[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1424 Placed on Calendar Senate (PCS)]
Calendar No. 610
110th CONGRESS
2d Session
H. R. 1424
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
March 6, 2008
Received and read the first time
March 7, 2008
Read the second time and placed on the calendar
_______________________________________________________________________
AN ACT
To amend section 712 of the Employee Retirement Income Security Act of
1974, section 2705 of the Public Health Service Act, section 9812 of
the Internal Revenue Code of 1986 to require equity in the provision of
mental health and substance-related disorder benefits under group
health plans, to prohibit discrimination on the basis of genetic
information with respect to health insurance and employment, and for
other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. ORGANIZATION OF ACT INTO DIVISIONS; TABLE OF CONTENTS.
(a) Divisions.--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) Table of Contents.--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.
DIVISION A--PAUL WELLSTONE MENTAL HEALTH AND ADDICTION EQUITY ACT OF
2008
SEC. 101. SHORT TITLE.
This division may be cited as the ``Paul Wellstone Mental Health
and Addiction Equity Act of 2008''.
SEC. 102. AMENDMENTS TO THE EMPLOYEE RETIREMENT INCOME SECURITY ACT OF
1974.
(a) Extension of Parity to Treatment Limits and Beneficiary
Financial Requirements.--Section 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) Treatment limits.--In the case of a group health plan
that provides both medical and surgical benefits and mental
health or substance-related disorder benefits--
``(A) No treatment limit.--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) Treatment limit.--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 requirements.--For 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) Inpatient, in-network.--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-network.--Items
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) Outpatient, in-network.--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-network.--Items
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) Emergency care.--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) Treatment limit defined.--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) Predominance.--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 requirements.--In 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 requirement.--If 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
requirements.--If 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 requirements.--If
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 defined.--
For 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 Definition.--Such 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) Mental health benefits.--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 benefits.--The 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
Necessity.--Subsection (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 information.--The 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 Requirements.--Subsection (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 benefits.--In 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 general.--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 services.--
For 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) Emergency.--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) Inpatient.--Items and
services not described in subclause (I)
furnished on an inpatient basis.
``(III) Outpatient.--Items and
services not described in subclause (I)
furnished on an outpatient basis.''.
(e) Revision of Increased Cost Exemption.--Paragraph (2) of
subsection (c) of such section is amended to read as follows:
``(2) Increased cost exemption.--
``(A) In general.--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) Applicable percentage.--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 actuaries.--Determinations
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) 6-month determinations.--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) Notification.--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) In general.--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) Requirement.--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) Confidentiality.--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 law.--The
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) Construction.--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 Employers.--Subsection
(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 Provision.--Such section is amended by
striking subsection (f).
(h) Clarification Regarding Preemption.--Such section is further
amended by inserting after subsection (e) the following new subsection:
``(f) Preemption, Relation to State Laws.--
``(1) In general.--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
plans.--Nothing in this section shall be construed to affect or
modify the provisions of section 514 with respect to group
health plans.
``(3) Other state laws.--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) In general.--The heading of such section is amended to
read as follows:
``SEC. 712. EQUITY IN MENTAL HEALTH AND SUBSTANCE-RELATED DISORDER
BENEFITS.''.
(2) Clerical amendment.--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) Effective Date.--
(1) In general.--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 agreements.--In
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 Compliance.--The 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 Beneficiaries.--The 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.
SEC. 103. AMENDMENTS TO THE PUBLIC HEALTH SERVICE ACT RELATING TO THE
GROUP MARKET.
(a) Extension of Parity to Treatment Limits and Beneficiary
Financial Requirements.--Section 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) Treatment limits.--In the case of a group health plan
that provides both medical and surgical benefits and mental
health or substance-related disorder benefits--
``(A) No treatment limit.--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) Treatment limit.--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 requirements.--For 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) Inpatient, in-network.--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-network.--Items
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) Outpatient, in-network.--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-network.--Items
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) Emergency care.--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) Treatment limit defined.--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) Predominance.--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 requirements.--In 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 requirement.--If 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
requirements.--If 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 requirements.--If
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 defined.--
For 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 Definition.--Such 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) Mental health benefits.--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 benefits.--The 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
Necessity.--Subsection (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 information.--The 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 Requirements.--Subsection (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 benefits.--In 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 general.--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 services.--
For 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) Emergency.--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) Inpatient.--Items and
services not described in subclause (I)
furnished on an inpatient basis.
``(III) Outpatient.--Items and
services not described in subclause (I)
furnished on an outpatient basis.''.
(e) Revision of Increased Cost Exemption.--Paragraph (2) of
subsection (c) of such section is amended to read as follows:
``(2) Increased cost exemption.--
``(A) In general.--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) Applicable percentage.--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 actuaries.--Determinations
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) 6-month determinations.--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) Notification.--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) In general.--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) Requirement.--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) Confidentiality.--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) Construction.--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 Employers.--Subsection
(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 Provision.--Such section is amended by
striking out subsection (f).
(h) Clarification Regarding Preemption.--Such section is further
amended by inserting after subsection (e) the following new subsection:
``(f) Preemption, Relation to State Laws.--
``(1) In general.--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) Construction.--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 Heading.--The heading of such section
is amended to read as follows:
``SEC. 2705. EQUITY IN MENTAL HEALTH AND SUBSTANCE-RELATED DISORDER
BENEFITS.''.
(j) Effective Date.--
(1) In general.--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) Elimination of sunset.--The amendment made by
subsection (g) shall apply to benefits for services furnished
after December 31, 2007.
(3) Special rule for collective bargaining agreements.--In
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.
SEC. 104. AMENDMENTS TO THE INTERNAL REVENUE CODE OF 1986.
(a) Extension of Parity to Treatment Limits and Beneficiary
Financial Requirements.--Section 9812 of the Internal Revenue Code of
1986 is amended--
(1) in subsection (a), by adding at the end the following
new paragraphs:
``(3) Treatment limits.--In the case of a group health plan
that provides both medical and surgical benefits and mental
health or substance-related disorder benefits--
``(A) No treatment limit.--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) Treatment limit.--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 requirements.--For 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) Inpatient, in-network.--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-network.--Items
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) Outpatient, in-network.--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-network.--Items
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) Emergency care.--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) Treatment limit defined.--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) Predominance.--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 requirements.--In 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 requirement.--If 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
requirements.--If 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 requirements.--If
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 defined.--
For 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 Definition.--Section 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) Mental health benefits.--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 benefits.--The 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
Necessity.--Subsection (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 information.--The 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 Requirements.--Subsection (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 benefits.--In 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 general.--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 services.--
For 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) Emergency.--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) Inpatient.--Items and
services not described in subclause (I)
furnished on an inpatient basis.
``(III) Outpatient.--Items and
services not described in subclause (I)
furnished on an outpatient basis.''.
(e) Revision of Increased Cost Exemption.--Paragraph (2) of section
9812(c) of such Code is amended to read as follows:
``(2) Increased cost exemption.--
``(A) In general.--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) Applicable percentage.--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 actuaries.--Determinations
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) 6-month determinations.--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) In general.--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) Requirement.--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) Confidentiality.--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) Construction.--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 Employers.--Paragraph (1) of
section 9812(c) of such Code is amended to read as follows:
``(1) Small employer exemption.--
``(A) In general.--This section shall not apply to
any group health plan for any plan year of a small
employer.
``(B) Small employer.--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 Provision.--Section 9812 of such Code is
amended by striking subsection (f).
(h) Conforming Amendments to Heading.--
(1) In general.--The heading of section 9812 of such Code
is amended to read as follows:
``SEC. 9812. EQUITY IN MENTAL HEALTH AND SUBSTANCE-RELATED DISORDER
BENEFITS.''.
(2) Clerical amendment.--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) Effective Date.--
(1) In general.--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) Elimination of sunset.--The amendment made by
subsection (g) shall apply to benefits for services furnished
after December 31, 2007.
(3) Special rule for collective bargaining agreements.--In
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.
SEC. 105. MEDICAID DRUG REBATE.
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.''.
SEC. 106. LIMITATION ON MEDICARE EXCEPTION TO THE PROHIBITION ON
CERTAIN PHYSICIAN REFERRALS FOR HOSPITALS.
(a) In General.--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) Requirements described.--For purposes of subsection
(d)(3)(D), the requirements described in this paragraph for a
hospital are as follows:
``(A) Provider agreement.--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
capacity.--Except 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) Patient safety.--
``(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 reported.--The 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) Process.--
``(i) Establishment.--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 input.--
The 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 implementation.--The
Secretary shall implement the process under
clause (i) on the date that is 18 months after
the date of enactment of this subsection.
``(iv) Regulations.--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) Frequency.--The process described in
subparagraph (A) shall permit an applicable hospital to
apply for an exception up to once every 2 years.
``(C) Permitted increase.--
``(i) In general.--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
limitation.--The 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 beds.--In 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 hospital.--Any 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) Applicable hospital.--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 decisions.--The
Secretary shall publish final decisions with respect to
applications under this paragraph in the Federal
Register.
``(G) Limitation on review.--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 information.--
For 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) Physician owner defined.--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) Enforcement.--
(1) Ensuring compliance.--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) Audits.--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) Adjustment to PAQI Fund.--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''.
SEC. 107. STUDIES AND REPORTS.
(a) Implementation of Act.--
(1) GAO study.--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) Report.--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 Criteria.--Not 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 Coverage.--
Every 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.
DIVISION B--GENETIC INFORMATION NONDISCRIMINATION ACT OF 2008
SEC. 100. SHORT TITLE; FINDINGS.
(a) Short Title.--This division may be cited as the ``Genetic
Information Nondiscrimination Act of 2008''.
(b) Findings.--Congress makes the following findings:
(1) Deciphering the sequence of the human genome and other
advances in genetics open major new opportunities for medical
progress. New knowledge about the genetic basis of illness will
allow for earlier detection of illnesses, often before symptoms
have begun. Genetic testing can allow individuals to take steps
to reduce the likelihood that they will contract a particular
disorder. New knowledge about genetics may allow for the
development of better therapies that are more effective against
disease or have fewer side effects than current treatments.
These advances give rise to the potential misuse of genetic
information to discriminate in health insurance and employment.
(2) The early science of genetics became the basis of State
laws that provided for the sterilization of persons having
presumed genetic ``defects'' such as mental retardation, mental
disease, epilepsy, blindness, and hearing loss, among other
conditions. The first sterilization law was enacted in the
State of Indiana in 1907. By 1981, a majority of States adopted
sterilization laws to ``correct'' apparent genetic traits or
tendencies. Many of these State laws have since been repealed,
and many have been modified to include essential constitutional
requirements of due process and equal protection. However, the
current explosion in the science of genetics, and the history
of sterilization laws by the States based on early genetic
science, compels Congressional action in this area.
(3) Although genes are facially neutral markers, many
genetic conditions and disorders are associated with particular
racial and ethnic groups and gender. Because some genetic
traits are most prevalent in particular groups, members of a
particular group may be stigmatized or discriminated against as
a result of that genetic information. This form of
discrimination was evident in the 1970s, which saw the advent
of programs to screen and identify carriers of sickle cell
anemia, a disease which afflicts African-Americans. Once again,
State legislatures began to enact discriminatory laws in the
area, and in the early 1970s began mandating genetic screening
of all African Americans for sickle cell anemia, leading to
discrimination and unnecessary fear. To alleviate some of this
stigma, Congress in 1972 passed the National Sickle Cell Anemia
Control Act, which withholds Federal funding from States unless
sickle cell testing is voluntary.
