[House Report 110-28]
[From the U.S. Government Publishing Office]
110th Congress Rept. 110-28
HOUSE OF REPRESENTATIVES
1st Session Part 3
======================================================================
GENETIC INFORMATION NONDISCRIMINATION ACT OF 2007
_______
March 29, 2007.--Committed to the Committee of the Whole House on the
State of the Union and ordered to be printed
_______
Mr. Dingell, from the Committee on Energy and Commerce, submitted the
following
R E P O R T
together with
ADDITIONAL VIEWS
[To accompany H.R. 493]
The Committee on Energy and Commerce, to whom was referred
the bill (H.R. 493) to prohibit discrimination on the basis of
genetic information with respect to health insurance and
employment, having considered the same, report favorably
thereon with an amendment and recommend that the bill as
amended do pass.
CONTENTS
Page
Amendment........................................................ 2
Purpose and Summary.............................................. 26
Background and Need for Legislation.............................. 26
Hearings......................................................... 30
Committee Consideration.......................................... 31
Committee Votes.................................................. 31
Committee Oversight Findings..................................... 31
Statement of General Performance Goals and Objectives............ 31
New Budget Authority, Entitlement Authority, and Tax Expenditures 31
Earmarks and Tax and Tariff Benefits............................. 31
Committee Cost Estimate.......................................... 31
Congressional Budget Office Estimate............................. 32
Federal Mandates Statement....................................... 32
Advisory Committee Statement..................................... 32
Constitutional Authority Statement............................... 32
Applicability to Legislative Branch.............................. 32
Section-by-Section Analysis of the Legislation................... 32
Changes in Existing Law Made by the Bill, as Reported............ 47
Additional Views................................................. 64
Amendment
The amendment is as follows:
Strike all after the enacting clause and insert the
following:
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``Genetic Information
Nondiscrimination Act of 2007''.
(b) Table of Contents.--The table of contents of this Act is as
follows:
Sec. 1. Short title; table of contents.
Sec. 2. Findings.
TITLE I--GENETIC NONDISCRIMINATION IN HEALTH INSURANCE
Sec. 101. Amendments to Employee Retirement Income Security Act of
1974.
Sec. 102. Amendments to the Public Health Service Act.
Sec. 103. Amendments to title XVIII of the Social Security Act relating
to medigap.
Sec. 104. Privacy and confidentiality.
Sec. 104A. Privacy and confidentiality.
Sec. 105. Assuring coordination.
Sec. 106. Relationship to title II with respect to enforcement.
Sec. 107. Regulations; effective date.
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 PROVISION
Sec. 301. Severability.
SEC. 2. FINDINGS.
Congress makes the following findings:
(1) Deciphering the sequence of the human genome and other
advances in genetics open major new opportunities for medical
progress. New knowledge about the genetic basis of illness will
allow for earlier detection of illnesses, often before symptoms
have begun. Genetic testing can allow individuals to take steps
to reduce the likelihood that they will contract a particular
disorder. New knowledge about genetics may allow for the
development of better therapies that are more effective against
disease or have fewer side effects than current treatments.
These advances give rise to the potential misuse of genetic
information to discriminate in health insurance and employment.
(2) The early science of genetics became the basis of State
laws that provided for the sterilization of persons having
presumed genetic ``defects'' such as mental retardation, mental
disease, epilepsy, blindness, and hearing loss, among other
conditions. The first sterilization law was enacted in the
State of Indiana in 1907. By 1981, a majority of States adopted
sterilization laws to ``correct'' apparent genetic traits or
tendencies. Many of these State laws have since been repealed,
and many have been modified to include essential constitutional
requirements of due process and equal protection. However, the
current explosion in the science of genetics, and the history
of sterilization laws by the States based on early genetic
science, compels Congressional action in this area.
(3) Although genes are facially neutral markers, many genetic
conditions and disorders are associated with particular racial
and ethnic groups and gender. Because some genetic traits are
most prevalent in particular groups, members of a particular
group may be stigmatized or discriminated against as a result
of that genetic information. This form of discrimination was
evident in the 1970s, which saw the advent of programs to
screen and identify carriers of sickle cell anemia, a disease
which afflicts African-Americans. Once again, State
legislatures began to enact discriminatory laws in the area,
and in the early 1970s began mandating genetic screening of all
African Americans for sickle cell anemia, leading to
discrimination and unnecessary fear. To alleviate some of this
stigma, Congress in 1972 passed the National Sickle Cell Anemia
Control Act, which withholds Federal funding from States unless
sickle cell testing is voluntary.
(4) Congress has been informed of examples of genetic
discrimination in the workplace. These include the use of pre-
employment genetic screening at Lawrence Berkeley Laboratory,
which led to a court decision in favor of the employees in that
case Norman-Bloodsaw v. Lawrence Berkeley Laboratory (135 F.3d
1260, 1269 (9th Cir. 1998)). Congress clearly has a compelling
public interest in relieving the fear of discrimination and in
prohibiting its actual practice in employment and health
insurance.
(5) Federal law addressing genetic discrimination in health
insurance and employment is incomplete in both the scope and
depth of its protections. Moreover, while many States have
enacted some type of genetic non-discrimination law, these laws
vary widely with respect to their approach, application, and
level of protection. Congress has collected substantial
evidence that the American public and the medical community
find the existing patchwork of State and Federal laws to be
confusing and inadequate to protect them from discrimination.
Therefore Federal legislation establishing a national and
uniform basic standard is necessary to fully protect the public
from discrimination and allay their concerns about the
potential for discrimination, thereby allowing individuals to
take advantage of genetic testing, technologies, research, and
new therapies.
TITLE I--GENETIC NONDISCRIMINATION IN HEALTH INSURANCE
SEC. 101. AMENDMENTS TO EMPLOYEE RETIREMENT INCOME SECURITY ACT OF
1974.
(a) Prohibition of Health Discrimination on the Basis of Genetic
Information or Genetic Services.--
(1) No enrollment restriction for genetic services.--Section
702(a)(1)(F) of the Employee Retirement Income Security Act of
1974 (29 U.S.C. 1182(a)(1)(F)) is amended by inserting before
the period the following: ``(including information about a
request for or receipt of genetic services by an individual or
family member of such individual)''.
(2) 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--
(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 discrimination in group premiums based on genetic
information.--For purposes of this section, a group health
plan, or a health insurance issuer offering group health
insurance coverage in connection with a group health plan,
shall not adjust premium or contribution amounts for a group on
the basis of genetic information concerning an individual in
the group or a family member of the individual (including
information about a request for or receipt of genetic services
by an individual or family member of such individual).''.
(b) Limitations on Genetic Testing.--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, or 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.--Nothing in this part shall be
construed to--
``(A) limit the authority of a health care
professional who is providing health care services with
respect to an individual to request that such
individual or a family member of such individual
undergo a genetic test;
``(B) limit the authority of a health care
professional who is employed by or affiliated with a
group health plan or a health insurance issuer and who
is providing health care services to an individual as
part of a bona fide wellness program to notify such
individual of the availability of a genetic test or to
provide information to such individual regarding such
genetic test; or
``(C) authorize or permit a health care professional
to require that an individual undergo a genetic test.
``(d) Application to All Plans.--The provisions of subsections
(a)(1)(F), (b)(3), and (c) shall apply to group health plans and health
insurance issuers without regard to section 732(a).''.
(c) Remedies and Enforcement.--Section 502 of the Employee Retirement
Income Security Act of 1974 (29 U.S.C. 1132) is amended by adding at
the end the following:
``(n) Enforcement of Genetic Nondiscrimination Requirements.--
``(1) Injunctive relief for irreparable harm.--With respect
to any violation of subsection (a)(1)(F), (b)(3), or (c) of
section 702, a participant or beneficiary may seek relief under
subsection 502(a)(1)(B) prior to the exhaustion of available
administrative remedies under section 503 if it is demonstrated
to the court, by a preponderance of the evidence, that the
exhaustion of such remedies would cause irreparable harm to the
health of the participant or beneficiary. Any determinations
that already have been made under section 503 in such case, or
that are made in such case while an action under this paragraph
is pending, shall be given due consideration by the court in
any action under this subsection in such case.
``(2) Equitable relief for genetic nondiscrimination.--
``(A) Reinstatement of benefits where equitable
relief has been awarded.--The recovery of benefits by a
participant or beneficiary under a civil action under
this section may include an administrative penalty
under subparagraph (B) and the retroactive
reinstatement of coverage under the plan involved to
the date on which the participant or beneficiary was
denied eligibility for coverage if--
``(i) the civil action was commenced under
subsection (a)(1)(B); and
``(ii) the denial of coverage on which such
civil action was based constitutes a violation
of subsection (a)(1)(F), (b)(3), or (c) of
section 702.
``(B) Administrative penalty.--
``(i) In general.--An administrator who fails
to comply with the requirements of subsection
(a)(1)(F), (b)(3), or (c) of section 702 with
respect to a participant or beneficiary may, in
an action commenced under subsection (a)(1)(B),
be personally liable in the discretion of the
court, for a penalty in the amount not more
than $100 for each day in the noncompliance
period.
``(ii) Noncompliance period.--For purposes of
clause (i), the term `noncompliance period'
means the period--
``(I) beginning on the date that a
failure described in clause (i) occurs;
and
``(II) ending on the date that such
failure is corrected.
``(iii) Payment to participant or
beneficiary.--A penalty collected under this
subparagraph shall be paid to the participant
or beneficiary involved.
``(3) Secretarial enforcement authority.--
``(A) General rule.--The Secretary has the authority
to impose a penalty on any failure of a group health
plan to meet the requirements of subsection (a)(1)(F),
(b)(3), or (c) of section 702.
``(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 individual 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 such
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.''.
(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) the spouse of the individual;
``(B) a dependent child of the individual, including
a child who is born to or placed for adoption with the
individual; and
``(C) all other individuals related by blood to the
individual or the spouse or child described in
subparagraph (A) or (B).
``(6) Genetic information.--
``(A) In general.--Except as provided in subparagraph
(B), the term `genetic information' means information
about--
``(i) an individual's genetic tests;
``(ii) the genetic tests of family members of
the individual; or
``(iii) the occurrence of a disease or
disorder in family members of the individual.
``(B) Exclusions.--The term `genetic information'
shall not include information about the sex or age of
an 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 (such as obtaining,
interpreting, or assessing genetic information); or
``(C) genetic education.''.
(e) Regulations and Effective Date.--
(1) Regulations.--Not later than 1 year after the date of
enactment of this title, the Secretary of Labor shall issue
final regulations in an accessible format 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 title.
SEC. 102. AMENDMENTS TO THE PUBLIC HEALTH SERVICE ACT.
(a) Amendments Relating to the Group Market.--
(1) Prohibition of health discrimination on the basis of
genetic information or genetic services.--
(A) No enrollment restriction for genetic services.--
Section 2702(a)(1)(F) of the Public Health Service Act
(42 U.S.C. 300gg-1(a)(1)(F)) is amended by inserting
before the period the following: ``(including
information about a request for or receipt of genetic
services by an individual or family member of such
individual)''.
(B) 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--
(i) in paragraph (2)(A), by inserting before
the semicolon the following: ``, except as
provided in paragraph (3)''; and
(ii) by adding at the end the following:
``(3) No discrimination in group premiums based on genetic
information.--For purposes of this section, a group health
plan, or a health insurance issuer offering group health
insurance coverage in connection with a group health plan,
shall not adjust premium or contribution amounts for a group on
the basis of genetic information concerning an individual in
the group or a family member of the individual (including
information about a request for or receipt of genetic services
by an individual or family member of such individual).''.
(2) Limitations on genetic testing.--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, or 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) Certain rules of construction.--Nothing in this part
shall be construed to--
``(A) limit the authority of a health care
professional who is providing health care services with
respect to an individual to request that such
individual or a family member of such individual
undergo a genetic test;
``(B) limit the authority of a health care
professional who is employed by or affiliated with a
group health plan or a health insurance issuer and who
is providing health care services to an individual as
part of a bona fide wellness program to notify such
individual of the availability of a genetic test or to
provide information to such individual regarding such
genetic test; or
``(C) authorize or permit a health care professional
to require that an individual undergo a genetic test.
``(3) Rule of construction regarding payment.--
``(A) In general.--Subject to subparagraph (B),
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 conditioning payment on
obtaining the results of a genetic test or informing
members of such policies. For purpose of the preceding
sentence, the term `payment' includes reimbursement,
billing, claims management, claims adjudication, review
of health care services with respect to medical
necessity, coverage under a health plan,
appropriateness of care, or justification of charges,
and utilization review (including precertification,
prior authorization, concurrent and retrospective
review).
``(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.
``(d) Application to All Plans.--The provisions of subsections
(a)(1)(F), (b)(3), and (c) shall apply to group health plans and health
insurance issuers without regard to section 2721(a).
``(e) 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--
``(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.''.
(3) 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 following provisions 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), or (c) of section 2702 or section 2701 or
2702(b)(1) with respect to genetic information.
``(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 individual 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 such
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.''.
(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 information about--
``(i) an individual's genetic tests;
``(ii) the genetic tests of family members of
the individual; or
``(iii) the occurrence of a disease or
disorder in family members of the individual.
``(B) Inclusion of genetic services and participation
in genetic research.--Such term includes, with respect
to any individual, any request for genetic services,
receipt of genetic services, or participation in any
clinical research, or any other program, which includes
genetic services, by such individual or any family
member of such individual.
``(C) Exclusions.--The term `genetic information'
shall not include information about the sex or age of
an 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 (such as obtaining,
interpreting, or assessing genetic information); or
``(C) genetic education.''.
(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 (including information about a request for or receipt of
genetic services by an individual or family member of such individual).
``(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 (including information
about a request for or receipt of genetic services by an individual or
family member of such 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
(including information about a request for or receipt of genetic
services by an individual or family member of such individual), 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) Certain rules of construction.--Nothing in this part
shall be construed to--
``(A) limit the authority of a health care
professional who is providing health care services with
respect to an individual to request that such
individual or a family member of such individual
undergo a genetic test;
``(B) limit the authority of a health care
professional who is employed by or affiliated with a
health insurance issuer and who is providing health
care services to an individual as part of a bona fide
wellness program to notify such individual of the
availability of a genetic test or to provide
information to such individual regarding such genetic
test; or
``(C) authorize or permit a health care professional
to require that an individual undergo a genetic test.
``(3) Rule of construction regarding payment.--
``(A) In general.--Subject to subparagraph (B),
nothing in paragraph (1) shall be construed to preclude
a health insurance issuer offering health insurance
coverage in the individual market from conditioning
payment on obtaining the results of a genetic test or
informing members of such policies. For purpose of the
preceding sentence, the term `payment' includes
reimbursement, billing, claims management, claims
adjudication, review of health care services with
respect to medical necessity, coverage under a health
plan, appropriateness of care, or justification of
charges, and utilization review (including
precertification, prior authorization, concurrent and
retrospective review).
``(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.
``(e) 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--
``(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) and (c) of
section 2702 and the provisions of section 2702(b) to
the extent that such provisions apply to genetic
information (or information about a request for or the
receipt of genetic services by an individual or a
family member of such individual).''.
(d) Regulations and Effective Date.--
(1) Regulations.--Not later than 1 year after the date of
enactment of this title, the Secretary of Labor and the
Secretary of Health and Human Services (as the case may be)
shall issue final regulations in an accessible format 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
title; 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 title.
SEC. 103. AMENDMENTS TO TITLE XVIII OF THE SOCIAL SECURITY ACT RELATING
TO MEDIGAP.
(a) Nondiscrimination.--
(1) In general.--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)(i) An issuer of a medicare supplemental policy
shall not deny or condition the issuance or
effectiveness of the policy, and shall not discriminate
in the pricing of the policy (including the adjustment
of premium rates) of an eligible individual on the
basis of genetic information concerning the individual
(or information about a request for, or the receipt of,
genetic services by such individual or family member of
such individual).
``(ii) For purposes of clause (i), the terms `family
member', `genetic services', and `genetic information'
shall have the meanings given such terms in subsection
(x).''.
(2) Effective date.--The amendment made by paragraph (1)
shall apply with respect to a policy for policy years beginning
after the date that is 18 months after the date of enactment of
this Act.
