Getting to Know GINA: History and Analysis of the Genetic

Non-discrimination ActBrian N. Fink, PhD

February 10, 2010

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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/cgi-bin/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 268-148.

• 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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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 family-based 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.html

• National Human Genome Research Institute: http://www.genome.gov/24519851

• U.S. Department of Health & Human Services: http://www.hhs.gov/ohrp/humansubjects/guidance/gina.html

Any questions?

Thank you.