The Genetic Information Nondiscrimination
Act of 2008 (GINA)
Amanda K. Sarata
Specialist in Health Policy
James V. DeBergh
Legislative Attorney
December 19, 2011
Congressional Research Service
7-5700
www.crs.gov
RL34584
CRS Report for Congress
Pr
epared for Members and Committees of Congress
The Genetic Information Nondiscrimination Act of 2008 (GINA)
Summary
On May 21, 2008, the Genetic Information Nondiscrimination Act of 2008 (GINA), referred to by
its sponsors as the first civil rights act of the 21st century, was enacted. GINA, P.L. 110-233,
prohibits discrimination based on genetic information by health insurers and employers. The
sequencing of the human genome and subsequent advances raise hope for genetic therapies to
cure disease, but this scientific accomplishment is not without potential problems. An employer
or health insurer could decide to take adverse action based on a genetic predisposition to disease,
and situations have arisen where discriminatory action based on genetic information did occur. In
addition, there is evidence that the fear of genetic discrimination has an adverse effect on those
seeking genetic testing, as well as on participation in genetic research. GINA was enacted to
remedy this situation.
GINA is divided into two main parts: Title I, which prohibits discrimination based on genetic
information by health insurers; and Title II, which prohibits discrimination in employment based
on genetic information. Title I of GINA amends the Employee Retirement Income Security Act of
1974 (ERISA), the Public Health Service Act (PHSA), and the Internal Revenue Code (IRC),
through the Health Insurance Portability and Accountability Act of 1996 (HIPAA), as well as the
Social Security Act, to prohibit health insurers from engaging in genetic discrimination. Title II of
GINA prohibits discrimination in employment because of genetic information and, with certain
exceptions, prohibits an employer from requesting, requiring, or purchasing genetic information.
The law prohibits the use of genetic information in employment decisions—including hiring,
firing, job assignments, and promotions—by employers, unions, employment agencies, and labor-
management training programs.
This report provides background on genetic information, legal implications regarding the use of
this information, and relevant laws. It also discusses the statutory provisions of GINA and the
regulations regarding both health insurance and employment.
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The Genetic Information Nondiscrimination Act of 2008 (GINA)
Contents
Introduction...................................................................................................................................... 1
Background...................................................................................................................................... 1
Human Genome Research ......................................................................................................... 1
Concerns About the Use of Genetic Information ...................................................................... 2
Federal Law Relating to Genetic Discrimination Prior to GINA .............................................. 4
Health Insurance Portability and Accountability Act of 1996 (HIPAA) ............................. 4
Americans with Disabilities Act.......................................................................................... 5
Executive Order................................................................................................................... 6
State Statutes Relating to Genetic Nondiscrimination............................................................... 7
Genetic Information Nondiscrimination Act of 2008 (GINA)......................................................... 8
Background................................................................................................................................ 8
Overview of Statutory Provisions.............................................................................................. 9
Definition of Genetic Information............................................................................................. 9
Definition of Genetic Test ....................................................................................................... 10
Genetic Nondiscrimination and Health Insurance................................................................... 11
Overview of Health Insurance Provisions......................................................................... 11
Prohibited Health Insurer Practices................................................................................... 11
Application to Genetic Information of a Fetus or Embryo................................................ 12
Rule of Construction ......................................................................................................... 12
Privacy and Confidentiality............................................................................................... 13
Remedies and Enforcement............................................................................................... 13
Genetic Nondiscrimination and Employment ......................................................................... 14
Overview of Employment Provisions ............................................................................... 14
Definition of Employee and Employer ............................................................................. 14
Prohibited Employment Practices ..................................................................................... 14
Exceptions to Prohibited Practices.................................................................................... 15
Confidentiality of Genetic Information............................................................................. 17
Remedies and Enforcement............................................................................................... 18
Disparate Impact ............................................................................................................... 19
Construction ...................................................................................................................... 19
Manifested Diseases.......................................................................................................... 20
Authorization of Appropriations and Effective Date......................................................... 21
Title III—Miscellaneous Provisions........................................................................................ 21
Issues for Consideration .......................................................................................................... 21
Contacts
Author Contact Information........................................................................................................... 22
Acknowledgments ......................................................................................................................... 22
Congressional Research Service
The Genetic Information Nondiscrimination Act of 2008 (GINA)
Introduction
On May 21, 2008, the Genetic Information Nondiscrimination Act of 2008 (GINA), referred to by
its sponsors as the first civil rights act of the 21st century, was enacted. GINA, P.L. 110-233,
prohibits discrimination based on genetic information by health insurers and employers.
In April 2003, the sequence of the human genome was deposited into public databases. Scientists
involved in the Human Genome Project (HGP)1 reported that the finished sequence consists of
overlapping fragments covering 99% of the coding regions of the human genome, with an
accuracy of 99.999%.2 These rapid advances provide powerful tools for determining the causes
of, and potentially the cures for, many common, complex diseases such as diabetes, heart disease,
Parkinson’s disease, bipolar disorder, and asthma.
Although the sequence information should facilitate the identification of genes underlying disease
and create a foundation for the development of genetic therapies, this scientific accomplishment
is not without potential problems. For instance, the presence of a specific genetic variation may
indicate a predisposition to disease but does not guarantee that the disease will manifest. An
employer or health insurer could decide to take adverse action based on a genetic predisposition,
and situations have arisen where discriminatory action based on genetic information did occur.
GINA was enacted to remedy this potential situation. This report provides background on genetic
information, legal implications regarding the use of this information, and relevant laws. It also
discusses the statutory provisions of GINA, the Department of Health and Human Service’s
(HHS’s) regulations on health insurance, and the Equal Employment Opportunity Commission’s
(EEOC’s) regulations on employment.3
Background
Human Genome Research
In congressional testimony, Dr. Francis Collins, then Director of the National Human Genome
Research Institute, described the potential that the information generated by the HGP holds for
medicine and public health.4 He stated that
1 The Human Genome Project, begun in 1990, was a 13-year effort coordinated and funded by the U.S. Department of
Energy and the National Institutes of Health to identify all of the protein-coding genes in human DNA; determine the
sequence of the 3 billion chemical bases that make up human DNA; store this information in databases; develop tools
for data analysis; and address the ethical, legal, and social issues (ELSI) that may arise from the project. For more
detailed information see “The National Human Genome Research Institute,” http://www.genome.gov/, and “Human
Genome Project Information,” http://www.ornl.gov/sci/techresources/Human_Genome/home.shtml.
2 “International Human Genome Sequencing Consortium Describes Finished Human Genome Sequence,” Oct., 20,
2004, at http://www.genome.gov/12513430.
3 For a discussion of the Equal Employment Opportunity Commission (EEOC) regulations for Title II of GINA see
CRS Report R41527, The Genetic Information Nondiscrimination Act (GINA): Final Employment Regulations, by
James V. DeBergh.
4 Dr. Collins stepped down as Director of the National Human Genome Research Institute to assume the position of
Director of the National Institutes of Health. For more information on NHGRI, please see http://www.genome.gov/.
