Genetic Information
Nondiscrimination Act:
an overview
NCHPEG
Bethesda, MD
4 September 2008
Sharon F. Terry, MA
President & CEO, Genetic Alliance
Chair, Coalition for Genetic Fairness
Why GINA?
 Genetics continues to transform how we look at human health
 Integrating genetic information into health management
requires proactive and informed decision-making
However,
 We are ALL susceptible to genetic discrimination
 The patchwork of state laws left many vulnerable, and privacy
protections from HIPAA weren’t adequate
 We were all losing under the old guidelines—consumers would
forego genetic testing services, healthcare providers had to inform
patients of the potential for discrimination, and researchers had
reduced cohorts for clinical trials
Science: Genetic
Discrimination and
Health Insurance
Collins et al
October 1995
Department of Labor
Report: Genetic
Information and the
Workplace
January 1997
NIH-DOE ELSI
National Action Plan
on Breast Cancer
workshop on
genetic
discrimination in
employment
October 1996
1995
1996
Science: Genetic
Discrimination:
Perspectives of
Consumers
Clinton
Executive
Order 13145:
To Prohibit
Discrimination
in Federal
Employment
Coalition for
Genetic Fairness
Founded
Spring 1997
Clinton
endorses
H.R. 306
July 1997
February 2000
Collins et al
October 1996
August 1999
1998
August 2000
1999
2000
April 1996
December 1995
2001
2002
Senate hearing on
S.318
Snowe: S.1694
Slaughter: H.R.2748
April 2001
SACGT
letter to
Congress
supporting
S. 1322 and
H.R. 2457
Science: Privacy in
Genetics Research
Weiss et al
1997
Settlement
against
Burlington
Northern
Santa Fe
Railway
July 2001
Senate hearing on
S.89
Slaughter: H.R.306
Snowe: S.89
January 1997
Senate hearing on
S.1322
Snowe: S.1995
March 2001
July 2000
May 1998
Daschle: S.1322
Slaughter: H.R.2457
Slaughter: H.R. 602
Daschle: S.318
Snowe: S.382
July 1999
February 2001
Senate hearing
on
S.318 & S.382
February 2002
SACGHS
releases Public
Perspectives on Genetic
Discrimination
February 2005
Coalition for Genetic
Fairness holds Hill
briefing
November 2004
March 2007
Washington
Times: Newt
Gingrich and
Robert Egge
editorial
supports GINA
April 2007
Science: Genetic
Discrimination:
Time to Act
July 2006
SACGHS
letter to
Sec. Leavitt
supporting
H.R.1227
Collins et al
October 2003
Bush issues SAP
on S.1053
October 2003
2003
NPR All Things
Considered:
coverage of
H.R.493
Bush issues SAP on
S.306
2004
New York Times:
Bush calls for
genetic antidiscrimination
legislation at NIH
May 2005
Washington
Times: coverage
of H.R.493
March 2007
January 2007
2005
2006
2007
Slaughter: H.R.493
Snowe: S.358
January 2007
Slaughter: H.R.1910
Snowe:S.1053
Senate passes S.1053 (95-0)
October 2003
Senate
passes S.306
(98-0)
February
2005
May 2003
Snowe: S.306
Senate HELP Committee approves
S.1053
May 2003
February 2005
Biggert: H.R.1227
March 2005
Senate HELP Committee
approves S.358
January 2007
House Ways
House Ed and Labor and Means
Committee approves Committee
approves
H.R.493
H.R.493
March 2007
February 2007
House Energy
and
Commerce
Committee
approves
H.R.493
March 2007
Secretary Leavitt says “GINA
will pass this year” in several
public appearances
President Bush Signs
Genetic Information
Nondiscrimination Act
May 21, 2008
September 2007
Coalition for Genetic
Fairness Conducts many
campaigns
Genetics Day on
the Hill:
150 Advocates
visit all 100
Senate offices
Numerous calls for
GINA to be taken
up by the Senate,
including articles
on Dr. NO
July 2007
2008
2007
House of
Representatives
Passes GINA
420-3
Senator
Coburn
Places hold
on the bill
April 25, 2007
May 2007
Senator
Coburn
Promises
“you will have
your bill in
September”
July 26, 2007
Senate
Attempts
Omnibus w/
GINA
December 2007
House of
Representatives
Passes GINA as
part of the Mental
Health Parity Bill
268-148
March 6, 2008
Senate
Passes
Gina
95-0
April 24,
2008
House of
Representatives
Passes GINA
414-1
May 1, 2008
The Long Road to Passage
 Genetic nondiscrimination legislation was first introduced in the
House in 1995 by Rep. Louise Slaughter (D-NY).