(4) Congress has been informed of examples of genetic
discrimination in the workplace. These include the use of pre-
employment genetic screening at Lawrence Berkeley Laboratory,
which led to a court decision in favor of the employees in that
case Norman-Bloodsaw v. Lawrence Berkeley Laboratory (135 F.3d
1260, 1269 (9th Cir. 1998)). Congress clearly has a compelling
public interest in relieving the fear of discrimination and in
prohibiting its actual practice in employment and health
insurance.
(5) Federal law addressing genetic discrimination in health
insurance and employment is incomplete in both the scope and
depth of its protections. Moreover, while many States have
enacted some type of genetic non-discrimination law, these laws
vary widely with respect to their approach, application, and
level of protection. Congress has collected substantial
evidence that the American public and the medical community
find the existing patchwork of State and Federal laws to be
confusing and inadequate to protect them from discrimination.
Therefore Federal legislation establishing a national and
uniform basic standard is necessary to fully protect the public
from discrimination and allay their concerns about the
potential for discrimination, thereby allowing individuals to
take advantage of genetic testing, technologies, research, and
new therapies.
TITLE I--GENETIC NONDISCRIMINATION IN HEALTH INSURANCE
SEC. 101. AMENDMENTS TO EMPLOYEE RETIREMENT INCOME SECURITY ACT OF
1974.
(a) No Discrimination in Group Premiums Based on Genetic
Information.--Section 702(b) of the Employee Retirement Income Security
Act of 1974 (29 U.S.C. 1182(b)) is amended--
(1) in paragraph (2)(A), by inserting before the semicolon
the following: ``except as provided in paragraph (3)''; and
(2) by adding at the end the following:
``(3) No group-based discrimination on basis of genetic
information.--For purposes of this section, a group health
plan, and a health insurance issuer offering group health
insurance coverage in connection with a group health plan, may
not adjust premium or contribution amounts for the group
covered under such plan on the basis of genetic information.''.
(b) Limitations on Genetic Testing; Prohibition on Collection of
Genetic Information; Application to All Plans.--Section 702 of the
Employee Retirement Income Security Act of 1974 (29 U.S.C. 1182) is
amended by adding at the end the following:
``(c) Genetic Testing.--
``(1) Limitation on requesting or requiring genetic
testing.--A group health plan, and a health insurance issuer
offering health insurance coverage in connection with a group
health plan, shall not request or require an individual or a
family member of such individual to undergo a genetic test.
``(2) Rule of construction.--Paragraph (1) shall not be
construed to limit the authority of a health care professional
who is providing health care services to an individual to
request that such individual undergo a genetic test.
``(3) Rule of construction regarding payment.--
``(A) In general.--Nothing in paragraph (1) shall
be construed to preclude a group health plan, or a
health insurance issuer offering health insurance
coverage in connection with a group health plan, from
obtaining and using the results of a genetic test in
making a determination regarding payment (as such term
is defined for the purposes of applying the regulations
promulgated by the Secretary of Health and Human
Services under part C of title XI of the Social
Security Act and section 264 of the Health Insurance
Portability and Accountability Act of 1996, as may be
revised from time to time) consistent with subsection
(a).
``(B) Limitation.--For purposes of subparagraph
(A), a group health plan, or a health insurance issuer
offering health insurance coverage in connection with a
group health plan, may request only the minimum amount
of information necessary to accomplish the intended
purpose.
``(4) Research exception.--Notwithstanding paragraph (1), a
group health plan, or a health insurance issuer offering health
insurance coverage in connection with a group health plan, may
request, but not require, that a participant or beneficiary
undergo a genetic test if each of the following conditions is
met:
``(A) The request is made, in writing, pursuant to
research that complies with part 46 of title 45, Code
of Federal Regulations, or equivalent Federal
regulations, and any applicable State or local law or
regulations for the protection of human subjects in
research.
``(B) The plan or issuer clearly indicates to each
participant or beneficiary, or in the case of a minor
child, to the legal guardian of such beneficiary, to
whom the request is made that--
``(i) compliance with the request is
voluntary; and
``(ii) non-compliance will have no effect
on enrollment status or premium or contribution
amounts.
``(C) No genetic information collected or acquired
under this paragraph shall be used for underwriting
purposes.
``(D) The plan or issuer notifies the Secretary in
writing that the plan or issuer is conducting
activities pursuant to the exception provided for under
this paragraph, including a description of the
activities conducted.
``(E) The plan or issuer complies with such other
conditions as the Secretary may by regulation require
for activities conducted under this paragraph.
``(d) Prohibition on Collection of Genetic Information.--
``(1) In general.--A group health plan, and a health
insurance issuer offering health insurance coverage in
connection with a group health plan, shall not request,
require, or purchase genetic information for underwriting
purposes (as defined in section 733).
``(2) Prohibition on collection of genetic information
prior to enrollment.--A group health plan, and a health
insurance issuer offering health insurance coverage in
connection with a group health plan, shall not request,
require, or purchase genetic information with respect to any
individual prior to such individual's enrollment under the plan
or coverage in connection with such enrollment.
``(3) Incidental collection.--If a group health plan, or a
health insurance issuer offering health insurance coverage in
connection with a group health plan, obtains genetic
information incidental to the requesting, requiring, or
purchasing of other information concerning any individual, such
request, requirement, or purchase shall not be considered a
violation of paragraph (2) if such request, requirement, or
purchase is not in violation of paragraph (1).
``(e) Application to All Plans.--The provisions of subsections
(a)(1)(F), (b)(3), (c), and (d), and subsection (b)(1) and section 701
with respect to genetic information, shall apply to group health plans
and health insurance issuers without regard to section 732(a).''.
(c) Application to Genetic Information of a Fetus or Embryo.--Such
section is further amended by adding at the end the following:
``(f) Genetic Information of a Fetus or Embryo.--Any reference in
this part to genetic information concerning an individual or family
member of an individual shall--
``(1) with respect to such an individual or family member
of an individual who is a pregnant woman, include genetic
information of any fetus carried by such pregnant woman; and
``(2) with respect to an individual or family member
utilizing an assisted reproductive technology, include genetic
information of any embryo legally held by the individual or
family member.''.
(d) Definitions.--Section 733(d) of the Employee Retirement Income
Security Act of 1974 (29 U.S.C. 1191b(d)) is amended by adding at the
end the following:
``(5) Family member.--The term `family member' means, with
respect to an individual--
``(A) a dependent (as such term is used for
purposes of section 701(f)(2)) of such individual, and
``(B) any other individual who is a first-degree,
second-degree, third-degree, or fourth-degree relative
of such individual or of an individual described in
subparagraph (A).
``(6) Genetic information.--
``(A) In general.--The term `genetic information'
means, with respect to any individual, information
about--
``(i) such individual's genetic tests,
``(ii) the genetic tests of family members
of such individual, and
``(iii) subject to subparagraph (D), the
manifestation of a disease or disorder in
family members of such individual.
``(B) Inclusion of genetic services.--Such term
includes, with respect to any 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.
``(C) Exclusions.--The term `genetic information'
shall not include information about the sex or age of
any individual.
``(D) Application to family members covered under
same plan.--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.
``(7) Genetic test.--
``(A) In general.--The term `genetic test' means an
analysis of human DNA, RNA, chromosomes, proteins, or
metabolites, that detects genotypes, mutations, or
chromosomal changes.
``(B) Exceptions.--The term `genetic test' does not
mean--
``(i) an analysis of proteins or
metabolites that does not detect genotypes,
mutations, or chromosomal changes; or
``(ii) an analysis of proteins or
metabolites that is directly related to a
manifested disease, disorder, or pathological
condition that could reasonably be detected by
a health care professional with appropriate
training and expertise in the field of medicine
involved.
``(8) Genetic services.--The term `genetic services'
means--
``(A) a genetic test;
``(B) genetic counseling (including obtaining,
interpreting, or assessing genetic information); or
``(C) genetic education.
``(9) Underwriting purposes.--The term `underwriting
purposes' means, with respect to any group health plan, or
health insurance coverage offered in connection with a group
health plan--
``(A) rules for, or determination of, eligibility
(including enrollment and continued eligibility) for
benefits under the plan or coverage;
``(B) the computation of premium or contribution
amounts under the plan or coverage;
``(C) the application of any pre-existing condition
exclusion under the plan or coverage; and
``(D) other activities related to the creation,
renewal, or replacement of a contract of health
insurance or health benefits.''.
(e) ERISA Enforcement.--Section 502 of the Employee Retirement
Income Security Act of 1974 (29 U.S.C. 1132) is amended--
(1) in subsection (a)(6), by striking ``(7), or (8)'' and
inserting ``(7), (8), or (9)''; and
(2) in subsection (c), by redesignating paragraph (9) as
paragraph (10), and by inserting after paragraph (8) the
following new paragraph:
``(9) Secretarial enforcement authority relating to use of
genetic information.--
``(A) General rule.--The Secretary may impose a
penalty against any plan sponsor of a group health
plan, or any health insurance issuer offering health
insurance coverage in connection with the plan, for any
failure by such sponsor or issuer to meet the
requirements of subsection (a)(1)(F), (b)(3), (c), or
(d) of section 702 or section 701 or 702(b)(1) with
respect to genetic information, in connection with the
plan.
``(B) Amount.--
``(i) In general.--The amount of the
penalty imposed by subparagraph (A) shall be
$100 for each day in the noncompliance period
with respect to each participant or beneficiary
to whom such failure relates.
``(ii) Noncompliance period.--For purposes
of this paragraph, the term `noncompliance
period' means, with respect to any failure, the
period--
``(I) beginning on the date such
failure first occurs; and
``(II) ending on the date the
failure is corrected.
``(C) Minimum penalties where failure discovered.--
Notwithstanding clauses (i) and (ii) of subparagraph
(D):
``(i) In general.--In the case of 1 or more
failures with respect to a participant or
beneficiary--
``(I) which are not corrected
before the date on which the plan
receives a notice from the Secretary of
such violation; and
``(II) which occurred or continued
during the period involved;
the amount of penalty imposed by subparagraph
(A) by reason of such failures with respect to
such participant or beneficiary shall not be
less than $2,500.
``(ii) Higher minimum penalty where
violations are more than de minimis.--To the
extent violations for which any person is
liable under this paragraph for any year are
more than de minimis, clause (i) shall be
applied by substituting `$15,000' for `$2,500'
with respect to such person.
``(D) Limitations.--
``(i) Penalty not to apply where failure
not discovered exercising reasonable
diligence.--No penalty shall be imposed by
subparagraph (A) on any failure during any
period for which it is established to the
satisfaction of the Secretary that the person
otherwise liable for such penalty did not know,
and exercising reasonable diligence would not
have known, that such failure existed.
``(ii) Penalty not to apply to failures
corrected within certain periods.--No penalty
shall be imposed by subparagraph (A) on any
failure if--
``(I) such failure was due to
reasonable cause and not to willful
neglect; and
``(II) such failure is corrected
during the 30-day period beginning on
the first date the person otherwise
liable for such penalty knew, or
exercising reasonable diligence would
have known, that such failure existed.
``(iii) Overall limitation for
unintentional failures.--In the case of
failures which are due to reasonable cause and
not to willful neglect, the penalty imposed by
subparagraph (A) for failures shall not exceed
the amount equal to the lesser of--
``(I) 10 percent of the aggregate
amount paid or incurred by the plan
sponsor (or predecessor plan sponsor)
during the preceding taxable year for
group health plans; or
``(II) $500,000.
``(E) Waiver by secretary.--In the case of a
failure which is due to reasonable cause and not to
willful neglect, the Secretary may waive part or all of
the penalty imposed by subparagraph (A) to the extent
that the payment of such penalty would be excessive
relative to the failure involved.