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the human genome sequence provides foundational information that now will allow
development of a comprehensive catalog of all of the genome’s components, determination
of the function of all human genes, and deciphering of how genes and proteins work together
in pathways and networks. Completion of the human genome sequence offers a unique
opportunity to understand the role of genetic factors in health and disease, and to apply that
understanding rapidly to prevention, diagnosis, and treatment. This opportunity will be
realized through such genomics-based approaches as identification of genes and pathways
and determining how they interact with environmental factors in health and disease, more
precise prediction of disease susceptibility and drug response, early detection of illness, and
development of entirely new therapeutic approaches.5
As Dr. Collins stated, with completion of the human genome sequence, scientists will now focus
on understanding the clinical and public health implications of the sequence information. All
disease has a genetic component and, therefore, genomic research has the potential to
substantially reduce the collective burden of disease in the general population. Clinical genetic
tests are becoming available at a rapid rate; in addition, private insurers are beginning to include
some clinical genetic tests in their health insurance benefits packages as evidence of the tests’
clinical validity accumulates.6
Concerns About the Use of Genetic Information
These scientific advances in genetics, while promising, are not without potential problems. The
ethical, social, and legal implications of genetic research have been the subject of significant
scrutiny, and a portion of the funds for the Human Genome Project were set aside to support the
analysis and research of these issues.7 As scientific knowledge about genetics becomes
increasingly widespread, numerous researchers and commentators, including Dr. Francis Collins,
have expressed concerns about how this information will be used.8 In congressional testimony,
Dr. Collins stated,
while genetic information and genetic technology hold great promise for improving human
heath, they can also be used in ways that are fundamentally unjust. Genetic information can
be used as the basis for insidious discrimination....The misuse of genetic information has the
potential to be a very serious problem, both in terms of people’s access to employment and
health insurance and the continued ability to undertake important genetic research.9
5 Testimony of Francis S. Collins, former Director, National Human Genome Research Institute, National Institutes of
Health, Before the Subcommittee on Health of the House Committee on Energy and Commerce (May 22, 2003).
6 For more information on the status of genetic tests and further discussion of what constitutes “genetic information,”
see CRS Report RL33832, Genetic Testing: Scientific Background for Policymakers, by Amanda K. Sarata.
7 The group working on these issues is referred to as the Ethical, Legal and Social Implications (ELSI) program. See
http://www.genome.gov/page.cfm?pageID=10001618.
8 Testimony by Dr. Francis Collins, former Director, National Center for Human Genome Research, before the Senate
Committee on Labor and Human Resources (Mar. 6, 1996). See also, Hudson, Rothenberg, Andrews, Kahn, and
Collins, “Genetic Discrimination and Health Insurance: An Urgent Need for Reform,” 270 Science 391 (Oct. 20, 1995);
Annas, Glantz, and Roche, “Drafting the Genetic Privacy Act: Science, Policy and Practical Considerations,” 23 J. of
Law, Medicine and Ethics 360 (1995); Gostin, “Genetic Discrimination: The Use of Genetically Based Diagnostic and
Prognostic Tests by Employers and Insurers,” 17 Am. J. of Law & Med. 109 (1991); Rothstein, Mark, Genetic Secrets:
Protecting Privacy and Confidentiality in the Genetic Era (1997).
9 Testimony of Francis S. Collins, former Director, National Human Genome Research Institute, National Institutes of
Health, before the Senate Health, Education, Labor and Pensions Committee (July 20, 2000).
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Legal cases of genetic discrimination have been few.10 However, studies have shown that public
fear of discrimination is substantial and negatively influences the uptake of genetic testing and the
use of genetic information by consumers and health professionals. The Secretary’s Advisory
Committee on Genetics, Health and Society (SACGHS) learned that 68% of Americans are
concerned about who would have access to their personal genetic information; 31% state this
concern would prevent them from having a genetic test; and 68% agree that insurers would do
everything possible to use genetic information to deny health coverage.11 A 2010 survey found
that Americans are increasingly concerned about access to their genetic information; specifically,
this survey found that 71% of Americans are concerned about storage of and access to their
information, with the same percentage concerned specifically about access by health insurers.12
In addition, SACGHS as well as its predecessor committee, the Secretary’s Advisory Committee
on Genetic Testing (SACGT), sponsored two public forums in 2000 and 2004 to gather
perspectives on genetic discrimination. Many comments were received from patients, consumers,
health professionals, scientists, genetic test developers, educators, industry representatives,
policymakers, lawyers, students, and others representing a wide range of diverse ethnic and racial
groups.13 The comments and testimony revealed several anecdotal cases of discrimination.
SACGT sent a letter to the Secretary of HHS urging support for nondiscrimination protections
after the 2000 forum:
During consultations with the public SACGT heard from many Americans who are
concerned about the misuse of genetic information by third parties, such as health insurers
and employers, and the potential for discrimination based on that information. Many stated
that fear of genetic discrimination would dissuade them from undergoing a genetic test or
participating in genetic research studies. Others stated that they would pay out of pocket for a
genetic test to prevent the results from being placed in their medical record. Such concerns
are a deterrent to advances in the field of genetic testing and may limit the realization of the
benefits of genetic testing.14
A joint report by the Department of Labor, the Department of Health and Human Services, the
Equal Employment Opportunity Commission (EEOC), and the Department of Justice
summarized the various studies on discrimination based on genetic information and argued for
10 But see Norman-Bloodsaw v. Lawrence Berkeley Laboratory, 135 F.3d 1260 (9th Cir. 1998), where blood tests for
sickle cell trait were found to give rise to a Title VII claim. See also the discussion of the Americans with Disabilities
Act, supra, and Geller, Alper, Billings, Barash, Beckwith, and Natowicz, “Individual, Family, and Societal Dimensions
of Genetic Discrimination: A Case Study Analysis,” 2 Science and Engineering Ethics 71 (1996), which found that a
number of institutions, including health and life insurance companies, health care providers, blood banks, adoption
agencies, the military, and schools, were reported to have engaged in genetic discrimination against asymptomatic
individuals. This study has been criticized by the insurance industry as relying on anecdotal information. See American
Council of Life Insurance, “Statement Regarding the Council for Responsible Genetics ‘Study’ on Genetic
Discrimination” (Apr. 11, 1996).
11 Meeting of the Secretary’s Advisory Committee on Genetics, Health, and Society, October 2005. Accessed at
http://oba.od.nih.gov/oba/SACGHS/meetings/October2005/White.pdf on December 19, 2011.
12 Cogent Research, “Americans’ Concern about the Privacy of Their Genetic Information Reaches New High,”
Accessed at http://www.cogentresearch.com/news/Press%20Releases/CGAT%202010_press%20release%20-
%20Privacy%20Concerns%20-%2001-10-11.pdf on December 19, 2011.
13 Highlights and transcripts of Jan. 27, 2000, testimony can be found on the SACGT website at http://oba.od.nih.gov/
oba/sacgt/reports/Public%20Consultation%20Summary.pdf. Transcripts of the Oct. 18, 2004, testimony can be found
on the SACGHS website at http://oba.od.nih.gov/SACGHS/sacghs_past_meeting_2004_oct_18.html.
14 From a letter from SACGT to Secretary Tommy Thompson, May 3, 2001, at http://oba.od.nih.gov/oba/sacgt/
ltr_to_secDHHS5-3-01.pdf.
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the enactment of federal legislation. The 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” and
that “because an individual’s genetic information has implications for his or her family members
and future generations, misuse of genetic information could have intergenerational effects that are
far broader than any individual incident of misuse.”15 Concluding that existing protections are
minimal, the report went on to call for the enactment of legislation.
The National Council on Disability (NCD), an independent federal agency that advises the
President and Congress on issues affecting individuals with disabilities, published a position
paper on March 4, 2002, arguing for the enactment of federal legislation prohibiting genetic
discrimination. The NCD argued that recent advances in genetic research have brought an
increasing potential for genetic discrimination, that genetic discrimination is a historical and
current reality, that genetic discrimination undermines the purposes of genetic research and
testing, that genetic test information has little value for purposes of making employment decisions
and insurance decisions, and that existing laws are insufficient to protect individuals from genetic
discrimination.16
Federal Law Relating to Genetic Discrimination Prior to GINA
Health Insurance Portability and Accountability Act of 1996 (HIPAA)
Title I of GINA extends the current HIPAA protections against discrimination by group health
plans and issuers of health insurance in both the group and individual markets. HIPAA prohibits a
group health plan or issuer of a group health plan from using genetic information to establish
rules for eligibility or continued eligibility and provides that genetic information shall not be
treated as a preexisting condition in the absence of the diagnosis of the condition related to such
information. It also prohibits a group health plan or issuer of a group health plan from using
genetic information in setting a premium contribution. These protections apply to individuals
within the group plans; however, they do not apply to the acceptance of the whole group or to the
premiums set for the group. Thus, HIPAA prohibits group health plans or issuers of group health
plans from charging an individual a higher premium than a similarly situated individual; however,
the law does not prevent an entire group from being charged more. The HIPAA nondiscrimination
provisions do not apply to individual health insurance policies, and genetic information may be
used to set premiums for individual policies (although HIPAA establishes both guaranteed issue
for individuals who lose group coverage and guaranteed renewal for those with existing
individual coverage).
