Transcript Getting to Know GINA: History and Analysis of the Genetic Non-discrimination Act Brian N.

Getting to Know GINA: History
and Analysis of the Genetic
Non-discrimination Act
Brian N. Fink, PhD
February 10, 2010
History: The Need for GINA
• In 1996, the Health Insurance Portability and
Accountability Act (HIPAA) was passed to
address concerns about discrimination based
on a person’s health information
• HIPAA was the first step toward restricting the
use of genetic information by limiting its use in
setting insurance premiums and determining a
person’s eligibility for benefits in group health
plans.
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History: The Need for GINA
• HIPAA did not prevent health insurers from charging a
higher insurance rate for a group by raising a
company’s insurance premium when it learned that
the business employed several individuals who had a
genetic disease or disorder
• HIPAA did not limit insurance companies from
collecting genetic information, nor did it prevent
insurers from requiring that an individual take a
genetic test before issuing health insurance coverage
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History: The Need for GINA
• Both patients and genetics health professionals
have concerns about the potential for
discrimination by insurance companies based
on their genetic test results
• Their primary concern was the potential for
genetic discrimination by insurance companies
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H.R. 493: GINA
• H.R. 493 for the 110th Congress
http://thomas.loc.gov/cgibin/query/z?c110:H.R.493:
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Genetic Test vs. Genetic Information
• Genetic Test: a test that assess genotypes, mutations,
or chromosomal changes.
• Genetic Information: includes
• genetic tests of a person’s family members (up to and
including fourth-degree relatives)
• any manifestation of a disease or disorder in a family
member
• participation of a person or family member in research
that includes genetic testing, counseling, or education
• Genetic information does not include information
about sex or age.
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GINA: What does it do?
• GINA is not retroactive
• It now prohibits certain uses of genetic information in
connection with health coverage and employment, no
matter when the information was collected
• For example, a health insurer that has been collecting
or using genetic information for underwriting now
needs to change its business practices
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Legislative History of GINA
• January 16, 2007 – The Genetic Information
Nondiscrimination Act is introduced in the House of
Representatives.
• March 21, 2007 – The Genetic Information
Nondiscrimination Act is approved by the House
Committee on Ways and Means.
• March 23, 2007 – The Genetic Information
Nondiscrimination Act is approved by the House
Committee on Energy and Commerce by a unanimous
vote.
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Legislative History of GINA
• April 25, 2007 – The Genetic Information
Nondiscrimination Act passes in the House under a
suspension of the rules by a vote of 420-3.
• March 5, 2008 – The Genetic Information
Nondiscrimination Act is included in the Paul
Wellstone Mental Health and Addiction Equity Act
(H.R.1424) which passes the House by a vote of 268148.
• April 24, 2008 – The Genetic Information
Nondiscrimination Act (H.R.493) passes the Senate by
a vote of 95-0. View the vote breakdown.
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Legislative History of GINA
• May 1, 2008 – The Genetic Information
Nondiscrimination Act (H.R.493) passes the
House by a vote of 414-1.
• May 21, 2008 – The Genetic Information
Nondiscrimination Act (H.R.493) is signed by
President George W. Bush.
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Title 1: Genetic Nondiscrimination in Health Insurance
• GINA covers genetic information of an
individual and the genetic information of family
members
• GINA does not cover an individual’s manifested
disease or condition (where an individual is
experiencing symptoms, being treated for, or
that has been diagnosed)
• This provision took effect May 21, 2009
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Health Insurance Prohibitions
• Health insurers may not require individuals to
provide their genetic information or the genetic
information of a family member to the insurer
for eligibility, coverage, underwriting, or
premium-setting decisions.
• May not use genetic information either collected
with intent, or incidentally, to make enrollment
or coverage decisions;
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Health Insurance Prohibitions
• May not request or require that an individual or an
individual’s family member undergo a genetic test
• In the Medicare supplemental policy and individual
health insurance markets, genetic information cannot
be used as a preexisting condition.
• An exception exists for research, where individuals
may voluntarily choose to undergo genetic testing –
this will not have an effect on their premium or
enrollment status
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Health Insurance – Claim Submission
• Insurer may request only the minimum amount
of information necessary for decision-making.
• If an individual would not like to provide genetic
information to their health insurer about such a
claim, the individual can elect to pay for the test
or treatment out-of-pocket.
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What does GINA not do?
• Does not include protections from genetic
discrimination in life, disability, or long-term care
insurance.
• Health insurance provisions do not apply to U.S.
Military, veterans obtaining care through the VA, or the
Indian Health Service
• Does not apply to federal employees obtaining
healthcare through the Federal Employees Health
Benefits Plans.
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Title 1: What does GINA not do?
• Does not restrict genetic services, the practice
of medicine, or the authority of healthcare
professionals, whether or not they are affiliated
with a health plan or issuer or an employer.
• Does not pre-empt state law; therefore if a
state’s genetic discrimination law provides more
extensive protections than GINA, GINA does
not change it.
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Title II: Genetic Non-discrimination in Employment
• Title II outlines unlawful activities for an
employer, employment agency, labor
organization, or training program in the use of
genetic information.
• The protections took effect November 21, 2009.