``(F) Definitions.--Terms used in this paragraph
which are defined in section 733 shall have the
meanings provided such terms in such section.''.
(f) Regulations and Effective Date.--
(1) Regulations.--The Secretary of Labor shall issue final
regulations not later than 1 year after the date of enactment
of this Act to carry out the amendments made by this section.
(2) Effective date.--The amendments made by this section
shall apply with respect to group health plans for plan years
beginning after the date that is 18 months after the date of
enactment of this Act.
SEC. 102. AMENDMENTS TO THE PUBLIC HEALTH SERVICE ACT.
(a) Amendments Relating to the Group Market.--
(1) No discrimination in group premiums based on genetic
information.--Section 2702(b) of the Public Health Service Act
(42 U.S.C. 300gg-1(b)) is amended--
(A) in paragraph (2)(A), by inserting before the
semicolon the following: ``except as provided in
paragraph (3)''; and
(B) by adding at the end the following:
``(3) No group-based discrimination on basis of genetic
information.--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.''.
(2) Limitations on genetic testing; prohibition on
collection of genetic information; application to all plans.--
Section 2702 of the Public Health Service Act (42 U.S.C. 300gg-
1) is amended by adding at the end the following:
``(c) Genetic Testing.--
``(1) Limitation on requesting or requiring genetic
testing.--A group health plan, and a health insurance issuer
offering health insurance coverage in connection with a group
health plan, shall not request or require an individual or a
family member of such individual to undergo a genetic test.
``(2) Rule of construction.--Paragraph (1) shall not be
construed to limit the authority of a health care professional
who is providing health care services to an individual to
request that such individual undergo a genetic test.
``(3) Rule of construction regarding payment.--
``(A) In general.--Nothing in paragraph (1) shall
be construed to preclude a group health plan, or a
health insurance issuer offering health insurance
coverage in connection with a group health plan, from
obtaining and using the results of a genetic test in
making a determination regarding payment (as such term
is defined for the purposes of applying the regulations
promulgated by the Secretary under part C of title XI
of the Social Security Act and section 264 of the
Health Insurance Portability and Accountability Act of
1996, as may be revised from time to time) consistent
with subsection (a).
``(B) Limitation.--For purposes of subparagraph
(A), a group health plan, or a health insurance issuer
offering health insurance coverage in connection with a
group health plan, may request only the minimum amount
of information necessary to accomplish the intended
purpose.
``(4) Research exception.--Notwithstanding paragraph (1), a
group health plan, or a health insurance issuer offering health
insurance coverage in connection with a group health plan, may
request, but not require, that a participant or beneficiary
undergo a genetic test if each of the following conditions is
met:
``(A) The request is made pursuant to research that
complies with part 46 of title 45, Code of Federal
Regulations, or equivalent Federal regulations, and any
applicable State or local law or regulations for the
protection of human subjects in research.
``(B) The plan or issuer clearly indicates to each
participant or beneficiary, or in the case of a minor
child, to the legal guardian of such beneficiary, to
whom the request is made that--
``(i) compliance with the request is
voluntary; and
``(ii) non-compliance will have no effect
on enrollment status or premium or contribution
amounts.
``(C) No genetic information collected or acquired
under this paragraph shall be used for underwriting
purposes.
``(D) The plan or issuer notifies the Secretary in
writing that the plan or issuer is conducting
activities pursuant to the exception provided for under
this paragraph, including a description of the
activities conducted.
``(E) The plan or issuer complies with such other
conditions as the Secretary may by regulation require
for activities conducted under this paragraph.
``(d) Prohibition on Collection of Genetic Information.--
``(1) In general.--A group health plan, and a health
insurance issuer offering health insurance coverage in
connection with a group health plan, shall not request,
require, or purchase genetic information for underwriting
purposes (as defined in section 2791).
``(2) Prohibition on collection of genetic information
prior to enrollment.--A group health plan, and a health
insurance issuer offering health insurance coverage in
connection with a group health plan, shall not request,
require, or purchase genetic information with respect to any
individual prior to such individual's enrollment under the plan
or coverage in connection with such enrollment.
``(3) Incidental collection.--If a group health plan, or a
health insurance issuer offering health insurance coverage in
connection with a group health plan, obtains genetic
information incidental to the requesting, requiring, or
purchasing of other information concerning any individual, such
request, requirement, or purchase shall not be considered a
violation of paragraph (2) if such request, requirement, or
purchase is not in violation of paragraph (1).
``(e) Application to All Plans.--The provisions of subsections
(a)(1)(F), (b)(3), (c) , and (d) and subsection (b)(1) and section 2701
with respect to genetic information, shall apply to group health plans
and health insurance issuers without regard to section 2721(a).''.
(3) Application to genetic information of a fetus or
embryo.--Such section is further amended by adding at the end
the following:
``(f) Genetic Information of a Fetus or Embryo.--Any reference in
this part to genetic information concerning an individual or family
member of an individual shall--
``(1) with respect to such an individual or family member
of an individual who is a pregnant woman, include genetic
information of any fetus carried by such pregnant woman; and
``(2) with respect to an individual or family member
utilizing an assisted reproductive technology, include genetic
information of any embryo legally held by the individual or
family member.''.
(4) Definitions.--Section 2791(d) of the Public Health
Service Act (42 U.S.C. 300gg-91(d)) is amended by adding at the
end the following:
``(15) Family member.--The term `family member' means, with
respect to any individual--
``(A) a dependent (as such term is used for
purposes of section 2701(f)(2)) of such individual; and
``(B) any other individual who is a first-degree,
second-degree, third-degree, or fourth-degree relative
of such individual or of an individual described in
subparagraph (A).
``(16) Genetic information.--
``(A) In general.--The term `genetic information'
means, with respect to any individual, information
about--
``(i) such individual's genetic tests,
``(ii) the genetic tests of family members
of such individual, and
``(iii) subject to subparagraph (D), the
manifestation of a disease or disorder in
family members of such individual.
``(B) Inclusion of genetic services.--Such term
includes, with respect to any 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.
``(C) Exclusions.--The term `genetic information'
shall not include information about the sex or age of
any individual.
``(D) Application to family members covered under
same plan.--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.
``(17) Genetic test.--
``(A) In general.--The term `genetic test' means an
analysis of human DNA, RNA, chromosomes, proteins, or
metabolites, that detects genotypes, mutations, or
chromosomal changes.
``(B) Exceptions.--The term `genetic test' does not
mean--
``(i) an analysis of proteins or
metabolites that does not detect genotypes,
mutations, or chromosomal changes; or
``(ii) an analysis of proteins or
metabolites that is directly related to a
manifested disease, disorder, or pathological
condition that could reasonably be detected by
a health care professional with appropriate
training and expertise in the field of medicine
involved.
``(18) Genetic services.--The term `genetic services'
means--
``(A) a genetic test;
``(B) genetic counseling (including obtaining,
interpreting, or assessing genetic information); or
``(C) genetic education.
``(19) Underwriting purposes.--The term `underwriting
purposes' means, with respect to any group health plan, or
health insurance coverage offered in connection with a group
health plan--
``(A) rules for, or determination of, eligibility
(including enrollment and continued eligibility) for
benefits under the plan or coverage;
``(B) the computation of premium or contribution
amounts under the plan or coverage;
``(C) the application of any pre-existing condition
exclusion under the plan or coverage; and
``(D) other activities related to the creation,
renewal, or replacement of a contract of health
insurance or health benefits.''.
(5) Remedies and enforcement.--Section 2722(b) of the
Public Health Service Act (42 U.S.C. 300gg-22(b)) is amended by
adding at the end the following:
``(3) Enforcement authority relating to genetic
discrimination.--
``(A) General rule.--In the cases described in
paragraph (1), notwithstanding the provisions of
paragraph (2)(C), the succeeding subparagraphs of this
paragraph shall apply with respect to an action under
this subsection by the Secretary with respect to any
failure of a health insurance issuer in connection with
a group health plan, to meet the requirements of
subsection (a)(1)(F), (b)(3), (c), or (d) of section
2702 or section 2701 or 2702(b)(1) with respect to
genetic information in connection with the plan.
``(B) Amount.--
``(i) In general.--The amount of the
penalty imposed under this paragraph shall be
$100 for each day in the noncompliance period
with respect to each participant or beneficiary
to whom such failure relates.
``(ii) Noncompliance period.--For purposes
of this paragraph, the term `noncompliance
period' means, with respect to any failure, the
period--
``(I) beginning on the date such
failure first occurs; and
``(II) ending on the date the
failure is corrected.
``(C) Minimum penalties where failure discovered.--
Notwithstanding clauses (i) and (ii) of subparagraph
(D):
``(i) In general.--In the case of 1 or more
failures with respect to an individual--
``(I) which are not corrected
before the date on which the plan
receives a notice from the Secretary of
such violation; and
``(II) which occurred or continued
during the period involved;
the amount of penalty imposed by subparagraph
(A) by reason of such failures with respect to
such individual shall not be less than $2,500.
``(ii) Higher minimum penalty where
violations are more than de minimis.--To the
extent violations for which any person is
liable under this paragraph for any year are
more than de minimis, clause (i) shall be
applied by substituting `$15,000' for `$2,500'
with respect to such person.
``(D) Limitations.--
``(i) Penalty not to apply where failure
not discovered exercising reasonable
diligence.--No penalty shall be imposed by
subparagraph (A) on any failure during any
period for which it is established to the
satisfaction of the Secretary that the person
otherwise liable for such penalty did not know,
and exercising reasonable diligence would not
have known, that such failure existed.
``(ii) Penalty not to apply to failures
corrected within certain periods.--No penalty
shall be imposed by subparagraph (A) on any
failure if--
``(I) such failure was due to
reasonable cause and not to willful
neglect; and
``(II) such failure is corrected
during the 30-day period beginning on
the first date the person otherwise
liable for such penalty knew, or
exercising reasonable diligence would
have known, that such failure existed.
``(iii) Overall limitation for
unintentional failures.--In the case of
failures which are due to reasonable cause and
not to willful neglect, the penalty imposed by
subparagraph (A) for failures shall not exceed
the amount equal to the lesser of--
``(I) 10 percent of the aggregate
amount paid or incurred by the employer
(or predecessor employer) during the
preceding taxable year for group health
plans; or
``(II) $500,000.
``(E) Waiver by secretary.--In the case of a
failure which is due to reasonable cause and not to
willful neglect, the Secretary may waive part or all of
the penalty imposed by subparagraph (A) to the extent
that the payment of such penalty would be excessive
relative to the failure involved.''.
(b) Amendment Relating to the Individual Market.--
(1) In general.--The first subpart 3 of part B of title
XXVII of the Public Health Service Act (42 U.S.C. 300gg-51 et
seq.) (relating to other requirements) is amended--
(A) by redesignating such subpart as subpart 2; and
(B) by adding at the end the following:
``SEC. 2753. PROHIBITION OF HEALTH DISCRIMINATION ON THE BASIS OF
GENETIC INFORMATION.
``(a) Prohibition on Genetic Information as a Condition of
Eligibility.--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.
``(b) Prohibition on Genetic Information in Setting Premium
Rates.--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.
``(c) Prohibition on Genetic Information as Preexisting
Condition.--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.
``(d) Genetic Testing.--
``(1) Limitation on requesting or requiring genetic
testing.--A health insurance issuer offering health insurance
coverage in the individual market shall not request or require
an individual or a family member of such individual to undergo
a genetic test.