HIPAA would not prohibit group health plans or issuers of plans (i.e., insurers) from requiring or
requesting genetic information or testing and does not prevent them from excluding coverage for
a particular condition or imposing lifetime caps on all benefits, or on specific benefits. Finally,
15 Department of Labor, Department of Health and Human Services, Equal Employment Opportunity Commission,
Department of Justice, “Genetic Information and the Workplace,” Jan. 20, 1998, http://www.dol.gov/oasam/programs/
history/herman/reports/genetics.htm.
16 National Council on Disability, “Position Paper on Genetic Discrimination Legislation,” at http://www.ncd.gov/
publications/2002/March42002.
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HIPAA does not address the use of genetic information in contexts other than health insurance,
such as employment.
Under the HIPAA Privacy Rule, health plans and insurers may use or disclose health information
for payment and other health care operations, including underwriting, premium rating, and other
activities related to the creation, renewal, or replacement of an insurance contract.
Americans with Disabilities Act
The Americans with Disabilities Act (ADA)17 prohibits discrimination against an individual with
a disability in employment, public services, public accommodations, and communications. The
threshold issue in any ADA case is whether the individual alleging discrimination is an individual
with a disability. The ADA as amended by the ADA Amendments Act, P.L. 110-325, defines the
term disability with respect to an individual as having “(A) a physical or mental impairment that
substantially limits one or more of the major life activities of such individual; (B) a record of such
an impairment; or (C) being regarded as having such an impairment (as described in paragraph
(3)).”18 Although the statutory language of the ADA does not reference genetic traits, there was a
discussion of the issue during congressional debate of the original legislation.19 So far there have
been no judicial decisions specifically dealing with genetic predisposition to disease and the
ADA, but one case was brought by the EEOC and settled.20 In addition, Terri Seargent filed with
the EEOC alleging genetic discrimination and received a determination on November 21, 2000,
that the EEOC’s investigation supported her allegation of discrimination under the ADA.21
The ADA had been interpreted by the EEOC, prior to the enactment of the ADA Amendments
Act, as including genetic information relating to illness, disease, or other disorders.22 The
17 42 U.S.C. §12101 et seq. For a detailed discussion of the ADA see CRS Report 98-921, The Americans with
Disabilities Act (ADA): Statutory Language and Recent Issues, by Emily C. Barbour and James V. DeBergh.
18 42 U.S.C. §12102, as amended by P.L. 110-325. §4(a). For a more detailed discussion of the ADA Amendments Act
see CRS Report RL34691, The ADA Amendments Act: P.L. 110-325, by Emily C. Barbour and James V. DeBergh.
19 Rep. Owens stated that “[t]hese protections of the ADA will also benefit individuals who are identified through
genetic tests as being carriers of a disease-associated gene. There is a record of genetic discrimination against such
individuals, most recently during sickle cell screening programs in the 1970s. With the advent of new forms of genetic
testing, it is even more critical that the protections of the ADA be in place.” 136 Cong. Rec. H 4623 (daily ed. July 12,
1990) (remarks of Rep. Owens). Similarly, Rep. Edwards and Rep. Waxman also stated that individuals who are
carriers of a disease-associated gene may not be discriminated against under the ADA. 136 Cong. Rec. H 4625 (daily
ed. July 12, 1990) (Statement of Rep. Edwards); Id. at H 4627 (Statement of Rep. Waxman).
20 The EEOC alleged that Burlington Northern Sante Fe (BNSF) Railroad tested its employees for a genetic marker
linked to carpal tunnel syndrome in an attempt to address a high number of repetitive stress injuries leading to
employee compensation. The EEOC and BNSF reached a settlement agreement rejecting the testing of employees for
the genetic marker. See Paul Miller, EEOC commissioner, “Analyzing Genetic Discrimination in the Workplace,” 12
Human Genome News (Feb. 2002) at http://www.ornl.gov/sci/techresources/Human_Genome/publicat/hgn/v12n1/
09workplace.shtml.
21 Testimony of Janiori Goldman before the House Committee on Energy and Commerce, Subcommittee on Health,
107th Cong., 1st sess. (Mar. 22, 2001).
22 Equal Employment Opportunity Commission, Compliance Manual, vol. 2, section 902, order 915.002,902-45 (1995).
It is also possible that Title VII of the Civil Rights Act of 1964, 42 U.S.C. § 2000e et seq., may provide some
protection against certain kinds of genetic discrimination since an argument could be made that discrimination based on
genetic disorders that are more common in certain racial or ethnic groups, such as sickle cell disease, is prohibited
under Title VII. There are relatively few genetic conditions that have a strong connection with a racial or ethnic group,
thus limiting the scope of potential coverage. However, in Norman-Bloodsaw v. Lawrence Berkeley Laboratory, 135
F.3d 1260 (9th Cir. 1998), blood tests for sickle cell trait were found to give rise to a Title VII claim.
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legislative history was cited by the EEOC in its guidance to the definition of disability for its
compliance manual. In this guidance, the EEOC examined the definition of disability under the
ADA, noting that the definition was composed of three prongs: disability means (1) a physical or
mental impairment that substantially limits one or more of the major life activities of an
individual, (2) a record of such an impairment, or (3) being regarded as having such an
impairment.23 It was under the third prong that the EEOC determined that discrimination based on
genetic information relating to illness, disease, or other disorders was prohibited.
Although this EEOC interpretation was widely heralded as a significant step for the protection of
rights for individuals whose genes indicate an increased susceptibility to illness, disease, or other
disorders, it is limited in its application and was even more limited by Supreme Court decisions
on the definition of disability.24 However, the EEOC has not withdrawn this guidance, and at
Senate hearings EEOC Commissioner Paul Miller stated that the ADA “can be interpreted to
prohibit employment discrimination based on genetic information. However, the ADA does not
explicitly address the issue and its protections are limited and uncertain.” In addition,
Commissioner Miller observed that even if the ADA were found to cover genetic discrimination,
the requirements of the ADA may not protect workers from all types of genetic discrimination. He
stated, “for example, the ADA does not protect workers from requirements or requests to provide
genetic information to their employers.... In addition, once the applicant is hired, the employer
may request that the employee take a medical exam, such as a genetic test, if the employer can
demonstrate that the information from that test is job related and consistent with business
necessity.”25
Although the combination of the ADA’s legislative history and the EEOC’s guidance led some
commentators to argue that the ADA would cover genetic discrimination, the merit of these
arguments has been uncertain since there have been no reported cases holding that the ADA
prohibits genetic discrimination. This uncertainty increased after Supreme Court decisions on the
definition of disability under the ADA, although the Supreme Court’s decisions did not directly
address ADA coverage of genetic discrimination.
The ADA Amendments Act rejected the Supreme Court’s limited interpretation of the definition
of disability, and amended the ADA to provide for broader coverage. However, the ADA
Amendments Act does not specifically mention genetic discrimination although the expanded
definition would increase the likelihood of coverage. Even if the ADA was found to cover genetic
discrimination, GINA’s protections are more targeted to protecting genetic information.
Executive Order
On February 8, 2000, President Clinton issued an executive order prohibiting discrimination
against federal employees based on protected genetic information. The executive order defines
“protected genetic information” as “(A) information about an individual’s genetic tests; (B)
information about the genetic tests of an individual’s family members; or (C) information about
the occurrence of a disease; or medical condition or disorder in family members of the
individual.” Current health status information would not be protected under this executive order
23 42 U.S.C. §12102(2).
