limit on the duration or scope of treatment under the plan or coverage.
(E)For
purposes of this subsection, a treatment limit or financial requirement with
respect to a category of items and services is considered to be predominant if
it is the most common or frequent of such type of limit or requirement with
respect to such category of items and services.
(4)Beneficiary
financial requirementsIn the
case of a group health plan that provides both medical and surgical benefits
and mental health or substance-related disorder benefits—
(A)No beneficiary
financial requirementIf the plan or coverage does not include a
beneficiary financial requirement (as defined in subparagraph (C)) on
substantially all medical and surgical benefits within a category of items and
services (specified under paragraph (3)(C)), the plan or coverage may not
impose such a beneficiary financial requirement on mental health or
substance-related disorder benefits for items and services within such
category.
(B)Beneficiary
financial requirement
(i)Treatment of
deductibles, out-of-pocket limits, and similar financial
requirementsIf the plan or
coverage includes a deductible, a limitation on out-of-pocket expenses, or
similar beneficiary financial requirement that does not apply separately to
individual items and services on substantially all medical and surgical
benefits within a category of items and services (as specified in paragraph
(3)(C)), the plan or coverage shall apply such requirement (or, if there is
more than one such requirement for such category of items and services, the
predominant requirement for such category) both to medical and surgical
benefits within such category and to mental health and substance-related
disorder benefits within such category and shall not distinguish in the
application of such requirement between such medical and surgical benefits and
such mental health and substance-related disorder benefits.
(ii)Other financial
requirementsIf the plan or
coverage includes a beneficiary financial requirement not described in clause
(i) on substantially all medical and surgical benefits within a category of
items and services, the plan or coverage may not impose such financial
requirement on mental health or substance-related disorder benefits for items
and services within such category in a way that results in greater
out-of-pocket expenses to the participant or beneficiary than the predominant
beneficiary financial requirement applicable to medical and surgical benefits
for items and services within such category.
(C)Beneficiary
financial requirement definedFor purposes of this paragraph, the
term beneficiary financial requirement includes, with respect to a
plan or coverage, any deductible, coinsurance, co-payment, other cost sharing,
and limitation on the total amount that may be paid by a participant or
beneficiary with respect to benefits under the plan or coverage, but does not
include the application of any aggregate lifetime limit or annual
limit.
;
and
(2)in subsection
(b)—
(A)by striking
construed—
and all that follows through (1) as
requiring
and inserting construed as requiring
;
(B)by striking
; or
and inserting a period; and
(C)by striking
paragraph (2).
(b)Expansion to
substance-related disorder benefits and revision of
definitionSuch section is further amended—
(1)by striking
mental health benefits
each place it appears (other than in any
provision amended by paragraph (2)) and inserting mental health or
substance-related disorder benefits
,
(2)by striking
mental health benefits
each place it appears in subsections
(a)(1)(B)(i), (a)(1)(C), (a)(2)(B)(i), and (a)(2)(C) and inserting
mental health and substance-related disorder benefits
, and
(3)in subsection (e),
by striking paragraph (4) and inserting the following new paragraphs:
(4)The term mental health benefits
means
benefits with respect to services for mental health conditions, as defined
under the terms of the plan and in accordance with applicable law, but does not
include substance-related disorder benefits.
(5)Substance-related
disorder benefitsThe term
substance-related disorder benefits
means benefits with respect
to services for substance-related disorders, as defined under the terms of the
plan and in accordance with applicable
law.
.
(c)Availability of
plan information about criteria for medical necessitySubsection (a) of such section, as amended
by subsection (a)(1), is further amended by adding at the end the following new
paragraph:
(5)Availability of
plan informationThe criteria
for medical necessity determinations made under the plan with respect to mental
health and substance-related disorder benefits (or the health insurance
coverage offered in connection with the plan with respect to such benefits)
shall be made available by the plan administrator (or the health insurance
issuer offering such coverage) in accordance with regulations to any current or
potential participant, beneficiary, or contracting provider upon request. The
reason for any denial under the plan (or coverage) of reimbursement or payment
for services with respect to mental health and substance-related disorder
benefits in the case of any participant or beneficiary shall, on request or as
otherwise required, be made available by the plan administrator (or the health
insurance issuer offering such coverage) to the participant or beneficiary in
accordance with
regulations.
.
(d)Minimum benefit
requirementsSubsection (a) of such section is further amended by
adding at the end the following new paragraph:
(6)Minimum scope of
coverage and equity in out-of-network benefits
(A)Minimum scope of
mental health and substance-related disorder benefitsIn the case of a group health plan (or
health insurance coverage offered in connection with such a plan) that provides
any mental health or substance-related disorder benefits, the plan or coverage
shall include benefits for any mental health condition or substance-related
disorder included in the most recent edition of the Diagnostic and Statistical
Manual of Mental Disorders published by the American Psychiatric
Association.
(B)Equity in
coverage of out-of-network benefits
(i)In the case of a plan or coverage that provides both
medical and surgical benefits and mental health or substance-related disorder
benefits, if medical and surgical benefits are provided for substantially all
items and services in a category specified in clause (ii) furnished outside any
network of providers established or recognized under such plan or coverage, the
mental health and substance-related disorder benefits shall also be provided
for items and services in such category furnished outside any network of
providers established or recognized under such plan or coverage in accordance
with the requirements of this section.
(ii)Categories of
items and servicesFor
purposes of clause (i), there shall be the following three categories of items
and services for benefits, whether medical and surgical benefits or mental
health and substance-related disorder benefits, and all medical and surgical
benefits and all mental health and substance-related disorder benefits shall be
classified into one of the following categories:
(I)Items
and services, whether furnished on an inpatient or outpatient basis, required
for the treatment of an emergency medical condition (as defined in section
1867(e) of the Social Security Act,
including an emergency condition relating to mental health or substance-related
disorders).
(II)Items
and services not described in subclause (I) furnished on an inpatient
basis.
(III)Items and services not described in
subclause (I) furnished on an outpatient
basis.
.
(e)Revision of
increased cost exemptionParagraph (2) of subsection (c) of such
section is amended to read as follows:
(2)
(A)With respect to a
group health plan (or health insurance coverage offered in connection with such
a plan), if the application of this section to such plan (or coverage) results
in an increase for the plan year involved of the actual total costs of coverage
with respect to medical and surgical benefits and mental health and
substance-related disorder benefits under the plan (as determined and certified
under subparagraph (C)) by an amount that exceeds the applicable percentage
described in subparagraph (B) of the actual total plan costs, the provisions of
this section shall not apply to such plan (or coverage) during the following
plan year, and such exemption shall apply to the plan (or coverage) for 1 plan
year.
(B)With respect to a plan (or coverage), the applicable
percentage described in this paragraph shall be—
(i)2 percent in the
case of the first plan year to which this paragraph applies; and
(ii)1
percent in the case of each subsequent plan year.
(C)Determinations
by actuariesDeterminations
as to increases in actual costs under a plan (or coverage) for purposes of this
subsection shall be made in writing and prepared and certified by a qualified
and licensed actuary who is a member in good standing of the American Academy
of Actuaries. Such determinations shall be made available by the plan
administrator (or health insurance issuer, as the case may be) to the general
public.
(D)If a group health plan (or a health insurance
issuer offering coverage in connection with such a plan) seeks an exemption
under this paragraph, determinations under subparagraph (A) shall be made after
such plan (or coverage) has complied with this section for the first 6 months
of the plan year involved.
(E)An
election to modify coverage of mental health and substance-related disorder
benefits as permitted under this paragraph shall be treated as a material
modification in the terms of the plan as described in section 102(a) and notice
of which shall be provided a reasonable period in advance of the change.
(F)Notification of
appropriate agency
(i)A group health plan
that, based on a certification described under subparagraph (C), qualifies for
an exemption under this paragraph, and elects to implement the exemption, shall
notify the Department of Labor of such election.
(ii)A
notification under clause (i) shall include—
(I)a description of
the number of covered lives under the plan (or coverage) involved at the time
of the notification, and as applicable, at the time of any prior election of
the cost-exemption under this paragraph by such plan (or coverage);
(II)for both the plan
year upon which a cost exemption is sought and the year prior, a description of
the actual total costs of coverage with respect to medical and surgical
benefits and mental health and substance-related disorder benefits under the
plan; and
(III)for both the
plan year upon which a cost exemption is sought and the year prior, the actual
total costs of coverage with respect to mental health and substance-related
disorder benefits under the plan.
(iii)A
notification under clause (i) shall be confidential. The Department of Labor
shall make available, upon request to the appropriate committees of Congress
and on not more than an annual basis, an anonymous itemization of such
notifications, that includes—
(I)a breakdown of
States by the size and any type of employers submitting such notification;
and
(II)a summary of the
data received under clause (ii).
(G)No impact on
application of State lawThe fact that a plan or coverage is
exempt from the provisions of this section under subparagraph (A) shall not
affect the application of State law to such plan or coverage.
(H)Nothing
in this paragraph shall be construed as preventing a group health plan (or
health insurance coverage offered in connection with such a plan) from
complying with the provisions of this section notwithstanding that the plan or
coverage is not required to comply with such provisions due to the application
of subparagraph
(A).
.
(f)Change in
exclusion for smallest employersSubsection (c)(1)(B) of such
section is amended—
(1)by inserting
(or 1 in the case of an employer residing in a State that permits small
groups to include a single individual)
after at least 2
the first place it appears; and
(2)by striking
and who employs at least 2 employees on the first day of the plan
year
.
(g)Elimination of
sunset provisionSuch section is amended by striking subsection
(f).
(h)Clarification
regarding preemptionSuch section is further amended by inserting
after subsection (e) the following new subsection:
(f)Preemption,
relation to State laws
(1)This part shall not
be construed to supersede any provision of State law which establishes,
implements, or continues in effect any consumer protections, benefits, methods
of access to benefits, rights, external review programs, or remedies solely
relating to health insurance issuers in connection with group health insurance
coverage (including benefit mandates or regulation of group health plans of 50
or fewer employees) except to the extent that such provision prevents the
application of a requirement of this part.
(2)Continued
preemption with respect to group health plansNothing in this section shall be construed
to affect or modify the provisions of section 514 with respect to group health
plans.
(3)Nothing in this section
shall be construed to exempt or relieve any person from any laws of any State
not solely related to health insurance issuers in connection with group health
coverage insofar as they may now or hereafter relate to insurance, health
plans, or health
coverage.
.
(i)Conforming
amendments to heading
(1)The heading of such section is amended to read as
follows:
712. EQUITY IN
MENTAL HEALTH AND SUBSTANCE-RELATED DISORDER
BENEFITS.
.
(2)The table of contents in section 1 of such Act is
amended by striking the item relating to section 712 and inserting the
following new item:
Sec. 712. Equity in mental health and
substance-related disorder
benefits.
.
(j)
(1)The amendments made by this section shall apply with
respect to plan years beginning on or after January 1, 2009.
(2)Special rule for
collective bargaining agreementsIn the case of a group health plan
maintained pursuant to one or more collective bargaining agreements between
employee representatives and one or more employers ratified before the date of
the enactment of this Act, the amendments made by this section shall not apply
to plan years beginning before the later of—
(A)the date on which
the last of the collective bargaining agreements relating to the plan
terminates (determined without regard to any extension thereof agreed to after
the date of the enactment of this Act), or
(B)January 1,
2009.
For purposes
of subparagraph (A), any plan amendment made pursuant to a collective
bargaining agreement relating to the plan which amends the plan solely to
conform to any requirement added by this section shall not be treated as a
termination of such collective bargaining agreement.(k)DOL annual
sample complianceThe
Secretary of Labor shall annually sample and conduct random audits of group
health plans (and health insurance coverage offered in connection with such
plans) in order to determine their compliance with the amendments made by this
division and shall submit to the appropriate committees of Congress an annual
report on such compliance with such amendments. The Secretary shall share the
results of such audits with the Secretaries of Health and Human Services and of
the Treasury.
(l)Assistance to
participants and beneficiariesThe Secretary of Labor shall provide
assistance to participants and beneficiaries of group health plans with any
questions or problems with compliance with the requirements of this division.
The Secretary shall notify participants and beneficiaries how they can obtain
assistance from State consumer and insurance agencies and the Secretary shall
coordinate with State agencies to ensure that participants and beneficiaries
are protected and afforded the rights provided under this division.
103.Amendments to the
Public Health Service Act relating to
the group market
(a)Extension of
Parity to Treatment Limits and Beneficiary Financial
RequirementsSection 2705 of the Public Health Service Act (42 U.S.C. 300gg–5)
is amended—
(1)in subsection (a),
by adding at the end the following new paragraphs:
(3)In the case of a group
health plan that provides both medical and surgical benefits and mental health
or substance-related disorder benefits—
(A)If the plan or coverage does not include a treatment limit
(as defined in subparagraph (D)) on substantially all medical and surgical
benefits in any category of items or services (specified in subparagraph (C)),
the plan or coverage may not impose any treatment limit on mental health or
substance-related disorder benefits that are classified in the same category of
items or services.
(B)If the plan or coverage includes a treatment limit on
substantially all medical and surgical benefits in any category of items or
services, the plan or coverage may not impose such a treatment limit on mental
health or substance-related disorder benefits for items and services within
such category that is more restrictive than the predominant treatment limit
that is applicable to medical and surgical benefits for items and services
within such category.
(C)Categories of
items and services for application of treatment limits and beneficiary
financial requirementsFor purposes of this paragraph and
paragraph (4), there shall be the following five categories of items and
services for benefits, whether medical and surgical benefits or mental health
and substance-related disorder benefits, and all medical and surgical benefits
and all mental health and substance related benefits shall be classified into
one of the following categories:
(i)Items and services not described in clause (v)
furnished on an inpatient basis and within a network of providers established
or recognized under such plan or coverage.
(ii)Inpatient,
out-of-networkItems and services not described in clause (v)
furnished on an inpatient basis and outside any network of providers
established or recognized under such plan or coverage.
(iii)Items and services not described in clause (v)
furnished on an outpatient basis and within a network of providers established
or recognized under such plan or coverage.
(iv)Outpatient,
out-of-networkItems and services not described in clause (v)
furnished on an outpatient basis and outside any network of providers
established or recognized under such plan or coverage.
(v)Items and services, whether furnished on an inpatient or
outpatient basis or within or outside any network of providers, required for
the treatment of an emergency medical condition (as defined in section 1867(e)
of the Social Security Act, including
an emergency condition relating to mental health or substance-related
disorders).
(D)For purposes of this paragraph, the term treatment
limit means, with respect to a plan or coverage, limitation on the
frequency of treatment, number of visits or days of coverage, or other similar
limit on the duration or scope of treatment under the plan or coverage.
(E)For
purposes of this subsection, a treatment limit or financial requirement with
respect to a category of items and services is considered to be predominant if
it is the most common or frequent of such type of limit or requirement with
respect to such category of items and services.
(4)Beneficiary
financial requirementsIn the
case of a group health plan that provides both medical and surgical benefits
and mental health or substance-related disorder benefits—
(A)No beneficiary
financial requirementIf the plan or coverage does not include a
beneficiary financial requirement (as defined in subparagraph (C)) on
substantially all medical and surgical benefits within a category of items and
services (specified in paragraph (3)(C)), the plan or coverage may not impose
such a beneficiary financial requirement on mental health or substance-related
disorder benefits for items and services within such category.
(B)Beneficiary
financial requirement
(i)Treatment of
deductibles, out-of-pocket limits, and similar financial
requirementsIf the plan or coverage includes a deductible, a
limitation on out-of-pocket expenses, or similar beneficiary financial
requirement that does not apply separately to individual items and services on
substantially all medical and surgical benefits within a category of items and
services, the plan or coverage shall apply such requirement (or, if there is
more than one such requirement for such category of items and services, the
predominant requirement for such category) both to medical and surgical
benefits within such category and to mental health and substance-related
disorder benefits within such category and shall not distinguish in the
application of such requirement between such medical and surgical benefits and
such mental health and substance-related disorder benefits.
(ii)Other financial
requirementsIf the plan or
coverage includes a beneficiary financial requirement not described in clause
(i) on substantially all medical and surgical benefits within a category of
items and services, the plan or coverage may not impose such financial
requirement on mental health or substance-related disorder benefits for items
and services within such category in a way that results in greater
out-of-pocket expenses to the participant or beneficiary than the predominant
beneficiary financial requirement applicable to medical and surgical benefits
for items and services within such category.
(C)Beneficiary
financial requirement definedFor purposes of this paragraph, the
term beneficiary financial requirement includes, with respect to a
plan or coverage, any deductible, coinsurance, co-payment, other cost sharing,
and limitation on the total amount that may be paid by a participant or
beneficiary with respect to benefits under the plan or coverage, but does not
include the application of any aggregate lifetime limit or annual
limit.
;
and
(2)in subsection
(b)—
(A)by striking
construed—
and all that follows through (1) as
requiring
and inserting construed as requiring
;
(B)by striking
; or
and inserting a period; and
(C)by striking
paragraph (2).
(b)Expansion to
Substance-Related Disorder Benefits and Revision of
DefinitionSuch section is further amended—
(1)by striking
mental health benefits
each place it appears (other than in any
provision amended by paragraph (2)) and inserting mental health or
substance-related disorder benefits
,
(2)by striking
mental health benefits
each place it appears in subsections
(a)(1)(B)(i), (a)(1)(C), (a)(2)(B)(i), and (a)(2)(C) and inserting
mental health and substance-related disorder benefits
, and
(3)in subsection (e),
by striking paragraph (4) and inserting the following new paragraphs:
(4)The term
mental health benefits
means benefits with respect to services
for mental health conditions, as defined under the terms of the plan and in
accordance with applicable law, but does not include substance-related disorder
benefits.
(5)Substance-related
disorder benefitsThe term
substance-related disorder benefits
means benefits with respect
to services for substance-related disorders, as defined under the terms of the
plan and in accordance with applicable
law.
.
(c)Availability of
Plan Information About Criteria for Medical NecessitySubsection
(a) of such section, as amended by subsection (a)(1), is further amended by
adding at the end the following new paragraph:
(5)Availability of
plan informationThe criteria
for medical necessity determinations made under the plan with respect to mental
health and substance-related disorder benefits (or the health insurance
coverage offered in connection with the plan with respect to such benefits)
shall be made available by the plan administrator (or the health insurance
issuer offering such coverage) in accordance with regulations to any current or
potential participant, beneficiary, or contracting provider upon request. The
reason for any denial under the plan (or coverage) of reimbursement or payment
for services with respect to mental health and substance-related disorder
benefits in the case of any participant or beneficiary shall, on request or as
otherwise required, be made available by the plan administrator (or the health
insurance issuer offering such coverage) to the participant or beneficiary in
accordance with
regulations.
.
(d)Minimum Benefit
RequirementsSubsection (a) of such section is further amended by
adding at the end the following new paragraph:
(6)Minimum scope of
coverage and equity in out-of-network benefits
(A)Minimum scope of
mental health and substance-related disorder benefitsIn the case
of a group health plan (or health insurance coverage offered in connection with
such a plan) that provides any mental health or substance-related disorder
benefits, the plan or coverage shall include benefits for any mental health
condition or substance-related disorder included in the most recent edition of
the Diagnostic and Statistical Manual of Mental Disorders published by the
American Psychiatric Association.
(B)Equity in
coverage of out-of-network benefits
(i)In the case of a group health plan (or health insurance
coverage offered in connection with such a plan) that provides both medical and
surgical benefits and mental health or substance-related disorder benefits, if
medical and surgical benefits are provided for substantially all items and
services in a category specified in clause (ii) furnished outside any network
of providers established or recognized under such plan or coverage, the mental
health and substance-related disorder benefits shall also be provided for items
and services in such category furnished outside any network of providers
established or recognized under such plan or coverage in accordance with the
requirements of this section.
(ii)Categories of
items and servicesFor purposes of clause (i), there shall be the
following three categories of items and services for benefits, whether medical
and surgical benefits or mental health and substance-related disorder benefits,
and all medical and surgical benefits and all mental health and
substance-related disorder benefits shall be classified into one of the
following categories:
(I)Items
and services, whether furnished on an inpatient or outpatient basis, required
for the treatment of an emergency medical condition (as defined in section
1867(e) of the Social Security Act,
including an emergency condition relating to mental health or substance-related
disorders).
(II)Items
and services not described in subclause (I) furnished on an inpatient
basis.
(III)Items
and services not described in subclause (I) furnished on an outpatient
basis.
.
(e)Revision of
Increased Cost ExemptionParagraph (2) of subsection (c) of such
section is amended to read as follows:
(2)
(A)With respect to a group health plan (or health insurance
coverage offered in connection with such a plan), if the application of this
section to such plan (or coverage) results in an increase for the plan year
involved of the actual total costs of coverage with respect to medical and
surgical benefits and mental health and substance-related disorder benefits
under the plan (as determined and certified under subparagraph (C)) by an
amount that exceeds the applicable percentage described in subparagraph (B) of
the actual total plan costs, the provisions of this section shall not apply to
such plan (or coverage) during the following plan year, and such exemption
shall apply to the plan (or coverage) for 1 plan year.
(B)With respect to a plan (or coverage), the applicable
percentage described in this paragraph shall be—
(i)2
percent in the case of the first plan year to which this paragraph applies;
and
(ii)1
percent in the case of each subsequent plan year.
(C)Determinations
by actuariesDeterminations
as to increases in actual costs under a plan (or coverage) for purposes of this
subsection shall be made in writing and prepared and certified by a qualified
and licensed actuary who is a member in good standing of the American Academy
of Actuaries. Such determinations shall be made available by the plan
administrator (or health insurance issuer, as the case may be) to the general
public.