``(2) Rule of construction.--Paragraph (1) shall not be
construed to limit the authority of a health care professional
who is providing health care services to an individual to
request that such individual undergo a genetic test.
``(3) Rule of construction regarding payment.--
``(A) In general.--Nothing in paragraph (1) shall
be construed to preclude a health insurance issuer
offering health insurance coverage in the individual
market from obtaining and using the results of a
genetic test in making a determination regarding
payment (as such term is defined for the purposes of
applying the regulations promulgated by the Secretary
under part C of title XI of the Social Security Act and
section 264 of the Health Insurance Portability and
Accountability Act of 1996, as may be revised from time
to time) consistent with subsections (a) and (c).
``(B) Limitation.--For purposes of subparagraph
(A), a health insurance issuer offering health
insurance coverage in the individual market may request
only the minimum amount of information necessary to
accomplish the intended purpose.
``(4) Research exception.--Notwithstanding paragraph (1), a
health insurance issuer offering health insurance coverage in
the individual market may request, but not require, that an
individual or a family member of such individual undergo a
genetic test if each of the following conditions is met:
``(A) The request is made pursuant to research that
complies with part 46 of title 45, Code of Federal
Regulations, or equivalent Federal regulations, and any
applicable State or local law or regulations for the
protection of human subjects in research.
``(B) The issuer clearly indicates to each
individual, or in the case of a minor child, to the
legal guardian of such child, to whom the request is
made that--
``(i) compliance with the request is
voluntary; and
``(ii) non-compliance will have no effect
on enrollment status or premium or contribution
amounts.
``(C) No genetic information collected or acquired
under this paragraph shall be used for underwriting
purposes.
``(D) The issuer notifies the Secretary in writing
that the issuer is conducting activities pursuant to
the exception provided for under this paragraph,
including a description of the activities conducted.
``(E) The issuer complies with such other
conditions as the Secretary may by regulation require
for activities conducted under this paragraph.
``(e) Prohibition on Collection of Genetic Information.--
``(1) In general.--A health insurance issuer offering
health insurance coverage in the individual market shall not
request, require, or purchase genetic information for
underwriting purposes (as defined in section 2791).
``(2) Prohibition on collection of genetic information
prior to enrollment.--A health insurance issuer offering health
insurance coverage in the individual market shall not request,
require, or purchase genetic information with respect to any
individual prior to such individual's enrollment under the plan
in connection with such enrollment.
``(3) Incidental collection.--If a health insurance issuer
offering health insurance coverage in the individual market
obtains genetic information incidental to the requesting,
requiring, or purchasing of other information concerning any
individual, such request, requirement, or purchase shall not be
considered a violation of paragraph (2) if such request,
requirement, or purchase is not in violation of paragraph (1).
``(f) Genetic Information of a Fetus or Embryo.--Any reference in
this part to genetic information concerning an individual or family
member of an individual shall--
``(1) with respect to such an individual or family member
of an individual who is a pregnant woman, include genetic
information of any fetus carried by such pregnant woman; and
``(2) with respect to an individual or family member
utilizing an assisted reproductive technology, include genetic
information of any embryo legally held by the individual or
family member.''.
(2) Remedies and enforcement.--Section 2761(b) of the
Public Health Service Act (42 U.S.C. 300gg-61(b)) is amended to
read as follows:
``(b) Secretarial Enforcement Authority.--The Secretary shall have
the same authority in relation to enforcement of the provisions of this
part with respect to issuers of health insurance coverage in the
individual market in a State as the Secretary has under section
2722(b)(2), and section 2722(b)(3) with respect to violations of
genetic nondiscrimination provisions, in relation to the enforcement of
the provisions of part A with respect to issuers of health insurance
coverage in the small group market in the State.''.
(c) Elimination of Option of Non-Federal Governmental Plans To Be
Excepted From Requirements Concerning Genetic Information.--Section
2721(b)(2) of the Public Health Service Act (42 U.S.C. 300gg-21(b)(2))
is amended--
(1) in subparagraph (A), by striking ``If the plan
sponsor'' and inserting ``Except as provided in subparagraph
(D), if the plan sponsor''; and
(2) by adding at the end the following:
``(D) Election not applicable to requirements
concerning genetic information.--The election described
in subparagraph (A) shall not be available with respect
to the provisions of subsections (a)(1)(F), (b)(3),
(c), and (d) of section 2702 and the provisions of
sections 2701 and 2702(b) to the extent that such
provisions apply to genetic information.''.
(d) Regulations and Effective Date.--
(1) Regulations.--Not later than 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.
(2) Effective date.--The amendments made by this section
shall apply--
(A) with respect to group health plans, and health
insurance coverage offered in connection with group
health plans, for plan years beginning after the date
that is 18 months after the date of enactment of this
Act; and
(B) with respect to health insurance coverage
offered, sold, issued, renewed, in effect, or operated
in the individual market after the date that is 18
months after the date of enactment of this Act.
SEC. 103. AMENDMENTS TO THE INTERNAL REVENUE CODE OF 1986.
(a) No Discrimination in Group Premiums Based on Genetic
Information.--Subsection (b) of section 9802 of the Internal Revenue
Code of 1986 is amended--
(1) in paragraph (2)(A), by inserting before the semicolon
the following: ``except as provided in paragraph (3)''; and
(2) by adding at the end the following:
``(3) No group-based discrimination on basis of genetic
information.--For purposes of this section, a group health plan
may not adjust premium or contribution amounts for the group
covered under such plan on the basis of genetic information.''.
(b) Limitations on Genetic Testing; Prohibition on Collection of
Genetic Information; Application to All Plans.--Section 9802 of such
Code is amended by redesignating subsection (c) as subsection (f) and
by inserting after subsection (b) the following new subsections:
``(c) Genetic Testing.--
``(1) Limitation on requesting or requiring genetic
testing.--A group health plan may not request or require an
individual or a family member of such individual to undergo a
genetic test.
``(2) Rule of construction.--Paragraph (1) shall not be
construed to limit the authority of a health care professional
who is providing health care services to an individual to
request that such individual undergo a genetic test.
``(3) Rule of construction regarding payment.--
``(A) In general.--Nothing in paragraph (1) shall
be construed to preclude a group health plan from
obtaining and using the results of a genetic test in
making a determination regarding payment (as such term
is defined for the purposes of applying the regulations
promulgated by the Secretary of Health and Human
Services under part C of title XI of the Social
Security Act and section 264 of the Health Insurance
Portability and Accountability Act of 1996, as may be
revised from time to time) consistent with subsection
(a).
``(B) Limitation.--For purposes of subparagraph
(A), a group health plan may request only the minimum
amount of information necessary to accomplish the
intended purpose.
``(4) Research exception.--Notwithstanding paragraph (1), a
group health plan may request, but not require, that a
participant or beneficiary undergo a genetic test if each of
the following conditions is met:
``(A) The request is made pursuant to research that
complies with part 46 of title 45, Code of Federal
Regulations, or equivalent Federal regulations, and any
applicable State or local law or regulations for the
protection of human subjects in research.
``(B) The plan clearly indicates to each
participant or beneficiary, or in the case of a minor
child, to the legal guardian of such beneficiary, to
whom the request is made that--
``(i) compliance with the request is
voluntary; and
``(ii) non-compliance will have no effect
on enrollment status or premium or contribution
amounts.
``(C) No genetic information collected or acquired
under this paragraph shall be used for underwriting
purposes.
``(D) The plan notifies the Secretary in writing
that the plan is conducting activities pursuant to the
exception provided for under this paragraph, including
a description of the activities conducted.
``(E) The plan complies with such other conditions
as the Secretary may by regulation require for
activities conducted under this paragraph.
``(d) Prohibition on Collection of Genetic Information.--
``(1) In general.--A group health plan shall not request,
require, or purchase genetic information for underwriting
purposes (as defined in section 9832).
``(2) Prohibition on collection of genetic information
prior to enrollment.--A group health plan shall not request,
require, or purchase genetic information with respect to any
individual prior to such individual's enrollment under the plan
or in connection with such enrollment.
``(3) Incidental collection.--If a group health plan
obtains genetic information incidental to the requesting,
requiring, or purchasing of other information concerning any
individual, such request, requirement, or purchase shall not be
considered a violation of paragraph (2) if such request,
requirement, or purchase is not in violation of paragraph (1).
``(e) Application to All Plans.--The provisions of subsections
(a)(1)(F), (b)(3), (c), and (d) and subsection (b)(1) and section 9801
with respect to genetic information, shall apply to group health plans
without regard to section 9831(a)(2).''.
(c) Application to Genetic Information of a Fetus or Embryo.--Such
section is further amended by adding at the end the following:
``(f) Genetic Information of a Fetus or Embryo.--Any reference in
this chapter to genetic information concerning an individual or family
member of an individual shall--
``(1) with respect to such an individual or family member
of an individual who is a pregnant woman, include genetic
information of any fetus carried by such pregnant woman; and
``(2) with respect to an individual or family member
utilizing an assisted reproductive technology, include genetic
information of any embryo legally held by the individual or
family member.''.
(d) Definitions.--Subsection (d) of section 9832 of such Code is
amended by adding at the end the following:
``(6) Family member.--The term `family member' means, with
respect to any individual--
``(A) a dependent (as such term is used for
purposes of section 9801(f)(2)) of such individual, and
``(B) any other individual who is a first-degree,
second-degree, third-degree, or fourth-degree relative
of such individual or of an individual described in
subparagraph (A).
``(7) Genetic information.--
``(A) In general.--The term `genetic information'
means, with respect to any individual, information
about--
``(i) such individual's genetic tests,
``(ii) the genetic tests of family members
of such individual, and
``(iii) subject to subparagraph (D), the
manifestation of a disease or disorder in
family members of such individual.
``(B) Inclusion of genetic services.--Such term
includes, with respect to any 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.
``(C) Exclusions.--The term `genetic information'
shall not include information about the sex or age of
any individual.
``(D) Application to family members covered under
same plan.--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.
``(8) Genetic test.--
``(A) In general.--The term `genetic test' means an
analysis of human DNA, RNA, chromosomes, proteins, or
metabolites, that detects genotypes, mutations, or
chromosomal changes.
``(B) Exceptions.--The term `genetic test' does not
mean--
``(i) an analysis of proteins or
metabolites that does not detect genotypes,
mutations, or chromosomal changes, or
``(ii) an analysis of proteins or
metabolites that is directly related to a
manifested disease, disorder, or pathological
condition that could reasonably be detected by
a health care professional with appropriate
training and expertise in the field of medicine
involved.
``(9) Genetic services.--The term `genetic services'
means--
``(A) a genetic test;
``(B) genetic counseling (including obtaining,
interpreting, or assessing genetic information); or
``(C) genetic education.
``(10) Underwriting purposes.--The term `underwriting
purposes' means, with respect to any group health plan ,or
health insurance coverage offered in connection with a group
health plan--
``(A) rules for, or determination of, eligibility
(including enrollment and continued eligibility) for
benefits under the plan or coverage;
``(B) the computation of premium or contribution
amounts under the plan or coverage;
``(C) the application of any pre-existing condition
exclusion under the plan or coverage; and
``(D) other activities related to the creation,
renewal, or replacement of a contract of health
insurance or health benefits.''.
(e) Enforcement.--
(1) In general.--Subchapter C of chapter 100 of the
Internal Revenue Code of 1986 (relating to general provisions)
is amended by adding at the end the following new section:
``SEC. 9834. ENFORCEMENT.
``For the imposition of tax on any failure of a group health plan
to meet the requirements of this chapter, see section 4980D.''.