(b) Limitations on Genetic Testing.--
(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.--
``(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.--Nothing in this title
shall be construed to--
``(i) limit the authority of a health care
professional who is providing health care
services with respect to an individual to
request that such individual or a family member
of such individual undergo a genetic test;
``(ii) limit the authority of a health care
professional who is employed by or affiliated
with an issuer of a medicare supplemental
policy and who is providing health care
services to an individual as part of a bona
fide wellness program to notify such individual
of the availability of a genetic test or to
provide information to such individual
regarding such genetic test; or
``(iii) authorize or permit a health care
professional to require that an individual
undergo a genetic test.
``(2) Definitions.--In this subsection:
``(A) Family member.--The term `family member' means
with respect to an individual--
``(i) the spouse of the individual;
``(ii) a dependent child of the individual,
including a child who is born to or placed for
adoption with the individual; or
``(iii) any other individuals related by
blood to the individual or to the spouse or
child described in clause (i) or (ii).
``(B) Genetic information.--
``(i) In general.--Except as provided in
clause (ii), the term `genetic information'
means information about--
``(I) an individual's genetic tests;
``(II) the genetic tests of family
members of the individual; or
``(III) the occurrence of a disease
or disorder in family members of the
individual.
``(ii) Exclusions.--The term `genetic
information' shall not include information
about the sex or age of an 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 (such as obtaining,
interpreting, or assessing genetic
information); or
``(iii) genetic education.
``(E) 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) 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).''.
(3) Effective date.--The amendments made by this subsection
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.
(c) 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. 104. PRIVACY AND CONFIDENTIALITY.
(a) Applicability.--Except as provided in subsection (d), the
provisions of this section shall apply to group health plans and health
insurance issuers that offers group health insurance coverage in
connection with a group health plan, without regard to--
(1) section 732(a) of the Employee Retirement Income Security
Act of 1974 (29 U.S.C. 1191a(a));
(2) section 9831(a)(2) of the Internal Revenue Code of 1986.
(b) Compliance With Certain Confidentiality Standards With Respect to
Genetic Information.--
(1) In general.--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) shall apply to the use or
disclosure of genetic information by a group health plan or by
a health insurance issuer that offers group health insurance
coverage in connection with a group health plan.
(2) Prohibition on underwriting and premium rating.--
Notwithstanding paragraph (1), a group health plan or a health
insurance issuer that offers group health insurance coverage in
connection with a group health plan shall not use or disclose
genetic information (including information about a request for
or a receipt of genetic services by an individual or family
member of such individual) for purposes of underwriting,
determinations of eligibility to enroll, premium rating, or the
creation, renewal or replacement of a plan, contract or
coverage for health insurance or health benefits.
(c) Prohibition on Collection of Genetic Information.--
(1) In general.--A group health plan or a health insurance
issuer that offers group health insurance coverage in
connection with a group health plan shall not request, require,
or purchase genetic information (including information about a
request for or a receipt of genetic services by an individual
or family member of such individual) for purposes of
underwriting, determinations of eligibility to enroll, premium
rating, or the creation, renewal or replacement of a plan,
contract or coverage for health insurance or health benefits.
(2) Limitation relating to the collection of genetic
information prior to enrollment.--A group health plan or a
health insurance issuer that offers group health insurance
coverage in connection with a group health plan shall not
request, require, or purchase genetic information (including
information about a request for or a receipt of genetic
services by an individual or family member of such individual)
concerning a participant, beneficiary, or enrollee prior to the
enrollment, and in connection with such enrollment, of such
individual under the plan or coverage.
(3) Incidental collection.--Where a group health plan obtains
or a health insurance issuer that offers group health insurance
coverage in connection with a group health plan genetic
information incidental to the requesting, requiring, or
purchasing of other information concerning a participant,
beneficiary, or enrollee, such request, requirement, or
purchase shall not be considered a violation of this subsection
if--
(A) such request, requirement, or purchase is not in
violation of paragraph (1); and
(B) any genetic information (including information
about a request for or receipt of genetic services)
requested, required, or purchased is not used or
disclosed in violation of subsection (b).
(d) Application of Confidentiality Standards.--The provisions of
subsections (b) and (c) shall not apply--
(1) to group health plans or health insurance issuers that
are not otherwise covered under 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); and
(2) to genetic information that is not considered to be
individually-identifiable health information under 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).
(e) Enforcement.--A group health plan or a health insurance issuer
that offers group health insurance coverage in connection with a group
health plan that violates a provision of this section shall be subject
to the penalties described in sections 1176 and 1177 of the Social
Security Act (42 U.S.C. 1320d-5 and 1320d-6) in the same manner and to
the same extent that such penalties apply to violations of part C of
title XI of such Act.
(f) Preemption.--
(1) In general.--A provision or requirement under this
section or a regulation promulgated under this section shall
supersede any contrary provision of State law unless such
provision of State law imposes requirements, standards, or
implementation specifications that are more stringent than the
requirements, standards, or implementation specifications
imposed under this section or such regulations. No penalty,
remedy, or cause of action to enforce such a State law that is
more stringent shall be preempted by this section.
(2) Rule of construction.--Nothing in paragraph (1) shall be
construed to establish a penalty, remedy, or cause of action
under State law if such penalty, remedy, or cause of action is
not otherwise available under such State law.
(g) Coordination With Privacy Regulations.--The Secretary shall
implement and administer this section in a manner that is consistent
with the implementation and administration by the Secretary of 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).
(h) Definitions.--In this section:
(1) Genetic information; genetic services.--The terms
``family member'', ``genetic information'', ``genetic
services'', and ``genetic test'' have the meanings given such
terms in section 2791 of the Public Health Service Act (42
U.S.C. 300gg-91), as amended by this Act.
(2) Group health plan; health insurance issuer.--The terms
``group health plan'' and ``health insurance issuer'' include
only those plans and issuers that are covered under the
regulations described in subsection (d)(1).
(3) Secretary.--The term ``Secretary'' means the Secretary of
Health and Human Services.
SEC. 104A. PRIVACY AND CONFIDENTIALITY.
(a) PHSA Provisions.--
(1) Group health plans.--
(A) In general.--Title XXVII of the Public Health
Service Act is amended by inserting after section 2702
the following new section:
``SEC. 2703. PRIVACY AND CONFIDENTIAL OF GENETIC INFORMATION.
``(a) Compliance With Certain Confidentiality Standards With Respect
to Genetic Information.--
``(1) In general.--The regulations promulgated by the
Secretary 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) shall apply to the use or disclosure of genetic
information by a group health plan or by an health insurance
issuer in connection with health insurance coverage offered in
connection with a group health plan.
``(2) Prohibition on underwriting and premium rating.--
Notwithstanding paragraph (1), a group health plan or a health
insurance issuer (in connection with health insurance coverage
offered in connection with a group health plan) shall not use
or disclose genetic information (including information about a
request for or a receipt of genetic services by an individual
or family member of such individual) for purposes of
underwriting, determinations of eligibility to enroll, premium
rating, or the creation, renewal or replacement of a plan,
contract or coverage for health insurance or health benefits.
``(b) Prohibition on Collection of Genetic Information.--
``(1) In general.--A group health plan or health insurance
issuer (in connection with health insurance coverage offered in
connection with a group health plan) shall not request,
require, or purchase genetic information (including information
about a request for or a receipt of genetic services by an
individual or family member of such individual) for purposes of
underwriting, determinations of eligibility to enroll, premium
rating, or the creation, renewal or replacement of a plan,
contract or coverage for health insurance or health benefits.
``(2) Limitation relating to the collection of genetic
information prior to enrollment.--A group health plan or health
insurance issuer (in connection with health insurance coverage
offered in connection with a group health plan) shall not
request, require, or purchase genetic information (including
information about a request for or a receipt of genetic
services by an individual or family member of such individual)
concerning a participant, beneficiary, or enrollee prior to the
enrollment, and in connection with such enrollment, of such
individual under the plan or coverage.
``(3) Incidental collection.--Where a group health plan or
health insurance issuer (in connection with health insurance
coverage offered in connection with a group health plan)
obtains genetic information incidental to the requesting,
requiring, or purchasing of other information concerning a
participant or beneficiary, such request, requirement, or
purchase shall not be considered a violation of this subsection
if--
``(A) such request, requirement, or purchase is not
in violation of paragraph (1); and
``(B) any genetic information (including information
about a request for or receipt of genetic services)
requested, required, or purchased is not used or
disclosed in violation of subsection (a).
``(c) Application of Confidentiality Standards.--The provisions of
subsections (a) and (b) shall not apply--
``(1) to group health plans or health insurance issuers that
are not otherwise covered under the regulations promulgated by
the Secretary 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); and
``(2) to genetic information that is not considered to be
individually-identifiable health information under the
regulations promulgated by the Secretary 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).
``(d) Coordination With Privacy Regulations.--The Secretary shall
implement and administer this section in a manner that is consistent
with the implementation and administration by the Secretary of the
regulations promulgated by the Secretary 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).''.
(B) Application to small group health plans.--Section
2721(a) of such Act (42 U.S.C. 300gg-21(a)) is amended
by inserting ``(other than section 2703)'' after
``subparts 1 and 3''.
(2) Individual health insurance.--Such title is further
amended by inserting after section 2744 the following new
section:
``SEC. 2744A. PRIVACY AND CONFIDENTIALITY OF GENETIC INFORMATION.
``(a) Compliance With Certain Confidentiality Standards With Respect
to Genetic Information.--
``(1) In general.--The regulations promulgated by the
Secretary 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) shall apply to the use or disclosure of genetic
information by an health insurance issuer in connection with
individual health insurance coverage.
``(2) Prohibition on underwriting and premium rating.--
Notwithstanding paragraph (1), a health insurance issuer shall
not use or disclose genetic information (including information
about a request for or a receipt of genetic services by an
individual or family member of such individual) for purposes of
underwriting, determinations of eligibility to enroll, premium
rating, or the creation, renewal or replacement of a plan,
contract or coverage for health insurance or health benefits in
the individual market.
``(b) Prohibition on Collection of Genetic Information.--
``(1) In general.--A health insurance issuer shall not
request, require, or purchase genetic information (including
information about a request for or a receipt of genetic
services by an individual or family member of such individual)
for purposes of underwriting, determinations of eligibility to
enroll, premium rating, or the creation, renewal or replacement
of a plan, contract or coverage for health insurance or health
benefits in the individual market.
``(2) Limitation relating to the 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
(including information about a request for or a receipt of
genetic services by an individual or family member of such
individual) concerning an enrollee prior to the enrollment, and
in connection with such enrollment, of such individual under
the coverage.
``(3) Incidental collection.--Where a health insurance issuer
obtains genetic information incidental to the requesting,
requiring, or purchasing of other information concerning an
enrollee in the individual market, such request, requirement,
or purchase shall not be considered a violation of this
subsection if--
``(A) such request, requirement, or purchase is not
in violation of paragraph (1); and
``(B) any genetic information (including information
about a request for or receipt of genetic services)
requested, required, or purchased is not used or
disclosed in violation of subsection (a).
``(c) Application of Confidentiality Standards.--The provisions of
subsections (a) and (b) shall not apply--
``(1) to health insurance issuers that are not otherwise
covered under the regulations promulgated by the Secretary
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); and
``(2) to genetic information that is not considered to be
individually-identifiable health information under the
regulations promulgated by the Secretary 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).
``(d) Coordination With Privacy Regulations.--The Secretary shall
implement and administer this section in a manner that is consistent
with the implementation and administration by the Secretary of the
regulations promulgated by the Secretary 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).''.
(b) Application to Medicare Supplemental Policies.--Section 1882 of
the Social Security Act (42 U.S.C. 1395ss), as amended by section
103(b)(1), is amended by adding at the end the following new
subsection:
``(y) Privacy and Confidentiality of Genetic Information.--
``(1) Compliance with certain confidentiality standards with
respect to genetic information.--
``(A) In general.--The regulations promulgated by the
Secretary 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) shall apply to the
use or disclosure of genetic information by an issuer
of a medicare supplemental policy.
``(B) Prohibition on underwriting and premium
rating.--Notwithstanding subparagraph (A), an issuer of
a medicare supplemental policy shall not use or
disclose genetic information (including information
about a request for or a receipt of genetic services by
an individual or family member of such individual) for
purposes of underwriting, determinations of eligibility
to enroll, premium rating, or the creation, renewal or
replacement of a plan, contract or coverage for health
insurance or health benefits in connection with such
policy.
``(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 (including information
about a request for or a receipt of genetic services by
an individual or family member of such individual) for
purposes of underwriting, determinations of eligibility
to enroll, premium rating, or the creation, renewal or
replacement of a plan, contract or coverage for health
insurance or health benefits in connection with such
policy.
``(B) Limitation relating to the collection of
genetic information prior to enrollment.--An issuer of
a medicare supplemental policy shall not request,
require, or purchase genetic information (including
information about a request for or a receipt of genetic
services by an individual or family member of such
individual) concerning an enrollee prior to the
enrollment, and in connection with such enrollment, of
such individual under the policy.
``(C) Incidental collection.--Where the issuer of a
medicare supplemental policy obtains genetic
information incidental to the requesting, requiring, or
purchasing of other information concerning an enrollee
in connection with such a policy, such request,
requirement, or purchase shall not be considered a
violation of this paragraph if--
``(i) such request, requirement, or purchase
is not in violation of subparagraph (A); and
``(ii) any genetic information (including
information about a request for or receipt of
genetic services) requested, required, or
purchased is not used or disclosed in violation
of paragraph (1).
``(3) Application of confidentiality standards.--The
provisions of paragraphs (1) and (2) shall not apply--
``(A) to health insurance issuers that are not
otherwise covered under the regulations promulgated by
the Secretary 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); and
``(B) to genetic information that is not considered
to be individually-identifiable health information
under the regulations promulgated by the Secretary
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).
``(4) Coordination with privacy regulations.--The Secretary
shall implement and administer this subsection in a manner that
is consistent with the implementation and administration by the
Secretary of the regulations promulgated by the Secretary 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).''.
SEC. 105. ASSURING COORDINATION.
(a) In General.--Except as provided in subsection (b), the Secretary
of the Treasury, the Secretary of Health and Human Services, and the
Secretary of Labor 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.
(b) Authority of the Secretary.--The Secretary of Health and Human
Services has the sole authority to promulgate regulations to implement
section 104.
SEC. 106. RELATIONSHIP TO TITLE II WITH RESPECT TO ENFORCEMENT.
With respect to the relationship between title II and this title (and
the amendments made by this title):
(1) The genetic nondiscrimination requirements and remedies
of this title (and such amendments) are exclusive for--
(A) group health plans;
(B) health or other insurance coverage issued in
connection with group heath plans;
(C) individual health insurance coverage; and
(D) and medicare supplemental policies.
(2) Nothing in title II shall be construed to establish a
requirement or remedy under such title with respect to group
health plans, health or other insurance coverage issued in
connection with group heath plans, individual health insurance
coverage, or medicare supplemental policies, notwithstanding
any provision of such title.
SEC. 107. REGULATIONS; EFFECTIVE DATE.
(a) Regulations.--Not later than 1 year after the date of enactment
of this title, the Secretary of Labor, the Secretary of Health and
Human Services, and the Secretary of the Treasury shall issue final
regulations in an accessible format to carry out this title.
(b) Effective Date.--Except as provided in section 103, the
amendments made by this title shall take effect on the date that is 18
months after the date of enactment of this Act.
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) the spouse of the individual;
(B) a dependent child of the individual, including a
child who is born to or placed for adoption with the
individual; and
(C) all other individuals related by blood to the
individual or the spouse or child described in
subparagraph (A) or (B).
(4) Genetic information.--
(A) In general.--Except as provided in subparagraph
(B), the term ``genetic information'' means information
about--
(i) an individual's genetic tests;
(ii) the genetic tests of family members of
the individual; or
(iii) the occurrence of a disease or disorder
in family members of the individual.
(B) Exceptions.--The term ``genetic information''
shall not include information about the sex or age of
an 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 (such as obtaining,
interpreting or assessing genetic information); or
(C) genetic education.
(7) Genetic test.--
(A) In general.--The term ``genetic test'' means the
analysis of human DNA, RNA, chromosomes, proteins, or
metabolites, that detects genotypes, mutations, or
chromosomal changes.
(B) Exception.--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) Use of 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 information about a request for or
the receipt of genetic services by such employee or family
member of such 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 (or
information about a request for or the receipt of genetic
services by such employee or family member of such 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 (or information about a request for the receipt of genetic
services by such employee or a family member of such 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; 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 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;
(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) or (2) of
subsection (a) or treated or disclosed in a manner that violates
section 206.
