Understanding GINA How the Genetic Information Nondiscrimination Act

Understanding GINA: How the Genetic Information Nondiscrimination Act Protects Our Community This resource was created by Genetic Alliance, the Genetics and Public Policy Center, and the National Coalition for Health Professional Education in Genetics through funding by The Pew Charitable Trusts April 2010 DRAFT 1

What is GINA? The Genetic Information Nondiscrimination Act of 2008 • Federal law that protects individuals from genetic discrimination in health insurance & employment • Genetic discrimination is the misuse of genetic information • This presentation includes: – Background and history of GINA – Introduction to GINA’s protections – Examples of how the law applies 2

Why GINA? • Genetics continues to transform how we understand health • Integrating genetic information into healthcare enables proactive and informed decision-making • However, fear of genetic discrimination was a barrier to utilization of genetic services and participation in research 3

The History of GINA • 1995: First introduction of federal legislation for genetic nondiscrimination in health insurance • 2002: GINA was introduced for the first time, then reintroduced in every subsequent Congressional session, only passing in the Senate in 2007 • 2008: GINA passed in the House by a vote of 414 -1 and in the Senate by a vote of 95 -0 4

President George W. Bush signs the Genetic Information Nondiscrimination Act into law on May 21, 2008 GINA represents the culmination of thirteen years of perseverance from the entire genetics community and more than 500 Congressional offices on Capitol Hill

GINA’s Protections: An Overview • Title I of GINA – Unlawful practices for health insurers in the use of genetic information – Applies to group, individual, and Medicare supplemental policies – Effective December 7, 2009 • Title II of GINA – Unlawful practices for employers in the use of genetic information – Applies to employers, employment agencies, labor organizations, and training programs – Effective November 21, 2009 6

Definitions within GINA Genetic Information: – Information about an individual’s genetic test results – Genetic test results of family members, and the occurrence of a disease or disorder in family members (family health history) – Request for or receipt of genetic services, or participation in clinical research that includes genetic services by an individual or their family members 7

Definitions within GINA Family Member: first-, second-, third-, or fourth- degree relative Genetic Services: genetic testing, genetic counseling, genetic education, or participation in a research study 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 8

Genetic Tests Covered by GINA Examples of tests covered by GINA: - BRCA 1/BRCA 2 or HNPCC mutations for hereditary cancers - Carrier screening for disorders such as cystic fibrosis and fragile X syndrome - Classifications of genetic properties of tumors to help determine therapy Examples of tests NOT covered by GINA: routine tests such as blood counts, cholesterol tests, liver-function tests 9

What Do GINA’s Health Insurance Protections Mean? It is against the law for health insurers to request, require or use genetic information to make decisions about: – Eligibility for health insurance – Premium, contribution amounts, or terms of coverage This means is is against the law for a health insurer to use genetic test results or family health history as a reason to deny someone health insurance or to determine how much they pay for their coverage 10

What Do GINA’s Health Insurance Protections Mean? GINA also makes it against the law for health insurers to: – Consider a genetic test result or family health history as a pre-existing condition – Ask or require someone to have a genetic test – Use any genetic information they do have to discriminate against someone 11

What Do GINA’s Health Insurance Protections Mean? Health insurers may still ask for genetic information to make decisions about whether or not they will pay for a requested test, treatment or procedure, in order to determine the medical need for the service, but according to GINA: – The insurer can request only the minimum amount of information required to make the decision – Once they do have the information, it cannot be used to discriminate against the person 12

GINA & Manifest Disease GINA does not cover an individual’s manifested disease or condition • In a case where a disease is already diagnosed, GINA does not protect information about that disease simply because it is genetic • A genetic test result, in the absence of other signs and symptoms, does not constitute a diagnosed condition under GINA 13

What Do GINA’s Employment Protections Mean? GINA makes it against the law for employers to use genetic information in the following ways: – To make decisions regarding hiring, firing, promotion, pay privileges or terms of employment – To limit, segregate, classify or otherwise mistreat an employee This means it is against the law for an employer to use family health history and genetic test results in making decisions related to employment 14

What Do GINA’s Employment Protections Mean? GINA also make it against the law for employers to: – Request, require or purchase the genetic information of a potential or current employee, or his or her family members – Fail or refuse to refer an individual for employment on the basis of genetic information – Use genetic information to make decisions about admission to or employment in any program for apprenticeship or training 15

What Do GINA’s Employment Protections Mean? When it is legal for employers to have genetic information about an employee: 1. Inadvertent acquisition 2. When information is publicly available 3. Genetic monitoring programs of the biological effects of toxic substances in the workplace 4. When an employer offers health or genetic services 5. Certification process for FMLA leave 6. When the employer operates as a law enforcement entity and requires DNA for quality control or forensic purposes 16

What Do GINA’s Employment Protections Mean? When an employer does have genetic information: – They cannot use genetic information in a discriminatory way – They cannot disclose genetic information about applicants or employees – The information must be kept confidential and in a separate medical file 17

What Does GINA Not Cover? • Members of the US military who receive care through the Tricare military health system • Veterans who receive their care through the Veteran’s Administration • Federal Employees who receive care through the Federal Employee’s Health Benefit Plan • The Indian Health Service • Life, disability, or long-term-care insurance • Employers with fewer than 15 employees 18