(D)If a group health plan (or a health insurance
issuer offering coverage in connection with such a plan) seeks an exemption
under this paragraph, determinations under subparagraph (A) shall be made after
such plan (or coverage) has complied with this section for the first 6 months
of the plan year involved.
(E)A
group health plan under this part shall comply with the notice requirement
under section 712(c)(2)(E) of the Employee
Retirement Income Security Act of 1974 with respect to a
modification of mental health and substance-related disorder benefits as
permitted under this paragraph as if such section applied to such plan.
(F)Notification of
appropriate agency
(i)A group health plan
that, based on a certification described under subparagraph (C), qualifies for
an exemption under this paragraph, and elects to implement the exemption, shall
notify the Secretary of Health and Human Services of such election.
(ii)A
notification under clause (i) shall include—
(I)a description of
the number of covered lives under the plan (or coverage) involved at the time
of the notification, and as applicable, at the time of any prior election of
the cost-exemption under this paragraph by such plan (or coverage);
(II)for both the plan
year upon which a cost exemption is sought and the year prior, a description of
the actual total costs of coverage with respect to medical and surgical
benefits and mental health and substance-related disorder benefits under the
plan; and
(III)for both the
plan year upon which a cost exemption is sought and the year prior, the actual
total costs of coverage with respect to mental health and substance-related
disorder benefits under the plan.
(iii)A
notification under clause (i) shall be confidential. The Secretary of Health
and Human Services shall make available, upon request to the appropriate
committees of Congress and on not more than an annual basis, an anonymous
itemization of such notifications, that includes—
(I)a breakdown of
States by the size and any type of employers submitting such notification;
and
(II)a summary of the
data received under clause (ii).
(G)Nothing
in this paragraph shall be construed as preventing a group health plan (or
health insurance coverage offered in connection with such a plan) from
complying with the provisions of this section notwithstanding that the plan or
coverage is not required to comply with such provisions due to the application
of subparagraph
(A).
.
(f)Change in
Exclusion for Smallest EmployersSubsection (c)(1)(B) of such
section is amended—
(1)by inserting
(or 1 in the case of an employer residing in a State that permits small
groups to include a single individual)
after at least 2
the first place it appears; and
(2)by striking
and who employs at least 2 employees on the first day of the plan
year
.
(g)Elimination of
Sunset ProvisionSuch section is amended by striking out
subsection (f).
(h)Clarification
Regarding PreemptionSuch section is further amended by inserting
after subsection (e) the following new subsection:
(f)Preemption,
Relation to State Laws
(1)Nothing in this section shall be construed to preempt any
State law that provides greater consumer protections, benefits, methods of
access to benefits, rights or remedies that are greater than the protections,
benefits, methods of access to benefits, rights or remedies provided under this
section.
(2)Nothing
in this section shall be construed to affect or modify the provisions of
section 2723 with respect to group health
plans.
.
(i)Conforming
Amendment to HeadingThe heading of such section is amended to
read as follows:
2705.Equity in
mental health and Substance-Related disorder
benefits
.
(j)
(1)Except as otherwise provided in this subsection, the
amendments made by this section shall apply with respect to plan years
beginning on or after January 1, 2009.
(2)The amendment made by subsection (g) shall apply to
benefits for services furnished after December 31, 2007.
(3)Special rule for
collective bargaining agreementsIn the case of a group health
plan maintained pursuant to one or more collective bargaining agreements
between employee representatives and one or more employers ratified before the
date of the enactment of this Act, the amendments made by this section shall
not apply to plan years beginning before the later of—
(A)the date on which
the last of the collective bargaining agreements relating to the plan
terminates (determined without regard to any extension thereof agreed to after
the date of the enactment of this Act), or
(B)January 1,
2009.
For purposes
of subparagraph (A), any plan amendment made pursuant to a collective
bargaining agreement relating to the plan which amends the plan solely to
conform to any requirement added by this section shall not be treated as a
termination of such collective bargaining agreement.104.Amendments to the
Internal Revenue Code of 1986
(a)Extension of
parity to treatment limits and beneficiary financial
requirementsSection 9812 of the Internal Revenue Code of 1986 is
amended—
(1)in subsection (a),
by adding at the end the following new paragraphs:
(3)In the case of a group health plan that provides both
medical and surgical benefits and mental health or substance-related disorder
benefits—
(A)If the plan does not include a treatment limit (as defined
in subparagraph (D)) on substantially all medical and surgical benefits in any
category of items or services (specified in subparagraph (C)), the plan may not
impose any treatment limit on mental health or substance-related disorder
benefits that are classified in the same category of items or services.
(B)If the plan includes a treatment limit on substantially all
medical and surgical benefits in any category of items or services, the plan
may not impose such a treatment limit on mental health or substance-related
disorder benefits for items and services within such category that is more
restrictive than the predominant treatment limit that is applicable to medical
and surgical benefits for items and services within such category.
(C)Categories of
items and services for application of treatment limits and beneficiary
financial requirementsFor purposes of this paragraph and
paragraph (4), there shall be the following five categories of items and
services for benefits, whether medical and surgical benefits or mental health
and substance-related disorder benefits, and all medical and surgical benefits
and all mental health and substance related benefits shall be classified into
one of the following categories:
(i)Items and services not described in clause (v)
furnished on an inpatient basis and within a network of providers established
or recognized under such plan.
(ii)Inpatient,
out-of-networkItems and
services not described in clause (v) furnished on an inpatient basis and
outside any network of providers established or recognized under such
plan.
(iii)Items and services
not described in clause (v) furnished on an outpatient basis and within a
network of providers established or recognized under such plan.
(iv)Outpatient,
out-of-networkItems and
services not described in clause (v) furnished on an outpatient basis and
outside any network of providers established or recognized under such
plan.
(v)Items and services, whether furnished on an inpatient or
outpatient basis or within or outside any network of providers, required for
the treatment of an emergency medical condition (as defined in section 1867(e)
of the Social Security Act, including
an emergency condition relating to mental health or substance-related
disorders).
(D)For purposes of this paragraph, the term treatment
limit means, with respect to a plan, limitation on the frequency of
treatment, number of visits or days of coverage, or other similar limit on the
duration or scope of treatment under the plan.
(E)For
purposes of this subsection, a treatment limit or financial requirement with
respect to a category of items and services is considered to be predominant if
it is the most common or frequent of such type of limit or requirement with
respect to such category of items and services.
(4)Beneficiary
financial requirementsIn the case of a group health plan that
provides both medical and surgical benefits and mental health or
substance-related disorder benefits—
(A)No beneficiary
financial requirementIf the plan does not include a beneficiary
financial requirement (as defined in subparagraph (C)) on substantially all
medical and surgical benefits within a category of items and services
(specified in paragraph (3)(C)), the plan may not impose such a beneficiary
financial requirement on mental health or substance-related disorder benefits
for items and services within such category.
(B)Beneficiary
financial requirement
(i)Treatment of
deductibles, out-of-pocket limits, and similar financial
requirementsIf the plan
includes a deductible, a limitation on out-of-pocket expenses, or similar
beneficiary financial requirement that does not apply separately to individual
items and services on substantially all medical and surgical benefits within a
category of items and services, the plan shall apply such requirement (or, if
there is more than one such requirement for such category of items and
services, the predominant requirement for such category) both to medical and
surgical benefits within such category and to mental health and
substance-related disorder benefits within such category and shall not
distinguish in the application of such requirement between such medical and
surgical benefits and such mental health and substance-related disorder
benefits.
(ii)Other financial
requirementsIf the plan
includes a beneficiary financial requirement not described in clause (i) on
substantially all medical and surgical benefits within a category of items and
services, the plan may not impose such financial requirement on mental health
or substance-related disorder benefits for items and services within such
category in a way that results in greater out-of-pocket expenses to the
participant or beneficiary than the predominant beneficiary financial
requirement applicable to medical and surgical benefits for items and services
within such category.
(C)Beneficiary
financial requirement definedFor purposes of this paragraph, the
term beneficiary financial requirement includes, with respect to a
plan, any deductible, coinsurance, co-payment, other cost sharing, and
limitation on the total amount that may be paid by a participant or beneficiary
with respect to benefits under the plan, but does not include the application
of any aggregate lifetime limit or annual
limit.
,
and
(2)in
subsection (b)—
(A)by striking
construed—
and all that follows through (1) as
requiring
and inserting construed as requiring
,
(B)by striking
; or
and inserting a period, and
(C)by striking
paragraph (2).
(b)Expansion to
substance-related disorder benefits and revision of
definitionSection 9812 of such Code is further amended—
(1)by striking
mental health benefits
each place it appears (other than in any
provision amended by paragraph (2)) and inserting mental health or
substance-related disorder benefits
,
(2)by striking
mental health benefits
each place it appears in subsections
(a)(1)(B)(i), (a)(1)(C), (a)(2)(B)(i), and (a)(2)(C) and inserting
mental health and substance-related disorder benefits
, and
(3)in subsection (e),
by striking paragraph (4) and inserting the following new paragraphs:
(4)The term
mental health benefits
means benefits with respect to services
for mental health conditions, as defined under the terms of the plan and in
accordance with applicable law, but does not include substance-related disorder
benefits.
(5)Substance-related
disorder benefitsThe term
substance-related disorder benefits
means benefits with respect
to services for substance-related disorders, as defined under the terms of the
plan and in accordance with applicable
law.
.
(c)Availability of
plan information about criteria for medical necessitySubsection (a) of section 9812 of such
Code, as amended by subsection (a)(1), is further amended by adding at the end
the following new paragraph:
(5)Availability of
plan informationThe criteria
for medical necessity determinations made under the plan with respect to mental
health and substance-related disorder benefits shall be made available by the
plan administrator in accordance with regulations to any current or potential
participant, beneficiary, or contracting provider upon request. The reason for
any denial under the plan of reimbursement or payment for services with respect
to mental health and substance-related disorder benefits in the case of any
participant or beneficiary shall, on request or as otherwise required, be made
available by the plan administrator to the participant or beneficiary in
accordance with
regulations.
.
(d)Minimum benefit
requirementsSubsection (a) of section 9812 of such Code is
further amended by adding at the end the following new paragraph:
(6)Minimum scope of
coverage and equity in out-of-network benefits
(A)Minimum scope of
mental health and substance-related disorder benefitsIn the case of a group health plan that
provides any mental health or substance-related disorder benefits, the plan
shall include benefits for any mental health condition or substance-related
disorder included in the most recent edition of the Diagnostic and Statistical
Manual of Mental Disorders published by the American Psychiatric
Association.
(B)Equity in
coverage of out-of-network benefits
(i)In the case of a group health plan that provides both
medical and surgical benefits and mental health or substance-related disorder
benefits, if medical and surgical benefits are provided for substantially all
items and services in a category specified in clause (ii) furnished outside any
network of providers established or recognized under such plan, the mental
health and substance-related disorder benefits shall also be provided for items
and services in such category furnished outside any network of providers
established or recognized under such plan in accordance with the requirements
of this section.
(ii)Categories of
items and servicesFor
purposes of clause (i), there shall be the following three categories of items
and services for benefits, whether medical and surgical benefits or mental
health and substance-related disorder benefits, and all medical and surgical
benefits and all mental health and substance-related disorder benefits shall be
classified into one of the following categories:
(I)Items
and services, whether furnished on an inpatient or outpatient basis, required
for the treatment of an emergency medical condition (as defined in section
1867(e) of the Social Security Act,
including an emergency condition relating to mental health or substance-related
disorders).
(II)Items
and services not described in subclause (I) furnished on an inpatient
basis.
(III)Items and services not described in
subclause (I) furnished on an outpatient
basis.
.
(e)Revision of
increased cost exemptionParagraph (2) of section 9812(c) of such
Code is amended to read as follows:
(2)
(A)With respect to a
group health plan, if the application of this section to such plan results in
an increase for the plan year involved of the actual total costs of coverage
with respect to medical and surgical benefits and mental health and
substance-related disorder benefits under the plan (as determined and certified
under subparagraph (C)) by an amount that exceeds the applicable percentage
described in subparagraph (B) of the actual total plan costs, the provisions of
this section shall not apply to such plan during the following plan year, and
such exemption shall apply to the plan for 1 plan year.
(B)With respect to a plan, the applicable percentage
described in this paragraph shall be—
(i)2 percent in the case of the first plan
year to which this paragraph applies, and
(ii)1
percent in the case of each subsequent plan year.
(C)Determinations
by actuariesDeterminations
as to increases in actual costs under a plan for purposes of this subsection
shall be made in writing and prepared and certified by a qualified and licensed
actuary who is a member in good standing of the American Academy of Actuaries.
Such determinations shall be made available by the plan administrator to the
general public.
(D)If a group health plan seeks an exemption under
this paragraph, determinations under subparagraph (A) shall be made after such
plan has complied with this section for the first 6 months of the plan year
involved.
(E)Notification of
appropriate agency
(i)A group health plan
that, based on a certification described under subparagraph (C), qualifies for
an exemption under this paragraph, and elects to implement the exemption, shall
notify the Secretary of the Treasury of such election.
(ii)A
notification under clause (i) shall include—
(I)a description of
the number of covered lives under the plan (or coverage) involved at the time
of the notification, and as applicable, at the time of any prior election of
the cost-exemption under this paragraph by such plan (or coverage);
(II)for both the plan
year upon which a cost exemption is sought and the year prior, a description of
the actual total costs of coverage with respect to medical and surgical
benefits and mental health and substance-related disorder benefits under the
plan; and
(III)for both the
plan year upon which a cost exemption is sought and the year prior, the actual
total costs of coverage with respect to mental health and substance-related
disorder benefits under the plan.
(iii)A
notification under clause (i) shall be confidential. The Secretary of the
Treasury shall make available, upon request to the appropriate committees of
Congress and on not more than an annual basis, an anonymous itemization of such
notifications, that includes—
(I)a breakdown of
States by the size and any type of employers submitting such notification;
and
(II)a summary of the
data received under clause (ii).
(F)Nothing
in this paragraph shall be construed as preventing a group health plan from
complying with the provisions of this section notwithstanding that the plan is
not required to comply with such provisions due to the application of
subparagraph
(A).
.
(f)Change in
exclusion for smallest employersParagraph (1) of section 9812(c)
of such Code is amended to read as follows:
(1)
(A)This section shall
not apply to any group health plan for any plan year of a small
employer.
(B)For purposes of subparagraph (A), the term small
employer means, with respect to a calendar year and a plan year, an
employer who employed an average of at least 2 (or 1 in the case of an employer
residing in a State that permits small groups to include a single individual)
but not more than 50 employees on business days during the preceding calendar
year. For purposes of the preceding sentence, all persons treated as a single
employer under subsection (b), (c), (m), or (o) of section 414 shall be treated
as 1 employer and rules similar to rules of subparagraphs (B) and (C) of
section 4980D(d)(2) shall
apply.
.
(g)Elimination of
sunset provisionSection 9812 of such Code is amended by striking
subsection (f).
(h)Conforming
amendments to heading
(1)The heading of section 9812 of such Code is amended to
read as follows:
9812.Equity in
mental health and substance-related disorder
benefits
.
(2)The table of sections for subchapter B of chapter 100
of such Code is amended by striking the item relating to section 9812 and
inserting the following new item:
Sec. 9812. Equity in mental health and
substance-related disorder
benefits.
.
(i)
(1)Except as otherwise provided in this subsection, the
amendments made by this section shall apply with respect to plan years
beginning on or after January 1, 2009.
(2)The amendment made by subsection (g) shall apply to
benefits for services furnished after December 31, 2007.
(3)Special rule for
collective bargaining agreementsIn the case of a group health plan
maintained pursuant to one or more collective bargaining agreements between
employee representatives and one or more employers ratified before the date of
the enactment of this Act, the amendments made by this section (other than
subsection (g)) shall not apply to plan years beginning before the later
of—
(A)the date on which
the last of the collective bargaining agreements relating to the plan
terminates (determined without regard to any extension thereof agreed to after
the date of the enactment of this Act), or
(B)January 1,
2009.
For purposes
of subparagraph (A), any plan amendment made pursuant to a collective
bargaining agreement relating to the plan which amends the plan solely to
conform to any requirement added by this section shall not be treated as a
termination of such collective bargaining agreement.105.Paragraph (1)(B)(i) of
section 1927(c) of the Social Security Act (42 U.S.C. 1396r–8(c)) is
amended—
(1)by striking
and
at the end of subclause (IV);
(2)in subclause
(V)—
(A)by inserting
and before January 1, 2009, and after December 31, 2014,
after
December 31, 1995,
; and
(B)by striking the
period at the end and inserting ; and
; and
(3)by adding at the
end the following new subclause:
(VI)after December 31,
2008, and before January 1, 2015, is 20.1
percent.
.
106.Limitation on
Medicare exception to the prohibition on certain physician referrals for
hospitals
(a)Section 1877 of the
Social Security Act (42 U.S.C. 1395nn) is amended—
(1)in subsection (d)(2)—
(A)in subparagraph
(A), by striking and
at the end;
(B)in subparagraph
(B), by striking the period at the end and inserting ; and
;
and
(C)by adding at the
end the following new subparagraph:
(C)in the case where
the entity is a hospital, the hospital meets the requirements of paragraph
(3)(D).
;
(2)in subsection
(d)(3)—
(A)in subparagraph
(B), by striking and
at the end;
(B)in subparagraph
(C), by striking the period at the end and inserting ; and
;
and
(C)by adding at the
end the following new subparagraph:
(D)the hospital meets
the requirements described in subsection (i)(1) not later than 18 months after
the date of the enactment of this
subparagraph.
;
and
(3)by adding at the end the following new
subsection:
(i)Requirements for
hospitals To qualify for hospital exception to ownership or investment
prohibition
(1)For purposes of subsection (d)(3)(D), the requirements
described in this paragraph for a hospital are as follows:
(A)The hospital had—
(i)physician
ownership on the date of enactment of this subsection; and
(ii)a
provider agreement under section 1866 in effect on such date of
enactment.
(B)Limitation on
expansion of facility capacityExcept as provided in paragraph (3), the
number of operating rooms and beds of the hospital at any time on or after the
date of the enactment of this subsection are no greater than the number of
operating rooms and beds as of such date.
(C)Preventing
conflicts of interest
(i)The hospital
submits to the Secretary an annual report containing a detailed description
of—
(I)the identity of
each physician owner and any other owners of the hospital; and
(II)the nature and
extent of all ownership interests in the hospital.
(ii)The hospital has
procedures in place to require that any referring physician owner discloses to
the patient being referred, by a time that permits the patient to make a
meaningful decision regarding the receipt of care, as determined by the
Secretary—
(I)the ownership
interest of such referring physician in the hospital; and
(II)if applicable,
any such ownership interest of the treating physician.
(iii)The hospital
does not condition any physician ownership interests either directly or
indirectly on the physician owner making or influencing referrals to the
hospital or otherwise generating business for the hospital.
(iv)The hospital
discloses the fact that the hospital is partially owned by physicians—
(I)on any public
website for the hospital; and
(II)in any public
advertising for the hospital.
(D)Ensuring bona
fide investment
(i)Physician owners
in the aggregate do not own more than 40 percent of the total value of the
investment interests held in the hospital or in an entity whose assets include
the hospital.
(ii)The investment
interest of any individual physician owner does not exceed 2 percent of the
total value of the investment interests held in the hospital or in an entity
whose assets include the hospital.
(iii)Any ownership or
investment interests that the hospital offers to a physician owner are not
offered on more favorable terms than the terms offered to a person who is not a
physician owner.
(iv)The hospital (or any investors in the
hospital) does not directly or indirectly provide loans or financing for any
physician owner investments in the hospital.
(v)The hospital (or any investors in the
hospital) does not directly or indirectly guarantee a loan, make a payment
toward a loan, or otherwise subsidize a loan, for any individual physician
owner or group of physician owners that is related to acquiring any ownership
interest in the hospital.
(vi)Investment
returns are distributed to each investor in the hospital in an amount that is
directly proportional to the investment of capital by such investor in the
hospital.
(vii)Physician owners
do not receive, directly or indirectly, any guaranteed receipt of or right to
purchase other business interests related to the hospital, including the
purchase or lease of any property under the control of other investors in the
hospital or located near the premises of the hospital.
(viii)The hospital
does not offer a physician owner the opportunity to purchase or lease any
property under the control of the hospital or any other investor in the
hospital on more favorable terms than the terms offered to an individual who is
not a physician owner.
(E)
(i)Insofar as the
hospital admits a patient and does not have any physician available on the
premises to provide services during all hours in which the hospital is
providing services to such patient, before admitting the patient—
(I)the hospital
discloses such fact to a patient; and
(II)following such disclosure, the hospital
receives from the patient a signed acknowledgment that the patient understands
such fact.
(ii)The hospital has
the capacity to—
(I)provide assessment
and initial treatment for patients; and
(II)refer and transfer
patients to hospitals with the capability to treat the needs of the patient
involved.
(2)Publication of
information reportedThe
Secretary shall publish, and update on an annual basis, the information
submitted by hospitals under paragraph (1)(C)(i) on the public Internet website
of the Centers for Medicare & Medicaid Services.
(3)Exception to
prohibition on expansion of facility capacity
(A)
(i)The
Secretary shall establish and implement a process under which an applicable
hospital (as defined in subparagraph (E)) may apply for an exception from the
requirement under paragraph (1)(B).
(ii)Opportunity for
community inputThe process under clause (i) shall provide
individuals and entities in the community that the applicable hospital applying
for an exception is located with the opportunity to provide input with respect
to the application.
(iii)Timing for
implementationThe Secretary shall implement the process under
clause (i) on the date that is 18 months after the date of enactment of this
subsection.
(iv)Not
later than the date that is 18 months after the date of enactment of this
subsection, the Secretary shall promulgate regulations to carry out the process
under clause (i).