(2) Conforming amendment.--The table of sections for
subchapter C of chapter 100 of such Code is amended by adding
at the end the following new item:
``Sec. 9834. Enforcement.''.
(f) Regulations and Effective Date.--
(1) Regulations.--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.
(2) Effective date.--The amendments made by this section
shall apply with respect to group health plans for plan years
beginning after the date that is 18 months after the date of
the enactment of this Act.
SEC. 104. AMENDMENTS TO TITLE XVIII OF THE SOCIAL SECURITY ACT RELATING
TO MEDIGAP.
(a) Nondiscrimination.--Section 1882(s)(2) of the Social Security
Act (42 U.S.C. 1395ss(s)(2)) is amended by adding at the end the
following:
``(E) An issuer of a medicare supplemental policy
shall not deny or condition the issuance or
effectiveness of the policy (including the imposition
of any exclusion of benefits under the policy based on
a pre-existing condition) and shall not discriminate in
the pricing of the policy (including the adjustment of
premium rates) of an individual on the basis of the
genetic information with respect to such individual.''.
(b) Limitations on Genetic Testing and Genetic Information.--
(1) In general.--Section 1882 of the Social Security Act
(42 U.S.C. 1395ss) is amended by adding at the end the
following:
``(x) Limitations on Genetic Testing and Information.--
``(1) Genetic testing.--
``(A) Limitation on requesting or requiring genetic
testing.--An issuer of a medicare supplemental policy
shall not request or require an individual or a family
member of such individual to undergo a genetic test.
``(B) Rule of construction.--Subparagraph (A) shall
not be construed to limit the authority of a health
care professional who is providing health care services
to an individual to request that such individual
undergo a genetic test.
``(C) Rule of construction regarding payment.--
``(i) In general.--Nothing in subparagraph
(A) shall be construed to preclude an issuer of
a medicare supplemental policy from obtaining
and using the results of a genetic test in
making a determination regarding payment (as
such term is defined for the purposes of
applying the regulations promulgated by the
Secretary under part C of title XI and section
264 of the Health Insurance Portability and
Accountability Act of 1996, as may be revised
from time to time) consistent with subsection
(s)(2)(E).
``(ii) Limitation.--For purposes of clause
(i), an issuer of a medicare supplemental
policy may request only the minimum amount of
information necessary to accomplish the
intended purpose.
``(D) Research exception.--Notwithstanding
subparagraph (A), an issuer of a medicare supplemental
policy may request, but not require, that an individual
or a family member of such individual undergo a genetic
test if each of the following conditions is met:
``(i) The request is made pursuant to
research that complies with part 46 of title
45, Code of Federal Regulations, or equivalent
Federal regulations, and any applicable State
or local law or regulations for the protection
of human subjects in research.
``(ii) The issuer clearly indicates to each
individual, or in the case of a minor child, to
the legal guardian of such child, to whom the
request is made that--
``(I) compliance with the request
is voluntary; and
``(II) non-compliance will have no
effect on enrollment status or premium
or contribution amounts.
``(iii) No genetic information collected or
acquired under this subparagraph shall be used
for underwriting, determination of eligibility
to enroll or maintain enrollment status,
premium rating, or the creation, renewal, or
replacement of a plan, contract, or coverage
for health insurance or health benefits.
``(iv) The issuer notifies the Secretary in
writing that the issuer is conducting
activities pursuant to the exception provided
for under this subparagraph, including a
description of the activities conducted.
``(v) The issuer complies with such other
conditions as the Secretary may by regulation
require for activities conducted under this
subparagraph.
``(2) Prohibition on collection of genetic information.--
``(A) In general.--An issuer of a medicare
supplemental policy shall not request, require, or
purchase genetic information for underwriting purposes
(as defined in paragraph (3)).
``(B) Prohibition on collection of genetic
information prior to enrollment.--An issuer of a
medicare supplemental policy shall not request,
require, or purchase genetic information with respect
to any individual prior to such individual's enrollment
under the policy in connection with such enrollment.
``(C) Incidental collection.--If an issuer of a
medicare supplemental policy obtains genetic
information incidental to the requesting, requiring, or
purchasing of other information concerning any
individual, such request, requirement, or purchase
shall not be considered a violation of subparagraph (B)
if such request, requirement, or purchase is not in
violation of subparagraph (A).
``(3) Definitions.--In this subsection:
``(A) Family member.--The term `family member'
means with respect to an individual, any other
individual who is a first-degree, second-degree, third-
degree, or fourth-degree relative of such individual.
``(B) Genetic information.--
``(i) In general.--The term `genetic
information' means, with respect to any
individual, information about--
``(I) such individual's genetic
tests,
``(II) the genetic tests of family
members of such individual, and
``(III) subject to clause (iv), the
manifestation of a disease or disorder
in family members of such individual.
``(ii) Inclusion of genetic services.--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.
``(iii) Exclusions.--The term `genetic
information' shall not include information
about the sex or age of any individual.
``(C) Genetic test.--
``(i) In general.--The term `genetic test'
means an analysis of human DNA, RNA,
chromosomes, proteins, or metabolites, that
detects genotypes, mutations, or chromosomal
changes.
``(ii) Exceptions.--The term `genetic test'
does not mean--
``(I) an analysis of proteins or
metabolites that does not detect
genotypes, mutations, or chromosomal
changes; or
``(II) an analysis of proteins or
metabolites that is directly related to
a manifested disease, disorder, or
pathological condition that could
reasonably be detected by a health care
professional with appropriate training
and expertise in the field of medicine
involved.
``(D) Genetic services.--The term `genetic
services' means--
``(i) a genetic test;
``(ii) genetic counseling (including
obtaining, interpreting, or assessing genetic
information); or
``(iii) genetic education.
``(E) Underwriting purposes.--The term
`underwriting purposes' means, with respect to a
medicare supplemental policy--
``(i) rules for, or determination of,
eligibility (including enrollment and continued
eligibility) for benefits under the policy;
``(ii) the computation of premium or
contribution amounts under the policy;
``(iii) the application of any pre-existing
condition exclusion under the policy; and
``(iv) other activities related to the
creation, renewal, or replacement of a contract
of health insurance or health benefits.
``(F) Issuer of a medicare supplemental policy.--
The term `issuer of a medicare supplemental policy'
includes a third-party administrator or other person
acting for or on behalf of such issuer.''.
(2) Application to genetic information of a fetus or
embryo.--Section 1882(x) of such Act, as added by paragraph
(1), is further amended by adding at the end the following:
``(4) Genetic information of a fetus or embryo.--Any
reference in this section to genetic information concerning an
individual or family member of an individual shall--
``(A) with respect to such an individual or family
member of an individual who is a pregnant woman,
include genetic information of any fetus carried by
such pregnant woman; and
``(B) with respect to an individual or family
member utilizing an assisted reproductive technology,
include genetic information of any embryo legally held
by the individual or family member.''.
(3) Conforming amendment.--Section 1882(o) of the Social
Security Act (42 U.S.C. 1395ss(o)) is amended by adding at the
end the following:
``(4) The issuer of the medicare supplemental policy
complies with subsection (s)(2)(E) and subsection (x).''.
(c) Effective Date.--The amendments made by this section shall
apply with respect to an issuer of a medicare supplemental policy for
policy years beginning on or after the date that is 18 months after the
date of enactment of this Act.
(d) Transition Provisions.--
(1) In general.--If the Secretary of Health and Human
Services identifies a State as requiring a change to its
statutes or regulations to conform its regulatory program to
the changes made by this section, the State regulatory program
shall not be considered to be out of compliance with the
requirements of section 1882 of the Social Security Act due
solely to failure to make such change until the date specified
in paragraph (4).
(2) NAIC standards.--If, not later than June 30, 2008, the
National Association of Insurance Commissioners (in this
subsection referred to as the ``NAIC'') modifies its NAIC Model
Regulation relating to section 1882 of the Social Security Act
(referred to in such section as the 1991 NAIC Model Regulation,
as subsequently modified) to conform to the amendments made by
this section, such revised regulation incorporating the
modifications shall be considered to be the applicable NAIC
model regulation (including the revised NAIC model regulation
and the 1991 NAIC Model Regulation) for the purposes of such
section.
(3) Secretary standards.--If the NAIC does not make the
modifications described in paragraph (2) within the period
specified in such paragraph, the Secretary of Health and Human
Services shall, not later than 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.
(4) Date specified.--
(A) In general.--Subject to subparagraph (B), the
date specified in this paragraph for a State is the
earlier of--
(i) the date the State changes its statutes
or regulations to conform its regulatory
program to the changes made by this section, or
(ii) October 1, 2008.
(B) Additional legislative action required.--In the
case of a State which the Secretary identifies as--
(i) requiring State legislation (other than
legislation appropriating funds) to conform its
regulatory program to the changes made in this
section, but
(ii) having a legislature which is not
scheduled to meet in 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.
SEC. 105. PRIVACY AND CONFIDENTIALITY.
(a) In General.--Part C of title XI of the Social Security Act is
amended by adding at the end the following new section:
``application of hipaa regulations to genetic information
``Sec. 1180. (a) In General.--The Secretary shall revise the HIPAA
privacy regulation (as defined in subsection (b)) so it is consistent
with the following:
``(1) Genetic information shall be treated as health
information described in section 1171(4)(B).
``(2) The use or disclosure by a covered entity that is a
group health plan, health insurance issuer that issues health
insurance coverage, or issuer of a medicare supplemental policy
of protected health information that is genetic information
about an individual for underwriting purposes under the group
health plan, health insurance coverage, or medicare
supplemental policy shall not be a permitted use or disclosure.
``(b) Definitions.--For purposes of this section:
``(1) Genetic information; genetic test; family member.--
The terms `genetic information', `genetic test', and `family
member' have the meanings given such terms in section 2791 of
the Public Health Service Act (42 U.S.C. 300gg-91), as amended
by the Genetic Information Nondiscrimination Act of 2008.
``(2) Group health plan; health insurance coverage;
medicare supplemental policy.--The terms `group health plan'
and `health insurance coverage' have the meanings given such
terms under section 2791 of the Public Health Service Act (42
U.S.C. 300gg-91), and the term `medicare supplemental policy'
has the meaning given such term in section 1882(g).
``(3) HIPAA privacy regulation.--The term `HIPAA privacy
regulation' means the regulations promulgated by the Secretary
under this part and section 264 of the Health Insurance
Portability and Accountability Act of 1996 (42 U.S.C. 1320d-2
note).
``(4) Underwriting purposes.--The term `underwriting
purposes' means, with respect to a group health plan, health
insurance coverage, or a medicare supplemental policy--
``(A) rules for eligibility (including enrollment
and continued eligibility) for, or determination of,
benefits under the plan, coverage, or policy;
``(B) the computation of premium or contribution
amounts under the plan, coverage, or policy;
``(C) the application of any pre-existing condition
exclusion under the plan, coverage, or policy; and
``(D) other activities related to the creation,
renewal, or replacement of a contract of health
insurance or health benefits.
``(c) Procedure.--The revisions under subsection (a) shall be made
by notice in the Federal Register published not later than 60 days
after the date of the enactment of this section and shall be effective
upon publication, without opportunity for any prior public comment, but
may be revised, consistent with this section, after opportunity for
public comment.
``(d) Enforcement.--In addition to any other sanctions or remedies
that may be available under law, a covered entity that is a group
health plan, health insurance issuer, or issuer of a medicare
supplemental policy and that violates the HIPAA privacy regulation (as
revised under subsection (a) or otherwise) with respect to the use or
disclosure of genetic information shall be subject to the penalties
described in sections 1176 and 1177 in the same manner and to the same
extent that such penalties apply to violations of this part.''.