SEC. 203. EMPLOYMENT AGENCY PRACTICES.
(a) Use of 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 (or information
about a request for or the receipt of genetic services by such
individual or family member of such 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 information about a request for
or the receipt of genetic services by such individual or family
member of such 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 (or information about a request for the
receipt of genetic services by such individual or a family member of
such 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) or (2) of
subsection (a) or treated or disclosed in a manner that violates
section 206.
SEC. 204. LABOR ORGANIZATION PRACTICES.
(a) Use of 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 (or
information about a request for or the receipt of genetic
services by such member or family member of such 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 information
about a request for or the receipt of genetic services by such
member or family member of such 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 (or information about a request for the receipt of
genetic services by such member or a family member of such 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) or (2) of
subsection (a) or treated or disclosed in a manner that violates
section 206.
SEC. 205. TRAINING PROGRAMS.
(a) Use of 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 (or information
about a request for or the receipt of genetic services by such
individual or a family member of such 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 information about a request for or receipt of genetic
services by such individual or family member of such
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 (or information about a request
for the receipt of genetic services by such individual or a family
member of such 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;
(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; 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 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;
(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) or (2) 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 (or information about a request for or receipt of
genetic services by such employee or member or family member of such
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.
(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 (or information
about a request for or receipt of genetic services by such employee or
member or family member of such employee or member) except--
(1) to the employee (or family member if the family member is
receiving the genetic services) or member of a labor
organization at the 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 provide the employee or member with adequate
notice to challenge the court 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 Regulation.--
(1) In general.--In the case of an entity that is subject 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), the entity is not subject to the provisions of
this title that regulate the use and disclosure of information
to which such regulation applies.
(2) Rule of construction.--Nothing in paragraph (1) shall
affect the application of protections under this title against
discrimination in hiring, firing, promotion, or job placement
and other unlawful employment practices that do not relate to
the matters to which the regulations referred to in paragraph
(1) apply.
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 (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 (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).
(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 (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 (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).
(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 (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 (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).
(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 (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 (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).
(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 (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 (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).
(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 Act,
``disparate impact'', as that term is used in section 703(k) of the
Civil Rights Act of 1964 (42 U.S.C. 2000e-2(k)), on the basis of
genetic information does not establish a cause of action under this
Act.
(b) Commission.--On the date that is 6 years after the date of
enactment of this Act, there shall be established a commission, to be
known as the Genetic Nondiscrimination Study Commission (referred to in
this section as the ``Commission'') to review the developing science of
genetics and to make recommendations to Congress regarding whether to
provide a disparate impact cause of action under this Act.
(c) Membership.--
(1) In general.--The Commission shall be composed of 8
members, of which--
(A) 1 member shall be appointed by the Majority
Leader of the Senate;
(B) 1 member shall be appointed by the Minority
Leader of the Senate;
(C) 1 member shall be appointed by the Chairman of
the Committee on Health, Education, Labor, and Pensions
of the Senate;
(D) 1 member shall be appointed by the ranking
minority member of the Committee on Health, Education,
Labor, and Pensions of the Senate;
(E) 1 member shall be appointed by the Speaker of the
House of Representatives;
(F) 1 member shall be appointed by the Minority
Leader of the House of Representatives;
(G) 1 member shall be appointed by the Chairman of
the Committee on Education and the Workforce of the
House of Representatives; and
(H) 1 member shall be appointed by the ranking
minority member of the Committee on Education and the
Workforce of the House of Representatives.
(2) Compensation and expenses.--The members of the Commission
shall not receive compensation for the performance of services
for the Commission, but shall be allowed travel expenses,
including per diem in lieu of subsistence, at rates authorized
for employees of agencies under subchapter I of chapter 57 of
title 5, United States Code, while away from their homes or
regular places of business in the performance of services for
the Commission.
(d) Administrative Provisions.--
(1) Location.--The Commission shall be located in a facility
maintained by the Equal Employment Opportunity Commission.
(2) Detail of government employees.--Any Federal Government
employee may be detailed to the Commission without
reimbursement, and such detail shall be without interruption or
loss of civil service status or privilege.
(3) Information from federal agencies.--The Commission may
secure directly from any Federal department or agency such
information as the Commission considers necessary to carry out
the provisions of this section. Upon request of the Commission,
the head of such department or agency shall furnish such
information to the Commission.
(4) Hearings.--The Commission may hold such hearings, sit and
act at such times and places, take such testimony, and receive
such evidence as the Commission considers advisable to carry
out the objectives of this section, except that, to the extent
possible, the Commission shall use existing data and research.
(5) Postal services.--The Commission may use the United
States mails in the same manner and under the same conditions
as other departments and agencies of the Federal Government.
(e) Report.--Not later than 1 year after all of the members are
appointed to the Commission under subsection (c)(1), the Commission
shall submit to Congress a report that summarizes the findings of the
Commission and makes such recommendations for legislation as are
consistent with this Act.
(f) Authorization of Appropriations.--There are authorized to be
appropriated to the Equal Employment Opportunity Commission such sums
as may be necessary to carry out this section.
SEC. 209. CONSTRUCTION.
Nothing in this title shall be construed to--
(1) limit the rights or 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) establish a violation under this title for an employer,
employment agency, labor organization, or joint labor-
management committee of a provision of the amendments made by
title I;
(3) 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;
(4) apply to the Armed Forces Repository of Specimen Samples
for the Identification of Remains;
(5) limit or expand the protections, rights, or obligations
of employees or employers under applicable workers'
compensation laws;
(6) 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); and
(7) 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.
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 in an accessible format 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 PROVISION
SEC. 301. SEVERABILITY.
If any provision of this Act, an amendment made by this Act, or the
application of such provision or amendment to any person or
circumstance is held to be unconstitutional, the remainder of this Act,
the amendments made by this Act, and the application of such provisions
to any person or circumstance shall not be affected thereby.
Purpose and Summary
H.R. 493, the Genetic Information Nondiscrimination Act of
2007, amends the Employee Retirement Income Security Act of
1974 (ERISA) and the Public Health Service Act (PHSA) to expand
the prohibition against discrimination by group health plans
and health insurance issuers in the group and individual
markets on the basis of genetic information or services to
prohibit: (1) enrollment and premium discrimination based on
information about a request for or receipt of genetic services;
and (2) requiring genetic testing. The bill also sets forth
penalties for violations of its requirements.
H.R. 493 amends title XVIII of the Social Security Act
(Medicare) to prohibit issuers of Medicare supplemental
policies from discriminating on the basis of genetic
information. H.R. 493 also extends medical privacy and
confidentiality rules to the disclosure of genetic information;
makes it an unlawful employment practice for an employer,
employment agency, labor organization, or training program to
discriminate against an individual or deprive such individual
of employment opportunities because of genetic information;
prohibits the collection and disclosure of genetic information,
with certain exceptions; and establishes a Genetic
Nondiscrimination Study Commission to review the developing
science of genetics and advise Congress on the advisability of
providing for a disparate impact cause of action under the
Civil Rights Act of 1964.
Background and Need for Legislation
Deciphering the sequence of the human genome and other
advances in genetics have opened major new opportunities for
medical progress. Science is only beginning to unlock the
complex nature of the interaction between genes and the
environment in common diseases and their respective
contributions to the disease process. The information gleaned
from the Human Genome Project will help, and is currently
helping, scientists and clinicians to identify common genetic
variations that contribute to disease. Knowledge of the
potential relevance of genetic information to the clinical
management of nearly all patients, coupled with the lack of
complete information about the genetic and environmental
factors underlying diseases, creates a challenging climate for
public policymaking.
In many cases, the results of genetic testing may be used
to guide clinical management of patients. For example, more
frequent screening may be recommended for individuals at
increased risk of certain diseases by virtue of their genetic
make-up, such as colorectal and breast cancer. Decisions about
course of treatment and dosing may also be guided by genetic
testing. Many diseases, however, do not have any treatments
available (for example, Huntington's Disease). In these cases,
the benefits of genetic testing lie largely in the information
they provide an individual about his or her risk of future
disease or current disease status. The value of genetic
information in these cases is personal to individuals, who may
choose to utilize this information to help guide medical and
other life decisions for themselves and their families. This
information can affect decisions about reproduction, the types
or amount of health, life, or disability insurance to purchase,
or career and education choices.
These advances give rise to the potential misuse of genetic
information to discriminate in health insurance and employment.
Concerns about privacy and the use and misuse of genetic
information need to be balanced with the potential of genetics
and genetic technology to change how care is delivered and to
personalize medical care and treatment of disease.
A January 20, 1998 joint report put forth by the Department
of Labor, the Department of Health and Human Services (HHS),
the Equal Employment Opportunity Commission (EEOC), and the
Department of Justice (DoJ), entitled, ``Genetic Information
and the Workplace,'' summarized the various studies on
discrimination based on genetic information and argued for the
enactment of Federal legislation. The joint report stated that,
``genetic predisposition or conditions can lead to workplace
discrimination, even in cases where workers are healthy and
unlikely to develop disease or where the genetic condition has
no effect on the ability to perform work.'' With these
misconceptions so prevalent, employers may come to rely on
genetic testing to `weed out' those employees who carry genes
associated with diseases. The joint report concluded that
existing protections are minimal and called for the enactment
of legislation which states that: 1) employers should not
require or request that employees or potential employees take a
genetic test or provide genetic information as a condition of
employment or benefits; 2) employers should not use genetic
information to discriminate against, limit, segregate, or
classify employees; and 3) employers should not obtain or
disclose genetic information about employees or potential
employees under most circumstances.
The joint report acknowledged that genetic testing has the
unique ability to detect and prevent health disorders, but
pointed out that this information can be misused to
discriminate against or stigmatize individuals seeking health
insurance. It is feared that a health insurance company might
wrongly view the presence of a gene mutation to mean that the
person would definitely contract the disease with which that
gene is associated and improperly deny that person insurance
coverage. The report cited a 1996 survey of individuals at risk
of developing a genetic condition and parents of children with
specific genetic conditions. This report identified more than
200 cases of genetic discrimination among the 917 people who
responded. The cases involved discrimination by insurance
companies, employers, and other organizations that use genetic
information. Another survey of genetic counselors, primary care
physicians, and patients, identified 550 people who had been
denied employment or insurance based on their genetic
predisposition to an illness. In addition, because an
individual's genetic information has implications for his or
her family members and future generations, misuse of genetic
information could have inter-generational effects that are far
broader than any individual incident of misuse. Furthermore,
the joint report warned that many Americans are reluctant to
take advantage of new breakthroughs in genetic testing for fear
that the results will not be used to improve their health, but
rather to deny them jobs or health insurance.
The appropriate use of genetic information offers enormous
opportunities to save lives and prevent the onset of disease.
However, the medical progress made possible by genetic research
is dependent on the willingness of study volunteers and
patients to undergo genetic testing. Such consent may be
difficult to obtain today. Fears about the possible misuse or
unauthorized disclosure of genetic information appear to
adversely impact the desire of individuals to participate in
genetic research. Such fears also extend to clinical practice,
discouraging both patients and providers from taking full
advantage of genetic tests and technologies. There is
substantial reluctance among at-risk populations to undergo
genetic testing--even when that testing may allow patients to
take steps to lower their risks of contracting a disease. For
example, only 43 percent of those at risk for hereditary colon
cancer participated in a genetic testing program. Later studies
found that 39 percent of those who declined testing cited fears
about the potential effect of test results on their health
insurance coverage as the primary reason for their refusal.
Although other factors contribute to the decision not to get
tested, such asthe lack of an effective treatment, fear of
genetic discrimination appears to be a primary reason that many people
forgo getting genetic tests.
To fill the void created by the absence of clear
protections at the Federal level, many States have enacted laws
that seek to prohibit genetic discrimination in health
insurance and employment. To date, 34 States, and the District
of Columbia, have passed laws on genetic discrimination in
employment and 48 have passed laws on genetic discrimination in
health insurance. Among the States that prohibit discrimination
in the issuing of health insurance, many cover only the group
health insurance market and exclude individual health insurance
policies, while others do the reverse. Many States exclude
family medical histories from their definition of genetic
information or include only the results of tests that are
performed with the announced intention of detecting genetic
mutations.
Regardless of the technical aspects of any particular State
law, there is necessarily a significant gap in any State's
ability to deter genetic discrimination in health insurance.
Congress delegated to the States the authority to regulate most
aspects of insurance through enacting the McCarran-Ferguson Act
of 1945. However, employer-purchased plans were exempted from
State regulation by the Employee Retirement Income Security Act
of 1974. Under ERISA, no State may regulate the type of health
insurance plans typically provided to employees as part of
their employment benefits. Only the Congress can therefore
enact a truly comprehensive law prohibiting genetic
discrimination in all areas of health insurance.
Federal genetic nondiscrimination legislation addresses the
need for national comprehensive protections. The legislation is
supported by President Bush, whose Administration has issued
two Statement of Administration Policies (SAPs) supporting
Senate-passed genetic nondiscrimination legislation. The most
recent SAP, issued on February 16, 2005, stated, ``The
Administration supports Senate passage of S. 306, as reported,
which would prohibit group health plans and health insurers
from denying coverage to a healthy individual or charging that
person higher premiums based solely on a genetic predisposition
to developing a disease in the future. The legislation would
also bar employers from using individuals' genetic information
when making hiring, firing, job placement, or promotion
decisions.''
The Committee believes the Secretary of HHS should consider
periodically publishing non-binding guidance on whether a given
type of analysis ``detects a genotype, mutation, or chromosomal
change'' as those terms are used in GINA's definition of
``genetic test''. In so doing, the Secretary should utilize an
open and inclusive process that affords an opportunity for
experts and stakeholders to provide the Secretary with their
advice and input. Further, the Committee intends that at no
point in this process should any personally identifiable
information, including any person's genetic information or
family history, be utilized or disclosed.
CURRENT FEDERAL LAW ON GENETIC DISCRIMINATION IN HEALTH INSURANCE
The Health Insurance Portability and Accountability Act
(HIPAA) has several important limitations in protecting
Americans against genetic discrimination in health insurance.
First, its protections against denying coverage on the basis of
factors related to health status apply only to the group
insurance market. HIPAA does not address discrimination in the
individual market, and State laws vary considerably with regard
to restrictions on using genetic information to set premiums or
determine eligibility. In addition, HIPAA does not prohibit an
insurance company from raising the premiums for the group
health plan as a whole, based on the genetic information of an
individual in that group.
HIPAA AND PRIVACY
HHS medical privacy regulations are of obvious relevance to
the debate on genetic discrimination. While people fear
discriminatory action based on their genes, they also fear the
unauthorized disclosure or collection of genetic information.
The need to protect the privacy of genetic information is
important. Knowledge that a person has a particular medical
condition or genetic trait may be embarrassing or damaging to
that individual, or his or her family members. Although the HHS
privacy regulations are extensive in many respects, they are
limited by the underlying statutory framework of HIPAA, which
authorized them to apply only to three named categories of
entities: providers, payers and information clearinghouses.
However, medical information may be widely dispersed beyond
these `covered entities'. Due to the underlying statutory
constraints of HIPAA, the HHS privacy regulations cannot
directly affect employers or other non-covered entities.
Instead, the regulations require any non-covered entity (a
`business associate') to enter into a contract with a covered
entity promising that it will respect the privacy of
information transmitted from the covered entity to the non-
covered entity. Further statutory provisions are needed to
regulate directly the collection and disclosure of genetic
information by employers and other workforce organizations not
covered directly within the framework of the HIPAA regulations.
FEDERAL PROTECTIONS AGAINST GENETIC DISCRIMINATION IN EMPLOYMENT
Federal employees have considerable protection against
genetic discrimination under the terms of Executive Order 13145
issued on February 10, 2000, 65 CFR 6877. Under this order,
Federal employees may not be discharged or otherwise subjected
to restrictions in their employment, or their employment-
related benefits, on the basis of protected genetic
information. The Executive Order also provides protections
against improper collection of employees' genetic information
and against unauthorized disclosure of that information.
Despite these protections, the Executive Order has no
enforcement provisions.