(B)The
process described in subparagraph (A) shall permit an applicable hospital to
apply for an exception up to once every 2 years.
(C)
(i)Subject to clause (ii) and subparagraph (D), an
applicable hospital granted an exception under the process described in
subparagraph (A) may increase the number of operating rooms and beds of the
applicable hospital above the baseline number of operating rooms and beds of
the applicable hospital (or, if the applicable hospital has been granted a
previous exception under this paragraph, above the number of operating rooms
and beds of the hospital after the application of the most recent increase
under such an exception) by an amount determined appropriate by the Secretary.
(ii)Lifetime 50
percent increase limitationThe Secretary shall not permit an increase
in the number of operating rooms and beds of an applicable hospital under
clause (i) to the extent such increase would result in the number of operating
rooms and beds of the applicable hospital exceeding 150 percent of the baseline
number of operating rooms and beds of the applicable hospital.
(iii)Baseline
number of operating rooms and bedsIn this paragraph, the term
baseline number of operating rooms and beds
means the number of
operating rooms and beds of the applicable hospital as of the date of enactment
of this subsection.
(D)Increase limited
to facilities on the main campus of the hospitalAny increase in
the number of operating rooms and beds of an applicable hospital pursuant to
this paragraph may only occur in facilities on the main campus of the
applicable hospital.
(E)In this paragraph, the term applicable
hospital
means a hospital—
(i)that is located in
a county in which the percentage increase in the population during the most
recent 5-year period (as of the date of the application under subparagraph (A))
is at least 200 percent of the percentage increase in the population growth of
the United States during that period, as estimated by Bureau of the
Census;
(ii)whose annual
percent of total inpatient admissions and outpatient visits that represent
inpatient admissions and outpatient visits under the program under title XIX is
equal to or greater than the average percent with respect to such admissions
and visits for all hospitals located in the State;
(iii)that does not
discriminate against beneficiaries of Federal health care programs and does not
permit physicians practicing at the hospital to discriminate against such
beneficiaries;
(iv)that is located
in a State in which the average bed capacity in the State is less than the
national average bed capacity; and
(v)in the case of a
hospital located—
(I)in a core-based
statistical area, that is located in such an area in which the average bed
occupancy rate in such area is greater than 80 percent; or
(II)outside of a
core-based statistical area, that is located in a State in which the average
bed occupancy rate is greater than 80 percent.
(F)Publication of
final decisionsThe Secretary shall publish final decisions with
respect to applications under this paragraph in the Federal Register.
(G)There shall be no administrative or judicial review under
section 1869, section 1878, or otherwise of the process under this paragraph
(including the establishment of such process).
(4)Collection of
ownership and investment informationFor purposes of clauses (i)
and (ii) of paragraph (1)(D), the Secretary shall collect physician ownership
and investment information for each hospital as it existed on the date of the
enactment of this subsection.
(5)For purposes of this subsection, the term physician
owner means a physician (or an immediate family member of such
physician) with a direct or an indirect ownership interest in the
hospital.
.
(b)
(1)The Secretary of Health and Human Services shall
establish policies and procedures to ensure compliance with the requirements
described in subsection (i)(1) of section 1877 of the Social Security Act, as
added by subsection (a)(3), beginning on the date such requirements first
apply. Such policies and procedures may include unannounced site reviews of
hospitals.
(2)Beginning
not later than 18 months after the date of the enactment of this Act, the
Secretary of Health and Human Services shall conduct audits to determine if
hospitals violate the requirements referred to in paragraph (1).
(c)Section
1848(l)(2)(A)(i)(III) of the Social Security Act (42 U.S.C.
1395w–4(l)(2)(A)(i)(III)), as amended by section 101(a)(2) of the Medicare,
Medicaid, and SCHIP Extension Act of 2007 (Public Law 110–173), is amended by
striking $4,960,000,000
and inserting
$5,120,000,000
.
107.
(a)
(1)The Comptroller General of the United States shall conduct
a study that evaluates the effect of the implementation of the amendments made
by this division on—
(A)the cost of health
insurance coverage;
(B)access to health
insurance coverage (including the availability of in-network providers);
(C)the quality of
health care;
(D)Medicare,
Medicaid, and State and local mental health and substance abuse treatment
spending;
(E)the number of
individuals with private insurance who received publicly funded health care for
mental health and substance-related disorders;
(F)spending on public
services, such as the criminal justice system, special education, and income
assistance programs;
(G)the use of medical management of mental
health and substance-related disorder benefits and medical necessity
determinations by group health plans (and health insurance issuers offering
health insurance coverage in connection with such plans) and timely access by
participants and beneficiaries to clinically-indicated care for mental health
and substance-use disorders; and
(H)other matters as
determined appropriate by the Comptroller General.
(2)Not
later than 2 years after the date of enactment of this Act, the Comptroller
General shall prepare and submit to the appropriate committees of the Congress
a report containing the results of the study conducted under paragraph
(1).
(b)GAO report on
uniform patient placement criteriaNot later than 18 months after the date of
the enactment of this Act, the Comptroller General shall submit to each House
of the Congress a report on availability of uniform patient placement criteria
for mental health and substance-related disorders that could be used by group
health plans and health insurance issuers to guide determinations of medical
necessity and the extent to which health plans utilize such criteria. If such
criteria do not exist, the report shall include recommendations on a process
for developing such criteria.
(c)DOL biannual
report on any obstacles in obtaining coverageEvery 2 years, the
Secretary of Labor, in consultation with the Secretaries of Health and Human
Services and the Treasury, shall submit to the appropriate committees of each
House of the Congress a report on obstacles, if any, that individuals face in
obtaining mental health and substance-related disorder care under their health
plans.
BGenetic
Information Nondiscrimination Act of 2008
100.
(a)This division may be cited as the
Genetic Information Nondiscrimination Act of 2008
.
(b)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.
<enum>I</enum><header>GENETIC
NONDISCRIMINATION IN HEALTH INSURANCE</header>
<section id="H1B1401D8631549528303AB72A1A9477F"><enum>101.</enum><header>Amendments to
<act-name parsable-cite="ERISA">Employee Retirement Income Security Act of
1974</act-name></header>
<subsection id="H02661449886844F484B85FC0571FE3F"><enum>(a)</enum><header>No discrimination
in group premiums based on genetic information</header><text>Section 702(b) of
the <act-name parsable-cite="ERISA">Employee Retirement Income Security Act of
1974</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/29/1182">29 U.S.C. 1182(b)</external-xref>) is amended—</text>
<paragraph id="H9B1EC67C0A4149FFABF71DA2F524A93F"><enum>(1)</enum><text>in paragraph
(2)(A), by inserting before the semicolon the following: <quote>except as
provided in paragraph (3)</quote>; and</text>
</paragraph><paragraph id="HB6607CD8E1E449E8B87E559F503B8755"><enum>(2)</enum><text>by adding at the
end the following:</text>
<quoted-block id="HF53927FEE62A459DBE1F8345C62479E4" style="OLC">
<paragraph commented="no" id="H32EB0B346CDF452FABE26740BE284DAB"><enum>(3)</enum><header>No group-based
discrimination on basis of genetic information</header><text display-inline="yes-display-inline">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.</text>
</paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></subsection><subsection id="HFF3D77099AB0484DA900FDDC8DBA90B2"><enum>(b)</enum><header>Limitations on
genetic testing; prohibition on collection of genetic information; application
to all plans</header><text>Section 702 of the <act-name parsable-cite="ERISA">Employee Retirement Income Security Act of
1974</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/29/1182">29 U.S.C. 1182</external-xref>) is amended by adding at the end the
following:</text>
<quoted-block act-name="Employee" id="H66951C32992E46BFB500E1F89D4BDD3" style="OLC">
<subsection id="HAF2022834D9146038511536EC6E972FF"><enum>(c)</enum><header>Genetic
Testing</header>
<paragraph id="H46E2A992AA874F029869DED9966836A0"><enum>(1)</enum><header>Limitation on
requesting or requiring genetic testing</header><text>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.</text>
</paragraph><paragraph id="HDB5A84F566CD4FEEA255F4095773E856"><enum>(2)</enum><header>Rule of
construction</header><text>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.</text>
</paragraph><paragraph id="H8C9CA0CB66D049569E9FCFC69F32BC6D"><enum>(3)</enum><header>Rule of
construction regarding payment</header>
<subparagraph id="H2737B53B617D41CC8CFA29BC1EDF0130"><enum>(A)</enum><header>In
general</header><text>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
<act-name parsable-cite="SSA">Social Security Act</act-name> and section 264 of
the <act-name parsable-cite="HIPAA">Health Insurance Portability and
Accountability Act of 1996</act-name>, as may be revised from time to time)
consistent with subsection (a).</text>
</subparagraph><subparagraph id="H7AA4668EBAEF4AF2A91950BF4D955C4"><enum>(B)</enum><header>Limitation</header><text display-inline="yes-display-inline">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.</text>
</subparagraph></paragraph><paragraph commented="no" id="HD24B550237664EF49F00E7102558D3F7"><enum>(4)</enum><header>Research
exception</header><text>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 <inline-comment display="no">an individual or a family member of
such individual</inline-comment>undergo a genetic test if each of the following
conditions is met:</text>
<subparagraph commented="no" id="H4321651257444B08B2039897BCE37478"><enum>(A)</enum><text>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.</text>
</subparagraph><subparagraph commented="no" id="H1FEDD679CCAA41CAAAABEAC6F0AA13A8"><enum>(B)</enum><text>The plan or issuer
clearly indicates to each participant or beneficiary<inline-comment display="no">individual</inline-comment>, or in the case of a minor child, to
the legal guardian of such <inline-comment display="no">child</inline-comment>beneficiary, to whom the request is made
that—</text>
<clause commented="no" id="H69D8E96A15FC4F75BC00B1D173B403F7"><enum>(i)</enum><text>compliance with
the request is voluntary; and</text>
</clause><clause commented="no" id="H9216B62073CE4C7C9500B212BCDBC561"><enum>(ii)</enum><text>non-compliance
will have no effect on enrollment status or premium or contribution
amounts.</text>
</clause></subparagraph><subparagraph commented="no" id="HBBB367990A16490DBA21F1156561F2D2"><enum>(C)</enum><text>No genetic
information collected or acquired under this paragraph shall be used for
underwriting purposes. <inline-comment display="no">Q: Aren’t these activities
already generally prohibited under HIPAA after the application of the other
amendments made by this Act?</inline-comment></text>
</subparagraph><subparagraph commented="no" id="HBF3653F479FC42538314BE91F4A2D81E"><enum>(D)</enum><text>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.</text>
</subparagraph><subparagraph commented="no" id="H9B6981E8DF844E19A4DD1F4801B98068"><enum>(E)</enum><text>The plan or issuer
complies with such other conditions as the Secretary may by regulation require
for activities conducted under this paragraph.</text>
</subparagraph></paragraph></subsection><subsection display-inline="no-display-inline" id="HB1EE85FB6AB5422E005472189D898DCB"><enum>(d)</enum><header>Prohibition on
collection of genetic information</header>
<paragraph id="HE93F139EE4524A0E8D8405CF564CB821"><enum>(1)</enum><header>In
general</header><text display-inline="yes-display-inline">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).</text>
</paragraph><paragraph id="H0AB2BB828DDB4B14A9F2879F8EC2C3CD"><enum>(2)</enum><header>Prohibition on
collection of genetic information prior to enrollment</header><text display-inline="yes-display-inline">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.</text>
</paragraph><paragraph id="H8068330E258D4908BCF765652D7C7522"><enum>(3)</enum><header>Incidental
collection</header><text display-inline="yes-display-inline">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).</text>
</paragraph></subsection><subsection id="H3D23ECF27DC44DA68CD723EDB175D2AB"><enum>(e)</enum><header>Application to
All Plans</header><text>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).</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="H512272DED807492AB7D0981626B35D30"><enum>(c)</enum><header>Application to
genetic information of a fetus or embryo</header><text>Such section is further
amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="HB7AB2464DD1240BC8F364C3F2F8D34D4" style="OLC">
<subsection id="HAD1A8B0B910B4C17A74689D2C8E68BE3"><enum>(f)</enum><header>Genetic
information of a fetus or embryo</header><text>Any reference in this part to
genetic information concerning an individual or family member of an individual
shall—</text>
<paragraph id="H8453C0A222F240E78EFB78A9E87438D5"><enum>(1)</enum><text>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</text>
</paragraph><paragraph id="HF5B63D1D15214531BDA0B8108E834E00"><enum>(2)</enum><text>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.</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="H0691C4C7A23A4D748D6C7D00AA794B12"><enum>(d)</enum><header>Definitions</header><text>Section
733(d) of the <act-name parsable-cite="ERISA">Employee Retirement Income
Security Act of 1974</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/29/1191b">29 U.S.C. 1191b(d)</external-xref>) is amended by adding at
the end the following:</text>
<quoted-block act-name="Employee" id="H94E68779DF6D4CEA91374F3F9369BE84" style="OLC">
<paragraph id="H08C7815EFDD54827AF42D89E77349739"><enum>(5)</enum><header>Family
member</header><text>The term <term>family member</term> means, with respect to
an individual—</text>
<subparagraph commented="no" id="HDC811C257C4E4B18845EE69B4DC550DD"><enum>(A)</enum><text>a dependent (as
such term is used for purposes of section 701(f)(2)) of such individual,
and</text>
</subparagraph><subparagraph commented="no" id="H66FE9DA8A8BB461598643CE6B5EF75A3"><enum>(B)</enum><text>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).</text>
</subparagraph></paragraph><paragraph id="HDC660892F6044BAA8BEAD36796E874EC"><enum>(6)</enum><header>Genetic
information</header>
<subparagraph commented="no" display-inline="no-display-inline" id="HAD81722E54BF4F8B9C60E6791FD43F32"><enum>(A)</enum><header>In
general</header><text>The term <term>genetic information</term> means, with
respect to any individual, information about—</text>
<clause commented="no" display-inline="no-display-inline" id="H7E2DBDDC91AE44D29DCF00C93FFC57D9"><enum>(i)</enum><text>such individual’s
genetic tests,</text>
</clause><clause commented="no" id="H1EDD1988044E49E6AF5D0253BDC47CC"><enum>(ii)</enum><text>the genetic tests
of family members of such individual, and</text>
</clause><clause commented="no" id="HC9E75AAA99124874BB045C720500D9D0"><enum>(iii)</enum><text>subject to
subparagraph (D), the manifestation of a disease or disorder in family members
of such individual.</text>
</clause></subparagraph><subparagraph id="H7878EA4DDE89499BA637A93664F9DE4"><enum>(B)</enum><header>Inclusion of
genetic services</header><text display-inline="yes-display-inline">Such term
includes, with respect to any individual, any request for, or receipt of,
genetic services (including genetic services received pursuant to participation
in clinical research) by such individual or any family member of such
individual.</text>
</subparagraph><subparagraph commented="no" id="HD4C36AFBAFE246389E5DC96B4316CD19"><enum>(C)</enum><header>Exclusions</header><text>The
term <term>genetic information</term> shall not include information about the
sex or age of any individual.</text>
</subparagraph><subparagraph commented="no" id="HB7CEEFB590B64DB0A3AEF960EB2B6D5F"><enum>(D)</enum><header>Application to
family members covered under same plan</header><text>Information described in
clause (iii) of subparagraph (A) shall not be treated as genetic information to
the extent 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.</text>
</subparagraph></paragraph><paragraph id="H65B58C9845844E8CA36B19C30912FF07"><enum>(7)</enum><header>Genetic
test</header>
<subparagraph id="HC10D0A9894E7497BA5EE4C7ED5749FD2"><enum>(A)</enum><header>In
general</header><text>The term <term>genetic test</term> means an analysis of
human DNA, RNA, chromosomes, proteins, or metabolites, that detects genotypes,
mutations, or chromosomal changes.</text>
</subparagraph><subparagraph id="H9E3C3B8E5FE640279EE5512CFCDEBE60"><enum>(B)</enum><header>Exceptions</header><text>The
term <term>genetic test</term> does not mean—</text>
<clause id="H46182CD0E8434141B122C6B00694FF5"><enum>(i)</enum><text>an
analysis of proteins or metabolites that does not detect genotypes, mutations,
or chromosomal changes; or</text>
</clause><clause id="H922B92962D274F9EA172E600DCC8346B"><enum>(ii)</enum><text>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.</text>
</clause></subparagraph></paragraph><paragraph id="H7C1666697B8A4B7DB2BADBFA47D07F56"><enum>(8)</enum><header>Genetic
services</header><text>The term <term>genetic services</term> means—</text>
<subparagraph id="H73D9AE8A5C5D4114942885C4291D5110"><enum>(A)</enum><text>a genetic
test;</text>
</subparagraph><subparagraph id="HE79EB7B42EEE42168154AF1E4652FD2F"><enum>(B)</enum><text>genetic counseling
(including obtaining, interpreting, or assessing genetic information);
or</text>
</subparagraph><subparagraph id="H0BD11D2AF4D241C7804BD600520480DB"><enum>(C)</enum><text>genetic
education.</text>
</subparagraph></paragraph><paragraph id="HD432BFEA63784F86AA4E4E1B6782EF32"><enum>(9)</enum><header>Underwriting
purposes</header><text display-inline="yes-display-inline">The term
<quote>underwriting purposes</quote> means, with respect to any group health
plan, or health insurance coverage offered in connection with a group health
plan—</text>
<subparagraph id="H9132B2E26CCD467097B412653E953260"><enum>(A)</enum><text>rules for, or
determination of, eligibility (including enrollment and continued eligibility)
for benefits under the plan or coverage;</text>
</subparagraph><subparagraph id="H2C1B35B5193843878C4D13F41F243EB9"><enum>(B)</enum><text display-inline="yes-display-inline">the computation of premium or contribution
amounts under the plan or coverage;</text>
</subparagraph><subparagraph id="H64D76B40198B4F089E1FAF01A9E66D97"><enum>(C)</enum><text display-inline="yes-display-inline">the application of any pre-existing
condition exclusion under the plan or coverage; and</text>
</subparagraph><subparagraph id="HB03B9A908212477C86162B91F6E5BFC4"><enum>(D)</enum><text>other activities
related to the creation, renewal, or replacement of a contract of health
insurance or health
benefits.</text>
</subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection display-inline="no-display-inline" id="HF8284A8A88534685B646B765EDAB7D6"><enum>(e)</enum><header>ERISA
enforcement</header><text>Section 502 of the Employee Retirement Income
Security Act of 1974 (<external-xref legal-doc="usc" parsable-cite="usc/29/1132">29 U.S.C. 1132</external-xref>) is amended—</text>
<paragraph id="H9D1A5CF7FFCE4017B94FE1F54C28C58E"><enum>(1)</enum><text>in subsection
(a)(6), by striking <quote>(7), or (8)</quote> and inserting <quote>(7), (8),
or (9)</quote>; and</text>
</paragraph><paragraph id="H14917F04191B4C23A6E7E2436CC097A8"><enum>(2)</enum><text>in subsection (c),
by redesignating paragraph (9) as paragraph (10), and by inserting after
paragraph (8) the following new paragraph:</text>
<quoted-block display-inline="no-display-inline" id="HD132CBA446E542C4AB541B1680000293" style="OLC">
<paragraph id="HC426CCF514CD496F8E752D4285B5D7F7"><enum>(9)</enum><header>Secretarial
enforcement authority relating to use of genetic information</header>
<subparagraph id="HD227884C71074EA1B800F915697815F0"><enum>(A)</enum><header>General
rule</header><text>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.</text>
</subparagraph><subparagraph id="H69497FD68F874D90AAA0195100FED514"><enum>(B)</enum><header>Amount</header>
<clause id="HE715B037C2754BB88D7DFD04536812F6"><enum>(i)</enum><header>In
general</header><text>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.</text>
</clause><clause id="HD7C06261741242D1AF9E038181B709A1"><enum>(ii)</enum><header>Noncompliance
period</header><text>For purposes of this paragraph, the term