(b) Regulations; Effective Date.--
(1) Regulations.--Not later than 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.
(2) Effective date.--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.
SEC. 106. ASSURING COORDINATION.
Except as provided in section 105(b)(1), the Secretary of Health
and Human Services, the Secretary of Labor, and the Secretary of the
Treasury shall ensure, through the execution of an interagency
memorandum of understanding among such Secretaries, that--
(1) regulations, rulings, and interpretations issued by
such Secretaries relating to the same matter over which two or
more such Secretaries have responsibility under this title (and
the amendments made by this title) are administered so as to
have the same effect at all times; and
(2) coordination of policies relating to enforcing the same
requirements through such Secretaries in order to have a
coordinated enforcement strategy that avoids duplication of
enforcement efforts and assigns priorities in enforcement.
TITLE II--PROHIBITING EMPLOYMENT DISCRIMINATION ON THE BASIS OF GENETIC
INFORMATION
SEC. 201. DEFINITIONS.
In this title:
(1) Commission.--The term ``Commission'' means the Equal
Employment Opportunity Commission as created by section 705 of
the Civil Rights Act of 1964 (42 U.S.C. 2000e-4).
(2) Employee; employer; employment agency; labor
organization; member.--
(A) In general.--The term ``employee'' means--
(i) an employee (including an applicant),
as defined in section 701(f) of the Civil
Rights Act of 1964 (42 U.S.C. 2000e(f));
(ii) a State employee (including an
applicant) described in section 304(a) of the
Government Employee Rights Act of 1991 (42
U.S.C. 2000e-16c(a));
(iii) a covered employee (including an
applicant), as defined in section 101 of the
Congressional Accountability Act of 1995 (2
U.S.C. 1301);
(iv) a covered employee (including an
applicant), as defined in section 411(c) of
title 3, United States Code; or
(v) an employee or applicant to which
section 717(a) of the Civil Rights Act of 1964
(42 U.S.C. 2000e-16(a)) applies.
(B) Employer.--The term ``employer'' means--
(i) an employer (as defined in section
701(b) of the Civil Rights Act of 1964 (42
U.S.C. 2000e(b)));
(ii) an entity employing a State employee
described in section 304(a) of the Government
Employee Rights Act of 1991;
(iii) an employing office, as defined in
section 101 of the Congressional Accountability
Act of 1995;
(iv) an employing office, as defined in
section 411(c) of title 3, United States Code;
or
(v) an entity to which section 717(a) of
the Civil Rights Act of 1964 applies.
(C) Employment agency; labor organization.--The
terms ``employment agency'' and ``labor organization''
have the meanings given the terms in section 701 of the
Civil Rights Act of 1964 (42 U.S.C. 2000e).
(D) Member.--The term ``member'', with respect to a
labor organization, includes an applicant for
membership in a labor organization.
(3) Family member.--The term ``family member'' means, with
respect to an individual--
(A) a dependent (as such term is used for purposes
of section 701(f)(2) of the Employee Retirement Income
Security Act of 1974) of such individual, and
(B) any other individual who is a first-degree,
second-degree, third-degree, or fourth-degree relative
of such individual or of an individual described in
subparagraph (A).
(4) Genetic information.--
(A) In general.--The term ``genetic information''
means, with respect to any individual, information
about--
(i) such individual's genetic tests,
(ii) the genetic tests of family members of
such individual, and
(iii) subject to subparagraph (D), the
manifestation of a disease or disorder in
family members of such individual.
(B) Inclusion of genetic services.--Such term
includes, with respect to any 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.
(C) Exclusions.--The term ``genetic information''
shall not include information about the sex or age of
any individual.
(5) Genetic monitoring.--The term ``genetic monitoring''
means the periodic examination of employees to evaluate
acquired modifications to their genetic material, such as
chromosomal damage or evidence of increased occurrence of
mutations, that may have developed in the course of employment
due to exposure to toxic substances in the workplace, in order
to identify, evaluate, and respond to the effects of or control
adverse environmental exposures in the workplace.
(6) Genetic services.--The term ``genetic services''
means--
(A) a genetic test;
(B) genetic counseling (including obtaining,
interpreting, or assessing genetic information); or
(C) genetic education.
(7) Genetic test.--
(A) In general.--The term ``genetic test'' means an
analysis of human DNA, RNA, chromosomes, proteins, or
metabolites, that detects genotypes, mutations, or
chromosomal changes.
(B) Exceptions.--The term ``genetic test'' does not
mean an analysis of proteins or metabolites that does
not detect genotypes, mutations, or chromosomal
changes.
SEC. 202. EMPLOYER PRACTICES.
(a) Discrimination Based on Genetic Information.--It shall be an
unlawful employment practice for an employer--
(1) to fail or refuse to hire, or to discharge, any
employee, or otherwise to discriminate against any employee
with respect to the compensation, terms, conditions, or
privileges of employment of the employee, because of genetic
information with respect to the employee; or
(2) to limit, segregate, or classify the employees of the
employer in any way that would deprive or tend to deprive any
employee of employment opportunities or otherwise adversely
affect the status of the employee as an employee, because of
genetic information with respect to the employee.
(b) Acquisition of Genetic Information.--It shall be an unlawful
employment practice for an employer to request, require, or purchase
genetic information with respect to an employee or a family member of
the employee except--
(1) where an employer inadvertently requests or requires
family medical history of the employee or family member of the
employee;
(2) where--
(A) health or genetic services are offered by the
employer, including such services offered as part of a
bona fide wellness program;
(B) the employee provides prior, knowing,
voluntary, and written authorization;
(C) only the employee (or family member if the
family member is receiving genetic services) and the
licensed health care professional or board certified
genetic counselor involved in providing such services
receive individually identifiable information
concerning the results of such services; and
(D) any individually identifiable genetic
information provided under subparagraph (C) in
connection with the services provided under
subparagraph (A) is only available for purposes of such
services and shall not be disclosed to the employer
except in aggregate terms that do not disclose the
identity of specific employees;
(3) where an employer requests or requires family medical
history from the employee to comply with the certification
provisions of section 103 of the Family and Medical Leave Act
of 1993 (29 U.S.C. 2613) or such requirements under State
family and medical leave laws;
(4) where an employer purchases documents that are
commercially and publicly available (including newspapers,
magazines, periodicals, and books, but not including medical
databases or court records) that include family medical
history;
(5) where the information involved is to be used for
genetic monitoring of the biological effects of toxic
substances in the workplace, but only if--
(A) the employer provides written notice of the
genetic monitoring to the employee;
(B)(i) the employee provides prior, knowing,
voluntary, and written authorization; or
(ii) the genetic monitoring is required by Federal
or State law;
(C) the employee is informed of individual
monitoring results;
(D) the monitoring is in compliance with--
(i) any Federal genetic monitoring
regulations, including any such regulations
that may be promulgated by the Secretary of
Labor pursuant to the Occupational Safety and
Health Act of 1970 (29 U.S.C. 651 et seq.), the
Federal Mine Safety and Health Act of 1977 (30
U.S.C. 801 et seq.), or the Atomic Energy Act
of 1954 (42 U.S.C. 2011 et seq.); or
(ii) State genetic monitoring regulations,
in the case of a State that is implementing
genetic monitoring regulations under the
authority of the Occupational Safety and Health
Act of 1970 (29 U.S.C. 651 et seq.); and
(E) the employer, excluding any licensed health
care professional or board certified genetic counselor
that is involved in the genetic monitoring program,
receives the results of the monitoring only in
aggregate terms that do not disclose the identity of
specific employees; or
(6) where the employer conducts DNA analysis for law
enforcement purposes as a forensic laboratory, includes such
analysis in the Combined DNA Index System pursuant to section
210304 of the Violent Crime Control and Law Enforcement Act of
1994 (42 U.S.C. 14132), and requests or requires genetic
information of such employer's employees, but only to the
extent that such genetic information is used for analysis of
DNA identification markers for quality control to detect sample
contamination.
(c) Preservation of Protections.--In the case of information to
which any of paragraphs (1) through (6) of subsection (b) applies, such
information may not be used in violation of paragraph (1) or (2) of
subsection (a) or treated or disclosed in a manner that violates
section 206.
SEC. 203. EMPLOYMENT AGENCY PRACTICES.
(a) Discrimination Based on Genetic Information.--It shall be an
unlawful employment practice for an employment agency--
(1) to fail or refuse to refer for employment, or otherwise
to discriminate against, any individual because of genetic
information with respect to the individual;
(2) to limit, segregate, or classify individuals or fail or
refuse to refer for employment any individual in any way that
would deprive or tend to deprive any individual of employment
opportunities, or otherwise adversely affect the status of the
individual as an employee, because of genetic information with
respect to the individual; or
(3) to cause or attempt to cause an employer to
discriminate against an individual in violation of this title.
(b) Acquisition of Genetic Information.--It shall be an unlawful
employment practice for an employment agency to request, require, or
purchase genetic information with respect to an individual or a family
member of the individual except--
(1) where an employment agency inadvertently requests or
requires family medical history of the individual or family
member of the individual;
(2) where--
(A) health or genetic services are offered by the
employment agency, including such services offered as
part of a bona fide wellness program;
(B) the individual provides prior, knowing,
voluntary, and written authorization;
(C) only the individual (or family member if the
family member is receiving genetic services) and the
licensed health care professional or board certified
genetic counselor involved in providing such services
receive individually identifiable information
concerning the results of such services; and
(D) any individually identifiable genetic
information provided under subparagraph (C) in
connection with the services provided under
subparagraph (A) is only available for purposes of such
services and shall not be disclosed to the employment
agency except in aggregate terms that do not disclose
the identity of specific individuals;
(3) where an employment agency requests or requires family
medical history from the individual to comply with the
certification provisions of section 103 of the Family and
Medical Leave Act of 1993 (29 U.S.C. 2613) or such requirements
under State family and medical leave laws;
(4) where an employment agency purchases documents that are
commercially and publicly available (including newspapers,
magazines, periodicals, and books, but not including medical
databases or court records) that include family medical
history; or
(5) where the information involved is to be used for
genetic monitoring of the biological effects of toxic
substances in the workplace, but only if--
(A) the employment agency provides written notice
of the genetic monitoring to the individual;
(B)(i) the individual provides prior, knowing,
voluntary, and written authorization; or
(ii) the genetic monitoring is required by Federal
or State law;
(C) the individual is informed of individual
monitoring results;
(D) the monitoring is in compliance with--
(i) any Federal genetic monitoring
regulations, including any such regulations
that may be promulgated by the Secretary of
Labor pursuant to the Occupational Safety and
Health Act of 1970 (29 U.S.C. 651 et seq.), the
Federal Mine Safety and Health Act of 1977 (30
U.S.C. 801 et seq.), or the Atomic Energy Act
of 1954 (42 U.S.C. 2011 et seq.); or
(ii) State genetic monitoring regulations,
in the case of a State that is implementing
genetic monitoring regulations under the
authority of the Occupational Safety and Health
Act of 1970 (29 U.S.C. 651 et seq.); and
(E) the employment agency, excluding any licensed
health care professional or board certified genetic
counselor that is involved in the genetic monitoring
program, receives the results of the monitoring only in
aggregate terms that do not disclose the identity of
specific individuals.
(c) Preservation of Protections.--In the case of information to
which any of paragraphs (1) through (5) of subsection (b) applies, such
information may not be used in violation of paragraph (1), (2), or (3)
of subsection (a) or treated or disclosed in a manner that violates
section 206.