TITLE VII OF THE CIVIL RIGHTS ACT
Title VII of the Civil Rights Act of 1964 makes it illegal
for an employer, labor organization, employment agency, or
training program to `discriminate against any individual . . .
because of such individual's race, color, religion, sex, or
national origin.' While this law provides robust guarantees
against discrimination on the basis of these characteristics,
its applicability to genetic discrimination is limited. The
plain language of the statute provides no explicit protection
against genetic discrimination. Title VII may indirectly offer
some protections against discrimination on the basis of a
person's genetic makeup when that discrimination
disproportionately affects individuals on the basis of one of
the characteristics named in the Act. For acts of genetic
discrimination that do not have a discriminatory effect on
members of class of individuals named in the Civil Rights Act,
Title VII would provide no apparent protection against genetic
discrimination.
Hearings
The Subcommittee on Health held a hearing on H.R. 493 on
Thursday, March 8, 2007. The hearing was divided into two
panels. Panel I consisted of testimony from the following:
Francis S. Collins, M.D., Ph.D., Director, National Human
Genome Research Institute, National Institutes of Health,
Department of Health and Human Services; Christopher J.
Kuczynski, J.D., Assistant Legal Counsel and Director,
Americans with Disabilities Act Policy Division, Equal
Employment Opportunity Commission; and Susan McAndrew, J.D.,
Deputy Director for Health Information Privacy, Office for
Civil Rights, Department of Health and Human Services.
Panel II consisted of testimony from the following: Sharon
F. Terry, M.A., L.H.D., Chair, Coalition for Genetic Fairness,
President and CEO, Genetic Alliance; William Corwin, M.D.,
Medical Director, Clinical Policy, Harvard Pilgrim Health Care,
on behalf of the America's Health Insurance Plans (AHIP);
Burton J. Fishman, J.D., Esq., Fortney & Scott, LLC, on behalf
of the Genetic Information Nondiscrimination in Employment
Coalition (GINE); Karen Pollitz, M.P.P., Research Professor,
Georgetown University Health Policy Institute; Frank Swain,
J.D., Senior Vice President, B&D Consulting; Janet Trautwein,
Executive Vice President and CEO, National Association of
Health Underwriters; Kathy Hudson, Ph.D., Director, Genetics
and Public Policy Center, Associate Professor, Berman Institute
of Bioethics, Johns Hopkins University.
Committee Consideration
On Tuesday, March 13, 2007, the Subcommittee on Health met
in open markup session and approved H.R. 493 for full Committee
consideration, amended, by voice vote.
On Friday, March 23, 2007, the full Committee met in open
markup session and ordered H.R. 493 favorably reported to the
House, amended, by voice vote.
Committee Votes
Clause 3(b) of rule XIII of the Rules of the House of
Representatives requires the Committee to list the record votes
on the motion to report legislation and amendments thereto.
There were no record votes taken on amendments or in connection
with ordering H.R. 493 reported. A motion by Mr. Dingell to
order H.R. 493 favorably reported to the House, amended, was
agreed to by voice vote.
Committee Oversight Findings
Regarding clause 3(c)(1) of rule XIII of the Rules of the
House of Representatives, the Committee has not held oversight
or legislative hearings on this legislation.
Statement of General Performance Goals and Objectives
The goals and objectives of H.R. 493 are to protect
individuals from discrimination in health insurance and
employment on the basis of genetic information. Establishing
these protections will allay concerns about the potential for
discrimination and encourage individuals to participate in
genetic research and to take advantage of genetic testing, new
technologies, and new therapies. The legislation will provide
substantive protections to those individuals who may suffer
from actual genetic discrimination now and in the future.
New Budget Authority, Entitlement Authority, and Tax Expenditures
In compliance with clause 3(c)(2) of rule XIII of the Rules
of the House of Representatives, the Committee finds that H.R.
493 would result in no new or increased budget authority,
entitlement authority, or tax expenditures or revenues.
Earmarks and Tax and Tariff Benefits
In compliance with clause 9 of rule XXI of the Rules of the
House of Representatives, H.R. 493 does not contain any
congressional earmarks, limited tax benefits, or limited tariff
benefits as defined in clause 9(d), 9(e), or 9(f) of rule XXI.
Committee Cost Estimate
The Committee will adopt as its own the cost estimate
prepared by the Director of the Congressional Budget Office
pursuant to section 402 of the Congressional Budget Act of
1974.
Congressional Budget Office Estimate
Regarding clause 3(c)(3) of rule XIII of the Rules of the
House of Representatives, a cost estimate by the Congressional
Budget Office pursuant to section 402 of the Congressional
Budget Act of 1974 was not available as of the time of the
filing of this report by the Committee.
Federal Mandates Statement
The Committee adopts as its own the estimate of Federal
mandates prepared by the Director of the Congressional Budget
Office pursuant to section 423 of the Unfunded Mandates Reform
Act.
Advisory Committee Statement
No advisory committees within the meaning of section 5(b)
of the Federal Advisory Committee Act were created by this
legislation.
Constitutional Authority Statement
Pursuant to clause 3(d)(1) of rule XIII of the Rules of the
House of Representatives, the Committee finds that the
Constitutional authority for this legislation is provided in
the provisions of Article I, section 8, clause 3, which grants
Congress the power to regulate commerce with foreign nations,
among the several States, and with the Indian tribes.
Applicability to Legislative Branch
The Committee finds that the legislation does relate to the
terms and conditions of employment or access to public services
or accommodations within the meaning of section 102(b)(3) of
the Congressional Accountability Act. H.R. 493 prohibits
discrimination on the basis of genetic information with respect
to health insurance and employment for Congressional and
Executive Branch employees. With respect to health insurance,
the provisions of H.R. 493 would indirectly apply to the
Federal Employees Health Benefits Program (FEHBP), which
contracts with insurance issuers and provides coverage to
Members and employees of the legislative branch. The impact of
this legislation on the FEHBP may not be relevant, however,
given that the FEHBP already has broad non-discrimination rules
in place, and given the fact that, pursuant to existing laws
and regulations, eligibility for enrollment in the FEHBP is
based solely on employment with the Federal Government, not
medical conditions. With respect to employment, Executive Order
13145, issued February 10, 2000, prohibits discrimination in
Federal employment based on genetic information, and current
laws and regulations ensure that disqualification for Federal
employment can only be based on job-related criteria.
Section-by-Section Analysis of the Legislation
Section 1. Short title; table of contents
Section 1 establishes the short title as the ``Genetic
Information Nondiscrimination Act of 2007''. This section also
provides a table of contents.
Section 2. Findings
Section 2 provides findings that support the overall goals
and objectives of the bill.
Title I--Genetic Non-Discrimination in Health Insurance
Section 101. Amendments to Employee Retirement Income Security Act of
1974
Subsection (a). Prohibition of health discrimination on the basis of
genetic information or genetic services
Section 101(a)(1). No enrollment restriction for genetic
services
Section 101(a)(1) amends ERISA 702(a)(1)(F) to include
``information about a request for or receipt of genetics
services by an individual or family member of such
individual.''
Section 101(a)(2). No discrimination in group premiums
based on genetic information
Section 101(a)(2) amends ERISA 702(b) to prohibit a health
insurance issuer offering group health coverage in connection
with a group health plan from adjusting premium or contribution
amounts for a group on the basis of genetic information
concerning an individual in the group or a family member of the
individual.
Section 101(b). Limitations on genetic testing
Section 101(b) amends section 702 of ERISA to include a
prohibition on genetic testing. Specifically, this provision
prohibits a group health plan or a health insurance issuer
offering group health insurance coverage in connection with a
group health plan from requesting or requiring an individual or
a family member of such individual to undergo a genetic test.
This section does not limit the authority of the treating
health care professional to request that such individual or
family member undergo a genetic test. Nor does it limit the
authority of a health care professional who is employed by or
affiliated with the group health plan or health insurance
issuer and who is providing health care services to the
enrolled individual as part of a bona fide wellness program
from notifying such individual about the availability of a
genetic test or providing information about the genetic test.
Finally, this section does not authorize or permit a health
care professional to require that an individual undergo a
genetic test.
Application to All Plans--This provision applies the
requirements of the amendments made by section 101 of the
Genetic Information Nondiscrimination Act to small group health
plans (and group health insurance coverage offered in
connection with a group health plan) that are otherwise exempt,
under section 732(a) of ERISA, from the other non-
discrimination prohibitions under section 702 of ERISA. The
requirements of such amendments apply to a group health plan
(and group health insurance coverage offered in connection with
a group health plan) that, on the first day of the plan year,
has less than two participants who are current employees for
any plan year. Such amendments also apply to retiree only group
health plans (and group health insurance coverage offered in
connection with a group health plan).
Section 101(c). Remedies and enforcement
Section 101(c) amends section 502 of ERISA to clarify and
strengthen remedies available to group health plan participants
for violations of the genetic nondiscrimination provisions
added by title I.
Secretarial Enforcement Authority--The Secretary is
provided specific authority to issue administrative penalties
for violation of sections 101 and 104(b).
Amount of Penalty--The Secretary of Labor may impose a
civil penalty against a group health plan sponsor or issuer for
any violation of this section in the amount of $100 for each
day of noncompliance with respect to each individual to whom
such failure relates. A higher penalty of $2,500 for each day
of non-compliance shall be applied where there is one or more
failures with respect to an individual involved and where the
plan did not correct the failure within the specified time. A
penalty of $15,000 shall be applied if the violation under this
title in any year is more than de minimis.
Section 101(d). Definitions
Section 101(d) adds new definitions to section 733(d) of
ERISA with respect to genetic non-discrimination.
Family Member--Means the spouse of the individual, a
dependent child, including adopted children; and all other
individuals related by blood to the individual or the spouse or
child.
Genetic Information--Means information about an
individual's genetic tests, the genetic tests of family members
of the individual, or the occurrence of a disease or disorder
in family members of the individual. It does not include
information about the sex or age of an individual.
Genetic Test--Means an analysis of human DNA, RNA,
chromosomes, proteins, or metabolites, that detects genotypes,
mutations, or chromosomal changes. It does not mean an analysis
of proteins or metabolites that does not detect genotypes,
mutations, or chromosomal changes or 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.
Genetic Services--Means a genetic test; genetic counseling
(including obtaining, interpreting, or assessing genetic
information or providing genetic advice); or genetic education.
Section 101(e). Regulations and effective date
Section 101(e) states that the Secretary of Labor shall
issue final regulations not later than one year after
enactment. The amendments made by this act shall apply to group
health plans for plan years beginning 18 months after
enactment.
Section 102. Amendments to the Public Health Service Act
Subsection (a). Amendments relating to the group market
(1) Prohibition of Health Discrimination on the Basis of
Genetic Information or Genetic Services--Sections 2702(a)(1)(F)
and 2702(b) of the Public Health Service Act currently prohibit
a group health plan and a health insurance issuer offering
group health insurance coverage in connection with a group
health plan from discriminating--in eligibility for enrollment
or premium contributions--against an individual in the group
based on the individual's health status related factors,
including genetic information. In general, this section
clarifies and expands this provision by prohibiting
discrimination based on genetic information, including
information about a request for or receipt of genetic services
by an individual or family member of the individual.
(A) No Enrollment Restriction for Genetic Services--This
provision clarifies that within the existing prohibition
banning discrimination in enrollment against an individual in
the group that the term genetic information includes
``information about a request for or receipt of genetics
services by an individual or family member of such
individual.''
(B) No Discrimination in Group Premiums Based on Genetic
Information--This provision prohibits a health insurance issuer
offering group health coverage in connection with a group
health plan from adjusting premiums or contribution amounts for
a group on the basis of genetic information concerning an
individual in the group or a family member of the individual.
(2) Limitations on Genetic Testing--This section amends
section 2702 of the Public Health Service Act to include a
prohibition on genetic testing. Specifically, this provision
prohibits a group health plan or a health insurance issuer
offering group health insurance coverage in connection with a
group health plan from requesting or requiring an individual or
a family member of such individual to undergo a genetic test.
Section 102 does not limit the authority of the treating health
care professional to request that such individual or family
member undergo a genetic test. Nor does it limit the authority
of a health care professional who is employed by or affiliated
with the group health plan or health insurance issuer and who
is providing health care services to the enrolled individual as
part of a wellness program (as defined under regulations
implementing PHSA section 2702 at 45 CFR 146.121(f)) from
notifying such individual about the availability of a genetic
test or providing information about the genetic test. This
section does not authorize or permit a health care professional
to require that an individual undergo a genetic test. Finally,
this section clarifies that a health insurance company can
condition payment of an insurance claim on obtaining the
results of a genetic test or informing members of such
policies. However, the insurance company can only request the
minimum amount of information necessary to accomplish their
intended purpose. An exampleof why this would be necessary
could include a situation where someone was getting colonoscopies every
6 months and asking their health insurance provider to pay for these
services. A health insurance company should have the ability to ask why
these tests are occurring so frequently and should be able to require
evidence as to why this is medically necessary.
Application to All Plans--This provision applies the
requirements of the amendments made by section 102(a) of the
Genetic Information Nondiscrimination Act to small group health
plans (and group health insurance coverage offered in
connection with a group health plan) that are otherwise exempt,
under section 2721(a) of the Public Health Service Act, from
the nondiscrimination prohibitions under section 2702.
Genetic Information of a Fetus or Embryo--This section
amends title I to state that any reference to genetic
information concerning an individual or family member shall
also include the genetic information of any fetus carried by a
pregnant woman and shall include the genetic information of an
embryo legally held by an individual or family member (i.e.,
with respect to assisted reproductive technology, such as in-
vitro fertilization).
(3) Remedies and Enforcement--This section amends section
2722(b) of the Public Health Service Act to allow for
enforcement of the requirements the amendments made by section
102(a) against health insurance issuers offering group health
insurance coverage in connection with a group health plan. The
enforcement mechanism is the same as that created by HIPAA to
enforce existing non-discrimination provisions against health
insurance issuers offering group health insurance coverage in
connection with a group health plan under section 2702 of the
PHSA.
Enforcement Authority Relating to Genetic Discrimination--
In cases where the Secretary of HHS determines that a State has
failed to substantially enforce the requirements of the
amendments made by section 102(a) against a health insurance
issuer offering group health insurance coverage, the Secretary
has the authority to impose a civil monetary penalty on the
issuer.
Amount of Penalty--The Secretary of HHS may impose a civil
penalty against a group health plan for any violation of the
amendments made by section 102(a) in the amount of $100 for
each day of noncompliance with respect to each individual to
whom such failure relates. A higher penalty of $2,500 for each
day of non-compliance shall be applied where there are one or
more failures with respect to an individual and where the plan
did not correct the failure within the specified time. A
penalty of $15,000 shall be applied where the violation under
the amendments made by section 102(a) in any year is more than
de minimis.
Limitations--No penalty applies under this paragraph if the
Secretary determines that the person did not know, or through
reasonable diligence would not have known, that such failure
existed. No penalty shall be imposed on any failures due to
reasonable cause and not willful neglect; and if such failure
is corrected within 30 days of discovery. The overall
limitation for unintentional failures due to reasonable cause
shall not exceed the lesser of 10 percent of the amount paid or
incurred by the employer during the preceding taxable year for
group health plans or $500,000. The Secretary may waive all or
part of any penalty imposed by this section if the penalty
would be excessive relative to the failure involved.
(4) Definitions--This section adds new definitions to
section 2791(d) of the PHSA with respect to genetic non-
discrimination. A `Family Member' means, with respect to an
individual, a dependent of such individual as outlined in
section 2701(f)(2) and any other individual up to the fourth-
degree relative of such individual or dependent. `Genetic
Information' is defined as information about an individual's
genetic test; the genetic tests of family members; or the
occurrence of a disease or disorder in family members of the
individual. This section clarifies that genetic information
with respect to participation in clinical trials is included
within the scope of GINA's definition of genetic information.
Information about the sex or age of an individual is not
included. The definitions for `Genetic Test' and `Genetic
Services' are identical to the definitions applicable to group
health plans under section 101.
Subsection (b). Amendment relating to the individual market
(b)(1). This section adds a new section 2753 to subpart 2
to title XXVII of the PHSA relating to genetic
nondiscrimination.
Section 2753(a)--Prohibition on genetic information as a
condition of eligibility
A health insurance issuer in the individual market may not
establish rules for eligibility (including continued
eligibility) for an individual to enroll for coverage based on
genetic information (including information about a request for
or receipt of genetic services by an individual or family
member of such individual).
Section 2753(b)--Prohibition on genetic information in
setting premium rates
A health insurance issuer in the individual market shall
not adjust the premium or contribution amounts for an
individual on the basis of such individual's genetic
information (including information about a request for or
receipt of genetic services).