<term>noncompliance period</term> means, with respect to any failure, the
period—</text>
<subclause id="HD7C10C5F77AB45C9AEA3711D9110132"><enum>(I)</enum><text>beginning on the
date such failure first occurs; and</text>
</subclause><subclause id="HCE96F0DB81B4498A99B54015CC042950"><enum>(II)</enum><text>ending on the
date the failure is corrected.</text>
</subclause></clause></subparagraph><subparagraph id="H96EC5B5CBC844DF0B81ECB8B750B774"><enum>(C)</enum><header>Minimum penalties
where failure discovered</header><text>Notwithstanding clauses (i) and (ii) of
subparagraph (D):</text>
<clause id="H822C71A7D62C4127AFC1FFF938D9BBE"><enum>(i)</enum><header>In
general</header><text>In the case of 1 or more failures with respect to a
participant or beneficiary—</text>
<subclause id="HD21512BA1ECA419C87C9D19EFEBDD11"><enum>(I)</enum><text>which are not
corrected before the date on which the plan receives a notice from the
Secretary of such violation; and</text>
</subclause><subclause id="H2A6C0659E234497D9B28E2871A37F8C"><enum>(II)</enum><text>which occurred or
continued during the period involved;</text>
</subclause><continuation-text continuation-text-level="clause">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.</continuation-text></clause><clause id="H52BC0EBEFF6E42FD8EB94F863ED4E9DD"><enum>(ii)</enum><header>Higher minimum
penalty where violations are more than de minimis</header><text>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
<quote>$15,000</quote> for <quote>$2,500</quote> with respect to such
person.</text>
</clause></subparagraph><subparagraph id="HE153A4D9A9B1495CA9274400F7F7BD88"><enum>(D)</enum><header>Limitations</header>
<clause id="H1CFB0905EEFF4DC28F9F538799A5DC97"><enum>(i)</enum><header>Penalty not to
apply where failure not discovered exercising reasonable
diligence</header><text>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.</text>
</clause><clause id="H28206AC927C54BD1B7B8C7DAD56D7098"><enum>(ii)</enum><header>Penalty not to
apply to failures corrected within certain periods</header><text>No penalty
shall be imposed by subparagraph (A) on any failure if—</text>
<subclause id="H0399B70155E740B48DA093E2FD89597"><enum>(I)</enum><text>such failure was
due to reasonable cause and not to willful neglect; and</text>
</subclause><subclause id="HBB04B5DEE0D04D99A998471568985B4F"><enum>(II)</enum><text>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.</text>
</subclause></clause><clause id="H16FB8FFD9372449D9828CC33FF4758FB"><enum>(iii)</enum><header>Overall
limitation for unintentional failures</header><text>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—</text>
<subclause id="H53471C19A3304DE4A0FAB1DE7C5E5690"><enum>(I)</enum><text>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</text>
</subclause><subclause id="HF3540B866EEF46388D305497FAB388E4"><enum>(II)</enum><text>$500,000.</text>
</subclause></clause></subparagraph><subparagraph id="H1E7D145F3D2047E0A044F4E0EE009E1B"><enum>(E)</enum><header>Waiver by
secretary</header><text>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.</text>
</subparagraph><subparagraph id="HF3D159E8D5CF4C19917E757FC1E0D4E0"><enum>(F)</enum><header>Definitions</header><text>Terms
used in this paragraph which are defined in section 733 shall have the meanings
provided such terms in such
section.</text>
</subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></subsection><subsection id="H16B964AA3ADB4E8A8C808FE446C7E88"><enum>(f)</enum><header>Regulations and
Effective Date</header>
<paragraph id="H3383FDD56A9B450200C2142D97D13D88"><enum>(1)</enum><header>Regulations</header><text>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.</text>
</paragraph><paragraph id="HF29DB3DE59254FED889B4395B064C9FE"><enum>(2)</enum><header>Effective
date</header><text>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.</text>
</paragraph></subsection></section><section id="HAD5F910D1CFA4BC684D95743363EEBEE"><enum>102.</enum><header>Amendments to
the <act-name parsable-cite="PHSA">Public Health Service
Act</act-name></header>
<subsection id="H35916EF73361416DA06DDB1BF362EC5"><enum>(a)</enum><header>Amendments
Relating to the Group Market</header>
<paragraph display-inline="no-display-inline" id="H7C4E9A83B0AE46F1BBC3164E00222F62"><enum>(1)</enum><header>No
discrimination in group premiums based on genetic
information</header><text>Section 2702(b) of the
<act-name parsable-cite="ERISA">Public Health Service Act </act-name> (42
U.S.C. 300gg–1(b)) is amended—</text>
<subparagraph id="HBC0DFD01D9F248C69B0374BBB5E65619"><enum>(A)</enum><text>in paragraph
(2)(A), by inserting before the semicolon the following: <quote>except as
provided in paragraph (3)</quote>; and</text>
</subparagraph><subparagraph id="HFD4599DE6079453FAAB9FC00298F00EC"><enum>(B)</enum><text>by adding at the
end the following:</text>
<quoted-block id="H1A9EFFAB65224B46AC84ADFB3CE51DAF" style="OLC">
<paragraph commented="no" id="H5E23DEB97E684B6D911EE22E44463C00"><enum>(3)</enum><header>No group-based
discrimination on basis of genetic information</header><text display-inline="yes-display-inline">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.</text>
</paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</subparagraph></paragraph><paragraph id="H80BDA6F79E38441C87538570A316E81F"><enum>(2)</enum><header>Limitations on
genetic testing; prohibition on collection of genetic information; application
to all plans</header><text>Section 2702 of the <act-name parsable-cite="PHSA">Public Health Service Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/42/300gg-1">42 U.S.C. 300gg–1</external-xref>)
is amended by adding at the end the following:</text>
<quoted-block act-name="Public Health Service Act" id="H969DD6C9DD8F4C4389A09AEBFC5CAA" style="OLC">
<subsection display-inline="no-display-inline" id="H5ED5AE0A662640688700A46C1DB71F1C"><enum>(c)</enum><header>Genetic
Testing</header>
<paragraph id="HC818979AE7BE473390DC563451FF4850"><enum>(1)</enum><header>Limitation on
requesting or requiring genetic testing</header><text>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.</text>
</paragraph><paragraph id="HC151A62B30814A0081CA5539546232A2"><enum>(2)</enum><header>Rule of
construction</header><text>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.</text>
</paragraph><paragraph display-inline="no-display-inline" id="HF8393A4EF33E4E7FAECDB696E925C89B"><enum>(3)</enum><header>Rule of
construction regarding payment</header>
<subparagraph id="HC426EC2F136E4591A741A48314900934"><enum>(A)</enum><header>In
general</header><text>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 <act-name parsable-cite="SSA">Social
Security Act</act-name> and section 264 of the <act-name parsable-cite="HIPAA">Health Insurance Portability and Accountability Act of
1996</act-name>, as may be revised from time to time) consistent with
subsection (a).</text>
</subparagraph><subparagraph id="H6F672D26DBA0410FAB814993F211B431"><enum>(B)</enum><header>Limitation</header><text display-inline="yes-display-inline">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.</text>
</subparagraph></paragraph><paragraph commented="no" id="HFD6236341BE048EF84D915A9C1742C75"><enum>(4)</enum><header>Research
exception</header><text>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 <inline-comment display="no">an individual or a family member of
such individual</inline-comment>undergo a genetic test if each of the following
conditions is met:</text>
<subparagraph commented="no" id="H0C3ED3FA8EB04CEBA62417117C8C2060"><enum>(A)</enum><text>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.</text>
</subparagraph><subparagraph commented="no" id="H93AFAD1C4B964EDD8808714246F7ACA6"><enum>(B)</enum><text>The plan or issuer
clearly indicates to each participant or beneficiary<inline-comment display="no">individual</inline-comment>, or in the case of a minor child, to
the legal guardian of such beneficiary<inline-comment display="no">child</inline-comment>, to whom the request is made that—</text>
<clause commented="no" id="H7B65369CEF314FA88F52DA003BCDF9D8"><enum>(i)</enum><text>compliance with
the request is voluntary; and</text>
</clause><clause commented="no" id="HA93BD5C2133548F1B122EA6C90D8C1F9"><enum>(ii)</enum><text>non-compliance
will have no effect on enrollment status or premium or contribution
amounts.</text>
</clause></subparagraph><subparagraph commented="no" id="HC270BCBFC66940AB92DE40BF949EA8B8"><enum>(C)</enum><text>No genetic
information collected or acquired under this paragraph shall be used for
underwriting purposes. <inline-comment display="no">Q: Aren’t these activities
already generally prohibited under HIPAA after the application of the other
amendments made by this Act?</inline-comment></text>
</subparagraph><subparagraph commented="no" id="H6F4854E969D94959BDD0811D8DBFCD72"><enum>(D)</enum><text>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.</text>
</subparagraph><subparagraph commented="no" id="H4EF90DBC1A854FD78DB80268D1197013"><enum>(E)</enum><text>The plan or issuer
complies with such other conditions as the Secretary may by regulation require
for activities conducted under this paragraph.</text>
</subparagraph></paragraph></subsection><subsection display-inline="no-display-inline" id="HA7358DE345524A47BB889BA324EE1E2F"><enum>(d)</enum><header>Prohibition on
collection of genetic information</header>
<paragraph id="H5B5F6FD090D0480B9BD16915E5A2F641"><enum>(1)</enum><header>In
general</header><text display-inline="yes-display-inline">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).</text>
</paragraph><paragraph id="H035A7D451392407789C061AEC96D92D6"><enum>(2)</enum><header>Prohibition on
collection of genetic information prior to enrollment</header><text display-inline="yes-display-inline">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.</text>
</paragraph><paragraph id="H29362272396F46E1B8908174CFA5A6A0"><enum>(3)</enum><header>Incidental
collection</header><text display-inline="yes-display-inline">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).</text>
</paragraph></subsection><subsection display-inline="no-display-inline" id="HA54470CEE701416FA81543AA26EC0382"><enum>(e)</enum><header>Application to
All Plans</header><text>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).</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph><paragraph id="H864BF26FD05B45C585723DEEB089899E"><enum>(3)</enum><header>Application to
genetic information of a fetus or embryo</header><text>Such section is further
amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="HF9C4A72AD5D54295B944ADA9DC476D93" style="OLC">
<subsection id="HD34F685C1E014F95855FA1FB4D3513B0"><enum>(f)</enum><header>Genetic
information of a fetus or embryo</header><text>Any reference in this part to
genetic information concerning an individual or family member of an individual
shall—</text>
<paragraph id="H8E9C28D4E16244CD91B7DDE6FADB56C"><enum>(1)</enum><text>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</text>
</paragraph><paragraph id="H41C2F7F32E6E40F694B782EECC5CBBA"><enum>(2)</enum><text>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.</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph><paragraph id="H007941235F434721B8001DA1200AC89"><enum>(4)</enum><header>Definitions</header><text>Section
2791(d) of the <act-name parsable-cite="PHSA">Public Health Service
Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/42/300gg-91">42 U.S.C. 300gg–91(d)</external-xref>) is amended by adding at the end the
following:</text>
<quoted-block act-name="Public Health Service Act" id="H386484A026ED4759B3FCA951E854A6CE" style="OLC">
<paragraph id="H71874689231F4DCDA5648E768000BAA8"><enum>(15)</enum><header>Family
member</header><text display-inline="yes-display-inline">The term <quote>family
member</quote> means, with respect to any individual—</text>
<subparagraph id="HE4EF4E6D2F2A41D1BF574771A53B69F1"><enum>(A)</enum><text>a dependent (as
such term is used for purposes of section 2701(f)(2)) of such individual;
and</text>
</subparagraph><subparagraph id="H15812311952B4F72008EB8F7DE95D54D"><enum>(B)</enum><text>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).</text>
</subparagraph></paragraph><paragraph display-inline="no-display-inline" id="H58480845C4C74380895295783CD04070"><enum>(16)</enum><header>Genetic
information</header>
<subparagraph commented="no" display-inline="no-display-inline" id="H5899774FA1D34FF6A1E36939C143567C"><enum>(A)</enum><header>In
general</header><text>The term <term>genetic information</term> means, with
respect to any individual, information about—</text>
<clause commented="no" display-inline="no-display-inline" id="H1E4239EFEE204922A0CC6D4B1C47FDDA"><enum>(i)</enum><text>such individual’s
genetic tests,</text>
</clause><clause commented="no" id="H715F8ADB28704F4D81DA43A9CF403236"><enum>(ii)</enum><text>the genetic tests
of family members of such individual, and</text>
</clause><clause commented="no" id="H3EFFC2302DB54F88BBB6FF1D9DB0B812"><enum>(iii)</enum><text>subject to
subparagraph (D), the manifestation of a disease or disorder in family members
of such individual.</text>
</clause></subparagraph><subparagraph id="H123ABFFFF51D4E4580BB92A87585A78F"><enum>(B)</enum><header>Inclusion of
genetic services</header><text display-inline="yes-display-inline">Such term
includes, with respect to any individual, any request for, or receipt of,
genetic services (including genetic services received pursuant to participation
in clinical research) by such individual or any family member of such
individual.</text>
</subparagraph><subparagraph commented="no" id="H5C392374ED754C95AD0051244C806445"><enum>(C)</enum><header>Exclusions</header><text>The
term <term>genetic information</term> shall not include information about the
sex or age of any individual.</text>
</subparagraph><subparagraph commented="no" id="HAC806F08078D40B2B23645FFFA893F25"><enum>(D)</enum><header>Application to
family members covered under same plan</header><text>Information described in
clause (iii) of subparagraph (A) shall not be treated as genetic information to
the extent 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.</text>
</subparagraph></paragraph><paragraph id="HE1BDCC5D85DD4C3883F44C4EFA5EC280"><enum>(17)</enum><header>Genetic
test</header>
<subparagraph id="H0E619F19705D4B6C8B4CDF00B01BEA9F"><enum>(A)</enum><header>In
general</header><text>The term <term>genetic test</term> means an analysis of
human DNA, RNA, chromosomes, proteins, or metabolites, that detects genotypes,
mutations, or chromosomal changes.</text>
</subparagraph><subparagraph id="HBEE51C2159D245BBB129636E25E6553F"><enum>(B)</enum><header>Exceptions</header><text>The
term <term>genetic test</term> does not mean—</text>
<clause id="HCD0382B8EA6E4BF59F7285002658A5D9"><enum>(i)</enum><text>an
analysis of proteins or metabolites that does not detect genotypes, mutations,
or chromosomal changes; or</text>
</clause><clause id="H587DE77E378941F6BF2079E2C95BC154"><enum>(ii)</enum><text>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.</text>
</clause></subparagraph></paragraph><paragraph id="H87B52CC4786046B0B147802B0861FF19"><enum>(18)</enum><header>Genetic
services</header><text>The term <term>genetic services</term> means—</text>
<subparagraph id="HFCA004DECC1D464AA9BE029E49D2FDAA"><enum>(A)</enum><text>a genetic
test;</text>
</subparagraph><subparagraph id="H8585CD7071FE4BF4883B1FD8004D297C"><enum>(B)</enum><text>genetic counseling
(including obtaining, interpreting, or assessing genetic information);
or</text>
</subparagraph><subparagraph id="H95818078B9344AB791B26BBE6323FF"><enum>(C)</enum><text>genetic
education.</text>
</subparagraph></paragraph><paragraph id="H63063E1587134065A13738FF71429037"><enum>(19)</enum><header>Underwriting
purposes</header><text display-inline="yes-display-inline">The term
<quote>underwriting purposes</quote> means, with respect to any group health
plan, or health insurance coverage offered in connection with a group health
plan—</text>
<subparagraph id="HBD9DAD6736E74DD3ABC8745B5FD7DCC"><enum>(A)</enum><text>rules for, or
determination of, eligibility (including enrollment and continued eligibility)
for benefits under the plan or coverage;</text>
</subparagraph><subparagraph id="H1D2EF7ED836D42159543D36E657442D5"><enum>(B)</enum><text display-inline="yes-display-inline">the computation of premium or contribution
amounts under the plan or coverage;</text>
</subparagraph><subparagraph id="H50E12F7246614D4F8990C1B7EB1704D"><enum>(C)</enum><text display-inline="yes-display-inline">the application of any pre-existing
condition exclusion under the plan or coverage; and</text>
</subparagraph><subparagraph id="H07D12A25347C4D5794BDBCB422E9C6E8"><enum>(D)</enum><text>other activities
related to the creation, renewal, or replacement of a contract of health
insurance or health
benefits.</text>
</subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph><paragraph id="H2351CC587411446FAC866FD06270A8DB"><enum>(5)</enum><header>Remedies and
enforcement</header><text>Section 2722(b) of the <act-name parsable-cite="PHSA">Public Health Service Act</act-name> (42 U.S.C.
300gg–22(b)) is amended by adding at the end the following:</text>
<quoted-block act-name="Public Health Service Act" id="H972E12F9CF674FD9B833D35B45E08BC2" style="OLC">
<paragraph id="H3B07070664334531BD28C3C4A84E8612"><enum>(3)</enum><header>Enforcement
authority relating to genetic discrimination</header>
<subparagraph id="H3DA219EB3BF246ABA73592235B7D01E5"><enum>(A)</enum><header>General
rule</header><text display-inline="yes-display-inline">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.</text>
</subparagraph><subparagraph id="H657E433F8F29493DA10814DBCCE6DF53"><enum>(B)</enum><header>Amount</header>
<clause id="H974E0F2A9B704AF5873160136612EDA6"><enum>(i)</enum><header>In
general</header><text>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.</text>
</clause><clause id="HFDB07DB4EA55452C927DE2AFD2D70039"><enum>(ii)</enum><header>Noncompliance
period</header><text>For purposes of this paragraph, the term
<term>noncompliance period</term> means, with respect to any failure, the
period—</text>
<subclause id="H73E04B39AF6045B4A13C8EBF1B612B78"><enum>(I)</enum><text>beginning on the
date such failure first occurs; and</text>
</subclause><subclause id="H746B2839956246E6833F342B0631E629"><enum>(II)</enum><text>ending on the
date the failure is corrected.</text>
</subclause></clause></subparagraph><subparagraph id="H17BD102F09C64A18944E09672CF31E8B"><enum>(C)</enum><header>Minimum
penalties where failure discovered</header><text>Notwithstanding clauses (i)
and (ii) of subparagraph (D):</text>
<clause id="H988A3B0BEBE74A4CA95BA23F335D50C7"><enum>(i)</enum><header>In
general</header><text>In the case of 1 or more failures with respect to an
individual—</text>
<subclause id="H0ED8631120CC42BF8F2655438CF483FB"><enum>(I)</enum><text>which are not
corrected before the date on which the plan receives a notice from the
Secretary of such violation; and</text>
</subclause><subclause id="HA5ECA994F0FC458DADCB1266CB7C26BD"><enum>(II)</enum><text>which occurred or
continued during the period involved;</text>
</subclause><continuation-text continuation-text-level="clause">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.</continuation-text></clause><clause id="H891D5522A8BC4CE500314D8700918921"><enum>(ii)</enum><header>Higher minimum
penalty where violations are more than de minimis</header><text>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
<quote>$15,000</quote> for <quote>$2,500</quote> with respect to such
person.</text>
</clause></subparagraph><subparagraph id="H74B10B3608284A1896D7AB30A6836D10"><enum>(D)</enum><header>Limitations</header>
<clause id="H08A3D53F982842AFB4699D8811F64124"><enum>(i)</enum><header>Penalty not to
apply where failure not discovered exercising reasonable
diligence</header><text>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.</text>
</clause><clause id="H1362CF99A2D745989F095BB0D8ADC738"><enum>(ii)</enum><header>Penalty not to
apply to failures corrected within certain periods</header><text>No penalty
shall be imposed by subparagraph (A) on any failure if—</text>
<subclause id="HB1EE3FC85E7547BF8CD69F5D8CB287E"><enum>(I)</enum><text>such failure was
due to reasonable cause and not to willful neglect; and</text>
</subclause><subclause id="H381CE815C3AA4CF297D9D82CEA52BCFC"><enum>(II)</enum><text>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.</text>
</subclause></clause><clause id="H965EE9FF452A4A5BABAC08A3A92EB25E"><enum>(iii)</enum><header>Overall
limitation for unintentional failures</header><text>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—</text>
<subclause id="H429938554BA84A27830379AED0632F8"><enum>(I)</enum><text>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</text>
</subclause><subclause id="HB1EEDAE1279B49C2AAE1A0C8FD31C7F"><enum>(II)</enum><text>$500,000.</text>
</subclause></clause></subparagraph><subparagraph id="HAA5D46EF82B149B0BF81061C38A3E956"><enum>(E)</enum><header>Waiver by
secretary</header><text>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.</text>
</subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></subsection><subsection id="HFB6D4422EFB24C6998ADE3DFA63789F5"><enum>(b)</enum><header>Amendment
Relating to the Individual Market</header>
<paragraph id="H6F180D4374E34B4DA0E1F87E3371C58"><enum>(1)</enum><header>In
general</header><text>The first subpart 3 of part B of title XXVII of the
<act-name parsable-cite="PHSA">Public Health Service Act</act-name> (42 U.S.C.