SEC. 204. LABOR ORGANIZATION PRACTICES.
(a) Discrimination Based on Genetic Information.--It shall be an
unlawful employment practice for a labor organization--
(1) to exclude or to expel from the membership of the
organization, or otherwise to discriminate against, any member
because of genetic information with respect to the member;
(2) to limit, segregate, or classify the members of the
organization, or fail or refuse to refer for employment any
member, in any way that would deprive or tend to deprive any
member of employment opportunities, or otherwise adversely
affect the status of the member as an employee, because of
genetic information with respect to the member; or
(3) to cause or attempt to cause an employer to
discriminate against a member in violation of this title.
(b) Acquisition of Genetic Information.--It shall be an unlawful
employment practice for a labor organization to request, require, or
purchase genetic information with respect to a member or a family
member of the member except--
(1) where a labor organization inadvertently requests or
requires family medical history of the member or family member
of the member;
(2) where--
(A) health or genetic services are offered by the
labor organization, including such services offered as
part of a bona fide wellness program;
(B) the member provides prior, knowing, voluntary,
and written authorization;
(C) only the member (or family member if the family
member is receiving genetic services) and the licensed
health care professional or board certified genetic
counselor involved in providing such services receive
individually identifiable information concerning the
results of such services; and
(D) any individually identifiable genetic
information provided under subparagraph (C) in
connection with the services provided under
subparagraph (A) is only available for purposes of such
services and shall not be disclosed to the labor
organization except in aggregate terms that do not
disclose the identity of specific members;
(3) where a labor organization requests or requires family
medical history from the members to comply with the
certification provisions of section 103 of the Family and
Medical Leave Act of 1993 (29 U.S.C. 2613) or such requirements
under State family and medical leave laws;
(4) where a labor organization purchases documents that are
commercially and publicly available (including newspapers,
magazines, periodicals, and books, but not including medical
databases or court records) that include family medical
history; or
(5) where the information involved is to be used for
genetic monitoring of the biological effects of toxic
substances in the workplace, but only if--
(A) the labor organization provides written notice
of the genetic monitoring to the member;
(B)(i) the member provides prior, knowing,
voluntary, and written authorization; or
(ii) the genetic monitoring is required by Federal
or State law;
(C) the member is informed of individual monitoring
results;
(D) the monitoring is in compliance with--
(i) any Federal genetic monitoring
regulations, including any such regulations
that may be promulgated by the Secretary of
Labor pursuant to the Occupational Safety and
Health Act of 1970 (29 U.S.C. 651 et seq.), the
Federal Mine Safety and Health Act of 1977 (30
U.S.C. 801 et seq.), or the Atomic Energy Act
of 1954 (42 U.S.C. 2011 et seq.); or
(ii) State genetic monitoring regulations,
in the case of a State that is implementing
genetic monitoring regulations under the
authority of the Occupational Safety and Health
Act of 1970 (29 U.S.C. 651 et seq.); and
(E) the labor organization, excluding any licensed
health care professional or board certified genetic
counselor that is involved in the genetic monitoring
program, receives the results of the monitoring only in
aggregate terms that do not disclose the identity of
specific members.
(c) Preservation of Protections.--In the case of information to
which any of paragraphs (1) through (5) of subsection (b) applies, such
information may not be used in violation of paragraph (1), (2), or (3)
of subsection (a) or treated or disclosed in a manner that violates
section 206.
SEC. 205. TRAINING PROGRAMS.
(a) Discrimination Based on Genetic Information.--It shall be an
unlawful employment practice for any employer, labor organization, or
joint labor-management committee controlling apprenticeship or other
training or retraining, including on-the-job training programs--
(1) to discriminate against any individual because of
genetic information with respect to the individual in admission
to, or employment in, any program established to provide
apprenticeship or other training or retraining;
(2) to limit, segregate, or classify the applicants for or
participants in such apprenticeship or other training or
retraining, or fail or refuse to refer for employment any
individual, in any way that would deprive or tend to deprive
any individual of employment opportunities, or otherwise
adversely affect the status of the individual as an employee,
because of genetic information with respect to the individual;
or
(3) to cause or attempt to cause an employer to
discriminate against an applicant for or a participant in such
apprenticeship or other training or retraining in violation of
this title.
(b) Acquisition of Genetic Information.--It shall be an unlawful
employment practice for an employer, labor organization, or joint
labor-management committee described in subsection (a) to request,
require, or purchase genetic information with respect to an individual
or a family member of the individual except--
(1) where the employer, labor organization, or joint labor-
management committee inadvertently requests or requires family
medical history of the individual or family member of the
individual;
(2) where--
(A) health or genetic services are offered by the
employer, labor organization, or joint labor-management
committee, including such services offered as part of a
bona fide wellness program;
(B) the individual provides prior, knowing,
voluntary, and written authorization;
(C) only the individual (or family member if the
family member is receiving genetic services) and the
licensed health care professional or board certified
genetic counselor involved in providing such services
receive individually identifiable information
concerning the results of such services; and
(D) any individually identifiable genetic
information provided under subparagraph (C) in
connection with the services provided under
subparagraph (A) is only available for purposes of such
services and shall not be disclosed to the employer,
labor organization, or joint labor-management committee
except in aggregate terms that do not disclose the
identity of specific individuals;
(3) where the employer, labor organization, or joint labor-
management committee requests or requires family medical
history from the individual to comply with the certification
provisions of section 103 of the Family and Medical Leave Act
of 1993 (29 U.S.C. 2613) or such requirements under State
family and medical leave laws;
(4) where the employer, labor organization, or joint labor-
management committee purchases documents that are commercially
and publicly available (including newspapers, magazines,
periodicals, and books, but not including medical databases or
court records) that include family medical history;
(5) where the information involved is to be used for
genetic monitoring of the biological effects of toxic
substances in the workplace, but only if--
(A) the employer, labor organization, or joint
labor-management committee provides written notice of
the genetic monitoring to the individual;
(B)(i) the individual provides prior, knowing,
voluntary, and written authorization; or
(ii) the genetic monitoring is required by Federal
or State law;
(C) the individual is informed of individual
monitoring results;
(D) the monitoring is in compliance with--
(i) any Federal genetic monitoring
regulations, including any such regulations
that may be promulgated by the Secretary of
Labor pursuant to the Occupational Safety and
Health Act of 1970 (29 U.S.C. 651 et seq.), the
Federal Mine Safety and Health Act of 1977 (30
U.S.C. 801 et seq.), or the Atomic Energy Act
of 1954 (42 U.S.C. 2011 et seq.); or
(ii) State genetic monitoring regulations,
in the case of a State that is implementing
genetic monitoring regulations under the
authority of the Occupational Safety and Health
Act of 1970 (29 U.S.C. 651 et seq.); and
(E) the employer, labor organization, or joint
labor-management committee, excluding any licensed
health care professional or board certified genetic
counselor that is involved in the genetic monitoring
program, receives the results of the monitoring only in
aggregate terms that do not disclose the identity of
specific individuals; or
(6) where the employer conducts DNA analysis for law
enforcement purposes as a forensic laboratory, includes such
analysis in the Combined DNA Index System pursuant to section
210304 of the Violent Crime Control and Law Enforcement Act of
1994 (42 U.S.C. 14132), and requests or requires genetic
information of such employer's apprentices or trainees, but
only to the extent that such genetic information is used for
analysis of DNA identification markers for quality control to
detect sample contamination.
(c) Preservation of Protections.--In the case of information to
which any of paragraphs (1) through (6) of subsection (b) applies, such
information may not be used in violation of paragraph (1), (2), or (3)
of subsection (a) or treated or disclosed in a manner that violates
section 206.
SEC. 206. CONFIDENTIALITY OF GENETIC INFORMATION.
(a) Treatment of Information as Part of Confidential Medical
Record.--If an employer, employment agency, labor organization, or
joint labor-management committee possesses genetic information about an
employee or member, such information shall be maintained on separate
forms and in separate medical files and be treated as a confidential
medical record of the employee or member. An employer, employment
agency, labor organization, or joint labor-management committee shall
be considered to be in compliance with the maintenance of information
requirements of this subsection with respect to genetic information
subject to this subsection that is maintained with and treated as a
confidential medical record under section 102(d)(3)(B) of the Americans
With Disabilities Act (42 U.S.C. 12112(d)(3)(B)).
(b) Limitation on Disclosure.--An employer, employment agency,
labor organization, or joint labor-management committee shall not
disclose genetic information concerning an employee or member except--
(1) to the employee or member of a labor organization (or
family member if the family member is receiving the genetic
services) at the written request of the employee or member of
such organization;
(2) to an occupational or other health researcher if the
research is conducted in compliance with the regulations and
protections provided for under part 46 of title 45, Code of
Federal Regulations;
(3) in response to an order of a court, except that--
(A) the employer, employment agency, labor
organization, or joint labor-management committee may
disclose only the genetic information expressly
authorized by such order; and
(B) if the court order was secured without the
knowledge of the employee or member to whom the
information refers, the employer, employment agency,
labor organization, or joint labor-management committee
shall inform the employee or member of the court order
and any genetic information that was disclosed pursuant
to such order;
(4) to government officials who are investigating
compliance with this title if the information is relevant to
the investigation; or
(5) to the extent that such disclosure is made in
connection with the employee's compliance with the
certification provisions of section 103 of the Family and
Medical Leave Act of 1993 (29 U.S.C. 2613) or such requirements
under State family and medical leave laws.
(c) Relationship to HIPAA Regulations.--With respect to the
regulations promulgated by the Secretary of Health and Human Services
under part C of title XI of the Social Security Act (42 U.S.C. 1320d et
seq.) and section 264 of the Health Insurance Portability and
Accountability Act of 1996 (42 U.S.C. 1320d-2 note), this title does
not prohibit a covered entity under such regulations from any use or
disclosure of health information that is authorized for the covered
entity under such regulations. The previous sentence does not affect
the authority of such Secretary to modify such regulations.
SEC. 207. REMEDIES AND ENFORCEMENT.
(a) Employees Covered by Title VII of the Civil Rights Act of
1964.--
(1) In general.--The powers, remedies, and procedures
provided in sections 705, 706, 707, 709, 710, and 711 of the
Civil Rights Act of 1964 (42 U.S.C. 2000e-4 et seq.) to the
Commission, the Attorney General, or any person, alleging a
violation of title VII of that Act (42 U.S.C. 2000e et seq.)
shall be the powers, 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).
(2) Costs and fees.--The powers, remedies, and procedures
provided in subsections (b) and (c) of section 722 of the
Revised Statutes of the United States (42 U.S.C. 1988), shall
be powers, remedies, and procedures this title provides to the
Commission, the Attorney General, or any person, alleging such
a practice.
(3) Damages.--The powers, remedies, and procedures provided
in section 1977A of the Revised Statutes of the United States
(42 U.S.C. 1981a), including the limitations contained in
subsection (b)(3) of such section 1977A, shall be powers,
remedies, and procedures this title provides to the Commission,
the Attorney General, or any person, alleging such a practice
(not an employment practice specifically excluded from coverage
under section 1977A(a)(1) of the Revised Statutes of the United
States).
(b) Employees Covered by Government Employee Rights Act of 1991.--
(1) In general.--The powers, remedies, and procedures
provided in sections 302 and 304 of the Government Employee
Rights Act of 1991 (42 U.S.C. 2000e-16b, 2000e-16c) to the
Commission, or any person, alleging a violation of section
302(a)(1) of that Act (42 U.S.C. 2000e-16b(a)(1)) shall be the
powers, remedies, and procedures this title provides to the
Commission, or any person, respectively, alleging an unlawful
employment practice in violation of this title against an
employee described in section 201(2)(A)(ii), except as provided
in paragraphs (2) and (3).