How Does GINA Work? • GINA’s protections apply regardless of when they took a genetic test or utilized genetic services • GINA is not retroactive: it does not apply to discriminatory acts that occurred before GINA’s effective dates • GINA provides a federal floor (minimum) for protections, for states with stronger protections, the state law applies • GINA required that state health insurance regulations match GINA’s protections as of May 21, 2009 19

How Does GINA Work? • Enforcement – Health Insurance: the Department of the Treasury, and the Department of Health and Human Services (HHS) – Employment: the Equal Employment Opportunity Commission (EEOC) • Corrective Action – Health Insurance: Individuals are to contact their state health insurance commissioner – Employment: Individuals are to file a claim with the EEOC 20

GINA’s Protections: Summary • GINA protects individuals from genetic discrimination in health insurance and employment • It is illegal for a health insurer to use genetic information as a reason to deny health insurance or determine the cost of insurance • It is illegal for an employer to use genetic information in making decisions related to employment With GINA’s protections individuals can feel comfortable talking about family health history with their family and doctor, and using genetic testing and other services to learn about health risks without fears of genetic discrimination 21

GINA Exercises The following four exercises are designed to facilitate discussion and understanding of GINA. The exercises put GINA in the context of family health history, genetic testing, diagnosis, predisposition, and prenatal issues. 22

GINA Exercise: Family Health History A mother and her teenage son go to their doctor for routine care. The doctor collects family health history from the mother through three generations and learns that the child’s mother, grandmother, and maternal great aunt have adult onset (Type II) diabetes. How does GINA Apply? 23

GINA Exercise: Family Health History (answer) • The definition of genetic information under GINA includes the diagnosis of a disease in a family member (in this case, diabetes). The family history information of diabetes (the son’s high risk) is protected under GINA. – A health insurer may not use family history information for underwriting purposes. – An insurer may still use family history to determine the necessity for further medical surveillance, testing, or preventive care or treatment. 24

GINA Exercise: Genetic Testing A 25 -year-old man decides to use the genetic screening services of a direct-to- consumer (DTC) commercial company. When he received his results, he learned he had an apolipoprotein E 4 (apo. E 4) genotype that indicates an increased risk for cardiovascular disease. The man decides to make an appointment with his healthcare provider for a physical exam, including a lipid profile. How does GINA Apply? 25

GINA Exercise: Genetic Testing (answer) • The man’s DTC test result is protected by GINA. • The discussion he has with his doctor about use of genetic services is protected by GINA. • The family history obtained by the doctor is protected by GINA. • Because 25 years of age is too young for current lipid profile screening recommendations, the health insurer may request to see the man’s DTC results that demonstrate his increased cardiovascular disease risk as evidence for need of the test. – Under GINA, the information about his apo. E 4 genotype cannot be used to deny him access to health insurance. 26

GINA Exercise: Diagnosis and Predisposition A 39 -year-old woman goes to her doctor after finding a lump in her right breast. Her doctor refers her to a surgeon, who evaluates her and suggests she undergo a biopsy. The biopsy result indicates breast cancer. Because of the woman’s young age, her doctor refers her for genetic counseling and testing. She learns she carries a BRCA 1 mutation. After reviewing her options, she opts for a bilateral mastectomy. The woman decides to tell her 32 -year old sister that she may be at risk to carry a BRCA 1 mutation and develop cancer at an early age. The sister now wants a genetic test. How does GINA Apply? 27

GINA Exercise: Diagnosis and Predisposition (answer) • GINA does not prevent a health insurer from using the diagnosis of breast cancer in underwriting decisions. But the increased risk of other cancers based on her BRCA 1 mutation is genetic information protected by GINA. • The sister’s insurer may need family history information to approve BRCA testing for her, but the information cannot be used against her by her health insurance in continuing her coverage. • Individuals should feel more comfortable sharing information about a diagnosis or genetic risk within families and with providers. 28

GINA Exercise: Prenatal Issues A 33 -year-old white woman goes to her prenatal provider for her 13 -week pregnancy check-up. Her doctor offers her cystic fibrosis (CF) carrier screening, which she accepts. The screening reveals that she is a carrier of CF. The woman’s husband is tested and is also found to be a CF carrier. Because the couple has a 25% chance of having a child affected with cystic fibrosis, they are offered genetic counseling and amniocentesis for a prenatal diagnosis. In reviewing their options about genetic testing for CF in their child, either prenatally or as a newborn, the couple asks whether a prenatal diagnosis of CF would constitute a pre-existing condition for their child’s health insurance after birth. How Does GINA Apply? 29

GINA Exercise: Prenatal Issues (answer) • Under GINA, health insurance companies cannot consider genetic information a pre-existing condition. • The child’s increased risk for CF (based on the parents’ carrier screening results) is protected by GINA. • If the parents decide to undergo prenatal DNA testing by amniocentesis, the results are protected by GINA. • The results of the biochemical newborn screening test for CF are covered by GINA. • If the infant is diagnosed with CF, GINA does not prevent underwriting on the basis of that manifest disease. 30

Additional Resources Coalition for Genetic Fairness GINA Resource Genetics and Public Policy Center GINA FAQ Equal Employment Opportunity Commission (EEOC) GINA Fact Sheet National Human Genome Research Institute (NHGRI) Genetic Discrimination Fact Sheet Secretary’s Advisory Committee on Genetics, Health & Society GINA Activity 31