300gg–51 et seq.) (relating to other requirements) is amended—</text>
<subparagraph id="H95EA1620BEB6412AA1F6BBC611BB1595"><enum>(A)</enum><text>by redesignating
such subpart as subpart 2; and</text>
</subparagraph><subparagraph id="H84C175EB7E8347F2B76FFBD2C033C07D"><enum>(B)</enum><text>by adding at the
end the following:</text>
<quoted-block id="H5322972747BE4A4E9E4D9DD1B5D3C9D5" style="OLC">
<section id="H0D6F18C037A44D1BAC3C50609509EAB"><enum>2753.</enum><header>Prohibition of
health discrimination on the basis of genetic information</header>
<subsection id="H7B255457F12C4BB7BFEBE5E5C6B700C0"><enum>(a)</enum><header>Prohibition on
Genetic Information as a Condition of Eligibility</header><text>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.</text>
</subsection><subsection id="HB8F4914940A44D33BF199F531875BF5"><enum>(b)</enum><header>Prohibition on
Genetic Information in Setting Premium Rates</header><text>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.</text>
</subsection><subsection display-inline="no-display-inline" id="H495C8C6968D04BABA6D85C26AADA08B5"><enum>(c)</enum><header>Prohibition on
genetic information as preexisting condition</header><text display-inline="yes-display-inline">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.</text>
</subsection><subsection id="H9573CCC82EDB450C9BAF4C092075F7B9"><enum>(d)</enum><header>Genetic
Testing</header>
<paragraph id="H69BFA87E5E794ABE88A18133C7C5C08B"><enum>(1)</enum><header>Limitation on
requesting or requiring genetic testing</header><text>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.</text>
</paragraph><paragraph display-inline="no-display-inline" id="HBCED154E9BEE49000063ABACEFF8A8F5"><enum>(2)</enum><header>Rule of
construction</header><text>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.</text>
</paragraph><paragraph display-inline="no-display-inline" id="H3E547DE3D98B46D0AC7E314F9C86ED54"><enum>(3)</enum><header>Rule of
construction regarding payment</header>
<subparagraph id="HBE93A82B62724475804BF3C8A523F209"><enum>(A)</enum><header>In
general</header><text>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 <act-name parsable-cite="SSA">Social Security Act</act-name> and section
264 of the <act-name parsable-cite="HIPAA">Health Insurance Portability and
Accountability Act of 1996</act-name>, as may be revised from time to time)
consistent with subsections (a) and (c).</text>
</subparagraph><subparagraph id="H515400158DAE49669485AECCE720D102"><enum>(B)</enum><header>Limitation</header><text display-inline="yes-display-inline">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.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H6BE231D64F02451EAE9F1FE503F063FB"><enum>(4)</enum><header>Research
exception</header><text>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:</text>
<subparagraph commented="no" id="H67B325FCF2DD4692BF35F3923CFB0B2"><enum>(A)</enum><text>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.</text>
</subparagraph><subparagraph commented="no" id="HCEECB6D7CCE54DA496F9CAFB37D6EBAD"><enum>(B)</enum><text>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—</text>
<clause commented="no" id="H54A9C37460D64FA8BC7E949E8703F77D"><enum>(i)</enum><text>compliance with
the request is voluntary; and</text>
</clause><clause commented="no" id="H36157FA5A57B43D6AE528DE6E1342729"><enum>(ii)</enum><text>non-compliance
will have no effect on enrollment status or premium or contribution
amounts.</text>
</clause></subparagraph><subparagraph commented="no" id="HDB08FA06FD864E6400DAE5848B28D9EF"><enum>(C)</enum><text>No genetic
information collected or acquired under this paragraph shall be used for
underwriting purposes. <inline-comment display="no">Q: Aren’t these activities
already generally prohibited under HIPAA after the application of the other
amendments made by this Act?</inline-comment></text>
</subparagraph><subparagraph commented="no" id="H2F6F8C1C6A1043379491CDFCE223FC93"><enum>(D)</enum><text>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.</text>
</subparagraph><subparagraph commented="no" id="HA48DEB950A92475FACE4C34F690059AA"><enum>(E)</enum><text>The issuer
complies with such other conditions as the Secretary may by regulation require
for activities conducted under this paragraph.</text>
</subparagraph></paragraph></subsection><subsection id="H2E30B0CF878A4A3A9D3BCFED3C2A0F5"><enum>(e)</enum><header>Prohibition on
collection of genetic information</header>
<paragraph id="H561EF742A6A44085007B1C1366006649"><enum>(1)</enum><header>In
general</header><text display-inline="yes-display-inline">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).</text>
</paragraph><paragraph id="H9595BCC67D66494CA1433178658B5593"><enum>(2)</enum><header>Prohibition on
collection of genetic information prior to enrollment</header><text display-inline="yes-display-inline">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.</text>
</paragraph><paragraph id="HD3CBA29C8ECC4F3EAE93AE9C9F8DD433"><enum>(3)</enum><header>Incidental
collection</header><text display-inline="yes-display-inline">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).</text>
</paragraph></subsection><subsection display-inline="no-display-inline" id="H3523CD2E98034413A2C0172699D1E696"><enum>(f)</enum><header>Genetic
information of a fetus or embryo</header><text>Any reference in this part to
genetic information concerning an individual or family member of an individual
shall—</text>
<paragraph id="H2FB383C25BBB430DB5C73E606D783B07"><enum>(1)</enum><text>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</text>
</paragraph><paragraph id="HF5225765537E47279495A5159502DD52"><enum>(2)</enum><text>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.</text>
</paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</subparagraph></paragraph><paragraph id="HD217FB561A4B4F74A8934E46E773F483"><enum>(2)</enum><header>Remedies and
enforcement</header><text>Section 2761(b) of the <act-name parsable-cite="PHSA">Public Health Service Act</act-name> (42 U.S.C.
300gg–61(b)) is amended to read as follows:</text>
<quoted-block act-name="Public Health Service Act" id="H3E3DBB31905044918DC2AD7E02D9F3E7" style="OLC">
<subsection id="HBFA72C17F4D3462F9BA44C5CDD7F9674"><enum>(b)</enum><header>Secretarial
Enforcement Authority</header><text>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.</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></subsection><subsection id="H3FDB005D3143400B8359FDCA81602DE4"><enum>(c)</enum><header>Elimination of
Option of Non-Federal Governmental Plans To Be Excepted From Requirements
Concerning Genetic Information</header><text>Section 2721(b)(2) of the
<act-name parsable-cite="PHSA">Public Health Service Act</act-name> (42 U.S.C.
300gg–21(b)(2)) is amended—</text>
<paragraph id="H5B3CEB4A9C414647B69D9CEED7CAF5FB"><enum>(1)</enum><text>in subparagraph
(A), by striking <quote>If the plan sponsor</quote> and inserting <quote>Except
as provided in subparagraph (D), if the plan sponsor</quote>; and</text>
</paragraph><paragraph id="HD5C0F776C1A84CC1B65EE6CB5C926DC6"><enum>(2)</enum><text>by adding at the
end the following:</text>
<quoted-block id="H3CF3D629D06D44FDBE0045B91CB089EF" style="OLC">
<subparagraph id="HA2D94B4CFBC343A0921436FEA946DECD"><enum>(D)</enum><header>Election not
applicable to requirements concerning genetic information</header><text>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.</text>
</subparagraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></subsection><subsection id="HDDC44779164D4AACB9A72700CBE17239"><enum>(d)</enum><header>Regulations and
Effective Date</header>
<paragraph id="HC17B0690B4AD43CD823BC61C98F3EAF1"><enum>(1)</enum><header>Regulations</header><text>Not
later than 1 year 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.</text>
</paragraph><paragraph id="H6DEE385340CE442DA31FA9005418A858"><enum>(2)</enum><header>Effective
date</header><text>The amendments made by this section shall apply—</text>
<subparagraph id="H3695968926DD4CAAA3E3EBDD9E6000DF"><enum>(A)</enum><text>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 18 months
after the date of enactment of this Act; and</text>
</subparagraph><subparagraph id="H3890590DDC774ABD936341C5C65CB68E"><enum>(B)</enum><text>with respect to
health insurance coverage offered, sold, issued, renewed, in effect, or
operated in the individual market after the date that is 18 months after the
date of enactment of this Act.</text>
</subparagraph></paragraph></subsection></section><section commented="no" display-inline="no-display-inline" id="HF5CC42F102A346C2AFA5EB9BCAB1447B" section-type="subsequent-section"><enum>103.</enum><header>Amendments to
<act-name parsable-cite="ERISA">the Internal Revenue Code of
1986</act-name></header>
<subsection commented="no" id="HE470EFDBEDF140DB9B5544CC3831EE62"><enum>(a)</enum><header>No
discrimination in group premiums based on genetic
information</header><text>Subsection (b) of section 9802 of the Internal
Revenue Code of 1986 is amended—</text>
<paragraph commented="no" id="HB530A11AEB5B4B2B932800CBCB35CB92"><enum>(1)</enum><text>in paragraph
(2)(A), by inserting before the semicolon the following: <quote>except as
provided in paragraph (3)</quote>; and</text>
</paragraph><paragraph commented="no" id="HA443D6FBF38E4DA198DF7EA5D76259D"><enum>(2)</enum><text>by adding at the
end the following:</text>
<quoted-block id="HA62590AC2F964E7EB191F84E90B32AD" style="OLC">
<paragraph commented="no" id="H4A69209D7ECD4773B8A1F93F816DCBA9"><enum>(3)</enum><header>No group-based
discrimination on basis of genetic information</header><text>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.</text>
</paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></subsection><subsection commented="no" id="H4AE5D83CEACB469B9F5F0067FDB1531E"><enum>(b)</enum><header>Limitations on
genetic testing; prohibition on collection of genetic information; application
to all plans</header><text>Section 9802 of such Code is amended by
redesignating subsection (c) as subsection (f) and by inserting after
subsection (b) the following new subsections:</text>
<quoted-block act-name="Employee" id="H4937EEB4F0B94E0C00575D35C5777C1C" style="OLC">
<subsection commented="no" id="H375E1B3185304C7F9C680909A0E5818B"><enum>(c)</enum><header>Genetic
testing</header>
<paragraph commented="no" id="HAC58E2E7934D4492A3BF96C3F1795710"><enum>(1)</enum><header>Limitation on
requesting or requiring genetic testing</header><text>A group health plan may
not request or require an individual or a family member of such individual to
undergo a genetic test.</text>
</paragraph><paragraph display-inline="no-display-inline" id="HD146FCE3799B4C999EF57B594F1D8800"><enum>(2)</enum><header>Rule of
construction</header><text>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.</text>
</paragraph><paragraph display-inline="no-display-inline" id="HC84959BF5CC94E3CB259CB00E784264B"><enum>(3)</enum><header>Rule of
construction regarding payment</header>
<subparagraph id="H7129D4B4731C4B5798C6D5A893212942"><enum>(A)</enum><header>In
general</header><text>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 <act-name parsable-cite="SSA">Social Security Act</act-name> and section 264 of the
<act-name parsable-cite="HIPAA">Health Insurance Portability and Accountability
Act of 1996</act-name>, as may be revised from time to time) consistent with
subsection (a).</text>
</subparagraph><subparagraph id="HE0E631570FBB474A9DE132ED74A4C309"><enum>(B)</enum><header>Limitation</header><text display-inline="yes-display-inline">For purposes of subparagraph (A), a group
health plan may request only the minimum amount of information necessary to
accomplish the intended purpose.</text>
</subparagraph></paragraph><paragraph commented="no" id="HD08629EC138241BEB782BC64F8C791B9"><enum>(4)</enum><header>Research
exception</header><text>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:</text>
<subparagraph commented="no" id="H4A2DB815E7574A2D8E74EAB7A5C675BF"><enum>(A)</enum><text>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.</text>
</subparagraph><subparagraph commented="no" id="HAC5921E19DCB458F974D01554126E35B"><enum>(B)</enum><text>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—</text>
<clause commented="no" id="HF2CA5C3ED2424678B951A8300300FD32"><enum>(i)</enum><text>compliance with
the request is voluntary; and</text>
</clause><clause commented="no" id="HB4AB035FCBDD47FBB8B1EC9DB96796AE"><enum>(ii)</enum><text>non-compliance
will have no effect on enrollment status or premium or contribution
amounts.</text>
</clause></subparagraph><subparagraph commented="no" id="H587DDAAD64FE4C269361BB5F85A5CA6"><enum>(C)</enum><text>No genetic
information collected or acquired under this paragraph shall be used for
underwriting purposes. <inline-comment display="no">Q: Aren’t these activities
already generally prohibited under HIPAA after the application of the other
amendments made by this Act?</inline-comment></text>
</subparagraph><subparagraph commented="no" id="H6E42A16F230148A2A0007822C500AF23"><enum>(D)</enum><text>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.</text>
</subparagraph><subparagraph commented="no" id="H361F8811B3894DA1005FACE24B877E9F"><enum>(E)</enum><text>The plan complies
with such other conditions as the Secretary may by regulation require for
activities conducted under this paragraph.</text>
</subparagraph></paragraph></subsection><subsection id="H32989A60808E4B329850104BFBC1F000"><enum>(d)</enum><header>Prohibition on
collection of genetic information</header>
<paragraph id="H33086F68A71844EB9D614BF0A0F3ED75"><enum>(1)</enum><header>In
general</header><text>A group health plan shall not request, require, or
purchase genetic information for underwriting purposes (as defined in section
9832).</text>
</paragraph><paragraph id="H4BE893FBEEAA4327A31BBBCC32E41970"><enum>(2)</enum><header>Prohibition on
collection of genetic information prior to enrollment</header><text>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.</text>
</paragraph><paragraph id="H17614B44A21C4B74B342AC0083303F76"><enum>(3)</enum><header>Incidental
collection</header><text display-inline="yes-display-inline">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).</text>
</paragraph></subsection><subsection commented="no" id="H0C705803A71B4CBF9F0000735594BA6F"><enum>(e)</enum><header>Application to
all plans</header><text display-inline="yes-display-inline">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).</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="HE99C2D5DFDC84137A2C399895B740045"><enum>(c)</enum><header>Application to
genetic information of a fetus or embryo</header><text>Such section is further
amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H1DB1C0E3BE964083BBB489FA50239DEF" style="OLC">
<subsection id="HA06BF912BF5D42B591E8220841AB3B00"><enum>(f)</enum><header>Genetic
information of a fetus or embryo</header><text>Any reference in this chapter to
genetic information concerning an individual or family member of an individual
shall—</text>
<paragraph id="H68BE343410324943AC64D96480246D5D"><enum>(1)</enum><text>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</text>
</paragraph><paragraph id="HF7965812BD2647BC80E9F754D045481E"><enum>(2)</enum><text>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.</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" id="HD270535C63424CCD98874C6CCEAA004B"><enum>(d)</enum><header>Definitions</header><text>Subsection
(d) of section 9832 of such Code is amended by adding at the end the
following:</text>
<quoted-block act-name="Employee" id="H56ACA7B9B42943E5B95291022313B194" style="OLC">
<paragraph commented="no" id="HF53610187C6C4BA99DB5F2C9008BDBE3"><enum>(6)</enum><header>Family
member</header><text>The term <term>family member</term> means, with respect to
any individual—</text>
<subparagraph commented="no" id="H58FC1E97DEF94F11AC80C7B4596F81BD"><enum>(A)</enum><text>a dependent (as
such term is used for purposes of section 9801(f)(2)) of such individual,
and</text>
</subparagraph><subparagraph commented="no" id="H4C1FA9AB68C447B59E323F79229D4CFA"><enum>(B)</enum><text>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).</text>
</subparagraph></paragraph><paragraph commented="no" id="H9C5B86E0C4FB446389E780D42057AA49"><enum>(7)</enum><header>Genetic
information</header>
<subparagraph commented="no" id="HF2FA50F14CBB4A4980BA235E78F47BB8"><enum>(A)</enum><header>In
general</header><text>The term <term>genetic information</term> means, with
respect to any individual, information about—</text>
<clause commented="no" display-inline="no-display-inline" id="HC872D111FEE64BA7B2ECDEF546D96CD4"><enum>(i)</enum><text>such individual’s
genetic tests,</text>
</clause><clause commented="no" id="H720BD97C0D7B4955B14DAAFEB0E600A2"><enum>(ii)</enum><text>the genetic tests
of family members of such individual, and</text>
</clause><clause commented="no" id="H30E353DFB47346F3B0FDCC792BE6B6D7"><enum>(iii)</enum><text>subject to
subparagraph (D), the manifestation of a disease or disorder in family members
of such individual.</text>
</clause></subparagraph><subparagraph display-inline="no-display-inline" id="HAE4D6FD3BE7E4463809D66EB1CBC8E6C"><enum>(B)</enum><header>Inclusion of
genetic services</header><text display-inline="yes-display-inline">Such term
includes, with respect to any individual, any request for, or receipt of,
genetic services (including genetic services received pursuant to participation
in clinical research) by such individual or any family member of such
individual.</text>
</subparagraph><subparagraph commented="no" id="HB1344C8E89E44A20AA8D63E3394BFF8F"><enum>(C)</enum><header>Exclusions</header><text>The
term <term>genetic information</term> shall not include information about the
sex or age of any individual.</text>
</subparagraph><subparagraph commented="no" id="HEDBD4B6B5ED543BCBCEC61007CA95E2C"><enum>(D)</enum><header>Application to
family members covered under same plan</header><text>Information described in
clause (iii) of subparagraph (A) shall not be treated as genetic information to
the extent 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.</text>
</subparagraph></paragraph><paragraph commented="no" id="H5E6A4DC356B3441985AFE3D2FFEDAF49"><enum>(8)</enum><header>Genetic
test</header>
<subparagraph commented="no" id="HE57C52816F2546A68D5267BF17BFD2FF"><enum>(A)</enum><header>In
general</header><text>The term <term>genetic test</term> means an analysis of
human DNA, RNA, chromosomes, proteins, or metabolites, that detects genotypes,
mutations, or chromosomal changes.</text>
</subparagraph><subparagraph commented="no" id="HD987DE0A36474A4A92BB5DBDEB352065"><enum>(B)</enum><header>Exceptions</header><text>The
term <term>genetic test</term> does not mean—</text>
<clause commented="no" id="HB14D55867F8E4B07881B3ED7927F2E82"><enum>(i)</enum><text>an analysis of
proteins or metabolites that does not detect genotypes, mutations, or
chromosomal changes, or</text>
</clause><clause commented="no" id="HCCDE17555F8C4B8A8C8BBA011DA79D45"><enum>(ii)</enum><text>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.</text>
</clause></subparagraph></paragraph><paragraph display-inline="no-display-inline" id="H27509073237C4EE8AEA7C2299F078F40"><enum>(9)</enum><header>Genetic
services</header><text>The term <term>genetic services</term> means—</text>
<subparagraph id="HDD5A623D81634FD085B57C8884453280"><enum>(A)</enum><text>a genetic
test;</text>
</subparagraph><subparagraph id="HC91A118B081C40D7823C7FDE44B05F7"><enum>(B)</enum><text>genetic counseling
(including obtaining, interpreting, or assessing genetic information);
or</text>
</subparagraph><subparagraph id="HD184B11068104EECAD69725335B300CD"><enum>(C)</enum><text>genetic
education.</text>
</subparagraph></paragraph><paragraph id="H2945C6CDD71C4EE59C6173B8EFEEB12F"><enum>(10)</enum><header>Underwriting
purposes</header><text display-inline="yes-display-inline">The term
<quote>underwriting purposes</quote> means, with respect to any group health
plan ,or health insurance coverage offered in connection with a group health
plan—</text>
<subparagraph id="H433857E8592C4EF0A7FE8861649465FC"><enum>(A)</enum><text>rules for, or
determination of, eligibility (including enrollment and continued eligibility)
for benefits under the plan or coverage;</text>
</subparagraph><subparagraph id="HA0376AFDCF7E490497FF850553A5EC13"><enum>(B)</enum><text display-inline="yes-display-inline">the computation of premium or contribution
amounts under the plan or coverage;</text>
</subparagraph><subparagraph id="H371D78A7B9FF417BAB3FA03805EF4DF6"><enum>(C)</enum><text display-inline="yes-display-inline">the application of any pre-existing
condition exclusion under the plan or coverage; and</text>
</subparagraph><subparagraph id="H2AD308542C3E46D8983F4150E7831EB1"><enum>(D)</enum><text>other activities
related to the creation, renewal, or replacement of a contract of health
insurance or health
benefits.</text>
</subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" id="H57C89C711A754D6A00C300643089A3A3"><enum>(e)</enum><header>Enforcement</header>
<paragraph commented="no" id="HBF6EE73D7A8246E5AC0533D6FF65BF7"><enum>(1)</enum><header>In
general</header><text>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:</text>
<quoted-block display-inline="no-display-inline" id="H314520482828486795391C92FDF18CD2" style="OLC">
<section commented="no" id="HF28AC6C08C97401581DD081C07F100A"><enum>9834.</enum><header>Enforcement</header><text display-inline="no-display-inline">For the imposition of tax on any failure of
a group health plan to meet the requirements of this chapter, see section
4980D.</text>
</section><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph><paragraph commented="no" id="HE452FEB39B2E4457B91E4B8892415EAA"><enum>(2)</enum><header>Conforming
amendment</header><text>The table of sections for subchapter C of chapter 100
of such Code is amended by adding at the end the following new item:</text>
<quoted-block display-inline="no-display-inline" id="HFCF8F487FEFC4B7D9CE38E0018D03191" style="OLC">
<toc container-level="quoted-block-container" idref="H314520482828486795391C92FDF18CD2" lowest-bolded-level="division-lowest-bolded" lowest-level="section" quoted-block="no-quoted-block" regeneration="yes-regeneration">
<toc-entry idref="HF28AC6C08C97401581DD081C07F100A" level="section">Sec. 9834. Enforcement.</toc-entry>
</toc>
<after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></subsection><subsection commented="no" id="HCF3E80BC08D34036BAA9A6F1EF7B2EF6"><enum>(f)</enum><header>Regulations and
effective date</header>
<paragraph commented="no" id="H11857EE3A57D4889B300ED2D8FD2B5E7"><enum>(1)</enum><header>Regulations</header><text>The
Secretary of the Treasury shall issue final regulations or other guidance not
later than 1 year after the date of the enactment of this Act to carry out the
amendments made by this section.</text>
</paragraph><paragraph commented="no" id="H00BB94EDFDD24AA6B90038CF99415FE7"><enum>(2)</enum><header>Effective
date</header><text>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 the enactment of this Act.</text>
</paragraph></subsection></section><section id="H2155C04836484CA0A1D14C0182BB9C6B"><enum>104.</enum><header>Amendments to
title XVIII of the <act-name parsable-cite="SSA">Social Security Act</act-name>
relating to medigap</header>
<subsection id="H3BD0E46B79DB404700AC306F8860126F"><enum>(a)</enum><header>Nondiscrimination</header><text>Section
1882(s)(2) of the <act-name parsable-cite="SSA">Social Security Act</act-name>
(<external-xref legal-doc="usc" parsable-cite="usc/42/1395ss">42 U.S.C. 1395ss(s)(2)</external-xref>) is amended by adding at the end the following:</text>
<quoted-block act-name="Social Security Act" id="HDC5A008BBBD64DDB95FA04D4FED35E27" style="OLC">
<subparagraph id="H03BF3A3491C04674A7E26204FCA094DA"><enum>(E)</enum><text>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.</text>
</subparagraph><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="H35DA4254F3DC444F81ACADEC91840200"><enum>(b)</enum><header>Limitations on
genetic testing and genetic information</header>
<paragraph id="H06DD1250077845B28EE6EED54DF075F5"><enum>(1)</enum><header>In
general</header><text>Section 1882 of the <act-name parsable-cite="SSA">Social
Security Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/42/1395ss">42 U.S.C. 1395ss</external-xref>) is amended by adding at the end the
following:</text>
<quoted-block act-name="Social Security Act" id="H130F8B12003947DD9B486FF5BC19496B" style="OLC">
<subsection id="HCB02C373AB00416495B6266DDC8EF71B"><enum>(x)</enum><header>Limitations on
Genetic Testing and Information</header>
<paragraph id="H22D86EBA89E949329C642703DFF00D0"><enum>(1)</enum><header>Genetic
testing</header>
<subparagraph id="H7390799B642B4BFB81C7F05FEB29DA3E"><enum>(A)</enum><header>Limitation on
requesting or requiring genetic testing</header><text>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.</text>
</subparagraph><subparagraph display-inline="no-display-inline" id="H025D91EF6245451E92ED26D61CC266B6"><enum>(B)</enum><header>Rule of
construction</header><text>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.</text>
</subparagraph><subparagraph display-inline="no-display-inline" id="H6255E567249E4A8FA0005B20C7525DFE"><enum>(C)</enum><header>Rule of
construction regarding payment</header>
<clause id="H39E7D883F21641EA84C090BB560202A9"><enum>(i)</enum><header>In
general</header><text>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
<act-name parsable-cite="HIPAA">Health Insurance Portability and Accountability
Act of 1996</act-name>, as may be revised from time to time) consistent with
subsection (s)(2)(E).</text>
</clause><clause id="H555708679EC94A5BB715235E6FAB28F3"><enum>(ii)</enum><header>Limitation</header><text display-inline="yes-display-inline">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.</text>
</clause></subparagraph><subparagraph commented="no" id="H1330DB200DBA4381B4BEBB7181DF912"><enum>(D)</enum><header>Research
exception</header><text>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:</text>
<clause commented="no" id="H673DF3C892664DA8A47CDEFEA56A1AF"><enum>(i)</enum><text>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.</text>
</clause><clause commented="no" id="HEDB353E4A62748EB80C219DEC37383DF"><enum>(ii)</enum><text>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—</text>
<subclause commented="no" id="HF94717362A5F4AF0A66E5BA3CA1CF774"><enum>(I)</enum><text>compliance with
the request is voluntary; and</text>
</subclause><subclause commented="no" id="H805F051FA8EB4394816B140990FFCF"><enum>(II)</enum><text>non-compliance will
have no effect on enrollment status or premium or contribution amounts.</text>
</subclause></clause><clause commented="no" id="H407D00E17BF0486EA9450065D220EEBC"><enum>(iii)</enum><text>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.