(2) Costs and fees.--The powers, remedies, and procedures
provided in subsections (b) and (c) of section 722 of the
Revised Statutes of the United States (42 U.S.C. 1988), shall
be powers, remedies, and procedures this title provides to the
Commission, or any person, alleging such a practice.
(3) Damages.--The powers, remedies, and procedures provided
in section 1977A of the Revised Statutes of the United States
(42 U.S.C. 1981a), including the limitations contained in
subsection (b)(3) of such section 1977A, shall be powers,
remedies, and procedures this title provides to the Commission,
or any person, alleging such a practice (not an employment
practice specifically excluded from coverage under section
1977A(a)(1) of the Revised Statutes of the United States).
(c) Employees Covered by Congressional Accountability Act of
1995.--
(1) In general.--The powers, remedies, and procedures
provided in the Congressional Accountability Act of 1995 (2
U.S.C. 1301 et seq.) to the Board (as defined in section 101 of
that Act (2 U.S.C. 1301)), or any person, alleging a violation
of section 201(a)(1) of that Act (42 U.S.C. 1311(a)(1)) shall
be the powers, remedies, and procedures this title provides to
that Board, or any person, alleging an unlawful employment
practice in violation of this title against an employee
described in section 201(2)(A)(iii), except as provided in
paragraphs (2) and (3).
(2) Costs and fees.--The powers, remedies, and procedures
provided in subsections (b) and (c) of section 722 of the
Revised Statutes of the United States (42 U.S.C. 1988), shall
be powers, remedies, and procedures this title provides to that
Board, or any person, alleging such a practice.
(3) Damages.--The powers, remedies, and procedures provided
in section 1977A of the Revised Statutes of the United States
(42 U.S.C. 1981a), including the limitations contained in
subsection (b)(3) of such section 1977A, shall be powers,
remedies, and procedures this title provides to that Board, or
any person, alleging such a practice (not an employment
practice specifically excluded from coverage under section
1977A(a)(1) of the Revised Statutes of the United States).
(4) Other applicable provisions.--With respect to a claim
alleging a practice described in paragraph (1), title III of
the Congressional Accountability Act of 1995 (2 U.S.C. 1381 et
seq.) shall apply in the same manner as such title applies with
respect to a claim alleging a violation of section 201(a)(1) of
such Act (2 U.S.C. 1311(a)(1)).
(d) Employees Covered by Chapter 5 of Title 3, United States
Code.--
(1) In general.--The powers, remedies, and procedures
provided in chapter 5 of title 3, United States Code, to the
President, the Commission, the Merit Systems Protection Board,
or any person, alleging a violation of section 411(a)(1) of
that title, shall be the powers, remedies, and procedures this
title provides to the President, the Commission, such Board, or
any person, respectively, alleging an unlawful employment
practice in violation of this title against an employee
described in section 201(2)(A)(iv), except as provided in
paragraphs (2) and (3).
(2) Costs and fees.--The powers, remedies, and procedures
provided in subsections (b) and (c) of section 722 of the
Revised Statutes of the United States (42 U.S.C. 1988), shall
be powers, remedies, and procedures this title provides to the
President, the Commission, such Board, or any person, alleging
such a practice.
(3) Damages.--The powers, remedies, and procedures provided
in section 1977A of the Revised Statutes of the United States
(42 U.S.C. 1981a), including the limitations contained in
subsection (b)(3) of such section 1977A, shall be powers,
remedies, and procedures this title provides to the President,
the Commission, such Board, or any person, alleging such a
practice (not an employment practice specifically excluded from
coverage under section 1977A(a)(1) of the Revised Statutes of
the United States).
(e) Employees Covered by Section 717 of the Civil Rights Act of
1964.--
(1) In general.--The powers, remedies, and procedures
provided in section 717 of the Civil Rights Act of 1964 (42
U.S.C. 2000e-16) to the Commission, the Attorney General, the
Librarian of Congress, or any person, alleging a violation of
that section shall be the powers, remedies, and procedures this
title provides to the Commission, the Attorney General, the
Librarian of Congress, or any person, respectively, alleging an
unlawful employment practice in violation of this title against
an employee or applicant described in section 201(2)(A)(v),
except as provided in paragraphs (2) and (3).
(2) Costs and fees.--The powers, remedies, and procedures
provided in subsections (b) and (c) of section 722 of the
Revised Statutes of the United States (42 U.S.C. 1988), shall
be powers, remedies, and procedures this title provides to the
Commission, the Attorney General, the Librarian of Congress, or
any person, alleging such a practice.
(3) Damages.--The powers, remedies, and procedures provided
in section 1977A of the Revised Statutes of the United States
(42 U.S.C. 1981a), including the limitations contained in
subsection (b)(3) of such section 1977A, shall be powers,
remedies, and procedures this title provides to the Commission,
the Attorney General, the Librarian of Congress, or any person,
alleging such a practice (not an employment practice
specifically excluded from coverage under section 1977A(a)(1)
of the Revised Statutes of the United States).
(f) Definition.--In this section, the term ``Commission'' means the
Equal Employment Opportunity Commission.
SEC. 208. DISPARATE IMPACT.
(a) General Rule.--Notwithstanding any other provision of this
division, ``disparate impact'', as that term is used in section 703(k)
of the Civil Rights Act of 1964 (42 U.S.C. 2000e-2(k)), on the basis of
genetic information does not establish a cause of action under this
division.
(b) Commission.--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 ``Commission'') to review the developing science of
genetics and to make recommendations to Congress regarding whether to
provide a disparate impact cause of action under this division.
(c) Membership.--
(1) In general.--The Commission shall be composed of eight
members, of which--
(A) one member shall be appointed by the Majority
Leader of the Senate;
(B) one member shall be appointed by the Minority
Leader of the Senate;
(C) one member shall be appointed by the Chairman
of the Committee on Health, Education, Labor, and
Pensions of the Senate;
(D) one member shall be appointed by the ranking
minority member of the Committee on Health, Education,
Labor, and Pensions of the Senate;
(E) one member shall be appointed by the Speaker of
the House of Representatives;
(F) one member shall be appointed by the Minority
Leader of the House of Representatives;
(G) one member shall be appointed by the Chairman
of the Committee on Education and Labor of the House of
Representatives; and
(H) one member shall be appointed by the ranking
minority member of the Committee on Education and Labor
of the House of Representatives.
(2) Compensation and expenses.--The members of the
Commission shall not receive compensation for the performance
of services for the Commission, but shall be allowed travel
expenses, including per diem in lieu of subsistence, at rates
authorized for employees of agencies under subchapter I of
chapter 57 of title 5, United States Code, while away from
their homes or regular places of business in the performance of
services for the Commission.
(d) Administrative Provisions.--
(1) Location.--The Commission shall be located in a
facility maintained by the Equal Employment Opportunity
Commission.
(2) Detail of government employees.--Any Federal Government
employee may be detailed to the Commission without
reimbursement, and such detail shall be without interruption or
loss of civil service status or privilege.
(3) Information from federal agencies.--The Commission may
secure directly from any Federal department or agency such
information as the Commission considers necessary to carry out
the provisions of this section. Upon request of the Commission,
the head of such department or agency shall furnish such
information to the Commission.
(4) Hearings.--The Commission may hold such hearings, sit
and act at such times and places, take such testimony, and
receive such evidence as the Commission considers advisable to
carry out the objectives of this section, except that, to the
extent possible, the Commission shall use existing data and
research.
(5) Postal services.--The Commission may use the United
States mails in the same manner and under the same conditions
as other departments and agencies of the Federal Government.
(e) Report.--Not later than 1 year after all of the members are
appointed to the Commission under subsection (c)(1), the Commission
shall submit to Congress a report that summarizes the findings of the
Commission and makes such recommendations for legislation as are
consistent with this division.
(f) Authorization of Appropriations.--There are authorized to be
appropriated to the Equal Employment Opportunity Commission such sums
as may be necessary to carry out this section.
SEC. 209. CONSTRUCTION.
(a) In General.--Nothing in this title shall be construed to--
(1) limit the rights or protections of an individual under
any other Federal or State statute that provides equal or
greater protection to an individual than the rights or
protections provided for under this title, including the
protections of an individual under the Americans with
Disabilities Act of 1990 (42 U.S.C. 12101 et seq.) (including
coverage afforded to individuals under section 102 of such Act
(42 U.S.C. 12112)), or under the Rehabilitation Act of 1973 (29
U.S.C. 701 et seq.);
(2)(A) limit the rights or protections of an individual to
bring an action under this title against an employer,
employment agency, labor organization, or joint labor-
management committee for a violation of this title; or
(B) 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;
(3) apply to the Armed Forces Repository of Specimen
Samples for the Identification of Remains;
(4) limit or expand the protections, rights, or obligations
of employees or employers under applicable workers'
compensation laws;
(5) limit the authority of a Federal department or agency
to conduct or sponsor occupational or other health research
that is conducted in compliance with the regulations contained
in part 46 of title 45, Code of Federal Regulations (or any
corresponding or similar regulation or rule);
(6) limit the statutory or regulatory authority of the
Occupational Safety and Health Administration or the Mine
Safety and Health Administration to promulgate or enforce
workplace safety and health laws and regulations; or
(7) require any specific benefit for an employee or member
or a family member of an employee or member under any group
health plan or health insurance issuer offering group health
insurance coverage in connection with a group health plan.
(b) Genetic Information of a Fetus or Embryo.--Any reference in
this title to genetic information concerning an individual or family
member of an individual shall--
(1) with respect to such an individual or family member of
an individual who is a pregnant woman, include genetic
information of any fetus carried by such pregnant woman; and
(2) with respect to an individual or family member
utilizing an assisted reproductive technology, include genetic
information of any embryo legally held by the individual or
family member.
SEC. 210. MEDICAL INFORMATION THAT IS NOT GENETIC INFORMATION.
An employer, employment agency, labor organization, or joint labor-
management committee shall not be considered to be in violation of this
title based on the use, acquisition, or disclosure of medical
information that is not genetic information about a manifested disease,
disorder, or pathological condition of an employee or member, including
a manifested disease, disorder, or pathological condition that has or
may have a genetic basis.
SEC. 211. REGULATIONS.
Not later than 1 year after the date of enactment of this title,
the Commission shall issue final regulations to carry out this title.
SEC. 212. AUTHORIZATION OF APPROPRIATIONS.
There are authorized to be appropriated such sums as may be
necessary to carry out this title (except for section 208).
SEC. 213. EFFECTIVE DATE.
This title takes effect on the date that is 18 months after the
date of enactment of this Act.
TITLE III--MISCELLANEOUS PROVISIONS
SEC. 301. GUARANTEE AGENCY COLLECTION RETENTION.
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:
``(ii) 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 `22 percent' for `23 percent'.''.
SEC. 302. SEVERABILITY.
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.
Passed the House of Representatives March 5, 2008.
Attest:
LORRAINE C. MILLER,
Clerk.
Calendar No. 610
110th CONGRESS
2d Session
H. R. 1424
_______________________________________________________________________
AN ACT
To amend section 712 of the Employee Retirement Income Security Act of
1974, section 2705 of the Public Health Service Act, section 9812 of
the Internal Revenue Code of 1986 to require equity in the provision of
mental health and substance-related disorder benefits under group
health plans, to prohibit discrimination on the basis of genetic
information with respect to health insurance and employment, and for
other purposes.
_______________________________________________________________________
March 7, 2008
Read the second time and placed on the calendar