24 See Sutton v. United Airlines, 527 U.S. 471 (1999); Murphy v. United Parcel Service, Inc.,527 U.S. 516 (1999).
25 Statement of Commissioner Paul Steven Miller, U.S. Equal Employment Opportunity Commission, before the Senate
Committee on Health, Education, Labor and Pensions, July 20, 2000.
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unless it was derived from the information described above. The EEOC has issued guidance on
the executive order.26
State Statutes Relating to Genetic Nondiscrimination
Many states have enacted statutes dealing with various aspects of genetic discrimination. Early
state statutes focused on particular genetic conditions. The first statute to prohibit discrimination
based on a genetic trait was enacted in North Carolina and prohibited employment discrimination
based on the sickle cell trait. In 1991 Wisconsin became the first state to enact a comprehensive
law to prohibit discrimination based on genetic test results. Currently, the states vary in their
provisions with some prohibiting discrimination in employment while others deal solely with
discrimination in insurance. In its discussion of the final regulations, the EEOC notes that over 30
states have laws concerning genetic discrimination. The EEOC states that it will provide
information on these state and local laws on its website.27
In a 2008 survey of state law, the National Conference of State Legislatures similarly found that
34 states and the District of Columbia have enacted genetic nondiscrimination in employment
laws.28 These laws vary and the NCSL noted the following:
All laws prohibit discrimination based on the results of genetic tests; many extend the
protections to inherited characteristics, and some include test results of family members,
family history and information about genetic testing, such as the receipt of genetic services.
Most states also restrict employer access to genetic information, with some prohibiting
employers from requesting, requiring and obtaining genetic information or genetic test
results, or directly or indirectly performing or administering genetic tests. Some states may
also make exceptions to statutory requirements if, for example, genetic information may
identify individuals who may be a safety risk in the workplace.29
A related survey found that 47 states and the District of Columbia have passed laws pertaining to
the use of genetic information in health insurance.30 Many state genetic laws also include specific
provisions relating to genetic privacy.31 In a 2008 survey, 27 states were found to require consent
to disclose genetic information while 17 states require informed consent for a third party to
perform or require a genetic test or obtain genetic information. Nineteen states were found that
establish specific penalties for violating genetic privacy laws.32
Although these state statutes do provide some measure of protection against discrimination, they
do not cover employer self-funded plans providing private health insurance for employees and
their dependents. These plans are exempt from state insurance laws due to the preemption
26 http://www.eeoc.gov/policy/docs/guidance-genetic.html
27 75 FED. REG. 68929 (November 9, 2010).
28 National Conference of State Legislatures, Genetics Tables, State Genetics Employment Laws, http://www.ncsl.org/
programs/health/genetics/ndiscrim.htm.
29 Id.
30 National Conference of State Legislatures Genetics Tables, State Genetic Nondiscrimination in Health Insurance,
http://www.ncsl.org/programs/health/genetics/ndishlth.htm.
31 National Conference of State Legislatures Genetics Tables, State Genetic Privacy Laws, http://www.ncsl.org/
programs/health/genetics/prt.htm.
32 Id.
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provision in the federal Employee Retirement Income Security Act (ERISA).33 Since 60% of
covered workers obtain their coverage through self-funded plans, the ERISA exemption limits the
application of state laws significantly.34
Genetic Information Nondiscrimination Act of 2008
(GINA)
Background
On May 21, 2008, GINA was signed into law. The path to enactment of P.L. 110-233 was lengthy
and tortuous. H.R. 493, the Genetic Information Nondiscrimination Act of 2007, was introduced
by Representative Slaughter with 143 cosponsors on January 16, 2007. After being reported out
of the House Education and Labor Committee, the House Energy and Commerce Committee, and
the House Ways and Means Committee, the bill passed the House on April 25, 2007, by a vote of
420 to 3. On April 24, 2008, the Senate took up H.R. 493, replaced the existing language with an
amendment in the nature of a substitute, added new language strengthening the “firewall”
between Title I (discrimination by health insurers) and Title II (discrimination in employment),
and passed the measure, as amended, by a vote of 95-0. The House passed H.R. 493 (as amended)
on May 1, 2008. On May 2, 2008, both the House and Senate passed H.Con.Res. 340 to make
corrections in the enrollment of H.R. 493. These changes would
• revise deadlines for implementation of requirements related to Medicare
supplemental policies;
• exempt an employer that conducts DNA analysis for purposes of human remains
identification from the prohibition against an employer, labor organization, or
joint labor-management committee requesting, requiring, or purchasing an
employee’s genetic information; and
• remove the requirement that DNA analysis conducted by an employer for law
enforcement purposes as a forensics laboratory be included in the Combined
DNA Index System.
The first legislation relating to genetic discrimination was introduced in 1995 by Representative
Slaughter (H.R. 2748, 104th Congress) and Representative Stearns (H.R. 2690, 104th Congress). In
each subsequent Congress legislation was introduced, and twice legislation passed the Senate. In
the 108th Congress, the Senate passed the Genetic Information Nondiscrimination Act of 2003 (S.
1053).35 This bill would have prohibited health insurance plans from denying enrollment or
charging higher premiums to individuals based on the individual’s or family members’ genetic
information. In addition, the bill banned the collection, use, and disclosure of genetic information
for insurance underwriting purposes. In the employment context, this bill would have prohibited
the use of genetic information in employment decisions, such as hiring, firing, job assignments,
33 29 U.S.C. §§1001-1145.
34 Kaiser Family Foundation, “Employer Health Benefits, Annual Survey 2011,” accessed at http://ehbs.kff.org/pdf/
2011/8225.pdf.
35 149 Cong. Rec. S12394-12508 (daily ed. Oct. 4, 2003).
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The Genetic Information Nondiscrimination Act of 2008 (GINA)
and promotions. The bill also would have prevented the acquisition and disclosure of genetic
information as well as applied the procedures and remedies authorized under the Civil Rights Act
of 1964 to cases of genetic discrimination. Although President Bush supported genetic
discrimination legislation and the House held a hearing in July 2004,36 the House did not pass a
bill in the 108th Congress.
In the 109th Congress, S. 306, the Genetic Information Nondiscrimination Act of 2005, was
introduced by Senator Snowe on February 7, 2005. The Senate Health, Education, Labor and
Pensions Committee reported S. 306 out with an amendment in the nature of a substitute by a
voice vote. The bill was passed, with an amendment, on February 17, 2005, by a vote of 98-0.
The amendment would have deleted former Section 103, which would have added a prohibition
of discrimination based on genetic information or services in church health insurance plans to the
Internal Revenue Code, because this provision had to originate in the House. A companion bill,
H.R. 1227, was introduced in the House on March 10, 2005, by Representative Biggert but did
not pass.
Overview of Statutory Provisions
GINA contains a statement of findings which discusses the significance of the sequencing of the
human genome, the history of discrimination based on genetics, and the inadequacy of current
federal and state laws. The statute is then divided into three titles: Title I, which prohibits genetic
discrimination in health insurance; Title II, which prohibits genetic discrimination in
employment; and Title III, which contains miscellaneous provisions on severability and child
labor protections.
Definition of Genetic Information
One of the most discussed provisions of GINA was the definition of genetic information.
Discussions were focused on decisions that would impact the term’s scope, centering largely on
the exclusions for the definition (i.e., basic demographic information that implies genetic
information, such as sex) as well as how to incorporate the concept of family history. Specifically,
the definition of genetic information relies on three terms, two defined in the law—“genetic test”
and “family member”—and one added through regulation, “manifestation” or “manifested.”
Together, these terms serve to delineate the scope of the law’s protections.