<inline-comment display="no">Q: Aren’t these activities already generally
prohibited under HIPAA after the application of the other amendments made by
this Act?</inline-comment></text>
</clause><clause commented="no" id="H8A37D7ADC27141F58173F85DBD67EB2"><enum>(iv)</enum><text>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.</text>
</clause><clause commented="no" id="HA51F7225B4904D65B3008861C986E940"><enum>(v)</enum><text>The issuer
complies with such other conditions as the Secretary may by regulation require
for activities conducted under this subparagraph.</text>
</clause></subparagraph></paragraph><paragraph id="H167131B0471A49AF8F9361F3D43109AF"><enum>(2)</enum><header>Prohibition on
collection of genetic information</header>
<subparagraph display-inline="no-display-inline" id="HE0F0E391D97046FE8B9D4D04EB84E23"><enum>(A)</enum><header>In
general</header><text display-inline="yes-display-inline">An issuer of a
medicare supplemental policy shall not request, require, or purchase genetic
information for underwriting purposes (as defined in paragraph (3)).</text>
</subparagraph><subparagraph display-inline="no-display-inline" id="H8AFBBA2FCEE749A69448B0C86383904"><enum>(B)</enum><header>Prohibition on
collection of genetic information prior to enrollment</header><text display-inline="yes-display-inline">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.</text>
</subparagraph><subparagraph display-inline="no-display-inline" id="H70ED21FFDBB947F400C845FA7FE1B02"><enum>(C)</enum><header>Incidental
collection</header><text display-inline="yes-display-inline">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).</text>
</subparagraph></paragraph><paragraph id="H22F7DA42E5C34CCBB17971E156956E88"><enum>(3)</enum><header>Definitions</header><text>In
this subsection:</text>
<subparagraph id="H2F0CBC3206BA4337AFB64477D007025"><enum>(A)</enum><header>Family
member</header><text display-inline="yes-display-inline">The term <term>family
member</term> 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.</text>
</subparagraph><subparagraph id="HE7A4F5CF38E14CD19C896834AECB5755"><enum>(B)</enum><header>Genetic
information</header>
<clause commented="no" display-inline="no-display-inline" id="H00907E7CC51A4B5DA8BA76765425BE8D"><enum>(i)</enum><header>In
general</header><text>The term <term>genetic information</term> means, with
respect to any individual, information about—</text>
<subclause commented="no" display-inline="no-display-inline" id="H42EA18DDDAD44F278D067C01CB8430D1"><enum>(I)</enum><text>such individual’s
genetic tests,</text>
</subclause><subclause commented="no" id="H81479D85B6014D7DBC8F9803DACF483B"><enum>(II)</enum><text>the genetic tests
of family members of such individual, and</text>
</subclause><subclause commented="no" id="H6B8EB670A9464F7EAC2580F88E4B14B8"><enum>(III)</enum><text>subject to
clause (iv), the manifestation of a disease or disorder in family members of
such individual.</text>
</subclause></clause><clause display-inline="no-display-inline" id="H013C2864D86D405C9D12D2482F96C6D7"><enum>(ii)</enum><header>Inclusion of
genetic services</header><text display-inline="yes-display-inline">Such term
includes, with respect to any individual, any request for, or receipt of,
genetic services (including genetic services received pursuant to participation
in clinical research) by such individual or any family member of such
individual.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H1161C86CF28E42A1B4B8793B81532348"><enum>(iii)</enum><header>Exclusions</header><text>The
term <term>genetic information</term> shall not include information about the
sex or age of any individual.</text>
</clause></subparagraph><subparagraph id="HF91BAD448B1440128E9ECB22151948A9"><enum>(C)</enum><header>Genetic
test</header>
<clause id="HA9A558C8E309496C8B8073787175054E"><enum>(i)</enum><header>In
general</header><text>The term <term>genetic test</term> means an analysis of
human DNA, RNA, chromosomes, proteins, or metabolites, that detects genotypes,
mutations, or chromosomal changes.</text>
</clause><clause id="H3C0952613D904D929355E74605005781"><enum>(ii)</enum><header>Exceptions</header><text>The
term <term>genetic test</term> does not mean—</text>
<subclause id="H94CF82B5E09844CE9FB9C957EA628FEF"><enum>(I)</enum><text>an analysis of
proteins or metabolites that does not detect genotypes, mutations, or
chromosomal changes; or</text>
</subclause><subclause id="H6EA0B272610D47648FDE9948E83BC257"><enum>(II)</enum><text>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.</text>
</subclause></clause></subparagraph><subparagraph id="HEDB7A015A2EB4933A638EDE9AD938D16"><enum>(D)</enum><header>Genetic
services</header><text>The term <term>genetic services</term> means—</text>
<clause id="H20B4CC5752D9453CBF4B87BF9B54E01"><enum>(i)</enum><text>a
genetic test;</text>
</clause><clause id="H13E791D25CE14363B236D5B476EE8500"><enum>(ii)</enum><text>genetic
counseling (including obtaining, interpreting, or assessing genetic
information); or</text>
</clause><clause id="H02E1F07DB07D436B992E55A19D3B8134"><enum>(iii)</enum><text>genetic
education.</text>
</clause></subparagraph><subparagraph display-inline="no-display-inline" id="HC66EAEF470C3433796F577BE259BB06D"><enum>(E)</enum><header>Underwriting
purposes</header><text display-inline="yes-display-inline">The term
<quote>underwriting purposes</quote> means, with respect to a medicare
supplemental policy—</text>
<clause id="H8357FAEFA8E64670861D4C10B4FF34E1"><enum>(i)</enum><text>rules for, or
determination of, eligibility (including enrollment and continued eligibility)
for benefits under the policy;</text>
</clause><clause id="HB9472039112943B7AA67A5A06D1322B1"><enum>(ii)</enum><text display-inline="yes-display-inline">the computation of premium or contribution
amounts under the policy;</text>
</clause><clause id="H1FC3C41167494022BCC8BDA8F3F88C0"><enum>(iii)</enum><text display-inline="yes-display-inline">the application of any pre-existing
condition exclusion under the policy; and</text>
</clause><clause id="H2F4625DF1C7A4C76A70760FB281DEC8E"><enum>(iv)</enum><text>other activities
related to the creation, renewal, or replacement of a contract of health
insurance or health benefits.</text>
</clause></subparagraph><subparagraph id="HD3B10F073A2047A68E45009FA09BA9C2"><enum>(F)</enum><header>Issuer of a
medicare supplemental policy</header><text>The term <term>issuer of a medicare
supplemental policy</term> includes a third-party administrator or other person
acting for or on behalf of such
issuer.</text>
</subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph><paragraph id="HC9C11D89CA7E4E708C138297ACB17508"><enum>(2)</enum><header>Application to
genetic information of a fetus or embryo</header><text>Section 1882(x) of such
Act, as added by paragraph (1), is further amended by adding at the end the
following:</text>
<quoted-block display-inline="no-display-inline" id="HC786720F1C1F407C88A9B8978670ADD4" style="OLC">
<paragraph display-inline="no-display-inline" id="HD053FA8F480A41F1A0F2ACF17D7DEB96"><enum>(4)</enum><header>Genetic
information of a fetus or embryo</header><text>Any reference in this section to
genetic information concerning an individual or family member of an individual
shall—</text>
<subparagraph id="H6BB74B386FAD4027B13584506E577F2D"><enum>(A)</enum><text>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</text>
</subparagraph><subparagraph id="HA36807D78F234AE89E6715F100A44AC"><enum>(B)</enum><text>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.</text>
</subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph><paragraph id="H2ECC1BD93AB740EB83CD00CC00243995"><enum>(3)</enum><header>Conforming
amendment</header><text>Section 1882(o) of the <act-name parsable-cite="SSA">Social Security Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/42/1395ss">42 U.S.C. 1395ss(o)</external-xref>) is
amended by adding at the end the following:</text>
<quoted-block act-name="Social Security Act" id="H13C31F671D224E46BF5EF35B80FA5E76" style="OLC">
<paragraph id="H310A2467655E46A1B1A484B8CC31381E"><enum>(4)</enum><text>The issuer of the
medicare supplemental policy complies with subsection (s)(2)(E) and subsection
(x).</text>
</paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></subsection><subsection id="H1E9663F5923549EA84D5177843B41738"><enum>(c)</enum><header>Effective
date</header><text>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 18 months after the date of enactment of this
Act.</text>
</subsection><subsection id="H618DF72C2C0042479684D1FAD24C48F2"><enum>(d)</enum><header>Transition
Provisions</header>
<paragraph id="H488AD91A94D94E5392BD861900F9FF76"><enum>(1)</enum><header>In
general</header><text>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 <act-name parsable-cite="SSA">Social Security
Act</act-name> due solely to failure to make such change until the date
specified in paragraph (4).</text>
</paragraph><paragraph id="HD3539733796949388EB6C538C16DEBE"><enum>(2)</enum><header>NAIC
standards</header><text>If, not later than June 30, 2008, the National
Association of Insurance Commissioners (in this subsection referred to as the
<quote>NAIC</quote>) modifies its NAIC Model Regulation relating to section
1882 of the <act-name parsable-cite="SSA">Social Security Act</act-name>
(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.</text>
</paragraph><paragraph id="H8EBF454F321E4FD6A0C5FEA1346E7823"><enum>(3)</enum><header>Secretary
standards</header><text>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 October 1, 2008, 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.</text>
</paragraph><paragraph id="HD521C810EBE34F03B093DDBED8B2A5C6"><enum>(4)</enum><header>Date
specified</header>
<subparagraph id="HBBE4CB1897A74F3BB773D75CC3B8353F"><enum>(A)</enum><header>In
general</header><text>Subject to subparagraph (B), the date specified in this
paragraph for a State is the earlier of—</text>
<clause id="H664698B4F41C441EB653CA18B13F3DC"><enum>(i)</enum><text>the
date the State changes its statutes or regulations to conform its regulatory
program to the changes made by this section, or</text>
</clause><clause id="H710D6D379D38423D96CCAC151F88535F"><enum>(ii)</enum><text>October 1,
2008.</text>
</clause></subparagraph><subparagraph id="H85D91A520E264D6488FEC045EC3BF5C"><enum>(B)</enum><header>Additional
legislative action required</header><text>In the case of a State which the
Secretary identifies as—</text>
<clause id="H40F61AC3F07E465AA3AD0013EEE8F5"><enum>(i)</enum><text>requiring State
legislation (other than legislation appropriating funds) to conform its
regulatory program to the changes made in this section, but</text>
</clause><clause id="H4AF27E6F40074C56B5D304079C0020D"><enum>(ii)</enum><text>having a
legislature which is not scheduled to meet in 2008 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, 2008. 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.</text>
</clause></subparagraph></paragraph></subsection></section><section display-inline="no-display-inline" id="H2608C285D00049E38E752212088798E7" section-type="subsequent-section"><enum>105.</enum><header>Privacy and
confidentiality</header>
<subsection id="H21FCAD8FE7774AA888EE491181B42E4C"><enum>(a)</enum><header>In
general</header><text display-inline="yes-display-inline">Part C of title XI of
the Social Security Act is amended by adding at the end the following new
section:</text>
<quoted-block id="H52559CFB1D8344629929D5C96B882D02" style="traditional">
<section id="HAEC6E425554D4677AD5529F3B9EDD9C"><enum>1180.</enum><header>Application of HIPAA regulations to genetic
information</header><subsection commented="no" display-inline="yes-display-inline" id="HE8E855EC55FE4248B7BDC1D8466B00A9"><enum>(a)</enum><header>In
general</header><text>The Secretary shall revise the HIPAA privacy regulation
(as defined in subsection (b)) so it is consistent with the following:</text>
<paragraph commented="no" id="HCB0A5DCC659340F0BB68ACD2E8768F08"><enum>(1)</enum><text display-inline="yes-display-inline">Genetic information shall be treated as
health information described in section 1171(4)(B).</text>
</paragraph><paragraph id="H6BEF6429430B457BAD910041E4549D4B"><enum>(2)</enum><text>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.</text>
</paragraph></subsection><subsection id="HDCC6FC92CBD6401F9FFF31E0210004D2"><enum>(b)</enum><header>Definitions</header><text>For
purposes of this section:</text>
<paragraph id="HEAB888A1407E4F089516401C00A43350"><enum>(1)</enum><header>Genetic
information; genetic test; family member</header><text>The terms <quote>genetic
information</quote>, <quote>genetic test</quote>, and <quote>family
member</quote> have the meanings given such terms in section 2791 of the Public
Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300gg-91">42 U.S.C. 300gg–91</external-xref>), as amended by the
<short-title>Genetic Information Nondiscrimination Act of
2008</short-title>.</text>
</paragraph><paragraph id="H193845CE81F94BB298E2AA20DEC15F54"><enum>(2)</enum><header>Group health
plan; health insurance coverage; medicare supplemental policy</header><text>The
terms <quote>group health plan</quote> and <quote>health insurance
coverage</quote> have the meanings given such terms under section 2791 of the
Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300gg-91">42 U.S.C. 300gg–91</external-xref>), and the term <quote>medicare
supplemental policy</quote> has the meaning given such term in section
1882(g).</text>
</paragraph><paragraph id="HFF2627B2455F4937B6047F76D4369BF5"><enum>(3)</enum><header>HIPAA privacy
regulation</header><text display-inline="yes-display-inline">The term
<quote>HIPAA privacy regulation</quote> means the regulations promulgated by
the Secretary under this part and section 264 of the
<act-name parsable-cite="HIPAA">Health Insurance Portability and Accountability
Act of 1996</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/42/1320d-2">42 U.S.C. 1320d–2</external-xref> note).</text>
</paragraph><paragraph id="HB5CA028EDE34409DB0DDEB89A20087CA"><enum>(4)</enum><header>Underwriting
purposes</header><text display-inline="yes-display-inline">The term
<quote>underwriting purposes</quote> means, with respect to a group health
plan, health insurance coverage, or a medicare supplemental policy—</text>
<subparagraph id="H250C7A89774D42E7A11E7400D609BE82"><enum>(A)</enum><text>rules for
eligibility (including enrollment and continued eligibility) for, or
determination of, benefits under the plan, coverage, or policy;</text>
</subparagraph><subparagraph id="H00C80BE1A149496394FE22B783811177"><enum>(B)</enum><text>the computation of
premium or contribution amounts under the plan, coverage, or policy;</text>
</subparagraph><subparagraph id="H091F6017A603429FB191005FC2286F6C"><enum>(C)</enum><text>the application of
any pre-existing condition exclusion under the plan, coverage, or policy;
and</text>
</subparagraph><subparagraph id="H5DA9FA8E3AE84313BE095B83DE7F5EC8"><enum>(D)</enum><text>other activities
related to the creation, renewal, or replacement of a contract of health
insurance or health benefits.</text>
</subparagraph></paragraph></subsection><subsection id="HF109FFC7EC18431B82BBE09CAF3DFB"><enum>(c)</enum><header>Procedure</header><text>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.</text>
</subsection><subsection id="HD0B5D36339124784B6D52E5E9032E7B1"><enum>(d)</enum><header>Enforcement</header><text>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.</text>
</subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="H3DB5EF30896C4B56AD5446D1EAB6E6DE"><enum>(b)</enum><header>Regulations;
effective date</header>
<paragraph id="H4DD966C8B20F488EA1105C4B9D84A6E3"><enum>(1)</enum><header>Regulations</header><text display-inline="yes-display-inline">Not later than 1 year 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.</text>
</paragraph><paragraph id="H3154D70B2F69408D9C627CE51B1BAB64"><enum>(2)</enum><header>Effective
date</header><text display-inline="yes-display-inline">The amendment made by
subsection (a) shall take effect on the date that is 18 months after the date
of the enactment of this Act.</text>
</paragraph></subsection></section><section display-inline="no-display-inline" id="H4DC8E0B3568642BC98003F8124FEF7DD"><enum>106.</enum><header>Assuring
coordination</header><text display-inline="no-display-inline">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—</text>
<paragraph id="H8B2B84496938498A92A2040500D4B7CD"><enum>(1)</enum><text>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</text>
</paragraph><paragraph id="H8F5CB02935CC4A6CA10018AA72424908"><enum>(2)</enum><text>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.</text>
</paragraph></section><enum>II</enum><header>PROHIBITING
EMPLOYMENT DISCRIMINATION ON THE BASIS OF GENETIC INFORMATION</header>
<section id="HAB4E3D3E22C54236B4C1C112BF447CA2"><enum>201.</enum><header>Definitions</header><text display-inline="no-display-inline">In this title:</text>
<paragraph id="HB3B165ED532C41289DCFB2F8428E2495"><enum>(1)</enum><header>Commission</header><text>The
term <term>Commission</term> means the Equal Employment Opportunity Commission
as created by section 705 of the <act-name parsable-cite="CRA64">Civil Rights
Act of 1964</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/42/2000e-4">42 U.S.C. 2000e–4</external-xref>).</text>
</paragraph><paragraph id="H10AB30E778AD45F7B98CDC06308366FA"><enum>(2)</enum><header>Employee;
employer; employment agency; labor organization; member</header>
<subparagraph id="H84B304A4E170469498F251740013BDF7"><enum>(A)</enum><header>In
general</header><text>The term <term>employee</term> means—</text>
<clause id="H469974A4286F476E972D8C949DC37EAB"><enum>(i)</enum><text>an
employee (including an applicant), as defined in section 701(f) of the
<act-name parsable-cite="CRA64">Civil Rights Act of 1964</act-name> (42 U.S.C.
2000e(f));</text>
</clause><clause id="HD91647210D074632BAAD13E7D4B27477"><enum>(ii)</enum><text>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));</text>
</clause><clause id="HC10828F46C4E4FA28CE0F79D4DB4D9FD"><enum>(iii)</enum><text>a
covered employee (including an applicant), as defined in section 101 of the
Congressional Accountability Act of 1995 (<external-xref legal-doc="usc" parsable-cite="usc/2/1301">2 U.S.C. 1301</external-xref>);</text>
</clause><clause id="HE88CB522E739444781D5B7A06EF5D112"><enum>(iv)</enum><text>a
covered employee (including an applicant), as defined in section 411(c) of
title 3, United States Code; or</text>
</clause><clause id="HC1E72A68BB134150A36EEBC494B45DFD"><enum>(v)</enum><text>an
employee or applicant to which section 717(a) of the
<act-name parsable-cite="CRA64">Civil Rights Act of 1964</act-name> (42 U.S.C.
2000e–16(a)) applies.</text>
</clause></subparagraph><subparagraph id="H99E30C66C9654E879B083D3F9E00D594"><enum>(B)</enum><header>Employer</header><text>The
term <term>employer</term> means—</text>
<clause id="H586D2E12E1464258A9177956BD2F3C12"><enum>(i)</enum><text>an
employer (as defined in section 701(b) of the <act-name parsable-cite="CRA64">Civil Rights Act of 1964</act-name> (42 U.S.C.