 In 1996, Sen. Olympia Snowe introduced similar legislation in
the Senate.
Both bills specifically addressed nondiscrimination in health
insurance.
Similar legislation was introduced in the 105th and 106th Congresses.
 Sen. Olympia Snowe first introduced GINA in 2002, the 107th
Congress, addressing both health insurance and employment.
 GINA not pass in 107th, 108th, or 109th Congress.
GINA Victory
May 21, 2008: After passing
the House of
Representatives 414-1 and
the Senate 95-0 in the
110th Congress, President
Bush signed GINA into law.
President Bush Signs the Genetic Information
Nondiscrimination Act (GINA) into Law
May 21, 2008
The passage of GINA is the culmination of thirteen years of dedication and perseverance from
the entire genetics community, led by the Coalition for Genetic Fairness, and more than 500
Congressional offices on Capitol Hill.
The Party (important for ANA CEUs)
July 11, 2008: Genetic Alliance Annual Conference, the
genetics community came together to share in the
excitement for the future of genetics and health.
For the party videos: Genetic Alliance Channel on YouTube
What Does GINA Mean?
 Title I of GINA outlines unlawful practices for health
insurers in the use of genetic information.
Includes provisions for the group, individual, and Medicare
supplemental policy markets.
The health insurance provisions of the bill will be active one year from
the date of signing, on May 21, 2009.
 Title II of GINA provides protections to individuals in
the use of genetic information in employment.
Includes provisions for employers, employment agencies, labor
organizations, and training programs.
The employment provisions of the bill will be active eighteen months
from the date of signing, on November 21, 2009.
Definitions within GINA
Genetic information: information about an individual’s genetic
tests or the genetic tests of the individual’s family members, and
the manifestation of a disease or disorder in the individual’s
family members.
Genetic information also includes the request or receipt of genetic
services or participation in clinical research that includes genetic
services, for both the individual and the individual’s family members.
Information regarding an individual’s sex or age is NOT protected genetic
information under GINA. Furthermore, GINA does not protect disease
manifestation in an individual.
Definitions within GINA
Genetic test: the analysis of human DNA, RNA, chromosomes,
proteins, or metabolites that detects genotypes, mutations, or
chromosomal changes.
GINA does not include genetic tests that analyze proteins or metabolites
directly related to the manifestation of a disease.
Examples of tests covered by GINA: tests for BRCA1/BRCA2 or HNPCC
(colon cancer) mutations, carrier screening for disorders such as cystic
fibrosis and fragile X syndrome, and classifications of genetic
properties of an existing tumor to help determine therapy.
Examples of tests NOT covered by GINA: routine tests such as routine
blood counts, cholesterol tests, and liver-function tests.
Definitions within GINA
 Genetic services: a genetic test, genetic counseling, genetic education,
or participation in a research study.
 Family member: a dependent or any other individual who is a first,
second, third, or fourth degree relative.
 Genetic monitoring: the periodic examination of employees to
evaluate acquired modifications to their genetic materials, 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. The purpose of the
monitoring is to identify, evaluate, and respond to the effects or
control adverse environmental exposures in the workplace.
What Does GINA Mean?
Title I: Genetic Nondiscrimination in Health Insurance
GINA strictly prohibits the following:
 Health insurers may not require individuals to provide their genetic
information or the genetic information of a family member for
eligibility, coverage, underwriting, or premium-setting decisions;
 Health insurers may not use genetic information either collected with
intent, or incidentally, to make enrollment or coverage decisions;
 Health insurers may not request or require that an individual or an
individual’s family member undergo a genetic test; and
 In the Medicare supplemental policy and individual health insurance
markets, genetic information cannot be used as a preexisting
condition.
What Does GINA Mean?
Title I: Genetic Nondiscrimination in Health Insurance
Research exception for joint research activities conducted by
health insurers in collaboration with external research entities:
A health insurer may request but not require that an individual
undergo a genetic test, if
 Compliance is voluntary
 Noncompliance has no negative effect on the premium or
enrollment status of the individual.
 Genetic information may only be used for research and not
underwriting purposes.
What Does GINA Mean?