Section 2753(c).--Prohibition on genetic information as
preexisting condition
A health insurance issuer in the individual market shall
not impose any preexisting condition exclusion for an
individual on the basis of such individual's genetic
information (including information about a request for or
receipt of genetic services).
Section 2753(d).--Genetic testing
This provision prohibits a health insurance issuer in the
individual market from requesting or requiring an individual or
a family member of such individual to undergo a genetic test.
This provision does not limit the authority of the treating
health care professional to request that such individual or
family member undergo a genetic test. Nor does it limit the
authority of a health care professional who is employed by or
affiliated with the group health plan or health insurance
issuer and who is providing health care services to the
enrolled individual as part of a wellness program (as defined
under regulations implementing PHSA section 2702 at 45 CFR
146.121(f)) from notifying such individual about the
availability of a genetic test or providing information about
the genetic test. Finally, this provision does not authorize or
permit a health care professional to require that an individual
undergo a genetic test.
Genetic Information of a Fetus or Embryo--This section
states that any reference to genetic information concerning an
individual or family member shall also include the genetic
information of any fetus carried by a pregnant woman and shall
include the genetic information of an embryo legally held by an
individual or family member (i.e., with respect to assisted
reproductive technology, such as in-vitro fertilization).
(2) Remedies and Enforcement--This section amends section
2761 of the PHSA to establish the same enforcement mechanism
and Secretarial authority against health insurance issuers in
the individual market as is provided for enforcing the genetic
non-discrimination provisions against health insurance issuers
in the group market.
Subsection (c). Elimination of option of non-federal governmental plans
to be excepted from requirements concerning genetic information
This subtitle creates an exception to the existing opt-out
provision under section 2721(a)(1)(2) of the PHSA that provides
non-Federal governmental plans the ability to opt out of
certain requirements created by HIPAA. Therefore, all non-
Federal governmental health plans must comply with the genetic
non-discrimination requirements created by this Act in the same
manner as other non-governmental group health plans.
Subsection (d).--Regulations and effective date
Not later than one year after the date of enactment of this
title, the Secretary of Labor and the Secretary of HHS (as the
case may be) shall issue final regulations to carry out the
amendments made by this section. The amendments made by this
section shall apply to group health plans and insurance for
plan years beginning after the date that is 18 months after the
date of the enactment of this title. The amendments made by
this section shall apply to insurance in the individual market
18 months after the date of enactment.
Section 103. Amendments to Title XVIII of the Social Security Act
relating to Medigap
Subsection (a). Nondiscrimination
Section 103(a)(1). In general
Section 103(a)(1) amends section 1882(s)(2) of the Social
Security Act by adding the following:
An issuer of a Medicare supplemental policy shall not deny
or condition the issuance or effectiveness of the policy, and
shall not discriminate in the pricing of the policy (including
premium rate adjustments) of an individual on the basis of
genetic information (or information about a request for, or
receipt of, genetic services by such individual or family
member of such individual).
Section 103(a)(2). Effective date
Section 103(a)(2) states that the amendment made in section
103(a)(1) applies to a policy for policy years beginning after
the date that is 18 months after the date of enactment.
Section 103(b)(1). Limitation on genetic testing
Section 103(b)(1) amends section of 1882 of the Social
Security Act to prohibit an issuer of a Medicare supplemental
policy from requesting or requiring an individual or a family
member of such individual to undergo a genetic test. This
provision does not limit the authority of the treating health
care professional to request that such individual or family
member undergo a genetic test. Nor does it limit the authority
of a health care professional who is employed by or affiliated
with the issuer of the Medicare supplemental policy and who is
providing health care services to the enrolled individual as
part of a wellness program from notifying such individual about
the availability of a genetic test or providing information
about the genetic test. Finally, this provision does not
authorize or permit a health care professional to require that
an individual undergo a genetic test.
Definitions--The definitions of `family member,' `genetic
information,' and `genetic test,' and `genetic services' are
identical to the definitions applying to group health plans
under section 101. This subsection includes the following
additional definition:
Issuer of a Medicare Supplemental Policy--includes a third-
party administrator or other person acting for or on behalf of
such issuer.
Section 103(b)(2). Conforming amendment
Section 103(b)(2) requires an issuer to conform to and
abide by the protections against genetic discrimination
described in this section in order to be certified by the
Secretary as an issuer of a Medigap policy.
Section 103(c). Transition provisions
Section 103(c) requires the Secretary of HHS to identify
whether a State needs to change its statutes or regulations to
comply with this section. A State has until the earlier of the
date the State changes its statute or regulations to conform to
this section, or October 1, 2008 to make the necessary changes
and will not be considered out of compliance until such date.
The National Association of Insurance Commissioners (NAIC)
regulations shall be considered to be the applicable NAIC model
regulation if such regulations are updated in a timely manner
to be consistent with the Genetic Information Nondiscrimination
Act. If the NAIC does not modify its model regulations in the
timeframe established, the Secretary of HHS shall, not later
than October 1, 2008, promulgate the regulation. If a State
requires conforming legislation but its legislature is not
scheduled to meet in 2008, the date of required compliance
specified by 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 a State that has a 2-year legislative
session, each year of such sessions shall be deemed to be a
separate regular session of the State legislature.
Section 104. Privacy and confidentiality
Section 104(a). Applicability
The provisions in this section apply to all group health
plans and health insurance issuers that offer group health
insurance coverage in connection with a group health plan
without regard to section 732(a) of ERISA and section
9831(a)(2) of the Internal Revenue Code of 1986.
Section 104(b). Compliance with certain confidentiality standards with
respect to genetic information
In General--Part C of title XI of the Social Security Act
and section 264 of HIPAA shall apply to the use and disclosure
of genetic information by a group health plan or by a health
insurance issuer that offers group health insurance coverage in
connection with a group health plan.
Prohibition on Underwriting and Premium Rating--A group
health plan or health insurance issuer of a group health plan
shall not use or disclose genetic information (including
information about a request for or a receipt of genetic
services by an individual or family member of such individual)
for purposes of underwriting, determining eligibility to
enroll, premium rating, or the creation, renewal or replacement
of a plan, contract or coverage for health insurance or
benefits.
Section 104(c). Prohibition on collection of genetic information
(1) In General--A group health plan, health insurance
issuer, or issuer of a Medicare supplemental policy shall not
request, require, or purchase genetic information for purposes
of underwriting, determining eligibility to enroll, premium
rating, or the creation, renewal or replacement of a plan,
contract or coverage under the plan or for health insurance or
benefits.
(2) Limitation Relating to the Collection of Genetic
Information Prior to Enrollment--A group health plan, health
insurance issuer, or issuer of Medicare supplemental policy
shall not request, require, or purchase genetic information
concerning a participant, beneficiary, or enrollee prior to the
enrollment, and in connection with such enrollment, of such
individual under the plan, coverage, or policy.
(3) Incidental Collection--Where a group health plan,
health insurance issuer, or issuer of a Medicare supplemental
policy obtains genetic information incidental to the
requesting, requiring, or purchasing of other information
concerning an individual, such request, requirement, or
purchase shall not be considered a violation if it is not
obtained for purposes of underwriting as defined under
paragraph (1) and any genetic information obtained incidentally
is not used or disclosed in violation of the HHS medical
privacy regulations.
Section 104(d). Application of confidentiality standards
The requirements of this section apply only to group health
plans, health insurance issuers, and issuers of Medicare
supplemental policies that are otherwise covered under the HHS
medical privacy regulations. Therefore, the health plan
exceptions contained in the medical privacy regulations also
apply with respect to the requirements under this section. The
requirements of this section do not apply to genetic
information that is not considered to be individually-
identifiable under HHS medical privacy regulations.
Section 104(e). Enforcement
Covered entities under this section are subject to the same
penalties that exist for medical privacy regulations under
sections 1176 and 1177 of the Social Security Act for privacy
and confidentiality violations of genetic information under
section 104.
Section 104(f). Preemption
The preemption provision for this section is the same
standard that exists for the medical privacy regulations.
Specifically, a requirement under this section shall supersede
any contrary provision of State law unless such provision of
State law imposes requirements, standards, or implementation
specifications that are more stringent than those imposed under
this section. No penalty, remedy, or cause of action to enforce
such State law that is more stringent shall be preempted by
this section. This provision shall not be construed to
establish a penalty, remedy, or cause of action under State law
if it is not otherwise available under State law.
Section 104(g). Coordination with privacy regulations
The Secretary of HHS shall implement and administer this
section in a manner that is consistent with the medical privacy
regulations.
Section 104(h)(1). Definitions
The definitions of `family member,' `genetic information,'
`genetic services,' and `genetic test' are identical to the
definitions in section 2791 of the PHSA, as amended by the
bill.
(2) Group Health Plan/Health Insurance Issuer--These terms
include only those plans and issuers that are otherwise covered
under subsection (d)(1).
(3) Secretary--This term means the Secretary of Health and
Human Services.
Section 104A. Privacy and confidentiality
Section 104A(a). PHSA provisions
Section 104A(a)(1). Group health plans
This section amends title XXVII of the PHSA by adding a new
section 2703:
Section 2703. Privacy and confidentiality of genetic information
(a) Compliance with Certain Confidentiality Standards with
Respect to Genetic Information--The regulations established by
the Secretary in part C of title XI of the Social Security Act
and section 264 of HIPAA shall apply to the use or disclosure
of genetic information in the group health market. A group
health plan or health insurance insurer (in connection with
health insurance coverage offered in connection with a group
health plan) shall not use or disclose genetic information
(including information about a request for or a receipt of
genetic services by an individual or family member of such
individual) for purposes of underwriting, determining
eligibility, setting premiums, or creating, renewing or
replacing a health plan.
(b) Prohibition on Collection of Genetic Information--
(1) In General--A group health plan or health insurance
issuer (in connection with health insurance coverage offered in
connection with a group health plan) shall not request,
require, or purchase genetic information (including information
about a request for or a receipt of genetic services by an
individual or family member of such individual) for purposes of
underwriting, determining eligibility to enroll, premium
rating, or the creation, renewal or replacement of a plan,
contract or coverage under the plan or for health insurance or
benefits.
(2) Limitation Relating to the Collection of Genetic
Information Prior to Enrollment--A group health plan or health
insurance issuer (in connection with health insurance coverage
offered in connection with a group health plan) shall not
request, require, or purchase genetic information (including
information about a request for or a receipt of genetic
services by an individual or family member of such individual)
concerning a participant, beneficiary, or enrollee prior to the
enrollment, and in connection with such enrollment, of such
individual under the plan or coverage.
(3) Incidental Collection--Where a group health plan or
health insurance issuer (in connection with health insurance
coverage offered in connection with a group health plan)
obtains genetic information incidental to the requesting,
requiring, or purchasing of other information concerning an
individual, such request, requirement, or purchase shall not be
considered a violation if it is not obtained for purposes of
underwriting as defined under paragraph (1) and any genetic
information obtained incidentally is not used or disclosed in
violation of the HHS medical privacy regulations.
(c) Application of Confidentiality Standards--The
requirements of this section apply only to group health plans
and health insurance issuers that are otherwise covered under
the HHS medical privacy regulations. Therefore, the health plan
exceptions contained in the medical privacy regulations also
apply with respect to the requirements under this section. The
requirements of this section do not apply to genetic
information that is not considered to be individually-
identifiable under HHS medical privacy regulations.
(d) Coordination with Privacy Regulations--The Secretary of
HHS shall implement and administer this section in a manner
that is consistent with the medical privacy regulations.
(B) Application to Small Group Health Plans
This section amends section 2721(a) of the PHSA. Certain
small group health plans are currently exempt from the
requirements of subparts 1 and 3 of title XXVII of the PHSA.
These groups will continue to receive this exemption, but will
not be exempt from section 2703 of the PHSA.
Section 104A(a)(2). Individual health insurance
This section amends title XXVII of the PHSA by adding a new
section 2745:
Section 2745. Privacy and confidentiality of genetic information
(a) Compliance with Certain Confidentiality Standards with
Respect to Genetic Information--The regulations established by
the Secretary in part C of title XI of the Social Security Act
and section 264 of HIPAA shall apply to the use or disclosure
of genetic information in the individual health insurance
market. A health insurance insurer shall not use or disclose
genetic information (including information about a request for
or a receipt of genetic services by an individual or family
member of such individual) for purposes of underwriting,
determining eligibility, setting premiums, or creating,
renewing or replacing a health plan.
(b) Prohibition on Collection of Genetic Information--
(1) In General--A health insurance issuer shall not
request, require, or purchase genetic information (including
information about a request for or a receipt of genetic
services by an individual or family member of such individual)
for purposes of underwriting, determining eligibility to
enroll, premium rating, or the creation, renewal or replacement
of a plan, contract or coverage under the plan or for health
insurance or benefits.
(2) Limitation Relating to the Collection of Genetic
Information Prior to Enrollment--A health insurance issuer
shall not request, require, or purchase genetic information
(including information about a request for or a receipt of
genetic services by an individual or family member of such
individual) concerning a participant, beneficiary, or enrollee
prior to the enrollment, and in connection with such
enrollment, of such individual under the coverage.
(3) Incidental Collection--Where a health insurance issuer
obtains genetic information incidental to the requesting,
requiring, or purchasing of other information concerning an
individual, such request, requirement, or purchase shall not be
considered a violation if it is not obtained for purposes of
underwriting as defined under paragraph (1) and any genetic
information obtained incidentally is not used or disclosed in
violation of the HHS medical privacy regulations.
(c) Application of Confidentiality Standards--The
requirements of this section apply only to health insurance
issuers that are otherwise coveredunder the HHS medical privacy
regulations. Therefore, the health plan exceptions contained in the
medical privacy regulations also apply with respect to the requirements
under this section. The requirements of this section do not apply to
genetic information that is not considered to be individually-
identifiable under HHS medical privacy regulations.
(d) Coordination with Privacy Regulations--The Secretary of
HHS shall implement and administer this section in a manner
that is consistent with the medical privacy regulations.
Section 104A(b). Application to Medicare supplemental policies
This section amends section 1882 of the Social Security Act
by adding a new section (x):
(x) Privacy and Confidentiality of Genetic Information.
(1) Compliance with Certain Confidentiality Standards with
Respect to Genetic Information--The regulations established by
the Secretary in part C of title XI of the Social Security Act
and section 264 of HIPAA shall apply to the use or disclosure
of genetic information in by an issuer of a medicare
supplemental policy. An issuer of a medicare supplemental
policy shall not use or disclose genetic information (including
information about a request for or a receipt of genetic
services by an individual or family member of such individual)
for purposes of underwriting, determining eligibility, setting
premiums, or creating, renewing or replacing a plan, contract
or coverage.
(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
(including information about a request for or a receipt of
genetic services by an individual or family member of such
individual) for purposes of underwriting, determining
eligibility to enroll, premium rating, or the creation, renewal
or replacement of a plan, contract or coverage.
(B) Limitation Relating to the Collection of Genetic
Information Prior to Enrollment--An issuer of a medicare
supplemental policy shall not request, require, or purchase
genetic information (including information about a request for
or a receipt of genetic services by an individual or family
member of such individual) concerning an enrollee prior to the
enrollment, and in connection with such enrollment, of such
individual under the policy.
(C) Incidental Collection--Where the issuer of a medicare
supplemental policy obtains genetic information incidental to
the requesting, requiring, or purchasing of other information
concerning an enrollee, such request, requirement, or purchase
shall not be considered a violation if it is not obtained for
purposes of underwriting as defined under paragraph (1) and any
genetic information obtained incidentally is not used or
disclosed in violation of the HHS medical privacy regulations.
(3) Application of Confidentiality Standards--The
requirements of this section apply only to health insurance
issuers that are otherwise covered under the HHS medical
privacy regulations. Therefore, the health plan exceptions
contained in the medical privacy regulations also apply with
respect to the requirements under this section. The
requirements of this section do not apply to genetic
information that is not considered to be individually-
identifiable under HHS medical privacy regulations.
(d) Coordination with Privacy Regulations--The Secretary of
HHS shall implement and administer this section in a manner
that is consistent with the medical privacy regulations.
Section 105. Assuring coordination
Section 105 states that the Secretaries of Health and Human
Services, Labor and Treasury shall ensure, through the
execution of an interagency memorandum of understanding, that
regulations, rulings, and interpretations are administered to
have the same effect when there are two or more agencies of
jurisdiction. Such Secretaries shall pursue coordinated
enforcement strategies and assign priorities in enforcement.