2000e(b)));</text>
</clause><clause id="HD5AAA2D36251475882CD105B1D8F90C9"><enum>(ii)</enum><text>an
entity employing a State employee described in section 304(a) of the Government
Employee Rights Act of 1991;</text>
</clause><clause id="H8ECC5B0D505D43F100A8BDDA903B49C9"><enum>(iii)</enum><text>an
employing office, as defined in section 101 of the Congressional Accountability
Act of 1995;</text>
</clause><clause id="HAEFFCED19FC543D68204CF98554D400"><enum>(iv)</enum><text>an
employing office, as defined in <external-xref legal-doc="usc" parsable-cite="usc/3/411">section 411(c)</external-xref> of title 3, United States Code;
or</text>
</clause><clause id="H41F572A4FB0D4550B84FBFA04B76B61D"><enum>(v)</enum><text>an
entity to which section 717(a) of the <act-name parsable-cite="CRA64">Civil
Rights Act of 1964</act-name> applies.</text>
</clause></subparagraph><subparagraph id="H4CFF3082311E4D89811338A35C6EA5EB"><enum>(C)</enum><header>Employment
agency; labor organization</header><text>The terms <term>employment
agency</term> and <term>labor organization</term> have the meanings given the
terms in section 701 of the <act-name parsable-cite="CRA64">Civil Rights Act of
1964</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/42/2000e">42 U.S.C. 2000e</external-xref>).</text>
</subparagraph><subparagraph id="HAA1AD00D673649BABE3DA28F425CC4B8"><enum>(D)</enum><header>Member</header><text>The
term <term>member</term>, with respect to a labor organization, includes an
applicant for membership in a labor organization.</text>
</subparagraph></paragraph><paragraph display-inline="no-display-inline" id="H0A11E8E030C343B18FA938282B6EF4C1"><enum>(3)</enum><header>Family
member</header><text>The term <term>family member</term> means, with respect to
an individual—</text>
<subparagraph commented="no" id="H2C692DC4D0504EFAAFD259C7380800D"><enum>(A)</enum><text>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</text>
</subparagraph><subparagraph commented="no" id="H72567CDCE945498F976BB44E6E72CB3B"><enum>(B)</enum><text>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).</text>
</subparagraph></paragraph><paragraph id="HD8955B8FFC76454F8ECF67ACB0B10063"><enum>(4)</enum><header>Genetic
information</header>
<subparagraph commented="no" display-inline="no-display-inline" id="HB0E0EA7F07F641F4B873A64D3759E960"><enum>(A)</enum><header>In
general</header><text>The term <term>genetic information</term> means, with
respect to any individual, information about—</text>
<clause commented="no" display-inline="no-display-inline" id="HD49F08C790F24525985BF963CD30BBCE"><enum>(i)</enum><text>such individual’s
genetic tests,</text>
</clause><clause commented="no" id="HE168EDB6EFE242CE98A4134ED7937DBD"><enum>(ii)</enum><text>the genetic tests
of family members of such individual, and</text>
</clause><clause commented="no" id="HD7408CBFB7194CE692D760A98B02C14E"><enum>(iii)</enum><text>subject to
subparagraph (D), the manifestation of a disease or disorder in family members
of such individual.</text>
</clause></subparagraph><subparagraph id="HA341B326AC3049C790EF27938746ED65"><enum>(B)</enum><header>Inclusion of
genetic services</header><text display-inline="yes-display-inline">Such term
includes, with respect to any individual, any request for, or receipt of,
genetic services (including genetic services received pursuant to participation
in clinical research) by such individual or any family member of such
individual.</text>
</subparagraph><subparagraph commented="no" id="H90808C3DE87C45D18BD5007BC31B883D"><enum>(C)</enum><header>Exclusions</header><text>The
term <term>genetic information</term> shall not include information about the
sex or age of any individual.</text>
</subparagraph></paragraph><paragraph id="H2A0D3C478F524941BDAB0077619F06F3"><enum>(5)</enum><header>Genetic
monitoring</header><text>The term <term>genetic monitoring</term> 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.</text>
</paragraph><paragraph id="H4891A9AF923D46CE858349A665B33400"><enum>(6)</enum><header>Genetic
services</header><text>The term <term>genetic services</term> means—</text>
<subparagraph id="H5EB52173F05D40D3A2A8EC6114088B21"><enum>(A)</enum><text>a genetic
test;</text>
</subparagraph><subparagraph id="H9034FF89A0124ACD9532F0FAE0A4628C"><enum>(B)</enum><text>genetic counseling
(including obtaining, interpreting, or assessing genetic information);
or</text>
</subparagraph><subparagraph id="HCA21411F990046D9B473C77CDE44C353"><enum>(C)</enum><text>genetic
education.</text>
</subparagraph></paragraph><paragraph id="HBA99EC0C3E364722B6A7B13E4FE1A74C"><enum>(7)</enum><header>Genetic
test</header>
<subparagraph id="HD3FC9A7073CF46F1B92350571EFB7CFE"><enum>(A)</enum><header>In
general</header><text>The term <term>genetic test</term> means an analysis of
human DNA, RNA, chromosomes, proteins, or metabolites, that detects genotypes,
mutations, or chromosomal changes.</text>
</subparagraph><subparagraph id="H118D4C5E76424BAC86439C00A69298E3"><enum>(B)</enum><header>Exceptions</header><text display-inline="yes-display-inline">The term <term>genetic test</term> does not
mean an analysis of proteins or metabolites that does not detect genotypes,
mutations, or chromosomal changes.</text>
</subparagraph></paragraph></section><section id="HFB34CB13139D4E7981D433AB91C6FA50"><enum>202.</enum><header>Employer
practices</header>
<subsection id="H49F14A0472974BB2A89BDABD27CF7E94"><enum>(a)</enum><header>Discrimination
based on Genetic Information</header><text>It shall be an unlawful employment
practice for an employer—</text>
<paragraph id="HB79BD8E4E30F4567A781644186751B68"><enum>(1)</enum><text>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</text>
</paragraph><paragraph id="H16884871417F46709B05953F8DC01953"><enum>(2)</enum><text>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.</text>
</paragraph></subsection><subsection commented="no" id="HEBCF27B9F29F406B8296F1CE1100F454"><enum>(b)</enum><header>Acquisition of
Genetic Information</header><text>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—</text>
<paragraph commented="no" id="HA68C626F41214A3AB7D4DAC420609F4B"><enum>(1)</enum><text>where an employer
inadvertently requests or requires family medical history of the employee or
family member of the employee;</text>
</paragraph><paragraph commented="no" id="H9D0F4BD37650463982788F09CF2D003C"><enum>(2)</enum><text>where—</text>
<subparagraph commented="no" id="HCFB3FC8641E9413887893BBD3865C85B"><enum>(A)</enum><text>health or genetic
services are offered by the employer, including such services offered as part
of a bona fide wellness program;</text>
</subparagraph><subparagraph commented="no" id="H68F1E863EFBE4F1D91C4E1BC54B75A3"><enum>(B)</enum><text>the employee
provides prior, knowing, voluntary, and written authorization;</text>
</subparagraph><subparagraph commented="no" id="HC2092743570E4A1CA7528DBE974FE049"><enum>(C)</enum><text>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</text>
</subparagraph><subparagraph commented="no" id="H45F48B92E6B442CDA2FEE187B78537D"><enum>(D)</enum><text>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;</text>
</subparagraph></paragraph><paragraph commented="no" id="H4DDB1263526B42AD8CE5C0E3A750D4F1"><enum>(3)</enum><text>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 (<external-xref legal-doc="usc" parsable-cite="usc/29/2613">29 U.S.C. 2613</external-xref>) or such requirements under State family and medical
leave laws;</text>
</paragraph><paragraph commented="no" id="H7B6AB78AF1B84D3FAE45C94D7BB6F1D0"><enum>(4)</enum><text>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;</text>
</paragraph><paragraph commented="no" id="H2121E304A1A24A869500D4B537F3D225"><enum>(5)</enum><text>where the
information involved is to be used for genetic monitoring of the biological
effects of toxic substances in the workplace, but only if—</text>
<subparagraph commented="no" id="HA4F9AFC7C585450F923EDFDD2FA0EB7B"><enum>(A)</enum><text>the employer
provides written notice of the genetic monitoring to the employee;</text>
</subparagraph><subparagraph commented="no" id="HF443022C7B3844BA82194BED8FBB3E70"><enum>(B)</enum><clause commented="no" display-inline="yes-display-inline" id="H64EA6BC40791402A8F10BFB363F5BBD8"><enum>(i)</enum><text>the employee provides
prior, knowing, voluntary, and written authorization; or</text>
</clause><clause commented="no" id="HB5EDD553CDE5496981730015206C21EE" indent="up1"><enum>(ii)</enum><text>the genetic monitoring is required
by Federal or State law;</text>
</clause></subparagraph><subparagraph commented="no" id="H721AAE7076CE4D67916F233D10FD789C"><enum>(C)</enum><text>the employee is
informed of individual monitoring results;</text>
</subparagraph><subparagraph commented="no" id="H68D6E3C12AB6435794BE485292BC72AC"><enum>(D)</enum><text>the monitoring is
in compliance with—</text>
<clause commented="no" id="HFB935CF008D94EE6BE6523963394D6D5"><enum>(i)</enum><text>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 (<external-xref legal-doc="usc" parsable-cite="usc/29/651">29 U.S.C. 651 et seq.</external-xref>), the Federal Mine Safety and Health
Act of 1977 (<external-xref legal-doc="usc" parsable-cite="usc/30/801">30 U.S.C. 801 et seq.</external-xref>), or the <act-name parsable-cite="AEA54">Atomic Energy Act of 1954</act-name> (42 U.S.C. 2011 et
seq.); or</text>
</clause><clause commented="no" id="HD1523BA0662245F0A822144CBBC8BFBB"><enum>(ii)</enum><text>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 (<external-xref legal-doc="usc" parsable-cite="usc/29/651">29 U.S.C. 651 et seq.</external-xref>); and</text>
</clause></subparagraph><subparagraph commented="no" id="HE3B6EE2B840D48198C2CD079A5000855"><enum>(E)</enum><text>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</text>
</subparagraph></paragraph><paragraph id="HA0909B7C9A09493A9D6EFEE1F31817F1"><enum>(6)</enum><text display-inline="yes-display-inline">where the employer conducts DNA analysis
for law enforcement purposes as a forensic laboratory, includes such analysis
in the Combined DNA Index System pursuant to section 210304 of the Violent
Crime Control and Law Enforcement Act of 1994 (<external-xref legal-doc="usc" parsable-cite="usc/42/14132">42 U.S.C. 14132</external-xref>), 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.</text>
</paragraph></subsection><subsection id="HB95EB510D66344679FE4C3AEBAB196B"><enum>(c)</enum><header>Preservation of
Protections</header><text>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.</text>
</subsection></section><section id="HDBF9023C69E444C9B02364C3FBE0A0FB"><enum>203.</enum><header>Employment
agency practices</header>
<subsection id="H79F1B3A8589A43D98CB300FEAC3B2203"><enum>(a)</enum><header>Discrimination
based on Genetic Information</header><text>It shall be an unlawful employment
practice for an employment agency—</text>
<paragraph id="H43DF8A7813CD49659D28705D4C670150"><enum>(1)</enum><text>to fail or refuse
to refer for employment, or otherwise to discriminate against, any individual
because of genetic information with respect to the individual;</text>
</paragraph><paragraph id="H88C09DB46D7D4D8486E3513228578BC"><enum>(2)</enum><text>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</text>
</paragraph><paragraph id="HF8CC2DCE6EDF4B7D92A1C1E62FCAC54"><enum>(3)</enum><text>to
cause or attempt to cause an employer to discriminate against an individual in
violation of this title.</text>
</paragraph></subsection><subsection id="H5E6A3C446BB7481394514D548493FF17"><enum>(b)</enum><header>Acquisition of
Genetic Information</header><text display-inline="yes-display-inline">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—</text>
<paragraph id="H132F895F4DD641E48D00D1733BE98EBB"><enum>(1)</enum><text display-inline="yes-display-inline">where an employment agency inadvertently
requests or requires family medical history of the individual or family member
of the individual;</text>
</paragraph><paragraph id="H3F9B0FFFFF534B3BB4BD0018B6F73112"><enum>(2)</enum><text>where—</text>
<subparagraph id="H97F036EE02304ED4838B182049308DCB"><enum>(A)</enum><text>health or genetic
services are offered by the employment agency, including such services offered
as part of a bona fide wellness program;</text>
</subparagraph><subparagraph id="HB807D4FFC4A2422C9554B38DBE524F2"><enum>(B)</enum><text>the individual
provides prior, knowing, voluntary, and written authorization;</text>
</subparagraph><subparagraph id="H8369ECC654D54C6D8B02BF26061562DC"><enum>(C)</enum><text>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</text>
</subparagraph><subparagraph id="HC0DEA6D03D174B4ABAF93D56FD866265"><enum>(D)</enum><text>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;</text>
</subparagraph></paragraph><paragraph id="HDB74F49397F241F4999F89287DE1B64"><enum>(3)</enum><text>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 (<external-xref legal-doc="usc" parsable-cite="usc/29/2613">29 U.S.C. 2613</external-xref>) or such requirements under State
family and medical leave laws;</text>
</paragraph><paragraph id="HF441791BE91A44C9A74B1E2C9765E754"><enum>(4)</enum><text>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</text>
</paragraph><paragraph id="HEEEFD4EEAF914C7CBBDFF6A350B334F8"><enum>(5)</enum><text>where the
information involved is to be used for genetic monitoring of the biological
effects of toxic substances in the workplace, but only if—</text>
<subparagraph id="HCAB940FAC08145368EED2E13C29032F1"><enum>(A)</enum><text>the employment
agency provides written notice of the genetic monitoring to the
individual;</text>
</subparagraph><subparagraph id="HC9EF9F2DDB6A4D3291B4CDB633F4C023"><enum>(B)</enum><clause commented="no" display-inline="yes-display-inline" id="H0F45F9CE71C04776A268745DF7861CF"><enum>(i)</enum><text>the individual provides
prior, knowing, voluntary, and written authorization; or</text>
</clause><clause id="H41FE305B9E8646C291EBBCAC0800F4B0" indent="up1"><enum>(ii)</enum><text>the genetic monitoring is required
by Federal or State law;</text>
</clause></subparagraph><subparagraph id="HEA84AE65D5E240508488EF2D10E5D34E"><enum>(C)</enum><text>the individual is
informed of individual monitoring results;</text>
</subparagraph><subparagraph id="HE7E15EAE458B49739FBBEDDEB6C295F5"><enum>(D)</enum><text>the monitoring is
in compliance with—</text>
<clause id="H7A2073DED6B94E6F8B29BA3358917000"><enum>(i)</enum><text>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 (<external-xref legal-doc="usc" parsable-cite="usc/29/651">29 U.S.C. 651 et seq.</external-xref>), the Federal Mine Safety and
Health Act of 1977 (<external-xref legal-doc="usc" parsable-cite="usc/30/801">30 U.S.C. 801 et seq.</external-xref>), or the
<act-name parsable-cite="AEA54">Atomic Energy Act of 1954</act-name> (42 U.S.C.
2011 et seq.); or</text>
</clause><clause id="HE29FA18C735745AA817C0700DF50CEEF"><enum>(ii)</enum><text>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 (<external-xref legal-doc="usc" parsable-cite="usc/29/651">29 U.S.C. 651 et seq.</external-xref>); and</text>
</clause></subparagraph><subparagraph id="H2A94177BA1ED46259301DC11B4E4D188"><enum>(E)</enum><text>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.</text>
</subparagraph></paragraph></subsection><subsection id="HB4C52A66C613455E99F308BDC8E974CE"><enum>(c)</enum><header>Preservation of
Protections</header><text>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.</text>
</subsection></section><section id="H0DEEE04A8D3649E8B2EB590072DBF3F"><enum>204.</enum><header>Labor
organization practices</header>
<subsection id="H6813BFD12B4D4702BEB96455416BA5EF"><enum>(a)</enum><header>Discrimination
based on Genetic Information</header><text>It shall be an unlawful employment
practice for a labor organization—</text>
<paragraph id="H66A1A1FD5404499BBD3186B9CA9DDFBF"><enum>(1)</enum><text>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;</text>
</paragraph><paragraph id="H7DD9E517253A42E39C195E8EE43942F1"><enum>(2)</enum><text>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</text>
</paragraph><paragraph id="HFCDE33C0C75844F191251D5CB5A1C580"><enum>(3)</enum><text>to cause or
attempt to cause an employer to discriminate against a member in violation of
this title.</text>
</paragraph></subsection><subsection id="H7D5D40FB625F4E318FFD28F754D64C94"><enum>(b)</enum><header>Acquisition of
Genetic Information</header><text display-inline="yes-display-inline">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—</text>
<paragraph id="H2B842B412DE34AD78FCB15CD41AC96B9"><enum>(1)</enum><text display-inline="yes-display-inline">where a labor organization inadvertently
requests or requires family medical history of the member or family member of
the member;</text>
</paragraph><paragraph id="H8313663AF5B649B7A291419201A300B7"><enum>(2)</enum><text>where—</text>
<subparagraph id="HECFBA694A2A04639BE00EAE12676108D"><enum>(A)</enum><text>health or genetic
services are offered by the labor organization, including such services offered
as part of a bona fide wellness program;</text>
</subparagraph><subparagraph id="HAE1B2FA9F3FC42BCA530565317B712D9"><enum>(B)</enum><text>the member
provides prior, knowing, voluntary, and written authorization;</text>
</subparagraph><subparagraph id="HACE855A9568840A5A71462E76346FAE"><enum>(C)</enum><text>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</text>
</subparagraph><subparagraph id="HA831688C8BEA4D95A757B00D4606ED1"><enum>(D)</enum><text>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 labor organization
except in aggregate terms that do not disclose the identity of specific
members;</text>
</subparagraph></paragraph><paragraph id="H5F7AD52704BB4AFC8F613C17A2077100"><enum>(3)</enum><text>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 (<external-xref legal-doc="usc" parsable-cite="usc/29/2613">29 U.S.C. 2613</external-xref>) or such requirements under State
family and medical leave laws;</text>
</paragraph><paragraph id="H6415670ABF7F45A79092F17EC2194232"><enum>(4)</enum><text>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</text>
</paragraph><paragraph id="H54B2CAE81AAE4CFFB0D62572396B735B"><enum>(5)</enum><text>where the
information involved is to be used for genetic monitoring of the biological
effects of toxic substances in the workplace, but only if—</text>
<subparagraph id="HAA952BB35C1344C0A2F8A6CFE600AC57"><enum>(A)</enum><text>the labor
organization provides written notice of the genetic monitoring to the
member;</text>
</subparagraph><subparagraph id="H1B60D5B0433F414A8356C7D87D3298BD"><enum>(B)</enum><clause commented="no" display-inline="yes-display-inline" id="H37DE91F0876C4031BDA49BA1DA002070"><enum>(i)</enum><text>the member provides
prior, knowing, voluntary, and written authorization; or</text>
</clause><clause id="H620EDF70BD58424D00705B17331F6881" indent="up1"><enum>(ii)</enum><text>the genetic monitoring is required
by Federal or State law;</text>
</clause></subparagraph><subparagraph id="H428E715322244E608559F1C0087C6962"><enum>(C)</enum><text>the member is
informed of individual monitoring results;</text>
</subparagraph><subparagraph id="HB5936ACE3A074AF984A678DD2DD600D8"><enum>(D)</enum><text>the monitoring is
in compliance with—</text>
<clause id="H6AD92884011A41B6B5BDADD8C055FF4"><enum>(i)</enum><text>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 (<external-xref legal-doc="usc" parsable-cite="usc/29/651">29 U.S.C. 651 et seq.</external-xref>), the Federal Mine Safety and
Health Act of 1977 (<external-xref legal-doc="usc" parsable-cite="usc/30/801">30 U.S.C. 801 et seq.</external-xref>), or the
<act-name parsable-cite="AEA54">Atomic Energy Act of 1954</act-name> (42 U.S.C.