Both Title I and Title II contain a definition of genetic information which states the following
(key terms are in bold, emphasis added):
GENETIC INFORMATION-(A) IN GENERAL -The term ‘genetic information’ means,
with respect to any individual, information about—(i) such individual’s genetic tests, (ii) the
genetic tests of family members of such individual, and (iii) the manifestation of a disease
or disorder in family members of such individual.(B) INCLUSION OF GENETIC
SERVICES AND PARTICIPATION IN GENETIC RESEARCH -Such term includes, with
respect to any individual, any request for, or receipt of, genetic services, or participation in
clinical research which includes genetic services, by such individual or any family member
36 “Genetic Non-Discrimination: Examining the Implications for Workers and Employers” Subcommittee on
Employer-Employee Relations, House Committee on Education and Workforce (July 22, 2004).
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of such individual. (C) EXCLUSIONS -The term ‘genetic information’ shall not include
information about the sex or age of any individual.37
As mentioned previously, regulations have been promulgated implementing both titles of GINA.
The Departments of Health and Human Services, Treasury, and Labor jointly issued interim final
regulations with request for comments implementing Sections 101 through 103 of Title I of
GINA38, excluding Section 104 (“Amendments to title XVIII of the Social Security Act relating
to medigap”) and Section 105 (“Privacy and confidentiality”). The Department of Health and
Human Services, Office for Civil Rights, issued a proposed rule to implement Section105,39 and
Section104 incorporates, by reference to the Social Security Act, Section 1882, provisions of a
model NAIC regulation which addresses Medigap issuers.40 Additionally, the Equal Employment
Opportunity Commission (EEOC) has issued regulations for Title II of GINA.
All of these regulations follow the statutory definition for “genetic information.” The EEOC
regulations clarify that neither race nor ethnicity (if this information is not derived from genetic
tests) are considered to be genetic information.41
Definition of Genetic Test
As is the case with the definition for the term genetic information, the definition of genetic test is
also of pivotal importance to defining the scope, and ultimately determining the impact, of the
nondiscrimination protections in GINA. Importantly, this definition is different in Title I and Title
II of the act. The Title I definition exempts genetic tests that are “an analysis of proteins or
metabolites that [are] 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.” Title II defines genetic test as
(A) IN GENERAL.—The term “genetic test” means an analysis of human DNA, RNA,
chromosomes, proteins, or metabolites, that detects genotypes, mutations, or chromosomal
changes.
(B) Exceptions.—The term “genetic test” does not mean an analysis of proteins or
metabolites that does not detect genotypes, mutations, or chromosomal changes.42
While Title II does not include the exception regarding manifested diseases contained in Title I, it
does contain Section 210, which states,
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,
37 42 U.S.C. §2000ff(4).
38 74 Fed. Reg. 51644 (October 7, 2009).
39 74 Fed. Reg. 51698 (October 7, 2009).
40 74 Fed. Reg. 18808 (April 24, 2010).
41 75 Fed. Reg. 68916 (November 9, 2010).
42 42 U.S.C. §2000ff(7).
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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.43
The interim final regulations follow the statutory language with respect to the definition of
genetic test except that they provide specific examples of genetic and non-genetic tests to
illustrate the definition’s scope.
The EEOC’s final regulations also mirror the statutory language except that the regulations
provide specific examples of genetic tests and of tests or procedures that are not genetic tests. For
example, a genetic test includes a test to determine whether an individual has a BRCA1 or
BRCA2 variant, which would indicate a predisposition to breast cancer, and would include
preimplantation genetic diagnosis on embryos.44 One of the examples given in the regulations of a
test that is not a genetic test is a test for cholesterol levels, since a cholesterol test does not detect
mutations. Similarly, testing for the presence of alcohol or illegal drugs is also not considered a
genetic test since it is not an analysis of DNA or RNA, but a test to determine whether an
individual has a genetic predisposition for alcoholism or drug use is a genetic test.45
Genetic Nondiscrimination and Health Insurance
Overview of Health Insurance Provisions
Title I of GINA strengthens and clarifies existing HIPAA nondiscrimination and portability
provisions through amendments to the Employee Retirement Income Security Act of 1974
(ERISA), the Public Health Service Act (PHSA), and the Internal Revenue Code (IRC), as well as
to the Social Security Act (SSA). In this way, group plans under ERISA, group and individual
plans under the PHSA, Church Plans under the IRC, and Medigap plans under the SSA are all
brought under the jurisdiction of the law. The complexity of the health care financing system
required this approach to extend protection to all covered individuals, regardless of their
insurance situation. The HHS interim final regulations implement Sections 101, 102, and 103 of
Title I of GINA; as mentioned above, they do not address the application of GINA to Medigap
issuers nor do they implement Section105 of the title.46
Prohibited Health Insurer Practices
Broadly, GINA prohibits health insurers from engaging in three practices: (1) using genetic
information about an individual to adjust a group plan’s premiums, or, in the case of individual
plans, to deny coverage, adjust premiums, or impose a preexisting condition exclusion; (2)
requiring or requesting genetic testing; and (3) requesting, requiring, or purchasing genetic
information for underwriting purposes. Each of these provisions is discussed below in more
detail, and where applicable, modifications made by the regulations are noted.
43 42 U.S.C. §2000ff-9.
44 29 C.F.R. §1635.3(f)(2); 75 Fed. Reg. 68933 (November 9, 2010).
45 29 C.F.R. §1635.3(f)(3); 75 Fed. Reg. 68933 (November 9, 2010).
46 74 Fed. Reg. 51665 (October 7, 2009).
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Discrimination in Premium Setting and Eligibility Prohibited
GINA prohibits health plans, group and individual health insurers and issuers, and issuers of
Medicare supplemental policies from adjusting a group or individual’s premium based on genetic
information about an individual in the group, an individual seeking individual coverage, or an
individual’s family members. It also prohibits individual insurers from conditioning eligibility or
continuing eligibility on genetic information, and prohibits individual insurers from treating
genetic information as a preexisting condition. Issuers of supplemental Medicare policies may not
deny or condition the issuance of a policy based on genetic information (and may not impose a
preexisting condition exclusion based on genetic information).
Genetic Testing Requests or Requirements Prohibited
GINA prohibits health plans, group and individual health insurers and issuers, and issuers of
Medicare supplemental policies from requesting or requiring that individuals or their family
members undergo a genetic test. This prohibition does not limit the authority of a health care
professional to request that an individual undergo genetic testing as part of his or her course of
health care. The act provides for a research exception to this provision, by allowing a group or
individual insurance issuer to request, but not require, an individual to undergo genetic testing if
specific conditions are met.
Collection and Use of Genetic Information Restricted
GINA prohibits health plans, group and individual health insurers and issuers, and issuers of
Medicare supplemental policies from requesting, requiring, or purchasing genetic information for
the purposes of underwriting prior to an individual’s enrollment or in connection with enrollment.
“Incidental collection” of genetic information would not be considered a violation. The HHS final
interim rules clarify that “purposes of underwriting” does not include a request for family history
or other genetic information to make a determination whether a benefit is medically appropriate
for purposes of payment.47
Application to Genetic Information of a Fetus or Embryo
Title I of the act clarifies that genetic discrimination based on the genetic information of either the
fetus of a pregnant woman or an embryo legally held by an individual or family member is
prohibited. The HHS interim final regulations do not modify this provision.48
Rule of Construction
GINA provides clearly that nothing in the act should be construed to preclude the use of
information about a manifested disease or disorder in an individual (or an individual’s family
member) by health plans, group and individual health insurers and issuers, and issuers of
Medicare supplemental policies to establish premiums or conditions of eligibility. The HHS
interim final regulations additionally clarify that insurers may not utilize the manifestation of a
47 74 Fed. Reg. 51668 (October 7, 2009).
48 74 Fed. Reg. 51679 (October 7, 2009).