Title I: Genetic Nondiscrimination in Health Insurance
Coverage Determinations
 The insurer could require genetic information in making
coverage determinations, however, the insurer may request only
the minimum amount of information necessary for decisionmaking.
 Example: an insurer may request BRCA status to determine
coverage for a prophylactic mastectomy.
What Does GINA Mean?
Title II: Genetic Nondiscrimination in Employment
GINA strictly prohibits the following for employers, employment agencies, labor
organizations, and training programs:
 The use of genetic information in making decisions regarding hiring,
promotion, terms, privileges, compensation, or termination;
 The limiting, segregating, or classifying of an employee on the basis of genetic
information;
 The request, requirement, or purchase of genetic information of an individual
or a family member of the individual, except in rare cases;
 The failure or refusal to refer an individual for employment on the basis of
genetic information, or causing an employer to discriminate against an
individual on the basis of genetic information; and
 The use genetic information to make decisions about admission to or
employment in any program for apprenticeship or training.
What Does GINA Mean?
Title II: Genetic Nondiscrimination in Employment
Rare instances when the employment entities under GINA may have access to
genetic information include:
 When the information is inadvertently provided as part of the individual’s
medical history or the medical history of a family member;
 When the information is publicly available;
 When the employer offers an employer-sponsored genetic monitoring
program of the biological effects of toxic substances in the workplace;
 When the employer offers health or genetic services, including services
offered as part of a wellness program; and
 When the employer operates as a law enforcement entity and requires the
individual’s DNA for quality control purposes in the forensic lab or human
remains identification settings.
What Does GINA Mean?
Title II: Genetic Nondiscrimination in Employment
Employers, employment agencies, labor organizations, and training
programs must take the following steps to ensure confidentiality of
genetic information:
• Genetic information must be treated as part of the confidential
medical record.
• Genetic information may not be disclosed except with the individual’s
written request or in response to a court order.
• Genetic information may be provided to comply with Federal, State, or
local authorities.
What Does GINA not Do?
 GINA does not apply to members of the US military, to veterans obtaining
healthcare through the Veteran’s Administration, or to the Indian Health
Service.
 GINA does not provide protections from genetic discrimination in life,
disability, or long-term-care insurance.
 GINA applies to those employers covered under the Americans with
Disabilities Act (ADA) and Title VII of the Civil Rights Act of 1964; therefore it
does not cover employers with fewer than 15 employees.
 GINA does not cover an individual’s manifested disease or condition—one that
has already appeared.
 GINA does protect information about manifested disease in an individual’s
family members.
 GINA does not pre-empt state law, it provides a federal baseline for protection
for all Americans.
What Does GINA not Do?
• GINA does not restrict genetic services, the practice of
medicine, or the authority of healthcare professionals.
• GINA does not interfere with an employee’s ability to qualify for
family or medical leave under state or federal Family and
Medical Leave laws.
• GINA does not restrict an employee’s ability to participate in an
employer-sponsored wellness program or other genetic services
offered by an employer.
• GINA does not interfere with an employer’s ability to offer a safe
and healthy work environment through federal or state required
genetic monitoring of the biological effects on employees of
toxic substances in the workplace.
With the passage of GINA,
what’s on the horizon?
 The regulatory phase—ensuring the right regulations are written
 Raise awareness of GINA, alleviate fear and concerns
 Educate and inform the various sectors impacted by GINA
 Human resources divisions of businesses must respond to the treatment
of genetic information
 The informed consent process for clinical trials—genetic discrimination is
one of the risks associated with clinical trial participation. Researchers
must include updated information about GINA to participants, or at least
a resource for questions.
 State legislatures must adjust for the new federal baseline of protections
With the passage of GINA,
what’s on the horizon?
 Much of the information from this presentation is accessible through the
new GINA resource from the Coalition for Genetic Fairness, entitled “What
Does GINA Mean? A Guide to the Genetic Information Nondiscrimination
Act”.
 This is the first step for raising awareness to the genetics community
 It is a flexible tool that can be easily customized within communities
 It will be continually enhanced, and we will include any questions about
GINA not answered by the resource in an FAQ.
Energy of the community can turn to the opportunities that
“drinking from the fire hose” afford us – and we can invest
ourselves in the partnerships that will enable the informed
decision making that will animate and accelerate translational
research
More information
geneticfairness.org
geneticalliance.org
genome.gov
dnapolicy.org