Section 106. Relationship to title II with respect to enforcement
Section 106 states that the requirements of title I apply
to group health plans; health or other insurance coverage
issued in connection with group health plans, individual health
insurance coverage, and medicare supplemental policies. Nothing
in title II shall affect these entities.
Section 107. Regulations; effective date
Section 107 states that no later than one year after the
date of enactment, the Secretaries of HHS, Labor and Treasury
shall issue final regulations. The amendments made by this
title shall take effect 18 months after enactment, except as
provided in section 103.
Title II--Prohibiting Employment Discrimination on the Basis of Genetic
Information
Section 201. Definitions
Section 201 defines the term Commission and the parties
covered by the act--employee, employer, employment agency,
labor organization, member--and ensures that State, Federal and
congressional employees receive the same protections as other
employees who are covered by this act. Family members are
defined as the spouse or dependent child of an individual,
including a child who is born to or placed for adoption with
the individual, and all other individuals related by blood to
the individual or his/her spouse. Genetic information is
defined as information about genetic tests of an individual or
his/her family member. Genetic information also means
information about the occurrence of disease or disorder in
family members of the individual. It does not, however, include
information about the sex or age of an individual. Genetic
monitoring is defined as the periodic examination of employees
to evaluate acquired modifications to their genetic material
that may have occurred during employment. Genetic test is
defined as the analysis of human DNA, RNA, chromosomes,
proteins, or metabolites for certain reasons. It does not,
however, include analysis that does not detect genotypes,
mutations, or chromosomal changes. The section defines genetic
services consistent with title I.
Section 202. Employer practices
Section 202 makes it unlawful for an employer to request,
require or purchase genetic information. Several specific
exceptions are included: where an employer inadvertently
requests or requires family medical history information;
pursuant to an employer-sponsored wellness program; where the
information relating to a family member is requested or
required to comply with the certification provisions of Federal
or State family and medical leave laws; where an employer
purchases family medical history information that is publicly
available through such items as newspapers, periodicals and
books; or where the information is used for genetic monitoring
of the biological effects of toxic substances in the workplace.
Despite lawful acquisition of the information through these
exceptions, the section makes clear that the employer still may
not use or disclose the information in violation of the title.
Section 203. Employment agency practices
Section 203 extends parallel obligations and exceptions to
employment agencies as apply to employers under section 202.
Section 204. Labor organization practices
Section 204 extends parallel obligations and exceptions to
labor organizations as apply to employers under section 202.
Section 205. Training programs
Section 205 extends parallel obligations and exceptions to
joint labor-management committees as apply to employers under
section 202.
Section 206. Confidentiality of genetic information
Section 206 provides that an individual's genetic
information shall be treated and maintained as part of the
individual's confidential medical records. The information
shall be maintained on separate forms and in separate medical
files.
Disclosure is prohibited, except to: the individual; an
occupational or health researcher; in response to an order of a
court; to government officials investigating compliance with
this title; or to the extent that disclosure is made in
connection with the employee's compliance with the
certification provisions of section 103 of the Family and
Medical Leave Act, or such requirements under State family and
medical leave laws.
This section also states that HIPAA-covered entities will
remain covered by HIPAA. Non-HIPAA covered entities will be
covered by this Act.
Section 207. Remedies and enforcement
Section 207 incorporates by reference the powers, remedies,
and procedures set forth in title VII of the Civil Rights Act
of 1964, as amended. Similar powers, remedies and procedures
are specified for State, Federal and congressional employees.
Section 208. Disparate impact
Section 208 prohibits claims based on disparate impact, and
establishes a commission to review the science of genetics and
make recommendations to Congress regarding whether to provide a
disparate impact cause of action under the Civil Rights Act of
1964.
Section 209. Construction
Section 209 provides several rules of construction to
clarify the intent of the Committee and to assist courts in
interpreting the title. The section makes clear that this title
shall not be construed to limit the rights or protections of
individuals under the Americans with Disabilities Act or the
Rehabilitation Act of 1973. Similarly, the section clarifies
that title II does not create violations for employers,
employment agencies, labor organizations, or joint labor-
management committees of provisions under title I; section 106
also relates to this issue. The section clarifies that the Act
sets the floor for individual rights and protections and does
not limit the rights and protections under other Federal or
State laws. Workers compensation laws are neither expanded nor
restricted by the bill. Finally, the section provides rules of
construction to ensure the proper operation of Federal programs
and laws, including the Armed Services Repository of Specimen
Samples, occupational health and safety research, and workplace
safety and health laws and regulations.
Section 210. Medical information that is not genetic information
Section 210 makes clear that the Act does not extend to
manifested diseases and illnesses.
Section 211. Regulations
Section 211 states that not later than one year after the
date of enactment of this title, the Genetic Nondiscrimination
Study Commission shall issue final regulations to carry out
this title.
Section 212. Authorization of appropriations
Section 212 authorizes the appropriation of such sums as
may be necessary to carry out this title, except for section
208.
Section 213. Effective date
Section 213 states that this title takes effect 18 months
after the date of enactment.
Title III--Miscellaneous
Section 301. Severability
Section 301 states that if any provision of this Act is
held to be unconstitutional, the remainder of the Act shall not
be affected thereby.
Changes in Existing Law Made by the Bill, as Reported
In compliance with clause 3(e) of rule XIII of the Rules of
the House of Representatives, changes in existing law made by
the bill, as reported, are shown as follows (existing law
proposed to be omitted is enclosed in black brackets, new
matter is printed in italic, existing law in which no change is
proposed is shown in roman):
EMPLOYEE RETIREMENT INCOME SECURITY ACT OF 1974
* * * * * * *
TITLE I--PROTECTION OF EMPLOYEE BENEFIT RIGHTS
* * * * * * *
Subtitle B--Regulatory Provisions
* * * * * * *
Part 5--Administration and Enforcement
* * * * * * *
CIVIL ENFORCEMENT
Sec. 502. (a) * * *
* * * * * * *
(c) Genetic Testing.--
(1) Limitation on requesting or requiring genetic
testing.--A group health plan, or 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.--Nothing in this part shall
be construed to--
(A) limit the authority of a health care
professional who is providing health care
services with respect to an individual to
request that such individual or a family member
of such individual undergo a genetic test;
(B) limit the authority of a health care
professional who is employed by or affiliated
with a group health plan or a health insurance
issuer and who is providing health care
services to an individual as part of a bona
fide wellness program to notify such individual
of the availability of a genetic test or to
provide information to such individual
regarding such genetic test; or
(C) authorize or permit a health care
professional to require that an individual
undergo a genetic test.
(d) Application to All Plans.--The provisions of subsections
(a)(1)(F), (b)(3), and (c) shall apply to group health plans
and health insurance issuers without regard to section 732(a).
* * * * * * *
Part 7--Group Health Plan Requirements
Subpart A--Requirements Relating to Portability, Access, and
Renewability
* * * * * * *
SEC. 702. PROHIBITING DISCRIMINATION AGAINST INDIVIDUAL PARTICIPANTS
AND BENEFICIARIES BASED ON HEALTH STATUS.
(a) In Eligibility To Enroll.--
(1) In general.--Subject to paragraph (2), a group
health plan, and a health insurance issuer offering
group health insurance coverage in connection with a
group health plan, may not establish rules for
eligibility (including continued eligibility) of any
individual to enroll under the terms of the plan based
on any of the following health status-related factors
in relation to the individual or a dependent of the
individual:
(A) * * *
* * * * * * *
(F) Genetic information (including
information about a request for or receipt of
genetic services by an individual or family
member of such individual).
* * * * * * *
(b) In Premium Contributions.--
(1) * * *
(2) Construction.--Nothing in paragraph (1) shall be
construed--
(A) to restrict the amount that an employer
may be charged for coverage under a group
health plan except as provided in paragraph
(3); or
* * * * * * *
(3) No discrimination in group premiums based on
genetic information.--For purposes of this section, a
group health plan, or a health insurance issuer
offering group health insurance coverage in connection
with a group health plan, shall not adjust premium or
contribution amounts for a group on the basis of
genetic information concerning an individual in the
group or a family member of the individual (including
information about a request for or receipt of genetic
services by an individual or family member of such
individual).
(c) Genetic Testing.--
(1) Limitation on requesting or requiring genetic
testing.--A group health plan, or 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.--Nothing in this part shall
be construed to--
(A) limit the authority of a health care
professional who is providing health care
services with respect to an individual to
request that such individual or a family member
of such individual undergo a genetic test;
(B) limit the authority of a health care
professional who is employed by or affiliated
with a group health plan or a health insurance
issuer and who is providing health care
services to an individual as part of a bona
fide wellness program to notify such individual
of the availability of a genetic test or to
provide information to such individual
regarding such genetic test; or
(C) authorize or permit a health care
professional to require that an individual
undergo a genetic test.
(d) Application to All Plans.--The provisions of subsections
(a)(1)(F), (b)(3), and (c) shall apply to group health plans
and health insurance issuers without regard to section 732(a).
* * * * * * *
Subpart C--General Provisions
* * * * * * *
SEC. 733. DEFINITIONS.
(a) * * *
* * * * * * *
(d) Other Definitions.--For purposes of this part--
(1) * * *
* * * * * * *
(5) Family member.--The term ``family member'' means
with respect to an individual--
(A) the spouse of the individual;
(B) a dependent child of the individual,
including a child who is born to or placed for
adoption with the individual; and
(C) all other individuals related by blood to
the individual or the spouse or child described
in subparagraph (A) or (B).
(6) Genetic information.--
(A) In general.--Except as provided in
subparagraph (B), the term ``genetic
information'' means information about--
(i) an individual's genetic tests;
(ii) the genetic tests of family
members of the individual; or
(iii) the occurrence of a disease or
disorder in family members of the
individual.
(B) Exclusions.--The term ``genetic
information'' shall not include information
about the sex or age of an 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 (such as obtaining,
interpreting, or assessing genetic
information); or
(C) genetic education.
* * * * * * *
----------
PUBLIC HEALTH SERVICE ACT
* * * * * * *
TITLE XXVII--REQUIREMENTS RELATING TO HEALTH INSURANCE COVERAGE
Part A--Group Market Reforms
Subpart 1--Portability, Access, and Renewability Requirements
* * * * * * *
SEC. 2702. PROHIBITING DISCRIMINATION AGAINST INDIVIDUAL PARTICIPANTS
AND BENEFICIARIES BASED ON HEALTH STATUS.
(a) In Eligibility To Enroll.--
(1) In general.--Subject to paragraph (2), a group
health plan, and a health insurance issuer offering
group health insurance coverage in connection with a
group health plan, may not establish rules for
eligibility (including continued eligibility) of any
individual to enroll under the terms of the plan based
on any of the following health status-related factors
in relation to the individual or a dependent of the
individual:
(A) * * *
* * * * * * *
(F) Genetic information (including
information about a request for or receipt of
genetic services by an individual or family
member of such individual).
* * * * * * *
(b) In Premium Contributions.--
(1) * * *
(2) Construction.--Nothing in paragraph (1) shall be
construed--
(A) to restrict the amount that an employer
may be charged for coverage under a group
health plan, except as provided in paragraph
(3); or
* * * * * * *
(3) No discrimination in group premiums based on
genetic information.--For purposes of this section, a
group health plan, or a health insurance issuer
offering group health insurance coverage in connection
with a group health plan, shall not adjust premium or
contribution amounts for a group on the basis of
genetic information concerning an individual in the
group or a family member of the individual (including
information about a request for or receipt of genetic
services by an individual or family member of such
individual).''.
(c) Genetic Testing.--
(1) Limitation on requesting or requiring genetic
testing.--A group health plan, or 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) Certain rules of construction.--Nothing in this
part shall be construed to--
(A) limit the authority of a health care
professional who is providing health care
services with respect to an individual to
request that such individual or a family member
of such individual undergo a genetic test;
(B) limit the authority of a health care
professional who is employed by or affiliated
with a group health plan or a health insurance
issuer and who is providing health care
services to an individual as part of a bona
fide wellness program to notify such individual
of the availability of a genetic test or to
provide information to such individual
regarding such genetic test; or
(C) authorize or permit a health care
professional to require that an individual
undergo a genetic test.
(3) Rule of construction regarding payment.--
(A) In general.--Subject to subparagraph (B),
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 conditioning payment on obtaining
the results of a genetic test or informing
members of such policies. For purpose of the
preceding sentence, the term ``payment''
includes reimbursement, billing, claims
management, claims adjudication, review of
health care services with respect to medical
necessity, coverage under a health plan,
appropriateness of care, or justification of
charges, and utilization review (including
precertification, prior authorization,
concurrent and retrospective review).
(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.
(d) Application to All Plans.--The provisions of subsections
(a)(1)(F), (b)(3), and (c) shall apply to group health plans
and health insurance issuers without regard to section 2721(a).
(e) 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--
(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. 2703. PRIVACY AND CONFIDENTIAL OF GENETIC INFORMATION.
(a) Compliance With Certain Confidentiality Standards With
Respect to Genetic Information.--
(1) In general.--The regulations promulgated by the
Secretary 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) shall apply to the
use or disclosure of genetic information by a group
health plan or by an health insurance issuer in
connection with health insurance coverage offered in
connection with a group health plan.
(2) Prohibition on underwriting and premium rating.--
Notwithstanding paragraph (1), a group health plan or a
health insurance issuer (in connection with health
insurance coverage offered in connection with a group
health plan) shall not use or disclose genetic
information (including information about a request for
or a receipt of genetic services by an individual or
family member of such individual) for purposes of
underwriting, determinations of eligibility to enroll,
premium rating, or the creation, renewal or replacement
of a plan, contract or coverage for health insurance or
health benefits.
(b) Prohibition on Collection of Genetic Information.--
(1) In general.--A group health plan or health
insurance issuer (in connection with health insurance
coverage offered in connection with a group health
plan) shall not request, require, or purchase genetic
information (including information about a request for
or a receipt of genetic services by an individual or
family member of such individual) for purposes of
underwriting, determinations of eligibility to enroll,
premium rating, or the creation, renewal or replacement
of a plan, contract or coverage for health insurance or
health benefits.
(2) Limitation relating to the collection of genetic
information prior to enrollment.--A group health plan
or health insurance issuer (in connection with health
insurance coverage offered in connection with a group
health plan) shall not request, require, or purchase
genetic information (including information about a
request for or a receipt of genetic services by an
individual or family member of such individual)
concerning a participant, beneficiary, or enrollee
prior to the enrollment, and in connection with such
enrollment, of such individual under the plan or
coverage.
(3) Incidental collection.--Where a group health plan
or health insurance issuer (in connection with health
insurance coverage offered in connection with a group
health plan) obtains genetic information incidental to
the requesting, requiring, or purchasing of other
information concerning a participant or beneficiary,
such request, requirement, or purchase shall not be
considered a violation of this subsection if--
(A) such request, requirement, or purchase is
not in violation of paragraph (1); and
(B) any genetic information (including
information about a request for or receipt of
genetic services) requested, required, or
purchased is not used or disclosed in violation
of subsection (a).
(c) Application of Confidentiality Standards.--The provisions
of subsections (a) and (b) shall not apply--
(1) to group health plans or health insurance issuers
that are not otherwise covered under the regulations
promulgated by the Secretary 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);
and
(2) to genetic information that is not considered to
be individually-identifiable health information under
the regulations promulgated by the Secretary 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).
(d) Coordination With Privacy Regulations.--The Secretary
shall implement and administer this section in a manner that is
consistent with the implementation and administration by the
Secretary of the regulations promulgated by the Secretary 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).
* * * * * * *
Subpart 4--Exclusion of Plans; Enforcement; Preemption
SEC. 2721. EXCLUSION OF CERTAIN PLANS.
(a) Exception for Certain Small Group Health Plans.--The
requirements of subparts 1 and 3 (other than section 2703)
shall not apply to any group health plan (and health insurance
coverage offered in connection with a group health plan) for
any plan year if, on the first day of such plan year, such plan
has less than 2 participants who are current employees.
(b) Limitation on Application of Provisions Relating to Group
Health Plans.--
(1) * * *
(2) Treatment of nonfederal governmental plans.--
(A) Election to be excluded.--[If the plan
sponsor] Except as provided in subparagraph
(D), if the plan sponsor of a nonfederal
governmental plan which is a group health plan
to which the provisions of subparts 1 through 3
otherwise apply makes an election under this
subparagraph (in such form and manner as the
Secretary may by regulations prescribe), then
the requirements of such subparts insofar as
they apply directly to group health plans (and
not merely to group health insurance coverage)
shall not apply to such governmental plans for
such period except as provided in this
paragraph.