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disease in an individual in a group as genetic information about other group members in
determining the premium (for example, in the case of family members covered under the same
policy, where the manifestation of a disease or condition in an individual might be relevant to the
other family members’ risk of manifesting that same disease or condition).49 In addition, nothing
in the act should be construed to prohibit health plans, group and individual health insurers and
issuers, and issuers of Medicare supplemental policies from obtaining or using the results of
genetic tests to determine payment. However, only the minimum amount of information required
to achieve this purpose may be requested. HHS’s interim final regulations clarify that where the
appropriateness of a treatment depends on the patient’s genetic makeup, an insurer may condition
payment on the results of a genetic test or may deny payment for the treatment in the absence of
the genetic test.50 A double mastectomy, for example, might be indicated for an individual without
a personal history of breast cancer only in the presence of a positive BRCA1/2 genetic test result;
an insurer might not cover the surgical procedure only in the presence of family history of disease
but in the absence of a confirmatory genetic test. However, the rules explain that in a case like
this, the use of the genetic information to determine payment would not be a violation of GINA.
Privacy and Confidentiality
GINA directs the Secretary of Health and Human Services to revise the HIPAA Privacy Rule51 to
reflect that genetic information shall be treated as health information and the use or disclosure by
a covered entity of protected health information (i.e., genetic information) for the purposes of
underwriting shall not be a permitted use or disclosure. The Secretary, in consultation with the
Secretaries of Labor and the Treasury, had 12 months after enactment of the act to issue final
regulations to carry out these revisions. On October 7, 2009, the Department of Health and
Human Services, Office for Civil Rights, published a proposed rule to implement this section.
Among other things, the proposed rule would provide that
Notwithstanding any other provision of this subpart [the HIPAA Privacy Rule], a health plan
shall not use or disclose protected health information that is genetic information for
underwriting purposes.52
Additionally, under the terms of the proposed rule, the use of an individual’s genetic information
for underwriting purposes is barred even if authorized by an individual.53
Remedies and Enforcement
GINA permits the Secretary to impose a penalty of $100 per day per beneficiary or participant to
whom the failure relates during a period of noncompliance with the provisions in Title I. Where
willful neglect was found, there is established a minimum penalty of $2,500, or $15,000 for more
severe or prolonged violations. There are three limitations to the penalties that may be imposed
by the Secretary. First, the penalty does not apply if the person otherwise liable for the penalty did
not know that the noncompliance occurred. Second, the penalty does not apply to failures
49 74 Fed. Reg. 51680 (October 7, 2009).
50 74 Fed. Reg. 51687 (October 7, 2009).
51 45 C.F.R. Part 46.
52 74 Fed. Reg. 51709.
53 74 Fed. Reg. 51703, 51709.
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corrected within 30 days (in cases not due to willful neglect). Finally, a limit to the total penalty
for unintentional failures is set at $500,000 or 10% of the aggregate amount paid or incurred by
the plan sponsor during the preceding year for group health plans. The HHS interim final
regulations are silent on the HHS and DOL secretarial enforcement authorities regarding the use
of genetic information that were added under GINA; these will be addressed in future
rulemaking.54
Genetic Nondiscrimination and Employment
Overview of Employment Provisions
GINA prohibits discrimination in employment because of genetic information and, with certain
exceptions, prohibits an employer from requesting, requiring, or purchasing genetic information.
The law prohibits the use of genetic information in employment decisions, including hiring;
firing; job assignments; and promotions by employers, unions, employment agencies, and labor-
management training programs. The EEOC has issued regulations for Title II which generally
closely track the statutory language.55
Definition of Employee and Employer
GINA defines employees and employers as those defined in Section 701(b) and (f) of Title VII of
the Civil Rights Act of 1964,56 a state employee or employer as defined in Section 304(a) of the
Government Employee Rights Act of 1991,57 and a covered employee or employing office as
defined in Section 101 of the Congressional Accountability Act.58 Generally, this includes
employees and applicants working in the private sector for an employer who employs 15 or more
employees, federal and state governments, as well as congressional employees. The
corresponding employers of these individuals, as well as employment agencies, labor
organizations, and training programs, also are covered by the law. The EEOC’s regulations echo
the statutory language regarding employees and also include former employees.59
Prohibited Employment Practices
As noted previously, GINA prohibits the use of genetic information in employment decisions,
including hiring, firing, job assignments, and promotions by employers, unions, employment
agencies, and labor-management training programs.60 In addition, an employer, employment
54 74 Fed. Reg. 51665 (October 7, 2009).
55 75 Fed. Reg. 68912 (November 9, 2010). For a discussion of these regulation see CRS Report R41527, The Genetic
Information Nondiscrimination Act (GINA): Final Employment Regulations, by James V. DeBergh.
56 42 U.S.C. §§2000e(f)(employees), 2000e(b)(employers).
57 42 U.S.C. §2000e-16c(a).
58 2 U.S.C. §1301.
59 29 C.F.R. §1635.2(c); 75 FED. REG. 68932 (November 9, 2010). The Supreme Court in Robinson v. Shell Oil Co.,
519 U.S. 337, 346 (1997), held that the term employee under Title VII, which is referenced in the definition in GINA,
includes former employees.
60 In its regulations, the EEOC, instead of referencing the different categories of employers covered by GINA, refers to
them as “covered entities.” 29 C.F.R. §1635.2(b); 75 FED. REG. 68932 (Nov. 9, 2010).
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agency, labor union, or training program may not “request, require or purchase genetic
information” with respect to the employee, individual, union member, or family member.61
Exceptions to Prohibited Practices
There are statutory exceptions to the prohibition on the acquisition of genetic information for
employers, employment agencies, labor unions, and training programs.62 However, GINA
provides that, even if an exception applies, genetic information may not be used in a manner that
violates nondiscrimination or confidentiality requirements.63
Inadvertent Requests
The first exception applies when one of these entities inadvertently requests or requires family
medical history of the employee, individual, union member, or a family member. The House
Education and Labor Report noted that this exception “addresses the so-called ‘water cooler’
problem, in which an employer unwittingly receives otherwise protected genetic information in
the form of family medical history through casual conversations with a worker.”64 Family medical
history is not defined in the statute but the EEOC regulations define the term as meaning
“information about the manifestation of disease or disorder in family members of the
individual.”65
Wellness Programs
The second exception is for health or genetic services offered by the entity as part of a wellness
program.66 To qualify for the exemption:
• the employee, individual or union member must provide prior, knowing,
voluntary, and written authorization;
• only the employee, individual, union member, or family member and the licensed
health care profession or board certified genetic counselor involved in providing
such services can receive individually identifiable information concerning the
results of the services; and
• any individually identifiable genetic information is only available for such
services and shall not be disclosed to the employer except in aggregate terms that
do not identify individuals.
61 42 U.S.C. §2000ff-1(a)-(b)(employers); 42 U.S.C. §2000ff-2(a)-(b)(employment agencies); 42 U.S.C. §2000ff-3(a)-
(b)(labor organizations); 42 U.S.C. §2000ff-4(a)(b)(training programs).
62 42 U.S.C. §2000ff-1(b)(employers); 42 U.S.C. §2000ff-2(b)(employment agencies); 42 U.S.C. §2000ff-3(b)(labor
organizations); 42 U.S.C. §2000ff-4(b)(training programs).
63 42 U.S.C. §2000ff-1(c)(employers); 42 U.S.C. §2000ff-2(c)(employment agencies); 42 U.S.C. §2000ff-3(c)(labor
organizations); 42 U.S.C. §2000ff-4(c)(training programs).
64 H.Rept. 110-28, Part 1 at 37 (March 5, 2007).
65 29 C.F.R. §1635.3(b); 75 FED. REG. 68933 (November 9, 2010).
66 For a discussion of the legal issues involving wellness programs generally, see CRS Report R40661, Wellness
Programs: Selected Legal Issues, coordinated by James V. DeBergh.
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The EEOC regulations reiterate the exception and its requirements67 but also provide that
inducements may be offered to encourage individuals to participate in wellness programs.