2011 et seq.); or</text>
</clause><clause id="HD795F47C714849B1AD8BC048C8506B3B"><enum>(ii)</enum><text>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 (<external-xref legal-doc="usc" parsable-cite="usc/29/651">29 U.S.C. 651 et seq.</external-xref>); and</text>
</clause></subparagraph><subparagraph id="HAF1CC22ADD25450E80BD8D651FB547EB"><enum>(E)</enum><text>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.</text>
</subparagraph></paragraph></subsection><subsection id="H92D71905DF3940D6897E4BB34E154ECE"><enum>(c)</enum><header>Preservation of
Protections</header><text>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.</text>
</subsection></section><section id="HD01DCDB6BC28402E84C3DB49FB362100"><enum>205.</enum><header>Training
programs</header>
<subsection id="H8032CC7BED67415DA64FA39D11A26F54"><enum>(a)</enum><header>Discrimination
based on Genetic Information</header><text>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—</text>
<paragraph id="H1C4AD6022D35462500883236F5939E19"><enum>(1)</enum><text>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;</text>
</paragraph><paragraph id="H67415425A40240639E00208529DC31DA"><enum>(2)</enum><text>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</text>
</paragraph><paragraph id="HBF248E42086B4C2EB18FA0F455DF2D8C"><enum>(3)</enum><text>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.</text>
</paragraph></subsection><subsection id="H6E173985E95E4E19955DC3BA2E039B9"><enum>(b)</enum><header>Acquisition of
Genetic Information</header><text display-inline="yes-display-inline">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—</text>
<paragraph id="H14374ADC31964E26B31F17201881D868"><enum>(1)</enum><text display-inline="yes-display-inline">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;</text>
</paragraph><paragraph id="HEB6758943C25448596177864EBF5806B"><enum>(2)</enum><text>where—</text>
<subparagraph id="H035FA19EE59B432B96BA00E041B8796F"><enum>(A)</enum><text>health or genetic
services are offered by the employer, labor organization, or joint
labor-management committee, including such services offered as part of a bona
fide wellness program;</text>
</subparagraph><subparagraph id="H14CE0FC1CE6345198054CB7FE6910028"><enum>(B)</enum><text>the individual
provides prior, knowing, voluntary, and written authorization;</text>
</subparagraph><subparagraph id="H160C46A25D9743EDA0000014D7BBDE00"><enum>(C)</enum><text>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</text>
</subparagraph><subparagraph id="H3949EE24B520479DA84D46035B26CF52"><enum>(D)</enum><text>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;</text>
</subparagraph></paragraph><paragraph id="H280F22569FCB4A3780813860DF78E9FF"><enum>(3)</enum><text>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 (<external-xref legal-doc="usc" parsable-cite="usc/29/2613">29 U.S.C. 2613</external-xref>) or such requirements under State family and medical leave
laws;</text>
</paragraph><paragraph id="HA87EDE9403434AC7BFE1DF62F75D5D13"><enum>(4)</enum><text>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;</text>
</paragraph><paragraph id="H3E0A95E3C9914085B37CB3EED3D75619"><enum>(5)</enum><text>where the
information involved is to be used for genetic monitoring of the biological
effects of toxic substances in the workplace, but only if—</text>
<subparagraph id="H60C9EC4142B345458773A580A0DD06F4"><enum>(A)</enum><text>the employer,
labor organization, or joint labor-management committee provides written notice
of the genetic monitoring to the individual;</text>
</subparagraph><subparagraph id="HDE9F0A6386EB4CB2A2463BFB6D2BA24"><enum>(B)</enum><clause commented="no" display-inline="yes-display-inline" id="H38F7F9225B9E46ECB0708C8764F6C2F7"><enum>(i)</enum><text>the individual provides
prior, knowing, voluntary, and written authorization; or</text>
</clause><clause id="H037DF75ED4BD49E28ED548F381462314" indent="up1"><enum>(ii)</enum><text>the genetic monitoring is required
by Federal or State law;</text>
</clause></subparagraph><subparagraph id="H1E528443F95A449BBA67C8FAB6715588"><enum>(C)</enum><text>the individual is
informed of individual monitoring results;</text>
</subparagraph><subparagraph id="HDC3B0529F850408A9D26AD002D87F02D"><enum>(D)</enum><text>the monitoring is
in compliance with—</text>
<clause id="H36E448B27EEE44A799D81C21B7B6B57"><enum>(i)</enum><text>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 (<external-xref legal-doc="usc" parsable-cite="usc/29/651">29 U.S.C. 651 et seq.</external-xref>), the Federal Mine Safety and
Health Act of 1977 (<external-xref legal-doc="usc" parsable-cite="usc/30/801">30 U.S.C. 801 et seq.</external-xref>), or the
<act-name parsable-cite="AEA54">Atomic Energy Act of 1954</act-name> (42 U.S.C.
2011 et seq.); or</text>
</clause><clause id="H45DF0D6E974647FFAB6189C293EB4DFC"><enum>(ii)</enum><text>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 (<external-xref legal-doc="usc" parsable-cite="usc/29/651">29 U.S.C. 651 et seq.</external-xref>); and</text>
</clause></subparagraph><subparagraph id="H9463101C5F984A20BAC29FA10977DE11"><enum>(E)</enum><text>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</text>
</subparagraph></paragraph><paragraph id="HDDD4ED23C6A74C6EB97DAC862500BCA9"><enum>(6)</enum><text display-inline="yes-display-inline">where the employer conducts DNA analysis
for law enforcement purposes as a forensic laboratory, includes such analysis
in the Combined DNA Index System pursuant to section 210304 of the Violent
Crime Control and Law Enforcement Act of 1994 (<external-xref legal-doc="usc" parsable-cite="usc/42/14132">42 U.S.C. 14132</external-xref>), 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.</text>
</paragraph></subsection><subsection id="HE24DAB28BAA54A989BD871DA112F1F16"><enum>(c)</enum><header>Preservation of
Protections</header><text>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.</text>
</subsection></section><section commented="no" id="H90B6EE87C6AE4423992B2C4FE541913"><enum>206.</enum><header>Confidentiality
of genetic information</header>
<subsection commented="no" id="H494C427DC623471BA4E246DE652DBF42"><enum>(a)</enum><header>Treatment of
Information as Part of Confidential Medical Record</header><text display-inline="yes-display-inline">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 (<external-xref legal-doc="usc" parsable-cite="usc/42/12112">42 U.S.C. 12112(d)(3)(B)</external-xref>).</text>
</subsection><subsection commented="no" id="H8D534433583B4A258BE017B565CCB0B7"><enum>(b)</enum><header>Limitation on
Disclosure</header><text>An employer, employment agency, labor organization, or
joint labor-management committee shall not disclose genetic information
concerning an employee or member except—</text>
<paragraph commented="no" id="H3B00C09A7F744FAC81FE0000BC92381C"><enum>(1)</enum><text>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;</text>
</paragraph><paragraph commented="no" id="HCD9B68DB471645D6B4BEE3FB4E29637E"><enum>(2)</enum><text>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;</text>
</paragraph><paragraph commented="no" id="HCB8685A0D6AC4B6290B9CAA78CEA7884"><enum>(3)</enum><text>in response to an
order of a court, except that—</text>
<subparagraph commented="no" id="H36E4E75ED5E34FED90F7341E99368D71"><enum>(A)</enum><text>the employer,
employment agency, labor organization, or joint labor-management committee may
disclose only the genetic information expressly authorized by such order;
and</text>
</subparagraph><subparagraph commented="no" id="H26736ECAE9214DEB88B2985C067798F9"><enum>(B)</enum><text>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;</text>
</subparagraph></paragraph><paragraph commented="no" id="HF56F84E03BFF45FB942608737275655B"><enum>(4)</enum><text>to government
officials who are investigating compliance with this title if the information
is relevant to the investigation; or</text>
</paragraph><paragraph commented="no" id="HD08D408E1601452FA96E86E1B5141E46"><enum>(5)</enum><text>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 (<external-xref legal-doc="usc" parsable-cite="usc/29/2613">29 U.S.C. 2613</external-xref>) or such requirements under State family and medical leave
laws.</text>
</paragraph></subsection><subsection id="HAC45C2250725449B99C05CE6C3D56EF6"><enum>(c)</enum><header>Relationship to
HIPAA regulations</header><text>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 (<external-xref legal-doc="usc" parsable-cite="usc/42/1320d">42 U.S.C. 1320d et seq.</external-xref>) and section 264 of the Health
Insurance Portability and Accountability Act of 1996 (<external-xref legal-doc="usc" parsable-cite="usc/42/1320d-2">42 U.S.C. 1320d–2</external-xref> 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.</text>
</subsection></section><section id="H61C520FC2EA84576001463AA0700DA55"><enum>207.</enum><header>Remedies and
enforcement</header>
<subsection id="HFC886250020A46D0AB1196962EDB90D4"><enum>(a)</enum><header>Employees
Covered by Title <enum-in-header>VII</enum-in-header> of the
<act-name parsable-cite="CRA64">Civil Rights Act of 1964</act-name></header>
<paragraph id="HD32FCD8A5FCF4D799105E1667C9BB0B0"><enum>(1)</enum><header>In
general</header><text>The powers, remedies, and procedures provided in sections
705, 706, 707, 709, 710, and 711 of the <act-name parsable-cite="CRA64">Civil
Rights Act of 1964</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/42/2000e-4">42 U.S.C. 2000e–4 et seq.</external-xref>) to the Commission,
the Attorney General, or any person, alleging a violation of title VII of that
Act (<external-xref legal-doc="usc" parsable-cite="usc/42/2000e">42 U.S.C. 2000e et seq.</external-xref>) shall be the powers, remedies, and procedures
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).</text>
</paragraph><paragraph id="H699B30589EE74BACA011BF53353FC804"><enum>(2)</enum><header>Costs and
fees</header><text>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.</text>
</paragraph><paragraph id="H407AA88069C849D7B42817A4EC00A2A6"><enum>(3)</enum><header>Damages</header><text>The
powers, remedies, and procedures provided in section 1977A of the Revised
Statutes of the United States (<external-xref legal-doc="usc" parsable-cite="usc/42/1981a">42 U.S.C. 1981a</external-xref>), 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).</text>
</paragraph></subsection><subsection id="H138C626657DF4B18A733B5195D7F59FE"><enum>(b)</enum><header>Employees
Covered by Government Employee Rights Act of 1991</header>
<paragraph id="H4D3E56B540354CF1BC85FB2941D9E5AE"><enum>(1)</enum><header>In
general</header><text>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).</text>
</paragraph><paragraph id="H4D254D2A203D4EABBA2B7496BDB8C2A0"><enum>(2)</enum><header>Costs and
fees</header><text>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.</text>
</paragraph><paragraph id="H4D51C6CC72174B8BB779024471809DA9"><enum>(3)</enum><header>Damages</header><text>The
powers, remedies, and procedures provided in section 1977A of the Revised
Statutes of the United States (<external-xref legal-doc="usc" parsable-cite="usc/42/1981a">42 U.S.C. 1981a</external-xref>), 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).</text>
</paragraph></subsection><subsection id="HA791D85B747E4F7488F793AB6BB9350"><enum>(c)</enum><header>Employees Covered
by Congressional Accountability Act of 1995</header>
<paragraph id="H7EA9F18648D449CCBABBFB00133109C9"><enum>(1)</enum><header>In
general</header><text>The powers, remedies, and procedures provided in the
Congressional Accountability Act of 1995 (<external-xref legal-doc="usc" parsable-cite="usc/2/1301">2 U.S.C. 1301 et seq.</external-xref>) to the Board
(as defined in section 101 of that Act (<external-xref legal-doc="usc" parsable-cite="usc/2/1301">2 U.S.C. 1301</external-xref>)), or any person,
alleging a violation of section 201(a)(1) of that Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1311">42 U.S.C. 1311(a)(1)</external-xref>)
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).</text>
</paragraph><paragraph id="HF0E1ED3993D24AC391DCF76BA1E20000"><enum>(2)</enum><header>Costs and
fees</header><text>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.</text>
</paragraph><paragraph id="H39B5103D424244FD852B00610074D249"><enum>(3)</enum><header>Damages</header><text>The
powers, remedies, and procedures provided in section 1977A of the Revised
Statutes of the United States (<external-xref legal-doc="usc" parsable-cite="usc/42/1981a">42 U.S.C. 1981a</external-xref>), 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).</text>
</paragraph><paragraph id="HD76230DDBFB645C381669461D4FB5034"><enum>(4)</enum><header>Other applicable
provisions</header><text>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)).</text>
</paragraph></subsection><subsection id="HF2F3EB3D55D844E8802BD968679300CF"><enum>(d)</enum><header>Employees
Covered by Chapter <enum-in-header>5</enum-in-header> of Title
<enum-in-header>3</enum-in-header>, United States Code</header>
<paragraph id="HEC420EFA32E844B7A8C0A1310006D9C8"><enum>(1)</enum><header>In
general</header><text>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).</text>
</paragraph><paragraph id="H633352510583450C82A0BCA94CCA00"><enum>(2)</enum><header>Costs and
fees</header><text>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.</text>
</paragraph><paragraph id="H5CB9C199D24E40D1B6659D9DDB6F7E77"><enum>(3)</enum><header>Damages</header><text display-inline="yes-display-inline">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).</text>
</paragraph></subsection><subsection id="H8DD58C752A5C426383705DE1E28C005C"><enum>(e)</enum><header>Employees
Covered by Section <enum-in-header>717</enum-in-header> of the
<act-name parsable-cite="CRA64">Civil Rights Act of 1964</act-name></header>
<paragraph id="HF79DD53298144790A5F5A5FDA811D615"><enum>(1)</enum><header>In
general</header><text>The powers, remedies, and procedures provided in section
717 of the <act-name parsable-cite="CRA64">Civil Rights Act of 1964</act-name>
(<external-xref legal-doc="usc" parsable-cite="usc/42/2000e-16">42 U.S.C. 2000e–16</external-xref>) 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).</text>
</paragraph><paragraph id="HD8CB963D41D547BC92ED18AE7699A5D8"><enum>(2)</enum><header>Costs and
fees</header><text display-inline="yes-display-inline">The powers, remedies,
and procedures provided in subsections (b) and (c) of section 722 of the
Revised Statutes of the United States (<external-xref legal-doc="usc" parsable-cite="usc/42/1988">42 U.S.C. 1988</external-xref>), 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.</text>
</paragraph><paragraph id="H80204362A0734F3C87A51F9821B7C790"><enum>(3)</enum><header>Damages</header><text display-inline="yes-display-inline">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).</text>
</paragraph></subsection><subsection id="H7EA45D98FBDF43ADBA357BA16F289BA7"><enum>(f)</enum><header>Definition</header><text>In
this section, the term <term>Commission</term> means the Equal Employment
Opportunity Commission.</text>
</subsection></section><section id="H1F46213D25E645C790BCCD721EBA2FAF"><enum>208.</enum><header>Disparate
impact</header>
<subsection id="HC53692EE40B3449E865CB9A66E5D24D3"><enum>(a)</enum><header>General
Rule</header><text>Notwithstanding any other provision of this division,
<quote>disparate impact</quote>, as that term is used in section 703(k) of the
<act-name parsable-cite="CRA64">Civil Rights Act of 1964</act-name> (42 U.S.C.
2000e–2(k)), on the basis of genetic information does not establish a cause of
action under this division.</text>
</subsection><subsection id="H993054CFED1E48C18959D4C18FF282B"><enum>(b)</enum><header>Commission</header><text>On
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 <quote>Commission</quote>) 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 division.</text>
</subsection><subsection id="H258AF09AA6BF4AC3B1B98F7154595300"><enum>(c)</enum><header>Membership</header>
<paragraph id="H1B5019D7E96C4D63A346EDF3E5FB2D"><enum>(1)</enum><header>In
general</header><text>The Commission shall be composed of eight members, of
which—</text>
<subparagraph id="H41984127537C4704A356A36B27A27EF"><enum>(A)</enum><text>one member shall be
appointed by the Majority Leader of the Senate;</text>
</subparagraph><subparagraph id="H073E744FE0D64F91A39854002F15C455"><enum>(B)</enum><text>one member shall
be appointed by the Minority Leader of the Senate;</text>
</subparagraph><subparagraph id="H4E4378546C454869B28460F6D77D02D2"><enum>(C)</enum><text>one member shall
be appointed by the Chairman of the Committee on Health, Education, Labor, and
Pensions of the Senate;</text>
</subparagraph><subparagraph id="H34492E265F044E7D8C096821477C7F26"><enum>(D)</enum><text>one member shall
be appointed by the ranking minority member of the Committee on Health,
Education, Labor, and Pensions of the Senate;</text>
</subparagraph><subparagraph id="H8433AA6938594F5400001517A470C3C6"><enum>(E)</enum><text>one member shall
be appointed by the Speaker of the House of Representatives;</text>
</subparagraph><subparagraph id="H7AAA20188E7943DCABBB0150E13715E3"><enum>(F)</enum><text>one member shall
be appointed by the Minority Leader of the House of Representatives;</text>
</subparagraph><subparagraph id="H05BC87A7364E40CABDF960C801B51F88"><enum>(G)</enum><text>one member shall
be appointed by the Chairman of the Committee on Education and Labor of the
House of Representatives; and</text>
</subparagraph><subparagraph id="H8B2CB9069C8C4C4D83CF47D6D063FF90"><enum>(H)</enum><text>one member shall
be appointed by the ranking minority member of the Committee on Education and
Labor of the House of Representatives.</text>
</subparagraph></paragraph><paragraph id="H38F3716267624E9F00A09400036B149E"><enum>(2)</enum><header>Compensation and
expenses</header><text>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.</text>
</paragraph></subsection><subsection id="HECE82DEDDF53417E8B9824A9BDA4341E"><enum>(d)</enum><header>Administrative
Provisions</header>
<paragraph id="H3A3016B94131430795A3B1EB7BECE127"><enum>(1)</enum><header>Location</header><text>The
Commission shall be located in a facility maintained by the Equal Employment
Opportunity Commission.</text>
</paragraph><paragraph id="H2EF32F3DBCF741C2B9EB147B7D2D461C"><enum>(2)</enum><header>Detail of
government employees</header><text>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.</text>
</paragraph><paragraph id="H7CF4B749EB364AB58DB2B137FD3C7A7"><enum>(3)</enum><header>Information from
federal agencies</header><text>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.</text>
</paragraph><paragraph id="H1F6D7792F8C24A34B1F043AEB84204E4"><enum>(4)</enum><header>Hearings</header><text>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.</text>
</paragraph><paragraph id="H085A2398CBDF4F97AAF5CCBC68B935F0"><enum>(5)</enum><header>Postal
services</header><text>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.</text>
</paragraph></subsection><subsection id="H72235610311F490886BD736E4E1330A9"><enum>(e)</enum><header>Report</header><text>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 division.</text>
</subsection><subsection id="HA9E542A6570B4E57937EA768DB1EAD6B"><enum>(f)</enum><header>Authorization of
Appropriations</header><text>There are authorized to be appropriated to the
Equal Employment Opportunity Commission such sums as may be necessary to carry
out this section.</text>
</subsection></section><section id="HFAFC0770B5F940C18FEE7886C85D543B"><enum>209.</enum><header>Construction</header>
<subsection id="H043B38DB69DC44F889C5098B815DFBDF"><enum>(a)</enum><header>In
general</header><text display-inline="yes-display-inline">Nothing in this title
shall be construed to—</text>
<paragraph id="H1FA4B1ABDA0F4E54B2A46636432D4D77"><enum>(1)</enum><text>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 (<external-xref legal-doc="usc" parsable-cite="usc/42/12112">42 U.S.C. 12112</external-xref>)), or under the <act-name parsable-cite="REH">Rehabilitation Act of 1973</act-name> (29 U.S.C. 701 et
seq.);</text>
</paragraph><paragraph id="HF857DE99CF864A28AC61C6FE13CFC228"><enum>(2)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="HF72B828913484762846469E020B5A7C9"><enum>(A)</enum><text>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</text>
</subparagraph><subparagraph commented="no" id="H1F2EBC6422D84F52864CFE330400801C" indent="up1"><enum>(B)</enum><text display-inline="yes-display-inline">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 the
enforcement of which, or penalties for which, are provided under the amendments
made by title I;</text>
</subparagraph></paragraph><paragraph id="HAEBCFB980F8C47C499F1E944A1EB9B8E"><enum>(3)</enum><text>apply to the Armed
Forces Repository of Specimen Samples for the Identification of Remains;</text>
</paragraph><paragraph id="H084071EEAEC84D2286C3454D033B3F50"><enum>(4)</enum><text>limit or expand
the protections, rights, or obligations of employees or employers under
applicable workers’ compensation laws;</text>
</paragraph><paragraph id="HD2840A9B83FD4548A100DADBE77080E9"><enum>(5)</enum><text>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);</text>
</paragraph><paragraph id="HDDB5E0323FFE4C39AA45571F16F9311D"><enum>(6)</enum><text>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</text>
</paragraph><paragraph commented="no" id="H2BEE370D2AC54EB394BBA3FFC46723ED"><enum>(7)</enum><text>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.</text>
</paragraph></subsection><subsection id="H70CEAC312C1141BEBAE0C5B1D8B9870"><enum>(b)</enum><header>Genetic
information of a fetus or embryo</header><text>Any reference in this title to
genetic information concerning an individual or family member of an individual
shall—</text>
<paragraph id="HB1994FABF8844F4BBD1263BB41CB5072"><enum>(1)</enum><text>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</text>
</paragraph><paragraph id="H00B49E8C660A44D98C01655723000090"><enum>(2)</enum><text>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.</text>
</paragraph></subsection></section><section commented="no" id="HE9132D64B20E46BE9EA484638C673206"><enum>210.</enum><header>Medical
information that is not genetic information</header><text display-inline="no-display-inline">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.</text>
</section><section id="HB104169C8F244B43BBD2F9AEE869C1E"><enum>211.</enum><header>Regulations</header><text display-inline="no-display-inline">Not later than 1 year after the date of
enactment of this title, the Commission shall issue final regulations to carry
out this title.</text>
</section><section id="HF6A7F02A828E4BF590D397A270A6DAE"><enum>212.</enum><header>Authorization of
appropriations</header><text display-inline="no-display-inline">There are
authorized to be appropriated such sums as may be necessary to carry out this
title (except for section 208).</text>
</section><section id="HEC11F46084A2463B947B674F7F95D792"><enum>213.</enum><header>Effective
date</header><text display-inline="no-display-inline">This title takes effect
on the date that is 18 months after the date of enactment of this Act.</text>
</section><enum>III</enum><header>MISCELLANEOUS
PROVISIONS</header>
<section display-inline="no-display-inline" id="H05915284B19C4965B00058DB586000DD" section-type="subsequent-section"><enum>301.</enum><header>Guarantee agency
collection retention</header><text display-inline="no-display-inline">Clause
(ii) of section 428(c)(6)(A) of the Higher Education Act of 1965 (20 U.S.C.
1078(c)(6)(A)) is amended to read as follows:</text>
<quoted-block display-inline="no-display-inline" id="HE3713EA2419E49F0AA30C5B6456051E" style="OLC">
<clause id="HD4600407B9B643960060AB0441E694D9" indent="up1"><enum>(ii)</enum><text display-inline="yes-display-inline">an amount equal to 23 percent of such
payments for use in accordance with section 422B, except that beginning October
1, 2007, and ending September 30, 2008, this subparagraph shall be applied by
substituting <quote>22 percent</quote> for <quote>23 percent</quote>.</text>
</clause><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section id="H9C0FAF52EAC546DBACDCA1D7A992DBC4"><enum>302.</enum><header>Severability</header><text display-inline="no-display-inline">If any provision of this division, an
amendment made by this division, or the application of such provision or
amendment to any person or circumstance is held to be unconstitutional, the
remainder of this division, the amendments made by this division, and the
application of such provisions to any person or circumstance shall not be
affected thereby.</text>
</section>
Passed the House of
Representatives March 5, 2008.
Lorraine C. Miller,
Clerk.