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Title II: Non-discrimination in Employment - Protections
• An employer may not use genetic information in
making decisions regarding hiring, promotion,
terms or conditions, privileges of employment,
compensation, or termination.
• An employer, employment agency, labor
organization, or training program may not limit,
segregate, or classify an employee or member,
or deprive that employee or member of
employment opportunities, on the basis of
genetic information.
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Title II: Non-discrimination in Employment - Protections
• May not request, require, or purchase genetic
information of the individual or a family member
of the individual except in rare cases.
• May not fail or refuse to refer an individual for
employment on the basis of genetic information,
and may not cause an employer to discriminate
against an individual on the basis of genetic
information.
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Title II: Non-discrimination in Employment - Protections
• May not use genetic information in making
decisions regarding admission to or
employment in any program for apprenticeship
or training and retraining, including on-the-job
training.
• A labor organization may not exclude or expel
from membership, or otherwise discriminate
against, an individual because of genetic
information.
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When can an employer, employment agency, labor organization,
or training program have access to genetic information?
• 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 has obtained the individual’s
written authorization as part of an employer-sponsored
genetic monitoring program of the biological effects of
toxic substances in the workplace.
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When can an employer, employment agency, labor organization,
or training program have access to genetic information?
• When the employer offers health or genetic
services, including services offered as part of a
wellness program, and with the individual’s
written authorization.
• Where 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.
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Title 2: What does GINA not do?
• Does not cover employers with fewer than 15
employees.
• The employment provisions of GINA apply to
those employers covered under the Americans
with Disabilities Act (ADA) and Title VII of the
Civil Rights Act of 1964
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Title 2: What does GINA not do?
• Does not interfere with an employee’s ability to qualify
for family or medical leave under state or federal
Family and Medical Leave laws, nor to participate in
an employer-sponsored wellness program or other
genetic services offered by an employer.
• 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.
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Examples of Protected Tests
• Tests for BRCA1/BRCA2 (breast cancer) or HNPCC
(colon cancer) mutations
• Classifications of genetic properties of an existing
tumor to help determine therapy
• Tests for Huntington disease mutations
• Carrier screening for disorders, such as cystic fibrosis,
sickle cell anemia, spinal muscular atrophy, and the
fragile X syndrome
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Examples of Unprotected Tests
• Analysis, including DNA analysis, of infectious agents
such as bacteria, viruses, and fungi.
• An HIV test is not covered. It is a retrovirus that inserts
itself into human DNA, HIV is not itself human DNA
and measuring its presence does not constitute a
genetic test under the law’s definition.
• Routine tests such as complete blood counts (CBC, or
blood panel), cholesterol tests, and liver-function tests
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For Clinicians
• GINA does not restrict genetic services, the
practice of medicine, or the authority of
healthcare professionals, whether or not they
may be affiliated with a health plan issuer or an
employer.
• Clinicians and healthcare providers can
recommend that an individual or an individual’s
family member undergoes a genetic test for the
purposes of that individual’s medical benefit.
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www.dnapolicy.org
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Privacy and Confidentiality: Disclosure of
Patient’s Genetic Information
• Protecting the patient’s personal information
from third parties is key to building trust
• One practical suggestion for facilitating familybased communication is providing patients with
education and information materials to facilitate
disease susceptibility discussions with family
members.
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Example: Patient’s right to know versus
family member’s autonomy
• Patient with a family history of a hereditary cancer is
interested in predictive genetic testing and convinces
an affected family member, who initially expresses
unwillingness, to be tested in order to establish the
familial mutation
• Surviving family member admits to feeling pressured
into consenting for genetic testing
• Both the patient and the affected family member are
patients
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Example: Patient’s right to know versus
family member’s autonomy
• What to do?
• Explore, with the patient, alternatives to testing that do
not involve the participation of the unwilling family
member, such as testing stored tissue of a deceased
relative.
• If the patient does not want to consider other options
and the family member has agreed to be tested
without coercion or interference, inform the family
member of the implications of the test results,
including risks and benefits, and assess her emotional
well-being prior to testing.
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GINA: Summary
• GINA generally makes it illegal for health insurance
companies, group health plans, and most employers to
discriminate against you based on your genetic
information. GINA protects people in the following ways:
• Health insurance companies and group health plans may
not request your genetic information that we get from this
research.
• Health insurance companies and group health plans may
not use your genetic information when making decisions
regarding your eligibility or premiums.
• Employers with 15 or more employees may not use your
genetic information that we get from this research when
making a decision to hire, promote, or fire you or when
setting the terms of your employment.
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GINA: Summary
• All health insurance companies and group
health plans must follow this law by May 21,
2010.
• All employers with 15 or more employees were
required to abide by this law as of November
21, 2009.
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GINA: FAQs
• Genetics and Public Policy Center
• http://www.dnapolicy.org/gina/faqs.html
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GINA: Additional Educational Links
• Coalition for Genetic Fairness:
http://www.geneticfairness.org/ginaresource.ht
ml
• National Human Genome Research Institute:
http://www.genome.gov/24519851
• U.S. Department of Health & Human Services:
http://www.hhs.gov/ohrp/humansubjects/guidan
ce/gina.html
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Any questions?
Thank you.