However, these inducements may not be offered to provide genetic information. The EEOC
provides the following example in the regulations as a situation that does not violate GINA:
A covered entity offers $150 to employees who complete a health risk assessment with 100
questions, the last 20 of them concerning family medical history and other genetic
information. The instructions for completing the health risk assessment make clear that the
inducement will be provided to all employees who respond to the first 80 questions, whether
or not the remaining 20 questions concerning family medical history and other genetic
information are answered.68
In contrast, if the health risk assessment does not make clear which questions must be answered,
it would violate GINA.69
The regulations also provide that they do not limit the rights or protections available under the
ADA, other civil rights laws, or the Health Insurance Portability and Accountability Act
(HIPAA). For example, an employer must make reasonable accommodations, as required under
the ADA to enable a person with a disability to participate in a wellness program.
Certification Procedures Under Medical Leave Laws
The third statutory exception is for information necessary for certification procedures under
federal and state family and medical leave laws. This exception was described as “eliminat[ing]
the potential for conflict with existing laws.”70 The EEOC regulations track the statutory
provisions.71
Inadvertent Acquisition of Genetic Information by Purchase of Documents
The fourth exception, like the first, concerns the inadvertent acquisition of genetic information by
the purchase of documents, such as newspapers, that are commercially and publicly available and
that include family medical history. This exception was intended to address the concern that
GINA could be violated by such actions as the purchase of a newspaper “containing the obituary
of an employee’s parent who died of breast cancer.”72 The EEOC’s regulations include electronic
media, such as the Internet, television, and movies, as potential sources of genetic information.73
In its discussion of this exception, the EEOC examines the factors used in deciding whether a
document is commercially or publicly available and determines that the key criterion is “whether
access requires permission of an individual or is limited to individuals in a particular group, not
whether the source is categorized as a social networking site, personal Web site, or blog.”74 The
67 29 C.F.R. §1635.8(b)(2), 75 FED. REG. 68935 (November 9, 2010).
68 29 C.F.R. §1635.8(b)(2)(ii)(A), 75 FED. REG. 68935 (November 9, 2010).
69 29 C.F.R. §1635.8(b)(2)(ii)(B), 75 FED. REG. 68935 (November 9, 2010).
70 H.Rept. 110-28, Part 1 at 38 (March 5, 2007).
71 29 C.F.R. §1635.8(b)(3), 75 FED. REG. 68936 (November 9, 2010).
72 Id.
73 29 C.F.R. §1635.8(b)(4), 75 FED. REG. 68936 (November 9, 2010).
74 75 Fed. Reg. 68925 (November 9, 2010).
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EEOC also notes that the exception does not apply to genetic information gathered by actively
searching for genetic information from commercially and publicly available sources, or to the
acquisition of genetic information from a source likely to contain such information, such as a
website that focuses on genetic testing.75
Genetic Monitoring of Toxic Substances
The fifth exception applies when the information involved is to be used for genetic monitoring of
the biological effects of toxic substances in the workplace. However, in order for this exception to
apply,
• the employer, employment agency, labor union, or training program must provide
written notice of the genetic monitoring to the employee;
• the employee, individual, or union member must provide prior, knowing,
voluntary, and written authorization; or the genetic monitoring is required by
federal or state law;
• the employee, individual, or union member must be informed of individual
monitoring results;
• the monitoring must be in compliance with federal genetic monitoring
regulations, or state genetic monitoring regulations; and
• the employer, employment agency, labor union, or training program, excluding
any licensed health care professional or board certified genetic counselor, must
receive the results only in aggregate terms that do not disclose the identity of
specific employees.
DNA Analysis for Law Enforcement Purposes
There is a sixth exception for employers and training programs but not for employment agencies
or labor unions. This exception, which was changed by H.Con.Res. 340, would allow employers
and training programs that conduct DNA analysis for law enforcement purposes as a forensic
laboratory or for purposes of human remains identification to request or require genetic
information from their employees, but only when it is used for analysis of DNA identification
markers for quality control to detect sample contamination. The EEOC notes that this is a very
limited exception.76
Confidentiality of Genetic Information
Generally, GINA requires that genetic information shall be maintained on separate forms and in
separate medical files and be treated as a confidential medical record, and prohibits employers,
employment agencies, labor unions, and joint labor-management committees from disclosing
genetic information. These entities are considered to be in compliance with the maintenance of
information requirements if the genetic information is treated as a confidential record under
75 Id.
76 75 Fed. Reg. 68926 (November 9, 2010).
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Section 102(d)(3)(B) of the Americans with Disabilities Act.77 However, the general prohibition
on disclosure is subject to six exceptions. Genetic information may be disclosed
• to the employee or member of a labor union (or family member receiving genetic
services) at the written request of the employee or member;
• to an occupational or other health researcher if the research is conducted in
compliance with 45 C.F.R. Part 46, which provides for protection of human
research subjects;
• in response to a court order except that only the genetic information expressly
authorized by the order shall be disclosed; if the court order was obtained without
the knowledge of the employee or member to whom the information refers, the
employee or member shall be informed of the court order and the information
may be disclosed;
• to government officials who are investigating compliance with Title II of GINA,
if the information is relevant;
• where such disclosure is made in connection with the certification provisions of
the Family and Medical Leave Act or state family and medical leave laws; or
• to a federal, state, or local public health agency regarding a contagious disease
that presents an imminent hazard of death or life-threatening illness, and there is
notification.
GINA also contains a provision concerning the relationship of the confidentiality provisions with
the HIPAA Privacy Rule. GINA does not prohibit an entity covered under HIPAA “from any use
or disclosure of health information that is authorized for the covered entity under such
regulations.”
The EEOC final regulations track the legislative language.78 The EEOC in its discussion of the
final regulations addresses several concerns raised by commenters. For example, the EEOC states
that genetic information that had been placed in a personnel file prior to the effective date of
GINA, need not be removed and its existence does not create a violation of GINA. However,
disclosing such information to a third party would violate the law.79
Remedies and Enforcement
Generally, GINA uses the remedies and enforcement mechanisms available in Title VII of the
Civil Rights Act of 1964,80 although for employees covered by the Government Employee Rights
Act of 1991, the Congressional Accountability Act of 1995, chapter 5 of Title 3 of the U.S. Code,
or Section 717 of the Civil Rights Act of 1964, the remedies and procedures track those acts and
statutory provisions. The EEOC regulations describe these remedies as compensatory and
77 42 U.S.C. §12112(d)(3)(B).
78 29 C.F.R. §1635.9, 75 FED. REG. 68937 (November 9, 2010).
79 75 Fed. Reg. 68927 (November 9, 2010).
80 42 U.S.C. §2000e-4 et seq.
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punitive damages, reasonable attorney’s fees, including expert fees, and injunctive relief,
including reinstatement and hiring, back pay, and other equitable remedies.81
Disparate Impact
Section 703(k) of Title VII of the Civil Rights Act of 1964 provides for a cause of action based on
the disparate impact of a particular employment practice on employment based on race, color,
religion, sex, or national origin.82 GINA specifically provides that such disparate impact does not
create a cause of action under its provisions. However, GINA requires that a commission be
established six years after the date of enactment to review the science of genetics and make
recommendations to Congress regarding whether to provide a disparate impact cause of action
under GINA.
Construction
Section 209 of GINA contains several rules of construction, including a provision concerning the
relationship between Title I and Title II of the act. GINA provides that nothing in Title II is to be
construed to limit the rights or protections of an individual under any federal or state statute that
provides equal or greater protection. In addition, nothing in Title II is to limit the rights or
protections of an individual to bring an action, or provide for enforcement of, or penalties for, any
violation under Title I of GINA, certain sections of ERISA, the Public Health Service Act, and the
Internal Revenue Code. This provision has been referred to as a “firewall” between Titles I and II,
and has been described as clarifying “that employers are not liable for health insurance violations
under civil rights laws unless the employer has separately violated a provision of Title II
governing employers.”83
GINA also states that it does not
• apply to the Armed Forces repository of specimen samples for the identification
of remains;
• limit or expand the protections, rights, or obligations of employees or employers
under applicable workers’ compensation laws;
• limit the authority of a federal department or agency to conduct or sponsor health
research conducted in compliance with rules for research on human subjects;
• limit the statutory or regulatory authority of the Occupational Safety and Health
Administration or the Mine Safety and Health Administration regarding
workplace safety and health laws and regulations; or
• require any specific benefit for an employee or member or a family member
under any group health plan.