* * * * * * *
(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) and (c) of section 2702
and the provisions of section 2702(b) to the
extent that such provisions apply to genetic
information (or information about a request for
or the receipt of genetic services by an
individual or a family member of such
individual).
SEC. 2722. ENFORCEMENT.
(a) * * *
(b) Secretarial Enforcement Authority.--
(1) * * *
* * * * * * *
(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 following provisions
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), or (c) of section 2702 or section 2701
or 2702(b)(1) with respect to genetic
information.
(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 individual 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 such
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.
* * * * * * *
SEC. 2744A. PRIVACY AND CONFIDENTIALITY OF GENETIC INFORMATION.
(a) Compliance With Certain Confidentiality Standards With
Respect to Genetic Information.--
(1) In general.--The regulations promulgated by the
Secretary 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) shall apply to the
use or disclosure of genetic information by an health
insurance issuer in connection with individual health
insurance coverage.
(2) Prohibition on underwriting and premium rating.--
Notwithstanding paragraph (1), a health insurance
issuer shall not use or disclose genetic information
(including information about a request for or a receipt
of genetic services by an individual or family member
of such individual) for purposes of underwriting,
determinations of eligibility to enroll, premium
rating, or the creation, renewal or replacement of a
plan, contract or coverage for health insurance or
health benefits in the individual market.
(b) Prohibition on Collection of Genetic Information.--
(1) In general.--A health insurance issuer shall not
request, require, or purchase genetic information
(including information about a request for or a receipt
of genetic services by an individual or family member
of such individual) for purposes of underwriting,
determinations of eligibility to enroll, premium
rating, or the creation, renewal or replacement of a
plan, contract or coverage for health insurance or
health benefits in the individual market.
(2) Limitation relating to the 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 (including information
about a request for or a receipt of genetic services by
an individual or family member of such individual)
concerning an enrollee prior to the enrollment, and in
connection with such enrollment, of such individual
under the coverage.
(3) Incidental collection.--Where a health insurance
issuer obtains genetic information incidental to the
requesting, requiring, or purchasing of other
information concerning an enrollee in the individual
market, such request, requirement, or purchase shall
not be considered a violation of this subsection if--
(A) such request, requirement, or purchase is
not in violation of paragraph (1); and
(B) any genetic information (including
information about a request for or receipt of
genetic services) requested, required, or
purchased is not used or disclosed in violation
of subsection (a).
(c) Application of Confidentiality Standards.--The provisions
of subsections (a) and (b) shall not apply--
(1) to health insurance issuers that are not
otherwise covered under the regulations promulgated by
the Secretary 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); and
(2) to genetic information that is not considered to
be individually-identifiable health information under
the regulations promulgated by the Secretary 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).
(d) Coordination With Privacy Regulations.--The Secretary
shall implement and administer this section in a manner that is
consistent with the implementation and administration by the
Secretary of the regulations promulgated by the Secretary 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).
* * * * * * *
Part B--Individual Market Rules
* * * * * * *
Subpart [3] 2--Other Requirements
* * * * * * *
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 (including information
about a request for or receipt of genetic services by an
individual or family member of such individual).
(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 (including information about a request for or
receipt of genetic services by an individual or family member
of such 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 (including information about a request for
or receipt of genetic services by an individual or family
member of such individual), 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) Certain rules of construction.--Nothing in this
part shall be construed to--
(A) limit the authority of a health care
professional who is providing health care
services with respect to an individual to
request that such individual or a family member
of such individual undergo a genetic test;
(B) limit the authority of a health care
professional who is employed by or affiliated
with a health insurance issuer and who is
providing health care services to an individual
as part of a bona fide wellness program to
notify such individual of the availability of a
genetic test or to provide information to such
individual regarding such genetic test; or
(C) authorize or permit a health care
professional to require that an individual
undergo a genetic test.
(3) Rule of construction regarding payment.--
(A) In general.--Subject to subparagraph (B),
nothing in paragraph (1) shall be construed to
preclude a health insurance issuer offering
health insurance coverage in the individual
market from conditioning payment on obtaining
the results of a genetic test or informing
members of such policies. For purpose of the
preceding sentence, the term ``payment''
includes reimbursement, billing, claims
management, claims adjudication, review of
health care services with respect to medical
necessity, coverage under a health plan,
appropriateness of care, or justification of
charges, and utilization review (including
precertification, prior authorization,
concurrent and retrospective review).
(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.
(e) 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--
(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.
Subpart 3--General Provisions
SEC. 2761. ENFORCEMENT.
(a) * * *
[(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) 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.]
(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.
* * * * * * *
Part C--Definitions; Miscellaneous Provisions
SEC. 2791. DEFINITIONS.
(a) * * *
* * * * * * *
(d) Other Definitions.--
(1) * * *
* * * * * * *
(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 information about--
(i) an individual's genetic tests;
(ii) the genetic tests of family
members of the individual; or
(iii) the occurrence of a disease or
disorder in family members of the
individual.
(B) Inclusion of genetic services and
participation in genetic research.--Such term
includes, with respect to any individual, any
request for genetic services, receipt of
genetic services, or participation in any
clinical research, or any other program, which
includes genetic services, by such individual
or any family member of such individual.
(C) Exclusions.--The term ``genetic
information'' shall not include information
about the sex or age of an 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 (such as obtaining,
interpreting, or assessing genetic
information); or
(C) genetic education.
----------
SOCIAL SECURITY ACT
* * * * * * *
TITLE XI--GENERAL PROVISIONS, PEER REVIEW, AND ADMINISTRATIVE
SIMPLIFICATION
* * * * * * *
TITLE XVIII OF THE SOCIAL SECURITY ACT
Part E--Miscellaneous Provisions
* * * * * * *
CERTIFICATION OF MEDICARE SUPPLEMENTAL HEALTH INSURANCE POLICIES
Sec. 1882. (a) * * *
* * * * * * *
(o) The requirements of this subsection are as follows:
(1) * * *
* * * * * * *
(4) The issuer of the medicare supplemental policy
complies with subsection (s)(2)(E) and subsection (x).
* * * * * * *
(s)(1) * * *
(2)(A) * * *
* * * * * * *
(E)(i) An issuer of a medicare supplemental policy shall not
deny or condition the issuance or effectiveness of the policy,
and shall not discriminate in the pricing of the policy
(including the adjustment of premium rates) of an eligible
individual on the basis of genetic information concerning the
individual (or information about a request for, or the receipt
of, genetic services by such individual or family member of
such individual).
(ii) For purposes of clause (i), the terms ``family member'',
``genetic services'', and ``genetic information'' shall have
the meanings given such terms in subsection (x).
* * * * * * *
(x) Limitations on Genetic Testing.--
(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.--Nothing in this
title shall be construed to--
(i) limit the authority of a health
care professional who is providing
health care services with respect to an
individual to request that such
individual or a family member of such
individual undergo a genetic test;
(ii) limit the authority of a health
care professional who is employed by or
affiliated with an issuer of a medicare
supplemental policy and who is
providing health care services to an
individual as part of a bona fide
wellness program to notify such
individual of the availability of a
genetic test or to provide information
to such individual regarding such
genetic test; or
(iii) authorize or permit a health
care professional to require that an
individual undergo a genetic test.
(2) Definitions.--In this subsection:
(A) Family member.--The term ``family
member'' means with respect to an individual--
(i) the spouse of the individual;
(ii) a dependent child of the
individual, including a child who is
born to or placed for adoption with the
individual; or
(iii) any other individuals related
by blood to the individual or to the
spouse or child described in clause (i)
or (ii).
(B) Genetic information.--
(i) In general.--Except as provided
in clause (ii), the term ``genetic
information'' means information about--
(I) an individual's genetic
tests;
(II) the genetic tests of
family members of the
individual; or
(III) the occurrence of a
disease or disorder in family
members of the individual.
(ii) Exclusions.--The term ``genetic
information'' shall not include
information about the sex or age of an
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 (such as
obtaining, interpreting, or assessing
genetic information); or
(iii) genetic education.
(E) 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.
(y) Privacy and Confidentiality of Genetic Information.--
(1) Compliance with certain confidentiality standards
with respect to genetic information.--
(A) In general.--The regulations promulgated
by the Secretary 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) shall apply to the use or
disclosure of genetic information by an issuer
of a medicare supplemental policy.
(B) Prohibition on underwriting and premium
rating.--Notwithstanding subparagraph (A), an
issuer of a medicare supplemental policy shall
not use or disclose genetic information
(including information about a request for or a
receipt of genetic services by an individual or
family member of such individual) for purposes
of underwriting, determinations of eligibility
to enroll, premium rating, or the creation,
renewal or replacement of a plan, contract or
coverage for health insurance or health
benefits in connection with such policy.
(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 (including
information about a request for or a receipt of
genetic services by an individual or family
member of such individual) for purposes of
underwriting, determinations of eligibility to
enroll, premium rating, or the creation,
renewal or replacement of a plan, contract or
coverage for health insurance or health
benefits in connection with such policy.
(B) Limitation relating to the collection of
genetic information prior to enrollment.--An
issuer of a medicare supplemental policy shall
not request, require, or purchase genetic
information (including information about a
request for or a receipt of genetic services by
an individual or family member of such
individual) concerning an enrollee prior to the
enrollment, and in connection with such
enrollment, of such individual under the
policy.
(C) Incidental collection.--Where the issuer
of a medicare supplemental policy obtains
genetic information incidental to the
requesting, requiring, or purchasing of other
information concerning an enrollee in
connection with such a policy, such request,
requirement, or purchase shall not be
considered a violation of this paragraph if--
(i) such request, requirement, or
purchase is not in violation of
subparagraph (A); and
(ii) any genetic information
(including information about a request
for or receipt of genetic services)
requested, required, or purchased is
not used or disclosed in violation of
paragraph (1).
(3) Application of confidentiality standards.--The
provisions of paragraphs (1) and (2) shall not apply--
(A) to health insurance issuers that are not
otherwise covered under the regulations
promulgated by the Secretary 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); and
(B) to genetic information that is not
considered to be individually-identifiable
health information under the regulations
promulgated by the Secretary 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).
(4) Coordination with privacy regulations.--The
Secretary shall implement and administer this
subsection in a manner that is consistent with the
implementation and administration by the Secretary of
the regulations promulgated by the Secretary 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).
* * * * * * *
ADDITIONAL VIEWS
Although the Committee has made important improvements to
H.R. 493, the ``Genetic Information Non-Discrimination Act''
(GINA), we believe it is imperative that all parties continue
to work to improve this legislation and address the issues we
raise in these additional views. We believe there are
significant technical problems with the legislation in its
current form. We respect the changes and the work of the
Committee in the short period of time from the hearing to full
committee markup. We note the inclusion of information on
embryos, fetuses, and adopted children; a clear statement that
Title II does not apply to group health plans and insurers; a
clear statement that nothing affects claims processing and
related items; and, an exemption from the unworkable Title II
mandates for entities already subject to regulations governing
personally identifiable health information. Among other things
we believe these changes should be consistent with group health
plans and health insurance issuers providing information to
providers or individuals about genetic tests for coverage and
benefits, treatment alternatives, disease management, case
management, patient care management, care coordination and
prevention programs. These programs are today improving the
quality of health care and nothing in this bill should
undermine such efforts. These are solid steps in the right
direction,
The primary author of the House bill, Ms. Slaughter, has
stated:
GINA prohibits group health plans and health insurers
from denying coverage to a healthy individual or
charging that person higher premiums based solely on a
genetic predisposition to develop a disease in the
future. Furthermore, it bars employers from using an
individual's genetic information when making hiring,
firing, job placement or promotion decisions.
We want to focus the legislation on these objectives and
not go beyond them. The drafting simply does not match, or at
least is not tailored to, the statement of the primary sponsor.
The legislation, in its current form, will needlessly disrupt
and hinder positive activities and policies for employers,
insurers and health care. These are not easy issues. The
protagonists of GINA have delved into some sweeping and
difficult arenas: the ability to define and segregate ``genetic
information'' from other medical information, new permutations
of civil rights laws, new restrictions on health information,
occupational safety issues, and Federal-State relations are
among them. We think the suggestions we make below could be
very helpful.
The New Regulatory Regime in Title II for the Delivery of Health Care
and Related Services That May Be Offered by or Sponsored by Employers
is Inappropriate
CONCERNS REGARDING DELIVERY OF HEALTH CARE
Title III of GINA would launch a new health information
regulatory scheme that would be administered out of the Equal
Employment Opportunities Commission. Our understanding is this
scheme would cover, in part, the communications of certain
health care providers or companies providing electronic health
record services. Specifically, if an employer is providing a
health service or electronic record service, the provisions of
Title II of GINA attach. Providing a service includes both in-
house employees and contracts with other entities.
We fail to see why covering the delivery of health care and
health services in Title II has anything to do with hiring,
firing, job placement or promotion decisions. People delivering
health care and health services are not hiring or firing
people. Health information, including genetic information is
critical to the delivery of care. If a company is providing a
personal health record service it is technically problematic
and detrimental to the patient to sanitize information like
family medical history or other genetic information.
Here are the potential problems:
1. GINA provides that the medical decisions of certain
health care providers in using genetic information can be a
basis for a civil rights violation. That means the practice of
medicine may be subject to claims of discrimination, even
though they have nothing to do with hiring, firing, job
placement or promotion.
2. Under section 202(b), 202(c) and 206(b) the
communications in the process of health services are restricted
well above what is appropriate under the extensive privacy
regulations governed by the Department of Health and Human
Services.
3. These restrictions will inhibit the coordination of care
among health providers, slow down processing and care because
of the need to evaluate each document to sanitize or specially
handle information, and increase medical errors.
4. These restrictions will essentially make employer
participation in electronic health record services and personal
health record services extremely burdensome. Indeed,
contracting with a company to provide such services for
employees is covered under the information restrictions of
Title II.
5. This health information regulatory regime would be
inconsistent with the regime run by the Department of Health
and Human Services.
We should not penalize the good that employers can do for
their employees by providing health care services or electronic
health record services. Sponsorship of the delivery of health
care by an employer is not hiring, firing, job placement or
promotion. And genetic information is important to the delivery
of health care. We believe nothing in Title II should apply to
the actions or communication respecting the delivery,
administration, or operation of health care including any
health services, pharmacies, health records services, health
counseling, or health education. We also believe that nothing
in either title should regulate actions or communications
respecting the practice of medicine including but not limited
to diagnosis, treatment, counseling and education. These
activities clearly fall outside the scope of the author of
GINA's stated intent. We would like to work with all parties
and craft language that makes these points clear.
We are pleased at the amendments in Full Committee that
would exempt covered entities within the meaning of the Health
Insurance Portability and Accountability Act (HIPAA) Privacy
Rule from the unworkable mandates of Title II. This helps with
respect to the concerns we raise in a number of instances, but
not in others.
We have heard specific concerns regarding the application
of sections 202(b) and 206(b) and the broad definitions and
prohibitions as they might restrict or delay further adoption
of electronic health records and personal health records.
We note that the exclusion for HIPAA covered entities is
helpful but will not fully address the issues. We fear these
points are just the tip of the iceberg. We see no reason that
the delivery of health care should be regulated or restricted
by Title II. These issues have nothing to do with Ms.
Slaughter's stated purpose concerning making hiring, firing,
job placement or promotion decisions. However, the current bill
could drastically impede a much shared goal to transform our
health care system through utilization of electronic health
records.
The Information Regulations in Title II Are Overly Broad and Unworkable
A SWEEPING NEW REGULATORY SCHEME
Title II has sweeping breadth. It covers employers from the
FBI to NASA to laboratories, to State and local governments, to
nuclear power plants, to hospitals, and many more. Title II
restricts information flow in numerous settings from employers
involved in responses to pandemic flu outbreaks, to employers
involved in judicial proceedings, to health and safety
monitoring, and to employers administering or sponsoring
benefits. We cannot today easily imagine all of the
circumstances. The HIPAA Privacy Rule gives us a clue to this
complexity. It is a complex series of extensively debated
exceptions to prohibited uses and disclosures of information.
The proposed rule received over 50,000 comments and the next
proposed set of modifications received over 11,000 comments.