Section 209 also specifies that any reference in Title II to genetic information concerning an
individual or family member also includes the genetic information of any fetus carried by a
81 29 C.F.R. §1635.10(b), 75 Fed. Reg. 68938 (November 9, 2010).
82 42 U.S.C. §2000e-2(k).
83 154 Cong. Rec. H2972 (daily ed. May 1, 2008)(statement of Rep. Dingell).
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pregnant woman. In addition, genetic information on any embryo legally held by the individual or
family member would also be included in the reference to genetic information.
Finally, Section 209 provides that Title II does not prohibit the activity of a group health plan or
health insurance issuer offering group health insurance coverage that is authorized by Title I, and
certain sections of ERISA, the Public Health Service Act, and the Internal Revenue Code.
Manifested Diseases
Section 210 of GINA clarifies that the act does not cover medical information that is not genetic
information about a manifested disease, disorder, or pathological condition, including a
manifested disease, disorder, or pathological condition that has or may have a genetic basis. The
final EEOC regulations elaborate on the statutory language specifically stating that “the
acquisition, use, and disclosure of medical information that is not genetic information about a
manifested disease, disorder, or pathological condition is subject to applicable limitations under
sections 103(d)(1)- (4) of the Americans with Disabilities Act (42 U.S.C. 12112(d)(1)-(4)), and
regulations at 29 CFR 1630.13, 1630.14, and 1630.16.”84 In its discussion of the final regulations,
the EEOC notes that one commenter had expressed concern that individuals who have a
manifested genetic disease that is not yet substantially limiting may not be covered under either
law. The EEOC declined to address this issue, stating that it had no authority to expand the
coverage of GINA. However, the EEOC observed that with the enactment of the ADA
Amendments Act (ADAAA),85 which expanded the definition of disability under the ADA, it is
less likely that there would be a significant number of individuals who would not be covered by
either act.86
Both the EEOC rules and the HHS interim final rules add a definition for the terms
“manifestation” and “manifested.” Specifically, the rules define these terms to mean a disease,
disorder, or pathological condition that has been or could “reasonably be diagnosed by a health
care professional with appropriate training and expertise in the field of medicine involved.” The
rules add further that a “disease, disorder, or pathological condition is not manifested if a
diagnosis is based principally on genetic information.”87
The addition of these definitions may address the concern noted by the commenter (above)
regarding those individuals with a manifested genetic disease that is not yet substantially limiting.
The definitions have the effect of expanding the applicability of the protections under both titles
by further delimiting their exception through the exclusion of individuals with a manifested
disease diagnosed principally on genetic information. This implies that the diagnosis was not
carried out in the context of, or made based on, the existence of signs or symptoms of the disease
or disorder, and appears likely to include those individuals with a manifested (i.e., diagnosed)
genetic disease that is not yet substantially limiting (i.e., no substantial signs or symptoms).
84 29 C.F.R. §1635.12, 75 Fed. Reg. 68939 (November 9, 2010).
85 P.L. 110-325. For a discussion of the ADAAA see CRS Report RL34691, The ADA Amendments Act: P.L. 110-325,
by Emily C. Barbour and James V. DeBergh.
86 75 Fed. Reg. 68931 (November 9, 2010).
87 74 Fed. Reg. 51666 (October 7, 2009) and 75 Fed. Reg. 68917 (November 9, 2010).
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The Genetic Information Nondiscrimination Act of 2008 (GINA)
Authorization of Appropriations and Effective Date
Such sums as may be necessary are authorized to be appropriated. The effective date of GINA is
eighteen months after the date of enactment.
Title III—Miscellaneous Provisions
GINA includes a severability provision. If any provision of the act is declared unconstitutional,
the remainder of the act is not to be affected.
Section 16(e) of the Fair Labor Standards Act88 regarding child labor protections is amended.
Issues for Consideration
The enactment of GINA raises some issues for consideration. Educating the public and health
care providers about the scope and application of GINA will be an important part of the
implementation phase. Recent data indicate that awareness of the law amongst the public is
limited. A 2008 survey reported that, “only 16 percent of respondents to the survey knew that
there were laws that protect the privacy of genetic information, and only one-quarter of those felt
that protections were sufficient.”89 A similar survey conducted in 2010 found that awareness of
laws protecting privacy held steady at 16%, with 77% of Americans unsure whether they are
protected by law.90 Educational efforts are particularly relevant because there are several
limitations to the scope of the law of which the public and practitioners should be made aware in
order to avoid confusion or misunderstanding.
Importantly, the scope of the law is limited to the settings of health insurance and employment. It
does not cover the following: long term care insurance; life insurance; short-term disability
insurance; or long-term disability insurance. Moving forward, this distinction may need to be
presented clearly to the public, so there is not an expectation of blanket protection from genetic
discrimination in all settings where genetic information may be disclosed, requested, required or
used. The HHS proposed rule implementing Section105 (“Privacy and confidentiality”) of Title I
may extend certain of GINA’s protections to encompass long term care insurance; this is still to
be determined pending publication of the final rule. If this interpretation were to be maintained in
the final rule, it would be limited to the use of genetic information for underwriting purposes, as
required by Section105, and would not act to extend the protections established in Sections 101-
104 of Title I to long term care insurance.
In addition, GINA does not necessarily extend protections against discrimination in health
insurance and employment to individuals with manifested diseases or disorders, genetic or
otherwise. Specific provisions in Titles I and II clarify that health insurers and employers will not
be in violation of GINA if they utilize specified information about, or knowledge of, a manifested
88 29 U.S.C. §216(e).
89 SACGHS, “Genetics Education and Training of Health Care Professionals, Public Health Providers, and
Consumers,” (May 2010) accessed at http://oba.od.nih.gov/oba/SACGHS/
SACGHS%20Draft%20Genetics%20Education%20and%20Training%20Report.pdf#page=56 on December 19, 2010.
90 Council for Responsible Genetics, “Genetic Privacy Worries on the Rise,” accessed at
http://www.councilforresponsiblegenetics.org/genewatch/GeneWatchPage.aspx?pageId=324 on December 19, 2011.
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The Genetic Information Nondiscrimination Act of 2008 (GINA)
disease or disorder to establish premiums, set enrollment eligibility or preexisting exclusion
requirements, or make employment decisions. Again, educational efforts may be useful in
ensuring that the public is aware of relevant limitations in the scope of the law.
Finally, the recent passage of the Patient Protection and Affordable Care Act of 2010 (P.L. 111-
148), as amended by the Health Care Education Reconciliation Act of 2010 (P.L. 111-152), may
affect GINA, and Title I provisions in particular. The ACA established a number of reforms to the
private health insurance market, limiting insurers’ ability in many cases to use health status or
factors to discriminate in the issuance or renewal of policies. In addition, provisions in the ACA
address employer wellness programs, and the information that such programs may collect from
employees. This intersects with GINA in that family history or other genetic information may be
requested by the employer in the context of such programs. For more information about the
potential interaction between GINA and the ACA, see CRS Report R41314, The Genetic
Information Nondiscrimination Act of 2008 and the Patient Protection and Affordable Care Act of
2010: Overview and Legal Analysis of Potential Interactions, coordinated by Amanda K. Sarata.
Author Contact Information
Amanda K. Sarata
James V. DeBergh
Specialist in Health Policy
Legislative Attorney
asarata@crs.loc.gov, 7-7641
jdebergh@crs.loc.gov, 7-8022
Acknowledgments
This report was initially authored by Nancy Lee Jones.
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