Among other things, this draft document will point out below
how section 202(b) and 206 and other provisions of GINA fail to
include the numerous exclusions for use and disclosure that HHS
had to address in the Privacy Rule. The Americans with
Disabilities Act also has information regulations with respect
to disability related inquiries and medical examinations.
Rather than use the knowledge from either of these two models,
GINA strikes out on a third, unworkable scheme. The biggest
problem is that subsections like 202(b), 203(b), 204(b) and
206(b) start with sweeping prohibitions on either acquisition
or disclosure of information. These subsections then follow
with exactly five specific exemptions. Note that these
exemptions are not even coextensive between subsections 202(b)
and 206(b).
Based on this statutory structure, it may be impossible for
the Equal Employment Opportunities Commission to argue that it
could add to the list of statutory exemptions. Accordingly, the
authors of GINA must assume Congress has contemplated all
reasonable circumstances for acquisition and disclosure by
employers or sponsored activities and set them out in the
exemptions. Although the Privacy Rule starts out withbans on
use and disclosure, there are dozens of important exceptions. For
example, if you were to work with a contract organization to manage
records, that would fall under the business associate provisions of the
rule. Even disclosures for civil and criminal litigation, law
enforcement, to heirs of decedents, for serious threats to health and
safety, essential government functions, incidental uses, workers
compensation, treatment, payment, health care operations all have
specific exceptions. These exceptions are not in GINA. We are not
saying all of the Privacy Rule map perfectly to the employer context.
(We are saying that for delivery of health care). However, many of the
Privacy Rule's permitted uses and disclosures include normal and
routine uses and disclosures, including those important for the public
good. These would seem to make sense and be necessary within the
context of GINA.
EXAMPLES IN THE LAW ENFORCEMENT AND JUDICIAL SETTINGS
Moreover, even where GINA has exemptions they are not
always logical. Consider this concern voiced in technical
assistance from the FBI:
Section 206, subpart (b)(3), permits an employer to
provide genetic information concerning an employee or a
request by the employee for genetic services in
response to a court order ONLY after providing notice
to the employee of the court order and permitting the
employee to challenge the order. It doesn't distinguish
between civil cases and criminal cases, or those
situations in which the court order may require that
the recipient not disclose the order. The section also
does not describe how the recipient employer is
supposed to handle notice if the employee no longer
works for their company, or has moved from their last
address known to the employer, or has died.
These are valid considerations. In fact, we are wondering
why GINA would in any way suggest anything other than full
compliance with a court order. And why would GINA impose a duty
of notice concerning such an order to an employer. Notice to
the employee to challenge any order should come through the
court.
In fact, when compared with GINA, the HIPAA Privacy Rule
permits disclosures pursuant to warrants, subpoenas and
administrative orders. GINA does not. Is GINA forbidding
response to such orders? The Privacy Rule would allow a covered
entity to respond to the request of law enforcement officials
for blood type information. As discussed below, blood typing
seems to ``detect a genotype'' within the meaning of the GINA
definitions. Why should GINA be more restrictive with respect
to law enforcement and judicial proceedings that the current
HIPAA regulations?
Some employers use DNA identification tests, which appear
to be covered by the GINA definitions. For example, labs and
some policy enforcement organizations may take DNA samples to
help unravel contamination issues at labs or crime scenes. Some
employers provide for medical monitoring programs to protect
against injuries to employees. We received the following
technical assistance from FBI:
Section 201. Recommend narrowing the definition of
``genetic test'' to the following, and to strike the
subsection on Exceptions:
The term ``genetic test'' means--the analysis of
human DNA, RNA, chromosomes, proteins, or certain
metabolites in order to detect disease-related
genotypes or related phenotypes. The term does not
apply to any such testing which is conducted for the
exclusive purposes of identification, where no
information regarding the sample is to be provided to
any entity for the purposes of determining any health
related information regarding either the individual or
members of the individual's family.
We received this point as technical assistance from staff
in the Bureau of Alcohol, Tobacco, and Firearms (ATF):
``. . . . Please let me know if there is anything we
in the forensic DNA community can do to aid in the
modification of this bill so it will not have the
unintentional effects that it may have as written. I
have outlined my concerns below. . . .
Forensic DNA technology has progressed to the point
that it is possible to obtain a DNA profile from
handled objects or even a fingerprint. Because of this,
most forensic DNA labs have created a staff DNA index.
Any DNA profiles developed from evidence are then
compared to the staff index. This accomplishes two
things. First, if the DNA profile developed from the
evidence is actually from an investigator or laboratory
person and not the true perpetrator, a false exclusion
might be made. Second, unknown profiles developed from
evidence are typically uploaded to the Combined DNA
Index System (CODIS). If the investigator's profile or
laboratory scientist's profile is not caught through
the use of a staff index, the profile would be uploaded
to CODIS. If it happens again, two unrelated crimes
could subsequently linked that are not truly linked.''
We received this point as technical assistance from the
staff of the Veterans Administration:
This section does not authorize disclosure in
administrative or court proceedings in which the
employee has either placed the genetic condition at
issue or raised a claim for which the information is
clearly relevant. It would appear that VA, as an
employer, could not provide the records to an
administrative entity upon its request or order without
first obtaining a Federal court order to produce the
information.
EXAMPLES FOR HEALTH AND SAFETY MONITORING ISSUES
Beyond these judicial and law enforcement issues are safety
issues:
Mr. Deal asked the witness from the EEOC the following
question:
We want your interpretation of section 202(b)(5)(B).
Assume that genetic monitoring is not required by
Federal or state law. The business nonetheless feels
that safety requires such monitoring. If the employee
says he does not want to be subject to such monitoring,
does the employer still have the right to reassign him
away from the position that needed the monitoring? Or
must the employer allow the employee to continue
without the monitoring?
Our understanding is the EEOC witness stated that
reassigning an employee who refuses to provide information for
monitoring described above would be subject to a claim of an
illegal employer practice under GINA. This is a problem. Why
would we take away from employers the ability to demand
monitoring for worker safety?
We further note that the definition of acceptable genetic
monitoring is only in the context of exposure at the work
place. If an employer is monitoring for infectious diseases to
protect public safety, such monitoring does not seem to have an
exception to allow consideration of genetic information in that
context.
WAYS TO REDUCE THE PROBLEMS
All of the above pieces of technical assistance, letters,
or testimony identify unexpected problems with the prohibitions
on acquisition and disclosure. We believe these are just the
tip of the iceberg. The EEOC has provided some technical
assistance that might provide for regulatory authority to
create additional exemptions. In addition, employer
stakeholders have been asking Congress to not use language like
that in subsections 202(b) or 206(b). Employers note the model
under the Americans with Disabilities Act is familiar to them
and more workable. It seems entirely possible to use language
similar to that under the ADA provisions to make this law
consistent. Until there are changes to these sections, GINA
poses many counterproductive results. We would like to work
with all parties to eliminate these counterproductive results.
GINA Contains Inconsistent, Overly Broad and Unworkable Definitions of
Genetic Test and Genetic Information
The terms genetic test and genetic information are overly
broad in GINA. The definitions are inconsistent between titles
and not matched to the policy purpose. Forty-three states have
definitions. None of the state definitions are as broad or as
unworkable as the definitions in GINA. GINA simply includes
information well beyond tests intended to find a predictive
genetic marker for a genetic disease. Title II of GINA covers
blood typing, tissue typing, cancer tumor typing, DNA forensic
information, genotypic information useful to reduce adverse
reactions to treatments and therapies, and more. The definition
of genetic information includes ``the occurrence of a disease
in a family member''--even when not used for predictive
purposes.
Apparently, if we were to ask one of our staff how one of
their children were doing with the flu or other disease, we
would be requesting genetic information within the meaning of
GINA. Apparently, if an employer is testing for drugs but that
test also detects the blood type AB in an employee, that test
detected a genotype and would besubject to the sanctions of
this bill.
It is not alright to subject employers to vague and
unworkable standards and levy the threat of sanctions for civil
rights violations against them. The current language of this
bill could have serious negative consequences to both the
individual and public health by saddling health and safety
monitoring, electronic health information systems, health care
providers, emergency preparedness efforts, claims processing
for workers compensation and many other items with the burden
of separating legitimate medical information into two file
folders.
As Dr. Francis Collins testified, genetic information is
basically medical information. To treat it under a separate
regulatory regime for items such as medical monitoring for
employee safety or employee sponsored health services will
remove vital information for vital purposes. This will create
medical errors and needless bureaucracy.
PROBLEMS WITH THE SWEEP OF INCLUDING THE OCCURRENCE OF A DISEASE OR
DISORDER IN FAMILY MEMBERS WITHOUT FURTHER LIMITATION OR CLARIFICATION
On the point concerning ``the occurrence of a disease or
disorder in a family member'', under subsection 202(b) an
employer may not request or require such information, unless
pursuant to a specific exception. We realize that the
occurrence of a disease or disorder could be part of a scheme
to forecast a genetic disease in an employee. It is also useful
information for many other purposes. We believe that the basic
intent of the authors is to regulate a predictive assessment
concerning an individual's propensity to get an inheritable
genetic disease or disorder based on the occurrence of an
inheritable genetic disease or disorder in the family member.
After all, if an employer or insurer is not trying to make such
a predictive assessment, they really are not within the scope
of the policy purpose of the bill. By using the broader
universe of information concerning ``a disease or disorder in a
family member'' GINA opens up an incredible range of
workability problems. Note that ``a disease or disorder'' does
not have to be a genetic disease or disorder. It could just be
a cold or a disease that came from poisoning.
If an employer sponsors a benefit for an employee to raise
money for the employee's child's illness that employer seems to
have violated both subsection 202(b) and 206(b). What if an
employer wants information from an employee as back up for a
worker absence that is not pursuant to the Family Medical Leave
Act? What happens if an employer employs several family
members. Does the ``occurrence of a disease or disorder''
language apply to each employee? If so, would record keeping on
employee absences not be acceptable.
What if there are issues about infectious diseases? Under
the National Pandemic Flu Preparedness Plan, employers would
play a key role in information dissemination and assessment of
the spread of the disease. There are no exceptions for such
emergencies under GINA.
All of these problems would be unnecessary if the language
were restricted to a predictive assessment concerning an
individual's propensity to get an inheritable genetic disease
or disorder based on the occurrence of an inheritable genetic
disease or disorder in the family member.
NUMEROUS INCONSISTENCIES WITHIN THE BILL
On the definition of genetic test, we point out that the
definitions are, for no apparent reason, different in Title I
and Title II. In conjunction with this we note the treatment of
manifested diseases and how they affect regulation are also
different in Title I and Title II for no apparent reason. We
further note that the treatment of tests which identify
genotype, mutation, or chromosomal changes, based on protein or
metabolite analysis in the context of manifested diseases are
excluded under Title I. Yet a test which identifies the same
things based on DNA or chromosome analyses are not excluded for
purposes of Title I. There is no manifested disease exclusion
in the definitions in Title II. This means some tests that can
type a cancer tumor fall into one regulatory category and
others do not. And this is all just in one bill. Please
understand this bill will partially override 43 State
definitions of genetic tests and genetic information creating
maximum confusion.
FAILURE TO LIMIT DEFINITION TO GENETIC MARKERS FOR GENETIC DISEASES
Under GINA, the term `genetic test' means an analysis of
human DNA, RNA, chromosomes, proteins, or metabolites that
detects genotypes, mutations, or chromosomal changes. Francis
Collins, head of the National Human Genome Research Institute
said the GINA reference to detecting a genotype covered, among
other things, tests to look at genetic profiles to select safer
drugs, forensic DNA identification tests, tissue typing for
organ donation; and paternity tests. He stated that the fact
that someone has an O or AB blood type also detects that person
has the O or AB genotype. He also made clear that certain DNA
tests for tumor typing of cancer are covered by the definition.
He further stated that the phrase ``occurrence of a disease or
disorder in family members of the individual'' was not limited
to inheritable genetic disease and that this might include
infectious or contagious diseases of family members. We have
tried to review definitions of genetic information or test
under state laws. None of them have the breadth of the GINA
definitions.
As confirmed by Committee Counsel during the markup we do
not read any requirement that the detection of ``genotypes''
within this paragraph is limited to genotypes related to
genetic diseases, disorders or pathological conditions. Our
further concern is that more and more clinical diagnostics will
``detect a genotype'' in at least one part of the analysis.
This may be true even if it is not the purpose of the test to
look for genetic markers for disease. It may also be true if
the basic purpose of the test is not to look for a blood type.
Yet if the test detects a blood type, it would appear to be
covered by the GINA definitions. This means a tremendous level
of basic information is not defined as a genetic test or
genetic information well beyond the core purposes of the bill.
We remain unclear on how tests for the effects of viruses
or pathogens might fit in to GINA. Some types of viruses
actually physically insert their genes into the host's genome
(it is the defining feature of retroviruses, the family of
viruses that includes HIV, the virus that causes AIDS). This
incorporates the genes of that virus among the genes of the
host cell for the life span of that cell. Beyond this some
viruses, such as the Hepatitis C virus, also add material to
human chromosomes or DNA.
We believe there may be analyses of human DNA, RNA,
chromosomes, proteins, or metabolites that provide direct
evidence of retroviruses or other viruses. These analyses may
be construed to detect a human chromosomal change or mutation.
We recognize the insertion into the human chromosome or
mutation to DNA is, in part, an insertion of viral DNA. There
nonetheless appears to be a change in the sequence of the human
DNA, genotype or chromosome. We want to know whether the phrase
``detects a genotype, mutation, chromosomal change'' could
refer to such mutations and chromosomal changes in humans
caused by such viruses. If it can we have further concerns
about the effect of this legislation with respect to health and
safety monitoring and employer precautions.
Again, Ms. Slaughter's stated concern was discrimination
``based solely on a genetic predisposition to develop a disease
in the future.'' This would be consistent with the language in
Executive Order 13145 which was limited to tests done ``in
order to detect disease-related genotypes or mutations.'' In
the 108th Congress, Ms. Slaughter's bill exempted from the
definition of protected genetic information any ``information
about physical exams of the individual and other information
that indicates the current health status of the individual.''
This is a very useful exception. It's just not in GINA. We keep
asking, what do DNA forensic evidence, blood typing, tissue
typing, cancer tumor typing, or pharmacogenomics have to do
with predicting a genetic disease?
The downsides of the inconsistent and overly broad
definitions are many. Employers and employer sponsored benefit
programs will have several information regimes for medical
information. GINA force separation of such information which
will be a bureaucratic nightmare, lead to medical errors,
create inconsistencies in communications with providers, limit
medical monitoring, create confusion in law enforcement and
judicial functions. If important information related to viruses
or contagious diseases are also covered, we may be compromising
the ability of an employer to help in public safety efforts or
to protect the public's health and safety. We would not want to
see medical monitoring for infectious diseases precluded from
an employers tool box for instances where public health and
safety is at stake.
The discouraging part of this is that the 43 states that
have definitions do not have these problems. They all limit
regulations to genetic markers that predispose toward a future
disease. Many specifically refer to inherited genetic material.
Many have specific exceptions for items like HIV testing or
drug and alcohol tests. Despite these problems we have been met
with a seeming unwillingness from the protagonists to address
any of these issues. We hope that is not the case.
GINA Will Create Confusion for the 43 States That Currently Have Laws
Prohibiting Discrimination Based on Genetic Information
We have not done a complete survey but understand that 43
States already have programs and definitions. We would then
want to ask Members if they find the programs in their state
inadequate. If you were to superimpose the GINA requirements on
those states it will involve a lot of confusion. Many
exemptions and clear statements regarding HIV testing, drug
testing, and other issues would appear to be wiped out. Even
more frustrating for the regulatory community the operative
Federal-state relationship rule is whatever part of a state law
is more stringent survives. This means pieces of state law will
apply while other pieces will be preempted. This would all have
to be sorted out by the courts. We think there are better
approaches. The worst approach is this partial preemption
approach. For some programs there is across the board
preemption. In other cases, a state is allowed to submit its
program for evaluation as a whole. If such programs are
adequate or substantially promoting the policy, they would stay
intact. We believe our States are substantially meeting the
policy and do not see the need for disruption. In any event,
some Federal agency should at least sort out what law applies
in advance so that the regulated community is not held hostage
to more lawyers and uncertainty.
Joe Barton.
Nathan Deal.
Michael Burgess.
Steve Buyer.
Barbara Cubin.
Mike Rogers.
John Shadegg.
Cliff Stearns.
Lee Terry.
Heather Wilson.
Tim Murphy.